- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.
RulingsFinal written decision- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56
Patent outcomesUS 12,054,758 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–250 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126
- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3
Patent outcomesUS 12,060,590 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,060,590 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims 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
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 54
- 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 74
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117
Patent outcomesUS 12,091,692 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,091,692 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 12,264,345 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 25, 2026 · PGR2025-00039 · APJ Michael A Valek · PGR · Final written decision
Claims 1–4 and 7–11 are unpatentable because the challenged claims lack written-description support and are not enabled.
RulingsFinal written decision- Adverse judgmentAdverse judgmentOther
“1 Although the Petition was directed to claims 1–11 of the ’185 patent, Patent Owner filed a statutory disclaimer of claims 5 and 6 prior to institution, leaving just claims 1–4 and 7–11 at issue. See Ex. 2003.” slip op. at 2
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“B. Claim Construction In a post-grant review, we interpret a claim “using the same claim” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“For these reasons, we find that a preponderance of the evidence” slip op. at 59
Patent outcomesUS 12,104,185 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,104,185 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentablePTAB · Jul 10, 2026 · IPR2025-00147 · APJ Linda E Horner · IPR · Final written decision
The Board found claims 1–6 and 8–20 not shown unpatentable under three obviousness grounds, principally because the proposed combinations did not establish a feasible curved battery or transparent potting encapsulating the components.
RulingsFinal written decision- Skill levelSkill level board ownOther
“at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶ 29). Petitioner also contends that a person of ordinary skill would have been “familiar with, e.g., sensor system design, including inertial and other motion sensor system design, and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 25. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’124 patent and the references cited in the Petition.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not reach the issue of whether the preamble is limiting for purposes of determining patentability of the challenged claims. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a finger-worn ring wearable computer device, Petitioner has relied on Schröder in each ground to disclose a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). We agree with Petitioner that Schröder discloses such a device. Thus, no explicit claim construction is necessary for this decision.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successReasonable expectation not foundNot shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position for several reasons. First, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “would have to be reduced in size on the 6 There is no Exhibit 2022 in the record of this case. magnitude of 5-10x from its current size to fit in a ring of Schröder.” Resp. 38 (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Second, Petitioner relies on evidence in the Reply that Petitioner failed to specifically identify in the Petition. Compare Reply 3–5 (citing Ex. 1369 ¶¶ 7–14; Ex. 1079 ¶¶ 47, 71; Ex. 2022, 138:7–143:1; Ex. 1002 ¶¶ 96, 337; Ex. 2021, 12–13, 307:7–17; Ex. 2020, 212:6–214:13; Ex. 1081, 130:18–131:14; Ex. 1010 ¶ 168), 9 (referring back to Section § II.B.2) with Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99; Ex. 1010 ¶¶ 157, 163, 168, 201, Fig. 6). More specifically, while the portion of Dr. Anthony’s Declaration cited in the Petition (see Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99)) mentions the Technology Background Section V of his Declaration (Ex. 1002 ¶¶ 42–147), neither Petitioner nor Dr. Anthony sufficiently explains what evidence supports his opinion that it was feasible to incorporate batteries or battery-like devices into finger-rings, or how a person of ordinary skill in the art would have miniaturized a curved battery for incorporation into Schröder’s ring. Ex. 1002 ¶ 196 (describing that rechargeable batteries powering wearable electronic devices were “well-known by 2013” and “had also undergone significant advances in terms of miniaturization and energy density [that] made it feasible to incorporate batteries or battery-like devices such as supercapacitors into smaller form factors, such as finger rings, without sacrificing functionality” such as “lithium-polymer (Li-Po) batteries and solid-state batteries.”). Moreover, some of Petitioner’s citations in the Reply appear to be incorrect as there is no Exhibit 2022 of record in this case, as noted above. These issues undermine the strength of Petitioner’s showing by making it difficult to follow its reasoning, much less identify where in the record that reasoning finds support. See DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”); United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like pigs, hunting for truffles buried in briefs.”). Third, even considering Petitioner’s new Reply arguments and” slip op. at 27
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“We credit Dr. Mercier’s testimony over Dr. Anthony’s and agree that Dr. Anthony’s testimony fails to account for the constraints of a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶ 140. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’124 patent, we also have evidence that prior art “finger ring wearables up to the ’124 patent had used ‘coin’ type batteries.” Resp. 40 (citing Ex. 2018 ¶ 140). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would have looked to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 141. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura patent), Fig. 24; Ex. 2018 ¶¶ 74–84. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 85. We also agree with Dr. Mercier that Dr. Anthony’s testimony lacks evidence or a technical analysis of the power requirements for the various sensors he suggests including in a wearable device and the capacity of the proposed GMBPow battery. See, e.g., Ex. 1002 ¶¶ 94, 210, 214–17; Ex. 2018 ¶ 97. Moreover, Dr. Anthony does not address the issues with the batteries that are identified in the references he discusses. For example, Dr. Anthony does not address Lee’s disclosure that “direct coating of electrode slurry onto plain paper led to the occasional internal-shorting of the device due to the leakage of the electrode material through a large-sized hole in the paper.” Ex. 1019, 2415. In contrast, Dr. Mercier discusses the pitfalls the skilled artisan faced in developing finger-ring devices. See, e.g., Ex. 2018 ¶¶ 77–79 (discussing the issues Rhee’s and Asada’s large rings), 83 (identifying power requirements as a design constraint). For example, Dr. Mercier explains that “flexible or curved batteries include flexible packaging materials such as aluminum laminated films that house the electrodes and electrolyte” such that “once the battery packaging is added to a battery such as GMBPow and then placed within a housing (e.g., external housing shell and internal potting), the resulting device would have dimensions that are not suitable for a finger-worn ring.” Id. ¶ 96 (citing Ex. 2026).” slip op. at 34
Patent outcomesUS 11,188,124 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,188,124 - Abbott Laboratories v. Miracor Medical SASome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,674,517 - Abbott Laboratories v. Miracor Medical SASome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,351,356 - Abbott Laboratories v. Miracor Medical SANo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,754,077
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.