• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,054,758
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 1, 2026 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description, lack of enablement, and indefiniteness; the Board did not find them unpatentable as obvious.

  RulingsFinal written decision

  • 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 7

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

    “Specification of the ’345 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 ’345 patent. Indeed, the definitions of “PH20” and “modified PH20 polypeptide” both require hyaluronidase activity. See Ex. 1001, 44:20–21, 49:4–7 (“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”); 47:8–11 (“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 61:60–67. 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 ’345 patent. Id. at 71:16-18, 74:11–13. 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 47:3–11.” slip op. at 20

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “description (see Capon, 418 F.3d at 1357–58), Patent Owner is trying to extend that to include that which is at most obvious from the prior art, as opposed to what is actually described. That is, it may have been obvious to a POSA to align PH20 sequences with other known hyaluronidase enzymes and to use the crystal structure of a different hyaluronidase (Hyal-1) in SWISS-MODEL to generate a three-dimensional structure, but none of that is described in the common disclosure itself. “[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352. While a POSA might be able to embark on their own research program to try to find suitable multiply-modified PH20 polypeptides, the four corners of the written description do not demonstrate possession of such. See id. at 1356‒57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent[s] a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 66

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “instances of epistasis are “rare” and an inactive PH20 polypeptide “will stay inactive . . . absent intentional ‘rescue’ mutations.” See Sur-reply 12–14. But the claims encompass far more than combinations of just two substitutions, and even Dr. Petsko concedes there are “billions” of sequences within the recited sequence space that will not properly fold. See Ex. 2070 ¶ 347; see also Ex. 1133 ¶ 237 (“While some [residues critical to protein structure] can be predicted (e.g., highly conserved positions), many others cannot without experimentation.”). Accordingly, we find Petitioner’s position more persuasive than Patent Owner’s competing position and evidence.” slip op. at 108

  Patent outcomesUS 12,264,345 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 12,264,345
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,104,185
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision

  Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) 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 mutants retained hyaluronidase activity, even with the single substitution data provided by the ’652 patent.” slip op. at 58

  • 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 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner

    “exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68

  Patent outcomesUS 12,049,652 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,049,652
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

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

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

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

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Resmed Corp. v. Cleveland Medical Devices, Inc.All claims unpatentable
  PTAB · Jun 29, 2026 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 15–29 are unpatentable as obvious over the asserted combinations; the contingent motion to amend claims 30–41 is denied for lack of written-description support.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, ResMed Inc., as a real party in interest. Paper 39. Petitioner filed an opposition. Paper 42. Patent Owner filed a reply. Paper 43. We denied the Motion to Terminate. Paper 51.” slip op. at 3

  • Skill levelSkill level board ownOther

    “understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44); PO Resp. 4. 9 Patent Owner does not assert any objective indicia of nonobviousness. See generally PO Resp. 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.4. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

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

    “Patent Owner does not persuade us to construe the term as “a value [or calculated value] that indicates how dire a patient’s symptoms are.” Patent Owner points to nothing in the intrinsic record that purportedly supports this construction, and we agree with Petitioner that “the patent specification’s disclosures regarding determining a level of symptom severity are broad, establishing that it can generally be derived from any sensor data and/or breathing events.” Pet. Reply 3–4; see also Ex. 1001, 3:44–46 (“Signals from the[] sensors are then analyzed to determine the level of severity of the symptoms of the subject’s sleep disorder.”). Patent Owner relies only on expert declarations to support its construction. But as indicated by the Federal Circuit, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable here, where neither Dr. D’Ambrosio’s nor Dr. Schwartz’s declaration was prepared for this proceeding, and neither declarant was subject to cross examination on their opinions. Moreover, neither of the declarants was opining on claim construction; rather, they were addressing indefiniteness and/or written description issues. See Ex. 1058 at 7 (heading addressing definiteness); Ex. 2026 at 18 (heading addressing written description). Further, Dr. Schwartz appears to have been making an argument about certain patent claims (not the challenged ’333 patent) based on Patent Owner’s own statements made during prosecution of a separate patent application. See Ex. 2026 ¶ 47 (“[T]he similar term used in the ’284 patent claims (‘data of severity of sleep disorder symptoms’) does not find written description support in the specification by a disclosure of the same statistics disclosed in Wright, because CleveMed argued those statistics are not related to severity of sleep disorder symptoms.” (emphasis added)). Patent Owner has not persuaded us that Dr. Schwartz’s testimony has direct applicability to the claim term at issue here. Dr. Borkholder’s testimony is likewise unpersuasive. Aside from citing Dr. D’Ambrosio’s and Dr. Schwartz’s declarations, Dr. Borkholder cites Exhibits 2027 and 2016. These exhibits discuss indices such as AHI and RDI that are used to assess the severity of a patient’s symptoms, but Patent Owner has not adequately explained how they bear on construction of the claim term at issue here, which is not addressed in these exhibits. Ex. 2022 ¶¶ 32–33. Accordingly, we accord Dr. Borkholder’s claim construction opinions little weight, because they are unsupported by reference to objective, corroborating evidence of record. See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”).” slip op. at 23

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

    “We find that Petitioner has the better argument. Tidal volume refers to “the volume of air that is inspired or expired during a respiratory cycle.” Ex. 2028, 13–14; PO Resp. 10. “[H]ypopnea events are defined as a reduction of ≥50 % or 74 % in tidal volume from baseline and apnea events as absence of tidal volume for at least 10s.” Ex. 2028, 13–14 (emphasis omitted). Toge teaches that a control unit analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. The calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. As Dr. Chatterjee explains: Toge discloses that tidal volume Fp is a quantified level of data because Toge discloses that Fp is monitored with respect to threshold values (id., [0051]) and because Fp is a function of Ft, Fa, and Fb, which are quantitative values. Toge discloses that tidal volume Fp is severity data because Toge discloses that tidal volume is indicative of whether the patient’s breathing warrants “emergency measures” (id., [0039]) and whether to “send an alert” in “an emergency where the patient’s breathing has drastically weakened” (id., [0055]). . . . . Because Toge discloses determining tidal volume (determine a quantified level of severity data) based on Ft, Fa, and Fb (id., [0035]), which corresponds to the subject’s condition (subject’s sleep apnea symptoms) while using the device (during the therapy) (id., [0036], [0037]), Toge discloses determin[ing] a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy. Ex. 1005 (Chatterjee Decl.) ¶¶ 122–125. Patent Owner’s attempt to dismiss tidal volume as a mere “breathing metric” is unavailing. First, Petitioner correctly “notes that in the paragraph PO cites to in Dr. Schwartz’s declaration, he indicates that breathing metrics are a level of severity data.” Pet. Reply 8 (citing Ex. 2026 ¶ 46 (“standard sleep disordered breathing metrics” [ ] were well validated indicators of the type and severity of sleep disordered breathing”)). Second, Dr. Kirkness explains that tidal volume represents the level of airway obstruction, e.g., apnea “is the most severe form of reduction in airflow [and] the absence of airflow results in quantified tidal volume of zero milliliters per breath.” Ex. 1003 (Kirkness Decl.) ¶¶ 157, 159; see also PO Resp. 10–11 (Patent Owner recognizing that an apnea is defined as absence of tidal volume for at least 10 seconds). The calculated tidal volume thus indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158; Pet. 15–16; Ex. 1044 (Toge) ¶ 39.” slip op. at 26

  Patent outcomesUS 11,857,333 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,857,333
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 29, 2026 · IPR2025-00247 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–19 were not shown unpatentable under any of six obviousness grounds because Truitt did not teach or suggest the claimed severity calculation and index, and the Mumford combinations lacked the required sensor disclosures.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, Resmed Inc., as a real party in interest. Paper 29. Petitioner filed an opposition. Paper 31. Patent Owner filed a reply. Paper 32. We denied the Motion to Terminate. Paper 40.” slip op. at 2

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

    “disorder symptoms” require a “quantitative” calculation or use of an algorithm, we also disagree. See PO Resp. 14–16. First, nothing in the language of the claims themselves describes or requires a “quantitative” calculation or an algorithm. See generally Ex. 1001, 23:6–26:59. To be sure, the ’029 patent discloses embodiments that use known algorithms to “quantify the level of severity of the subject’s sleeping disorder or symptoms.” See, e.g., id. at 20:16–19. But the Specification does not require an algorithm. The Specification also indicates that quantification is merely “preferable” (i.e., not required), and is merely one embodiment. See, e.g., id. at 19:8–12 (“The signals from the one or more sensors used in various embodiments of the present invention are preferably analyzed using a processor and software that can quantitatively estimate or determine the severity of the subject’s sleeping disorder or symptoms.”) (emphasis added), 4:51–59 (“Finally, in still another embodiment, the present invention includes a sleeping disorder treatment system comprising a device for diagnosing and creating a quantitative output of a level of severity of a subject’s sleeping disorder or symptoms . . . .”) (emphasis added); see also Reply 5–6 (citing Ex. 1001, 4:3–59 and 19:8–12 and stating that the ’029 patent lists “numerous embodiments where only one of seven include a quantitative assessment”). Elsewhere, the Specification more generally states that signals from sensors are “analyzed to determine the level of severity of the symptoms,” without specifying that such analysis must be “quantitative” or performed by an algorithm. See Ex. 1001, 3:41–44. In view of these disclosures, Patent Owner does not persuade us to adopt its narrowing claim construction. Indeed, our reviewing court has “repeatedly warned against confining the claims” to specific embodiments disclosed in the Specification. Phillips, 415 F.3d at 1323. Patent Owner’s reliance on a prior Board decision in PGR2024- 00012, which related to the parent of the ’029 patent, is unavailing. See PO Resp. 15–16. We agree with Petitioner that in the cited case, “[t]he Board made no findings about the meaning of the term calculating ‘the data of a severity of the sleep disorder symptoms of the subject’ for claim construction.” Reply 8. Indeed, neither party offered any claim construction, and the Board determined that no claim construction was necessary for purposes of that decision. See ResMed Corp., PGR2024- 00012, Paper 7 at 8. The page of the decision Patent Owner cites addresses written description support in the specification for the claims challenged in that PGR, not claim construction. See id. at 16. In any event, the cited decision is a decision on institution. The Board’s statements there are, by nature, preliminary findings and conclusions based on a preliminary record, and are not binding here. For at least the above reasons, Patent Owner does not persuade us to adopt its narrowing claim construction and we find that the term “data of a severity” does not need construction because the words of the term are clear on their face.” slip op. at 31

  • Strike new argumentNew argument disregardedDecided for patent owner

    “skilled artisan would have incorporated only portions of Mumford’s algorithm into Truitt’s PAP (i.e., only those portions related to “the detection of sleep disordered events” and not the portions of the algorithm related to “determin[ing] sleep stage”) comes too late because this argument was not in the Petition. See, e.g., Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017) (rejecting petitioner’s “attempts to cure the petition’s deficiencies in its subsequent briefing to the Board”). The Petition does not discuss modifying Mumford’s sleep efficacy algorithm before incorporating it into Truitt’s PAP device or incorporating only certain features of the algorithm. Indeed, the Petition and Dr. Kirkness rely on Mumford’s ability to detect sleep arousals when mapping Mumford to the claimed “data of a severity” and “index.” See Pet. 69–70; Ex. 1003 (Kirkness Decl.) ¶¶ 323–325. Mumford discloses that the mask electrodes detect arousals. See Ex. 1009 (Mumford) 2:4–10, 11:39–48. The same lack of disclosure plagues Petitioner’s belated Reply argument that Truitt’s ports 74 and 76 can incorporate electric sensing elements that would have functioned similar to Mumford’s electrodes. See Reply 22. The Petition did not mention ports 74 and 76 or otherwise suggest that a skilled artisan would have added functionality similar to Mumford’s electrodes to Truitt’s PAP, and we find that it is too late on Reply for Petitioner to posit this modification.” slip op. at 40

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable to Dr. Jafari’s opinions. His declaration was not prepared for this proceeding and thus Dr. Jafari was not subject to cross examination in this proceeding. See Reply 6 n.3. Moreover, Dr. Jafari was not opining on claim construction; rather, he was addressing the alleged indefiniteness. See Ex. 2020 (Jafari Decl.) 12 (heading addressing definiteness), ¶¶ 41–42, 46. Additionally, paragraphs 41–42 of Dr. Jafari’s declaration discuss claim terms phrases in a different patent (US 11,375,921), which explicitly include the terms “quantified” and “quantitative.” See Reply 6–7; Ex. 2020 (Jafari Decl.) ¶ 34. For at least these reasons, Patent Owner has not persuaded us that Dr. Jafari’s testimony is applicable here. Further, regarding the portion of Patent Owner’s proposed construction reciting “the degree of deviation from the baseline characteristics of a patient without sleep disorder symptoms,” Dr. Borkholder does not do his own analysis, but instead simply states that he “agree[s] with the litigation claim construction opinions of Dr. Jafari.” Ex. 2019 (Borkholder Decl.) ¶ 53. This is insufficient, and thus we do not credit Dr. Borkholder’s testimony regarding claim construction. We instead credit Dr. Kirkness’s statement that “[s]everity data is frequently calculated as the deviation from baseline characteristics of the patient himself, not a generic person ‘without sleep disorder symptoms.’” Ex. 1071 (Kirkness Reply Decl.) ¶ 13; Reply 9. As Dr. Kirkness explains, and Patent Owner does not dispute (see generally Sur-reply), “[t]he ‘baseline characteristics of a [generic] patient without sleep disorder symptoms’ would be irrelevant to any particular patient with their own unique breathing patterns and sleep disorder symptoms.” Ex. 1071 (Kirkness Reply Decl.) ¶ 13 (second alteration in original). For at least these reasons, we reject Patent Owner’s proposed claim construction.” slip op. at 30

  Patent outcomesUS 11,872,029 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,872,029
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.

  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 8

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

    “1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59

  • 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 70

  Patent outcomesUS 12,018,298 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,018,298
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 5, 2026 · IPR2025-00160 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–5, 7, 8, 10–13, 15–18, and 20–31 were not shown unpatentable because the proposed Toge-Kumar combination did not establish the claimed remote internet site hosted on a server.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed a Response. Paper 23 (“PO Resp.”). Petitioner filed a Reply. Paper 27 (“Reply”). Patent Owner filed a Sur-reply. Paper 35 (“Sur-reply”). Additionally, during trial, Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name a real party in interest (namely, Petitioner’s corporate parent, Resmed Inc.). Paper 37. Petitioner filed an opposition. Paper 38. Patent Owner filed a reply. Paper 39. We denied the Motion to Terminate. Paper 44.” slip op. at 2

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

    “We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability. C. Level of Ordinary Skill in the Art” slip op. at 11

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s proposed level of ordinary skill in the art because it appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level). D. Summary of the Asserted Prior Art” slip op. at 12

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

    “summarized above, we determine that a person of ordinary skill in the art would not have implemented Toge’s physician-side computer as a web server using a “localhost” architecture as proposed by Petitioner because such a configuration cannot communicate with external devices over the public internet, a deficiency that directly contradicts Petitioner’s stated motivations for the combination of permitting broad data access. Petitioner’s expert, Dr. Chatterjee, expressly acknowledged in his Reply Declaration that when a client and server reside on the same machine, the communications between them do not traverse the internet. Ex. 1069 ¶ 8. Specifically, Dr. Chatterjee cited the Microsoft Computer Dictionary’s definition of “localhost” as “[t]he name that is used to represent the same computer on which a TCP/IP message originates,” noting that “[a]n IP packet sent to localhost has the IP address 127.0.0.1 and does not actually go out to the Internet.” Id. (citing Ex. 1070, 316). Accordingly, Petitioner’s proposed configuration of placing both the client and web server on Toge’s physician-side computer would create a closed loop of communication that does not reach the broader network. Id. As noted by Patent Owner, “[i]f ‘the physician-side computer and the web server are on one machine,’ the local web server would not communicate with other devices via the Internet.” Sur-Reply, 3–4 (comparing Ex. 1069 ¶ 19 with id. at ¶ 8). Thus, the consequence of Petitioner’s proposed Toge-Kumar configuration is that other devices in the system, such as the PAP device that generates the treatment data and any remote client devices that might need to access that data, would be unable to send data to or retrieve data from the localhost web server. Patent Owner persuasively argues, supported by evidence of record, that under Petitioner’s proposed configuration, “the PAP device could not send data thereto nor could other clients receive data therefrom, as only the local client browser can exchange data.” Id. (citing Ex. 1069 ¶ 8); see Ex. 2003, 4 (one-tier architecture “is not suitable for a web application” because “it can only access data available in a single computer or server” and therefore “is not suitable for a web application.”); Ex. 2022, 3 (Unlike more advanced multi-tier systems, a one-tier architecture “cannot transmit information from one client machine to another.”); Ex. 2020, 4 (While “the client process and server process can be on the same computer,” this architecture “is rarely used today” precisely because it cannot “take advantage of the distributed computing environment.”).” slip op. at 29

  Patent outcomesUS 11,786,680 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,786,680

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.