- 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 - Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.All claims unpatentablePTAB · Sep 28, 2026 · IPR2025-00611 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–10, 12, 13, 19, and 20 are unpatentable under § 103 over the stated Douglas–Mark and Hamilton-based grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties agree that experience could substitute for a degree, and vice versa. Pet. 3; PO Resp. 10. The parties’ proposed levels of ordinary skill are substantially similar. For this decision, as in the Institution Decision, we adopt Petitioner’s proposed level, which is supported by credible testimonial evidence and is consistent with the problems addressed in the ’774 patent. See Ex. 1001, 1:16–52. Our decision would be the same, however, if we were to adopt Patent Owner’s proposal.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“Neither Petitioner nor Patent Owner argues that we need to construe any claim terms explicitly. See Pet. 2–3; PO Resp. 10. However, the parties contest two material claim-construction issues which we address below. To the extent that the parties’ positions depend on interpreting other claim language in a particular way, we discuss the relevant claim language below in the context of the parties’ arguments regarding the prior art.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner that a person of ordinary skill in the art would have understood that limitation 1.2 must be performed before limitations 1.3 or 1.4. See Ex. 1001, 35:21–24. See Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1342 (Fed. Cir. 2001) (“Unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one.” (citing Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999)). The evidence suggests that a “target printer” is any printer that is ultimately selected for fabricating the object, and such a printer could send its configuration information either before or after that determination is made in limitation 1.2. This interpretation does not render the word “target” meaningless. At some point, a printer must be determined to be the target printer, which is the one intended to ultimately fabricate the three-dimensional object. But the target printer still exists, and is capable of being queried, before that determination is made. We find the examples in the ’774 patent pertinent to this question. The ’774 patent states that “the target printer may include more than one printer.” Ex. 1001, 18:66–67. In discussing the step of “query target printer for properties 306” (Fig. 3A), the ’774 patent states that “[i]n one aspect, numerous queries are sent to numerous printers, e.g., for use in selecting one or more of the printers as the target printer.” Id. at 19:8–10. Alternatively, “the query is sent to a printer that is not necessarily the target printer as described herein, e.g., when the query or information received from a response to the query is used for the selection of the target printer.” Id. at 19:11–14. Importantly, the second embodiment states that the queried printer “is not necessarily the target printer,” suggesting that the queried printer could be the target printer even before it is determined to be such. Id. at 19:11–12 (emphasis added). Based on the evidence of record, a person of ordinary skill in the art would have understood that the “target printer” can be determined after the query recited in limitation 1.3 or the reception of configuration information recited in limitation 1.4. Thus, the evidence does not impose an ordering between limitations 1.2 and 1.3 or between limitations 1.2 and 1.4. The evidence also does not support Patent Owner’s argument that the two reverse-order examples in the ’774 patent are unclaimed embodiments.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner
“We disagree that Petitioner’s arguments are based on impermissible hindsight, because they are based on the disclosures in Douglas and Mark, and Petitioner has articulated a persuasive reason to combine those references without referring to the ’774 patent itself, as we discuss below. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (an obvious rationale is not improper hindsight if it “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”).” slip op. at 29
Patent outcomesUS 11,886,774 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,886,774 - 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 & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.
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 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“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”14) 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 53
- 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”14) 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 53
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78
Patent outcomesUS 12,110,520 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - Savant Technologies LLC D/B/A GE Lighting / Ledvance LLC et al. v. Feit Electric Company, Inc.All claims unpatentablePTAB · Aug 28, 2026 · IPR2024-01357 · APJ Kevin W Cherry · IPR · Final written decision
Claims 1–3, 6, 7, 9, 10, 16–21, 25, 26, and 29 are unpatentable; substitute claims 30–49 were not reached.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“E. Credibility of Dr. Doolittle Patent Owner argues that we should give no weight to Dr. Doolittle’s testimony because, “[o]n cross examination, Prof. Doolittle repeatedly contradicted himself, dodged questions, and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions.” PO Resp. 25. Patent Owner raises two major complaints about Dr. Doolittle. First, Patent Owner argues that he took inconsistent positions by asserting in these IPR proceedings that the claims were entitled to their plain and ordinary meaning, while in the parallel district court proceeding, asserting that certain claim terms were indefinite. Id. at 26–28. Second, Patent Owner argues that Dr. Doolittle “repeatedly dodged questions and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions,” and that “[d]uring cross examination Patent Owner was forced to object to Prof. Doolittle’s nonresponsive answers no less than eighteen times.” Id. at 28. We strongly disagree with Patent Owner’s characterization of Dr. Doolittle’s testimony. We have reviewed the entirety of both of Dr. Doolittle’s depositions. We are impressed with his forthrightness, candor, and good humor in the face of Patent Owner’s counsel’s aggressive questioning. Contrary to Patent Owner’s assertions, we find that his testimony was well-reasoned, forthright, honest, and entitled to significant weight. Dr. Doolittle explained the different claim construction positions We also strongly disagree that Dr. Doolittle’s answers were nonresponsive or “evasive” as Patent Owner argues. Patent Owner’s numerous attempts to “strike” portions of his testimony belie Dr. Doolittle’s efforts to honestly and in good faith respond to Patent Owner’s counsel’s questions. Ex. 2025, 22:10–23:15, 25:9–26:14, 30:14–22, 40:3-9, 58:12–59:1, 60:18–61:13, 65:1–10, 83:15–84:16, 92:15–95:20, 96:18–99:9, 102:22–106:16, 135:3–136:22. An answer is not “non-responsive” simply because it does not conform to the conclusion you want or undermines the logic underlying your questioning. Dr. Doolittle explained his answers and addressed the issues Patent Owner asked about. Accordingly, we decline Patent Owner’s invitation to give Dr. Doolittle’s testimony no weight. Instead, we assess Dr. Doolittle’s testimony on a case-by-case basis as discussed below.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“lower wavelength might offer, there were other drawbacks that a person of ordinary skill would have to balance. But “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, Shimizu, and Stokes—that made this tradeoff. Moreover, “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). We find that the prior art of record demonstrates that a person of ordinary skill in the art at the time of the invention would have such an expectation in making the combination of Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success.” slip op. at 41
- Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner
“7. Summary As discussed above, we find that Patent Owner has failed to show a” slip op. at 35
Patent outcomesUS 8,604,678 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 8,604,678 - 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 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.
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 understanding of a person of ordinary skill in the art (sometimes referred to 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”) (Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 BIOCHEMISTRY 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70
Patent outcomesUS 12,152,262 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,152,262 - Motorola Mobility LLC / Google LLC v. Multifold International Incorporated Pte. Ltd.All claims unpatentablePTAB · May 15, 2026 · IPR2025-00038 · APJ Kristen L Droesch · IPR · Final written decision
Claims 1–7, 10–13, 16, 17, 19, and 20 are unpatentable as obvious over Chin; the Board did not find them anticipated by Chin or Whitehorn.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts that [a] person of ordinary skill in the art . . . (‘POSITA’) would have had at least a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field plus at least two years of work or post-graduate experience in image capture, image processing, image display, user interfaces, or a related field. Additional education could offset a lesser amount of experience and vice versa. Pet. 16. Patent Owner accepts Petitioner’s definition. See PO Resp. 25. We adopt Petitioner’s undisputed definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’842 Patent Specification and the asserted prior art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We agree with Petitioner that claim construction is unnecessary. As demonstrated in the analysis provided below addressing this claim limitation in view of the prior art, we need not explicitly construe “wherein in each image capture mode a display on the first or second screen is different.” See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Similarly, we need not construe any other claim terms or phrases to resolve the controversy between the parties.” slip op. at 9
- Strike new argumentNew argument disregardedDecided for patent owner
“We agree with Patent Owner that Petitioner’s arguments relying on Kennametal are belated. A “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019)6 at II.I. Thus, we need not consider Petitioner’s belated argument raised for the first time in the Reply. In any event, we agree that Kenneametal is inapplicable for the purpose of supplying a claim limitation missing from Chin’s disclosure. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274 (Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would ‘at once envisage’ the missing limitation.”). Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not 6 Available at www.uspto.gov/patents/ptab/trial-practice-guide. displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See generally Ex. 1004.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that the theory of inherency was not raised in the Petition and is therefore waived. Compare Pet. 29–33, with Pet. Reply 11–15. In any event, we also agree that Petitioner’s speculation regarding the disclosure of Chin is insufficient to support a theory of inherency. See Pet. Reply 11–15. As explained above, Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See Ex. 1004. Speculation regarding the possibilities and probabilities of what is displayed on first display 51 in self-photographing mode, and what is displayed on second display 52 in outward-facing mode are insufficient to establish inherency. See In re Robertson, 169 F.3d at 745. For the forgoing reasons and based on the entire record developed during trial, the preponderance of the evidence does not support Petitioner’s showing that Chin discloses “wherein in each image capture mode a display on the first or second screen is different.” Accordingly, based on the entire record developed during trial the preponderance of the evidence does not support Petitioner’s showing that Chin anticipates claim 1.” slip op. at 20
Patent outcomesUS 8,836,842 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,836,842 - Deltran USA LLC v. The Noco CompanyAll claims unpatentablePTAB · Mar 13, 2026 · IPR2025-00885 · APJ Avelyn M Ross · IPR · Final written decision
Claims 1–11 are unpatentable under Richardson-based obviousness grounds; the Yu and Paparrizos grounds do not establish unpatentability.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art, “[a]s of the claimed priority date of July 3, 2014, . . . would have been a person with a bachelor’s degree in electrical engineering or its equivalent and two years of experience in the field of electrical engineering including some experience in design of battery charging systems.” Pet. 21 (citing Ex. 1003 ¶¶ 19–30). Patent Owner “does not propose a different level of skill in the art[.]” PO Resp. 16. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art, because it is supported by the testimony of C. Arthur MacCarley and not disputed by Patent Owner.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“As neither party proposes an express construction for our consideration and because we determine that claim construction is not necessary, we do not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11
- PTAB / AIA Trials › §315(e) estoppelNot reached
“arguments relating to whether the prior findings are “necessary to the determination” or whether estoppel applies to arguments relating to Richardson being inoperative. See Pet. Reply 27. Nor does Petitioner respond to our inquiry about whether collateral estoppel maybe applied on a limitation by limitation basis. See Pet. Reply 27. At the hearing, however, Petitioner confirmed that resolution of the issue is not necessary to our final determination. JUDGE ROSS: Do we even need to decide the collateral estoppel issue? I mean, it seems to me that if your petition clearly made out your case for the combination of Richardson and Zhao, then we don't even need to reach that. MR. CHANDRA: That’s exactly right, Your Honor. That is our position, as well. We believe collateral estoppel applies, but you don't need to decide that issue in order to find these claims unpatentable. As I mentioned before, these are the same references. We have fairly sought out all of the portions of Richardson, we cited to specific portions. Not just relying on collateral estoppel, but the teachings of the reference itself. So, while this is an issue, we believe that collateral estoppel should apply. It does not have to apply in order to find the challenged claims unpatentable. Tr. 19:9–20. We are persuaded, as discussed in Section II.G., that Petitioner has shown where Richardson in combination with Zhao meets each limitation of the claims of the ’203 patent. Accordingly, we need not address whether Petitioner has demonstrated sufficiently that collateral estoppel applies here.” slip op. at 14
- Strike new argumentNew argument consideredOther
“Our Practice Guide states, that “[o]nce a trial is instituted, the Board may decline to consider arguments set forth in a preliminary response unless they are raised in the patent owner response.” Consolidated Trial Practice Guide (“Practice Guide”), 52 (Nov. 2019) (citing In re Nuvasive, Inc., 842 F.3d 1376, 1381 (Fed. Cir. 2016) (explaining that a patent owner waives an issue presented in its preliminary response if it fails to renew the issue in its response after trial is instituted)).12 In addition, in our Scheduling Order, we stated that “Patent Owner is cautioned that any arguments not raised in the response may be deemed waived.” Paper 9 at 10; see also Practice Guide, 94 (same). Patent Owner confirmed at the Oral Hearing its understanding that arguments raised in its Preliminary Response and not reasserted in its Patent Owner Response were not appropriate for consideration during trial. Tr. 4:10–6:17. Petitioner does not identify any particular argument raised in the Patent Owner Preliminary Response that is not present in the Patent Owner Response. But, in this Final Written Decision, we do not consider arguments made in the Patent Owner Preliminary Response and instead assess only those fairly presented in the Patent Owner Response.” slip op. at 15
Patent outcomesUS 11,667,203 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,667,203
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.