• 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
• Bj’S Wholesale Club Holdings, Inc. v. Walmart Apollo, LLCAll claims unpatentable
  PTAB · Apr 10, 2024 · IPR2022-01564 · APJ Patrick R Scanlon · IPR · Final written decision

  Claims 1–14 are unpatentable as anticipated by Keith; the Board did not reach the alternative obviousness ground over Hanson and Keith.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “claims of the later-filed application must be supported by the written description in the parent ‘in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.’” Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1335 (Fed. Cir. 2010) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)). “[T]he hallmark of written description is disclosure,” and the test “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” of that application. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)). “[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. But, “[i]t is not sufficient for purposes of the written description requirement of [35 U.S.C.] § 112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood, 107 F.3d at 1572.” slip op. at 33

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

    “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. Inc., v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). Moreover, “[b]ecause the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Whether a reference anticipates is assessed from the perspective of an ordinarily skilled artisan. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“‘[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.”). slip op. at 13

  • BurdenFwd all claims unpatentableDecided for petitioner

    “preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R. § 42.1(d) (2022). “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 12

  Patent outcomesUS 10,803,435 unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,803,435
• Apple Inc. v. Rfcyber Corp.All claims unpatentable
  PTAB · Jan 19, 2024 · IPR2022-01256 · APJ Kevin W Cherry · IPR · Final written decision

  Claims 1–11 are unpatentable as obvious over Buhot, GPC, and Zhu.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “earlier applications, in particular Application No. 11/534,653 (“the ’653 application”), which issued as U.S. Patent No. 8,118,218 B2 (“the ’218 patent”). “‘It is elementary patent law that a patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.’” PowerOasis, Inc. v. T- Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008). The test for determining compliance with the written description requirement under § 112(a) is whether the original disclosure of the earlier-filed application reasonably would have conveyed to one with ordinary skill in the art that the inventor had possession of the claimed subject matter at the time of the earlier-filed application. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). It is well settled that “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571−72 (Fed. Cir. 1997). “It is not sufficient for purposes of the written description requirement of § 112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Id. We agree with Petitioner there does not appear to be support for limitation [1(j)] in the ’653 application. We find that the disclosure of the ’653 application—limited to general teachings of a smart card, an operating system, and a smart card manager—is insufficient to show possession of limitation [1(j)]. See Ex. 2001 (’218 patent), 4:47–56. As we explained above, “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed.” Lockwood, 107 F.3d at 1571−72. The ’653 Application contains no disclosure of replacing applications, even if the disclosure might render such replacing obvious, it is not sufficient to show the possession required to establish entitlement to a priority date. Accordingly, we agree with Petitioner that the challenged claims of the ’724 patent are entitled to a priority date no earlier than March 4, 2012.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the declaration testimony of Mr. Smith, Petitioner contends that an ordinarily skilled artisan for the ’724 patent “would have had at least a bachelor’s degree in computer engineering, computer science, electrical engineering, or a related field, with at least one year of experience in the field of mobile payment technology. Additional pertinent education might substitute for the requisite experience and vice versa.” Pet. 6–7 (citing Ex. 1007 (Smith Decl.) ¶¶ 34–35). Patent Owner states that “[t]he parties agree on the level of skill in the art.” PO Resp. 11. Accordingly, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’724 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art).” slip op. at 11

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

    “Petitioner contends that it applies “the plain and ordinary meaning as understood by a [person of ordinary skill in the art] for all terms not expressly construed below,” and indicates that in parallel District Court litigation, the parties agreed to claim construction for the term “emulator device” to mean “hardware device, alone or containing software, that pretends to be another particular device or program that other components expect to interact with.” Pet. 8. Petitioner proposes that the term “application” should be construed to mean “‘software program suitable for being executed on a portable device,’” but that the “distinction between the parties’ respective proposals need not be resolved for this proceeding.” Id. at 8–9. Petitioner finally contends that the phrase “a portion of or in entirety” in each independent claim means “in its entirety or partially,” but not both. Id. at 9. Patent Owner submits that “[t]he parties agree that the Board should construe ‘emulator device’ as ‘hardware device, alone or containing software, that pretends to be another particular device or program that other components expect to interact with.’” PO Resp. 11. Patent Owner “does not believe that any other terms require construction to resolve the issues presented in this proceeding.” Id. We apply the agreed upon constructions above, but otherwise find that no express constructions are necessary for this decision.” slip op. at 12

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

    “We agree with Petitioner that, even if the applications were stored in “generic memory” as Patent Owner contends, Zhu provides adequate security and would not undermine Petitioner’s motivation to combine. See Intel, 61 F.4th at 1380 (“It’s not necessary to show that a combination is the best option, only that it be a suitable option.”). Indeed, Zhu addresses the problem Patent Owner contends it would cause in the combination.3 As Zhu 3 Patent Owner argues that Petitioner should be precluded from discussing Zhu’s encryption embodiment because it was not raised in the Petition. See Sur-Reply 6–7. We disagree. The claims do not recite anything about how the data should be stored. Thus, it is not surprising that the Petition did not address it. Patent Owner raised the teaching away argument regarding the security of the data. See PO Resp. 12–16. Petitioner relies on the exact same mapping, same motivation, and same arguments why Zhu accounted for certain limitations. See Reply 4–11. Petitioner’s Reply merely explained that Zhu did address the problem Patent Owner contended would “teach away” from the combination. Indeed, Patent Owner was aware of Zhu’s teachings and addressed them in their Patent Owner Response. The Federal recognizes, “[l]oading one of the smart card applications already resident on the smart card to another memory location on the mobile device can provide sufficient memory for the selected smart card application, but can also create a security problem.” Ex. 1006 (Zhu), 3:25–34. To address this problem, Zhu proposes encrypting these applications in generic memory which “reduces the possibility of unauthorized access to the information.” Id. at 3:59–61, 8:30–55, 9:28–33; Ex. 1033 (Smith Supp. Decl.) ¶¶ 5–6. Although acknowledging this disclosure, Patent Owner’s expert, Dr. Weaver, testifies that Zhu’s encryption is inadequate and that encryption would have certain drawbacks. See Ex. 2002 (Weaver Decl.) ¶ 69. We find this testimony, which directly contradicts the teachings of Zhu that encryption is an adequate solution, lacks sufficient support to be entitled to much weight. Dr. Weaver provides no citations to support his contention that a person of ordinary skill at the time of the invention would find encryption so inadequate or problematic as he now contends. Moreover, we find that Dr. Weaver’s testimony on cross examination provides an additional, independent basis to give this testimony little weight. On cross examination, Dr. Weaver contended that there was nothing uniquely inadequate about the particular encryption scheme disclosed in Zhu, but rather that his “opinion was more general, that encryption schemes known in the 2012 time frame were all breakable with computing power and time,” and thus, inadequate Circuit has explained that “the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the patent owner.” Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018). That is the case here, so we find that Petitioner’s arguments and evidence regarding Zhu’s encryption are proper. for storing payment applications in a mobile device’s general memory. Ex. 1027 (Weaver Tr.), 26:11–23; see also id. at 23:3–8 (“[D]oes encryption ever provide a sufficiently high security to permit storing payment application on a mobile device’s general memory? A. No”); 24:15–25:23 (testifying all publicly known encryption schemes in 2012 were breakable). However, when confronted with the fact that the ’724 patent discloses storing payment application on general baseband memory using an encryption method that was breakable, id. at 26:24–29:7, Dr. Weaver testified that this encryption method was sufficient to allow storing payment applications in general baseband memory even though it was “not perfectly secure,” id. at 29:8–14. Dr. Weaver provides no explanation or rationale why the encryption method in the ’724 patent, which he admits suffers from the same drawbacks he identified with respect to Zhu, is sufficient, but other encryption methods would not be sufficient. In its Sur-reply, Patent Owner attempts to rehabilitate Dr. Weaver’s testimony with justifications and qualifications not found in his original testimony. Sur-Reply 7–8. Yet, Dr. Weaver’s testimony discussed above was clear and unequivocal. See Ex. 1027 (Weaver Tr.), 24:15–29:14. Patent Owner made no effort to redirect his testimony at his deposition, so it cannot now do so through mere attorney argument. We find the inconsistency between Dr. Weaver’s treatment of Zhu and his treatment of similar disclosure in the ’724 patent exposes the insufficient reasoning supporting his opinions regarding the adequacy of Zhu’s use of encryption in the combination. Accordingly, we give no weight to his testimony that a skilled artisan would not have combined Zhu with a Buhot/GPC system due to security concerns. In contrast, we find the testimony of Mr. Smith regarding the use of encryption and the tradeoffs with the benefits of adopting Zhu’s memory management technique, which he offers in his Supplemental Declaration, to be well-reasoned, consistent with the disclosure of Zhu and the ’724 patent4, and entitled to substantial weight. See Ex. 1033 (Smith Supp. Decl.) ¶¶ 4–15. As Petitioner recognizes, “‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’” Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016). As Mr. Smith and Dr. Weaver testified, decryption without access to the security keys is an extremely computationally intensive and time-consuming process. Ex. 1033 (Smith Supp. Decl.) ¶¶ 6–8; Ex. 1027 (Weaver Tr.), 23:17–25:2; see also Ex. 10175, 132. Mr. Smith testifies that the benefits of using encryption would be sufficient to resolve the security concerns Patent Owner raises, and that any burden of generating a certificate would be outweighed by the benefits of using encryption and the memory advantages Zhu’s technique would offer. See Ex. 1033 (Smith Supp. Decl.) ¶¶ 4–15. Accordingly, we find that Patent Owner’s security concerns would be” slip op. at 25

  Patent outcomesUS 11,018,724 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,018,724
• 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
• Yantai Jereh Petroleum Equipment & Technologies Co., Ltd v. BJ Energy Solutions, LLCNo claims unpatentable
  PTAB · Feb 6, 2023 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Final written decision

  Claims 1–28 were not shown unpatentable on any asserted ground; the Board found the prior art failed to establish key limitations and rejected the enablement and indefiniteness challenges.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In reply, Petitioner argues that the ’764 patent’s control system is not complex as there are no detailed algorithms, logic, or software. Pet. Reply 4. Instead, the control system merely raises or lowers power of the pumps in accordance with the demand HHP of the job design. Id. (citing Ex. 1036, 97:15–98:18, 98:21–99:25, 100:1–101:25, 102:2–7, 115:4–9, 115:24–116:4, 116:17–22; Ex. 1001, 5:2–6, 6:36–7:7, 10:4–64). According to Petitioner, this “rudimentary control concept” does not necessitate the higher skill level proposed by Patent Owner. Id. Petitioner further notes that Dr. Adnan testifies that “a mechanical engineer who has worked in the industry developing programming and control systems could fall within this definition,” and the person of ordinary skill in the art “is ‘just a specifier.’” Id. (quoting Ex. 2003 ¶ 22; Ex. 1036, 161:21–164:18). Based on our review of the record before us, particularly the ’764 patent’s description and Dr. Adnan’s testimony, we agree with Petitioner that the ordinary level of skill in the art does not require the high level of specialized knowledge of control systems suggested by Patent Owner. Moreover, we find that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the evidence of record, including the asserted prior art. Accordingly, for the purposes of this Decision, we apply Petitioner’s definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Based on the full record, we are not persuaded that Mr. Marscher is unqualified to serve as an expert in this proceeding. As noted above, a person of ordinary skill in the art is not required to have been a fracturing operator. Patent Owner’s proposed definition does not even require experience as a fracturing operator. See PO Resp. 20–21. Furthermore, Mr. Marscher testifies that he has extensive experience developing pumps for fracturing applications. Ex. 2027, 6:24–8:7. Mr. Marscher also testifies that he has experience with control systems relating to pumps and pumps units. Id. at 212:19–23. This testimony, as well as his declaration and curriculum vitae, show that Mr. Marscher has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004. Accordingly, we are not persuaded that Mr. Marscher’s qualifications or experience provide reason to discount the weight associated with Mr. Marscher’s testimony.” slip op. at 10

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

    “In its Reply, Petitioner argues that the maximum power output value is the pump unit’s highest HHP output and one of ordinary skill in the art would have understood this value is the pump unit’s output power in intermittent duty. Pet. Reply 2–3 (citing Ex. 1003 ¶¶ 71–72, 123–124; Pet. 9–10; Ex. 1036, 64:17–67:13, 119:17–120:11, 124:7–24, 198:9–200:9, 221:8–222:15). However, even if Petitioner is correct that the “maximum power output value” is near or equivalent to a pump unit’s output power in intermittent duty, we are still not persuaded that the term “maximum intermittent power” should be tied to the “maximum power output value,” in conflict with the definition provided in the Specification. Petitioner also argues that Patent Owner’s proposed construction is indefinite. Pet. Reply 3. For the reasons discussed below (see supra § II.I.1), we determine that Petitioner has not shown by a preponderance of the evidence that the term “maximum intermittent power,” as defined in the Specification, is indefinite. Thus, based on the complete record before us, we maintain our prior construction of “maximum intermittent power” for this Final Written Decision.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “3. Additional Terms We determine that we need not expressly construe any other claim terms to resolve the parties’ disputes because doing so would have no effect on the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

  Patent outcomesUS 10,815,764 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,815,764
• 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
• Yantai Jereh Petroleum Equipment & Technologies Co., Ltd v. BJ Energy Solutions, LLCInstituted
  PTAB · Feb 8, 2022 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Institution

  The Board instituted PGR on claims 1–28 and all petition grounds, finding the Luharuka, API 674, and Karassik challenge more likely than not to prevail on claim 1.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 324(a), a post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2

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

    “These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in the range of approximately 70% to 100% of a maximum continuous power (MCP) level,” and “the second output power . . . being in the range of approximately 70% of the MCP level to approximately a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’764 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8

  • Skill levelOther

    “This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Lastly, on the current record, we disagree with Patent Owner’s argument that Mr. Marscher is not qualified to serve as an expert in this proceeding. See Prelim. Resp. 8. Mr. Marscher’s declaration and curriculum vitae show that he has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004.” slip op. at 11

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,815,764
• Yantai Jereh Petroleum Equipment & Technologies Co., Ltd v. BJ Energy Solutions, LLCInstituted
  PTAB · Feb 8, 2022 · PGR2021-00102 · APJ Patrick R Scanlon · PGR · Institution

  The Board instituted PGR on claims 1–28 on all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 324(a), a post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in a selected range of a maximum continuous power (MCP) level,” and “the second output power . . . being in a selected range of the MCP level to a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’459 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8

  • Skill levelOther

    “This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11

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

    “We agree with Patent Owner that Petitioner has not explained sufficiently what a “maximum power output value” means in the context of the ’459 patent. Nor has Petitioner explained sufficiently why “maximum intermittent power” should be tied to the “maximum power output value.” In contrast, Patent Owner’s proposed construction is supported by the Specification, although we do not agree with the last clause of the construction because the references to “typical” values do not assist in understanding the claim language. Accordingly, for purposes of this Decision, we preliminarily construe “maximum intermittent power” to mean “an elevated operating output level that the pump unit may operate intermittently throughout its operating life without excessive damage to the pump unit.”” slip op. at 14

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
  Patents in suitUS 10,907,459
• 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

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.