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Tune to the Right Channel: Disclosure Lacking Fraud Information Isn’t an FCA Qui Tam Bar

by Cecilia Choy, Ph.D. | Aug 17, 2023 | Patents

The US Court of Appeals for the Ninth Circuit reversed a district court’s decision to dismiss a qui tam action brought under the False Claims Act (FCA) after analyzing the public disclosure bar channels. The case required the Ninth Circuit to examine Congress’s 2010 amendments to the FCA public disclosure bar to determine whether the claims were substantially the same as information publicly disclosed in any one of three enumerated channels. Silbersher v. Valeant Pharm. Int’l, Inc., No. 20-16176 (9th Cir. Aug. 3, 2023) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on anyone who knowingly presents a fraudulent claim for payment to the federal government. The FCA includes a qui tam provision that allows private citizens (or “relators”) to bring fraud claims on behalf of the government. In 2010, Congress’s public disclosure bar precluded qui tam actions if substantially the same allegations or transactions were publicly disclosed in one of three channels:

In a federal criminal, civil or administrative hearing in which the government or its agent is a party
In a congressional, Government Accountability Office (GAO) or other Federal Report hearing, audit or investigation
From the news media, unless the action is brought by the Attorney General or the person bringing the action is an original source of the information.

Valeant owns the “Otterbeck patents” for its drug Apriso’s delayed-release formula. Valeant initiated an infringement action against Lupin, a generic drug manufacturer that attested in an abbreviated new drug application (ANDA) that the Otterbeck patents were invalid because of prior art that described a similar delayed-release formula. Thereafter, Valeant extended its monopoly by applying for and being granted a new patent that claimed a recent discovery that Apriso was effective when taken without food. GeneriCo then challenged the new patent in an inter partes review (IPR) proceeding, arguing that it was obvious that Apriso would be effective without food. GeneriCo presented two medical studies as support. The Patent Trial & Appeal Board agreed and invalidated the claims in the new patent.

Zachary Silbersher, GeneriCo’s IPR lawyer and a relator in another FCA suit in the same court, discovered that Valeant failed to disclose certain information to the US Patent &Trademark Office (PTO) during the IPR proceeding. Specifically, he discovered that three years before applying for the new patent, Valeant applied for another patent where it claimed it made an unexpected finding that taking Apriso’s active ingredient with food made the drug more effective. This claim was the opposite of the claim made in the new application that had been invalidated in the IPR proceeding.

Silbersher brought an FCA case seeking damages from Valeant, alleging that Valeant fraudulently obtained the Otterbeck and new patent to prolong its monopoly and charge an artificially high price for Apriso. The district court dismissed Silbersher’s qui tam action as precluded by the public disclosure bar because the IPR qualified as an “other Federal hearing” under channel two of the bar, as described above. Silbersher appealed.

The Ninth Circuit analyzed whether [...]

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Noncompulsory Counterclaims Don’t Confer Appellate Jurisdiction

by Kathleen Lynch | Aug 17, 2023 | Antitrust, Patents, Trade Secrets

The US Court of Appeals for the Federal Circuit determined that it does not have appellate jurisdiction to review noncompulsory patent counterclaims in a case otherwise unrelated to the originally asserted patents. Teradata Corp. v. SAP SE, Case No. 22-1286 (Fed. Cir. Aug. 1, 2023) (nonprecedential) (Lourie, Taranto, Hughes, JJ.)

Teradata makes and sells data warehouse systems and services. SAP develops and sells software. The two companies began collaborating while SAP was simultaneously developing its own database (HANA) and component software. SAP eventually informed Teradata that it would stop selling certain Teradata products. Teradata sued SAP, alleging misappropriation of trade secrets on the theory that SAP used Teradata’s proprietary information to create HANA. Teradata also alleged various antitrust violations, arguing that SAP “illegally tied” HANA and HANA’s supporting software. In response, SAP filed counterclaims against Teradata for allegedly infringing SAP patents related to database organization and optimization. On Teradata’s motion, the district court agreed to sever one of the four patent infringement claims but allowed the others to proceed. The district court reasoned that Teradata’s claims and SAP’s counterclaims all arose from “the same transaction or occurrence,” namely SAP’s development of HANA.

The district court granted summary judgment to SAP on Teradata’s antitrust and technical trade secret claims and stayed proceedings on Teradata’s business trade secret claim and to Teradata on SAP’s patent counterclaims. Teradata appealed to the Federal Circuit.

SAP moved to transfer the appeal to the Ninth Circuit. The Federal Circuit denied the motion but instructed the parties to address the jurisdictional issue in the merits brief. 28 U.S.C. § 1295(a)(1) grants the Federal Circuit exclusive appellate jurisdiction over final decisions in which a party claims or asserts a compulsory counterclaim related to patents. As it relates to this case, the issue was whether SAP’s patent infringement counterclaims were “compulsory,” meaning SAP would be unable to later sue on these patent infringement allegations “if it did not press them in this action.”

The Federal Circuit began by looking at Federal Rules of Civil Procedure 13(a), which states that a counterclaim is “compulsory” if it arises from the same transaction or occurrence as a plaintiff’s claim. The Court explained that it uses three tests to determine whether the transaction or occurrence is sufficiently related between the claim and counterclaim:

Whether the legal and factual issues are substantially the same
Whether the evidence will be substantially the same
Whether there is “a logical relationship between the claim and the counterclaim.”

Taken together, these tests essentially ask if there is substantial overlap between what the plaintiff and the defendant must establish to succeed on the claim and counterclaim, respectively.

The Federal Circuit found that the first two tests clearly weighed against SAP’s counterclaim being compulsory. While an understanding of the accused products and alleged trade secrets would be necessary for both the claim and the counterclaim, “same-field overlap” is not enough to make the issues or necessary evidence “substantially the same.”

As to the third test, the Federal Circuit found [...]

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New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

by Tessa Kroll | Aug 17, 2023 | Patents

Addressing the issue of new claim constructions presented by a patent owner after the institution of inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found that a petitioner is entitled to argue and present evidence under the new construction so long as it relies on the same prior art embodiments used in the petition. Axonics, Inc. v. Medtronic, Inc., Case No. 22-1532 (Fed. Cir. Aug. 7, 2023) (Dyk, Lourie, and Taranto, JJ.)

Medtronic owns two patents directed to the transcutaneous charging of implanted medical devices via inductive coupling between a primary coil in an external charger and a secondary coil in the implanted device. The relevant claims of each patent require the external charger’s power to be automatically varied based on “a value associated with the current passing through the internal power source” (the value limitation) and “a measured current associated with the current passing through the internal power source” (the measured current limitation).

Axonics filed two IPR petitions challenging Medtronic’s patents, arguing that the claims were anticipated by three prior art references. Axonics’s petitions did not propose any express claim constructions, but its claim charts stated that the measured current limitation simply narrows the “value” in the value limitation to “measured current” and does not require a separate measurement. Under this “one-input” construction, both limitations would be satisfied if the external power source automatically varied its power output based on the implanted device’s current. In its preliminary response, Medtronic agreed that while claim construction was not necessary, the prior art failed to anticipate the claimed device under the one-input construction. In its institutional decision, the Patent Trial & Appeal Board agreed that “no term requires express construction.”

In its patent owner response, Medtronic (for the first time) advanced a new claim construction, arguing that the value limitation and the measured current limitation required separate inputs (the two-input construction). In Axonics’ reply, it defended the one-input construction and further argued that the three prior art references also disclosed the claimed device under the two-input construction. In support of its reply, Axonics submitted a supplemental expert declaration citing additional disclosures in the prior art references pertaining to the same embodiments relied upon in the petition. Medtronic argued that it would be prejudicial for the Board to consider Axonics’ new reply arguments without providing Medtronic an opportunity to submit a supplemental expert declaration. Medtronic, however, did not seek leave to submit a new declaration.

In its final written decision, the Board adopted the two-input construction and declined to consider Axonics’ arguments and evidence under the new construction, considering them to be improper reply arguments. Axonics appealed.

The Federal Circuit acknowledged that a petition is required to identify “in writing and with particularity…the grounds on which the challenge to each claim is based, and the evidence that supports the grounds.” To that end, a petitioner may not submit new evidence or arguments in a reply that could have been raised earlier but may respond to new arguments [...]

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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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Holy Pulmonary Hypertension, Batman: Method of Treatment Not Constrained by Safety and Efficacy

by Nitya Anand | Aug 3, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit also affirmed the district court’s holding that certain claims of the product-by-process patent were invalid because the claimed product was in the prior art, regardless of the process by which it was made. United Therapeutics Corporation v. Liquidia Technologies, Inc., Case Nos. 22-2217; 23-1021 (Fed. Cir. July 24, 2023) (Lourie, Dyk, Stoll, JJ.)

United Therapeutics is the maker of Tyvaso®, a treprostinil formulation approved for treating pulmonary hypertension. United Therapeutics asserted two patents covering Tyvaso® against Liquidia’s § 505(b)(2) new drug application (NDA) on Yutrepia™. One patent was a method of treatment patent claiming to treat pulmonary hypertension by administering a “therapeutically effective” dose of a treprostinil formulation, and the other was a product-by-process patent claiming a treprostinil composition with lowered levels of impurities made by a specific salt formation process.

The district court found that United Therapeutics showed that a single administration of treprostinil improves a patient’s hemodynamics, establishing that administration of Liquidia’s Yutrepia, comprising treprostinil, would directly infringe the method of treatment claims. The district court also concluded that even though Yutrepia’s label did not provide hemodynamic data, the label’s instructions would inevitably lead to the administration of a therapeutically effective single event dose. The court thus concluded that Liquidia would induce infringement of the method of treatment claims.

The district court further found that the asserted claims were not invalid for lack of enablement or written description. The court reasoned that a skilled artisan would not need to engage in undue experimentation to practice the full scope of the claimed treatment of pulmonary hypertension, despite potential safety concerns in treating certain patients, since the claims did not require safety and efficacy. The court found that the claims were not invalid for lack of written description, finding that a skilled artisan would, based on the specification, understand that treprostinil would effectively vasodilate the pulmonary vasculature, improve hemodynamics and treat a patient’s elevated pulmonary blood pressure.

Liquidia appealed on five issues: claim construction of the term “treating pulmonary hypertension,” enablement, written description, induced infringement and infringement of the product by process claims. United Therapeutics cross-appealed on anticipation of the product by process claims and non-infringement of those claims.

First, regarding the construction of “treating pulmonary hypertension,” the Federal Circuit affirmed that the term encompassed all recognized groups of pulmonary hypertension but noted that the claim language “treating pulmonary hypertension” did not import any additional efficacy limitations or safety limitations, even those in a group that would not benefit from the treatment. The Court declined to read any safety or efficacy requirements into the claims, explaining that absent incorporation into the claims, the safety and efficacy of a claimed treatment are the purview of the US Food & Drug Administration (FDA), not patent law.

Regarding enablement and written description, Liquidia argued that the method [...]

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No Need for Unnecessary RPI Determinations

by Joshua Revilla | Jul 27, 2023 | Patents

The US Patent & Trademark Office Director partially vacated the Patent Trial & Appeal Board’s real-party-in-interest (RPI) determination because that determination was not necessary to resolve the underlying proceeding. Unified Patents, LLC v. MemoryWeb, LLC, IPR2021-01413, Paper 76 (PTAB May 22, 2023) (Vidal, Dir.)

Unified Patents filed a petition requesting inter partes review (IPR) of a patent owned by MemoryWeb. In its petition, Unified certified that it was the only RPI. Prior to institution, both parties briefed whether Unified should have identified two third parties as RPIs under 35 U.S.C. § 312(a)(2). In its institution decision, the Board declined to determine whether the third parties were RPIs because there was no allegation in the proceeding of a time bar or estoppel based on there being an unnamed RPI, and therefore the proceedings would not have created a time bar or estoppel under 35 U.S.C. § 315 even if the third parties were included as RPIs.

After institution, MemoryWeb continued to argue that the Board should terminate the proceeding because of Unified’s alleged failure to name the third parties as RPIs while also arguing that in the alternative, the Board should find the two third parties estopped from challenging the validity of the claims at issue in two different IPRs covering the same patent. The Board then issued an order identifying the third parties as RPIs, explaining that it was now appropriate to determine whether the two third parties were RPIs “[b]ecause the issue of Section 315(e) estoppel has been put before us [as relevant to the subsequent IPR challenges filed by the third parties], and we now have a complete factual record available to fully address the RPI question, and to avoid unnecessary prejudice to Patent Owner.” The Board also explained that it was now necessary to determine whether the third parties were RPIs in the case at hand to determine whether they would be estopped in a subsequent proceeding.

Unified filed a request for Director review of the Board’s RPI determination. Unified argued that the panel erred by issuing a non-binding advisory opinion on RPI that prejudiced the third parties by prejudging the RPI issue without their participation and where the decision could bind them in their later-filed proceedings. Unified also cited the Board’s precedential decision in SharkNinja v. iRobot, arguing that the Board should not resolve an RPI issue when it would not create a time bar or estoppel under 35 U.S.C. § 315 in the proceeding.

The Director concluded that the Board can and should determine the RPIs or real parties in privity in a proceeding where that determination may impact the underlying proceeding, including (but not limited to) a time bar under 35 U.S.C. § 315(b) or estoppel under 35 U.S.C. § 315(e) that might apply. However, the Director determined that such was not the situation here since determining the RPI issue was not necessary to resolve the proceeding. The Director, therefore, vacated the Board’s RPI determinations.

No Snipe Hunting: AIA Adherence Means No Interference (Proceedings)

by Jake B. Vallen | Jul 27, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit concluded that patents and applications that have only ever contained claims with an effective filing date after March 16, 2013—i.e., pure America Invents Act (AIA) patents—may not be subjected to an interference proceeding by the US Patent & Trademark Office (PTO) Director. SNIPR Techs. Ltd. v. Rockefeller Univ., Case No. 2022-1260 (Fed. Cir. July 14, 2023) (Chen, Wallach, Hughes, JJ.)

SNIPR Technologies owns a family of five patents directed to methods of selectively killing bacteria using clustered regulatory interspaced short palindromic repeats (CRISPR) gene editing. SNIPR was involved in an interference proceeding with Rockefeller University, which filed a patent application for technology also directed to selectively killing bacteria. The SNIPR patents claimed priority to a Patent Cooperation Treaty application filed on May 3, 2016, thus placing the SNIPR patents squarely within the scope of the AIA. The Rockefeller application claimed priority to, among other things, a US provisional application filed on February 7, 2013, making the Rockefeller application a pure pre-AIA application. The Patent Trial & Appeal Board initially declared an interference between claims 20 to 33 of the Rockefeller application and all claims of the SNIPR patents. The Board ultimately identified Rockefeller as the senior party and canceled all of SNIPR’s claims. SNIPR appealed.

The issue before the Federal Circuit was whether the Board had the authority to cancel SNIPR’s pure AIA claims for lack of invention priority under pre-AIA § 102(g), and more broadly, whether pure AIA patents may, as a matter of law, be part of an interference proceeding.

First, the Federal Circuit examined the plain language of AIA § 3(n) and the statutory purpose and history of the AIA. The Court reasoned that “AIA § 3(n) makes clear that [unless Congress provides otherwise,] only pure pre-AIA and mixed patents may be part of an interference.” As the Court stated, AIA § 3(n)(1) does not permit the AIA’s amendments to apply retroactively and the AIA repealed the statutory grant of power to hear interferences (pre-AIA § 135), instead providing for derivation proceedings.

Next, the Federal Circuit addressed Rockefeller’s and the Director’s arguments that the statutory language of pre-AIA § 135(a) authorizes the Director to declare an interference for “any unexpired patent”—including unexpired pure AIA patents. Unpersuaded, the Court concluded that pre-AIA § 135(a), read in conjunction with the AIA, excludes pure AIA patents for the following reasons:

The AIA replaced interference proceedings with derivation proceedings.
The AIA deleted all other references to interferences.
The AIA repealed the first-to-invent system of patentability, rendering interference proceedings superfluous.
Permitting interferences for pure AIA patents would subject AIA patents to interferences “for over twenty years after the AIA’s effective date,” which would be contrary to the purpose of the AIA—to implement the first-to-file system of patentability.

Moreover, such a statutory construction would belie AIA § 3(n)(2), which expressly allows for interferences for mixed patents (i.e., patents and applications that contain, or contained at any time, at least one claim with [...]

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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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Reissue Boat Won’t Float: “Original Patent” Rule Sinks New Floating Grill Claims

by Kathleen Lynch | Jul 20, 2023 | Patents

Addressing the same invention requirement for reissue patents, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision to reject an overly broad reissue application. In re Float‘N’Grill LLC, Case No. 22-1438 (Fed. Cir. July 12, 2023) (Prost, Linn, Cunningham, JJ.)

Float‘N’Grill (FNG) owned a patent directed to a floating device that supports a grill so that users can grill food while in water. The patent’s specification lays out a single embodiment, illustrated in Figure 1 below, which includes a float (20) that has two supports (46, 48), each of which “includes a plurality of magnets” (60) so that the grill can be removably attached to the float:

FNG filed a reissue application that claimed new ways to “more generically” removably attach a grill to the float. In rejecting the reissue claims, the Examiner found that three of the new requested claims required zero magnets, three claims required one magnet, and one claim did not specifically require magnets but referred to a magnet in the preamble. This was in contrast to the issued patent’s only embodiment, which required multiple magnets. The Examiner, therefore, rejected the reissue claims for failure to meet the “original patent” requirement of 35 U.S.C. § 251. The Board affirmed. FNG appealed.

The question on appeal was whether FNG’s newly requested claims complied with § 251. The Federal Circuit explained that the only path to expanding the coverage of an issued patent is through a reissue application, which is subject to § 251’s limitations. Pertinent here, § 251 requires reissue claims to be directed to the same invention disclosed in the original patent. Citing Supreme Court and Federal Circuit decisions, the Court described the “original patent” requirement as a question of whether the issued patent’s disclosed invention “on its face, explicitly and unequivocally describe[s] the invention as recited in the reissue claims.”

Turning to FNG’s reissue claims, the Federal Circuit agreed with the Board, finding that the new claims were not directed to the same invention as the original patent and thus failed to satisfy § 251. The Court explained that the specification of FNG’s issued patent had just one embodiment, which featured “a plurality of magnets” to removably attach a grill to the floating device. The reissue claims, however, contemplated more general attachments without magnets.

FNG argued that its claims were acceptable under § 251 because the magnets were a “non-essential embodiment” of the invention. The Federal Circuit disagreed for four reasons:

An element of a patent may be deemed essential even if the patent does not explicitly state as much. Thus, the magnets were essential to FNG’s original patent, even if not labeled so.
It is irrelevant that a person of skill in the art may know to replace an original patent element with “some other undisclosed mechanism” to reach the same result. Here, a new way to attach a grill to the [...]

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Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

by Kavya Rallabhandi | Jul 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.