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  • PTAB · Jan 30, 2026 · IPR2021-01449 · APJ Jon M Jurgovan · IPR · Remand

    Claims 3–5 are unpatentable; claims 1 and 2 are not shown unpatentable. Claims 3 and 4 are obvious over the applied grounds under the remand construction of “movement vector.”

    RulingsRemand decision
    • RemandOther

      “was incorrect, vacated the Final Written Decision as to claims 3 and 4, and remanded the case to the Board to determine the ordinary and customary meaning of “movement vector” and decide the outcome for claims 3 and 4 in accordance with that meaning. Atos, LLC v. Allstate Insurance Company, 2025 WL 1482404, at *5 (Fed. Cir. May 23, 2025); Paper 35 (“Federal Circuit Remand,” “Remand,” or “Fed. Cir. Remand”). Pursuant to the Federal Circuit’s instructions, the Board authorized the” slip op. at 3

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “considered individually and together, have well-understood, common meanings to ordinarily skilled artisans as of the invention date, reflected by the ’174 patent’s specification and other evidence of record noted above. Accordingly, we determine that the ordinary and customary meaning of “movement vector” is “a vector indicating movement of an object.” 3) “operation indicator” Petitioner” slip op. at 20

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “Dr. Kanellakopoulos’s explanation that angular momentum is not inherent to an object, and its computation requires an arbitrary choice of a point of origin that has no physical meaning in the context of vehicle motion, also supports Patent Owner’s position. Id. ¶ 71 (citing Ex. 2004, 262). Accordingly, Patent Owner’s argument, that angular momentum cannot be used to detect a vehicle turning, is persuasive. Id. We also find persuasive, as Dr. Kanellakopoulos explains, that Petitioner’s argument regarding the figure on Kleppner 234 is based on misinterpretation of the vectors in that figure. Id. ¶ 67 (explaining that Kleppner 233–234 does not depict a gravity vector).” slip op. at 35

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “Kleppner does not disclose a rotation vector, a person of ordinary skill would have used the knowledge of a rotation vector (because it is a term of art) alongside Kleppner’s teaching, to arrive at claim 1. See Pet. Reply 11. This argument does not satisfy Petitioner’s burden to provide articulated reasoning with some rational underpinning to support the conclusion of obviousness. See KSR, 550 U.S. at 419 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Petitioner does not explain which teaching of Kleppner a person of ordinary skill would have selected and combined with their knowledge of a rotation vector to yield the method of claim 1, or explain why a person of ordinary skill would have recognized based on Kleppner that estimating the angle between a rotation vector and gravity vector could be used to detect a vehicle turning. Nor does Petitioner respond to Patent Owner’s assertion that Kleppner provides no rationale for estimating an angle of alignment between a rotation vector and gravity vector as a way of detecting a vehicle turning. See Ex. 2001 ¶ 65.” slip op. at 35

    Patent outcomesUS 9,846,174 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,846,174
  • PTAB · Jul 10, 2023 · IPR2022-00605 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–6, 8–10, and 12–17 are unpatentable over Gravesen and Brister; claims 7, 11, and 18–28 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The person of ordinary skill in the art as of the earliest possible effective filing date (“POSITA”) would have had a Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, or a related subject, and one or more years of experience researching, developing and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a Master’s Degree, and vice versa. Pet. 14–15 (citing Ex. 1003 (Fletcher Decl.) ¶ 22). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 11 n.1. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 8

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

      “Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “On the full trial record, we again find that Patent Owner’s proposed narrowing is unwarranted. First, the intrinsic record does not support Patent Owner’s required “central” axis. Patent Owner argues that the Specification describes two inserter embodiments as having “rotors,” and those rotors have a central axis. PO Resp. 17–18 (citing Ex. 1001, 29:25–28, 29:55–59, Figs. 32, 45). Patent Owner, however, fails to explain why those embodiments should be understood to limit the claims. For example, in Phillips, the Federal Circuit “expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323; see also SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“[A] particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Although the Petition does state that a person of ordinary skill in the art “would understand the plain and ordinary meaning of a ‘recess’ to include ‘an indentation in a line or surface (as an alcove in a room),’” the Petition does not specify what else is “include[d]” in this term, nor does it specify that the plain and ordinary meaning of “recess” includes the entire interior of a housing. The Petition also does not invoke the Specification as demonstrating that the plain and ordinary meaning of “recess” includes the entire housing.13 Pet. 64 (emphasis added). Petitioner’s belated proposal also conflicts with the language of the claims themselves. Independent claim 1 recites “a rotor disposed within the inserter housing.” Ex. 1001, 43:42. Dependent claim 7 narrows claim 1 by reciting that “the housing comprises a recess in which the rotor is received.” Id. at 44:11–12. If the interior of the inserter housing and the recess could be one and the same as Petitioner proposes, there would be no need for claim 7, because it would not further limit claim 1. See 35 U.S.C. § 112(d) (“a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed”); see also Nazomi Commc’ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1370 (Fed. Cir. 2005) (“The concept of claim differentiation ‘normally means that limitations stated in dependent claims are not to be read into the independent claim from which they depend.’”) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed. Cir. 1999)). Accordingly, we decline Petitioner’s belated request to construe “recess” to include “an entire cavity of a housing or a cylinder.” 13 We acknowledge that Petitioner argued that the entire interior of Gravesen’s housing maps to the claimed “recess,” but this was in the context of comparing the prior art to the claim as construed. Indeed, Petitioner asserted that “the space within [Gravesen’s] housing is an alcove.” Pet. 64– 65 (emphasis added). In sum, Petitioner did not timely argue that the plain and ordinary meaning of the term “recess” includes an entire cavity of a housing or a cylinder. We adopt the only construction Petitioner offered and supported in the Petition. In view of the above, we construe “recess” as meaning “an indentation in a line or surface (as an alcove in a room).”” slip op. at 16

    Patent outcomesUS 10,945,649 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,945,649
  • PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

    The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.

    RulingsFinal written decision
    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

      “VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77

    • ExcludeMotion to exclude, deniedDenied

      “A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29

    • Skill levelSkill level board ownOther

      “Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25

    Patent outcomesUS 10,766,685 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,766,685
  • PTAB · 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 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · 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 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · 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 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,875,007
  • PTAB · May 18, 2023 · IPR2022-00042 · 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 Fab binding was not predictable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “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. C.” slip op. at 12

    • 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 [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. Having considered the parties’ positions and evidence of record, we determine that the express construction of any other claim term is unnecessary to resolve the disputed issues in this matter. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 14

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation 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 [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 38

    Patent outcomesUS 10,875,007 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,875,007
  • PTAB · Apr 24, 2023 · IPR2022-00193 · APJ John G New · IPR · Final written decision

    Claims 1–8, 10–18, and 20 are unpatentable as obvious over Spenser and Spenser II; claims 9 and 19 were not shown unpatentable.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

      “Spenser II provides that its cloth “has a thickness ranging from about 1 to 5 mm.” Spenser and Levi both teach a valve that has a diameter of 25 mm and 26 mm respectively when fully expanded. Accordingly, even if we were to assume a POSITA used the thinnest possible cloth in Spenser II, Petitioner’s proposed combination using the smaller Spenser 25 mm diameter (12.5 mm radius) expanded valve covered by a 1 mm cloth resulting in a 27 mm diameter (13.5 mm radius) valve…. From this we can conservatively estimate how much cloth is required for a cross-section of the proposed device (Acloth) by calculating the total area of a cross-section of the cloth-covered valve (π*(13.5 mm)2) and subtracting the area of a cross-section of just the valve (π*(12.5 mm)2). Acloth = π*(13.5 mm)2 - π*(12.5 mm)2 = 81.68 mm2 Accordingly, Petitioner’s proposed combination requires 81.68 mm2 of outer cloth in a given cross-section of the device.” slip op. at 78

    • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia no nexusDecided for petitioner

      “that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16

    Patent outcomesUS 10,881,538 mixed
    § 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,881,538
  • PTAB · Mar 10, 2023 · IPR2021-01446 · APJ Alyssa A Finamore · IPR · Final written decision

    Claims 1–4, 6, 10, 12–14, 16, 17, and 19–21 are unpatentable under §103; claim 15 was not shown unpatentable.

    RulingsFinal written decision
    • ExcludeMotion to exclude, grantedGranted

      “Our rules and Consolidated Trial Practice Guide are clear on this prohibition. And, the Consolidated Trial Practice Guide explains: “[w]here a party believes it has a basis to request relief on a ground not identified in the rules, the party should contact the Board and arrange for a conference call with the Board and opposing party to discuss the requested relief with the judge handling the proceeding.” CTPG 75. Thus, the Board identifies appropriate ways for a party to address matters that it considers to be beyond the specific procedures outlined in the rules. Merely submitting new evidence was not authorized by Board rules or guidance and Patent Owner did not seek authorization to file the new evidence. The facts warrant excluding Exhibits 2030–2032 and we grant the Motion. See CTPG 81.” slip op. at 83

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

      “underpinnings, why a person of ordinary skill would have been motivated to modify the prior art to achieve the claimed invention. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner . . . must . . . articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” (citing KSR, 550 U.S. at 418)). Nonetheless, “a disclosure that anticipates under § 102 also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (CCPA 1982)); see also Application of Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]his court has sanctioned the practice of nominally basing rejections on § 103 when, in fact, the actual ground of rejection is that the claims are anticipated by the prior art. The justification for this sanction is that a lack of novelty in the claimed subject matter, e.g., as evidenced by a complete disclosure of the invention in the prior art, is the ‘ultimate or epitome of obviousness.’” (citations and footnote omitted)).” slip op. at 14

    Patent outcomesUS 9,047,170 mixed
    § 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,047,170
  • PTAB · Jan 24, 2023 · IPR2021-01209 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–4, 6, and 9–25 are unpatentable; claims 5, 7, and 8 are not shown unpatentable, based on anticipation by Kim and obviousness grounds.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

      “C. Claim Construction In inter partes reviews, we interpret claims under the same standard” slip op. at 10

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “Accordingly, Petitioner fails to establish that Kim discloses “determining that the individual is a driver of the vehicle based at least in part on acceleration, forces, velocity, the at least one location point, and time.”” slip op. at 46

    • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

      “nexus and therefore fails to establish that any alleged evidence of objective indicia supports a finding of non-obviousness. Accordingly, we give Patent Owner’s reliance on objective indicia of non-obviousness no weight in our obviousness analysis.” slip op. at 65

    Patent outcomesUS 9,152,609 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,152,609
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