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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

  • The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
  • Ikan’s counsel [...]

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New PTO Guidance: Use KSR Flexible Approach to Obviousness

On February 27, 2024, the US Patent & Trademark Office (PTO) published updated guidance for examiners on how to make a proper determination of obviousness. The guidance expands upon and reinforces the legal framework for obviousness determinations discussed by the Supreme Court in KSR Int’l. v. Teleflex (2007) and Graham v. John Deere Co. (1966) through the lens of post-KSR precedential Federal Circuit cases. The guidance does not have the force and effect of law and is not intended by the PTO to convey any new practice or procedure.

Drawing from more than 30 Federal Circuit cases, the guidance addresses several themes. An overriding theme concerns the implementation of a flexible approach to obviousness and the need for a reasoned explanation when concluding that a claimed invention would have been obvious. In its discussion, the PTO characterizes the flexibility expressed by the KSR court and reiterated by subsequent Federal Circuit cases as mandating a proper understanding of the scope of the prior art and providing appropriate reasons to modify the prior art.

Regarding the scope and content of the prior art, the guidance draws attention to understanding the prior art and all that it may reasonably suggest to a person of ordinary skill in the art (POSITA) who would naturally apply common sense and glean suggestions from the art – even where such suggestions are not explicitly stated. Thus, the obviousness inquiry need not seek out precise teachings regarding a solution to a technological problem but can take account of the inferences, creative steps and common knowledge that a POSITA would employ. In one precedential example, the Federal Circuit held that a POSITA would have combined certain prior art elements based on common knowledge of an industry’s concern for rider stability when using water recreational devices. (Zup v. Nash Mfg. (2018).) The guidance also affirms the need for an evaluation of analogous prior art, which must be evaluated using a flexible approach when considering the “same field of endeavor” and “reasonably pertinent” tests in combination with evidence concerning the knowledge and perspective of a POSITA.

According to the guidance, a flexible approach to obviousness should provide a reasoned explanation with evidentiary support for modifying the prior art. To facilitate compact prosecution, the examiner should clearly articulate this explanation early in the prosecution. The PTO also cautions that wholesale use of “common sense” as a rationale is no substitute for reasoned analysis and evidentiary support. There should be an explanation of why common sense would have compelled a finding of obviousness, especially where limitations are not expressly disclosed in the prior art.

The guidance further emphasizes that decision-makers are not free to ignore relevant evidence before them, including Graham’s secondary considerations or other objective indicia of obviousness, to establish prima facie obviousness. At the same time, conclusory opinions by an expert in a declaration or attorney argument alone should not be accorded weight in the absence of factual support. The guidance notes that in keeping with the flexible approach to obviousness [...]

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Not Admitted to PTO Bar? No Problem.

On February 21, 2024, the US Patent & Trademark Office (PTO) issued a Notice of Proposed Rulemaking that would give parties the option to designate a non-registered practitioner as lead counsel in proceedings before the Patent Trial & Appeal Board. 89 Fed. Reg. 13017 (Feb. 21, 2024) (to be codified at 37 C.F.R. pt. 42).

37 CFR 42.10(a) currently requires each party to designate a lead counsel and at least one back-up counsel. The lead counsel must be a registered practitioner. Non-registered practitioners can serve as back-up counsel pro hac vice, but only upon a showing that they are an experienced litigating lawyer serving as back-up counsel and that they possess significant familiarity with the subject matter at issue. Permission for back-up status requires grant of a pro hac vice motion filed by counsel presenting specific statements of fact showing good cause for admission, as well as an affidavit or declaration by counsel attesting to good standing before the courts, familiarity with the PTO’s Patent Trial Practice Guide and the Board’s Rules of Practice for Trial set forth in part 42 of 37 C.F.R., and familiarity with the subject matter at issue.

The proposed changes to 37 C.F.R. 42.10 would:

  • Permit non-registered practitioners to serve as lead counsel for a party in Board proceedings as long as at least one other counsel designated to appear on behalf of the party is a registered practitioner.
  • Permit parties to proceed without back-up counsel upon a showing of good cause. A party may show good cause by demonstrating that it lacks the financial resources to retain both lead and back-up counsel.
  • Create a new streamlined procedure for pro hac vice recognition of Board-recognized practitioners. This procedure applies to non-registered practitioners who have previously been admitted pro hac vice in a different Board proceeding and have not been subsequently denied pro hac vice recognition in a different Board proceeding.
  • Clarify that those recognized pro hac vice have a duty to inform the Board if the information presented in a request for pro hac vice recognition is no longer accurate or complete.

The PTO seeks public comments on the proposed rulemaking by May 21, 2024, through the Federal eRulemaking Portal. Enter docket number PTO-P-2023-00587 on the homepage and select “search.”

For further details, click here.




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Consider Invention When Assessing Support for Claimed Range

The US Court of Appeals for the Federal Circuit affirmed in part and vacated in part a Patent Trial & Appeal Board finding that the claims at issue were either invalid under 35 U.S.C. §112 as unsupported by written description or obvious under 35 U.S.C. §103. RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., Case No. 22-1862 (Fed. Cir. Feb. 9, 2024) (Chen, Stoll, Cunningham, JJ.)

RAI owns a patent with claims directed to “electrically powered smoking devices that provide an inhalable vapor by heating tobacco or other substances without significant combustion.” Philip Morris challenged the patent in a post-grant review (PGR).

The Board issued a final written decision concluding that two dependent claims, which recited limitations requiring a heating member with “a length of about 75% to about 85% of a length of the disposable aerosol forming substance,” lacked § 112 written description support. The specification disclosed ranges of 75% – 125%, 80% – 120%, 85% – 115% and 90% – 110%. The Board explained that written description support was lacking because “the claimed range is different from and substantially narrower than the specific ranges disclosed in the specification.”

The Board found that the remaining claims were unpatentable as obvious based on a combination of prior art references where the heater found in one reference, Robinson, was replaced with the heater from another, Greim. Robinson explained that its heating element could be altered and acknowledged design choices, thus inviting skilled artisans to select an alternate appropriate heating element. Greim disclosed certain advantages to its heater. Thus, the Board found that a skilled artisan would have been motivated to replace Robinson’s heater with that of Greim, rendering the claims obvious. RAI appealed.

Citing its expert, RAI argued that the ranges disclosed in the specification all centered around 100%, so that a person of ordinary skill in the art (POSITA) would not “conclude that the inventors possessed a range that went no higher than 85%[.]” The Federal Circuit began by summarizing a line of numerical range cases, including:

  • In re Wertheim (CCPA 1976), which found that a described range of 25% – 60%, with examples of 36% and 50%, supported a claim directed to a range of 35% – 60%.
  • In re Blaser (CCPA 1977), which found that a described range of 60° – 200° C supported a claim reciting a range of 80° – 200° C.
  • Kolmes v. World Fibers Corp. (Fed. Cir. 1997), which found that a described range of 4 – 12 turns per inch, and preference for 8 turns per inch, supported claims directed to 8 – 12 turns per inch.
  • In re Baird (CCPA 1965), which found that a relatively unexplained disclosure of 32 – 176° F did not support claims directed to a range from 40° to “at least as low as” 60° F.
  • Indivior UK v. Dr. Reddy’s Laboratories (Fed. Cir. 2021), which found that:
    • Disclosure of ranges of at least 25%, at least 50% and “any” value [...]

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I Hear Ya: Claim Terms Not as Narrow as Features in Specification

The US Court of Appeals for the Federal Circuit vacated a district court’s final judgment of noninfringement, finding that the district court improperly narrowed the constructions of certain claim terms to particular features recited in the specification. Promptu Sys. Corp. v. Comcast Corp., Case No. 22-1939 (Fed. Cir. Feb. 16, 2024) (Moore, Prost, Taranto, JJ.)

Promptu filed a lawsuit against Comcast alleging infringement of two patents. The patents describe and claim subject matter generally related to voice recognition but have materially different specifications. The first patent describes using remote voice recognition systems to deliver content in response to a user’s speech request (content delivery patent), while the second patent describes using remote voice recognition systems to control a user’s television set based on a user’s speech command (control patent).

The content delivery patent’s representative claim recites a method for using a “back channel containing a multiplicity of identified speech channels from a multiplicity of user sites presented to a speech processing system at a wireline node in a network supporting at least one of cable television delivery and video delivery” as well as a “method of operating at least part of a speech recognition system coupled to a wireline node in a network [for] processing a multiplicity of received identified speech channels to create a multiplicity of identified speech content.” Meanwhile, the claim of the control patent recites “a centralized multi-user voice operated television control system, comprising . . . a centralized processing station configured to receive and process second output from a multitude of television set top boxes by applying voice recognition.”

During the underlying district court proceeding, the district court adopted claim constructions proposed by Comcast. Based on those claim constructions, Promptu stipulated to and moved for entry of a final judgment of no infringement. After the district court granted Promptu’s motion, Promptu appealed.

Promptu challenged the district court’s construction of three claim limitations from the content delivery patent (“back channel,” “multiplicity of received identified speech channels” and “speech recognition system coupled to a wireline node”) and one claim limitation from the control patent (“centralized processing station”). In accordance with long-standing precedent, the Federal Circuit reviewed claim construction by affording the words of the claims their ordinary meaning in the context of the claims and specification.

The Federal Circuit concluded that the district court erred by narrowly construing “back channel” in the content delivery patent as being limited to a “fixed band of frequencies or time slot(s) for transmitting signals to a speech processing system or engine” because nothing in the claim language or the specification required limitation to a “fixed band of frequencies or time slot.” To the contrary, the specification of the patent disclosed the back channel broadly while recognizing the possibility of using different protocols and formats along different subsections of the path or route from user site to speech recognition system. Given the breadth of the techniques for the back channel disclosed in the specification, the Court found no reason to narrow the claims [...]

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PTO on AI Inventorship: Will the Real Natural Human Inventors Please Stand Up?

On February 13, 2024, the US Patent & Trademark Office (PTO) issued a notice with examination guidance and request for comment regarding inventorship in applications involving artificial intelligence (AI)-assisted inventions. The guidance reinforces the patentability of AI-assisted inventions and sets forth preliminary guidelines for determining inventorship with a focus on human contributions in this process.

The PTO released the guidance in response to President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (October 30, 2023). The executive order mandated that the PTO, within 120 days, present “guidance to USPTO patent examiners and applicants addressing inventorship and the use of AI, including generative AI, in the inventive process, including illustrative examples in which AI systems play different roles in inventive processes and how, in each example, inventorship issues ought to be analyzed.”

As in any inventorship determination for non-AI-generated inventions, “AI-assisted inventions must name the natural person(s) who significantly contributed to the invention as the inventor or joint inventor, even if an AI system may have been instrumental in the creation of the claimed invention.” As is the case for all inventions, the threshold question for inventorship in AI-assisted inventions is who made a “significant contribution” to the conception of at least one claim of the patent. For this evaluation, the Pannu factors (Federal Circuit 1998, Pannu v. Iolab Corp.) for inventorship should be considered.

With specific reference to AI-assisted inventions, the notice provides a non-exhaustive list of principles based on the Pannu factors for AI inventorship determinations:

  • Use of AI systems is not a barrier to inventorship. Use of an AI system does not negate a natural person making a significant contribution to an AI-assisted invention. To be an inventor, a natural person must have significantly contributed to each claim in a patent application or patent.
  • Recognizing a problem or obtaining a solution may be insufficient. The mere recognition of a problem or having a general goal or plan to pursue or obtain a solution from the AI input does not rise to the level of conception. The way in which a person constructs a prompt in view of the problem for eliciting a particular solution may be important for qualifying that person as an inventor.
  • Reduction to practice alone is insufficient. Reducing an invention to practice alone does not constitute a “significant contribution,” nor does the mere recognition and appreciation of the AI system output rise to the level of inventorship, especially where the output would be apparent to those of ordinary skill. By contrast, a significant contribution may exist where a person makes a significant contribution to the output or conducts a successful experiment from the output to create an invention.
  • Developing an essential building block of an AI system may be sufficient. A person developing an essential building block of an AI system to address a specific problem, where the building block is instrumental in eliciting a solution from the output, may be a proper inventor.
  • “Intellectual domination” over [...]

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Uncle Sam Can March In: Government Licenses Under Bayh-Dole Aren’t Subject to “Strict Timing Requirements”

In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the government for federally funded research based on work that occurred prior to the effective date of a funding agreement. University of South Fl. Board of Trustees v. United States, Case No. 22-2248 (Fed. Cir. Feb. 9, 2024) (Reyna, Taranto, Stoll, JJ.)

University of South Florida (USF) owns a now-expired patent directed to transgenic mice expressing a certain gene causing an accelerated pathology for Alzheimer’s disease. The patent’s subject matter was conceived while the two named inventors worked at USF, but both inventors transitioned their work to the Mayo Clinic prior to the first actual reduction to practice of the claimed invention. The mice remained at USF, under the care of USF professors, while the named inventors continued to oversee the project from Mayo. The first actual reduction to practice occurred while the inventors were at Mayo.

While the named inventors were still at USF, one inventor submitted a grant application to the National Institutes of Health (NIH). The NIH awarded the inventors (while they were still at USF) a grant covering the mouse project. After the inventors moved to Mayo but prior to the award grant, the designated grantee changed from USF to Mayo. In November 1997, Mayo and USF entered into a subcontract whereby Mayo would pay USF for grant-covered work occurring at USF.

USF sued the United States alleging infringement of the mouse patent by a third party with the government’s authorization and consent. The third party was producing and using mice covered by the patent for the government. The US asserted a license defense under the Bayh-Dole Act, which gives the government a license to practice certain federally funded inventions. The Claims Court granted judgment to the US under its license defense, determining that USF operated pursuant to an implied contract with Mayo based on the understanding that Mayo would use funding from the NIH grant to pay USF for work done there. The Claims Court therefore determined that USF was a contactor with an implied subcontract that was a funding agreement under Bayh-Dole. Since the invention was therefore invented by a government contractor operating under a funding agreement, it was a “subject invention” that was first actually reduced to practice under a government contract. Therefore, under Bayh-Dole, the government was entitled to a license. USF appealed, arguing that the invention was not a “subject invention” within the meaning of § 202(c)(4) of Bayh-Dole.

USF argued that to trigger § 202(c)(4), a funding agreement must be in place at the time of the relevant work and there was no implied agreement in April 1997, the time the work that led to the reduction to practice commenced. The Federal Circuit determined that the November 1997 subcontract was adequate to support entitlement to claim a government license under § [...]

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No Home Away From Home: Federal Circuit Confirms PTO Domicile Requirements

The US Court of Appeals for the Federal Circuit confirmed the US Patent & Trademark Office’s (PTO) refusal to register a trademark based on the applicant’s failure to comply with the domicile address requirement of 37 C.F.R. §§ 2.32(a)(2) and 2.189. In re Chestek PLLC, Case No. 22-1843 (Fed. Cir. Feb. 13. 2024) (Lourie, Chen, Stoll, JJ.)

Chestek included only a PO box for its domicile address in its trademark application. The PTO found this information noncompliant with the domicile address rule, which requires trademark applicants to either have a domicile within the United States or be represented by US counsel. The PTO implemented the requirement in 2019 following a notice-and-comment period. Chestek appealed the PTO’s refusal to register based on the Administrative Procedure Act (APA) and challenged the processes surrounding implementation of the domicile address requirement.

Chestek first argued that the requirement was improperly instituted because the PTO failed to comply with the notice-and-comment rulemaking requirement under 5 U.S.C. § 533 by failing to provide notice of the domicile address requirement adopted in the final rule. However, the Federal Circuit held that the formalities of the notice-and-comment were not required under § 533(b)(A) because the rule was procedural, not substantive (i.e., effecting a change in existing law or policy that affects individual rights and obligations). As the Court explained, the rule did not affect the substantive trademark standards used during examination to evaluate applications but was simply an applicant information requirement.

Chestek next argued that the domicile address requirement was arbitrary and capricious because in implementing the final rule, the PTO “offered an insufficient justification for the domicile address requirement” and failed to consider important repercussions of the requirement, such as its effects on privacy. The Federal Circuit rebuffed that argument, explaining that the domicile requirement and the explanations given for it (determining whether the US attorney requirement applied) were “at least reasonably discernable.” The Court stated that as long as an agency does not give “almost no reason at all” for a new policy, the change is sufficiently justified and not arbitrary or capricious. The Court also noted that the APA does not require an agency to consider and respond to every impact of a proposed policy change.




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Lost Connection: Preliminary Injunction Against Unreleased Product Is a No-Go

Addressing a preliminary injunction motion directed to a competitor’s yet-to-be-released product, the US Court of Appeals for the Federal Circuit determined that the district court did not abuse its discretion in finding that the patent holder failed to establish irreparable harm based on speculative evidence. SmartSky Networks, LLC v. Gogo Bus. Aviation, LLC, Case No. 23-1058 (Fed. Cir. Jan. 31, 2024) (Cunningham, Chen, Hughes, JJ.) (non-precedential).

SmartSky Networks and Gogo Business Aviation are competing aviation network providers that offer air-to-ground in-flight internet networks for aircrafts. SmartSky sued Gogo in early 2020, alleging that Gogo’s 5G network infringed four patents related to wireless in-flight internet connections. SmartSky also moved to preliminarily enjoin Gogo from selling its 5G network, which is not yet operational and has yet to be released. In late 2022, the district court denied SmartSky’s motion for preliminary injunction, finding that SmartSky had not shown a likelihood of success or irreparable harm. SmartSky appealed.

SmartSky first moved to supplement the record with new materials relevant to market share, sales and switching costs. The Federal Circuit first denied SmartSky’s motions to supplement the record, noting that it would not consider new evidence on appeal absent extraordinary circumstances, such as instances where the court can take judicial notice of new facts or where the facts would alter the appropriateness of injunctive relief. Because the district court found no likelihood of irreparable harm, despite acknowledging that SmartSky had shown consumer stickiness and direct competition between the parties, the Court concluded that documents related to market share, sales and switching costs would not alter the appropriateness of injunctive relief. The Court further declined to take judicial notice of the facts, which were subject to dispute.

The Federal Circuit then turned to SmartSky’s argument that the district court erred in finding no likelihood of irreparable harm from lost sales and market share, price erosion, lost reputation and goodwill, and lost research and development and investments. Regarding lost sales, SmartSky argued that the district court ignored Gogo’s sales of AVANCE L5 equipment (used for Gogo’s 4G and 5G networks) and that Gogo’s 5G network was not “yet-to-be-released” because it had been on sale since late 2021. The Court found these arguments unpersuasive. The Court noted that SmartSky did not dispute that Gogo had yet to launch its 5G network and found that the district court did not abuse its discretion in concluding that any such sales were quantifiable. As for AVANCE L5, the Court observed that the equipment was currently sold as part of Gogo’s unaccused 4G network, and that the alleged harm would only occur if Gogo launched its 5G network and customers upgraded. Thus, the Court found that any harm from the sales of AVANCE L5 was highly speculative, particularly because the parties are not the only two players in the market and customers may have other non-infringing options.

SmartSky next argued that the district court ignored testimony that customers used Gogo’s pricing to negotiate discounts from SmartSky. The Federal Circuit disregarded this [...]

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Sliced and Diced: Operating Manuals Are Printed Publications

The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s non-obviousness determination, finding that the Board erred in determining that an operating manual did not qualify as printed publication prior art. Weber, Inc. v. Provisur Technologies, Inc., Case Nos. 22-1751; -1813 (Fed. Cir. Feb. 8, 2024) (Reyna, Hughes, Stark, JJ.)

Provisur owns two patents related to advanced high-speed mechanical slicers used in food processing facilities that precisely slice and package food items such as meats and cheeses. The key components recited in the patent claims are a “loading apparatus” designed to load food items, a “feeding apparatus” responsible for supplying food items to a slicer, and a “stop gate” intended to regulate the assembly of food items prior to their entry into the slicing mechanism.

Weber filed inter partes review (IPR) petitions challenging the validity of several claims of the patents based on certain operating manuals. During the IPR proceedings, the Board determined that Weber’s operating manuals did not qualify as prior art printed publications because they were distributed selectively and subject to confidentiality restrictions. The Board also concluded that the prior art combinations, which included Weber, failed to disclose crucial claim limitations, notably the “disposed over” and “stop gate” limitations. The Board found the challenged claims not unpatentable. Weber appealed.

Weber argued that the Board erred in determining that the operating manuals were insufficiently accessible to constitute printed publications, specifically contending that the Board misapplied the Federal Circuit’s 2009 decision in Cordis Corp. v. Boston Scientific Corp. The Court agreed. It explained that unlike Cordis, where academic monographs were limited to distribution among a select few, Weber’s operating manuals were intended for distribution to purchasers of the machines and others to provide instructions on food slicer usage and maintenance. The Court explained that the evidence in the form of delivery records and email exchanges showed that manuals were available to customers upon purchase or request. The Federal Circuit also noted that the manuals were not bound by any confidentiality restrictions. The Court thus concluded that the operating manuals qualified as printed publications.

Turning to claim construction, the Federal Circuit reversed the Board’s interpretation of the “disposed over” and “stop gate” limitations. Consistent with long-standing precedent, the Court emphasized the importance of examining intrinsic evidence, including the claims themselves, the specification and the patent’s prosecution history. Weber argued that the claims’ language implied a broader feed apparatus positioning over the loading apparatus without strict alignment requirements. Supported by expert opinions, Weber contended that neither the claim language nor the specification mandated direct alignment. The Court agreed with Weber. The Court emphasized that “disposed over” demanded only a general positioning of the feed apparatus above the loading apparatus, not a direct positioning as the Board had construed.

Similarly, concerning the “stop gate” limitation, the Federal Circuit agreed that the Board’s determination was not supported by substantial evidence because evidence, such as the manuals, disclosed the claimed conveyer mechanism in a manner sufficient to establish its [...]

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