Director review Archives

PTO Proposes New Guidelines for Director Review in Board Proceedings

by Jake B. Vallen | Apr 25, 2024 | America Invents Act, Patents

The US Patent & Trademark Office (PTO) proposed new rules governing the process for Director review of Patent Trial & Appeal Board decisions in America Invents Act (AIA) proceedings. Rules Governing Director Review of Patent Trial and Appeal Board Decisions, 89 Fed. Reg. 26,807 (proposed Apr. 16, 2024) (to be codified at 37 C.F.R. pt. 42).

The Notice of Proposed Rulemaking (NPRM) proposes adding 37 C.F.R. § 42.75, which includes rules addressing the following issues:

Limited Availability of Director Review. The NPRM proposes that Director review in AIA proceedings would only be available to a party from institution decisions, final written decisions or panel decisions granting rehearing of a decision on institution or a final written decision. However, the Director would have authority to review any interlocutory decisions rendered in reaching such decisions. The NPRM also proposes that the Director may sua sponte review institution decisions, final written decisions or decisions granting rehearing.

Timing, Format and Content of Requests for Director Review. The NPRM proposes that requests for Director review would have to be sought within the time period set forth by 37 C.F.R. § 42.71(d), comply with the formatting and length requirements of 37 C.F.R. §§ 42.6(a) and 42.24(a)(1)(v), and would not be allowed to introduce new evidence. Any sua sponte Director review would have to be initiated within 21 days after the deadline to seek rehearing.

Effect of Director Review. The NPRM proposes that a decision on institution, a final written decision or a decision granting rehearing would become final agency action unless Director review was timely sought or timely initiated sua sponte or a request for Director review was denied.

Director Review Process. The NPRM proposes that Director review would not stay the underlying proceeding, but if the Director grants review, the review would conclude with the issuance of a decision or order that provides the reasons for the Director’s disposition of the case. A party would be permitted to appeal a Director review decision of either a final written decision or a decision granting rehearing of a final written decision (not institution decisions or decisions granting rehearing of institution decisions) to the Federal Circuit in accordance with the procedures set forth in 35 U.S.C. §§ 141(c) and 319. A request for Director review would be treated as a request for rehearing and would reset the time for appeal until Director review was resolved.

Delegation. The NPRM proposes that delegation of Director review would be permitted, subject to conditions set forth by the Director.

Communications With the PTO. The NPRM proposes that communications from a party concerning a specific Director review request or proceeding would have to copy counsel for all parties. Other than authorized amicus briefings, communications from third parties would not be allowed.

Comments are due by June 17, 2024, and can be submitted through the federal eRulemaking portal here.

New PTAB Claim Construction? Give the Parties Review Opportunity

by Benjamin Ediger, Ph.D. | Mar 28, 2024 | Patents

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”:

The Board’s construction newly added a limitation that neither the petitioner nor the patent owner proposed
The Board’s construction was erroneous
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.

Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

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

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

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

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

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

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

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

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