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Be Cool: Don’t Construe the Construction

by Keval Amin | Mar 21, 2024 | Patents

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 (nonprecedential).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 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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PTO Seeks Permanent Rules Regarding Motion to Amend Practice Before Board

by Peter Brunovskis, PhD | Mar 14, 2024 | America Invents Act

On March 4, 2024, the US Patent & Trademark Office published a Notice of Proposed Rulemaking seeking to revise its Motion to Amend (MTA) pilot program practice in connection with certain America Invents Act (AIA) proceedings. 89 Fed. Reg. 15531 (Mar. 4, 2024). The PTO set a May 3, 2024, deadline for stakeholders to submit written comments in response to the proposed rules.

The MTA pilot program has evolved since its inception nearly five years ago and has been extended to September 16, 2024. The proposal seeks to make permanent certain provisions of the pilot program in response to the PTO’s May 2023 request for comments. The rules would apply to the existing consolidated set of rules relating to trial practice for inter partes review (IPR), post-grant review (PGR) and derivation proceedings in trial proceedings under the AIA.

Under the existing MTA pilot program, patent claims challenged during an AIA trial proceeding provide the patent owner with two options when proposing substitute claims in response to a petitioner’s opposition. The first option gives the patent owner the ability to file an MTA so that the Patent Trial & Appeal Board can issue preliminary non-binding guidance regarding the likelihood of an invalidation decision. The PTO proposes to revise its rules of practice to provide for the issuance of preliminary guidance in response to an MTA and to provide a patent owner with the option of filing one additional revised MTA.

The Board’s preliminary guidance typically would come in the form of a short paper issued after a petitioner files its opposition to the MTA and typically would provide the Board’s preliminary views on the MTA, specifically whether the MTA meets the statutory and regulatory requirements for an MTA, whether the parties have met their respective burdens of proof and whether the substitute claims are likely to be found unpatentable. However, the preliminary guidance would not be binding on the Board.

The proposed provisions would also provide the Board with greater authority to raise new grounds of unpatentability based on a preponderance of evidence standard. The new grounds of unpatentability could rely on the entirety of the record, including all prior art of record. The guidance would be accompanied by citations to the evidence in support of these new grounds. Further, where no opposition is filed or other circumstances constitute a lack of opposition, the prior art of record may further include references obtained from the PTO (i.e., examiners) in response to a request from the Board.

The proposed provisions would allow a patent owner to file a revised MTA after receiving a petitioner’s opposition to the original MTA or after receiving the Board’s preliminary guidance. Under the current pilot program, a revised MTA must be preauthorized for “good cause.” Under the revised provisions, the patent owner would be able to file a revised MTA without preauthorization. A revised MTA would replace the original MTA and must include new proposed substitute claims in place of the originally proposed claims. [...]

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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

by Kyle Sorenson, PhD | Mar 7, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
Ikan’s counsel [...]

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Not Admitted to PTO Bar? No Problem.

by Peter Brunovskis, PhD | Feb 29, 2024 | Uncategorized

On February 21, 2024, the US Patent & Trademark Office (PTO) issued a Notice of Proposed Rulemaking that would give parties the option to designate a non-registered practitioner as lead counsel in proceedings before the Patent Trial & Appeal Board. 89 Fed. Reg. 13017 (Feb. 21, 2024) (to be codified at 37 C.F.R. pt. 42).

37 CFR 42.10(a) currently requires each party to designate a lead counsel and at least one back-up counsel. The lead counsel must be a registered practitioner. Non-registered practitioners can serve as back-up counsel pro hac vice, but only upon a showing that they are an experienced litigating lawyer serving as back-up counsel and that they possess significant familiarity with the subject matter at issue. Permission for back-up status requires grant of a pro hac vice motion filed by counsel presenting specific statements of fact showing good cause for admission, as well as an affidavit or declaration by counsel attesting to good standing before the courts, familiarity with the PTO’s Patent Trial Practice Guide and the Board’s Rules of Practice for Trial set forth in part 42 of 37 C.F.R., and familiarity with the subject matter at issue.

The proposed changes to 37 C.F.R. 42.10 would:

Permit non-registered practitioners to serve as lead counsel for a party in Board proceedings as long as at least one other counsel designated to appear on behalf of the party is a registered practitioner.
Permit parties to proceed without back-up counsel upon a showing of good cause. A party may show good cause by demonstrating that it lacks the financial resources to retain both lead and back-up counsel.
Create a new streamlined procedure for pro hac vice recognition of Board-recognized practitioners. This procedure applies to non-registered practitioners who have previously been admitted pro hac vice in a different Board proceeding and have not been subsequently denied pro hac vice recognition in a different Board proceeding.
Clarify that those recognized pro hac vice have a duty to inform the Board if the information presented in a request for pro hac vice recognition is no longer accurate or complete.

The PTO seeks public comments on the proposed rulemaking by May 21, 2024, through the Federal eRulemaking Portal. Enter docket number PTO-P-2023-00587 on the homepage and select “search.”

For further details, click here.

No Home Away From Home: Federal Circuit Confirms PTO Domicile Requirements

by Anisa Noorassa | Feb 22, 2024 | Trademarks

The US Court of Appeals for the Federal Circuit confirmed the US Patent & Trademark Office’s (PTO) refusal to register a trademark based on the applicant’s failure to comply with the domicile address requirement of 37 C.F.R. §§ 2.32(a)(2) and 2.189. In re Chestek PLLC, Case No. 22-1843 (Fed. Cir. Feb. 13. 2024) (Lourie, Chen, Stoll, JJ.)

Chestek included only a PO box for its domicile address in its trademark application. The PTO found this information noncompliant with the domicile address rule, which requires trademark applicants to either have a domicile within the United States or be represented by US counsel. The PTO implemented the requirement in 2019 following a notice-and-comment period. Chestek appealed the PTO’s refusal to register based on the Administrative Procedure Act (APA) and challenged the processes surrounding implementation of the domicile address requirement.

Chestek first argued that the requirement was improperly instituted because the PTO failed to comply with the notice-and-comment rulemaking requirement under 5 U.S.C. § 533 by failing to provide notice of the domicile address requirement adopted in the final rule. However, the Federal Circuit held that the formalities of the notice-and-comment were not required under § 533(b)(A) because the rule was procedural, not substantive (i.e., effecting a change in existing law or policy that affects individual rights and obligations). As the Court explained, the rule did not affect the substantive trademark standards used during examination to evaluate applications but was simply an applicant information requirement.

Chestek next argued that the domicile address requirement was arbitrary and capricious because in implementing the final rule, the PTO “offered an insufficient justification for the domicile address requirement” and failed to consider important repercussions of the requirement, such as its effects on privacy. The Federal Circuit rebuffed that argument, explaining that the domicile requirement and the explanations given for it (determining whether the US attorney requirement applied) were “at least reasonably discernable.” The Court stated that as long as an agency does not give “almost no reason at all” for a new policy, the change is sufficiently justified and not arbitrary or capricious. The Court also noted that the APA does not require an agency to consider and respond to every impact of a proposed policy change.

Stay in the Know: Informational Message Is Not a Source Identifier

by Sydney E. McDermott | Feb 1, 2024 | Trademarks

Addressing whether the mark EVERYBODY VS. RACISM was registrable, the US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s final refusal to register the mark because it failed to function as a source identifier. In re: GO & Assoc., LLC, Case No. 22-1961 (Fed. Cir. Nov. 13, 2023) (nonprecedential) (Fed. Cir. Jan. 22, 2024) (precedential) (Lourie, Reyna, Hughes, JJ.)

On June 2, 2020, GO & Associates filed a trademark application seeking registration on the principal register of EVERYBODY VS. RACISM, identifying the goods and services as various apparel “promoting public interest and awareness of the need for racial reconciliation and encouraging people to know their neighbor and then affect change in their own sphere of influence.”

In a non-final office action, the examining attorney refused to register the mark, asserting that it “failed to function as a source identifier for GO’s goods and services.” The examiner noted that the mark “merely convey[ed] support of, admiration for, or affiliation with the ideals conveyed by the message.” The examiner presented examples of the mark being used in informational settings, such as by referees in the National Basketball Association; in YouTube videos; on clothing; and in titles of rap songs, podcasts and church sermons. Although GO presented evidence that the mark had hardly been used or searched prior to its use in May 2020, the examining attorney continued to reject the application. The examiner found that “the ornamental uses of the mark only reinforced the fact that consumers would likely view the mark as a sentiment rather than a source.” The examiner also noted that the applicant’s first use of the mark coincided with the “general timeline of the heated anti-racism protests throughout the nation in the wake of the George Floyd killing.”

GO appealed to the Board. The Board found “that the record as a whole show[ed] wide use of the proposed mark in a non-trademark manner to consistently convey an informational, anti-racist message to the public, as opposed to a source identifier of GO’s goods and services,” and affirmed the examiner’s refusal to register the mark. GO appealed to the Federal Circuit.

Affirming the Board’s decision, the Federal Circuit emphasized that the threshold requirement for the issuance of a mark is whether it is source identifying: “what makes a trademark a trademark under the Lanham Act is its source-identifying function.” The mark must identify the source for the public and distinguish that source from others.

The Federal Circuit noted that whether a mark is source identifying depends on “how the mark is used in the marketplace and how consumers perceive it.” In particular, the US Patent & Trademark Office prohibits registering marks that it calls “informational matter” (i.e., “slogans, terms, and phrases used by the public to convey familiar sentiments, because consumers are unlikely to perceive the matter as a trademark or service mark for any goods and services”). Reviewing the Board’s findings for substantial evidence, the Court found that the Board properly weighed the [...]

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

by Cecilia Choy, Ph.D. | Feb 1, 2024 | Patents

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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First Amendment Bowled Over by Lanham Act – Again

by Anisa Noorassa | Jan 25, 2024 | Trademarks

In response to the Supreme Court of the United States’ ruling in Jack Daniel’s, the US Court of Appeals for the Ninth Circuit reconsidered its 2022 decision in Punchbowl v. AJ Press and determined that Jack Daniel’s reset prior Ninth Circuit precedents regarding the interaction of First Amendment rights and the Lanham Act. The Ninth Circuit reversed its original decision and remanded the case to the district court to conduct a likelihood of confusion analysis under Lanham Act precedent. Punchbowl, Inc. v. AJ Press, LLC, Case No. 21-55881 (9th Cir. Jan. 12, 2024) (Owens, Bress, Fitzwater, JJ.)

The Ninth Circuit had previously held that despite use of the PUNCHBOWL trademark for a news service covering politics, AJ Press was not subject to liability under the Lanham Act. The PUNCHBOWL mark was registered by Punchbowl, Inc., a website specializing in online communications “with a focus on celebrations, holidays, events and memory making.” The Ninth Circuit’s original decision was based on the Court’s understanding of the Rogers test, which protected creative use of trademarks if the defendant could “make a threshold legal showing that its allegedly infringing use is part of an expressive work protected by the First Amendment.” This test was easily met if the artistic relevance of the trademark’s use was “above zero.” Shortly after the Ninth Circuit issued its initial decision, the Supreme Court granted certiorari in Jack Daniel’s Properties v. VIP Products, a case that addressed the same basic underlying precedent.

In its Jack Daniel’s decision, the Supreme Court held that the Rogers test exception to the Lanham Act did not apply when the expressive mark was used as a mark. The Supreme Court therefore drew a line between VIP’s use of “Bad Spaniels,” a direct play on “Jack Daniel’s” that was an expressive use of a mark as a mark, and use of a mark that was expressive but not used as a trademark. The Supreme Court’s ruling prompted the Ninth Circuit to reconsider its original decision in Punchbowl.

In its new decision, the Ninth Circuit, applying the rule of Jack Daniel’s, held that the Rogers test did not apply and that AJ Press’s use of the mark “Punchbowl” was not excepted from the Lanham Act as protected First Amendment expression. Rather, AJ Press’s use of “Punchbowl” was as a mark identifying its news service.

The Ninth Circuit stressed that this was not an automatic victory for Punchbowl, however. The Ninth Circuit instructed the district court on remand to proceed with a likelihood-of-confusion analysis test under the Lanham Act – an analysis that would consider many of the factors (such as the expressive nature of the trademark’s use) that had been relevant to the application of the Rogers test.

PTO Continues to Wave Wands in Assessing Enablement

by Christopher M. Bruno | Jan 18, 2024 | Patents

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance with the enablement requirement under 35 U.S.C. § 112. (89 Fed. Reg. 1563 (Jan. 10, 2024).) Unsurprising to those familiar with the Amgen decision, the PTO hewed closely to existing practice.

The PTO collected the Supreme Court’s clarifications regarding the relationship between the enablement requirement and an amount of experimentation, namely that although particular disclosure of all embodiments is not required, claims are not enabled if they require more than reasonable experimentation. Regarding the “reasonable experimentation” requirement, the PTO explained that consistent with several post-Amgen US Court of Appeals for the Federal Circuit opinions, it would continue to apply the factors that the Federal Circuit announced in its 1988 In re Wands decision.

Although the PTO intends to continue to rely on pre-Amgen Federal Circuit Wands analyses as instructive, it found particular persuasive force since the Federal Circuit’s decision was affirmed by the Supreme Court in Amgen. There, according to the guidance, the Federal Circuit concluded that the genus claims were not enabled because of the amount of experimentation required to test whether antibodies satisfied certain functional limitations. Thus, because “the scope of the claims was far broader in functional diversity than the disclosed examples, … [and] the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, … there was not adequate guidance in the specification.”

The PTO also noted that the Federal Circuit’s 2023 Baxalta v. Genentech decision, like Amgen, found claims directed to antibodies that contained certain functional limitations to be invalid. There, the Court, like the PTO, detected no appreciable difference between the reasonable experimentation standard as articulated in Wands and the standard as set forth in Amgen. The guidance canvassed other post-Amgen enablement decisions, all of which the PTO read to support continued reliance on Wands.

Practice Note: Although the PTO says that it will continue to apply the Wands factors as it has before, the Amgen decision may, as a practical matter, make establishing enablement of functional limitations more difficult. Whether examiners—especially those in life sciences technology areas—change the course of their review post-Amgen remains to be seen.

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