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Clearly, the Disclosure Was an Error

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) finding that claimed subject matter was not disclosed in asserted prior art where the prior art reference contained an “obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art,” even though the error went unrecognized and uncorrected for 20 years until an expert conducted an extensive analysis. LG Electronics Inc. v. ImmerVision, Inc., Case Nos. 21-2037; -2038 (Fed. Cir. Jul. 11, 2022) (Stoll, Newman, Cunningham, JJ.) (Newman, J., dissenting)

The issue before the Federal Circuit was whether an error in the prior art that remained uncorrected in the public domain for 20 years and took an expert many hours of analysis to uncover, was an obvious error that would meet the standard set in the 1970 Court of Customs and Patent Appeals (CCPA) case In re Yale. Since the CCPA is a predecessor court to the Federal Circuit, its decisions are mandatory authority. Under the Yale standard, “where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter. . . . The remainder of the reference would remain pertinent prior art disclosure.”

The patent at issue pertains to capturing and displaying panoramic images using an objective lens. The claims require a certain image point distribution function and that the objective lens “compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.”

LG’s expert reconstructed a lens depicted in an embodiment of the asserted prior art using information found in Table 5 of the reference. Based on this reconstruction, LG argued that certain limitations of the claims at issue were found in a prior art patent to Tada, and thus the claims at issue were obvious.

ImmerVision had its own expert attempt to create the same lens model based on the same information. However, ImmerVision’s expert noticed something was wrong, as the resulting output image from the lens was distorted. Upon further investigation, ImmerVision’s expert discovered that the disclosure in Tada Table 5, on which LG’s expert relied, was intended to correspond to a different embodiment. The inconsistency was caused by a transcription error from the Japanese priority application in terms of the embodiment associated with Table 5. It was undisputed that when the correct values were used, the subject matter was not disclosed.

The question on appeal was whether the Board correctly held that the error in Tada would have been apparent to a person of ordinary skill in the art such that the person would have disregarded the disclosure or corrected the error to meet the Yale standard. [...]

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Threat of ITC Exclusion Order Is Too Speculative to Constitute Irreparable Harm

The US Court of Appeals for the Federal Circuit affirmed a decision by a federal district court denying a defendant’s motion for a preliminary injunction seeking to enjoin a parallel International Trade Commission (ITC) investigation against it. The Federal Circuit agreed that the defendant’s alleged irreparable harm (a “cloud” over its business) was too conclusory and speculative to support relief. Koninklijke Philips N.V. v. Thales Dis Ais USA LLC, Case No. 21-2106 (Fed. Cir. July 13, 2022) (Moore, C.J., Dyk, Chen, JJ)

Koninklijke filed a complaint at the ITC requesting a Section 337 investigation based on alleged infringement by Thales of four patents designated essential to the 3G and 4G telecommunications standards. Koninklijke simultaneously filed a parallel district court action against Thales in the Delaware district court based on those four patents. At the district court, Thales moved for a preliminary injunction seeking to enjoin Koninklijke from pursuing an exclusion order at the ITC because of an alleged breach of contract. The district court denied that motion, and Thales appealed to the Federal Circuit.

Meanwhile, the ITC investigation continued, and the administrative law judge (ALJ) issued an initial determination finding no violation of Section 337 with respect to any of the four patents. Subsequently, the Federal Circuit held oral arguments on the district court appeal, during which the judges questioned whether there could be irreparable harm if the ITC were to adopt the ALJ’s determination and consequently not issue an exclusion order. Thales argued that the threat of an exclusion order had left a “cloud” over its business and cited customer concerns that Thales might not be able to deliver products in the future. The ITC subsequently affirmed the ALJ’s finding of no violation and terminated the investigation without issuing any exclusion order.

A week later, the Federal Circuit issued a decision affirming the district court’s denial of the preliminary injunction motion. The Court held that Thales had failed to meet its burden to establish irreparable harm because it had not presented any evidence that it had actually lost any customers, that any customers had delayed purchases or that it had struggled to gain new customers because of the threat from the ITC investigation. The Court also found that the cloud over Thales’ business and the potential loss of business were too speculative to justify a preliminary injunction.

Practice Note: While the ITC investigation was ongoing, Thales filed a civil action in France against Koninklijke—a fellow European company—alleging that Koninklijke’s attempt to obtain injunctive relief in the United States for standard essential patents constituted an anti-competitive act that violated French civil law. Thales sought EUR 13.5 million in damages for the legal fees that it had incurred in defending the ITC investigation.




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PTO Lowers the Bar for Genericness Refusals

The US Patent & Trademark Office (PTO) recently issued Examination Guide 1-22, Clarification of Examination Evidentiary Standard for Marks Refused as Generic (Guide 1-22), which amends the PTO’s stance on the appropriate evidentiary burden for examining attorneys refusing registration based on genericness. Previously, the Trademark Manual of Examining Procedure (TMEP) required an examining attorney to meet the demanding “clear evidence” standard to establish the prima facie case necessary for a genericness refusal. Guide 1-22, however, sets forth a lesser burden, stating that examining attorneys need only sufficient evidence to support a “reasonable predicate” for finding a mark generic. The shift marks a clear departure from longstanding TMEP practice.

The PTO credits the US Court of Appeals for the Federal Circuit as the initial source of the “clear evidence” standard. In its 1987 case In re Merrill Lynch, Pierce, Fenner, and Smith, Inc., the Federal Circuit relied on language in the TMEP stating that “the showing [for a genericness refusal] must be based on clear evidence of generic use.” Following this decision, the TMEP was revised to include the “clear evidence” standard, and the Federal Circuit later found that “clear evidence” is equivalent to “clear and convincing evidence.”

Despite years of reliance on the “clear evidence” standard, Guide 1-22 asserts that “there is no statutory basis for applying a heightened standard.” The guide states that the Federal Circuit initially misinterpreted the TMEP: “Read in context, the term ‘clear’ was meant to convey the ordinary meaning of the term, not an evidentiary burden.” Further, the Federal Circuit’s interpretation of “clear evidence” as equivalent to “clear and convincing evidence” “was not intended by the TMEP and is inconsistent with the preponderance of the evidence burden the Federal Circuit requires to prove claims that a registered mark is generic in the inter partes cancellation context.”

Following issuance of Guide 1-22, the PTO revised the TMEP to reflect the “reasonable predicate” evidentiary standard for genericness refusals. (See TMEP § 1209.01(c)(i).)

Practice Note: Agency guidelines do not have the force of law, so it will be interesting to see how the Federal Circuit treats these updated guidelines.




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Expert Testimony Excluded Based on Inadmissible Evidence

Circuit Judge Bryson, sitting by designation in the US District Court for the District of Delaware, excluded a plaintiff’s damages expert opinion because the evidence relied upon by the expert was unreliable and therefore inadmissible, but permitted the plaintiff to serve short addendum opinions. IOENGINE, LLC v. PayPal Holdings, Inc., C.A. No. 18-452-WCB (D. Del. June 23, 2022) (Bryson, J.)

IOENGINE asserted two patents against PayPal and Ingenico in Delaware. Less than a month before the first trial, the district court struck essentially all of IOENGINE’s damages report, including testimony regarding a non-party license, two previous jury verdicts on a related patent involving different defendants and different products, and two settlements related to those jury verdicts. The order left IOENGINE with essentially no damages case to present at trial.

Two days after the order issued, IOENGINE requested a conference to discuss the damages issues and the parties engaged in letter briefing. IOENGINE asked the district court to reconsider its decision, arguing that the expert’s testimony was admissible under FRE 703, even if the underlying licenses, verdicts and settlement agreements were not admissible. Alternatively, IOENGINE requested the ability to serve short addendums to its technical and damages reports, or a bifurcation or adjournment of the trial date. PayPal and Ingenico argued that FRE 703 did not make the damages expert’s testimony admissible, and that any addendum or change in trial date would be highly prejudicial.

Judge Bryson ruled that FRE 703 did not permit IOENGINE’s damages expert to testify about otherwise inadmissible evidence. First, the district court looked to the Advisory Committee Notes for FRE 703. The notes explained that FRE 703 applied to situations such as a medical expert relying on hearsay statements by patients and their families and opinions by other medical professionals, because a medical expert would rely on that sort of information in diagnosing and treating a patient. Next, the court turned to a leading Third Circuit case holding that the reliability requirements of FRE 702 are equivalent to the requirements in FRE 703. The Third Circuit further held that the evidence on which an expert relies must meet a threshold requirement of reliability. Finally, the court cited another district court order that applied this standard. The order stated that the court was not judging the credibility of the expert witness, but rather whether the opinion was based on reliable data.

In balancing the parties’ various interests, Judge Bryson allowed IOENGINE to file addendums, but because these issues were of IOENGINE’s own creation, he attempted to find the solution that was most fair to PayPal and Ingenico. The court bifurcated the first trial, allowing the liability portion to go forward but holding the damages trial in abeyance. If IOENGINE prevailed on infringement and validity, a damages trial would be set. The second trial was adjourned until the first trial was resolved. The court gave IOENGINE one week to submit its short addendums (one to two pages for the technical expert and no more than 10 for the [...]

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Split Federal Circuit Reverses Contempt Order, Sanctions Award in Protective Order Dispute

A split panel of the US Court of Appeals for the Federal Circuit reversed a district court’s contempt order and sanctions award, finding that there was a fair ground of doubt regarding whether the defendant’s counsel’s disclosure to a third party under a joint defense agreement constituted a violation of a protective order (PO). Static Media LLC v. Leader Accessories LLC, Case No. 21-2303 (Fed. Cir. June 28, 2022) (Dyk, Taranto, JJ.) (Reyna, J., dissenting).

Static Media sued Leader Accessories for infringement of a design patent relating to a stadium seat. The parties entered into a PO that restricted the disclosure of discovery documents designated as confidential. The PO restricted disclosure of confidential-designated documents to a limited group of people, including “outside independent persons” retained to provide consulting, technical or expert services or to give testimony (i.e., an independent consultant). The PO also required that an independent consultant execute a “written assurance.” The written assurance required that the independent consultant read and agree to be bound by the terms of the PO and prohibited the consultant from copying or using any confidential information except under the terms of the PO.

After the parties agreed to the PO, Static sent a cease-and-desist letter to another company, OJ Commerce, for infringement of the same patent. Counsel for OJ Commerce contacted Leader’s lawyer, and the parties entered into a joint defense group governed by a joint defense agreement. Static subsequently sued OJ Commerce in a different district, after which counsel for Leader shared a copy of the PO and written assurance, which counsel for OJ Commerce signed and returned. Counsel for Leader then shared with OJ Commerce two deposition transcripts containing “a few pages” of confidential-designated information relating to Static’s licensing and royalty agreements.

During settlement negotiations, counsel for OJ Commerce revealed to Static’s counsel (who was not involved in the Leader case and was not a signatory to the PO) that he was “fully aware” of the actual royalties Static had received in the past. Static moved for discovery sanctions and an order holding Leader in contempt for violation of the PO. The magistrate judge ordered Leader to pay Static’s attorneys’ fees and a $1,000 sanction. After the district court judge affirmed, Leader appealed.

Reviewing under an abuse of discretion standard, the Federal Circuit evaluated the legal theories used by the magistrate judge and the district court. The district court concluded that Leader’s counsel should be held in contempt because he was responsible for OJ Commerce’s counsel’s improper use of the confidential information. Separately, the magistrate judge based its finding on the fact that Leader’s counsel “knew or should have known” that OJ Commerce’s counsel would use the information to bolster its defense in its own case. The Federal Circuit disagreed with both of these views, finding that Static failed to prove by clear and convincing evidence that Leader violated the PO. The Court concluded that Leader’s counsel “did exactly what was required to ensure [OJ Commerce’s counsel] would abide by the [...]

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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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Fifth Circuit Takes U-Turn, But Still Concludes Automotive Supplier Can’t Force SEP Holder to Issue License

In response to a petition for panel rehearing, the US Court of Appeals for the Fifth Circuit withdrew its prior decision finding that an automotive parts supplier did not have constitutional standing to pursue an antitrust lawsuit against owners of standard essential patents (SEPs). The Court issued a new opinion summarily affirming the district court’s original decision finding constitutional standing but dismissed the case based on lack of antitrust standing. Continental Automotive Systems, Inc. v. Avanci, LLC et al., Case No. 20-11032 (5th Cir. June 21, 2022) (Stewart, Ho, Engelhardt, JJ.) (per curiam).

Continental sued several SEP holders and their licensing agent, Avanci, for violation of Sections 1 and 2 of the Sherman Antitrust Act based on Avanci’s refusal to license the SEPs on fair, reasonable and nondiscriminatory (FRAND) terms. Avanci moved to dismiss, arguing that Continental lacked both constitutional standing and antitrust standing. The district court found that Continental had constitutional standing because its lack of success obtaining licenses on FRAND terms was an injury. However, the district court found that Continental lacked antitrust standing and therefore dismissed the lawsuit. Continental appealed.

The Fifth Circuit issued its original opinion in March 2022, finding that Continental’s theory of injury was insufficient to confer constitutional standing. The Court explained that Avanci’s refusal to sell licenses did not result in a cognizable injury to Continental, and that Continental had no rights to enforce FRAND contracts between the individual patent holders and the standard setting organization (SSO) since Continental was not part of the SSO to which the SEP holders belonged. The Court also found that even if Continental was contractually entitled to a license on FRAND terms, the SSO contract had not been breached because the individual patent holders fulfilled their obligations to the SSO by actively licensing Continental’s customer, which meant that the SEP licenses were (derivatively) available to Continental on FRAND terms. Finding that Continental lacked constitutional standing, the Court did not reach the issue of whether Continental lacked antitrust standing.

Continental filed a petition for panel rehearing and rehearing en banc. Numerous third parties, including legal and economic scholars, industry associations and tech companies, also filed amici briefs supporting Continental, arguing that the Fifth Circuit wrongly found that Continental was not an intended beneficiary of the FRAND obligations that the SEP owners made to the relevant SSO.

On June 14, 2022, the Fifth Circuit issued an order withdrawing its March 2022 opinion. A week later, the Court issued a new opinion summarily stating that “[h]aving reviewed the district court’s detailed order, and considered the oral arguments and briefs filed by the parties and amicus curiae, we AFFIRM the judgment of the district court that Continental failed to state claims under Sections 1 and 2 of the Sherman Act.”

Practice Note: Although the ultimate outcome did not change, the Fifth Circuit withdrew its previous finding that third-party beneficiaries to SSOs did not have constitutional standing to file a lawsuit.




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Since Vacatur Seeks Equitable Relief, Clean Hands Matter

In an opinion related to its 2021 ruling that a decision in earlier inter partes reexaminations of related patents had a preclusive effect that collaterally estopped the Patent Trial & Appeal Board (Board) from making new findings on the same issue, the US Court of Appeals for the Federal Circuit vacated the Board’s decision on remand since the patent at issue expired. SynQor, Inc. v. Vicor Corp, Case No. 20-1259 (Fed. Cir. Jun. 17, 2022) (Chen, Prost, JJ.), (Lourie, J., dissenting) (non-precedential).

Background

After being sued by SynQor, Vicor petitioned for reexamination of several SynQor patents (including the ’021 and ’190 patents). In the ’190 patent reexamination proceeding, Vicor successfully argued that the ’190 patent claims (including new claims sought to be added by SynQor) were unpatentable over two references. After appeals to the Board (which reversed the examiner) and Federal Circuit (which reversed-in-part, vacated-in-part), the case was remanded to the Board to consider the examiner’s obviousness rejections in light of the Court’s conclusion that prior art patents anticipated certain claims.

On remand, the Board affirmed almost all of the examiner’s rejections and applied a new ground of rejection to one of SynQor’s proposed new claims. However, before the Board issued its final decision regarding the new claims, the ’190 patent expired and SynQor appealed to the Federal Circuit to vacate the Board’s decisions regarding the new claims on the ground that the ’190 patent’s expiration rendered the Board’s patentability decision moot. The Court agreed and vacated the Board’s decisions, explaining that the inability to issue the new claims meant that “the Board’s patentability determinations were unreviewable for mootness” since the Court would be “frustrated by the vagaries of circumstance” (thereby falling under the Supreme Court’s Munsingwear doctrine) from reviewing the Board’s determinations on the merits.

Similarly, in the ’021 patent’s reexamination, the examiner rejected all challenged claims, including two new claims that SynQor proposed. The Board affirmed the examiner’s rejections, and on appeal the Federal Circuit affirmed-in-part, vacated-in-part and remanded for the Board to reconsider two obviousness grounds it deemed the Board had unjustifiably reached inconsistent conclusions on (relative to a separate reexamination proceeding for another related patent). On remand, the Board again found SynQor’s proposed new claims unpatentable, unaware that the ’021 patent had expired over a year prior. In its rehearing petition, SynQor informed the Board of the ’021 patent’s expiration and asked the Board to vacate its decision on the merits. SynQor appealed after the Board declined to do so.

Appeal on the ’021 Patent

On appeal, SynQor requested that the Federal Circuit vacate the Board’s decision (for the same reasoning as in the ’190 patent appeal). Vicor argued that the Court lacked Article III jurisdiction to consider the request, and that SynQor was not entitled to equitable relief because of its failure to inform the Board of the ’021 patent’s expiration date, which caused the remand decision to be issued. Vicor also argued that the timing of the ’021 patent expiring before [...]

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Clarification or Raising the Bar? PTO Director Issues New Guidance for Discretionary PTAB Denials

On June 21, 2022, US Patent & Trademark Office (PTO) Director Katherine K. Vidal issued a memorandum addressing interim procedures for discretionary denials in America Invents Act (AIA)-post grant proceedings at the Patent Trial & Appeal Board (Board). In 2020, in order to minimize the potential conflict between the Board and parallel district court proceedings, the PTO designated the Board’s opinion in Apple v. Fintiv as precedential. Since Fintiv, the Board has issued several discretionary denials of institution based on parallel proceedings in district (and in some cases other administrative) courts. Director Vidal’s memo seeks to provide additional guidance on the PTO’s interpretation of Fintiv and its progeny and addresses multiple factors that were previously left to individual administrative law judge (ALJ) interpretation.

The memo includes rendering an initial evaluation of the merits of the petition. In particular, the Board will not deny institution of an inter partes review (IPR) or post-grant review (PGR) under Fintiv when a petition presents compelling evidence of unpatentability. This standard is higher than the institution standard, which requires only that “there is a reasonable likelihood that petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” While the memo does not elaborate on the evidence required to meet this compelling standard, numerous decisions were cited as illustrative. (See: e.g., Illumina Inc. v. Trs. of Columbia Univ., IPR2020-00988, Paper 20 (PTAB Dec. 8, 2020); Synthego Corp. v. Agilent Techs., Inc., IPR2022-00402, Paper 11 (May 31, 2022); Samsung Elecs. Co. v. Scramoge Tech., Ltd., IPR2022-00241, Paper 10 (June 13, 2022).)

Additionally, Director Vidal confirmed that Fintiv does not apply to parallel proceedings before the International Trade Commission nor where there has been a stipulation not to pursue the same grounds in a district court proceeding. The stipulation applies to grounds that are actually raised in the petition and any grounds that could have reasonably been raised in the petition, suggesting that there may be some dispute later in the district court proceeding about what grounds “could have reasonably been raised in the petition.”

Finally, the memo clarified the second factor of the Fintiv analysis: the speed with which the district court case may go to trial and be resolved. The Board will consider not only the scheduled trial date, but also the median time-to-trial for the particular district court, number of cases before the specific district court judge and the speed and availability of other dispositions.

Practice Note: While the standard for institution has not changed, the new compelling standard effectively ups the bar for any IPR, PGR or covered business method (CBM) proceedings where there is a parallel district court case. Prior to filing a new petition, patent challengers should objectively weigh the merits of their challenge or consider stipulating not to pursue the same invalidity grounds in the parallel district court proceeding.




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Claim Construction and Jurisdictional Discovery Are More Than Skin Deep

Referencing the use of antecedents from a “wherein” clause, the US Court of Appeals for the Federal Circuit reversed a district court’s claim construction and vacated its summary judgment ruling of indefiniteness that relied on that construction. University of Massachusetts v. L’Oréal S.A., Case No. 21-1969 (Fed. Cir. June 13, 2022) (Prost, Mayer, Taranto, JJ.) The Court also reversed the dismissal of a defendant based on personal jurisdiction, finding error in the district court’s refusal to permit jurisdictional discovery before granting a motion to dismiss on that basis.

This case involved two patents directed towards the topical treatment of skin with a composition of adenosine at a certain concentration, held by the University of Massachusetts (UMass). L’Oréal is French-based company (L’Oréal S.A.) and its US-based company (L’Oréal USA) were involved in the suit. L’Oréal S.A. moved to dismiss for lack of personal jurisdiction, and the district court granted the motion without an opportunity for UMass to conduct jurisdictional discovery. After the dismissal, the district court ruled on the construction of a claim limitation and subsequently wielded that construction to invalidate another limitation as indefinite. The district court entered a final judgment of invalidity on this basis. UMass appealed, challenging the claim construction and lack of jurisdictional discovery.

Construction Using “Wherein” Clause

The Federal Circuit explained that there are two steps in reviewing claim construction: determining whether there is a plain meaning of a disputed term and, as necessary, properly construing the term. After determining that there was no plain meaning of the claim term “concentration,” the Court addressed the construction of the phrase “topically applying to the skin a composition comprising a concentration of adenosine.” The Court found that the district court erred in its determination that the “concentration applied to the dermal cells” meant that the concentration must be measured by the concentration directly applied to the dermal cells beneath the skin, rather than the composition applied to the surface of the skin. The Patent Trial & Appeal Board had adopted the same interpretation in an inter partes review, and therefore “concentration applied to the dermal cells” required no further construction.

UMass challenged that the proper construction. The Federal Circuit, citing to support in the specification, stated that the concentration of adenosine found in the composition should be construed as that applied to the epidermis. Viewing the claim as a whole and use of antecedents, the Court explained that “applied” could relate to both direct and indirect application. The Court specifically noted the use of the word “the” in the wherein clause, and found that this read, for antecedent, as the concentration of the composition. In viewing the prosecution history, the Court determined there was no disavowal of indirect application, and the specification and dependent claims supported a read of the term “concentration” to mean the composition applied to the surface of the skin, rather than requiring testing of the concentration to which the dermal cells were actually exposed. The Court also noted that in the prosecution history, UMass [...]

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