- 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 - Google LLC v. Withrow Networks Inc.All claims unpatentablePTAB · Sep 25, 2026 · IPR2025-00775 · APJ Justin T Arbes · IPR · Final written decision
Claims 1–9 are unpatentable as obvious over each of the five asserted §103 grounds, including Carmel with Mattavelli and Carmel with Wang.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that at the relevant time of the invention claimed in the ’849 patent (April 2005),2 a person of ordinary skill in the art would have had “at least a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent field requiring learning computation principles, and two years of work experience in networking or streaming media systems, particularly audio and video, over the Internet,” where “[a]dditional education could compensate for less practical experience and vice versa.” Pet. 5–6 (citing Ex. 1002 ¶¶ 18–23). In the Decision on Institution, the Board agreed with and applied Petitioner’s proposed definition. Dec. on Inst. 9–11. Patent Owner proposes a very similar definition of “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field, and two to three years of experience in the design or development of (1) video processing systems, audio processing systems, and/or the equivalent; and (2) networking and communications systems, or the equivalent,” where “[a]dditional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education.” PO Resp. 23 2 Petitioner states that it “uses [the earliest possible priority date of April 18, 2005] as the priority date of the challenged claims.” Pet. 6. Patent Owner agrees that the “earliest effective filing date” of the challenged claims is April 18, 2005. PO Resp. 19. The ’849 patent is expired. See Ex. 1001, codes (63), (*); Paper 8, 33. would be the same under either level” of ordinary skill in the art. Id. Based on the full record developed during trial, including our review of the ’849 patent and the types of problems and solutions described in the ’849 patent and cited prior art, we maintain the previously adopted definition of the level of ordinary skill in the art, but remove the term “at least” to avoid unnecessary ambiguity. Our analysis herein, however, would be the same under either party’s proposed definition.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“37 C.F.R. § 42.100(b). Petitioner states in the Petition that it “does not presently contend that any term requires express construction.” Pet. 6. Patent Owner “does not believe any terms of the ’849 [p]atent require express constructions for purposes of” this proceeding. PO Resp. 24; Sur-Reply 11. The Board did not interpret any terms in the Decision on Institution. Dec. on Inst. 8. We agree that no terms require express interpretation to determine whether Petitioner has met its burden to prove unpatentability of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Finally, Petitioner explains in detail why and how a person of ordinary skill in the art would have had reason to combine the teachings of Carmel and Mattavelli, with a reasonable expectation of success. See Pet. 50–55. Specifically, an ordinarily skilled artisan would have modified Carmel’s system to use “Mattavelli’s CGD techniques to optimize the decoding of in more efficient network bandwidth usage and improved playback of multimedia data streams. Id. at 50, 52–53, 55. Petitioner contends that Carmel and Mattavelli are both directed to processing multimedia data playback “for the appreciation of a user,” while providing the highest perceived audio and video output quality possible in view of system constraints to ensure playback continuity. Id. at 50–51 (citing Ex. 1003, 7:35–49, 10:48–54, 11:9–18, Figs. 3D, 6B; Ex. 1004, 2309–10). Petitioner argues that Carmel and Mattavelli both pertain to compression of multimedia data using well-known coding and compression standards for video streaming. Id. at 51 (citing Ex. 1003, 7:25–26, 11:24–52; Ex. 1004, 2309–11). Petitioner further asserts that a person of ordinary skill in the art would have appreciated that Carmel and Mattavelli “complement[]” each other because Carmel addresses constraints on available network bandwidth and Mattavelli addresses limits on available processing resources at the client/multimedia player. Pet. 52 (citing Ex. 1003, code (57), 7:36–41; Ex. 1004, 2309–2312). According to Petitioner, an ordinarily skilled artisan would have been motivated to combine the complementary teachings in Carmel and Mattavelli to create a more robust streaming system that addresses both bandwidth constraints and client processing limits to provide the best possible playback experience. Id. (citing Ex. 1002 ¶¶ 212–215). Petitioner also contends that Mattavelli teaches that merely optimizing transmission bandwidth is not sufficient and is potentially harmful, which provides an express motivation to combine Carmel’s and Mattavelli’s complementary teachings to ensure that different, related links in the streaming playback chain are optimized together. Id. at 53 (citing Ex. 1002 express disclosure that would have motivated a person of ordinary skill in the art to incorporate Mattavelli’s complementary teachings regarding decoding because Carmel states that multimedia playback is achieved “preferably with only a minimal necessary transmission and decoding delay.” Id. at 53–54 (quoting Ex. 1003, 10:50–54; citing Ex. 1002 ¶ 218). Patent Owner in its Response does not dispute that Carmel and Mattavelli teach the preamble and limitations 1[a.i]–1[c.i], or that a person of ordinary skill in the art would have been motivated to combine the references’ teachings in the manner asserted by Petitioner.6 Nonetheless, the burden remains on Petitioner to demonstrate unpatentability. Dynamic Drinkware, 800 F.3d at 1378 (discussing the burden of proof in inter partes review). Having reviewed Carmel and Mattavelli, on the complete trial record, we agree with Petitioner’s analysis, as supported by the testimony of” slip op. at 22
Patent outcomesUS 10,771,849 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,771,849 - 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 - Tanklogix, LLC v. SiteproInstitution deniedPTAB · Oct 10, 2025 · IPR2025-00650 · APJ Sheila F Mcshane · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 18–32 and 34 were unpatentable over Kahn or Kahn and Gutierrez.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has not established a reasonable likelihood of prevailing with respect to the unpatentability of at least one claim of the ’871 patent. Accordingly, for the reasons that follow, we decline to institute an inter partes review of claims 18–32 and 34 of the ’871 patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“The respective proposed levels of qualifications for a person of ordinary skill in the art are similar, with Patent Owner proposing two years of experience compared to Petitioner proposing significant experience with remotely controlling fluid-handling devices, like SCADA systems. Patent Owner also proposes more extensive experience in lieu of educational experience. While we find Petitioner’s proposed qualifications to be acceptable, we adopt Patent Owner’s proposed qualifications for the purposes of this Decision because they offer a wider range of qualifications that nonetheless comport with the level of skill necessary to understand and implement the teachings of the ’871 patent and the asserted prior art. Our analysis and findings herein, however, do not turn on any differences in the qualifications adopted.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that we need not expressly construe any claim terms to resolve the parties’ disputes on the current record. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“actuators and the remote control of fluid handling devices, including the receipt with the user-interface module of “a user command to actuate an actuator via a presented control interface” (limitation [18.7]) and “account authorized to send commands to remotely control fluid handling devices” (limitation [18.11]). We agree with Patent Owner that the Petition fails to demonstrate that Kahn discloses or teaches these limitations because the evidence does not provide support that there is remote control of fluid handling devices or the use of a user command on a control interface to send a command to a fluid handling device, for instance. Kahn is directed to providing access to fluid sensing data and analyzing and providing visual information on that data, but we do not discern that it teaches or discloses the capability to remotely control fluid handling devices. See, e.g., Ex. 1005, code (54), 1:27–36, 2:50–3:2. More specifically, the Kahn disclosures that Petitioner repeatedly relies upon for allegedly teaching this control are deficient. See Ex. 1005, 10:62–67, 14:35– 15:2, 15:62–16:32; see also Pet. 12–14, 16–18. Kahn discloses that “the communication unit 112B can include on-site alerts such as optical (indicator lights), audible alerts (e.g., alarm sounds), tactile (e.g., vibration of the unit) or can be interfaced to an appropriate control valve for simply shutting off the supply of fluid upon the detection of emergency events, for instance.” Ex. 1005, 10:62–67. Communication unit 112B is part of the local “sensor unit,” wherein the detection conditions determined by the sensor are communicated to remote devices by communication unit 112B. See id. at 3:31–33, 5:62–6:2, 6:27–35, 7:33–37, 13:7–12, Figs. 1A–1C. Kahn discloses that the sensor units, which include communication units 112B, can be located near shut-off valves and can communicate with distant locations. See id. at 11:1–13. There are no disclosures, however, in the above passages that there is remote control of fluid handling devices, that there is a user command on a control interface that actuates an actuator, or that there is a command sent to the facility actuators via a network connection, as required in limitations [18.5]–[18.7] and [18.9]–[18.12], respectively. Rather, the disclosure indicates that the communication unit 112B includes on-site alerts and that the local (non-remote) communication unit 112B can be interfaced with the control valve.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,488,871 - PTAB · Oct 2, 2025 · IPR2025-00673 · APJ Michael R Zecher · IPR · Institution
The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that Amazon would show at least one claim unpatentable over Shin and Aoyama.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“shown that there is a reasonable likelihood that it would prevail in demonstrating at least one of claims 1–7 of the ’675 patent is unpatentable. We begin our analysis with the principles of law that generally apply to an asserted ground based on obviousness, we then assess the level of skill in the art, next we provide brief overviews of Shin and Aoyama, and then we address the parties’ contentions with respect to independent claims 1, 6, and 7.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“time it was made, we consider the level of ordinary skill in the pertinent art at the time of the invention. Graham, 383 U.S. at 17. “The importance of resolving the level of ordinary skill in the art lies in the necessity of maintaining objectivity in the obviousness inquiry.” Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991). The “person having ordinary skill in the art” is a hypothetical construct, from whose vantage point obviousness is assessed. In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). Factors pertinent to a determination of the level of ordinary skill in the art include “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Env’t Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). “Not all such factors may be present in every case, and one or 4 At this stage in the proceeding, SoundClear does not present arguments or evidence of secondary considerations. See Prelim. Resp. more of these or other factors may predominate in a particular case.” Id. at 696–97. Relying on the testimony of Dr. Stern, Amazon argues the following: [a] person of ordinary skill in the art . . . would have had a minimum of a bachelor’s degree in computer engineering, computer science, electrical engineering, or a similar field, and approximately two years of industry or academic experience in a field related to controlling the audio output of electronic devices. Work experience could substitute for formal education and additional formal education could substitute for work experience. Pet. 7 (citing Ex. 1002 ¶¶ 28–32). In the Preliminary Response, SoundClear does not address Amazon’s assessment of the level of skill in the art. See Prelim. Resp. At this stage of the proceeding, we adopt Amazon’s uncontested assessment of the level of skill in the art because (1) it is consistent with the ’675 patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Stern.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“arguments and evidence for purposes of institution that would support determining that a person of ordinary skill in the would have been motivated to combine the teachings of Shin and Aoyama. As one example, Amazon contends that the proposed combination is merely the addition of one known element (i.e., “Aoyama’s natural language processing and information retrieval”) to another known element (i.e., “Shin’s voice processing and response device”) to obtain predictable results (i.e., “identifying a user’s intent and providing information responsive to such intent”). Pet. 19–20 (citing KSR, 550 U.S. at 417; Ex. 1002 ¶ 83). As another example, Amazon contends the proposed combination also represents the addition of one known element (i.e., “Aoyama’s word replacement” feature) to another known element (i.e., “Shin’s distance-based content abbreviation/simplification”) to obtain predictable results (i.e., “using word replacement to simply content for distant users”). Id. at 25–26 (citing KSR, 550 U.S. at 417; Ex. 1002 ¶ 100). Amazon also presents sufficient arguments and evidence for purposes of institution that would support determining there is a reasonable expectation of success in making the proposed combination. Id. at 20 (citing Ex. 1002 ¶ 84), 27–28 (citing Ex. 1002 ¶ 102; Ex. 1011 ¶¶ 97, 98 Fig. 7). To the extent SoundClear argues that Amazon is required to identify a problem a person of ordinary skill in the art would have sought to solve when combining the teachings of Shin and Aoyama, we do not agree. See Prelim. Resp. 31–32. This line of argument runs contrary to the principles of law articulated in KSR. In KSR, the Supreme Court emphasized “an expansive and flexible approach” to an obviousness evaluation. KSR, 550 U.S. at 415; see also Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1363 (Fed. Cir. 2018) (“KSR did not impose a rigid requirement to identify . . . a problem to be solved in the art . . . .”). The Supreme Court stated that, “[o]ften, it will be necessary for a court to look to interrelated teachings of multiple patents,” amongst other things, “to determine whether there was apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. Moreover, the Supreme Court explained that, “[u]nder the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420.” slip op. at 26
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Based on the preliminary record, we discern no deficiency in Amazon’s characterizations of Shin, Aoyama, or the general background knowledge in the art. In addition, for purposes of institution, we are persuaded by Dr. Stern’s testimony concerning the relevant disclosures in Shin and Aoyama. At this stage of the proceeding, SoundClear argues that Shin does not teach limitations 1[b]—“a voice classifying unit configured 1[b][i] to calculate a distance between the user and the output-content control device by a proximity sensor 1[b][ii] to classify the voice into either a first voice or a second voice based on the calculated distance.” See Prelim. Resp. 19–22. a. Limitations 1[b]—“a voice classifying unit configured to 1[b][i] calculate a distance between the user and the output-content control device by a proximity sensor to 1[b][ii] classify the voice into either a first voice or a second voice based on the calculated distance” In the Preliminary Response, SoundClear contends that Shin fails to teach voice classification because “Shin is incapable of distinguishing [between] multiple voices.” Prelim. Resp. 21. More specifically, SoundClear argues that Shin cannot teach classifying a voice into a first voice or second voice because “Shin never refers to a ‘first user’ or ‘second user’ or ‘multiple users.’” Id. (citing Ex. 1003 generally); see also id. at 26– 27 (arguing that Amazon misstates the record because Shin never discloses a “first voice” nor a “second voice”). Instead, SoundClear asserts that Shin only contemplates a single user (i.e., user 10) when calculating the distance between the user and an electronic device (e.g., Shin’s electronic device 100). Id. at 21–22 (citing Ex. 1003 ¶¶ 37, 38). Based on the preliminary record, Amazon presents sufficient evidence that would support a finding that Shin teaches “a voice classifying unit configured to calculate a distance between the user and the output-content control device by a proximity sensor to classify the voice into either a first voice or a second voice based on the calculated distance.” Pet. 10–14. Shin discloses that “processor 120 may determine an output scheme of corresponding content based on a distance between a user and the electronic device 101.” Ex. 1003 ¶ 53. Shin’s processor 120 accomplishes this distance calculation by using distance detection module 180, which may include various sensors, such as a proximity sensor. Id. ¶ 66; see also id. ¶ 153 (disclosing an embodiment where electronic device 901 includes sensor module 940, which, in turn, includes proximity sensor 940G). Shin’s Table 3 illustrates how the distance between the user and electronic device 101 determines the output scheme. Id. ¶ 86, Table 3. For instance, Shin’s Table 3 illustrates classifying the user’s voice input as a “first voice” when the distance between the user and electronic device 101 is between 1 to 2 meters, and classifying the user’s voice input as a “second voice” when the distance between the user and electronic device 101 is less than 1 meter. Id. ¶¶ 86, 87, Table 3.” slip op. at 23
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,244,675
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.