- 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 - PTAB · May 15, 2025 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–12 and 14–19 on all asserted grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of the art or arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- Skill levelSkill level board ownOther
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:49–51 (claim 1 reciting “sequencing the amplified products comprising the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS sequencing now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’108 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 19
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,876,108 - PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“To accord substantial weight to evidence of secondary considerations, it “must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16
- Skill levelSkill level board ownDecided for petitioner
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,036,012 - PTAB · May 14, 2025 · IPR2025-00027 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR on claims 1–16 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’241 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 10.) Petitioner cites the ’241 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1001, 4:14–21; see Pet. 10.) According to Petitioner, this described function can be performed by any oligonucleotide. Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’241 patent for its disclosure that “appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.” (Ex. 1001, 9:34–37; see Pet. 10.) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by McCloskey” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In summary, Petitioner presents evidence, which we find preliminarily persuasive, showing that McCloskey, Porreca, and Schmitt disclose aspects of the claims that were alleged in the prosecution to be missing in McCloskey 2007. For at least the reasons noted above, we determine that each of Porreca, McCloskey 2007, and Schmitt are not substantially the same as either McCloskey 2007 or Samuels. Accordingly, the first part of the framework of Advanced Bionics is not met and we are not persuaded there is a reason to exercise our discretion to deny institution of review at least on the basis of anticipation under 35 U.S.C. § 102(a) over Porreca, McCloskey, or Schmitt. Because we do not exercise discretion to deny institution of review on the basis of at least one ground of challenge raised by Petitioner, we institute trial on all claims and all grounds asserted in the Petition. See 35 U.S.C. § 314(a); SAS Inst., 584 U.S. at 362.” slip op. at 46
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are not persuaded at this point in the proceeding by Patent Owner’s arguments because Dr. Metzker testifies that McCloskey refers to the redundant hypermethylated and hypomethylated sequences, which one of ordinary skill in the art would have understood to mean both the identical target sequence and the identical barcode to be used to identify duplicates. (See Ex. 1003 ¶ 90.) At this point in the proceeding, in the absence of contradictory evidence, we are persuaded that Petitioner has provided sufficient evidence that McCloskey teaches “identifying sequence reads with identical identifier and target sequences as duplicates.”” slip op. at 15
Claim constructionDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,725,241 - PTAB · May 14, 2025 · IPR2025-00026 · APJ Deborah Katz · IPR · Institution
Instituted IPR of claims 1–10 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over Porreca and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is 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). We determine whether to institute inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“(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 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.” slip op. at 42
- Skill levelSkill level board ownOther
“Patent Owner asserts that Petitioner’s definition requiring a Ph.D. or a Master’s degree and several years of experience indicates higher than ordinary skill because by 2008 next generation sequencing was performed in laboratories according to published protocols and would have been accessible to experienced laboratory technicians and graduate students. (Prelim. Resp. 8.) Patent Owner proposes that, instead, the appropriate level of ordinary skill in the art was a Ph.D. in a field related to molecular biology, or a B.S. or M.S. degree with three to five years of experience working in a molecular biology lab. (See id.) On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 9.) Petitioner cites the ’357 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1002, 4:20-25; see Pet. 9–10.) According to Petitioner, this described function can be performed by any oligonucleotide. (See Pet. 10.) Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’357 patent and claims of the ’241 patent, which is a continuation of the ’357 patent, in support of this construction. (See Pet. 9–10 (citing Ex. 1002, 9:43–46 (“appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.”) (emphasis omitted); Ex. 1001, claim 10).) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by Porreca” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,098,357 - Arthrex, Inc. v. Medshape, Inc.Institution deniedPTAB · Apr 25, 2025 · IPR2025-00053 · APJ James A Tartal · IPR · Institution
The Board denied institution of IPR challenging claims 1–10, exercising § 314(a) discretion because the Fintiv factors, considered holistically, favored denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied discretionary otherInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2023). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is 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). However, institution of inter partes review is discretionary. Upon consideration of the Petition, the Preliminary Response, the Preliminary Reply, the Preliminary Sur-reply, and the evidence of record, we exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 314(a) in view of the co-pending district court litigation.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“7. Balancing the Fintiv Factors As discussed above, factors 1 and 3–5 each favor denial. Factor 2 is the only factor that favors institution because there is no trial date in the Parallel Proceeding and the evidence presented of a median time-to-trial for civil trials in that district suggests a potential trial date after the statutory deadline for a final written decision in this proceeding. However, Patent Owner also shows that discovery and any dispositive motions will be completed in the Parallel Proceeding well before the statutory deadline for a final written decision in this proceeding, which presents a risk of duplicated efforts given the unmitigated overlap in issues between proceedings. On balance, considerations concerning an uncertain trial date in the Parallel Proceeding under Factor 2 do not outweigh the more substantial reasons identified under the other Fintiv Factors. Thus, considering all of the factors holistically, we find on balance that the factors on this unique record weigh in favor of discretionary denial of the Petition. Accordingly, we exercise discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 15
Discretionary denialPatents in suitUS 7,985,222 - PTAB · Apr 17, 2025 · IPR2024-01473 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 7, 17, and 22–25 because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim, including its Cai-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence currently of record, we determine the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of claims 1–4, 6, 7, 17, and 22–25 of the ’360 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficient. According to the ’360 patent, “[t]he field of the invention is related to sensor arrays for the detection and diagnosis of disease states.” Ex. 1001, 1:28–29. The Specification describes accomplishing such by analysis of protein coronas using techniques such as LC-MS/MS. See id. at 4:43–5:2 (describing Figure 1). The prior art cited by Petitioner also describes the analysis of protein coronas using similar analytical techniques. See, e.g., Ex. 1005, 584; Ex. 1007, 1870; Ex. 1008, 355–356. Accordingly, the present record supports that a POSA would have an understanding of both proteins and the analytical techniques, e.g., mass spectrometry, that can be used to characterize them. We understand Petitioner’s definition of a POSA to encompass these elements. It requires a formal degree in chemistry,5 which itself entails some knowledge of proteins and related analytical techniques, along with several years’ additional experience in proteomics, protein analysis, or mass spectrometry. Moreover, Petitioner’s definition is flexible in that it allows higher education or skill with, e.g., mass spectrometry, to make up for a lack of specific experience with proteomics assay and protein coronas. This explanation is reasonable and supported on the current record.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Third, and perhaps most importantly, there is “no requirement for perfect match between an expert’s experience and the relevant field.” See Consolidated Trial Practice Guide (Nov. 2019) 34, available at https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (“CTPG”). (citing SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010)). A person need not be a person of ordinary skill in the art to testify as an expert under Federal Rule of Evidence 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). Here, there is no dispute that Dr. Vargas is qualified in the art of mass spectrometry and, on the current record, we discern no reason why she is not qualified to offer the testimony in her declaration. At most, Patent Owner’s argument that Dr. Vargas lacks experience “perform[ing] mass spectrometry techniques specifically for protein analysis,” goes to the weight we should afford her testimony at trial. See Prelim. Resp. 28–29. It is not a sufficient reason to deny institution, particularly given that Dr. Vargas’s testimony is only part of the showing offered in support of the Petition. 6 Patent Owner’s narrow characterization of Dr. Vargas’s experience (see Prelim. Resp. 28–29) is arguably inconsistent with the description in her CV (Ex. 1004). In any event, Patent Owner will have an opportunity to examine Dr. Vargas regarding her qualifications.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “submits that no express construction of terms is necessary.” Pet. 15. Patent Owner agrees no construction is needed at this stage. See Prelim. Resp. 26. We agree that no formal claim construction is necessary for this decision. 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)). To the extent we have concerns regarding the parties’ apparent interpretation of the claim language, or in some instances Patent Owner’s attempt to read-in unrecited limitations, we address those arguments below.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,435,360 - 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 13, 2025 · IPR2025-00104 · APJ Michael A Valek · IPR · Institution
The Board instituted review of claims 1, 2, 4–7, and 9–18 on all petition grounds and granted joinder to IPR2024-00770.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“1. The “Reasonable Likelihood” Standard for Instituting Trial In the 770 IPR, we determined that Petitioner TikTok Inc. (“TikTok”) satisfied the “reasonable likelihood” standard for instituting trial. See IPR2024-00770, Paper 8 (“770 IPR Inst. Dec.”) at 13–48. Here, Petitioner presents substantively identical challenges to claims 1, 2, 4–7, and 9–18 of the ’030 patent based on the same prior art, the same evidence, and the same unpatentability theories as TikTok presents in the 770 IPR. Compare Pet. 10–81, with IPR2024-00770, Paper 2 (“770 Pet.”) 11–81; see also Mot. 5 (asserting that “[t]here are no substantive differences between the LifeScan Petition and the [770] IPR Petition”). Because Petitioner presents substantively identical challenges to claims 1, 2, 4–7, and 9–18 of the ’030 patent based on the same prior art, evidence, and unpatentability theories in the 770 IPR, Petitioner satisfies the “reasonable likelihood” standard for instituting trial for the same reasons the “reasonable likelihood” standard for instituting trial was satisfied in the 770 IPR. See 770 IPR Inst. Dec. 13–48.” slip op. at 9
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“If joined to the 770 IPR, Petitioner agrees “to adhere to all applicable deadlines set forth in the [770] IPR Scheduling Order.” Id. at 7. Petitioner also stipulates that it “will act as an ‘understudy’ and will not assume an active role unless Petitioner TikTok ceases to participate in the proceeding.” Id. a 2. Petitioner agrees that the following conditions will apply “[u]nless and until Petitioner TikTok ceases to participate in the [770] IPR”: a) The Joining Petitioners shall not make any substantive filing and shall be bound by the filings of Petitioner TikTok, unless a filing concerns termination and settlement, or issues solely involving the Joining Petitioners; b) The Joining Petitioners shall not present any argument or make any presentation at oral hearing unless an issue solely involves the Joining Petitioners, or when addressing Board-approved motions that do not affect Petitioner TikTok, or its respective position; c) The Joining Petitioners shall not seek to cross-examine or defend the cross-examination of any witness, unless the topic of cross-examination concerns issues solely involving the Joining Petitioners; d) The Joining Petitioners shall not seek discovery from Patent Owner on issues not solely involving the Joining Petitioners; e) The Joining Petitioners will not rely on expert testimony beyond that submitted by Petitioner TikTok unless Petitioner TikTok is terminated from the case. Id. at 7–8. For the reasons stated by Petitioner in the Motion, and in the absence of any opposition by Patent Owner, we agree that Petitioner’s joinder to the 770 IPR is appropriate and will not materially affect the trial schedule for the 770 IPR. See Mot. 4–9.” slip op. at 11
NonePatents in suitUS 8,904,030 - PTAB · Mar 13, 2025 · IPR2025-00103 · APJ Gregg I Anderson · IPR · Institution
The Board instituted IPR on all asserted grounds for claims 1–15 and granted LifeScan, Senseonics, and Ascensia’s motion to join the TikTok IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Here, Petitioner presents substantively identical challenges to claims 1–15 of the ’766 patent based on the same prior art, the same evidence, and the same unpatentability theories as TikTok presents in the 769 IPR. Compare Pet. 15–111, with IPR2024-00769, Paper 2 (“769 Pet.”) 15–118; see also Mot. 5 (asserting that “[t]here are no substantive differences between the LifeScan Petition and the [779] IPR Petition”). Because Petitioner presents substantively identical challenges to claims 1–15 of the ’766 patent based on the same prior art, evidence, and unpatentability theories in the 769 IPR, Petitioner satisfies the “reasonable likelihood” standard for instituting trial for the same reasons the “reasonable likelihood” standard for instituting trial was satisfied in the 769 IPR. See 769 IPR Inst. Dec. 15–55.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Here, Petitioner asserts that joinder is appropriate because the Petition “challenges the validity of the same claims of the ’766 patent on identical grounds to those in the [769] IPR,” and “[t]here are no substantive differences between the LifeScan Petition and the [769] IPR Petition.” Mot. 5. Petitioner’s “supporting materials―including its supporting expert declaration, exhibits, and exhibit numbering―are substantively identical to those presented in the [769] IPR.” Id. at 6. As such, Petitioner argues that a joined proceeding would “will not raise any new issues of unpatentability and will not impose any additional burden on the Board or Patent Owner, or add additional complexity to the case.be more efficient and less wasteful, as only a single trial on these common grounds would be required.” Id. If joined to the 769 IPR, Petitioner agrees “to adhere to all applicable deadlines set forth in the [769] IPR Scheduling Order.” Id. at 7. Petitioner also stipulates that it “will act as an ‘understudy’ and will not assume an active role unless Petitioner TikTok ceases to participate in the proceeding.” Id. a 2. Petitioner agrees that the following conditions will apply “[u]nless and until Petitioner TikTok ceases to participate in the [769] IPR”:” slip op. at 12
NonePatents in suitUS 9,900,766
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.