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The Road Less Traveled: IPR Denial Decisions Appealable via Mandamus

The US Court of Appeals for the Federal Circuit concluded that while it did not have jurisdiction to consider the direct appeal of a Patent Trial & Appeal Board decision denying institution, it could review the decision under its mandamus jurisdiction. Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., Case No. 20-1071 (Fed. Cir. Mar. 12, 2021) (Moore, J.)

In 2019, Janssen sued Mylan in district court for infringement of one patent. Less than six months later, Mylan petitioned the Board for inter partes review (IPR) of that patent. Opposing institution, Janssen argued that the IPR would be an inefficient use of Board resources because of two co-pending district court actions (one involving Mylan and one involving a third party) that implicated the same validity issues as the IPR petition. Janssen also argued that those district court actions would likely reach final judgment before any IPR final decision. The Board agreed with Janssen. Mylan appealed and also requested mandamus relief.

On appeal, Mylan argued that the Board’s determination to deny institution based on the timing of a separate district court action that did not involve Mylan undermined constitutional and due process rights.

Before addressing the merits of the appeal, the Federal Circuit addressed two jurisdictional questions: whether it had jurisdiction over Mylan’s direct appeal and whether it had jurisdiction over the mandamus request. As to the first question, the Court relied on its decision in St Jude Medical v. Volcano, finding that decisions denying institution are not subject to review on direct appeal. As to the second question, the Court concluded that judicial review was available in extraordinary circumstances, and particularly in situations involving denial of petitions. The Court stated that “[t]o protect our future jurisdiction, we have jurisdiction to review any petition for a writ of mandamus denying institution of an IPR.”

Having found that it had jurisdiction, the Federal Circuit turned to the merits. The Court explained that when a mandamus petition challenges a decision denying institution, it will be especially difficult to satisfy the requirements for mandamus because the relevant statute bestows the Board with significant discretion. The Court concluded that there is no reviewability of a Board denial of institution except for colorable constitutional claims. The Court found that Mylan lacked a clear and indisputable right to relief and also failed to state a colorable claim for constitutional relief since it did not identify a deprivation of “life, liberty or property” necessary to a procedural due process claim. The Court also found that there were no substantive due process claims since there is no fundamental right to have the Board consider whether to institute on an IPR petition based only upon co-pending litigation to which petitioner is a party. The Court thus denied Mylan’s petition.




Doesn’t Scan: Skin Cancer Detection Device Just Combination of Familiar Elements

The US Court of Appeals for the Federal Circuit overturned a finding of non-obviousness of certain claims relating to a device for the detection of skin cancer, finding that the Patent Trial & Appeal Board erred in applying the law of obviousness. Canfield Scientific, Inc. v. Melanoscan, LLC, Case No. 19-1927 (Fed. Cir. Feb. 18, 2021) (Newman, J.)

Canfield Scientific filed a petition for inter partes review challenging the validity of claims of a Melanoscan patent as obvious in view of several prior art references. After the Board upheld the validity of the challenged claims, Canfield appealed.

The device disclosed in the patent is “an enclosure fitted with cameras and lights arranged in a manner that allows for imaging of [all or part] of non-occluded body surfaces in order to detect health and cosmetic disease.” The two challenged independent claims both required:

  • An enclosure configured to receive a person or portion thereof, wherein the enclosure defines a specified imaging position for placing the person or portion thereof within the enclosure
  • A plurality of imaging devices, wherein the plurality of imaging devices are vertically spaced relative to each other, a plurality of the imaging devices are located on opposite sides of the centerline of the specified imaging position
  • A plurality of light sources spaced relative to each other and peripheral to the plurality of imaging devices.

Canfield listed four references in support of its obviousness argument—Voigt, Hurley, Crampton and Daanen. Voigt disclosed an enclosure containing cameras and lights for analyzing and measuring images on the skin of a patient. Voigt did not disclose imaging devices (cameras) vertically and laterally spaced and on opposite sides of the center line. Instead, Voigt taught positioning the subject along the wall and positioning the cameras in a single direction.

Hurley, Crampton and Daanen each taught placement of a subject in the center of the enclosure, with cameras arranged vertically, laterally and on opposite sides of the centerline.

Canfield argued that the combined teachings of the prior art would have reasonably suggested the subject matter of the challenged claims. The Board found this argument unpersuasive, concluding that “Voigt’s rear wall would have blocked the view of the two rear-facing cameras, and Voigt’s horizontally adjustable sliders would have partially blocked the views of the remaining cameras.” Thus a person of skill in the art would not have been motivated to combine “the unmodified Voigt system with Hurley’s arrangement of imaging devices.” The Board did not discuss Crampton or Daanen.

The Federal Circuit disagreed with the Board’s conclusion and stated that the references showed the subject being imaged placed against a wall in Voigt, and centrally placed within the framework in Hurley, Crampton and Daanen. The references showed the cameras laterally and vertically spaced to each other about a center line. Citing the seminal Supreme Court KSR obviousness decision, the Federal Circuit noted that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable [...]

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Jetting along the Thin Line between Appellate Standing and Admitting Infringement

The US Court of Appeals for the Federal Circuit found that an inter partes review (IPR) petitioner that had not been accused of infringement had standing to appeal a final decision in an IPR because the petitioner alleged facts establishing that there was a substantial risk of infringement of the challenged claims. General Elec. Co. v. Raytheon Techs. Corp., Case No. 19-1319 (Fed. Cir. Dec. 23, 2020) (Hughes, J.)

Raytheon owns a patent directed to a configuration for mounting a turbofan gas turbine engine to an aircraft pylon. Turbofan engines rely on four main component sections—the fan, compressor, combustor and turbine—to generate thrust from the continuous ignition of a mixture of fuel and pressurized air. The compressor and turbine sections are further divided into high-pressure and low-pressure segments. Each of these segments consists of stages, which include a matched set of rotating blades and stationary airfoils. The patent claims recite a “first” spool, which the parties equate with a low-pressure spool, turbine and compressor, and a “second” spool, consisting of the high-pressure spool, turbine and compressor. The claimed “second” spool includes “at least two stages.”

General Electric (GE) competes with Raytheon in the commercial aviation engine market and petitioned for IPR, challenging several claims based on two prior art references, Wendus and Moxon. Wendus discloses all elements recited in the challenged claims, except that it teaches a single-stage high-pressure turbine instead of the claimed “at least two-stage” high-pressure turbine. Moxon states that to improve fuel efficiency, “a move to one instead of two HP turbine stages is thought unlikely.” The Patent Trial and Appeal Board found that all elements recited in the challenged claims were found in the prior art but found that the claims were not proven to be non-obvious, in part because Wendus expressly considered at least some of the one-stage versus two-stage tradeoffs and specifically chose the one-stage option. This express consideration meant that Wendus taught away from combination with Moxon, the Board reasoned. GE appealed.

Before reaching the merits of the appeal, Raytheon moved to dismiss the appeal for lack of standing, arguing that it had never sued or threatened to sue GE for infringing the patent. Accordingly, the standing dispute centered on whether GE had sufficiently alleged an injury in fact. The Federal Circuit explained that “when an appellant relies on potential infringement liability . . . it must establish that it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement.” In the context of an appeal of an IPR proceeding, “it is generally sufficient for the appellant to show that it has engaged in, is engaging in, or will likely engage in activity that would give rise to a possible infringement suit.” GE presented evidence that it spent $10 to $12 million in 2019 developing a geared turbofan architecture and design and that it offered its geared turbofan design to Airbus in response to a request for [...]

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Patent Owner’s Disavowal of Appeal from District Court’s Noninfringement Judgment Moots IPR Appeal

Addressing the standard for mootness in inter partes review (IPR) proceedings following a district court noninfringement judgment, the US Court of Appeals for the Federal Circuit held that a petitioner’s IPR appeal was moot after the patent owner decided not to appeal the final judgment of noninfringement. ABS Global, Inc. v. Cytonome/ST, LLC, Case No. 19-2051 (Fed. Cir., Jan. 6, 2021) (Stoll, J.) (Prost, C.J., dissenting in part).

In June 2017, Cytonome/ST filed a complaint against ABS asserting infringement of six patents, including the patent of interest in this case. ABS filed a petition for IPR of all claims of the patent. In April 2019, the Patent Trial and Appeal Board (PTAB, the Board) issued its final written decision invalidating certain claims of the patent. Two weeks later, the district court granted ABS partial summary judgment, holding that the accused products did not infringe any of the asserted patent’s claims. In June 2019, ABS appealed the PTAB’s final written decision. In a briefing before the Federal Circuit, Cytonome/ST’s counsel filed an affidavit stating that Cytonome/ST “has elected not to pursue an appeal of the district court’s finding of non-infringement as to the patent and hereby disclaims such an appeal.” In June 2020, the district court entered final judgment, including as to non-infringement of the patent.

The Federal Circuit dismissed ABS’ appeal of the PTAB’s final written decision on the ground that the appeal was moot in view of the district court’s non-infringement judgment. The Court characterized the question as one under the voluntary-cessation doctrine. In the context of intellectual property infringement cases, the voluntary-cessation doctrine requires the property owner claiming mootness to prove that the “allegedly wrongful behavior could not reasonably be expected to recur,” i.e., that it will not assert the intellectual property right against the same accused products again. If it does, the burden shifts to the accused infringer to show that it “engages in or has sufficiently concrete plans to engage in activities” that would not be covered by the property owner’s non-assertion decision.

Applying the doctrine, the Federal Circuit concluded that Cytonome/ST could not reasonably be expected to assert infringement of the patent against ABS because ABS had already secured a district court judgment that the accused products do not infringe and Cytonome/ST disclaimed any appeal of the non-infringement judgment. In effect, ABS was insulated from liability for infringement, including for future infringement for products that are “essentially the same” as ABS’ currently accused products pursuant to the Kessler doctrine. Further, the Court found that ABS had not demonstrated it could reasonably expect Cytonome/ST to sue it for infringement of the patent in the future as ABS had not shown it had current or concrete future plans to engage in activities not covered by Cytonome/ST’s disavowal: “Cytonome’s disavowal of its right to appeal the summary judgment of noninfringement ‘estops Cytonome from asserting liability against ABS for infringement of the…patent claims in connection with the accused products, thereby allowing ABS to make, use, and sell those products [...]

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State University Challenges Board on Sovereign Immunity in Inter Partes Review

The US Court of Appeals for the Federal Circuit reiterated that “[s]overeign immunity does not apply to IPR proceedings when the patent owner is a state.” Board of Regents of the University of Texas System v. Baylor College of Medicine, Case No. 20-1469 (Fed. Cir. Dec. 10, 2020) (per curiam).

Baylor College of Medicine petitioned for inter partes review (IPR) of two patents owned by the Board of Regents of the University of Texas System (UT). UT moved to dismiss the petitions on state sovereign immunity grounds. The Patent Trial and Appeal Board denied the motion, citing Regents of the University of Minnesota v. LSI Corp. (IP Update, Vol. 22, No. 7).

UT appealed, arguing that University of Minnesota was wrongly decided, but admitted that the panel was bound by it. Predictably, the panel affirmed the Board.

Practice Note: UT’s strategy implies that it intends to use its case as a vehicle to seek en banc (and possibly Supreme Court) review of the University of Minnesota decision.




IP Implications of the Consolidated Appropriations Act, 2021

On December 27, 2020, Congress signed the Consolidated Appropriations Act, 2021, into law. The omnibus act includes new legislation affecting patent, copyright and trademark law. A brief summary of key provisions is provided below.

Patents – Section 325 Biological Product Patent Transparency

42 USC § 262(k) was amended to require that the US Food and Drug Administration (FDA) provide the public with more information about patented biological products. Within six months, the FDA must make the following information available to the public on its Database of Licensed Biological Products or “Purple Book,” and it must update the list every 30 days:

  • A list of each biological product, by nonproprietary name, for which a biologics license is in effect
  • The license date and application number
  • The license and marketing status (as available)
  • Exclusivity periods

The amendment requires that the holders of a license to market a biologic drug now disclose all patents believed to be covering that drug. The new law is designed to prevent errors that could delay biosimilars from coming to the market.

Copyrights – The CASE Act of 2020

The Consolidated Appropriations Act incorporates the Copyright Alternative in Small-Claims Enforcement (CASE) Act of 2020, as well as legislation designed to increase criminal penalties for the unauthorized digital streaming of copyright-protected content. The CASE Act includes revisions to the Copyright Act, 17 USC §§ 101 et seq., with the goal of creating a new venue for copyright owners to enforce their rights instead of having to file an action in federal court.

The Copyright Claims Board

The CASE Act established the Copyright Claims Board (a small claims court), which is designed to serve as an alternative forum where parties may voluntarily seek to resolve certain copyright claims regarding any category of copyrighted work. A party may opt out upon being served with a claim, choosing instead to resolve the dispute in federal court. A party to a proceeding before the Board may, but is not required to, be represented by a lawyer. A party may also be represented by a law student who is qualified under applicable law, and who provides such representation on a pro bono basis. The Board consists of three copyright claims officers who may conduct individualized proceedings to resolve disputes and must issue written decisions setting forth their factual findings and legal conclusions.

Procedural Matters

The Board must follow the law in the federal jurisdiction in which the action could have been brought if filed in federal court. Because jurisdictional conflicts may arise where a dispute may have been brought in multiple jurisdictions, the CASE Act provides that the Board may apply the law of the jurisdiction that the Board determines has the most significant ties to the parties and the conduct at issue.

Although formal motion practice is not permitted, discovery is allowed on a limited basis, including requests for documents, written interrogatories and written requests for admission. The Board may consider evidence, documentary and (non-expert) testimony, without the application of formal [...]

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PTAB Designates Two Precedential Opinions for Evaluating Impact of District Court Litigations on Discretionary Denial under § 314(a)

In the wake of its May 13, 2020, precedential decision in Apple v. Fintiv, Inc., the Patent Trial and Appeal Board designated as precedential two additional decisions that weigh the Fintiv factors. In Fintiv, the Board articulated six factors for consideration when determining to exercise discretion to deny institution of an inter partes review (IPR) petition under § 314(a) in view of a parallel district court proceeding:

  • Existence of a stay pending IPR
  • Proximity of the court’s trial date to the Board’s deadline for issuing a final written decision
  • Expended investment in the parallel proceeding
  • Overlap between issues raised each proceeding
  • Whether the petitioner and the defendant are the same party
  • Other circumstances.

The two new precedential decisions provide further insight as to what circumstances may tip the balance for each factor. In each decision, the Board found that the circumstances of the parallel district court proceeding did not weigh in favor of a discretionary denial of institution.

In Sotera Wireless, Inc. v. Masimo Corp., Case No. IPR2020-01019, Paper 12 (USPTO Dec. 1, 2020 (Chagnon, APJ) (designated precedential as to § II.A on Dec. 17, 2020), the Board weighed the Fintiv factors and declined to deny institution based on the parallel district proceeding. In particular, the PTAB found that the already granted stay weighed strongly against exercising discretion to deny institution under the first factor. The Board rejected speculative arguments that if it declined review, the district court would lift the already granted stay and would set a trial date to pre-date the timeframe for issuing a final written decision in the IPR proceeding. The Board concluded that the second factor also weighed against denial because discovery was not complete and the district court had not issued a claim construction order or any other significant rulings. The Board also found that the fourth factor (issue overlap) weighed against denial because materially different invalidity grounds had been raised in the district court contentions as compared to the grounds at issue in the IPR petition.

In Snap, Inc. v. SRK Technology, LLC, Case No. IPR2020-00820, Paper 15 (USPTO Oct. 21, 2020 (Droesch, APJ) (designated precedential as to § II.A on Dec. 17, 2020), the Board again weighed the Fintiv factors and declined to deny institution based on the parallel district proceeding. Because the district court had not yet ruled on the motion to stay pending the outcome of the IPR, the Board found that the “stay factor” did not weigh for or against denying institution. As for the issue overlap factor, the Board found that a stipulation by the defendant to not pursue in district court any ground raised, or that could have reasonably been raised, in the IPR weighed strongly in favor of not exercising discretion to deny institution.




PTAB Designates Three Opinions as Precedential

In RPX Corp. v. Applications in Internet Time, LLC, Case Nos. IPR2015-01750, -01751, -01752 (Oct. 2, 2020) (Boalick, CAPJ) (designated precedential on Dec. 4, 2020), the Patent Trial and Appeal Board (Board) terminated institution of RPX’s petitions for inter partes review (IPR) because Salesforce—served with a complaint more than one year before—should have been named as a real party-in-interest (RPI) to the proceedings. As a result, RPX’s petition was time-barred under § 315(b).

The Board’s determination came after remand from the Federal Circuit, which vacated the Board’s prior finding that Salesforce was not an RPI. (IP Update, Vol. 21, No. 8). The Federal Circuit instructed the Board to use the common law understanding of “real party-in-interest” and a “flexible approach that takes into account both equitable and practical considerations, with an eye toward determining whether the non-party is a clear beneficiary that has a pre-existing, established relationship with the petitioner.” On remand, the Board took additional discovery to examine the relationship between RPX and Salesforce, including RPX’s business model, Salesforce’s relationship with RPX, whether RPX represents Salesforce’s interests in invalidating the patents, and the significance of the fact that Salesforce and RPX had overlapping Board members. After considering the relationship, the Board found the evidence pointed clearly toward a common interest—between RPX and its members—in invalidating the patents in IPR proceedings. It found RPX could not avoid the time bar under § 315(b), or estoppel under § 315(e) for its members, by creating the appearance that RPX acts independently of its members’ interests when filing IPR petitions.

In SharkNinja Operating LLC v. iRobot Corp., Case No. IPR2020-00734 (Oct. 6, 2020) (Melvin, APJ) (designated precedential on Dec. 4, 2020), the Board declined to address—for purposes of institution—the patent owner’s claim that the IPR petition failed to name an alleged RPI under § 312(a)(2)’s requirement that a petition “identif[y] all real parties-in-interest.” iRobot alleged that JS Global was an unnamed RPI because it was intertwined with SharkNinja’s business and was in a position to fund and exercise control over the IPR petition. The Board declined to reach a determination on the issue because it would have no impact on the proceeding, absent evidence that (1) JS Global was a time-barred or an otherwise estopped entity whose addition to the petition would result in its dismissal under § 315 or (2) SharkNinja’s omission of JS Global was done in bad faith. Even if SharkNinja was mistaken in its decision not to name JS Global as an RPI, the Board’s precedent would allow SharkNinja to correct the mistake during the proceeding.

In Apple Inc. v. Uniloc 2017 LLC, Case No. IPR2020-00854 (Oct. 28, 2020) (Quinn, APJ) (designated precedential on Dec. 4, 2020), the Board exercised its discretion to deny Apple’s motion for joinder because it would have resulted in a “serial attack” on Uniloc’s patent. Apple had previously filed an IPR petition on the same patent, alleging various grounds of invalidity. The Board denied institution because it failed to show a reasonable likelihood [...]

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Federal Circuit Will Not Second-Guess IPR Institution Denials

In a series of non-precedential orders, the US Court of Appeals for the Federal Circuit reiterated that it lacks jurisdiction to hear appeals on whether the Patent Trial and Appeal Board properly decided to deny inter partes review (IPR) petitions based on parallel district court litigation. Cisco Systems Inc. v. Ramot at Tel Aviv University, Case Nos. 20-2047, -2049 (Fed. Cir. Oct. 30, 2020); Google LLC v. Uniloc 2017 LLC, Case No. 20-2040 (Oct. 30, 2020); In re: Cisco Systems Inc., Case No. 2020-148 (Fed. Cir. Oct. 30, 2020); Apple Inc. v. Maxell, Ltd., Case No. 20-2132, -2211, -2212, -2213, 21-1033 (Fed. Cir. Oct. 30, 2020).

The 2011 Leahy-Smith America Invents Act (AIA) created various mechanisms for challenging the validity of issued patents in post-grant proceedings before the US Patent and Trademark Office PTO) by adding transitional covered business method and post-grant review proceedings to existing ex parte re-examination, and expanding and renaming inter partes re-examination to inter partes review (IPR).

Under 35 USC §§ 311, 312, a petition for IPR must identify all real parties in interest, identify and support the prior art grounds for challenges to the claims, and provide “such other information as the Director may require by regulation.” Under 35 USC § 314 and 37 CFR 42.4(a), the Board institutes a trial on behalf of the PTO Director, and a “determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.” In deciding whether to institute the trial, the Board considers, at a minimum, whether a petitioner has satisfied the relevant statutory institution standard. Even when a petitioner has satisfied the institution standard, the Director has statutory discretion under 35 USC 314(a) and 324(a) to deny a petition.

In 2016, the Supreme Court of the United States held in Cuozzo Speed Techs. v. Lee that “the agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion,” and that there is “no mandate to institute review.” The Supreme Court also found that the Director is given broad discretion under 35 USC 315(d) and 325(d) to determine the manner in which “multiple proceedings” before the PTO involving the same patent may proceed, “including providing for stay, transfer, consolidation, or termination of any such matter or proceeding.” Subsequent PTO policies and precedential Board decisions set forth factors affecting the case-specific analysis of whether to institute an AIA proceeding, and particularly a follow-on or serial petition, or discretionary denial due to the timing of parallel district court proceedings.

In Cisco v. Ramot, the Board denied Cisco’s petitions to institute IPRs against two patents that Ramot had asserted against it in a district court case. The decisions denying Cisco’s petitions cited the Board’s discretion under 35 USC § 314(a) not to institute review and relied on the factors determining whether efficiency, fairness and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding. Specifically, the Board [...]

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Size Matters in Obviousness Analysis

The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an artificial heart valve that does not require removal of the damaged native heart valve. St. Jude Medical, LLC v. Snyders Heart Valve LLC, Case Nos. 19-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020) (Taranto, J.).

St. Jude filed two petitions for inter partes review (IPR) of a patent for an artificial heart valve and a system for inserting the valve. Both petitions were instituted by the Board and resulted in final written decisions. In the first decision, the Board found that St. Jude failed to establish unpatentability of the challenged claims, rejecting St. Jude’s contention that all challenged claims were anticipated by and obvious over the Leonhardt prior art reference. In the second decision, the Board found that certain claims were anticipated by the Bessler prior art reference, but rejected St. Jude’s contentions as to all other claims. St. Jude appealed, arguing that the Board erred in the first decision by erroneously construing the term “band” and erred in the second decision by finding that St. Jude failed to prove that a skilled artisan would have made a particular combination of Bessler and the Johnson prior art. Snyders cross-appealed in the second decision as to the claims the Board found were anticipated by Bessler.

The Federal Circuit affirmed the Board’s conclusions in the first decision, finding that not only was the Board’s construction of the term “band” proper, but that it was actually broader than St. Jude’s proposed construction—and that St. Jude expressly accepted the Board’s construction. The Board construed the heart valve band to mean “a structure generally in the shape of a closed strip or ring” (replacing St. Jude’s “circular” with “closed”). In the prior art, Leonhardt discloses a graft material which extends the length of the entire structure. The Federal Circuit agreed with the Board’s finding that Leonhardt’s graft material was “like a sleeve” as opposed to “a closed strip or ring.” St. Jude argued that an ordinary skilled artisan’s understanding of the term “band” does not include a length restriction, that a Leonhardt’s material was just a long band, and that the Board effectively changed its construction of the term. The Federal Circuit, however, was not persuaded by St. Jude’s unlimited-length definition of “band,” instead turning to dictionary definitions that included terms like “thin” and “narrow,” and looking to the patent specification that did not explicitly disclaim any length restrictions. The Court ultimately rejected St. Jude’s arguments, finding that St. Jude should have proposed a claim construction that precluded any limitations on length if it wished to argue such. The Federal Circuit affirmed the Board’s findings as to first decision.

The Federal Circuit next addressed Snyder’s cross-appeal. Snyder disputed the board’s construction of the “size[] and shape[]” of a frame that the patent requires must be inserted [...]

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