• 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
• Abbott Laboratories v. Miracor Medical SASome claims unpatentable
  PTAB · Jun 11, 2026 · IPR2025-00115 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1–4, 10, 11, 14, 17, 21, 22, 24, 26, 28–30, 32, 33, and 35 are unpatentable; claim 15 is not shown unpatentable, based on the four asserted obviousness grounds.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude portions of Dr. Wieselthaler’s Declaration (Exhibit 1041), portions of Mr. Crosby’s Reply Declaration (Exhibit 1042), portions of the deposition transcript of Dr. Wieselthaler (Exhibit 2028), and the exhibits “upon which that testimony is based” (Exhibits 1015, 1038, 1044, 1046, 1049, and 1050). Mot. 1. According to Patent Owner, the Motion was made “to preserve objections previously made in the record.” Id. (citations omitted). Patent Owner did not timely move to strike any of the evidence at issue as being outside the scope of reply evidence. Patent Owner asserts that because an inter partes review must be based on prior art consisting of patents or printed publications (citing 35 U.S.C. § 311(b)), the testimony of Mr. Crosby and Dr. Wieselthaler concerning “various physical devices allegedly known” to a person of ordinary skill in the art is inadmissible, along with all of the exhibits (consisting of printed materials such a journal abstracts, press releases, and papers) related to those physical devices. Id. at 3–4; see also Mot. Reply 1–4 (arguing that “devices that Petitioner’s witnesses assert were in public use prior to the claimed inventions, are not prior art that can form the basis of an inter partes review”). According to Patent Owner, Dr. Wieselthaler was unable to “link two of these physical devices to the printed prior art asserted in this [inter partes review], but those attempts fell apart during his cross examination.” Id. at 4. Patent Owner further reasons that because the evidence “cannot be the basis” of an inter partes review, it “has probable,” “is irrelevant and not admissible,” “presents substantial danger of confusing the issues, causing undue delay, and wasting time in this trial,” and “are not ‘based on sufficient facts[,] the product of reliable principles and methods[, or] ‘a reliable application of the principles and methods to the facts of the case.’” Id. at 7 (citing Fed. R. Evid. 401–403, 702) (modification in original). With regard to Exhibits 1015, 1038, 1044, 1046, 1049, and 1050, Petitioner argues, and we agree, that Patent Owner identifies no plausible legal theory for their inadmissibility based on the contention that they discuss physical devices. See Mot. Resp. 3. We also agree with Petitioner that the exhibits are not “the basis for any ground” asserted in this proceeding, and may be properly relied upon by Dr. Wieselthaler and Mr. Crosby as support for their rebuttal testimony directed to Patent Owner’s arguments disputing Petitioner’s asserted motivation to combine the prior art relied upon in the instituted grounds. See id. at 3–4. In regard to the disputed testimony of Dr. Wieselthaler and” slip op. at 80

  • Skill levelSkill level board ownOther

    “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors” slip op. at 14

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “‘electronics for power and control’”). According to Mr. Crosby, a person of ordinary skill in the art “would have understood based on the disclosure of this setup that these speed and motor parameters were monitored by a sensor providing feedback to the controller.” Ex. 1003 ¶ 725. Mr. Crosby identifies no support for this opinion, which we give little weight to. The mere fact that Bourque’s pump used software to control speed and motor parameters does not show that Bourque used “one or more sensors” to provide feedback signals to the external control unit. Indeed, Petitioner fails to identify any evidence that Bourque used any “sensor” to monitor “speed and motor parameters.” Mr. Crosby also states that “[e]ach of the ‘ultrasonic flow probe’ and the ‘solid-state catheter-type pressure transducer’ described in [Bourque] is a ‘sensor’ as recited in Claim 33 that provides feedback signals to the external control unit (e.g., ‘electronics for power and control’ and ‘data acquisition’).” Id. ¶¶ 581, 726. Mr. Crosby’s opinion is again unsupported by the evidence, because, as explained above, there is no teaching in Bourque that either the “ultrasonic flow probe” or the “pressure transducers” used in the “in vitro characterization” studies were part of the heart assist pump device. Based on our review and consideration of Petitioner’s arguments and evidence directed to claim 11, we find that Petitioner has not shown by a preponderance of the evidence that the asserted combination of Bourque and Wampler teaches or suggests each of the limitations of dependent claim 11. We reach the same conclusion for the same reasons with regard to claim 33.” slip op. at 48

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

    “1. “magneto coupling” Claim 1 recites, in relevant part, a second magnetic device “positioned” slip op. at 25

  Patent outcomesUS 11,674,517 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,674,517
• Abbott Laboratories v. Miracor Medical SASome claims unpatentable
  PTAB · Jun 11, 2026 · IPR2025-00096 · APJ James A Tartal · IPR · Final written decision

  Claims 1–4, 6, 7, 10, 12, and 13 are unpatentable as obvious over Schima and Akamatsu; claim 5 was not shown unpatentable.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “consequence in determining the action.” Fed. R. Evid. 401. Fed. R. Evid. 702 serves “a ‘gatekeeping role,’ the objective of which is to ensure that expert testimony admitted into evidence is both reliable and relevant.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1360 (Fed. Cir. 2008). There is no question that the disputed testimony of Dr. Wieselthaler and Mr. Crosby is relevant to the asserted motivation to combine and reliable, only whether it becomes “not relevant” or “unreliable,” in light of limited scope upon which grounds of unpatentability may be based under 35 U.S.C. § 311(b), because the testimony is based on, or supported by, knowledge of physical devices and publications discussing physical devices. Patent Owner directs us to no support for the notion that an expert’s testimony in an inter partes review must be limited to only the prior art relied upon as grounds for unpatentability and may not take into account any knowledge of, or publications concerning, other “physical devices” that would have been known to a person of ordinary skill at the relevant time. See generally Mot.25 In sum, we find that Patent Owner has 25 Patent Owner improperly asserts for the first time in its Reply in support of the Motion that “Petitioner in this case is improperly relying on non-prior art evidence.” Mot. Reply 3. This argument was not made in the Motion, and Patent Owner fails to identify what “non-prior art evidence” it seeks to exclude. We recognize that Petitioner appears to raise the argument that “non-prior art evidence” may be relied upon by an expert, but Petitioner also fails to identify what evidence it is referring to and that argument was not responsive to any issue Patent Owner raised in the Motion. See Mot. Resp. 5. To the extent the Parties intend “non-prior art evidence” to refer to the testimony of Dr. Wieselthaler and Mr. Crosby, we view the issue as pertaining to the weight afforded that testimony, in light of the supporting evidence relied upon, rather than one of admissibility. for the exclusion of evidence in this proceeding and deny the Motion.” slip op. at 83

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “D. Claim Construction In this proceeding we construe claims using the same claim” slip op. at 20

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

    “5. Rationale in Support of Asserted Combination Petitioner shows, and there is no dispute, that Bourque and Wampler” slip op. at 48

  Patent outcomesUS 11,351,356 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,351,356
• Abbott Laboratories v. Miracor Medical SANo claims unpatentable
  PTAB · Jun 11, 2026 · IPR2025-00116 · APJ John D Hamann · IPR · Final written decision

  The Board held claims 1–5, 7, 10, 16–24, 26, and 28 not unpatentable under any of the four § 103 grounds because the petition failed to prove required limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that the ’077 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’077 patent is consistent with the definition of one of ordinary skill in the art proposed by Petitioner, which we adopt. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We further find that our determinations in this Decision would be the same if we were to instead adopt the level of skill proposed by Patent Owner.” slip op. at 11

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

    “We agree with Patent Owner that “axially adjacent” should be given its plain and ordinary meaning of “adjacent to one another as measured along a central axis.” PO Resp. 5–6; see also Ex. 2015 ¶¶ 73–79 (Mr. Leschinsky addressing the claim term “axially adjacent” and explaining that a person of ordinary skill would have understood it to mean that the “first magnetic device and the rotor are ‘adjacent’ to one another, i.e., disposed next to one another, as measured along the central axis about which the rotor spins”). Patent Owner’s construction also is supported by Petitioner’s expert, Mr. Crosby, who agrees that “adjacent to one another as measured along a central axis,” could be “one meaning,” along with “many other meanings.” Ex. 2014,8 19:13–20:11. In sum, consistent with our Institution Decision, we conclude that the plain and ordinary meaning of “axially adjacent” is “at a position adjacent to one another as measured along a central axis.” See Dec. on Inst. 12.” slip op. at 14

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

    “Second, for the reasons below, we determine that we do not need to construe any other claim terms to resolve the disputes between the parties. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (“[W]e need only construe” slip op. at 14

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

    “We agree with Patent Owner. As we discuss above, we find “axially adjacent” to mean “adjacent to one another as measured along a central arguments that rest on Petitioner’s assertion that in the Parallel Litigation, Patent Owner “asserts that a magnetic element sealed within a rotor is . . . ‘axially adjacent.’” Id. at 20–21, n.6 (citing Ex. 1019, 5–7). In particular, we find unavailing Petitioner’s argument that Wampler teaches that magnetic pieces 88 (“a first magnetic device”) “are inserted [‘axially adjacent’] in…the impeller.” Id. at 20–21 (citing Ex. 1008 ¶ 80, Fig. 13; Ex. 1003 ¶ 174). We also find unavailing Petitioner’s reliance on Wampler’s Figure 13 and Mr. Crosby’s cited testimony that “the ‘impeller’ and ‘magnetic pieces’ are axially adjacent—situated next to each other on the same axis.” Id. at 21–22 (annotating Ex. 1008, Fig. 13; citing Ex. 1003 ¶¶ 174–176). Petitioner does not sufficiently explain this argument, but appears to conflate being adjacent along a central axis with about an axis. Id. We also find unavailing Petitioner’s argument that under Patent Owner’s construction, Wampler also teaches this limitation, because Patent Owner “concedes that ‘axially adjacent’ components ‘have positioning that is next to one another, perhaps touching or sharing a common side, when measured along the axis.’” Pet. Reply 14–15 (citing PO Resp. 14). Petitioner mischaracterizes Patent Owner’s arguments and ignores Patent Owner’s showing that “axially adjacent” components are “distinct from components that are aligned with one another such that they overlap or occupy the same portion of an axis upon which they are positioned.” PO Resp. 14 (citing Ex. 2015 ¶ 78). For the preceding reasons, Petitioner fails to show by a” slip op. at 24

  Patent outcomesUS 11,754,077 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,754,077
• Abbott Laboratories v. Miracor Medical SASome claims unpatentable
  PTAB · Jun 10, 2026 · IPR2025-00114 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1, 2, 4, 5, 7, 8, 11, 12, 14–16, 18, and 19 are unpatentable under §103; claim 20 was not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyDenied

    “IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude portions of Dr. Wieselthaler’s Declaration (Exhibit 1041), portions of Mr. Crosby’s Reply Declaration (Exhibit 1042), portions of the deposition transcript of Dr. Wieselthaler (Exhibit 2028), and the exhibits “upon which that testimony is based” (Exhibits 1015, 1038, 1044, 1046, 1049, and 1050). Mot. 1. According to Patent Owner, the Motion was made “to preserve objections previously made in the record.” Id. (citations omitted). Patent Owner did not timely move to strike any of the evidence at issue as being outside the scope of reply evidence. Patent Owner asserts that because an inter partes review must be based on prior art consisting of patents or printed publications (citing 35 U.S.C. § 311(b)), the testimony of Mr. Crosby and Dr. Wieselthaler concerning “various physical devices allegedly known” to a person of ordinary skill in the art is inadmissible, along with all of the exhibits (consisting of printed materials such a journal abstracts, press releases, and papers) related to those physical devices. Id. at 3–4; see also Mot. Reply 1–4 (arguing that “devices that Petitioner’s witnesses assert were the basis of an inter partes review”). According to Patent Owner, Dr. Wieselthaler was unable to “link two of these physical devices to the printed prior art asserted in this [inter partes review], but those attempts fell apart during his cross examination.” Id. at 4. Patent Owner further reasons that because the evidence “cannot be the basis” of an inter partes review, it “has no tendency to make any fact of consequence in this trial more or less probable,” “is irrelevant and not admissible,” “presents substantial danger of confusing the issues, causing undue delay, and wasting time in this trial,” and “are not ‘based on sufficient facts[,] the product of reliable principles and methods[, or] ‘a reliable application of the principles and methods to the facts of the case.’” Id. at 7 (citing Fed. R. Evid. 401–403, 702) (modification in original). With regard to Exhibits 1015, 1038, 1044, 1046, 1049, and 1050, Petitioner argues, and we agree, that Patent Owner identifies no plausible legal theory for their inadmissibility based on the contention that they discuss physical devices. See Mot. Resp. 3. We also agree with Petitioner that the exhibits are not “the basis for any ground” asserted in this proceeding, and may be properly relied upon by Dr. Wieselthaler and Mr. Crosby as support for their rebuttal testimony directed to Patent Owner’s arguments disputing Petitioner’s asserted motivation to combine the prior art relied upon in the instituted grounds. See id. at 3–4. In regard to the disputed testimony of Dr. Wieselthaler and” slip op. at 77

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

    “1. “magneto coupling” Claim 1 recites, in relevant part, “a second magnetic device . . . positioned to magnetically drive rotation of the magnetically driven rotor via a magneto coupling with the first magnetic device.” Ex. 1001, 5:34–37. Claim 11 recites, in relevant part, “the second magnetic device positioned axially closer to the first magnetic device than to the magnetically driven rotor so as to magnetically drive rotation of the magnetically driven rotor relative to the one or more walls via a magneto coupling with the first magnetic device.” Id. at 6:42–48. Petitioner argues that “magneto coupling” means “a transfer of torque from one rotating permanent magnetic component to another rotating permanent magnetic component via a magnetic field.” Pet. 8–9 (citing Ex. 1003 ¶¶ 68–87). According to Petitioner, this construction is consistent with the ’879 patent, which describes “a coupling between two rotating ‘bar magnets’—a drive wheel rotates one bar magnet which causes another bar magnet (connected to a rotor) to rotate.” Id. (citing Ex. 1003 ¶¶ 54–55 (analyzing Ex. 1001, 2:28–52, 4:44–64, Fig. 2)). Patent Owner argues that “magneto coupling” should be afforded “its plain and ordinary meaning, which would encompass a magnetic coupling through both rotating magnets and the use of a rotating magnetic Owner directs us to the testimony of Mr. Leschinsky, who explains that a person of ordinary skill in the art would have understood the ’879 patent to use “magneto coupling” to generally describe “a way to couple the rotor to a drive element while sealing the two from one another and avoiding use of a direct mechanical coupling.” Ex. 2015 ¶ 67. According to Patent Owner, “Petitioner provides no recognizable basis for limiting the plain meaning of magnetic coupling to one type of magnet and excluding another type of magnet.” PO Resp. 6–7 (citing Johnson Worldwide Associates, Inc., v. Zebco Corp., 175 F.3d 985, 989–992 (Fed. Cir. 1999)). We agree with Patent Owner that Petitioner does not provide a sufficient basis for limiting the plain meaning of “magneto coupling.” That the ’879 patent describes embodiments using bar magnets does not serve to require the use of permanent magnets for the recited “magneto coupling.” See Sisvel Int’l S.A. v. Sierra Wireless, Inc., 81 F.4th 1231, 1236 (Fed. Cir. 2023) (quoting Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”)). Moreover, the claim language here is not so limited. 13 Patent Owner notes that Petitioner’s grounds of unpatentability based on Wampler and Bourque depend on the disclosure only of electromagnetic drives in each reference, implying that “Petitioner does not believe its own proposed narrower construction.” PO Resp. 6; see also Pet. 8 (Petitioner alleging that in the Parallel Proceeding Patent Owner “conflates ‘magneto coupling’ . . . with a stator drive using a stationary electromagnet, instead of a rotating magnet, to rotate the rotor magnet,” and asserting that as the basis for Petitioner’s reliance on Wampler and Bourque as teaching a “magneto coupling” in this proceeding (citing Ex. 1019, 7; Ex. 1003 ¶¶ 84–87)).” slip op. at 24

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

    “reasons discussed above. See supra Section III.D.3. Accordingly, because Petitioner’s contentions are premised on an unsupported claim construction that we reject, Petitioner fails to show how Wampler teaches or suggests “a magnetically driven rotor . . . axially adjacent to a first magnet device,” as required by claims 1 and 11, as well as by claims 2, 4, 5, 7, 8, 11, 12, 14– 16, and 18–20, which depend from either claim 1 or claim 11. In its Reply, Petitioner suggests that “[u]nder [Patent Owner’s] construction from the [Patent Owner Response], Wampler also teaches or suggests this limitation,” because Patent Owner “concedes [that] ‘axially adjacent’ components ‘have” slip op. at 36

  Patent outcomesUS 11,572,879 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,572,879

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.