- Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3, 7, 9, 10, and 17–25 are unpatentable as obvious over Makower and Fang; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner
“Based on the record before us, including the types of problems and solutions described in the ’675 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. In reaching our finding, we note that, although we agree with Petitioner that the ’675 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’675 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 30. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’675 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. Accordingly, we do not agree with Patent Owner” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, we credit the testimony of the experts that, on balance, further confirms that skilled clinicians knew how to manage and remove fluids to the extent necessary. Dr. Bu-Saba testifies that typical steps for RF ablation procedures (even before 2006) included positioning the patient in a seated or slightly reclined position to facilitate the flow of any mucus or fluids away from the nasal cavity, application of topical decongestants, and “[i]n some circumstances,” if mucus or blood was still in the treatment area, “a 11 Nor does Patent Owner identify any disclosure in any other technical literature (either before or after 2006) expressing concerns that electrolytic fluids at the operative site could not be managed and/or would prevent targeted application of RF ablation energy to tissues at that site. See, e.g., Ex. 2003 ¶¶ 91–97 (testifying about the hypothetical “fluid” problem, but identifying no independent recognition of such a problem in any corroborating reference); Ex. 2005 ¶¶ 66–76 (same). visualization of the surgical site.” Ex. 1098 ¶¶ 81–89; Pet. Reply 14–15. Patent Owner’s expert, Dr. Levine, concurs that skilled clinicians knew how to remove mucus and other fluids, testifying that “[i]f [mucus] was obstructing my view” and “[i]f it was this thick . . . I might have to mechanically remove it with forceps, I might have to suction it, I might have to irrigate the nose with a saline solution to wash out the nose.” Ex. 1089 (Levine Tr.), 83:3–84:6 (admitting residual saline could either be swallowed or suctioned out); see also id. at 86:1–16 (testifying a patient may be positioned such that by “[v]irtue of gravity . . . fluid would fall to the bottom”).” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claim 22, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 22.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
Patent outcomesUS 10,610,675 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,610,675 - PTAB · Jun 18, 2025 · IPR2025-00289 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–15 under all four asserted §103 grounds because the petition 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
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’005 patent’s challenged claims. In a separate decision, the Acting Director denied Patent Owner’s request for discretionary denial. Paper 9. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 17 (citing Ex. 1003 ¶ 35). Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s definition in its Preliminary Response. Prelim. Resp. 26. We apply Petitioner’s proposed POSA level for this Decision, which level appears to be reasonable and consistent with the cited prior art.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“disclosure about filament features) includes the same disclosures concerning “loop” and “bight” embodiments as in the patent challenged in the 1157 IPR. Ex. 1017 ¶¶ 64–69, Figs. 6–9. And claim 1 of the ’005 patent encompasses, but is not limited to, filaments that form a loop. Thus, similar to our preliminary decision in the 1157 IPR, we decline at this time to construe the filament of claim 1 of the ’005 patent as limited to a “flexible” filament.13” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends a POSA would have been motivated to use Schaffer’s hemostasis valve in Garrison’s aspiration system for several reasons. Pet. 35–37. For example, Petitioner contends that Garrison discloses that adjustable-opening valves may be used, that Schaffer suggests its valve may be used with interventional catheters of the type described in Garrison, and that a skilled artisan would have recognized that Schaffer’s valve, with its features biasing the valve to a closed position, could simplify operation of Garrison’s system by avoiding a need to manually close/seal the valve during procedures. Id. (citing Ex. 1003 ¶¶ 95–99). We find that Petitioner’s contentions are supported by the cited teachings in the references and the testimony of Mr. Thornton. Petitioner’s evidence is sufficient at this stage and we determine that Petitioner is reasonably likely to prevail in showing that at least claim 1 would have been obvious over Garrison and Schaffer. Below we explain why Patent Owner’s counterargument does not undermine Petitioner’s showing on this record.” slip op. at 29
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,554,005 - PTAB · May 23, 2025 · IPR2025-00195 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the petition’s grounds, finding a reasonable likelihood of success on at least one 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 will prevail with respect to at least one of the claims challenged in the petition. See 35 U.S.C. § 314(a). For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’998 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) at the relevant time “would have had a bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a similar discipline with at least one year of experience with portable electronic devices,” and that “[m]ore education can substitute for practical experience and vice versa.” Pet. 6 (citing Ex. 1003 ¶¶ 23–25). Patent Owner does not at this time dispute Petitioner’s definition of the POSA’s skill level. Prelim. Resp. 14. We apply Petitioner’s proposed POSA level, which appears to be generally consistent with the cited prior art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this time, express claim interpretation is not needed to resolve the controversy. According to Patent Owner, “claim construction is unnecessary at this stage because the prior art fails to invalidate under any reasonable construction of the claims.” Prelim. Resp. 14. Patent Owner does not, however, challenge Petitioner’s contentions under any of Grounds 1–5 that the asserted prior art teaches or suggests the claimed subject matter. Patent Owner’s counterargument at this time is limited to whether the asserted references qualify as prior art. See, e.g., id. at 510 (arguing most of Petitioner’s references (e.g., Downey) “fail to qualify as prior art due to their 9 Unless otherwise stated, emphases appear in the cited paper or evidence. 10 Patent Owner’s Preliminary Response includes an initial unnumbered page and the second page is numbered page “6.” The unnumbered page is, therefore, cited herein as page “5.” according to Patent Owner) or “due to insufficient evidence of public availability (in the case of Ohgi).”). We address this counterargument, which does not turn on a dispute about the meaning of any claim terms, below. See infra Sections III.D and III.G.11 Regarding Petitioner’s contention of “ambiguity” in the phrase “each of the measurements” in claims 1 and 8, Patent Owner states only that “there is no ambiguity.” Prelim. Resp. 14. If Patent Owner believes that either of Petitioner’s suggested “broader” or “narrower” interpretations of the phrase is incorrect, or if Patent Owner wants to propose another interpretation altogether, Patent Owner may address such issues in its Response during trial. And, should it elect to do so, Patent Owner will have the opportunity at trial to explain why the claims do not read on the asserted art under any interpretation advanced by Petitioner or proposed by Patent Owner.” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“sufficient written description support in either the ’315 PCT Application or the ’422 Provisional for a sensing unit that comprises a compass. The ’315 PCT Application (and similarly the ’422 Provisional) describes the sensing unit as “includ[ing] accelerometer means and gyroscope means” and that a processor is adapted to receive from a sensing unit having those features (i.e., an accelerometer and gyroscope) measurements from which data indicative of a training activity can be calculated. See, e.g., Ex. 1005, 5:13–19, 5:30–33; Ex. 1004, 5:2–28, 12:2–31. Patent Owner identifies no express or inherent disclosure of a compass in the priority applications filed before March 11, 2009. It seems all “compass” disclosures were added only when the CIP application that issued as the ’998 patent was filed. Compare, e.g., Ex. 1001, 10:23–29, 50– 59 (new or revised paragraphs adding references to a compass), with Ex. 1005, 14 (no corresponding paragraphs or descriptions of a compass). That a compass might be “compatible” with devices described in the ancestral applications or even provide alleged benefits (e.g., mitigating a swimmer’s “drift” compared to a fixed external reference, as argued by Patent Owner) misses the point. Prelim. Resp. 12–13; Paper 9, 1–2. To obtain the priority benefit of the ancestral applications’ filing dates, those applications must describe the invention of the challenged claims. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997) (explaining that, to claim “the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112”). And whether it might have been obvious to add a compass is not the proper inquiry. Ariad Pharm., Inc. v. Eli Lilly description that merely renders the invention obvious does not satisfy the [written description] requirement”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 7,980,998 - PTAB · May 15, 2025 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–12 and 14–19 on all asserted grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of the art or arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- Skill levelSkill level board ownOther
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:49–51 (claim 1 reciting “sequencing the amplified products comprising the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS sequencing now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’108 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 19
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,876,108 - PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“To accord substantial weight to evidence of secondary considerations, it “must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16
- Skill levelSkill level board ownDecided for petitioner
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,036,012 - PTAB · May 14, 2025 · IPR2025-00027 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR on claims 1–16 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’241 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 10.) Petitioner cites the ’241 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1001, 4:14–21; see Pet. 10.) According to Petitioner, this described function can be performed by any oligonucleotide. Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’241 patent for its disclosure that “appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.” (Ex. 1001, 9:34–37; see Pet. 10.) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by McCloskey” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In summary, Petitioner presents evidence, which we find preliminarily persuasive, showing that McCloskey, Porreca, and Schmitt disclose aspects of the claims that were alleged in the prosecution to be missing in McCloskey 2007. For at least the reasons noted above, we determine that each of Porreca, McCloskey 2007, and Schmitt are not substantially the same as either McCloskey 2007 or Samuels. Accordingly, the first part of the framework of Advanced Bionics is not met and we are not persuaded there is a reason to exercise our discretion to deny institution of review at least on the basis of anticipation under 35 U.S.C. § 102(a) over Porreca, McCloskey, or Schmitt. Because we do not exercise discretion to deny institution of review on the basis of at least one ground of challenge raised by Petitioner, we institute trial on all claims and all grounds asserted in the Petition. See 35 U.S.C. § 314(a); SAS Inst., 584 U.S. at 362.” slip op. at 46
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are not persuaded at this point in the proceeding by Patent Owner’s arguments because Dr. Metzker testifies that McCloskey refers to the redundant hypermethylated and hypomethylated sequences, which one of ordinary skill in the art would have understood to mean both the identical target sequence and the identical barcode to be used to identify duplicates. (See Ex. 1003 ¶ 90.) At this point in the proceeding, in the absence of contradictory evidence, we are persuaded that Petitioner has provided sufficient evidence that McCloskey teaches “identifying sequence reads with identical identifier and target sequences as duplicates.”” slip op. at 15
Claim constructionDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,725,241 - PTAB · May 14, 2025 · IPR2025-00026 · APJ Deborah Katz · IPR · Institution
Instituted IPR of claims 1–10 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over Porreca and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 42
- Skill levelSkill level board ownOther
“Patent Owner asserts that Petitioner’s definition requiring a Ph.D. or a Master’s degree and several years of experience indicates higher than ordinary skill because by 2008 next generation sequencing was performed in laboratories according to published protocols and would have been accessible to experienced laboratory technicians and graduate students. (Prelim. Resp. 8.) Patent Owner proposes that, instead, the appropriate level of ordinary skill in the art was a Ph.D. in a field related to molecular biology, or a B.S. or M.S. degree with three to five years of experience working in a molecular biology lab. (See id.) On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 9.) Petitioner cites the ’357 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1002, 4:20-25; see Pet. 9–10.) According to Petitioner, this described function can be performed by any oligonucleotide. (See Pet. 10.) Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’357 patent and claims of the ’241 patent, which is a continuation of the ’357 patent, in support of this construction. (See Pet. 9–10 (citing Ex. 1002, 9:43–46 (“appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.”) (emphasis omitted); Ex. 1001, claim 10).) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by Porreca” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,098,357 - PTAB · Apr 25, 2025 · IPR2025-00016 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–3, 5–12, and 14–19 on all asserted grounds, finding a reasonable likelihood that Meyer anticipates claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“During prosecution of the ’340 application, the Examiner specifically acknowledged that Jones 2005 “does not teach massively parallel sequencing as required by” the claim that issued as independent claim 1. Ex. 1017, 2421. Thus, contrary to Patent Owner’s assertion, the Examiner did not find Jones 2005 “discloses each limitation of claim 1 of the ’108 patent.” See Prelim. Resp. 39. In other words, the Examiner did not make “the same arguments with respect [to] Jones 2005 publication during the prosecution of the ’340 application.” Id. As a result, Petitioner’s anticipation challenge based on Meyer is not the same or substantially the same as the Examiner’s obviousness rejections based on Jones 2005.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“it “never discloses increasing the percentage of the sequence of interest as compared to any other component of the sample.” Prelim. Resp. 25. But contrary to this assertion, Meyer specifically discloses that a single copy of the broken chain T-primer was found in “16% of the total” raw reads, “slightly more than the expectation (~10%).” Ex. 1006, 9. If the expected 3' end fragments are 10% of the total reads, the combined 5' end fragments and internal fragments would be 90%. By employing the broken chain T-primer, Meyer increased the percentage of the 3' end fragments to 16% of the total reads, which means the combined 5' end fragments and internal fragments would be decreased to 84%. In other words, Meyer discloses increasing the percentage of the 3' end fragments, which contains the broken chain T-primer sequence, as compared to the 5' end fragments and internal fragments. Patent Owner does not explain persuasively why, under such circumstances, enrichment is not met. Patent Owner emphasizes that Meyer “is directed toward improving the error rate of sequencing reads.” Prelim. Resp. 26 (citing Ex. 2021 ¶¶ 124–130); see also id. at 28 (“The ‘homopolymer problem’ that Meyer was trying to fix is an issue caused by the 454 sequencer.”). We agree with Patent Owner on this issue. Patent Owner, however, has not explained sufficiently why Meyer’s method of reducing read artifacts by increasing the proportion of 3' end fragments in the total read does not meet the claimed enrichment.” slip op. at 19
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not see a material difference in the parties’ proposed levels of education and work experience. Indeed, although Petitioner asserts that a POSA “would have a PhD or equivalent training,” it allows more work experience to compensate for less education. Pet. 23 (stating that a POSA could have “commensurately less education and more work experience”). We, nevertheless, adopt Patent Owner’s proposal in this aspect because it specifies the years of experience needed. Patent Owner also disputes Petitioner’s proposal that a POSA would have had experience with “implementing and designing library preparation methods 454 and Illumina, the leading NGS platforms in 2012.” Id. at 15 (quoting Pet. 23, emphasis added by Patent Owner removed). According to Patent Owner, “[t]his level of skill inappropriately requires the POSA to be an inventor of library preparation methods.” Id. On this record, we agree with Patent Owner that “experience with implementing and designing library preparation methods 454 and Illumina” is above ordinary skill. We, however, find insufficient Patent Owner’s proposal that “the POSA would have had experience with DNA sequencing methods.” Id. at 15–16 (citing Ex. 2021 ¶¶ 65–68). The challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See Ex. 1002, 35:49–51 (claim 1 reciting “sequencing the amplified products comprising the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). As Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS sequencing now allowed sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 4. As such, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (id. at 15–16) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’108 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededOther
“Petitioner proposes that we construe the terms “sequence of interest” and “barcode.” Pet. 24–25. According to Petitioner, the ’108 patent defines nucleic acid sequence” and “target sequence,” as “a polynucleotide sequence of interest, for which enrichment is desired.” Id. at 24 (citing Ex. 1002, 21:3–5, 21:8–11). Patent Owner does not dispute Petitioner’s proposed construction of this term.8 See Prelim. Resp. 17. On this record, we adopt Petitioner’s proposed construction of the term “sequence of interest.” Petitioner also proposes that we construe the term “barcode.” Pet. 25. Patent Owner points out that the term “barcode” only appears in dependent claim 8 and argues that we do not need to construe this term. Prelim. Resp. 17. For purposes of this Decision, we agree with Patent Owner on this issue. Neither party proposes any special meaning for the term “enrich.” We see no reason to do so either. To the extent express construction of “enrich” is necessary, we adopt the plain and ordinary meaning of the term. See Ex. 3001 (entry e defining “enrich” to mean “to process so as to add or increase the proportion of a desirable ingredient”). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any other claim term expressly.” slip op. at 12
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,876,108 - PTAB · Apr 25, 2025 · IPR2025-00015 · APJ Zhenyu Yang · IPR · Institution
Instituted IPR of claims 1–3 and 5–22 on all asserted grounds; Meyer anticipation of claim 1 met the reasonable-likelihood threshold.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“the ’785 application. See generally Ex. 1016. Also, the Examiner did not issue any anticipation rejection during prosecution of the ’785 application. Id. Instead, the Examiner rejected claims as obvious over Jones 2005 in combination with other prior art. Id. at 190–96. The Examiner specifically acknowledged that Jones 2005 “does not teach massively parallel sequencing as required by” the claim that issued as independent claim 1. Id. at 192. Thus, contrary to Patent Owner’s assertion, Jones 2005 could not have “disclosed the same elements that Petitioner claims Meyer discloses.” See Prelim. Resp. 40. As a result, Petitioner’s anticipation challenge based on Meyer is not the same or substantially the same as the Examiner’s obviousness rejections based on Jones 2005.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record and for purposes of institution, we find Petitioner has shown sufficiently that Meyer discloses enrichment of the 3′ end fragments, which include the broken chain T primer sequence.” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not see a material difference in the parties’ proposed levels of education and work experience. Indeed, although Petitioner asserts that a POSA “would have a PhD or equivalent training,” it allows more work experience to compensate for less education. Pet. 25 (stating that a POSA could have “commensurately less education and more work experience”). We, nevertheless, adopt Patent Owner’s proposal in this aspect because it specifies the years of experience needed. Patent Owner also disputes Petitioner’s proposal that a POSA would have had experience with “implementing and designing library preparation methods 454 and Illumina, the leading NGS platforms in 2012.” Id. at 16 (quoting Pet. 25, emphasis added by Patent Owner removed). According to Patent Owner, “[t]his level of skill inappropriately requires the POSA to be an inventor of library preparation methods.” Id. On this record, we agree with Patent Owner that “experience with implementing and designing library preparation methods 454 and Illumina” is above ordinary skill. We, however, find insufficient Patent Owner’s proposal that “the POSA would have had experience with DNA sequencing methods.” Id. (citing Ex. 2021 ¶¶ 65–68). As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 13; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS sequencing now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 4. As such, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (id. at 16) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner proposes that we construe the terms “sequence of interest” and “barcode.” Pet. 26–27. According to Petitioner, the ’012 patent defines “sequence of interest,” which is used interchangeably with terms “target nucleic acid sequence” and “target sequence,” as “a polynucleotide sequence of interest, for which enrichment is desired.” Id. at 26 (citing Ex. 1001, 21:1–3, 21:6–9). Patent Owner does not dispute Petitioner’s proposed construction of this term.8 See Prelim. Resp. 17. On this record, we adopt Petitioner’s proposed construction of the term “sequence of interest.”” slip op. at 15
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,036,012 - PTAB · Apr 22, 2025 · IPR2025-00156 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–9 under all seven grounds, finding a reasonable likelihood of success on at least one claim based on the Schaffer–Hartley and Schaffer–Eller combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’012 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“B. Level of Ordinary Skill in the Art Petitioner proposes that the person of ordinary skill in the art (“POSA”) in September 2017 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of product design or engineering experience.” Pet. 15 (citing Ex. 1003 ¶ 35). Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s definition in its Response. Prelim. Resp. 21. obviousness precedents cited herein remain applicable despite this change in the timing of the obviousness inquiry. 9 Petitioner states that it is not aware of any objective indicia of nonobviousness (Pet. 94) and Patent Owner’s Preliminary Response does not provide argument about any objective indicia. level appears to be reasonable and consistent with the cited prior art.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“several threads, lines, cords, robes, ribbons, flat wires, sheets, or tapes. The Specification supports such interpretation. Ex. 1001, 9:21–23. Nevertheless, as Patent Owner argues, Petitioner’s interpretation is incomplete and does not address persuasively the dispute raised here— whether the “filament,” as recited in claim 1, requires flexibility. Based on the parties’ arguments at this preliminary stage, we agree with Patent Owner that flexibility is necessary. The claims, as understood by the POSA, suggest that the filament must be flexible. Claim 1 “recites that ‘the first filament [is] formed into a loop around the collapsible tubular sidewall” and that the “diameter of the valve lumen decreases in response to reducing a diameter of the loop.” See supra Section II.D. As Dr. Zalesky credibly explains “[t]o ‘reduc[e] a diameter of the loop,’ the filament must be ‘flexible’ because if it were rigid or inflexible the loop would retain the same diameter when acted on by the first actuator.” Ex. 2001 ¶ 58 (“This inherent property of flexibility is essential to the loop structure of the claims.”). We observed essentially the same principle in the related 1157 IPR for embodiments where the filament forms a “loop” around the collapsible tubular member, such as shown in Figure 6 of the patent. IPR2024-01157, Paper 7 at 16 (“Thus, in the above embodiment [(shown in Fig. 6)] a flexible filament is required (i.e., a the loop to constrict and seal the valve).”).11” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“22:10. Petitioner contends that, as a general rule, a preamble does not limit the scope of a claim, and that the preamble term “aspiration” here merely describes a non-limiting “intended use” of an otherwise structurally-complete invention defined by the body of the claim. Pet. 18–19. Patent Owner responds that whether the term “aspiration” limits claim 1 is “not germane to Patent Owner’s arguments here.” Prelim. Resp. 21. We need not decide at present if “aspiration” in the preamble phrase “aspiration catheter” is limiting. No dispute at this stage turns on whether “aspiration” is limiting, or on that term’s meaning. Realtime Data, 912 F.3d necessary to resolve matters in dispute).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,697,012
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.