subject matter eligibility Archives

subject matter eligibility

Not Just a Blip: Section 101 as Affirmative Defense

by Brett Meyerhoff | Aug 15, 2024 | Patents

On appeal from a motion to dismiss based on subject matter eligibility, the US Court of Appeals for the Federal Circuit held that a district court appropriately analyzed certain claims as representative claims and that the claims were directed to an abstract idea and did not recite an inventive concept. Mobile Acuity, Ltd. v. Blippar Ltd., Case No. 22-2216 (Fed. Cir. Aug. 6, 2024) (Lourie, Bryson, Stark, JJ.)

Mobile Acuity sued Blippar for infringement of claims from two patents directed to software for accessing stored information with a captured image. Mobile Acuity’s operative second amended complaint asserted that Blippar infringed “at least Claims 9, 11, and 16” of one patent and “Claims 9, 11, and 16” of the other. Blippar asserted that claim 9 of each patent was “representative of the entire claim set in each respective Asserted Patent” and that the patents were invalid under 35 U.S.C. § 101. The district court granted Blippar’s motion and subsequently denied Mobile Acuity’s motion to amend the judgment and for leave to file a third amended complaint.

Mobile Acuity appealed, asserting that the district court committed several errors, including the treatment of claim 9 in each asserted patent as a representative claim and the holding that the asserted patents were invalid as claiming ineligible subject matter.

Mobile Acuity first argued that the district court erred in holding that a challenge under § 101 is not an affirmative defense. The Federal Circuit agreed that an eligibility challenge on § 101 grounds is an affirmative defense but found that the district court simply misspoke when it stated during oral argument “[w]e are not talking about an affirmative defense.” However, the Federal Circuit concluded that the “error in word choice was harmless because the district court applied the correct legal standard for evaluating an affirmative defense at the motion to dismiss stage.”

In support of its denied motion to amend, Mobile Acuity argued that “the district court required it to ‘anticipate [the] defendant’s affirmative defense in its complaint.’” The Federal Circuit rebuffed this argument, concluding that the district court did not grant the motion to dismiss on the grounds that Mobile Acuity failed to address patentable subject matter in its complaints but correctly dismissed based on an affirmative defense that “clearly appears on the face of the pleading.” The Court stated that “as we have repeatedly recognized, it is possible and proper to determine patent eligibility under 35 U.S.C. § 101 on a Rule 12(b)(6) motion.”

On the merits, the Federal Circuit first determined that the district court did not merely treat claim 9 of each of the asserted patents as representative of all claims. The Federal Circuit explained that “the court did more, separately analyzing all six claims Mobile Acuity specifically identified in the operative complaint,” as well as two additional claims. The Federal Circuit also agreed with the district court that the six claims were representative “of all claims of the two Asserted Patents.”

As to the merits of the motion to dismiss, [...]

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AI Takeover: PTO Issues More Patent Eligibility Guidance for AI Inventions

by Peter Brunovskis, PhD | Jul 25, 2024 | Patents, Technology

The US Patent & Trademark Office (PTO) issued a 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence, which focuses on subject matter eligibility for artificial intelligence (AI)-based inventions. 89 Fed. Reg. 58128 (July 17, 2024).

The new guidance is part of the PTO’s ongoing efforts since 2019 to provide clarity on the issue of subject matter eligibility under 35 U.S.C. § 101 and to promote responsible innovation, competition and collaboration in AI technology development as espoused in the Biden administration’s Executive Order 14110, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The guidance follows on the heels of the PTO’s recently issued Guidance on Use of AI-Based Tools in Practice Before the PTO and Inventorship Guidance for AI-Assisted Inventions.

The new guidance aims to assist PTO examiners, patent practitioners and stakeholders in evaluating the subject matter eligibility of patent claims involving AI technology. The guidance includes three main sections:

Section I provides background on issues concerning patentability of AI inventions.
Section II provides a general overview of the PTO’s patent subject matter eligibility guidance developed over the past five years.
Section III provides an update to certain areas of the guidance applicable to AI inventions.

As in the prior subject matter eligibility updates and discussions, the guidance document’s analysis of subject matter eligibility focuses on the Alice two-step analysis: an evaluation of whether a claim is directed to a judicial exception (i.e., abstract ideas, natural phenomena, laws of nature), and if so, an evaluation of whether the claim as a whole integrates the judicial exception into a practical application of that exception and/or an analysis of whether the claim recites additional elements that amount to significantly more than the recited judicial exception itself. The guidance highlights a number of relevant recent Federal Circuit cases and is further accompanied by three new examples with hypothetical patent claims for assisting PTO examiners in applying the guidance to an analysis of patent claim eligibility under 35 U.S.C. § 101.

The PTO requests written comments to the guidance through the Federal eRulemaking Portal by September 16, 2024. If there is anything to be gleaned from the guidance or the current state of patentability for AI inventions, the topic will remain highly controversial and heavily debated.

House Rules: Remote Gambling Activity Claims Go Bust

by Cecilia Choy, Ph.D. | Jul 18, 2024 | Patents

The US Court of Appeals for the Federal Circuit applied the Alice/Mayo framework to assess whether claims directed to remote gambling were patent eligible under 35 U.S.C. § 101 and determined that the claims were directed to a patent-ineligible abstract idea and did not otherwise recite an inventive concept. Beteiro, LLC v. DraftKings Inc., Case Nos. 22-2275; -2277; -2278; -2279; -2281; -2283 (Fed. Cir. June 21, 2024) (Dyk, Prost, Stark, JJ.)

Beteiro owned several patents related to facilitating live gaming and/or gambling activity at a gaming venue remote from the user’s physical location so that a user can participate via a communication device away from the gaming venue location. In 2021 and 2022, Beteiro filed at least six patent infringement cases against the defendants. The district court granted the defendants’ motions to dismiss the claims on the grounds that the asserted claims were patent ineligible under § 101. Beteiro appealed.

The Federal Circuit agreed with the district court’s assessment of the claims under the first step of the Alice/Mayo framework and found that the claims “exhibit several features that are well-settled indicators of abstractness”:

The claims “broadly recited generic steps of a kind” frequently held to be abstract, such as “detecting information, generating and transmitting a notification based on the information, receiving a message (bet request), determining (whether the bet is allowed based on location data), and processing information (allowing or disallowing the bet).”
Claims like these, e., drafted with largely “result-focused functional language” without specifying how the purported invention achieves those results, are “almost always found to be ineligible.”
Citing earlier decisions, the Court found broadly analogous claims were abstract as involving methods of providing particularized information to individuals based on their locations. The Court also noted in a footnote that several district courts have found remote-gaming patents analogous to Beteiro’s patents ineligible.
The claimed methods were similar to “fundamental practices long prevalent,” an indicia that they are abstract and unpatentable. For example, the Federal Circuit referred to the district court’s analogy to real-world activities, including one step in the claims where “those accepting bets have always had to confirm that the bettor with whom they were dealing was located in a place where gambling was allowed.”

The Federal Circuit also agreed with the district court’s analysis of the second step of the Alice/Mayo framework and its conclusion that the claims failed to provide an inventive concept and “simply describe[d] a conventional business practice executed by generic computer components.” The Court disagreed with Beteiro’s argument that there was genuine dispute as to whether using geolocation and global positing as an “integral data point” in processing mobile wagers was conventional technology at the time of the earliest claimed priority date, 2002. Beteiro only briefly referred to conventional use of GPS in connection with several types of conventional computers but failed to describe differences between equipping GPS on a mobile phone versus any other described conventional computers. The asserted patents did not describe any advanced GPS mobile device technology [...]

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Virtually Done: Computer Visualization Patents Are Ineligible for Protection

by Courtney Seams | Apr 18, 2024 | Patents

Addressing subject matter eligibility under 35 U.S.C. § 101, the US Court of Appeals for the Federal Circuit upheld the district court’s finding that patents related to computer visualizations of medical scans were patent ineligible. AI Visualize, Inc. v. Nuance Communications, Inc., Case No. 22-2019 (Fed. Cir. Apr. 4, 2024) (Moore, Reyna, Hughes, JJ.)

AI Visualize asserted four related patents, each having a substantially similar specification and the same title, against Nuance Communications. The patents are generally directed at systems and methods for users to virtually view a volume visualization dataset (a three-dimensional collection of data representing the scanned area of an MRI) on a computer without having to transmit or locally store the entirety of the dataset.

Nuance moved to dismiss the case, asserting that the claims were directed to patent-ineligible subject matter and invalid under § 101. The district court applied the two-step Alice inquiry to the claims, which the parties had grouped into three representative claims:

Claims where a web application directs the server to check what frames of a virtual view are stored locally and creates any additional frames necessary to create and display the virtual view of the medical image.
Claims with the further requirement that any previously requested virtual view be given a unique key, which the server checks for (and displays if the key exists) prior to completing the steps of the independent claim.
Claims without the requirement of checking to see if any images are stored locally.

In applying part one of Alice, the district court concluded that the asserted claims were directed to the abstract idea of “retrieving user-requested, remotely stored information” and not, as AI Visualize argued, to improvements in computer functionality. The district court then applied Alice step two and considered each of the three representative claims. The district court concluded that none of the claim limitations transformed the claims into patent-eligible applications of an abstract idea. Ultimately, the district court determined that all asserted claims were patent ineligible under § 101. AI Visualize appealed.

The Federal Circuit also applied the Alice analytical framework. Applying Alice step one, the Court considered whether the focus of the claimed advance was on an improvement in computer technologies, rather than the use of computers, and whether the claim limitations described a claimed advance over the prior art. The Court upheld the district court’s finding under Alice step one (i.e., that all three types of asserted claims were directed to an abstract idea) because the steps of obtaining, manipulating and displaying data, when claimed at a high level of generality, constitute an abstract concept. The Court did not agree with AI Visualize’s arguments that the creation of the virtual views is a technical solution to a technical problem because it requires the creation of “on the fly” virtual views at the client computer. In doing so, the Court refused to import details from the specification into the claims.

Applying Alice step two, the Federal Circuit upheld the district court’s finding that [...]

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Struggling to Master the Alice Two-Step: Search Result Display Ineligible for Patent Protection

by Kathleen Lynch | Jan 18, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a lawsuit involving two software patents directed toward enhancements to search result displays, finding that both patents claimed subject matter that is ineligible under 35 U.S.C. § 101. IBM v. Zillow Group, Inc., Case No. 22-1861 (Fed. Cir. Jan. 9, 2024) (nonprecedential) (Prost, Hughes, JJ.) (Stoll, J., dissenting).

IBM sued Zillow for infringing five patents. Claims from two of the patents were dismissed. For the remaining three patents, Zillow filed a motion to dismiss, arguing that all three patents were ineligible under § 101. The district court granted Zillow’s motion to dismiss, finding the asserted claims ineligible. IBM appealed.

Only two of the patents were subject to the appeal. The first patent was directed to a graphical user interface that improves search and selection based on user input to produce better results, and the second patent was directed to improvements in how to display search results to users.

IBM raised two arguments on appeal:

The district court erred in dismissing both patents, because the complaint and IBM’s inventor declaration were enough to show patent eligibility and—at minimum—survive the pleading stage.
The district court failed to resolve a claim construction dispute over a term in the second patent.

The Federal Circuit began by providing a primer on the Alice two-step process for evaluating patent eligibility. For step one, courts must “determine whether a patent claim is directed to an unpatentable law of nature, natural phenomena, or abstract idea.” When the patent involves software, claims are ineligible where they merely describe a process or system that uses a computer as a tool applied to an otherwise abstract idea. For step two, courts must analyze whether the claims simply describe an abstract method. If the claims instead go further and transform an otherwise abstract idea into something new via an “inventive concept,” then the subject matter may be patentable.

Turning to the appeal, the Federal Circuit first addressed whether IBM’s complaint and inventor declaration should have been enough to establish subject matter eligibility at the pleading stage for either patent. Applying the Alice two-step test, the Court found that they were not and upheld the district court’s dismissal.

For the first patent directed to a graphical user interface, the Federal Circuit agreed with the district court’s conclusion that the patent had three clear indicia of abstractness. First, the process could be done with pen and paper. Second, the claim language was result-oriented. Third, the patent focused on intangible information. The Court also found that the claims did “not disclose any technical improvement” to computer software. Thus, the claims failed at Alice step one. The Court found that IBM fared no better at step two, explaining that IBM’s argument for an inventive process hinged on the inventor declaration, which made no reference to the patent’s actual claim language. The Court explained that “[s]imply including allegations of inventiveness in a complaint, detached from what is claimed or discussed in [...]

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Should This Be an Alice Two-Step or a Section 112 Enablement Waltz?

by Katherine Pappas | Aug 10, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a lawsuit for lack of subject matter eligibility under 35 U.S.C. § 101 based on an Alice two-step analysis, with Judge Newman filing a sharp dissent focused on “the current law of § 101.” Realtime Data LLC v. Array Networks Inc., Case No. 2021-2251 (Fed. Cir. Aug. 2, 2023) (non-precedential) (Reyna, Taranto, JJ.) (Newman, J., dissenting).

From November 2017 through December 2018, Realtime brought suits against multiple defendant corporations asserting infringement of multiple Realtime patents related to methods and systems for digital data compression. In 2019, some defendants moved to dismiss for failure to state a claim, arguing that the asserted patent claims were patent ineligible under § 101. In an oral ruling from the bench, the district court granted the motion to dismiss. On appeal, the Federal Circuit found that the district court had provided too cursory a ruling to allow for meaningful appellate review, and therefore vacated and remanded for the district court to provide a more detailed § 101 analysis.

On remand in 2021, the district court issued a written opinion working through the two-step analysis laid down by the Supreme Court in Alice. Step 1 evaluates whether the asserted claims are directed to a patent-ineligible concept, such as an abstract idea, and Step 2 searches for an “inventive concept” by considering the claims to determine whether any elements “transform the nature of the claim” from ineligible subject matter into a patent-eligible application, which must amount to more than “well-understood, routine, or conventional activities.” The district court found the patents invalid under § 101 and granted the motions to dismiss Realtime’s complaints but gave Realtime the opportunity to file amended complaints. After Realtime did so, the defendants renewed their motions to dismiss. The district court again dismissed Realtime’s complaints based on § 101. In ruling so, the district court first found that there were no material differences between Realtime’s prior and amended complaints with respect to the § 101 analysis. Next, the court incorporated by reference its prior ruling’s legal analysis, reaffirmed its finding that the claims were invalid under § 101 and granted dismissal, this time without granting Realtime leave to file amended complaints. Realtime appealed.

This time the Federal Circuit affirmed the district court’s dismissal. In affirming, the Federal Circuit worked through the Alice two-step inquiry and agreed with the district court on each step. At Step 1, the Court agreed that “none of the claims at issue specifies any particular technique to carry out the compression of data” but instead were all “data manipulation claims that are recited at a high level of result-oriented generality and that lack sufficient recitation of how the purported inventions accomplish the results” (quoting Koninklijke). At Step 2, the Court agreed that the asserted patents “simply apply an abstract idea on generic computers with generic techniques,” thus failing to cross over into eligible subject matter. Accordingly, the Court held that the claims were directed to patent-ineligible subject matter and affirmed dismissal under § 101.

Judge [...]

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Invoking Generic Need for Claim Construction Won’t Avoid § 101 Dismissal

by Katherine Pappas | Jul 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a patent infringement suit on § 101 grounds, rejecting the patentee’s argument that claim construction or discovery was required before assessing patent eligibility. Trinity Info Media, LLC v. Covalent, Inc., Case No. 22-1308 (Fed. Cir. July 14, 2023) (Stoll, Bryson, Cunningham, JJ.)

Trinity Info Media sued Covalent for infringement of patents related to poll-based networking systems that connect users in real time based on answers to polling questions. Covalent moved to dismiss, arguing that the patent claims were invalid under 35 U.S.C. § 101 because they were directed to patent-ineligible subject matter. In resolving the motion, the district court found that the claims were directed to the abstract idea of “matching users who gave corresponding answers to a question” and did not contain an inventive concept. The district court further found that the purported invention did not improve computer functionality but simply used “generic computer components as tools to perform the functions faster than a human would.” Accordingly, it found the asserted claims invalid under § 101 and granted the motion to dismiss. Trinity appealed.

Trinity argued that the district court erred by granting the motion without first allowing fact discovery and conducting claim construction. The Federal Circuit disagreed, finding that in order to overcome a motion to dismiss on § 101 grounds, “the patentee must propose a specific claim construction or identify specific facts that need development and explain why those circumstances must be resolved before the scope of the claims can be understood for § 101 purposes.” Trinity had identified claim terms to the district court, but never proffered any proposed constructions or explained how construction would affect the § 101 analysis. Because Trinity did not identify specific facts to be discovered or propose any particular claim construction that would alter the § 101 analysis, Trinity’s generic arguments were insufficient to avoid the motion to dismiss.

The Federal Circuit went on to analyze whether the asserted claims were invalid under the two-step framework established by Mayo and Alice. Under this framework, Step 1 evaluates whether the asserted claims are directed to a patent-ineligible concept, such as an abstract idea. Step 2 searches for an “inventive concept” by considering the claims to determine whether any elements “transform the nature of the claim” from ineligible subject matter into a patent-eligible application.

At Step 1, the Federal Circuit concluded that the claims were directed to the patent-ineligible abstract idea of “matching based on questioning.” The Court noted that a “telltale sign of abstraction is when the claimed functions are mental processes that can be performed in the human mind or using a pencil and paper” (citing Personal-Web), finding that the “human mind could review people’s answers to questions and identify matches based on those answers.” Further, the trivial variations appearing in some claims (e.g., using a handheld device, reviewing matches by swiping and matching based on gender) did not change the focus of the asserted claims. The Court explained that for software inventions, Step 1 [...]

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Coons and Tillis Introduce Two Bills Intended to Change Patent Landscape

by Christopher M. Bruno | Jul 13, 2023 | Patents

In late June 2023, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced two bills in Congress that, if enacted, would change the patent adjudication landscape:

The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act is the latest iteration of a multiyear effort to reform patent law to address perceived problems with the Patent Trial & Appeal Board’s inter partes review (IPR) and post-grant review (PGR) processes.
The Patent Eligibility Restoration Act of 2023 seeks to bring certainty to subject matter eligibility Section 101 jurisprudence.

The PREVAIL Act is essentially a reintroduction of the previously unsuccessful STRONGER Patents Act of 2019 bill and would change fundamental aspects of how the Board operates. Under current practice, the Board judges who rules on institution and also decides the outcome of an instituted proceeding. Under the PREVAIL Act, institution decisions would be made by a separate set of judges from those that render a decision on a petition’s merits. Through proposed changes to the initiation and estoppel provisions, a patent challenger could bring its attack on patent validity in either the district court or the Board, but not both. And as part of the harmonization of district court and Board proceedings, the PREVAIL Act would adopt the “clear and convincing” standard for Board review and codify existing Board practice of applying the same claim construction standard as district courts apply.

The PREVAIL Act would also change who can bring issues to the Board by imposing standing and revised real-party-in-interest requirements. An IPR petitioner would have to establish standing equivalent to that required for a district court declaratory judgment action. Moreover, anyone who financially contributes to an IPR would be deemed a real party in interest to avoid multiple petitions backed by the same entity. To reduce the multiplicity of proceedings, the PREVAIL Act would establish a presumption against a joinder for time-barred petitions. The PREVAIL Act also includes several provisions directed to the independence and transparency of the Board’s decision-making, including establishing a code of conduct and requiring recordation of the Director’s actions that affect Board proceedings.

Turning to subject matter eligibility, the Patent Eligibility Restoration Act would overrule Supreme Court decisions importing a judicial exception to Section 101 and would codify many of the existing categories of ineligible subject matter, including mathematical formulae; substantially economic, financial, social, cultural and artistic practices (in other words, fundamental human activity); natural processes and products made independent of human activity; and mental processes. The Patent Eligibility Restoration Act specifically would authorize early resolution and limited discovery on Section 101 ineligibility.

Practice Note: Although both acts have been introduced before without much success, Congress’s present focus on technology (such as artificial intelligence) may serve to propel one or both bills forward. Of course, it remains to be seen whether Congress has an appetite for modifying patent law, particularly in the lead-up to an election year.

Branding Function Patent Yet Another 1[01] to Bite the Dust

by Thomas DaMario | Apr 20, 2023 | Patents

Addressing the patentability of claims directed to digital image branding functions, the US Court of Appeals for the Federal Circuit affirmed a district court’s determination that claims across three related patents were invalid under 35 U.S.C. § 101 for lacking patent-eligible subject matter. Sanderling Mgmt. Ltd. v. Snap Inc., Case No. 21-2173 (Fed. Cir. Apr. 12, 2023) (Chen, Cunningham, Stark, JJ.)

Sanderling owns three patents, each titled “Dynamic Promotional Layout Management and Distribution Rules.” The three patents share a common specification and are generally directed to a method using distribution rules to load digital imaging branding functions to users when certain conditions are met. The specification explains that a distribution rule is “a rule used in determining how to target a group of end users, for instance, a rule that determines that only a group of end users having certain characteristics and/or match a certain requirement.”

Sanderling asserted each of the three patents against Snap in the Northern District of Illinois. Snap moved to transfer venue to the Central District of California and to dismiss the case under Fed. R. Civ. P. 12(b)(6) for failure to state a claim based on the allegation that the asserted patents’ claimed ineligible subject matter under § 101. After the case was transferred, the Central District of California found the claims patent ineligible and granted Snap’s motion to dismiss. Sanderling appealed.

The Federal Circuit reviewed the decision by engaging in the two-step Alice framework for subject matter eligibility. Under step one, the Court determined that the claims were directed to the abstract idea of providing information—in this case, a processing function—based on meeting a condition (e.g., matching a GPS location indication with a geographic location). The Court explained that for computer-related inventions, the relevant question is whether the claims are directed to an improvement to computer functionality or to an abstract idea. The Court found that the claims in issue were not directed to an improvement in computer functionality, but instead to the use of computers as a tool—specifically, a tool to identify when a condition is met and then to distribute information based on satisfaction of that condition.

Even if directed to an abstract idea, patent claims may still be eligible under step two of the Alice framework if there are additional features that constitute an inventive concept. The Federal Circuit, however, found that the claims failed this step also. The Court explained that if a claim’s only inventive concept is the application of an abstract idea using conventional and well-understood techniques, the claim has not been transformed into a patent-eligible application of an abstract idea. The distribution rule of the asserted claims was just that: the application of the abstract idea using common computer components. Accordingly, the Court affirmed the district court’s decision that the patent claims were invalid under § 101.

Practice Note: On appeal, Sanderling argued that the district court erred at step one of the Alice analyses by failing to construe certain claim terms that were allegedly crucial to the determination. [...]

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Patenting a Nice Cool Glass of Nicotinamide Riboside? Claims Covering Milk Invalid under § 101

by Alexander Piala, PhD | Feb 23, 2023 | Patents

The US Court of Appeals for the Federal Circuit found that claims covering a naturally occurring composition were not patent eligible under 35 U.S.C. § 101 merely because one component of the composition had been “isolated.” ChromaDex, Inc. v. Elysium Health, Inc., Case No. 2022-1116 (Fed. Cir. Feb. 13, 2023) (Chen, Prost, Stoll, JJ.)

ChromaDex sued Elysium (a former ChromaDex customer) for infringement of its patent directed to dietary supplements containing nicotinamide riboside (NR). Elysium moved for summary judgment, arguing that the asserted claims were invalid under the § 101 prohibition against patenting natural phenomena. After the district court granted summary judgment, ChromaDex appealed.

The asserted claims were directed to a composition comprising:

Isolated NR
One or more of tryptophan, nicotinic acid or nicotinamide
One of 22 carriers
Increased NAD+ biosynthesis after eating.

Both parties conceded that milk satisfies every element of the asserted claims with the exception that its NR is not “isolated.” Both parties also conceded that milk is a naturally occurring material and thus not patent eligible under § 101.

On these facts, the issue presented was whether the claim limitation that the NR must be “isolated” (which does not occur in nature) was sufficient to make the claims patent eligible. The Federal Circuit responded “no.”

The Federal Circuit analyzed the asserted claims under two tests: the “markedly different characteristics” test set out in Chakrabarty, and the Alice two-step test (unsure whether Chakrabarty remains controlling precedent).

Under the Chakrabarty test, a claimed composition is not a natural phenomenon if it has “markedly different characteristics” from what occurs in nature. The Federal Circuit found that ChromaDex’s claimed composition had no markedly different characteristics from natural milk. While ChromaDex argued that isolation potentially allowed for unnaturally high concentrations of NR, the claims did not require such concentrations. The claims included compositions structurally and functionally identical to milk and therefore failed the “markedly different characteristics” Chakrabarty test.

Proceeding to the two-part Alice test, under step 1 the Federal Circuit found that the claims were directed to a product of nature because there were no structural differences between the claimed composition and natural milk. Under step two, the Court found that there was no “inventive step” because the claims were merely directed to increasing NAD+ biosynthesis, which was a natural principle that resulted from drinking milk.

Practice Note: During claim drafting, care should be taken to avoid claims that encompass all structural and functional components of a naturally occurring material.

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