- 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 - Globus Medical, Inc. v. Spinelogik, Inc.All claims unpatentablePTAB · Jul 10, 2026 · IPR2025-00226 · APJ Matthew S Meyers · IPR · Final written decision
Claims 1–5, 7, and 9 are unpatentable under §103 over Moskowitz and Steffee; the Board did not reach the Moskowitz-only ground and rejected the Hess ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that one of ordinary skill in the art would have had a bachelor’s or equivalent degree in mechanical engineering or a related discipline (e.g., biomedical or metals and materials engineering), and at least five years of experience consisting of (a) designing, developing, evaluating and/or using spine devices, (b) anatomy, physiology and biology of soft and calcified tissues including bone healing and fusion, and (c) biomechanical and functional loading of orthopedic implants. Pet. 17 (citing Ex. 1002 ¶ 49). Petitioner also asserts that “[m]ore education can supplement practical experience and vice versa.” Id. (citing Ex. 1002 ¶ 49). “Patent Owner does not dispute the proffered definition for a POSA.” PO Resp. 9. Based on the full record, we determine that Petitioner’s undisputed proposed level of skill is reasonable and consistent with the ’385 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “channel” Throughout the challenged claims, “channel” appears together with “curved” in the term “curved channel.” For example, claim 1 recites “the fusion member comprising a first curved channel and a second curved channel,” “a first anchoring member configured to insert through the first curved channel,” and “second anchoring member configured to insert through the second curved channel.” Ex. 1001, 26:58–59, 26:60–61, 26:65– 66. Prior to institution, Petitioner asserted that one of ordinary skill in the art would “understand the claim term ‘channel’ to refer to a passage through which something moves or is conveyed.” Pet. 18 (citing Ex. 1002 ¶ 54). And, for purposes of our Decision on Institution, we adopted Petitioner’s proposed construction as being “consistent with the intrinsic record.” Institution Dec. 10. the ’385 [p]atent is readily understood by a POSA in context without needing explicit construction” and the plain and ordinary meaning should apply. PO Resp. 9–10. According to Patent Owner, the ’385 patent “consistently uses ‘channel’ to refer to a pathway within the fusion member through which an anchoring member traverses” and “explicitly states that channels may have different shapes and sizes and need not have a constant diameter, indicating the patentee did not intend to narrow the term beyond its common understanding.” Id. Petitioner replies noting that Patent Owner’s understanding “is substantively identical to Petitioner’s construction (‘a passage through which something moves or is conveyed’), specifically applied to an anchoring member.” Pet. Reply 6 (Pet. 18; PO Resp. 9–10). Thus, Petitioner concludes that “[t]he parties thus agree with the Board’s construction.” Id. Based on the full record, we agree with Petitioner that the parties’ positions on the meaning of the term “channel” are “substantively identical.” Because we see no difference between the parties’ position on the meaning of “channel,” we continue to adopt Petitioner’s proposed construction as it is consistent with the plain language of the claims and Specification. See Pet. 18 (citing Ex. 1001, 9:42–44, 9:53–55, 10:63–66, 11:47–63, 14:25–31, 14:65–67, 16:32–35, 22:51–57, 24:55–67) (The Specification uniformly refers to a “channel” as “a passage through which something (e.g., an anchoring member) traverses.”).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“between the spinous processes in order to decompress the spinal canal, and thus, “relieve pressure on the spinal cord and nerves by increasing the area of the spinal canal.” Ex. 1006, 1:32–34, 1:50–52, 2:1–6. In contrast, the ’385 patent identifies that “the goal is to achieve solid bony fusion between the involved endplates and eliminate the symptoms caused by motion and associated degenerative and other reactive changes between these unstable vertebral segments.” Ex. 1001, 1:53–57. Thus, Hess’s disclosed implant is designed to distract and stabilize the spinous processes, not to promote solid bony fusion between adjacent vertebral bodies. Consequently, we agree with Patent Owner that “converting Hess for intervertebral fusion would require eliminating its core dynamic stabilization functionality—directly contradicting Hess’s stated design objectives.” PO Resp. 42 (citing Ex. 1006, 2:5–26, 7:43–45). We also are not persuaded that Petitioner adequately explains why a person of ordinary skill would have modified Hess’s implant in the manner proposed. Petitioner contends that only “minimal modifications” to Hess’s shell dimension and shape would be required for intervertebral use. Pet. 61–67; Ex. 1002 ¶¶ 122–128. However, simply modifying the shape and size of Hess’s shell does not, without more, support a motivation to redesign Hess’s device from a posterior interspinous implant engaging spinous processes to an interbody implant positioned between vertebral bodies and anchored into vertebral bodies. Here, Hess discloses that modifying its dimensions serves to “preserv[e] mobility and alignment.” Ex. 1006, 7:5–7. Conversely, the ’385 patent’s fusion implant serves to limit mobility between vertebrae by achieving “solid bony fusion between the fusion member and the adjacent vertebral bodies.” Ex. 1001, 24:67–25:3. spinal fusion procedures” (id. at 6:49–52), we do not find that statement, without more, to disclose or suggest reconfiguring Hess’s interspinous implant as an “a fusion member configured to position between first and second vertebral bodies,” as required by limitation [1.1]. At most, Hess’s “adjunct to” statement suggests that the interspinous implant may be used in connection with, or in support of, a fusion procedure. It does not explain how or why Hess’s implant would be redesigned for placement between two adjacent vertebral bodies, nor does it teach that Hess’s locking wings would be reoriented or adapted to anchor into vertebral bodies rather than spinous processes. On this point, Mr. Culbert states that “[t]he only changes required to modify Hess for use as an intervertebral implant would be to modify the dimensions of Hess’s shell, which was ‘dimensioned and configured for placement between the spinous processes’” (Ex. 1002 ¶ 126 (citing Ex. 1006, 7:3–4)), but Mr. Culbert does not explain how Hess’s locking wings and guide tracks would be reoriented or adapted to function as anchoring members that are inserted into adjacent vertebral bodies rather as opposed to spinous processes. Instead, Mr. Culbert simply states that “Hess’s locking wings would engage and at least partially penetrate the superior and inferior adjacent vertebrae” (emphasis added) (Ex. 1002 ¶ 135) without explaining how or why one of ordinary skill in the art would have made the modification with a reasonable expectation of success.” slip op. at 17
- Expert testimonyPetitioner expert discountedDecided for patent owner
“modify Hess for use as an intervertebral implant would be to modify the dimensions of Hess’s shell, which was ‘dimensioned and configured for placement between the spinous processes’” (Ex. 1002 ¶ 126 (citing Ex. 1006, 7:3–4)), but Mr. Culbert does not explain how Hess’s locking wings and guide tracks would be reoriented or adapted to function as anchoring members that are inserted into adjacent vertebral bodies rather as opposed to spinous processes. Instead, Mr. Culbert simply states that “Hess’s locking wings would engage and at least partially penetrate the superior and inferior adjacent vertebrae” (emphasis added) (Ex. 1002 ¶ 135) without explaining how or why one of ordinary skill in the art would have made the modification with a reasonable expectation of success. Hess’s disclosure that its shell may have shape variations to match adjacent bone (Ex. 1006, 7:7–13) also does not adequately explain why a person of ordinary skill would have had a reason to redesign Hess’s device for a different intervertebral environment, or why such a redesign would and “anchoring members,” i.e., locking wings. And, to the extent Hess discloses matching the shell to “the profile of the adjacent bone when deployed” (Ex. 1006, 7:11–13), Hess never suggests adapting the shell for placement between two adjacent vertebral bodies or for use as a fusion cage, it discloses that the “shell 12 is dimensioned and configured for placement between the spinous processes of symptomatic disc levels” (id. at 7:2–4). Thus, we agree with Patent Owner that the proposed modification “minimizes the structural differences and conflicting functional objectives inherent in modifying a device intended for the posterior elements of the spine for use in the anterior load-bearing column” (emphasis omitted). PO Resp. 41. For the reasons discussed above, we determine that Petitioner’s reliance on Mr. Culbert’s testimony amounts to more than just providing a motivation to modify Hess. Here, it amounts to relying on expert testimony to supply a missing limitation. As such, Petitioner’s arguments are not persuasive to demonstrate that the prior art teaches the limitations of the claim by a preponderance of the evidence. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9, 16 (PTAB Aug. 24, 2022) (precedential) (explaining that relying on expert testimony “is particularly problematic in cases where, like here, expert testimony is offered not simply to provide a motivation to combine prior-art teachings, but rather to supply a limitation missing from the prior art.”).” slip op. at 18
Patent outcomesUS 8,460,385 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,460,385 - Globus Medical, Inc. v. Spinelogik, Inc.All claims unpatentablePTAB · Jul 10, 2026 · IPR2025-00225 · APJ Matthew S Meyers · IPR · Final written decision
Claims 1–6, 11, 12, and 15–17 are unpatentable: claims 1–4, 6, 11, 12, 15, and 17 over Blain; claims 5 and 16 over Blain, Bray, and Steffee.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that one of ordinary skill in the art would have had a bachelor’s or equivalent degree in mechanical engineering or a related discipline (e.g., biomedical engineering, metals and materials engineering), and at least five years of experience with a) designing, developing, evaluating and/or using spine devices, b) anatomy, physiology and biology of soft and calcified tissues including bone healing and fusion, and c) biomechanical and functional loading of orthopedic implants. Pet. 18–19 (citing Ex. 1002 ¶¶ 77–78). Petitioner also asserts that “[m]ore education can supplement practical experience and vice versa.” Id. (citing Ex. 1002 ¶ 78). “Patent Owner does not dispute the proffered definition for a POSA.” PO Resp. 10. proposed level of skill is reasonable and consistent with the ’805 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“Based on the full record, we determine that “housing,” as it appears in the context of the term “delivery housing” is a component that is a part of the delivery mechanism (see Ex. 1001, 11:27–31) and that simply contains and guides another component during delivery. See Ex. 1001, 13:25–27, 21:30–50. Thus, we apply the ordinary meaning of “housing,” as it appears in the context of the term “delivery housing,” and address in the context of “delivery housing,” as recited by claims 2 and 4.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“understanding of plain and ordinary meaning as set forth in the litigation.” Pet. Reply 13 (citing Ex. 1022, 2 (“channel . . . [that] has a curved path”)). Thus, Petitioner concludes that the parties agree on construction of “curved channel.” Id. at 13–14.10 9 Although the parties refer to “curved” alone or to a “curved channel,” we understand the parties to be referring to a “channel of the fusion member [that] is curved,” as recited in claims 5 and 16. 10 At oral argument, the parties confirmed that there was no dispute as to the meaning of “curved channel.” See Tr. 15:12–14 (Petitioner stating that “the term “curved channel” appears consistent with the plain language of the claims and Specification. Thus, we adopt the parties’ agreed-upon construction and construe a channel that is “curved” to mean a channel following a curved trajectory.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have considered Petitioner’s arguments and evidence, and Patent Owner’s counterarguments and find, on the complete trial record, that Petitioner demonstrates, by a preponderance of the evidence, that Blain discloses “a fusion member for positioning between two vertebral bodies, the fusion member having a first plurality of channels, each channel of the first plurality of channels having an opening on a same side of the fusion member,” as recited by limitation 1.1. At the outset, we find Patent Owner fails to establish that any of the alleged differences between Blain’s “apertures and the ’805 [p]atent’s internal channel geometry” relate to any particular recitation in argued limitation 1.1. Although we acknowledge that claims 5 and 16 each requires curved trajectories (see, e.g., claim 5 reciting “each channel of the fusion member is curved”), limitation 1.1 does not recite such a feature. As Petitioner correctly notes, “[n]othing in the claim requires a special ‘internal channel geometry,’ ‘shaped block,[’] ‘curved tubular channels,’ non ‘straight-through’ apertures, or ‘flexible’ anchors.” Pet. Reply 14 (footnote omitted). See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (rejecting arguments “not based on limitations appearing in the claims”). Therefore, after reviewing the arguments and evidence, we determine that Petitioner has shown by a preponderance of the evidence that Blain discloses the subject matter of limitation 1.1.” slip op. at 19
Patent outcomesUS 9,730,805 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,730,805 - 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
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.