- 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 - Uatp IP LLC v. Slick Slide LLCSome claims unpatentablePTAB · Oct 2, 2026 · PGR2024-00054 · APJ Brian D Range · PGR · Final written decision
Claims 22–26 are unpatentable based on obviousness; claims 1–17, 27, and 28 were not shown unpatentable. Patent Owner’s motion to terminate was denied.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“1. Mesh Layer Petitioner contends “no formal claim construction is necessary in this” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“5. Analysis On this complete record, we determine that Petitioner’s arguments do” slip op. at 31
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“form of nylon and some form of Teflon (and possible combinations thereof) having the specific coefficient of friction range given in limitation [1c] breaks down, because the building blocks of the obviousness argument are not sufficiently identified in Phillips alone, nor in the supporting testimony. Accordingly, we determine that Petitioner’s arguments and evidence fail to show that Phillips renders the challenged claims obvious. 6. Conclusion Based on the foregoing, we determine that Petitioner has not established by a preponderance of the evidence that claims 1–4, 6, and 7 would have been anticipated by or obvious in view of Phillips.” slip op. at 33
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“2. Products and Nexus We first consider the issue of whether certain evidence relied upon by” slip op. at 20
Patent outcomesUS 11,998,854 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham · NautilusPatents in suitUS 11,998,854 - Alpinestars S.P.A. / Alipinestars USA Inc. v. Dainese S.P.A.Rehearing deniedPTAB · Feb 9, 2026 · IPR2025-00750 · APJ Benjamin D M Wood · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood of prevailing on claims 1–22 under the challenged obviousness grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioner misstates the Decision’s reasoning. As is clear from the previous discussion, we determined that Petitioner’s articulated reasons for combining EP’536 with CN’180 lacked a rational underpinning, not because “EP’536 does not relate to ‘air bags,’” but because the means by which EP’536’s device inflates differs fundamentally from that of CN’180’s device. Dec. 17–18. Petitioner did not acknowledge this critical difference in the Petition, and continues not to do so in its Rehearing Request.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“EP’536 with CN’180 lacked a rational underpinning because EP’536’s inflation mechanism differs fundamentally from CN’180’s inflation mechanism. Dec. 17–18. As we stated, whereas CN’180’s fall-protection belt uses an airbag that requires an external source of pressurized air to inflate, EP’536’s garment does not need an external inflation device because “the gas generating agent 18 in each envelope automatically generates gas and inflates the envelopes in response to rising temperatures.” Id. at 18 (citing Ex. 1004 ¶ 15; Ex. 1005 ¶¶ 5, 19). This difference reflects the fundamentally different purposes of the two devices: CN’180’s device is designed to provide “fall protection” to, e.g., “elderly people,” (Ex. 1005 ¶ 1, 3), whereas EP’536’s device provides “adaptive thermal insulation” for, e.g., garments worn by fire fighters. Ex. 1004 ¶¶ 1–3, 250. Because of the different means by which EP’536’s and CN’180’s devices inflate and the different purposes for doing so, we were not persuaded that one of ordinary skill in the art would have combined the references as Petitioner proposed. Dec. 18. We further noted that the modification would not have improved the reusability of EP’536’s device “by having only one mechanism to recharge,” because EP’536’s “gas generating agent does not need any ‘mechanism to recharge.’” Dec. 18. Instead, we noted EP’536’s teaching that its gas generating agent “automatically recombines or condenses in response to a temperature decrease to return the envelopes, and therefore the garment, to its original thickness, at which point the gas generating agent is ready for subsequent reactivation.” Id. (citing Ex. 1004 ¶¶ 139–141). Finally, we determined that replacing EP’536’s envelopes with CN’180’s airbag “would have made EP’536’s invention unsuitable for its intended purpose: providing a protective garment with ‘adaptive thermal insulation.’” Dec. 19. We stated that “Petitioner does not suggest, and we have found nothing in the record to establish, that CN’180’s airbag would provide this feature.” Id. at 20.” slip op. at 3
- Obviousness (§103) › KSR rationalesMotivation not foundNot shown unpatentable
“rationales for combining EP’536 and CN’180. Reh’g Req. 6–7. First, Petitioner asserts that we “improperly rejected Petitioner’s ‘simple substitution’ evidence in view of [the Board’s] incorrect conclusion that EP’536 does not disclose an ‘external source of inflation [EP’536’s dosing aids].’” Id. at 6 (citing Dec. 18–19). This argument is unpersuasive at least because, as we discussed above, EP’536’s dosing aids do not constitute an external source of inflation. Petitioner further argues that we incorrectly evaluated its “obvious to try” rationale because, contrary to our analysis, Petitioner did in fact identify a problem to be solved by its “finite number of solutions”: “simplify[ing] the design and reduc[ing] the number of required inflation mechanisms.” Id. at 6–7. The Petition’s entire “obvious to try” discussion is as follows: [A] POSITA would have found it obvious to try a one-piece airbag 10 with strip-shaped inflation units 12 in the EP’536- CN’180 airbag system because it would have been a selection from a finite number of identified predictable solutions (i.e., using one chamber with connected individual inflation units 12 versus multiple individual envelopes 20). 5 Petitioner also argues that dosing aids are “needed in order to make the disclosed device reusable.” Reh’g Req. 5–6. This is incorrect, as EP’536 conveys that the reusability of the device is a result of the gas generating agent condensing or recombining when temperatures fall. Ex. 1004 ¶¶ 139– 141. Even if it were true, however, it is unclear how it would support Petitioner’s argument. Pet. 16. As is evident, Petitioner did not identify a design need, market pressure, or other problem that would have been addressed by its identified “solutions,” and therefore we were not persuaded by this rationale. Dec. 19. Petitioner’s attempt to cure this deficiency in its Rehearing Request is tardy. We cannot misapprehend or overlook an assertion that Petitioner fails to make in the Petition. It is also insufficient. Petitioner does not provide any evidence of a known design need or market pressure to “simplify [EP’536’s] design” or reduce the number of “required inflation mechanism” it uses.” slip op. at 7
§ 103 obviousnessPatents in suitUS 12,012,065 - Solaris Oilfield Site Services Operating, LLC / Solaris Oilfield Site Services Personnel, LLC v. Masaba, Inc.All claims unpatentablePTAB · Jan 26, 2026 · IPR2024-01179 · APJ Carl M Defranco · IPR · Final written decision
Claims 1–25 are unpatentable under § 103 over the asserted combinations of Waldner, Dynatek, and additional references; the Board cancelled all challenged claims.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Also, to the extent Masaba relies on extrinsic expert testimony, we note that Masaba’s expert cites absolutely no support for his understanding of the claims, much less explains why we should adopt his understanding over the plain and ordinary meaning of “conveying aggregate” and “moving aggregate.” See Ex. 2004 ¶ 34. Absent supporting citations, such extrinsic testimony is entitled to little, if any, weight. As such, we reject the notion that Waldner’s discharge chute member 242 is not a conveyor “for conveying aggregate” or “for moving aggregate,” as required by claim elements 1[h] and 1[i].” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“We disagree that Dr. Durham does not possess the necessary level of skill in the art to qualify as an expert in this case. Looking at the specification of the ’689 patent and the prior art of record, we think Masaba sets the bar too high. We acknowledge that one of ordinary skill in the art should have some education and/or experience in the mechanical art of conveying aggregate materials, but we do not think opining on the ’689 patent and asserted prior art necessarily requires that person to have the amount of education and experience that Masaba advocates. The ’689 patent relates generally to an “aggregate transferring system for receiving aggregate from a vehicle and elevating the aggregate to a higher vertical level for deposit into, for example, a silo.” Ex. 1001, 1:15– 18. And, as described in the ’689 patent and discussed later, the transferring system is an assembly of known types of conveyors, such as a belly-dump truck conveyor, a bucket elevator, and an articulated belt conveyor, for transferring the aggregate horizontally and vertically from a belly-dump truck to the discharge point, such as a silo. Without doubt, Dr. Durham has enough education and experience to reliably opine on the combination of known parts.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction needed
“We reject this argument for several reasons. First, nowhere does the plain language of the claims specify how the aggregate is conveyed or moved from the conveyor extension assembly’s inlet to its outlet, be it passively by means of gravity or actively by means of a conveyor belt. Instead, the claims simply use those verbs according to their plain and ordinary meaning, which is “to transfer or deliver” or “to cause to go or pass” from one place to another. See Ex. 3001, 253 (defining “convey”), 760 (defining “move”).10 Second, the specification of the ’689 patent similarly uses these terms in a plain and ordinary sense, without ever attributing to them some sort of special meaning. See, e.g., Ex. 1001, 4:9–12 (“The apparatus 10 is suitable for performing the transfer of aggregate from 10 We reference the original pagination of the dictionary in which these definitions appear. one location to another, such as, for example, from a vehicle carrying the aggregate to a silo 1 for storing the aggregate.”). The ’689 patent specification also makes clear that active conveyance of the aggregate is an option and not a requirement of the claimed invention, stating that the conveyor extension assembly “may further include a conveyor belt 150.” Ex. 1001, 10:60–66 (emphasis added). Limiting claim elements 1[h] and 1[i] to a device “for actively conveying” or “for actively moving aggregate” would improperly import limitations from the specification into the claims. Thus, based on the intrinsic evidence, we determine that claim elements 1h and 1k are properly construed to encompass passive and/or active movement of the aggregate via the conveyor extension assembly.” slip op. at 20
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Not reached
“Owner asserts” that two claim terms—“unloader structure” and “trailer structure”—should be construed as means-plus-function limitations under 35 U.S.C. § 112(f), Solaris submits an express construction detailing the corresponding structure in the specification for performing the recited function of the claimed unloader and trailer structures. See id. at 24–25. Only in disputing Solaris’s Ground 3 does Masaba advocate that the claim term “trailer structure” should be construed under § 112(f), and then only in conjunction with dependent claims 3 and 21. See PO Resp. 58. As such, we address Masaba’s proposed construction in our analysis of Ground 3. We now turn to Solaris’s grounds of unpatentability.” slip op. at 12
Patent outcomesUS 11,780,689 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 11,780,689 - Weatherford U.S., L.P v. Halliburton Energy Services, Inc.Some claims unpatentablePTAB · Dec 9, 2025 · IPR2024-00990 · APJ Brent M Dougal · IPR · Final written decision
Claims 11–12 and 14–20 are unpatentable; claims 1–10 and 21–23 are not shown unpatentable. Substitute claims 29–37 are unpatentable, and the motion to amend is denied as to them.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The level of skill is uncontested. Patent Owner adopts the level of skill identified by Petitioner as: [at] the time of the alleged invention in 2018, a POSITA[2] would have had a B.S. degree in mechanical or petroleum engineering or a similar technical discipline, with at least five years of experience in oil or gas well drilling, completion, and/or subsurface production operations or in technical support of such operations including at least some experience in unconsolidated formations utilizing sand control methods and means. Also,” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“on embodiments of Yeh with concentric sand screens having nine shunt tubes (six transport tubes and three packing tubes) (Yeh Figures 4A–B) and eccentric sand screens with four shunt tubes (two transport tubes and two packing tubes) (Yeh Figures 8A, 8C). See Pet. 32–37, 39, 41–43. Yet, Petitioner’s reasoning as to why “a higher-pressure shunt tube assembly necessitated greater wall thickness” rests on an unspoken one to one comparison between the shunt tubes of the different systems. See id.; see also Ex. 1003 ¶¶ 291–297 (Petitioner’s declarant comparing possible transport tubes of different pressure regions without considering or addressing any difference in the number of transport tubes). However, the embodiments relied on by Petitioner have different numbers of shunt tubes, and thus the greater wall thickness does not appear to be “necessitated” in the way inferred by Petitioner. Further, Petitioner’s analysis would seem to be most appropriate when comparing two concentric sand screens for different pressure regions, or two eccentric sand screens for different pressure regions. relies on Yeh’s teachings related to a horizontal well bore of 5000 feet for the “concentric screen → crossover tool → eccentric screen” arrangement, as well as, for why the concentric screen needs to be rated for a high pressure. Pet. 32–37, 39, 41–43. Petitioner also refers to these features for why one of skill in the art would combine the teachings of Yeh and Yeh2. Id. at 32. However, on cross-examination, Petitioner’s declarant agreed that it is concentric sand screens having a 6x3 shunt tube design that would provide the noted benefits of being rated for a higher pressure and being more robust (as relied on in the Petition), as compared to eccentric sand screens. Ex. 2013, 42:20–43:8; Sur-reply 4–5. This also exposes another issue with Petitioner’s arguments. Though Petitioner identifies that one of skill in the art would be aware that material choice, wall thickness, and pipe diameter all impact burst pressure of a pipe (Pet. 42 (citing Ex. 1017, 24 (Equation (14))), the Petition essentially ignores the fact that the claims do not require a single pipe in isolation. The claims require two shunt tube assemblies, each surrounding a base pipe within a wellbore. It is uncontested that a wellbore provides a confined space for such a system and thus any change in wall thickness of one pipe can result in a significant impact in the function of the other pipes. We find the testimony of Petitioner’s declarant (see, e.g., Ex. 1003 ¶¶ 290–297) unpersuasive when discussing wall thickness because it focusses on basic considerations of a standalone pipe, without sufficient consideration of the claimed completion assembly with its required pipe and tube structure. PO Resp. 20–26.” slip op. at 17
- Strike new argumentNew argument disregardedDecided for patent owner
“In response to Patent Owner’s argument concerning Yeh’s embodiments relied on in the Petition, Petitioner argues for the first time that Patent Owner’s declarant “conceded, Yeh discloses that both concentric and 47:19–48:21). Petitioner does not provide a citation to Yeh or a citation to where the Petition relies on the same number of shunt tubes between concentric and eccentric screens. The deposition cited by Petitioner discusses Yeh at column 16, lines 26 through 35. However, the Petition does not cite or rely on these teachings of Yeh. Thus, we decline to consider this late argument.4 See 35 U.S.C. § 312(a)(3) (requiring the petition to identify “with particularity . . . the grounds on which the challenge to each claim is based, and the evidence that supports the grounds”); 37 C.F.R. § 42.104(b)(5).” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“Thus, we agree with Petitioner that the combination of Yeh and Yeh2 teaches determining the shunt tube system operating pressures associated with the distal end of the production zone, but also more generally, determining the operating pressures along the entire production zone. With this knowledge of the system operating pressures, Petitioner argues that one of skill in the art would have selected eccentric screens for the distal end of the production zone “at any point at which the slurry pressure dropped below the pressure capacity of the eccentric screen shunt tubes.” Pet. 66 (citing Ex. 1005, 30:16–20; Ex. 1003 ¶ 388). In other words, knowing that the pressure decreases as you approach the toe, Yeh’s low-pressure rated eccentric screens could be used from some point prior to and covering the toe. determined pressure.” PO Resp. 37–38. We disagree. As discussed above, the record supports Petitioner’s position that one of skill in the art would have “understood the need to determine the shunt tube system operating pressure throughout the horizontal wellbore.” Ex. 1003 ¶ 383; see also Pet. 64–65. We find convincing Petitioner’s argument that one of skill with this understanding of the system pressures would select a shunt tube system rated to not only address the distal end, but also to address the needs of the adjacent region, so long as the pressure rating supported such a selection. See Pet. 65–67; Ex. 1003 ¶¶ 385–388.” slip op. at 22
Patent outcomesUS 11,333,007 mixedClaim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 11,333,007 - Tesla, Inc. v. Iqar Inc.Rehearing deniedPTAB · Nov 6, 2025 · IPR2024-00543 · APJ Sean P O’Hanlon · IPR · Rehearing
The Board denied Tesla’s rehearing request and left claims 8 and 18 not shown unpatentable under §103 over Hongo, Obradovich, Niki, and Newstrom.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Id.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Petitioner’s counsel during the hearing or any of Petitioner’s arguments and evidence. As confirmed by Petitioner’s counsel, Petitioner relies solely on Newstrom’s disclosure of loading its spatial database 20 into solid state memory via a “wireless connection to [a] server” in asserting that the database “may be hosted on a server that is remote from a vehicle.” Pet. 83 (citing Ex. 1012, 8:26–38; Ex. 1003 ¶ 197). Column 8, lines 27–29 is the only disclosure in Newstrom of a “wireless connection.” Although Petitioner argues that Newstrom’s system communicates wirelessly with the geospatial database while the vehicle is being driven (see Dec. 38 (citing Pet. 83); Tr. 19:20–22), Petitioner relies solely on the single instance of “wireless” in Newstrom’s disclosure to satisfy the recitation that the database (which Petitioner maps to Newstrom’s geospatial database 20) is “remote.” In the Decision, we explained that Petitioner’s reliance on Newstrom’s “wireless connection” and its assertion that the geospatial database may be hosted on a remote server were not persuasive to satisfy Petitioner’s burden to prove the unpatentability of claims 8 and 18 by a preponderance of the evidence, especially given Newstrom’s express disclosure that the geospatial database is located on the vehicle. Dec. 40–42. For example, we stated: Petitioner does not explain adequately why Newstrom’s disclosure that, when first initializing the database manager, the geospatial database is loaded into solid state memory by, for example, wirelessly transferring data from a server means that the geospatial database is remote from the vehicle. Similarly, Petitioner does not explain adequately why Newstrom’s disclosure that the database manager can load new portions of the data into solid state memory as the vehicle location changes means that the geospatial database is remote from the vehicle. Nor does Petitioner’s conclusory contention that “the geospatial database 20 may be hosted on a server that is remote from a vehicle” (Pet. 83 (emphasis added)) apprise us of disclosure that Newstrom’s geospatial database is remote from the vehicle. Dr. Morellas’ testimony is substantially identical to the Petition (see Ex. 1003 ¶197) and, thus, also fails to provide adequate support for Petitioner’s assertions. During the hearing, counsel for Petitioner confirmed that it relied solely on Newstrom’s disclose of the database using a “wireless connection” by which the database manager communicates with the database in arguing that Newstrom’s geospatial database 20 is remote from vehicle 12. Tr. 19:14–24; see also Ex. 1012, 8:27–29. Petitioner, however, fails to explain adequately how such wireless communication indicates that the database is not located on vehicle, especially given Newstrom’s express disclosure (discussed above) that the database is onboard the vehicle.” slip op. at 5
- Strike new argumentNew argument disregardedDecided for patent owner
“Initially, Petitioner’s reliance on assertions made in its Reply, relying on Dr. Morellas’ second declaration, fail to persuade us that we overlooked or misapprehended any arguments made in the Petition. Such post-institution arguments attempting to bolster the Petition are untimely and, thus, improper. See Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019).6 Even considering Petitioner’s Reply arguments, however, we are not” slip op. at 7
§ 103 obviousnessPatents in suitUS 10,882,399 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Formycon AG v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00233 · APJ Michael A Valek · IPR · Institution
The Board denied institution under § 314(a) based on the Fintiv factors and denied joinder; it did not reach the merits of the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“B. The Fintiv Factors and Related Guidance The Board’s precedential decision in Fintiv outlines factors that balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here. Fintiv 5–6. These factors are: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. “[I]n evaluating the factors, the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“III. DISCRETION UNDER 35 U.S.C. § 314(A) We begin by addressing Patent Owner’s arguments for discretionary denial. As explained below, we find those arguments persuasive. Thus, we exercise discretion to deny institution of the Petition under 35 U.S.C. § 314(a) without reaching the merits of Petitioner’s asserted grounds of unpatentability.” slip op. at 8
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“35 U.S.C. § 314(a) to deny institution of the Petition and deny the Joinder Motion.” slip op. at 2
Discretionary denialPatents in suitUS 11,084,865 - Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00176 · APJ Michael A Valek · IPR · Institution
The Board denied institution of IPR on all challenged claims under § 314(a), finding the Fintiv factors—particularly investment, overlap, and merits—weighed against review.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“raised by this overlap, but given the circumstances, it does not effectively mitigate them. First, the disputed issues for Petitioner’s ODP defense are the same or substantially similar to those for the obviousness grounds in the Petition, but the Sotera stipulation does not prevent Petitioner from litigating those issues before both the district court (as part of its ODP defense) and here in the event an IPR is instituted.19 Second, the MDL proceeding 19 ODP or nonstatutory double patenting is, as the name implies, not premised on any statute. See, e.g., Ostuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (“Nonstatutory double patenting is a judicially created doctrine grounded in public policy.”). Accordingly, it is not a ground Petitioner reasonably could have raised in this IPR. See 35 U.S.C. § 311(b) (inter partes review may be requested “only on a ground that could be raised under section 102 or 103”). includes other biosimilar applicant defendants who are similarly motivated to try to invalidate the ’865 patent claims, but who are not subject to any Sotera stipulation. Even if we institute review on Petitioner’s grounds here, those other defendants remain free to litigate the same grounds in the consolidated MDL proceeding. For these reasons and given the particular circumstances of this case, Petitioner’s Sotera stipulation does not sufficiently mitigate the risks of duplicated efforts or inconsistent decisions by making this IPR a “true alternative” to resolution of these issues by the district court. See Motorola Solutions, Inc. v. Stellar, LLC, IPR2024-01205, Paper 19, 3–4 (PTAB Mar. 28, 2005) (determining on Director Review that a Sotera stipulation did not ensure IPR would be a “true alternative” because Petitioner’s invalidity arguments “include combinations of the prior art asserted in these proceedings with unpublished system prior art, which Petitioner’s stipulation is not likely to moot” and thus the same or similar issues would remain in the parallel proceeding); SAP America, Inc. v. Cyandia, Inc., IPR2024-01496, Paper 13, 8–9 (PTAB Apr. 7, 2025) (similar).” slip op. at 19
Discretionary denialPatents in suitUS 11,084,865
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.