- 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 · Oct 5, 2026 · IPR2025-00438 · APJ Lilan Ren · IPR · Final written decision
Claims 1–5, 7–13, and 16–20 are unpatentable; the Board found the challenged claims unpatentable on the grounds set out in its conclusions and summary table.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s definition of the level of ordinary skill in the art, and Petitioner’s definition appears consistent with the disclosures of the ’466 patent and the prior art of record. Accordingly, we adopt Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). C. Claim Construction” slip op. at 12
- BurdenUnpatentable
“Decision under 35 U.S.C. § 318(a) as to the patentability of the challenged claims of the ’466 patent. For the reasons discussed below, we determine Petitioner has established by a preponderance of the evidence that claims 1– 5, 7–13, and 16–20 of the ’466 patent are unpatentable.” slip op. at 2
Patent outcomesUS 10,569,466 unpatentableNonecites Phillips · KSR · GrahamPatents in suitUS 10,569,466 - 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 - Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.All claims unpatentablePTAB · Sep 29, 2026 · IPR2025-00532 · APJ Hyun J Jung · IPR · Final written decision
Claims 1–16 are unpatentable under § 103 over Warren, Warren and Dunn, Calderon and RepRap20208, and Calderon, RepRap20208, and Dunn.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“of ordinary skill in the art would have made the proposed combination in the manner asserted with a reasonable expectation of success. Weighing our underlying factual determinations, a preponderance of the evidence persuades us that claim 7 of the ’381 patent is unpatentable over Calderon, RepRap20208, and Dunn. Arctic Cat, 876 F.3d at 1361.” slip op. at 108
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). Whether a document qualifies as a printed publication is a legal conclusion based on underlying factual determinations. Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018). slip op. at 69
Patent outcomesUS 10,556,381 unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,556,381 - 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 - Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.Some claims unpatentablePTAB · Sep 28, 2026 · IPR2025-00531 · APJ Hyun J Jung · IPR · Final written decision
Claims 1–11 and 13–15 are unpatentable over the stated obviousness grounds; claim 12 was not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner filed a Petition (Paper 2, “Pet.”) requesting institution of an inter partes review of claims 1–15 of the ’698 patent. Discretionary denial of institution was determined to be not appropriate in this proceeding, and the proceeding was referred to the Board. Paper 10. Pursuant to 35 U.S.C. § 314, we instituted an inter partes review of claims 1–15 of the ’698 patent on all presented challenges. Paper 11 (“Inst. Dec.”), 15.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 (2025). For the reasons that follow, we determine that Shenzhen Tuozhu Technology Co., Ltd. (“Petitioner”) has shown by a preponderance of the evidence that claims 1–11 and 13–15, but not claim 12, of U.S. Patent No. 9,168,698 B2 (Ex. 1001, “the ’698 patent”) are unpatentable.” slip op. at 2
Patent outcomesUS 9,168,698 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,168,698 - 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
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.