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Written Description

Outlier? Split Federal Circuit Denies En Banc Review of Written Description Requirement

by Jenny Chen, Ph.D. | Mar 31, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s request for en banc rehearing of a panel decision that invalidated a patent for lack of written description on the basis that a person of skill in the art would not be able to recognize the clinical efficacy of the claimed dose and thus would not recognize that the inventors were in possession of the claimed invention at filing. Biogen International GMBH, Biogen MA, Inc. v. Mylan Pharmaceuticals Inc., Case No. 20-1933 (Fed. Cir. March 16, 2022) (per curiam) (Moore, C.J., Lourie, Newman, JJ., dissenting).

Biogen owns a patent relating to the drug Tecfidera®. The patent claims a method of treating multiple sclerosis with dimethyl fumarate (DMF) at a specific dose of 480 mg per day via oral administration (DMF480). In the written description, the patent describes a method for treating a neurological disease using DMF and states that the neurological disease can be multiple sclerosis. The patent discloses that an effective dose of DMF for oral administration can be “from about 0.1 g to 1 g per day, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day, or from about 480 mg to about 720 mg per day; or about 720 mg per day).”

Biogen sued Mylan for infringement after Mylan submitted an abbreviated new drug application (ANDA) for a generic version of Tecfidera®. Mylan challenged the validity of the patent based on lack of written description. The district court invalidated the patent, finding that the claimed method lacked written description support because the DMF480 dose was listed only once in the specification and finding that the specification’s focus on basic research and broad DMF-dosage ranges showed that the inventors did not possess a therapeutically effective DMF480 dose at the time of filing. Biogen appealed.

In a 2–1 panel decision, the Federal Circuit affirmed the district court finding, explaining that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF-dosage range and not listed as an independent therapeutically efficacious dose.”

Judge O’Malley issued a dissenting opinion, questioning whether the district court erred in requesting clinical data showing efficacy of the claimed DMF480 dose under the written description context.

Biogen timely petitioned for en banc review, raising two questions:

Must a “written description” prove the invention’s efficacy?
Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?

The Federal Circuit issued a 6–3 decision denying the en banc petition. Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman, calling this case “an outlier” at “the farthest end of the spectrum of cases where written description has not been found” given that every claim limitation was expressly described [...]

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Patent Venue Statute Doesn’t Apply to Third-Party Counterclaim Defendant; Acts in Furtherance of Partnership May Be Imputed to Partner for Venue Purposes

by Paul Devinsky | Mar 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s determination of proper venue, finding that the patent venue statute, 28 U.S.C. § 1400(b), does not apply to a third-party counterclaim defendant and that acts done by separate entities in furtherance of a partnership can be imputed to a partner for purposes of venue determination. The Federal Circuit also affirmed and reversed jury verdicts of adequate written description and patent co-ownership. BASF Plant Sci., LP v. Commonwealth Sci. and Indus. Rsch. Org., Case Nos. 20-1415; -1416; -1919; -1920 (Fed. Cir. Mar. 15, 2022) (Newman, Taranto, Chen, JJ.) (Newman, J., dissenting).

Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research arm of the Australian government, owns six patents directed to the engineering of plants, particularly canola, to produce specified oils not native to the plants. BASF Plant Science is a plant biotechnology company. CSIRO and BASF each explored genetic modification of familiar oilseed crop plants, such as canola, to get them to produce omega-3 long-chain polyunsaturated fatty acids (LCPUFAs), commonly known as “fish oil,” that could be fed to farm-raised fish and are beneficial to human health. In 2007, CSIRO and BASF discussed a focused collaboration and in 2008 entered into a two-year Materials Transfer and Evaluation Agreement (MTEA) to advance that goal. In 2010, following the conclusion of the MTEA, CSIRO partnered with another Australian government entity, Grains Research and Development Corporation, and private company, Nuseed, to commercialize its products. CSIRO granted Nuseed an exclusive license to CSIRO’s LCPUFA technology and patents. In 2011, BASF entered into a commercialization agreement with Cargill. BASF developed a canola seed line that it used to apply for regulatory approvals, which Cargill used in cross-breeding work. As part of the joint project, BASF deposited seeds with the American Type Culture Collection (ATCC) to support BASF’s patent applications.

During this period, BASF and CSIRO entered negotiations for BASF to take a license to CSIRO’s LCPUFA technology, but the negotiations broke down. In 2016, Nuseed sent Cargill a letter identifying multiple CSIRO patents and inviting Cargill to discuss CSIRO’s omega-3 patent portfolio. In April 2017, BASF sued Nuseed in the District of Delaware, seeking a declaratory judgment that BASF did not infringe certain CSIRO patents listed in the 2016 letter. The District of Delaware dismissed the case for lack of jurisdiction.

In 2017, BASF filed a declaratory judgment action in the Eastern District of Virginia against CSIRO, Nuseed and Grains Research (collectively, CSIRO). CSIRO filed an answer and counterclaims asserting infringement of the asserted patents against BASF and Cargill. BASF entered the case as a party and asserted co-ownership of the asserted patents under the MTEA. Cargill moved to dismiss the counterclaims for lack of personal jurisdiction and improper venue. The district court denied the motion, determining that it had personal jurisdiction over Cargill and that venue was proper. Cargill did not dispute that it had a regular and established place of business in the Eastern District of Virginia but argued that it [...]

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Federal Circuit Won’t Rescue Parachute Patent

by Sarah J. Fischer | Mar 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)

Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.

Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.

Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]

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Count On It, Plural Term Means More Than One

by Yoshiko Ito | Mar 17, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed Patent Trial & Appeal Board (Board) patentability decisions after determining that the Board did not err in construing multiple terms within the challenged patents. Apple Inc. v. MPH Technologies Oy, Case Nos. 21-1532; -1533; -1534 (Fed. Cir. Mar. 9, 2022) (Moore, C.J.; Prost, Taranto, JJ.)

MPH owns three patents related to a method for forwarding a message from a first computer to a second computer via an intermediate computer via a network and provides secure message forwarding without relying on any extra encapsulation overhead. Apple petitioned for inter partes review (IPR) of MPH’s patents, challenging the claims in the three patents as obvious over a combination of non-patent literature (RFC3104) and a US patent (Grabelsky). During the proceedings, a series of claim construction disputes were raised. The Board issued final written decisions, finding that Apple failed to show that some claims would have been obvious over the combination of RFC3104 and Grabelsky. Apple appealed.

In seeking to overturn the Board’s decision, Apple raised four claim construction disputes. First, Apple argued that the Board erred in finding that the claim limitation “information fields” requires “two or more fields.” Apple argued that “a plural term covers one or more items” and thus the claim limitation was taught by Grabelsky, which uses a single field. Apple further argued that a word such as “plurality” must be used to clarify that the limitation requires more than one item. The Federal Circuit rejected Apple’s argument, explaining that common English usage presumes that a plural term refers to two or more items. The Court found that the Board did not err in construing the claim limitation because the term “information fields” is plural, thus requiring more than one field, and nothing in the claim language or written description suggested otherwise.

Second, Apple argued that the Board’s interpretation that the message was sent from the mobile computer directly to the first address was inconsistent with the claim limitation “intermediate computer configured to receive from a mobile computer a secure message sent to the first network address” in one of MPH’s patents. Apple argued that the passive language of the claim limitation suggested that “the mobile computer need not send the message to the first network address so long as the message is sent there eventually,” and thus the claim limitation was taught by RFC3104, in which a message sent to a first network address is received at another address before being forwarded to the first network address. The Federal Circuit rejected Apple’s arguments, finding that the Board did not err in construing the claim limitation because the plain language established direct sending of the message from the mobile computer to the first address, and nothing in the remainder of the claims or written description suggested otherwise.

Third, Apple argued that the Board erred in construing the term “substitute” in the claim limitation “substitute the unique identity read from the secure message with another unique identity prior to [...]

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Silence May Be Sufficient Written Description Disclosure for Negative Limitation

by Mandy H. Kim | Jan 13, 2022 | Patents

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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Rounding Error: Intrinsic Evidence Informs Plain and Ordinary Meaning

by Joshua Revilla | Dec 16, 2021 | Patents

Vacating a stipulated infringement judgment based on an incorrect claim construction, the US Court of Appeals for the Federal Circuit explained that it is improper to isolate claim language from the intrinsic evidence when determining the plain and ordinary meaning of a disputed term. AstraZeneca AB v. Mylan Pharms. Inc., Case No. 21-1729 (Fed. Cir. Dec. 8, 2021) (Stoll, J.) (Taranto, J., dissenting).

AstraZeneca sued Mylan Pharmaceuticals for infringement of three patents listed in the US Food and Drug Administration’s (FDA) orange book covering the Symbicort® pressurized metered-dose inhaler for the treatment of asthma and COPD. 3M submitted an abbreviated new drug application (ANDA) to the FDA to manufacture and sell a generic version of the Symbicort® inhaler and certain interests to the ANDA were later transferred to Mylan. After receiving a Paragraph IV letter from Mylan, AstraZeneca filed an infringement suit.

Shortly before trial, the district court held a claim construction hearing to determine the meaning of “0.001%,” the claimed concentration of PVP (one of the active ingredients). The district court construed the term based on its “plain and ordinary meaning, that is, expressed with one significant digit.” Based on this definition, Mylan stipulated to infringement and the district court entered judgment. The district court held a bench trial on invalidity, ultimately determining that Mylan did not prove that the claims were invalid as obvious. Mylan appealed the stipulated judgment stemming from the claim construction determination and the judgment of no invalidity.

First, Mylan challenged the district court’s claim construction of “0.001%.” AstraZeneca argued that the district court improperly construed the term to encompass a range from 0.0005% to 0.0014%. Mylan contended that, in view of the specification and the prosecution history, the term was to be defined precisely at 0.001% with only “minor variations” allowed. The Federal Circuit agreed, finding that Mylan’s proposed construction was more properly aligned with the patent’s description as further informed by the prosecution history.

The Federal Circuit stated that the proper construction of 0.001% only allowed minor variations from 0.00095% to 0.00104%. There was no dispute that the term 0.001% would ordinarily encompass the range of 0.0005% to 0.0014%. AstraZeneca argued that this “ordinary meaning” would control absent lexicography or disclaimer. The Court disagreed, finding that it would improperly isolate the term from the claim language, specification and patent prosecution history. The Court explained that the “ordinary meaning” is not the ordinary meaning in the abstract but is instead the “meaning to the ordinary artisan after reading the entire patent,” and therefore the claims must be read in view of both the written description and the prosecution history. The Court’s rationale for narrower construction was based on the intrinsic record reflecting that the written description and prosecution history showed that very minor differences in PVP concentration would impact stability.

The Federal Circuit found that the written description explained that stability was one of the most important factors and that even very minor differences in PVP concentration could impact stability. The written description also [...]

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IPR on Written Description? Claims Found Unpatentable Based on Lack of Entitlement to Priority Date

by Art Dykhuis | Dec 9, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) ruling, based on a written description analysis, that certain claims were invalid as anticipated by an earlier priority application from the same family. Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., Case Nos. 20-2073, -2142 (Fed. Cir. Nov. 24, 2021) (Lourie, J.) (Linn, J., concurring in part and dissenting in part).

Indivior’s patent, which issued from a fifth continuation application claiming priority back to 2009, claimed orally dissolvable films with therapeutic agents. Some of the claims recited numeric ranges, such as “about 40% wt to about 60% wt of a water-soluble polymeric matrix.” Instead of a range, one claim recited a specific amount of “about 48.2% wt” of the polymeric matrix. The patent’s specification did not expressly mention the claimed ranges or the specific 48.2% amount, but it did contain tables comprising quantities of polymer from which Indivior contended a person of ordinary skill in the art could calculate the percentage of polymer by weight.

Indivior argued that the polymer weight percentage limitations were supported by the priority application and, therefore, the patent was entitled to that priority date. Dr. Reddy’s contended that since the polymer weight percentage limitations were added later, an intervening patent publication (Myers) was prior art and anticipated the claims. Indivior did not contest that if Myers was prior art, it anticipated the claims. As a result, the Board’s decision on anticipation under 35 U.S.C. §102 turned on the priority analysis which, in turn, hinged on written description. The Board found that the tables disclosed formulations from which the “48.2% wt” could be calculated and, thus, claims reciting that limitation were not anticipated by Myers. However, the Board found that the claimed ranges (i.e., about 40% wt to about 60% wt) were not disclosed in the specification, and those claims were therefore anticipated by Meyers. Indivior appealed the Board’s anticipation finding, and Dr. Reddy’s appealed the no anticipation finding.

The Federal Circuit first analyzed the specification and concluded that there was no written description support for the broader range of “about 40% wt to about 60% wt.” The Court explained that the range was not disclosed in the specification, the specific values of 40% and 60% were not disclosed and there was another “inconsistent” teaching for weights of “at least 25%.” The Court noted that two specific tables in the specification “do not constitute ranges; they are only specific, particular examples. For written description support of a claimed range, more clarity is required.” The Court explained that “[h]ere, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [] application to create an otherwise unstated range. That is not a written description of the claimed range.” The Court applied similar analysis in finding lack of written description for other claims reciting a slightly different range. Ultimately, the Court agreed that there was no written [...]

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Another Genus Claim Bites the Dust for Lack of Written Description

by Mandy H. Kim | Sep 9, 2021 | Patents

Addressing the issue of written description in the context of antibody-related genus claims, the US Court of Appeals for the Federal Circuit reversed a $1.2 billion jury verdict and found genus claims using functional language invalid for lack of written description. Juno Therapeutics, Inc. v. Kite Pharma, Inc., Case No. 20-1758 (Fed. Cir. Aug. 26, 2021) (Moore, J.)

Kite’s YESCARTA® is a therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19. Juno sued Kite, alleging infringement of a patent relating to a nucleic acid polymer encoding a three-part CAR for a T cell. The three-part CAR comprises:

An intracellular domain of the CD3 ζ (zeta) chain, a signaling domain that is activated to create an initial immune response
A costimulatory region comprising of a specific amino acid sequence (here, a specific CD28 sequence) that, when activated, directs the T cells to multiply
A binding element that determines what target molecule or antigen the CAR can bind to, such as a single-chain antibody variable fragment (scFV).

Juno’s patent disclosed two scFVs (one that binds CD19 and another that binds PSMA) but did not disclose the amino acid sequence of either scFV.

After a two-week trial, the jury reached a verdict in Juno’s favor, finding in relevant part that Kite failed to prove that any of the asserted claims were invalid for lack of written description or enablement. The jury awarded damages amounting to a $585 million upfront payment and an almost 28% running royalty. The district court denied Kite’s motions for judgment as a matter of law and enhanced the total award to approximately $1.2 billion in addition to the 28% running royalty. Kite appealed.

The Federal Circuit reversed, concluding that no reasonable jury could find adequate written description because the patent disclosed neither representative species nor common structural features of the claimed scFV genus to identify which of the millions of billions of scFVs would function as claimed. Turning first to lack of representative species, the Court explained that the broadest asserted claims cover any scFV that binds to any target of clinical interest but fails to provide a representative sample of species within, or defining characteristics for, that expansive genus. The Court also disagreed that the two working embodiments in the patent were representative of the entire genus of vast number of possible scFVs that bind to an undetermined number of targets without more in the disclosure (such as the characteristics of the exemplary scFVs that allow them to bind to particular targets or nucleotide sequences). The Court stated that even if such scFVs were known as Juno argued, the specification provided no means of distinguishing which scFVs would bind to which targets.

Turning next to lack of structural features common to the claimed genus, the Federal Circuit held that general assertions that scFVs generally have a common structure in the context of the technology in this case were insufficient because an scFV with the [...]

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“Gradual” and “Continuous” Includes Step-Wise

by Jackie Toney | Nov 19, 2020 | Patents

The US Court of Appeals for the Federal Circuit affirmed a priority decision in favor of the senior party, upholding a claim construction that was based upon a verbatim definition set forth in the patent specification of the application from which the count in interference was copied. Chevron U.S.A. Inc. v. University of Wyoming Research Corp., Case No. 19-1530 (Fed. Cir. Nov. 4, 2020) (Schall, J.) (Newman, J., dissenting).

Wyoming Research provoked a patent interference proceeding by copying into its pending application a claim from Chevron’s pending patent application. Under the now-discontinued interference statute, the patent for an invention claimed by more than one party was awarded to the first-to-invent party. If the Patent Trial and Appeal Board (Board)determined there was an interference in fact—that is, two patent applications claimed the same subject matter—then the Board could proceed to determine priority of inventorship. A finding of interference in fact required the copying party’s patent specification to contain adequate written description and enablement to support the copied claim.

The copied claim was directed to a method of fractioning asphaltenes from crude oil. The technology used a mobile phase into which an alkane solvent was introduced and its concentration “gradually and continuously” changed over time, and the resulting eluted fractions were analyzed. The disputed claim limitation was: “gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent.”

Chevron argued that “gradually and continuously changing” referred to the act of feeding alkane mobile phase solvent into the inlet of the column. Relying on intrinsic evidence, the Board instead adopted Wyoming’s construction, concluding that the limitation’s “gradually and continuously changing” referred to the change of solvents in the column and not to changes at the inlet to the column. The distinction was important because at the inlet, the Wyoming invention introduced solvent in a step-wise manner. The parties agreed that Wyoming’s specification supported only the construction adopted by Board, and Wyoming was declared to be the senior party for the priority contest.

Because Chevron had filed a priority statement that indicated that its earliest corroborated conception coupled with diligence date was later than Wyoming’s priority date, the Board determined that Chevron was unable to prevail on priority and entered judgment in favor of Wyoming. Chevron appealed.

On appeal, Chevron argued that the Board’s construction was inconsistent with Chevron’s patent specification. Chevron contended that its application disclosed that the solvent was “gradually and continuously” changed at the column’s inlet and that the Board’s construction rendered the limitation meaningless because it encompassed even “sudden, abrupt immediate solvent switches.”

The Court affirmed the Board’s construction, holding that the broadest reasonable construction of “gradually and continuously changing” did not require a change of solvents at the column inlet. The Court reasoned that the Board’s construction was consistent, and indeed tracked verbatim, with the Chevron application’s express definition of “gradually.” While the Court acknowledged that certain examples in the Chevron application illustrated that one way to implement a “gradual and continuous change” of the [...]

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Federal Circuit Extends Arthrex to Ex Parte Re-Examination Proceedings

by Jodi Benassi | Jul 15, 2020 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a decision issued by the Patent Trial and Appeal Board (PTAB), holding that its decisions in Arthrex and VirnetX also apply to ex parte examinations at the PTAB. In re: Boloro Global Ltd., Case Nos. 19-2349, -2351, -2353 (Fed. Cir. July 7, 2020) (Dyk, J.).

The issue regarding ex parte appeals started to take shape in October 2019—in the context of an inter partes review (IPR) proceeding—when the Federal Circuit held that the appointment of administrative patent judges (APJs) at the PTAB is unconstitutional. Arthrex v. Smith & Nephew (IP Update, Vol. 22, No. 11). APJs are appointed by the secretary of commerce in consultation with the director of the US Patent and Trademark Office (PTO) pursuant to 35 USC § 6(a). In Arthrex, The Federal Circuit determined that APJs are principal officers and are not constitutionally appointed, because as principal officers they must be appointed by the president with the advice and consent of the Senate.

Having concluded that the appointment of APJs violated the Appointments Clause, the Federal Circuit held that “where the final decision was rendered by a panel of APJs who were not constitutionally appointed,” and “where the parties presented an Appointments Clause challenge on appeal,” the decision below “must be vacated and remanded.” The Court further instructed that, on remand, a new panel of APJs must be designated and a new hearing granted. The Court put a bookend on its holding, ruling that where an Appointment Clause challenge was not raised in an opening brief, the challenge was waived. So PTAB decisions that issued before Arthrex, if timely appealed and subject to an Appointment Clause challenge in the opening brief, could be vacated as unconstitutional and remanded for a new panel of APJs.

In May 2020, the Federal Circuit extended its decision in Arthrex to final decisions issued by APJs in inter partes re-examination proceedings (VirnetX v. Cisco Systems). In VirnetX, the Court discerned no differences between the duties of an APJ in an IPR proceeding as compared to an inter partes examination proceeding, because both proceedings involve third-party challenges to an issued patent and in both proceedings APJs exercise significant authority by issuing final decisions that decide the patentability of the challenged claims, and the PTO director does not have an independent way of reviewing those final determinations.

The present case arose in the context of an appeal from an examiner in ex parte prosecution. Boloro argued that APJs in ex parte appeals also exercise significant authority by virtue of the matters on which they are asked to render judgment, and carry out similar functions when they carry out their function of deciding IPRs. Boloro asserted that although ex parte appeals were not specifically addressed in Arthrex, the PTAB also has the power in ex parte appeals to disqualify counsel, to admit people pro hac vice, and to order appellants to additionally brief any matter that the PTAB considers to [...]

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