• Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution

  Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset 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”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19

  • BurdenDecided for patent owner

    “As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,253,572
• Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution denied
  PTAB · 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 · Graham
  Patents in suitUS 10,106,603
• Envirologix Inc. v. Ionian Technologies, Inc.Rehearing denied
  PTAB · 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 anticipation
  Patents in suitUS 9,562,264
• Envirologix Inc. v. Ionian Technologies, Inc.Rehearing denied
  PTAB · Oct 11, 2018 · IPR2018-00405 · APJ Christopher G Paulraj · IPR · Rehearing

  The Board denied rehearing and maintained its denial of institution, finding no reasonable likelihood that Ehses anticipated any challenged claim.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 4

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “We remain unpersuaded by this argument. As discussed in our Decision, anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 19 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 82). In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “2 Although not established as prior art, the Ehses Dissertation indicates that TO- PRO-1 fluoresces in the presence of double stranded DNA, whereas SYBR Gold detects both double and single-stranded products. See Ex. 1004, 37. zero when fluorescence begins to increase and continues during the reaction. Req. Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation reflects the understanding of those of ordinary skill at the relevant time. See Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses Dissertation was sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon any teachings of Ehses Dissertation, particularly Figure 3.4, to support an inherency argument for Ehses anticipation grounds in the Petition. A request for rehearing is not an opportunity for the requestor to present new arguments or evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we overlooked or misapprehended Petitioner’s anticipation arguments in light of the newly cited disclosure of the Ehses Dissertation.” slip op. at 5

  § 102 anticipation
  Patents in suitUS 9,562,263
• Fustibal LLC v. Bayer Healthcare LLCInstitution denied
  PTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,637,553
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution denied
  PTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “[U]nless a reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,667,061
• Zimmer Biomet Holdings, Inc. / Zimmer Inc. et al. v. Advanced Orthopaedic Solutions, Inc.Institution denied
  PTAB · Jun 7, 2016 · IPR2016-00311 · APJ Lora M Green · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 6–11, 13–15, 19, and 20 were unpatentable over the asserted grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . 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 Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review.” slip op. at 2

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We agree with Patent Owner that Petitioner has not sufficiently established that Shavit discloses an insert having a lower surface that is operative to contact a bone screw. Petitioner relies primarily on Figures 1B and 4 of Shavit to establish that the insert contacts the bone screw. As noted by Patent Owner (Prelim. Resp. 16), “[i]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” Hockerson-Halberstadt, Inc. v. Avia Group Int’l Inc., 222 F.3d 951, 956 (Fed. Cir. 2000). “Ordinarily drawings which accompany an application for a patent are merely illustrative of the principles embodied in the alleged invention claimed therein and do not define the precise proportions of elements relied upon to endow the claims with patentability.” In re Olson, 212 F.2d 590, 592 (CCPA 1954).” slip op. at 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “In challenging claim 19 over the combination of Shavit and Kilpela, as to the limitation that “said lower surface [of an insert] operative to engage a bone screw extending through said aperture,” Petitioner states that for the reasons discussed as to claim 8, Shavit in view of Kilpela renders that limitation obvious. Pet. 37 (emphasis added). Petitioner relies on that same analysis as to the challenge of claim 19 over the combination of Shavit, Kilpela, and Bramlet. Id. at 46. In its discussion of claim 8 as being obvious over the combination of Shavit and Kilpela, Petitioner relies on Kilpela for a reason to have a longitudinal passageway through the insert. Id. at 28. As to the remaining limitations of claim 8, which depends from claim 6, Petitioner relies on its discussion of claim 6 as being anticipated by Shavit. Id. Petitioner, therefore, does not rely on either Kilpela or Bramlet to make up the deficiency of Shavit as discussed above as to the anticipation challenge of independent claim 6. Thus, for the reasons discussed above in Section II.B.ii.a, we determine that Petitioner has not sufficiently established that claim 19 is rendered by the combination of Shavit and Kilpela, or the combination of Shavit, Kilpela, and Bramlet. Similarly, Petitioner relies on its discussion of independent claims 6, 13, and 19 in contending that claim 8 is rendered obvious by the combination of Shavit and Kilpela (Pet. 28), that claims 14, 15, and 20 are rendered obvious by the combination of Shavit and Kilpela (Pet. 31–33, 39– 40) or by the combination of Shavit, Kilpela, and Bramlet (Pet. 40–45, 47), and that claim 11 is rendered obvious by the combination of Shavit and Bramlet (Pet. 47–48). As Petitioner again does not rely on either Kilpela or Bramlet to remedy the above discussed deficiency of Shavit, we determine also that Petitioner has not sufficiently established that claims 8, 11, 14, 15, and 20 are rendered by the Shavit in combination with Kilpela and/or Bramlet.” slip op. at 18

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We determine that, for purposes of this Decision, none of the terms in the challenged claims require express construction at this time. See, e.g. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 3 Bramlet et al., US Patent No. 6,443,954 B1, issued Sep. 3, 2002 (Ex. 1007) (“Bramlet”). 1999) (noting that only claim terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 8

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,092,454
• Neptune Generics, LLC v. Nektar TherapeuticsInstitution denied
  PTAB · Apr 27, 2016 · IPR2016-00049 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–4 were anticipated by Bentley or obvious over Bentley, Erez, and Ouchi.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . 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 Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of claims 1–4. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

  • BurdenNot shown unpatentable

    “We agree with Patent Owner. That is, Petitioner has not demonstrated that “the size of [the] Bentley genus ‘depends solely on the number’ of monomer units in the PEG moiety.” Prelim. Resp. 25 (quoting Pet. 26–27). Petitioner fails to demonstrate why the ordinary artisan would immediately envisage Formula V of Bentley in which AO is the configuration of Formula Ia, the linkage is a simple ether linkage, and having the required number of monomer units in the PEG moiety. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (noting that an anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.”).” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We agree with Patent Owner. That is, Petitioner has not demonstrated that “the size of [the] Bentley genus ‘depends solely on the number’ of monomer units in the PEG moiety.” Prelim. Resp. 25 (quoting Pet. 26–27). Petitioner fails to demonstrate why the ordinary artisan would immediately envisage Formula V of Bentley in which AO is the configuration of Formula Ia, the linkage is a simple ether linkage, and having the required number of monomer units in the PEG moiety. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (noting that an anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.”).” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “We do not disagree with Petitioner that the challenged claims are encompassed by the genus of Bentley, and that all the components of the compounds recited by the challenged claims are also known. To establish the claims are obvious, however, Petitioner must also identify a reason that would have led a person of ordinary skill in the art to combine the elements of Bentley, Ouchi, and Erez in the manner specified by the claims. See KSR, 550 U.S. at 418 (“[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.”); see also id. (“[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.”). Specifically, assuming that Formula V of Bentley, i.e., R-POLY-X- AO, is the proper starting point, Bentley teaches that “[i]n a preferred embodiment, R is methoxy, POLY is poly(ethylene glycol), X is a hydrolytically stable linkage such as amide, amine, carbamate, sulfide, ether, thioether, or urea, and AO has the structure shown in Formula Ia or Formula Ib above.” Ex. 1003 ¶¶ 113–114. Petitioner has failed provide a reason, with rational underpinning, why the ordinary artisan would have picked the conjugate of Ia, combined with a simple ether linkage, and use the required number of monomer units in the PEG moiety to arrive at the compound of the challenged claims.” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,786,133
• Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution denied
  PTAB · Apr 6, 2016 · IPR2016-00017 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that any of claims 1–10 was unpatentable over the asserted references.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “For the reasons provided below, we determine Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’264 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under that standard, and absent any special definitions, we assign claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention,16 in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, however, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 6

  • BurdenNot shown unpatentable

    “[T]he hallmark of written description is disclosure.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The test for written description “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. No particular form of disclosure is required, but “a description that merely renders the invention obvious does not satisfy the requirement.” Id. at 1352. To find an element inherently disclosed demands that “the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.” Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (emphasis added). In the present case, Petitioner presents no expert opinion with respect to the understanding of one of ordinary skill in the art, much less with respect to the disclosure of the Zamore ’185 provisional application. Petitioner’s assertion that “Zamore had possession of the means to avoid PKR when utilizing the gene silencing technology, based on his reference to the ‘length, sequence, and/or structure’ of the constructs . . . and their effect on ‘induction of the interferon response’” (Pet. 26) fails to convince us that one of ordinary skill in the art would understand that the ’185 provisional application inherently discloses the ranges claimed in the Zamore patent. Accordingly, we are not persuaded that the Zamore patent qualifies as prior art under 35 U.S.C. § 102(e). Absent such a showing, Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’264 patent based on this reference. slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “ʼ264 patent is January 22, 2002. See Ex. 1001, 1; Pet. 4–5; Prelim. Resp. 28. Zamore issued from a non-provisional application filed on July 12, 2002, and claimed benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, [21], [22], [60], 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written description support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112 ¶ 1.”).” slip op. at 7

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,829,264
• Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution denied
  PTAB · Mar 31, 2016 · IPR2016-00016 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution on claims 1–10 because Benitec did not establish a reasonable likelihood of showing any challenged claim unpatentable over the asserted references.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “For the reasons provided below, we determine Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’776 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior art

    “Ex. 1001, 1; Pet. 8; Prelim. Resp. 23. Zamore issued from a non-provisional application filed on July 12, 2002, and claiming benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, [21], [22], [60], 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written descriptive support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1.”). The claims of the Zamore patent are generally directed to nucleic acids “capable of inducing RNA interference (RNAi) in a mammalian cell in vivo.” See Ex. 1003, claim 1. Independent claims 1 and 41 require first and second stem portions comprising complementary RNA sequences of “about 18 to about 40 nucleotides” in length. Id. at claims 1, 41. Various dependent claims further recite stem portions of “18 to 40 nucleotides” (id. at claims 20, 58), “22 to 28 nucleotides,” (id. at claims 21, 59), “18 to 30 nucleotides,” (id. at claim 22), and “18 to 40 nucleotides” (id. at claim 58). The Zamore ʼ185 provisional application, by contrast, describes stem portions of “19 to 22,” “21 or 22,” and “21 or 40” nucleotides in length. Ex. 1004, 2, 7. For the reasons discussed on pages 24 through 27 of Patent Owner’s Preliminary Response, we agree that these disclosures do not provide written descriptive support for the ranges claimed in the issued patent.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)

    “genes using genetic elements known to be active in eukaryotic cells. See, e.g., Ex. 1005, 17:39–51 (“Plasmid pEGFP.BEV.1 (FIG. 9) is capable of expressing the BEV polymerase structural gene as a GFP fusion polypeptide under the control of the CMV-IE promoter sequence.”); see id. at 8:4–34. Petitioner, however, points to no evidence indicating that such constructs were ever introduced into mammalian cells; nor do we discern in Graham any evidence that the disclosed constructs were successfully expressed in mammalian cells, or that they subsequently produced a measurable effect on a target gene in accord with the claim language. Based on our review of the record to date, we acknowledge the substantial complexity of the subject matter16 and unpredictability of the art. See Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001) (recognizing the unpredictability of the biological arts); In re Fisher, 16 See e.g., Ex. 1002, 854 ¶ 43 (cited in full, infra) (“Further evidence of the non-obviousness of the Hannon et al. invention is evidenced in the complicated nature of the methods provided in the cited references.”). 427 F.2d 833, 839 (CCPA 1970) (2008) (contrasting predictable factors involving mechanical or electrical elements with “cases involving unpredictable factors, such as most chemical reactions and physiological activity”). Given this background, and Petitioner’s lack of testimonial evidence, we do not find that Petitioner has established that Graham expressly or inherently discloses a molecule “stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner . . . whereby expression of the target gene is inhibited,” as required by claim 1. For at least this reason, Petitioner has not shown that Graham anticipates the challenged claims.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away found

    “i. Graham Petitioner relies on Graham as teaching shRNAs, in particular, “short dsRNA constructs for gene silencing” (Pet. 45 (citing Ex. 1005, 6:25–40, 10:22–32), and the “desirability of using short hairpin sequences to avoid cellular responses” (id. at 38–39 (citing Ex. 1005, 6:25–40)). As discussed above in the context of anticipation, however, Graham teaches that the potential of hairpin formation was a problem to be solved. Indeed, rather than teaching the “desirability” of using hairpin sequences, as Petitioner contends, Graham indicates that hairpins should be avoided and, thus, teaches away from the use of shRNAs for gene silencing in mammalian cells. Accordingly, Graham does not teach or suggest the use of “a sequence encoding a short hairpin RNA molecule comprising a double-stranded region wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,” as required by claim 1.” slip op. at 15

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,153,776

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.