- 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 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - L’Oréal USA, Inc. v. University Of MassachusettsRehearing deniedPTAB · Nov 16, 2018 · IPR2018-00779 · APJ David Cotta · IPR · Rehearing
The Board denied rehearing and affirmed denial of institution because Petitioner did not show that the Board abused its discretion in construing the adenosine concentration limitation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Accordingly, Petitioner has not persuaded us that we have misapprehended or overlooked any matters with respect to our decision to deny institution. 37 C.F.R. § 42.71(d). III. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not shown that the Board abused its discretion in denying institution of the challenged claims. See 37 C.F.R. § 42.71(d). ORDER Accordingly, it is ORDERED that Petitioner’s Request for Rehearing is denied.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“related grounds: that claims 1–7, and 9 are anticipated by JP ’1532; that claim 4 is obvious over JP ’153; and that claims 1–7 and 9 would have been obvious over the combination of JP ’153 and DE ’1073. Pet. 6–7. We declined to institute inter partes review. Dec.” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“adenosine may be topically applied to the epidermal layer of the skin, but also that adenosine so applied will penetrate the epidermis to reach the dermal layer. Dec. 9 (citing Ex. 1002, 5:20–23 (“For topical application, the penetration of the adenosine into skin tissue may be enhanced by a variety of methods known to those of ordinary skill in the art.”)). Topical application of adenosine will, therefore, result in adenosine being brought into contact with both the epidermis and the dermis. As also discussed in the Decision, the specification provides examples in which a concentration of adenosine within the range recited in the claims (10-4 M) is applied directly to dermal cells (fibroblasts), suggesting that the inventors considered it desirable for the dermal cells to receive the claimed concentration of adenosine. Id. In this context, the meaning of claim 1 is clear: adenosine is first topically applied to the epidermal layer of the skin and, only after it penetrates this outer skin layer, is a specific concentration (10-4 M to 10-7 M) of the adenosine “applied” to the dermal cells.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for patent owner
“A prosecution history disclaimer must be clear and unambiguous. “[W]hile the prosecution history can inform whether the inventor limited the claim scope in the course of prosecution, it often produces ambiguities created by ongoing negotiations between the inventor and the PTO. Therefore, the doctrine of prosecution disclaimer only applies to unambiguous disavowals.” Grober v. Mako Prods., Inc., 686 F.3d 1335, 1341 (Fed. Cir. 2012) (citing Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1289 (Fed. Cir. 2009)). A “heavy presumption” exists in favor of the ordinary meaning of claim language. Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). To overcome this presumption, the patentee must “clearly set forth” and “clearly redefine” a claim term away from its ordinary meaning. Id. The disavowal must be “unmistakable” and “unambiguous.” Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1322 (Fed. Cir. 2013). This standard is “exacting.” Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012).” slip op. at 7
Claim constructioncites PhillipsPatents in suitUS 6,645,513 - L’Oréal USA, Inc. v. University Of MassachusettsRehearing deniedPTAB · Nov 16, 2018 · IPR2018-00778 · APJ David Cotta · IPR · Rehearing
The Board denied rehearing, leaving institution denied for claims 1–7 and 9 because Petitioner did not show an abuse of discretion in the claim construction underlying the denial.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing the decision should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for patent owner
“A prosecution history disclaimer must be clear and unambiguous. “[W]hile the prosecution history can inform whether the inventor limited the claim scope in the course of prosecution, it often produces ambiguities created by ongoing negotiations between the inventor and the PTO. . . . Therefore, the doctrine of prosecution disclaimer only applies to unambiguous disavowals.” Grober v. Mako Prods., Inc., 686 F.3d 1335, 1341 (Fed. Cir. 2012) (citing Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1289 (Fed. Cir. 2009)). A “heavy presumption” exists in favor of the ordinary meaning of claim language. Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001) (internal quotation marks and citation omitted). To overcome this presumption, the patentee must “clearly set forth” and “clearly redefine” a claim term away from its ordinary meaning. Id. (internal quotation marks and citations omitted). The disavowal must be “unmistakable” and “unambiguous.” Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1322 (Fed. Cir. 2013). This standard is “exacting.” Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“As discussed in the Decision, the Specification discloses not only that adenosine may be topically applied to the epidermal layer of the skin, but also that adenosine so applied will penetrate the epidermis to reach the dermal layer. Dec. 10 (citing Ex. 1001, 5:13–14 (“For topical application, the penetration of the adenosine into skin tissue may be enhanced by a variety of methods known to those of ordinary skill in the art.”)). Topical application of adenosine will, therefore, result in adenosine being brought into contact with both the epidermis and the dermis. As also discussed in the Decision, the specification provides examples in which a concentration of adenosine matching the high end recited in the claims (10-4 M) is applied directly to dermal cells (fibroblasts), suggesting that the inventors considered it desirable for the dermal cells to receive the claimed concentration of adenosine. Id. In this context, the meaning of claim 1 is clear: adenosine is first topically applied to the epidermal layer of the skin and, only after it penetrates this outer skin layer, is a specific concentration (10-4 M to 10-7 M) of the adenosine “applied” to the dermal cells.” slip op. at 6
Claim constructioncites PhillipsPatents in suitUS 6,423,327 - Envirologix Inc. v. Ionian Technologies, Inc.Rehearing deniedPTAB · Oct 11, 2018 · IPR2018-00406 · APJ Ulrike W Jenks · IPR · Rehearing
The Board denied EnviroLogix’s rehearing request, leaving institution denied because Ehses did not show a reasonable likelihood of proving any challenged claim anticipated.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 20 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 49).” slip op. at 3
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableNot shown unpatentable
“anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 20 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 49).” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached
“zero when fluorescence begins to increase and continues during the reaction. Req. Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation reflects the understanding of those of ordinary skill at the relevant time. See Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses Dissertation was sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon any teachings of Ehses Dissertation, particularly Figure 3.4, to support an inherency argument for Ehses anticipation grounds in the Petition. A request for rehearing is not an opportunity for the requestor to present new arguments or evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we overlooked or misapprehended Petitioner’s anticipation arguments in light of the newly cited disclosure of the Ehses Dissertation.” slip op. at 6
§ 102 anticipationPatents in suitUS 9,562,264 - Envirologix Inc. v. Ionian Technologies, Inc.Rehearing deniedPTAB · Oct 11, 2018 · IPR2018-00405 · APJ Christopher G Paulraj · IPR · Rehearing
The Board denied rehearing and maintained its denial of institution, finding no reasonable likelihood that Ehses anticipated any challenged claim.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 4
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“We remain unpersuaded by this argument. As discussed in our Decision, anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 19 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 82). In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“2 Although not established as prior art, the Ehses Dissertation indicates that TO- PRO-1 fluoresces in the presence of double stranded DNA, whereas SYBR Gold detects both double and single-stranded products. See Ex. 1004, 37. zero when fluorescence begins to increase and continues during the reaction. Req. Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation reflects the understanding of those of ordinary skill at the relevant time. See Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses Dissertation was sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon any teachings of Ehses Dissertation, particularly Figure 3.4, to support an inherency argument for Ehses anticipation grounds in the Petition. A request for rehearing is not an opportunity for the requestor to present new arguments or evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we overlooked or misapprehended Petitioner’s anticipation arguments in light of the newly cited disclosure of the Ehses Dissertation.” slip op. at 5
§ 102 anticipationPatents in suitUS 9,562,263 - Celltrion, Inc. / Pfizer, Inc. v. Genentech, IncAll claims unpatentablePTAB · Oct 3, 2018 · IPR2017-02063 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–14 are unpatentable as obvious over Baselga 1996, Seidman 1996, and the 1995 TAXOL PDR entry; the contingent motion to amend is denied for lack of written-description support.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“Id. The applicant responded that [T]he expression[] “extend the time to disease progression”. . . [is] clear from the specification . . . and would be readily understood by the skilled oncologist. Clearly, the combination of anti-ErbB2 antibody and taxoid is administered in an amount effective to extend the time to disease progression relative to an untreated patient. Id. at 416 (Response dated January 17, 2002) (emphasis added). In the next office action, the examiner withdrew the rejection. See Ex. 1004, 624 (Office Action dated March 27, 2002) (stating “[a]ll claims were allowable” but suspending prosecution due to potential interference). In other words, the applicant overcame the indefiniteness rejection by providing a specific definition of the term “extend the time to disease progression;” and our construction merely reflects that choice. See Paulsen, 30 F.3d at 1480 (holding an applicant may choose to be his own lexicographer).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Even if we were to disregard Petitioner’s reliance on the four principles of combination therapy, we still would find an ordinary artisan would have had a reason to combine trastuzumab and paclitaxel for metastatic HER2-positive breast cancer. Indeed, as detailed below, the prior art repeatedly and explicitly teaches this combination. Baselga 1996 teaches that “rhuMAb HER2 is well tolerated and” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner further argues that Yu13 discourages the use of taxoids in HER2-positive patients. PO Resp. 42. According to Patent Owner, Yu explicitly warns that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol.” Id. (citing Ex. 2029, 1362). Yu drew that conclusion, however, based on an in vitro study, using cell lines growing on culture plates. Ex. 2029, 1360–62. On this issue, we agree with Dr. Earhart and Petitioner that an ordinary artisan “would have regarded the in vivo preclinical and clinical results reported in Baselga-1996 and Seidman-1996, which were obtained from studies of actual tumor cells in live animals and human patients, as being far more predictive than Yu’s results, which were obtained in artificially-engineered cells on culture plates.” Reply 6 (citing Ex. 1054 ¶ 17); see also Ex. 1040, 222:11–224:9 (Dr. Kerbel, Patent Owner’s expert witness, testifying that a living animal model, though imperfect, is “closer” to a human and “better than a petri dish”). Moreover, in an obviousness inquiry, we must analyze the prior art as a whole, not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). Other evidence of record shows paclitaxel was known at the relevant time to be effective in treating HER2-positive cancers (see, e.g., Ex. 1011), demonstrates “strong synergy” of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1010,14 5; Ex. 1019, 4; 13 Yu et al., Overexpression of c-erbB-2/neu in Breast Cancer Cells Confers Increased Resistance to Taxol Via mdr-1-independent Mechanisms, 13 ONCOGENE 1359–65 (1996) (Ex. 2029). 14 Seidman et al., Memorial Sloan-Kettering Cancer Center Experience with Paclitaxel in the Treatment of Breast Cancer, 22 SEMINARS in ONCOL. (Suppl.) 108–16 (1995) (Ex. 1010, “Seidman 1995”) Ex. 1021,15 3), and suggests clinical trials of the claimed combination therapy (see, e.g., Ex. 1010, 5; Ex. 1020, 9). Weighing all evidence of record, we are not persuaded that Yu, a single reference based on an in vitro study, would have dissuaded an ordinary artisan from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers. See also MTA Sur-reply 6 (citing Ex. 1043,16 6–9 (noting a review paper regarding paclitaxel sensitivity in breast cancer does not cite Yu, but “cites Seidman ’96, Baselga ’96 and the Baselga xenograft studies as suggesting that HER2+ tumors are sensitive to paclitaxel, and that combining trastuzumab with paclitaxel increased its antitumor activity”).” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“For objective evidence of secondary considerations to be accorded substantial weight, its proponents must establish a nexus between the evidence and the merits of the claimed invention.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” Id. We find that the nexus between the merits of the invention and the evidence of long-felt-butunmet need, praise, and commercial success, if any, is weak. Patent Owner asserts that Herceptin is the commercial embodiment of the ’441 patent. PO Resp. 65. For commercial success, “if the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed.” Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000). The patent challenger, however, may rebut the presumed nexus. Id. And here, Petitioner has sufficiently rebutted that presumption. For example, each challenged claim in this proceeding requires the combination of an anti-HER2 antibody and a taxoid. Herceptin, however, was also approved for single-agent use. Reply 25 (citing Ex. 2012). Patent Owner has not shown what portion of the sales of Herceptin is attributable to the claimed combination, and not the single-agent use.29 Id. Furthermore, “evidence related solely to the number of units sold slip op. at 41
Patent outcomesUS 7,846,441 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,846,441
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.