- Asetek Danmark A/S v. Coolit Systems, Inc.Some claims unpatentablePTAB · Oct 12, 2021 · IPR2020-00825 · APJ Scott C Moore · IPR · Final written decision
Claims 1, 2, 4, 5, and 9 are unpatentable over Bezama or Bezama and Chiang; claims 13–15 were not shown unpatentable over Kang or Anderson.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“the 2007 Provisional describes the material of which plate 240 is made, much less indicates that the inventor had possession of an invention including a manifold body (i.e., plate 240) defining a pair of compliant surfaces. See generally Ex. 1005.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Bezama discloses all limitations of claims 1 and 9. See Pet. 23–39; Ex. 1003 ¶¶ 65–86. Patent Owner’s attempt to disqualify Bezama as prior art fails because claims 1 and 9 are not entitled to a priority date earlier than July 27, 2011. See supra § II.E. On this record, and considering all of the evidence and arguments put forth by the parties, we find that Petitioner has shown by a preponderance of the evidence that claims 1 and 9 are unpatentable as anticipated by Bezama. G.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“teach or suggest each limitation recited in claims 2, 4, and 5, and these contentions are supported by testimony from Dr. Tilton. See Pet. 54–66; Ex. 1003 ¶¶ 114–137. Petitioner additionally identifies rationales for why a person of ordinary skill in the art would have had reason to combine the teachings of Bezama and Chiang to arrive at the inventions recited in those claims. See id.” slip op. at 31
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“bifurcated flow limitation of claim 13. Resp. 46–52. In particular, Patent Owner asserts, with support from Dr. Pokharna, that the fluid entering any of Kang’s inlet channels 44 would mix with fluid from adjacent inlet channels, and that the bulk of the fluid from any inlet channel would exit through adjacent outlet channels, rather than traveling to the outer-most outlet channels as Petitioner suggests. Id. at 47–48; Ex. 2038 ¶¶ 105–114. Patent Owner’s argument is persuasive and supported by well-reasoned testimony from Dr. Pokharna. For example, Dr. Pokharna correctly points out that Dr. Tilton has admitted that microchannels have high flow resistance. Ex. 2038 ¶ 112 (citing Ex. 1003 ¶ 158). We agree with Dr. Pokharna that because of this high flow resistance, fluid entering a microchannel through any inlet channel 44 would tend to exit through the path of least resistance (i.e., the nearest outlet channel 47) rather than traveling to each end of the microchannel and exiting through the most distant outlets. See id. ¶ 112. contention that in Kang that the bulk of any fluid entering a microchannel would exit through the closest outlet channel 47. See Reply 17–18. Instead, Petitioner contends that at least some portion of the fluid will reach each end of the microchannel. See id. This argument is not persuasive because claim 13 recites that the flow that enters each channel through the one aperture “bifurcates into two sub flows,” and requires that each of the recited outlet regions receives “one of the two sub flows” or “the other of the two sub flows.” This claim language is not satisfied by an outlet region that receives only a portion of one of the two recited sub flows. Claim 13 requires that each outlet region receive one of the same two sub flows that originally entered the microchannel. See also Ex. 2038 ¶ 108. Petitioner neither proposes a claim construction that would encompass such an embodiment, nor offers any persuasive evidence that a POSITA would read claim 13 to encompass such an embodiment. Accordingly, on this record, we are not persuaded by a preponderance of the evidence that Kang teaches or suggests a flow of heat exchange fluid that is bifurcated into two sub flows within each of the microchannels, wherein each of these two sub flows is received by one of the two outlet regions adjacent to the opposing ends of the microchannels, in the manner required by claim 13.” slip op. at 36
Patent outcomesUS 10,274,266 mixed§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,274,266 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,407,213
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