IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Inter Partes Review (IPR)
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Drawing Can Teach Claim Limitations If “Clear on Its Face”

by | Apr 18, 2024 |

Addressing when a drawing in a prior art reference includes a teaching that is “clear on its face,” the Director of the US Patent & Trademark Office vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) petition. MAHLE Behr Charleston Inc. v. Catalano, IPR2023-00861 (PTAB Decision Review, Apr. 5, 2024) (Vidal, PTO Dir.)

MAHLE Behr filed a petition requesting institution of an IPR, challenging claims of a patent owned by Catalano. The patent is directed to a device known as a sacrificial anode that prevents corrosion in motor vehicle radiators caused by electrolysis. One of the claim terms at issue requires the anode to be “within 10 inches” of another element. MAHLE argued that a figure in a prior art reference anticipated or rendered obvious several challenged claims.

The Board denied the institution after determining that MAHLE did not establish a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. The Board cited the Federal Circuit’s 2000 decision in Hockerson-Halberstadt v. Avia Group International to explain that “[p]atent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” The Board concluded that the figure relied on by MAHLE did not provide exact dimensions and thus could not be sufficient to render the claims invalid.

MAHLE filed a request for Director Review, which was granted. In its request, MAHLE argued that the Board erred in its application of Federal Circuit case law on the use of patent drawings as prior art teachings. The Director agreed, explaining that “the Board did not adequately address [MAHLE’s] arguments regarding what [the figure in the prior art] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” Federal Circuit case law established that a claim may be anticipated or rendered obvious by a figure in the prior art if the drawing clearly discloses the claim limitation. If “a person of skill in the art could derive the claimed dimensions from the patent’s disclosure, there is no additional requirement that the specification must explicitly disclose the precise proportions or particular sizes.”

The Director further explained that “the Board did not adequately address MAHLE’s arguments regarding what [the prior art figure] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” While the prior art figure did not disclose the precise proportions or measured quantity specified in the challenged claims, the figure showed the elements being located as claimed (necessarily within the 10 inches recited). The Director explained that the Board should have considered whether a person of ordinary skill in the art would have understood the figure to disclose the claimed elements being within 10 inches of each other.

The Director vacated the Board’s decision and remanded the petition with instructions to consider both what the prior art figure [...]

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New PTAB Claim Construction? Give the Parties Review Opportunity

by | Mar 28, 2024 |

The US Patent & Trademark Office (PTO) Director vacated Final Written Decisions issued by the Patent Trial & Appeal Board that presented a sua sponte construction of a claim term in dispute, holding that the parties were not provided adequate notice of the Board’s new construction. Assa Abloy AB v. CPC Patent Technologies Pty., Ltd., IPR2022-01006, -01045, -01089 (PTAB Decision Review Mar. 15, 2024) (Vidal, PTO Dir.)

The Board issued Final Written Decisions in three inter partes reviews (IPRs), holding that the petitioner failed to demonstrate that any of the challenged claims were unpatentable. The petitioner requested Director Review, raising three issues concerning the Final Written Decisions’ treatment of the claim term “biometric signal”:

  1. The Board’s construction newly added a limitation that neither the petitioner nor the patent owner proposed
  2. The Board’s construction was erroneous
  3. The Board inconsistently addressed this claim limitation among the IPRs at issue.

The Director decided that review was appropriate.

The Director explained that in view of the petitioner’s and patent owner’s divergent post-institution positions regarding this limitation, the Board had authority to construe “biometric signal” even though its institution decisions indicated that the Board would give this claim term its plain and ordinary meaning. The petitioner argued that the term meant “the input and output of the biometric sensor,” and the patent owner argued that the term meant a “physical attribute of the user” (i.e., a fingerprint, facial pattern, iris, retina or voice). The Board held that it meant “a physical or behavioral biometric attribute that provides secure access to a controlled item.”

The Director vacated and remanded the Final Written Decisions, explaining that the Board failed to provide the petitioner and the patent owner reasonable notice of its new construction or the opportunity to present arguments concerning it, as required under the Administrative Procedure Act (APA). The Director noted that neither party requested the Board’s inclusion of a construction that required an attribute of the claimed signal to “provide[] secure access to a controlled item” and concluded this was the sort of “difficult to imagine” sua sponte construction that the US Court of Appeals for the Federal Circuit held (in its 2021 decision in Qualcomm v. Intel) lacked sufficient notice if appearing for the first time in a Final Written Decision.

The Director instructed that on remand the Board should authorize the petitioner to file a supplemental briefing that addresses the Board’s construction and its application to the asserted prior art and authorize the patent owner to respond to the petitioner’s supplemental briefing.

The Director also noted that the patent owner’s proposed claim construction in the IPRs was similar to the construction that the Board adopted in its institution decisions in other IPRs challenging two of the patents at issue. In recognition of this situation, the Director also invited the petitioner, in its supplemental briefing, to address the perceived inconsistencies in these claim constructions.



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Specially Convened Rehearing Panel Vacates IPR Institution Denial

by | Mar 21, 2024 | ,

In a rehearing decision issued by a Delegated Rehearing Panel specially convened by the US Patent & Trademark Office (PTO) Director, the Patent Trial & Appeal Board vacated a prior panel decision denying institution, modified the claim construction to account for a “clear and unmistakable” prosecution history disclaimer, and remanded for further proceedings consistent with the modified claim construction. SynAffix B.V. v. Hangzhou DAC Biotech Co., Ltd., No. IPR2022-01531, Paper 23 (PTAB Mar. 4, 2024) (Kim, Acting Deputy Chief APJ; Gongola, Vice Chief APJ; Worth, Acting Senior Lead APJ).

SynAffix filed a petition for inter partes review (IPR) of certain patent claims owned by Hangzhou DAC Biotech. The claims at issue are directed to a hydrophilic linker of formula (I), reproduced below.

A Board panel issued a prior decision denying institution. In the prior decision, the Board noted that it was undisputed that moieties Y or Z enable connection of the linker to a cell-binding agent (Y) or a cytotoxic drug (Z), and that Q and T are one sulfone, sulfoxide or phosphinate. That said, the central issue was whether Y or Z must act independently or whether they can act in concert with an adjoined Q or T compound. The Board concluded that Y and Z must act independently to enable their respective chemical reactions without assistance from an adjoining Q or T compound, because during prosecution the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional adjacent sulfone, sulfoxide or phosphinate to overcome a rejection based on a prior art reference (Lees). Thus, the Board denied institution.

SynAffix subsequently sought review by the Director. The Director issued an order delegating director review to a rehearing panel. The rehearing panel reviewed whether the prior decision misapprehended or overlooked any issue raised in the request for director review. In particular, the rehearing panel considered whether, when the hydrophilic linker contains a vinylsulfone group, one of Y and Z may be understood to be a vinyl group with one of Q and T as a sulfone group (i.e., the vinyl group and the sulfone group mapped to separate letters), or instead whether one of Y and Z must be a vinylsulfone group (i.e., the vinyl group and the sulfone group mapped to the same letter).

While the rehearing panel agreed with the first version of the prosecution history disclaimer in the prior decision, it rejected a second under which two sulfone groups would not fall within the scope of the claim. First, the rehearing panel accepted the Board’s prior finding that the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional sulfone, sulfoxide or phosphinate. However, the conclusion (in the prior decision) that the challenged independent claim excludes compounds in which the sole terminal group is vinyl sulfone without one or more adjacent Q and [...]

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Be Cool: Don’t Construe the Construction

by | Mar 21, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision after concluding that the patent owner’s proposed construction would require the parties to construe the construction. CoolIT Systems, Inc. v. Katherine Vidal, Director of the United States Patent & Trademark Office, Case No. 22-1221 (Fed. Cir. March 7, 2024) (Lourie, Bryson, Stark, JJ.) (nonprecedential).

CoolIT Systems owns a patent directed to a system for fluid heat transfer to cool electronic devices. The patent focuses on a heat exchange system comprising various components including a heat sink, a housing member and a compliant member. The patent claims priority from two provisional applications. Asetek Danmark petitioned for inter partes review (IPR) of the patent based on anticipation and obviousness. During the IPR proceeding, the parties disputed the meaning of the term “matingly engaged,” a term introduced in the later provisional application. To preserve validity, CoolIT argued that the term should be construed narrowly to mean “mechanically joined or fitted together to interlock.” Asetek sought a broader construction of “joined or fitted together to make contact,” which would encompass all methods of joining two surfaces.

The Board found both interpretations extreme and partially construed the term as being satisfied when at least a portion of the compliant member fits within the recessed region of the housing member. Despite agreement on the term “mate” to mean “join or fit together,” there was disagreement on the term “engage.” However, the Board did not determine whether “matingly engaged” could encompass forms of engagement beyond fitting.

The Board found that the cited prior art suggested a compliant member fitting the housing, thus rendering the claims obvious. CoolIT appealed. The US Patent & Trademark Office (PTO) intervened after Asetek withdrew from the appeal based on settlement.

CoolIT argued that the Board’s interpretation was flawed, and that the prior art did not meet the requirements of the “matingly engaged” limitation irrespective of the interpretation adopted. CoolIT contended that its proposed construction aligned with the invention’s purpose and properly distinguished between the 2007 and 2011 provisional applications. CoolIT also argued that the compliant member must partition features to control coolant flow, necessitating a specific type of joining or fitting.

In response, the PTO argued that CoolIT’s proposed construction read limitations from the specification into the claim. The PTO contended that neither the claims nor the specification required “interlock” and disputed CoolIT’s interpretation of the 2007 provisional application. The PTO did not propose an alternative construction, however.

The Federal Circuit concluded that “matingly engaged” should properly be construed as “mechanically joined or fitted together,” as that construction accurately reflected the term’s meaning and aligned with arguments presented by both parties. The Court rejected CoolIT’s proposal to add the word “interlock” because it would cause more confusion than clarity, noting that even CoolIT and the PTO still disagreed over what the term “interlock” meant and thus adding that term to the construction would provide little guidance.

The Federal Circuit found that the Board [...]

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Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

by | Mar 14, 2024 | ,

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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Even a Non-Explicit Claim Construction Can Be Erroneous

by | Feb 15, 2024 |

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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Scattered Disclosures May Not Lead to Inference of Fraud in FCA Claim

by | Feb 1, 2024 |

The US Court of Appeals for the Ninth Circuit denied a petition for panel rehearing and rehearing en banc and issued an amended opinion that reversed a district court’s decision regarding the False Claims Act’s (FCA) public disclosure bar. Silbersher v. Valeant Pharm. Int’l, Inc., Case No. 20-16176 (9th Cir. Aug. 3, 2023; amended Jan. 5, 2024) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on those who knowingly present a fraudulent claim for payment to the federal government and allows “relators” to bring fraud claims on behalf of the government.

Valeant owns a set of patents that cover a delayed-release formula for a medication prescribed to treat ulcerative colitis. In 2015, a generic drug manufacturer, GeneriCo, challenged one of Valeant’s patents in an inter partes review (IPR) proceeding. Ultimately, the Patent Trial & Appeal Board found Valeant’s patent unpatentable based on two articles co-authored by Valeant’s head of research.

Silbersher was GeneriCo’s lawyer in the IPR proceeding. He discovered that three years before applying for the challenged patent, Valeant had applied for another patent that disclosed the exact opposite of what Valeant would claim in the challenged patent. Silbersher brought an FCA action alleging that Valeant failed to disclose this information in the IPR proceeding. In response, Valeant argued that the public disclosure bar applied. The district court decided that an IPR qualified as an “other Federal hearing” under channel (ii) of the public disclosure bar and dismissed Silbersher’s action. Silbersher appealed.

On appeal, the Ninth Circuit reversed the district court. Valeant filed a petition for panel rehearing and rehearing en banc. The Court issued an amended decision that refocused on its analysis under its 2016 decision in Mateski v. Raytheon. Under Mateski, the public disclosure bar applies when “the disclosure at issue occurred through one of the channels specified in the statute; the disclosure was ‘public;’ and the relator’s actions are ‘based upon’ the allegations or transactions publicly disclosed.”

The Ninth Circuit discussed whether Valeant’s disclosures revealed “substantially the same allegations or transactions” as Silbersher’s qui tam action. As discussed in the original decision, this was a first for this court, which had not yet “interpreted substantially the same prong of the public disclosure bar” under the 2010 Congress amendments. Mateski explained that to disclose a public fraudulent transaction according to the formulation X+Y=Z (where Z is the fraud allegation and X and Y are the essential elements), “the combination of X and Y must be revealed from which readers or listeners may infer Z, the conclusion that fraud has been committed.”

The Ninth Circuit then applied the Mateski framework to conclude that the qualifying public disclosures here did not collectively disclose a combination of facts sufficient to permit a reasonable inference of fraud. It explained that although “scattered disclosures when viewed together possibly reveal some of these true and misrepresented facts,” fraud could not reasonably be inferred from the combinations. Neither Valeant’s patent prosecutions nor disclosures revealed the critical information necessary to support [...]

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Keep Calm and Party On: New Issue Prohibition Doesn’t Apply to Motions to Amend

by | Jan 25, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness determination, explaining that inter partes review (IPR) statutory provisions that prohibit an otherwise time-barred party from introducing new issues into the proceeding do not apply to motions to amend. CyWee Group Ltd. v. ZTE (USA), Inc. et al., Case No. 21-1855 (Fed. Cir. Jan. 18, 2024) (Prost, Hughes, Stoll JJ.)

CyWee owns a patent directed to a “three-dimensional (3D) pointing device capable of accurately outputting a deviation including yaw, pitch and roll angles in a 3D reference frame and preferably in an absolute manner.” ZTE filed a petition for IPR of the patent asserting that certain claims were unpatentable. The Board instituted the IPR. LG later filed an IPR petition challenging the patent and moved to join ZTE’s ongoing IPR, stating that it would “act as a passive ‘understudy’ and [would] not assume an active role unless [ZTE] ceases to participate in the instituted IPR.”

While LG’s motion was pending, CyWee moved to amend its patent claims, contingent on cancellation of the original claims. ZTE opposed the motion to amend. The Board gave preliminary guidance that the proposed claims lacked written description support and introduced new matter, and also that one of the proposed claims was invalid over the asserted prior art.

The Board granted LG’s motion to join ZTE’s IPR proceeding but placed restrictions on LG’s participation that required LG to consolidate filings with ZTE, rely on ZTE to take and defend depositions, refrain from requesting or reserving additional deposition or oral hearing time, and agree to other procedural concessions to minimize delay to the IPR proceeding.

After LG’s joinder, CyWee filed a revised motion to amend. ZTE indicated that it did not oppose the motion. LG, arguing that ZTE was no longer actively participating in the IPR, moved for leave to oppose CyWee’s motion to amend. Ultimately, the Board permitted LG to present argument and evidence independent from ZTE. LG filed an opposition arguing that CyWee’s proposed revised claims were obvious over Withanawasam, Bachmann and Bachmann2. Notably, ZTE had not cited Withanawasam in its opposition to CyWee’s initial motion to amend.

After the Board issued its final decision finding that the proposed revised claims were obvious over Withanawasam, Bachmann and Bachmann2, CyWee appealed.

CyWee argued that the Board erred by allowing LG to oppose CyWee’s motion to amend in a manner that violated the terms of LG’s joinder and by allowing LG to raise Withanawasam in opposition to the motion to amend. The Federal Circuit rejected both arguments. The Court explained that the Board concluded that although ZTE still participated in the IPR, the proceeding “no longer appear[ed] to be meaningfully adversarial” as to the revised motion to amend. The Court found no error in the Board’s conclusion that ZTE was no longer an active participant in the IPR proceeding, and thus there was no violation of the joinder terms.

The Federal Circuit also concluded that the Board did not err [...]

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Don’t Assume Sweet Success: Forum Selection Clause Doesn’t Preclude IPR

by | Jan 11, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to bar a petitioner from challenging certain patents at the US Patent & Trademark Office (PTO) because of a forum selection clause in a settlement agreement. The Court found that the patent owner was unlikely to succeed on the merits based on the likelihood of success factor. DexCom, Inc. v. Abbott Diabetes Care, Inc., Case No. 23-1795 (Fed. Cir. Jan. 3, 2024) (Dyk, Hughes, Stoll, JJ.)

DexCom and Abbott are competing manufacturers of continuous glucose monitoring systems. In 2014, the parties entered into a settlement agreement that included a cross-license to certain patents, covenants not to sue or challenge the patents for a “Covenant Period,” and a forum selection clause identifying the US District Court for the District of Delaware as the exclusive jurisdiction “over any dispute arising from or under or relating to [the] Agreement, to the extent permitted by law.” After expiration of the Covenant Period, DexCom sued Abbott in the Western District of Texas. Abbott moved to transfer the case to the District of Delaware and added a breach of contract counterclaim, citing the settlement agreement’s forum selection clause. The case was transferred to Delaware, after which Abbott filed eight petitions for inter partes review (IPR) at the PTO. DexCom responded to the breach of contract counterclaim by alleging that Abbott had breached the forum selection clause by filing the IPR petitions. Until this point, DexCom had consistently taken the position that the asserted claims were not subject to the cross-license, rendering the forum selection clause inapplicable.

Six months after Abbott filed the IPR petitions, DexCom moved for a preliminary injunction prohibiting the IPRs from proceeding. The district court denied the preliminary injunction. In evaluating the four injunctive relief factors (i.e., likelihood of success on the merits, irreparable harm, balance of hardships and public interest), the district court simply assumed the likelihood of success in favor of DexCom. It nevertheless denied the injunction because DexCom waited six months to file the motion (suggesting there was no irreparable harm) and because DexCom had taken inconsistent legal positions with respect to whether the challenged patents were licensed, thus weighing against DexCom in the balance of hardships factor. DexCom sought interlocutory appeal of the district court’s order.

The Federal Circuit focused on the first factor, likelihood of success on the merits. While the district court assumed that this factor favored DexCom, the Federal Circuit disagreed. The Court noted that the agreement required that DexCom and Abbott “shall not Challenge” each other’s patents during the Covenant Period, with the exception that “each Party reserves its rights and is permitted to Challenge any of the patents of the other Party if there is a statute, regulation, or rule that sets a deadline to make the Challenge,” assuming certain conditions were met. The Court first explained that “challenge” includes IPRs of the patents and that nothing in the forum selection clause differentiated between the [...]

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Wave Goodbye: Arguments Incorporated by Reference Are Waived

by | Nov 30, 2023 |

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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