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  • PTAB · Aug 18, 2026 · IPR2025-00339 · APJ Kristen L Droesch · IPR · Final written decision

    Claims 22, 23, 28, and 30 are unpatentable over Choi, Labaziewicz, and Yu; claims 1–3, 10–12, 24, 25, 32, and 33 were not shown unpatentable.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

      “We decline Patent Owner’s invitation to construe “during a frame” of “independently controlling simultaneous data acquisition with each of the first and second channels during a frame” by importing the extraneous limitations “at some point between the beginning and the end of the exposure interval during which the image sensors capture a single image.” As pointed out by Petitioner, Patent Owner’s proposed construction is unsupported by the language of claim 22 and the ’180 Specification because Specification does not disclose an exposure interval nor suggest “during a frame” is limited to an exposure interval. Patent Owner and its expert Dr. Saber cite only extrinsic evidence (Exs. 2006, 2009) to support its argument that claim 22 should be limited to an “exposure interval during which the image sensors capture a single image.” See PO Resp. 16–17; Ex. 2020 ¶ 64. Similarly, Patent Owner relies only on extrinsic evidence (e.g., Ex. 2011, 1; Ex. 2022, 1; Ex. 2020 ¶ 66) to limit “during” to “at some point between the beginning and the end.” See id. at 18. When considered in the context of claim 22 and the ’180 Patent Specification which do not limit “during a frame” to an exposure interval, we find that we cannot rely on Patent Owner’s citations to extrinsic evidence to yield a reliable construction for “during a frame.” As demonstrated in the analysis below, we need not provide an explicit construction for “during a frame” to resolve the parties’ disputes regarding the merits of the patentability challenges. See Realtime, 912 F.3d at 1375. We apply the ordinary and customary meaning for “during a frame.” To the extent that an explicit identification of the ordinary and customary meaning may aid the understanding of our analysis, consistent with the language of claim 22 and the ’180 Patent Specification, we find that the ordinary and customary meaning for “during a frame” is “during the period of time that data for an image frame is acquired.” See Ex. 1001, code (57), 20:6–24, 25:23–35.” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and 2-3 years of experience in digital imaging systems,” and that “[l]ess experience may be necessary with additional education, and likewise, less education may be necessary with additional work experience.” Pet. 6 (citing Ex. 1003 ¶¶ 16–19). Patent Owner does not dispute Petitioner’s definition. See generally PO Resp. We adopt Petitioner’s definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’180 Patent Specification and the prior art of record.” slip op. at 20

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “Owner to show that Labaziewicz is not prior art because the ’180 Patent is entitled to the earliest August 25, 2004, filing date of the ’854 Provisional Application. See Dynamic Drinkware, 800 F.3d at 1379–1380. For a claim in a later-filed application to be entitled to the filing date of an earlier application, the earlier application must provide written description support for the claimed subject matter. Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1337 (Fed. Cir. 2010). To satisfy the written description requirement, “a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also VasCath v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (“[T]he applicant must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . . . now claimed.” (emphasis omitted)), Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (“[I]t is the specification itself that must demonstrate possession.”). Patent Owner’s arguments fail to meet this burden of production because, aside from addressing deficiencies of written description support the ’854 Provisional Application provides written description support for all of the limitations of the claimed invention. See PO Resp. 60–64; PO Sur-reply 25–28. Specifically, Patent Owner does not address written description support in the ’854 Provisional Application for “independently controlling simultaneous data acquisition with each of the first and second channels during a frame”––limitation [22.3]––the heart of the parties’ claim construction disputes addressed above in Section II.A. See PO Resp. 60–64; PO Sur-reply 25–27. Accordingly, Patent Owner has not met its burden of production in coming forward with evidence or argument to show possession of the claimed invention in the ’854 Provisional Application. As a result, the burden of production does not shift back to Petitioner, and, therefore, the ’180 Patent is not entitled to the benefit of the August 25, 2004, filing date of the ’854 Provisional Application.” slip op. at 23

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

      “Petitioner does not present arguments that it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the teachings of Matsushima to acquire data for images 62A and 62B at the argues that Matsushima renders obvious this limitation. See id. at 21, 23, 30; PO Resp. 33–34 (“[T]he Petition provides no further explanation why Matsushima renders this limitation obvious.”). In the Reply for the first time, Petitioner asserts that “a POSITA would understand that Matsushima’s disclosure, including its multi-channel architecture, synchronous control of channels, and capturing two images that are scaled versions of the same scene, renders obvious simultaneous acquisition during a frame. Pet. Reply 13 (citing Ex. 1069 ¶ 49). We do not consider Petitioner’s belated argument because it exceeds the proper scope of a reply. A reply may only respond to arguments raised in the corresponding patent owner response. See 37 C.F.R. § 42.23. As explained in the Trial Practice Guide, “respond” “does not mean proceed in a new direction with a new approach as compared to the positions taken in a prior filing.” Trial Practice Guide at II.I. (December 2025)(citing 37 C.F.R. § 42.23).10 A reply that raises a new issue or belatedly presents evidence may not be considered. See id. For example, a “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Id.” slip op. at 32

    Patent outcomesUS 7,916,180 mixed
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 7,916,180
  • PTAB · Jul 21, 2026 · IPR2025-00339 · APJ Kristen L Droesch · IPR · Final written decision

    Claims 22, 23, 28, 30, and 33 are unpatentable over Choi, Labaziewicz, and Yu under § 103; claims 1–3, 10–12, 24, 25, and 32 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art “would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and 2-3 years of experience in digital imaging systems,” and that “[l]ess experience may be necessary with additional education, and likewise, less education may be necessary with additional work experience.” Pet. 6 (citing Ex. 1003 ¶¶ 16–19). Patent Owner does not dispute Petitioner’s definition. See generally PO Resp. We adopt Petitioner’s definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’180 Patent Specification and the prior art of record.” slip op. at 20

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “Owner to show that Labaziewicz is not prior art because the ’180 Patent is entitled to the earliest August 25, 2004, filing date of the ’854 Provisional Application. See Dynamic Drinkware, 800 F.3d at 1379–1380. For a claim in a later-filed application to be entitled to the filing date of an earlier application, the earlier application must provide written description support for the claimed subject matter. Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1337 (Fed. Cir. 2010). To satisfy the written description requirement, “a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also VasCath v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (“[T]he applicant must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . . . now claimed.” (emphasis omitted)), Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (“[I]t is the specification itself that must demonstrate possession.”).” slip op. at 23

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

      “We do not agree with Petitioner’s arguments based on retrieval of data from CCD 18A and CCD 18B. Although Matsushima’s CCD drive circuits 20A and 20B are driven synchronously by timing generator 28 (see Ex. 1007 ¶ 27), Matsushima discloses that “accumulated signal charges are retrieved by CCD drive pulses applied by CCD drive circuits 20A and 20B, and are sequentially output from CCD 18A and CCD 18B as voltage signals (analog image signals) corresponding to each signal charge” (see Ex. 1007 ¶ 23) (emphasis added). In other words, regardless of whether CCD drive circuits 20A and 20B are driven synchronously by timing generator 28, Matsushima discloses that voltage signals corresponding to the accumulated 8 Petitioner’s citation erroneously includes ¶¶ 34–36 of Exhibit 1069. CCD 18A and CCD 18B sequentially––not output at the same time or simultaneously.” slip op. at 30

    • Strike new argumentNew argument disregardedDecided for patent owner

      “argues that Matsushima renders obvious this limitation. See id. at 21, 23, 30; PO Resp. 33–34 (“[T]he Petition provides no further explanation why Matsushima renders this limitation obvious.”). In the Reply for the first time, Petitioner asserts that “a POSITA would understand that Matsushima’s disclosure, including its multi-channel architecture, synchronous control of channels, and capturing two images that are scaled versions of the same scene, renders obvious simultaneous acquisition during a frame. Pet. Reply 13 (citing Ex. 1069 ¶ 49). We do not consider Petitioner’s belated argument because it exceeds the proper scope of a reply. A reply may only respond to arguments raised in the corresponding patent owner response. See 37 C.F.R. § 42.23. As explained in the Trial Practice Guide, “respond” “does not mean proceed in a new direction with a new approach as compared to the positions taken in a prior filing.” Trial Practice Guide at II.I. (December 2025)(citing 37 C.F.R. § 42.23).9 A reply that raises a new issue or belatedly presents evidence may not be considered. See id. For example, a “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Id. Petitioner clarifies that the Petition does not argue inherency. See Pet.” slip op. at 33

    Patent outcomesUS 7,916,180 mixed
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 7,916,180
  • PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

    The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

      “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

      “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

    Patent outcomesUS 10,993,942 mixed
    Claim construction§ 112 disclosure
    Patents in suitUS 10,993,942
  • PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

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

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

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

    • ExcludeMotion to exclude, deniedDenied

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

    • Skill levelSkill level board ownOther

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

    • Expert testimonyPetitioner expert discountedDecided for patent owner

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

    Patent outcomesUS 10,766,685 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,766,685
  • PTAB · 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

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.