- Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only 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 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Life Spine, Inc. v. Globus Medical, Inc.Institution deniedPTAB · Apr 18, 2023 · IPR2022-01601 · APJ Kristi L R Sawert · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–8, 10–18, and 20 were unpatentable over Chung, Olmos, or Olmos in view of Chung.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows that there is a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“1[d] and 11[d] recite that the “second expansion portion” is “longitudinally spaced from the first expansion portion.” Ex. 1001, 21:54–55, 22:38–39 (emphasis added). On this record, we find that the annotated excerpt of Chung’s Figure 2 is inconclusive as to whether dovetail (32) (blue) is longitudinally spaced from the expansion portion (yellow). Based on the excerpt of Chung’s Figure 2, it is equally likely that the structures colored blue and yellow terminate in the same plane, as shown in Patent Owner’s annotated excerpt of Chung’s Figure 2, reproduced below: Prelim. Resp. 45–46. In Patent Owner’s annotated excerpt of Chung’s Figure 2 reproduced above, Patent Owner demonstrates that Chung’s dovetail (32) longitudinally terminates in the same plane as the ramped surfaces that flank the dovetail (shown by the orange arrows), and does not appear to be longitudinally spaced past the plane where the expansion portion terminates. See id. (citing Ex. 1005, 10; Ex. 2001 (Culbert Decl.) ¶ 85). On this record, we find Patent Owner’s interpretation of Chung Figure 2 more plausible than Petitioner’s.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“certain limitations of claims 1 and 11 (i.e., limitations 1[f], 1[g], 11[f], 11[e]), but relies only on Olmos for limitations 1[d] and 11[d]. See Pet. 99 (stating that “Olmos discloses each and every element of” the challenged claims); id. at 99–101 (discussing the combination of Olmos and Chung with respect to only limitations 1[f], 1[g], 11[f], 11[e]); see also Prelim. Resp. 82 (noting that, for claim limitations 1[d] and 11[d], “Petitioner’s analysis of the asserted combination relies completely on its discussion of Olmos”). We refer back to our analysis above in determining that Petitioner has not sufficiently shown for institution that Olmos teaches limitations 1[d] and 11[d] (relating to “second expansion portion” that is “longitudinally spaced from the first expansion portion”). Supra § II.G. Accordingly, for at least the same reasons discussed above for claims 1 and 11, on this record we determine that Petitioner has not shown a reasonable likelihood that these claims are unpatentable as obvious over Olmos in view of Chung.” slip op. at 30
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Seal. Paper 3 (“Motion”). Petitioner requests that we seal Exhibit 1010 (a claim chart submitted as an exhibit to Patent Owner’s litigation infringement contentions). Id. at 1. Petitioner represents that the material it seeks to seal contains its trade secrets. Id. at 2–3. Petitioner filed a proposed protective order, which includes modifications to the Board’s default protective order. See Ex. 1018; Ex. 1019. Patent Owner filed a Response to Petitioner’s Motion. Paper 7. Patent Owner indicates that it does not oppose “the Board sealing Petitioner’s confidential information,” but does oppose Petitioner’s proposed protective order. Id. at 1 (citing Ex. 1018; Ex. 1019). However, Patent Owner represents that “the parties have conferred and agree to the terms of the stipulated protective order filed as Exhibit 2100.” Id.; see also Ex. 2101 (redline comparison of Ex. 2100 to the Board’s default protective order). We find that Petitioner has established good cause to seal its trade secret information. Accordingly, we grant Petitioner’s Motion. 37 C.F.R. § 42.14. We also enter the stipulated protective order filed as Exhibit 2100.” slip op. at 31
§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,925,752 - Life Spine, Inc. v. Globus Medical, Inc.InstitutedPTAB · Mar 24, 2023 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Institution
Instituted IPR on all asserted grounds against claims 1–15 after finding a reasonable likelihood that claim 15 is anticipated by Chung.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the same or substantially the same prior art or arguments previously were presented to the Office.” The Board analyzes this issue under a two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering all of the arguments and evidence of record, we determine that for purposes of institution, Petitioner has sufficiently shown that Chung discloses an intervertebral implant that teaches all limitations of claim 15. See Pet. 57–62. The arguments and evidence for limitation 15[g]’s “extension” are the same as for the “extension” of claim 1. See, e.g., Pet. 58, Prelim. Resp. 32–47. Thus, we refer back to our analysis above (see supra Section II.F.1.a.i) in determining that Petitioner has sufficiently shown for purposes of institution that Chung teaches the claimed “extension.” On this record, Petitioner has shown a reasonable likelihood of establishing that claim 15 is anticipated by Chung. On that basis, we institute an inter partes review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed” slip op. at 43
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“On this preliminary record, Petitioner has the better argument. It appears that Patent Owner’s construction improperly reads in limitations from example embodiments, such as the embodiments depicted in Figures 25 and 46 of the ’731 patent. See Prelim. Resp. 39 (Patent Owner’s annotated Figures 25 and 46). Petitioner demonstrates that both the Specification and the Examiner used the term “extension” more broadly to refer to a variety of structures, not merely to structures that “increase the length of the central ramp.” See, e.g., Prelim. Reply 3; Ex. 1001, 5:47–58, Fig. 10, 11:8–10, 11:40–42, Fig. 23, 9:40–45, 10:1–19, Fig. 24, claims 2, 3; Ex. 1004, 42–44, 66–67, 126–27. Patent Owner seeks to ignore the Specification and Examiner’s use of the term “extension” in connection with structures other than the central ramp (see, e.g., Prelim. Sur-reply 4), but on this record nothing indicates that the patentee intended a special definition for the term “extension” in the context of the central ramp. For purposes of this Decision, we apply the plain and ordinary meaning of the term “extension,” i.e., “an addition to a main structure.” See Ex. 3001, 4. This construction is consistent with the broad use of the term “extension” in the Specification to refer to a variety of additions to a main structure having a variety of shapes.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“Petitioner’s annotated excerpt of Chung’s Figure 1 (reproduced above on the left) does not appear to show that extension/dovetail (32) extends in a longitudinal direction from the expansion portion (yellow). Instead, it terminates in the longitudinal direction at or before the edges of the expansion portion (yellow). Additionally, on this record, we find that the annotated excerpt of Chung’s Figure 2 is inconclusive as to whether extension/dovetail (32) extends in a longitudinal direction from the expansion portion (yellow). Based on the excerpt of Chung’s Figure 2, it is equally likely that the structures colored blue and yellow terminate in the same plane, as shown in Patent Owner’s further annotated excerpt of Chung’s Figure 2, reproduced below: Prelim. Resp. 77. In Patent Owner’s further annotated excerpt of Chung’s Figure 2 reproduced above, Patent Owner demonstrates that Chung’s dovetail (blue) protrudes in a direction (shown by the blue dashed arrow) that is acute to the longitudinal axis (red dashed line), but does not appear to extend in a longitudinal direction past the plane where the expansion portion (yellow) terminates. See id. On this record, we find Patent Owner’s interpretation of Chung Figure 2 more plausible than Petitioner’s.” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,845,731 - 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
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.