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Innovation Patent Law Uncategorized

Federal Circuit Improperly Extends Abstract Idea Exception to Industrial Machines

a gavel on a table in front of booksAn oil well drilling rig is not an abstract idea. A method of operating an oil well drilling rig is also not an abstract idea. This proposition should be clear to all, but in TDE Petroleum Data Solutions v AKM Enterprise, the Federal Circuit held that a method of operating an oil well drilling rig is directed to the abstract idea of “storing data, receiving data, and using mathematics or a computer to organize that data and generate additional information.”

Section 101 of the Patent Act has been interpreted to prohibit the patenting of abstract ideas, laws of nature, and natural phenomena. Although recent Supreme Court cases have universally found the patents at issue ineligible, Bilski, Alice and Mayo cite approvingly to a previous Supreme Court case, Diamond v. Diehr, which found a process for molding rubber articles with the aid of a computer to be patent eligible.

Alice and Mayo established a now-famous two-part test to determine whether a patent claims ineligible subject matter. The first step of the Alice/Mayo test asks whether the claim is “directed to” one of the prohibited categories. The second step asks whether the claim involves an “inventive concept” sufficient to confer patent eligibility. The Federal Circuit has applied this test with ruthless efficiency to invalidate patents, although sanity is slowly returning as the court has upheld patents improving computer animation of faces and the preservation of liver cells.

Unfortunately, the Federal Circuit rarely compares the facts of the cases before it to controlling Supreme Court precedent. The clear similarity between the claims to operating an oil well drilling rig in TDE and the claims to curing rubber in Diehr show how far off course the Federal Circuit has veered in interpreting section 101.

In Diehr, the claimed method used a computer to precisely control a rubber molding process. The computer allowed the inventors to measure and recalculate the time to cure the rubber while it was in the mold. At the end of the method, a rubber article was produced. In TDE, the claimed method used a computer to control the drilling of an oil well. The computer permitted the inventors to accurately determine the state of the well operation. Different claims provided for different ends of the method, including adjusting the operation of the drill (claim 30) and selecting the state of the well operation (claim 1).

A side-by-side analysis of representative claims from TDE and Diehr at the bottom of this post shows exactly how similar they are. Each claim recites (1) an industrial process that uses (2) initial data combined with (3) newly collected data that is (4) analyzed to (5) improve the output or operation of the industrial process.

It is worth repeating: in both Diehr and TDE, the claims were directed to an industrial process. The general industrial processes existed previously in the art. Molding rubber using the defined equation was well known. Drilling an oil well with consideration of the state of the well operation was known. The contributions in both Diehr and TDE were the addition of data collection and analysis to improve the operation of the industrial process. Neither portion of the Federal Circuit’s analysis in TDE cites to Diehr, let alone analyzes the obvious similarities between the claims at issue and those found patent eligible by the Supreme Court.

In a single paragraph of analysis regarding step one of the Mayo/Alice test, the Federal Circuit held that claim 1 of the TDE patent was directed to the abstract idea of “storing data, receiving data, and using mathematics or a computer to organize that data and generate additional information.” It completely ignored parts of the claim that required the data to be collected from an oil well drilling operation and to be used for the oil well drilling operation. Of course, ignoring these parts of the claim was required to find that the claim was directed to an abstract idea of data manipulation.

Also taking only a single paragraph, the Federal Circuit’s analysis of Mayo/Alice step two was similarly devoid of engagement with the explicit claim requirements of an oil well drilling operation. Instead, it focused only on what the computer was doing in the process, rather than the process as a whole. Diehr, along with many other cases, explicitly requires that the process be considered as a whole in the section 101 analysis.

The Federal Circuit’s error here is worse than it was in Ariosa v. Sequenom. In Ariosa, the court engaged with the closest factual Supreme Court precedent, although it felt bound by Mayo to find the claims ineligible. However, the court in TDE completely ignored and disregarded Diehr, the Supreme Court case that aligns in both law and fact with the claims at issue. Had the court analyzed or considered Diehr, it is likely the outcome would have been different.

To the extent that one asserts the final method of utilizing the data distinguished claim 1 in Diehr from claim 1 in TDE, dependent claim 30 of the patent at issue in TDE cured this defect. Claim 30 recites: “[t]he method of claim 1, further comprising using the state of the well operation to evaluate parameters and provide control for the well operation.” (emphasis added). Thus, the patent in TDE explicitly claimed the actual operation of the industrial machinery, just as the claim in Diehr.

The Federal Circuit stated that it was not considering separately the remaining claims of the patent, ostensibly because TDE did not “distinguish those claims from representative claim 1.” On the contrary, TDE argued claim 30 and related claims separately on precisely the ground that claim 30 “closed [the] loop” and required control of the well.

At this point, it is clear that neither the Federal Circuit nor the Supreme Court are going to step in to fix the wayward path of patent eligibility law. It will therefore be up to Congress to affirm what should be apparent to all: an oil rig is not an abstract idea.


Diehr – Claim 1* (US Application No. 05/602,463) TDE – Claim 1 (US Patent No. 6,892,812) Analysis
1 – Preamble A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising: An automated method for determining the state of a well operation, comprising: Both claims are directed to industrial processes where the underlying process (rubber molding or oil well drilling) existed prior to the invention
2 – Initial Data providing said computer with a database for said press, including at least,

natural logarithm conversion data (ln),

the activation energy constant (C) unique to each batch of said compound being molded, and

a constant (x) dependent upon the geometry of the particular mold of the press,

storing a plurality of states for a well operation; Both claims require data to be provided prior to operation of the method to interpret data collected.
3 – New Data Collection initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,

constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,

constantly providing the computer with the temperature (Z),

receiving mechanical and hydraulic data reported for the well operation from a plurality of systems; Both claims require collecting data from sources that are specific to the machinery being operated. Therefore, both claims require specific machinery, not just a general purpose computer.
4 – Data Analysis repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is

ln v = CZ + x

where v is the total required cure time,

repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and

and determining that at least some of the data is valid by comparing the at least some of the data to at least one limit, the at least one limit indicative of a threshold at which the at least some of the data do not accurately represent the mechanical or hydraulic condition purportedly represented by the at least some of the data; and when the at least some of the data are valid, based on the mechanical and hydraulic data, Both claims analyze the data.

Although not apparent on the face of the claims, the underlying data analysis existed in the art for both claims. The Arrhenius equation was well known. Validating well drilling data against a limit was known in the art although its usefulness was disputed.

5 – Utilizing the Data opening the press automatically when a said comparison indicates equivalence. automatically selecting one of the states as the state of the well operation. Both claims use the data generated in the industrial process. Selecting an individual state of a well operation in a necessary component of operating the well.

*Claim 1 is representative for both the application in Diehr and the patent in TDE.

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Innovation Internet Patent Law Patentability Requirements Software Patent Uncategorized

Federal Circuit Again Finds Computer-Implemented Invention Patent Eligible

dictionary entry for the word "innovate"In Tuesday’s McRO v. Bandai decision, the Federal Circuit has once again reversed a district court’s determination that a computer-implemented invention (aka “software patent”) was not patent eligible under Section 101 of the Patent Act. This continues the Federal Circuit’s recent trend of clarifying the Supreme Court’s two-step patent-eligibility test under Mayo and Alice. The first step asks whether the invention is “directed to” a patent-ineligible concept, such as an abstract idea. If so, the second step then asks whether there is an “inventive concept” that transforms the concept into a patent-eligible invention. While the Supreme Court gave little guidance on what “directed to” and “inventive concept” mean in practice, the Federal Circuit’s recent decisions have made the Mayo-Alice test far less abstract—rather ironic, given that the test itself assesses abstractness.

This past May, the Federal Circuit held in Enfish that, in the software context, the “directed to” inquiry looks at whether “the plain focus of the claims is on an improvement to computer functionality itself.” Since the database claims at issue focused on specific improvements to computer capabilities, they were not “directed to” a patent-ineligible concept under Section 101. Two months later in Bascom, the Federal Circuit stated that an “inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.” And even though each software claim, related to filtering content on the internet, was “known in the art” when taken individually, the Federal Circuit held that the claims, in combination, were patent eligible because they transformed “the abstract idea of filtering content into a particular, practical application of that abstract idea.”

Adding to this recent line of cases upholding the patent-eligibility of computer-implemented inventions, the Federal Circuit’s new opinion in McRO v. Bandai sheds even more light on the Section 101 analysis under the Mayo-Alice test. The invention at issue involved automated lip-syncing for computer-generated animation, which the district court held was drafted too broadly to be patent eligible. The Federal Circuit reversed, noting that courts “must look to the claims as an ordered combination,” even under the first step of the Mayo-Alice test. The Court of Appeals thus found that the proper analytical centerpiece was “whether the claims in these patents focus on a specific means or method that improves the relevant technology.” Since the invention constituted a “combined order of specific rules that renders information into a specific format that is then used and applied to create desired results,” the Federal Circuit held it patent eligible under Section 101.

Several commentators have praised the Federal Circuit’s decision. Bob Sachs, who specializes in patentable subject matter as a partner at Fenwick & West, points out that the Federal Circuit, for the first time, has used preemption to find that the invention was not “directed to” patent-ineligible subject matter. The Federal Circuit here looked at preemption as part of the first step of the Mayo-Alice test, finding it relevant to whether the invention was “directed to” a patent-ineligible concept in the first place. As Sachs explains, the Federal Circuit “confirms Enfish’s holding that the improvement provided by the specific claim limitations can be considered” under the first step of the Mayo-Alice test. Moreover, Sachs notes that the “panel here makes clear that a demonstration of meaningful non-preemption is sufficient to establish that a claim is not ‘directed to’ an abstract idea, and thus eligible at step 1.”

Other observers, including Erich Andersen, VP and Deputy General Counsel at Microsoft, and Gene Quinn of IPWatchdog, have applauded the Federal Circuit for making the patent-eligibility analysis even more concrete in light of the Supreme Court’s rather abstract abstractness test in Mayo and Alice. If anything, the Federal Circuit here has not only built upon its prior precedents in Enfish and Bascom, it has tied them together by explaining that ordered combinations are relevant to both the first and second steps of the Mayo-Alice test. In the end, the patent eligibility of a computer-implemented invention appears far more settled than ever before–a great result for inventors of so-called “software patents.” The Federal Circuit’s decision is certainly a far cry from the supposed death-knell for “software patents” predicted by several commentators after the Supreme Court’s opinion in Alice.

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Administrative Agency Commercialization Copyright Copyright Licensing Infringement Innovation Internet Legislation Supreme Court Uncategorized

Letter on FCC Set-Top Box Regulation Once Again Confuses the Issue

Washington, D.C. at nightLast week, a group of law professors wrote a letter to the acting Librarian of Congress in which they claim that the current FCC proposal to regulate cable video navigation systems does not deprive copyright owners of the exclusive rights guaranteed by the Copyright Act. The letter repeats arguments from response comments they  filed along with the Electronic Frontier Foundation (EFF), accusing the Copyright Office of misinterpreting the scope of copyright law and once again bringing up Sony v. Universal to insist that copyright owners are overstepping their bounds. Unfortunately, the IP professors’ recurring reliance on Sony is misplaced, as the 30-year-old case does not address the most significant and troubling copyright violations that will result from the FCC’s proposed rules.

In 1984, the Supreme Court in Sony held that recording television shows on a personal VCR was an act of “time-shifting” and therefor did not constitute copyright infringement. The court also ruled that contributory liability requires knowledge, and such knowledge will not be imputed to a defendant based solely on the characteristics or design of a distributed product if that product is “capable of substantial noninfringing uses.” But while this precedent remains good law today, it does not apply to the real concerns creators and copyright owners have with the FCC’s attempt to redistribute their works without authorization.

The FCC’s proposed rules would require pay-TV providers to send copyrighted, licensed TV programs to third parties, even if the transmission would violate the agreements that pay-TV providers carefully negotiated with copyright owners. A different group of IP scholars recently explained to the FCC that by forcing pay-TV providers to exceed the scope of their licenses, the proposed rules effectively create a zero-rate compulsory license and undermine the property rights of creators and copyright owners. The compulsory license would benefit third-party recipients of the TV programs who have no contractual relationship with either the copyright owners or pay-TV providers, depriving creators and copyright owners of the right to license their works on their own terms.

This unauthorized siphoning and redistribution of copyrighted works would occur well before the programming reaches the in-home navigational device, a fact that the authors of the recent letter to the Librarian of Congress either don’t understand, or choose to ignore. Creators and copyright owners are not attempting to “exert control over the market for video receivers,” as the letter suggests. The manufacture and distribution of innovative devices that allow consumers to access the programming to which they subscribe is something that copyright owners and creators embrace, and a thriving market for such devices already exists.

As more consumers resort to cord cutting, countless options have become available in terms of navigational devices and on-demand streaming services. Apple TV, Roku, Nexus Player and Amazon Fire Stick are just a few of the digital media players consumers can choose from, and more advanced devices are  always being released. But while the creative community supports the development of these devices, it is the circumvention of existing licenses and disregard for the rights of creators to control their works that has artists and copyright owners worried.

Sony has become a rallying cry for those arguing that copyright owners are attempting to control and stymie the development of new devices and technologies, but these critics neglect the substantial problems presented by the transmission of digital media that Sony couldn’t predict and does not address. In the era of the VCR, there was no Internet over which television was broadcast into the home. In 1984, once a VCR manufacturer sold a unit, they ceased to have any control over the use of the machine. Consumers could use VCRs to record television or play video cassettes as they pleased, and the manufacturer wouldn’t benefit from their activity either way.

The difference with the current navigation device manufacturers is that they will receive copyrighted TV programs to which they’ll have unbridled liberty to repackage and control before sending them to the in-home navigation device. The third-party device manufacturers will not only be able to tamper with the channel placement designed to protect viewer experience and brand value, they will also be able to insert their own advertising into the delivery of the content, reducing pay-tv ad revenue and the value of the license agreements that copyright owners negotiate with pay-TV providers. The FCC’s proposal isn’t really about navigational devices, it’s about the control of creative works and the building of services around TV programs that the FCC plans to distribute to third parties free of any obligation to the owners and creators of those programs.

The authors of the letter conflate two distinct issues, misleading influential decision makers that may not be as well versed in the intricacies of copyright law. By stubbornly comparing the copyright issues surrounding the FCC’s proposed rules to those considered by the Supreme Court in Sony, they craftily try to divert attention away from the real matter at hand: Not what consumers do with the creative works they access in the privacy of their own homes, but how those works are delivered to consumers’ homes in the first place.

It’s curious that after many rounds of back-and-forth comments discussing the FCC’s proposal, proponents of the rules still refuse to address this primary copyright concern that has been continuously raised by creators and copyright owners in corresponding comments, articles, and letters (see also here, here, here, and here). Perhaps the authors of the recent letter simply do not grasp the real implications of the FCC’s plan to seize and redistribute copyrighted content, but given their years of copyright law experience, that is unlikely. More probable is that they recognize the complications inherent in the proposal, but do not have a good answer to the questions raised by the proposal’s critics, so they choose instead to cloud the issue with a similar-sounding but separate issue. But if they truly want to make progress in the set-top box debate and clear the way for copyright compliant navigational devices, they’ll need to do more than fall back on the same, irrelevant arguments.

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Biotech High Tech Industry History of Intellectual Property Innovation Intellectual Property Theory Inventors Legislation Patent Law Patent Litigation Patent Theory Patentability Requirements Software Patent Supreme Court Uncategorized

Federal Circuit Brings Some Clarity and Sanity Back to Patent Eligibility Doctrine

By Adam Mossoff and Kevin Madigan

closeup of a circuit boardFollowing the Supreme Court’s four decisions on patent eligibility for inventions under § 101 of the Patent Act, there has been much disruption and uncertainty in the patent system. The patent bar and most stakeholders in the innovation industries have found the Supreme Court’s decisions in Alice Corp. v. CLS Bank (2014), AMP v. Myriad (2013), Mayo Labs v. Prometheus (2012), and Bilski v. Kappos (2010) to be vague and doctrinally indeterminate. Given the moral panic about the patent system that has been created as a result of ten years of excessive lobbying in D.C. for legislation that weakens patent rights, judges have responded to the excessive discretion they have under these cases by invalidating whole swaths of patented innovation in the high-tech, biotech, and pharmaceutical industries. The Patent Office is also rejecting patent applications at record levels, even for traditional inventions outside of high-tech and life sciences directly affected by the recent § 101 case law.

In Sequenom v. Ariosa, the Supreme Court had the opportunity to bring some clarity to the law of patent eligibility and to reign in some of the judicial and Patent Office excesses, but unfortunately it rejected this opportunity when it denied Sequenom’s cert petition this past June. Fortunately, the Court of Appeals for the Federal Circuit is now taking the lead in providing some much-needed legal guidance on patent eligibility to the inventors and companies working in the innovation industries. In two recent decisions, Enfish v. Microsoft and Rapid Litigation Management v. CellzDirect, the Federal Circuit has set forth some important doctrinal guideposts for defining what counts as a patent-eligible invention. Not only do these two decisions bring some reason and clarity back to the law of patent eligibility under § 101, they provide important doctrinal insights on how stakeholders may wish to address this problem if they ultimately choose to seek relief in Congress.

Enfish and the Patentability of Computer-Implemented Inventions (a/k/a “Software Patents”)

At the time it was decided, some commentators believed that the Alice decision was a directive from on high that most, if not all, computer software programs were not patentable inventions. This was a surprising claim if only because the Alice Court did not once use the phrase “software” in its entire opinion. Of course, “software patent” is not a legal term in patent law; the proper term is “computer-implemented invention,” as used by the Alice Court, and so the Court may have been only avoiding vague rhetoric from the patent policy debates. More important, though, this claim about Alice contradicts the Court’s opinion in Bilski just four years earlier, when the Court warned the Federal Circuit not to adopt a bright-line rule that limited § 101 to only physical inventions of the “Industrial Age,” because this created unnecessary and innovation-killing “uncertainty as to the patentability of software.”

Unfortunately, the ambiguities in Alice and in the Court’s prior patentable subject matter decisions, such as Mayo, left enough discretionary wiggle room in applying the generalized patent-eligibility test to permit judges and patents examiners to wage war on computer-implemented inventions. They thus made real again in the twenty-first century Justice Robert Jackson’s famous observation in 1949 that “the only patent that is valid is one which this Court has not been able to get its hands on.” Jungersen v. Ostby & Barton Co., 335 U.S. 560, 572 (1949) (Jackson, J., dissenting). As one commentator remarked several months after Alice was decided, “It’s open season on software patents.” The data over the next several years has borne out the truth of this statement.

The key argument against patents on computer-implemented inventions, such as key components of word processors, programs that run internet searches (like the patented innovation that started Google), and encryption software, is that such inventions are inherently “abstract.” The judicial interpretation of § 101 has long maintained that abstract ideas, laws of natural, and natural phenomena are unpatentable discoveries. In Alice, for instance, the Court held that a complex software program for extremely complex international financial transactions was an “abstract idea” and thus unpatentable under § 101. But beyond claims that something long known is “abstract,” the Court has failed to define with precision what it means for a discovery to be abstract. With little to no specific guidance from the Alice Court, it is no wonder that judges and examiners have succumbed to the recent moral panic about patents and declared “open season” on patents covering computer-implemented inventions.

In this context, the Federal Circuit’s decision in Enfish v. Microsoft is extremely important because it ends the unreasoned, conclusory “I know it when I see it” rejections of patents as “abstract” by judges and examiners.

In Enfish, the Federal Circuit reversed a trial court’s summary judgment that a patent on a computer-implemented invention was an unpatentable abstract idea. The patent covered a type of database management system on computers, a classic incremental innovation in today’s digital world. In its decision, the trial court dissected the invention down into the most basic ideas in which all inventions can be reframed as representing; for example, methods of using internal combustion engines can easily be reframed in terms of the basic laws in thermodynamics. In this case, the trial court asserted that this patent on a computer-implemented invention covered merely the “abstract purpose of storing, organizing, and retrieving” information. The trial court thus easily concluded that the invention was merely “abstract” and thus unpatentable.

The Federal Circuit rejected the trial court’s conclusory assertion about the invention being “abstract” and further held that such assertions by courts are a legally improper application of § 101. With respect to the patent at issue in this case, Judge Todd Hughes’ opinion for the unanimous panel found that

the plain focus of the claims is on an improvement to computer functionality itself, not on economic or other tasks for which a computer is used in its ordinary capacity. Accordingly, we find that the claims at issue in this appeal are not directed to an abstract idea within the meaning of Alice.

More important, the Enfish court cautioned courts against the methodological approach adopted by the trial court in this case, in which “describing the claims at such a high level of abstraction and untethered from the language of the claims all but ensures that the exceptions to § 101 swallow the rule.” The court recognized that adopting a “bright-line” rule that computer-implemented inventions—the “software patents” decried by critics today—are necessarily “abstract” runs counter to both § 101 and the recent Supreme Court cases interpreting and applying this provision: “We do not see in Bilski or Alice, or our cases, an exclusion to patenting this large field of technological progress.”

Further confirming that Enfish represents an important step forward in how courts properly secure technological innovation in the high-tech industry, the Federal Circuit relied on Enfish in its recent decision in BASCOM Global Services Internet Inc v AT&T Mobility LLC. Here, the Federal Circuit again rejected the trial court’s dissection of a patent claim covering a software program used on the internet into an “abstract” idea of merely “filtering content.” The BASCOM court emphasized that courts must assess a claim as a whole—following the Alice Court’s injunction that courts must assess a patent claim as “an ordered combination of elements”—in determining whether it is a patentable invention under § 101. As numerous patent scholars explained in an amicus brief filed in support of Sequenom in its failed cert petition before the Supreme Court, requiring a court to construe a “claim as a whole” or “the invention as a whole” is a basic doctrinal requirement that runs throughout patent law, as it is essential to ensuring that patents are properly evaluated both as to their validity and in their assertion against infringers.

CellzDirect and the Patentability of Discoveries in the Bio-Pharmaceutical Industry

The high-tech industry is not the only sector of the innovation industries that has been hit particularly hard by the recent §101 jurisprudence. The biotech and pharmaceutical industries have also seen a collapse in the proper legal protection for their innovative discoveries of new therapeutic treatments. One recent study found that the examination unit at the Patent Office responsible for reviewing personalized medicine inventions (art unit 1634) has rejected 86.4% of all patent applications since the Supreme Court’s decision in Mayo. Anecdotal evidence abounds of numerous rejections of patent applications on innovative medical treatments arising from extensive R&D, and the most prominent one was the invalidation of Sequenom’s patent on its groundbreaking innovation in prenatal diagnostic tests.

In this light, the decision on July 5, 2016 in Rapid Litigation Management v. CellzDirect is an extremely important legal development for an industry that relies on stable and effective patent rights to justify investing billions in R&D to produce the miracles that comprise basic medical care today. In CellzDirect, the trial court found unpatentable under § 101 a patent claiming new methods for freezing liver cells for use in “testing, diagnostic, and treating purposes.” The trial court asserted that such a patent was “directed to an ineligible law of nature,” because scientists have long known that these types of liver cells (hepatocytes) could be subjected to multiple freeze-thaw cycles.

In her opinion for a unanimous panel, Chief Judge Sharon Prost held that the method in this case is exactly the type of innovative process that should be secured in a patent. Reflecting the same methodological concern in Enfish and BASCOM, the CellzDirect court rejected the trial court’s dissection of the patent into its foundational “laws of nature” and conventional ideas long-known in the scientific field:

The claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims of the ’929 patent are directed to a new and useful laboratory technique for preserving hepatocytes. This type of constructive process, carried out by an artisan to achieve “a new and useful end,” is precisely the type of claim that is eligible for patenting.

In other words, merely because a patentable process operates on a subject matter that constitutes natural phenomena does not mean the patent improperly claims either those natural phenomena or the laws of nature that govern them. To hold otherwise fails to heed the Mayo Court’s warning that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and thus to dissect all patents down into these unpatentable foundations would “eviscerate patent law.” The CellzDirect court was explicit about this key methodological point in evaluating patents under § 101: “Just as in [the industrial process held valid by the Supreme Court in] Diehr, it is the particular ‘combination of steps’ that is patentable here”—the invention as a whole.

Conclusion

The U.S. has long prided itself as having a “gold standard” patent system—securing to innovators stable and effective property rights in their inventions and discoveries. As scholars and economic historians have long recognized, the patent system has been a key driver of America’s innovation economy for more than two hundred years. This is now threatened under the Supreme Court’s § 101 decisions and the “too broad” application of the Court’s highly generalized patent-eligibility tests to inventions in the high-tech and bio-pharmaceutical sectors. The shockingly high numbers of rejected applications at the Patent Office and of invalidation of patents by courts, as well as the general sense of legal uncertainty, are threatening the “gold standard” designation for the U.S. patent system. This threatens the startups, new jobs, and economic growth that the patent system has been proven to support. Hopefully, the recent Enfish and CellzDirect decisions are the first steps in bringing back to patent-eligibility doctrine both reason and clarity, two key requirements in the law that have been sorely lacking for inventors and companies working in the innovation economy.

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Administrative Agency Innovation Inventors Patent Law Patent Litigation Uncategorized

Overview of Comments on the USPTO's July 2015 Update to the Interim Examination Guidance

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

In late July, the USPTO issued its July 2015 Update to the 2014 Interim Section 101 Patent Eligibility Guidance (IEG). The July 2015 Update addresses a number of the issues and concerns raised in the public comments to the IEG and is supposed to assist examiners in applying the 2014 IEG during the patent examination process. The July 2015 Update also includes a new set of examples of claims involving abstract ideas and sample analysis under the Mayo framework. The USPTO is seeking public comments on the July 2015 Update, and comments are due on October 28, 2015, via email at 2014_interim_guidance@uspto.gov.

Here is an overview of what I think are the key issues and concerns with the July 2015 Update. Feel free to use any of my analysis in your comments to the USPTO.

1. Requirements of Prima Facie Case and the Role of Evidence

A significant number of the public comments on the 2014 IEG noted that examiners have the burden to make the prima facie case that a patent claim is ineligible, and that the Administrative Procedures Act (APA) and Federal Circuit case law requires that this determination be made based on “substantial evidence,” and not examiner opinion. In particular, all of the public comments that addressed this issue stated that examiners should have to provide documentary evidence to support a conclusion that a claim is directed to a judicial exception or that claim limitations are well understood, routine, and conventional.

In the July 2015 Update, the USPTO responded by stating that whether a claim is ineligible is a question of law and courts do not rely on evidence to establish that a claim is directed to a judicial exception, and therefore examiners likewise do not need to rely on any evidence that a particular concept is abstract, or a fundamental economic concept, or even a law of nature. The USPTO’s reliance on the judicial model is legally incorrect. First, examiners are bound by the APA and judges are not. Second, that eligibility is a question of law does not mean that there are not factual issues, as well—it merely determines whether the court or a jury is to make the finding. Obviousness is likewise a question of law, but there are clearly factual issues involved. Third, when judges take judicial notice, they are making a finding of fact, and they must do so under the requirements of Federal Rules of Evidence, Rule 201, which states that “The court may judicially notice a fact that is not subject to reasonable dispute because it: … can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” This requirement is similar to the requirements of Official Notice set forth in MPEP 2144.03: “Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known.” Thus, by its own logic, examiners should comply with the requirements of MPEP 2144.03.

As to the role of evidence, again the public comments that discussed this issue all took the position that examiners must cite authoritative documentary evidence, such as textbooks or similar publications to support a conclusion that a claim recites a judicial exception or that certain practices are well known, conventional or routine. The public comments on this issue all made the same argument: that the Supreme Court in Bilski and Alice cited references in support of their conclusions that the claims were ineligible.

In response to this uniform opinion, the USPTO maintained its position that citations of references was not necessary because the references in Bilski and Alice were technically not “evidence” since the Court is an appellate court, and further that the references were not necessarily prior art. This argument misses the point. Regardless of whether the references were evidence under the Federal Rules of Evidence, the Court felt it necessary and proper to cite them. Further, the Court did not cite references as prior art or suggest that they need to be prior art—rather, the Court cited the references as an authoritative basis to show that the claims were directed to longstanding, well-known concepts. That the Court did this not once, but twice, is strong guidance that the USPTO should follow suit.

Similarly, examiners should be instructed to accept and give substantial weight to documentary evidence submitted by applicants rebutting the examiner’s conclusions under either Step 2A or 2B of the Mayo framework. This includes declarations from the inventor or others showing that particular limitations are not considered judicial exceptions by a person of ordinary skill in the relevant technical or scientific community, or that claims limitations would be considered “significantly more” by such person, or that the claim limitations provide improvements to the art.

2. The Role of Preemption in the Mayo Framework

The majority of public comments stated that preemption is the core concern underlying the judicial exceptions to Section 101, and that the examiner should be required to establish that a claim preempts a judicial exception in order to find the claim ineligible. The USPTO again took an opposing view to this consensus interpretation, asserting that questions of preemption are inherently addressed in the two-part Mayo test. The USPTO also stated that “while a preemptive claim may be ineligible, the absence of complete preemption does not guarantee that a claim is eligible.” This has effectively eliminated arguments made by applicants that their claims were patent eligible because they did not preempt other practical applications of the judicial exception. Neither the Supreme Court nor the Federal Circuit has endorsed the concept that preemption does not matter given the Mayo framework. Instead, the courts continue to evaluate patent claims with respect to preemption even after the Mayo framework has been applied.

More significantly, the USPTO’s argument fails to address the more likely situation: that a claim blocks (preempts) only a narrow range of applications or implementations of the identified judicial exception. This is not merely a case of an absence of complete preemption; it is the absence of any significant degree of preemption at all. The Supreme Court recognized that preemption is a matter of degree and held that a claim is ineligible where there is a disproportionate risk that the judicial exception is fully preempted. In Alice, the Court stated:

The former [claims on fundamental building blocks] “would risk disproportionately tying up the use of the underlying” ideas, and are therefore ineligible for patent protection. The latter [claims with limitations that provide practical applications] pose no comparable risk of pre-emption, and therefore remain eligible for the monopoly granted under our patent laws.” 134 S.Ct. at 2354 (emphasis added).

Since by definition a claim must preempt something, it is only where the scope of the claim covers the full scope of the judicial exception that the claim is rendered ineligible. Judge Lourie, whose explanation of the Mayo framework in CLS v. Alice was directly adopted by the Supreme Court, put it this way:

Rather, the animating concern is that claims should not be coextensive with a natural law, natural phenomenon, or abstract idea; a patent-eligible claim must include one or more substantive limitations that, in the words of the Supreme Court, add “significantly more” to the basic principle, with the result that the claim covers significantly less. See Mayo 132 S. Ct. at 1294. Thus, broad claims do not necessarily raise § 101 preemption concerns, and seemingly narrower claims are not necessarily exempt. What matters is whether a claim threatens to subsume the full scope of a fundamental concept, and when those concerns arise, we must look for meaningful limitations that prevent the claim as a whole from covering the concept’s every practical application.

Thus, both the Supreme Court and the Federal Circuit use preemption as the mechanism to evaluate whether a claim is eligible or not by applying it on both sides of the question: ineligible if preemptive, eligible if not preemptive. In addition, over 100 district court decisions since Alice have expressly considered whether the claims preempt, even after applying the Mayo framework. If the Mayo framework inherently addressed the preemption issue as the USPTO asserts, there would be no reason for the courts to address it. Finally, by removing preemption from the Mayo framework, the USPTO has turned the framework into the sole test for patent eligibility—directly contrary to the Supreme Court’s holding in Bilski that there is no one sole test for eligibility.

Lourie’s statement that a claim is patent eligible when it includes “substantive limitations…with the result that the claim covers significantly less” than the judicial exception provides a simple and expedient basis for using preemption as part of the streamlined analysis–something the USPTO has resisted in the July 2015 Update. Examiners are well trained to evaluate the scope of a claim based on its express limitations. Accordingly, they can typically determine for the majority of claims that, whatever the claim covers, it has limitations that prevent it from covering the full scope of some judicial exception. If the point of the streamlined analysis is to avoid the unnecessary burden of the Mayo framework, then a preemption analysis provides the best way to achieve that goal.

Finally, to suggest that the Mayo framework is precise enough to be a definitive test is to ignore the obvious: both steps of the framework are undefined. See McRO, Inc. v. Sega of America,, Inc., No. 2:12-cv-10327, 2014 WL 4749601,at *5 (C.D. Cal. Sept. 22, 2014) (Wu, J.) (“[T]he two-step test may be more like a one step test evocative of Justice Stewart’s most famous phrase [‘I know it when I see it’].”). The Court refused to define the scope of abstract ideas in Alice (Step 2A), and Step 2B entails evaluating the subjective requirement of “significantly more” or “enough.” What is left, then, is analysis by analogy and example—and both common sense and life experience tell us that these approaches very often lead to mistakes. Analogies can be good or bad, and most examples can be argued either way. Preemption serves as a way of evaluating whether the outcome from such analysis is consistent with the underlying rationale for the judicial exceptions in the first place.

3. Abstract Ideas Must be Prevalent and Longstanding in the Relevant Community

The majority of public comments on the IEG argued that to establish that an idea is abstract, an examiner must show that the idea is “fundamental” in the sense of being “long-standing” and “prevalent,” following the statements of the Supreme Court. Various commentators suggested specific rules for examiners, such as evidence that the idea has been known and used in practice for a period of 25 or more years. Even those who supported a restrictive view of patent eligibility suggested that examiner should look to “basic textbooks” to identify abstract ideas.

The USPTO responded in the July 2015 Update by asserting that abstract ideas need not be prevalent and longstanding to be fundamental, arguing that even novel abstract ideas are ineligible: “examiners should keep in mind that judicial exceptions need not be old or long‐prevalent, and that even newly discovered judicial exceptions are still exceptions.” The USPTO stated that ”The term ’fundamental‘ is used in the sense of being foundational or basic.” This analysis begs the question. An idea is foundational or basic because it is widely accepted and adopted in the relevant community—it is fundamental to the practices of the community. Indeed, any textbook on the “foundations” of a particular scientific field would explain the principles and concepts that are long-standing and widely-accepted by scientists in that field. It would not be a significant burden on the examiner to cite to such publications to support a finding under Step 2A. Indeed, the inability of an examiner to do so would be strong evidence that a claim is not directed to a foundational or basic practice.

4. USPTO Reliance on Non-Precedential Federal Circuit Decisions

Public comments noted that the 2014 IEG included citations and discussions of non-precedential Federal Circuit cases, such as Planet Bingo, LLC v VKGS LLC, and SmartGene, Inc. v Advanced Biological Labs, and indicated that because the cases are non-precedential, they should not be cited and relied upon by the USPTO as the basis of its guidance to examiners. Further, it was pointed out that the 2014 IEG mischaracterizes the abstract ideas at issue in these cases.

For example, the USPTO characterizes SmartGene as holding that “comparing new and stored information and using rules to identify options” is an abstract idea. The Federal Circuit’s actual holding was much more specific: that “the claim at issue here involves a mental process excluded from section 101: the mental steps of comparing new and stored information and using rules to identify medical options.” The court itself unambiguously limited the scope of its decision: “[o]ur ruling is limited to the circumstances presented here, in which every step is a familiar part of the conscious process that doctors can and do perform in their heads.” Thus, the USPTO’s characterization removed key aspects of the court’s expressly-limited holding: that the comparing steps were inherently mental steps (not computer steps) performed by a doctor considering medical rules (not any type of rules) to evaluate medical options (not other types of options). The court’s ruling cannot be generalized to all types of comparisons on all types of information using all types of rules. The improper generalization of the court’s holding has resulting in examiners applying SmartGene to find many claims for computer-implemented inventions ineligible. This is because many, if not most, computer processes can be characterized as comparing stored and new information and applying a decision rule to produce a useful result. For example, most automobiles use computers and embedded software to monitor vehicle sensors and take actions. A typical fuel management computer compares a current measure of fuel (new value) with a predefined minimum amount of fuel (stored information) and determines whether to turn on a low fuel light (using rules to identify option). Under the USPTO’s characterization of SmartGene, a claim to such a process would be deemed an abstract idea, an obviously incorrect outcome.

The USPTO did not address any of the problems identified by the public comments regarding non-precedential cases. Instead, the July 2015 Update simply states that the “2014 IEG instructs examiners to refer to the body of case law precedent in order to identify abstract ideas by way of comparison to concepts already found to be abstract,” and makes multiple other references to precedent. Even so, the July 2015 Update relies repeatedly on non-precedential Federal Circuit decisions, such as Dietgoal Innovations LLC v. Bravo Media LLC, Fuzzysharp Technologies Inc. v. Intel Corporation, Federal Home Loan Mortgage Corp. aka Freddie Mac v. Graff/Ross Holdings LLP, Gametek LLC v. Zynga, Inc., Perkinelmer, Inc. v. Intema Limited, and Cyberfone Systems, LLC v. CNN Interactive Group, Inc.

The USPTO should eliminate any discussion of or reliance upon non-precedential decisions. In the alternative, the USPTO should at minimum explain to examiners that such decisions are limited to their specific facts and are not to be generalized into controlling examples or rules.

5. There is No Separate Category for Methods of Organizing Human Activity

Public comments to the 2014 IEG pointed out various issues with the category of “methods of organizing human activities” as a basis of abstract ideas, and in particular requested clarification as to which types of method would fall within the category. Here too there was a broad agreement among the commentators that the proper interpretation of Bilski and Alice: The Court found that the claims in Alice and Bilski were abstract ideas because they were directed to a fundamental economic practice, not because the claims were methods of organizing human activity. The Court noted that Bilski’s claims were methods of organizing human activity only to rebut Alice’s arguments that abstract idea must always be “fundamental truths.” The Court’s analysis does not logically imply that methods of organizing human activity are inherently abstract ideas.

The USPTO responded by broadly interpreting the scope of the category, stating that many different kinds methods of organizing human activity can also be abstract ideas, but providing no explanation (other than examples) to determine when this is the case and when is it not. The USPTO then mapped various Federal Circuit case into this category, even where the court itself did not expressly rely upon such categorization. For example, the USPTO listed buySAFE, DealerTrack, Bancorp, PlanetBingo, Gametex, and Accenture as examples of cases dealing with methods of organizing human activity. However, none of these cases actually held that the methods in suit were methods of organizing human activity. Instead, every single one of these cases held that the claims were abstract as either mental steps or fundamental economic practices. Attempting to map Federal Circuit cases into this category is both confusing to examiners and the public and unnecessary.

The USPTO should remove this category from the Guidance until such time as the Federal Circuit or the Supreme Court provides a clear definition of its bounds.

6. There is No Separate Category for “An Idea of Itself”

Public comments noted that this is catch-all category that the courts have mentioned in passing but have never provided any definition of its contours, and further suggested that the USPTO clarify that this is not a distinct category of abstract ideas.

In response, once again the USPTO broadly described the category and linked various Federal Circuit cases to it as examples, where the court itself never so characterized the invention. The USPTO lists in this category cases the court held to be ineligible in other categories, such as mental steps (Cybersource, Smartgene*, Classen*, Perkinelmer*, Ambry, Myriad CAFC*, Content Extraction); mathematical algorithms (In re Grams, Digitech); and economic activities (Ultramercial) (*indicates non-precedential decision). In fact, there is no precedential Federal Circuit or Supreme Court case that has defined “an idea of itself” as a distinct category. It is only mentioned in dicta, never in a holding.

The result of the USPTO’s categorization of cases into multiple, different undefined categories is to make it more difficult, not less, for examiners to properly determine which types of claims are within which category. Further, where an examiner asserts that a claim falls into multiple categories (which is a simple assertion to make, since most inventions deal with multiple different concepts), the applicant is forced to rebut each categorization.

7. “Mathematical Algorithms” Are Limited to Solutions to Problem in Pure Mathematics

This category, more than any other, reflects the USPTO’s failure to substantively and meaningfully analyze the issues and provide clear guidance. Public comments to the 2014 IEG provided extensive analysis of the case law and the problems arising from mathematical algorithms being considered abstract ideas. The USPTO did not respond to the substantive analysis at all. Instead, the July 2015 Update merely lists cases that have held claims invalid as mathematical algorithms, without explanation. This is inadequate for several reasons.

First, the USPTO must clarify that the presence of a mathematical algorithm in the specification or claims is not a per se indication that the claims are directed to an abstract idea. In Alice, the Court expressly stated that “[o]ne of the claims in Bilski reduced hedging to a mathematical formula, but the Court did not assign any special significance to that fact, much less the sort of talismanic significance petitioner claims.” Equally so, examiners must not assign any special significance to the presence of a mathematical formula either in the disclosure or in the claim. What matters is the underlying concept, not how it is expressed (e.g. “no special significance”), whether in words or mathematical symbols.

Second, the presence of a mathematical formula or equation does not make an invention abstract for a very simple reason: mathematics is a language that allows for the very precise and formal description of certain types of ideas. All modern engineering, including, civil, mechanical, electrical, chemical, computer, etc., as well as all of the physical sciences, relies on mathematical analysis for design and formulation. Using a mathematical equation is simply one—albeit highly precise—way of expressing concepts, which may be either patent-eligible or not. Thus, the presence of a mathematical equation does not by itself imply or suggest anything about the underlying concept, and should not be relied upon by examiners as an automatic evidence of an ineligible abstract idea. While mathematics may be used to describe abstract ideas like the laws of mathematics, it can equally be used to describe entirely mundane and non-abstract ideas like fuel-efficient aircraft approach procedures (U.S. Patent No. 8,442,707), compressing video for transmission on cell phones (U.S. Patent No 8,494,051), efficiently allocating farming resources (U.S. Patent No. 6,990,459), or calculating golf handicaps and the difficulty of golf courses (U.S. Patent No. 8,282,455).

The correct interpretation of “mathematical algorithms” as used by the Supreme Court are algorithms that are solutions to inherently mathematical problems. This was the specific definition used by the Supreme Court in Benson, and confirmed in Diehr. In Benson, the Court stated:

A procedure for solving a given type of mathematical problem is known as an “algorithm.” The procedures set forth in the present claims are of that kind; that is to say, they are a generalized formulation for programs to solve mathematical problems of converting one form of numerical representation to another.

Later, in Diehr, the Court stated that in Benson “we defined ‘algorithm’ as a ‘procedure for solving a given type of mathematical problem,” noting that “our previous decisions regarding the patentability of ’algorithms‘ are necessarily limited to the more narrow definition employed by the Court.” The Court expressly rejected a broader definition that covered any “sequence of formulas and/or algebraic/logical steps to calculate or determine a given task; processing rules.”

The USPTO should clarify that this more limited definition of mathematical algorithms is to be used. This approach beneficially distinguishes between inventions in pure mathematics—which as the Court stated are precisely those that have the disproportionate risk of preemption because they can be used in an unlimited number of different fields—from inventions in applied mathematics, the mathematics used in the engineering and physical sciences. Examiners are well-accustomed by their formal scientific and technical training to distinguish between claims to these two types of inventions making use of mathematical formulas and equations.

8. Identifying Whether a Claim Limitation Recites a Conventional, Routine, and Well-Understood Function of a Computer

The public comments to the 2014 IEG discussed the problems resulting from considering the normal operations of a computer to be merely “generic” functions that are conventional, well-understood, and routine, and therefore by definition insufficient to support eligibility of a patent claim.

In response, the USPTO again ignored the substantive arguments, instead simply stating that examiners may rely on what the courts have recognized as “well understood, routine, and conventional functions” of computers, including “performing repetitive calculations,” “receiving, processing, and storing data,” “receiving or transmitting data over a network”. The July 2015 Update goes on to state that “This listing is not meant to imply that all computer functions are well‐understood, routine and conventional.”

This caveat is hardly sufficient, since the list essentially wipes out all computing operations as they are typically claimed. Just as claims for mechanical processes use verbs and gerunds that describe well-known mechanical operations, so too do claims for computer-based inventions necessarily describe the operations of a computer: receive, transmit, store, retrieve, determine, compare, process, and so forth. There is no other way to claim the operations of a computer except to use such terminology.

Accordingly, since the Supreme Court did not hold that all software and computer-implemented inventions are per se ineligible, the proper interpretation of the Court’s discussion of the generic functions of a computer is more narrowly-focused. Specifically, it is necessary to consider the entirety of each claim limitation, not merely the gerund or verb that introduces a method step. The claim limitation as a whole must recite nothing more than generic functions. When considering computer processing steps on computer data, limitations as to the source of data, the types of data, the operations performed on the data, how the outputs is generated, where the data is stored or transmitted, must all be considered. This is because it is these limitations that distinguish between the merely generic operations (“receiving a data input and determining an output”) and the particular applications.

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#AliceStorm In June: A Deeper Dive into Court Trends, and New Data On Alice inside the USPTO

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

The most important thing that happened in June was not the invalidation of yet another pile of patents, but the rather more consequential decision of the Supreme Court to recognize the right of same-sex couples to marry. Unlike patent law issues, when it comes to constitutional law, the Court can recognize the complexity and depth of the issue and, not surprisingly, the Court is deeply divided. That the Court is unanimous on equally complex and divisive issues in patent law—such as eligibility—speaks to me that they do not have the same deep understanding of the domain.

Now, let’s do the #AliceStorm numbers. First, the federal courts:

Table1

Since my May 28 update, there have been 19 § 101 decisions including two Federal Circuit decisions, Internet Patents Corp. v. Active Network, Inc. and Ariosa Diagnostics, Inc. v. Sequenom, Inc., both holding the challenged patents ineligible. Overall, the Federal Court index is up 3.1% in decisions and an (un?)healthy 6.2% in patents. The Motions on Pleading index is holding steady; the last five decisions on § 101 motions to dismiss have found the patents in suit invalid.

We can look more specifically at the invalidity rate by type of motion and tribunal:

Table2

For example, the 73.1% invalidity rate in the federal courts breaks down into 70.2% (66 of 96) in the district courts and a stunning 92.9% in the Federal Circuit (13 for 14). Motions on the pleadings and motions to dismiss are running equally, at a 69% defense win rate.

The 73.7% summary judgment success rate is consistent with the high rate on motions to dismiss. Since the courts have taken the position that there are no relevant facts to patent eligibility and there is no actual presumption of validity in practice, there is now little difference between the underlying showings required for the two types of motions. That’s odd since on the motions to dismiss the court is to look only at the pleadings, while on summary judgment they have the full file history, expert testimony, the inventor’s testimony and other evidence before them. Why such evidence is not helping—and indeed appears to be hurting—patentees is because the court is evaluating it from their lay perspective. In my opinion, the correct perspective is that of a person of ordinary skill in the art (POSITA). What a court may consider merely abstract may be easily recognized as a real-world technology by an engineer; a claim term that appears trivial to a court (“lookup table”, “isolated”) or may be significant to the expert.

We can also evaluate how individual the various district courts are doing.

Table3

(The (-1) values in the bottom five rows indicate that the court held that patent was not invalid).

Of the 66 district court decisions since Alice that have invalidated patents on § 101, Delaware, the Central and Northern Districts of California account for 58% of the decisions. The most prolific judges are shown here:

Table4

Yet, when it comes to finding abstract ideas, the USPTO remains the champ. The best avenue to attack a patent under § 101 is through the Covered Business Method (CBM) review program. A challenger files an institution petition before the Patent Trial and Appeal Board (PTAB) arguing that the challenged patent is directed to a financial product or service, and setting forth their ineligibility arguments. PTAB then issues an institution decision as to whether to grant the petition or not. The standard at this stage is whether it is more likely than not that the claims are ineligible. Once instituted, there is a full proceeding leading up to a final decision as to whether or not the patent is invalid.

At PTAB, CBM institution decisions are up (19 since May 28), and PTAB leads the race with the courts with an 88.6% invalidity rate on CBM institutions, and an unbeatable 100% rate (unchanged) on CBM final decisions.

Table5

If only the SF Giants could play their game this well.

Alice and the Patent Prosecutor

In my previous post, I drilled down in the impact of Alice on prosecution in terms of office action rejections and abandonments. My dataset was some 300,000 applications for the pre- and post-Alice period prepared for me by the team at Patent Advisor. Since then, I’ve received an additional 190,000 samples, comprising all office actions issued by the USPTO in September and October 2014. Together, the data set has over 490,000 office actions and notices of allowances:

Table6

The additional data from September and October fill in the trends in § 101 rejections that I showed before. As I explained, Tech Center 3600 includes more than just business methods, including literally down-to-earth technologies like earth moving and well boring. The § 101 rejections are concentrated in three E-commerce work groups:

Table7

There is some good news for software. The computer-related art units, TC 2100 and TC 2400, show considerably lower and steady § 101 rejection rates pre- and post-Alice.

Table8

After Alice, I think most software prosecutors expected to get non-final § 101 rejections, and consistent with past practice, expected to overcome them by amendment and argument. That would lead to final rejection based on prior art or an allowance. And that’s generally been true—except in a number of areas. In this following table, I compare the percentage of final office actions with § 101 rejections before and after Alice, in various Tech Centers and within TC 3600.

Table9

It’s important to remember the obvious: that you don’t get to a final rejection on § 101 without a first having a non-final rejection. Thus, this comparison shows how successful prosecutors were in overcoming non-final § 101 rejections before and after Alice—or equally how aggressive examiners were in maintaining these rejections. For example, before Alice 8.1% of final rejections in TC 1600 included a § 101 rejection, doubling to 16.7% after Alice—thus indicating that examiners were much more likely to maintain the rejection after Alice, but still a relatively low rate overall. By comparison in TC 2600, the rate of final rejections on § 101 declined after Alice, from 10% to 7.7%. This could be because it’s easier to explain why an invention in more traditional fields is an improvement in technology, one of the Alice safe harbors.

But when it comes to business methods, we see the killer statistics: prior to Alice, prosecutors overcame the non-final § 101 rejections generally about 62% of the time, leading to final rejection rates in the 23-46% range; thus prosecutors had more or less even odds of getting over the rejection. What is shocking is that after Alice, the final rejection rate soared into the 90% range. If you felt frustrated that your crafted (or crafty) arguments failed to impress the Examiner, get in line.

Now I’ve reviewed several hundred post-Alice rejections, and I’ve talked to a large number of prosecutors. What I’ve found is that majority of the non-final § 101 rejections were relatively formalistic, with little actual substantive analysis. Likewise, in a review of 87 office actions issued in November 2014 with § 101 rejections, Scott Alter and Richard Marsh found that 63 percent of those actions were “boilerplate” rejections. In my view, most prosecutors put forward at least a decent argument to show that the claims are not abstract, have at least one significant limitation, and do not preempt the abstract idea. Response arguments to § 101 rejections tend to run longer than response to prior art rejections, and I’ve seen many that resemble appeal briefs if not legal treatises, all to overcome a one paragraph rejection. They all presented at least enough of an argument to overcome the prima facie case for the rejection. And yet the final rejections keep coming—and often with little or no substantive rebuttal of the prosecutor’s arguments.

Outside of business methods, I found only two technology areas that had post-Alice rejection rates in excess of 30%: Amusement and Education devices in Tech Center 3700 (bottom row above) and molecular biology/bioinformatics/genetics in TC 1600 (not shown). This is a peculiar side effect of Alice. Historically, games and educational devices are classic fields of invention. There are thousands of patents on games, such as card games, board games, physical games, and the like. What is now hurting these applications are two aberrations in the law of patent eligibility: mental steps and methods of organizing human activity. The majority of § 101 rejections for games argue that the rules that define a game are simply ways of organizing human activity and can be performed by mental steps. Examiners typically cite the Federal Circuit’s Planet Bingo v. VKGS decision for the proposition that a game is an abstract idea and can be performed mentally. Only a small problem here: Planet Bingo is non-precedential and thus limited to its facts. In particular, the court did not hold that the game of bingo was an abstract idea. Instead, the alleged abstract idea was of “solving a tampering problem and also minimizing other security risks during bingo ticket purchases.” Thus, the case cannot be extended by examiners to argue that all games are abstract ideas.

As to methods of organizing human activity, it cannot be the case that all such methods are ineligible, since a vast array of such methods are in fact patented in fields such as farming, metalworking, sewing, manufacturing, tooling, conveying, and the like. This is just another example how simplistic rules of patent eligibility, taken out of context from one court opinion and repurposed generally, are at complete odds with the reality of invention.

Here is another view of the final rejection data on § 101, this time organized by the technology groups most negatively impacted by Alice (left side) and most positively impacted (right side).

Table10

The data here is organized by the percentage change in § 101 final rejection rates post-Alice. The group on the left is all of the technology areas that have had more than a 10% increase in final § 101 since Alice. Every other technology work group in the USPTO had less than 10% change in final rejection rates. On the right, we find the groups that seemed to benefit from Alice, in that the final rejection rates on § 101 declined. Most of these groups are in the computer area—and I’m sure that many of their applications have claims for purely software operations that could just as easily be argued to be mere data gathering, mental steps, or fundamental practices. And yet the examiners in these groups do not on average impose such blanket formulations on the claims, but appear overall to treat these inventions for what they are: real technology solving real world problems with real commercial applications.

To me, the data points to a clear conclusion. Contrary to what the USPTO’s Interim Guidance states as policy–that there is no per se exception for business methods–the behavior of examiners suggests that precisely such an exception is being applied in fact.

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The One Year Anniversary: The Aftermath of #AliceStorm

The following post, by Robert R. Sachs, first appeared on the Bilski Blog, and it is reposted here with permission.

It’s been one year since the Supreme Court’s decision in Alice Corp. v. CLS Bank. On its face the opinion was relatively conservative, cautioning courts to “tread carefully” before invalidating patents, and emphasizing that the primary concern was to avoid preemption of “fundamental building blocks” of human ingenuity. The Court specifically avoided any suggestion that software or business methods were presumptively invalid. But those concerns seem to have gone unheeded. The Court’s attempt to side step the tricky problem of defining the boundary of an exception to patent eligibility—”we need not labor to delimit the precise contours of the ‘abstract ideas category in this case'”—has turned into the very mechanism that is quickly “swallow[ing] all of patent law.” The federal courts, the Patent Trial and Appeal Board, and the USPTO are using the very lack of a definition to liberally expand the contours of abstract ideas to cover everything from computer animation to database architecture to digital photograph management and even to safety systems for automobiles.

Let’s look at the numbers to present an accurate picture of the implications of the Supreme Court’s decision. My analysis is a data-driven attempt to assess the implications of Alice one year out. It is with an understanding of how the Supreme Court’s decision is actually playing out in the theater of innovation that we can better project and position ourselves for what the future holds.

Alice at Court

Table 0 Fed Courts

As of June 19, 2015 there have been 106 Federal Circuit and district court decisions on § 101 grounds, with 76 decisions invalidating the patents at issue in whole or in part. In terms of patents and claims, 65% of challenged patents have been found invalid, along with 76.2% of the challenged claims.

The success rate of motions on the pleadings (including motions to dismiss and judgments on the pleadings) is extremely impressive: 67% of defense motions granted, invalidating 54% of asserted patents. There has never been a Supreme Court ruling that the presumption of validity does not apply to § 101—only the Court’s use of the originally metaphorical notion that eligibility is a “threshold” condition. Given that, and the general rule that to survive a motion to dismiss the patentee (historically) need only show that there was a plausible basis that the complaint states a cause of action— there is a plausible basis that the patent claim is not directed to an abstract idea, law of nature, or natural phenomena. One would be forgiven for thinking, as did former Chief Judge Rader in Ultramercial, LLC v. Hulu, LLC that a “Rule 12(b)(6) dismissal for lack of eligible subject matter will be the exception, not the rule.” Apparently the rules change in the middle of the game.

Turning specifically to the Federal Circuit, the numbers are stark:

Table 00Fed Circuit

Of the 13 decisions, 11 are in software or e-commerce and only two are in biotech. The one case where the court held in favor of the patentee, DDR Holdings, LLC v. Hotels.com, L.P. appeared to offer a narrow avenue for patentees to avoid invalidation. However, only nine district court opinions have relied upon DDR to find patent eligibility, with over 30 court opinions distinguishing DDR as inapplicable. Even more interesting is the fact that in DDR the Federal Circuit essentially held that creating a website that copies the look and feel of another website is patent eligible. In the Silicon Valley, that’s called phishing, and it’s not a technology in which most reputable companies invest.

Alice at the Office

The impact of Alice is similarly impacting practitioners before the USPTO. In December, 2014 the Office issued its Interim Guidance on Patent Subject Matter Eligibility, providing guidance to patent examiners as to how to apply the Alice, Mayo, and Myriad decisions along with various Federal Circuit decisions, to claims during prosecution. Importantly, the Guidance noted that “the Supreme Court did not create a per se excluded category of subject matter, such as software or business methods, nor did it impose any special requirements for eligibility of software or business methods,” and it reminded examiners that “Courts tread carefully in scrutinizing such claims because at some level all inventions embody, use, reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea.” Alas, most patent examiners are acting as if the patent applications before them are the exceptions to these cautionary instructions.

With the assistance of Patent Advisor, I compiled a dataset of almost 300,000 office actions and notice of allowances sampled in two week periods during 2013, 2013, 2014 and early 2015, and all actions during March, April and May 2015, across all technology centers:

Table0 Number of Apps

About 100,000 actions were notices of allowances, leaving about 200,000 office actions. Each office action was coded as to whether it included rejections under §§ 101, 102 and 103. For each office action the art unit and examiner was identified as well, and the status of the application (abandoned, pending or patented) as of the date that the data was obtained. I then analyzed the data for office actions rejections based on § 101, allowance rates, and examiner rejection rates. Here’s what I found.

Percent of all Actions with § 101 Rejections

Table2

Here, we have the percentage of all actions in each period that received a § 101 rejection, considering both rejections issued and notices of allowances. The black line separates pre-Alice from post-Alice data. For example, in TC 1600, the biotech area, in January, 2012 6.81% of all actions issued (counting both office actions and notices of allowances) were office actions with § 101 rejections; by May 2015 that percentage almost doubled to 11.86% of actions.

Overall, data shows that in 2012 subject matter rejections were mainly in the computer related Tech Centers (2100, 2400) and began declining thereafter, while escalating in biotechnology (1600) and so-called “business methods” Tech Center, TC 3600, following Mayo and Alice. Other technology centers such as semiconductors and mechanical engineering had essentially low and constant rejection rates. But that’s not because there are no software patents in these technology centers: you find plenty of software patents in these groups. Rather, my view is that it is because examiners in these groups treat software patents as they do any other technology.

The rejection rates in Tech Center 3600 in the 30-40% range are higher than any other group, but they also mask what’s really going on, since TC 3600 covers more than business methods. Tech Center 3600 has nine work groups:

Percent of all Actions with § 101 Rejections in TC 3600 Work Groups

Table3 Ecomm Rej

In TC 3600 most of the work groups handle good old-fashioned machines and processes, such as transportation (3610), structures like chairs and ladders (3630), airplanes, agriculture, and weapons (3640), wells and earth moving equipment (3670), etc. Three work groups handle e-commerce applications: specifically, 3620, 3680 and 3690. Here we see that these groups have significantly higher § 101 rejections than the rest of TC 3600. But let’s drill down further.

Each of work groups 3620, 3680 and 3690 have between five and 10 individual art units that handle specific types of e-commerce technologies, but they are not all under the same work group. For example business related cryptography is handed by both art units 3621 and 3685; healthcare and insurance is handled by art units 3626 and 3686; operations research is handled in 3623, 3624, 3682 and 3684. If we consolidate the data according to technology type and then look at rates of § 101 rejections we get the following:

Percent of all Actions with § 101 Rejections in E-Commerce Art Units by Technology Type

Table3 Ecomm Rej

What’s going on? After Bilski in 2010, the § 101 rejections were running between 17% and 50%. Not great but tolerable since these were mostly formal and were overcome with amendments adding hardware elements (“processor,” “memory”) to method claims or inserting “non-transitory” into Beauregard claims.

But after Alice, everything changed and § 101 rejections started issuing like paper money in a hyperinflation economy. If your perception as a patent prosecutor was that the every application was getting rejected under § 101, this explains your pain. Here’s another view of this data, in terms of actual number of § 101 rejections per sample period:

Number of Office Actions with § 101 Rejections in E-Commerce Art Units by Technology Type

Table4 Ecomm Rej Nos

Notice here that the number of office actions in March, 2015 fell dramatically, and then in April the flood gates opened and hundreds of actions issued with § 101 rejections. This is consistent with the Office’s statements in January 2015 that it was training examiners in view of the 2014 Interim Guidance, so office actions were being held until the training was completed. Apparently, the training skipped the part about no per se exclusions of business methods.

Now let’s consider notice of allowance rates. First with respect to all Tech Centers.

Percent of Actions that Are Notices of Allowance

Table5 All TCs NOA

This data reflects, of all the actions that were issued in a given period, the percentage that were notices of allowances. (Note here that contrary to the preceding tables, red cells are low percentage, and green cells are high since notices of allowance are good things, not bad things). The numbers look good, with a general increasing trend over time.

Now consider what’s happening in TC 3600’s business methods art units.

Percent of Actions that Are Notices of Allowance in Business Methods

Table6 NOAs in Ecomm

Now the picture is quite different. The rate of NOAs drops dramatically after Alice, especially in finance and banking and operations research. If it seemed that you were no longer getting a NOAs, this is why. The zero percent rate in March, 2015 is a result of the Office holding up actions and NOAs in view of the Interim Guidance training, as mentioned above.

Patents issued in the business methods art units typically are classified in Class 705 for “Data Processing.” I identified all patents with a primary classification in Class 705 since January, 2011, on a month by month basis, to identify year over year trends. Again the black line separates pre-Alice from post-Alice data.

Table7 Class 705 Patents

This table shows a precipitous decline in the number of business method patents issued following Alice, especially year over year. The lag between the June, 2014 Alice decision and the drop off in October 2014 is an artifact of the delay between allowance and issuance, as well as the USPTO’s unprecedented decision to withdraw an unknown number of applications for which the issue fee had already been paid, and issue § 101 rejections. It’s an interesting artifact, as well, that the number of Class 705 patents issued peaked in the month after Alice: you have to remember that these patents were allowed at least three months, and as much as a year, before the Alice decision; it just took a long time to actually get printed as a patent.

Next, we’ll consider abandonment rates, on a comparative basis, looking at the percentages of applications that were ultimately abandoned in relationship to whether or not they received a § 101 rejection. We’ll compare the data from January 2012 to July 2014. Again, consider the entire patent corps:

Percent of Abandoned Applications with Prior § 101 Rejection

Table8 Abandon all TCs

Here we see that of the applications that were abandoned during the respective sample periods, the vast majority did not have a prior § 101 rejection. Only in TC 3600 did the majority shift after Alice with 51.83% applications that received § 101 rejections in July 2014 being subsequently abandoned by May 31, 2015. Again, let’s drill down into the business method art units in TC 3600:

Percent of Abandoned Applications with Prior § 101 Rejection

Table9 Ecomm Abandon

First, prior to Alice, abandonments in the business method units appeared to result more frequently from other than § 101 rejections, typically prior art rejections. This is shown by the fact that the Jan. 2012 “No” column (no prior 101 rejection) is greater than the Jan. 2012 “Yes” column. Then after Alice, there is a huge shift with the vast majority of applications that were abandoned having § 101 rejections, as shown by the July, 2014 “Yes” column. The vast majority of abandonments, upwards of 90%, followed a 101 rejection. That’s applicants essentially giving up over what only a few years ago was a relatively minor hurdle. That’s what happens when you change the rules in the middle of the game. Second, there is also significant differential behavior in the business method areas as compared to the rest of the technology centers after Alice.

Here’s my personal favorite.

Rates of Examiner § 101 Rejections in TC 3600

Table12 Examiner Rates

This table shows the numbers of examiners in the business method art units with respect to the percentage of applications in which they issued § 101 rejections after Alice. The first row shows that during the sampled periods since Alice, 58 business methods examiners issued § 101 rejections in 100% of their applications, for a total of 443 applications. Twenty examiners issued § 101 rejections for between 90% and 99% of their cases, covering 370 applications. In short, 199 examiners issued § 101 rejections more than 70% of the time, covering 3,304 applications or about 70.6% of all applications. This is not “treading carefully.”

We find similar, though less dramatic, trends and variations in TC 1600 which handles biotechnology, pharma, and chemistry.

Percent of all Actions with § 101 Rejections in TC 1600 Work Groups

Table10 1600 101 Rej Rate

The red line separate pre-Mayo/Myriad data from post-Mayo/Myriad, and the increase in the post-period is significant. Here too, the various work groups mask the more significant rejection rates in specific technology areas, with the rejection rate in microbiology first jumping up to 34.6% post-Mayo and steadily climbing to the current 53.2%.

Percent of all Actions with § 101 Rejections in TC 1600 by Technology

Table11 1600 Tech Type Rej

This table breaks down the work groups into technology types, and then these are sorting average rejection rate over the past four months. Following Alice, we see a significant increase in eligibility rejections in bioinformatics related applications–inventions that rely on analysis and identification of biological and genetic information, and which are frequently used in diagnostics and drug discovery. This is especially disconcerting because bioinformatics is critical to the development of new diagnostics, therapies and drugs.

Note as well the enormous spike in rejections for plant related applications from 0% between July 2015 and April 2015, to 50% in May 2015. This is likely a result again of the USPTO’s Interim Guidance which essentially instructed examiners to reject any claim that included any form of a natural product.

At least pesticides and herbicides are safe from Alice, since we definitely need more of those. The irony is that the more pesticides and herbicides that come to market, the more we need bioinformatics inventions to identify and treat conditions potentially resulting from these products.

Alice at the Board

The Patent Trial and Appeal Board has been even more hostile to software and business methods patents under the Covered Business Method review program:

Total Petitions

Petitions Granted

Percent Invalid

PTAB CBM Institution on § 101

72

64

89%

PTAB Final Decisions on § 101

27

27

100%

Covered Business Method review is available for patents that claim “a method, apparatus, or operation used in the practice, administration, or management of a financial product or service.” The Board takes a very broad view of what constitutes a financial product or service: if the patent specification happens to mention that the invention may be used in a financial context such as banking, finance, shopping or the like, then that’s sufficient. The Board has found CBM standing in 91% of petitions, and instituted trial in 89% of petitions asserting § 101 invalidity. Once a CBM trial has been instituted, the odds are heavily in the petitioner’s favor: of the 27 final CBM decisions addressing § 101, the Board has found for the petitioner 100% of the time.

Finally, we look at the Board’s activity in handling ex parte appeals from § 101 rejections for the period of March 1, 2015 to May 30, 2015:

  • 32 Ex Parte Decisions on § 101, with 15 in TC 3600.
  • 28 Affirmances overall, 13 in TC 3600
  • Two Reversals on § 101, both in TC 3600
  • Four New Grounds of Rejection for § 101

Following suit with how the Board is handling CBMs, they are also heavily supporting examiners in affirming § 101 rejections. More disconcerting is the trend of new grounds of rejection under § 101. While only four were issued in this period, there have been several dozen since Alice. In this situation, the applicant has appealed, for example, a § 103 rejection. The Board can reverse the examiner on that rejection, but then sua sponte reject all of the claims under § 101. What are the odds that the examiner will ever allow the case? Close to zero. What are the odds that an appeal back to the Board on the examiner’s next § 101 rejection will be reversed? If the Board’s 100% rate of affirming its CBM institution decisions on § 101 is any indication, then you know the answer.

Conclusions

Looking at the overall context of the Alice decision, it’s my view that Supreme Court did not intend this landslide effect. While they were certainly aware of the concerns over patent trolls and bad patents, they framed their decision not as a broadside against these perceived evils, but as simple extension of Bilski and the question of whether computer implementation of an abstract idea imparts eligibility. At oral argument, the members of the Court specifically asked if they needed to rule on the eligibility of software and they were told by CLS and the Solicitor General that they did not. To the extent that there is broad language in that opinion, it is the cautionary instructions to the courts to avoid disemboweling the patent law from the inside, and the emphasis on preemption of fundamental ideas—not just any ideas—as the core concern of the exclusionary rule. The evidence above shows that these guideposts have been rushed past quite quickly on the way to some goal other than the preservation of intellectual property rights.

If the present trends hold, and I see no reason to suggest that they will not, we will continue to see the zone of patent eligibility curtailed in software (not to mention bio-technology after Mayo and Myriad). Indeed, the more advanced the software technology—the more it takes over the cognitive work once done exclusively by humans, the more seamless it becomes in the fabric of our daily lives—the less patent eligible it is deemed to be by the courts and the USPTO. What technologies will not be funded, what discoveries will not be made, what products will never come to market we do not know. What we do know is this: there is only one law that governs human affairs and that is the law of unintended consequences.

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Biotech Gene Patents Innovation Intellectual Property Theory Inventors Patent Law Patent Litigation Patent Theory Patentability Requirements Supreme Court Uncategorized

Federal Circuit Threatens Innovation: Dissecting the Ariosa v. Sequenom Opinion

By Patent Publius

Earlier this month, the Federal Circuit issued its opinion in Ariosa v. Sequenom, a closely-watched biotechnology case with significant repercussions for patent-eligibility analysis generally. Unfortunately, the Federal Circuit misapplies the Supreme Court’s analytical framework from Mayo v. Prometheus, striking down Sequenom’s important innovation for the prenatal diagnosis of fetal abnormalities. The shame here is that the Mayo opinion itself was unnecessarily broad, and the Federal Circuit has now interpreted it to be even broader.

Section 101 of the Patent Act provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . may obtain a patent therefor,” but there are judicial exceptions for “laws of nature, natural phenomenon, and abstract ideas.” Those exceptions are relevant here, where the Federal Circuit considers whether the claimed method of using cell-free fetal DNA (“cffDNA”) to make diagnoses is patentable subject matter.

In the Mayo opinion, the Supreme Court established a two-step analysis for determining whether method claims merely “set forth laws of nature” or instead apply those natural laws with “additional features” so as to become patent-eligible processes. The first step looks at whether the claims are directed to a patent-ineligible law of nature, and the second step looks at whether additional elements “transform the nature of the claim” into something that amounts to more than a claim on the law of nature itself.

Applying Mayo to the case at hand, the Federal Circuit’s analysis of the first step is perfunctory:

In this case, the asserted claims of the ‘540 patent are directed to a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum—a naturally occurring non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. . . . It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. . . . The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.

The Federal Circuit’s conclusion that the method “begins and ends with a natural phenomenon” tells us very little of how this principle is to be applied generally. Certainly, the method begins with a biological sample of maternal plasma or serum that contains paternally-inherited cffDNA, and it makes sense to say that it begins with a natural phenomenon. Of course, everything begins with a natural phenomenon, so this is hardly instructive.

But it’s inaccurate to say that the method simply ends with cffDNA. The method itself takes the miniscule amount of cffDNA found in the sample and exponentially amplifies it to detectable levels. The resulting substance, unlike the beginning sample, gains significant and new utility from a diagnostic perspective. What comes out of the process is an artificially-enriched substance that, unlike the maternal plasma or serum fed into the process, can be used for many diagnostic purposes. That is, the method ends with a substance that is anything but a natural phenomenon.

Applying the second step of the Mayo framework, the Federal Circuit finds that Sequenom’s claimed methods are not significantly transformative:

Like the patentee in Mayo, Sequenom contends that the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997. The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.

The last sentence is the most perplexing: The “discovery of the presence of cffDNA in maternal plasma or serum” is what sets Sequenom’s method apart from that which was “well-understood, routine, and conventional activity in 1997.” The problem here stems from the Federal Circuit’s failure to consider the claimed method as a whole, as it purportedly sets out to do: “[W]e next consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application.”

Undoubtedly, some parts of Sequenom’s method were already well-known. No one denies, for example, that some of the techniques involved in amplifying and then detecting cffDNA were, in their general features, already conventional activity in the field (e.g., PCR). What makes the Sequenom method patentable is the sum of its parts, that is, the method as a whole that the Federal Circuit acknowledges to contain the new and useful discovery of cffDNA in the maternal plasma or serum.

This is the principal feature of Sequenom’s claimed invention and its central argument throughout the litigation. Yet, the Federal Circuit relegates it to one of “Sequenom’s remaining arguments” and addresses it in a brief paragraph near the end of the opinion, where it inexplicably claims: “This argument implies that the inventive concept lies in the discovery of cffDNA in plasma or serum. Even if so, this is not the invention claimed by the ’540 patent.” On the contrary, this discovery is anything but conventional, and the method as a whole transforms a natural phenomenon into something both artificial and patentable.

Overbroad (and Dangerous) Principles

The overbreadth of the Federal Circuit’s analysis threatens diagnostic methods across the board. If a method of detecting a natural phenomenon is always “directed to” that natural phenomenon, as the Federal Circuit suggests, then all such methods are prima facie patent-ineligible under the first step of the Mayo framework and must fight the uphill battle under its second step. This is particularly troubling since virtually all diagnostic tests detect natural phenomena. Moreover, the Federal Circuit’s application of the second step of the Mayo framework looks at each part of the method individually, ignoring the claimed method as a whole.

Not only is this principle breathtakingly broad in the damage it could cause to the diagnostics industry, it is neither required by, nor even consistent with, the controlling case law. Only claims to natural phenomena are per se patent-ineligible; however, applications of natural phenomena are generally patentable. Detecting a natural phenomenon is not the same thing as the phenomenon itself. It is instead a specific application of that phenomenon. While the Federal Circuit states that applications of natural phenomena are patent-eligible, it quickly proceeds to categorically suggest a principle under which all diagnostic inventions may have one foot in the Section 101 grave.

Another overly-broad principle from the Federal Circuit opinion comes from this statement: “For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.” This may at first seem obvious and uncontroversial, but in the context of the rest of the opinion, it proves quite problematic. The Federal Circuit cites Parker v. Flook as support: “The process itself, not merely the mathematical algorithm, must be new and useful.” But note the subtle distinction between the two quotes. The Supreme Court discussed the “process itself,” while the Federal Circuit discusses the “process steps.”

This distinction has two important effects. First, it is one of many signals in the opinion that demonstrates the Federal Circuit’s improper dissection of the claimed method into its components parts. Rather than consider whether the “process itself” is “new and useful,” as the Flook opinion had done, the Federal Circuit analyzes each step individually. There’s no consideration of how the steps integrate into the process as a whole, and there’s no mention of whether that entire process claims something other than the natural phenomenon itself.

Second, the Federal Circuit looks at each step in a very general way and ignores the details of the steps that confer patent eligibility. For example, the opinion spends much time discussing how routine the PCR method was at the time of filing. But Sequenom never claimed the PCR method itself. The Federal Circuit fails to address Sequenom’s central argument: The claimed method is a new process of detecting cffDNA by devising a novel sample source from which to extract it, namely, maternal plasma or serum. The application and adaptation of known techniques in this inventive way to a newly-discovered sample source is not conventional.

Finally, the most problematic and new principle that may emerge from this opinion is a subtle, yet very significant, extension of Mayo to invalidate claims directed to routine and conventional applications of natural laws. Mayo teaches that the mere addition of what is purely routine and conventional at the time of filing cannot save a claim directed to a law of nature: “In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.”

The Federal Circuit appears to exclude from the patent system a routine application of a law of nature, rather than, as Mayo requires, a law of nature to which merely routine activities have been appended. That is, if one skilled in the art could, after being informed of a newly-discovered law of nature, use routine skill to arrive at the claimed invention, then that claimed invention may be invalidated under the Federal Circuit’s reasoning.

This is contrary to Mayo, and it could conceivably invalidate huge swaths of meritorious inventions. Once the principles underlying a new method are known, application of those principles to devise that method will very often be obvious. The Supreme Court has been very consistent in saying that applications of laws of nature are patent-eligible, including those applications that would have been obvious in view of newly-discovered laws of nature. It is a subtle, but important, point to recognize that Mayo did not say the opposite, as the Federal Circuit now interprets it.

The Preemption Question

One potential bright spot in the Federal Circuit’s opinion is its treatment of preemption. Instead of being a test for patent eligibility, preemption is properly understood as being solely a policy underlying eligibility exclusions. It can at most serve as an after-the-fact check on whether an already-reached conclusion of eligibility is consistent with this policy. The Federal Circuit here mostly validates this position:

The Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability. Alice, 134 S. Ct at 2354 (“We have described the concern that drives this exclusionary principal as one of pre-emption”). For this reason, questions on preemption are inherent in and resolved by the § 101 analysis. . . . Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.

This may ultimately be a hollow victory, however. The Federal Circuit also says: “While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.” The problem here is that it is impossible to ever show complete preemption because it is impossible to know at the time of filing whether something outside the claims could also be conceived. Inventions are, by definition, unforeseeable.

Moreover, allowing anything less than complete preemption to be sufficient to invalidate a claim threatens to invalidate far too much subject matter. By their very nature, patents are preemptive. Allowing courts and patent examiners to freely draw the line between allowable and prohibited levels of preemption invites unpredictable and arbitrary decisions based on personal value judgments. That very problem arose here, where the district court held the claims invalid, at least in part, because they covered what the judge deemed to be “the only commercially viable way of detecting” the embodiment of the law of nature.

The Promising Potential in Judge Linn’s Concurrence

Judge Linn’s concurrence is promising, but it falls short of its full potential. Judge Linn does a better job than the majority in recognizing and understanding the legal significance of the important facts of this case:

[N]o one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” . . . because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”

It is encouraging to see that a Federal Circuit judge has finally gone on record to point out the problems caused by ever-broadening applications of Mayo:

I join the court’s opinion invalidating the claims of the ‘540 patent only because I am bound by the sweeping language of the test set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc. . . . In my view, the breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.

Judge Linn errs, however, in his acquiescence that Mayo requires the majority’s conclusion. Judge Linn’s concurrence generally reads more like a dissent, but he undercuts his own criticism of Mayo and its effects by calling his opinion a “concurrence.” As he laments:

The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.

But the second half of this sentence shows the critical distinction that makes Sequenom’s claims patent-eligible, even in view of Mayo. Unlike the claims analyzed in Mayo, Sequenom’s process is new and not routinely engaged in by researchers in the field. Judge Linn even states the point better elsewhere in his own concurrence:

Unlike in Mayo, the ‘540 patent claims a new method that should be patent eligible. While the instructions in the claims at issue in Mayo had been widely used by doctors—they had been measuring metabolites and recalculating dosages based on toxicity/inefficacy limits for years—here, the amplification and detection of cffDNA had never before been done.

Judge Linn should be praised for critiquing Mayo as bad law that has led to the invalidation of untold meritorious patent claims. Unfortunately, however, he may have unintentionally contributed to the expansive scope of Mayo about which he complains by failing to factually distinguish (and hence cabin) the Supreme Court’s opinion when presented with such a good opportunity to do so.

All told, the Federal Circuit’s opinion in Ariosa v. Sequenom is a predictable, yet unfortunate, application of the Supreme Court’s disastrous reasoning in Mayo. The unintended consequences of the Supreme Court’s opinion have been further realized in the Federal Circuit’s denial of Sequenom’s innovative claimed method for diagnosing fetal abnormalities. Only time will tell how many other innovations will suffer under the Supreme Court’s careless expansion of Section 101’s patent eligibility analysis.

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Commercialization Copyright Copyright Licensing Legislation Supreme Court Uncategorized

Summary of Kirtsaeng v. John Wiley & Sons by Professor Chris Newman

Kirtsaeng v. John Wiley & Sons, U.S. Supreme Court, decided March 19, 2013

Chris Newman
Assistant Professor of Law
George Mason University School of Law

This is best described as a decision in which the Court felt compelled to choose between two readings of the Copyright Act, either of which led to unpalatable results.   One reading would eviscerate the exclusive importation right that Congress had sought to grant copyright owners.  The other would insert a huge loophole into the first-sale doctrine, which denies a copyright owner the right to control how people dispose of copies of protected works once they lawfully acquire ownership of them.   The argument was largely couched in the language of statutory interpretation, but at the end of the day the question was which horrible did more of the Justices fear more.  

The majority, in an opinion by Justice Breyer, chose to sacrifice the importation right.  This means that U.S. copyright owners may not rely on copyright law to aid them in segmenting the world market into domestic and foreign exclusive distribution zones.   Which is nice—at least in the short run—for U.S. consumers who want to buy cheap gray market imports.  It may turn out to be less nice in the long run for petitioner Kirtsaeng’s fellow citizens in Thailand, to whom U.S. textbook publishers may no longer be willing to sell books at prices that support arbitrage.  As Justice Kagan frankly acknowledged in concurrence, this is a suboptimal result that might have been avoided had the court taken a different route in an earlier case.  

The three dissenters would have opted to preserve the importation right, and in terms of straightforward textual interpretation, this commenter thinks Justice Ginsburg got the better of the argument.   What cost her the day was her inability to read the statute in a way that definitively closed the potential loophole in first sale doctrine, so as to dispel the spectre of permitting copyright owners to move all their manufacturing overseas and thereby gain the right to control all downstream distribution and display of copies even after they had been legally sold.   To be sure, this would indeed be an undesirable result, and Justice Ginsburg certainly did not believe it to be a correct or desirable application of copyright law.  But the only way she could avoid it while preserving the importation right was to argue that first sale doctrine is not really governed by the language in which it was codified in the statute.  Her solution makes sense as a matter of policy, but there was no way for the Court to adopt and make it stick in the context of this case, which would have left the spectre seemingly at large and triumphant.