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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 · 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 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A POSA at the time of the alleged invention would have at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner

      “The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16

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

      “In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 9,358,286
  • PTAB · Jul 10, 2025 · IPR2025-00175 · APJ Jo-Anne M Kokoski · IPR · Institution

    The Board instituted review of claims 1–17 on all asserted grounds, finding a reasonable likelihood of unpatentability on at least one challenged claim.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . 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 (2018); see also 37 C.F.R. § 42.4 (2023). For the reasons discussed below, we determine that Petitioner establishes a reasonable likelihood of prevailing with respect to the patentability of at least one claim of the ’562 patent. Accordingly, we institute an inter partes review of claims 1–17 of the ’562 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(“POSITA”) would have had “at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design,” and “[a]dditional education could substitute for professional experience and vice versa.” Pet. 6 (citing Ex. 1002 ¶¶ 80–” slip op. at 6

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

      “customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Neither party proposes any explicit construction of any term. See Pet. 7 (“For the purposes of this IPR, the plain meaning of each term can be applied.”). We do not expressly construe any term for purposes of this Decision.” slip op. at 7

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

      “On this record, we are persuaded that Petitioner adequately establishes that Usui discloses all of the limitations of claim 1. Usui discloses that aluminum or aluminum alloy layer 15 is in electrical contact with titanium underlayer 13, and titanium nitride layer 14 is located “intermediate the [titanium underlayer] 13 and the aluminum or aluminum alloy layer 15” to prevent “reaction between the aluminum layer 15 and underlayer 13.” Ex. 1004, 3:27–29, 3:38–41, 3:58–63. Usui further discloses that “a capping layer is provided above layer 15,” and that “[p]referred capping layers are titanium nitride and combinations of as layer 18 of a group IVA metal, preferably titanium with a titanium nitride layer 19.” Id. at 3:67–4:6. Usui teaches that titanium nitride layer 19 is about 150 to 800 Å thick, and that the thickness of titanium underlayer 13 is between about 90 to 110 Å. Id. at 3:31–33, 4:6–8. Usui also teaches that the interconnect metallurgy structures described therein “exhibit[] enhanced electromigration characteristics” and “are especially useful for forming electrical connections or wiring such as between active and/or passive devices of an integrated circuit structure.” Id. at 1:8–14. Usui’s description of a plurality of metal layers (layers 13–18) and a capping layer formed over the plurality of metal layers (layer 19), along with its description of the structure’s usefulness for forming electrical connections in an integrated circuit structure, is sufficient, on this record, to establish that Usui discloses “an electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. Usui’s teaching that the capping layer is a refractory metal nitride (titanium nitride) that has a thickness (150–800 Å) greater than the bottommost layer of the plurality of metal layers (layer 13, 90–110 Å), sufficiently establishes, on this record, that Usui discloses the “said capping layer consisting only of a refractory metal nitride, said refractory metal nitride forming a top of said electrical contact and having a thickness greater than that of a bottommost layer of said plurality of metal layers” limitation of claim 1.” slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 8,686,562
  • PTAB · Jul 3, 2025 · IPR2024-00399 · APJ Christopher M Kaiser · IPR · Final written decision

    Claims 11–19 are unpatentable as obvious: claims 11–14 over Kalliola, Turunen, Oswald, Vauclair, and Kalayjian; claims 15–18 with Thorn; and claim 19 with Thorn and Sharp.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that the level of ordinary skill in the art corresponds to “a bachelor’s degree in computer science, computer engineering, electrical engineering, or a similar technical field and 2-4 years of experience with wireless ranging and positioning systems, wireless communication devices, and associated computer programming.” Pet. 4 (citing Ex. 1003 ¶ 35). “Patent Owner agrees that this description reasonably represents the level of ordinary skill required to understand and implement the teachings of the ’246 Patent, as well as the prior art cited in the Petition.” PO Resp. 14 (citing Ex. 2002 ¶ 22). Accordingly, we adopt Petitioner’s proposed level of skill.” slip op. at 8

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

      “device.” This term appears twice in claim 11, once in the phrase “an orientation sensor to detect rotation of the mobile communication device,” and once in the phrase “rotation of the mobile communication device detected by the orientation sensor.” Ex. 1001, 39:13–14, 39:36–38. Patent Owner argues that we should construe this term as limited to “detecting the rotation of the mobile communication device as a whole, not the movement of individual components.” PO Resp. 15–18. Petitioner disputes this, arguing that “rotation of the mobile communication device” should be construed not only to cover rotation of the device as a whole but also should “encompass[] any rotation of the mobile communication device relative to any object, including itself,” which would extend to rotation of “any component of the device.” Reply 4–5. We need not resolve this dispute to determine the outcome of Petitioner’s asserted challenges to the ’246 patent. As discussed more fully below, under either party’s proposed construction of “rotation of the mobile communication device,” Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9

    • Expert testimonyOther

      “On the record developed during trial, we are persuaded that Petitioner has shown by a preponderance of the evidence that Kalliola teaches “an orientation sensor to detect rotation of the mobile communication device,” where “rotation of the mobile communication device” includes rotation of the device as a whole, regardless of whether it also includes rotation of one portion of the device relative to another. Kalliola teaches “motion sensors integrated in WCD 100” that are “used to detect when WCD 100 is being moved,” as well as to detect “when user 110 moves WCD 100 too quickly for an accurate DoA estimation.” Ex. 1004 ¶¶ 84, 86. Although Patent Owner argues that Kalliola’s motion sensors do not detect rotation of the device, this is incorrect on the record as developed at trial. Kalliola teaches that the motion sensor may take “the form of a semiconductor gyroscope chip.” Id. ¶ 84. There is ample evidence that gyroscopes detect rotation. Ex. 1013, 38 (identifying as an “orientation sensor” a “[t]hree-axis gyro” and a “[d]ynamic [h]igh [r]ange [gyro]”); Ex. 1046, 49:18–20 (Dr. Feuerstein testifying that gyroscopes “can be used to detect angular velocity”); Ex. 1047 ¶ 47 (citing Ex. 1051, 170; Ex. 1053, 9) (Dr. Buehrer testifying that a person of ordinary skill in the art “would understand that gyroscopes are well-known inertial sensors that specifically detect rotational motion”). Thus, by a preponderance of the evidence, Petitioner has shown that Kalliola teaches the “orientation sensor to detect rotation of the mobile communication device” of this limitation.” slip op. at 17

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “whether Kalliola’s teaching of pausing and resuming its DoA estimation based on detected rotational motion, or Kalliola’s teaching of speeding up its DoA estimation based on detected rotational motion, amounts to determining direction based on rotation. Pet. 63–64; PO Resp. 25–27; Reply 24–27; Sur-Reply 11–14. On the record developed during trial, we are persuaded that the preponderance of the evidence supports a finding that Kalliola teaches determining direction based on rotation. First, Kalliola discloses “pausing a DoA estimation until the motion of the WCD is detected by the motion sensors,” then resuming “the updating of the DoA estimation” when motion is detected. Ex. 1004 ¶¶ 14, 84. Second, Kalliola discloses a “correction or compensation mode” that is “employed when user 110 moves WCD 100 too quickly for an accurate DoA estimation,” with this “increase[d] speed of the DoA estimation” being triggered by the “[i]ncreased activity detected by motion sensors in WCD 100.” Id. ¶ 86. As discussed above with respect to limitation 11(d), the detected motion that triggers either of these modes can be rotational motion of the WCD detected by a gyroscope.” slip op. at 22

    Patent outcomesUS 11,350,246 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,350,246
  • PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

    Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

    • Expert testimonyPetitioner expert creditedMixed

      “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

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

      “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See 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)).” slip op. at 26

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

    Patent outcomesUS RE47,045 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
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