- Cipla Limited v. Gilead Sciences, Inc.Institution deniedPTAB · May 15, 2025 · IPR2025-00033 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–13 under § 314(a), finding the Fintiv factors favored denial and the petition did not present compelling merits.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“We determine that this factor weighs heavily in favor of exercising discretion to deny the Petition. The trial date in the district court litigation is scheduled for October 6, 2025. See Prelim. Resp. 16 (citing Ex. 2010). This date is at least six months before our projected statutory deadline should we go forward in this case. Patent Owner points out that this trial date is nine months later than the median time to trial in the District of Delaware, and in Patent Owner’s view, the parties are on track to satisfy the current schedule. Id. at 16–17 (citing Ex. 2011).” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“1 Patent Owner also asserts that the Petition should be denied under 35 U.S.C. § 325(d), but we need not reach this issue because we are exercising discretion under Section 314(a) to deny the Petition. See Prelim. Resp. 2–3.” slip op. at 2
Discretionary denialPatents in suitUS 11,744,802 - Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentablePTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30
Patent outcomesUS 11,672,803 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,672,803 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13
- BurdenDecided for petitioner
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730 - Jiangsu Favored Nanotechnology Co., Ltd. v. P2i Ltd.All claims unpatentablePTAB · Apr 11, 2025 · IPR2024-00380 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1–5, 7, and 9–14 are unpatentable as obvious over Cohen and Legein or Francesch and Legein; Petitioner’s motion to strike is denied as moot.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“The parties agree that a person of ordinary skill in the art in the field of the ’087 patent in June 20154 “would have had at least a bachelor’s degree in a field such as chemistry, physics, or chemical engineering, as well as at least two years of experience with plasma-polymerization techniques.” Pet. 20 (citing Ex. 1002 ¶¶ 22–29); PO Resp. 13 (Patent Owner stating that it “does not dispute this characterization of the level of ordinary skill in the art.”); see also PO Sur-reply 1–2 (noting both parties’ agreement on the education and experience level of the ordinarily skilled artisan).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the fully developed trial record, we determine that no claims need an express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Because of Patent Owner’s shifting definitions of the education and experience level of the ordinarily skilled artisan, it is unclear on the complete record what precise definition Patent Owner and Dr. Senkevitch are applying when arguing the skilled artisan’s capabilities. PO Resp. 13, 22–27, 31–32, 34–40; PO Sur-reply 1–6, 11–13; Ex. 2007 ¶¶ 30, 31, 33, 34, 37, 40, 52–55, 60, 68, 74, 76, 77, 80–86, 89, 91, 94, 95, 100, 102–105, 108, 110, 111, 113–116, 118–120, 122, 124, 127–134. We, therefore, give Dr. Senkevitch’s testimony regarding the capabilities of a person of ordinary skill in the art minimal weight, which leaves us with Patent Owner’s insufficiently supported arguments regarding the skilled artisan’s capabilities. PO Resp. 13, 22–27, 31–32, 34–40; PO Sur-reply 1–6, 11–13. Moreover, as Petitioner correctly points out, the ʼ087 patent expressly teaches that the precise conditions for forming a protective polymeric coating “will vary depending upon factors such as, without limitation, the nature of the monomer compound, the crosslinking agent, the substrate, as well as the desired properties of the coating” and that such “conditions can be determined using routine methods.” Ex. 1001 15:1–15:5 (emphasis added); Pet. Reply 17. Where the patent itself leaves to the judgment of an ordinarily skilled artisan the assessment of these factors to ascertain suitable conditions for forming the protective coating, we find persuasive Petitioner’s view that it would have been well within the level of ordinary skill to ascertain such suitable conditions.” slip op. at 20
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We disagree with Patent Owner. Although the claims of the ʼ087 patent recite obtaining the protective cross-linked polymeric coating “by exposing the device or component to a plasma,” the field of endeavor analysis in an analogous art inquiry does not exclusively turn on the claims at issue, but rather takes account of the entirety of a patent’s disclosure. See In re Bigio, 381 F.3d 1320, 1326 (Fed. Cir. 2004) (explaining that “the PTO must show adequate support for its findings on the scope of the field of endeavor in the application’s written description and claims” (emphasis added)); In re Mettke, 570 F.3d 1356, 1359 (Fed. Cir. 2009) (rejecting an argument that the field of endeavor was limited to a claimed “Internet terminal” when “the specification describes various communication media, including facsimile machines and email, as related to the invention.”). This is significant here because the ʼ087 patent discloses that “[t]he … invention relates to protective coatings” and specifically “relates to protective coatings for electronic or electrical devices and components thereof, and methods of forming such coatings.” Ex. 1001, 1:14–17. Based on this disclosure, we find that the ʼ087 patent’s field of endeavor relates to “protective coatings for electronic or electrical devices and components thereof” broadly, not just those formed on such devices or components via a plasma polymerization process as asserted by Patent Owner. Id. Although Cohen does not explicitly disclose that its crosslinked polymers constitute a “protective coating,” Cohen does disclose that its “copolymerizable mixture can be cast into films” (Ex. 1004, 2:61–62), that the polymerization can “effected in situ,” and that the polymers may be used in “numerous” electrical applications (id. at 5:17–25). Tr. 8:9–10:2, 27:2– 21; see Pet. Reply 5 (explaining how “Cohen described insulating polymers that could be applied as films and be used to protect substrates including cables and electrical coils.” (citing Ex. 1004, 2:60–63, 5:13–25)). These disclosures suggest strongly that Cohen’s crosslinked polymers––if cast into a film or formed in situ on an electrical device or component––would serve as a protective coating on that electrical device or component, even though Cohen does not expressly refer to its crosslinked polymers ipsis verbis as a “protective coating.” Thus, we find that Cohen is within the field of endeavor of the ʼ087 patent.” slip op. at 15
Patent outcomesUS 11,041,087 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,041,087 - PTAB · Apr 11, 2025 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–19, finding a reasonable likelihood of unpatentability on multiple obviousness grounds, while declining institution under Ground 9 at the preliminary merits stage.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–19 of the ’752 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we determine that Petitioner has established a reasonable likelihood of prevailing in showing that claims 1 and 4–14 are obvious over the combination of Native and Bianchi ’254. In particular, we are persuaded by Petitioner that the combination of Native and Bianchi ’254 discloses a deodorant stick comprising each element of claims 1 and 4–14. Pet. 41–50. We also find that Petitioner has shown sufficiently on the record before us that a person of ordinary skill in the art would have had a reasonable expectation of success to implement Bianchi ’254’s hardness range in Native’s formula. Here, we credit Dr. Michniak-Kohn’s testimony that a person of ordinary skill in the art would have understood how to adjust hardness using the structurants in a deodorant composition. Ex. 1002 ¶ 41, 191–192.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“biased testimony from an employee” and the Petition therefore lacks sufficient evidence to establish the images provided in the Squatch declaration as containing prior art printed publication material. Id. at 27–28 (citing Finnigan Corp. v. ITC, 180 F.3d 1354, 1366 (Fed. Cir. 1999) (“[T]he law has long looked with disfavor upon invalidating patents on the basis of mere testimonial evidence absent other evidence that corroborates that testimony.”); Nobel Biocare Services AG v. Instradent USA, Inc., 903 F.3d 1365, 1377-78 (Fed. Cir. 2018) (“corroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.”). 3. Discussion Having considered the parties’ positions and evidence of record, summarized above, we find Patent Owner to have, at this stage of the proceeding, the better position.. Accordingly, we determine that there is insufficient evidence to indicate a reasonable likelihood that Petitioner will prevail in establishing that that claims 15–19 would have been obvious over the combination of Squatch and Sturgis for the reasons set forth in the Preliminary Response and summarized above. However, we will make our final determination on these issues on the full record developed during this proceeding. See Hulu LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 11 (PTAB Dec. 20, 2019) (precedential) (“To prevail in a final written decision in an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.”).” slip op. at 30
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“35 U.S.C. § 325(d). Prelim. Resp. 29–38. In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 32
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,844,752 - Kinderfarms LLC v. Genexa Inc.All claims unpatentablePTAB · Mar 24, 2025 · PGR2023-00051 · APJ Deborah Katz · PGR · Final written decision
Claims 1–24 are unpatentable as obvious under § 103 over FR458 with the ’4666 patent and WO133; claims 1–17 are also unpatentable over WO742 with the ’4666 patent and WO133.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties’ positions about the level of ordinary skill in the art are similar. (See Pet., 13–14; see PO Resp., 10–12.) In light of the parties’ arguments and evidence, we determine that the ordinarily skilled artisan would have had a bachelor of science degree in a relevant life sciences field, such as chemistry, biochemistry, or pharmacy, with at least three to four years of work or laboratory experience in pharmaceutical formulations and would have had access to team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals. (See Pet. 13–14; see PO Resp. 10–12; see Dec. 6–7.) Both of the parties’ proposals as to the level of ordinary skill in the art are consistent with the disclosure of the ’795 patent and the asserted prior art. The distinction between the parties’ proposals is minimal and would not change the outcome of this Decision. Thus, we adopt and apply Patent Owner’s proposal.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Although Petitioner puts forth constructions for terms in the claims of the ’795 patent, Patent Owner argues that we need not expressly construe any terms to resolve the controversy between the parties. (See Pet. 14–19; see PO Resp. 12.) Except as indicated below, we agree that express construction of the claim terms is not required because the parties do not materially dispute the meanings of the terms. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Limitation (c) of claim 1 recites “syrup formulation” once and then “syrup” by itself twice. The parties agree that two recitations of “syrup” by itself mean and are synonymous with “syrup formulation.” (See Tr. 15:16– 19 (counsel for Petitioner: “[T]he term, syrup, by itself, means the formulation. And for that reason, we--it’s our position that it’s the syrup formulation that has the specific viscosity requirements as well as the other features that we discussed.”); 31:17–20 (counsel for Patent Owner: “But those wherein clauses, what it’s referring to, the syrup formulation and the syrup -- it was all to a complete to a final formulation, right, it’s not just the agave syrup. Everybody here recognizes and understands that from that perspective.”).) Thus, the parties agree that the “viscosity of less than 1500 centipoise at about 22 degrees” limits the final “pharmaceutical syrup formulation for oral administration,” not the “agave syrup” limitation in limitation (b) of claim 1.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues further that Dr. Crowley testifies that, “[g]enerally, suspensions having a viscosity in the range of 20 to 150 cP are considered readily pourable,” but that this range is well below the viscosity range of 200–900 cP taught in WO133 and the preferred viscosity range of 1000–3000 cP taught in the ’4666 patent. (See PO Resp. 45 (quoting Ex. 1003 ¶ 59).) Dr. Crowley testifies that “increasing the viscosity of a suspension formulation has been shown to impair the dissolution characteristics of immediate release acetaminophen” and that, “[w]ith respect to suspensions for oral administration, having a higher viscosity is generally not desirable.” (Ex. 1003 ¶ 59.) According to Patent Owner, this is a “teaching away” because Petitioner’s own expert testimony demonstrates a motivation not to combine the acetaminophen formulation of FR458- Example 1 with the 1000-3000 cP range of the ’4666 patent and the 200-900 cP range of WO133 since by his own admission doing so would yield bad results (i.e., impairing the dissolution characteristics of the acetaminophen) and generally undesirable higher viscosity. (PO Resp. 46 (citing Berkland Decl., Ex. 2009 ¶ 148).) Dr. Crowley’s cited testimony, however, is about general characteristics of suspensions for oral administration, whereas the WO133 refers specifically to sweetened analgesic formulations. (See Ex. 1006, 8:1– 3 (“The viscosity of the acetaminophen composition generally ranges from about 200–900 centipoise, preferably from about 300–700 centipoise.”); see Pet. Reply 8–9.) As Petitioner notes, Dr. Crowley also testifies that the viscosity of 29 commercially available, pediatric liquid oral antibiotic formulations were measured and determined to range from 20 to 1,780 cP” and that “[t]he viscosity of Children’s Tylenol has been reported to be less than 1,000 centipoise at shear rates between 0.05 and 0.2 reciprocal seconds.” (Ex. 1005 ¶ 58.) Thus, we are not persuaded that Dr. Crowley’s testimony contradicts the teachings regarding viscosity of analgesic formulations in the cited prior art.” slip op. at 23
Patent outcomesUS 11,617,795 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 11,617,795 - PTAB · Mar 7, 2025 · IPR2024-01353 · APJ Tawen Chang · IPR · Institution
Instituted IPR of claims 1–20 on all asserted grounds; the Board found a reasonable likelihood of unpatentability over Kanan and Neri, with Famulok for claim 16.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314(a).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On the current record, for purposes of this Decision, we apply Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’848 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We note, 8 “POSA” refers to “person of ordinary skill in the art.” Pet., cover page. experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s definition. C. Claim Construction” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“As an initial matter, two criteria determine whether prior art is analogous: “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). We find that, at this stage of the proceeding, Petitioner has sufficiently shown that Kanan and Neri are and/or are reasonably pertinent to the problem which the inventor is involved, in particular “encoding individual members of a library of chemicals with unique nucleotide sequences that can later be detected and analyzed to determine the identification of the members involved in the interaction.” Pet. 17.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“argument does not undermine Petitioner’s challenge at this stage. In particular, Petitioner has explained that the modification of Kanan with Neri’s self-assembly sequence would “reduce the time to synthesize a library where all members can interact.” Pet. 18 (citing Ex. 1005 ¶¶ 97–101). Similarly, Petitioner has explained the reason for including a “coding region” for each library member, i.e., to “provide a unique nucleic acid identification sequence for each conjugate that can be identified downstream,” as for instance taught by Neri. Id. at 30 (citing Ex. 1005 ¶ 97). Finally, Petitioner has explained “a POSA . . . would . . . add the d-spacer taught in Neri, as this prevents the identification sequence element of pool B members from interacting with the identification sequence element of supports Petitioner’s contentions and that testimony is, at present, substantively unrebutted. On the record before us, and at this preliminary stage of the proceeding, we do not find Petitioner’s asserted motivations to be improperly disparate or based on hindsight. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (explaining that reconstruction of prior art is not improper “so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”). To the extent Patent Owner is also arguing that Petitioner’s assertions regarding reasonable expectation of success are unsupported, Prelim. Resp. 24, the argument is similarly unavailing. Petitioner has pointed to teachings in Neri and the knowledge of an ordinarily skilled artisan to support its assertions. Pet. 21–23 (citing, e.g., Ex. 1005 ¶¶ 104–105, 149, 171, 183 and Ex. 1011 ¶¶ 10, 82 to explain why an ordinarily skilled artisan would have reasonably expected success in applying, to Kanan’s small molecules, Neri’s “method of preparing organic molecules, peptides, and oligomeric proteins linked to an oligonucleotide that results in stable self-assembled associated oligonucleotides”). In this regard, we note that “the expectation of success need only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).” slip op. at 25
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,883,848 - Tennant Company v. Oxygenator Water Technologies, Inc.No claims unpatentablePTAB · Feb 28, 2025 · IPR2021-00625 · APJ Kristina M Kalan · IPR · Remand
Claims 13, 14, and 17–27 were not shown unpatentable because Tennant did not establish that Wikey or Davies inherently disclosed the claimed microbubbles and nanobubbles.
RulingsRemand decision- RemandOther
“The Federal Circuit vacated and remanded our anticipation determinations as to claims 13, 14, and 17–27. Tennant, 11.1 The Federal Circuit further stated: “Because we vacate and remand to the Board to consider Tennant’s anticipation argument, we do not reach Tennant’s obviousness arguments (which depends on its contention that either Wikey or Davies produce nanobubbles).” Id. at 11. On September 19, 2024, we authorized the parties to file supplemental briefing, stating also that the “parties are not authorized to present new factual assertions, provide additional exhibits, or raise new arguments beyond those directed to the issues raised in the remand.” Ex. 3001. Pursuant to this authorization, Petitioner filed an Opening Brief on Remand (Paper 61; “Pet. Br. Rem.”) in support of its contentions. Patent Owner filed a Lead Brief on Remand (Paper 62; “PO Br. Rem.”) in support of its contentions. Petitioner filed a Reply Brief on Remand (Paper 66; “Pet. Reply Br. Rem.”). Patent Owner filed a Responsive Brief on Remand (Paper 65; “PO Resp. Br. Rem.”).” slip op. at 3
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“Accordingly, and in line with our previous determination that “Wikey appears to disclose each limitation of claim 13 except ‘microbubbles and nanobubbles having a bubble diameter of less than 50 microns’” (Final Dec. 20), we determine that Petitioner has not demonstrated that Wikey inherently discloses microbubbles or nanobubbles. Accordingly, Petitioner has not demonstrated that Wikey discloses every limitation of claim 13.” slip op. at 56
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“The Federal Circuit vacated and remanded our anticipation determinations as to claims 13, 14, and 17–27. Tennant, 11.1 The Federal Circuit further stated: “Because we vacate and remand to the Board to consider Tennant’s anticipation argument, we do not reach Tennant’s obviousness arguments (which depends on its contention that either Wikey or Davies produce nanobubbles).” Id. at 11.” slip op. at 3
Patent outcomesUS RE45,415 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham - PTAB · Jan 29, 2025 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–8 and 10–23, finding a reasonable likelihood that claims 1, 3, 4, and 8 are unpatentable, including over Lesniak-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We determine that the first part of the Advanced Bionics framework is satisfied. Although the Examiner did not specifically apply Lesniak, Phinney, or Sturgis to the grounds of rejection for ’706 patent application, the Examiner considered these references as evidenced on the face of the ’706 patent indicating these were cited references, as well as by the Information Disclosure Statement that listed these three references. See Ex. 1001, code (56); Ex. 2001, 287, 297, 304. Various combinations of these references are asserted in six of the nine grounds before us in this proceeding. Therefore, we determine that same or substantially the same art previously was presented to the Office.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claims 1, 3, 4, and 8 challenged in Grounds I through IV.2 We are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to make the different combinations of Lesniak, Phinney, Lamb, Bianchi ’518, Bianchi ’254 and Anconi for Grounds I through IV to arrive at the deodorant stick of at least claims 1, 3, 4, and 8 with a reasonable expectation of success. Below, we discuss how Petitioner has shown a reasonable likelihood of success that the teachings of Lesniak for claim 1 and the various combinations of Grounds II through IV would render obvious claims 3, 4, and 8, representative claims for these grounds.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“rational motivation to combine, supported by Dr. Michniak-Kohn’s testimony, stating that Lesniak and Phinney are in the same field of endeavor as the ’706 patent—personal care compositions, including deodorant and/or antiperspirant sticks, that contain known antimicrobials and focus on the use of natural ingredients. Pet. 25 (citing Ex. 1001, Abstract, 1:26–44, 14:32– 60; 17:58–12, 18:65–26:36; Ex. 1003, Abstract, Title, 1:16–35, 3:39, 4:22, 4:61–67; 5:5–31, 8:43–46, 9:45, 10:27–33; Ex. 1004, Abstract, Title, 1:5–9, 5:52–60, 6:1–34, 8:40–44; Ex. 1002 ¶ 80). Petitioner points to Phinney’s teaching that that “’a mixture of the hydroxides of zinc and magnesium could provide long lasting protection against odour due to perspiration,’” versus using zinc oxide alone, which was less effective “due to insolubility and low hydrolysis rate to a hydroxide form that could show some activity.” Pet. 25–26 (citing Ex. 1004, 1:12–22, 2:33–37; 5:64–66, 5:48–49; Ex. 1002 ¶ 82); see Ex. 1002 ¶ 77.” slip op. at 32
- Expert testimonyPetitioner expert creditedOther
“Dr. Michniak-Kohn testifies that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Ex. 1002 ¶ 77. Dr. Michniak-Kohn also testifies that “a POSA would have appreciated that deodorant compositions could be formed through various combinations of known ingredients, such as antimicrobials, as simple design choices.” Id. ¶ 79. We credit Dr. Michniak-Kohn’s testimony here as supported by the record before us at this stage of the proceeding. On the record before us, we determine that Petitioner has shown sufficiently a reason to combine the teachings of Lesniak and Phinney to arrive at claim 3.” slip op. at 33
§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 11,497,706
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.