USPTO Issues Patent Eligibility Guidance In View Of CellzDirect and Sequenom

USPTO Issues Patent Eligibility Guidance In View Of CellzDirect and SequenomThe USPTO issued a memorandum to the examining corps entitled Recent Subject Matter Eligibility Rulings (Rapid Litigation Management v. CellzDirect and Sequenom v. Ariosa) on July 14, 2016. The Patent 213 Blog has previously reviewed each of these cases. The USPTO notes that the decisions do not change the subject matter eligibility framework and that the subject matter eligibility guidance previously issued is consistent with both CellzDirect and Sequenom. The USPTO did, however, acknowledge that the CellzDirect decision provided guidance on the proper inquiry for determining whether the claims are “directed to” a judicial exception.

In the CellzDirect decision, the Federal Circuit found the claims patentable under step one of the Alice framework (which corresponds to Step 2A in the USPTO’s analytical framework). Specifically, the court characterized the claims as being directed to “a new and useful laboratory technique for preserving hepatocytes” and determined that such processes carried out to achieve “a new and useful end is precisely the type of claim that is eligible for patenting.”

The July memorandum takes notice of several important points in the CellzDirect decision. Specifically, the USPTO quoted the portion of the CAFC’s opinion outlining the requirements under the “directed to” inquiry. In CellzDirect, the panel noted the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.” In discussing this point, the July Memorandum notes that the claims in CellzDirect were not simply an “observation or recitation” of the ability of hepatocytes to survive multiple freeze-thaw cycles but were directed to specific process steps that manipulated the hepatocytes to “in accordance with their ability to survive multiple freeze-thaw cycles.” The July Memorandum stresses determination of the “focus” of the claims under the directed to inquiry. The claims in CellzDirect, as focused on the process for achieving the desired outcome, were not directed to the judicial exception.  The USPTO noted that a similar approach was used in the recent Enfish decision.

The “directed to” INQUIRY requires an analysis of whether the end result of the process, the essence of the whole, was a patent-ineligible concept.

Finally, the distinction made by the Federal Circuit between the claims in CellzDirect on one hand and Sequenom and Mayo on the other was noted. The claims in Mayo and Sequenom, rather than being focused on a process for achieving a desired outcome “were found to be directed to a patent-ineligible concept when they ‘amounted to nothing more than observing or identifying the ineligible concept itself.’”

Regarding Sequenom, the July Memorandum specifically notes that the U.S.S.C.’s denial of cert “does not elevate” the significance of the original decision or alter the way in which the original decision is applied.

CAFC Dissects Alice Patent Eligibility Analysis in Bascom Global Internet Services

laptop locked chainsThis case arose on an appeal from the grant of a motion to dismiss for failure to state a claim, with the district court finding the asserted claims of Bascom’s U.S. Patent No. 5,987,606 were invalid as a matter of law under 35 U.S.C. §101. The technology at issue in the ‘606 patent concerns software tools to control the type of information received over the Internet. The district court found the claims directed to the abstract idea of filtering content and specifically pointed to the lack of a specific method in the claims for filtering the content as raising the risk that the claims could preempt all other filtering application in the field.

The prior art utilized several filtering methods. One method installed the filtering software on individual machines; this approach allowed individualized filtering settings but required intensive maintenance and was subject to circumvention by computer-literate users. Another method involved installing the filtering software on a local server or ISP rather than individual machines; this approach addressed some of the problems with locally installed software but applied a single set of filtering criteria for all users. The ‘606 describes an improvement on the prior art methods of filtering internet content that provided the advantages of the filtering software being housed at the ISP while still retaining the ability of individual users to customize filter settings. As described in the ‘606 patent, the ISP server receives a request to access a website, associates the request with a particular user, identifies the requested website and uses the filtering tool to apply the filtering mechanism associated with the particular user to the requested website to determine whether such request is allowed under the filter settings.

Claim 1 of the ‘606 patent:

A content filtering system for filtering content retrieved from an Internet computer network by individual controlled access network accounts, said filtering system comprising:

  • a local client computer-generating network access requests for said individual controlled access network accounts;
  • at least one filtering scheme;
  • a plurality of sets of logical filtering elements; and
  • a remote ISP server coupled to said client computer and said Internet computer network, said ISP server associating each said network account to at least one filtering scheme and at least one set of filtering elements, said ISP server further receiving said network access requests from said client computer and executing said associated filtering scheme utilizing said associated set of logical filtering elements.

Before addressing the merits of the case, the CAFC noted that under the two-step §101 analysis mandated under Alice the court had found software-related patent claims eligible under step one when the claims were clearly “directed to” subject matter that amounted to more than a mere abstract idea (citing Enfish and the improvement to relational databases/computer function). In other cases when there are “close calls about how to characterize what the claims are directed to” the court found such claims eligible under step two of the Alice analysis (citing DDR Holdings and the use of a computer-based solution to solve an internet-based problem). In discussing the step two analysis, the court stated some claims may appear to be “directed to” an abstract idea “…but under step two of the Alice analysis, it might become clear that the specific improvements in the recited computer technology go beyond ‘well-understood, routine, conventional activit[ies]’ and render the invention patent-eligible.”

Under step one of Alice, the court determined that claim 1 (and claim 22, which claimed a similar method) could indeed be characterized as directed to the concept of filtering internet content, further noting the specification reinforced this interpretation. The court further found that filtering internet content is an abstract idea as a “well-known method of organizing human behavior, similar to concepts previously found to be abstract” under previous case law (citing Intellectual Venture, Content Extraction and Digitech Image Tech). The patentee argued that the claims were directed to a specific manner of filtering internet content in a customized manner and did not require placement on local computers or servers (claim 1) and to allow user customization to be administered by a user in a simple manner (claim 22). The panel found that the claims at issue in the ‘606 patent represented a “close call [] about how to characterize what the claims are directed to.” The court distinguished Enfish, where a specific claim limitation reciting a specific algorithm was used to demonstrate that the claims “understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities.” As a result, the court turned to the step two of the Alice inquiry.

An Inventive Concept Can be Found in the Non-Conventional and Non-Generic Arrangement of Known, Conventional Pieces.

Under step two and the search for inventive concept, the panel stated the inventive concept “may arise in one or more of the individual claim limitations or in the ordered combination of the limitations.” The district court found that the claims “considered individually, or as an ordered combination, are no more than routine additional steps involving generic computer components and the Internet, which interact in well-known ways to accomplish the abstract idea of filtering Internet content,” giving weight to the fact that the code for the filtering step was available in the art. While agreeing with the step-one analysis, the CAFC found the district court’s analysis of the ordered combination to be flawed stating the “inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art.” In this case, the claims defined the installation of a filtering tool at a specific location, remote from the end users, with customizable filtering features specific to each end user, providing advantages over the prior art.  The court found by “taking a prior art filter solution (one-size-fits-all filter at the ISP server) and making it more dynamic and efficient (providing individualized filtering at the ISP server), the claimed invention represents a ‘software-based invention[] that improve[s] the performance of the computer system itself.’” The panel found that nothing in the record showed that such steps were routine or generic. As such, based on the record presented to the panel, the claims were found to satisfy step two of the Alice inquiry.

Regarding the preemption issue, Judge Newman stated in a concurring opinion “it is not the policy of patent law to permit only narrow claims when an inventor has made a new, broad invention. When an invention is new and unobvious and described and enabled, commensurate patent rights are not barred on policy grounds.”

While this case was presented as an appeal on a record that may not have been fully developed, this case provides valuable guidance on how the CAFC analyzes the threshold determinations under the two step Alice inquiry. The court’s statement on the ability of combinations of known claim limitations to nonetheless provide patentable combinations is also welcome. As with previous cases, a description of how the claims relate to improving the technological process is also important. However, in Bascom, the exact method of how the improvement was implemented was not specifically described (and in fact was not described as novel) as was done in Enfish (where the implementation of the method was a specifically described algorithm). This point potentially further enlarges the ability to patent software-related inventions and may suggest that the exact description of how the improvement in computer technology is implemented is not absolutely required for patentability of software invention under the Alice guidelines.

 

July Fireworks: Federal Circuit Finds Claims to Cryopreservation Method Eligible Under 35 USC §101

Fireworks over a lakeOn July 5, the Federal Circuit found claims directed to cryopreservation methods for hepatocytes patent eligible under 35 USC §101, reversing the district court decision finding the claims invalid on motion for summary judgement. In reaching this conclusion, the court offered valuable guidance on the proper analysis of claims that involve natural products and provided comments on how the claims differed from previous Federal Circuit cases in the §101 arena.

The patent at issue was U.S. Patent No. 7,604,929. The court focused the analysis on claim 1, which defined the general cryopreservation process, and dependent claim 5 which described a preparation of hepatocytes from more than one source/donor (referred to as a pooled preparation).

Claim 1 of the ‘929 patent reads:

A method of producing a desired preparation of multicryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:

  • subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable
    hepatocytes,

  • recovering the separated viable hepatocytes, and

  • cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step
    after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations and
    wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

Claim 5 further defined the composition of the preparation and reads:

The method of claim 1, wherein said preparation comprises a pooled preparation of hepatocytes of multiple sources.

The district court found all asserted claims invalid under §101. The district court discussed the limitations of the prior art methods, noting such methods led to poor recovery of viable cells and could not produce pooled preparations of cryopreserved cells due to the understanding in the art that hepatocytes could be frozen and thawed only one time and the short life span/scarcity of hepatocytes. The district court also recognized the inventive aspects of the claimed methods, noting the discovery by the inventors that a certain fraction of hepatocytes isolated after an initial freeze/thaw procedure could be re-frozen and still yield viable hepatocytes. As such, the methods enabled the production of pooled preparations of hepatocytes. Despite these findings, the district court found the claims ineligible under §101 after application of the two-step framework mandated by Alice, concluding in step one that the claims were directed to an ineligible law of nature (the discovery that hepatocytes are capable of surviving multiple free-thaw cycles) and concluding in step two that the additional steps in the method claims failed to provide the required “inventive concept” to transform the claims as the additional methods steps were well known.

The Federal Circuit disagreed with the district court’s analysis of both steps of the Alice framework. With regard to step one, the Federal Circuit found the panel characterized the claims as being directed to “a new and useful laboratory technique for preserving hepatocytes” and determined that such processes carried out to achieve “a new and useful end is precisely the type of claim that is eligible for patenting.” The Federal Circuit discussed the multiple steps required to carry out the claimed methods. The panel recognized that the discovery rested in part on the discovery of hepatocytes to survive multiple free-thaw cycles, but emphasized the inventors did not patent this idea in isolation; rather the inventors “employed their natural discovery to create new and improved ways of preserving hepatocyte cells for later use” (citing Myriad for the idea that the first to discover knowledge is in an excellent position to claim applications of that knowledge).

Processes carried out to achieve a new and useful end is precisely the type of claim that is eligible for patenting

The panel also distinguished prior case law (Genetic Technologies, Ariosa and In re BRCA), where the claims were “directed to” a patent-ineligible concept when the claims did nothing more than identify/observe the ineligible concept and did nothing more. The panel emphasized that the “natural ability of the subject matter to undergo the process does not make the claim directed to that natural ability.” If so, the court noted that such an interpretation would lead to the invalidity of numerous method claims (citing as one example, treating cancer with chemotherapy, which would be ineligible based on the cancer cells’ inability to survive such treatment). The court also distinguished Funk Brothers on the basis that the claims were not composition claims directed to the cryopreserved pool, but to methods of producing the pool, making the question of whether the cells behaved in their natural way or acquired a different use irrelevant.

In addition, the Federal Circuit defended its application of the two-step framework (holding the claims eligible at step one, as done previously in Enfish), stating that step one requires more than identification of a patent-ineligible concept, but requires determining what the claim is “directed to.” Applying the directed to inquiry, the panel found the claims directed to a new and useful technique of cryopreserving hepatocytes that “falls squarely outside those categories of inventions that are ‘directed to’ patent-ineligible concepts.”

The Federal Circuit went on to undertake the step two analysis and would have determined the claims were patent eligible at this stage as well. Importantly, the court applied rationale from the computer arts cases in making this determination, citing claims that “improve[] an existing technological process” are sufficient to “transform[] the process into an inventive application” of the patent-ineligible concept (citing Alice as well as referencing Mayo and Diehr). The court found the claimed methods provide significant improvements over the prior art, including improved viability and the production of pooled samples of hepatocytes. Regarding the use of well-known techniques in the claimed method for cryopreservation (which is normally fatal under the step two analysis), the panel determined that the inclusion of well-known steps in a method claim is not fatal (citing Diehr) and that in this case the act of repeating the freeze-thaw process itself was not well known. The fact that the inventor’s discovery of “something natural” led to the methods was not controlling. The court stated “To require something more at step two would be to discount the human ingenuity that comes from applying a natural discovery in a way that achieves a ‘new and useful end.’”

The court also addressed pre-emption at the end of the opinion, noting that the patent “does not lock up the natural law in its entirety” and noting that competitors had already engineered around the claims at issue.

This case does share many similarities with previous cases where the claims were found patent ineligible. One wonders how the concept of using a fraction of maternal plasma/serum (which the art had taught to discard) differs from performing an additional step in a known process (which the art taught as harmful) when the remainder of the steps in the recited methods are common in the art. In the present case, the court concluded that the inventive step (additional freeze/thaw cycles) in the claimed methods was in fact not known and as such this inventive contribution was enough to satisfy the “directed to” inquiry at step one of the framework and transform the claims at step two of the framework.

In summary, this opinion offers significant guidance to patent drafters in how to approach subject matter involving a natural process/phenomenon. Further, the Federal Circuit’s explicit recognition of improvements to an existing technological process offer the drafter the opportunity to creatively draft the specification and claims to take advantage of this exception.

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

woman-in-labTo the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can come from the discovery of the natural phenomenon itself. This distinction would allow the Court to differentiate a meritorious invention like Sequenom’s from the method that was held patent-ineligible in Mayo. In Mayo, the natural phenomenon was well known- those of skill in the art were aware of the differential metabolism of thiopurine drugs and how this differential metabolism impacted dosing considerations and patient care. In other words, the natural phenomenon was well known. In contrast, the discovery of a natural phenomenon—the presence of paternally inherited cffDNA in maternal plasma—was what made Sequenom’s invention groundbreaking. After all, no one was using paternally inherited cffDNA from maternal blood plasma for prenatal diagnosis prior to Sequenom’s discovery. In both cases, absent the natural phenomenon implicated in the claims, it is fair to say the remaining elements of the claim were routine.

Furthermore, the denial of the Sequenom’s petition was all the more surprising based on the dicta in Myriad. The Myriad Court explained what was not implicated in that decision—diagnostic method claims. Myriad did not involve new applications to knowledge about the BRCA1 and BRCA2 genes, but to composition claims of BRCA1 and BRCA2.

However, the Myriad Court seemed to endorse Judge Bryson’s statement:

“[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge.”

Sequenom tried to do just that, by claiming their pioneering application for the non-invasive diagnostic testing of genetic abnormalities of a fetus, spending $70 million on development of their test prior to 2011 (named “MaterniT21”). Sequenom’s competitor, Ariosa, launched a competing test. Because Sequenom’s claims were invalidated under the Mayo/Myriad framework, Ariosa did not have to pay a dime in royalties.

As Sequenom noted in their Petition:

“[i]f combining a new insight about the natural world with ‘available elements’ to achieve  extraordinary new results is unpatentable subject matter—as is now U.S. law absent [the U.S. Supreme Court’s] intervention—no such breakthroughs are patent-eligible. That means anyone who would invest in making, validating, or commercializing inventions like these for human medical use must invite others along for the free ride, with predictably unfortunate results.”

Sequenom remarked that application of the current Mayo/Myriad test “undermines just about any biomedical breakthrough you can conceive. Vaccines? They combine the natural fact of immune response with known methods of drug administration. Even for previously unstudied diseases like Zika? Yes. Aspirin—perhaps the world’s most successful patented medicine? It combined a natural plant product with basic chemistry techniques.” While Sequenom’s remarks regarding the scope of § 101 may be a bit overreaching (for example, Example 28 of the Subject Matter Eligibility Examples released in May of this year indicate that at least the USPTO will still provide a relatively broad scope of protection for vaccines), the specter that many groundbreaking diagnostic inventions are now likely unpatentable is real. Regrettably, the Court was unmoved by these policy arguments made by Sequenom and several amici of the effect of continuing uncertainty on the biotechnology industry if Sequenom’s Petition was denied.

Indeed, the Federal Circuit’s interpretation of the Mayo/Myriad framework is expansive, making it difficult to know what will be eligible for patenting. Of the four cases that have come before the Federal Circuit since Mayo and Myriad that involve molecular diagnostics, the court invalidated all challenged claims. That trend is likely to continue with the Court’s denial of Sequenom’s Petition. Judge Dyk confirms this idea in the en banc opinion: “I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.”

By refusing Sequenom’s Petition, the Court has decided that the bounds for the Mayo/Myriad framework need no further clarification, refusing to make bright line distinctions between newly discovered natural phenomena and what is already known and lending certainty to patent practice in the biotechnology field. The natural phenomenon remains divorced from the additional steps of the method. Under § 101, methods are supposed to be generally patent-eligible subject matter. The judicial exceptions to patent-eligible subject matter (laws of nature, natural phenomena, and abstract ideas) should be just that—exceptions to the rule. Unfortunately, as applied to biotechnology inventions, the exception has become the rule, and § 101 lacks any discernable limits.

Fingers Crossed: Supreme Court to Decide Patentability of Newly Discovered Natural Phenomena

Fingers Crossed: Supreme Court to Decide Patentability of Newly Discovered Natural PhenomenaThe Federal Circuit threw down the gauntlet, and we are waiting to see whether the U.S. Supreme Court will take it up. Sequenom’s petition for certiorari was scheduled for conference on June 23rd; the Court’s decision whether to hear the case will likely be announced next week. In the Federal Circuit en banc opinion denying rehearing of Ariosa v. Sequenom, Judge Lourie said “it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility,” and Judge Dyk added: “we are bound by the language of Mayo, and further guidance must come from the Supreme Court, not this court.”

The claims at issue in Sequenom’s patent were directed to methods for detecting paternally inherited cell-free fetal DNA (cffDNA) in maternal blood samples, useful for performing prenatal diagnosis. You can read more about the denial en banc here. In brief, the court was bound by the precedent of Mayo. The presence of paternally inherited cffDNA in maternal blood was a natural phenomenon, falling within a judicial exception to the general subject-matter eligibility of methods under § 101. After the claim elements that related to the natural phenomenon were removed from consideration, the remaining steps of the method were not enough to transform the claim into patentable subject matter under  what the Court described as “routine, conventional” laboratory techniques.

Sequenom’s petition for certiorari asks whether a novel method is patent-eligible where: (1) a researcher is first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.

If the Court grants certiorari, then it will be partly because the en banc opinion and the 22 amici persuaded the Court that the way that the § 101 analysis is being applied is too broad, preventing the patenting of meritorious discoveries. In the en banc opinion, Judge Dyk explained:

“In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself. This is especially true in the life sciences . . . . I worry that method claims that apply newly discovered natural laws and phenomena in somewhat conventional ways are screened out by the Mayo test. In this regard I think that Mayo may not be entirely consistent with the Supreme Court’s decision in Myriad.”

While a complete review of the issues raised by the 22 amici are not discussed here, several themes emerged from a review of the arguments filed.

International Implications

Briefly, the Mayo/Myriad framework conflicts with internationally accepted standards of patent eligibility. The brief submitted by the Institute of Professional Representatives before the European Patent Office points out the Mayo/Myriad framework results in an overbroad application that is at variance with the EPC and the requirements of Art. 27 of the TRIPS treaty. For example, in Genetic Technologies v. Merial, the Federal Circuit recently held the claims invalid, whereas a parallel patent application was granted by the EPO without objection as to eligibility. As it stands, the Federal Circuit is applying a rigid rule in which claims directed to a newly discovered law of nature, natural phenomenon, or an abstract idea cannot rely on the novelty of that discovery for the inventive concept. In contrast, the EPC allows claims directed to a discovery of laws of nature, natural phenomena, and abstract ideas if the discovery is put to practical use.

Mayo/Myriad Overbroad when Applied to Diagnostics

Population Diagnostics et al. and BIO echo the idea that the Mayo/Myriad framework is applied too broadly, explaining that courts and the USPTO, when faced with a claim that contains a judicial exception, reflexively invalidate the claim. “A natural substance being measured is labeled as a ‘natural phenomenon’ and a medical condition is labeled a ‘law of nature.’” Once step one of the Mayo test has been dispensed with, the claim elements are either: “(i) ignored; (ii) examined individually in isolation and found in isolation to be conventional; or (iii) examined as a combination – independent of their combined effect with the judicial exception – and again found to be conventional. In none of this analysis is the claim considered as a whole.”

In the Institute of Professional Representatives brief, this overbroad analysis is applied to something everyone understands: a hypothetical patent application with method claims for making an omelet. Beginning with step one of the Mayo test, the omelet method claims are “directed to” a product of nature. The method begins with eggs, ends with an egg product and is therefore “directed to” eggs. The transformation of the egg to an omelet is overlooked because cooking food in a pan is routine and conventional. Similarly, in Ariosa, the amplification step, the resulting amplified sequences, and the new utility of the amplification product were overlooked, and the claims held as directed to patent ineligible subject matter.

Certainty in Patent Law Drives Innovation

Several amici discuss the unintended consequences of this overbroad application of the Mayo/Myriad. The Amarantus Bioscience Holdings brief relates how potential investors have refused to invest in their promising biotechnology because patents in this area cannot be trusted. Lack of investment capital can kill new companies or prevent them from forming in the first place. Prior to Mayo/Myriad, the PTO issued some 40,000 DNA-related patents, covering about 20 percent of the genes in the human genome, giving investors certainty as to the enforceability of gene patents.

Obviously, the Court did not give much weight to longstanding PTO practice in deciding Mayo/Myriad, radically changing the enforceability of gene patents. However, longstanding PTO practice was used to decide a recent Federal Circuit case. The plaintiff in Immersion v. HTC challenged the longstanding PTO practice of filing a continuation on the same day as the parent application issues a patent (same-day continuation). The Federal Circuit relied on the “longstanding administrative construction” doctrine in upholding the use of same-day continuations: Adopting “HTC’s position would disturb over 50 years of public and agency reliance on the permissibility of same-day continuations . . . and would affect the priority dates of more than ten thousand patents.”

It is puzzling why the U.S. Supreme Court did not use “longstanding administrative construction” to uphold the pre-Myriad/Mayo/Alice interpretation of § 101. That ship has sailed, although the effects are manifold. Since 86 percent of diagnostic patent applications receive § 101 rejections, the validity of issued claims is in jeopardy. Hopefully, the Court will grant certiorari and refine the test so that certainty in patent law will incentivize development and disclosure to the benefit of the public.

USPTO Releases Update on Patent Eligibility Decision in Light of Enfish

On May 19, the USPTO released an update to patent examiners regarding the U.S. Court of Appeals for the Federal Circuit’s (CAFC) recent decision in Enfish, LLC v. Microsoft Corp. and TLI Communications LLC v. A.V. Automotive, LLC. Both cases were recently discussed in the 213 Blog. In Enfish, the CAFC held that a claimed database software designed as a “self-referential” table is patent eligible under 35 U.S.C. § 101, holding the software was not directed to an abstract idea. In TLI Communications, the court found claims directed to the steps of recording, administration and archiving of digital images to be abstract ideas as claims described generalized steps to be performed on a computer using conventional computer activity.

USPTO Releases Update on Patent Eligibility Decision in Light of Enfish

The USPTO characterized the Enfish and TLI Communications decisions as consistent with the UPTO’s previous guidance documents, stating “While the decision does not change the subject matter eligibility framework, it provides additional information and clarification on the inquiry for identifying abstract ideas (Step 2A of the subject matter eligibility examination guidelines).”

The fact that a claim is directed to an improvement in computer-related technology can demonstrate that the claim does not recite a concept similar to previously identified abstract ideas.

The update highlights four points made by the CAFC in subject matter eligibility analysis in the Enfish decision. First, the update reinforces the principle of comparing the concepts claimed in the claims at issue to concepts that were previously found to be abstract ideas or non-abstract ideas in previous court decisions. The final paragraph of the update reiterates this point stating “In summary, when performing an analysis of whether a claim is directed to an abstract idea (Step 2A), examiners are to continue to determine if the claim recites … a concept that is similar to concepts previously found abstract by the courts. The fact that a claim is directed to an improvement in computer-related technology can demonstrate that the claim does not recite a concept similar to previously identified abstract ideas.”

Second, the update emphasized the “directed to” inquiry as applying a filter to claims (interpreted in view of the specification) to determine if the character of the claims as a whole is directed to a patent ineligible concept. On this point, the update did not directly discuss the CAFC’s expanded analysis of the invention at Step 2A of the guidelines. However, the CAFC’s logic in finding the claims patent eligible in Enfish was discussed briefly, particularly with regard to examining the specification for the benefits of the claimed improvement over the prior art. The update clearly states that an examiner may determine that a claim directed to improvements in computer-related technology is not an abstract idea under Step 2A without analyzing the additional elements under Step 2B, thereby truncating the analysis.

Third, and importantly, the Federal Circuit cautions against describing a claim at a “high level of abstraction untethered from the language of the claim when determining the focus of the claimed invention” as the CAFC made abundantly clear in the Enfish decision. From a review of the previous subject matter eligibility guidelines, this is the strongest statement to date on this point. Fourth, and finally, the update notes that “an invention’s ability to run on a general purpose computer does not automatically doom the claim.”

The update concludes by comparing the TLI Communications decision with Enfish, noting in particular that the claimed functions, namely recording, administration and archiving of digital images, were found to be abstract ideas in Step 2A. The additional elements recited in the claims (a telephone and a server) did not add significantly more to the abstract idea as they were well- understood, routine, conventional activities.

In summary, it is likely that the examining corps will continue to undertake the Step 2A analysis by comparing the concepts of the claims under examination to concepts previously found to be abstract or non-abstract under previous case law and not undertake any in-depth analysis of the claims at Step 2A, as was done in the Enfish decision. One important point from the new update is the cautionary statement about characterizing the claims at a high level of abstraction. This concept was not stated clearly in the previous guidance documents (July 2012, March 2014, July 2015 or June 2016) and can provide a patent applicant responding to a subject matter eligibility rejection with strong arguments in appropriate circumstances. In this regard, remember the specification in Enfish recited a specific algorithm for the implementation of the claimed self-referential database, and this fact was cited by the CAFC as tailoring the scope of the claims in such a way that the claims did not read as “generalized” steps to be performed on a computer using conventional computer activity. Patent applicants should be mindful to provide a full description of the invention, including appropriate description of how the claimed invention functions and the improvements achievable by the claimed invention over the prior art.

Abstract Idea Exception Rules the Day in TLI Communications

Abstract Idea Exception Rules the Day in TLI CommunicationsThe Court of Appeals for the Federal Circuity (CAFC) has been busy on the patent eligibility front this month. After the recent Enfish decision, the CAFC handed down TLI Communications LLC v. AC Automotive, LLC the very next day. Unlike the decision in Enfish, the panel found the asserted claims invalid under 35 USC §101 as directed to an abstract idea.

TLI Communications recently asserted U.S. Patent No. 6,038,295 against a variety of parties. The ’295 patent “describes an apparatus for recording of a digital image, communicating the digital image from the recording device to a storage device and administering the digital image in the storage device.”

The court chose claim 17 as representative of the claims (although the patent also contained other independent claims reciting apparatus and system claims). Claim 17 recites:

A method for recording and administering digital images, comprising the steps of:

  • recording images using a digital pick-up unit in a telephone unit;
  • storing the images recorded by the digital pick-up unit in a digital form as digital images;
  • transmitting data including at least the digital images and classification information to a server, wherein said classification information is prescribable by a user of the telephone unit for allocation to the digital images;
  • receiving the data by the server;
  • extracting classification information which characterizes the digital images from the received data; and
  • storing the digital images in the server, said step of storing taking into consideration the classification information.

The district court concluded the claims were directed to “the abstract idea of taking, organizing, classifying, and storing photographs.”

The decision itself is not surprising given the claimed subject matter and the breadth with which the subject matter was claimed. The CAFC analyzed the claims under the two-step analysis in Alice, first determining if the claims at issue were directed to a patent-ineligible concept, and if so, considering claim elements individually and as an ordered combination to determine if the additional elements transform the nature of the claim into a patent-eligible application. In implementing step one of the Alice analysis, the CAFC concluded that claims directed to attaching classification data to images for the purpose of storing the images in an organized way is a well-established “basic concept,” citing Content Extraction for this purpose, and as such were encompassed by the step one analysis. In step two, the CAFC concluded that the claims failed to provide any element or combination of elements sufficient to transform the abstract idea into a patent-eligible application of that idea, stating that mere recitation of tangible components that perform well-understood conventional activity is insufficient to confer patent eligibility to an otherwise abstract idea.

“Although the claims recite that the abstract idea of classifying and storing digital images in an organized manner is carried out in a telephone system, the ’295 patent fails to provide the requisite details necessary to carry out that idea.”

TLI argued that the claimed methods were directed to an “improvement to computer functionality” as successfully argued in Enfish. The CAFC disagreed stating “…the problem facing the inventor was not how to combine a camera with a cellular telephone, how to transmit images via a cellular network, or even how to append classification information to that data. Nor was the problem related to the structure of the server that stores the organized digital images.”  Rather the court characterized the improvements claimed as providing “…for recording, administration and archiving of digital images simply, fast and in such way that the information therefore may be easily tracked.” The panel noted that the specification does not describe a new telephone, a new server, or a new physical combination of the two and described the components in vague and general terms consistent with their use in the art, resulting in the components behaving “exactly as expected according to their ordinary use.”

The step two analysis in Alice touched on many of the same issues as discussed in step one, namely the use of generic physical components that performed as known in the art. The CAFC also noted that the specification “fails to provide the requisite details necessary to carry out” the ideas claimed (note that in Enfish the method for creating the self-referential tables was limited to the use of a particular four-step algorithm described).

In Enfish, the CAFC terminated the Alice inquiry at step one, finding that the claims as a whole were not “directed to excluded subject matter” and determined the self-referential database claimed improved computer functionality thereby satisfying an exception to the abstract idea classification. As such, the court examined the merits of the claimed invention in detail.  While conducting the entire two-step analysis in this case, the panel appeared to examine a wider range of factors than in previous cases under the step one analysis as done in Enfish. As a result, the court in step one did more than compare the concept claimed to other concepts that had been determined to be abstract ideas in previous cases. It will be interesting to see if this expanded step one inquiry trend continues.

In summary, the factors that weighed against the claims in this case were the description in the specification that stressed the conventional activity of the recited tangible components and the failure of the specification to provide a clear means by which to solve a technological problem in the art (i.e., a challenge particular to the Internet or improving the functionality of a computer). In order to avoid a similar fate, in claims directed to subject matter that has been held to be an abstract idea by the courts, care must be taken to clearly point out how to implement the ideas described and link the described solutions to the solution of a particular problem known in the art.

Not All Software Claims are Abstract Ideas Under Alice

Not All Software Claims are Abstract Ideas Under AliceOn May 9, Mercury navigated its way between the earth and the sun (a “transit “in astronomical terms), an event that will not occur again until 2019. The Federal Circuit in Enfish, LLC v. Microsoft Corp (2015-1244) provided a legal equivalent this month by holding that claims directed to a data storage and retrieval system for computer memory successfully transited the two-pronged Alice test and were valid under 35 USC §101.

In 2012 Enfish asserted U.S. Patent Nos. 6,151,604 and 6,163,775 against several parties, including Microsoft. The Federal Circuit described the claims as a logical model (a model of data explaining how the various elements of information in a computer database are related to one another) that included all data entities in a single table, with column definitions provided by rows in that same table (i.e., a “self-referential” database). The prior art computer databases are relational (each type of information is provided in a separate table of rows and columns with relationships between those tables informing the relationships between rows in different tables). Advantages of the self-referential database (from the specification) included faster searching of data, more effective storage of data and added flexibility in configuring the database.

Claim 17 of the ‘604 patent was exemplary of the claims at issue:

A data storage and retrieval system for a computer memory comprising means for configuring said memory according to a logical table, including:

  • A plurality of logical rows, with each said logical row including an object identification number (OID) to identify each said logical row, each said logical row corresponding to a record of information;
  • A plurality of logical columns intersecting said plurality of logical rows to define a plurality of logical cells, each said logical column including an OID to identify each said logical column; and
  • Means for indexing data stored in said table.

The district court found all asserted claims invalid under §101. The district court analyzed the claim limitation “means for configuring” under 35 USC 112(6), thereby limiting the term to the four-step algorithm described in the specification and concluded the claims were directed to “the concept of organizing information using tabular formats” which amounts to an abstract idea under current law.

The Federal Circuit analyzed the claims under the traditional two-part test in Alice. In step one of the analysis, a court must determine whether the claims at issue are “directed to” a patent-ineligible concept and, if so, determine in step two whether any element or combination of elements in the claims is enough to ensure that the claims cover something more than the judicial exception. The court characterized the “directed to” inquiry in step one as “meaningful” and one that “cannot simply ask whether the claims involve a patent-ineligible concept.” Rather the “directed to” inquiry applies a filter to the claims, considered in light of the specification, to determine if their character as a whole is directed to excluded subject matter, citing Internet Patents Corp. and the search for an inventive concept analysis which “is facilitated by considerations analogous to those of the §§102 and 103…”.

The court declined to read Alice broadly to mean all improvements in computer-related technology are inherently abstract and concluded that where the claims are not squarely directed to excluded subject matter (for example, fundamental economic and conventional business practices), the “directed to” inquiry in step one can include the inventive concept analysis.

As a result, the court’s first step in the Alice inquiry here focused on whether the claims directed to self-referential databases were improvements in computer operation or were directed to the process of organizing information where the computer is merely a tool (an abstract idea). The Federal Circuit reached the conclusion that the claims “…are directed to a specific improvement to the way computers operate, embodied in the self-referential table” and as such were more than a mere abstract idea. Because the court found step one of the Alice inquiry was satisfied, the step two analysis was not required.

In sum, the self-referential table recited in the claims on appeal is a specific type of data structure designed to improve the way a computer stores and retrieves data in memory.

The court criticized the district court’s analysis of the claims as being conducted at “a high level of abstraction and untethered from the language of the claims” that would all but ensure the exceptions to §101 will swallow the rule. The court viewed the claims as not directed to any form of storing tabular data, but to the disclosed self-referential table for a computer database resulting from the four-step algorithm, thereby limiting the scope of the claims (a factor which distanced the claimed from an abstract idea, see Internet Patents Corp.). The court noted that the function of the self-referential tables were different from conventional database structures and that these structures provided distinct advantages over the prior art (in both cases, relying heavily on the specification).

In the Enfish analysis, the court altered the Alice test, providing a way to avoid the full two-step analysis if the claimed invention is clearly not abstract (which is still determined in large part based on comparison of the invention to prior 101 case-law). In such cases, Alice is now a one-prong analysis. The Federal Circuit also recognized the improvement can be implemented on a general-purpose computer and is not defined by a physical component, concluding these factors do not always indicate an abstract idea. The court distinguished prior decisions as adding conventional computer components to well-known business practices or reciting general steps to be carried out on a computer using conventional computer activity and noted that “Much of the advancement made in computer technology consists of improvements to software that, by their very nature, may not be defined by particular physical features but rather by logical structures and processes.”

A claim drafting consideration as a result of this decision is to consider describing how the invention is an improvement over the prior art, particularly when improving the operation of a computer or system is at issue. As the claims in this case point out, the improvements described do not need to be presented in the independent claims. Of course, when pointing out the benefits of the invention, thought must be given to how these statements could result in estoppel. Enfish also makes it clear that the claims are not required to include a physical/hardware component to comply with section §101. Finally, methodology for applying invention should be disclosed and support for tailored claims should be provided in order to avoid the rejections based on undue breadth of the claims.

The Government Whittles Away at Life Sciences Patents

The Government Whittles Away at Life Sciences PatentsThe current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention.  The Court has attempted to carve out special exceptions to the congressional mandate that patents will be granted for “any new and useful process, machine, manufacture, or composition of matter” to target inventions in software and the life sciences. However, it has done so unartfully by issuing vaguely worded decisions, leaving the regulated public in a cloud of great uncertainty. In an attempt to disperse this cloud of uncertainty, the United States Patent and Trademark Office (USPTO) has issued several lengthy statements as to how it will attempt to apply the Court’s decisions.

Up until now, the USPTO has provided guidance on software patents and patents for naturally derived products, but no guidance has been provided for the most vexing Supreme Court ban: the ban on methods of diagnosing disease. On May 2, 2016, the USPTO finally issued guidance on diagnostic methods and additional guidance on patenting naturally derived products. An especially helpful part of this guidance comes in the form of numerous specific examples of patent eligible and non-eligible life science inventions. The examples are summarized below.

Vaccines

One of the USPTO’s examples includes seven vaccine claims. The USPTO has taken the position that both killed and attenuated vaccines are patent eligible; the examples are for killed and attenuated virus particles, but the same logic should apply to other pathogens such as bacteria. Vaccines containing isolated antigens will also be allowed, if the vaccine contains another functionally significant ingredient, such as an adjuvant or a non-natural carrier that improves its function. However, the USPTO will not allow claims to a vaccine that is an isolated antigen in water or another carrier that does not affect the functioning of the vaccine. This is a significant departure from previous policy! Up until the present time, claims to any kind of pharmaceutical preparation comprising a natural compound (such as an antigen) and a pharmaceutically acceptable carrier have been allowed, so long as the compound is not naturally found in the carrier.

This policy shift will make it difficult to patent new vaccines based on isolated antigens. Antigen-based vaccines have been a boon to humanity in their ability to prompt highly specific immunity with fewer side effects and less cross-reactivity. However, apparently these can only be patented in the future in combination with other ingredients that modify their effects. Despite this guidance, note that one can still claim a method of vaccinating a person by administering the antigen, although the scope of protection differs from claiming the vaccine itself.

Medical Diagnosis

Since the Supreme Court’s renewed interest in patents, methods of diagnosing disease have been one of the areas of technology that have been the hardest hit. The Supreme Court’s ban on medical diagnosis was especially obtuse, and the USPTO has probably waited until this time to articulate its policy in order to let lower courts attempt to make sense of it. The USPTO has now taken the position that a method of diagnosis is not patent eligible if it includes only conventional steps such as obtaining a biological sample and testing the sample for the presence of a biomarker. However, the USPTO will allow patents on methods of detecting the biomarker without making a diagnosis — but only if the method of detecting the biomarker meets the ordinary patenting requirements of newness and inobviousness.  Consequently, testing for a previously unknown biomarker can be patented, but the discovery that a known biomarker has a new diagnostic value cannot. In addition, the use of new diagnostic reagents can be patented, such as a recombinant antibody or a xeno-antibody. A method of treating the disease state with a new treatment after diagnosis can also be patented.

These examples support the status quo ante at the USPTO that methods of diagnosing disease by testing for the presence or concentration of biomarkers are banned from patenting.

Food Additives

Example #30 is a hypothetical dietary sweetener, but it could apply to any newly discovered natural product that is useful as a food additive. As in the vaccine example, the USPTO will not allow a claim to a natural sweetener in water. A claim to the sweetener in water at a specific concentration range will not be allowed either, unless the concentration in question imparts a non-natural property to the sweetener. On the other hand, claims to the sweetener in combination with other ingredients, with which it does not occur naturally, will be allowed. It is interesting to note that the USPTO has taken the position that a qualifier such as “in a controlled release formulation” will be allowed, as the property of controlled release does not occur naturally.

Just as a vaccine cannot be defined as a newly discovered antigen, alone or in a generic carrier, a food additive cannot be defined as a newly discovered natural compound, alone or in solution. In order to obtain a patent, the invention must be defined as the additive in combination with another ingredient that changes the additive’s properties.

Genetic Screening

The Supreme Court’s first ban against patenting life science inventions was directed at synthetic DNA for genetic screening, and this remains a somewhat difficult technology to patent in the U.S. When it comes to genetic screening, the USPTO will not allow patents for the simple act of comparing a patient’s genome to another sequence because this is viewed as an “abstract mental step.” However, methods of genetic screening can be patented that are limited to specific chemical methods of genetic comparison, such as probe hybridization in combination with a specific method of detecting the hybridized probe. The USPTO will also allow methods to be patented that include highly specific and unusual chemical reactions.  It is particularly interesting to note that methods of DNA hybridization and amplification that omit any step for evaluating the meaning of the results for the patient will be allowed.

Based on this guidance, it will continue to be difficult to patent methods of genetic screening if the gene in question was already known, regardless of whether its function was understood. It would appear that one can claim methods of detecting newly discovered genes, but the value of such claims in the era of big genomics is highly questionable.

What Hasn’t Changed?

Prior guidance from the USPTO does not appear to have been disturbed by the new guidance.  Patents will still be allowed for DNA and RNA with artificial sequences (such as cDNA), natural products with additives such as preservatives (such as preserved fruit juice), chemically modified forms of natural compounds with modified properties or functions (such as botanical compounds, humanized antibodies, chimeric antibodies, and antibiotics), methods of treating disease by administering natural substances as medicines, genetically modified organisms (such as bacteria and human cell lines), fluorescently labelled natural compounds, and genetic vectors containing natural genes.

Previous guidance has also stated that patents will not normally be allowed for the purified forms of anything natural (nucleic acids, antibodies, proteins, cell lines, etc.), except if purification somehow changes its structure and function. For example, if purifying a compound that is naturally in solution results in an unnatural crystalline form of the compound, then the purified compound can be patented.  Isolated nucleic acids having natural sequences seem to be categorically excluded. Although adding a natural compound to a pharmaceutical carrier will not result in a patent, the USPTO has previously said that claiming a natural compound in a capsule is allowed, although the reason for this difference is not completely clear. Combining natural things without changing their function cannot be patented, but any change in function of such natural things in combination as compared to uncombined can be the basis for a patent. For example, a microbial consortium can be patented only if the bacteria in combination accomplish something that no species could accomplish alone.

How to Adapt?

The USPTO guidance does not have the force of law, and there is no guarantee that courts will follow it. For the most part, the guidance is clear and generally well-reasoned based on the Supreme Court’s recent rulings. Innovative life sciences companies can adapt to the new landscape by evaluating their technology early in development to determine whether versions of the invention that are allowable in the United States have any commercial value. If not, then concentrate on the needs of markets outside of the United States where by and large patents still cover useful, newly discovered natural substances and methods of medical diagnosis.

It may be possible to keep newly discovered natural products or biomarkers as trade secrets where no regulatory approval is required. Even when regulatory approval is required, instead of seeking regulatory approval for the non-patentable natural compound, consider generating a chemically modified version, maintaining the natural parent compound as a trade secret, then applying for patent protection and regulatory approval only for the modified version. Other alternative strategies are possible depending on the situation.

Novel Applications of Natural Laws Remain Unpatentable Under 35 USC §101

Novel Applications of Natural Laws Remain Unpatentable Under 35 USC §101In Genetic Technologies (GTG), the U.S. Court of Appeals for the Federal Circuit (CAFC) held the line in the patent eligibility saga in the field of biotechnology.  GTG asserted U.S. Patent No. 5,612,179 against Merial and Bristol Myers. The ‘179 patent claims a method of genetic analysis based on the discovery that the presence of certain DNA sequences in coding regions (exons) of genes are correlated with the presence of certain DNA sequences in non-coding regions (introns) of the genome. In other words, a specified exon sequence is preferentially inherited together with a specified intron sequence. When this occurs, the sequences are said to be in linkage disequilibrium. As a result, an allele (or particular form) of a gene may be detected not by analyzing the coding region of the gene but rather by amplifying and analyzing non-coding regions known to be in linkage disequilibrium with the allele. The information can be used to diagnose and treat genetic disorders and diseases correlated with those alleles (for example, cystic fibrosis).

The district court granted a motion to dismiss for failure to state a claim (without conducting a claim construction hearing) and found claims 1–25 and 33–36 of the ’179 patent invalid under 35 U.S.C. § 101. On appeal, the parties stipulated that claim 1 (below) was representative of the claims regarding eligibility under §101.

A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

  • amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
  • analyzing the amplified DNA sequence to detect the allele.

CAFC Logic
In determining the subject matter eligibility question, the CAFC employed the Supreme Court’s two-part test described in Alice and Mayo. Step one requires a determination of whether the claims at issue are directed to a patent-ineligible concept. If so, step two requires an analysis of the claims for an “inventive concept,” which has been applied as requiring the claims to provide something inventive, beyond mere “well-understood, routine, conventional activity” (in other words, the “inventive concept” cannot be furnished by the law of nature itself). The purpose of step two is to ensure that the claims, when practiced, add up to significantly more than a patent upon the patent-ineligible concept itself.

In part one of the analysis, the CAFC found the relationships recited in claim 1 to be a law of nature, stating “linkage disequilibrium is indisputably a universal, inherent feature of human DNA.” The court further spoke to the breadth of the claims, stating claim 1 covers “any comparison, for any purpose, of any non-coding region sequence known to be linked with a coding region allele” and the methods were not limited to detecting particular alleles linked to any particular non-coding sequences.

In step two of the analysis, the court found claim 1 contained two implementation steps: 1.) “amplifying genomic DNA with a primer pair;” and 2.) “analyzing the amplified DNA sequence to detect the allele.” The court found both of these concepts to be well-understood, routine and conventional activity, citing portions of the patent specification, prosecution history and general knowledge as of the filing date of the ‘179 patent.

The court found two arguments advanced by GTG to be unpersuasive in step two of the analysis. First, GTG argued that the claims required analysis of man-made amplified DNA, which differs from naturally occurring DNA (for example, in methylation status). The court found the amplified sequence to primarily represent the information content of the genomic DNA and that the minor chemical differences between genomic DNA and amplified DNA were irrelevant, mirroring the USSC logic in Ass’n for Molecular Pathology. Second, GTG argued that claim 1 requires a user to to analyze the amplified non-coding DNA sequence to detect the coding region once the non-coding DNA has been amplified and analyzed. In rejecting this argument, the CAFC found that this step was simply a mental step that could be conducted by the human mind and was tantamount to a claim describing the natural law with the instructions “apply it” (again making analogies to Mayo). The court concluded by stating the “simple mental process step of detect[ing] the allele in claim 1, either alone or in combination with the physical steps described above, does not supply sufficient inventive concept to make the claim patent-eligible under §101.”

The court also dismissed, with little comment, GTG’s argument that claim 1 was patentable based on its usefulness, noting that the claims in Mayo and Ariosa were also useful, were held to be invalid under §101, and that the rejection of claim 1 was not based on lack of utility.

Implications
This decision clearly shows that certain judges of the CAFC read the requirements of step two of the Alice/Mayo test as requiring a new physical technique to be disclosed in claims and will dismiss arguments that the methods themselves are unique/have not been used. In this case (like in Ariosa), the method claimed was a new and innovative application of knowledge. In addition, did the court not provide adequate consideration of the “primer pair” limitations as requiring a physical structure that would result in a specific application of the natural law? It should be noted that the claims at issue here did not specify particular primer pairs or specific combinations of exon and intron sequences, although the ‘179 specification contained support for such combinations. One wonders whether a claim reciting a specific exon/intron combination with specific primers would be patentable. While such a claim would still rely on the natural law of linkage disequilibrium, the presence of specific compositions and relationships would clearly limit the application of the natural law in a way that relied on a defined combination. In evaluating such claims, courts should consider the USSC warning in Myriad that overzealous application of the subject matter eligibility exceptions will “eviscerate patent law.”

When drafting patent claims to diagnostic techniques or analytical techniques, claims specifying particular applications and particular combinations of physical elements should be included to allow for focused arguments against rejections under §101 when possible.

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