• MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand

  Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.

  RulingsRemand decision

  • RemandOther

    “More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner

    “In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56

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

    “same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10

  • ExcludeMotion to exclude, grantedGranted

    “motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58

  Patent outcomesUS 7,041,786 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,041,786
• Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentable
  PTAB · Jan 26, 2026 · IPR2024-01105 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–15 are unpatentable: claims 1, 3–8, and 11–14 as anticipated by Lesniak; claims 2, 9, 10, and 15 as obvious over the respective asserted combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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. 27 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. PO Resp. 7– 8. We adopt and apply Petitioner’s proposed definition of a POSA, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7

  • 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 stick range. PO Resp. 8–10. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 27 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 6

  • Expert testimonyPetitioner expert creditedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. d) Conclusion as to claim 1 Having considered the parties’ positions and evidence of record, summarized above, we are persuaded by Petitioner’s analysis that Lesniak discloses all elements of claim 1. We are not persuaded to Patent Owner’s arguments to the contrary. Accordingly, we determine that Lesniak anticipates claim 1.” slip op. at 20

  Patent outcomesUS 10,966,915 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,966,915
• Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentable
  PTAB · Jan 21, 2026 · IPR2024-01104 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–18 are unpatentable under § 103: claims 1–7, 9–13, and 15–18 over Lesniak, Phinney, and Bianchi ’518; claim 8 adds Lamb; claim 14 adds Bianchi ’254; and claims 1–18 are also unpatentable over the …

  RulingsFinal written decision

  • 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 stick being free of an aluminum salt” and “said stick” having a particular hardness range. PO Resp. 8–9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 30 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any other claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that a person of ordinary skill in the art (“POSA”) 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, ¶¶ 26–28). Patent Owner does not dispute 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 7

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

    “We have considered Patent Owner’s arguments but find, on this record, Petitioner to have the better position. In particular, we are persuaded that a POSA would have been motivated to add magnesium hydroxide to Lesniak’s compositions because Phinney teaches that: (i) zinc oxide has “low activity” as a “deodorant agent”; (ii) magnesium hydroxide is “an effective synergistic effects, hence motivating a POSA to add magnesium hydroxide to Lesniak’s zinc oxide deodorants. Ex. 1004, 1:13- 3:16, 5:61-67. Reply 10; see also PO Resp. 25–26 (arguing that a POSA would have found it obvious to add magnesium hydroxide to the composition of Lesniak because zinc oxide is not a particularly efficacious antimicrobial in deodorants when used alone, whereas magnesium hydroxide is an effective deodorant). We acknowledge that Phinney suggests mixing zinc oxide with water in order to convert zinc oxide to zinc hydroxide. See, e.g., Ex. 1004, 1:17– 19 (“It was also found that a mixture of the hydroxides of zinc and magnesium could provide long lasting protection against odour due to perspiration.”). The evidence of record, however, shows that both magnesium hydroxide and zinc oxide were known options for deodorant antimicrobials, and claim 1 does not require a minimal level of effectiveness such that the combination of magnesium hydroxide and zinc oxide would need to outperform any other combination including the mixture of zinc and magnesium hydroxides. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“Our case law does not require that a particular combination must be the preferred, or the most desirable, combination[.]”). Here, we also credit the testimony of Dr. Michniak-Kohn that “POSA would understand that the water-based vs. anhydrous distinction is not relevant, as a POSA would understand that magnesium hydroxide would still function as an antimicrobial in anhydrous compositions such as those disclosed by Lesniak.” Ex. 1086 ¶ 9 (citing Ex. 1072, 1-2, 5 (disclosing deodorants without added water and with zinc oxide and/or magnesium hydroxide)). Accordingly, we are persuaded by Petitioner that “a POSA would have been” slip op. at 22

  • Obviousness (§103) › KSR rationalesMotivation foundUnpatentable

    “teaches baking soda as an effective ingredient in a deodorant. Ex. 1005, 131–33. Baking soda is also known to cause irritation that may motivate some to remove it from deodorants. See Ex. 2011 ¶ 109–110. Thus, the specific set of advantages and disadvantages for using baking soda in a deodorant was known to a person of skill in the art. On this record, the inclusion or exclusion of baking soda presents no unexpected result and the evidence of record establishes that it would have been an obvious matter of design choice within the skill of the art to balance the advantages and disadvantages associated therewith. See Medichem, S. A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”); see also Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n. 8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”) In view of the above, we determine that the preponderance of the evidence supports Petitioner’s argument that claim 8 would have been obvious over the combination of Lesniak, Phinney, Bianchi ’518, and Lamb. Accordingly, we determine that claim 8 is obvious by the combination of Lesniak, Phinney, Bianchi ’518, and Lamb.” slip op. at 32

  Patent outcomesUS 11,540,999 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,540,999
• Illumina Inc. v. Molecular Loop Innovations LLCAll claims unpatentable
  PTAB · Jan 16, 2026 · IPR2024-00965 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1–6 are unpatentable: Gloor anticipates them, Parameswaran and Gloor render them obvious, and Parameswaran, Binladen, and Bentley render claim 6 obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 18 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 20–23). After reviewing the record, we adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We acknowledge the ambiguous nature of the disputed claim language. On its face, it could require two or more identifier sequences together be uniquely associated with the nucleic acid of interest, as Petitioner argues; or it could require two or more identifier sequences, each individual identifier sequence must be uniquely associated with the nucleic acid of interest, as Patent Owner asserts. See Reply 2–3; Sur-reply 1–6. We, therefore, must examine the words of the claim and the specification to ascertain the scope of this limitation. The specification states that “[w]hile the pair of barcodes associated with any given template is unique, individual barcode sequences can be used with multiple templates as long as no pair is used across two different samples.” Ex. 1001, 2:50–53 (emphasis added). Elsewhere, it states that [t]he first and second identifiers are designed such that each set of identifiers is correlated to a particular sample (e.g., material obtained from a particular patient or group of patients), allowing samples to be distinguished and/or validated. The first and second identifiers may be the same or different, so long as the combination is unique with respect to the sample or sub-sample that one seeks to distinguish and/or validate. Id. at 3:15–22 (emphases added). We agree with Petitioner that the specification supports its proposed construction. See Reply 2.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “Claim 5 recites “homopolymer region.” The ’200 patent specification provides an express definition for the term, stating that “the barcode sequences can be designed to have minimal or no homopolymer regions, i.e., 2 or more of the same base in a row such as AA or CCC, within the barcode sequence.” Ex. 1001, 9:6–10. Thus, we agree with Patent Owner that the term “homopolymer region” should be construed as “two or more of the same base in a row.” See PO Resp. 13 (citing Ex. 2001 ¶ 24). 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 expressly construe any other claim term.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “A reference is considered publicly accessible if it is “made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1355 (Fed. Cir. 2018). To “determine whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents,” we “must consider all of the facts and circumstances surrounding the disclosure.” In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009); see also In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004) (explaining that a determination of whether a reference qualifies as a printed publication “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public”).” slip op. at 15

  Patent outcomesUS 11,768,200 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,768,200
• Illumina Inc. v. Molecular Loop Innovations LLCNo claims unpatentable
  PTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.

  RulingsFinal written decision

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

    “specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24

  Patent outcomesUS 11,041,852 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,041,852
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentable
  PTAB · Dec 17, 2025 · IPR2024-01077 · APJ Michael A Valek · IPR · Final written decision

  Claims 1, 11, and 13–20 were not shown unpatentable over either Yuen and Mestas or Schröder and Mestas, principally because the curved-battery and waterproof-cavity showings were deficient.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors.” slip op. at 8

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

    “We agree with Petitioner that the term “ring” is not limited to a finger- worn ring. All of the challenged independent recite a “wearable ring computing device” (claims 1 and 11) or “ring computing device” (claim 14). Nothing in the claim language itself refers to where that device is worn. Moreover, the fact that Patent Owner has in several related patents added claim language to expressly recite a ring that is “finger-worn” or “worn around the finger” evidences that the plain meaning of the term “ring” by itself does not require such. Ex. 1362, 44:45–46:61 (claims 1–18); Ex. 1363, 44:64–46:56 (claims 1–17); Ex. 1364, 48:22–23 (claim 1); see Nystrom v. TREX Co., Inc., 424 F.3d 1135, 1143 (Fed. Cir. 2005) (explaining that the fact that another claim recites a “wood decking board” suggests the term “board” is not itself limited to one made from wood or cut from a log because “[w]hen different words or phrases are used in separate claims, a difference in meaning is presumed”). This understanding is further supported by the Specification of the ’859 patent. It is true, as Patent Owner asserts, that the Specification describes a preferred embodiment that is a finger-worn ring. See, e.g., Ex. 1001, Figs. 22A–B, 23A (depicting a finger-worn ring). But precedent cautions against importing limitations from the preferred embodiment into claims. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2004) (en banc) (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”). Indeed, the Specification here anticipates such arguments and makes clear that the applicants’ wearable computing device (WCD) is not limited to a ring worn on the finger: The WCD can be in the form of a ring that can be worn on the finger of a human (or animal) user. Although the WCD of the present disclosure is depicted as a ring that can be worn on the finger of a user, other shapes, designs, and form factors can be utilized for the WCD. For example, the WCD can be in the form of a wrist band, bracelet, necklace, earring, or any other type of wearable accessory. In this regard, references to the finger of a user in the present application can be considered to apply to other portions of a human body depending on the form of the WCD, such as wrist, neck, ear, etc. Ex. 1001, 8:51–61.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “ordinarily-skilled artisan to modify Yuen’s device to form the waterproof cavity recited in claim 1, much less explain the particular modifications Petitioner contends that artisan would have made to Yuen’s device housing to achieve such. This is particularly problematic given that the figures Petitioner relies upon in Yuen and Mestas uniformly depict larger, wrist/arm-band type devices. See Ex. 1006, Figs. 2–13, 12:52–55 (depicting a “wrist-worn or arm-mounted accessory such as a watch or bracelet”); Ex. 1010, Figs. 1–6, ¶ 151 (same). Thus, Petitioner’s obviousness theory requires multiple modifications to Yuen’s depicted structure: (1) modifying the identified portions of Yuen’s device housing so that they form a waterproof cavity therebetween; and (2) shrinking that device and its components down to a ring designed to fit around a single toe. We credit Dr. Mercier’s testimony that such modifications would require a “complex” re-engineering of Yuen’s existing structure that Petitioner and Dr. Anthony do not sufficiently explain. See Ex. 2018 ¶¶ 108–109, 129–130, 137–138. The testimony in Dr. Anthony’s supplemental declaration does not provide the missing explanation. Dr. Anthony continues to assert that Yuen’s sensor protrusion is sealed in the space between the alleged bounding members, relying on the same annotated versions of Figures 4 and 5, without addressing the fact that according to Petitioner’s own annotations those bounding members only form a shell that is open to the attachment band at either end. See Ex. 1079 ¶¶ 26–28. Indeed, Dr. Anthony appears to acknowledge that Yuen only teaches attaching the sensor module portion of the alleged cavity with watertight glue, but asserts that “it would not make sense to have a device that is waterproof in some areas and not others.” Id. ¶ 29. That assertion, however, is not supported by anything beyond Dr. Anthony’s say-so and ignores that Yuen’s teachings regarding a watertight seal/glue refer only to the sensor package portion of the alleged cavity. See Ex. 1006, 14:66–15:4, 15:10–14. Dr. Anthony’s assertion that Mestas teaches additional “waterproofing techniques” that could be applied to Yuen’s housing is similarly cursory. See Ex. 1079 ¶ 30. He does not identify what those techniques are or how a POSITA would use them to modify Yuen. Id. Accordingly, we do not credit this testimony.” slip op. at 27

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia with nexusDecided for patent owner

    “the asserted evidence of secondary considerations and a patent claim if the patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988) (emphasis added)). “That is, presuming nexus is appropriate when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.” Id. (internal quotation marks omitted). If, on the other hand, “the thing that is commercially successful is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process, the patentee is not entitled to a presumption of nexus.” Id. (internal quotation marks omitted).” slip op. at 33

  Patent outcomesUS 10,139,859 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,139,859
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.All claims unpatentable
  PTAB · Dec 2, 2025 · IPR2024-00928 · APJ Neil T Powell · IPR · Final written decision

  Claims 1–5, 11–13, and 16–18 are unpatentable as obvious over Schröder and Yuen, LeBoeuf, or LeBoeuf and Wissmar; Schröder alone did not render its challenged claims unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. PO Resp. 14. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’034 patent and the references cited in the Petition.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “Petitioner has the better position, as we agree with Petitioner that the ’034 patent discloses an embodiment that uses transparent potting as a window, rather than to form the overall form factor and encapsulate components: [Figure] 16C is a perspective view of the WCD with potting material 1630. As described above, the PCB, battery, and components can be disposed within the space. Once disposed therein, a potting 1630 can be provided atop the components and within the cutaway portion 1616. The potting 1630 can be transparent to allow for transmission of light through the cutaway portions 1616. Ex. 1001, 20:51–57. This configuration is shown below in Figure 16C. “[Figure] 16C is a perspective view of the WCD with potting material.” Ex. 1001, 6:1–2. As Figure 16C shows, potting material 1616 forms a window in only a portion of the WCD’s exterior. can be used to encapsulate components and form the overall form factor in some embodiments. E.g., Ex. 1001, 17:4–8, 18:61–62. But Patent Owner does not persuade us that claim 12 is limited to those embodiments. PO Resp. 29; SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.”). Accordingly, we do not construe claim 12’s “external transparent potting” as requiring material that “forms the ‘overall form factor of the WCD 120, in addition to providing a housing for one or more electronic components,’” as suggested by Patent Owner. PO Resp. 29. Nor do we construe the claim language as requiring material that “also fills the space and encapsulates the components,” as suggested by Patent Owner. Id.” slip op. at 11

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position. Although Schröder describes some aspects that are similar to those of a printed circuit board, Petitioner has not sufficiently demonstrated that a person having ordinary skill in the art would understand Schröder’s inlay 12 or carrier foil to be a “printed circuit board,” as recited in independent claims 1, 11, and 16. As an initial matter, while Schröder refers to a “circuit board” in another context, it never refers to the carrier foil or inlay in its finger-ring embodiment as such. See Ex. 1007, 22:48–49; see also Ex. 1079 ¶ 21 (Dr. Anthony acknowledging that Schröder’s only reference to a “circuit board” is “unrelated to Schröder’s finger-ring teachings”). Instead, Schröder describes features of that inlay, explaining that “[t]he carrier foil itself consists of a flexible plastic material, e.g.[,] PET or Kapton” and “antenna coil 8 can for example be printed on the carrier foil by means of a conductive paste” and “a depression is manufactured in the carrier foil, e.g.[,] by milling, lasering, etching, before the chip module 10, the antenna coil 8 and optional further electronic devices are inserted into the depression.” Ex. 1007, 13:26–31, 13:35–37. Schröder further describes that “[a]t least one further foil can be applied to the carrier foil or the ring blank on at least one side” to produce a “multilayer foil composite” that can be “interconnected” by means of “glue” slip op. at 23

  • Expert testimonyPetitioner expert discountedOther

    “show that Schröder’s inlay 12 is a PCB. Relying on testimony from Dr. Anthony, Petitioner asserts that Schröder’s inlay 12 serves as a flexible carrier made of materials “commonly understood to be printed circuit board materials” such as PET and Kapton. Pet. 23 (citing Ex. 1002 ¶ 172; Ex. 1006, 12:28–29). Dr. Anthony did not provide a clear explanation of a person of ordinary skill in the art’s understanding of a PCB in his direct testimony. article describing a PCB as a “laminated sandwich structure of conductive and insulating layers” was an accurate description of a PCB: Q. So is the first sentence of this Wiki page, in your mind, an accurate description of a printed circuit board? A. So, the first sentence, “A printed circuit board (PCB)[] also called [a] printed wiring board, []is a laminated sandwich structure of conductive and insulating layers, each with a pattern of traces, planes, and other features (similar to wires on a flat surface) etched from one or more sheets of copper laminated onto or between sheet layers of nonconductive substrate.” And so your question again was? Q. Is that a fair definition of printed circuit board in your mind? A. It’s a fair description of the general process for circuit boards, layers of conductive traces.” slip op. at 21

  Patent outcomesUS 9,582,034 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 9,582,034
• Salvacion USA, Inc. v. Trutek CorpAll claims unpatentable
  PTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11

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

    “of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9

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

    “We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10

  Patent outcomesUS 8,163,802 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,163,802
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.Some claims unpatentable
  PTAB · Nov 25, 2025 · PGR2024-00030 · APJ Linda E Horner · PGR · Final written decision

  Claims 17 and 18 are unpatentable under §112(d) for improper dependent form; claims 1–10 and 12–16 were not shown unpatentable on the asserted obviousness grounds.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We do not credit Dr. Anthony’s testimony, which is based on the arbitrary shading in Figure 7 (see Ex. 1002 ¶ 174), that Schröder teaches or suggests limitation 1[d] because it (1) is inconsistent with Petitioner’s reasoning for limitation 1[c], and (2) it is based on an admitted misreading of the embodiment of Schröder’s Figure 5 (see Ex. 1002 ¶ 175). As to the first item, Dr. Anthony states that “a POSITA would have been motivated to place a battery in a part of the cavity that is far from a PCB holding other electrical components because that configuration allows for better thermal management.” Ex. 1002, para. 175. The problem with this statement is that Petitioner relies on Schröder’s teaching that inlay 12, i.e., the alleged PCB, could include “other electrical components,” such as a battery to support its position that Schröder suggests placing a battery between the ring halves. See, e.g., Pet. Reply 2 (pointing to Dr. Mercier’s depo testimony that inlay 12 with “other components” is inserted between ring halves); id. at 3 (relying on Schröder’s teaching about placing components in depressions on inlay 12). So, Petitioner earlier asserts for the battery limitation 1[c] that Schröder teaches or suggests putting a battery on inlay 12 inside the ring halves, but then for limitation 1[d], Dr. Anthony testifies that a POSITA would place the battery “far” away from the inlay 12 (i.e., the alleged PCB). These positions are inconsistent.” slip op. at 25

  • Skill levelSkill level board ownOther

    “at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶¶ 18–22). Petitioner also contends that a person of ordinary skill would have been “familiar with, for example, sensor system design and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 26. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’178 patent and the references cited in the Petition.” slip op. at 10

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

    “Patent Owner indicates that in the related ITC proceeding involving the ’178 patent, the Administrative Law Judge (ALJ) adopted three constructions agreed-upon by the parties in that proceeding8 and also construed two disputed terms.9 Resp. 26–27 (citing Ex. 2016, 5, 6, 14). Patent Owner agrees with Petitioner, however, that no terms need to be construed to decide the issues raised in the Petition. Id. at 27. We reviewed the constructions adopted by the ITC. Ex. 2016, 5, 6, 14. 8 In the ITC proceeding, the ALJ adopted the parties’ agreed-upon constructions that: (1) the preamble of claim 1 [a finger-worn wearable ring device] is limiting; (2) [positioned/configured to fit] within a “cavity” is [positioned/configured to fit] within a “hollow space”; and (3) [the internal housing component] “coupled with” [the external housing component] is [the internal housing component] “connected with” [the external housing component]. Ex. 2016, 5. 9 In the ITC proceeding, the ALJ construed the claims such that: (1) the internal and external housing components of claims 1, 12, and 17 enclose space and do not necessarily exclude potting material; and (2) “circumferential,” as recited in claims 1, 17, and 18, does not require a closed shape. Ex. 2016, 14, 17. These constructions are not germane to the issues we need to decide to resolve this proceeding. Thus, we agree that no explicit claim construction is necessary for this decision. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “The record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “Mestas’s batteries, layout, and other components . . . would have to be scaled down 5 to 10 times to be appropriately sized for a finger worn ring.” Resp. 64 (internal quotation marks omitted) (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Moreover, we do not credit Dr. Anthony’s testimony that miniaturization of the battery would have been “trivial to implement.” Ex. 1002 ¶ 242. Dr. Anthony admitted on cross-examination that it would not have been within the level of skill of a person having ordinary skill in the art to design a smaller version of Mestas’s battery, and that such a person would need to procure a battery of the appropriate size and specifications for implementation in a finger-ring from a battery manufacturer. Ex. 2021, 315:9–318:9. Yet Dr. Anthony had not ascertained, for purposes of his testimony, whether there was a battery available in 2013 that was appropriate to fit within the inlay space of the modified version of Schröder’s finger-ring that he and Petitioner allege would have been obvious to one of skill in the art at that time. Id. at 321:5–10. Further, we credit Dr. Mercier’s testimony that Dr. Anthony’s testimony fails to consider the differences in power requirements between Mestas and Schröder or to account for the constraints of such a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶¶ 159–160. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’178 patent, we also have evidence that prior art “finger ring wearables up to the ’178 patent had used ‘coin’ type batteries.” Id. at 66 (citing Ex. 2018 ¶ 161). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would look to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 161. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura), Fig. 24; Ex. 2018 ¶¶ 61–70. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring-type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 71. Based on these findings, Petitioner has not met its burden to show by a preponderance of the evidence that a person having ordinary skill in the art would have been led to modify Schröder’s finger-ring to place a curved battery between the internal and external housing components in light of the teachings in Mestas. Thus, Petitioner has not met its burden to show by a preponderance of the evidence that dependent claim 3 of the ’178 patent is unpatentable over Schröder and Mestas.” slip op. at 38

  Patent outcomesUS 11,868,178 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,868,178
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13

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

    “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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 14

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,195,773

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.