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PTO Can and Should Use Alice/Mayo Framework to Assess Eligibility

Addressing a challenge of the Alice/Mayo framework in the context of the Administrative Procedure Act (APA) and the Fifth Amendment’s due process clause, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision finding that patent claims directed to analyzing social security benefit applications were patent ineligible under 35 U.S.C. § 101. In re Killian, Case No. 21-2113 (Fed. Cir. Aug. 23, 2022) (Taranto, Clevenger, Chen, JJ.)

Jeffrey Killian filed a patent application related to a system and method for determining eligibility for social security disability insurance (SSDI) benefits through a computer network. The examiner rejected the claims under § 101, finding that they were directed to the abstract idea of “determining eligibility for social security disability insurance . . . benefits” and lacked additional elements amounting to significantly more than the abstract idea because the additional elements were simply generic recitations of generic computer functionalities. Killian appealed to the Board, which affirmed the examiner’s rejection. The Board explained that the claims were directed to the patent ineligible abstract idea of “a search algorithm for identifying people who may be eligible for SSDI benefits they are not receiving,” and that the “determining” and “selecting” limitations of the claims could be performed by the human mind and thus were an “abstract mental process.” Killian appealed.

Killian raised several arguments that generally fell into three categories:

  1. The Alice/Mayo standard is indefinite under the APA.
  2. The § 101 analysis for software violated Killian’s Fifth Amendment due process rights.
  3. Step 2 of the Alice/Mayo analysis has no basis in patent law.

Addressing the first argument, the Federal Circuit noted that the APA cannot apply to the decisions of courts because courts are not agencies. Next, the Court dismissed Killian’s argument that all § 101 decisions are void because the Alice/Mayo standard is indefinite. The Court explained that it has routinely found that mental processes are abstract ideas, including claims that were directed to data gathering, analysis and notification on generic computers. The Court found that nothing in Killian’s claims provided an inventive manner to accomplish the claimed method, and thus the § 101 rejection was entirely proper. As a final point, the Court stated that it was bound to Supreme Court precedent and only new overruling precedent would change the analysis it applied.

The Federal Circuit also rejected Killian’s due process argument. Killian argued that his due process rights were violated because he did not have an opportunity to appear in the other cases regarding patent eligibility. As an initial matter, the Court noted that no “void-for-vagueness” doctrine argument was put forward, and the doctrine requires a case-by-case analysis. The Court found that this was not a close case, as data gathering and analysis methods run afoul of established § 101 precedent. Next, the Court addressed the common law approach of not requiring “a single governing definitional context” and a comparison to previously decided cases finding it appropriate. Killian’s due process rights were found to [...]

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PTO Presentation Seeks to Clarify Subject Matter Eligibility Requirements

On August 9, 2022, the US Patent & Trademark Office (PTO) gave a public presentation, “Subject Matter Eligibility Under 35 U.S.C. § 101: USPTO Guidance and Policy.” During the presentation, the PTO indicated that its goal is to identify eligible subject matter and not reject patent applications under 35 U.S.C. § 101 where possible. However, subject matter eligibility must be determined in accordance with Supreme Court precedent as set forth in Bilski v. Kappos (2010); Mayo Collaborative Servs. v. Prometheus Labs, Inc. (2012); Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Alice Corp. v. CLS Bank International (2014). The PTO presented several biotech examples demonstrating how subject matter ineligible claims could be redrafted to encompass eligible subject matter.

The PTO presented a detailed explanation of the two-step subject matter eligibility flowchart in MPEP § 2106 and emphasized the differences between the two prongs of Step 2A. The first prong is to evaluate whether the claim recites a judicially recognized exception to eligibility. If the claims do not recite an exception, they qualify as eligible subject matter. If the claims do recite a judicial exception, the analysis proceeds to the second prong of Step 2A, which is to evaluate whether the claims recite additional elements that integrate the exception into a practical application of the exception. If the claims do recite additional elements integrating the exception into a practical application of the exception, they qualify as eligible subject matter. If the claims do not do so, the analysis proceeds to Step 2B to determine whether the claims recite additional elements that amount to significantly more than the judicial exception.

While there is significant overlap between Step 2A prong two and Step 2B, the PTO noted that under Step 2A prong two, the additional elements may be well understood, routine, conventional activity, unlike in Step 2B. For example, if conventional steps were used to affect a particular treatment or prophylaxis for a disease or medical condition, or if conventional material was used in an unconventional application, the claims would be subject matter eligible.

The PTO warned against claiming methods as a series of mental processes, mere data gathering or steps that merely apply the judicial exception.

As noted, the PTO highlighted techniques for transforming subject matter ineligible claims into subject matter eligible claims. These techniques include reciting properties that naturally occurring compositions do not possess, showing that the claimed composition possesses properties not found in naturally occurring compositions, using a conventional material or conventional method in an unconventional application and specifying a particular treatment.

Practice Note: Readers may be interested in an IP Update Legislative Alert reporting on a bill introduced by Senator Tillis to amend §101, which can be found here.




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Standard Techniques Applied in Standard Way to Observe Natural Phenomena? Not Patent Eligible

In what may be another blow to diagnostic patents, the US Court of Appeals for the Federal Circuit affirmed the patent ineligibility of claims that it held to be directed to detecting natural phenomena by conventional techniques. CareDx, Inc. v. Natera, Inc., Case No. 2022-1027 (Fed. Cir. July 18, 2022) (Lourie, Bryson, Hughes, JJ.)

CareDx is the exclusive licensee of three Stanford University patents directed to diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. Detecting the naturally increased levels of donor cfDNA (due to the deteriorating organ condition) can be used to diagnose the likelihood of an organ transplant rejection.

The representative claims were summarized as having four steps for detecting a donor’s cfDNA in a transplant recipient:

  1. “Obtaining” or “providing” a “sample” from the recipient that contains cfDNA
  2. “Genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”
  3. “Sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing, or performing “digital PCR”
  4. “Determining” or “quantifying” the amount of donor cfDNA.

CareDx filed two lawsuits, one alleging that Natera’s kidney transplant rejection test infringed the patents, and another alleging that Eurofins Viracor’s various organ transplant rejection tests infringed one of the patents. Natera and Eurofins moved to dismiss the complaints for failing to state a claim because of a lack of patent-eligible subject matter under 35 U.S.C. § 101. The magistrate judge who reviewed the motions recommended that they be denied, finding that the claims were a “purportedly new, unconventional combination of steps” to detect natural phenomena. Although the recommendation was vacated with regard to Natera because the complaint was amended, the district court adopted the magistrate’s recommendation as to Eurofins with modified reasoning that the patent “specifications raise doubts about the patents’ validity” by suggesting that the steps were neither new nor unconventional. Still, the district court was wary of ruling prematurely and denied the motion so that the parties could conduct discovery to develop the record on what was considered conventional in the art.

Following expert discovery relating to § 101 eligibility, Natera and Eurofins moved for summary judgment on patent ineligibility. The district court denied summary judgment, citing a factual dispute as to the conventionality of the techniques for performing the claimed methods. Natera and Eurofins moved for certification of interlocutory appeals of the district court’s denial. After conferring with the parties, the district court agreed to reconsider its decision in view of case law raised in the certification motion. After reconsideration, the district court granted the summary judgment motions of ineligibility, finding that the asserted claims were directed to the detection of natural phenomena—specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection—and concluding that based on the specification’s many admissions, the claims recited only conventional techniques.

CareDx appealed, arguing [...]

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PTO Issues Report to Congress on Patent Eligible Subject Matter

On June 24, 2022, the US Patent & Trademark Office (PTO) issued a report to Congress titled “Patent Eligible Subject Matter: Public Views on the Current Jurisprudence in the United States.” The report comes in response to a March 5, 2021, letter from Senators Tillis (R-NC), Coons (D-DE), Hirono (D-HI) and Cotton (R-AR) expressing concern over a lack of consistency and clarity in US patent eligibility laws since the Supreme Court of the United States’ rulings in Alice Corp. v. CLS Bank International and Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. The PTO solicited public feedback until October 15, 2021, and the report summarizes the PTO’s findings based on the 141 comments it received.

The report found that supporters of the current state of the law on eligibility tended to be companies faced with abusive and costly litigation involving “overbroad” patents, mostly related to software. Those companies noted that the current law allows them to avoid or more efficiently resolve abusive and costly litigation. Some high-tech representatives noted that their investments and innovations have increased under current eligibility jurisprudence. Certain life sciences and patient advocacy organizations also favored the current law, noting its role in enhancing access to medical technologies.

Respondents critical of the current state of the law included many patent practitioners and innovative companies, especially companies involved in life sciences. These respondents stated that current law makes patents less available and rights less predictable and has inhibited investment in new technologies and companies. Several startups and small- and medium-sized enterprises also noted that the current law undermines innovation by decreasing the availability of private risk capital and works to concentrate markets in the hands of a few large, well-resourced entities, thereby decreasing competition. Some commenters stated that they no longer seek patents and instead rely on trade secrets, resulting in reduced public disclosure of technological innovations.

The PTO will continue to solicit feedback from stakeholders, including through listening sessions. The PTO noted that additional feedback and suggestions may be sent to 101@uspto.gov.




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2022 IP Outlook Report: The Developments Shaping Patent Law

Key Takeaways and Outlook for 2022

Tracking with this era’s continuation and uncertainty trends―global supply chain disruption, innovation outpacing legislation, the unstoppable internet of [all the] things (IoT)―2022 is expected to be another busy year in the world of patent litigation.

We fully expect persistence in these spaces:

  1. Patents/SEP FRAND Licensing
  2. Venue Developments
  3. Subject Matter Eligibility Roundup in 2021
  4. PTAB IPRs, CBMS and Other Proceedings

Read the full report.




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PTO Proposes Deferred Responses for Subject Matter Eligibility Rejections

In a January 6, 2022, Federal Register notice, the US Patent and Trademark Office (PTO) announced its intention to implement a pilot program to evaluate the effects of permitting applicants to defer responding to subject matter eligibility (SME) rejections in certain patent applications. Under this pilot program, applicants may receive invitations to participate if their applications meet the program’s criteria, including a criterion that the claims in the application necessitate rejections on SME and other patentability-related grounds. An applicant who accepts the invitation to participate in this pilot program must still file a reply addressing all the rejections except SME rejections in every office action mailed in the application but is permitted to defer responding to SME rejections until the earlier of final disposition of the application or the withdrawal or obviation of all other outstanding rejections.

Invitations to participate in the Deferred Subject Matter Eligibility Response pilot program will be mailed during the period between February 1, 2022, and July 30, 2022. The PTO may extend, modify or terminate the pilot program depending on the workload and resources necessary to administer the program, feedback from the public and the program’s effectiveness.

Because satisfaction of non-SME conditions for patentability (e.g., novelty, nonobviousness, adequacy of disclosure and definiteness) may resolve SME issues as well, the pilot program may result in improved examination efficiency and increased patent quality.

An examiner may invite a prospective applicant to participate in the pilot program by including a form paragraph in the first office action on the merits. An applicant receiving an invitation to participate in the pilot program may elect to accept or decline the invitation. If an applicant wishes to participate in the program, they must file a properly completed request form PTO/SB/456 concurrently with a timely response to the first office action on the merits. The request form must be submitted via the PTO’s patent electronic filing systems.

The limited waiver permits the applicant to defer addressing the SME rejections until the earlier of final disposition of the participating application or the withdrawal or obviation of all other outstanding rejections. A final disposition is the earliest of the following:

  • Mailing of a notice of allowance
  • Mailing of a final office action
  • Filing of a notice of appeal
  • Filing of a request for continued examination
  • Abandonment of the application.

Applicants must address the SME rejections in a response to a final rejection or the filing of a request for continued examination.

The public is invited to submit comments, which must be received by March 7, 2022, to ensure consideration.




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Federal Circuit Reverses Judge Stark Decision, Finds Computer Network Patent Eligible

The US Court of Appeals for the Federal Circuit concluded that a representative claim was directed to a patent-eligible improvement to computer functionality, and therefore reversed a decision authored by Judge Leonard P. Stark as a sitting judge in the US District Court for the District of Delaware. Mentone Solutions LLC v. Digi International Inc., Case Nos. 21-1202, -1203 (Fed. Cir. Nov. 15, 2021) (Moore, C.J.) (nonprecedential).

Mentone Solutions sued Digi International for infringement of Mentone’s patent directed to an improvement in dynamic resource allocation in a GPRS cellular network utilizing shifted uplink status flags (USF). Digi moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing that the patent claims were not patent eligible under 35 U.S.C. § 101. The district court granted the motion to dismiss, holding that the representative claim was patent ineligible for being “directed to the abstract idea of receiving a USF and transmitting data during the appropriate timeslots.” Mentone appealed.

The Federal Circuit began its analysis with a detailed explanation of the claimed technology and how its use of a “shifted USF” improved the normal operation of the communication system, noting that the shifted USF specifically allowed a mobile station to access previously restricted multi-slot configurations.

Reviewing the district court’s § 101 eligibility determination de novo, the Federal Circuit applied the Supreme Court’s two-step Alice framework, first determining whether the representative claim was directed to an abstract idea. The Court explained that in cases involving software, step one often turns on whether the claim focuses on specific asserted improvements in the computer’s capabilities rather than on an abstract idea which merely invoked a computer as a tool.

The Federal Circuit compared the claim in issue to those at issue in Packet Intelligence v. NetScout Sys., in which the Court found that the challenged claims were directed to a problem unique to computer networks and that the patent specification provided details on how the solution to the network problem was achieved. In Packet Intelligence, the Court looked to the patent specification to inform its understanding of the claimed invention and found that the specification made clear that the claimed invention solved a challenge unique to computers.

Similarly, in this case, the Federal Circuit explained that the representative claim did not recite generalized steps to be performed on a computer but rather a particular method of breaking the timing between the downlink USF and the subsequent uplink transmission. The Court noted that the term “shifted USF” was coined by the inventor, and that the specification and figures informed the Court’s understanding of the term, the claimed invention, the technical solution and how the elements of the claim work together to provide the solution. The Court concluded that the claimed invention solved a challenge unique to computer networks and was directed to patent-eligible improvements in computer functionality.

The Federal Circuit rejected the district court’s characterization of the claim as directed to the abstract idea of “receiving a USF and transmitting data during the appropriate [...]

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Bascom Cannot Save Your Claims if Your Own Patent Says You Used Known Technology

The US Court of Appeals for the Federal Circuit affirmed a district court determination that claims of several patents were patent ineligible under 35 U.S.C. § 101 because they did not recite an innovation with sufficient specificity to constitute an improvement to computer functionality. Universal Secure Registry LLC v. Apple Inc., Case No. 20-2044 (Fed. Cir. Aug. 26, 2021) (Stoll, J.)

Universal Secure Registry (USR) sued Apple, Visa and Visa U.S.A. (collectively, Apple), asserting four patents directed to securing electronic payment transactions, which USR alleged allowed for making credit card transactions “without a magnetic-stripe reader and with a high degree of security” (e.g., allegedly Apple Pay or Visa Checkout). Apple moved to dismiss the complaint under Fed. R. Civ. Pro. 12(b)(6), arguing that the asserted patents claimed patent-ineligible subject matter under 35 U.S.C. § 101. The Delaware magistrate judge, quoting Visual Memory v. NVIDIA (Fed. Cir. 2017), determined that all the representative claims were directed to a non-abstract idea because “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.”

The district court judge disagreed, concluding that the representative claims failed at both Alice steps, and granted Apple’s motion to dismiss. The district court found that the claimed invention was directed to the abstract idea of “the secure verification of a person’s identity,” and that the patents did not disclose an inventive concept—including an improvement in computer functionality—that transformed the abstract idea into a patent-eligible application. USR appealed.

In assessing the claims under the Alice two-part test, the Federal Circuit noted that in cases involving authentication technology, patent eligibility often turns on whether the claims provide sufficient specificity to constitute an improvement to computer functionality itself. For example, in its 2017 decision in Secured Mail Solutions v. Universal Wilde, the Court (at Alice step one), held that claims directed to using a conventional marking barcode on the outside of a mail object to communicate authentication information were abstract because they were not directed to specific details of the barcode, how it was processed or generated or how it was different from long-standing identification practices. Similarly, in its 2020 decision in Prism Technologies v. T-Mobile, where the claims broadly recited “receiving” identity data of a client computer, “authenticating” the identity of the data, “authorizing” the client computer and “permitting access” to the client computer, the Court held at Alice step one that the claims were directed to the abstract idea of “providing restricted access to resources,” not to a “concrete, specific solution.” At step two, the Court determined that the asserted claims recited conventional generic computer components employed in a customary manner such that they were insufficient to transform the abstract idea into a patent-eligible invention.

The claims in issue fared similarly. The district court held that the representative claim was not materially different from the Prism claims, and the Federal Circuit agreed. Although the [...]

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Targeted Advertising Still Patent Ineligible Subject Matter

The US Court of Appeals for the Federal Circuit found that targeted advertising is still an abstract idea and that a system providing targeted advertising must utilize something more than generic features and routine functions to be eligible for patent protection. Free Stream Media Corp. v. Alphonso Inc., Case No. 19-1506 (Fed. Cir. May 11, 2021) (Reyna, J.)

Free Stream Media, d.b.a. Samba, owns a patent directed to “a system providing a mobile phone user with targeted information (i.e., advertisements) that is deemed relevant to the user based on data gathered from the user’s television.” The system has three main components: (1) a networked device (e.g., a smart TV) that collects primary data, including program information, location, weather information or identification information; (2) a client device (e.g., a mobile device) on which applications run and advertisements may be shown; and (3) a relevancy-matching server that uses the primary data to select advertisement or other targeted data based on a relevancy factor associated with the user. Specifically, the relevancy-matching server “may also be configured to render the targeted data to the user through the networked device and/or the sandboxed application of the client device.”

Samba asserted infringement of the patent against Alphonso. In response, Alphonso filed a motion to dismiss on grounds that the asserted claims of the patent were directed to patent ineligible subject matter under 35 USC § 101. Alphonso subsequently filed a motion for summary judgment of non-infringement. The district court denied the § 101 motion but granted the summary judgment motion. Samba appealed the non-infringement finding, and Alphonso cross-appealed the § 101 finding.

The Federal Circuit started with the § 101 finding by first addressing Alice step 1 (abstract idea). The Court rejected the district court’s finding that the asserted claims were directed to “systems and methods for addressing barriers to certain types of information exchange between various technological devices . . . being used in the same place at the same time,” i.e., to bypass the security sandbox, and not an abstract idea of tailored advertising. To the contrary, the Court found that the asserted claims were directed precisely to the abstract idea of tailored advertising—specifically, gathering information about television users’ viewing habits, matching the information with other content and sending that content to a second device. Reiterating its prior holdings with respect to Alice step 1, the Court explained that the asserted claims only provided for the result of overcoming a security sandbox, and did not at all describe how that result is achieved. The Court also explained that even if the claims did recite a method for bypassing a security sandbox, Samba failed to demonstrate that this was anything more than a mere use of a computer as a tool, or that it somehow “improves the operability of these devices beyond providing a user with targeted content using generic processes and machinery.”

Turning to Alice step 2 (inventive concept), the Federal Circuit explained that the claimed abstract idea of providing targeted advertisements was not [...]

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2020 IP Law Year in Review: Patents

Executive Summary

In 2020, the US Supreme Court and Court of Appeals for the Federal Circuit continued to refine key aspects of intellectual property law on issues that will have an impact on litigation, patent prosecution and business strategy. This Special Report discusses some of the most important decisions.

The Federal Circuit issued several panel decisions clarifying the bounds of patent-eligible subject matter in the area of life sciences and computer technology. In the life sciences space, the court found several patents satisfied the conditions for patent eligibility. For example, the Federal Circuit found patent-eligible claims directed to preparing a fraction of cell-free DNA enriched in fetal DNA, claims directed to a method of operating a flow cytometry apparatus with a number of detectors to analyze at least two populations of particles in the same sample to be patent eligible, and claims directed to a method of treating type 2 diabetes mellitus using a DPP-IV inhibitor. In the area of computer technology, the court clarified that claims directed to an improvement to computer networks were patent eligible, but that claims directed to applying longstanding commercial practices to generic computer components remain ineligible. Given the uncertainty of patent eligibility law, questions surrounding life sciences and computer-related technology will continue to be raised in cases.

The Supreme Court issued one decision in 2020, in which it found that the Patent Trial and Appeal Board’s application of the time bar for filing a petition for inter partes review (IPR) is not appealable. The Federal Circuit issued two en banc decisions, including one decision confirming discussing the use of the phrase “consisting essentially of” in patent claims and patent eligibility of mechanical inventions.

Following on the heels of the Supreme Court’s 2017 TC Heartland v. Kraft Foods decision addressing patent venue, the Federal Circuit addressed patent venue in Hatch-Waxman litigation. The court explained that for the purposes of determining venue, infringement occurs only in judicial districts where actions related to the submission of an abbreviated new drug application (ANDA) occur, and not in all locations where future distribution of the generic products specified in the ANDA is contemplated. This ruling may have far-reaching consequences, including the ability for ANDA defendants to effectively control venue for litigation.

Patents

  1. § 101 Decisions in 2020
  2. 2020 at the Supreme Court
  3. Arthrex Decision
  4. En Banc at the Federal Circuit – Two Contentious Denials
  5. The Federal Circuit Limits Venue for Hatch-Waxman Litigation

2021 Outlook

The Supreme Court is set to hear at least two patent cases and one copyright case this term. In The United States of America v. Arthrex, Inc., the Court will consider whether PTAB judges are unconstitutionally appointed and the other addressing whether assignor estoppel and in Minerva Surgical, Inc. v. Hologic, Inc., et al., the Court will consider whether the doctrine of assignor estoppel bars an assignor from asserting invalidity of an assigned patent in district court. [...]

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