- 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 - Aroma360, LLC v. Air Esscentials, Inc.All claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00705 · APJ Eric C Jeschke · IPR · Final written decision
Claims 7–9 and 11 are unpatentable as obvious over Goubet; proposed substitute claim 21 is denied as indefinite.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Response, Patent Owner states that it “does not dispute” the definition of one of ordinary skill in the art proposed by Petitioner, but Patent Owner “reserves the right to address [the definition] should new issues materialize.” PO Resp. 5. Patent Owner did not address this issue in the Sur-reply. As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for patent owner
“The record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration, as asserted in Petitioner’s overall argument. See Pet. Reply 1–2. Contrary to Petitioner’s argument, in the cited general discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1; see also Pet. Reply 2 (arguing that “Dr. Micklow’s declaration is premised on understandings of claim scope that are inconsistent with the constructions advanced by both of the parties” (emphasis added)). Instead, we read the cited portions of Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also Pet. Reply 1 (citing Ex. 1046, 112:4–12, 113:13–20, 115:15–18). Next, we turn to each of the four specific claim terms that Petitioner highlights in its further arguments.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“B. Claim Construction In inter partes reviews, the Board interprets claim language using the same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 10–11; PO Resp. 5. Based on the complete record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. 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 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Florida Litigation a Joint Claim Construction statement that included stipulated claim constructions and disputed claim constructions for terms in the challenged patent as well as the ’449 patent and the ’918 patent. See Ex. 1018, Exhibit A (Stipulated Claim Constructions), Exhibit B (Disputed Claim Constructions). The parties stipulated to the construction of the terms “fluid dispersion” and “baffle” as recited in the challenged claim. See id., Exhibit A.10 10 When staying the Florida Litigation, the District Court cancelled the scheduled claim construction hearing. See ECF No. 67 (April 8, 2025) (granting joint motion to stay); ECF No. 68 (April 8, 2025) (cancelling the The stipulated construction of “fluid dispersion” merely restates the express definition of “fluid dispersion” from the challenged patent (although the definition is not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 3:8–20. Similarly, the stipulated construction of “baffle” essentially parrots one sentence in the challenged patent (again, not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 7:57–59. To the extent necessary, we determine that the complete record supports the parties’ stipulated constructions of “fluid dispersion” and “baffle,” and we apply those constructions below.” slip op. at 10
Patent outcomesUS 9,527,094 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 9,527,094 - 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 31, 2026 · IPR2025-00260 · APJ Kevin W Cherry · IPR · Final written decision
The Board held all challenged claims 1–3, 6, 7, 9–14, 16–21, 25, 26, and 29 unpatentable as obvious and granted the motion to amend for substitute claims 30–49.
RulingsFinal written decision- 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
- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the understanding of a person of ordinary skill in the art (“POSITA” or “POSA”). In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quoting Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d Relying on the declaration testimony of its expert, Dr. Doolittle, Petitioner contends that an ordinarily skilled artisan for the ’678 patent “would have had an undergraduate degree (i.e., B.S., B.S.E. or the equivalent) in electrical engineering, materials science, physics, or a similar discipline” and “would also have one to two years of experience in the field of LED packaging design.” Pet. 5–6. Petitioner additionally contends that “[m]ore education could substitute for experience, and vice versa.” Id. Petitioner further contends that “[t]his person would have been capable of understanding and applying the teachings of the ’678 patent and the prior-art references discussed herein,” and “[m]oreover, the prior art reflects the level of skill at the time of the claimed invention.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); Ex. 1102 ¶¶ 38–42). Patent Owner states that “solely for the purposes of this proceeding, Patent Owner and its technical expert employ the same level of skill in the art as Petitioners.” PO Resp. 24–25. Thus, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’678 patent and the asserted prior art, and we apply it in our obviousness analysis below.” slip op. at 10
- 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. 4. Summary We have reviewed Petitioner’s contentions regarding claims 1–3, 6, 9, 10, 16–21, and 25 (Pet. 19–53), and find that Petitioner has shown by a preponderance of the evidence that Basin-2007 and Basin-2005 teach the limitations of those claims, and that there would have been a motivation to combine the references in the manner suggested with a reasonable considerations does not outweigh the strong showing of obviousness. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that claims 1–3, 6, 9, 10, 16–21, and 25 would have been obvious over Basin-2007 and Basin-2005.” slip op. at 41
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“1. Nexus In order for secondary considerations to be awarded “substantial” slip op. at 22
Patent outcomesUS 8,604,678 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 8,604,678 - 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 - Par Health, Inc. v. Inforlife, S.A.Institution deniedPTAB · Aug 20, 2026 · PGR2026-00036 · APJ John A Squires · PGR · Institution
The Director denied institution because the petition did not show that Biomed was publicly accessible as prior art, so it failed to show any challenged claim was unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3
- Obviousness (§103) › Analogous artNot reached
“sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3
§ 102 anticipation§ 103 obviousnessPatents in suitUS 12,370,153 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552
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.