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prior art

Is Evidence of All Claimed Elements in Prior Art Enough? Not Without Motivation to Combine

by Sydney E. McDermott | Apr 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that disclosure in the prior art of all recited claim elements across multiple references, without more, does not establish obviousness unless there is evidence of a motivation to combine. Virtek Vision Int’l ULC v. Assembly Guidance Systems, Inc., Case No. 22-1998 (Fed. Cir. Mar. 27, 2024) (Moore, C.J.; Hughes, Stark, JJ.)

Virtek holds a patent that discloses “an improved method for aligning a laser projector with respect to a work surface.” Lasers are used to “project a template image onto a work surface to direct manufacturing processes.” The patent discloses a two-step process that improves efficiency over the prior art.

Aligned Vision petitioned for inter partes review (IPR), challenging all of the patent’s claims. Aligned Vision asserted four combinations of prior art references over which it contended the claims were obvious. In its Final Written Decision, the Board found that some of the claims were unpatentable as obvious, but others were not.

The Board determined that certain claims, which depended from the independent claim, would have been obvious over two combinations of references: Keitler and Briggs, and Briggs and Bridges. In pertinent part, the independent claim recites “identifying a pattern of the reflective targets on the work surface in a three dimensional coordinate system.” Save for the 3D claim element, all the other claim elements were disclosed in Bridges and Keitler. The Board found that a skilled artisan would have been motivated to use the 3D coordinate system disclosed in Briggs instead of the angular direction systems in Keitler or Bridges. The Board reasoned that this combination would have been obvious to try because Briggs disclosed both 3D coordinates and angular directions.

With respect to the direct appeal, the Federal Circuit found that the Board erred as a matter of law regarding motivation to combine. “It does not suffice to meet the motivation to combine requirement to recognize that two alternative arrangements such as an angular direction system using a single camera and a 3D coordinate system using two cameras were both known in the art.” Rather, the patent challenger must show that a skilled artisan would swap the element in one reference for an element in another reference. “The mere fact that these possible arrangements existed in the prior art does not provide a reason that a skilled artisan would have substituted the one-camera angular direction system in Keitler and Bridges with the two-camera 3D coordinate system disclosed in Briggs.”

Here, the patent challenger presented no argument in the IPR petition regarding why a skilled artisan would make this substitution, other than that the two different coordinate systems were “known to be used.” Specifically, Briggs made no mention of any benefits the 3D system might provide over the angular system. Aligned Vision’s expert testified multiple times that he could not provide a reason to combine the references, and Aligned Vision presented no evidence that “there are a finite number of [...]

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Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

by Alexander Piala, PhD | Mar 14, 2024 | Life Sciences, Patents

In an appeal from a Patent Trial & Appeal Board finding of invalidity, the US Court of Appeals for the Federal Circuit held that the result-effective variable doctrine can apply even when there is no overlap between a claimed range and a prior art range. The Court also held that before denying a motion to amend, the Board must address every element of proposed claims, and that a party cannot challenge the US Patent & Trademark Office (PTO) Director Review procedure if it cannot show prejudice. Pfizer Inc. v. Sanofi Pasteur, Inc., Case No. 19-1871 (Fed. Cir. Mar. 5, 2024), (Lourie, Bryson, Stark, JJ.)

Sanofi filed five inter partes review (IPR) petitions targeting a patent owned by Pfizer and directed to immunogenic glycoconjugates of Streptococcus antigens (i.e., combinations of sugar molecules found on the surface of Streptococcus bacteria capable of provoking an immune response). The challenged independent claim recited conjugates having a sugar from the 22F Streptococcus serotype and a molecular weight falling within a claimed range. Dependent claims further limited the independent claim by requiring combinations of specific sugars.

Sanofi challenged the claims based on a combination of two references: GSK-711 and Merck-086. GSK-711 described vaccines using sugars from 22F, and Merck-086 described immunogenic compositions using Streptococcus sugar conjugates. While neither reference disclosed the molecular weight of a 22F conjugate, the Board found that the molecular weight of a conjugate was a “result-effective variable” – i.e., a variable that affected the efficacy of the result – and thus it would have been obvious for a person of ordinary skill in the art (POSITA) to optimize the molecular weight of a 22F-based conjugate to achieve the claimed molecular weight range. The Board also found that the dependent claims would have been obvious, as GSK-711 disclosed the additionally claimed sugars. Pfizer filed a motion to amend to add new claims, but the Board denied the motion. Pfizer also requested Director Review of the Board’s decision, but the Director denied the request.

Pfizer appealed to the Federal Circuit alleging that the Board improperly applied the result-effective variable doctrine, that the Board improperly denied Pfizer’s request to amend the claims, and that the Director’s denial of review violated the Administrative Procedure Act (APA). The Federal Circuit affirmed the Board’s finding of invalidity, affirmed in part and remanded in part the issue of the proposed claim amendment, and finally held that any violation of the APA was harmless.

The Federal Circuit started with an analysis of the result-effective variable doctrine. Pfizer argued that the result-effective variable doctrine could not apply when there was no disclosure of an effective range in the prior art. Therefore, because neither GSK-711 nor Merck-086 disclosed an effective molecular weight range for a 22F conjugate, and because the relationship between molecular weight and efficacy was unpredictable, the independent claim was not obvious. The Court disagreed.

The Federal Circuit explained that, when there is a gap between the prior art and the claims, the relevant [...]

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Sliced and Diced: Operating Manuals Are Printed Publications

by Keval Amin | Feb 15, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s non-obviousness determination, finding that the Board erred in determining that an operating manual did not qualify as printed publication prior art. Weber, Inc. v. Provisur Technologies, Inc., Case Nos. 22-1751; -1813 (Fed. Cir. Feb. 8, 2024) (Reyna, Hughes, Stark, JJ.)

Provisur owns two patents related to advanced high-speed mechanical slicers used in food processing facilities that precisely slice and package food items such as meats and cheeses. The key components recited in the patent claims are a “loading apparatus” designed to load food items, a “feeding apparatus” responsible for supplying food items to a slicer, and a “stop gate” intended to regulate the assembly of food items prior to their entry into the slicing mechanism.

Weber filed inter partes review (IPR) petitions challenging the validity of several claims of the patents based on certain operating manuals. During the IPR proceedings, the Board determined that Weber’s operating manuals did not qualify as prior art printed publications because they were distributed selectively and subject to confidentiality restrictions. The Board also concluded that the prior art combinations, which included Weber, failed to disclose crucial claim limitations, notably the “disposed over” and “stop gate” limitations. The Board found the challenged claims not unpatentable. Weber appealed.

Weber argued that the Board erred in determining that the operating manuals were insufficiently accessible to constitute printed publications, specifically contending that the Board misapplied the Federal Circuit’s 2009 decision in Cordis Corp. v. Boston Scientific Corp. The Court agreed. It explained that unlike Cordis, where academic monographs were limited to distribution among a select few, Weber’s operating manuals were intended for distribution to purchasers of the machines and others to provide instructions on food slicer usage and maintenance. The Court explained that the evidence in the form of delivery records and email exchanges showed that manuals were available to customers upon purchase or request. The Federal Circuit also noted that the manuals were not bound by any confidentiality restrictions. The Court thus concluded that the operating manuals qualified as printed publications.

Turning to claim construction, the Federal Circuit reversed the Board’s interpretation of the “disposed over” and “stop gate” limitations. Consistent with long-standing precedent, the Court emphasized the importance of examining intrinsic evidence, including the claims themselves, the specification and the patent’s prosecution history. Weber argued that the claims’ language implied a broader feed apparatus positioning over the loading apparatus without strict alignment requirements. Supported by expert opinions, Weber contended that neither the claim language nor the specification mandated direct alignment. The Court agreed with Weber. The Court emphasized that “disposed over” demanded only a general positioning of the feed apparatus above the loading apparatus, not a direct positioning as the Board had construed.

Similarly, concerning the “stop gate” limitation, the Federal Circuit agreed that the Board’s determination was not supported by substantial evidence because evidence, such as the manuals, disclosed the claimed conveyer mechanism in a manner sufficient to establish its [...]

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Even a Non-Explicit Claim Construction Can Be Erroneous

by Brennen Baylor | Feb 15, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision finding the challenged patent claims not obvious over the prior art. The Court found that the Board, after concluding that no claim construction was required, implicitly construed the claim limitation at issue and did so erroneously. Google LLC v. EcoFactor, Case Nos. 22-1750; -1767 (Fed. Cir. Feb. 7, 2024) (Reyna, Taranto, Stark, JJ.)

Google filed a petition for inter partes review (IPR) challenging claims of an EcoFactor patent related to dynamic climate control systems that factor outside weather conditions and thermal conditions inside the home to balance comfort and energy savings. The challenged claims define a method for reducing the cycling time of a climate control system involving “retrieving a target time at which [the] structure [(e.g., a house)] is desired to reach a target temperature.” The challenged method claims recite a step of “determining a first time prior to said target time at which [the] climate control system should turn on to reach the target temperature by the target time.” The relevant claim limitation reads:

[D]etermining a first time prior to said target time at which said climate control system should turn on to reach the target temperature by the target time based at least in part on [i] said one or more thermal performance values of said structure, [ii] said performance characteristic of said climate control system, [iii] said first internal temperature, [iv] said first external temperature, and [v] the forecasted temperature.

During the IPR proceedings, the parties disputed whether a prior art reference disclosed a method involving determining a first time prior to the target time based on a first internal temperature. Google argued that the prior art taught a calculation of a first time prior to the target time based on thermal performance values (input [i]) calculated from internal temperature values (input [iii]). EcoFactor argued that each of the inputs in the claim limitation was a distinct value not dependent on or calculated from any other input. Based on the claim language, the Board determined that claim construction was unnecessary and concluded that inputs [i] – [v] of the relevant claim limitation were separate inputs using different data. The Board concluded that Google had not shown that the challenged claims were unpatentable, reasoning that Google’s theory of obviousness relied on a single input as the basis for both input [i] and input [iii].

Google appealed. Google argued that although the Board stated that no construction was necessary, it incorrectly construed the claim limitation to require five discrete inputs.

The Federal Circuit agreed with Google, finding that the Board’s assessment of the claim limitation implicitly established the claim scope by requiring inputs [i] – [v] to be completely separate. The Court reasoned that the plain claim language did not provide any indication that none of the listed inputs could be based on any other input(s). Imputing this requirement into the limitation was therefore an act of claim construction.

The Federal [...]

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Wave Goodbye: Arguments Incorporated by Reference Are Waived

by Benjamin Ediger, Ph.D. | Nov 30, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s patentability determination, finding that the patent challenger waived an argument it attempted to incorporate by reference to another brief. Medtronic, Inc. v. Teleflex Life Scis. Ltd., Case No. 2022-1721 (Fed. Cir. Nov. 16, 2023) (Lourie, Prost, Chen, JJ.)

Teleflex owns a patent directed to a method for using a guide extension catheter with a guide catheter. Medtronic challenged the patent in two inter partes review (IPR) proceedings, arguing that certain claims were obvious in light of Ressemann and Itou and that another claim was obvious in light of Ressemann, Itou and Kataishi. Teleflex argued that Itou was not prior art because the claimed invention was conceived prior to Itou’s filing date and was either actually reduced to practice before the critical date or diligently pursued until its constructive reduction to practice date. Medtronic did not contest Teleflex’s demonstration of conception but instead challenged Teleflex’s alleged showings of both actual reduction to practice and diligence until constructive reduction to practice.

The Board ultimately found that Itou did not qualify as prior art and that Medtronic therefore had not shown that the challenged claims were unpatentable. One of the issues before the Board was whether in vivo testing was required for actual reduction to practice because the claims at issue were method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board ultimately found that no such testing was required, explaining that Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” According to the Board, actual reduction to practice could “be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.” Medtronic appealed.

Medtronic challenged the Board’s determination regarding constructive reduction to practice, arguing as follows:

In addressing diligence, the Board simply adopted its earlier erroneous diligence analysis in IPR2020-00132. Appx61–62. Therefore, if this Court vacates the Board’s diligence holding in No. 21-2356, it should likewise vacate the Board’s decision here. Appellant’s Br. at 41.

The Federal Circuit explained that it did not vacate the diligence holding in the prior decision, so Medtronic’s condition precedent had not been met. Medtronic nevertheless urged the Court to decide the diligence question. The Court refused, finding that Medtronic improperly incorporated by reference an argument from another brief. The Court explained that it would be fundamentally unfair to allow Medtronic to use incorporation by reference to exceed the word limit on briefs. The Court observed that parties pursuing appeals must make certain strategic decisions concerning what material to include in their opening briefs, and here, Medtronic affirmatively chose not to include developed arguments on diligence. The Court therefore found that Medtronic waived its challenge to the Board’s diligence finding. With the diligence issue waived and conception stipulated, the Court affirmed [...]

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

by Katherine Pappas | Oct 5, 2023 | Patents

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:

The Board’s findings on motivation to combine were not supported by substantial evidence.
The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
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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Chilly Adventures: Design Patent Prior Art Comparison Applies to Article of Manufacture

by Amol Parikh | Sep 28, 2023 | Patents

Addressing a matter of first impression concerning the scope of prior art relevant to a design patent infringement analysis, the US Court of Appeals for the Federal Circuit concluded that “to qualify as comparison prior art, the prior-art design must be applied to the article of manufacture identified in the claim.” Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc., Case Nos. 21-2299; -2338 (Fed. Cir. Sept. 15, 2023) (Prost, Reyna, Hughes, JJ.)

Columbia owns a design patent that covers an ornamental design of a heat reflective material. Seirus markets and sells products (e.g., gloves) made with material that it calls HeatWave. An image of Columbia’s patented design and Seirus’s HeatWave material appear below:

Columbia Patented Design

Seirus HeatWave

Columbia sued Seirus for infringement. After the district court granted summary judgment of infringement, Seirus appealed to the Federal Circuit. The Court issued its decision in Columbia I, concluding that the district court improperly declined to consider the effect of Seirus’s logo in its infringement analysis and resolved certain issues that should have been left to the jury. The Court therefore vacated summary judgment and remanded for further proceedings.

On remand, the district court held a trial. Before trial, the district court limited admissible comparison prior art to “wave patterns of fabric,” declined to instruct the jury that “prior art” referred to prior designs of the claimed article of manufacture, and declined to instruct the jury that it did not need to find that any purchasers were deceived or that there was any actual or likelihood of confusion among consumers in the marketplace. Seirus was permitted to admit three prior art references that disclosed fabric, and Columbia was precluded from distinguishing the references by arguing that they did not disclose heat reflective material. The jury returned a verdict of noninfringement. Columbia appealed.

Among other things, Columbia challenged the exclusion of evidence and jury instructions concerning comparison prior art, and the jury instructions implicating Seirus’s logo.

The Federal Circuit began by discussing the appropriate prior art comparison in the context of design patent infringement. Citing its 2008 en banc decision in Egyptian Goddess v. Swisa, the Court explained that under the ordinary-observer test governing design patent infringement, prior art can help highlight distinctions and similarities between the claims and the accused design. For instance, when a claimed design is close to a prior art design, small differences between the accused design and the claim design are likely to be important. Conversely, if an accused design copied a particular feature of the claimed design that departs from the prior art, the accused design is likely to be regarded as deceptively similar to the claimed design, and thus infringing.

The question of first impression before the Federal Circuit was the proper scope of comparison prior art that may be [...]

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Hit Rewind: Analogous Art and Field of Endeavor

by Tessa Kroll | Sep 21, 2023 | Patents

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

by Mike Baldwin | Aug 31, 2023 | Patents

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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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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