- Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01452 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8, 9, 13, and 19 are unpatentable; claims 2–5, 11, 12, 17, and 18 were not shown unpatentable over Slater or Slater and Weaver.
RulingsRemand decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, 12, 17, and 18 of the ’716 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 188–196. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 191– 196. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 18
Patent outcomesUS 9,763,716 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,763,716 - Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01450 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8–10, 14, and 17 are unpatentable; claims 2–5, 12, and 13 were not shown unpatentable, based on anticipation by Slater and obviousness over Slater and Weaver.
RulingsRemand decision- RemandMixed
“Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 11 of U.S. Patent No. 8,529,608 B2 (“the ’608 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6, 8–10, 12–14, and 17 (the “Remanded Claims”) are similarly unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. at 14–15. We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written Decision on Remand pursuant to 35 U.S.C. §§ 144, 318 and 37 C.F.R. § 42.73 in an inter partes review involving Stryker Corporation and Wright Medical Technology, Inc. (collectively, “Petitioner”) and OsteoMed LLC (“Patent Owner”). For the reasons discussed below, after considering the entirety of the record in light of the Federal Circuit’s directives in Stryker, we find by a preponderance of the evidence that claims 6, 8–10, 14, and 17 are unpatentable. We also conclude that Petitioner has not demonstrated, by a preponderance of the evidence, that claims 2–5, 12, and 13 are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 12, and 13 of the ’608 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 37–39; Ex. 1002 ¶¶ 161–169. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 162– 163. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 37. Patent Owner raised no separate argument regarding the patentability of claims 6 and 8, instead relying solely on its argument that Slater does not anticipate independent claim 1, on which claims 6 and 8 depend. PO Resp. 46; Reply 4 (“Patent Owner does not challenge the combination of Slater and Weaver for claims 6 and 8.”). We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 6 and 8 and find that Petitioner establishes that the combination of Slater and Weaver discloses all of the limitations of claims 6 and 8, and that one of ordinary skill in the art would have been motivated to combine Slater and Weaver for the reasons provided by Petitioner. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 37–39.” slip op. at 19
Patent outcomesUS 8,529,608 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,529,608 - Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01451 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8, 9, and 13 were held unpatentable; claims 2–5, 11, and 12 were not shown unpatentable because Slater lacks the claimed central axis.
RulingsRemand decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed
“addressing the ’085 patent and by the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, and 12 of the ’776 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 169–74. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 169– 74. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 17
- RemandOther
“Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46, “FWD”) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 10 of U.S. Patent 9,351,776 B2 (“the ’776 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6 and 8, 9 and 11–13 (the “Remanded Claims”) are unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. 14– 15.” slip op. at 2
Patent outcomesUS 9,351,776 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,351,776 - Preomics GmbH / Biognosys AG. v. The Brigham And Women’S Hospital, Inc.Some claims unpatentablePTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23
Patent outcomesUS 11,435,360 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,435,360 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Extractiontek Sales LLC v. Gene Pool Technologies, Inc.Some claims unpatentablePTAB · Oct 23, 2023 · IPR2022-01011 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–7 and 9–11 are unpatentable over the asserted obviousness grounds; claims 8 and 12–20 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On the full trial record, we adopt Petitioner’s proposed level of ordinary skill in the art, with Patent Owner’s additions. The additions are consistent with the evidence of record. For example, we find that adding chemistry and biology degrees is appropriate in view of Dr. Miller’s testimony that college-level chemistry and biology courses typically include training on extractive technologies. Ex. 1017 (Miller Tr.), 38:9–39:18. We also agree with Patent Owner that the educational level of the inventors may be considered (see Env’t Designs, Ltd., 713 F.2d at 696), and on this record, we accept Patent Owner and Dr. Miller’s undisputed representation that “named inventor Jason Wasserman had a bachelor’s degree in Agricultural Science and Sustainable Agriculture, a life sciences degree.” Ex. 2008 (Miller Decl.) ¶ 32; PO Resp. 5. Thus, for the reasons above, we define a person of ordinary skill in the art as someone who would have had (1) a bachelor’s degree in chemistry, biology, mechanical engineering, chemical engineering, petroleum engineering, or an equivalent field of physical science, life science, or engineering; and some academic or industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices; or (2) at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices.” slip op. at 11
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Based on this experience, we determine that Dr. Miller qualifies as a person of ordinary skill in the art because by 1992, he had “at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices,” as required by the level of ordinary skill we adopt herein. He also avers that he gained additional training and engaged in additional extraction work prior to the effective filing date. Id. Additionally, between 2015 and 2020, Dr. Miller “enter[ed] the cannabis extraction and concentration industry, designing, building, and operating [his] own facility,” further qualifying him as a person of ordinary skill in the art. Ex. 2002 (Miller Decl.) ¶ 10; see also Reply 6 (acknowledging Dr. Miller’s post-2015 “experience and expertise in closed loop extraction systems”). Although this work started in 2015 (two years after the effective filing date of 2013), a person of ordinary skill in the art need not have been one of ordinary skill at the time of a patent’s filing date. See U.S. Endoscopy Group, Inc. v. CDX Diagnostics, Inc., IPR2014-00639, Paper 27, at 18 (Sept. 14, 2015) (“A witness must provide testimony about the level of skill in the art as of the critical date; however, the witness need not have acquired that knowledge as of the critical date.”). For the reasons discussed above, we determine that Dr. Miller is qualified in this proceeding to testify from the perspective of a person of ordinary skill in the art.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We find that Patent Owner has the better argument. Patent Owner’s citations demonstrate that “[t]he ’751 patent consistently describes ‘solvent collection line’ as a line, a pipe, hose, or tube used for the transport of gasses or liquids,” and that this usage is consistent with the way both parties’ declarants use the term “line.” PO Resp. 29–30; Ex. 1001, 9:16–10:41, 14:65–15:10, Figs. 1, 2, 5; Ex. 2002 (Miller Decl.), ¶ 60; Ex. 2003 (Chess Depo. Tr.), 100:6–17, 145:20–146:7, 169:18–171:2. In contrast, Petitioner’s argument is undermined by the same passage it cites. Specifically, “what the ’751 Patent explains in the same paragraph Petitioner cites is that the ‘solvent collection line 190 is configured to pass through condensing system 105 between second pump 102 and solvent collection container 15.’” Sur-reply 14–15 (quoting Ex. 1001, 8:60–63) (emphasis Patent Owner’s). “Figure 5 shows that both ‘solvent collection line 190’ and ‘coolant line 109’ are still ‘lines’ as they pass through ‘first condenser column 107.’” Id. at 15 (citing Ex. 1001, Fig. 5, 9:48–58). Figure 1, in contrast, shows that coolant pump 104 is a component that is distinct from coolant line 109. See id. (citing Ex. 1001, Fig. 1, 9:6–25). For the above reasons, we construe “line” to mean “a pipe, hose, or tube.”” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We need not define the exact contours of a “canister interface,” including deciding whether it is “more than a mere connector.” Nor do we need to construe the claim term “support.” It is sufficient to note that a canister interface is not simply the system’s canisters themselves. The plain language of the claims recite that the “canister interface” must be configured to “support” the canisters (thereby distinguishing the canister interface from the canisters themselves). The Specification likewise distinguishes the canister interface and the canisters, indicating that the canister interface “allow[s] canisters to be easily detached and reattached.” Ex. 1001, 11:61– 62. Similarly, Mr. Chess distinguished a “detachable canister interface” from the system’s canisters/containers, characterizing the former as a “fitting of some sort so that you can disconnect or connect the solvent source container to the extraction vessel or canister.” Ex. 2003 (Chess Depo. Tr.), 182:10–16 (emphasis added).” slip op. at 46
Patent outcomesUS 9,144,751 mixedClaim construction§ 103 obviousnesscites KSRPatents in suitUS 9,144,751 - Extractiontek Sales LLC v. Gene Pool Technologies, Inc.Some claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00625 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1 and 7–17 are unpatentable: claims 1, 7, 9–13 under §102 over Britt; claims 8 and 14 under §103 over Britt and Buese; and claims 15–17 under §103 over Hebert and Britt. Claims 2–6 …
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On the full trial record, we adopt Petitioner’s proposed level of ordinary skill in the art, as modified by Patent Owner. Patent Owner’s proposed additions to the educational level are consistent with the evidence of record. For example, we find that adding chemistry degrees is appropriate in view of Dr. Miller’s testimony that “extractive technologies are chemistry,” and that college level chemistry typically includes training on extractive technologies. Ex. 1023 (Miller Tr.), 35:9–22, 38:25–39:18. Similarly, adding biology degrees is appropriate because Dr. Miller testified that in training for a biology degree, one is exposed to college-level chemistry and training in extractive technologies. Id. at 38:9–24. We also agree with Patent Owner that the educational level of the inventors may be considered (see Envtl Designs, Ltd., 713 F.2d at 696), and on this record, we accept Patent Owner and Dr. Miller’s undisputed representation that “named inventor Jason Wasserman had a bachelor’s degree in Agricultural Science and Sustainable Agriculture, a life sciences degree.” Ex. 2007 (Miller Decl.) ¶ 37; PO Resp. 4.” slip op. at 10
- Expert testimonyDecided for patent owner
“ordinary skill in the art based on education because he holds degrees in geology and earth and environmental sciences, which are not specifically recited in the proposed level of ordinary skill in the art. Reply 3. Petitioner characterizes Dr. Miller’s degrees as “advanced degrees in life sciences” (id. at 3), while Patent Owner characterizes them as “at least an ‘equivalent physical science degree’” (Sur-reply 5). On this record, we determine that we need not resolve whether Dr. Miller’s degrees qualify him as a person of ordinary skill in the art, because we find that he is qualified based on his experience. Dr. Miller has “decades (1988 to present) of direct experience in the use of partial and complete extractions of diverse materials in environmental studies.” Ex. 2007 (Miller Decl.) ¶ 8. He has also “studied, used, and developed thousands of extractions to solubilize and remove oils, wastes, metals, and other toxins from soil, water, plants, and animal tissues for analysis.” Id. He avers that “[e]xtractive chemistry was core to [his] business practice in 1988 and remains so to this day,” and that “[b]y 1992 [he] would have developed ordinary skill in the art having 4 years of experience relevant to the current subject.” Id. ¶ 10. Based on this experience, we determine that Dr. Miller qualifies as a person of ordinary skill in the art because by 1992, he had “at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices,” as required by the level of ordinary skill we adopt herein. He also gained additional training and engaged in additional extraction work prior to the effective filing date. Id.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“of a source material,” and “[w]ithin the canister, the source material is exposed to a solvent to create an extract mixture.” Pet. 18 (citing Ex. 1001, 2:1–3). We adopt this understanding of the term “canister,” because it is supported by the cited portion of the Specification and is undisputed on this record.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Ex. 1001, 22:1–6. We agree with Petitioner this language does not require control over when the extract mixture formed in step 1(c) is communicated to the extract containers in step 1(d). Reply 7. Dr. Miller conceded that “[e]xtraction is going to start instantaneous[ly],” such that at least some portion of an extract mixture is instantaneously created in step 1(c). Ex. 1023 (Miller Tr.), 67:23–68:7, 120:8–13. Thus, “the next step could occur instantaneously.” Reply 9. We see nothing in the claim language requiring any degree of completion of step 1(c), or any waiting period, before step 1(d) begins. Nor do Patent Owner’s briefs point to any particular aspect of these limitations that allegedly demand such an interpretation. See generally PO Resp. 5; Sur-reply 6–9. Dr. Miller asserts that the plain meaning of steps “does not allow for a passive, automatic, and continuous flow of extract mixture from the canister to one or more extract containers” (Ex. 2007 (Miller Decl.) ¶¶ 30–31), but he too fails to identify what in the language of these terms prohibits this. The claims here “do not exclude a continuous process, in which later steps are initiated as soon as at least some product from the previous step forms, while previous steps are still ongoing.” Kaneka Corp. v. Xiamen Kingdomway Group Co., 790 F.3d 1298, 1306 (Fed. Cir. 2015).” slip op. at 17
Patent outcomesUS 9,587,203 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 9,587,203 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00044 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner
“Petitioner contends that based on Patent Owner’s implicit construction in the district court litigation “that the term ‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 15 (citing Ex. 1020 ¶¶ 41, 50, 58, 62, 74, 87).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 37
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Neither claim 1 nor claim 14 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG. Petitioner’s articulated rationale is that there was an expectation that the composition binds antibodies, including monoclonal antibodies, and therefore, would be useful in a process of for isolating antibodies. Petitioner contends that: A POSA would have also reasonably expected such a combination to achieve a process for isolating one or more target compounds using the recited affinity chromatography matrix given the well-known fact that each individual SPA domain, including the C domain, has affinity for antibodies (Ex. 1004, [1]) as well as Abrahmsén’s confirmation that a G29A mutation on SPA “would not interfere with folding [of SPA] or binding to [antibodies]” (Ex. 1005, 5:13-16). (Ex. 1002 ¶131.) Pet. 25; Reply 8 (“‘A POSA would not have been motivated only by Fab-binding ability, as even Dr. Bracewell agreed that ‘a POSA would have understood that it was desirable to purify monoclonal antibodies for therapeutic use in 2006.’(Ex. 1057, 75:17-76:4, 113:23-114:11, 157:24- 158:9; Ex. 1061 ¶29)”). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976); see In re Kemps, 97 F.3d 1427, 1430” slip op. at 44
Patent outcomesUS 10,343,142 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,343,142 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00041 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two Domain C units, or a functional fragments or variants thereof.” Ex. 1001, 7:27–30. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. 7: 44–45. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’142 patent’s express construction of the term, and because Patent Owner agrees with Petitioner’s construction, we apply it here.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 37
- Obviousness (§103) › KSR rationalesUnpatentable
“Here, the teachings of Linhult, Abrahmsén, and Hober suggest mutating the glycine at position 29 for an alanine in any one of the IgG binding domains of E, D, A, B, or C of SPA in order to avoid protein degradation. Ex. 1004, 2; Ex. 1005, 5:4–9. We, therefore, agree with Petitioner that the art expressly suggests that the glycine codon can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). Attaching any one of SPA mutated IgG binding domains E D A B or C to a matrix using “known ligand-construction methods to yield a predictable result[] (e.g., the claimed affinity chromatography matrix)” would have been obvious. Pet. 25 (citing Ex. 1002 ¶ 130). As the Federal Circuit has explained, “[w]here a skilled artisan merely pursues ‘known options’ from ‘a finite number of identified, predictable solutions,’ the resulting invention is obvious under Section 103.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). Accordingly, we agree with Petitioner that the combination of Linhult Abrahmsén, and Hober expressly suggests mutating the glycine codon for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). We also agree that the cited art teaches using these mutant SPA domains in column chromatography for the isolation of antibodies.” slip op. at 36
Patent outcomesUS 10,343,142 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,343,142 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00045 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“support, the ligand capable of binding the one or more target compound(s) and comprising at least two polypeptides.” Ex. 1001, 15:46–49; 17:28–31. Petitioner argues that “‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 19–20 (citing Ex. 1002 ¶¶ 43–45). Petitioner argues that this construction is consistent with Patent Owner’s implicit construction in the Delaware litigation between the parties. Id. Patent Owner does not challenge Petitioner’s claim construction. See generally PO Resp. According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“(c) No Teaching Away We are also not persuaded by Patent Owner’s contention that the art teaches away from the G29A substitution because it interferes with Fab binding. See PO Resp. 39–42; Sur-reply 9; Ex. 2009 at 2; Ex. 2010 at 25; Ex. 2012 at 25–26; Ex. 2029 at 7. None of claims 1, 2, or 20 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG.” slip op. at 44
Patent outcomesUS 10,875,007 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,875,007
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.