Patent Trial & Appeal Board Archives - Page 14 of 29

Patent Trial & Appeal Board

IPR Petition Cannot Be Based on Applicant Admitted Prior Art

by Thomas DaMario | Feb 10, 2022 | Patents

Addressing the type of prior art that may form the basis of an inter partes review (IPR) proceeding, the US Court of Appeals for the Federal Circuit vacated an unpatentability finding based on “applicant admitted prior art” in the challenged patent. Qualcomm Inc. v. Apple Inc., Case Nos. 20-1558, -1559 (Fed. Cir. Feb. 1, 2022) (Taranto, Bryson, Chen, JJ.)

Qualcomm owns a patent directed to integrated circuit devices having power detection circuits for systems with multiple supply voltages. The patent seeks to solve problems associated with stray currents causing level shifters in integrated circuits to trigger input/output devices for transmission, which results in erroneous output signals from the circuit. The patent describes various prior art methods for solving the stray current problem.

Apple filed IPR petitions based on two grounds. The first was based on the combination of four prior art references. In its final written decision, the Patent Trial & Appeal Board (Board) found that the combination of these four references did not render the challenged claims invalid. The second ground relied on the applicant admitted prior art disclosed in the specification of the challenged patent in combination with another prior art reference (Majcherczak). During the IPR proceedings, Qualcomm admitted that the combination of the applicant admitted prior art and Majcherczak taught every element of the challenged claims but argued that Apple’s use of the applicant admitted prior art as the basis for an invalidity ground is barred in an IPR proceeding. The Board disagreed with Qualcomm and found the challenged claims unpatentable based on Apple’s second ground. Qualcomm appealed.

Qualcomm argued on appeal that IPR proceedings may only be based on “prior art patents or prior art printed publications” and that 35 U.S.C. § 311(b), which governs IPR proceedings, does not allow for the use of “a patent owner’s admissions” that is contained in non-prior art documents. Apple countered, arguing that any prior art that is contained in “any patent or printed publication, regardless of whether the document itself is prior art, can be used as a basis for [an invalidity] challenge.”

The Federal Circuit agreed with Qualcomm, finding that applicant admitted prior art in a challenged patent may not form the “basis” for an invalidity claim in an IPR proceeding. The Court explained that invalidity grounds advanced in an IPR must be based on patents or printed publications that are themselves prior art to the challenged patent. In reaching this conclusion, the Court relied on the 2019 Supreme Court opinion in Return Mail, Inc. v. U.S. Postal Serv., which referred to “patents and printed publications” in the context of § 311(b) as “existing at the time of the patent application.” The Court also looked to its own interpretations of “prior art consisting of patents or printed publications” in the context of ex parte reexamination proceedings under 35 U.S.C. §§ 301 and 303, which “permits the Director to institute a reexamination after ‘consideration of other patents or printed publications.’” Accordingly, the Court vacated the unpatentability [...]

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Shots Fired: Challenger Must Have Requisite Standing Before Appealing Unfavorable IPR Decisions

by Paul Devinsky | Dec 16, 2021 | Patents

The US Court of Appeals for the Federal Circuit found, in the context of an appeal from an inter partes review (IPR) decision, that the appellant had Article III standing and affirmed a Patent Trial & Appeal Board (Board) decision, holding the challenged claims unpatentable as obvious. ModernaTX, Inc. v. Arbutus Biopharma Corporation, Case No. 20-2329 (Fed. Cir. Dec 2, 2021) (Lourie, J.)

Arbutus owns a patent pertaining to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.” Moderna petitioned for IPR of the patent, asserting three grounds:

Moderna alleged that all claims of the challenged patent would have been anticipated and/or obvious in light of International Pat. Publ. WO 2005/007196 (‘196 PCT) or US Pat. Publ. 2006/0134189 (‘189 publication).
Moderna alleged that all claims of the challenged patent would have been obvious over a combination of the ‘196 PCT, the ‘189 publication, Lin and Ahmad.
Moderna alleged that all claims of the challenged patent were anticipated by US Pat. Publ. 2006/0240554 (‘554 publication), and alternatively that the claims would have been obvious over the ‘554 publication.

The Board rejected each of Moderna’s allegations, finding that the claims were not unpatentable as obvious. Moderna appealed.

Before addressing Moderna’s appeal on its merits, the Federal Circuit addressed whether Moderna had proper standing to challenge the Board’s decision. The Court stated that well-established precedent dictates that an appellant seeking review of a Board decision in an IPR must have suffered an injury in fact that is fairly traceable to the challenged conduct of the appellee and is likely to be redressed by a favorable judicial decision. The Court underscored that under IPR statute, there is no standing requirement for petitioners to request institution of IPR by the Board, meaning that a requester need not have a concrete stake in the outcome. Additionally, where the statue itself grants judicial review (such as in the case of an IPR), standing criteria of immediacy and redressability may be “relaxed.” Nonetheless, the Court explained that a party’s participation in the underlying IPR alone does not confer standing on that party to appeal the Board decision before an Article III court such as the Federal Circuit. The party seeking review (in this case Moderna) must show that it possesses requisite injury for standing to appeal.

Moderna asserted that substantial risk existed that Arbutus would bring an infringement suit against Moderna based on Moderna’s COVID-19 vaccine if the challenged patent was to remain valid. In support, Moderna submitted a declaration from its senior vice president and deputy general counsel that Moderna was working to harness proprietary mRNA technology and planned on releasing and applying for emergency use authorization for a COVID-19 vaccine in December 2020. The declaration also described how Arbutus’s conduct created a substantial risk that it would bring subsequent infringement action against Moderna. An example of such conduct was a series of public statements [...]

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Post-AIA Patents Are Not Shielded from Interferences

by Jenny Chen, Ph.D. | Dec 16, 2021 | Patents

Addressing the applicability of interference proceedings to patent applications filed after the Leahy-Smith America Invents Act (AIA) was enacted, the Patent Trial & Appeal Board (Board) found it proper to declare an interference between a patent application with a priority date before March 16, 2013, the AIA implementation date, and a patent with a priority date after March 16, 2013. SNIPR Technologies Limited v. The Rockefeller University, Pat. Interf. No. 106,123 (DK) (PTAB Nov. 19, 2021) (Katz, APJ).

The AIA switched the US patent system from a “first to invent” to a “first inventor to file” system. In line with this change, the AIA eliminated the patentability requirement under 35 U.S.C. § 102(g), regarding whether another inventor made the invention first, and the interference proceeding under 35 U.S.C. §135 for determining who invented the claimed invention first. Section 3(n)(2) of the AIA provides a timing provision relating to this change. Under this section, the interference proceeding “shall apply to each claim of an application for patent, and any patent issued thereon, for which the amendments made by this section also apply, if such application or patent contains or contained at any time, a claim [having a priority date before March 16, 2013].”

The US Patent & Trademark Office (PTO) declared an interference between several patents owned by SNIPR and a pending application to The Rockefeller University. The claims involved were drawn to a method of killing or modifying specific bacteria in a mixed population of bacteria with different species using the CRISPR-mediated gene editing technology. The Rockefeller application asserted a priority date of February 7, 2013 (i.e., pre-AIA), while the SNIPR patents asserted the priority date of May 3, 2016 (i.e., post-AIA). SNIPR argued that the interference proceeding was improper since all involved patents were filed after the AIA was enacted.

The Board rejected SNIPR’s argument, explaining that Section 3(n)(2) provides for continuation of interference under certain circumstances. The Board noted that the patentability requirement under 35 U.S.C. §102(g) and interference still apply to each claim having a priority date before March 16, 2013, such as the claims of Rockefeller’s involved application. Accordingly, when the Rockefeller claims would otherwise be allowable, except for the existence of an interference with other claims such as SNIPR’s claims, Section 3(n)(2) necessarily calls for an interference proceeding between the Rockefeller application and the SNIPR patents. Otherwise, the PTO would not be able to determine whether Rockefeller was entitled to a patent under 35 U.S.C. §102(g).

The Board further reasoned that, instead of ending all interferences at the implementation of the AIA, US Congress enacted Section 3(n)(2) to continue the interference proceeding as applicable to certain cases after AIA. Congress also did not explicitly require that cases involved in interferences must all have priority dates before March 16, 2013. Therefore, the Board found that Congress contemplated interferences between pre-AIA and post-AIA applications and patents. Accordingly, the Board ruled in Rockefeller’s favor, finding it was the first to invent the claimed technology.

Obvious to Try Requires Reasonable Expectation of Success Tethered to Claimed Invention

by Mandy H. Kim | Dec 16, 2021 | Patents

Addressing obviousness in the context of method of treatment claims using particular drug dosages, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) final written decision holding that Teva failed to prove obviousness because it failed to show a reasonable expectation of success. Teva Pharms., LLC v. Corcept Therapeutics, Inc., Case No. 21-1360 (Fed. Cir. Dec. 7, 2021) (Moore, C.J.)

Corcept filed a New Drug Application (NDA) for Korlym, a 300 mg mifepristone tablet administered to certain patients with Cushing’s syndrome. The US Food and Drug Administration (FDA) approved Corcept’s application but required a drug-drug interaction clinical trial to determine drug safety when co-administered with strong CYP3A inhibitors such as ketoconazole (Lee memorandum). Corcept conducted the drug-drug interaction study and received a patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor based on the data from the Lee memorandum.

Teva sought post-grant review of the patent after Corcept asserted it against Teva in district court. Teva argued that the patent would have been obvious in view of Korlym’s label and the Lee memorandum and submitted a supporting expert declaration. The Board held that Teva failed to prove that a skilled artisan would have had a reasonable expectation of success for safe co-administration of more than 300 mg of mifepristone with a strong CYP3A inhibitor, and thus failed to prove that the patent was obvious. Teva appealed, arguing that the Board erroneously required precise predictability rather than reasonable expectation of success in achieving the claimed invention, and that the Board did not apply Federal Circuit prior art range precedents.

The Federal Circuit affirmed the Board’s decision. Turning first to reasonable expectation of success, the Court explained that the analysis must be tied to the scope of the claimed invention. Because the patent required safe administration of a specific amount of mifepristone, the Board did not err in requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. Applying this correct standard, the Court found that the evidence supported that a skilled artisan would have had no expectation as to whether co-administering dosages of mifepristone above the 300 mg/day threshold set forth in the Korlym label would be successful. The Federal Circuit also agreed with the Board that Teva’s expert testimony supported a finding of no expectation of success in achieving the claimed invention based on inconsistent testimony before and after institution.

Turning next to the applicability of Federal Circuit prior art range precedents, the Federal Circuit found that Teva had failed to prove that the general working conditions disclosed in the prior art encompassed the claimed invention. Substantial evidence supported the Board’s finding that there was no overlap in ranges because the prior art (Korlym label and industry publications) capped the range of co-administration dosages at 300 mg/day. The Court also noted that Teva’s reliance on mifepristone monotherapy dosages to create an overlap in the claimed ranges failed because the patent claims [...]

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

by Art Dykhuis | Dec 9, 2021 | Patents

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

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

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

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

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Design Patent Prior Art Must Be From Same or Analogous Field as Claimed Article of Manufacture

by Paul Devinsky | Oct 14, 2021 | Patents

Finding that the Patent Trial & Appeal Board (Board) applied an erroneous interpretation of claim scope, the US Court of Appeals for the Federal Circuit reversed a Board decision upholding an examiner’s rejection of a lip implant design patent as anticipated by a non-analogous art tool. In re: SurgiSil, Case No. 20-1940 (Fed. Cir. Oct. 4, 2021) (Moore, C.J.)

SurgiSil filed a design application for a lip implant shaped like a generally cylindrical rod that tapered to a point at each end. The examiner rejected the patent as anticipated by a “stump,” an art tool of similar, almost identical, shape used for smoothing and blending areas of pastel or charcoal. SurgiSil appealed the rejection to the Board. The Board affirmed the rejection, finding that the differences in the shapes of SurgiSil’s lip implant and the art tool were minor. The Board rejected SurgiSil’s argument that the two articles of manufacture were “very different,” reasoning that it is irrelevant whether a prior art reference is analogous for anticipation purposes. SurgiSil appealed.

Reviewing the Board’s legal conclusions de novo, the Federal Circuit found that the Board erred as a matter of law. Citing 35 U.S.C. § 171(a) and the 1871 Supreme Court decision in Gorham Co. v. White, the Court explained that a design patent claim does not cover the design in the abstract, and that it is limited to the particular article of manufacture identified in the claim. The Court concluded that the claimed design was limited to a lip implant, did not cover other articles of manufacture and that the Board’s decision therefore rested on an erroneous interpretation of the claim’s scope.

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

by Paul Devinsky | Aug 26, 2021 | Patents

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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Without More, Mere Automation is Abstract—Not Construing Interchangeable Terms Doesn’t Give Them the Cold Shoulder

by McDermott Will & Emery | Aug 19, 2021 | Patents

In the latest development relating to patent eligibility of content-based identifier patents, the US Court of Appeals for the Federal Circuit affirmed decisions finding patent claims ineligible under 35 U.S.C. § 101. PersonalWeb Techs. LLC v. Google LLC, YouTube, LLC, Case No. 20-1543 (Fed. Cir. Aug. 12, 2021) (Prost, J.) (consolidating PersonalWeb Techs. LLC v. Facebook, Inc., Case No. 20-1553, and PersonalWeb Techs. LLC, Level 3 Commc’ns. LLC v. EMC Corp., VMWare, Inc., Case No. 20-1554).

PersonalWeb sued technology companies in the Eastern District of Texas in 2011 over three of its patents. The patents were directed to data-processing systems that assign each data item a substantially unique content-based identifier, generated by hash algorithm, which changes when the content changes and is used to perform data-management functions. Several defendants successfully motioned for transfer to the Northern District of California, where their companies were headquartered and/or their employees responsible for the development of the accused products were based. After claim construction in Texas, the cases were transferred and stayed pending several inter partes reviews before the US Patent Trial & Appeal Board (Board). Previous decisions before the Federal Circuit affirmed the Board’s findings that using hash-based identifiers for data management was disclosed in the prior art, that content-based identifiers in performing file-management functions, such as backing up files, were also known and other independently unpatentable aspects were recited in the claims. After the stay was lifted, the California court granted the defendants’ motion for judgment on the pleadings that the remaining asserted claims were patent ineligible under 35 U.S.C. § 101. PersonalWeb appealed.

To assess patent eligibility, the Federal Circuit applied the two-step Mayo/Alice framework. Under step one (determining whether the claims at issue are directed to a patent-ineligible concept, such as an abstract idea), the Court considered the focus of the claimed advance over the prior art and found that the claims were directed to an abstract idea. PersonalWeb contended that its claims were directed to “a substantially unique, algorithm-derived, content-based identifier for all data items in a networked computer, which allows a computer within a network containing diverse computing and storage systems to locate and distribute data without knowing either the file system of any device within the network or the conventional name of any data item.” However, the Court adopted the district court’s view, which was that the patents were directed to “(1) using a content-based identifier generated from a ‘hash or message digest function,’ (2) comparing that content-based identifier against something else, [that is,] another content-based identifier or a request for data; and (3) providing access to, denying access to, or deleting data.” Given the focus in Mayo/Alice step one of “whether the claims of the asserted patents fall within the excluded category of abstract ideas,” and citing to parallel examples from precedent cases, the Court concluded that the claims were directed to the use of an algorithm-generated content-based identifier to perform the claimed data-management functions, which include controlling access to data items, retrieving and delivering copies [...]

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If Intrinsic Evidence Provides a Clear Meaning, Just Stop

by Paul Devinsky | Aug 19, 2021 | Patents

The US Court of Appeals for the Federal Circuit vacated a final written decision of the Patent Trial & Appeal Board (Board) based on its finding that the Board erred in its ultimate claim construction by relying on extrinsic evidence that was inconsistent with the intrinsic evidence. Seabed Geosolutions (US) Inc. v. Magseis FF LLC, Case No. 20-1237 (Fed. Cir. Aug. 11, 2021) (Moore, C.J.)

In April 2018, Seabed Geosolutions petitioned for inter partes review of a patent owned by Magseis directed to “seismometers for use in seismic exploration.” Every claim recited a “geophone internally fixed within” either a “housing” or an “internal compartment” of a seismometer. The Board construed this limitation to require a non-gimbaled geophone based entirely on extrinsic evidence. The Board found that the term “fixed” had a special meaning of “non-gimbaled” at the time of the invention. Based on this finding, the Board determined that Seabed had failed to prove that the challenged claims were unpatentable because the cited prior art did not disclose a non-gimbaled geophone. Seabed appealed.

The Federal Circuit reversed the Board’s claim construction of the term “fixed” because it relied on extrinsic evidence that was inconsistent with the intrinsic evidence and unnecessary to consider given the clarity of the intrinsic evidence. The Court reminded the Board that it “resort[s] to extrinsic evidence to construe claims only if it is consistent with the intrinsic evidence,” and that “[i]f the meaning of a claim term is clear from the intrinsic evidence, there is no reason to resort to extrinsic evidence,” citing prior Federal Circuit decisions.

Contrary to the special meaning found by the Board, the Federal Circuit determined that the term “fixed” carried its ordinary meaning (i.e., attached or fastened). The Court found that the term “specifies the geophone’s relationship with the housing, not the type of geophone.” As an initial matter, the specification was silent as to whether the geophone was gimbaled or not. “That silence does not support reading the claims to exclude gimbaled geophones,” in part because the specification used the term gimbaled when describing other aspects of the invention. Had the applicant intended to limit the claimed geophone, it would have done so.

Furthermore, the specification described the internal mounting of the geophone as a key feature to overcome issues with the then-conventional method of separating the geophone from the seismometer’s other components. The specification reiterated that by internally mounting the geophone, the invention was “self-contained.” The prosecution history also revealed that both the applicant and examiner understood the term to carry its plain and ordinary meaning, equating “internally fixed within” with “disposed, and electrically connected, within.” That equivalence indicates that the term was intended to describe the relationship of the geophone with the seismometer, rather than to limit the type of geophone as contemplated by the Board. Accordingly, the Court found that the intrinsic record was clear, and that the Board’s reliance on extrinsic evidence—much less extrinsic evidence that was inconsistent with the specification itself—was improper and remanded for [...]

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

by Cecilia Choy, Ph.D. | Jun 3, 2021 | Patents

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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