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Should This Be an Alice Two-Step or a Section 112 Enablement Waltz?

by Katherine Pappas | Aug 10, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a lawsuit for lack of subject matter eligibility under 35 U.S.C. § 101 based on an Alice two-step analysis, with Judge Newman filing a sharp dissent focused on “the current law of § 101.” Realtime Data LLC v. Array Networks Inc., Case No. 2021-2251 (Fed. Cir. Aug. 2, 2023) (non-precedential) (Reyna, Taranto, JJ.) (Newman, J., dissenting).

From November 2017 through December 2018, Realtime brought suits against multiple defendant corporations asserting infringement of multiple Realtime patents related to methods and systems for digital data compression. In 2019, some defendants moved to dismiss for failure to state a claim, arguing that the asserted patent claims were patent ineligible under § 101. In an oral ruling from the bench, the district court granted the motion to dismiss. On appeal, the Federal Circuit found that the district court had provided too cursory a ruling to allow for meaningful appellate review, and therefore vacated and remanded for the district court to provide a more detailed § 101 analysis.

On remand in 2021, the district court issued a written opinion working through the two-step analysis laid down by the Supreme Court in Alice. Step 1 evaluates whether the asserted claims are directed to a patent-ineligible concept, such as an abstract idea, and Step 2 searches for an “inventive concept” by considering the claims to determine whether any elements “transform the nature of the claim” from ineligible subject matter into a patent-eligible application, which must amount to more than “well-understood, routine, or conventional activities.” The district court found the patents invalid under § 101 and granted the motions to dismiss Realtime’s complaints but gave Realtime the opportunity to file amended complaints. After Realtime did so, the defendants renewed their motions to dismiss. The district court again dismissed Realtime’s complaints based on § 101. In ruling so, the district court first found that there were no material differences between Realtime’s prior and amended complaints with respect to the § 101 analysis. Next, the court incorporated by reference its prior ruling’s legal analysis, reaffirmed its finding that the claims were invalid under § 101 and granted dismissal, this time without granting Realtime leave to file amended complaints. Realtime appealed.

This time the Federal Circuit affirmed the district court’s dismissal. In affirming, the Federal Circuit worked through the Alice two-step inquiry and agreed with the district court on each step. At Step 1, the Court agreed that “none of the claims at issue specifies any particular technique to carry out the compression of data” but instead were all “data manipulation claims that are recited at a high level of result-oriented generality and that lack sufficient recitation of how the purported inventions accomplish the results” (quoting Koninklijke). At Step 2, the Court agreed that the asserted patents “simply apply an abstract idea on generic computers with generic techniques,” thus failing to cross over into eligible subject matter. Accordingly, the Court held that the claims were directed to patent-ineligible subject matter and affirmed dismissal under § 101.

Judge [...]

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Holy Pulmonary Hypertension, Batman: Method of Treatment Not Constrained by Safety and Efficacy

by Nitya Anand | Aug 3, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit also affirmed the district court’s holding that certain claims of the product-by-process patent were invalid because the claimed product was in the prior art, regardless of the process by which it was made. United Therapeutics Corporation v. Liquidia Technologies, Inc., Case Nos. 22-2217; 23-1021 (Fed. Cir. July 24, 2023) (Lourie, Dyk, Stoll, JJ.)

United Therapeutics is the maker of Tyvaso®, a treprostinil formulation approved for treating pulmonary hypertension. United Therapeutics asserted two patents covering Tyvaso® against Liquidia’s § 505(b)(2) new drug application (NDA) on Yutrepia™. One patent was a method of treatment patent claiming to treat pulmonary hypertension by administering a “therapeutically effective” dose of a treprostinil formulation, and the other was a product-by-process patent claiming a treprostinil composition with lowered levels of impurities made by a specific salt formation process.

The district court found that United Therapeutics showed that a single administration of treprostinil improves a patient’s hemodynamics, establishing that administration of Liquidia’s Yutrepia, comprising treprostinil, would directly infringe the method of treatment claims. The district court also concluded that even though Yutrepia’s label did not provide hemodynamic data, the label’s instructions would inevitably lead to the administration of a therapeutically effective single event dose. The court thus concluded that Liquidia would induce infringement of the method of treatment claims.

The district court further found that the asserted claims were not invalid for lack of enablement or written description. The court reasoned that a skilled artisan would not need to engage in undue experimentation to practice the full scope of the claimed treatment of pulmonary hypertension, despite potential safety concerns in treating certain patients, since the claims did not require safety and efficacy. The court found that the claims were not invalid for lack of written description, finding that a skilled artisan would, based on the specification, understand that treprostinil would effectively vasodilate the pulmonary vasculature, improve hemodynamics and treat a patient’s elevated pulmonary blood pressure.

Liquidia appealed on five issues: claim construction of the term “treating pulmonary hypertension,” enablement, written description, induced infringement and infringement of the product by process claims. United Therapeutics cross-appealed on anticipation of the product by process claims and non-infringement of those claims.

First, regarding the construction of “treating pulmonary hypertension,” the Federal Circuit affirmed that the term encompassed all recognized groups of pulmonary hypertension but noted that the claim language “treating pulmonary hypertension” did not import any additional efficacy limitations or safety limitations, even those in a group that would not benefit from the treatment. The Court declined to read any safety or efficacy requirements into the claims, explaining that absent incorporation into the claims, the safety and efficacy of a claimed treatment are the purview of the US Food & Drug Administration (FDA), not patent law.

Regarding enablement and written description, Liquidia argued that the method [...]

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Invoking Generic Need for Claim Construction Won’t Avoid § 101 Dismissal

by Katherine Pappas | Jul 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a patent infringement suit on § 101 grounds, rejecting the patentee’s argument that claim construction or discovery was required before assessing patent eligibility. Trinity Info Media, LLC v. Covalent, Inc., Case No. 22-1308 (Fed. Cir. July 14, 2023) (Stoll, Bryson, Cunningham, JJ.)

Trinity Info Media sued Covalent for infringement of patents related to poll-based networking systems that connect users in real time based on answers to polling questions. Covalent moved to dismiss, arguing that the patent claims were invalid under 35 U.S.C. § 101 because they were directed to patent-ineligible subject matter. In resolving the motion, the district court found that the claims were directed to the abstract idea of “matching users who gave corresponding answers to a question” and did not contain an inventive concept. The district court further found that the purported invention did not improve computer functionality but simply used “generic computer components as tools to perform the functions faster than a human would.” Accordingly, it found the asserted claims invalid under § 101 and granted the motion to dismiss. Trinity appealed.

Trinity argued that the district court erred by granting the motion without first allowing fact discovery and conducting claim construction. The Federal Circuit disagreed, finding that in order to overcome a motion to dismiss on § 101 grounds, “the patentee must propose a specific claim construction or identify specific facts that need development and explain why those circumstances must be resolved before the scope of the claims can be understood for § 101 purposes.” Trinity had identified claim terms to the district court, but never proffered any proposed constructions or explained how construction would affect the § 101 analysis. Because Trinity did not identify specific facts to be discovered or propose any particular claim construction that would alter the § 101 analysis, Trinity’s generic arguments were insufficient to avoid the motion to dismiss.

The Federal Circuit went on to analyze whether the asserted claims were invalid under the two-step framework established by Mayo and Alice. Under this framework, Step 1 evaluates whether the asserted claims are directed to a patent-ineligible concept, such as an abstract idea. Step 2 searches for an “inventive concept” by considering the claims to determine whether any elements “transform the nature of the claim” from ineligible subject matter into a patent-eligible application.

At Step 1, the Federal Circuit concluded that the claims were directed to the patent-ineligible abstract idea of “matching based on questioning.” The Court noted that a “telltale sign of abstraction is when the claimed functions are mental processes that can be performed in the human mind or using a pencil and paper” (citing Personal-Web), finding that the “human mind could review people’s answers to questions and identify matches based on those answers.” Further, the trivial variations appearing in some claims (e.g., using a handheld device, reviewing matches by swiping and matching based on gender) did not change the focus of the asserted claims. The Court explained that for software inventions, Step 1 [...]

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First Rule of the PTAB? Play by the Rules

by Christian Tatum | Jun 22, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed two Patent Trial & Appeal Board decisions holding the challenged claims unpatentable as obvious, even though the Board declined to consider evidence of antedating and found that the claims lacked written description support. Parus Holdings, Inc. v. Google LLC, Case Nos. 22-1269; -1270 (Fed. Cir. June 12, 2023) (Lourie, Bryson, Reyna, JJ.)

Parus Holdings owns two patents related to an interactive voice system to request information from a voice web browser. Google (among others) petitioned for inter partes review (IPR) of the patents.

During the IPR proceedings, the Board found that a publication (Kovatch) was prior art to the challenged patents. In reaching that decision, the Board declined to consider Parus’s arguments and evidence of an earlier conception and reduction to practice because they were only presented via incorporation by reference in violation of 37 C.F.R. § 42.6(a)(3). The Board ruled that Parus failed to meet its burden of production on antedating.

The Board also found that the publication of the application to which Parus’s challenged patents claimed priority (Kurganov-262) was prior art because the common specification failed to provide written description support for the challenged claims. Parus appealed the Board’s decision, raising two main arguments.

First, Parus contended that the Board erred when it declined to consider Parus’s arguments and evidence on antedating. Parus argued that § 42.6(a)(3)’s prohibition on incorporation by reference did not warrant the Board’s decision because Parus, as patent owner, need not have submitted a response at all. Parus also argued that the Federal Circuit’s 2017 decision in Aqua Products mandates that the Board consider all record evidence, regardless of the manner of presentation. The Federal Circuit rejected Parus’s arguments in turn.

Regarding Parus’s violation of the incorporation by reference rule, the Federal Circuit explained that Parus had assumed an affirmative burden of production when it chose to submit a response to antedate Kovatch. Along with that burden came other responsibilities, such as complying with the US Patent & Trademark Office’s (PTO) rules and regulations, including § 42.6(a)(3). The Court further explained that this burden of production could not be met without some combination of citing evidence with specificity and explaining the significance of the cited material. Parus did neither.

The Federal Circuit also rejected Parus’s argument that the Board is required by law to review all evidence in the record. The Court clarified that, while its Aqua Products holding requires the Board to decide all issues properly before it, nothing in Aqua Products requires the Board to review evidence or issues not introduced or introduced in violation of the Board’s rules. As the Court noted, “[t]he burden of production cannot be met simply by throwing mountains of evidence at the Board without explanation or identification of the relevant portions of that evidence. One cannot reasonably expect the Board to sift through hundreds of documents, thousands of pages, to find the relevant facts.”

Parus also argued that the Board exceeded its statutory authority under 35 U.S.C. [...]

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“TRUMP TOO SMALL” Trademark Decision Heads to Supreme Court

by Sarah Bro | Jun 15, 2023 | Cert Alert, Trademarks

The Supreme Court agreed to review the US Patent & Trademark Office’s (PTO) challenge to a February 2022 ruling by the US Court of Appeals for the Federal Circuit. In the ruling at issue, the Federal Circuit held that applying Sec. 2(c) of the Lanham Act (which bars registration of a trademark that consists of or comprises a name of a particular living individual without their written consent) may unconstitutionally restrict free speech in violation of the First Amendment in certain instances. Vidal v. Elster, Docket No. 22-704 (Supr. Ct., June 5, 2023).

In 2018, Steve Elster filed an application to register the mark TRUMP TOO SMALL for use on t-shirts, in reference to a 2016 Republican presidential primary debate exchange between then-candidate Donald Trump and Senator Marco Rubio (R-FL). The PTO examining attorney and subsequently the Trademark Trial & Appeal Board refused registration of the mark on grounds that it clearly referred to former President Trump, and that Elster did not have written consent to use former President Trump’s name, in violation of Sec. 2(c) of the Lanham Act. On Elster’s appeal, the Federal Circuit ruled that the Board’s refusal to register the trademark TRUMP TOO SMALL for use on t-shirts involved content-based discrimination that was not justified by a compelling or substantial government interest.

Following PTO Director Vidal’s January 2023 petition for a writ of certiorari, the Supreme Court granted cert and will consider whether the First Amendment allows content-based but viewpoint-neutral restrictions on which trademarks may be registered—and in this case, the PTO’s restriction on marks that consist of or comprise a name identifying a particular living individual (such as former President Donald Trump) except by their written consent.

The issue on which cert was granted: Whether the refusal to register a trademark under 15 U.S.C. § 1052(c) violates the free speech clause of the First Amendment when the mark contains criticism of a government official or public figure.

Hairy Situation: Trademark Act Doesn’t Provide Consumer Standing

by Eleanor B. Atkins | Jun 1, 2023 | Trademarks

The US Patent & Trademark Office Trademark Trial & Appeal Board found that a consumer did not have standing to oppose an application for registration because the consumer failed to establish a commercial interest and injury that would be proximately caused by the registration of the mark. Rebecca Curtin v. United Trademark Holdings, Inc. (TTAB May 4, 2023) (Adlin, Lynch, Bunn, ATJs.)

Rebecca Curtin, a trademark law professor, has purchased various toys for her daughter. Curtin filed an opposition to United Trademark Holdings’ (UTH) application to register RAPUNZEL for use in connection with “dolls; toy figures.” Curtin alleged that RAPUNZEL fails to function as a trademark and is generic (or merely descriptive) of the identified goods and that UTH committed fraud. Curtin lamented that competition would be impeded if “private companies are allowed ‘to trademark the name of a famous fairytale character in the public domain,’” which would likely force consumers to pay higher prices for the relevant goods. Curtin also stated that allowing this registration “could chill the creation of new dolls and toys by fans of the Rapunzel fairytale, crowding out the substantial social benefit of having diverse interpreters of the fairytale’s legacy.”

More than four years ago, the Board denied UTH’s motion to dismiss, finding that Curtin had standing by relying on a case from 1999 that addressed the Trademark Act’s bar to registration for “immoral” or “scandalous” marks. Months after the Board’s initial decision, however, the Supreme Court ruled in Iancu v. Brunetti that the portion of the Trademark Act barring registration for “immoral” or “scandalous” marks was unconstitutional, and updates were issued on the “standard for determining whether a party is eligible to bring a statutory cause of action.”

A plaintiff has standing to oppose registration of a mark “when doing so is within the zone of interests protected by the statute and [opposer] has a reasonable belief in damage that would be proximately caused by registration of the mark.” Here, the Board explained that the statute at issue was the Trademark Act, which identifies its interest as regulating commerce and protecting plaintiffs with commercial interests: “[A] mere consumer that buys goods or services is not under the Trademark Act’s aegis.”

Moreover, Curtin failed to demonstrate that an injury would result from registration of the mark. The Board was unconvinced by Curtin’s explanations of the potential harm to competition and resulting higher prices for consumers, stating that the “allegations of damage are [] too remote, because the alleged damage to Opposer depends first on the alleged effect of registration on other commercial doll markets or sellers.” The Board, therefore, dismissed the opposition.

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

by Cecilia Choy, Ph.D. | Jun 1, 2023 | Patents

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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PTO Proposes Trademark Fee Increases

by Amol Parikh | May 25, 2023 | Trademarks

On May 8, 2023, the US Patent & Trademark Office (PTO) announced proposed trademark fee increases. The proposed fee increases are the result of lower revenue than previously forecasted and higher-than-expected inflation. Aggregate PTO operating costs are projected to exceed aggregate fee revenue beginning this fiscal year.

To encourage efficient application filing behaviors, enhance the quality of incoming applications and improve processing efficiencies, the PTO proposed a new single basic application filing fee with additional premium application surcharge fees based on the following actions an applicant can take (or avoid) when filing:

Submitting incomplete applications (other than applications denied a filing date for failure to satisfy the requirements under 37 CFR § 2.21)
Providing custom descriptions of goods and services in the free-form field instead of using the preapproved drop-down fields containing acceptable identifications of goods and services from the Trademark Next Generation ID Manual
Providing excessively long identifications of goods or services when using the free-form field.

The PTO proposes a 12% fee increase per class for applications (paper submission) and a 40% fee increase per class for a basic application (formerly TEAS Plus). Proposed fee increases for intent-to-use (ITU) filings include 100% per class for an amendment to allege use (AAU), 50% per class for an AAU (paper submission), 50% per class for a statement of use (SOU) and 25% per class for an SOU (paper submission). The fee for a fourth and subsequent request for a six-month extension per class for filing an SOU would increase 100% and 56% per class for an SOU (paper submission).

Proposed fee increases for renewals include 17% per class for § 9 registration renewals, 10% per class (paper submission) and 17% for renewals filed at the World Intellectual Property Organization (WIPO).

The proposed fee increase for a Letter of Protest (LOP) would be 400%, and a petition to the director would increase 60% and 43% (paper submission). Petitions to revive an application would increase 67%, and petitions to revive (paper submission) would increase 40%.

Proposed fee increases for declarations of use include 33% per class for § 8 declarations and § 71 declarations, and 23% for paper submission. Section 15 declarations of incontestability would increase 25% per class and 17% per class (paper submission).

A hybrid public hearing is scheduled for June 5, 2023. Those wishing to present oral testimonies at the hearing must submit a written request by May 26, 2023. Written comments on the proposed fees will be accepted until June 12, 2023. The PTO anticipates that the fee changes will be implemented around November 2024.

For further details, including a complete list of the proposed fee increases, see the latest trademark fee setting information on the PTO website.

Breaking Up Is Hard to Do: Validity Upheld Based on Expert Separation Testimony

by Alexandra Cavazos, PhD | Apr 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court decision finding that two patents covering enantiomerically pure compositions of the psoriasis drug Otezla® (apremilast) were valid and one patent covering a dosage titration schedule was invalid as obvious. Amgen Inc. v. Sandoz Inc. Case No. 22-1147 (Fed. Cir. Apr. 19, 2023) (Lourie, Cunningham, Stark, JJ.)

Amgen markets apremilast, a phosphodiesterase-4 inhibitor that is used for treating psoriasis and related conditions, under the brand name Otezla®. Amgen has three patents covering Otezla®. Two of the patents are directed to orally administered pharmaceutical compositions of enantiomerically pure apremilast (composition patents), and one of the patents covers a dosage titration schedule for enantiomerically pure apremilast that ranges from a starting dose of 10 mg to a dose of 60 mg by the sixth day (dosage patent). Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of apremilast. Amgen filed suit against Sandoz for infringement of its three patents covering Otezla®.

Sandoz asserted that the composition patents were invalid based on prior art that had an example (Example 12) that described a 50%:50% racemic mixture of apremilast but did not disclose the purified apremilast (+) enantiomer recited in the claims. The prior art did state that apremilast could be isolated from this racemic mixture using chiral chromatography, a well-known technique. The district court rejected Sandoz’s argument, finding that there was insufficient evidence to conclude that a skilled artisan would have had reason to believe that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer (i.e., the (+) enantiomer). The district court also concluded that Sandoz had not demonstrated that a skilled artisan would have had a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components. Furthermore, the district court looked to objective indicia of non-obviousness, finding that apremilast unexpectedly provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability, and a nexus existed between the unexpected potency and the asserted claims.

Sandoz also argued that the dosage patent was invalid based on prior art that taught various dosage schedules and amounts for apremilast. The district court found that it would have been within the ability of a skilled artisan to titrate apremilast for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis with a drug (such as apremilast) that was known in the art to require dose titration to ameliorate side effects. The district court therefore found that the dosage patent was invalid. Sandoz appealed with respect to the composition patents, and Amgen appealed with respect to the dosage patent.

The Federal Circuit affirmed the district court’s decision with respect to the composition patents, finding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify apremilast’s (+) enantiomer from the racemic mixture disclosed in Example [...]

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If Prior Art Discloses Ingredients and How to Mix Them, the “Cake” Is Anticipated

by Kyle Sorenson, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed that challenged claims were invalid as anticipated based on principles of inherency where the disclosed prior art formulations and processes necessarily met a disputed claim limitation. Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 20-1183 (Fed. Cir. April 11, 2023) (Reyna, Schall, Chen, JJ.)

Arbutus Biopharma owns a patent that matured from an application filed on March 9, 2015, that claims priority to a provisional application filed on June 30, 2010. The claimed invention provides stable nucleic acid-lipid particle (SNALP) formulations with a non-lamellar structure that function to increase the efficiency of nucleic acid entry into cells to promote the downregulation of gene expression. The non-lamellar morphology of a SNALP formulation was known to depend on two factors: the lipids incorporated into the SNALP formulation, and the process used to form the SNALPs. The patent disclosed five SNALP formulations of various compositions that can be used and incorporated by reference two US patent publications, which describe two methods that can be used to make SNALP formulations: the Direct Dilution Method (DDM) and the Stepwise Dilution Method (SDM). The representative independent claim recites a composition of SNALPs, wherein each particle in the plurality of SNALP particles comprises a nucleic acid and various lipid types. The claim also requires that at least 95% of the particles in the plurality of particles have a non-lamellar morphology (the Morphology Limitation).

Moderna filed a petition for inter partes review (IPR) asserting that all the claims of the Arbutus patent were anticipated by a prior art patent. The Patent Trial & Appeal Board found that although the Morphology Limitation was not expressly found in the prior art, the claims were anticipated. The Board determined that the Morphology Limitation was an inherent property (or natural result) of the prior art disclosures. On appeal, Arbutus challenged the Board’s inherent and express anticipation findings for many of the challenged claims, including for the Morphology Limitation.

A limitation is inherent if it is the natural result flowing from the prior art’s explicit disclosure. In other words, a limitation is inherent when the limitation is a property necessarily present in the invention and not actually an additional requirement imposed by the claims. In the IPR proceeding, Moderna argued that the Morphology Limitation was inherent because one skilled in the art would necessarily obtain formulations meeting this limitation by making formulations using the five formulations disclosed by the patent and using the DDM method (from the incorporated-by-reference disclosures) to prepare the formulations.

Both the challenged patent and the prior art disclosed five formulations that can be used to obtain the SNALP formulations. Evidence showed that any differences between the formulations disclosed in these patents would not impact the Morphology Limitation. The Federal Circuit found that substantial evidence supported a finding that the formulations disclosed in both the challenged patent and the prior art were the same or essentially the same.

The Federal Circuit further explained that both the challenged patent and the [...]

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