- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–8 and 10–23 are unpatentable: the Board found claims 1–15 anticipated or obvious over the asserted grounds and claims 16–23 obvious over the Native combination.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 27–29). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1, 16, and 20 reciting “a deodorant stick” is limiting” as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any claim term 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claim 1.” slip op. at 22
Patent outcomesUS 11,497,706 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,497,706 - 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 - 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 - PTAB · Jan 27, 2025 · IPR2024-00965 · APJ Zhenyu Yang · IPR · Institution
Instituted review of claims 1–6 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . 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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 20; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for purposes of institution, Petitioner has met its burden to show a reasonable likelihood that Gloor was publicly accessible before the priority date of the ’200 patent. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“institution under § 325(d). Prelim. Resp. 21–29. Under 35 U.S.C. § 325(d), in determining whether to institute an inter 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 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 those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 11
§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,768,200 - PTAB · Jan 27, 2025 · IPR2024-00964 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–8 based on both asserted obviousness grounds: Parameswaran with Gloor and Parameswaran with Bentley.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . 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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 27; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for the purposes of institution, with Dr. Gloor’s declaration and the supporting exhibits attached therein, Petitioner has met this burden. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“detailed analysis to support its argument that the combination of Parameswaran and Gloor teaches or suggests each limitation of claim 1. Pet. 23–36. Petitioner also contends that an ordinarily skilled artisan would have been motivated combine the teachings of the two references and would have had a reasonable expectation of success in doing so. Id. at 36–45. Patent Owner counters that the combination does not teach or suggest two limitations, namely the amplifying and discarding steps of the method. Prelim. Resp. 18–24. Patent Owner also challenges Gloor’s prior art status. Id. at 24–28. Based on the current record, we find Petitioner’s argument with respect to the amplifying and discarding steps more persuasive. With respect to the remaining limitations, we find persuasive Petitioner’s analysis on the prior art’s teachings. We also find persuasive Petitioner’s analysis on the motivation to combine and reasonable expectation of success. For the purposes of institution, we adopt those analyses as our own. We address Patent Owner’s counterarguments below.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“cross-over events (id. at 18–21). Based on the current record, we find Petitioner’s argument more persuasive. Petitioner relies on the combination of Parameswaran and Gloor as teaching the amplifying step. See Pet. 31–33. As such, Patent Owner cannot show non-obviousness “by attacking references individually.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Patent Owner argues that “because Parameswaran used pyrosequencing on the surface of beads in a Roche 454 sequencer, it does not disclose the formation of clusters.” Prelim. Resp. 21 (citing Pet. 31). Petitioner, however, relies on Gloor for teaching “amplifying said nucleic acid templates on a surface of a flow cell thereby to form clusters.” Pet. 31–32. Patent Owner does not challenge this reliance. See generally Prelim. Resp. Patent Owner contends that Petitioner “equat[es] the claimed chimeric sequences with ‘mismatched’ or ‘misassigned’ sequences containing an ‘unexpected’ pair of forward and reverse barcode motifs identified in Parameswaran.” Prelim. Resp. 18–19. But, according to Patent Owner, “Petitioner does not point to any disclosure in Parameswaran identifying these “mismatched” motifs as chimeric sequences—as opposed to mere sequencing or sample handling error—nor does Petitioner cite any disclosure in Parameswaran regarding such sequences resulting from cross-over events.” Id. at 19. We find Patent Owner’s characterization of Petitioner’s argument inaccurate. As we understand it, Petitioner does not “equat[e]” the claimed chimeric sequences with “mismatched” sequences in Parameswaran. Instead, as Patent Owner acknowledges, “Petitioner argues that ‘sequences with mismatched barcode motifs’ in Parameswaran ‘include chimeric sequences resulting from cross-over events.’” Id. (quoting Pet. 32) (emphasis added).” slip op. at 14
§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,041,852 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision
Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10
- Strike new argumentOther
“Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56
Patent outcomesUS 10,849,908 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
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 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–38 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
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 an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491
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.