• Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentable
  PTAB · Jan 28, 2026 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 and 10–23 are unpatentable: the Board found claims 1–15 anticipated or obvious over the asserted grounds and claims 16–23 obvious over the Native combination.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 27–29). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “Patent Owner asserts that the preamble of independent claim 1, 16, and 20 reciting “a deodorant stick” is limiting” as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8

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

    “We find that the evidence of record fails to support Patent Owner’s argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claim 1.” slip op. at 22

  Patent outcomesUS 11,497,706 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,497,706
• Billerud Aktiebolag (Publ) v. Westrock MWV, LLCSome claims unpatentable
  PTAB · Mar 12, 2025 · IPR2023-01206 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1, 2, and 4–22 are unpatentable as obvious; claim 23 was not shown unpatentable. Substitute claims 25–26 are allowed, while 24 and 27 are denied for lack of written-description support.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “Exhibits 1013 and 1014 are also not admissible as expert testimony because Mr. Wirén is not “qualified as an expert by knowledge, skill, experience, training, or education.” Fed. R. Evid. 703. “To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art. Without that skill, the witness’ opinions are neither relevant nor reliable.” Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). Mr. Wirén does not meet our definition of a person of ordinary skill in the art. See Section II.B, supra. That definition is based on the undisputed testimony of Messrs. Zotterman and Klass. Ex. 1003 ¶ 24; Ex. 2003 ¶ 26. Although Mr. Wirén has a Master’s of Science in chemical engineering, he lacks any experience or specialization in paperboard manufacturing. Ex. 2011, 12:1–10, 19:6–25, 20:2–7. We therefore agree with Patent Owner that Exhibits 1013 and 1014 are the testimony of Mr. Wirén and should be excluded from evidence because Mr. Wirén is not a person of ordinary skill in the relevant art. PO MTE 5–6, 9; Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362 (Fed. Cir. 2008) (“Unless a patent lawyer is also a qualified technical” slip op. at 61

  • Skill levelSkill level board ownOther

    “Level of Ordinary Skill in the Art Based on the testimony of the parties’ witnesses, we determine that a person of ordinary skill in the art would have had a bachelor’s degree in paper science and engineering, chemical engineering, process engineering, mechanical engineering, or a related degree, with three to five years of experience in paperboard manufacturing, or a master’s degree in paper science and engineering, chemical engineering, process engineering, or mechanical engineering, or a similar field with a specialization in paperboard manufacturing. Ex. 1003 ¶ 24; Ex. 2003 ¶ 26. We find that the level of ordinary skill in the art, as articulated above, is consistent with the level of technical understanding and competence reflected in the ’142 Patent Specification and the asserted prior art references.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner

    “A claim construction that excludes a particular element is viewed as a “negative limitation.” Ethicon LLC v. Intuitive Surgical, Inc., 847 Fed. App’x 901, 907 (Fed. Cir. Mar. 15, 2021). “[S]uch exclusions must find support either in ‘the words of the claim’ or through an ‘express disclaimer or independent lexicography in the written description that would justify adding that negative limitation.’” Id. (citing Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366–67 (Fed. Cir. 2002)). “The standards for finding lexicography and disavowal are exacting.” GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014). “To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term,’ and ‘clearly express an intent to define the term.’” Id. (citing Thorner, 669 F.3d at 1365). Similarly, disclaimer or disavowal requires that the specification or prosecution history demonstrate that the invention does not include a particular feature. Id. Here, we find no claim language, lexicography, or disclaimer in the ’142 Patent or its file history that would support defining a “hot-hard calender” as requiring that only one of the two rollers be heated to an elevated temperature.” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “a contact surface of said thermo-roller is heated to an elevated temperature of at least 250°F.” Petitioner shows persuasively that the temperature limitation is taught by the combination of Fugitt and Papermaking. Pet. 32–34. Fugitt discloses that “[t]he rolls of the calender may be steam heated.” Ex. 1004 ¶ 26. In a section titled “Heated Rolls,” Papermaking discloses that “Steam can be used up to 170°C [338°F] surface temperature.” Ex. 1010, 95, 98. Petitioner is thus correct that, “[w]hile Fugitt teaches that a hot calender may be steam heated, Papermaking clarifies that one of ordinary skill in the art would understand that steam heated thermo-rollers may reach up to 338°F.” Pet. 36. Based on these disclosures, we are persuaded by Mr. Zotterman’s testimony that it would have been “obvious to heat the thermo-roller of Fugitt to at least 250°F.” Ex. 1003 ¶ 159. combine Fugitt and Papermaking because of Papermaking’s status as a “trusted handbook[],” because both references disclose a method of manufacturing a paperboard structure with hot calendering,” and “because of the known advantages of heated rollers.” Pet. 36–37; Ex. 1003 ¶¶ 157, 159, 162. Petitioner’s contention is supported by Papermaking’s disclosures that, for cartonboard, “[p]recalendering is used before the coater to reduce roughness and porosity” and “[h]igh thermo roll temperatures (in some cases over 200°C) result in bulk savings because of the temperature gradient.” Ex. 1005, 80–82; see also Pet. 38; Ex. 1003 ¶ 164 (citing these disclosures). Papermaking’s disclosed range of “up to 170°C [338°F]” for steam- heated rolls (Ex. 1010, 98), overlaps the claimed range of “at least 250°F.” Patent Owner agrees. Tr. 27:11–13. “If the relevant comparison between a disputed claim limitation and the prior art pertains to a range of overlapping values, ‘. . . even a slight overlap in range establishes a prima facie case of obviousness.’” Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1341 (Fed. Cir. 2020) (citing In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)). “[S]uch an overlap creates a presumption of obviousness, and . . . the burden of production falls upon the patentee to come forward with pertinent evidence that the overlapping range would not have been obvious in light of the prior art.” Id. (citing E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006, 1008 (Fed. Cir. 2018)). slip op. at 21

  Patent outcomesUS 11,293,142 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,293,142
• Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.All claims unpatentable
  PTAB · Jan 16, 2024 · PGR2021-00030 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1–5, 9, and 10 are unpatentable for lack of written description, lack of enablement, indefiniteness, and anticipation by Ogitani.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “respective definitions for the level of ordinary skill in the art. While there seems to be a slight difference in whether the ordinary artisan has ADC design experience obtained after a master’s degree or postdoctoral, neither party provides clear basis to explain how this will impact the analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior” slip op. at 10

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

    “III. CLAIM CONSTRUCTION We interpret claim terms using “the same claim construction standard” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “4. Analysis We note that “[i]t is not sufficient for purposes of the written” slip op. at 23

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “4. Analysis The facts here are consistent with the situation in Amgen, which” slip op. at 76

  Patent outcomesUS 10,808,039 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Phillips · Nautilus
  Patents in suitUS 10,808,039
• Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.Rehearing granted
  PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing

  The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

    “institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

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

    “35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, 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.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17

  Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
  Patents in suitUS 10,808,039
• Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.Rehearing granted
  PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing

  Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

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

    “3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted

    “skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24

  Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
  Patents in suitUS 10,808,039
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jul 28, 2020 · PGR2019-00027 · APJ Grace Karaffa Obermann · PGR · Final written decision

  Claims 1–29 are unpatentable as obvious over Harden combined with one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge was not proven.

  RulingsFinal written decision

  • BurdenUnpatentable

    “Based on the full trial record, we find that Petitioner demonstrates by a preponderance of the evidence that the subject matter of claim 1 would have been obvious. Varenna 2011 teaches that neridronate “seems to possess an excellent efficacy profile” in treating CRPS. Ex. 1006, 233. In the context of reporting the use of “[n]eridronic acid for the treatment of bone metabolic diseases,” Gatti teaches that “[i]ntravenous high doses of bisphosphonates are increasingly used for the treatment of [CRPS].”13 Ex. 1008, 1305, 1308. Gatti also reports that a clinical trial of neridronic acid “is underway.” Id. Muratore teaches that neridronate was “efficacious in the treatment of [CRPS].” Ex. 1007, 89. Thus, on this record, each of these references sufficiently teaches the efficacy of neridronic acid or its salt in treating CRPS, suggesting that a person of ordinary skill in the art would have been motivated to use neridronic acid in treating CRPS. With respect to the limitation of claim 1 requiring that the neridronic acid be “parenterally administer[ed],” each of Varenna 2011, Gatti, and Muratore teaches intravenous administration of neridronic acid. Ex. 1006, 233; Ex. 1007, 89; Ex. 1008, 1308. Intravenous administration is a type of parenteral administration. Ex. 1004 ¶ 44. 13 Gatti uses the terms “reflex sympathetic dystrophy syndrome” and “algodystrophy.” Ex. 1008, 1308. On the present record, we interpret both of these terms as synonymous with “complex regional pain syndrome,” “CRPS,” “complex regional pain syndrome type I,” “CRPS I,” “reflex sympathetic algodystrophy,” “reflex sympathetic dystrophy,” and “causalgia.” Ex. 1006, 227 (equating “algodystrophy,” “complex regional pain syndrome type I,” and “CRPS I”); Ex. 1007, 89 (using the term “reflex sympathetic algodystrophy”); Ex. 1019, 713 (equating “complex regional pain syndrome,” “CRPS,” “reflex sympathetic dystrophy,” and “causalgia”). Harden teaches that the Budapest Criteria are used as “clinical diagnostic criteria for CRPS” and that they include changes in skin blood flow, by reference to the symptoms of “temperature asymmetry” and “skin color asymmetry.” Ex. 1009, 274 (Appendix II). Further, Harden teaches that 69.4% of patients diagnosed with CRPS were observed on examination to exhibit temperature asymmetry, and 83.9% were observed on examination to exhibit skin color asymmetry. Id. at 271 (Table 2). Thus, Harden teaches that a majority of patient with CRPS suffer from changes in skin blood flow. Because Varenna 2011, Gatti, and Muratore teach that neridronic acid is effective in treating CRPS, the combination of any of those references with Harden14 would have suggested to a person of ordinary skill in the art that neridronic acid would be effective in alleviating changes in skin blood flow associated with CRPS. Thus, the combination of Harden and one or more of Varenna 2011,” slip op. at 26

  • ExcludeMotion to exclude, deniedMixed

    “Assuming that “October 2011” is hearsay, it is still admissible evidence under Rule 807 of the Federal Rules of Evidence. See Opp. Mot. 3–4 (asserting this hearsay exception). Under Rule 807, a statement “is not excluded,” even if it is hearsay, if it meets two requirements. First, the statement must be “supported by sufficient guarantees of trustworthiness— after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement.” Fed. R. Evid. 807(a)(1). Second, the statement must be “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Id. at 807(a)(2). Here, both requirements are satisfied. The statement “October 2011” on the face of Varenna 2011 is offered to prove that Varenna 2011 was published in October 2011. This statement is accompanied by several guarantees of trustworthiness. The statements “Received on July 15, 2011” and “Accepted on August 30, 2011,” when offered as corroboration of the October 2011 publication date, are not hearsay. Fed. R. Evid. 801 (statement is hearsay only if offered in evidence “to prove the truth of the matter asserted in the statement”). Accordingly, they may be admitted for this purpose, and they corroborate a publication in October 2011. Moreover, Exhibits 1038 and 1040 also provide some evidence that Varenna 2011 was published in October 2011. Ex. 1038, 1 (article with same title as Varenna 2011 published in “Fascicolo 5 2011”); Ex. 1040, 1 (“Fascicolo 5 2011” published in 2011). Thus, the record contains sufficient guarantees of trustworthiness of Varenna 2011’s statement that Varenna 2011 was published in October 2011. See Opp. Mot. 3 (citing Ex. 1004 ¶¶ 39–40). We find that Varenna 2011’s statement, indicating that the reference was published in October 2011, is “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Fed. R. Evid. 807(a)(2). It is difficult to imagine evidence more probative of the publication date of a journal article than the article’s own contemporaneous statement about when it was published.19 See Opp. Mot. 2–4 (for well-supported arguments on point). Accordingly, we determine that the exception of Rule 807 applies, and we conclude that the statement “October 2011” in Varenna 2011 should not be excluded.” slip op. at 48

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 9

  Patent outcomesUS 10,039,774 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 10,039,774
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jul 28, 2020 · PGR2019-00026 · APJ Grace Karaffa Obermann · PGR · Final written decision

  Claims 1–30 are unpatentable as obvious over Harden and one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge fails.

  RulingsFinal written decision

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

    “INTRODUCTION A. Background Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting a post-grant review of claims 1–30 of U.S. Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Antecip Bioventures II LLC (“Patent Owner”) did not file a Preliminary Response. We instituted review of all challenged claims on each of the grounds asserted in the Petition. Paper 6 (“Dec. Inst.”).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’352 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1001, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’352 patent, “[a] method of treating” hyperalgesia (claim 1) or edema (claim 17) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from hyperalgesia (claim 1) or edema (claim 17) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1001, 90:39–43, 91:23–27, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting, and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “Petitioner’s asserted references provides data showing that administering neridronic acid improves the symptoms of CRPS. PO Resp. 18–19. But “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011, Gatti, and Muratore would have informed the ordinarily skilled artisan that successful treatment of CRPS and its symptoms was likely; there is no requirement that Petitioner show that the prior art taught that success was certain.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “qualifies as a printed publication under 35 U.S.C. § 102. PO Resp. 4–17; PO Sur-Reply 14–21. “To qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are two ways to show that a reference was sufficiently accessible: show it was disseminated or show it was “otherwise made available to the extent that” interested people of ordinary skill in the art could have located it after exercising reasonable diligence. Id. Here, according to Petitioner, the asserted references “are articles published in periodical journals by an identified and reputable publisher.” Reply 3.11 Petitioner argues that the references were “disseminated on the[ir] stated publication date[s].” Id. at 5. We agree.” slip op. at 18

  Patent outcomesUS 9,931,352 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 9,931,352
• Donghee America, Inc. / Donghee Alabama, LLC v. Plastic Omnium Advanced Innovation And ResearchAll claims unpatentable
  PTAB · Dec 11, 2018 · IPR2017-01605 · APJ Christopher M Kaiser · IPR · Final written decision

  Claims 1–3, 7, 11, 12, and 14 are unpatentable: claims 1–3, 12, and 14 are anticipated by Linden, and claims 7 and 11 are obvious over Linden and Hata.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “article whose surface has at least one empty or concave part.” Id. at 11 (citing Ex. 1001, 1:66–67; Ex. 1007 ¶ 15). Patent Owner agrees. PO Resp. 15. The ’253 patent states that “[t]he term ‘hollow body’ is understood to mean any article whose surface has at least one empty or concave part.” Ex. 1001, 1:66–67. Where an inventor defines specific terms used to describe an invention, we will give effect to those definitions, as long as they are set out “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Here, the phrase “is understood to mean,” as used in the ’253 patent, signals that the inventor presents a clear, deliberate, and precise definition. Accordingly, we interpret “hollow body” as having the definition given it in the ’253 patent, “any article whose surface has at least one empty or concave part.”” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “supporting its proposed construction of “incorporate” as “insert.” First, Petitioner argues that the language of the ’253 patent requires a construction of “incorporating” as encompassing “inserting” rather than as limited to “attaching.” Reply 2–4. Both parties argue that the “incorporating” recited in the challenged claims must occur before the mold closes to form the hollow body. PO Resp. 16; Reply 2–3. We agree. Ex. 1001, 6:2–14 (“. . . after said step of incorporating, closing said mould . . .”). Thus, it is important to note the processes that the ’253 patent describes as occurring before, during, and after mold closure. Because “incorporating” must occur before mold closure, the process of “incorporating” may not be limited to any process that the patent describes as occurring during or after mold closure. Petitioner is correct that the ’253 patent describes a process in which a preassembled structure for supporting an accessory “may . . . be fastened by welding to the wall of the hollow body, upon closing the mould,” i.e., during, not before, mold closure. Ex. 1001, 4:23–30. Thus, the language of the ’253 patent does not support construing the term “incorporating” as limited to “attaching.” Petitioner also argues that both parties agreed in the related infringement suit in District Court that the proper construction of “incorporating” under the Phillips standard, used in that forum, was “inserting.” Reply 7–8 (citing Ex. 1010, at Ex. A, 4). Specifically, in that litigation, Patent Owner agreed that the correct construction of “incorporating at least one of an accessory or a duct within the hollow body” was “inserting an accessory or duct into the hollow body.” Ex. 1010, at Ex. A, 4. Here, we apply the broadest-reasonable-interpretation standard. 37 C.F.R. § 42.100(b) (2016). “The broadest reasonable interpretation of a claim term may be the same as or broader than the construction of a term under the Phillips standard. But it cannot be narrower.” Facebook, Inc. v. Pragmatus AV, LLC, 582 F. App’x 864, 869 (Fed. Cir. 2014) (non-precedential). Here, for the term “incorporating,” Patent Owner’s proposed broadest reasonable interpretation (“attaching”) is narrower than the Phillips construction Patent Owner has advanced (“inserting”). Thus, “attaching” cannot be the broadest reasonable interpretation of “incorporating.” Other than Patent Owner’s proposed “attaching” construction, the only construction the parties have proposed either in this case or in the related District Court case is Petitioner’s proposed “inserting” construction. PO Resp. 15–20 (discussing only “inserting” and “attaching” constructions); Reply 2–9 (Petitioner arguing in favor of “inserting”); Ex. 1010, at Ex. A, 4 (both parties proposing “inserting”). The ’253 patent supports such a construction, because it describes at least some of its embodiments as involving only insertion of an object between the sheets that will form the hollow body before mold closure. Ex. 1001, 4:23–30. Accordingly, for the foregoing reasons, we adopt Petitioner’s proposed construction of “incorporating” as “inserting.”” slip op. at 10

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Finally, Patent Owner directs us to the testimony of Professor Tim Osswald as support for its view that “incorporate” should mean “attach.” PO Resp. 16 (citing Ex. 2001 ¶¶ 40–42). In relevant part, this testimony states that, “[a]fter reading the specification of the ’253 patent, one of ordinary skill in the art would understand and interpret the word ‘incorporating’ to mean ‘fastening’ or ‘attaching’ so that the accessory or duct becomes part of the hollow body.” Ex. 2001 ¶ 42. Professor Osswald does not cite any evidence in support of his testimony. “[C]onclusory, unsupported assertions by experts as to the definition of a claim term are not useful.” Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (en banc). Accordingly, we give little weight to Professor Osswald’s statement regarding the proper construction of “incorporate.” See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he [PTAB] is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations . . . .” (citations omitted)).” slip op. at 9

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

    “preform which has at least one opening for that purpose, to be applied to the inside surface of the wall of the expanded hollow body.” Id. at 3:62–4:3. Patent Owner argues that this teaching is insufficient to disclose attaching the surge cup to the wall of the hollow body before the mold closes. PO Resp. 23–24. We agree that Linden does not teach attaching its accessory to the inside wall of the fuel tank before the mold closes around the preform. Instead, in Linden, the mold halves are closed around the preform and the mandrel, and “a suitable blowing agent . . . is introduced under pressure” through the mandrel, causing the preform to expand to press “against the inside wall defining the mold cavity,” and only then is the holding means for the accessory displaced to be brought into contact with the inner wall of the expanded preform, welding the holding means to the wall. Ex. 1003, 7:27–55, 8:11–29, Figs. 1–3. But, as discussed above, we disagree with Patent Owner about the proper construction of “incorporating” in the challenged claims. Claim 1 requires only that an accessory or a duct be “incorporat[ed] . . . within the hollow body” before mold closure occurs, and we construe “incorporating” to mean “inserting,” without requiring “attaching.” Thus, it is unimportant that Linden fails to teach attaching the surge cup to the wall before mold closure. All that is required is that Linden disclose inserting the surge cup into the preform before mold closure, and Linden does disclose this. Id. at 3:62–4:3, 7:27–49, Figs. 1–3. The next question is whether Linden discloses “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” As discussed above, Linden discloses closing the mold halves after placing the additional body within the preform. But Linden discloses that “[a]t its lower end the preform 28 is pressed around the mandrel 14 by virtue of closure of the mold halves 10a and 10b.” Id. at 7:40–42, Fig. 2. Because mandrel 14 is hollow, id. at 6:35–39; 6:46–54, it is not completely clear that closure of Linden’s hollow body around mandrel 14 necessarily eliminates any interface between the additional body inside Linden’s hollow body and the atmosphere outside the hollow body. On the other hand, the closure of the mold described in the ’253 patent occurs with blowing nozzle 6 “positioned between the two parts of the [mold],” and “blowing air is injected under pressure via the nozzle,” which is quite similar to the use of hollow mandrel 14 in Linden. Ex. 1001, 5:50–57. Given the similarity between Linden’s method and the method described in the ’253 patent, we determine that Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring the step of, “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” The final question with respect to claim 1 is whether Linden discloses that the additional body incorporated within the hollow body “is supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.” Petitioner argues that Linden’s “[h]olding means 24 is a preassembled structure” in which “leg members 44, 45” have “enlarged foot portion[s] 36.” Pet. 18 (citing Ex. 1003, 9:23–34). We agree. “[H]olding means 24 . . . substantially comprises first and second support or leg members 44, 45,” and “support or leg members 44, 45 are each provided with an enlarged foot portion 36 of substantially plate-like configuration.” Ex. 1003, 9:23–34. Even if Linden’s holding means 24 were not in the aggregate the recited “preassembled structure,” each leg member 44, 45, taken together with its respective foot portion 36 is. Ex. 1001, 4:26–28 (describing a “preassembled structure” as “for example, an arm provided with a tab for fastening to the wall of the hollow body”). Linden’s “foot portions 36 are pressed against the inside surface, which is still hot and thus plastic, . . . of the hollow body . . . thereby to produce a welded joint between the foot portions 36 and the inside surface.” Id. at 9:34–42. Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring that the accessory or duct be “supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.”” slip op. at 19

  Patent outcomesUS 7,166,253 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 7,166,253

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.