- Aroma360, LLC v. Air Esscentials, Inc.All claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00705 · APJ Eric C Jeschke · IPR · Final written decision
Claims 7–9 and 11 are unpatentable as obvious over Goubet; proposed substitute claim 21 is denied as indefinite.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Response, Patent Owner states that it “does not dispute” the definition of one of ordinary skill in the art proposed by Petitioner, but Patent Owner “reserves the right to address [the definition] should new issues materialize.” PO Resp. 5. Patent Owner did not address this issue in the Sur-reply. As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for patent owner
“The record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration, as asserted in Petitioner’s overall argument. See Pet. Reply 1–2. Contrary to Petitioner’s argument, in the cited general discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1; see also Pet. Reply 2 (arguing that “Dr. Micklow’s declaration is premised on understandings of claim scope that are inconsistent with the constructions advanced by both of the parties” (emphasis added)). Instead, we read the cited portions of Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also Pet. Reply 1 (citing Ex. 1046, 112:4–12, 113:13–20, 115:15–18). Next, we turn to each of the four specific claim terms that Petitioner highlights in its further arguments.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“B. Claim Construction In inter partes reviews, the Board interprets claim language using the same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms 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. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 10–11; PO Resp. 5. Based on the complete record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. 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 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Florida Litigation a Joint Claim Construction statement that included stipulated claim constructions and disputed claim constructions for terms in the challenged patent as well as the ’449 patent and the ’918 patent. See Ex. 1018, Exhibit A (Stipulated Claim Constructions), Exhibit B (Disputed Claim Constructions). The parties stipulated to the construction of the terms “fluid dispersion” and “baffle” as recited in the challenged claim. See id., Exhibit A.10 10 When staying the Florida Litigation, the District Court cancelled the scheduled claim construction hearing. See ECF No. 67 (April 8, 2025) (granting joint motion to stay); ECF No. 68 (April 8, 2025) (cancelling the The stipulated construction of “fluid dispersion” merely restates the express definition of “fluid dispersion” from the challenged patent (although the definition is not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 3:8–20. Similarly, the stipulated construction of “baffle” essentially parrots one sentence in the challenged patent (again, not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 7:57–59. To the extent necessary, we determine that the complete record supports the parties’ stipulated constructions of “fluid dispersion” and “baffle,” and we apply those constructions below.” slip op. at 10
Patent outcomesUS 9,527,094 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 9,527,094 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentablePTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision
The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27
Patent outcomesUS 11,896,675 not shown unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,896,675 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2023-00016 · APJ Michael A Valek · IPR · Remand
On remand, the Board held claims 1–6 not shown unpatentable because unexpected results outweighed the prima facie obviousness case, and granted Patent Owner’s motion to exclude.
RulingsRemand decision- RemandOther
“the Court of Appeals for the Federal Circuit (“Federal Circuit”)See Paper 83 (“CAFC Decision”). The Federal Circuit did not disturb our determination that Petitioner “established a prima facie case of obviousness.” See CAFC Dec. 6–8. However, it took issue with the unexpected results analysis in the Decision, explaining that “without more explanation from the Board as to its determination that the experiments [offered by Patent Owner to show unexpected results] compared the challenged claims to the closest prior art, we cannot reach a judgment on MSN’s challenges to the Board’s holding of non-obviousness.” Id. at 14. Accordingly, the Federal Circuit vacated the Decision and remanded the case for further consideration of the unexpected results evidence. Id.” slip op. at 2
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 35
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusObjective indicia outweighedDecided for patent owner
“We find Patent Owner’s evidence persuasive to show that the Glu3 substitution results in an unexpected improvement in interconversion stability. As explained above, RP-HPLC was a known technique for separating the topoisomers of human uroguanylin. Ex. 2010, 230–231; Ex. 2011, 27–28; Ex. 2020, 223; Ex. 2028, TRUL00018269; see also Ex. 1063 ¶¶ 37, 40 (Petitioner’s expert confirming same). It was also known that one of human uroguanylin’s topoisomers was biologically active, whereas the other, i.e., what we and the parties refer to as the “inactive” topoisomer, had significantly less or no activity at the same concentration. Ex. 2011, 31 (“compound I shows significant activity in the cGMP producing assay, whereas compound II is practically inactive”); see also Ex. 2010, 238–239 (Fig. 8) (showing the “A isomer” had a potency “with a minimal concentration between 10-7and 10-8 M,” but that the B isomer “had virtually no effect on cGMP level at 10-6 M”); Ex. 2074, 48 (compound II “showed maximal 10% of the activity of compound I at 10-6 M”). The chromatograph for uroguanylin in Patent Owner’s data is consistent with these teachings, showing two peaks representing the active and inactive topoisomers. Compare Ex. 2028, TRUL00018269 (Fig. 1) with Ex. 2011, 28 (Fig. 2). The chromatograph for SP-304 shows a markedly different result, i.e., a “single peak,” which was confirmed “using the cGMP T84 cell assay” to represent “the fully active conformer of SP-304.” Ex. 2028, TRUL00018269; Ex. 2024 ¶¶ 208–209. We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 34
- 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.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentable§ 103 obviousnessPatents in suitUS 7,041,786 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,041,786 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAdverse judgmentPTAB · Jan 12, 2026 · IPR2022-01513 · APJ Ryan H Flax · IPR · Adverse judgment
The Board granted Petitioners’ withdrawal and entered adverse judgment against them on remanded claims 5–8; claims 1–4 remained affirmed as unpatentable.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: . . . [a]bandonment of the contest.” 37 C.F.R. §42.73(b)(4). We find good cause exists to grant Petitioners’ request to withdraw from the proceedings, which is a request for adverse judgement (with respect to challenged claims 5–8). slip op. at 3
NonePatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAdverse judgmentPTAB · Jan 12, 2026 · IPR2022-01515 · APJ Ryan H Flax · IPR · Adverse judgment
The Board granted Petitioners’ withdrawal request and entered adverse judgment against them as to claims 5–8; claims 1–4 remained affirmed as unpatentable.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: . . . [a]bandonment of the contest.” 37 C.F.R. §42.73(b)(4). We find good cause exists to grant Petitioners’ request to withdraw from the proceedings, which is a request for adverse judgement (with respect to challenged claims 5–8). slip op. at 3
NonePatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAdverse judgmentPTAB · Jan 12, 2026 · IPR2022-00517 · APJ Ryan H Flax · IPR · Adverse judgment
The Board granted Petitioners’ withdrawal request and entered adverse judgment against them as to claims 5–8 after remand.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: . . . [a]bandonment of the contest.” 37 C.F.R. §42.73(b)(4). We find good cause exists to grant Petitioners’ request to withdraw from the proceedings, which is a request for adverse judgement (with respect to challenged claims 5–8). slip op. at 3
NonePatents in suitUS 10,828,310 - PTAB · Dec 11, 2025 · IPR2025-01025 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Garrison with Laub and/or Aklog.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’910 patent’s challenged claims. We institute inter partes review on all challenged claims and on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 18 (citing Ex. 1003 ¶¶ 35–36).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD Rsch., Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (internal quotation marks omitted).” slip op. at 12
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,974,910 - PTAB · Dec 11, 2025 · IPR2025-01021 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–12, 14–31, and 33–38 on all asserted grounds, finding a reasonable likelihood of success on at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“its challenge to the claims under Grounds 1A–4A. We have also considered Patent Owner’s counterarguments, which we find unavailing at this stage for reasons explained below. See infra Section III.E.3. Upon considering the parties’ argument and evidence, we find that Petitioner has established that it is reasonably likely to succeed in showing that at least claim 1 would have been obvious under Grounds 1A–4A. Based on the preliminary record, Petitioner persuades us that a POSA would have had reasons for adding a stopcock (or similar flow-control valve) to Laub’s system between the catheter and the cited clot canister and pressure source, as suggested by Garrison. See, e.g., Ex. 1006 ¶¶ 130–134; Ex. 1012, Fig. 1A; Ex. 1006, Fig. 34. Petitioner persuades us that Laub’s system, modified as proposed, would allow a user to close the valve while a pressure source (e.g., a pump) creates a negative pressure and vacuum between the valve and the pressure source, which vacuum may then be applied to a distal portion of the catheter upon opening the valve to facilitate a rapid aspiration of a portion of a PE into the clot canister. Pet. 38–42; Ex. 1003 ¶¶ 48, 103–114.” slip op. at 30
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 13 (citing Ex. 1003 ¶ 35). Patent Owner counters that Petitioner’s proposed definition is “insufficient” but does not, in the Preliminary Response, explain why it is “insufficient” or propose a definition of its own. Prelim. Resp. 20 (citing333 Ex. 2005 ¶ 52).14 Instead, in advancing Patent Owner’s counterarguments, “Patent Owner applies Petitioner’s definition.” Id. For this Decision, we apply Petitioner’s POSA definition, which appears to be reasonable and consistent with the prior art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that the term “filament” in, for example, dependent claim 11 means at least “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.” Pet. 15. Patent Owner notes its disagreement with Petitioner’s interpretation of the term “filament” in related proceedings (e.g., IPR2025-00289). Prelim. Resp. 20 n.3. But Patent Owner contends that the claim construction issue in related proceedings “is not germane” to Patent Owner’s arguments in the present case and, thus, the Board need not construe that term (or any other term of the ’333 patent’s challenged claims) at this time. We need not, at this stage, further construe the ’333 patent’s claims to address the issues that are presently in dispute.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“pumps, like described in Laub, Aklog, and Garrison would, in the proposed modified systems, generate a vacuum pressure as claimed will be best assessed on a full record at trial. As an initial matter, claim 1 does not recite a “maximum level of aspiration in a rapid fashion.” At most, Patent Owner’s argument (if accepted) may weaken some of Petitioner’s reasoning for modifying the prior art. In any event, we are at this stage unpersuaded that a pump would not, when a fluid control valve is closed, generate a vacuum pressure and operate in the manner claimed. See, e.g., Ex. 1003 ¶¶ 103–105 (testifying that a stopcock and aspiration pump would generate a vacuum and provide for rapid aspiration). Garrison does not disclose that only syringes have such capability, and Garrison teaches, in the same paragraph where the cited alternative aspiration sources may be used in its systems (“active source[s] of aspiration may be an aspiration pump, a regular or locking syringe, a hand-held aspirator, hospital suction, or the like”). Ex. 1006 ¶ 134. Garrison’s disclosure is, thus, not limited to use of syringes or even peristaltic pumps (as allegedly depicted in Figure 34). We also note (as pointed out by Petitioner) that the ’333 patent indicates that both pumps and syringes generate and store negative/vacuum pressure in an aspiration system.18 Ex. 1001, 7:28–41, dependent claim 15 (aspiration source comprises “an electric pump”); Prelim. Reply 5. That a POSA would have understood that both syringes and pumps, like disclosed in Garrison, can generate a vacuum pressure to permit rapid aspiration of clots also finds further evidentiary support in Dr. Turk’s testimony that surgeons have used pumps and syringes for that purpose since the early 2010s. Ex. 1022 ¶ 23. Moreover, although Laub teaches that running a pump continuously at high flow rates can assist with dislodging clots, Petitioner persuades us on the present record that a POSA would see benefit in modifying Laub’s system to also allow for an initial or intermittent rapid burst of vacuum pressure to help remove a clot. Ex. 1003 ¶¶ 106, 109.” slip op. at 33
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,969,333 - PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution
The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityDecided for petitioner
“STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms 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.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19
Claim construction§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 12,156,781
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.