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Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent, sufficient evidence for a finding of inequitable conduct. Belcher Pharmaceuticals, LLC v. Hospira, Inc., Case No. 20-1799 (Fed. Cir. Sept. 1, 2021) (Reyna, J.)

The patent in issue relates to injectable formulations of l-epinephrine. Epinephrine is a hormone that has been on the market since approximately 1938 and is used for a variety of medical purposes. It is also known that l-epinephrine degrades into a more potent isomer known as d-epinephrine. L-epinephrine also degrades into an impurity known as adrenalone through a process called oxidation.

In 2012, Belcher first submitted a New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based, meaning that Belcher did not perform any clinical or non-clinical studies on its epinephrine formulation to support its application. Among the materials submitted to the FDA was an article by Stepensky et al to support its statement that “racemization of the enantiomerically pure L-Epinephrine isomer in injectable formulations of epinephrine is a well-known process.” It also submitted data from Swiss pharmaceutical company Sintetica SA’s formulation that had a pH range of 3.1 – 3.3 and undetectable levels of adrenalone. Ultimately, Belcher pursued a formulation with a similar pH range of 2.8 – 3.3.

In 2014, Belcher filed a patent application that was ultimately issued as the asserted patent. The patent taught that increasing the in-process pH to 2.8 – 3.3 unexpectedly reduced the racemization of l-epinephrine to d-epinephrine at release by approximately two thirds. The asserted claims covered pharmaceutical epinephrine formulations having a pH between 2.8 – 3.3 and certain concentrations of l-epinephrine, d-epinephrine and adrenalone at the time of release and 12 months later.

The prosecution of the application involved a single office action in which the pending claims were rejected in view of Helenek. The examiner explained that Helenek taught 1 mg/ml of epinephrine injection that, among other things, had a pH range of 2.2 – 5.0. Belcher overcame this rejection by arguing that Helenek did not render obvious the claimed range of 2.8 – 3.3 because the claimed range was unexpectedly found to be critical to reduce racemization of l-epinephrine.

Hospiria also submitted an NDA seeking approval of an injectable l-epinephrine formulation, which included a certification under 21 U.S.C. § 355(b)(2)(A)(iv)(Paragraph IV) that the asserted patent’s claims were invalid, unenforceable and/or not infringed by Hospira’s NDA product. Belcher subsequently sued Hospira for patent infringement.

During trial, Darren Rubin, Belcher’s Chief Science Officer, testified that in his role at Belcher, he was involved in the drafting and development of the NDA and in the prosecution of the asserted patent—including drafting the claims and specification and responding to the examiner’s office action. Darren admitted he knew of Stepensky before the application was filed and that he possessed a label for a 1 mg/mL epinephrine product marked [...]

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Absent Explicit Statutory Language? The American Rule Still Applies

The US Court of Appeals for the Federal Circuit vacated a district court’s award of attorney’s fees under the prevailing party rule but affirmed the district court’s denial of the US Patent & Trademark Office’s (PTO) request for expert witness fees under 35 U.S.C. § 145. Hyatt v. Hirshfeld, Case Nos. 20-2321;–2325 (Fed. Cir. Aug. 18, 2021) (Hughes, J.). The case involved prolific inventor Gilbert Hyatt and the latest chapter in his battles with the PTO.

Mr. Hyatt is known for his prolific patent and litigation filings (including hundreds of extraordinarily lengthy and complex patent applications in 1995 alone) and for often “’adopt[ing] an approach to prosecution that all but guaranteed indefinite prosecution delay’ in an effort to submarine his patent applications and receive lengthy patent terms.” After the PTO denied some of his patent applications, Mr. Hyatt elected to pursue a district court appeal under 35 U.S.C. § 145 to challenge the PTO’s decisions. The district court ordered the PTO to issue some of the patents and awarded Mr. Hyatt attorney’s fees as the prevailing party. The PTO spent millions of dollars examining Mr. Hyatt’s applications and sought, under §145, reimbursement of its expert witness fees from the case. The district court denied the PTO’s request for expert witness fees, holding that its shifting of “[a]ll the expenses of the proceedings” to the applicant does not overcome the American Rule presumption against shifting expert fees. The PTO appealed.

The PTO challenged both the award of attorney’s fees and the denial of expert fees. In an earlier appeal by the PTO, the Federal Circuit held that the PTO correctly asserted prosecution laches as a defense against Mr. Hyatt, which “render[s] a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution that constitutes an egregious misuse of the statutory patent system under a totality of the circumstances.” Accordingly, the Court vacated the district court’s decision ordering the issuance of patents, and in this appeal, the Court vacated the district court’s holding that Mr. Hyatt is entitled to attorney’s fees—since he is no longer the prevailing party—and remanded for further proceedings.

According to the statute, in an action under § 145, “[a]ll the expenses of the proceedings shall be paid by the applicant.” However, the Federal Circuit agreed with the district court that the statutory language was not sufficiently explicit to overcome the presumption against fee-shifting under the American Rule and that litigants pay their own fees “unless a statute or contract provides otherwise.” In doing so, the Court looked at statutory phrasing, dictionary definitions (e.g., Black’s and Webster’s), legislative history, relevant case law and similarly phrased statutes to confirm whether expert fees were specifically and explicitly contemplated as being included by US Congress in the statute. The Supreme Court of the United States’ 2019 NantKwest decision (that “expenses” under §145 does not invoke attorney’s fees with enough clarity to overcome the American Rule) guided the Court’s analysis as did [...]

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Employee Agreement of What “Shall Be” is Future Promise, Not Present Assignment

The US Court of Appeals for the Federal Circuit concluded that university bylaws did not automatically effectuate a present automatic assignment of patent rights and affirmed the district court’s denial of a motion to dismiss for lack of standing by the transferee. Omni MedSci, Inc. v. Apple Inc., Case No. 20-1715 (Fed. Cir. Aug. 20, 2021) (Linn, J.) (Newman, J., dissenting).

Upon joining the faculty of the University of Michigan, Dr. Mohammed Islam executed an employment agreement assenting to abide by the university’s bylaws. The bylaws provide, in relevant part, that patents obtained by university staff that are supported directly or indirectly by university funds “shall be the property of the University.” In 2012, Dr. Islam took an unpaid leave of absence and filed several provisional patent applications. After he returned to the university in 2013, he filed non-provisional patent applications claiming priority to the 2012 provisional applications. Once those applications issued as patents, he assigned the patent rights to the plaintiff, Omni MedSci.

In 2018, Omni initiated a patent infringement action against Apple asserting certain patents, including one in the family of patents that Islam assigned to Omni. Apple moved to dismiss, arguing that Omni lacked standing to assert the patents-in-suit because the university—not Omni—owned the patents-in-suit. Apple argued that the university’s bylaws automatically transferred legal title to Dr. Islam’s patents to the university, leaving Dr. Islam with nothing to assign. Therefore, Omni had no standing to assert the patents.

The US District Court for the Eastern District of Texas denied the motion to dismiss and transferred the action to the Northern District of California. The California court certified the standing question to the Federal Circuit.

In this interlocutory appeal, the Federal Circuit considered whether the university bylaws automatically assigned the patent rights to the university. The Court explained that a patent assignment clause may presently assign a to-be-issued patent automatically—in which case no further acts to effectuate the assignment are necessary—or may merely promise to assign the patent in the future. The issue in the appeal was which type of assignment was intended by the “shall be the property of the University” language in the bylaws—i.e., whether it was “a statement of an intended outcome [or] a present assignment.” Analyzing the university bylaws, the Court agreed with the district court that the bylaws did not automatically assign the patent rights to the university and therefore did not negate Dr. Islam’s assignment of the patent rights to Omni.

The Federal Circuit concluded that the bylaw language “is most naturally read as a statement of intended disposition and a promise of a potential future assignment, not as a present automatic transfer. … It does not purport to effectuate the present transfer of a present or future right.”

In dissent, Judge Pauline Newman noted that at the district court, Dr. Islam only argued that he was not subject the bylaw obligation since the patent applications were filed without university support. However, the district court did not rule on that issue and [...]

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Don’t Let Prophetic Examples Work Against You

On July 1, 2021, the US Patent & Trademark Office (PTO) issued a notice reminding patent applicants that when their applications contain both prophetic and working examples, they must make a clear distinction between the two.

Prophetic examples illustrate reasonably expected results or anticipated results. They stem from experiments that have not been actually performed and are instead hypothetical simulations. In contrast, working examples result from experiments that were actually performed. In order to aid in distinguishing between the two example types within a patent application, prophetic examples should be written only in the future or present tense—not in the past tense. Prophetic examples cannot be used to meet the written description and enablement requirements for a patent application.

The PTO’s recent notice underscores the importance of the applicant’s duty to clearly distinguish between prophetic and working examples: “[k]nowingly asserting in a patent application that a certain result ‘was run’ or an experiment ‘was conducted’ when, in fact, the experiment was not conducted or the result was not obtained is fraud.”




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Federal Circuit Lacks Appellate Jurisdiction over Standalone Walker Process Claims

The US Court of Appeals for the Federal Circuit ordered the transfer of a case asserting standalone Walker Process antitrust claims involving an unenforceable patent to the regional circuit, in this case the US Court of Appeals for the Fifth Circuit. Chandler v. Phoenix Services LLC, Case No. 20-1848 (Fed Cir. June 10, 2021) (Hughes, J.) The case originated in the US District Court for the Northern District of Texas, over which the Fifth Circuit has appellate jurisdiction. The decision to transfer was based on a subject matter jurisdiction analysis for Walker Process claims. The Federal Circuit reiterated that its precedent does not mandate exclusive Federal Circuit jurisdiction over all Walker Process cases.

In 2006, Phoenix Services and Mark Fisher (collectively, Phoenix) acquired a company called Heat On-The-Fly and its patent to protect a purported proprietary fracking process. Heat-On-The-Fly, and later Phoenix, sought to enforce the patent against numerous parties. During the patent application process, however, Heat On-The-Fly had failed to disclose numerous public uses of the fracking process prior to the application filing. In 2018, in an unrelated case, Energy Heating, LLC v. Heat On-The-Fly, the Federal Circuit, held that “failure to disclose prior uses of the fracking process rendered the . . . patent unenforceable due to inequitable conduct.” The plaintiffs in the case at hand, Ronald Chandler, Chandler MFG., Newco Enterprises and Supertherm Heating Services (collectively, Chandler), alleged that Phoenix’s continued enforcement of the patent violated Walker Process pursuant to § 2 of the Sherman Act.

Walker Process monopolization claims originate from a 1965 Supreme Court decision that recognized an antitrust cause of action under the Sherman and Clayton Acts when a party fraudulently obtains a patent for the purpose of attempted monopolization. Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp. To succeed on a Walker Process claim, a plaintiff must satisfy two elements:

  • The plaintiff must show that the defendant obtained the patent through knowing and willful fraud on the US Patent & Trademark Office and enforced that patent with knowledge of its fraudulent procurement.
  • The plaintiff must be able to satisfy all other elements for a Sherman Act monopolization claim.

Pursuant to 28 U.S.C. § 1295(a)(1), the Federal Circuit retains jurisdiction over any civil case arising under any act of Congress relating to patents. In this instance, the Federal Circuit stated that Walker Process antitrust claims may relate to patents “in the colloquial use of the term,” but under 1988 Supreme Court precedent, Christianson v. Colt Indus., the Federal Circuit’s jurisdiction only extends to cases where the cause of action is created under federal patent law, or where the plaintiff’s right to relief “necessarily depends on resolution of a substantial question of federal patent law.”

Here, the Federal Circuit relied on its own 2018 precedent where it analyzed subject matter jurisdiction for Walker Process claims. Xitronix Corp v. KLA-Tencor Corp. (Xitronix I). Xitronix I involved alleged fraud by the defendants to obtain a patent. The Court acknowledged [...]

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PTO Rules Not Subject to the Paperwork Reduction Act

The US Court of Appeals for the Ninth Circuit concluded that certain challenged rules of the US Patent and Trademark Office (PTO) that relate to the patent application process do not violate the Paperwork Reduction Act (PRA) because each called for a response to an individualized communication; a category which is expressly exempted from the PRA. Hyatt v. Office of Management and Budget, Case No. 20-15590 (9th Cir. May 20, 2021) (Nguyen, J.).

Inventor Gilbert Hyatt and the American Association for Equitable Treatment (AAET) contended that patent applicants should not have to comply with certain PTO rules, alleging that the rules violated the PRA, which Congress passed to reduce the burden imposed on the public when responding to federal agencies’ requests for information from private individuals. The PRA requires federal agencies engaged in “collections of information” to first submit them to the Office of Management and Budget (OMB) for approval and an assignment of a control number. Collections of things other than “information” do not need to receive OMB approval, and the PRA applies only to “collections” seeking information through identical questions or requirements imposed on 10 or more people. Thus, the PRA and its regulations expressly exclude individualized communications from PRA applicability.

Hyatt asked OMB to review PTO rules 111, 115 and 116, arguing that those rules imposed “collections of information” under the PRA. Hyatt suggested that because the rules had not received OMB approval and control numbers, he was not required to maintain, provide or disclose the information these rules referenced. OMB responded that it had already determined that “these collections are not subject to the PRA because what is collected is not considered ‘information,’ pursuant to [three] exemptions in OMB’s PRA implementing regulation”:

  • Exemption 1: “[a]ffidavits, oaths, affirmations, certifications . . . provided that they entail no burden other than that necessary to identify the respondent, the date, the respondent’s address, and the nature of the instrument. . .”
  • Exemption 6: “request[s] for facts or opinions addressed to a single person”
  • Exemption 9: “[f]acts or opinions obtained or solicited through nonstandardized follow-up questions designed to clarify responses to approved collections of information.”

5 C.F.R. §§ 1320.3(h)(1), (6), (9).

AAET made similar arguments in submitting three requests to OMB on PTO rules 105, 130, 131 and 132 and MPEP § 2173.05(n). In its response to AAET, OMB only stated that “the requests under Rule 1.105 are not subject to the PRA because the responses to questions submitted under Rule 1.105 are not ‘information,’ but instead are exempt under” Exemption 9. AAET submitted three more requests to OMB on the same rules with similar arguments. OMB responded that Rules 105, 130, 131 and 132 and MPEP § 2173.05(n) were exempt under Exemptions 6 and 9; and Rules 130, 131 and 132 were additionally exempt under Exemption 1.

Hyatt and AAET sued OMB in district court, alleging that OMB’s denial of their petitions was arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law in [...]

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Inventions Not Made Under Employment Agreement

Applying a “middle ground” standard of review, the US Court of Appeals for the First Circuit affirmed a district court’s decision denying a company’s request for a declaratory judgment asking a former employee to assign patent rights to the company under the employment and separation agreements, because there were inconsistencies in the jury verdict. Covidien LP; Covidien Holding Inc. v. Brady Esch, Case No. 20-1515 (1st Cir. Apr. 8, 2021) (Gelpi, CDJ.)

During his employment with Covidien, Esch signed employment and separation agreements, which required a duty of confidentiality, an obligation to disclose any invention created during his employment with Covidien or within one year after leaving Covidien, and assignment of such inventions to Covidien. After his termination, Esch founded his own company (Venclose) and filed patent applications that were assigned to Venclose. Covidien sued Esch for breach of confidentiality and breach of obligation to disclose inventions.

At trial, the jury found that Esch breached his duty of confidentiality by publication of the patent applications, but did not breach his obligation to disclose inventions to Covidien under the agreements (question 3 on verdict form). The verdict form also included questions 6-8 concerning whether inventions were made under the agreements, but the jury was not required to answer these questions if the answer to question 3 was negative. After trial, Covidien moved for a declaratory judgment requesting that Esch assign patent rights to Covidien pursuant to the assignment provision of the agreements. The district court denied the motion, finding that the jury verdict questions were “internally inconsistent” and that “the jury’s ‘decisive’ negative answer to Question 3 could only be read as a factual finding that no ‘Inventions’ were made that are encompassed under the Employment Agreement.” Covidien appealed.

The First Circuit agreed with the district court, applying a “middle ground” standard, which is more rigorous than abuse of discretion but less open-ended than de novo review. This standard of review “requires attentively digest[ing] the facts and the district court’s stated reasons.” The Court found that the district court sufficiently addressed the agreements under applicable Massachusetts law and specifically explained the definition of “inventions” and the assignment requirement to the jury. The Court found that Covidien’s request that the jury should answer questions 6-8 regardless of the answer to question 3 was neither “substantively correct” nor “essential to an important issue,” and was an instruction “substantially covered in the charge.” Further, the Court found that the “internally inconsistent” jury verdict, namely that Esch met his disclosure obligation by violating his confidentiality duty via publication of the patent applications, could only be read as a factual finding that there were no inventions encompassed by the agreement. Accordingly, the First Circuit concluded that the district court did not abuse its discretion in denying Covidien’s post-trial declaratory judgment request.




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How Not to Build a Case of Trade Secret Misappropriation

The US Court of Appeals for the Ninth Circuit affirmed a dismissal of trade secret claims, finding that although misappropriation of a trade secret prior to the enactment of the Defend Trade Secrets Act (DTSA) does not preclude a claim arising from post-enactment or continued use of the same trade secret, the publication of a trade secret in a patent application extinguishes trade secret status. Eli Attia; Eli Attia Architect PC v. Google LLC, et al., Case No. 19-15771 (9th Cir. Dec. 16, 2020) (Wallace, J.)

Eli Attia is an architect who developed a system and method for automated design, fabrication and construction, called Engineered Architecture (EA). In 2010, Attia entered into a partnership with Google. Attia disclosed his trade secrets related to the technology to Google so that they could work together to develop a program that would implement EA. Attia executed patent assignments with Google, and a year later Google filed patent applications related to the EA trade secrets. The patents were published in 2012. Google then allegedly excluded Attia from the project and used EA to create Flux, a platform used by architects, engineers and construction workers, focused on making buildings more efficient and using artificial intelligence to streamline the design process.

In 2014, Attia sued Google under state law for trade secret misappropriation and breach of contract. In 2016, Congress enacted the DTSA. Since its inception, DTSA has been an enumerated predicate for the civil Racketeer Influenced and Corrupt Organizations Act (RICO), which means that plaintiffs can bring lawsuits claiming a conspiracy when theft of trade secrets is an underlying claim. Attia amended his complaint to add RICO claims based on Google’s alleged trade secret misappropriation. Google removed the action to federal court and moved to dismiss. Attia filed another amended complaint, this time asserting a new DTSA claim and two RICO claims.

The district court dismissed Attia’s federal claims with prejudice and declined to exercise supplemental jurisdiction over the state law claims. The district court found that the alleged trade secrets were already disclosed in Google’s 2012 published patent applications, and those publications extinguished the relevant trade secrets. The court held that Attia lacked standing to assert DTSA or RICO claims, and neither estoppel nor continued use could convert the 2012 publications into a DTSA violation. Attia appealed.

On appeal, the Ninth Circuit noted that the issue was one of first impression before the Court, and set out to determine whether, as a matter of law, the pre-enactment disclosure of a trade secret forecloses the possibility of a DTSA claim arising from the continued use of the trade secret after enactment. The Uniform Trade Secrets Act (UTSA), the established model statute for trade secret misappropriation that has been adopted by the majority of the states, contains an anti-continued use provision, the Court noted. The UTSA states that “ a continuing misappropriation that began prior to the effective date,”… “does not apply to the continuing misappropriation that occurs after the effective date.” The DTSA does not [...]

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Making Waves: Post-Employment Contract Assignment Provision Invalid Under California Law

The US Court of Appeals for the Federal Circuit invoked “precedents that are relevant but not directly on point” to examine when employment contract provisions may require assignment of inventions conceived post-employment and without use of the former employer’s confidential information, finding that an intellectual property assignment provision in the employer’s predecessor’s employment agreement was void under California law. Whitewater West Industries, Ltd. v. Richard Alleshouse, et al., Case No. 19-1852 (Fed. Cir. Nov. 19, 2020) (Taranto, J.)

Richard Alleshouse began working for Wave Loch in 2007 as an engineer in the field of large-scale sheet-wave water attractions, which are surf and wave simulators sometimes seen on cruise ships and in water parks. Alleshouse’s many duties for the company included the inspection, assessment and improvement of the company’s wave rides; the development of new rides; and product management of the company’s branded FlowRider sheet wave attraction.

After almost five years with the company, Alleshouse consulted with a lawyer, Yong Yeh, regarding the scope of his employment agreement with Wave Loch, which included intellectual property assignment terms that survived termination of the employment agreement. Following that consultation, Alleshouse and Yeh discussed the idea of starting their own company to design sheet-wave attractions. In August 2012, Alleshouse resigned from Wave Loch, and in October 2012, Alleshouse and Yeh filed provisional patent applications that resulted in three different US patents describing and claiming certain “water attractions involving a flowing body of water on a surface” and “nozzle shapes and configurations which create a flowing body of water over a surface.”

In 2017, Whitewater West Industries, the successor to Wave Loch, sued Alleshouse, Yeh and their new company, Pacific Surf Design, in federal district court in California, asserting claims for breach of contract and correction of inventorship. In particular, Whitewater sought an assignment of the three patents under the terms of Alleshouse’s employment contract with Wave Loch, and claimed that Yeh was improperly listed as an inventor on each of the three patents. The district court ruled for Whitewater and found that the intellectual property assignment provision in Alleshouse’s employment agreement was valid and thus breached due to the failure to assign the patent rights at issue. Alleshouse appealed.

Alleshouse challenged the employment agreement’s intellectual property assignment provision as invalid under California Labor Code § 16600, which prohibits any contract provision that restrains a person from a lawful profession, trade or business, and under § 2870(a), which prohibits requiring an employee to assign over any invention that an employee developed entirely on her own time without using the employer’s equipment, supplies, facilities or trade secret information (with certain enumerated exceptions for employee inventions related to the employer’s business or the employee’s work for the business). The parties agreed on two factual points that were important to the Federal Circuit’s analysis on appeal: that the inventions at issue were not conceived until after Alleshouse left his job at Wave Loch, and that Alleshouse did not use any trade secret or confidential information belonging to Wave [...]

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“Gradual” and “Continuous” Includes Step-Wise

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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