- PTAB · Sep 9, 2025 · IPR2025-00440 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claim 21 on both asserted § 103 grounds, finding a reasonable likelihood that claim 21 is obvious over Mizumura with the ’498 PCT and over Mizumura with McClymont.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an 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.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claim of the ’318 patent is unpatentable. Accordingly, we institute an inter partes review of the challenged claim on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Nevertheless, we determine that the contrary evidence Petitioner has cited suffices to establish a reasonable likelihood of success at this preliminary stage of the proceeding. In this regard, we also note Dr. Jain’s testimony — currently unrebutted — that an ordinarily skilled artisan would have known, based on Tokunaga’s sequence comparisons of Factor C proteins, that “certain sequence differences between [Limulus polyphemus] and Tachypleus tridentatus were non-conservative (i.e., potentially giving rise to changes in function in terms of enzymatic activity of Factor C).” Ex. 1002 ¶ 94 (citing Ex. 1022, 157). We likewise note Dr. Jain’s testimony that such artisan would have recognized Tokunaga’s conclusion, regarding “immunological and biochemical properties” of Factor C proteins of the two different horseshoe crab species, to be “based on only gross biophysical-biochemical properties” that are not “granular enough” to predict functional properties such as residual activity in presence of specific ions. Ex. 1002 ¶ 100.” slip op. at 22
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledOther
“submitted in a different proceeding and in a different forum, and our rules contemplate objections to admissibility only after institution. See 37 C.F.R. § 42.64(b)(1) (“Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial.”); also compare Fed. R. Evid. 801(c) (defining hearsay as a statement, not made at the current trial or hearing, “offer[ed] in evidence to prove the truth of the matter asserted”), with Fed. R. Evid. 801(d)(2) (excluding from hearsay statement offered against an opposing party where statement was made by “a person whom the party authorized to make a statement on the subject” or by a “party’s agent or employee on a matter within the scope of that relationship and while it existed”). Nevertheless, as discussed above, Petitioner has provided contrary evidence, including statements from Patent Owner’s patent application, suggesting that, “due to the various differences and diversity of biomolecules depending on the genus and species of the horseshoe crab,” it had not been possible “to accurately determine the full-length sequence structure, expression, and function of [Limulus] proteins and genes using conventional methods” more than 20 years after complete gene and amino sequences from two Tachypleus horseshoe crab species had been reported. Pet. 35 (citing, e.g., Ex. 1005 ¶¶ 12–17). Thus, even if we were to take the Frohman Declaration into account, we find that Petitioner has established a reasonable likelihood 28 of success that the ’767 application disclosures did not enable an ordinarily skilled artisan to make and use the invention of the challenged claim without undue experimentation. Furthermore, assuming that the disclosures in ’767 application would have enabled an ordinarily skilled artisan to express recombinant Limulus polyphemus Factor C protein in HEK293, we find Petitioner has established, sufficient for purposes of institution, that the disclosures do not enable an ordinarily skilled artisan to make such a protein exhibiting the “full scope” of the claimed residual activity, without undue experimentation. Patent Owner cites to disclosures in the ’767 application that (1) describe how to produce recombinant Factor C in HEK293 cells and measure residual activity, (2) suggest “Factor C expressed in mammalian cells can have low susceptibility to activity inhibition by ions,” and (3) provide examples where residual activity met the required minimum. Prelim. Resp. 26–27, 32–34. Nevertheless, whether an ordinarily skilled artisan would have been able to make, based on these disclosures and without undue experimentation, a recombinant Factor C protein having residual activity encompassed by claim 21 but higher — even significantly higher — than that achieved in the example, is a fact intensive issue that would benefit from further development during trial.15 See, e.g., In re” slip op. at 28
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’767 application does not provide adequate written description support for claim 21 of the ’318 patent and that, accordingly, Mizumura, the ’498 PCT, and McClymont qualify as prior art to the challenged claim.” slip op. at 19
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,236,318 - Mastercard Incorporated / Mastercard International Incorporated v. Ov Loop, Inc.All claims unpatentablePTAB · Aug 7, 2025 · IPR2023-01289 · APJ James A Tartal · IPR · Remand
On remand, the Board maintained that claims 1–33 are unpatentable as obvious over Collinge, including claims 10–13 and 27–30.
RulingsRemand decision- RemandDecided for petitioner
“Decision which components of Collinge “the Board relied on for claim 10’s limitation ‘receiving [at the remote computer system] an authorization request to authorize the transaction from the POS terminal.’” Remand Order 3. The Order instructs: “[o]n remand, the Board shall consider Patent Owner’s arguments as to claims 10 and 27, and their dependent claims. Regardless of the Board’s disposition on remand, the Board should address Patent Owner’s arguments and explain more fully its findings as to claims 10 and 27.” Id. The Remand Order further states that “this case is remanded to the Board for consideration of the arguments made in Patent Owner’s DR Request” and that we “should point more specifically to where in Collinge the argued limitation is taught, if anywhere, and which components of Collinge satisfy the limitation, if any.” Id. As instructed, in this Decision we consider Patent Owner’s arguments raised in the DR Request as to claims 10 and 27, and their dependent claims.3 As explained in detail below, and consistent with our determination in the Final Written Decision, we conclude Petitioner establishes by 3 We consider the arguments presented in Patent Owner’s DR Request in the context of arguments presented in Patent Owner’s Response, as arguments on the merits may be considered waived unless presented in that Response. See Paper 16, 9 (explaining that “Patent Owner is cautioned that any arguments not raised in the response may be deemed waived”). a preponderance of the evidence that the subject matter of claims 10–13 and 27–30 of the ’171 patent would have been obvious over Collinge.4” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Ex. 1011 ¶ 77. In short, although paragraph 77 of Collinge is cited in the Petition and addresses both issuer processing server 308 and acquirer processing server 312, Petitioner relies on and shows that issuer processing server 308 (not acquirer processing server 312) receives “an authorization request to authorize the transaction from the POS terminal,” as required by claim 10. Pet. 58–59; Pet. Reply 16–18; DR Req. Opp. 2–4. Furthermore, there is no dispute that in Collinge the “authorization process” is performed at issuer processing server 308 in response to a request it receives. Ex. 1011 ¶ 77 (“The issuer processing server 308 may then validate the application cryptogram”). Claim 10 requires “performing an authorization process” including “receiving an authorization request to authorize the transaction from the POS terminal” at the remote computer system. We recognize that acquirer processing server 312 facilitates receiving transaction information from the POS terminal and communicating an authorization request to the issuer processing server 308. See Ex. 1011 ¶ 77. It is merchant point-of-sale terminal 120, however, that transmits “the received payment information and any additional transaction information (e.g., transaction amount, merchant identifier, etc.) to the acquirer processing server 312,” so that “acquirer processing server 312 may then generate and submit an authorization request for the financial transaction” through payment network 124 to issuer processing server 308 for validation. Id. Thus, Petitioner shows that in Collinge the request received by the issuer processing server 308 is “from” the POS terminal, as required by claim 10. See Pet. 58–6-; Ex. 1011, ¶ 77, Fig. 7.” slip op. at 20
- Expert testimonyPetitioner expert creditedDecided for petitioner
“’095 Provisional, reproduced above). Reply 17–18 (citing Ex. 1009 ¶ 46, Fig. 7). We credit Dr. Fiske in this regard, who explains that “the functionality performed” in the components in the “Blue-Box Structures,” that is Collinge’s Cloud Systema and Issuer System, “share a ‘connection 178’ therebetween,” as shown in Figure 7 of the ’095 Provisional. Ex. 1050 ¶ 43. We also considered Dr. Easttom’s opinion that Collinge’s Cloud System 110 and Issuer System 108 (see Ex. 1011, Fig. 7) are not one computer system because, in his view, each item “is (one or more) separate systems that operated independently from the others.” Ex. 2009 ¶ 150; see also PO Resp. 36–37 (arguing that Petitioner presents “no evidence” to show that allegedly “distinct” components are part of one remote computer system). We find Dr. Easttom’s opinion untenable because it is contrary to the express disclosure of Collinge, which demonstrates that, rather than operating “independently,” Cloud System 110 and Issuer System 108, and specifically remote-SE system 110 and issuer processing server 308, are connected and operate together through that connection, remotely from the mobile device. The Final Written Decision expressly agrees with and adopts Petitioner’s contentions with regard to claim 10, and we maintain that position here. See FWD 56–59.” slip op. at 26
Patent outcomesUS 10,032,171 unpatentable§ 103 obviousnessPatents in suitUS 10,032,171 - Lululemon USA Inc. v. Nike, Inc.All claims unpatentablePTAB · Aug 6, 2025 · IPR2024-00460 · APJ Ken B Barrett · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–21 under Nishida grounds and claims 11 and 21 also over Nishida with Zuckerman; Zuckerman-only grounds fail for lack of a surrounding structure.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that: A hypothetical person of ordinary skill in the art (“POSA”) would have had at least a bachelor’s degree in textile engineering, mechanical engineering, or similar technical degree and at least 3 years of experience working with knitted textiles for use in fabric-based articles, including apparel such as footwear. Ex.1003, ¶¶34-37. For individuals with different educational backgrounds, a person could still be of ordinary skill in the art provided that person’s additional experience compensates for any differences in that person’s education as stated above. Id., ¶37. Pet. 14–15. Patent Owner states that, “[f]or purposes of this proceeding, Nike applies lululemon’s proposed level of skill in the art.” PO Resp. 13. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Id. at 99:12–25. Dr. Brookstein stated during his deposition that he has “49 years of experience of teaching textile engineering.” Id. at 97:6–8. We credit Dr. Brookstein’s testimony over that of Dr. Pastore’s because it is consistent with the reference and based on decades of experience in the textile field. Nishida’s claim 1 states that, “during the production of the material web (1), [shoe patterns] . . . are produced by . . . a textile production method within the material web.” Ex. 1005, 9. We find that Nishida’s claim language discloses the recited, “simultaneously knitting a textile element with a surrounding textile structure.”” slip op. at 22
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We find the District Court’s reasoning persuasive, and we, like the District Court, decline to adopt Petitioner’s overly broad proposed construction. However, for purposes of deciding the dispositive fact issue before us, we need not determine the precise boundaries of “surrounding textile structure,” for example whether it completely or mostly encircles the textile element, and if “mostly,” what percentage of encircling is required. See Pet. Reply 2 (Petitioner characterizing Patent Owner’s position as “mostly” means over 50%); id. at 4 (Petitioner impliedly arguing that the “surrounding” need not be complete, i.e., 100%); PO Sur-reply 3–4 (Patent Owner arguing that “Zuckerman’s textile structures . . . each abut only about 25% of the periphery of Zuckerman’s blank.”). We find that a person of ordinary skill in the art would not understand the portion of Zuckerman’s strip 13 in purple to surround the green blank 11 (textile element) under any reasonable construction of “surrounding textile structure.” Dr. Pastore testifies that “Zuckerman discloses two separate textile structures adjacent the blank—one on each side . . . they abut only two sides of Zuckerman’s blank, with each structure abutting only about a quarter of the blank’s periphery,” and opines that “a POSITA would not have understood these two separate structures, designated by purple in the figure above, to be a textile structure ‘surrounding’ the blank [shown in green].” Ex. 2003 ¶ 54. We find Dr. Pastore’s tesimony credible as it is consistent with Zuckerman’s Figure and with the plain and ordinary meaning of “surrounding” and with the Specification of the ’749 patent (particularly Figure 9). Dr. Brookstein’s testimony, on the other hand, is based on Petitioner’s overly broad proposed construction—that any part of a textile area that is not a textile element is “surrounding textile structure”—” slip op. at 44
Patent outcomesUS 8,266,749 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,266,749 - PTAB · Jul 25, 2025 · IPR2025-00237 · APJ Annette R Reimers · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, 5, 6, 11, 12, 17, 21, 23, 27, 28, or 30 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). 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). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’879 patent is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Patent Owner does not contest the level of ordinary skill in the art set forth in the Petition. Prelim. Resp. 19. Because Petitioner’s unopposed definition is consistent with the ’879 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 36–48. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’879 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 24, 30–31 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 155, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claim 1 are supported by the’124 provisional and/or whether the ’879 patent’s priority chain is intact. Pet. 57–66. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find that (1) the’124 provisional provides adequate written description support for each of the challenged claim elements; (2) the ’879 patent’s priority chain is intact; and (3) the ’879 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims. Because Frisen is not prior art, we do not specifically comment on its teachings, nor the factual assertions regarding its teachings provided by Petitioner or Patent Owner. 4. Conclusion For the foregoing reasons, we determine that Petitioner has not established a reasonable likelihood of showing that Frisen anticipates any of claims 1, 2, 5, 6, 11, 12, 17, 21, 23, 27, 28, and 30.” slip op. at 32
§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,001,879 - PTAB · Jul 25, 2025 · IPR2025-00236 · APJ Annette R Reimers · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, 6, 7, 12, 13, 18, 20, 21, 23, 25, 26, or 30 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). 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). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’468 patent is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a doctorate degree (or equivalent) in bioengineering, genetics, genomics, chemistry, biochemistry, biophysics, molecular imaging or a related discipline with at least 2-4 years of academic, research, or industry experience in genomic technology. In the course of their training and experience, the POSA would have acquired a working knowledge of nucleic acid arrays, combinatorial chemistry techniques for making and using such arrays, nucleic acid sequencing and sample preparation techniques, such as barcoding, imaging methods for signal detection, as well as histopathology techniques for cell permeabilization and tissue handling. Pet. 13–14 (citing Ex. 1102 ¶¶ 30–32). Patent Owner does not contest the level of ordinary skill in the art set forth in the Petition. Prelim. Resp. 19. Because Petitioner’s unopposed definition is consistent with the ’468 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 10
- Expert testimonyPatent owner expert creditedDecided for patent owner
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 37–44. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’468 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 25–26, 32–33 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 135, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 37–44. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’468 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 25–26, 32–33 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 135, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,662,468 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–4 and 7–9 are unpatentable as obvious, principally over Edwards-’535 and Stern for claims 1–3 and 7–9, and Makower, Edwards-’535, and Stern for claims 1, 2, and 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 27–28 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See PO Resp. 7 (proposing redlines). Instead, after reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer opinions under either definition. Moreover, the parties do not argue that their respective position would be different under either POSITA definition. See PO Resp. 8 (Patent Owner arguing that the challenges fail “[r]egardless of how a POSITA is defined”); Ex. 1083 ¶ 88 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of a POSITA.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Petitioner argues that the part of claim 1’s preamble “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner neither addresses this issue, nor proposes any other claim construction. PO Resp. 13 (“Patent Owner believes that no claim constructions are required to resolve the issues raised [in this IPR].”). On this record, we find Petitioner’s argument persuasive and determine that the part of claim 1’s preamble “to treat rhinitis” is not limiting.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“techniques of delivering bipolar RF ablation energy through expandable devices to the mucosal tissue of different body cavities.” Id. at 39. According to Petitioner, “combining Edwards-’535 and Stern involves applying Stern’s known bipolar pairing technique to Edwards-’535’s known device that was ready for improvement (because Edwards-’535 omits electrode wiring details) to yield predictable results.” Id. Thus, Petitioner concludes that an ordinarily skilled artisan would have had a reasonable expectation of success when modifying Edwards-’535 in view of Stern. Id. at 38–40. Patent Owner does not dispute Petitioner’s mapping for claim limitations 1[a]-1[c] and 1[f] above, nor does Patent Owner challenge Petitioner’s reasoning for combining Edwards-’535 with Stern. See PO Resp. 14. Patent Owner, however, argues that Petitioner has failed to show Stern teaches limitations 1[d] and 1[e] “because Stern teaches a device comprising only a single pair of bipolar radiofrequency electrodes and a single radiofrequency output channel.” Id. We find that a POSITA would have been motivated to combine the teachings of Edwards-’535 and Stern and would have had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-’535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim limitations 1[a]-1[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 26–33, 43–46; Ex. 1002 ¶¶ 84–102, 159–165. Below we address the parties’ arguments regarding the disputed limitations 1[d] and 1[e].” slip op. at 17
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In our view, nothing is missing. Stern teaches that the circuitry in Figure 15 is configured to form multiple pairs of bipolar RF electrodes. Ex. 1033, 12:61–13:2 (explaining “[a]s an example” the closing of certain switches in Figure 15 to activate a bipolar pair between electrodes 220 and 224 and a second bipolar pair between electrodes 222 and 226 and further noting that “[c]learly bipolar operation is not limited to these . . . pair couplings” because other switches could be operated to activate a bipolar pair between electrodes 220 and 222); Ex. 1002 ¶¶ 108–111, 135–138. Indeed, Stern consistently uses the word “pairs,” i.e., the plural not the singular, to describe the bipolar operation of its device. See, e.g., Ex. 1033, 2:36–40, 3:38–40, 12:20–25, 12:29–30, 13:27–44, 20:9–10 (describing the bipolar operation of “pairs” nine times). Accordingly, we disagree with Patent Owner’s argument that Stern teaches a device configured to have at most only a single pair of bipolar RF electrodes. Second, Stern teaches that the “embodiment of FIG. 15 . . . provides flexibility within the bipolar operation so that any pair or any combination of pairs may be utilized together.” Ex. 1033, 13:39–43 (emphasis added). Thus, even if claim 1 did require simultaneous activation of multiple bipolar pairs, we agree with Petitioner that such functionality is also taught by Stern. See Reply 5–6.” slip op. at 20
Patent outcomesUS 11,766,286 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,766,286 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00278 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4–6, 9, 10, 12, 13, and 15–17 are unpatentable as obvious over the asserted prior-art combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disputes the second part of Petitioner’s definition “because the ‘and/or’ encompasses within the definition . . . persons who only have experience with the clinical use or testing of medical devices.” Resp. 6. According to Patent Owner, one of ordinary skill “would have had more experience than just clinically using medical devices or simply conducting tests with medical devices” Id. at 6–7. To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 33–34 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer the opinions in his declarations under either definition. Moreover, Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1083 ¶ 103 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Neither side proposes any terms for express construction. Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. “Patent Owner believes that no claim constructions are required to resolve the issues raised” in this IPR. Resp. 13. Nevertheless, in their arguments over whether the prior art teaches certain claim elements, each side accuses the other of misinterpreting or reading requirements beyond their ordinary meaning into those terms. See Reply 3–10 (urging that Patent Owner’s arguments read requirements into elements 1[d] and 1[e]); Sur-Reply 9–15 (arguing Petitioner applies an incorrect definition of “radio frequency output channel”). To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context they are raised in our analysis below. No further express claim construction is necessary for this decision.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find that one of ordinary skill in the art would have been motivated to combine Edwards-535 and Stern, and had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim elements 1[a]-[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 7–14, 17–20; Ex. 1002 ¶¶ 79–103, 113–21. Below we address the parties’ arguments regarding the disputed elements 1[d] and 1[e].” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We find that Petitioner has the more persuasive position and has demonstrated that Stern teaches element 1[e]. Petitioner demonstrates Stern’s multiple RF output channels with the annotated version of Figure 15 shown below. Pet. 42–43. As shown by Petitioner’s annotations above, the channel (highlighted in orange) connecting the output received from voltage source 228 to the first bipolar pair (circled in green on the left) is distinct from the channel connecting the output to the second bipolar electrode pair (circled in purple on the right) because depending on which switches are closed, energy travels through a separate connection between those switches and the corresponding electrodes. We agree with Petitioner, and credit Dr. Martin’s testimony, that each of the output channels highlighted in orange in Stern’s Figure 15 above “are output channels as required by the claims because the channels are separately/individually connected to the electrodes” and “control individual pairs of bipolar RF electrodes.” Id. at 43–44; Ex. 1002 ¶¶ 124–128; see also Ex. 1083 ¶ 45 (“an ‘output channel’ connects electrodes and provides the ability to independently control pairs of electrodes”). This understanding of the term “output channel” is consistent with the claim language. Claim 1 recites “multiple radiofrequency output channels” wherein “each pair” of bipolar RF electrodes “is connected with a respective one of the multiple radio frequency output channels.” Ex. 1001, 52:27–33. The RF generator itself and its connection to the output channels is not recited in claim 1. Instead, the claim language focuses on the connection between the electrode pair and its respective output channel. The description in the specification also focuses on the connection to the electrodes and further explains that having a “separate, controlled electrical channel” for “each pair of electrodes” allows for “different regions of the treatment element to be activated separately.” Ex. 1001, 24:45–52, 48:63–65; see also Ex. 1083 ¶ 33 (“[e]very time the patent mentions ‘electrical channel’ or ‘output channel,’ it is referring to connections to electrodes”). This aligns with the depiction of the output channels in the ’318 patent’s figures. See Ex. 1001, Figs. 39–44 (showing RF output channel 961 connected to electrodes). Petitioner demonstrates this in the annotated version of Figure 39 shown below. Reply 8.” slip op. at 29
Patent outcomesUS 11,033,318 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,033,318 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00277 · APJ Michael A Valek · IPR · Final written decision
Claims 1–4, 6–12, and 16 are unpatentable as obvious over the Edwards-535, Kong, and Stern combinations, with Edwards-886 added for claim 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 29–31 (identifying evidence that clinical use and testing experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Ex. 1083 ¶¶ 5, 14–15 (explaining that clinicians who use such devices gain extensive experience regarding how they work); see also Ex. 1084, 82:13–83:20 (Dr. Bikson testifying that a physician would perform the claimed method steps). Accordingly, clinical experience using and testing them would inform their design and be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s expert, Dr. Martin, is qualified to offer the opinions in his declarations under either definition and Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1097 ¶ 49 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Moreover, as explained below, we are not persuaded by Patent Owner’s challenge to Dr. DelGaudio’s qualifications and give his testimony appropriate weight in our analysis. For these reasons, our findings and conclusions would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Third, nothing suggests that Dr. DelGaudio is not qualified to offer opinions regarding the knowledge and skill of one of ordinary skill in the art. In addition, to his relevant clinical experience, Dr. DelGaudio has experience designing different types of medical devices and consulting with device manufacturers to provide feedback and improve devices used in nasal surgery. Ex. 1083 ¶¶ 9–11. Thus, even if we had adopted a POSITA definition requiring design and development experience, Dr. DelGaudio would qualify as one of ordinary skill in the art because he has such experience in addition to his extensive clinical background. Id. Nevertheless, Patent Owner argues he is “not an individual capable of designing and developing the medical device used in the claimed method” because “Dr. DelGaudio has no experience in designing medical devices that deliver energy to tissue.” Sur-reply 22–24 (emphasis added). That argument is unavailing because such devices and methods of using them such as those recited in the claims of the ’271 patent are often developed by a team of individuals with different backgrounds and expertise. That Dr. DelGaudio working alone may not be capable of designing and developing such a device does not disqualify him from offering testimony from the perspective of one of ordinary skill in the art, particularly as it relates to those claim elements that recite the use of the device as opposed to its technical details.8 Moreover, Dr. DelGaudio was careful not to overstep the bounds of his expertise, relying on testimony from Dr. Martin to confirm his understanding concerning some of the engineering details of the devices themselves. See Ex. 1002 ¶¶ 94, 124, 127, 130, 151; see also Ex. 1083 ¶ 12 (explaining he relied on Dr. Martin to confirm his understanding of teachings in Stern that disclose “implementation details about circuitry used to operate the bipolar electrodes, the physics of delivering energy to tissue, among other things”); Ex. 1004 ¶¶ 66–131 (Dr. Martin testifying regarding a POSITA’s understanding of the prior art as it relates to such elements). Fourth, even if Dr. DelGaudio did not himself qualify as one of ordinary skill, we could still consider his testimony on those matters on which he was qualified. See Consolidated Trial Practice Guide (Nov. 2019), 52, available at https://www.uspto.gov/sites/default/files/documents /tpgnov.pdf (“CTPG”) (“A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be ‘qualified in the pertinent art.’”) (citing cases). We agree with Petitioner that this would include matters such as the use of the devices described in the cited references in a clinical setting. See Reply 28. 8 Indeed, by its logic, Patent Owner’s own expert would not be one of ordinary skill in the art because he is not himself capable of practicing the claimed method. See Ex. 1084, 24:13–22, 82:19–83:8 (testifying he has never used an RF device to treat a patient and would not himself perform the recited method).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s position is persuasive. Even without taking into account the reasoning based on Baker (which we address separately below), Petitioner has demonstrated a sufficient rationale for incorporating Stern’s arrangement of two rows of bipolar electrode pairs into Edwards-535’s device. Edwards-535 teaches that a plurality of electrodes may be positioned on the surface of its treatment element, but does not specify how those electrodes are arranged or controlled. Ex. 1010, 8:25–27; Ex. 1004 ¶¶ 68–69. Stern teaches a control system for selectively delivering power to bipolar electrode pairs arranged in two rows on the surface of its device that provides even heating and precise control. Ex. 1004 ¶¶ 80–85. As Dr. DelGaudio explains, one of ordinary skill in the art would have regarded these attributes to be particularly beneficial when delivering treatment to the “nasal passages . . . given the uneven morphology of nasal cavity tissue and the proximity of the RF energy delivery to a patient’s brain and other critical tissues within the head.” Ex. 1002 ¶ 94. We credit the testimony of Petitioner’s experts that one of ordinary skill would have been motivated to incorporate Stern’s teachings, including the complementary two-row surface electrode arrangement shown in Figure 19, for these reasons. See Ex. 1002 ¶¶ 93–94; Ex. 1004 ¶¶ 72–73, 75–88, 96–97 (explaining that Stern’s techniques would have been used to improve Edwards-535’s device in a similar way). Petitioner’s reasoning that “arranging electrodes in rows . . . facilitates simple spatial resolution of the applied energy” is also persuasive. See Pet. 47–48. As Dr. Martin explains, one of ordinary skill in the art would have understood that arranging bipolar electrodes in two or more rows was a “common way to arrange such electrodes” (Ex. 1004 ¶ 34) and a “simple way to direct energy to specific locations for treatment would have been to place pairs of electrodes in rows . . . along the device at the locations being treated.” Id. ¶ 95.” slip op. at 41
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Petitioner’s position is persuasive. Stern’s Figure 15 shows bipolar electrodes 220 and 224 in a first horizontal row and electrodes 222 and 226 in a second horizontal row. Stern teaches that bipolar pairs can be formed between various combination of these electrodes resulting in both pairs within a row and pairs formed across two rows. See Ex. 1033, 12:61–13:2 (explaining that “bipolar operation is not limited to [electrode] 220-224 and 222-226 pair couplings” because pairs could also be formed across rows, e.g., between electrodes 220 and 222). Stern’s Figure 19 likewise depicts a plurality of electrodes arranged in two rows. See Ex. 1004 ¶¶ 71–74 (Dr. Martin explaining that the physical arrangement in Figure 19 is complementary to the control structure in Figure 15 and that there are two rows regardless of which electrodes are paired). In bipolar operation, each of these figures depicts “two rows of bipolar electrode pairs” as recited in element 1[a] because there are two rows comprising multiple pairs.15 Patent Owner’s narrower interpretation of the phrase “two rows of bipolar electrode pairs” is not consistent with the intrinsic record. According to Patent Owner and Dr. Bikson, it is not enough that there are two rows of electrodes comprising multiple pairs––rather each row must itself contain multiple pairs. See Resp. 23; Ex. 2001 ¶ 75 (“A row of only two electrodes is not a row of bipolar electrode pairs because a row of only two electrodes has at most a single pair (not multiple pairs).”). As Petitioner points out, Patent Owner’s interpretation assumes that the “s” in “pairs” modifies each row individually, rather than the recited “rows” collectively. But the claim 15 In reply to Patent Owner’s argument that there must be at least three electrodes in a row for that row to contain multiple pairs, Petitioner shows that Stern also discloses rows with three or more electrodes. Ex. 1083 ¶¶ 36– 40; Ex. 1097 ¶¶ 39–41 (identifying rows with three or more electrodes in Stern’s Figures 4a and 19). We need not address that showing in detail because, as explained below, element 1[a] does not require that there be more than one pair in each row. language does not specify that each row has pairs (plural). Rather, given its plain meaning, “two rows of bipolar electrode pairs” encompasses an arrangement like that shown in Stern’s Figure 15. Ex. 1097 ¶ 30 (Dr. Martin explaining that “what is required is (1) more than one bipolar electrode pair that are (2) spread across rows”). This broader understanding is confirmed by the specification of the” slip op. at 35
Patent outcomesUS 11,241,271 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,241,271 - Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–20 are unpatentable as obvious under § 103 over each of the six asserted grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Here, as in our Institution Decision, we do not discern a significant difference between the parties’ respective proposed definitions beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 47, and Resp. 19–20; see also DI 7–8. Under either proposed definition, the ordinarily skilled artisan would have been very highly skilled and educated. For purposes of this Final Decision, we maintain that Patent Owner’s definition appears to be reasonable (and it falls between Petitioner’s two definitions asserted in the reexamination request and in the Petition). Further, Patent Owner’s proposed definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent itself, for example, Vilkin’s authors are a group of medical doctors and an editor of the journal is a PhD, Joost Louwagie, the named inventor of the ’781 patent, holds a PhD in Biochemistry, and the authors of Itzkowitz are medical doctors and PhDs. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he 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)); see Ex. 1005, 3 (list of authors); Ex. 1016 (Dr. Louwagie profile); Ex. 1055; see also generally Reply (Petitioner did not contest our similar determination at Institution). Therefore, we adopt and use Patent Owner’s definition of the ordinarily skilled artisan, set forth above. C.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no claim construction is necessary in this proceeding. See generally Pet. Similarly, Patent Owner states that it “does not believe that claim construction is necessary to resolve patentability” in this proceeding. Resp. 21. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We agree with the parties that no construction of any claim term is necessary for purposes of our Final Decision. D.” slip op. at 14
- Expert testimonyOther
“Pet. 12. In support of these grounds for unpatentability, Petitioner relies on, inter alia, the 1st and 2nd Declarations of Duncan Whitney, PhD. Ex. 1002; Ex. 1080. In support of its positions, Patent Owner relies on, inter alia, the 1st and 2nd Declarations of Vadim Backman, PhD, and the Declaration of Peter Wood. Ex. 2001; Ex. 2022; Ex. 2023.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“We have no reasonable doubt that aspects of the Cologuard product practice the invention of the ’781 patent’s claims 1 and 3, which are most generally directed to steps of collecting two portions of a fecal sample at home, and combining a respective buffer stabilizer/preservative with each of the two portions for claim 1, and then processing those fecal samples by testing for blood and nucleic acids (e.g., DNA) for claim 3. These appear to be nearly the most basic steps for using the Cologuard kit. See generally Ex. 2032. And, these steps do illustrate a certain ease of use and consumerfriendliness that may be a contributing factor in Cologuard’s success. See, e.g., Ex. 2022 ¶¶ 140–142, 155, 158–159, 170–171.” slip op. at 25
Patent outcomesUS 11,634,781 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,634,781 - Skechers U.S.A., Inc. v. Nike, Inc.Institution deniedPTAB · Jun 16, 2025 · IPR2025-00144 · APJ Michael J Fitzpatrick · IPR · Institution
The Board denied institution because neither obviousness ground showed a reasonable likelihood of establishing claims 1–20 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“III. CONCLUSION The Petition fails to show there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See 35 U.S.C. § 314(a); 37 C.F.R. § 42.108. Accordingly, we deny the Petition. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 23
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“claim 15). We agree that the Specification supports Patent Owner’s construction. Although Petitioner bases its construction on extrinsic evidence, Petitioner argues that its construction “is consistent with” the intrinsic evidence, which, according to Petitioner, “indicates a sole is optional.” Pet. 31. A sole is optional, Petitioner argues, because the Abstract of the ’511 patent states that “[t]he footwear may include an upper and a sole structure.” Pet. 31 (quoting Ex. 1001, Abstr. (Petitioner’s emphasis)). We are not persuaded. Petitioner reads too much into the sentence it quotes from the Abstract and its use of the word “may.” Indeed, by Petitioner’s logic, both the upper and the sole structure would be optional and footwear would lack any required structure. Petitioner also argues that “[o]ther intrinsic evidence” supports its construction. Pet. 31–32 (citing Ex. 1053, 4:55–58; Ex. 1002 ¶92). The alleged intrinsic evidence, however, is an unrelated patent, US 2,675,631, which purportedly was cited during the prosecution of the ’511 patent. Id. This argument is undeveloped by Petitioner. First, Petitioner fails to substantiate that US 2,675,631 is cited in the prosecution history, merely asserting it as fact without pointing to supporting evidence. See id. (no citation to the prosecution history provided). Further, even assuming US 2,675,631 is cited in the prosecution history of the ’511 patent and thus part of the intrinsic evidence,8 Petitioner fails to show that it is probative of 8 The Federal Circuit has held that “[t]he prosecution history, which we have designated as part of the ‘intrinsic evidence,’ consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317 (emphasis added). what the inventors of the ’511 patent meant by “article of footwear.” Petitioner points out that the inventor of US 2,675,631 considers “knitted footwear” as encompassing “hose, golf hose, three-quarter hose, half-hose and socks” but does not explain why such meaning should be incorporated into the ’511 patent. Ex. 1053, 4:55–58 (partly quoted at Pet. 31–32). US 2,675,631 is titled “Footwear Article of The Slipper-Sock Type.” Ex. 1053, Title. As is evidently clear from the specifications of both patents, the ’511 patent and US 2,675,631 are directed to different types of footwear within the broader (dictionary) definition cited by Petitioner. Ex. 1022, 67, 88. Patent Owner also proffers testimony from Dr. Pastore that a person” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“We construe the preambles of claims 1 and 15 to be limiting, as guided by case law. It is clear that the preambles are being used to help define the invention, i.e., an upper for an article of footwear in the case of claim 1 and an article of footwear having an upper in the case of claim 15. See Bell Communications Research Inc. v. Vitalink Commcations Corp., 55 F.3d 615, 620 (Fed. Cir. 1995) (“[A] claim preamble has the import that the claim as a whole suggests for it. In other words, when the claim drafter chooses to use both the preamble and the body to define the subject matter of the claimed invention, the invention so defined, and not some other, is the 9 Claim 15 is similar to claim 1, and, in challenging claim 1, Petitioner merely refers back to and relies exclusively on its analysis for claim 1. See Pet. 84 (Ground 1), 124–125 (Ground 2). Thus, although we may we discuss claim 1 alone at times, our analysis applies equally to claim 15. one the patent protects.”). Moreover, the bodies of both claims recite “the upper” which, in the case of claim 1, derives its antecedent basis directly from the preamble and, in the case of claim 15, relies on the preamble’s article of footwear which is recited as comprising an upper. See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) (“When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.”).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“However, it is not enough that Clark discloses a sole. See KSR Int'l, 550 U.S. at 418 (“[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.”). Petitioner must show that it would have been obvious to modify Cusinato to include a sole. Id. (“[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.”); see also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”). On this aspect, Petitioner fails. The Petition summarily states that “a POSITA would consider it obvious to add a sole to Cusinato’s ‘boot-like’ form” but – as noted by Patent Owner – the Petition does not explain why. Pet. 51; see Prelim. Resp. 35 (“The Petition is silent with respect to any alleged motivation.”). Dr. Adanur’s testimony does not add much. He summarily opines that “it would be obvious to add a sole to Cusinato’s ‘boot-like’ form to provide cushioning and protection.” Ex. 1002 ¶160.” slip op. at 18
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,918,511
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.