- 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 - Favored Tech Corporation v. P2i LtdNo claims unpatentablePTAB · Aug 23, 2021 · IPR2020-00478 · APJ Jeffrey W Abraham · IPR · Final written decision
Favored Tech did not prove claims 1–17 unpatentable: Baalmann did not anticipate the asserted claims, and the obviousness grounds lacked adequate disclosure or motivation with a reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededGranted
“After considering Petitioner’s arguments regarding claim 9, Patent Owner’s silence regarding claim 9, and the language in the ’070 patent itself (e.g., Ex. 1001, 11:45–52, 12:60–61), we agree with Petitioner that the term “1H, 1H, 2H, 3H-heptadecafluorodecylacylate” in claim 9 should be construed to correctly recite HDFDA (1H, 1H, 2H, 2H-heptadecafluorodecylacrylate). The error Petitioner identifies is conspicuous and undisputed, and the intrinsic record does not suggest a different interpretation. Fitbit, Inc. v. Valencell, Inc., 964 F.3d 1112, 1119–20 (Fed. Cir. 2020); Novo Industries, L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003). Additionally, after reviewing the parties’ remaining claim construction arguments and evidence, we determine that we do not need to expressly construe any other terms for purposes of this Decision because, as addressed in detail below, we find Petitioner’s showings deficient for reasons that do not depend on the construction of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art in the field of the ’070 patent would have had “at least a bachelor’s degree in a field such as chemistry, physics, or chemical engineering, as well as at least two years of experience with plasma-polymerization techniques.” Pet. 14 (citing Ex. 1002 ¶¶ 26–31). Patent Owner agrees with this proposed definition “with the understanding that ‘experience with plasma-polymerization techniques’ includes plasma-enhanced chemical vapor deposition (PECVD) techniques.” PO Resp. 9 (citing Ex. 2010 ¶ 20; Ex. 1002 ¶¶ 12, 63). In light of the record before us, we adopt Petitioner’s proposal regarding the level of one of ordinary skill in the art. As Patent Owner points out, Dr. Gleason states that PECVD is a form of plasma polymerization, and thus the parties agree that experience with plasma-polymerization techniques would include PECVD. PO Resp. 9; Ex. 1002 ¶ 63. The level of ordinary skill in the art is also reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner. Petitioner has failed to demonstrate adequately that each and every element in claim 1, arranged as recited in the claim, is found in a single prior art reference. NetMoneyIN, 545 F.3d at 1369; Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). Here, Petitioner combines several different teachings from Baalmann to support its anticipation argument. For example, Petitioner relies on the “evacuable chamber with a volume of 1 m3” from Baalmann’s Example 1, but not the power (2kW) expressly disclosed as being used with that reactor of Example 1. Ex. 1004 ¶ 47. With regard to power density, Petitioner relies on Baalmann’s general disclosure that “[t]he electrical power input per chamber volume is set between 0.5 kilowatt/m3 and 5 kilowatt/m3.” Ex. 1004 ¶ 20. As Patent Owner points out, however, that power density range is not tied to any particular reactor volume or plasma zone volume. PO Resp. 19. Baalmann also fails to expressly disclose the plasma zone volume of the reactor in Example 1. See Ex. 1004 ¶¶ 47–48. To attempt to overcome this absence of an express disclosure, Petitioner argues that, for the reactor used in Example 1, the plasma zone volume and reactor volume are the same based on the configuration of the electrodes in the reactor. Pet. 24–25. Baalmann, however, does not expressly disclose the electrode configuration of the reactor in Example 1. See Ex. 1004 ¶¶ 47–48. Instead, Petitioner relies on Baalmann’s general disclosure of an embodiment wherein one electrode is formed by the chamber wall itself. Pet. 24–25; Ex. 1004 ¶¶ 35, 61. In so doing, Petitioner ignores the fact that Baalmann also states that “[t]wo opposite rod-shaped electrodes may also be used.” Ex. 1004 ¶ 35. In view of this, we disagree with Petitioner’s conclusion that a person of ordinary skill in the art “would have understood that chamber to be configured as described throughout the rest of the specification: with the chamber wall serving as one of the electrodes.” Pet. 24. Even if we were persuaded by Petitioner’s argument, the fact remains that Petitioner’s anticipation challenge is based on the combination of different features disclosed in separate portions of Baalmann. “Such picking and choosing . . . has no place in the making of a 102, anticipation rejection.” In re Arkley, 455 F.2d 586, 587–88 (CCPA 1972) (cited with approval in Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1083 (Fed. Cir. 2008)); see also Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (stating that anticipation is not proven by multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“For all of the foregoing reasons, we are not persuaded by Petitioner’s argument that a person of ordinary skill in the art would have inferred the volume of the plasma zone10 in Coulson is 470 cm3 based on Coulson’s disclosure of a “glow discharge reactor” having a volume of 470 cm3. Pet. 38; Reply 15–16. In view of this, we are likewise not persuaded that Coulson discloses a power density of 85.1 W/m3, because Petitioner’s 9 Dr. Gleason confirmed that she did not perform any experiments to verify her opinions regarding Coulson’s plasma zone. Ex. 2017, 80:10–18. 10 As noted above, Petitioner presented its argument in the context of its proposed construction of plasma zone. Petitioner did not present an alternative argument supported by sufficient evidence addressing the volume of Coulson’s plasma zone based on Patent Owner’s proposed construction of plasma zone. Accordingly, we agree with Patent Owner’s assertion that we do not need to expressly construe the term plasma zone to resolve this issue. Sur-reply 1. argument that Coulson discloses this power density is based on its assertion that Coulson has a plasma zone volume of 470 cm3. Pet. 38. This finding is fatal to Petitioner’s obviousness challenge of claim 1 based on the combined teachings of Baalmann and Coulson because Coulson’s purported disclosure of using a power density of 85.1 W/m3 is an essential component of Petitioner’s obviousness challenge. An obviousness determination requires finding both “that a skilled artisan would have been motivated to combine the teachings of the prior art . . . and that the skilled artisan would have had a reasonable expectation of success in doing so.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367-68 (Fed. Cir. 2016). In attempting to establish a person of ordinary skill in the art would have had reason to combine the teachings of Baalmann and Coulson, and would have had a reasonable expectation of success in doing so, Petitioner repeatedly refers to using Coulson’s optimized reaction conditions, including power density, in Baalmann’s larger reactor. Pet. 48 (stating that a person of ordinary skill in the art “would have been motivated to maintain the same or similar reaction conditions within a larger reaction chamber that were present in Coulson’s chamber during Coulson’s reported plasma polymerization reactions, including power density and pressure, to preserve the same effective results.”), 48–49 (“That would have included motivation to maintain Coulson’s disclosed power density when scaling up to a larger reaction volume to preserve the beneficial results Coulson reported at that optimized power density.”); Reply 23 (referring to the “straightforward, compelling obviousness case set forth in the petition” that a person of ordinary skill in the art “would have expected to succeed performing Coulson’s reactions on a larger scale in view of Baalmann”); 23 (“The petition explained why a POSA would have modified Baalmann to use Coulson’s HDFDA monomer and reaction conditions to produce coatings with a reasonable expectation of success” ), 24 (stating the Petition “explained why a POSA would have expected success using known parameters from Coulson in an established large-scale apparatus”). During the oral hearing, counsel for Petitioner confirmed its obviousness positions depend on using Coulson’s power density. Tr. 20:10–21:16. Accordingly, Petitioner’s failure to demonstrate adequately that Coulson discloses or suggests a power density of 85.1 W/m3 undermines its reason to combine and reasonable expectation of success arguments. Petitioner’s argument that Baalmann discloses the claimed power” slip op. at 26
Patent outcomesUS 8,389,070 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,389,070 - 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.