- Neogenomics Laboratories, Inc. v. Natera, Inc.Institution deniedPTAB · Jun 21, 2024 · IPR2024-00346 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution for claims 1–28 under § 325(d), finding the same or substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework 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.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that the examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.10 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“erred when considering the multiplex-amplification limitation. See Advanced Bionics, 9 (“If 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.”). Under the asserted grounds, Petitioner relies on Forshew as the sole reference to teach this limitation, which is required in all challenged claims. Thus, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.” slip op. at 13
§ 103 obviousnessDiscretionary denialPatents in suitUS 11,530,454 - Sata GmbH & Co. KG v. Anest Iwata CorporationRehearing deniedPTAB · May 17, 2016 · IPR2015-01790 · APJ Jennifer S Bisk · IPR · Rehearing
The Board denied SATA’s rehearing request, leaving institution denied for claims 15–22 because the petition did not adequately explain how the evidence supported the proposed grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision[,]” which party “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.” 37 C.F.R. § 42.71(d). slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4
- BurdenDecided for patent owner
“Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“35 U.S.C. § 311(b) states that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Petitioner does not explain how the Final Written Decision of IPR2013-00111 or “the bulk of the entire proceedings” of that case qualify as either a patent or a printed publication under the statute. In particular, to qualify as a printed publication under § 102, a reference “must have been sufficiently accessible to the public interested in the art” at the time the patent application at issue was filed. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009) (internal quotation marks omitted). The results of IPR2013-00111 were, by definition, not available until well after the ’387 patent issued.” slip op. at 3
§ 102 anticipationPatents in suitUS 6,494,387 - The Johns Hopkins University v. Biocon LimitedInstitution deniedPTAB · May 12, 2016 · IPR2016-00175 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood of proving claim 1 anticipated by or obvious over Bedi.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“CONCLUSION Taking account of the information presented in the Petition and Preliminary Response, we determine that the Petition fails to show that there is a reasonable likelihood that Petitioner would prevail at trial with respect to claim 1 of the ’247 patent. ORDER It is ORDERED that the Petition is denied and no trial is instituted.” slip op. at 10
- BurdenDenied
“A. Anticipation by Bedi To establish anticipation, each and every element in a claim, “arranged or combined in the same way as recited in the claim,” must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Claim 1 requires a chimeric fusion protein comprising an “immunomodulating moiety” that “is SEQ ID NO: 4.” Ex. 1001, 69:45, 70:38. Claim 1 specifies that “SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Id. at 70:42–44. In claim 1, “the amino acid spacer is selected from SEQ ID NO: 3 or SEQ ID NO: 11.” Id. at 70:38–39.” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The Petition fails to explain how, in spite of that difference, the “heavy chain” fusion protein depicted in Bedi’s Figure 3 anticipates claim 1. Pet. 17, 19. On that point, the Petition states that Bedi’s Figure 3 depicts a “construct comprising” the requisite components of the invention, but does not explain why Bedi’s disclosure of a lysine residue, on the C-terminus of the heavy chain sequence, teaches the specific fusion protein recited in claim 1. Id. at 19; see id. at 17 (admitting that Bedi’s heavy chain sequence includes a lysine residue, and that the addition of that residue distinguishes Bedi’s fusion protein from the fusion protein of claim 1); Prelim. Resp. 16– 19. We agree with Patent Owner that the Petition does not address adequately the differences between the “heavy chain” fusion protein depicted in Bedi’s Figure 3 and the claimed invention. Id. at 18. Nor does the Petition address adequately how Bedi’s Figure 3 depicts a fusion protein wherein the immunomodulating moiety “is attached via the amino acid spacer to the C-terminus of” the light chain sequence, specified in claim 1 as SEQ ID NO: 6. Ex. 1001, 70:43–44. We agree with Petitioner that Bedi depicts the same light chain sequence (identified as SEQ ID NO: 71 in Figure 3) as SEQ ID NO: 6 in claim 1. Ex. 1003, Fig. 3. The Petition, however, lacks supported analysis explaining how or why a person of ordinary skill in the art would understand Bedi to disclose in Figure 3 a fusion protein in which the immunomodulating moiety is attached via the amino acid spacer to the “light chain” sequence identified as SEQ ID NO: 71 in Bedi. Pet. 19 (arguing, without any evidentiary support, that Figure 3 depicts “attaching to anti-EGFR1 heavy or light chain (SEQ ID NO: 2 or 71, respectively)”). That attachment is not depicted in Figure 3, and the Petition directs us to no disclosure supporting the view that an ordinary artisan would have understood Figure 3 to illustrate an alternative fusion protein in which the immunomodulating moiety is attached via the amino acid spacer sequence to the C-terminus of the light chain sequence. “[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.” Net MoneyIN, Inc., 545 F.3d at 1371. On this record, we determine that the Petition does not direct us to information sufficient to show that Bedi anticipates claim 1.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Petitioner’s obviousness challenge is interlaced with unsupported factual contentions. Pet. 20–29. The Petition rests on bare argument to establish how two asserted background references (Ex. 1007 and Ex. 1008) would have informed the understanding of an ordinary artisan’s reading of Bedi. Pet. 24–27. A lack of evidence also undermines Petitioner’s attempt to explain why “[o]ne of skill in the art would have been motivated to take the teachings of Bedi and apply them to constructing a fusion protein” according to claim 1 (id. at 27), “wherein SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Ex. 1001, 70:42–44. The Petition, moreover, directs us to no support for the argument that “one of ordinary skill in the art would appreciate that the Fox3+CD25+CD4 Tregs described in (Ex. 1007 and 1008) will inherently express EGFR under inflammatory conditions, and that EGFR-positive Treg cells are more immunosuppressive than EGFR-negative Treg cells.” Pet. 27. Compounding that evidentiary deficit, the Petition advances bare attorney argument that “one so skilled would be motivated to use the EGFR targeting moiety of Bedi, to target the most immunosuppressive Treg populations set forth in Bedi and” a background reference. Id.” slip op. at 8
§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,815,247 - Coalition For Affordable Drugs Xi LLC v. Insys Pharma, Inc.Institution deniedPTAB · Mar 10, 2016 · IPR2015-01800 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–3 obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, the information presented does not show sufficiently that an ordinary artisan would have modified the formulation of Ross GB’s Example 1 to include propylene glycol in a weight-percent amount that satisfies claims 1, 2, or 3. Both grounds asserted in the Petition depend upon that modification. Pet. 31–33. On this record, the Petition fails to establish a reasonable likelihood of prevailing with respect to claim 1, 2, or 3. III. CONCLUSION Taking account of the information in the Petition and Preliminary Response, we decline to institute review because the information presented does not demonstrate 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(a). IV. ORDER For the reasons given, it is ORDERED that the Petition is denied.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Critically lacking is any objective evidence—for example, a suggestion in the prior art—that a person of ordinary skill in the art would have understood that the amount of propylene glycol, optimized for use in an aerosol nitroglycerin formulation, would match the optimal amount of propylene glycol, useful in a propellant-free fentanyl formulation. Id. at 32–34. The Petition fails to address adequately how the compositional differences between the disparate formulations of Ross GB and Klokkers-Bethke would have informed that understanding. Compare Ex. 1003, 11:1–9 (Example 1 of Ross GB includes fentanyl, saccharin, ethanol, menthol, and citrate buffer), with Ex. 1004, 3:65–4:8 (Klokkers-Bethke’s formulation includes nitroglycerin, ethanol, propylene glycol, and propellant).” slip op. at 7
§ 103 obviousnessPatents in suitUS 8,486,972 - Coalition For Affordable Drugs Xi LLC v. Insys Pharma, Inc.Institution deniedPTAB · Mar 10, 2016 · IPR2015-01799 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–5 unpatentable over the asserted obviousness grounds or McCoy anticipation.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“III. CONCLUSION Taking account of the information in the Petition and Preliminary Response, we decline to institute review because the information presented does not demonstrate 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(a). IV. ORDER For the reasons given, it is ORDERED that the Petition is denied.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The broadest reasonable interpretation of “discrete liquid droplets” requires express construction. That term is not defined, but is closely associated with the term “spray,” in the ’460 patent specification. Ex. 1001, 3:17–20 (invention is directed to “a liquid spray formulation in the form of discrete liquid droplets”). Based on the information presented, we accept Petitioner’s view that the broadest reasonable interpretation of “discrete liquid droplets” is “water or other liquid broken up into minute droplets and blown, ejected into, or falling through the air.” Pet. 14 (quoting Ex. 1008) (dictionary definition of “spray”). That interpretation is reasonable in view of the claim wording, the specification, and the dictionary definition of “spray” advanced by Petitioner. No other claim term requires express construction for the purposes of this decision.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“[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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If identification of each claimed element in the prior art were sufficient to negate patentability, very few patents would ever issue.” In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). Obviousness can be established when the prior art, itself, would have suggested the claimed subject matter. In re Rinehart, 531 F.2d 1048, 1051 (CCPA 1976). But the Petition identifies no persuasive reason why the prior art would have recommended modifying Ross GB’s spray to alter the size, or mean diameter, of the droplets. Instead, the Petition selects elements from compositionally-different formulations and, without addressing those differences, argues that it would have been obvious to combine the selected elements in the manner that is specified in the challenged claims. Petitioner first argues that reducing the droplet size in Ross GB’s spray, to a size comparable to the droplets disclosed in McCoy or Whittle, would have been understood to provide “a higher surface area to be absorbed by the mucosa of the intra-oral cavity.” Pet. 22 (discussing McCoy) (quoting Ex. 1002 ¶ 22); see id. at 42 (discussing Whittle) (quoting Ex. 1002 ¶ 67). The Petition, however, fails to direct us to any disclosure in the asserted prior art, or any other credible evidence, from which we can reasonably conclude that an “ordinary artisan would have perceived the droplet sizes disclosed in” McCoy or Whittle to be smaller than those in Ross GB’s spray. Prelim. Resp. 20. That deficiency, standing alone, warrants denial of the obviousness grounds stated in the Petition. The Petition also fails to direct us to persuasive information that the mean diameter of droplets was of any concern in Ross GB’s spray—much less that one would have understood that Ross GB’s sublingual fentanyl spray would benefit from a modification to droplet surface area for the purpose of providing “a higher surface area to be absorbed by the mucosa of the intra-oral cavity.” Pet. 22, 42. In that regard, McCoy’s disclosure of droplet sizes is presented in the context of an intra-oral formulation that comprises an oral-absorption enhancer. Ex. 1005 ¶ 19. Whittle’s disclosure of droplet sizes is presented in the context of a formulation containing cannabinoids, and is not shown on this record to address increasing the surface area for absorption by mucosa. Pet. 42; see Ex. 1007, Abstract, 4:40–53 (disclosure of preferred range of particle sizes for “delivering cannabinoids”). The Petition directs us to no credible information that links a concern— about droplet size, mean diameter, or droplet surface area—to Ross GB’s spray, which includes no absorption enhancer and no cannabinoid. See Pet. 21–22, 42–43 (failing to establish that link, and directing us to no disclosure in Ross GB of a formulation comprising an absorption enhancer or a cannabinoid). That aspect of the Petition rests on bare opinion testimony that is not tethered adequately to objective evidence, tending to show that one would have combined the teachings of the references. Id. (citing Ex. 1002 ¶¶ 22–24, 67–68). slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The Petition directs us to McCoy’s teaching that the liquid droplets will be “sized within the range of about 1 to 200 microns, more preferably within the range of 10–100 microns.” Id. at 54 (quoting Ex. 1005 ¶ 19). Significantly, the Petition ignores that McCoy does not teach a “mean diameter” value or range for liquid droplets. Id. As Patent Owner points out, the Petition does not “explain how one of ordinary skill [in the art] would identify a particular range for mean diameter of droplets from a spectrum of possible droplet sizes that is about 2–5 times broader” than the mean diameter range “of from about 30 to about 70 microns” that is specified in claims 1, 4, and 5. Prelim. Resp. 51. In that regard, the Petition directs us to conclusory opinion testimony that McCoy’s preferred droplet sizes encompass the claimed “mean diameter” range of claim 1. Pet. 54 (citing Ex. 1002 ¶ 21). Patent Owner responds, and we agree, that the Petition fails to adequately explain how McCoy’s preferred droplet sizes correspond to a mean diameter value, which “would require information regarding distribution of droplet diameters across the broad spectrum of droplet sizes” disclosed in McCoy. Prelim. Resp. 51. Critically lacking is a cogent explanation of how an ordinary artisan “would have predicted a particular range for mean diameter of droplets from a spectrum of possible droplet sizes” disclosed in McCoy. Id. at 17. We agree with Patent Owner that Dr. Park’s sweeping, but unsupported, opinion that “there is no reasonable difference in how the claimed range operates over the range” disclosed in McCoy is insufficient to support a successful anticipation challenge. Id. at 18– 19 (quoting Ex. 1002 ¶ 21).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,835,460 - Coalition For Affordable Drugs Xi LLC v. Insys Pharma, Inc.Institution deniedPTAB · Mar 10, 2016 · IPR2015-01797 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood that any challenged claim was obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Patent 8,835,459 B2 (“the ’459 patent”). Paper 1 (“Pet.”). Patent Owner filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). We have statutory authority under 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless the Petition demonstrates “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Taking account of the information presented in the Preliminary Response, we conclude that the Petition fails to make that showing. On this record, we deny the Petition and decline to institute review.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“identify a persuasive reason why a person of ordinary skill in the art would have been prompted to combine the various elements of the prior art in the precise fashion required by the challenged claims. “[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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If identification of each claimed element in the prior art were sufficient to negate patentability, very few patents would ever issue.” In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998).” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“a mean Tmax of 29 minutes for 12 patients,” and that 29 minutes “is within the claimed range of ‘about 40.8 minutes to about 112.8 minutes.’” Pet. 31–32 (quoting Ex. 1002 ¶ 27). Petitioner relies on the Park Declaration for evidence that 29 minutes is “about 40.8” minutes as claimed. Id. Dr. Park testifies that 29 minutes is within the claimed range “because the adjective ‘about’ preceding 40.8 minutes indicates that the lower bound is approximate and because a mean time of 29 minutes is close to the approximate lower bound.” Ex. 1002 ¶ 27. Dr. Park’s opinion is conclusory and unpersuasive because it is not keyed to objective proof, regarding the understanding of a person of ordinary skill in the art. See 37 C.F.R. § 42.65(a) (opinion testimony that does not disclose underlying facts “is entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (lack of objective support for opinion testimony “may render the testimony of little probative value in a validity determination”). We find insufficient Petitioner’s further argument, and Dr. Park’s testimony, that “a subgroup” of two patients—plucked from among the larger group of twelve patients for which data is reported in Table 2 of Ross US—makes obvious a mean Tmax of 45 minutes in a fentanyl formulation. Pet. 32 (focusing on patients 11 and 12); see Ex. 1005, Table 2 (reporting data for patients 1 through 12); see also Ex. 1002, ¶ 27. Petitioner arrives at a mean Tmax of 45 minutes by averaging data reported for patients 11 and 12, to the exclusion of other data reported for patients 1 through 10. Id. We discern no reason for Petitioner’s focus on those two particular patients, except that the exercise produces a result that falls within the mean Tmax range of claim 1. That exercise is fraught with hindsight bias. slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableDecided for patent owner
“We find insufficient Petitioner’s further argument, and Dr. Park’s testimony, that “a subgroup” of two patients—plucked from among the larger group of twelve patients for which data is reported in Table 2 of Ross US—makes obvious a mean Tmax of 45 minutes in a fentanyl formulation. Pet. 32 (focusing on patients 11 and 12); see Ex. 1005, Table 2 (reporting data for patients 1 through 12); see also Ex. 1002, ¶ 27. Petitioner arrives at a mean Tmax of 45 minutes by averaging data reported for patients 11 and 12, to the exclusion of other data reported for patients 1 through 10. Id. We discern no reason for Petitioner’s focus on those two particular patients, except that the exercise produces a result that falls within the mean Tmax range of claim 1. That exercise is fraught with hindsight bias.” slip op. at 9
§ 103 obviousnessPatents in suitUS 8,835,459 - Sata GmbH & Co. KG v. Anest Iwata CorporationInstitution deniedPTAB · Feb 19, 2016 · IPR2015-01790 · APJ Jennifer S Bisk · IPR · Institution
Institution was denied for claims 15–22 because the §101 theory is not a permissible IPR ground and the §102/§103 challenges were substantially the same as those in the prior petition.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We are not persuaded that this argument presents a proper basis for instituting an inter partes review. 35 U.S.C. § 311(b) states that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Petitioner does not explain how this theory, explicitly referring only to § 101, is a ground that could be raised under §§ 102 or 103 as required by § 311.” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“arguments in the Prior Petition. We note that Petitioner does not refer to any particular portion of these declarations, but instead almost exclusively cites to the declarations—each of which is more than 30 pages—in their entirety. See, e.g., Pet. 20–22, 39–40, 44. While this is a violation of 37 C.F.R. § 42.6(a)(3), it also fails to direct us to the portions of the declarations that support Petitioner’s argument. Without such direction, it is difficult to give the testimony any weight. Moreover, we do not discern that the wholesale citation to the entirety of the declarations here amounts to the identification “with particularity” of “the evidence that supports the grounds for the challenge to each claim.” See 35 U.S.C. § 312(a)(3). In this case, merely bolstering previously-made arguments that we found lacking, generally accompanied with non-specific evidence, does not change the argument sufficiently for us to consider the argument not “substantially the same” for the purposes of § 325(d).8 We note, in addition, that Petitioner does not indicate that the additional testimony and references were unavailable when the Prior Petition was filed. Though, Petitioner is not barred from providing additional information in a later petition, we are more likely to exercise our discretion under § 325(d) where a petitioner uses repeated petitions to in an attempt to build a sufficient challenge incrementally.” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot reached
“Pet. 3, 30–42. In the Prior Institution Decision, we determined that Petitioner had not met its burden to show that JP ’950 inherently discloses “said discharge end of said tip portion of said paint nozzle projects from 0.3 mm to 0.8 mm from said front end of said central opening in said air cap” (“the nozzle projection limitation”). 111 Inst. Dec. 10–11. In this Petition, Petitioner repeats the arguments of the Prior Petition, including that the nozzle projection limitation is “inherently disclosed in JP ’950 to a person of ordinary skill in the art to which this claim pertains.” Pet. 38; see also Pet. 31–32. In contrast to the Prior Petition, to support this assertion, Petitioner provides testimony from two declarants, Dr. Ewald Schmon (Ex. 1021) and Mark E. Charpie (Ex. 1032). Petitioner also refers to other prior art references as alleged corroboration of the inherency of this limitation. See Pet. 32 (“This claim limitation read on the JP ’950 drawings and disclosure as understood by a person of ordinary skill in the art to which this invention pertains. EXHIBIT 1004 pages 1–14. USP5456414 EXHIBIT 1013, Page 5.”).” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“not provided sufficient reasoning or facts on which to base a conclusion that a person of ordinary skill in the art would have found it obvious in light of JP ’950’s disclosure . . . to include the physical dimension of the downstream projection of the guide walls recited by claim 15. 111 Inst. Dec. 12. In this Petition, Petitioner repeats the arguments of the Prior Petition, including that a person of ordinary skill in the art would know, looking at the drawings of JP ’950, the amount of projection of the tip portion—and by implication, would find obvious the nozzle projection limitation. Pet. 44. In contrast to the Prior Petition, to support this assertion, Petitioner provides testimony from two declarants. Petitioner also refers to other prior art references as corroboration for the declarants’ testimony. See Pet. 44 (“Corroboration by Ransburg patents 5344078 EXHIBIT 1012 and 5456414 EXHIBIT 1013.”); Pet. 50 (“[C]laims 15–22 of the ’387 are unpatentable under 35 U.S.C. § 103 as obvious in view of the prior art, particularly JP ’950 in view of USP5456414 EXHIBIT 1013 showing forward projection of 0.508 mm. and in view of what is in the public domain Dr. Schmon Declaration EXHIBIT 1021.”). Again, Petitioner fails to cite to the specific testimony within the declarations, and also fails to provide a detailed discussion of how the cited prior art references corroborate this testimony.” slip op. at 6
§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 6,494,387 - Neptune Generics, LLC. v. Auspex Pharmaceuticals, Inc.Institution deniedPTAB · Dec 9, 2015 · IPR2015-01313 · APJ Lora M Green · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–10 were unpatentable under § 103(a).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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.” 35 U.S.C. § 314. 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 1–10. Accordingly, we decline to institute an inter partes review of the challenged claims.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We recognize that an obvious analysis requires us to consider whether an ordinary artisan would have had a reasonable expectation of success, not absolute predictability of success. In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). We agree with Patent Owner, however, that Petitioner has not demonstrated that the ordinary artisan would have combined Fogelman with Miwa with a reasonable expectation of arriving at the invention claimed by the ’317 patent. Although Fogelman teaches that ODV may account for 90% of the pathway for intrinsic clearance of VF (Ex. 1003, 483), Fogelman 9 Amanda Yarnell, Heavy Hydrogen Drugs Turn Heads, Again, 87(25) Chem, Eng. News 36–39 (2009). teaches also that ODV has a receptor affinity profile similar to its parent compound VF (id. at 481). As noted by Patent Owner (Prelim. Resp. 32), Petitioner has not explained, through evidence or adequate scientific reasoning, why the ordinary artisan would have wanted to prevent the metabolism of VF to its pharmaceutically active metabolite, ODV. Stated differently, because ODV is a desired metabolite, as it has the same pharmacological activity as its parent compound, VF, Petitioner has not explained why the ordinary artisan would have had a reason to prevent VF from being metabolized to ODV, rather than only preventing metabolism to a non-active metabolite, or make a substitution that would prevent the further metabolism of ODV.” slip op. at 13
- Obviousness (§103) › KSR rationalesNot shown unpatentable
“We agree. In In re O’Farrell, the Federal Circuit set forth two situations in which an “obvious to try” rationale was usually applied improperly. In re O’Farrell, 853 F.2d at 903. The first improper situation was to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful.” Id. The second improper situation was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” Id.; see also In re Kubin, 561 F.3d 1351, 1358–1360 (Fed. Cir. 2009) (noting that the rationale in O’Farrell was “affirmed in the logical inverse” in KSR, 550 U.S. at 417, in a statement that “§103 bars patentability unless ‘the improvement is more than the predictable use of prior art elements according to their established functions.’”). Based on the above framework, we conclude that it would not have been obvious to try to achieve the invention of claim 1 of the ’317 patent. As noted by Patent Owner (Prelim. Resp. 35), and not disputed by Petitioner (see Pet. 10–11), there are approximately 227-1, or 124,217,727 deuterated forms of VF, minus some number of forms which are equivalent due to symmetry or rotatable bonds. Although Petitioner contends that as P-450 enzymes act on two main sites of VF—that is, -OCH3 and –N(CH3)2, arguing that it would have been obvious to deuterate only those sites (Pet. 10–11)—as discussed above, the ordinary artisan would not have had a reasonable expectation that deuteration of those sites would result in enhanced bioavailability and maintaining the activity of VF for a longer period of time. Thus, the ordinary artisan would be left with trying the over 100,000,000 possible deuterated forms of VF until possibly arriving at a successful result.” slip op. at 20
- Additional discoveryAdditional discovery, deniedDenied
“III. PENDING MOTIONS Patent Owner filed a Motion for Additional Discovery (Paper 9). In addition, Petitioner filed a Motion to Seal (Paper 18), as well as a Motion to Expunge Paper 17 (Paper 19). We grant Petitioner’s Motion to Expunge. We deny Patent Owner’s Motion for Additional Discovery as moot in view of our denial of the Petition. Finally, as we did not rely on the material Petitioner sought to seal, we decline to address the merits of the Motion to Seal. Petitioner is authorized to file a motion to expunge any material that it seeks to keep confidential within thirty (30) days of the date of this decision, or within thirty (30) days of a decision on rehearing, if rehearing is requested.” slip op. at 22
§ 103 obviousnessPatents in suitUS 7,456,317 - Coalition For Affordable Drugs V LLC. v. Biogen Ma Inc.Rehearing deniedPTAB · Oct 23, 2015 · IPR2015-01136 · APJ Fred E Mckelvey · IPR · Rehearing
The Board denied the Petitioner’s rehearing request, leaving in place its decision not to institute because the petition did not establish a reasonable likelihood of success on the asserted obviousness theories.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“to be” on page 9 of the Decision. We gave more weight to pre-litigation statement by Kappos than to post-litigation conclusory expert testimony. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (holding that Board did not abuse its discretion in giving more weight to documentary evidence vis-à-vis witness testimony). Furthermore, as Patent Owner points out, the word “appear” is also synonymous with “seem” (http://www.merriam-webster.com/dictionary/appear), and is consistent with our statement that what counts is what is described, not what appears or seems to have been tested. Decision, page 9.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Decision misapprehended or overlooked Dr. Linberg’s statement that the Kappos 2005 dose-ranging study would not have been undertaken unless BG00012 had been determined to be therapeutically active in treating patients with MS and that the Decision cites no substantial evidence for interpreting Kappos in a fundamentally different way. The reference to “substantial evidence” is curious since “substantial evidence” is an appellate standard of review for fact finding. The argument should have been that our finding was not supported by a preponderance of the evidence. In any event, Petitioner, in effect, attempts to reargue a case it attempted to make out in the petition and fails to point out how we misunderstood Dr. Linberg’s testimony. Petitioner failed to explain adequately in the Petition why one of ordinary skill in the art, based on Kappos, would have understood that DMF was useful for treating multiple sclerosis (MS).” slip op. at 3
- Strike new argumentNew argument disregardedOther
“stating a fact, i.e., that DMF had been determined to be effective, which is why there would have been a reasonable expectation of success. The argument concerning reasonable expectation of success, as pointed out by Patent Owner in the opposition, is new and therefore could not have been overlooked. Keebler Co. v. Murray Bakery Products, 866 F.2d 1386, 1388 (Fed. Cir. 1989) (prescience is not a required characteristic of the board and the board need not divine all possible afterthoughts of counsel that might be asserted for the first time on appeal). Moreover, in our view Petitioner has not pointed out where there is a clear statement in Kappos 2005 that those skilled in the art knew that DMF was useful in treating MS.” slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“to be” on page 9 of the Decision. We gave more weight to pre-litigation statement by Kappos than to post-litigation conclusory expert testimony. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (holding that Board did not abuse its discretion in giving more weight to documentary evidence vis-à-vis witness testimony). Furthermore, as Patent Owner points out, the word “appear” is also synonymous with “seem” (http://www.merriam-webster.com/dictionary/appear), and is consistent with our statement that what counts is what is described, not what appears or seems to have been tested. Decision, page 9.” slip op. at 3
NonePatents in suitUS 8,399,514
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.