- PTAB · Nov 18, 2021 · IPR2021-00854 · APJ Wesley B Derrick · IPR · Institution
The Board instituted IPR on claims 1–35 and all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Birnboim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition shows that there is “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Thus, based on the information presented, we institute an inter partes review of claims 1–35 of the ’240 patent on all grounds.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that A person of ordinary skill in the art . . . would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid 10 Koller, WO 91/02740, published Mar. 7, 1991. Ex. 1016. 11 Robert E. Farrell, Jr., Ph.D., “RNA Methodologies: A Laboratory Guide for Isolation and Characterization,” (3rd Ed., 2005). Ex. 1026. extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 7 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute Petitioner’s proposed definition at this stage. Prelim. Resp. 7. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’240 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B. Claim Construction” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Neither Petitioner nor Patent Owner offer any position on the construction of any claim term. See Pet.; Prelim. Resp. 7. On this record, and for purposes of this Decision, we decline to construe any claim terms beyond the limited extent we do so below in our analysis, because it is not necessary to do so in reaching our decision on institution. C. Principles of Law” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“and particularly claim 1. Petitioner provides a detailed analysis of where each element of claim 1 is found in Birnboim. Pet. 13–19. Specifically, Petitioner asserts that Birnboim’s Example 3 discloses an aqueous composition comprising the one or more chaotropes, one or more detergents, one or more reducing agents, one or more chelators, and one or more buffers, as recited in the claim. Id. at 13–18. Petitioner also asserts that “Birnboim’s reagents are present in an amount sufficient to perform the claimed functions.” Id. at 18–23 (heading capitalization normalized and underlining omitted).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,669,240 - PTAB · Nov 12, 2021 · IPR2021-00860 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–20 on all petitioned grounds because Petitioner showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Birnboim, Mori, and Farrell, Petitioner provides a detailed analysis of where each claim element is found in the cited references and discusses why one of ordinary skill in the art would have been motivated to combine those elements with a reasonable expectation of success. See e.g., Pet. 34–42 (discussing motivation to combine and reasonable expectation of success with respect to claim 1). For the purpose of institution, we focus on independent claim 1.” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Taylor, Petitioner asserts that A person of ordinary skill in the art (“POSA”) would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 10 citing Ex. 1002, ¶¶34–35. Patent Owner presently does not dispute Petitioner’s proposed definition. Prelim. Resp. 6. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’256 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionPlain and ordinary meaningDecided for petitioner
“According to Petitioner, we should apply the plain and ordinary meaning of “stock solution” as meaning “a formulated supply of solution for future use,” which, in the context of the instant claims, refers to “the aqueous composition before it is mixed with a sample.” Pet. 8 (citing Ex. 1029; Ex. 1002 ¶ 38). Patent Owner neither contests Petitioner’s definition of “stock solution” nor requests that we construe any other claim term, but reserves its right to do so. Prelim. Resp. 7. At this stage of the proceeding, we apply the plain and ordinary meaning of “stock” solution as Petitioner proposes. In section II.D.4, below, we note that Patent Owner implicitly relies on narrow constructions of “kills pathogens” and “without degrading nucleic acids.” As these terms may be critical to our final determination but have not been briefed by either party, we provisionally apply their plain and ordinary meaning. D. Ground 1: Obviousness in View of Birnboim, Mori, and Farrell” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner provides reasoned bases for why one of ordinary skill in the art would have combined the cited references to arrive at the claimed invention. See Pet. 34–42 (citations omitted). Summarizing its arguments, Petitioner concludes that one of ordinary skill in the art would have been motivated to prepare solutions comprising a chaotrope, a detergent, a reducing agent, a chelator, a shortchain alkanol, and a buffer (with the associated acid and base) at a pH of 5–7 with a reasonable expectation that, when combined with a biological sample, the solution would denature proteins, inactivate nucleases, and kill pathogens, all without degrading nucleic acids of the sample. Ex. 1002, ¶151. The POSA would have been motivated to use Mori’s surfactants or defoaming agents along with Farrell’s nuclease-free water in Birnboim’s stock solution and would have had a reasonable expectation of success in doing so. Ex. 1002, ¶¶137–152.” slip op. at 19
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,683,256 - Boragen, Inc. v. Syngenta Participations AGInstitution deniedPTAB · May 5, 2020 · IPR2020-00124 · APJ Timothy G Majors · IPR · Institution
The Board denied institution of IPR on claims 1–12 under § 325(d), finding the asserted prior art and arguments were substantially the same as those considered during prosecution and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 14 9. On the question of material error, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“Under 35 U.S.C. § 314(a), an inter partes may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon considering the arguments and evidence, we deny review of the Petition on a discretionary basis under 35 U.S.C. § 325(d). Thus, for reasons further explained below, we do not institute inter partes review of claims 1–12 of the ’096 patent.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Petitioner makes the same points about Kohn here. According to Petitioner, Kohn teaches “compounds with an oxaborole core structure could be used as fungicides to treat plants and seeds.” Pet. 26–27; see also id. at 42–43 (block quoting, with apparent approval, the Examiner’s findings about Kohn in combination with Austin). Like the Examiner, Petitioner cites Kohn’s teaching of the use of “boroxarophenanthrenes” as fungicides, and the application of such fungicides in effective amounts on vegetative hosts. Pet. 46 (claim chart, citing Kohn’s teachings). Indeed, Petitioner expressly invokes the reasons offered by the Examiner during prosecution as motivating the combination of Austin and Kohn. Pet. 44 (“For all the reasons discussed above and in the prosecution history, a POSITA would have been motivated to combine the teachings of Austin and Kohn with a reasonable expectation of success.”).14 14 In fact, the only reasons that are expressly offered in the Petition for combining Austin and Kohn come from the Examiner. Pet. 42–49 (Ground 2). Petitioner’s assertion that the declaration submitted during prosecution was “misleading” is not a reason for combining Austin and Kohn. Pet. 43–44. Nor do vague citations to testimony of Petitioner’s declarants, without any adequate explanation in the Petition itself, suffice to demonstrate persuasive reasons for combining the art. Id.; see also id. at 23 (asserting vaguely in a section titled “Overview of Grounds” that “[a] POSITA would also be motivated to combine Austin and Kohn to arrive at the claimed invention”) (citing Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65, 82–85). Even the cited testimony here is unpersuasive. For example, Dr. Hall’s cited testimony merely repeats that a skilled person “would have been motivated to combine Austin and Kohn with a reasonable expectation of success.” Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65 (conclusory opinion about an alleged “structure similar to that of a benzoxaborole compound” in Kohn), ¶¶ 82–85” slip op. at 19
- Expert testimonyPetitioner expert discountedDecided for patent owner
“14 In fact, the only reasons that are expressly offered in the Petition for combining Austin and Kohn come from the Examiner. Pet. 42–49 (Ground 2). Petitioner’s assertion that the declaration submitted during prosecution was “misleading” is not a reason for combining Austin and Kohn. Pet. 43–44. Nor do vague citations to testimony of Petitioner’s declarants, without any adequate explanation in the Petition itself, suffice to demonstrate persuasive reasons for combining the art. Id.; see also id. at 23 (asserting vaguely in a section titled “Overview of Grounds” that “[a] POSITA would also be motivated to combine Austin and Kohn to arrive at the claimed invention”) (citing Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65, 82–85). Even the cited testimony here is unpersuasive. For example, Dr. Hall’s cited testimony merely repeats that a skilled person “would have been motivated to combine Austin and Kohn with a reasonable expectation of success.” Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65 (conclusory opinion about an alleged “structure similar to that of a benzoxaborole compound” in Kohn), ¶¶ 82–85” slip op. at 19
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,130,096 - Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution deniedPTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects 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).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,106,603 - 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 - 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 - Hospira, Inc. v. Genentech, Inc.All claims unpatentablePTAB · Mar 9, 2018 · IPR2016-01771 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Kabbinavar and over the 2000 Press Release; anticipation by Kabbinavar was not established.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“summarized above, we conclude that Kabbinavar fails to disclose “assessing the patient for gastrointestinal perforation” as required by the challenged claims. In making this determination, we note that Kabbinavar expressly states that the patients enrolled in the disclosed study underwent regular “baseline tumor assessments [that] included a chest x-ray, abdominal and pelvis computed tomography [(“CT”)] scans.” Ex. 1005 at 3–4. We are not, however, persuaded by Petitioner’s argument that “Kabbinavar teaches that the subjects receiving bevacizumab underwent regular CT scans that the Skilled Artisan would have understood (1) were performed to determine whether the subjects were experiencing any GI injury including GI perforation and (2) would have detected signs of GI perforation.” Reply 12 (citing Ex. 1025 ¶¶ 26–29; Ex. 1026, 39:6–16) (emphasis added). Rather, we find that Kabbinavar expressly discloses that the CT scans were performed for the purposes of tumor assessment, and not for assessing the patient for GI perforation. While it is undisputed that CT scans of the abdominal and pelvis, such as those performed in Kabbinavar, are capable of detecting GI perforation (Ex. 1025 ¶ 26; Ex. 1026, 39:6–16; Ex. 1022; Ex. 1023; Ex. 1027, 55:1–57:4), the evidence of record supports a finding that a person of ordinary skill in the art looking for a GI perforation would have performed different steps that are not necessarily taken in cases where GI perforation is not suspected, such as in the case of performing baseline tumor assessments (or tumor staging). Here, we credit the testimony of Dr. Levy, Professor of Radiology at Georgetown University Medical Center, who testified that, where a patient is suspected to have GI perforation, a radiologist would use particular contrast agents and would use a setting known as a “lung window,” a setting that is better suited to detect the presence of free air and to more easily identify the location of the perforation. Ex. 2012 ¶¶ 24–35. In contrast, the record fails to establish that the same or equivalent steps would necessarily be used where a radiologist was performing baseline tumor assessments. See Reply 14–17; Ex. 1026, 53:8–60:17. Accordingly, based on the evidence of record, we conclude that the use of a CT scan in the manner disclosed in Kabbinavar would not have necessarily confirmed the presence or absence of GI perforation. That is, while a CT scan is capable of assessing a patient for GI perforation, Petitioner failed to show that the patients discussed in Kabbinavar necessarily underwent an evaluation to determine if those patients had GI perforation. As such, we find that Kabbinavar fails to explicitly or inherently disclose the requirement for “assessing the patient for gastrointestinal perforation.”” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“person of ordinary skill in the art would have had adequate reason to assess patients with colorectal cancer receiving bevacizumab in combination with chemotherapeutic agents, such as the patients disclosed in Kabbinavar and the 2000 Press Release, for GI perforation. In reaching this conclusion, we credit the testimony of Dr. Neugut that the standard of care and the knowledge of a person of ordinary skill in the art would have guided a physician to assess patients receiving bevacizumab for GI perforation. Ex. 1002 ¶¶ 92–108; Ex. 1025 ¶¶ 35–40. We are persuaded that such an assessment necessarily begins with evaluating patients for symptoms of GI perforation, such as nausea and abdominal pain, and in the event of a showing of such signs, a physician would have assessed the patient for GI perforation. Id. at ¶¶ 92–94. Guiding that physician would have been the knowledge that GI cancers and systemic chemotherapy each were known to be causally related to GI perforation. Pet. 48; Ex. 1002 ¶¶ 91, 96-99; Ex. 1025 ¶ 39; Ex. 1027, 64:1–24; Ex. 1026, 95:18–96:17; Ex. 1007, 9 (“ask if the patient has recently received chemotherapy as this may cause perforation by weakening the bowel wall at a site of tumor.”). The physician would have known that GI perforation was associated with a high rate of death, and thus the physician would have been particularly concerned with a life-threatening complication such as GI perforation. Pet. 47; Ex. 1002 ¶ 90; Ex. 1007, 11. The physician would have also known that chemotherapy promotes GI injury by killing tumor cells and effectively eroding away the tumor as well as by killing epithelial cells that line the gut wall. Pet. 48; Reply 23; Ex. 1002 ¶¶ 98–101; Ex. 1025 ¶ 39; Ex. 1009, 5; Ex. 1010, 3; Ex. 1013, 2. Finally, the physician would have known that the protein VEGF promotes GI injury repair and that a VEGF-neutralizing antibody, such as bevacizumab, could impair the ability of VEGF to promote GI injury repair and thus potentially exacerbate GI tissue injury caused by chemotherapy. Reply 23; Ex. 1002 ¶ 82; Ex. 1025 ¶ 39; Ex. 1008, 3, 8–9.” slip op. at 20
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“We further note that secondary consideration have not been asserted in this case.” slip op. at 21
Patent outcomesUS 7,622,115 unpatentable§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 7,622,115 - PTAB · Jan 11, 2018 · IPR2016-01102 · APJ Christopher L Crumbley · IPR · Rehearing
Petitioners’ rehearing requests concerning joinder of claim 7 were dismissed as moot because claim 1 was not proven unpatentable and claim 7’s grounds depended on claim 1.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01059 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable and no separate unpatentability ground was advanced for claim 7.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01103 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable, leaving no basis to find dependent claim 7 separately unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedOther
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772
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.