- 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 - Gaf Materials LLC v. Kirsch Research And Development, LLCAll claims unpatentablePTAB · May 24, 2022 · IPR2021-00192 · APJ Charles J Boudreau · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1, 8–12, and 19 are anticipated by Lou; the remaining claims are obvious over the stated Lou-based combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patent. See Phillips, 415 F.3d at 1315–17. The term “extrusion lamination” does not appear anywhere in the ’482 patent outside of issued claim 1, but our understanding is supported by the prosecution history of the ’482 patent. Claim 1 as originally filed in the application that issued as the ’482 patent recited, in relevant part, “a reinforcing scrim of interwoven strands for supporting tensile forces in multiple directions; and at least one layer of thermoplastic material affixed to a side of the reinforcing scrim for providing a weather-resistant barrier.” Ex. 1002 (’482 patent prosecution history), 33. In response to a rejection of the claims as anticipated by U.S. Patent No. 5,523,357 to Peterson, describing a rubber mill calendering process, the applicant amended claim 1 to add the phrase “by extrusion lamination.” Id. at 71, 76. We find nothing to suggest that a person of ordinary skill in the art would have understood that amendment to add a requirement of an additional layer of thermoplastic material, separate and apart from the “at least one layer of thermoplastic material” already recited in the original claim, to serve as a binder between the scrim and the original layer of thermoplastic material. The applicant explained in remarks accompanying the amendment, “Peterson fails to disclose forming a thermoplastic layer over the reinforcing scrim by an extrusion lamination process.” Id. at 71 (italics, underlining, and capitalization omitted). We, thus, find that the added phrase specifies how the recited “thermoplastic material” must be “affixed” to “the side of the reinforcing scrim,” but does not alter the recited function of the thermoplastic material, namely, “for providing a weather-resistant barrier.” Although the applicant’s remarks further state that “[c]ontrarily [to the rubber mill calendering process of Peterson], the roofing underlayment of the present invention is formed by an extrusion lamination process which bonds the various layers together, including the pre-formed films, reinforcement scrim, and slip-resistant material” (id.), claim 1 does not recite “pre-formed films” or “slip-resistant material”; such additional layers are recited in dependent claims 5 (“metallized film”) and 2 (“layer of slip-resistant material”), respectively (Ex. 1001, 6:29, 6:37). Looking finally to the extrinsic evidence of record, including the testimony of the parties’ experts and other exhibits filed by the parties, we find no persuasive evidence to show that the recitation of extrusion lamination requires an additional layer in addition to the recited scrim and the at least one layer of thermoplastic material affixed to a side of the scrim. In that regard, notwithstanding Patent Owner’s contentions, we are not persuaded that “extrusion lamination” and “extrusion coating” are mutually exclusive. Rather, we credit Mr. Kaczkowski’s testimony that extrusion coating would also be considered “extrusion lamination” if, for example, it “results in the extrudate being permanently bonded to the substrate.” Ex. 2020, 28:17–20. While Patent Owner argues that Mr. Kaczkowski’s statement “is nothing more than restatement of the extrusion coating process,” and “[t]o think otherwise would require believing that ‘extrusion coating’ involves a thermoplastic layer that is extruded, and thus coated, onto a substrate with the result being that it is not permanently bonded, i.e., it will delaminate from the substrate” (PO Sur-reply 5), we disagree with Patent Owner’s further contentions that “[s]uch a product makes no sense” and “[u]nder Petitioner’s theories, the [prior art] would not work” (id.). Although there could indeed be extrusion coating processes that would result in coatings that are not permanently bonded, it does not follow that the cited prior art used such processes. Further, although a laminate may be affixed to substrate by an adhesive or other binder, we find no persuasive evidence in the record that the binder must be a separate layer from the laminate.” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the “reinforcing scrim of interwoven strands” recited in claim 1 and Lou’s polypropylene polymer 2 to the recited “thermoplastic material.” Id. at 22– 23. Petitioner further contends that Lou discloses “affixing the thermoplastic material by extrusion lamination,” citing Lou’s disclosures that “[e]xtruder 20 supplies polypropylene polymer 2 through a slit orifice to deposit a thin continuous coating on the surface of sheet 1” and that coated sheet 3 is pressed by a calendaring nip formed by heated and unheated rolls. Id. at 23 (quoting Ex. 1005, 2:34–44) (citing Ex. 1003 ¶ 19; Ex. 1005, 2:45– 49).” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Having considered the parties’ respective arguments, we find that Petitioner’s contentions are supported by the evidence of record, and we find that Petitioner has articulated sufficient reasoning with rational underpinnings (including support both from the cited prior art and from Mr. Kaczkowski’s testimony) to combine the relevant teachings of Lou and Goodacre. We disagree with Patent Owner’s suggestion it is insufficient that Mr. Kaczkowski opined that a person of ordinary skill would have evaluated the proposed combination based on the combined teachings of the asserted references. As the Supreme Court has explained, 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. In that instance the fact that a combination was obvious to try might show that it was obvious under §103. KSR, 550 U.S. at 421. Patent Owner does not dispute Goodacre’s teachings or that combining those teachings with Lou would increase the tensile strength of Lou’s underlayment, but appears instead only to fault Mr. Kaczkowski for not determining whether those solutions would be less expensive than other alternatives. Such arguments are not persuasive. Although, as cited above, Petitioner alleges in the Petition that a skilled artisan would have recognized cross-lamination as “a simpler, less costly way to manufacture a nonwoven reinforcing scrim . . . consistent with Lou” (Pet. 37), we find that is only one among several reasons identified by Petitioner and Mr. Kaczkowski for the combination (see, e.g., id. at 34–35 (additionally identifying increased tensile strength as a well-known benefit of orienting polyolefin fabric)), each of which is independently persuasive.” slip op. at 53
- ExcludeMotion to exclude, grantedGranted
“Motion to Exclude. Federal Rule of Evidence 801 defines “hearsay” as a “a statement that: (1) the declarant does not make while testifying in the current trial or hearing; and (2) a party offers in evidence to prove the truth of the matter asserted in the statement.” Fed. R. Evid. 801(c). We agree with Petitioner that Patent Owner is offering Dr. Reitman’s testimony for its truth. As Petitioner points out, Dr. Reitman’s testimony is presented in the Patent Owner Response in alleged support of Patent Owner’s argument. See Reply Mot. Excl. 1 (citing PO Resp. 22 (“Maureen Reitman recognized that ‘extrusion coating’ and ‘extrusion lamination’ were two different processes”; “[A]s Ds. [sic] Reitman recognized, a POSITA would understand ‘extrusion coating’ to be different than ‘extrusion lamination.’”)). Further, Rule 802 provides that hearsay is not admissible unless a federal statute, the Federal Rules of Evidence, or other rules prescribed by the Supreme Court provide otherwise. Fed. R. Evid. 802. We agree with Petitioner that no exception or exclusion applies in this case. Mot. Excl. 1. Although, as Patent Owner contends, Federal Rule of Evidence 703 provides that “[a]n expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed,” and that “[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted,” we are not persuaded that opinions of others offered in litigation are the sort of “facts or data” that experts in the field of roofing underlayments would reasonably rely on in forming their own opinions.” slip op. at 64
Patent outcomesUS 6,308,482 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,308,482 - 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.