- Biocon Biologics, Inc. / Biocon Biologics Limited v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 24, 2026 · PGR2026-00039 · APJ John A Squires · PGR · Director review
The Director denied the petition and instituted no trial because it was filed more than nine months after the patent issued, contrary to § 321(c).
RulingsDirector review decision- PTAB / AIA Trials › §315(b) time barInstitution denied time barDenied
“I agree with Patent Owner that the Petition is barred by § 321(c). Section 321(c) provides that “[a] petition for a post-grant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as the case may be).” Joinder is authorized under 35 U.S.C. § 325(c), which provides that “[i]f more than 1 petition for a post-grant review under this chapter is properly filed against the same patent and the Director determines that more than 1 of these petitions warrants the institution of a post-grant review under section 324, the Director may consolidate such reviews into a single post-grant review.” Notably, the statutory authorization for joinder under § 325(c) does not provide an exception to the nine-month statutory bar, as it requires any petition considered for joinder to be “properly filed,” i.e., to meet the statutory filing requirements including the nine-month filing deadline recited in § 321(c). Petitioner argues that I have broad discretion to promulgate rules and permit exceptions, such as here where institution would increase efficiency. See Reply 2–3. I agree that my institution discretion is broad. But § 325(c) provides no exception to the time period in which a petition for post-grant review may be filed.1 The board rule on which Petitioner relies cannot override a clear statutory requirement, and Petitioner does not point” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“Section 321(c) provides that “[a] petition for a post-grant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as the case may be).” Joinder is authorized under 35 U.S.C. § 325(c), which provides that “[i]f more than 1 petition for a post-grant review under this chapter is properly filed against the same patent and the Director determines that more than 1 of these petitions warrants the institution of a post-grant review under section 324, the Director may consolidate such reviews into a single post-grant review.” Notably, the statutory authorization for joinder under § 325(c) does not provide an exception to the nine-month statutory bar, as it requires any petition considered for joinder to be “properly filed,” i.e., to meet the statutory filing requirements including the nine-month filing deadline recited in § 321(c). Petitioner argues that I have broad discretion to promulgate rules and permit exceptions, such as here where institution would increase efficiency. See Reply 2–3. I agree that my institution discretion is broad. But § 325(c) provides no exception to the time period in which a petition for post-grant review may be filed.1 The board rule on which Petitioner relies cannot override a clear statutory requirement, and Petitioner does not point 1 Although the Office continues to encourage joinder and early challenges to increase efficiency and resolve patentability challenges early in the life of the patent, these considerations must follow the statute.” slip op. at 3
Discretionary denialPatents in suitUS 12,168,036 - Pgr2026-00043InstitutedPTAB · Sep 23, 2026 · PGR2026-00043 · APJ John A Squires · PGR · Institution
The Board granted institution of PGR2026-00043 after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings: IPR2026-00336 PGR2026-00037 PGR2026-00043 IPR2026-00363 PGR2026-00042” slip op. at 2
NonePatents in suitUS 12,543,922 - Pgr2026-00042InstitutedPTAB · Sep 23, 2026 · PGR2026-00042 · APJ John A Squires · PGR · Institution
The Director granted institution of PGR2026-00042 after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:” slip op. at 2
NonePatents in suitUS 12,353,917 - Pgr2026-00037InstitutedPTAB · Sep 23, 2026 · PGR2026-00037 · APJ John A Squires · PGR · Institution
The Director granted institution of PGR2026-00037 after determining the petition showed the required likelihood of prevailing and no non-discretionary consideration warranted denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:” slip op. at 2
NonePatents in suitUS 12,347,711 - Pgr2026-00044InstitutedPTAB · Sep 9, 2026 · PGR2026-00044 · APJ John A Squires · PGR · Institution
The Board granted PGR2026-00044 after finding the petition showed the required likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings: IPR2026-00256 IPR2026-00312 IPR2026-00327 IPR2026-00257 IPR2026-00313 IPR2026-00334 IPR2026-00258 IPR2026-00314 PGR2026-00044 IPR2026-00259” slip op. at 2
NonePatents in suitUS 12,359,506 - 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 - Micron Technology, Inc. v. Yangtze Memory Technologies Company, Ltd.All claims unpatentablePTAB · Sep 2, 2026 · PGR2025-00021 · APJ Kimberly Mcgraw · PGR · Final written decision
Claims 1, 3–7, and 12–20 are unpatentable: the Board found the asserted Kim, Kim–Yang, Lee, and Lee–Haller obviousness grounds proved, but not Lee–Park.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(e.g., an advanced degree may substitute for professional experience).” Pet. 21 (citing Ex. 1003 ¶¶ 36–37). Petitioner further contends that a “POSITA would also have been aware of and generally knowledgeable about 3D memory’s structure, its component parts, and how it operates.” Id. Patent Owner does not dispute Petitioner’s definition of a POSITA. PO Resp. 9. Based on our review of the complete record, we adopt Petitioner’s uncontested definition of a POSITA.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The plain language of claim element [1.A] recites “wherein the first material layer is disposed over a first portion of the second material layer;” and claim element [1.B] recites “a landing pad disposed over a second portion of the second material layer.” Thus, the plain language of the claim merely recites that the first material layer is disposed over a first potion of the second material layer and the landing pad is disposed over a second portion of the second material layer. The plain language does not define what constitutes the first or second portions of the second material layer or define the first or second portions of the material layer by what is disposed above the layers. We agree with Petitioner that the term “portion” has a straightforward plain and ordinary meaning: a “part” of a larger whole. Pet. 5 (citing Ex. 1077, 406 (defining “portion” as “a part of a whole”)). The ’838 patent itself repeatedly uses the term “portion” this way. Ex. 1001, 5:40–43 (discussing both “an upper portion” and “lower portion” of a “staircase”), 5:66–6:1 (referencing “a portion of a top surface of a layer”); see also 4:39– 40, 7:15–17, 8:20–33, 8:34–65, 11:60–64, 12:38–59. Thus, we understand that the first and second portions of the second material layer are portions of (i.e., a part of the whole) second material layer. Neither the claims nor the Specification define what can constitute a first portion or a second portion of a second material layer.” slip op. at 11
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Dr. Giapis, argues Petitioner’s proposed modification of Lee requires a POSITA to (1) start with an oxide-based insulating layer 22 as shown in Figure 5B of Lee, (2) introduce an oxidant gas into the adjacent openings, and (3) oxidize a surface that is already oxide-based to form a curved surface. PO Resp. 78–81. Patent Owner provides credible evidence supporting its argument that a POSITA would not have been motivated to make these changes to Lee, as they are technically infeasible. Id. at 79 (citing Ex. 2019 ¶¶ 191–208). Dr. Giapis credibly explains that in Park’s process, an oxygen gas would be used to oxidize the silicon nitride or polysilicon, but “introducing such an oxidant into the openings of Lee’s structure above will not promote further oxidation to the existing oxide the relevant region . . . so nothing remains to be oxidized.” Ex. 2019 ¶¶ 192–193. We credit Dr. Giapis testimony that “[i]t is not possible to further oxidize a solid oxide material with oxygen gas as in Park. That is why Park’s thermal oxidation process is performed on silicon nitride or polysilicon, which are not oxides to begin with but they can be oxidized to form silicon dioxide.” Id. ¶ 193 (citing Ex. 2028 (Plummer) at 345–350). According to Dr. Giapis, a POSITA would have understood this and not expected the combination of Lee and Park to achieve any change in shape or any rounding in Lee’s Figure 5B. Ex. 2019 ¶ 193.” slip op. at 60
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Patent Owner, however, with persuasive supporting testimony from Dr. Giapis, argues Petitioner’s proposed modification of Lee requires a POSITA to (1) start with an oxide-based insulating layer 22 as shown in Figure 5B of Lee, (2) introduce an oxidant gas into the adjacent openings, and (3) oxidize a surface that is already oxide-based to form a curved surface. PO Resp. 78–81. Patent Owner provides credible evidence supporting its argument that a POSITA would not have been motivated to make these changes to Lee, as they are technically infeasible. Id. at 79 (citing Ex. 2019 ¶¶ 191–208). Dr. Giapis credibly explains that in Park’s process, an oxygen gas would be used to oxidize the silicon nitride or polysilicon, but “introducing such an oxidant into the openings of Lee’s structure above will not promote further oxidation to the existing oxide the relevant region . . . so nothing remains to be oxidized.” Ex. 2019 ¶¶ 192–193. We credit Dr. Giapis testimony that “[i]t is not possible to further oxidize a solid oxide material with oxygen gas as in Park. That is why Park’s thermal oxidation process is performed on silicon nitride or polysilicon, which are not oxides to begin with but they can be oxidized to form silicon dioxide.” Id. ¶ 193 (citing Ex. 2028 (Plummer) at 345–350). According to Dr. Giapis, a POSITA would have understood this and not expected the combination of Lee and Park to achieve any change in shape or any rounding in Lee’s Figure 5B. Ex. 2019 ¶ 193.” slip op. at 60
Patent outcomesUS 12,010,838 unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 12,010,838 - Pgr2026-00033OtherPTAB · Sep 2, 2026 · PGR2026-00033 · PGR · Order
Institution of PGR2026-00033 was granted after the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim, with no other non-discretionary basis for denial.
RulingsOther- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings: IPR2026-00271 IPR2026-00274 PGR2026-00032 IPR2026-00272 IPR2026-00275 PGR2026-00033 IPR2026-00273 IPR2026-00326” slip op. at 2
NonePatents in suitUS 12,417,756 - Pgr2026-00032OtherPTAB · Sep 2, 2026 · PGR2026-00032 · APJ John A Squires · PGR · Order
The Director granted institution of PGR2026-00032 after finding the petition showed the required likelihood of prevailing on at least one challenged claim.
RulingsOther- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings: IPR2026-00271 IPR2026-00274 PGR2026-00032 IPR2026-00272 IPR2026-00275 PGR2026-00033 IPR2026-00273 IPR2026-00326” slip op. at 2
NonePatents in suitUS 12,412,561 - 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
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.