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Heightened Written Description Standard for Negative Limitations?

Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the district court’s finding that the patent was not invalid for inadequate written description. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. June 21, 2022) (Moore, C.J.; Hughes, J.) (Linn, J., dissenting).

This is the second time this Hatch-Waxman case has been before the Federal Circuit. Novartis sued HEC, alleging that HEC’s abbreviated new drug application infringed a patent directed to methods of treating remitting multiple sclerosis (RRMS) with fingolimod or a fingolimod salt at a daily dose of 0.5 mg without an immediately preceding loading dose. The district court found sufficient written description for the claimed 0.5 mg daily dose and no-loading dose negative limitation. In January 2022, the Federal Circuit affirmed the district court’s decision finding adequate written description.

HEC petitioned for panel rehearing. The Federal Circuit granted the petition, vacated its January 2022 decision and reversed the district court’s judgment finding adequate written description for the no-loading dose negative limitation. The majority explained that “silence is generally not disclosure” because “[i]f it were, then every later-added negative limitation would be supported so long as the patent makes no mention of it.” The majority also explained that implicit disclosure cannot satisfy the written description requirement if it would render the limitation obvious to a skilled artisan. The majority emphasized that while a negative limitation need not be recited in the specification in haec verba, there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion—for example, a description of a reason to exclude the relevant element. Here, the majority found that the specification made no mention of the presence or absence of a loading dose. This silence cannot support a later-added claim limitation that precludes loading doses, particularly where there was no evidence that the patentee precluded the use of a loading dose and skilled artisans agreed that loading doses are sometimes given to RRMS patients.

Judge Linn (a member of the majority in the January 2022 opinion) dissented, arguing that the majority applied a heightened written description standard requiring not only a “reason to exclude” but a showing that the negative limitation was also “necessarily excluded.” He stated that the question was not whether the patentee precluded the use of a loading dose, but whether the claim limitation that precluded a loading dose was supported by the specification’s written description that disclosed only a daily dose. Judge Linn argued that disclosure along with the testimony of Novartis’s experts implied an absence of a loading dose to a skilled artisan, and that is all that is required for adequate written description. Citing precedent and the US Patent & Trademark Office’s guidance in the Manual of Patent Examining Procedure, he argued that newly added claims or claim limitations may be supported [...]

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This .SUCKS: Trademark Applications for Identical Characters Is a No-Go

The US Court of Appeals for the Federal Circuit affirmed a Trademark Trial and Appeal Board (Board) decision affirming the US Patent and Trademark Office’s (PTO) refusal to register two trademark applications for “.SUCKS.” In Re: Vox Populi Registry Ltd., Case No. 21-1496 (Fed. Cir. Feb. 2, 2022) (Lourie, Dyk, Stoll, JJ.)

Vox is a domain registry operator that maintains the master database of all domain names registered in each top-level domain. Vox filed two trademark applications for identical characters, one as a standard character and the other as a stylized form of .SUCKS, as shown below.

The PTO refused Vox’s applications on the grounds that, when used in connection with the domain services, each failed to function as a trademark. Vox appealed to the Board. The Board concluded that .SUCKS, whether as a standard mark or in the stylized form, would not be perceived as a source identifier. Vox appealed the Board’s decision only with respect to the stylized form of .SUCKS.

On appeal, the Federal Circuit noted that although Vox did not appeal the rejection of the standard character application, it spent much of its opening brief arguing that the standard character functions as a mark. As such, the Court reviewed the Board’s decision with respect to the standard character mark .SUCKS under the substantial evidence standard. Substantial evidence “means only such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” The Court found that substantial evidence supported the Board’s finding that consumers will view .SUCKS as only a non-source identifying part of a domain name, rather than as a trademark. The Court cited evidence reviewed by the Board, including Vox’s website, online articles and advertisements showing that .SUCKS refers to a product rather than as an identifiable provider or service. Ultimately, the Court found that the Board reasonably weighed the evidence.

The Federal Circuit next addressed the question of whether the stylized design of .SUCKS is registerable. The Court found no error in the Board’s analysis of whether the stylized form creates a separate commercial impression, where “all of the characters in the mark are the same height and width and are merely displayed in a font style that was once mandated by the technological limitations of computer screens.” Because the stylized design was not inherently distinctive, the Court rejected Vox’s application, thus affirming the Board’s decision in full.




Silence May Be Sufficient Written Description Disclosure for Negative Limitation

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and no-loading dose negative limitation. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. Jan. 3, 2022) (Linn, O’Malley, JJ.) (Moore, CJ, dissenting).

Novartis’s Gilenya is a 0.5 mg daily dose of fingolimod hydrochloride medication used to treat relapsing remitting multiple sclerosis (RRMS). HEC filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringed a patent directed to methods of treating RRMS with fingolimod or a fingolimod salt at a daily dosage of 0.5 mg without an immediately preceding loading dose.

The specification described the results of an Experimental Autoimmune Encephalomyelitis (EAE) experiment induced in Lewis rats showing that fingolimod hydrochloride inhibited disease relapse when administered daily at a dose of 0.3 mg/kg or administered orally at 0.3 mg/kg every second or third day or once a week, and a prophetic human clinical trial in which RRMS patients would receive 0.5, 1.25 or 2.5 mg of fingolimod hydrochloride per day for two to six months. The specification did not mention a loading dose associated with either the EAE experiment or the prophetic trial. It was undisputed that loading doses were well known in the prior art and used in some medications for the treatment of multiple sclerosis.

The district court found that HEC had not shown that the patent was invalid for insufficient written description for the claimed 0.5 mg daily dose or the no-loading dose negative limitation. The district court also found sufficient written description in the EAE experiment and/or prophetic trial and credited the testimony of two of Novartis’s expert witnesses. HEC appealed.

The Federal Circuit affirmed the district court’s decision. Turning first to the daily dose limitation, the majority held that the prophetic trial described daily dosages of 0.5, 1.25 or 2.5 mg and found no clear error by the district court in crediting expert testimony converting the lowest daily rat dose described in the EAE experiment to arrive at the claimed 0.5 mg daily human dose. Reciting Ariad, the Court explained that a “disclosure need not recite the claimed invention in haec verba” and further, that “[b]laze marks” are not necessary where the claimed species is expressly described in the specification, as the 0.5 mg daily dose was here.

Turning to the no-loading dose negative limitation, the majority disagreed with HEC’s arguments that there was no written description because the specification contained zero recitation of a loading dose or its potential benefits or disadvantages, and because the district court inconsistently found that a prior art abstract (Kappos 2006) did not anticipate the claims because it was silent as to loading doses. The Court explained that there is no “new and heightened standard for negative claim limitations.” The majority acknowledged that silence alone is insufficient disclosure but emphasized that [...]

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Injunctive Relief Available Even Where Laches Bars Trademark Infringement, Unfair Competition Damage Claims

The US Court of Appeals for the 11th Circuit affirmed a district court’s conclusion that laches barred an advertising and marketing company’s claims for monetary damages for trademark infringement and unfair competition, but remanded the case for assessment of injunctive relief to protect the public’s interest in avoiding confusion between two similarly named companies operating in the advertising sector. Pinnacle Advertising and Marketing Group, Inc. v. Pinnacle Advertising and Marketing Group, LLC, Case No. 19-15167 (11th Cir. Aug. 2, 2021) (Branch, J.)

Pinnacle Advertising and Marketing Group (Pinnacle Illinois) is an Illinois-based company and owner of two registered trademarks including the name “Pinnacle.” Pinnacle Illinois learned of a Florida-based company operating under almost the same name that was also in the advertising and marketing space—Pinnacle Advertising and Marketing Group (Pinnacle Florida) —through potential clients and a magazine’s accidental conflation of the two unrelated companies. Several years later, Pinnacle Illinois sued Pinnacle Florida for trademark infringement, unfair competition and cybersquatting. Pinnacle Florida filed a counterclaim seeking to cancel Pinnacle Illinois’s trademark registrations and also alleged that Pinnacle Illinois’s claims were barred by the doctrine of laches.

Following a jury trial, the district court granted Pinnacle Florida’s motion for judgment as a matter of law on Pinnacle Illinois’s cybersquatting claim. The jury returned a verdict in favor of Pinnacle Illinois on its claims for trademark infringement and unfair competition, awarding Pinnacle Illinois $550,000 in damages. The district court then granted Pinnacle Florida’s motion for judgment as a matter of law on its laches defense, concluding that Pinnacle Illinois’s trademark infringement and unfair competition claims were barred by laches because it waited more than four years to bring suit after it should have known that it had a potential infringement claim against Pinnacle Florida. The district court also cancelled Pinnacle Illinois’s registrations because it concluded that Pinnacle Illinois’s marks were merely descriptive and lacked secondary meaning. Pinnacle Illinois appealed.

Pinnacle Illinois argued that the district court abused its discretion in finding that Pinnacle Illinois’s claims were barred by laches, and that even if laches did bar Pinnacle Illinois’s claims for money damages, the district court should have considered whether injunctive relief was proper to protect the public’s interest in avoiding confusion between the two companies. Pinnacle Illinois also argued that the district court erred when it cancelled its registrations without regard to the jury’s findings of distinctiveness and protectability or the presumption of distinctiveness afforded to its registered marks.

The 11th Circuit found that the district court did not abuse its discretion in determining that laches barred Pinnacle Illinois from bringing its trademark infringement and unfair competition claims for monetary damages. Pinnacle Illinois sued after the Florida four-year statute of limitations had passed, and the Court found that the company was not excused for its delay because it did not communicate with Pinnacle Florida about the infringement until it filed suit. Pinnacle Florida also suffered economic prejudice because it invested significant time and money, including around $2 million, in developing its business under [...]

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Neither Narrow Proposed Claim Construction nor Work Product Claim Justify Withholding Material Factual Information

The Patent Trial & Appeal Board of the US Patent & Trademark Office (PTO) canceled all challenged claims across five patents because the patent owner failed to meet its duty of candor by selectively and improperly withholding material information that was inconsistent with its patentability arguments. Spectrum Solutions, LLC v. Longhorn Vaccines & Diagnostics, LLC, IPR2021-00847; -00850; -00854; -00857; -00860 (PTAB May 3, 2023) (Braden, Yang, Derrick, Pollock, APJs) (per curiam) (Braden, APJ concurring).

The Board instituted inter partes reviews (IPRs) against five Longhorn patents based on petitions filed by Spectrum. During the proceedings, Longhorn filed motions to amend, after which the Board issued preliminary guidance suggesting that Spectrum established a reasonable likelihood that the proposed substitute claims were unpatentable. Longhorn engaged Assured Bio Labs (ABL) to conduct biological testing that would support its arguments distinguishing a prior art reference, but Longhorn made attorney work product objections in Spectrum’s ABL depositions and withheld testing data inconsistent with its arguments on the patentability of the original and proposed substitute claims. The Board subsequently allowed additional questioning on certain ABL testing, after which Spectrum filed a motion for sanctions, requesting judgment against Longhorn, a finding that the prior art reference taught the claim limitations and precluding Longhorn from contesting the finding, and an award to Spectrum of compensatory expenses, including attorneys’ fees.

The Board determined that sanctions of adverse judgment as to all challenged claims was appropriate because Longhorn failed to meet its duty of candor and good faith. The Board explained that parties have a duty of candor and good faith before the Board that requires any factual contentions to be well supported by evidence. Parties have “a duty to disclose to the [PTO] all information known . . . to be material to patentability.” (37 C.F.R. §1.56(a).) Information is material to patentability when it is “not cumulative to information already of record or being made of record in the application and . . . it refutes, or is inconsistent with, a position the applicant takes in . . . asserting an argument of patentability.” Taking a position contrary to any known fact while shielding factual information from the Board violates the duty of candor and good faith to the PTO, even if the party may otherwise withhold the information as being immaterial to patentability or privileged.

The Board criticized Longhorn’s proposed claim constructions as too narrow and contrary to the express language in both the original and proposed substitute claims. The Board explained that although Longhorn was free to maintain arguments grounded on Longhorn’s claim constructions, that did not excuse Longhorn’s duty of candor and good faith dealing, including disclosing material information relating to the Board’s preliminary claim constructions. Longhorn could not “simply withhold information” that the PTO would find material to patentability and should instead contest the Board’s constructions at trial.

The Board also explained that Longhorn took an overly strict view of what was material to claim patentability and a lax view as to the duty of candor [...]

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Claim Duality: Multiple Dependent Claims Can Be Both Patentable and Unpatentable

Addressing, for the first time, the issue of patentability of multiple dependent claims under 35 U.S.C. § 112, fifth paragraph, the Director of the US Patent & Trademark Office (PTO) granted rehearing and modified the Patent Trial & Appeal Board’s (Board) Final Written Decision after finding that the patentability of a multiple dependent claim should be considered separately as to each of the claims from which it depends. Nested Bean, Inc. v. Big Beings US Pty. Ltd. et al., IPR2020-01234 (PTO Feb. 24, 2023) (Vidal, Dir.) (precedential).

Nested filed a petition for inter partes review challenging claims 1 through 18 of a patent owned by Big Beings. Claims 1 and 2 were independent, and claims 3 to 16 were multiple dependent claims, which depended directly from either claim 1 or 2. The Board granted institution and ultimately issued a Final Written Decision finding that Nested did not establish that claims 1, 17 and 18 were unpatentable, but that Nested had established that claims 2 through 16 were unpatentable.

Big Beings filed a Request for Director review, noting that each of claims 3 to 16 were multiple dependent claims that depended from both claims 1 and 2. Big Beings argued that because the Board found that Nested failed to show that claim 1 was unpatentable, the Board should have also found that Nested failed to show that claims 3 through 16, as depending from claim 1, were unpatentable. The Director granted review.

35 U.S.C. § 112, fifth paragraph, states, in relevant part, “[a] multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.” Big Beings argued that the statute requires the Board to separately consider the patentability of alternative dependencies of a multiple dependent claim. Nested responded by arguing that the statute should be read so that if any version of a multiple dependent claim is found unpatentable over the prior art, then all versions of the claim should be found unpatentable.

The Director found that this was an issue of first impression. Relying on 37 C.F.R. § 1.75(c) and 35 U.S.C. § 282, the Director concluded that “a multiple dependent claim is the equivalent of several single dependent claims. Thus, in the same way that the unpatentability of multiple single dependent claims would each rise or fall separately, so too should the dependent claims covered by a multiple dependent claim.” The Director also noted that the Federal Circuit in Dow Chemical and Dayco Products explained that “not addressing claim validity on an individual basis is an error and contravenes 35 U.S.C. 282[.]” The PTO Director concluded, quoting the Manual of Patent Examining Procedure (MPEP), that “a multiple dependent claim must be considered in the same manner as a plurality of single dependent claims.”




Little Weight Given to Conclusory Expert Declaration That Repeats IPR Petition Verbatim

The US Patent & Trademark Office Director affirmed and designated as precedential a Patent Trial & Appeal Board (Board) decision denying institution of an inter partes review (IPR) petition where the expert declaration presented conclusory assertions without underlying factual support and repeated verbatim the petitioner’s argument. Xerox Corp. v. Bytemark, Inc., IPR2022-00624 (PTAB Aug. 24, 2022) (Wood, Grossman, Tartal, APJs); Xerox Corp. v. Bytemark, Inc., IPR2022-00624 (Feb 10, 2023) (Vidal, Dir.)

Bytemark owns a patent directed to a method and system for distributing electronic tickets. According to the patent, a user can procure and store an electronic ticket on a device such as a mobile phone, and when the user presents the ticket, the ticket taker can verify the ticket by inspecting a visual object that a human can perceive without a machine scan. In addition to using a validating visual object, the patent teaches data integrity checking to ensure that the ticket data and the software managing that ticket data on the user’s device has not been altered improperly. As to the data integrity concept, the claims of the patent recite a server that is configured to “store in a data record associated with the user account a data value indicating the fraudulent activity” (fraud limitation).

Xerox filed an IPR petition challenging certain claims of the patent as obvious over the Terrell prior art reference in combination with various secondary references. Xerox argued that Terrell disclosed that after fraudulent activity is detected, “the purchaser of the ticket could be blocked from further use of the system or pursued in respect of their potential fraud.” Xerox asserted that a skilled artisan would understand that such blocking would require recording the blocking in a data record associated with that user’s account, and would find it obvious that blocking the account of the purchaser from further use of the system would include storing a data value indicating the fraudulent activity in a data record associated with the user account.

Bytemark responded that Terrell, at most, taught blocking a ticket purchaser from further use of the Terrell system based on potential fraud, but nowhere indicated that this would be achieved by using a data value indicating fraudulent activity, as opposed to some other manner of blocking a user, such as deleting the user’s account or reporting the user for fraud. Bytemark further argued that Xerox’s argument that a skilled artisan would find the fraud limitation obvious was conclusory and an improper attempt to use a skilled artisan’s common knowledge to supply a wholly missing claim limitation without evidentiary support.

The Board agreed with Bytemark, finding that Xerox did not provide sufficient evidence or persuasive reasoning to support either of Xerox’s arguments. The Board explained that Terrell taught blocking the purchaser rather than the account of the purchaser and that it was far from clear that blocking the purchaser would “require” recording the blocking in a record in the purchaser’s account, as opposed to deleting the purchaser’s account altogether. The Board noted that the [...]

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Took a DNA Test, Turns Out “100% THAT BITCH” Is 100% Registrable

Addressing a refusal to register for failure to function as a trademark, the Trademark Trial & Appeal Board (Board) reversed, finding that the evidence of consumer perception of “100% THAT BITCH” did not demonstrate that the proposed mark is such a widespread and common expression that it failed to function as a source identifier. In re Lizzo LLC, Serial Nos. 88466264, 88466281 (TTAB Feb. 2, 2023) (Cataldo, Pologeorgis, Coggins, ATJ).

World-renowned, Grammy-winning artist Lizzo, through her company, Lizzo LLC, filed two applications to register 100% THAT BITCH for use in connection with clothing and related goods in International Class 25. The mark is a reference to a lyric (“I just took a DNA test, turns out I’m 100% that bitch”) from her chart-topping hit, “Truth Hurts.” The US Patent & Trademark Office (PTO) issued an office action refusing to register the mark based on failure to function as a trademark under Sections 1, 2 and 45 of the Trademark Act. Specifically, the examining attorney asserted that the phrase is a “commonplace expression widely used by a variety of sources to convey an ordinary, familiar, well-recognized sentiment.” The PTO denied the request for reconsideration, and Lizzo appealed.

In assessing a refusal to register for failure to function as a trademark, the Board must look to consumer perception of the mark; specifically, whether the mark serves merely an ornamental or informational purpose rather than a source-identifying one. In this case, the relevant consumer consists of the general public, as there were no limitations on the channels of trade or classes of consumers identified in the applications. The examining attorney argued that the evidence demonstrated only that the mark, as used on the relevant goods, portrayed “a message of self-confidence and female empowerment used by many different entities in a variety of settings”—a message that Lizzo “did not originate[,] . . . but merely popularized.”

The Board discounted much of the evidence proffered to show that the mark was ornamental as it largely all referred to Lizzo, her music and/or her song, “Truth Hurts,” demonstrating that “consumers encountering 100% THAT BITCH on the specific types of clothing identified in the application—even when offered by third parties—associate the term with Lizzo and her music.” The Board further noted that all of the evidence regarding third-party use corresponded with the release of Lizzo’s “Truth Hurts”—a correlation that suggests the term was not widely known or used until Lizzo popularized it.

Although there was no disagreement that the proposed mark conveys a “feeling of female strength, empowerment and independence,” the Board found that the record supported that “most consumers would perceive 100% THAT BITCH used on goods in the application as associated with Lizzo rather than as a commonplace expression.” Accordingly, the Board reversed the refusal to register.




PTO and Copyright Office Seek Public Comments on Non-Fungible Tokens

On November 23, 2022, the US Patent & Trademark Office and the US Copyright Office announced that they are seeking public input on intellectual property (IP) considerations related to non-fungible tokens (NFTs). The agencies will hold three public roundtables directed to patents, trademarks and copyrights, respectively, scheduled as follows:

  • January 10, 2023 – Patents and NFTs
  • January 12, 2023 – Trademarks and NFTs
  • January 18, 2023 – Copyrights and NFTs.

The roundtables will be livestreamed, and the agencies will post instructions for registration to view them live. Requests to participate as a panelist in any of the roundtables must be received by December 21, 2022, to be considered.

The agencies also issued a request for comments, soliciting answers to 13 questions of particular interest:

  1. Describe current and potential future uses of NFTs in your field or industry.
  2. Describe any IP-related challenges or opportunities associated with NFTs or NFT markets.
  3. Describe how NFT markets affect the production of materials subject to IP protection.
  4. Describe whether, how and to what extent NFTs are used by or could be used by IP rights holders to
    1. Document the authenticity of an asset
    2. Document the seller’s ownership of or authority to sell an asset
    3. Document the seller’s authority to transfer any relevant or necessary IP rights associated with an asset
    4. Document any limitations related to IP rights surrounding the sale, or the purchaser’s use, of an asset.
  5. Describe whether, how and to what extent NFTs present challenges for IP rights holders, or those who sell assets using NFTs, with respect to the activities described in question 4.
  6. Describe whether, how and to what extent NFTs are used by, could be used by, or present challenges or opportunities for IP rights holders to
    1. Obtain their IP rights
    2. Transfer or license their IP rights
    3. Exercise overall control and management of their IP rights
    4. Enforce their IP rights.
  7. Describe how and to what extent copyrights, trademarks and patents are relied on, or anticipated to be relied on, in your field or industry to
    1. Protect assets that are associated with NFTs
    2. Combat infringement associated with NFT-related assets offered by third parties
    3. Ensure the availability of appropriate reuse of NFT-related assets.
  8. Are current IP laws adequate to address the protection and enforcement of IP in the context of NFTs? If not, explain why and describe any legislation you believe should be considered to address these issues.
  9. Describe any IP-related impacts those in your field or industry have experienced in connection with actual or intended uses of NFTs. Describe any legal disputes that have arisen in the following contexts, and the outcome of such disputes, including citations to any relevant judicial proceedings:
    1. The relationship between the transfer of an NFT and the ownership of IP rights in the associated asset
    2. The licensing of IP rights in the asset associated with an NFT
    3. Infringement claims when either (i) an NFT is associated with an asset in which another party [...]

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Another Kind of Term Limit: Delay Resulting from After-Allowance Amendments Deducted from PTA

The US Court of Appeals for the Federal Circuit affirmed the US Patent & Trademark Office’s (PTO) decision on a patent term adjustment (PTA), finding that it was appropriate to deduct days from a patent term when the applicant files an amendment after notice of allowance and could have completed prosecution earlier by withdrawing the amendment or abstaining from filing it in first instance. Eurica Califorrniaa v. Vidal, Case No. 22-1640 (Fed. Cir. Nov. 7, 2022) (Lourie, Dyk, Hughes, JJ.) (per curiam) (non-precedential).

Eurica Califorrniaa is the sole inventor of a patent application entitled “nondestructive means of ectopic pregnancy management,” which was filed on March 15, 2014. Near the close of an extended patent prosecution, the examiner identified minor additional changes to the claim language of the patent application that would place it in position for allowance. The examiner unilaterally made the amendments and provided Califorrniaa a notice of allowance. In response, Califorrniaa requested an interview with the examiner and provided a list of further proposed amendments that included changes to the examiner’s amended claim limitations as well as substantive changes unrelated to the Examiner’s Amendments. Following the interview, Califorrniaa formally submitted his proposed amendments for the examiner’s consideration. As a result, the PTO deducted 51 days from the adjusted patent term of the patent to account for the time it took the examiner to consider and accept Califorrniaa’s post-allowance amendments. Califorrniaa appealed the PTO’s calculations, first to the district court (which affirmed the PTO) and then to the Federal Circuit.

The PTO may extend the nominal 20-years-from-filing patent terms to account for each day of delay attributable to the PTO, minus the number of days of delay attributable to an applicant’s failure to engage in reasonable efforts to conclude prosecution. Congress has granted the PTO authority to define when this “reasonable efforts” standard is not met, and the PTO has created regulations to address the issue. In 2019, the Federal Circuit issued its decision in Supernus v. Iancu, finding that the PTO failed to properly consider whether the applicant reasonably engaged in efforts to conclude prosecution. In response, the PTO adjusted its regulations to distinguish between post-allowance amendments expressly requested by the PTO and those voluntarily made by the applicant, and to change the relevant timeframe for the calculation of a reduction in PTA. The PTO’s regulations state, in part, that an applicant’s decision to amend their patent application after the examiner has issued a notice of allowance is not a reasonable effort to conclude prosecution.

Unlike its ruling in Supernus, where no identifiable effort to conclude prosecution existed, here the Federal Circuit agreed with the PTO’s finding that Califorrniaa could have, at any time, withdrawn his post-allowance amendments and accepted the examiner’s amendments to conclude prosecution. As such, an “identifiable effort” existed by which Califorrniaa could have avoided additional delay and concluded prosecution. Therefore, the Court affirmed the 51-day deduction of the patent term.

The Federal Circuit also found that the PTO’s post-Supernus updates to [...]

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