- 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 · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’298 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:15–30 (emphasis added).” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution deniedPTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,349 - PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the prior art relevant to the ’600 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44‒46. On this” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XIII. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 60
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,952,600 - 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 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - PTAB · Apr 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 - PTAB · Apr 21, 2025 · PGR2024-00053 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 34–38, 40, 41, 43–46, and 58–60, finding a reasonable likelihood of obviousness over the asserted Mabuchi-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“post-grant 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.” 35 U.S.C. § 325(d). The Board uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“likely occur very close in time to the Board’s projected statutory deadline for a final written decision. . . . the claim construction hearing will occur on April 16, 2025” Prelim. Resp. 63. Neither party identifies a date for trial in the Parallel Litigation. On review of the Pacer record, it appears that the claim construction hearing was continued to April 23, 2025. There is no indication that the trial will be completed prior to a PTAB Final Written Decision, much less a court decision. Accordingly, this factor weighs against exercising discretion to deny institution.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a) (2018). Upon consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of at least one of claims 34–38, 40, 41, 43–46, and 58–60 of the ’482 patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“[a] person of ordinary skill in the art at the relevant time (“POSITA”) would have had a bachelor’s degree in mechanical engineering, or a related field, and two-to-three years of experience in the research, design, development, or testing of rotating or reciprocating mechanisms, with additional education substituting for experience and vice versa. Pet. 15 (citing Ex. 1002 ¶ 37). Patent Owner contends that [a] person of ordinary skill in the art (“POSITA”) at the time of the invention would have a working knowledge of product development, and would likely have a degree in engineering and/or industrial design, and/or at least three to five years of experience in conceiving, designing, engineering, and/or modifying such products and devices.” slip op. at 14
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham · NautilusPatents in suitUS 11,857,482 - PTAB · Apr 17, 2025 · IPR2024-01473 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 7, 17, and 22–25 because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim, including its Cai-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence currently of record, we determine the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of claims 1–4, 6, 7, 17, and 22–25 of the ’360 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficient. According to the ’360 patent, “[t]he field of the invention is related to sensor arrays for the detection and diagnosis of disease states.” Ex. 1001, 1:28–29. The Specification describes accomplishing such by analysis of protein coronas using techniques such as LC-MS/MS. See id. at 4:43–5:2 (describing Figure 1). The prior art cited by Petitioner also describes the analysis of protein coronas using similar analytical techniques. See, e.g., Ex. 1005, 584; Ex. 1007, 1870; Ex. 1008, 355–356. Accordingly, the present record supports that a POSA would have an understanding of both proteins and the analytical techniques, e.g., mass spectrometry, that can be used to characterize them. We understand Petitioner’s definition of a POSA to encompass these elements. It requires a formal degree in chemistry,5 which itself entails some knowledge of proteins and related analytical techniques, along with several years’ additional experience in proteomics, protein analysis, or mass spectrometry. Moreover, Petitioner’s definition is flexible in that it allows higher education or skill with, e.g., mass spectrometry, to make up for a lack of specific experience with proteomics assay and protein coronas. This explanation is reasonable and supported on the current record.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Third, and perhaps most importantly, there is “no requirement for perfect match between an expert’s experience and the relevant field.” See Consolidated Trial Practice Guide (Nov. 2019) 34, available at https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (“CTPG”). (citing SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010)). A person need not be a person of ordinary skill in the art to testify as an expert under Federal Rule of Evidence 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). Here, there is no dispute that Dr. Vargas is qualified in the art of mass spectrometry and, on the current record, we discern no reason why she is not qualified to offer the testimony in her declaration. At most, Patent Owner’s argument that Dr. Vargas lacks experience “perform[ing] mass spectrometry techniques specifically for protein analysis,” goes to the weight we should afford her testimony at trial. See Prelim. Resp. 28–29. It is not a sufficient reason to deny institution, particularly given that Dr. Vargas’s testimony is only part of the showing offered in support of the Petition. 6 Patent Owner’s narrow characterization of Dr. Vargas’s experience (see Prelim. Resp. 28–29) is arguably inconsistent with the description in her CV (Ex. 1004). In any event, Patent Owner will have an opportunity to examine Dr. Vargas regarding her qualifications.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “submits that no express construction of terms is necessary.” Pet. 15. Patent Owner agrees no construction is needed at this stage. See Prelim. Resp. 26. We agree that no formal claim construction is necessary for this decision. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). To the extent we have concerns regarding the parties’ apparent interpretation of the claim language, or in some instances Patent Owner’s attempt to read-in unrecited limitations, we address those arguments below.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,435,360 - Jiangsu Favored Nanotechnology Co., Ltd. v. P2i Ltd.All claims unpatentablePTAB · Apr 11, 2025 · IPR2024-00380 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1–5, 7, and 9–14 are unpatentable as obvious over Cohen and Legein or Francesch and Legein; Petitioner’s motion to strike is denied as moot.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“The parties agree that a person of ordinary skill in the art in the field of the ’087 patent in June 20154 “would have had at least a bachelor’s degree in a field such as chemistry, physics, or chemical engineering, as well as at least two years of experience with plasma-polymerization techniques.” Pet. 20 (citing Ex. 1002 ¶¶ 22–29); PO Resp. 13 (Patent Owner stating that it “does not dispute this characterization of the level of ordinary skill in the art.”); see also PO Sur-reply 1–2 (noting both parties’ agreement on the education and experience level of the ordinarily skilled artisan).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the fully developed trial record, we determine that no claims need an express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Because of Patent Owner’s shifting definitions of the education and experience level of the ordinarily skilled artisan, it is unclear on the complete record what precise definition Patent Owner and Dr. Senkevitch are applying when arguing the skilled artisan’s capabilities. PO Resp. 13, 22–27, 31–32, 34–40; PO Sur-reply 1–6, 11–13; Ex. 2007 ¶¶ 30, 31, 33, 34, 37, 40, 52–55, 60, 68, 74, 76, 77, 80–86, 89, 91, 94, 95, 100, 102–105, 108, 110, 111, 113–116, 118–120, 122, 124, 127–134. We, therefore, give Dr. Senkevitch’s testimony regarding the capabilities of a person of ordinary skill in the art minimal weight, which leaves us with Patent Owner’s insufficiently supported arguments regarding the skilled artisan’s capabilities. PO Resp. 13, 22–27, 31–32, 34–40; PO Sur-reply 1–6, 11–13. Moreover, as Petitioner correctly points out, the ʼ087 patent expressly teaches that the precise conditions for forming a protective polymeric coating “will vary depending upon factors such as, without limitation, the nature of the monomer compound, the crosslinking agent, the substrate, as well as the desired properties of the coating” and that such “conditions can be determined using routine methods.” Ex. 1001 15:1–15:5 (emphasis added); Pet. Reply 17. Where the patent itself leaves to the judgment of an ordinarily skilled artisan the assessment of these factors to ascertain suitable conditions for forming the protective coating, we find persuasive Petitioner’s view that it would have been well within the level of ordinary skill to ascertain such suitable conditions.” slip op. at 20
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We disagree with Patent Owner. Although the claims of the ʼ087 patent recite obtaining the protective cross-linked polymeric coating “by exposing the device or component to a plasma,” the field of endeavor analysis in an analogous art inquiry does not exclusively turn on the claims at issue, but rather takes account of the entirety of a patent’s disclosure. See In re Bigio, 381 F.3d 1320, 1326 (Fed. Cir. 2004) (explaining that “the PTO must show adequate support for its findings on the scope of the field of endeavor in the application’s written description and claims” (emphasis added)); In re Mettke, 570 F.3d 1356, 1359 (Fed. Cir. 2009) (rejecting an argument that the field of endeavor was limited to a claimed “Internet terminal” when “the specification describes various communication media, including facsimile machines and email, as related to the invention.”). This is significant here because the ʼ087 patent discloses that “[t]he … invention relates to protective coatings” and specifically “relates to protective coatings for electronic or electrical devices and components thereof, and methods of forming such coatings.” Ex. 1001, 1:14–17. Based on this disclosure, we find that the ʼ087 patent’s field of endeavor relates to “protective coatings for electronic or electrical devices and components thereof” broadly, not just those formed on such devices or components via a plasma polymerization process as asserted by Patent Owner. Id. Although Cohen does not explicitly disclose that its crosslinked polymers constitute a “protective coating,” Cohen does disclose that its “copolymerizable mixture can be cast into films” (Ex. 1004, 2:61–62), that the polymerization can “effected in situ,” and that the polymers may be used in “numerous” electrical applications (id. at 5:17–25). Tr. 8:9–10:2, 27:2– 21; see Pet. Reply 5 (explaining how “Cohen described insulating polymers that could be applied as films and be used to protect substrates including cables and electrical coils.” (citing Ex. 1004, 2:60–63, 5:13–25)). These disclosures suggest strongly that Cohen’s crosslinked polymers––if cast into a film or formed in situ on an electrical device or component––would serve as a protective coating on that electrical device or component, even though Cohen does not expressly refer to its crosslinked polymers ipsis verbis as a “protective coating.” Thus, we find that Cohen is within the field of endeavor of the ʼ087 patent.” slip op. at 15
Patent outcomesUS 11,041,087 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,041,087
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.