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When it Comes to Method of Use Claims, Preamble Language Regarding Intended Use is Limiting

by | Aug 26, 2021 |

The US Court of Appeals for the Federal Circuit issued three separate but related rulings (two precedential, one non-precedential) affirming decisions by the Patent Trial & Appeal Board (Board) regarding the validity of nine US patents and addressing the limitations of preamble language and motivation to combine. Eli Lilly Co. v. Teva Pharmaceuticals, Case Nos. 20-1876, -1877, -1878 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1747, -1748, -1750 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1749, -1751, -1752 (Fed. Cir. August 16, 2021) (Lourie, J.). These decisions come as the latest events in a dispute between Teva and Eli Lilly Company over competing products for the treatment of migraine headaches.

Teva owns nine patents directed to humanized antagonist antibodies that target calcitonin gene-related peptide. In 2018, the Food and Drug Administration (FDA) first approved Teva’s version of the biologic fremanezumab (Ajovy®) and then approved Lilly’s biologics license application for galcanezumab (Emgality®) eight days later. Both drugs are part of a new class of migraine therapeutic agents called calcitonin gene-related peptide antagonists.

Lilly challenged the validity of Teva’s nine patents covering Ajovy® in a series of inter partes review (IPR) petitions, arguing that the claims were obvious. The Board instituted IPR for all nine Teva patents. The similarity of subject matter and arguments led to three separate written opinions, each addressing three of the patents. In these decisions, the Board upheld the validity of three of the patents at issue (which covered methods of treating migraines with the antibodies) but found the claims of the six other patents directed to the antibodies themselves invalid.

Lilly appealed the first Board ruling covering methods of treating migraines to the Court. Lilly argued that the Board erred by (1) “reading a result into the constructions of the preambles and the term ‘effective amount,’” which led the Board to erroneously require Lilly to prove that a skilled artisan would have had “a reasonable expectation of achieving a result that was not claimed,” and (2) applying a too-high standard when weighing evidence to determine whether a skilled artisan would have a reasonable expectation of success. Lilly contended that a claim preamble containing only a statement of purpose cannot be a claim limitation and that no weight should have been given to the preambles. Teva argued that Lilly was basing its analysis on a false dichotomy between “limiting preambles” and preambles that are mere statements of purpose.

The Federal Circuit found the claim preambles to be limiting, reasoning that claims directed to methods of using compositions “are not directed to what the method ‘is’” but rather to “what the method ‘does,’” which usually is recited in the preamble. The preambles provided the only metric by which one practicing the claim could determine whether the amount administered is an “effective amount” and provided the antecedent basis for at least one later claim term in the independent claims.

After finding the preambles to [...]

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Even Judges Have a Boss: PTAB Must Sufficiently Articulate its Obviousness Reasoning

by | Jul 29, 2021 |

Addressing the sufficiency of the Patent Trial & Appeal Board’s (PTAB) justification of its inter partes review (IPR) determination, the US Court of Appeals for the Federal Circuit reversed the PTAB’s obviousness determinations, concluding that the PTAB’s findings regarding motivation to combine were not supported by substantial evidence. Chemours Company FC, LLC v. Daikin Industries, Ltd., Daikin America, Inc., Case No. 20-1289, -1290 (Fed. Cir., July 21, 2021) (Reyna, J.) (Dyk, J., concurring in part and dissenting in part).

Chemours, owner of the challenged patents, appealed the PTAB’s final written decisions in two IPRs initiated by Daikin. The challenged claims relate to a unique polymer for insulating communication cables formed by pulling wires through melted polymer to coat and insulate the wires, a process known as “extrusion.” The challenged claims of the patents recite that the polymer has a specific melt flow range of about 30+/- g/10 mins. The polymer’s melt flow range correlates with how fast the melted polymer can flow under pressure during extrusion. A higher melt flow rate means a faster coating of the polymer onto a wire. During the IPRs, the PTAB found all challenged claims unpatentable as obvious.

The Federal Circuit reviews the PTAB’s legal determinations de novo and its factual findings for substantial evidence, which “requires more than a ‘mere scintilla’ and must be enough such that a reasonable mind could accept the evidence as adequate to support the conclusion.” Obviousness is a question of law necessarily made on underlying findings of fact, and in making factual findings, the PTAB “must have both an adequate evidentiary basis for its findings and articulate a satisfactory explanation for those findings.”

In this instance, the Federal Circuit found that the PTAB’s obviousness findings were not supported by substantial evidence. According to the Court, while the PTAB may rely on prior art other than the references being applied or combined to inform itself of the state of the art at the time of the invention, the scope of the relevant prior art encompasses only that which is “’reasonably pertinent to the particular problem with which the inventor was involved.”’ Here, the Court explained that the only prior art reference relied on was not appropriate because it expressly taught away from the claimed invention and relied on teachings from other references that were not concerned with the particular problems the prior art sought to solve. As the Court noted, the PTAB “did not adequately grapple with why a skilled artisan would find it obvious to increase [the reference’s] melt flow rate to [the] claimed range while retaining its critical ‘very narrow molecular-weight distribution.’” To support its obviousness conclusion, the PTAB needed “competent proof showing a skilled artisan would have been motivated to, and reasonably expected to be able to, increase the melt flow rate of [the reference’s] polymer to the claimed range when all known methods for doing so would go against [the reference’s] invention by broadening molecular weight distribution.” By failing to provide its reasoning, the PTAB relied [...]

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It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

by | Jun 3, 2021 |

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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Prosecution History Prevents Patent Owner from “Intercepting” Win on Appeal

by | May 20, 2021 |

In reviewing whether the Patent Trial & Appeal Board (Board) correctly interpreted the meaning of “intercepting” in the context of Voice over Internet Protocol (VoIP) technology, the US Court of Appeals for the Federal Circuit found that the claim language and prosecution history supported the Board’s decision. The Court thus affirmed the Board’s construction and subsequent finding of obviousness. Uniloc 2017 LLC v. Apple Inc., Case Nos. 20-1403, -1404 (Fed. Cir. May 12, 2021) (Prost, C.J.)

Uniloc owns a patent directed to a system and method for using various VoIP features, such as caller-ID, call waiting, multi-line service, and different levels of service quality known as the “codec specification.” The patent explains that in order to generate revenue for these features, service providers must maintain control over which subscribers have paid for these additional features. To achieve that control, the system employs an enforcement mechanism that sits between the sender of the communication and the intended recipient. The enforcement mechanism ensures that both parties are authorized to use the particular features by intercepting the signaling message, determining whether the client is authorized, and filtering the signaling message based on the authorization. The majority of the claims require authorization related to only one service type. However, one of the claims (claim 18) requires authorization related to at least two service types.

Apple filed a petition for inter partes review (IPR), alleging that all claims of the patent were invalid as obvious over a prior art patent referred to as Kalmanek. Kalmanek discloses signaling messages that are routed through at least one “gate controller,” which can authenticate the identity of the calling party and authorize the services sought. The services include at least caller-ID and enhanced levels of call quality. Kalmanek’s process is accomplished by sending a SETUP message, which the calling party sends to the gate controllers and then to the intended recipient. After receipt, the called party sends a SETUPACK message along a return path to the gate controllers and then to the caller.

During the IPR, Apple asserted that the term “intercepting” a signaling message associated with the call, as recited in all independent claims, should be interpreted to mean “the signaling [message] is received by a network entity located between the endpoints of the call.” Uniloc disagreed and argued that the term should be interpreted as excluding the receipt of a signaling message by the intended recipient of the message. The Board agreed with Apple’s construction and subsequently found that all terms were invalid as obvious with the exception of claim 18. With respect to claim 18, the Board concluded that Apple failed to meet its burden to show that Kalmanek disclosed authorization related to a codec service. Furthermore, the Board opined that even assuming Apple had properly advanced such an argument, it would have lost on the merits.

On appeal, Uniloc challenged the Board’s construction of the “intercepting” term, and Apple cross-appealed the Board’s finding with respect to the non-obviousness of claim 18. The Federal Circuit affirmed [...]

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If You Can’t Build it, They Won’t Come: No Obviousness Based on Fanciful Engine Design

by | Apr 29, 2021 |

Reaffirming that a person of ordinary skill in the art must have been able to actually create a disclosure at the time of invention in order for it to serve as an obviousness reference, the US Court of Appeals for the Federal Circuit reversed a decision by the Patent Trial & Appeal Board (the Board) in an inter partes review (IPR), concluding that a patent covering certain turbofan engine technology was not rendered obvious by a prior art publication that could not be realized into practice. Raytheon Techs. Corp. v. General Electric Co., Case No. 20-1755 (Fed. Cir. Apr. 16, 2021) (Chen, J.)

The issue on appeal was relatively straightforward. In an IPR, GE challenged as obvious a Raytheon patent that covered a specific design of geared gas turbine engine that provided for a “power density” higher than previously invented turbine engines. The patent defined “power density” as a “sea-level-takeoff thrust” divided by the engine turbine volume. During the IPR, GE relied on a 1987 NASA technical memorandum as art and argued that the reference, which envisioned superior performance characteristics based on an advanced engine that was made entirely of composite materials, rendered the challenged claims obvious. The parties did not dispute that this engine was unattainable in 1987, and may still be impossible today, because the envisioned composite materials do not yet (and may never) exist. The memorandum disclosed several performance factors, but not power density, sea-level-takeoff thrust or turbine volume. Nonetheless, GE argued, and the Board agreed, that the memorandum disclosed performance parameters that would have permitted an ordinarily skilled artisan to derive power densities that would have fallen within the range claimed in Raytheon’s patent.

On appeal, the Federal Circuit agreed with Raytheon, concluding that the imaginary engine of the NASA memorandum could not serve as an invalidating reference. In reversing the Board, the Federal Circuit reiterated two bedrock principles of obviousness law:

  • An obviousness reference must be enabled by the knowledge of an ordinarily skilled artisan at the time of the invention (but need not be self-enabling).
  • An invention cannot be rendered obvious by a non-self-enabling reference if no other prior art evidence or reference enables the non-self-enabling reference.

In addition, when a reference’s enablement is challenged, the party offering the reference bears a burden to establish that the reference, itself or in combination with other contemporaneous knowledge, was enabled.

Applying these principles here, the Federal Circuit determined that GE had not met its burden to show that the memorandum was indeed enabled. The Board, wrongly in the Court’s view, focused solely on whether an ordinarily skilled artisan was taught the parameters to ascertain a power density, rather than whether the prior art disclosed a turbofan engine possessing the requisite power density. Finding no evidence in the record to conclude that “a skilled artisan could have made the claimed turbofan engine with the recited power density,” the Court reversed.

Practice Note: Although this case does not break new obviousness ground, it reinforces the general [...]

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Size Matters in Obviousness Analysis

by | Oct 29, 2020 |

The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an artificial heart valve that does not require removal of the damaged native heart valve. St. Jude Medical, LLC v. Snyders Heart Valve LLC, Case Nos. 19-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020) (Taranto, J.).

St. Jude filed two petitions for inter partes review (IPR) of a patent for an artificial heart valve and a system for inserting the valve. Both petitions were instituted by the Board and resulted in final written decisions. In the first decision, the Board found that St. Jude failed to establish unpatentability of the challenged claims, rejecting St. Jude’s contention that all challenged claims were anticipated by and obvious over the Leonhardt prior art reference. In the second decision, the Board found that certain claims were anticipated by the Bessler prior art reference, but rejected St. Jude’s contentions as to all other claims. St. Jude appealed, arguing that the Board erred in the first decision by erroneously construing the term “band” and erred in the second decision by finding that St. Jude failed to prove that a skilled artisan would have made a particular combination of Bessler and the Johnson prior art. Snyders cross-appealed in the second decision as to the claims the Board found were anticipated by Bessler.

The Federal Circuit affirmed the Board’s conclusions in the first decision, finding that not only was the Board’s construction of the term “band” proper, but that it was actually broader than St. Jude’s proposed construction—and that St. Jude expressly accepted the Board’s construction. The Board construed the heart valve band to mean “a structure generally in the shape of a closed strip or ring” (replacing St. Jude’s “circular” with “closed”). In the prior art, Leonhardt discloses a graft material which extends the length of the entire structure. The Federal Circuit agreed with the Board’s finding that Leonhardt’s graft material was “like a sleeve” as opposed to “a closed strip or ring.” St. Jude argued that an ordinary skilled artisan’s understanding of the term “band” does not include a length restriction, that a Leonhardt’s material was just a long band, and that the Board effectively changed its construction of the term. The Federal Circuit, however, was not persuaded by St. Jude’s unlimited-length definition of “band,” instead turning to dictionary definitions that included terms like “thin” and “narrow,” and looking to the patent specification that did not explicitly disclaim any length restrictions. The Court ultimately rejected St. Jude’s arguments, finding that St. Jude should have proposed a claim construction that precluded any limitations on length if it wished to argue such. The Federal Circuit affirmed the Board’s findings as to first decision.

The Federal Circuit next addressed Snyder’s cross-appeal. Snyder disputed the board’s construction of the “size[] and shape[]” of a frame that the patent requires must be inserted [...]

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No Due Process Violation When New Panel Hears Substantive Arguments

by | Oct 8, 2020 | ,

Affirming a Patent Trial and Appeal Board (Board) non-obviousness determination, the US Court of Appeals for the Federal Circuit found that the Board did not abuse its discretion in sanctioning a patent owner who engaged in ex parte communications by having a new panel hear the merits of the petition. Apple Inc. v. Voip-Pal.com Inc., Case Nos. 18-1456, -1457 (Fed. Cir. Sept. 25, 2020) (Reyna, J.).

Voip-Pal sued Apple for allegedly infringing two of its patents directed to routing communications between two different types of networks: public and private. Apple then petitioned for inter partes review (IPR) of several claims from both patents, arguing they were invalid as obvious. The Board ultimately found the claims were not invalid because Apple did not provide evidentiary support as to the motivation to combine multiple references.

During the IPR proceedings, Voip-Pal’s former CEO sent six letters to various parties, copying members of Congress, the President, federal judges and administrative patent judges at the Board criticizing the IPR system, complaining about the cancellation rate and requesting judgment in favor of Voip-Pal. The letters did not discuss the underlying merits of Apple’s petitions. In view of Voip-Pal’s conduct, Apple requested that the Board sanction Voip-Pal by entering adverse judgment against Voip-Pal or by vacating the final written decisions and assigning a new panel to preside over “constitutionally correct” new proceedings going forward.

For the sanctions proceeding, a new panel replaced the initial panel and determined that Voip-Pal had engaged in sanctionable conduct, and further determined that it  would preside over Apple’s petition for rehearing. The new panel found that Apple failed to show the initial panel had misapprehended or overlooked any matter, and even if the final panel were to accept Apple’s view of the prior art, it would not reach a different conclusion. Apple appealed.

On appeal, the Federal Circuit first addressed whether the appeal was moot. Before oral argument, the Court found in separate proceedings that some, but not all, of the claims at issue were invalid. Apple argued that this case mooted the entire appeal, even though the claims did not entirely overlap. Starting with the overlapping claims, the Court found that the appeal was moot in regards to these claims because Apple no longer had the potential for injury. However, the Court rejected Apple’s argument that the appeal was moot under a theory of claim preclusion in regards to the non-overlapping claims. The Court explained that any preclusive effect from the other appeal must be decided by a future court in any subsequent action brought by Voip-Pal. Thus, any discussion regarding claim preclusion would be advisory in nature and outside the scope of the Court’s Article III jurisdiction.

Turning to the merits, the Federal Circuit affirmed the Board did not violate the Administrative Procedure Act (APA) or Apple’s due process rights. The Board’s rules provide that “[t]he Board may impose a sanction” and explains that “[s]anctions include entry of one or more” of eight defined actions. Although the Board’s sanctions imposed [...]

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Challenge to PTAB’s Finding of Non-Obviousness Fails to Pay Out

by | Aug 13, 2020 | ,

Addressing whether the Patent Trial and Appeal Board (PTAB) ran afoul of the Administrative Procedure Act (APA) in finding that a dependent claim was valid despite the patent owner’s lack of validity arguments beyond those advanced for the corresponding and invalid independent claim, the US Court of Appeals for the Federal Circuit affirmed the PTAB’s ruling and found no APA violation. FanDuel, Inc. v. Interactive Games LLC, Case No. 19-1393 (Fed. Cir. July 29, 2020) (Hughes, J.) (Dyk, J. concurring in part and dissenting in part).

Interactive Games owns a patent directed to a method for allowing users to gamble remotely via a mobile device, according to certain game configurations. Specifically, the independent claim is directed to altering a user’s game outcome based on the gaming configuration associated with the location of a user’s mobile gaming device. A dependent claim adds the additional limitation of “accessing a lookup table which contains an ordered list of locations and associated game configurations.”

FanDuel petitioned for inter partes review (IPR) of the patent as obvious based on three references. The first reference (Carter) disclosed a mobile wagering system capable of determining a gambler’s location and restricting access based on the location. Carter’s system used a database that correlated various locations with applicable access levels. Importantly, the reference generally indicated that the system may employ various components such as “memory elements, processing elements, logic elements, look-up tables, and the like.” The second reference (Walker) disclosed enabling or disabling certain features on a mobile gaming device based on a user’s location. And the third reference (the webpage) included a list of slot payouts by casino, city and state, alphabetically organized by state. FanDuel also submitted an expert declaration that the use of look-up tables was well known in the art and that it would have been an obvious design choice to store Carter’s jurisdictional information in an “ordered list” similar to the webpage.

In its Preliminary Patent Owner Response, Interactive incorporated its validity arguments for the independent claim into its arguments for the dependent claim, but did not otherwise advance any substantive arguments specific to the dependent claim. The PTAB instituted IPR for all challenged claims. Following institution, Interactive submitted a patent owner response, which again did not advance any substantive arguments specific to the dependent claim. While Interactive did submit an expert declaration, the statements made by FanDuel’s expert specific to the dependent claim were uncontested. Ultimately, the PTAB found the independent claim invalid, but found the dependent claim valid. FanDuel appealed.

FanDuel argued that the PTAB’s decision with respect to the dependent claim violated the APA because the PTAB changed its obviousness theory midstream. FanDuel alleged that no further record development was presented regarding the dependent claim after institution, and therefore a finding of validity in light of the PTAB’s decision to institute amounted to a changed position by the PTAB, to which FanDuel was entitled notice and an opportunity to respond.

The Federal Circuit disagreed and affirmed the PTAB’s decision. In finding [...]

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Federal Circuit Extends Arthrex to Ex Parte Re-Examination Proceedings

by | Jul 15, 2020 |

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

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

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

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

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

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Reliance on Common Sense Permitted in Obviousness Analysis

by | Jul 9, 2020 | ,

The US Court of Appeals for the Federal Circuit affirmed a final written decision from the Patent Trial and Appeal Board (PTAB) finding patent claims directed to aircraft lavatories obvious based on prior art because a skilled artisan would have used common sense to incorporate a missing limitation into the prior art. B/E Aerospace, Inc. v. C&D Zodiac, Inc., Case Nos. 19-1935, -1936 (Fed. Cir. June 26, 2020) (Reyna, J.).

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