- 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 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 - 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 - PTAB · Apr 15, 2026 · IPR2025-00104 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1, 2, 4–7, and 9–18 based on all presented grounds, finding a reasonable likelihood of success on obviousness grounds 1A and 1B.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). The petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition shows a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) would have “had at least a bachelor’s degree in electrical engineering, computer engineering, or computer science, and two years of experience in the field [of] consumer electronics, with exposure to digital camera technology and wireless communications.” Pet. 5 (citing Ex. 1030 ¶¶ 94–95).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We find it unnecessary to construe any claim term to decide whether Petitioners satisfy the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. 35 U.S.C. § 103; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) when in evidence, objective evidence of nonobviousness.10 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An obviousness determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 8,904,030 - Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentablePTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27
Patent outcomesUS 11,406,402 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,406,402 - PTAB · Aug 13, 2025 · IPR2025-00147 · APJ Linda E Horner · IPR · Institution
The Board instituted inter partes review of claims 1–6 and 8–20 after finding a reasonable likelihood that Samsung would prove at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we grant the Petition and institute an inter partes review of claims 1‒6 and 8‒20 of the ’124 patent.” slip op. at 2
- Skill levelSkill level board ownDecided for petitioner
“At this stage of the proceeding, there is no dispute about the level of ordinary skill in the art.7 Based on the testimony of Dr. Anthony, we determine that a person of ordinary skill in the art would have had 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. A person of ordinary skill in the art would have also been familiar with, for example, sensor system design, including inertial and other motion sensor system design, signal processing, and human-machine interfaces. A higher level of education or skill can substitute for less experience, and vice versa. Ex. 1002 ¶ 29. We determine that the level of ordinary skill in the art adopted above is consistent with the level of technical understanding and competence reflected in the ’124 patent Specification and the asserted prior art references, based on our review of the limited record.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“We need not reach the issue of whether the preamble is limiting for purposes of determining institution. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a fingerworn ring, at this stage Petitioner has demonstrated that the cited art teaches or suggests such a limitation. That is, Petitioner relies on the fingerring of Schroder for the claimed form factor of 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). Further, to the extent Petitioner contends that Yuen’s toe band or earring is structurally and functionally equivalent to a finger-ring (Pet. 45, 57), Patent Owner has not, at this stage of the proceeding, structurally distinguished a device configured to worn around a finger from a toe band or earring. For instance, Patent Owner has not explained how a device to be worn around a finger differs in size, configuration, or design from a toe band or earring. And the ’124 patent recognizes that “a human being’s finger can come in various different sizes and so should the [wearable computing device].” Ex. 1001, 12:64‒65. For instance, challenged dependent claim 10 recites that the width of the external housing of the wearable computing device is within a range of 3 mm to 8 mm and a thickness of the device is within a range of 1.5 to 3 mm. Id. at 35:8‒12. Should Patent Owner pursue this argument during the proceeding, the record would benefit from further development on the structural similarities and dissimilarities between a fingerworn ring and a toe band.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“After considering the parties’ arguments and evidence, we determine that Petitioner’s showing of reasons to combine Mestas and Schröder is sufficient for purposes of granting institution of an inter partes review. Although general similarities between the references are usually not by themselves sufficient to show a reason to combine particular teachings, Petitioner here also provides more particularized contentions, such as “[i]mplementing Mestas’s device in Schröder’s ‘finger-ring’ form factor would ensure a tighter fit than a device worn, e.g., on the user’s arm or wrist, reducing motion artifacts, providing better shielding against ambient light, and permitting higher quality reading from device sensors (e.g., accelerometer, heart rate, temperature)” and that Mestas’s concern with “slippage around a user’s wrist or other body part” would have motivated a person of ordinary skill in the art “to consider placing the device on the finger, as in Schröder, to improve traction and prevent slippage.” Pet. 19‒20 (citing Ex. 1002 ¶ 169; Ex. 1010 ¶ 152). These reasons are sufficient to present a reasonable likelihood of prevailing as to at least one challenged claim based on the proposed combination of Mestas and Schroder for purposes of institution. Patent Owner will have an opportunity to further address Petitioner’s reasoning during the proceeding.” slip op. at 21
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,188,124 - PTAB · Jun 26, 2025 · IPR2024-00294 · APJ David Cotta · IPR · Final written decision
Claims 1–20 are unpatentable; proposed substitute claims 21–24 are also unpatentable, so the contingent motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“appear to be that Patent Owner specifies that the POSA’s knowledge and experience may include optical sensors and that the POSA may have a degree emphasizing software. We do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies and both parties agree that the POSA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 24; PO Resp. 11. We find the additional specificity of Patent Owner’s definition to be helpful. In addition, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’507 patent. Accordingly, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art. (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We note that we would reach the same outcome under either definition of the POSA. Cf., PO Resp. 12 (asserting that Petitioner’s proposed definition is “flawed” but also asserting that “patentability is confirmed” “[r]egardless of the level of skill”).” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Ex. 1007, 1528. The dispute between the parties focuses on whether D’Angelo was made available to attendees of the IEEE EMBS conference identified in this header and, if so, what effect that has.16 Accordingly, we begin our analysis by considering the conference.” slip op. at 42
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“understood Mendelson to disclose averaging signals. We do not find in Mendelson any discussion of summing or averaging signals. See generally Ex. 1011, 912–915. Our inability to find a teaching of averaging in Mendelson is consistent with the testimony of Drs. Kenny and Duckworth. Dr. Kenny testifies that “there is simply no disclosure in Mendelson itself of any summing or averaging of collected signals.” Ex. 1083 ¶ 23. And in his deposition, Dr. Duckworth was unable to identify any express disclosure of averaging in Mendelson. See Ex. 1087, 103:9–114:11 (confirming that certain aspects of his declaration testimony relating to averaging of signals are not discussed in Mendelson). Accordingly, Mendelson, standing alone, does not support that the POSA would have understood Mendelson’s Sensor Module to have output averaged signals” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“the PDA to read out ‘data that’s been stored’ (i.e., previously measured physiological data) even after the Receiver Module’s battery had died” because Mendelson’s Receiver Module lacks “a microSD card or other nonvolatile storage from which measured data could be ‘read out’ after its battery has died.” PO Resp. 37; see also Ex. 2037 ¶ 147 (testimony of Dr. Duckworth confirming that Mendelson’s system could not store data that could be read out after its battery died). Accordingly, Patent Owner argues the POSA “would not have been motivated to modify Mendelson’s Receiver Module to draw power from the PDA as proposed because doing so would not allow the PDA to ‘read out’ the previously ‘measured physiological data’ after the Receiver Module’s battery died.” PO Resp. 39.” slip op. at 60
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,736,507 - Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution deniedPTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,349 - Cipla Limited v. Gilead Sciences, Inc.Institution deniedPTAB · May 15, 2025 · IPR2025-00033 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–13 under § 314(a), finding the Fintiv factors favored denial and the petition did not present compelling merits.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“We determine that this factor weighs heavily in favor of exercising discretion to deny the Petition. The trial date in the district court litigation is scheduled for October 6, 2025. See Prelim. Resp. 16 (citing Ex. 2010). This date is at least six months before our projected statutory deadline should we go forward in this case. Patent Owner points out that this trial date is nine months later than the median time to trial in the District of Delaware, and in Patent Owner’s view, the parties are on track to satisfy the current schedule. Id. at 16–17 (citing Ex. 2011).” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“1 Patent Owner also asserts that the Petition should be denied under 35 U.S.C. § 325(d), but we need not reach this issue because we are exercising discretion under Section 314(a) to deny the Petition. See Prelim. Resp. 2–3.” slip op. at 2
Discretionary denialPatents in suitUS 11,744,802
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.