- Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,497,706 - Ascend Elements, Inc. v. Duesenfeld GmbHInstitution deniedPTAB · Oct 10, 2025 · PGR2025-00037 · APJ Kevin W Cherry · PGR · Institution
The Board denied institution of PGR on claims 1–14 because Petitioner did not show that any challenged claim was more likely than not unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–14 of the ’463 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–14 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art “would have had at least a Bachelor’s degree in electrical engineering, material science, chemical engineering, or an equivalent field, as well as at least 2 to 3 years of academic or industry experience in the recycling or processing of lithiumion batteries. Additional formal education focusing on processing of lithium batteries may substitute for practical experience and additional practical experience can substitute for less education.” Pet. 10–11. Patent Owner does not contest this definition of a person of skill in the art. See Prelim. Resp. 11. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as, on the present record, it appears consistent with the ’463 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“distinct from “comminute[ion],” Petitioner offers only the testimony of its expert, Mr. Juzkow, who equates Tomioka’s “cutting” with “comminute[ion].” See Ex. 1003 ¶ 121. However, Mr. Juzkow provides insufficient reasoning to support his conclusion, particularly given the intrinsic and extrinsic evidence discussed above. In contrast, Patent Owner’s expert, Mr. Dantam, provides extensive reasoning, supported by citations to other evidence, to support his conclusion that Tomioka’s “dismantling” is not the claimed “comminution.” Thus, we give more weight to Mr. Dantam’s testimony than Mr. Juzkow’s testimony. Weighing this evidence all together, we find that Petitioner has failed to show that it is more likely than not that Tomioka’s teaches the claimed comminution under Petitioner’s first theory.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundTeaching away not foundNot shown unpatentable
“obvious. Pet. 34–35. However, we agree with Patent Owner that Petitioner has also failed to show that it is more likely than not that Tomioka renders this limitation obvious. See Prelim. Resp. 28–31. To begin with, Petitioner’s contentions lack sufficient reasoning explaining why a person of ordinary skill would have modified Tomioka in the manner proposed. “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Petitioner merely asserts that a person of ordinary skill in the art could use the roller system in place of the dismantling disclosed for the embodiments in Figures 19 and 20. On this record, we find this bare contention insufficient. actual disclosure of Tomioka. The rollers in Tomioka are used to separate the “battery body” from the “resin package enclosing the battery body,” and Tomioka specifically discloses that this technique is designed to “avoid damaging the battery body.” Ex. 1005 ¶¶ 25, 26, 29; Ex. 2011 ¶¶ 72–73. Thus, there is a significant difference between what Tomioka teaches and what Petitioner proposes to use the roller system to do. In addition, as Patent Owner points out, Tomioka specifically discloses there are risks associated with mechanically crushing battery packs, such as “risk of sparking due to residual voltage if the battery units are damaged in the process.” Ex. 1005 ¶ 5. Although we do not agree with Patent Owner that this amounts to a “teaching away,” see In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), we do believe that this teaching suggests a trade off that should be weighed in determining whether to make the modification, see Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). However, Petitioner has failed to account adequately, if at all, for this trade off. Thus, we find that Petitioner has failed to show that it is more likely than not that Tomioka accounts for the claimed “comminuting.”” slip op. at 15
§ 103 obviousness§ 112 disclosurecites Phillips · Graham · NautilusPatents in suitUS 12,119,463 - Billerud Aktiebolag (Publ) v. Westrock MWV, LLCSome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,293,142 - Ecto World, LLC / Sv3, LLC v. Rai Strategic Holdings, Inc.Institution deniedPTAB · Mar 10, 2025 · PGR2024-00049 · APJ Jo-Anne M Kokoski · PGR · Institution
The Board denied institution because Petitioner did not show the patent was eligible for PGR; the challenged claims were supported by the 2006 priority application.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we determine that Petitioner does not demonstrate that it is more likely than not that the challenged claims lack written support in the Specification (and the ’634 application). That is, on this record, it appears that the challenged claims properly claim priority to the ’634 application and, accordingly, have an effective filing date in October 2006. 2. Conclusion: PGR Eligibility For the foregoing reasons, and based on the record before us, we determine that Petitioner has not demonstrated that it is more likely than not that the ’202 patent has, or had, at least one claim having an effective filing date on or after March 16, 2013. Accordingly, we determine that the ’202 patent is entitled to the filing date of the ’634 application (October 18, 2006), and, thus, the ’202 patent is not eligible for post-grant review.” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner
“Accordingly, the ’202 patent consistently and repeatedly characterizes the invention as incorporating tobacco in some form and ties the stated benefits of the invention to the inclusion of tobacco. Moreover, the Specification is directed to smoking articles containing tobacco, all of the embodiments include tobacco, and “the present invention” is described as a smoking article, where the smoking article includes tobacco. Consequently, we determine that “smoking article” as it is used in the challenged claims is limited to devices that include tobacco. See Mosaic Brands, Inc. v. Ridge Wallet LLC, 55 F.4th 1354, 1361 (Fed. Cir. 2022) (finding claimed “lip” is limited to “extrudable plastic materials” where specification states that “the device of the present invention is constructed of extrudable plastic materials” and “emphasizes the benefits of using extrudable plastics and describes them as benefits of the invention as a whole”); Poly-Am., L.P. v. described in the specification has inwardly extended short seals and every section of the specification indicates the importance of inwardly extended short seals. These two facts provide together a proper reason to limit the claims in this way.”); Phillips v. AWH Corp., 415 F.3d 1303, 1312–1317 (Fed. Cir. 2005) (en banc) (“[T]he specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor. In that instance as well, the inventor has dictated the correct claim scope, and the inventor’s intention, as expressed in the specification, is regarded as dispositive.”).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateNot shown unpatentable
“Petitioner’s argument is dependent on accepting Petitioner’s assertion that the claims include a smoking article that does not contain tobacco, which we have not done. Instead, as set forth above, we construe “smoking article” as being limited to devices that include tobacco. See § II.B.2, supra. Based on our construction of “smoking article” and the evidence of record in this proceeding, we determine that the challenged claims are supported by the specification of the ’202 patent, which is identical to the specification of all of the continuations in the chain leading back to the October 18, 2006 that the specification of the ’202 patent and every patent in its priority chain “have identical specifications”); Prelim. Resp. 13 (noting that Petitioner does not identify other limitations in the challenged claims “allegedly lacking support in the ’202 patent family’s applications dating back to U.S. App. No. 11/550,634, filed on October 18, 2006”). Accordingly, we determine that Petitioner does not demonstrate that it is more likely than not that the challenged claims lack written support in the Specification (and the ’634 application). That is, on this record, it appears that the challenged claims properly claim priority to the ’634 application and, accordingly, have an effective filing date in October 2006.” slip op. at 17
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,925,202 - Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites Phillips · NautilusPatents in suitUS 10,808,039 - 3M Company v. Bay Materials, LLCInstitutedPTAB · Jan 18, 2023 · IPR2022-01215 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted inter partes review of claims 1–4, 7, 11–14, 18, and 31 on all asserted grounds, finding at least one claim sufficiently shown anticipated by Yu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Petition includes detailed arguments that map the limitations of the challenged claims to specific disclosures in Yu (Sample 1). Id. at 50–62. The Petition also maps adequately the limitations of the challenged claims to specific disclosures in Stewart (Example 2). Id. at 62–66. For example, Petitioner shows sufficiently that Yu (Example 1) coextrudes “a multilayered polymeric film,” that is, a “sheet,” arranged in the hard-soft-hard-soft-hard, five-layer configuration required by claim 11. Pet. 50–51; Ex. 1002 ¶¶ 124, 126–128; Ex. 1012 ¶¶ 63, 78, 92. Petitioner also shows sufficiently that the hard layers in that configuration of Yu (Example 1) are “hard” and the hard layers are “hard” within the meaning of claim 11. Pet. 53; Ex. 1002 ¶ 131; Ex. 1012 ¶ 78. In other words, Petitioner shows sufficiently, on this record, that Yu (Example 1) anticipates claim 11. Based on the information presented, we find that Petitioner shows sufficiently, for purposes of trial institution, that at least one challenged claim of the ’263 patent is anticipated by Yu (Sample 1).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“That prior art disclosure of elastomeric materials for use as the outer layers in an unclaimed and disfavored soft-hard-soft layer configuration does not convey, with reasonable clarity, that the inventors had possession of the claimed subject matter, in which the elastomeric material forms the inner layer of a polymeric sheet in a hard-soft-hard layer configuration. See id. ¶¶ 7, 33–35, 109–110. Even if the hardness limitation of the challenged claims would have been obvious from the relied-upon disclosure of the ’176 application (Ex. 2001 ¶ 109), that circumstance is insufficient to establish written description support. “Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (quotations omitted); see Pet. 21 (quoting that precedent). Accordingly, we agree with Petitioner that the invention that Patent Owner seeks to protect in the ’263 patent does not appear to be “part of the invention” described in the ’176 application. Pet. 40; see Ex. 2001 ¶ 109 (describing elastomeric materials, having the specified hardness, only in the context of an unclaimed prior art soft-hard-soft embodiment). On this record, we preliminarily agree with Petitioner that the earliest effective filing date to which the ’263 patent appears to be entitled is December 18, 2019, namely, the filing date of the ’256 application, from which the ’263 patent issued. Ex. 1001, codes (21), (22). Patent Owner may contest this issue in a timely response to the Petition.” slip op. at 9
- Skill levelNot reached
“The parties disagree about whether the ordinarily skilled artisan would have had specific “experience with dental appliances or access to individuals with such experience.” Prelim. Resp. 17; see Pet. 14–15 n.1 (disagreeing with that proposition). Neither party explains why a resolution of that Stat. 284 (September 16, 2011), includes revisions to Section 102(a) that became effective on March 16, 2013. For reasons explained in this Decision, on this record it appears Petitioner is correct that the challenged claims are entitled to an effective filing date no earlier than December 18, 2019 and, therefore, the AIA provisions apply in this proceeding. See Pet. 22, 39–40; Ex. 1001, code (60). 2 WO 20010/043419 A1, published Apr. 22, 2010, with English Translation (Ex. 1015). 3 We take notice that the first and second grounds identified in the Petition assert anticipation based on the same prior art disclosure. 4 US Pub. 2004/0224283 A1, published Nov. 11, 2004 (Ex. 1008). dispute is necessary to this Decision to institute review. See, e.g., Prelim. Resp. 17 n.2 (“even under Petitioner’s proposed definition, the Petition fails to show a reasonable likelihood that any claim is unpatentable”); Pet. 14–15 & n.1 (arguing about the issue without explaining how a resolution of the dispute would change the outcome of the decision on institution). If either party believes that the difference in level of skill would have a material effect on the analysis of the patentability of the challenged claims, that issue should be specifically addressed in briefing during the trial. We will resolve that dispute only to the extent necessary in any final written decision. Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). “Petitioner discusses the terms “layer A,” “layer B,” “layer C,” “layer C,” “layer B',” inner layer B,” “inner layer B',” and “inner layer D.” Pet. 15–20. Patent Owner discusses the terms “layer” and “inner.” Prelim. Resp. 19–22. Taking account of the information presented, we determine that no claim term requires express construction for purposes of deciding whether to institute review. Compare Pet. 15–20 (addressing issues of claim construction, without demonstrating that an express construction is necessary to resolve whether to institute review), with Prelim. Resp. 19–22 (same).” slip op. at 7
Claim construction§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,870,263 - 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 PhillipsPatents in suitUS 10,808,039 - 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 PhillipsPatents in suitUS 10,808,039 - Beckman Coulter, Inc. v. Sysmex Corporation And Sysmex America, Inc.All claims unpatentablePTAB · Feb 18, 2022 · IPR2020-01503 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 7–15 are unpatentable as obvious over Nagai and Jagtiani; the priority applications lack written-description support for the claimed electrical detection and cell-counting combination.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Institution Decision, we determined that Petitioner’s definition was consistent with the disclosure of the ’351 patent and the scope and content of the asserted prior art to the extent that Petitioner’s definition requires familiarity with the design and operation of automated hematology analyzers available in the market. Dec. 8 (citing Ex. 1001, 1:45–61, 15:52– 58). We also determined that Petitioner’s proposal was more reasonable than Patent Owner’s with respect to the duration of a POSA’s practical experience, whether such practical experience is in addition to or possibly as experience could be merely using hardware and/or software for an analyzer, as opposed to developing such hardware and/or software. Id. at 8–9. Neither party contends that the differences in proposals affect the outcome of this proceeding, and we find that they do not. Nonetheless, on the full record now before us, we find that our identification of the level of ordinary skill in the art in the Institution Decision, modified to state that a higher level of experience can compensate for less technical education, is supported by the ’351 patent, the prior art of record, and the opinions of Mr. Roche and Dr. Robinson (which, as discussed above, recognize that additional work experience can compensate for technical education). Thus, we find that a POSA would have had at least a Bachelor’s or Master’s degree in biologic science, biomedical engineering, and/or electrical engineering or a related field and at least five years of experience in developing hardware and/or software for hematology analyzers, and would have been familiar with the design and operation of hematology analyzers available in the market. We also find that less technical education may be compensated by a higher level of experience, or vice versa.” slip op. at 10
- Prior constructionPrior construction adoptedDecided for petitioner
“a controller programmed to,” “optical detector,” “electrical detector,” and “mono-nucleated cells and poly-nucleated cells” as recited in claim 7, and “total count of nucleated cells” as recited in claims 8 and 13. Pet. 22–29. Patent Owner responds that “[t]he District Court issued an opinion regarding claim construction on April 6, 2021,” and, “[f]or purposes of this proceeding, Patent Owner applies the District Court’s constructions.” PO Resp. 13. Patent Owner also specifically addresses the terms “controller programmed to” and “electrical detector.” Id. at 13–14. Petitioner replies that its proposed claim constructions are consistent with the District Court’s constructions. Pet. Reply 4–5. At the oral hearing, the parties confirmed that they do not dispute the District Court’s claim constructions. See Tr. 16 (Petitioner’s counsel stating that “Petitioner would request that this Board adopt these same [District Court] constructions in this IPR”), 34 (Patent Owner’s counsel agreeing that “neither side has objected to the court’s claim construction”). Based on the parties’ apparent agreement, and considering the record before us and the Report and Recommendation from the District Court (Ex. 2065), we agree with and adopt the District Court’s claim constructions. See 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning the claim in a civil action . . . that is timely made of record in the inter partes review proceeding will be considered.”). Accordingly, we construe the terms “controller programmed to,” “electrical detector,” and “optical detector” as set forth below. slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“that Petitioner has established that the priority applications do not provide adequate written description support for the challenged claims. More specifically, we find that the priority applications do not reasonably convey to a POSA that the inventors were in possession of a sample analyzer that both (1) uses an electrical detector to electrically sense cells in a body fluid measurement sample, and (2) from the analysis of the cells sensed by the electrical detector, counts the number of mono-nucleated cells and poly-nucleated cells in the body fluid measurement sample as required by claim 7.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Based on our review of the record, we determine that Petitioner has established that a POSA would have had reason to combine the teachings of Nagai and Jagtiani to achieve the claimed subject matter. Nagai describes an electrical detector (RBC/PLT detection unit 42) that “is capable of measuring the number of red blood cells and platelets by a sheath flow-DC detection method.” Ex. 1044, 6:58–63, Fig. 5. Nagai also describes WBC detection unit 41 that produces a DIFF scattergram that, in the body fluid measuring mode, is analyzed in order to classify the white blood cells into two subclasses, namely, mono-nucleated cells and poly-nucleated cells. Id. at 5:56–58, 12:27–36. Nagai teaches that WBC detection unit 41 is “configured as an optical detection unit” that performs white blood cell classification in the body fluid measurement mode using a combination of electrical resistance and absorbed light. Id. at 5:56–58, 15:52–16:6. Jagtiani teaches a channel sensor that can detect impedance to differentiate between different types of cells in a biological sample, including differentiating between red blood cells, white blood cells, and platelets. Ex. 1045 ¶¶ 21, 25; see also id. ¶ 187 (“The channel sensor is based on impedance sensing using the Coulter principle.”). Jagtiani teaches the sensor can be configured to differentiate between and count the number of eosinophils, basophils, neutrophils, monocytes, and lymphocytes in the biological sample. Id. ¶ 25; see also id. ¶ 121 (“In some embodiments, the cell count can include a white blood differential, and can include a count of basophils, a count of eosinophils, a count of lymphocytes, a count of neutrophils, and/or a count of monocytes.”). Jagtiani further teaches that “[s]uch biological samples can include, for example, blood, serum, saliva, sweat, tears, urine, or any other biological sample or derivative suspended in a fluid.” Id. ¶ 119. In light of these teachings in Nagai and Jagtiani, we credit Mr. Roche’s testimony that Jagtiani demonstrates a known technique of detecting poly-nucleated and mono-nucleated white blood cells using an electrical detector. A POSA at the time of the invention would have been led to modify Nagai with the teaching of Jagtiani in the manner claimed to allow the body fluid measurement of Nagai to differentiate poly-nucleated and mono-nucleated blood cells (instead of measuring red blood cells alone). Such a motivation is found, for example, in Petitioner’s DxH system, which discloses use of an electrical detector in both a blood measuring mode and a fluid measuring mode. Ex. 1042 ¶¶ 30, 31. In the DxH system, use of an electrical detector in both the blood measuring mode and body fluid measuring mode allows identification of total number of cells in measured body fluid.” slip op. at 29
Patent outcomesUS 10,401,351 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSRPatents in suitUS 10,401,351 - Satco Products, Inc. v. The Regents Of The University Of CaliforniaInstitution deniedPTAB · Nov 8, 2021 · IPR2021-00661 · APJ Steven M Amundson · IPR · Institution
The Board denied institution of review for claims 1 and 2 under § 314(a), finding the Fintiv factors weighed against review because of the advanced, overlapping ITC investigation.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“The Fintiv factors “relate to whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Fintiv, IPR2020-00019, Paper 11 at 6. A stay of parallel litigation pending resolution of a Board proceeding “allays concerns about inefficiency and duplication of efforts.” Id. That the E.D.N.Y. case was stayed “at its earliest stage,” however, does not “allay[] concerns about inefficiency and duplication of efforts” in view of the 1220 investigation. Additionally, the E.D.N.Y. case was stayed “pending completion” of the 1220 investigation, not because of any Board proceeding. Ex. 3002, 1. With dates set in the 1220 investigation for the ALJ’s initial determination and the ITC’s final determination, a stay seems highly unlikely, especially with the initial determination date about a week away. Hence, factor (1) weighs against institution. See Fitbit, Inc. v. Koninklijke Philips N.V., IPR2020-00771, Paper 14 at 16–17 (PTAB Oct. 19, 2020).” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). But we have discretion to deny a petition even when a petitioner satisfies the “reasonable likelihood” threshold standard for instituting trial. See, e.g., Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”). Based on the current record and for the reasons explained below, we exercise our discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“essentially the same argument about the ’557 patent’s effective filing date for its challenge based on Nakamura-959 and Nakamura-949 as for its invalidity defense based on insufficient written-description support for claim 1. See Pet. 7, 12–21, 37; Ex. 2004, 29–33; Ex. 2005, 245–48; Ex. 2014, 64–65, 70. As we understand the arguments, resolving the ’557 patent’s effective filing date does not require interpreting any part of § 1.57. See Pet. 12–21; Prelim. Resp. 29–31. Instead, the issue turns on whether the ’154 application supports claim 1 according to § 112’s first paragraph. See Pet. 12–21; Prelim. Resp. 29–31. Also, the challenges based on Tanda present a similar issue whether the ’447 provisional supports claim 1 according to § 112’s first paragraph. See Pet. 12–21, 61; Prelim. Resp. 29–31, 36–37. “[T]he test for sufficiency 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.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Under the circumstances here, the ITC can apply the test for sufficiency of disclosure to the ’154 application and the ’447 provisional just as well as the Board.” slip op. at 27
§ 112 disclosureDiscretionary denialPatents in suitUS 10,658,557
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.