• 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
• Netflix, Inc. / Hulu, LLC v. Divx, LLCSome claims unpatentable
  PTAB · Sep 27, 2021 · IPR2020-00648 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 16, 17, and 19 are unpatentable over Pyle and Marusi; claims 1–6, 8–10, 13, and 14 were not shown unpatentable under the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we found that Petitioner’s proposal was consistent with the level of ordinary skill in the art reflected by the prior art of record and we preliminarily adopted Petitioner’s unopposed position. Inst. Dec. 8–9 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)). As neither party challenges our preliminary finding regarding the level of ordinary skill in the art, we see no reason to disturb that finding. Accordingly, we maintain and reaffirm that one of ordinary skill in the art at the time of the invention would have had “a bachelor’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with at least two years of experience in adaptive streaming and content management” or “a master’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with a specialization in adaptive streaming or content management” and that “[a] person with less education but more relevant practical experience may also meet this standard.” See Inst. Dec. 8–9 (setting forth and adopting Petitioner’s unopposed position as to the level of ordinary skill in the art) (alteration in original).” slip op. at 10

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

    “the case law makes clear that “an indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of ‘one or more’ in open-ended claims containing the transitional phrase ‘comprising’” unless an “extremely limited” exception applies. See Convolve, Inc. v. Compaq Computer Corp., 812 F.3d 1313, 1321 (Fed. Cir. 2016) (quoting KCJ Corp., 223 F.3d at 1356; Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008)). Here, claim 1 recites the transitional phrase “comprising,” meaning it is open-ended, and, therefore, the usual meaning of “a” as “one or more” would have been expected absent an extremely limited exception. In considering whether an exception applies, our review of the ’515 patent fails to indicate that the patentee intended the phrase to mean anything other than the usual meaning of “one or more.” Patent Owner asserts that “[t]he plain language of the claim clearly indicates only a single [list] is used to list multiple assets” and quotes two portions of the Specification, which state “a list of assets that satisfies criteria” and “a list of assets to which a . . . device is granted access.” PO Sur-reply 12–13 (quoting Ex. 1001, 12:60–67) (citing Ex. 1001, 2:23–34, 3:1–5, 4:21–23, 17:59–66). Although claim 1 of the ’515 patent recites “assets” in the plural, we fail to see how that conveys that the term “a” would have been understood as limited to “one.” Notably, neither party has identified any inconsistency, in the claims or other portions of the Specification (including the portions quoted and/or cited by Patent Owner), resulting from construing “a” as “one or more.” And, we find that there is no reason why the claims could not be met under the construction of “a” as “one or more.” Thus, we find that the ’515 patent does not “evince [ ] a clear intent to limit a or an to one.” See Convolve, 812 F.3d at 1321 (internal quotations omitted). Accordingly, we construe the term “a” in “a list of assets” as “one or more” such that the phrase “a list of assets” means “one or more list of assets.” Considering next the phrase “the list of assets” recited in limitation 1[e], the parties do not dispute that the use of the term “the” means that “the list of assets” refers back to the one or more list of assets retrieved in limitation 1[d] and discussed above. See PO Resp. 1–2; see generally Pet. Reply; PO Sur-reply 5. Similarly, the parties do not dispute that the phrase “the filtered list of assets,” recited in limitation 1[e], refers back to the list of assets resulting from the filtering step of limitation 1[d]. See PO Resp. 3–4; see generally Pet. Reply; PO Sur-reply 5. We agree with the parties that each of these phrases refers back to the previous instance of the recited terms.” slip op. at 15

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

    “motivated to combine these teachings for several reasons. Pet. 21. First, Petitioner contends “the combination is the use of a known technique to improve similar devices because using the capabilities of a client device to choose appropriately formatted content was a well-known technique.” Id. Petitioner asserts that “implementing Marusi’s techniques for organizing multiple representations and choosing among them based upon a client device’s capabilities would predictably function in Pyle’s system, which similarly seeks to target video content based on particular client device types and parameters.” Id. (citing Ex. 1004, 10:57–11:10; Ex. 1003 ¶ 147). Second, Petitioner argues that “detecting a client device’s capabilities based upon client device identifiers was a common and known solution to the problem of supplying information in a format usable by the client device.” Pet. 21. Petitioner contends that one of ordinary skill in the art “would have found it obvious to combine Marusi’s teachings with Pyle because it is one solution, from a finite number of known, and predictable solutions.” Id. (citing Ex. 1003 ¶ 148). Third, with respect to Marusi’s databases, Petitioner contends “[t]he combination of Marusi’s databases to manage the data in Pyle’s system uses a known technique to improve similar systems.” Pet. 21. In particular, Petitioner asserts that one of ordinary skill “would have been motivated to combine Marusi’s database teachings with Pyle because Pyle teaches storing the same content in multiple, different representations.” Id. at 21–22 (citing Ex. 1004, 9:64–10:21). Further, Petitioner argues that “[u]sing a database to store and manage multiple representations of the same data, or even to simply store voluminous data for retrieval, was an extremely well-known and common application of databases.” Id. at 22 (citing Ex. 1003 ¶ 149). Additionally, Dr. Reader opines that one of ordinary skill in the art “would have understood that the teachings of Pyle and Marusi were complementary, and therefore would have been motivated to combine Pyle with Marusi to enhance the efficiency of generating, storing, and delivering multimedia content tailored to the capabilities of particular playback devices.” Ex. 1003 ¶ 150.” slip op. at 27

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

    “Patent Owner that Petitioner and Dr. Reader fail to explain why one of ordinary skill in the art would have understood that Pyle generates a top level index file by placing a manifest file in memory for transmission to a client device. Pet. 35; see Ex. 1003 ¶ 184. “Opinions expressed without disclosing the underlying facts or data may be given little or no weight.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“Consolidated TPG”), 40–41, available at https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (citing Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997)). Here, there is no explanation or reason given for Petitioner’s assertion or Dr. Reader’s testimony and the connection, if any, is not otherwise apparent. Further, aside from Dr. Reader’s unexplained position, Petitioner has not pointed us to any evidence of record supporting the argument that one of ordinary skill in the art would have understood that placement of a file in memory for transmission teaches generating the file as recited in limitation 1[f]. Accordingly, without any explanation whatsoever, the record is without a sufficiently supported basis upon which to make that finding, resulting in a failure of proof by Petitioner with respect to claim 1.11 10 We also note that Petitioner’s Reply does not seek to add a new argument for our consideration; rather, Petitioner’s Reply asserts, albeit incorrectly, that the argument was raised in the Petition. See Pet. Reply 15. 11 Although Petitioner’s Reply sets forth several arguments in response to other arguments raised in Patent Owner’s Response, those additional arguments do not address to this aspect of limitation 1[f]. See, e.g., Pet. c. Dependent Claims 4, 5, 8–10, and 14 Petitioner contends that the combination of Pyle and Marusi would have rendered the subject matter of claims 4, 5, 8–10, and 14 obvious to one of ordinary skill in the art. Pet. 36–41. Claims 4, 5, 8–10, and 14 depend from claim 1 and, therefore, include limitation 1[f], as discussed above. Accordingly, for the same reasons discussed with respect to claim 1, Petitioner’s analysis of these claims suffers from the same deficiency.” slip op. at 34

  Patent outcomesUS 9,998,515 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,998,515
• Intel Corporation v. VLSI Technology LLCSome claims unpatentable
  PTAB · Jan 12, 2021 · IPR2019-01194 · APJ Minn Chung · IPR · Final written decision

  Claims 1 and 2 are unpatentable over Kim and Lee under § 103; Petitioner did not prove claims 4, 5, and 7 unpatentable because the combination was not adequately supported.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed

    “determine that Petitioner has demonstrated sufficiently that the combination of Kim and Lee teaches “a mode indicator generator for generating a mode indicator that indicates a desired mode of the power gated circuit,” as recited in claim 1, and has articulated sufficient reasoning with rational underpinning for combining Kim and Lee to arrive at the subject matter of this claim limitation. c. Conclusion on Claim 1” slip op. at 64

  • Expert testimonyOther

    “F. Testimonial Evidence Petitioner relies on two Declarations from David Harris, Ph.D. in” slip op. at 9

  Patent outcomesUS 8,081,026 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,081,026
• Intel Corporation v. VLSI Technology LLCSome claims unpatentable
  PTAB · Feb 6, 2020 · IPR2018-01144 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 2, 7, and 8 are unpatentable as obvious over Bednar and Gunther; claim 3 was not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “to the level of ordinary skill in the art was incorrect. Accordingly, because our preliminary finding is consistent with the level of ordinary skill in the art reflected by the prior art of record, we maintain and reaffirm that one of ordinary skill in the art at the time of the invention would have had “at least (1) an undergraduate degree in electrical engineering (or an equivalent subject), together with three years of post-graduate experience designing power management circuits; or (2) a master’s degree in electrical engineering (or equivalent subject) together with two years of post-graduate experience designing power management circuits.” Inst. Dec. 8; see Pet. 29 (citing Ex. 1102 ¶¶ 26–27).” slip op. at 10

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

    “construction is erroneous. Accordingly, because the ’922 patent defines “power island,” we maintain and reaffirm that “power island” means a “group of components with similar power requirements.”” slip op. at 12

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

    “not to expressly construe “conversion controller” was erroneous or that an express construction is required to resolve any dispute between the parties. Accordingly, we maintain and reaffirm that because the construction of “conversion controller” does not resolve a controversy in the matter before us, we decline to construe it expressly.” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “construction of “memory device,” specifically whether it encompasses a latch. Neither party argues that “memory device” is expressly defined in the ’922 patent. Accordingly, the plain and ordinary meaning of the term controls. And, the standard under which we construe the term is the broadest reasonable construction in light of the specification.” slip op. at 86

  Patent outcomesUS 8,004,922 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,004,922
• 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
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision

  The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedOther

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, the prior art itself demonstrates the 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 regarding 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)).” slip op. at 10

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Department Of Justice v. Discovery Patents, LLCSome claims unpatentable
  PTAB · Nov 9, 2017 · IPR2016-01041 · APJ Matthew R Clements · IPR · Final written decision

  Claims 11, 12, 14, 16–18, and 20–31 are unpatentable over Monroe ’183; claims 15 and 19 were not shown unpatentable over Monroe ’183.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “A petition for inter partes review may be considered only if, inter alia, “the petition identifies all real parties in interest.” 35 U.S.C. § 312(a)(2). The Office Patent Trial Practice Guide provides guidance regarding factors to consider in determining whether a party is a real party in interest. 77 Fed. Reg. 48,756, 48,759–60 (Aug. 14, 2012). Considerations may include whether a non-party “funds and directs and controls” an IPR petition or proceeding. Id. at 48,760. Additional relevant factors include: the non-party’s relationship with the petitioner; the non-party’s relationship to the petition itself, including the nature and/or degree of involvement in the filing; and the nature of the entity filing the petition. Id. Whether a party who is not a named participant in a given proceeding is a real party in interest to that proceeding “is a highly fact-dependent question.” Id. at 48,759. There is no “bright line test.” Id. Courts invoke the term real party in interest to describe relationships and considerations sufficient to justify applying conventional principles of estoppel and preclusion. Id. A non-party’s participation with a petitioner may be overt or covert, and the evidence may be direct or circumstantial, but the evidence as a whole must show that the non-party possessed effective control over the petitioner relating to the inter partes review. Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., Case IPR2013-00609, slip op. at 10 (PTAB Mar. 20, 2014) (Paper 15). We have considered Patent Owner’s and Petitioner’s arguments and evidence, and we determine that Petitioner was not required to identify the Third Parties as real parties in interest because there is insufficient evidence that any of these companies exercised, or could exercise, control over Petitioner with respect to this proceeding. Patent Owner’s arguments regarding the motion practice before the Court of Federal Claims and notification of that action to the Third Parties does not reflect otherwise. Although we acknowledge that the existence of the above-identified indemnification clauses supports Patent Owner’s argument, we are unaware of any inter partes review decision in which a real party in interest finding was based solely on evidence of an indemnification clause, and we decline to do so here.” slip op. at 7

  • PTAB / AIA Trials › Constitutional / APA (Arthrex, Oil States, due process)Decided for petitioner

    “We decline to consider Patent Owner’s constitutional challenge as, generally, “administrative agencies do not have jurisdiction to decide the constitutionality of congressional enactments.” See Riggin v. Office of Senate Fair Employment Practices, 61 F.3d 1563, 1569 (Fed. Cir. 1995); see also Harjo v. Pro-Football, Inc., 50 USPQ2d 1705, 1710 (TTAB 1999) (“[T]he Board has no authority . . . to declare provisions of the Trademark Act unconstitutional.”); Amanda Blackhorse v. Pro-Football, Inc., 111 USPQ2d 1080 (TTAB 2014), rev’d on other grounds, 284 F. Supp. 2d 96 (D.D.C. 2003); but see Am. Express Co. v. Lunenfeld, Case CBM2014- 00050, slip op. at 9–10 (PTAB May 22, 2015) (Paper 51) (“for the reasons articulated in Patlex [Corp. v. Mossinghoff, 758 F.2d 594 (Fed. Cir. 1985)], we conclude that covered business method patent reviews, like reexamination proceedings, comply with the Seventh Amendment”).” slip op. at 8

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

    “We agree with Petitioner. The ’980 patent states that “the term ‘secured location’ may refer to residences, commercial properties, public venues, such as hospitals and sports arenas, government facilities, military installations and any other location, outside or inside, which is protected by a security alarm system.” Ex. 1003, 3:20–24. This definition is non-limiting and does not exclude a changeable area or region. Based on the record developed during this proceeding, we maintain that the broadest reasonable construction in light of the ’980 patent of “secured location” is “any location, outside or inside, which is protected by a security alarm system.”” slip op. at 10

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

    “We agree with Petitioner. Although the Specification of the ’980 patent gives examples of “response agency,” e.g., Ex. 1003, 1:41–43 (“an emergency response agency (e.g., the police department, the fire department or an emergency medical team)”), Patent Owner does not identify, and we do not find, a definition in the specification limiting “response agency” to 911, police, or fire departments. Patent Owner also does not identify, and we do not find, anything in the entire disclosure of the ’980 patent requiring a “response agency” to be distinct from the “surveillance system infrastructure.” Accordingly, we decline to limit “response agency” to 911, police, or fire departments, or construe it to be distinct from surveillance system infrastructure.” slip op. at 11

  Patent outcomesUS 7,323,980 mixed
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,323,980

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.