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  • Stanford Asks Supreme Court to Revisit Subject Matter Eligibility on Diagnostic Claims

    By Kevin E. Noonan –

    Supreme Court Building #1"Hope springs eternal [in the human breast]" (Alexander Pope) and "Insanity is doing the same thing over and over and expecting different results" (the latter attributed variably to Albert Einstein and Werner Erhart) are two aphorisms that irresistibly come to mind with the recent filing of a petition for certiorari by patentees in CareDX, Inc. v. Natera, Inc. and CareDx, Inc. v. Eurofins Viracor, Inc.

    To recap, the case arose over CareDx's assertion of the claims in U.S. Patent Nos. 8,703,652, 9,845,497, and 10,329,607 directed to "methods to help predict the status or outcomes of transplant recipients through sequencing of cell-free nucleic acids ("cfDNA") found in the bodily fluids of a recipient."  The rationale behind the invention was that rejection of a transplanted organ in a recipient is accompanied by cell death, which releases donor-specific DNA into the recipient's bodily fluids.  Claim 1 of the '652 patent, claim 1 of the '497 patent, and claim 1 of the '607 patent were illustrative:

    Claim 1 of the '652 patent recites:

    1.  A method for detecting transplant rejection, graft dysfunction, or organ failure, the method comprising:
        (a) providing a sample comprising cell-free nucleic acids from a subject who has received a transplant from a donor;
        (b) obtaining a genotype of donor-specific polymorphisms or a genotype of subject-specific polymorphisms, or obtaining both a genotype of donor-specific polymorphisms and subject-specific polymorphisms, to establish a polymorphism profile for detecting donor cell-free nucleic acids, wherein at least one single nucleotide polymorphism (SNP) is homozygous for the subject if the genotype comprises subject-specific polymorphisms comprising SNPs;
        (c) multiplex sequencing of the cell-free nucleic acids in the sample followed by analysis of the sequencing results using the polymorphism profile to detect donor cell-free nucleic acids and subject cell-free nucleic acids; and
        (d) diagnosing, predicting, or monitoring a transplant status or outcome of the subject who has received the transplant by determining a quantity of the donor cell-free nucleic acids based on the detection of the donor cell-free nucleic acids and subject cell-free nucleic acids by the multiplexed sequencing,
        wherein an increase in the quantity of the donor cell-free nucleic acids over time is indicative of transplant rejection, graft dysfunction or organ failure, and wherein sensitivity of the method is greater than 56% compared to sensitivity of current surveillance methods for cardiac allograft vasculopathy (CAV).

    Claim 1 of the '497 patent recites:

    1.  A method of detecting donor-specific circulating cell-free nucleic acids in a solid organ transplant recipient, the method comprising:
        (a) genotyping a solid organ transplant donor to obtain a single nucleotide polymorphism (SNP) profile of the solid organ transplant donor;
        (b) genotyping a solid organ transplant recipient to obtain a SNP profile of the solid organ transplant recipient, wherein the solid organ transplant recipient is selected from the group consisting of: a kidney transplant, a heart transplant, a liver transplant, a pancreas transplant, a lung transplant, a skin transplant, and any combination thereof;
        (c) obtaining a biological sample from the solid organ transplant recipient after the solid organ transplant recipient has received the solid organ transplant from the solid organ transplant donor, wherein the biological sample is selected from the group consisting of blood, serum and plasma, and wherein the biological sample comprises circulating cell-free nucleic acids from the solid organ transplant; and
        (d) determining an amount of donor-specific circulating cell-free nucleic acids from the solid organ transplant in the biological sample by detecting a homozygous or a heterozygous SNP within the donor-specific circulating cell-free nucleic acids from the solid organ transplant in at least one assay,
        wherein the at least one assay comprises high-throughput sequencing or digital polymerase chain reaction (dPCR), and
        wherein the at least one assay detects the donor-specific circulating cell-free nucleic acids from the solid organ transplant when the donor-specific circulating cell-free nucleic acids make up at least 0.03% of the total circulating cell-free nucleic acids in the biological sample.

    Claim 1 of the '607 patent recites:

    1.  A method of quantifying kidney transplant-derived circulating [cfDNA] in a human kidney transplant recipient, said method comprising:
        (a) providing a plasma sample from said human kidney transplant recipient, wherein said human kidney transplant recipient has received a kidney transplant from a kidney transplant donor, wherein said plasma sample from said human kidney transplant recipient comprises kidney transplant-derived circulating [cfDNA] and human kidney transplant recipient-derived circulating [cfDNA];
        (b) extracting circulating [cfDNA] from said plasma sample from said human kidney transplant recipient in order to obtain extracted circulating [cfDNA], wherein said extracted circulating [cfDNA] comprises said kidney transplant-derived circulating [cfDNA] and human kidney transplant recipient-derived circulating [cfDNA];
        (c) performing a selective amplification of target [DNA] sequences, wherein said selective amplification of said target [DNA] sequences is of said extracted circulating [cfDNA], wherein said selective amplification of said target [DNA] sequences amplifies a plurality of genomic regions comprising at least 1,000 single nucleotide polymorphisms, wherein said at least 1,000 single nucleotide polymorphisms comprise homozygous single nucleotide polymorphisms, heterozygous single nucleotide polymorphisms, or both homozygous single nucleotide polymorphisms and heterozygous single nucleotide polymorphisms, and wherein said selective amplification of said target deoxyribonucleic acid sequences is by polymerase chain reaction (PCR);
        (d) performing a high throughput sequencing reaction, wherein said high throughput sequencing reaction comprises performing a sequencing-by-synthesis reaction on said selectively-amplified target [DNA] sequences from said extracted circulating [cfDNA], wherein said sequencing-by-synthesis reaction has a sequencing error rate of less than 1.5%;
        (e) providing sequences from said high throughput sequencing reaction, wherein said provided sequences from said high throughput sequencing reaction comprise said at least 1,000 single nucleotide polymorphisms; and
        (f) quantifying an amount of said kidney transplant-derived circulating [cfDNA] in said plasma sample from said human kidney transplant recipient to obtain a quantified amount, wherein said quantifying said amount of said kidney transplant-derived circulating [cfDNA] in said plasma sample from said human kidney transplant recipient comprises using markers distinguishable between said human kidney transplant recipient and said kidney transplant donor, wherein said markers distinguishable between said human kidney transplant recipient and said kidney transplant donor comprises single nucleotide polymorphisms selected from said at least 1,000 single nucleotide polymorphisms identified in said provided sequences from said high throughput sequencing reaction, and wherein said quantified amount of said kidney transplant-derived circulating [cfDNA] in said plasma sample from said human kidney transplant recipient comprises at least 0.03% of the total circulating [cfDNA] from said plasma sample from said human kidney transplant recipient.

    The District Court granted Natera's motion for summary judgment that the claims were invalid under Section 101 for lack of subject matter eligibility (the petition noting that the District Court characterized the state of Section 101 law as being "fraught, incoherent, unclear, inconsistent, and confusing, and indeterminate and often leading to arbitrary results"), and the Federal Circuit affirmed.  The panel found that the claims failed the first prong of the Alice eligibility test for being directed to a natural phenomenon and failed the second prong of the test by reciting only conventional, well-understood, and routine methods that did not rise to the ineluctable "something more" required for eligibility.  The Federal Circuit relied upon disclosure in the specification that was similar to the disclosure that supported the Court's affirmance of ineligibility in Ariosa v Sequenom, specifically that the disclosed methods applied to detect cfDNA specific for the transplanted organ were conventional, the panel citing the following disclosure from the '652 patent in support of their conclusions:

    • col. 9 ll. 8–14, which stated that "[d]etection, identification and/or quantitation of the donor-specific markers (e.g.[,] polymorphic markers such as SNPs) can be performed using real-time PCR, chips (e.g., SNP chips), high throughput shotgun sequencing of circulating nucleic acids (e.g.[,] [cfDNA]), as well as other methods known in the art");

    • col. 10 ll. 11–12, which stated that, to obtain cfDNA samples, "any technique known in the art may be used, e.g. a syringe or other vacuum suction device");

    • col. 13 ll. 51–53, which stated that step 2 of claimed methods can be performed "using existing genotyping platforms know[n] in the art");

    • col. 15 ll. 6–8, which stated that techniques recited in step 2 of claimed methods "can be accomplished through classic Sanger sequencing methods which are well known in the art");

    • col. 13 ll. 58–61, which stated that "[c]ompanies (such as Applied Biosystems, Inc.) currently offer both standard and custom designed TaqMan probe sets for SNP genotyping that can in principle target any desired SNP position for a PCR based assay");

    • col. 20 ll. 31–34 (stating that genotyping recited in claimed methods "may be performed by any suitable method known in the art including those described herein such as sequencing, nucleic acid array or PCR");

    • col. 15 ll. 22–65 (discussing commercial high throughput sequencing products);

    • col. 14 ll. 58–67 (citing articles from 2006 and 2007 as supporting the statement that "digital PCR is a much more accurate and reliable method to quantitate nucleic acid species");

    • col. 18 l. 55–col. 19 l. 2 (stating that "[m]ethods for quantifying nucleic acids," including high throughput genotyping, "are known in the art"); and

    • col. 21 ll. 5–9 (stating that "[t]he presence or absence of one or more nucleic acids from the transplant donor in the transplant recipient may be determined by any suitable method known in the art including those described herein such as sequencing, nucleic acid arrays or PCR").

    (Despite this litany, the petition faults the District Court for relying on a sole statement in the specification that "the methods 'employ[], unless otherwise indicated, conventional techniques'" and disregarding the qualifier "unless otherwise indicated" in assessing the purported conventionality of the disclosed detection methods.)  The opinion stated summarily that "[t]he claimed methods are indistinguishable from other diagnostic method claims the Supreme Court found ineligible in Mayo and that we found ineligible on multiple occasions," including Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019); Genetic Veterinary Scis., Inc. v. LABOKLIN GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2018); Roche Molecular Sys., Inc. v. Cepheid, 905 F.3d 1363 (Fed. Cir. 2018); Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

    The Federal Circuit's appreciation of the similarity to the Ariosa decision (which in some ways propelled the Court down this path of per se ineligibility) was express:

    Here, as in Ariosa, the claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive.  The claims here are equally as ineligible as those in Ariosa.

    Petitioner CareDx and Stanford argue in their certiorari petition that the District Court and the Federal Circuit erred in this conclusion of conventionality to distinguish this case from the earlier precedent, and assert as analytical error in the Federal Circuit's application of the Supreme Court test under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014), consideration of conventionality (and thus Section 103 issues) in the first prong of the Mayo/Alice test.

    The focus of Petitioner's argument is that the invention is an improvement on prior art methods that were ineffective, and that it is this improvement as expressly recited in the statute ("or any new and useful improvement thereof") that supports eligibility.  According to this argument, this improvement distinguishes the invalidated claims from the natural phenomenon that cfDNA from a transplanted organ exist in a recipient's blood or that such cfDNA could be detected therein.  The petition sets forth the history of efforts to detect organ rejection in transplant patients, from "invasive and expensive tissue biopsies from the organ" to detecting increased evidence of cfDNA in patients undergoing organ rejection, including cfDNA specific for Y chromosomes or human leukocyte antigen (HLA) gene fragments, none of which were effective "after ten year of unsuccessful attempts" and all of which were admitted prior art in the common specification of the patents-in-suit.

    The petition emphasizes the specific technical solutions of "high-throughput" and "multiplex" sequencing coupled with digital polymerase chain reaction technology using single nucleotide polymorphism detection to identify transplanted organ-specific cfDNA in recipient blood.  (These choices, the petition contends, are significant because the technologies were developed after the failed attempts by others and the targets, while not new, were not the targets used in earlier, failed attempts.  It should not escape the reader's attention that these considerations are also ones relevant to non-obviousness.)  The petition also notes that patentee disclaimed discovery of the natural phenomenon and preexisting methods for measuring it.

    The petition's asserted reasons for the Court to grant certiorari frankly tell the Court that it "needs to take another Section 101 case" based on the Justices calling for the views of the Solicitor General five times in the past five years (citing Hikma Pharm. v. Vanda Pharm., Inc.; HP Inc. v. Berkheimer; Am. Axle & Mfg., Inc. v. Neapco Holdings LLC; and most recently in Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electro Oy) and that the SG has counseled the Court that they should grant cert "in an appropriate Section 101 case."  This, according to the petition, is that case, even more so that Interactive Wearables or Tropp.  The reasons petitioner asserts in advocating for the Court to choose this case is that while it raises many of the same issues as in Tropp and Interactive Wearables, in this one "the problems are even worse."  Those cases are abstract-idea cases which, the petition argues "have not been the source of considerable controversy."  Not so application of the natural phenomenon eligibility exception in medical diagnostics claims, where the petition notes both the SG and the Federal Circuit have called for the Court's intervention (citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC; Am. Axle & Mfg., Inc. v. Neapco Holdings LLC; Interval Licensing LLC v. AOL, Inc.).  In those cases the circuit's judges have termed the subject matter eligibility question to be "baffling," leaving them "at a loss as to how to uniformly apply § 101," that it is "near impossible to know with any certainty whether [an] invention is or is not patent eligible," and that this situation "ha[s had] a serious effect on the innovation incentive in all fields of technology."  Similar sentiments from district courts and the U.S. Patent and Trademark Office and former Directors of the agency are cited in support of this argument.  The objective evidence for this state of affairs is the Federal Circuit's track record, wherein that Court has invalidated "every single diagnostic method patent it has encountered since Mayo[]."  Moreover, the petition notes that the cumulative effect of the Federal Circuit's jurisprudence on subject matter eligibility for medical diagnostics claims is that these claims are virtually per se ineligible (including citations to Cleveland Clinic Found. v. True Health Diagnostics LLC and Roche Molecular Sys., Inc. v. CEPHEID along with those cases cited earlier in the petition).  These decisions have "powerfully undercut[] the incentive to innovate and invest in life-saving medical diagnostics" consequently.

    In addition, the petition argues that this case is one where the claimed invention was "on specific improved methods for measuring the relative proportion of the donor's DNA [that] ensures the absence of any preemption concerns" because "[p]atents that claim specific improvements upon preexisting processes for applying a previously known natural phenomenon cannot monopolize the underlying phenomenon itself, because other methods already exist to apply it and thus remain outside the scope of the patent."  These circumstances, the petition states, provide the Court with an opportunity to "reinvigorate the role of Section 101's statutory text in a manner consonant with the preemption concerns that animate this Court's precedents."  The petition notes in support for this argument that the Court has not considered the application of Section 101 to such improvements "upon a preexisting useful process" and that this case provides such an opportunity.  The petition cites the Court's decision in Tilghman v. Proctor, 102 U.S. 707 (1880), as being consistent with these arguments by being "a particular mode of bringing about [a] desired result" (and perhaps being a basis for the Court to be persuaded by them).  And petitioners emphasize that claims to such an improvement do not claim either a natural phenomenon nor preexisting methods which are expressly in the prior art.

    Finally, the way the District Court and Federal Circuit considered issues of "conventionality" for both the first and second prongs of the Mayo/Alice test (the petition argues) was error needing Supreme Court correction.  Concerns over the (im)proper application of conventionality in the Mayo/Alice test was voiced by the Solicitor General in Interactive Wearables with regard to Step 2 but is arguably more erroneous here according to the petition, where the lower courts relied on conventionality in both Step 1 and Step 2 (the Federal Circuit going so far as to state that it had "repeatedly analyzed conventionality at step one," citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC and Universal Secure Registry LLC v. Apple Inc. in support of this practice).  (This argument has greater force than the corresponding argument regarding Step 2, where considerations of conventionality go hand in hand with the Supreme Court's instruction for courts to search for an "inventive concept," although the petition bravely argues that such conflation of Section 103 issues in a Section 101 determination is equally improper.)  The petition contends that the Federal Circuit's practice in this regard "collapses the entire Section 101 inquiry into 'a search for an inventive concept'" and "effectively conflat[es] Section 101 with the statutory requirements of novelty, 35 U.S.C. 102, nonobviousness, 35 U.S.C. 103, and enablement, 35 U.S.C. 112" (which while a persuasive argument for much of the patent bar may be less so for the Court, which has tended in earlier decisions to consider patent law with much less granularity; see Mayo).  And petitioners assert that in doing so the Federal Circuit "circumvented important protections guaranteed by this Court's obviousness precedents under Section 103," citing Graham v. John Deere and KSR Int'l Co. v. Teleflex Inc.  The petition characterizes the invention at issue here as being closer to an application of a law of nature as sanctioned by the Court's decision in Diamond v. Diehr than the invention in Mayo and notes that the Court held in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. that "new applications of knowledge about" natural phenomena are patent-eligible.

    Finally, the petition asks the Court "at a minimum" to hold the case until the Court has decided the outcome of the Interactive Wearables and Tropp cases.

    The arguments in the petition thus thread a very narrow needle in giving the Court a reason to grant certiorari and emphasize (as has been emphasized before) the need to do so.  Earlier in the petition the Court's attention is directed albeit somewhat obliquely to the "heav[y] investment CareDx made in bringing this technology to market" and the frankly infringing behavior of both Natera and Eurofin in bringing their own "copycat" products to market.  Those hoping for a certiorari grant (and positive outcome) have reason for such hopes if the Court is listening to these circumstances and the importance and negative consequences to innovation in the medical diagnostic arts that the lower courts' interpretations of their subject matter eligibility jurisprudence has produced over the past decade.

  • ChatGPT Throws Wrench into Europe’s Attempts to Regulate AI

    By Michael Borella —

    European Union (EU) FlagAfter using a large language model, such as ChatGPT, for a while, it is not hard to image an array of nightmarish scenarios that these generative artificial intelligence (AI) programs could bring about.  While ChatGPT and its emerging rivals currently have "guardrails" — ethical limits on what it will do in response to a prompt — the bounds thereof are not well understood.  Through clever prompting, it is not hard to convince the current iteration of ChatGPT to do away with certain guardrails from time to time.  Further, the companies behind these models have not defined the extent of the guardrails, while the very structures underlying the models are well known to behave in unpredictable ways.  Not to mention what might happen if a "jailbroken" large language model is ever released to the public.

    As an example, a user might ask the model to describe terrorist attack vectors that no human has ever previously conceived of.  Or, a model might generate software code and convince a gullible user to download and execute it on their computer, resulting in personal financial information being sent to a third party.

    Perhaps one of the most relevant risks of large language models is that once they are implemented and deployed, the marginal cost of creating misinformation becomes close to zero.  If a political campaign, interest group, or government wishes to inundate social media with misleading posts about a public figure, a policy, or a law, it will be able to do so at volume without having to employ a roomful of humans.

    In 2021, the European Commission of the European Union (EU) proposed harmonized rules for the regulation of AI.  The Commission recognized both the perils and the benefits of AI and attempted to come up with a framework for regulation that employs oversight in proportion to the specific dangers inherent in certain uses of AI.  The resulting laws enacted by member states would potentially have the Brussels Effect, in that EU regulation of its own markets become a de facto standard for the rest of the world.  This is largely what happened for the EU's General Data Protection Regulation (GDPR) laws.

    But very few people saw generative AI coming or the meteoric rise of ChatGPT at the end of 2022.  Thus, the Commission is in the process of re-evaluating its rules in view of these paradigm-breaking technologies.

    The Commission's proposal places all AI systems into one of three risk levels:  (i) unacceptable risk, (ii) high risk, and (iii) low or minimal risk.  The amount of regulation would be the greatest for category (i) and the least (e.g., none) for category (iii).

    Uses of AI that create an unacceptable risk include those that violate fundamental rights, manipulate individuals subliminally, exploit specific vulnerable groups (e.g., children and persons with disabilities), engage in social scoring (evaluating the trustworthiness of persons based on their social behavior), and facilitate real-time biometric recognition for purposes of law enforcement.  These uses would be prohibited.

    A high risk AI may be classified as such based on its intended purpose and modalities of use.  There are two main types of high risk systems: (i) those intended to be used as safety component of products (e.g., within machinery, toys, radio equipment, recreational vehicles, and medical devices), and (ii) other systems explicitly listed (e.g., involving biometrics, critical infrastructure, education, employment, law enforcement, and immigration).  These categories are quite broad and would impact many diverse industries.  The proposal sets forth detailed legal requirements for such systems relating to data governance, documentation and recording keeping, transparency and provision of information to users, human oversight, robustness, accuracy, and security, as well as conformity assessment procedures.

    Regarding low or minimal risk AI systems, their use would be permitted with no restrictions.  However, the Commission envisions these systems potentially adhering to voluntary codes of conduct relating to transparency concerns.

    To that point, the proposal also states that "[t]ransparency obligations will apply for systems that (i) interact with humans, (ii) are used to detect emotions or determine association with (social) categories based on biometric data, or (iii) generate or manipulate content ('deep fakes')."  In these situations, there is an obligation to disclose that the content has been machine-generated in order to allow the users to make informed choices.

    Currently, the Commission is considering whether to place ChatGPT and its ilk in the high risk category, thus subjecting it to significant regulation.  There has been pushback, however, from parties who believe that the regulations should distinguish between harmful uses of these models (e.g., spreading misinformation) and minimal-risk uses (e.g., coming up with new recipes, composing funny poems).  In other words, the amount of regulation that applied to ChatGPT should vary based on its use — and aesthetically pleasing goal but one that would be difficult to carry out in practice because of the model's broad scope and general applicability.

    Whether this results in the proposed regulations being delayed and/or rewritten remains to be seen.  The Commission will be taking up the issue.

  • Sequoia Technology LLC v. Dell Inc. (Fed. Cir. 2023)

    By Michael Borella —

    Federal Circuit SealThe patent statute requires that, to be patentable, the subject matter of an invention must be at least one of a process, machine, article of manufacture, or composition of matter.  It is hard to find examples of things that do not fall into these broad categories, though signals in motion and data at rest are two.  The former has been well-litigated at this point and it is accepted that various forms of computer-readable medium (CRM) claims must recite that the medium is non-transitory.  Consider the 2007 Federal Circuit decision of In re Nuijten as the standard bearer in this regard.

    Nonetheless, disputes over the interpretation of CRM language do pop up from time to time, as was the situation in this case.

    Sequoia asserted U.S. Patent No. 6,718,436 against Dell and several other companies (most notably, Red Hat, which is a subsidiary of IBM) in the District of Delaware.  The parties butted heads over claim construction issues in district court with Sequoia coming up on the losing end.  Thus, they stipulated non-infringement under this construction.  The District Court also found that claims 8-10 were ineligible under § 101 due to construction of the term "computer-readable recording medium" to include transitory media.  Sequoia appealed.

    Claim 8 of the '436 patent reads:

    8.    A computer-readable recording medium storing instructions for executing a method for managing a logical volume in order to support dynamic online resizing and minimizing a size of metadata, said method comprising the steps of:
        a) creating the logical volume by gathering disk partitions in response to a request for creating the logical volume in a physical storage space;
        b) generating the metadata including information of the logical volume and the disk partitions forming the logical volume and storing it the metadata to the disk partitions forming the logical volume;
        c) dynamically resizing the logical volume in response to a request for resizing, and modifying the metadata on the disk partitions forming the logical volume; and
        d) calculating and returning a physical address corresponding to a logical address of the logical volume by using mapping information of the metadata containing information of the physical address corresponding to the logical address;
        wherein the metadata includes,
            a disk partition table containing information of a disk partition in which the metadata is stored;
            a logical volume table for maintaining the information of the logical volume by storing duplicated information of the logical volume onto all disk partitions of the logical volume;
            an extent allocation table for indicating whether each extent in the disk partition is used or not used; and
            a mapping table for maintaining a mapping information for a physical address space corresponding to a logical address space which is a continuous address space equal in size of storage space to an entirety of said logical volume.

    As noted, the main part of the § 101 dispute was over the interpretation of the term "computer-readable recording medium."  The Federal Circuit immediately noted that this term explicitly recites a "recording medium storing instructions" and that "a person of ordinary skill would not understand transitory signals, such as carrier waves, to record or store instructions in memory systems."  This understanding is supported by other claim elements, such as "creating the logical volume in a physical storage space" and "storing [sic] the metadata to the disk partitions forming the logical volume."  All of this establishes that the computer-readable recording medium of claim 8 does not encompass non-persistent or transient storage.

    The Court found further support for its position in the specification.  Particularly, the specification provides several examples of hardware-only computer-readable media including RAM, CDROM, and various types of disk drives.

    One of the defendants, Red Hat, argued that the specification does not exclude transitory media.  But the Court pushed back, noting that the claim itself recites a "storage medium" and that Red Hat's proposed interpretation would contradict the teachings of the specification and render the invention inoperable.

    The Court also found that Red Hat's expert's testimony was "inconsistent with the intrinsic evidence and also based on different express definitions of CRM in patent specifications directed to different inventions."  Notably, the expert looked to 34 other patent applications to help define the claim term.  The Court was not amused:

    This evidence merely shows that in thirty-four other specifications, the inventors chose to be their own lexicographers and expressly defined CRM or like terms to include transitory media.  The inventors here chose otherwise.  That other inventors chose to be their own lexicographers and define CRM to include transitory signals does not demonstrate what CRM means in the context of the '436 patent.  Nor does it establish the plain and ordinary meaning of the claim term "computer-readable recording medium for storing."

    In a similar manner, Red Hat also relied on the Court's decision in Mentor Graphics Corp. v. EVE-USA, Inc., where the Court found that a claimed "computer readable medium" included transitory signals.  But this conclusion was based on that specification expressly including carrier waves in its definition of the term.  Accordingly, the Court found that how a term is defined other patents and applications cannot be used to contradict how it is defined in the specification at hand.  Specifically, the Court wrote "[s]imply put, extrinsic evidence of what other inventors chose to do cannot surmount the intrinsic evidence of what the inventors chose here; context is key in claim construction."  Thus, the Court discounted the testimony of Red Hat's expert and the relevance of these extrinsic documents.

    Finally, Red Hat pointed to the USPTO's 2010 memo on computer-readable medium claims, alleging that it establishes that the term in question should be interpreted broadly enough to include transitory media.  But, as the Court pointed out, this memo merely states that the broadest reasonable interpretation of a claim during prosecution may result in claims being interpreted to cover transitory media.  However, this does not provide the plain and ordinary meaning of the term to be used in litigation, nor does it mean that there is a presumption that claim 8 reads on transitory media.

    Given all of this, the Court concluded that the District Court erred, and reversed the finding of invalidity under § 101.

    A practice note from all of this is that you should explicitly recite in your CRM claims language that clearly establishes that the CRM is non-transitory.  This does not need to be the exact words "non-transitory" but however your language is defined in the specification should make that point clear and unambiguous.

    Unlike the claimed invention, this victory for Sequoia turned out to be transitory — it lost on other claim construction issues and the Court ultimately affirmed the determination of non-infringement.

    Sequoia Technology LLC v. Dell Inc. (Fed. Cir. 2023)
    Panel: Circuit Judges Lourie, Dyk, and Stoll
    Opinion by Circuit Judge Stoll

  • Conference & CLE Calendar

    CalendarApril 25, 2023 – "Amendments to Patent Claims — Global Updates" (Dannemann Siemsen) – 8:30 am (ET)

    April 25, 2023 – Listening session on current state of artificial intelligence (AI) technologies and inventorship issues (U.S. Patent and Trademark Office) – 10:30 am to 3:30 pm (ET), Alexandria, VA

    April 25, 2023 – "Using Disclaimers at the EPO: A Practical Guide" (J A Kemp) – 16:00 pm (BST)

    April 25, 2023 – "Women and Intellectual Property: Accelerating Innovation and Creativity" (IPWatchdog and IP.com) – 12:00 pm (ET)

    April 26, 2023 – "MentorshIP: The secret sauce for women entrepreneurs" (U.S. Patent and Trademark Office) – 12:00 pm to 1:00 pm (ET), Alexandria, VA

    April 26, 2023 – "Women in IP: Opportunities & Challenges" (Center for Intellectual Property, Information & Privacy Law at the University of Illinois Chicago School of Law) – 12:00 pm to 1:30 pm (CDT)

    April 27, 2023 – "Strategies for Adding Value and Building a Strong Biotech Patent Portfolio" (IPWatchdog and CAS) – 12:00 pm (ET)

  • USPTO AI Inventorship Listening Session

    USPTO SealThe U.S. Patent and Trademark Office will be holding a listening session to seek stakeholder input on the current state of artificial intelligence (AI) technologies and inventorship issues that may arise in view of the advancement of such technologies.  The event is being held from 10:30 am to 3:30 pm (ET) on April 25, 2023 at the National Inventors Hall of Fame Museum at the USPTO Headquarters in Alexandria, VA.  An agenda for the event can be found here.

    Those interested in registering for the event, can do so here.

  • Webinar on Amendments to Patent Claims

    Dannemann SiemsenDannemann Siemsen will be offering a webinar entitled "Amendments to Patent Claims — Global Updates" on April 25, 2023 at 8:30 am (ET).  Ankush Verma of Remfry & Saga; Alexander Wyrwoll of Winter, Brandl; and Monique Rodrigues Teixeira, Gustavo de Freitas Morais, and Patricia Porto of Dannemann Siemsen will discuss issues on amendments to patent claims in Brazil and other jurisdictions, including the following topics:

    • The allowable scope and extent of the amendments to a patent application claim;
    • The time limit for making claim amendments; and
    • The treatment given to this subject among the different jurisdictions.

    Those wishing to register for the webinar can do so here.

  • Webinar on Using Disclaimers at the EPO

    J A KempJ A Kemp will be offering a webinar entitled "Using Disclaimers at the EPO: A Practical Guide" on April 25, 2023 at 16:00 pm (BST).  Chris Milton and Imogen Parry of J A Kemp will review the current state of the law surrounding the use of disclaimers at the EPO, and then consider examples of how these can be used to your advantage, both when pursuing patent protection and when attacking problematic patents.  The webinar will address the following topics:

    • Considering when disclaimers may be appropriate at the EPO
    • The state of EPO case law concerning allowability of disclaimers
    • Preparing a case where disclaimers may be needed: drafting tips
    • Attacking weak disclaimers
    • Case studies
    • Audience questions

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • Webinar on Women in IP

    IPWatchdogIPWatchdog and IP.com will be offering a webinar entitled "Women and Intellectual Property: Accelerating Innovation and Creativity" on April 25, 2023 at 12:00 pm (ET).  Renée Quinn of IPWatchdog, Inc. will moderate a panel consisting of Nina Archie of the Department of Defense Office of Small Business Program, Alison Erickson of Hallmark, Susanne Hollinger of Newell Brands, and Marlene Valderrama of Halliburton, who will share their achievements, insights, and perspectives on the IP industry.  The webinar will explore the challenges that these women have overcome, their leadership and accomplishments, and their outlook on the industry.  The panel will also discuss the importance of encouraging more women to use the IP system to protect and add value to their work and how IP can help woman-led businesses support economic recovery and build a stronger future.

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • USPTO WE Event on MentorshIP

    We-full-webThe U.S. Patent and Trademark Office will be offering its next Women's Entrepreneurship (WE) event from 12:00 pm to 1:00 pm (ET) on April 26, 2023 at the USPTO Headquarters in Alexandria, VA.  The event on "MentorshIP: The secret sauce for women entrepreneurs" will feature a panel of experts who will discuss actionable tips on how to find a mentor, what to look for in a mentor, how to successfully engage with a mentor, and the benefits of mentorship when starting, growing, or expanding your business.

    Those interested in registering for the event, can do so here.

  • UIC Law Virtual Seminar on Women in IP

    UIC LawThe Center for Intellectual Property, Information & Privacy Law at the University of Illinois Chicago School of Law will be holding a virtual seminar entitled "Women in IP: Opportunities & Challenges" from 12:00 pm to 1:30 pm (CDT) on April 26, 2023.  The program will bring together speakers to discuss the opportunities and challenges of women working in the field of intellectual property law.

    Additional information about the program, including a list of speakers, can be found here.  While there is no fee for this event, those interested in registering for the event can do so here.