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  • PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

    RulingsRemand decision
    • RemandOther

      “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

    • BurdenNot shown unpatentable

      “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

    Patent outcomesUS 10,760,127 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 10,760,127
  • PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

      “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

    Patent outcomesUS 11,344,552 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,344,552
  • PTAB · Jun 9, 2026 · IPR2025-00321 · APJ Christopher M Kaiser · IPR · Final written decision

    The Board held claims 1, 2, 5–7, 9, 16, and 17 not unpatentable because the asserted combinations did not establish the required purge-tower teachings or prior-art status.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that one of ordinary skill in the art “would have had (1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶¶ 14–16). Petitioner also argues that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 24. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. We adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’324 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

      “According to the ’713 patent, “[p]urge tower 24 itself may be . . . recycled or otherwise discarded as desired.” Ex. 1001, 8:27–28. This description provides some support for Patent Owner’s view, because a purge tower too intimately integrated with the part would be difficult or impossible to recycle or discard. This is further supported by the ’713 patent’s statement that “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Id. at 8:30–34. It also is supported by Dr. Hickner’s testimony that the ’713 patent “clearly shows . . . the 24 purge tower separated from the part” and that “the purge tower is a separate physical object.” Ex. 2016, 28:8–10, 64:1–9. On the other hand, there is evidence supporting Petitioner’s view that, as long as the purge tower is generally separate from the part and the support structure, it may still make contact with those portions of the print. As noted above, “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Ex. 1001, 8:30–34. This language does not exclude locations adjacent to or in contact with the part or the support structure. Thus, determine that a “purge tower,” as that term is used in the context of the ’713 patent, may not be an integrated portion of a printed part or support structure but need not be free of all contact with the printed part or support structure.” slip op. at 9

    • BurdenNot shown unpatentable

      “There is evidence of record to support both Petitioner’s view and Patent Owner’s view. On the record developed at trial, however, we cannot say that the preponderance of the evidence favors Petitioner, who bears the burden of proof. See 35 U.S.C. § 316(e). Accordingly, Petitioner has not shown by a preponderance of the evidence that KISSlicer teaches printing a layer of a purge tower each time the printer switches one extruder to the operating mode. Because proving the obviousness of claims 1 and 16 requires such a showing, Petitioner has not shown by a preponderance of the evidence that claims 1 and 16 would have been obvious over the combination of Priedeman and KISSlicer. 5. Analysis of Remaining Claims Claims 2, 6, 7, 9, and 17 all depend, directly or indirectly, from claim 1 or claim 16. Accordingly, they all include the limitations of either claim 1 or claim 16. Because, as discussed above, Petitioner has not shown that the combination of Priedeman and KISSlicer teaches or suggests all the limitations of claims 1 and 16, Petitioner also has not proven by a preponderance of the evidence that claims 2, 6, 7, 9, and 17 would have been obvious over that combination of references.” slip op. at 21

    • Obviousness (§103) › Analogous artAnalogous artOther

      “On the record developed at trial, we agree with Petitioner. According to several industry forum posts, people interested in three-dimensional printing located the website where KISSlicer was posted between February 2012 and April 2012. Ex. 1028, 1 (post discussing and directing others to KISSlicer on April 11, 2012); Ex. 1031, 1 (two posts discussing KISSlicer on March 16, 2012, and March 21, 2012); Ex. 1032, 1 (two posts discussing KISSlicer on February 11, 2012, and February 14, 2012). Thus, not only was it possible for people of ordinary skill in the art to locate KISSlicer; people of ordinary skill in the art actually did locate it. Accordingly, Petitioner has shown by a preponderance of the evidence that KISSlicer was publicly accessible.” slip op. at 19

    Patent outcomesUS 9,421,713 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,421,713
  • PTAB · May 13, 2026 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–15 and 17–22 are unpatentable as obvious over the specified combinations of Shapero, Delseny, and, for certain claims, Hamady or Jones.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “In the DI, we addressed Patent Owner’s arguments disputing Petitioner’s proposed definition. DI 17–18 (citing Prelim. Resp. 11–12). We stated that 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. Id. at 18. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 12. Based on the entirety of the trial record, we maintain our finding of a POSA’s skill level.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “Claim Construction In an inter partes review, we construe a claim term “using the same 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 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” Id.” slip op. at 29

    Patent outcomesUS 10,036,012 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,036,012
  • PTAB · Jan 28, 2026 · IPR2024-01173 · APJ Susan L C Mitchell · IPR · Final written decision

    Claims 1–7, 9–13, and 16–19 are unpatentable: claims 16–17 are anticipated by Lesniak, and the remaining challenged claims are obvious over the stated combinations.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002 ¶¶ 27–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally PO Resp. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said deodorant stick being free of an aluminum salt” and “said deodorant stick” having a particular hardness range. PO Resp. 8–9. Patent Owner also points to dependent claims 5–8 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 10. We agree.” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “We find that the evidence of record fails to support Patent Owner’s argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate a deodorant stick within the parameters of claims 16 and 17. e) Conclusion as to Claims 16 and 17 We agree with Petitioner that “the challenged claims recite nothing more than well-known deodorant ingredients performing their conventional functions.” Pet. Reply 2. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claims 16 and 17.” slip op. at 22

    Patent outcomesUS 10,905,647 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,905,647
  • PTAB · Dec 12, 2025 · IPR2025-01175 · APJ James A Tartal · IPR · Institution

    The Board denied institution because Petitioner did not sufficiently show the patent was eligible for IPR when it filed the petition less than two months after issuance.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

      “We determine that Petitioner cannot credibly certify that the ’418 patent is available for inter partes review, based on a claim of priority on the face of the ’418 patent to the ’939 provisional application filed prior to the effective date of the AIA, where, as here, Petitioner contradictorily contends in the Petition that the ’939 provisional application “does not support all claim limitations” of the ’418 patent.4 Id. If Petitioner’s allegation that claims of the ’418 patent are not supported by the ’939 provisional application is correct, then the ’418 patent would be a post- AIA patent for which a petition may not be filed earlier than 9 months after the ’418 patent issued. See 35 U.S.C. § 311(c). Thus, based on the arguments and evidence presented by Petitioner, Petitioner fails to show that the ’418 patent is eligible for inter partes review when Petitioner filed the Petition less than two months after the ’418 patent issued. 35 U.S.C. § 311(c), 37 C.F.R. § 42.102(a)(1). We, therefore, deny the Petition. IV. CONCLUSION For the foregoing reasons, we find that Petitioner has not shown sufficiently that the Petition complies with 35 U.S.C. § 311(c) and, therefore, deny the Petition.” slip op. at 10

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportNot reached

      “review when the Petition was filed “because the ’418 Patent claims priority to December 7, 2012 and is therefore,” not a post-AIA patent. Pet. 17 (emphasis added). Contrary to Petitioner’s assertion, the ’418 patent is a post-AIA patent if any claim of the ’418 patent does not have priority to the ’939 provisional application, regardless of whether, on its face, the ’418 patent “claims priority” to an application filed prior to the effective date of the AIA. See In re NTP, Inc., 654 F.3d 1268, 1276–77 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.”).” slip op. at 9

    § 102 anticipation
    Patents in suitUS 12,290,418
  • PTAB · Dec 11, 2025 · IPR2025-01025 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Garrison with Laub and/or Aklog.

    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 ’910 patent’s challenged claims. We institute inter partes review on all challenged claims and on all asserted grounds. 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”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 18 (citing Ex. 1003 ¶¶ 35–36).” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 13

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD Rsch., Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (internal quotation marks omitted).” slip op. at 12

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,974,910
  • PTAB · Dec 11, 2025 · IPR2025-01021 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–12, 14–31, and 33–38 on all asserted grounds, finding a reasonable likelihood of success on at least claim 1.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “its challenge to the claims under Grounds 1A–4A. We have also considered Patent Owner’s counterarguments, which we find unavailing at this stage for reasons explained below. See infra Section III.E.3. Upon considering the parties’ argument and evidence, we find that Petitioner has established that it is reasonably likely to succeed in showing that at least claim 1 would have been obvious under Grounds 1A–4A. Based on the preliminary record, Petitioner persuades us that a POSA would have had reasons for adding a stopcock (or similar flow-control valve) to Laub’s system between the catheter and the cited clot canister and pressure source, as suggested by Garrison. See, e.g., Ex. 1006 ¶¶ 130–134; Ex. 1012, Fig. 1A; Ex. 1006, Fig. 34. Petitioner persuades us that Laub’s system, modified as proposed, would allow a user to close the valve while a pressure source (e.g., a pump) creates a negative pressure and vacuum between the valve and the pressure source, which vacuum may then be applied to a distal portion of the catheter upon opening the valve to facilitate a rapid aspiration of a portion of a PE into the clot canister. Pet. 38–42; Ex. 1003 ¶¶ 48, 103–114.” slip op. at 30

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 13 (citing Ex. 1003 ¶ 35). Patent Owner counters that Petitioner’s proposed definition is “insufficient” but does not, in the Preliminary Response, explain why it is “insufficient” or propose a definition of its own. Prelim. Resp. 20 (citing333 Ex. 2005 ¶ 52).14 Instead, in advancing Patent Owner’s counterarguments, “Patent Owner applies Petitioner’s definition.” Id. For this Decision, we apply Petitioner’s POSA definition, which appears to be reasonable and consistent with the prior art.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that the term “filament” in, for example, dependent claim 11 means at least “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.” Pet. 15. Patent Owner notes its disagreement with Petitioner’s interpretation of the term “filament” in related proceedings (e.g., IPR2025-00289). Prelim. Resp. 20 n.3. But Patent Owner contends that the claim construction issue in related proceedings “is not germane” to Patent Owner’s arguments in the present case and, thus, the Board need not construe that term (or any other term of the ’333 patent’s challenged claims) at this time. We need not, at this stage, further construe the ’333 patent’s claims to address the issues that are presently in dispute.” slip op. at 13

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “pumps, like described in Laub, Aklog, and Garrison would, in the proposed modified systems, generate a vacuum pressure as claimed will be best assessed on a full record at trial. As an initial matter, claim 1 does not recite a “maximum level of aspiration in a rapid fashion.” At most, Patent Owner’s argument (if accepted) may weaken some of Petitioner’s reasoning for modifying the prior art. In any event, we are at this stage unpersuaded that a pump would not, when a fluid control valve is closed, generate a vacuum pressure and operate in the manner claimed. See, e.g., Ex. 1003 ¶¶ 103–105 (testifying that a stopcock and aspiration pump would generate a vacuum and provide for rapid aspiration). Garrison does not disclose that only syringes have such capability, and Garrison teaches, in the same paragraph where the cited alternative aspiration sources may be used in its systems (“active source[s] of aspiration may be an aspiration pump, a regular or locking syringe, a hand-held aspirator, hospital suction, or the like”). Ex. 1006 ¶ 134. Garrison’s disclosure is, thus, not limited to use of syringes or even peristaltic pumps (as allegedly depicted in Figure 34). We also note (as pointed out by Petitioner) that the ’333 patent indicates that both pumps and syringes generate and store negative/vacuum pressure in an aspiration system.18 Ex. 1001, 7:28–41, dependent claim 15 (aspiration source comprises “an electric pump”); Prelim. Reply 5. That a POSA would have understood that both syringes and pumps, like disclosed in Garrison, can generate a vacuum pressure to permit rapid aspiration of clots also finds further evidentiary support in Dr. Turk’s testimony that surgeons have used pumps and syringes for that purpose since the early 2010s. Ex. 1022 ¶ 23. Moreover, although Laub teaches that running a pump continuously at high flow rates can assist with dislodging clots, Petitioner persuades us on the present record that a POSA would see benefit in modifying Laub’s system to also allow for an initial or intermittent rapid burst of vacuum pressure to help remove a clot. Ex. 1003 ¶¶ 106, 109.” slip op. at 33

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,969,333
  • PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

    Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

      “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

    Patent outcomesUS 8,901,378 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 8,901,378
  • PTAB · Sep 16, 2025 · IPR2025-00465 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of proving claim 1 obvious over Gwozdz and Meezan.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the relevant art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) secondary considerations (i.e., objective indicia) of nonobviousness when presented.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23–24; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 18. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only expressly construe terms to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). “[T]he test for sufficiency [of the written description requirement] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (explaining that “the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”) (internal quotation marks omitted); see also id. at 1352 (“[A] description that merely renders the invention obvious does not satisfy the requirement.”).” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,241,414
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