• 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
• Adama Agan Ltd. v. Bayer Cropscience LPInstitution denied
  PTAB · Feb 13, 2023 · PGR2022-00057 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–18 lacked written description or enablement, or were unpatentable over the asserted prior art.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have had at least a bachelor’s degree in agronomy, agricultural sciences, or a related field and at least 3-5 years of experience in the application of pesticides, including experience conducting weed science research, such as field trials to determine herbicide efficacy and safety.” Pet. 25 (citing Ex. 1002 ¶ 10). Patent Owner responds that it does not challenge Petitioner’s definition of a POSA at this stage of the proceeding. Prelim. Resp. 15. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case, as well as the ’463 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8

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

    “When claim 1 is read in light of the Specification of the ’463 patent, we find that Petitioner’s construction is too expansive and not commensurate with the appropriate scope of claim 1 when the Specification of the ’463 patent is considered. As the Specification of the ’463 patent makes clear, indaziflam has been in use as an herbicide and is well-characterized. See Ex. 1001, 3:17–6:6. The Specification of the ’463 patent incorporates by reference U.S. Patent No. 8,114,991, which describes indaziflam, and the Specification of the ’463 patent also describes several commercially available herbicides incorporating indaziflam as their active ingredient. See id. at 3:22–27, 4:15–41. The Specification of the ’463 patent sets forth embodiments with specific ranges for the amount of indaziflam. See id. at 5:45–6:6. Finally, the Specification of the ’463 patent states: A person having ordinary skill in the art would understand how to adjust dosages and concentrations depending on whether the composition is to be applied to a desirable plant or seed, part or habitat thereof, or directly to a site in which no desirable plants are present or growing (e.g., a monoculture of unwanted annual grass).” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANo construction needed

    “We find that Petitioner’s expansive construction of the claim phrase “a composition comprising a cellulose biosynthesis inhibitor” to be inconsistent with the meaning of the transitional phrase “comprising” within the context of the claim as a whole and also inconsistent with the teachings set forth in the Specification of the ’463 patent. The transitional phrase “comprising” is inclusive or open-ended and should be read to not exclude additional, unrecited elements or method steps. See, e.g., Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”) (citing In re Baxter, 656 F.2d 679, 686 (CCPA 1981). Therefore, although the term “comprising” does not exclude additional steps or elements, that does not mean that any other step or element may or should be added, such as any other chemical, as Petitioner asserts. The Specification of the ’463 patent contemplates using indaziflam as the herbicidally active ingredient, but also contemplates the addition of other active ingredients in the composition. Ex. 1001, 5:59–65; 6:7–11. The Specification of the ’463 patent also contemplates the addition of other ingredients in the composition as well. Specifically, the Specification states: These formulations are produced in any desired or known manner, for example by mixing the active compounds with extenders, such as liquid solvents, pressurized liquefied gases and/or solid carriers, optionally with the use of surface-active agents, such as emulsifiers and/or dispersants and/or foam formers. Id. at 17:6–11. This and the remainder of the Specification does not suggest the expansive interpretation of the claim limitation argued by Petitioner. For example, the Specification explains that the point of the invention is to treat vegetation that is or will be consumed by livestock animals, and, more specifically, that such animals will provide food (e.g., milk or meat) for others (e.g., people or pets) further up the food chain. Id. at 2:31–35, 2:39– 59. Reason and the evidence of record support that such goals are not commensurate with co-applying any chemical in any amount to the same area. See also Ex. 1002 ¶¶ 22–23, 30, 34–36, 38–43, 55, 59–61, 63” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,166,463
• Autostore System Inc. v. Ocado Innovation LimitedInstitution denied
  PTAB · Jul 20, 2022 · IPR2022-00443 · APJ Richard H Marschall · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–18 were unpatentable over Hognaland, alone or with Lert.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). Inter partes review may not be instituted “unless . . . 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). Upon consideration of the evidence and arguments in the record, we decline to institute inter partes review of the ’602 patent.” slip op. at 2

  • Skill levelOther

    “We note that the parties’ respective proposals overlap considerably, with Petitioner’s alternative proposal nearly identical to Patent Owner’s proposal. We need not resolve which proposal most closely aligns with the level of ordinary skill in the art here, however, because even if we adopt Petitioner’s proposal we would come to the same ultimate conclusion that Petitioner has failed to satisfy its burden of showing a reasonable likelihood of establishing the unpatentability of any of the challenged claims.” slip op. at 9

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

    “occupy a grid space.” Pet. 32–39. Patent Owner proposes different constructions for both terms. Prelim. Resp. 26–30. The “wheel hub motor” limitation only appears in dependent claims and we need not reach the merits of Petitioner’s allegations as to those claims in order to determine whether to institute an inter partes review. See id. at 29. Accordingly, we do not address the merits of the parties’ claim destruction dispute as to “wheel hub motor.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). slip op. at 10

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

    “adequately that Hognaland discloses either the No Obstruction limitation or the No Extension limitation. As to the No Obstruction limitation, Petitioner premises its argument on the assertion that Hognaland discloses a vehicle occupying only one grid space, but the only embodiment Hognaland discloses shows a vehicle occupying portions of two adjacent spaces that obstruct those spaces in the Y-direction and fail to meet the requirements of the No Obstruction limitation. See Pet. 56–58; Ex. 1005, 2:38–3:3, Fig. 9. Petitioner’s reliance on other text in Hognaland that allegedly “implies” that Hognaland discloses a device with no obstructions in the Y-direction lacks adequate support. For example, Petitioner relies on Hognaland’s statement that the wheels can be placed on the lower corners of the vehicle and that alterations may enable smaller-sized robots. Pet. 57 (citing Ex. 1005, 3:9– 12, 4:31–32). Placing wheels near the lower corners of the vehicle merely describes the existing Hognaland device shown in Hognaland’s figures, a device that fails to meet the claim limitations. See Ex. 1005, 3:9–12. Neither this description of Hognaland’s device nor the general statement that Hognaland’s approach enables smaller-sized robots, taken alone or together, suggest an express or inherent disclosure of an embodiment without any obstruction of adjacent grid spaces in the Y-direction that meets the No Obstruction limitation.” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 10,913,602
• BJ Energy Solutions, LLC v. Yantai Jereh Petroleum Equipment & Technologies Co., Ltd.Institution denied
  PTAB · Sep 7, 2021 · PGR2021-00060 · APJ Ryan H Flax · PGR · Institution

  The Board denied institution because the petition did not show claims 1–7 likely unpatentable, and a possible § 112(a) issue for claims 8–9 did not justify instituting on all claims and grounds.

  RulingsInstitution decision

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

    “not demonstrated with particularity that it is more likely than not that most claims challenged in the petition are unpatentable under the asserted grounds. Although there is a reasonable argument that claims 8 and 9 may be unpatentable under 35 U.S.C. § 112(a), as discussed above, this analysis is applicable to only these two dependent claims under a single ground for unpatentability, leaving Petitioner’s other ten grounds insufficient regarding independent claim 1 and dependent claims 2–7. As discussed above, instituting trial under these circumstances would not be an efficient use of the Board’s or the parties’ time and resources. See Chevron, IPR2018- 00923, Paper 9, 10–11; Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 41–43 (PTAB Jan. 24, 2019) (informative). Our decision at this stage derives from our review of the record presented. In accordance with the Court’s decision in SAS (138 S. Ct. at 1359– 60) and Office guidance, we deny institution of a post-grant review of the challenged claims of the ’631 patent on any grounds alleged by Petitioner. This decision does not reflect a final determination on the patentability of any claim.” slip op. at 66

  • Other 314aInstitution denied discretionary otherInstitution denied

    “Even when a petitioner satisfies the minimum statutory institution standard (e.g., demonstrating a reasonable likelihood of prevailing with respect to one or more claims in an inter partes review or that it is more likely than not that at least one claim is unpatentable in a post-grant review), institution of review remains discretionary. SAS Inst. v. Iancu, 138 S. Ct. 1348, 1356 (2018); Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“First of all, the PTO is permitted, but never compelled, to institute an IPR proceeding.”). Under such circumstances, the Board takes into account other considerations, including efficiency and fundamental fairness for all parties. See Adaptics Limited v. Perfect Co., IPR2018-01596, Paper 20 at 17 (PTAB Mar. 6, 2019) (informative); Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9 (PTAB Nov. 7, 2018) (informative); see also Consolidated Trial Practice Guide, 84 FR 64280, 53– 63 (2019) (addressing various considerations at institution phase, including efficiency and fundamental fairness for all parties).1 We conclude that Petitioner has not demonstrated in the petition that it is more likely than not that challenged claims 1–7 are unpatentable under any asserted grounds for unpatentability. Although it is a closer question as to whether Petitioner has demonstrated it is more likely than not that dependent claims 8 and 9 are unpatentable based on a single asserted unpatentability ground under § 112, we determine based on the record here that instituting a trial with respect to all challenged claims under all eleven asserted grounds for unpatentability is not an efficient use of the Board’s or the parties’ time and resources. Therefore, we do not institute post-grant review pursuant to 35 U.S.C. § 324. See SAS, 138 S. Ct. at 1359–60 (requiring institution on all claims, if any); see also Consolidated Trial Practice Guide, 55 (providing guidance in view of SAS).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “to read the concept of “flush with” into the claims. We agree with Petitioner’s position that such an interpretation is not supported by the ’631 patent’s written description, which illustrates and describes two embodiments, each having a turbine engine and reduction gearbox configured to be flush with one another, but refers to only the configuration of Embodiment 1 as being “directly connected” and refers to the configuration of Embodiment 2 as being merely “connected.” See Ex. 1001, 5:27–28, 5:62–6:2, Figs. 2, 3; see also Ex. 2001 ¶ 63 (Patent Owner’s expert witness confirming there is a difference between merely “connected” and “directly connected”). Thus, the intrinsic record supports a conclusion that the concept of “directly connected” is not related to whether one component is “flush with” another component. This disclosure of the ’631 patent also illuminates the meaning of “directly connected.” As shown in Embodiment 2, something may be connected with another thing even if there are intervening components, e.g., a transmission shaft or coupling; however, as shown in Embodiment 1, the ’631 patent uses the term “directly connected” only where no such intervening components are disclosed. Ex. 1001, 5:15– 6:19, Figs. 2, 3. Besides the guidance provided with respect to the embodiments discussed above, the ’631 patent does not otherwise expressly define the term “directly connected.” See generally Ex. 1001. Thus, we consider what the ordinarily skilled artisan would consider to be its ordinary and customary meaning. In this respect, Patent Owner also uses the word “uninterrupted” to describe “directly connected.” See Prelim. Resp. 6; see also Ex. 2001 ¶¶ 61–71. We conclude based on this record that the concept of “uninterrupted” is more apt than the concept of “flush with,” and find it to be a better description for the ordinary and customary meaning of “directly connected.” For example, the ’631 patent describes, in Embodiment 1, “the turbine engine 19 is connected to the plunger pump 18.” Ex. 1001, 5:26–27 (emphasis added). However, it is without question that Embodiment 1 positions a reduction gearbox between the turbine engine and plunger pump; thus, the engine and pump may be connected, but they are not directly connected. See, e.g., Fig. 2. On the other hand, regarding this same Embodiment 1, the ’631 patent describes that “the turbine engine 19 is directly connected to an input end of the reduction gearbox 24,” and there are no components illustrated or described as being between the turbine engine and reduction gearbox. Id. at 5:28–30 (emphasis added), Fig. 3. The connection between the turbine engine and reduction gearbox shown in Embodiment 1 is more aptly described as being uninterrupted. Thus, this illuminates the meaning of “directly connected.” In view of the above, we ascribe to the term “directly connected” its ordinary and customary meaning as it would have been understood by a person of ordinary skill in the art, and we find that ordinary and customary meaning to require that the turbine engine and reduction gearbox are connected with nothing intervening there-between so that their connection is uninterrupted.” slip op. at 29

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

    “Petitioner’s evidence shows that the Apollo 1 apparatus has two gearboxes and a clutch between its turbine engine and plunger pump, thus the Apollo 1 does not meet the claim limitation “the plunger pump is a plunger pump integrated with a reduction gearbox, the turbine engine is directly connected to an input end of the reduction gearbox integrated on the plunger pump.” Ex. 1001, 6:51–54. Petitioner’s Exhibit 1017 is explained by Mr. Zhang11 as having these two gearboxes and clutch, where at least one of the gearboxes and the clutch forecloses the system from having a single reduction gearbox that is both integrated on a pump and directly connected to a turbine engine. Ex. 2010 ¶¶ 8–12. Petitioner presents no evidence contradicting Mr. Zhang’s understanding of the Apollo 1 configuration and, notably never attempted to explain exactly what is shown in the above-reproduced photograph from its own Exhibit 1017, even when given the opportunity to address Mr. Zhang’s testimony in its Reply. See generally Reply.” slip op. at 50

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 10,865,631

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.