IP UPDATE
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Inter Partes Review (IPR)
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From Oops to Encore: The Board’s Premature Adverse Judgment

by | Jul 25, 2024 |

The Director of the US Patent & Trademark Office (PTO) overturned the Patent Trial & Appeal Board’s premature adverse judgment against a patent owner and remanded an inter partes review (IPR) proceeding based on the fact that the patent owner had initially instructed its counsel to cease work on the IPR while seeking new representation for related district court litigation, which contributed to the procedural delays. Shenzhen Xinzexing E-commerce Co., Ltd. v. Shenzhen Carku Technology Co., Ltd., IPR2024-00222 (PTO-Ofc. of Dir. July 10, 2024) (Vidal, PTO Dir.)

Shenzhen Xinzexing E-commerce Co. filed a petition for an IPR to challenge certain claims of a patent owned by Shenzhen Carku Technology Co. (Patent Owner). The petition and associated documents for the IPR were properly served on the Patent Owner at the address of record. The Board issued a notice on November 29, 2023, allowing the Patent Owner three months to file a preliminary response and requiring mandatory notice information to be submitted within 21 days. The Patent Owner did not comply with either obligation.

Following the Patent Owner’s failure to submit the required notices and response, the Board issued a sua sponte adverse judgment on May 21, 2024, interpreting the lack of response as abandonment of the IPR contest. However, on July 8, 2024, the Patent Owner filed the necessary notices and appointed new counsel, indicating that the previous counsel had been instructed to withdraw from the case and that new representation was being arranged.

The Director sua sponte overturned the Board’s adverse judgment, finding that it was premature. The Board’s communications did not clearly indicate that noncompliance with the notice requirements would result in adverse judgment. Given that the Patent Owner had shown efforts to rectify the situation by appointing new counsel and filing the required documents, the director vacated the adverse judgment and remanded the case for the Board to determine whether the petition showed a reasonable likelihood that any of the challenged patent claims were unpatentable.

Practice Note: This decision highlights the necessity of adhering to procedural deadlines and ensuring that consequences for noncompliance are clearly communicated. The Board’s failure to provide explicit notice of abandonment of the contest contributed to the premature adverse judgment, reinforcing the importance of clear procedural guidance.



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New Arguments Yield Same Unpatentability Outcome

by | Jun 13, 2024 |

On remand from the US Court of Appeals for the Federal Circuit in connection with inter partes review (IPR) proceedings, the Patent Trial & Appeal Board considered the petitioner’s reply arguments and evidence regarding the claim constructions that were first proposed in the patent owner’s response but again found that the claims were not unpatentable. Axonics, Inc. v. Medtronic, Inc., IPR2020-00712; -00680 (May 30, 2024) (Tartal, Jeschke, Dougal, APJ)

Axonics filed IPR petitions challenging two patents owned by Medtronic that are directed to the transcutaneous charging of implanted medical devices. In its petitions, Axonics did not propose any express claim constructions. In its preliminary response, Medtronic agreed that claim construction was not necessary. In its patent owner response, however, Medtronic – for the first time – advanced a new claim construction that differed from the interpretation of the relevant claims implied in Axonics’s claim charts. Axonics defended its own implicit construction but also offered new arguments and evidence that the prior art anticipated the patents even under the alternative construction. The Board adopted Medtronic’s new claim construction but refused to consider Axonics’s new arguments and evidence because they were first presented in the reply. The Board then found that Axonics failed to show by a preponderance of the evidence that the challenged claims were unpatentable. Axonics appealed.

Axonics did not dispute the new claim construction first introduced by Medtronic in its response and adopted by the Board; it argued only that the Board erred in refusing to consider its reply arguments and evidence under the new construction. The Federal Circuit agreed, concluding that in such a situation, “a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction, at least where it relies on the same embodiments for each invalidity ground as were relied on in the petition.” The Court remanded for the Board to consider Axonics’s new arguments.

On remand, the Board considered Axonics’s new arguments and evidence that the challenged claims were unpatentable over the prior art under the new construction. It also considered Medtronic’s amended sur-reply. The Board again determined that none of the challenged claims were unpatentable. In its analysis, the Board pointed out that some of Axonics’s new arguments and evidence regarding what the prior art disclosed in light of the new claim construction were inconsistent with the arguments and evidence it initially offered in its petition. In particular, the Board observed that the declaration testimony of Axonics’s expert regarding the prior art, on which Axonics relied in its petition, did not support the new claim construction, even considering the expert’s supplemental declaration. The Board also rejected Axonics’s attempts in its post-remand brief to discredit Medtronic’s arguments as “untimely and wrong,” “incorrect” and “contradictory of the positions on infringement it has taken in district court.” Citing the Federal Circuit, the Board pointed out that in an IPR, the burden of persuasion to prove unpatentability by a preponderance of the evidence [...]

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No Attorneys’ Fees Available for Successful IPR in Parallel Court Proceedings

by | May 30, 2024 |

The US Court of Appeals for the Federal Circuit concluded that a party that voluntarily elects to pursue parallel proceedings before the Patent Trial & Appeal Board and the district court is not entitled to recover attorneys’ fees under 35 U.S.C. § 285 (exceptional case doctrine) in connection with the Board proceedings, nor does § 285 entitle a party to hold opposing counsel jointly and severally liable for fees. Dragon Intellectual Property LLC v. Dish Network L.L.C., Case Nos. 2022-1621; -1777; -1622; -1779 (Fed. Cir. May 20, 2024) (Moore, C.J.; Stoll, J.) (Bencivengo, J., dissenting).

Dragon sued DISH Network, Sirius XM Radio (SXM) and eight others for patent infringement. The district court stayed proceedings as to DISH and SXM while they pursued inter partes review (IPR) but proceeded with claim construction for the other defendants. Following claim construction, all parties stipulated to noninfringement, and the district court accordingly entered a noninfringement judgment that was subsequently vacated following appeal to the Federal Circuit. Following the Board’s determination that the asserted claims were unpatentable, DISH and SXM filed a motion for attorneys’ fees in the district court proceeding. The district court granted the motion for time spent litigating the district court case but denied for fees incurred solely during the IPR proceedings and recovery from Dragon’s former counsel. DISH and SXM appealed the denial-in-part, and Dragon cross-appealed the grant-in-part.

The Federal Circuit affirmed the district court’s grant-in-part, finding that the district court did not abuse its discretion in declaring these cases exceptional. The Federal Circuit explained that the vacated noninfringement judgment did not require the district court to ignore its claim construction order in determining exceptionality. The Court further explained that even though Dragon was not entitled to a claim construction “do-over,” the prosecution history disclaimer issue was independently considered during the exceptionality inquiry, and Dragon did not provide any grounds for the conclusion that this constituted an inadequate inquiry.

The Federal Circuit also affirmed the denial of attorneys’ fees with regard to fees incurred during the IPR proceedings and Dragon’s former counsel’s liability for fee awards under § 285.

First, the Federal Circuit rejected DISH and SXM’s argument that § 285 allows recovery of fees incurred during parallel IPR proceedings, principally on the grounds that the IPR proceedings were pursued voluntarily. The Court reasoned that there are many advantages to leveraging IPR proceedings and, therefore, “where a party voluntarily elects to pursue an invalidity challenge through IPR proceedings, we see no basis for awarding IPR fees under § 285.”

Second, the Federal Circuit relied on the statutory text and determined that liability for attorneys’ fees awarded under § 285 does not extend to a party’s counsel. The Court explained that while other statutes explicitly allow parties to recover costs and fees from counsel, § 285 is silent as to who can be liable for a fee award, and therefore it is reasonable to conclude that fees cannot be assessed against counsel.

Sitting by designation, Judge Bencivengo of the US District Court for the Southern District of California dissented [...]

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How Close Are They? PTO Looking for “Significant Relationship” Between Sequential IPR Petitioners

by | May 9, 2024 |

Addressing the issue of whether to discretionally deny a petition for inter partes review (IPR) under the General Plastics factors when there is no “significant relationship” between the petitioners, the Director of the US Patent & Trademark Office (PTO) vacated the Patent Trial & Appeal Board’s decision denying institution. Videndum Prod. Sol., Inc. v. Rotolight Ltd., IPR2023-01218 (PTO-Ofc. of Dir., Apr. 19, 2024) (Vidal, PTO Dir.)

Videndum filed a petition requesting IPR challenging claims of a patent owned by Rotolight. In its Patent Owner’s Response, Rotolight argued to the Board that it should exercise its discretion to deny institution under 35 U.S.C. § 314(a), citing the Board’s 2017 precedential decision in General Plastic. Prior to Videndum’s petition, the Board instituted review of the same patent at the request of another party. However, one month prior to oral argument in that proceeding, the parties to that IPR proceeding jointly moved to terminate the proceeding on the basis of a settlement. The Board granted the parties’ joint petition.

In the present case, a split Board denied Videndum’s petition for institution, reasoning that Videndum’s petition was a “follow on” of the prior proceeding, and citied General Plastic even while conceding that the “Petitioner’s reliance on [the] earlier-filed petition …, even ‘as a menu and roadmap’” is not sufficient “to create ‘a significant relationship’ that favors denial under the first General Plastic factor.” The dissent agreed on that point but argued that the “General Plastic factors as whole weigh against exercising discretion to deny institution.”

Videndum requested Director review of the Board’s denial of institution based on an abuse of discretion argument. The Director granted review.

The Director found error with the Board’s application of the General Plastic factors in situations where the second-in-time petition is not by the same party that filed the first petition or by a party having a “significant relationship” with the first filer.

The General Plastic factors generally deal with how the Board should analyze whether to institute a subsequent petition on the same patent. Factor one explicitly asks whether the two petitioners are the same. However, the application of the General Plastic factors “is not limited solely to instances when multiple petitions are filed by the same petitioner.” But, when the factors are applied to different petitioners, they have been applied to petitioners who have a “significant relationship” with each other.

Here, both the parties and the Board agreed that there is not a “significant relationship” between the two petitioners. As the Director noted, the PTO has never extended the General Plastic factors “to any cases in which the first and second petitioners do not have a significant relationship.” The Director found the Board’s unprecedented extension of the General Plastics factors to be “improper[],” vacated the Board’s decision, and remanded the case with an instruction to the Board majority to “address the merits of the Petition.”

Practice Note: Patent owners fighting institution of an IPR by a subsequent petitioner should allege facts emphasizing the relationship between the two [...]

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Clean Up on Aisle PTAB: Clarification of Discretionary Denial Practice

by | May 2, 2024 |

The US Patent & Trademark Office (PTO) issued a Notice of Proposed Rulemaking (NPRM) for inter partes review (IPR) and post-grant review (PGR) proceedings before the Patent Trial & Appeal Board, seeking to codify existing precedent and guidance regarding the Board’s discretionary considerations in denying IPR or PGR petitions. 89 Fed. Reg. 28693 (Apr. 19, 2024).

The NPRM follows a 2020 request for comments and an April 2023 Advance Notice of Proposed Rulemaking (ANPR) that the PTO had hoped to finalize in terms of rulemaking by fall 2023. However, proposals in the ANPR hit a snag following criticism from Congress and more than 14,500 comments from stakeholders and the public, including charges that the PTO Director was overstepping her authority.

The newly proposed rules address:

  • Briefing on motions for discretionary denial
  • Factors for discretionary denial
  • Termination and settlement agreements

Briefing on Motions for Discretionary Denial

A significant aspect of the proposal provides for a separate briefing schedule between a patent owner’s preliminary response (POPR) and a request for discretionary denial, which must be filed no later than one month prior to the deadline for the POPR for briefing on its merits. Under the proposal, the discretionary denial arguments would be excluded from the preliminary response unless otherwise authorized by the Board and are intended to avoid encroaching on the wordcount limits for briefing on the merits. Under the proposed briefing process, there would be a 10-page limit for a patent owner’s request for discretionary denial and for the petitioner opposition, and a five-page limit for the patent owner’s sur-reply.

Factors for Discretionary Denial

The proposed rules address denial of institution for “parallel petitions” or “serial petitions” to provide a framework for considering whether previously presented art or arguments provide grounds for denial. The proposed rules also address treatment of joinder petitions, particularly in relation to already instituted petitions. Parallel petitions are defined in the proposed rule as two or more petitions by the same petitioner challenging the same patent that are filed on or before the filing of a POPR to any of the petitions or on or before the due date for filing a POPR to the first petition. Serial petitions are defined as challenged claims of the same patent overlapping with those in a previously filed petition for IPR, PGR or covered business method patent review.

According to the proposed rules, a parallel petition would not be instituted without a good cause showing of why more than one petition is necessary. Factors for a good cause showing include:

  • A petitioner’s ranking of desired petitions for consideration
  • An explanation of differences and materiality between the petitions
  • The number of challenged patent claims, including those asserted by the patent owner in district court litigation
  • A priority date dispute
  • Alternative claim constructions requiring different prior art references on mutually exclusive grounds
  • Knowledge of asserted claims at the time of filing a petition
  • Complexity of the technology

Similar considerations would also apply to joinder petitions.

[...]

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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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