• Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentable
  PTAB · 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 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,298,166
• Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentable
  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
• Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentable
  PTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29

  • ExcludeMotion to exclude, deniedDenied

    “As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “For the above reasons, on the full trial record we determine that” slip op. at 26

  Patent outcomesUS 10,682,414 mixed
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,682,414
• Syngenta Crop Protection AG v. FMC CorporationSome claims unpatentable
  PTAB · Aug 31, 2021 · PGR2020-00028 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–3, 9–13, and 21–30 are unpatentable for lack of enablement; claims 9–13 also lack written description. Petitioner did not prove anticipation or obviousness of claims 1–7 and 22–31.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider factors including the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Because Petitioner’s proposed definition is consistent with the prior art of record and the sophistication of the technology demonstrated by the record, we apply it here.5” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Based on the complete record developed at trial, we determine that to resolve the disputes herein, we do not need to expressly construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for disputed terms, and only as necessary to resolve the controversy).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We find that Dr. Dayan’s testimony on these points lacks sufficient supporting analysis. In opining that the tested substituents are representative of the steric and electrostatic properties across the claimed substituents, Dr. Dayan merely compares the properties of the tested substituents to each other. See, e.g., id. ¶¶ 52–56. He does not expressly compare them to the properties of the many remaining, untested substituents within the scope of the claims. See id.; see also Reply 14 (“At best, [Dr.] Dayan testified that the positive activity . . . at each substituent” suggests that the position is involved in herbicidal activity, “not that the tested compounds were sufficient to provide any reasonable expectation of success as to the billions of structurally diverse compounds covered” by the claims.). And although Dr. Dayan acknowledges that several tested compounds showed no herbicidal activity, he does not expressly explain how he took these compounds into account in nevertheless concluding that an ordinarily skilled artisan would expect at least some activity across all claimed substituents. See, e.g., Ex. 2011 ¶¶ 54–56 (noting exceptions to herbicidal activity). As one example, Dr. Dayan acknowledges the lack of activity shown in the data for substituents larger than hydrogen at the R6 position, but does not explain the impact of that data on the remaining claimed substituents. See id. ¶ 54 (Dr. Dayan noting that activity is “not as favored by larger alkyl groups” at R6, but nevertheless concluding that “one would expect at least some herbicidal activity” across all claimed R6 substituents). In contrast, Dr. Hunt compares the size and properties of the R6 substituents that showed no activity with the size and properties of other claimed but untested R6 substituents. Ex. 1003 ¶¶ 163, 166–68; Ex. 1029 ¶¶ 37, 38. This comparison indicates that the majority of R6 substituents are larger than the tested substituents, such that the vast majority of the claimed compounds (i.e., those with compounds having R6 substituents larger than those tested), could have no herbicidal activity. Ex. 1003 ¶ 167; Ex. 1029 ¶¶ 12, 37, 38. Thus, we find that the data in the Specification regarding at least position R6 gives a person of ordinary skill in the art reason to doubt that substantially all compounds within the full scope of claim 1 of the ’202 patent would exhibit herbicidal activity. Ex. 1003 ¶ 163; Ex. 1029 ¶¶ 11, 12, 38; In re Surrey, 370 F.2d 349, 355 (CCPA 1966) (“[W]here the applicant seeks to obtain a monopoly in exchange for his disclosure of a group of compounds there should be a disclosure which gives a reasonable assurance that all, or substantially all of them are useful.”).” slip op. at 29

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “We find that the need for iterative QSAR modeling, together with the sheer number of candidate compositions that must be synthesized (each of which would take at least a week to make) for both the modeling and herbicide testing, weighs against enablement, especially in light of the limited guidance in the Specification and the general unpredictability in the art. 3. Conclusion In sum, it is undisputed that claim 1 covers at least a billion compounds. The art is unpredictable, and the Specification indicates that not all of the compounds falling within claim 1 are effective herbicides. See, e.g., Pet. 22 (listing compounds that showed no herbicidal activity). Although the level of ordinary skill in the art is relatively high and the field is mature, Petitioner establishes by a preponderance of the evidence that the ’202 patent does not provide sufficient meaningful guidance or working examples across the full scope of claim 1 to allow a person of ordinary skill in the art to determine which other compounds across the full scope of the claim have herbicidal activity without undue experimentation.” slip op. at 45

  Patent outcomesUS 10,294,202 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 10,294,202
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Final written decision

  Claims 9, 10, and 13 were held unpatentable as obvious; claims 11 and 12 were not shown unpatentable.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 35

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

    “inherency, then the assertions of obviousness are mere conclusory statements. We are unable to recognize any proffered reasoning underlying the assertions of obviousness. “[Challenges] on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As yet another possible alternative, Petitioner may be basing its case on improper hindsight by relying on and quoting the Specification of the ’240 patent in its obviousness analysis. See Pet. 27. That, too, is unpersuasive. Regardless as to its theory of the case, we determine that Petitioner has failed to explain sufficiently why the claimed heat pipe having a configuration of two plates having bonded together circumferential edge lips would have been obvious. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 12 is unpatentable over Morikawa alone.” slip op. at 55

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 82

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00144 · APJ Linda E Horner · IPR · Final written decision

  Claims 9–12 were not shown unpatentable; claim 13 was shown unpatentable as obvious over Nakamura and Takahashi.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 36

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

    “made using related processes, however, says nothing about why one of ordinary skill in the art would combine them in a manner that renders the claimed subject matter obvious. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (quoting Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”)). Petitioner’s argument that the references are “similar and analogous” is not adequate reasoning, by itself, to support a conclusion of obviousness.” slip op. at 54

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 73

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

  RulingsFinal written decision

  • Expert testimonyOther

    “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

  • ExcludeMotion to exclude, deniedOther

    “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

  • Strike new argumentNew argument disregardedOther

    “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

  Patent outcomesUS 8,846,112 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,846,112

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.