- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.
RulingsFinal written decision- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56
Patent outcomesUS 12,054,758 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–250 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126
- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3
Patent outcomesUS 12,060,590 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,060,590 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 25, 2026 · PGR2025-00039 · APJ Michael A Valek · PGR · Final written decision
Claims 1–4 and 7–11 are unpatentable because the challenged claims lack written-description support and are not enabled.
RulingsFinal written decision- Adverse judgmentAdverse judgmentOther
“1 Although the Petition was directed to claims 1–11 of the ’185 patent, Patent Owner filed a statutory disclaimer of claims 5 and 6 prior to institution, leaving just claims 1–4 and 7–11 at issue. See Ex. 2003.” slip op. at 2
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“B. Claim Construction In a post-grant review, we interpret a claim “using the same claim” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“For these reasons, we find that a preponderance of the evidence” slip op. at 59
Patent outcomesUS 12,104,185 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,104,185 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78
Patent outcomesUS 12,110,520 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the understanding of a person of ordinary skill in the art (sometimes referred to 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 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70
Patent outcomesUS 12,152,262 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,152,262 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01173 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7, 9–13, and 16–19 are unpatentable: claims 16–17 are anticipated by Lesniak, and the remaining challenged claims are obvious over the stated combinations.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002 ¶¶ 27–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally PO Resp. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said deodorant stick being free of an aluminum salt” and “said deodorant stick” having a particular hardness range. PO Resp. 8–9. Patent Owner also points to dependent claims 5–8 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 10. We agree.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate a deodorant stick within the parameters of claims 16 and 17. e) Conclusion as to Claims 16 and 17 We agree with Petitioner that “the challenged claims recite nothing more than well-known deodorant ingredients performing their conventional functions.” Pet. Reply 2. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claims 16 and 17.” slip op. at 22
Patent outcomesUS 10,905,647 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,905,647 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - Apple Inc. v. Theta IP, LLCSome claims unpatentablePTAB · Nov 25, 2025 · IPR2024-00819 · APJ Russell E Cass · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over Behbahani, Leete, and Tan; claim 20 was not shown unpatentable because the references did not teach its required comparison of desired and interferer signal strengths.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner thus proposes a Master’s degree with two years of experience, while Patent Owner proposes a Bachelor’s degree with five years of experience. At the institution stage, we did not see a material difference in the proposals given that both parties also indicate that more education could substitute for less experience and vice versa, and thus adopted Patent Owner’s proposal. Inst. Dec. 9. We requested that the parties address during trial if either believed that the choice of one proposal over the other would make a difference in the patentability analysis. Id. Neither party has done so. Accordingly, because nothing in the record persuades us that our preliminary finding in the Institution Decision was incorrect, and because neither party has challenged our finding, we maintain our adoption of Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Here, as in the Director’s example, Petitioner advanced a narrower construction of the dynamic limitations before the district court, which the district court declined to adopt. Pet. 9; Ex. 2015; Ex. 2025, 31–47. Instead, the district court adopted a “plain-and-ordinary meaning” construction, which Patent Owner proposed. PO Resp. 38; PO Sur-reply 10 n.2; Ex. 2015; Ex. 2025, 31–47. In the Petition, Petitioner proposed applying the plain and ordinary meaning construction that had already been preliminarily adopted by the district court. Compare Pet. (filed May 1, 2024) with Ex. 2015 (preliminarily adopting plain and ordinary meaning construction on March 25, 2024). Applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR. Thus, we give the dynamic limitation its plain-and-ordinary meaning, which is “adjusting during operation based—at least in part—on information gained during operation.”” slip op. at 13
- Prior constructionPrior construction adoptedDecided for patent owner
“In our Institution Decision, we stated that we “will give the term ‘signal path’ its ‘plain and ordinary meaning’ and not limit it only to analog components, as the district court found and the parties agree.” Inst. Dec. 11. Given that the parties continue to agree on this point, we see no need to depart from the construction we adopted in our Institution Decision. Moreover, applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR for the same reasons as discussed above. In this proceeding, the dispute between the parties concerns the application of this and the surrounding claim language (i.e., “in the receiver signal path,” “in the signal path”) to the disclosures in Behbahani. See PO Resp. 43–45. Therefore, we will provide further discussion in the context of the parties’ arguments regarding Behbahani below. However, we agree with Patent Owner’s plain reading of the claim language to the extent it requires adjusting an impedance and/or bias current of a circuit while it is in the signal path. See Id. at 50–51.” slip op. at 14
- Expert testimonyPatent owner expert discountedOther
“Patent Owner’s arguments generally fail to address why Behbahani’s Variable Bandpass Filter Block does not teach the recited “plurality of circuits [comprising/including] . . . a filter,” and instead focus on why the low-pass and high-pass filter circuits do not teach the limitation, which is not Petitioner’s position. As stated above, we agree with Patent Owner’s plain reading of the claim language – i.e., that it “requires adjusting the bias, in or of a circuit.” See PO Resp. 49. However, Patent Owner’s reading of the claim does not persuasively address why the Variable Bandpass Filter Block does not teach the recited “circuit.” We have reviewed Dr. Larson’s cited testimony and disagree with Patent Owner that he provided “a well-supported opinion . . . as to why a [person of ordinary skill in the art] would not understand the entire bandpass box to be a single ‘circuit,’ or to reflect variation in ‘an impedance’ or ‘a bias’ in the claims.” Sur-reply 4 (citing Ex. 2020 ¶¶ 46–48, 71, 74–83). Dr. Larson testifies that the ’330 patent (which has the same specification as the ’164 patent) “teach[es] these adjustments [that dynamically change operating parameters] as changes effected in a single circuit block.” Ex. 2020 ¶ 46 (citing, e.g., Ex. 1001, Figs. 8A, 9A, 8:20–25, 8:36–39, 9:36–59, 10:1–18 (emphasis added)). Dr. Larson does not provide further explanation as to what he means by a “single circuit block,” but relies on Figures 8A and 9A, which show a “function block,” and other disclosures referring to a “function block.” See id. There is no dispute that the recited “circuit” in the receiver signal path is referring to these “function blocks.” See Tr. 22:20–23:4. The ’164 patent states that Figure 8A, which includes function block 820, is “an embodiment of the present invention” 8:28–30. Similarly, Figure 9A, which includes function block 920, “illustrate[s] one of the possible power saving techniques.” Id. at 3:41–42. The ’164 patent describes that “[f]unctional block 820 . . . may be a filter, mixer, amplifier, or other circuit or circuits in a wireless transceiver or other electronic circuits or system.” Id. at 8:30–33 (emphasis added). Based on these disclosures, we are not convinced that Function Block 820 or 920 cannot include multiple filters in a Variable Bandpass Filter Block, or that Behbahani’s Variable Bandpass Filter Block does not teach the recited “circuit.” Dr. Larson also relies on Figure 6 of the ’164 patent to conclude that” slip op. at 45
Patent outcomesUS 11,564,164 mixedClaim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,564,164 - Apple Inc. v. Theta IP, LLCAll claims unpatentablePTAB · Nov 24, 2025 · IPR2024-00816 · APJ Russell E Cass · IPR · Final written decision
Claims 1–7, 9–13, 16, 23, 25–27, and 29 are unpatentable as obvious over Behbahani, Leete, and Tan.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner thus proposes a Master’s degree with two years of experience, while Patent Owner proposes a Bachelor’s degree with five years of experience. At the institution stage, we did not see a material difference in the proposals given that both parties also indicate that more education could substitute for less experience and vice versa, and thus adopted Patent Owner’s proposal. Inst. Dec. 11. We requested that the parties address during trial if either believed that the choice of one proposal over the other would make a difference in the patentability analysis. Id. Neither party has done so. Accordingly, because nothing in the record persuades us that our preliminary finding in the Institution Decision was incorrect, and because neither party has challenged our finding, we maintain our adoption of Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Here, as in the Director’s example, Petitioner advanced a narrower construction of the dynamic limitations before the district court, which the district court declined to adopt. Pet. 10; Ex. 2015; Ex. 2025, 31–47. Instead, the district court adopted a “plain-and-ordinary meaning” construction, which Patent Owner proposed. PO Resp. 36–38; PO Sur-reply 10 n.2; Ex. 2015; Ex. 2025, 31–47. In the Petition, Petitioner proposed applying the plain and ordinary meaning construction that had already been preliminarily adopted by the district court. Compare Pet. (filed May 1, 2024) with Ex. 2015 (preliminarily adopting plain and ordinary meaning construction on March 25, 2024). Applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR. Thus, we give the dynamic limitation its plain-and-ordinary meaning, which is “adjusting during operation based—at least in part—on information gained during operation.”” slip op. at 14
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Variable Bandpass Filter Block does not teach the recited “component” or “impedance” that is dynamically adjusted, and instead focus on why the low-pass and high-pass filter circuits do not teach the limitation, which is not Petitioner’s position. As stated above, we agree with Patent Owner’s plain reading of the claim language – i.e., that it “requires adjusting a variable impedance of a circuit or component thereof, while it is in the signal path.” See PO Resp. 49. However, Patent Owner’s reading of the claim does not persuasively address why the Variable Bandpass Filter Block does not teach the recited “circuit” or “component.” We have reviewed Dr. Larson’s cited testimony and disagree with Patent Owner that he provided “a well-supported opinion . . . as to why a [person of ordinary skill in the art] would not understand the entire bandpass box to be “a component,” “a circuit,” or “an impedance” in the claims.” Sur-reply 4 (citing Ex. 2020 ¶¶ 46–48, 71, 74–83). Dr. Larson testifies that the ’330 patent “teach[es] these adjustments [that dynamically change operating parameters] as changes effected in a single circuit block.” Ex. 2020 ¶ 46 (citing, e.g., Ex. 1001, Figs. 8A, 9A, 8:20–25, 8:36–39, 9:36–59, 10:1–18 (emphasis added)). Dr. Larson does not provide further explanation as to what he means by a “single circuit block,” but relies on Figures 8A and 9A, which show a “function block,” and other disclosures referring to a “function block.” Id. There is no dispute that the recited “circuit” or “component” in the receiver signal path is referring to these “function blocks.” See Tr. 22:20–23:4. The ’330 patent states that Figure 8A, which includes function block 820, is “an embodiment of the present invention” that describes a “possible power saving technique[].” Ex. 1001, 3:30–33, 8:20–25. Similarly, Figure 9A, which includes function block 920, “illustrate[s] one of the possible power saving techniques.” Id. at 3:33–34. The ’330 patent describes that “[f]unctional block 820 . . . may be a filter, mixer, amplifier, or other circuit or circuits in a wireless transceiver or other electronic circuits or system.” Ex. 1001, 8:22–25 (emphasis added). Based on these disclosures, we are not convinced that Function Block 820 or 920 cannot include multiple filters in a Variable Bandpass Filter Block, or that Behbahani’s Variable Bandpass Filter Block does not teach the recited “circuit,” “component,” or “impedance.”” slip op. at 42
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“The absence of meaningful disclosure of the implementation details of the circuit in the ’330 patent suggests that the circuit implementation details Patent Owner argues about now would have been within the understanding of a person of ordinary skill in the art. That is, Patent Owner did not provide in its own specification “the type of detail [it] now argues is necessary in prior art references,” which permits a “finding that one skilled in the art would have known how to implement the features of the references and would have concluded that the reference disclosures would have been enabling.” In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994). When a patent specification does not “specifically describe[]” any “equipment or techniques to be used,” it may be deduced “that all of the equipment and technical knowledge required to perform the claimed method” is known to one of ordinary skill in the art. In re Fox, 471 F.2d 1405, 1407 (CCPA 1973); see also Southwire Co. v. Cerro Wire LLC, 870 F.3d 1306, 1312 (Fed. Cir. 2017) (without proof to the contrary, when there is no focus on a disputed claim limitation in the specification, the limitation is merely “an observed result of an old process”). To that end, Petitioner provides persuasive testimony from Dr. Abidi that signal strength measurement circuits were known in the art, and that a person of ordinary skill in the art would have understood how to implement a known technique for measuring signal strength, which is not disputed by Patent Owner. Ex. 1003 ¶¶ 180– 181; Ex. 1042 ¶¶ 12–16; see Pet. Reply 24–26; Pet. 60–62. Accordingly, we agree with Petitioner that Behbahani’s disclosure at least suggests circuitry for performing such a determination of signal strength. See Pet. Reply 24 (citing Pet. 60–61; Ex. 1003 ¶¶ 92–98, 179–181). Petitioner further argues that Tan “provides an example of circuitry used to detect signals at various points in the low-pass filter signal path as a means of implementing a prefilter automatic gain control.” Pet. 60–61 (citing Ex. 1006, 481); Ex. 1003 ¶ 180. The example in Tan is a peak detector circuit. Pet. 61; Ex. 1003 ¶ 180; Ex. 1006, Fig. 8. Dr. Abidi testifies that a person of ordinary skill in the art would have been motivated to use Tan’s signal strength measurement circuitry to measure nodes AI and AO. Ex. 1003 ¶ 180. In response to Patent Owner’s argument that Petitioner does not sufficiently explain how to use Tan’s peak detector in Behbahani (PO Resp. 70), Dr. Abidi provides testimony explaining how Tan’s peak detector circuit provides a measure of the signal strength, which we find persuasive, and is unrebutted by Patent Owner. Ex. 1042 ¶ 15.” slip op. at 30
Patent outcomesUS 7,010,330 unpatentableClaim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,010,330 - Apple Inc. v. Theta IP, LLCAll claims unpatentablePTAB · Nov 24, 2025 · IPR2024-00817 · APJ Kara L Szpondowski · IPR · Final written decision
Claims 1–8 are unpatentable as obvious over Behbahani, Leete, and Tan; Patent Owner’s motion to strike is denied.
RulingsFinal written decision- Strike new argumentNew argument consideredDenied
“Pursuant to 37 C.F.R. § 42.23(b), a reply “may only respond to arguments raised in the corresponding . . . patent owner response.” We agree with Petitioner, for the reasons stated in the Opposition, that the arguments and declaration testimony is responsive to arguments raised in the Patent Owner Response. See Opp Mot. 7–11 (explaining the positions taken in the Petition, Patent Owner’s arguments in Response, and the arguments presented in Reply); Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1008– 1009 (Fed. Cir. 2023). Petitioner does not provide a new theory of unpatentability; rather, Petitioner responds and elaborates on the theory presented in the Petition to explain why Patent Owner’s arguments are incorrect. E.g., Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F.3d 919, 925 (Fed. Cir. 2019) (“Parties are not barred from elaborating on their arguments on issues previously raised.”); Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081–82 (Fed. Cir. 2015) (reasoning that rebuttal evidence should be responsive such that it is offered “to explain, repel, counteract, or disprove the evidence of the adverse party”). “[T]he introduction of new evidence in the course of the trial is to be expected in [IPR] trial proceedings” and permissible “as long as the opposing party is given notice of the evidence and an opportunity to respond to it.” Genzyme Therapeutic Prods. Ltd. P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016).” slip op. at 12
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner thus proposes a Master’s degree with two years of experience, while Patent Owner proposes a Bachelor’s degree with five years of experience. At the institution stage, we did not see a material difference in the proposals given that both parties also indicate that more education could substitute for less experience and vice versa, and thus adopted Patent Owner’s proposal. Inst. Dec. 11. We requested that the parties address during trial if either believed that the choice of one proposal over the other would make a difference in the patentability analysis. Id. Neither party has done so. Accordingly, because nothing in the record persuades us that our preliminary finding in the Institution Decision was incorrect, and because neither party has challenged our finding, we maintain our adoption of Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Thus, the parties do not dispute the meaning of “signal path,” and we adopt the district court’s construction of plain and ordinary meaning, as agreed by the parties. See PO Resp. 40–41; Pet. 9; Ex. 2025, 14. The dispute concerns the application of this and the surrounding claim language (i.e., “in the receiver signal path”) to the disclosures in Behbahani. See PO Resp. 40–42. Therefore, we will provide further discussion in the context of the parties’ arguments regarding Behbahani below. However, we agree with Patent Owner’s plain reading of the claim language in limitation 1(e) and the corresponding limitations in independent claims 3, 5, 7, and 8 – i.e., that “[t]he plain language requires adjusting a bias current, or a bias current and an impedance, in a circuit, while it is in the signal path.” See PO Resp. 48. We determine that it is not necessary to provide an express interpretation of any other claim terms for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 20
- Settled expectationsNot reached
“Owner’s] settled expectations in long-standing patent rights, and Office policies and efficiency.” Id.; see id. at 25–26. Patent Owner’s arguments essentially reassert the arguments made in the Preliminary Response that inter partes review should be discretionarily denied under 35 U.S.C. § 314(a) and 35 U.S.C. § 325(d). In the Institution Decision, we were not persuaded by these arguments. Inst. Dec. 15–22. Patent Owner argues that in Ecto World, LLC v. RAI Strategic Holdings, Inc., IPR2024-01280, Paper 13 (PTAB May 19, 2025) (§ A precedential) supports denial under 35 U.S.C. § 325(d). Sur-reply 25. However, Ecto World was designated precedential on May 19, 2025, and our Standard Operating Procedure 2 provides that “[a] precedential decision is binding Board authority in subsequent matters involving similar facts or issues.” SOP2, 7 (emphasis added). Therefore, re-evaluation under Ecto World does not appear to be appropriate under the circumstances here. Patent Owner also argues that proceedings can be properly dismissed post-institution in the Director’s discretion. Sur-reply 26. In support, Patent Owner cites to Hulu LLV v. Piranha Media Distribution, LLC, IPR2024- 01252, Paper 17, at 3 (PTAB April 17, 2025). Id. However, in Hulu, the patent owner timely sought Director Review after the institution decision, and upon Director Review, the institution decision was vacated and denied. IPR2024-01252, Papers 16, 19, 27. By contrast, here, Patent Owner raised this issue for the first time in the Sur-reply (filed August 5, 2025, nearly three months after Ecto World was designated precedential), approximately three weeks prior to oral argument. Patent Owner also did not file a motion to terminate the proceeding. Although we recognize that “that the Board has the inherent authority to reconsider institution decisions (beyond the regulatory time for a patentee’s entitlement to seek reconsideration),” Sling TV, L.L.C. v. Realtime Adaptive Streaming LLC, 840 F. App’x 598, 598–99 (Fed. Cir. 2021), we decline to do so at this late stage in the proceeding.” slip op. at 63
Patent outcomesUS 10,129,825 unpatentableClaim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,129,825
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.