- 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 - PTAB · Oct 6, 2026 · IPR2025-00530 · APJ Scott C Moore · IPR · Final written decision
Original claims 1–9 were canceled; the non-contingent motion to add substitute claims 10–18 was denied for lack of written-description support, and claim 18 was also indefinite.
RulingsFinal written decision- 112 supportMotion to amend, deniedDenied
“that either the ’303 application or the ’838 provisional contain adequate written description support for the disputed feature of limitation [10.d]. Though the disclosures cited by Patent Owner indicate that a secondary identifier can be used to aid in verification of a UAV, these disclosures also make clear that both first and second identifiers are transmitted by and received from the UAV. See, e.g., Ex. 2002, 4:15–17, 30:24–31:6; Ex. 2003 ¶¶ 14, 66. Patent Owner’s reliance on disclosure characterized as transmitting an identifier from a remote computing system “through the UAV” (Reply 2) is not persuasive. The cited disclosures from the ’303 application and ’838 provisional generally disclose that the identifiers transmitted by a UAV can be “generated remotely,” such as by a “remote computing system.” Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45. But Patent Owner has not identified disclosure indicating that a remote computing system may transmit an identifier to the identification receiver. In the ’303 application and ’838 provisional, only the UAV (which is part of the discrimination system, and thus not “remote”) actually transmits identifiers to the identification receiver. Patent Owner is correct in its assertion that an “aerial system identifier can be generated on-board the aerial system” or “generated remotely . . . at a remote computing system.” Mot. 7 (citing Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45). But even if a UAV’s identifier was at some time in the past generated by a remote computing system, the subsequent transmission of that identifier from the UAV to the identification receiver would not satisfy the plain language of limitation [10.d]. The claim language “receive … a second identifier from a computing system that is remote to the discrimination system” requires the receipt of a transmission of the second identifier from a remote computing system. This claim language limits the source of the received transmission (i.e., where the particular transmission is “receive[d] … from”). Thus, the relevant issue is from where was the recited second identifier received. The relevant is not where the second identifier was originally generated.” slip op. at 12
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed
“We determine that the disputed language in limitation [10.d] is not indefinite. There is no recitation in proposed substitute claim 10 that the second identifier is transmitted solely from the identifier transmission system. Thus, the alleged irreconcilable contradiction cited by Petitioner is not recited in the claims. Petitioner’s position appears to rest on the fact that the ’303 application and ’838 provisional do not disclose receiving the second identifier from a remote computing system. See Sur-reply 6 (“To manufacture written description support, [Patent Owner] argues the claim encompasses identifiers routed ‘through the UAV.’”). Though we agree that limitation [10.d] lacks adequate written description support, this defect does not render the claim indefinite because the scope of limitation [10.d] is otherwise reasonably certain based on its plain language. See supra § III.C.4.” slip op. at 18
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artPriority date, deniedDecided for patent owner
“In contrast, the ’393 provisional never discloses that the described drone defense system may use the identity of a detected drone to develop a particular countermeasure. The disclosed RTSS certainly uses identity information to determine whether a drone is a threat. And if a threat is identified, the RTSS immediately starts “a series of processes … to determine what rule of engagement will be applied on the intruding drone.” Ex. 1006 ¶ 10. The ’393 provisional discloses that the system may select a particular countermeasure based on (i) the particular zone within a protected area within which a drone is located, (ii) “the behavior of the hostile drone,” or (iii) “other instructions.” Id. ¶¶ 9, 10. But the ’393 provisional never discloses that these “other instructions” may include the identity of the drone. The system disclosed in the ’393 provisional uses the identity of a drone to determine whether to activate the countermeasure system. See id. ¶¶ 16–18. But there is no disclosure in the ’393 provisional that the countermeasure system, once activated, uses the identity of the drone to develop the particular countermeasure to be employed. See generally Ex. 1006. Thus, though the Whitmarsh reference itself contains ample written description support for limitation [19e], the earlier-filed ’393 provisional does not. On this record, and having reviewed the ’393 provisional in its entirety, we determine that the ’393 provisional does not “reasonably convey[] to those skilled in the art that the inventor had possession of” the subject matter of limitation [19e] of Whitmarsh’s claim 19 “as of the filing date” of the ’393 provisional. See Ariad, 598 F.3d at 1351.” slip op. at 27
§ 102 anticipation§ 112 disclosurecites NautilusPatents in suitUS 10,249,199 - PTAB · Oct 6, 2026 · IPR2025-00525 · APJ Scott C Moore · IPR · Final written decision
Original claim 21 was canceled; the Board denied substitute claim 22 for new matter and held it obvious under §103 based on six combinations.
RulingsFinal written decision- 112 supportMotion to amend, deniedDenied
“First, Patent Owner has not shown possession of the disputed feature of a “radio communication module [that] is configured to utilize a secure identifier, the secure identifier comprising a specified excitation.” In the ’406 application, the term “excitation” is used exclusively to refer to a light beam signal. See Ex. 2015, 7:8–13, 9:8–10, 23:9.2 The ’406 application discloses that an identification box on an aircraft may include both an RF module and a separate light sensor. See Ex. 2015, 7:3–11. But nowhere does the ’406 application describe receiving a light beam (e.g., an excitation) with the RF module of the identification box (as opposed to the light sensor), so as to provide support for proposed substitute claim 22’s recitation of a “radio communication module” configured to utilize “a secure identifier . . . comprising a specified excitation.” We disagree with Patent Owner that it suffices that one of ordinary skill in the art “would recognize that these disclosures are equally applicable to the RF-only embodiments” (Reply 5). “It is not sufficient for purposes of the written description requirement . . . that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). On this record, and having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a radio communications module “configured to utilize a secure identifier” where “the secure identifier compris[es] a specified excitation.” Second, setting aside the “radio communication module” in proposed substitute claim 22, Patent Owner also has not shown that the named inventor was in possession of the feature of a “secure identifier comprising a specified excitation.” Patent Owner’s argument that the ’406 application describes a light beam directed to a particular aircraft (see Reply 4–5) is 2 The same is true of the ’153 provisional. See Ex. 2016 ¶¶ 29, 34. unavailing. The fact that the properties of a particular light beam indicate that the light beam is intended for a particular aircraft does not demonstrate that the light beam is a “secure identifier,” as we have construed that term. Patent Owner has not identified any disclosure in the ’406 application of a “secure identifier” comprising a light beam, let alone that such light beam can be utilized by a “radio communication module.” The only references to “secure” identifiers in the ’406 application describe radio frequency signals. See Ex. 2015, 2:4–6, 15:21–17:12.3 Having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a “secure identifier comprising a specified excitation.”” slip op. at 15
- ScopeDecided for patent owner
“not impermissibly broaden the scope of the claims of the ’959 Patent. As Patent Owner suggests, there were no limitations in original claim 21 on the type of radio signal the radio communication module could receive, and so it follows that proposed substitute claim 22 does not now encompass receiving a broader set of radio signals. We see no basis for Petitioner’s argument that the past tense verb “received” limited original claim 21 to “signals of a compatible ‘type’ and ‘range.’” Opp. 7. Moreover, the claim language (with the proposed deletion shown double brackets) provides that “the radio communication module is configured to receive a [[received]] radio signal.” Any radio signal that the radio communications module receives would necessarily be a “received” radio signal. Thus, deleting the redundant word “received” does not enlarge the scope of this claim limitation. We also are not persuaded by Petitioner’s suggestion that removing the term “received” broadens original claim 21 by deleting a requirement that the radio signal have already been previously received by the claimed device. See Sur-reply 9. Original claim 21 simply recited, using redundant language, that “the radio communication module is configured to receive a received radio signal.” Ex. 1001, 18:5–7. The most natural reading of this language is that the phrase “received radio signal” is just a description of a radio signal that is received by the recited radio communications module. Petitioner has cited no persuasive evidence that one of ordinary skill in the art would have counterintuitively interpreted this language to impose an additional requirement that the “received radio signal” must have been received twice—a first time by some other component of the device, and a second time by the recited radio communication module. Accordingly, we determine that the proposed amendment does not improperly broaden claim scope.” slip op. at 10
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable
“572 U.S. 898 (2014). See Memorandum: Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021).4 Under Nautilus, a claim is indefinite if fails to “inform those skilled in the art about the scope of the invention with reasonable certainty.” 572 U.S. at 910. We agree with Patent Owner that neither of the identified terms are indefinite. Regarding the term “low-altitude aircraft,” we determine the Specification provides a sufficient basis for understanding the scope and meaning of this term with reasonable certainty. The U.S. Court of Appeals for Federal Circuit has explained that, when a term of degree is recited in a claim, it is necessary “to determine whether the patent’s specification provides some standard for measuring that degree.” See Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984); see also Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005) (“Some objective standard must be provided in order to allow the public to determine the scope of the claimed invention.”). Here, the Specification describes the related art as including “small UASs (e.g., aircrafts up to 25 pounds flying up to 500 ft of the low altitude airspace).” Ex. 1001, 1:50–52. One of ordinary skill in the art would understand from the Specification that the cited disclosure provides an objective standard for determining the scope of a low-altitude aircraft as one that is designed to fly up to a maximum altitude of about 500 feet.” slip op. at 20
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s proposal that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Paper 13, 5 (citing Pet. 21). Patent Owner has not disputed this formulation; thus, we adopt it for purposes of this Decision. See Paper 13, 10–11 n. 8.” slip op. at 23
§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 10,713,959 - 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 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. 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)).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - 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 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.
RulingsFinal written decision- Director reviewDirector review, deniedDenied
“Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3
- Additional discoveryAdditional discovery, deniedDenied
“(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3
- 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
“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. 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 ’035 patent.” slip op. at 53
Patent outcomesUS 12,123,035 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,123,035 - Microsoft Corporation v. X1 Discovery, Inc.No claims unpatentablePTAB · Jun 18, 2026 · IPR2025-00254 · APJ Lisa A Murray · IPR · Final written decision
Claims 1–20 were not shown unpatentable under either §103 ground because Petitioner failed to establish motivation to combine and a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“29. In my opinion, the POSITA at the time of the alleged invention of the Asserted Patents would have had a (1) a Bachelor’s degree in a pertinent discipline, such as computer science, electric engineering, computer engineering, or a related field and (2) have 2–4 years of experience in working with computing devices and have an understanding of indexed search systems utilized by such computing devices. 30. I am aware that Petitioner has provided its own definition . . . . 31. I believe Petitioner’s definition is not meaningfully different from my definition of a POSITA. My opinions would not change regardless of which definition of POSITA is applied. Ex. 2001 ¶¶ 29–31. In our Decision on Institution, we adopted Mr. Haeberli’s formulation, finding it to be consistent with the evidence then of record, including the asserted prior art and the ’490 patent. Dec. 9. Following a review of the full record, we agree with Mr. Haeberli’s statement that Petitioner’s definition of one of ordinary skill in the art is “not meaningfully different” from Mr. Haeberli’s for the purposes of this proceeding. We continue to view Mr. Haeberli’s proposed definition as consistent with the ’490 patent and the asserted prior art, and we apply it in our analysis below. However, our analysis of the issues below would have been the same had we instead adopted Petitioner’s proposed definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In our Decision on Institution, the only term that we found it necessary to construe was the term “string separator character” in claim 1. We preliminarily construed this term to mean “a single-character string separator.” Dec. 11, 30–31. We invited the parties to address the appropriateness of this construction over the course of the trial. Id. at 11, 31. In its briefing, Patent Owner agrees with the Board’s preliminary construction, arguing that it is “consistent with the intrinsic evidence.” PO Resp. 8 (citing Ex. 1001, claims 8 and 20). Patent Owner further argues that a person of ordinary skill would have understood a multi-character Boolean operator such as “AND” to be “a search syntax instruction rather than a string separator.” Id. at 9 (citing Ex. 1059, 162; Ex. 2001 ¶ 112). Petitioner’s Reply Brief does not address the issue of claim construction. See generally Reply Br.; see also Pet. 11 (“Unless otherwise noted, Petitioner applies the plain and ordinary meaning of all claim terms below.”). Following our review of the full record, we determine that it is not necessary to construe this or any other claim term for the purposes of this Decision.2 See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy.). In our analysis below, we interpret the language of the claims according to its plain and ordinary meaning.” slip op. at 10
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Having reviewed the evidence of record, we find Mr. Haeberli’s testimony to be more persuasive and better supported by the evidence. According to Dr. Terveen, “[r]obust programming languages such as C and C++, together with well-developed operating system and UI frameworks, . . . allowed an ordinary programmer to build a UI that supported incremental searching, as evidenced by the numerous prior art systems that implemented such functionality, including Entourage, Eudora, Emacs, Canon Cat, SwyftWare, and others. Ex. 1100 ¶ 43 (citing Ex. 1004, 8–9, 161; Ex. 1021, 125, 127, 129; Ex. 1039, 102–103; Ex. 1043, 385–389). The relevant question, though, is not whether it would have been possible to build a user interface that supported incremental search, but whether it would have been “simple and straightforward” to execute an incremental search of multiple partial search strings on large, indexed multi-file databases such as those described in the Lotus Notes references, as Dr. Terveen alleges. None of the prior art discussed in the “State of the Art” section of Dr. Terveen’s initial declaration, taken individually or together, discloses incrementally searching a plurality of files using two partial search strings. See Ex. 1003 ¶¶ 32–33, 37, 40; Ex. 2001 ¶ 100. Thus, creating a user interface might be “simple,” but the evidence suggests that the back-end execution of an incremental search is not. See, e.g., Ex. 1021, 126 (Raskin, concluding that “almost all interface-building tools make it easy to implement delimited searches and difficult or impossible to implement incremental searches”).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“different approach from that taken in Lotus Notes. The difference between Raskin’s sequential scanning method and the index-based system described in Wilcox is that sequential scanning by definition can only scan one document at a time as each document is loaded into a “buffer.” See, e.g., Ex. 2020 ¶ 35. Lotus Notes, however, only needs to load the index into memory for a user to be able to locate the single index entry identifying all instances of an indexed term across all indexed files. In fact, Raskin acknowledges that indexing may be necessary to maintain an acceptable response time. Ex. 1021, 132 n.10; see also id. at 129 (indexing speeds search times). Mr. Haeberli’s third and final reason for concluding that one of ordinary skill would not have been motivated to combine Raskin’s incremental search with Lotus Notes is that at the time using incremental searches would have presented “extreme technical difficulties.” Ex. 2001 ¶ 101. Here again we find Mr. Haeberli’s explanation more persuasive than Dr. Terveen’s opinion that combining the teachings from Raskin with Lotus Notes’ teachings “would have required only simple and straightforward software modifications.” Ex. 1003 ¶ 80. According to Mr. Haeberli, “there are serious technical challenges with implementing the complex search strategies of the challenged claims in the systems on which Dr. Terveen relies.” Id. ¶ 96. As Patent Owner argues: searching across a set of files to find specific files requires the system to identify which files are in the set, access those files (which are often not loaded in active memory), search their contents, determine which files contain matches to search criteria, and then present results to the user; all tasks that do not exist in the same way (or at all) for a search confined to text in a single open file already loaded into memory. Sur-Reply 9; see Ex. 2020 ¶¶ 15, 35–36. There would have been other challenges as well. For example, “[t]he type of sequential scanning typically employed to search a single open document is very time and resource intensive if employed to search a large set of documents.” Ex. 2020 ¶ 15. Also, “[i]mplementing incremental search in the Lotus Notes indexed system would necessarily require a larger index, which would slow down, rather than increase the search speed.” PO Resp. 23; see Ex. 2020 ¶ 33. Finally, Raskin itself concludes that “even if incremental searching is advantageous, ‘almost all interface-building tools make it easy to implement delimited searches and difficult or impossible to implement incremental searches.’” Ex. 2001 ¶ 96 (emphasis added by Mr. Haeberli) (quoting Ex. 1021, 126). In short, Mr. Haeberli presents three significant reasons why there would have been no motivation or expectation of success in combining the teachings of Wilcox with those of Raskin. Dr. Terveen’s opinion to the contrary, on the other hand, is not supported by evidence. Dr. Terveen testifies that “[a] POSITA would have been motivated to perform Lotus Notes’ multi-string search incrementally for the reasons stated by Raskin: speed, effectiveness, and ease of use.” Ex. 1003 ¶ 78 (citing Ex. 1021 ¶¶ 125–127). The evidence, however, not only fails to support Dr. Terveen’s testimony, but also demonstrates that one attempting to make the proposed combination would not have reasonably expected the proposed combination to result in greater speed or effectiveness.” slip op. at 27
Patent outcomesUS 10,552,490 not shown unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 10,552,490
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.