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A Matter of Style: No Need to Select “Primary” Reference in Obviousness Challenge

The US Court of Appeals for the Federal Circuit affirmed an obviousness decision by the Patent Trial & Appeal Board, explaining that nothing requires a petitioner to identify a prior art reference as a “primary reference” in an obviousness challenge. Schwendimann v. Neenah, Inc., Case Nos. 22-1333; -1334; -1427; -1432 (Fed. Cir. Oct. 6, 2023) (Prost, Clevenger, Cunningham, JJ.)

Jodi Schwendimann filed lawsuits accusing Neenah of infringing several patents related to transfer sheets and methods for transferring images onto dark fabrics. Neenah filed several petitions for inter partes review (IPR) challenging various claims based on obviousness. The Board instituted the IPR challenges.

Schwendimann’s patents addressed a method for ensuring that dark images could be seen when transferred onto dark fabrics. Multilayer image transfer sheets were known in the prior art, teaching a two-step process to first apply a light background onto dark fabric and then apply the dark image on top. Schwendimann’s claims described a single-step solution, incorporating a white background, possibly of titanium dioxide, into the image transfer sheet so that a white background and dark image could be applied simultaneously onto a dark fabric.

All of the IPR petitions cited Kronzer as a prior art reference. Kronzer described multilayered image transfer sheets with varying configurations, although it lacked white pigment in a layer to transfer an image onto dark fabric. Another prior art reference, Oez, taught the use of a white pigment, such as titanium dioxide, in multilayered image transfer sheets. Schwendimann did not dispute that Kronzer and Oez taught or suggested all limitations recited in the challenged claims. Instead, she argued that there was no motivation for a skilled artisan to combine the references or to expect that such combination would yield a reasonable expectation of success. The Board considered and addressed each argument, relying on Neenah and Schwendimann’s experts’ testimony and the complementary and compatible nature of the references. The Board found the challenged claims obvious over Kronzer in view of Oez. Schwendimann appealed.

Schwendimann argued that substantial evidence did not support the Board’s findings that a skilled artisan would have been motivated to combine Kronzer and Oez and would have had a reasonable expectation of success in making the proposed combination. The Federal Circuit explained that substantial evidence means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion” and considered these two arguments together.

The Federal Circuit found that Schwendimann failed to show that the Board’s findings were not supported by “substantial evidence.” Like the Board, the Federal Circuit used both expert witnesses’ testimonies to explain that the references shared a common goal of improving image transfer characteristics. The Court found that Schwendimann’s arguments that Oez taught away from the proposed combination failed because Oez’s disclosure did not discourage a skilled artisan from using white pigment identified in the challenged patents or lead the skilled artisan in a direction divergent from the path taken in the challenged patents. Her argument that adding titanium dioxide into Kronzer’s transfer sheets could [...]

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PTO Proposes Rules Promoting Independence in Board Decision-Making

Seeking to bolster the independence of administrative patent judge (APJ) panels when issuing decisions and increase transparency regarding Patent Trial & Appeal Board processes, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking concerning the pre-issuance internal circulation and review of decisions. Rules Governing Pre-Issuance Internal Circulation and Review of Decisions Within the Patent Trial and Appeal Board, 88 Fed. Reg. 69578 (Oct. 6, 2023)

The proposed rules were developed in response to a July 2022 request for comments and would refine and codify interim processes and standards that have been in place since May 2022. If adopted, the proposed rules would be codified as Section 43 in Title 37 of the Code of Federal Regulations (37 C.F.R. §§ 43.1-43.6) relating to Board proceedings pending under 37 C.F.R. §§ 41 and 42.

Under the rules in newly proposed §§ 43.3 and 43.4, prior to issuance of a decision by the panel, senior PTO management and non-management APJs at the PTO (as defined in § 43.2) would be barred from communicating, directly or through intermediaries, with any panel member (unless they were themselves panel members) regarding the decision. Limited communications would be permitted for procedural status and generally applicable paneling guidance that don’t directly or otherwise influence the paneling or repaneling of any specific proceeding. The proposed rules would not forbid a panel member from requesting input on a decision prior to issuance from non-panel senior APJs, however. The proposed rules would stipulate that it is within the panel’s sole discretion to adopt any edits, suggestions or feedback from non-panel APJs.

The proposed rules substantially follow the interim processes in place except for a change regarding pre-issuance circulation of decisions to a pool of non-management APJs, known as the circulation judge pool (CPJ). Under the interim process, certain categories of Board decisions are required to be circulated to the CPJ prior to issuance. Those decisions include all America Invents Act (AIA) institution decisions, AIA final written decisions, AIA decisions on rehearing, inter partes reexamination appeal decisions, designated categories of ex parte appeals, ex parte reexamination appeals and reissue appeal decisions and all Board decisions (including AIA and ex parte appeal decisions) following a remand from the US Court of Appeals for the Federal Circuit. Under the proposed rules, circulation to the CJP would be optional.

The PTO will accept comments until December 5, 2023, through the Federal eRulemaking Portal.




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No Need To Be Explicit: Implicit Finding of Expectation of Success Is Sufficient

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability decision, finding that a combination of prior art references only requires an implicit indication of a reasonable expectation of success. Elekta Ltd. v. Zap Surgical Systems, Case No. 21-1985 (Fed. Cir. Sept. 21, 2023) (Reyna, Stoll, Stark JJ.)

Elekta owns a patent directed to a “method and apparatus for treatment by ionizing radiation.” The claimed invention uses a radiation source such as a linear accelerator (linac) mounted on concentric rings to deliver a beam of ionizing radiation to a target area on the patient. Zap challenged the patent as obvious in an inter partes review (IPR) proceeding. In its Final Written Decision, the Board agreed, concluding that a skilled artisan would have been motivated to combine the asserted prior art references. Elekta appealed.

Elekta raised three arguments on appeal:

  1. The Board’s findings on motivation to combine were not supported by substantial evidence.
  2. The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
  3. Even if the Board made such findings, they were not supported by substantial evidence.

The Federal Circuit first considered the issue of motivation to combine the prior art references disclosing radiation imagery with references disclosing radiation therapy, noting that the obviousness determination does not always require the prior art to expressly state a motivation for every obviousness combination. Elekta had challenged the asserted combination based on a physical impracticality in combining the art due to the weight of the linac. The Board, however, disagreed largely because of the level of skill in the art in addition to its definition of the relevant field as one that “includes the engineering design of sturdy mechanical apparatuses capable of rotationally manipulating heavy devices.” The Court found that the Board’s finding of motivation to combine was supported by substantial evidence, including the prosecution history, the prior art teaching and the expert testimony of record.

The Federal Circuit next considered Elekta’s argument that the Board erred by failing to articulate findings on reasonable expectation of success. The Court explained that “an obviousness determination requires finding that a person of ordinary skill in the art would have had a reasonable expectation of success,” referring to “the likelihood of success in combining references to meet the limitations of the claimed invention.” The Court concluded, however, that unlike the motivation to combine determination, which must be an explicit analysis under KSR, a finding of reasonable expectation of success may be implicit. The Court acknowledged that this could be seen as being in tension with its review of Board determinations under the Administrative Procedure Act but concluded that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including . . . those [regarding] a motivation to combine.”

Finally, the Federal Circuit addressed Elekta’s argument that, even if the Board made an implicit finding on reasonable expectation of [...]

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PTO Issues Oral Hearing Guide for Patent Trial & Appeal Board Proceedings

On August 31, 2023, the US Patent & Trademark Office (PTO) published an Oral Hearing Guide to aid parties with oral arguments before the Patent Trial & Appeal Board. The newest Oral Hearing Guide updates the 2019 Oral Hearing Guide published on August 30, 2019, and is meant to be read in conjunction with the procedures set forth in the 2019 PTAB Trial Practice Guide.

The Oral Hearing Guide addresses the following topics:

  • PTO locations for oral hearings
  • Request for an oral hearing
  • Notification of hearing in ex parte and reexamination hearings
  • Notification of hearing in America Invents Act (AIA) trials
  • Authorized persons to present oral arguments
  • Attendance at hearings
  • Guidelines for counsel during argument.

With a few minor exceptions, the administrative processes and procedures largely mirror those set forth in the 2019 Oral Hearing Guide and the 2019 PTAB Trial Practice Guide. The key changes are summarized below.

A Request for Oral Hearing in ex parte and reexamination proceedings must be filed as a separate paper with the required fee paid within a non-extendable time period. The Board will issue a Notice of Hearing to the parties involved once a case has been scheduled for oral argument, typically eight weeks before the scheduled hearing session. The Notice of Hearing provides information about the scheduled hearing, including the date, time, location, appearance options and general information about the oral hearing procedures before the Board.

In trial proceedings under the AIA—i.e., inter partes reviews (IPRs), covered business method reviews (CBMs or CBMRs), post-grant reviews (PGRs) and derivations—each party to a proceeding is afforded an opportunity to present its case before at least three members of the Board and is notified of the date and location options of an oral hearing in a Scheduling Order. The Guide further elaborates on the processes for requesting an oral argument, including the issuance of the Notice of Hearing (or Scheduling Order) when an oral hearing is requested. The Scheduling Order notifies the parties of the finalized hearing date, time and location. Once the Board has issued a Hearing Order, parties requiring a different arrangement should contact the Board with their request.

The Guide stipulates that the parties should state in their respective requests for oral argument whether they prefer a video hearing or an in-person hearing, and for in-person hearings, which available location the party prefers. To the extent the parties disagree, they should meet and confer. If the dispute cannot be resolved by meeting and conferring, the parties should inform the Board of each party’s individual preferences. The Board will notify the parties of its decision in accordance with current office policy.

The Guide further provides updated information stipulating that optional demonstrative exhibits must be marked with the words “DEMONSTRATIVE EXHIBIT – NOT EVIDENCE” in the footer and further elaborates on the procedures for parties to request pro hac vice admission for non-registered patent practitioners to participate in proceedings. Finally, the Guide discusses [...]

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Hit Rewind: Analogous Art and Field of Endeavor

Addressing the Patent Trial & Appeal Board’s application of the field of endeavor and reasonably pertinent tests for determining analogous art, the US Court of Appeals for the Federal Circuit found that the Board should not have required a petitioner to precisely articulate the relevant field of endeavor for the patent and prior art using the magic words, “field of endeavor.” However, the Court agreed with the Board that the prior art was not reasonably pertinent because it concerned a different problem than the challenge addressed by the patent. Netflix, Inc. v. DivX, LLC, Case No. 22-1138 (Fed. Cir. Sept. 11, 2023) (Stoll, Hughes, and Stark, JJ.)

Netflix filed an inter partes review (IPR) challenging DivX’s patent directed toward a feature called “trick play functionality,” which refers to the ability to fast forward, rewind and skip frames in a multimedia file. The patent’s background explains that the invention generally relates to the “encoding, transmission and decoding of multimedia files.” Notably, the claimed invention implements a multimedia file based on the Audio Video Interleave (AVI) structure with an additional storage structure called an “index chunk.”

In its petition, Netflix asserted that the challenged claims were obvious over two prior art references, Zetts in view of Kaku. Kaku disclosed the use of an AVI file with an index chunk to show image data and/or play sound data in a digital camera. Kaku explained that the invention’s primary object is to reproduce a motion image in a device with minimal memory but clarified that the invention is “applicable to every electronic appliance to reproduce motion images.” Netflix asserted that Zetts disclosed a system for facilitating trick play while Kaku disclosed using an AVI file format with an index chunk to store video/audio data.

In its patent owner response, DivX argued that Kaku was non-analogous art because the challenged patent relates to facilitating trick play in streamed multimedia content, whereas Kaku utilizes M-JPEG files in limited-memory cameras. DivX similarly argued that Kaku was not reasonably pertinent to the problem of “facilitating trick play functionality in streaming services.” Netflix countered that Kaku must be considered for its AVI teachings and/or the “encoding and decoding of multimedia files,” both of which are “applicable to every electronic appliance to reproduce motion images” and render Kaku reasonably pertinent. The Board rejected Netflix’s obviousness argument, holding that it failed to identify the field of endeavor for the DivX patent or Kaku, as well as the problem to be addressed by the DivX patent. Netflix appealed.

The Federal Circuit first considered the Board’s conclusion that Netflix failed to identify an overlapping field of endeavor for Kaku and the DivX patent. The Court explained that the field of endeavor is determined by reference to explanations of the invention’s subject matter in the specification and is not limited to the specific point of novelty or the particular focus within a field. Rather, a field of endeavor may be broadly defined because it relies on the specification’s complete disclosure. Applying this principle, the [...]

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Sins of the Fathers? Grandparent IPR Factors into Current Institution Decision

US Patent & Trademark Office (PTO) Director Kathi Vidal vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) because the Board improperly applied the precedential Advanced Bionics framework in rendering its decision. Keysight Tech., Inc. v. Centripetal Networks, Inc., IPR2022-01421 (PTAB Decision Review Aug. 24, 2023) (Vidal, Dir.)

Keysight Tech. petitioned for an IPR proceeding against a patent owned by Centripetal Networks, challenging the validity of all claims. After the Board denied institution, Director Vidal issued a sua sponte director review decision, vacating and remanding the Board’s decision.

The Centripetal patent is the great-grandchild of, and shares the same disclosure as, an earlier Centripetal patent that was subject to an IPR proceeding during the pendency of the presently challenged patent. The Final Written Decision (FWD) in the earlier IPR found all claims of the patent unpatentable. The patent owner included that FWD in an Information Disclosure Statement (IDS) submitted during the prosecution of the presently challenged patent, and the examiner initialed it as having been considered.

In its decision denying institution, the Board cited the guidance of Advanced Bionics, which articulates a framework that requires that the Board determine the following:

  • Whether the same or substantially the same prior art or arguments made in the petition were previously presented to the PTO during prosecution of the challenged patent
  • Whether the PTO erred in a manner material to the patentability of the challenged claims when it allowed the claims of the patent.

If both factors are met in the affirmative, the Board should not exercise its discretion to deny institution.

Here, the Board found that the first factor of the Advanced Bionics framework was met because the petitioner’s arguments in its petition were the same or substantially the same as those in the FWD in the IPR of the grandparent patent. However, the Board found that the second part of the framework was not satisfied and therefore denied institution.

Although Director Vidal agreed with the Board’s findings under the first factor, she vacated the Board’s findings pursuant to the second factor after determining that this factor was also met. Director Vidal found that the PTO erred in a manner material to the patentability of the challenged claims for the following reasons:

  • The challenged patent and the grandparent were directed to the same subject matter.
  • The prior art references submitted to the PTO during the prosecution of the challenged patent were the same as those asserted in earlier IPR and were considered by the examiner through the patent owner’s IDS.
  • In the grandparent IPR, the Board held all of the claims of the patent unpatentable due to these same prior art references.
  • The examiner’s statement of reasons for allowing the challenged patent was that the claims were directed to limitations that appeared in both the currently challenged claims and the claims found unpatentable in the grandparent patent.

As the director noted, the overlap between the claim limitations in the [...]

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Don’t Be So Stern: Copying Carries Significant Weight in Assessing Objective Evidence

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision invalidating a patent, finding that the Board erred in assessing nexus and weight to be accorded to objective evidence of nonobviousness. Volvo Penta of the Americas, LLC v. Brunswick Corp., Case No. 22-1765 (Fed. Cir. Aug. 24, 2023) (Moore, Lourie, Cunningham, JJ.)

Volvo Penta owns a patent directed to a tractor-type stern drive for a boat. A stern drive is a type of engine that is mounted in the hull of a boat and connected to a drive unit mounted outside of the hull, typically on the stern. In the industry, this arrangement is often referred to as an inboard/outboard drive. In 2015, Volvo Penta launched its commercial embodiment of the patent called the Forward Drive and was popular particularly for wake surfing and other water sports. The Forward Drive included forward-facing propellers that increased the distance between the propeller and swimmers or surfers compared to prior pulling-type stern drive boats.

In August 2020, Brunswick launched its own drive, the Bravo Four S, which embodies Volvo Penta’s patent. On that same day, Brunswick filed a petition for inter partes review asserting that the challenged claims were anticipated or obvious based on several references, two of which were Kiekhaefer and Brandt. In response, Volvo Penta argued that a person of ordinary skill in the art would not have been motivated to combine Kiekhaefer and Brandt with a reasonable expectation of success and that the objective indicia of nonobviousness overcame any prima facie case of obviousness. In support, Volvo Penta offered evidence of copying, industry praise, commercial success, skepticism, failure of others and long-felt but unsolved need. Volvo Penta also argued that it was entitled to a presumption of nexus between the objective indicia and the claimed invention, and, even if there was no presumption, there was still nexus.

The Board found that Kiekhaefer did not anticipate the challenged claims, but it would have been obvious to redesign the stern drive of Brandt in light of Kiekhaefer’s outboard motor to arrive at the challenged claims. After finding a motivation to combine (and prima facie obviousness), the Board turned to Volvo Penta’s objective evidence of nonobviousness. The Board first determined that Volvo Penta was not entitled to a presumption of nexus because, even though the Forward Drive and Bravo Four S indisputably embody the challenged claims, Volvo Penta did not make sufficient arguments on coextensiveness. The Board also found that regardless of the presumption, Volvo Penta did not otherwise show nexus because it failed to identify the “unique characteristics” or “merits” of the claimed invention.

Despite finding no nexus, the Board still analyzed the objective evidence and concluded that Volvo Penta’s objective evidence weighed somewhat in favor of nonobviousness but that Brunswick’s strong evidence of obviousness outweighed the objective evidence. The Board therefore concluded that the challenged claims were unpatentable. Volvo Penta appealed.

Volvo Penta raised three primary arguments on appeal:

  1. The Board’s [...]

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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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

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:

  1. In a federal criminal, civil or administrative hearing in which the government or its agent is a party
  2. In a congressional, Government Accountability Office (GAO) or other Federal Report hearing, audit or investigation
  3. 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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New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

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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