• 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
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

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

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Ascend Elements, Inc. v. Duesenfeld GmbHInstitution denied
  PTAB · 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 · Nautilus
  Patents in suitUS 12,119,463
• 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
• Ecto World, LLC / Sv3, LLC v. Rai Strategic Holdings, Inc.Institution denied
  PTAB · 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 Phillips
  Patents in suitUS 11,925,202
• Dental Recycling North America, Inc. v. Solmetex, LLCInstitution denied
  PTAB · Mar 19, 2024 · PGR2023-00055 · APJ Michael A Valek · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable under the asserted grounds.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; 37 C.F.R. § 42.4. Upon considering the present record, we determine that Petitioner has not satisfied its burden to show that it is more likely than not that any of the challenged claims are unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the testimony of its declarant, Petitioner contends a person of ordinary skill (“POSA”) “would have been an individual with at least a bachelor’s degree in mechanical engineering, or at least 3 years of experience designing or manufacturing vacuums, filters, medical devices, or the related components.” Pet. 22 (citing Ex. 1003 ¶¶ 94–95). Patent Owner does not respond to Petitioner’s contention in its Preliminary Response, but asks its declarant to apply Petitioner’s proposed level of skill in the art in his analysis. See Ex. 2001 ¶ 86. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this decision. C. Claim Construction” slip op. at 11

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

    “Petitioner contends that “[a]ll terms of the ’175 patent should be given their plain and ordinary meaning as understood by a POSA,” but does not propose any express claim construction for consideration. See Pet. 22–23. Petitioner further asserts that the preambles of the independent claims are limiting. Id. at 23–25. Patent Owner argues “that claim construction is not necessary at this time,” but urges that “in the event the Board determines that claim construction is necessary, Petitioner’s proposal to construe the preambles of the independent claims as limiting should be rejected.” Prelim. Resp. 65. We need not determine whether the preambles of the independent claims are limiting to reach the outcome in this decision. Accordingly, no express claim construction is necessary here. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). D. Grounds 1–4 and Petitioner’s Related Priority Challenge” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot shown unpatentable

    “Based on the record before us, Patent Owner has the better position. It is well settled that the original drawings may themselves be sufficient to provide description for later-filed claims. Vas-Cath, 935 F.2d at 1565 (holding that “drawings alone may provide a ‘written description’ of an invention as required by § 112”). That is the case here with respect to the original figures submitted with the Great-Grandparent application. We agree with Patent Owner and Dr. Garris that original Figures 4A–B and 5B show a flange or “radially protruding structure” configured as in the challenged claims. Ex. 2001 ¶¶ 106–113. Moreover, the original description in the Great-Grandparent application describes “removable retaining pins 13” that “ensure the recycling container,” i.e., container 12 in Figures 4A–B, “does not detach from the air-water separation tank 5 when there is no vacuum in the system.” Ex. 1002, 213 (¶ 92). Based on this description and the depiction of retaining pin 13 in the original Figure 2, a POSA would have understood that the pins engage with the radially protruding structure to hold the container in place as recited in the challenged claims. Ex. 2001 ¶ 114. Petitioner’s argument that the original figures do not depict the radially protruding structure and retaining pins working together to hold the container in place is unpersuasive. Patent Owner has sufficiently demonstrated that a POSA would have understood how the structures in original Figures 2 and 4A interact based on a side-by-side comparison of the same. See Pet. 38–43; Ex. 2001 ¶ 114. Indeed, the applicants made a similar comparison during prosecution, which proved persuasive to the Examiner. Ex. 1002, 87, 98. The Petition provides no reason to doubt that a POSA would understand the original figures and description just as Patent Owner contends. Moreover, contrary to Petitioner’s arguments, the fact that the specification and drawings were amended does not mean that Patent Owner had to add new matter to overcome the Examiner’s rejections. See Pet. 16– 17. In this case, the amendments to the specification during prosecution of the ’175 patent made the operation of the retaining pin and radially protruding structure, as shown by the original figures, even clearer. But that does not mean that the original description was inadequate.” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 11,660,175
• 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
• Microbiotica, Limited v. Board Of Regents, The University Of Texas SystemInstitution denied
  PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …

  RulingsInstitution decision

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

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

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

    “7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9

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

    “Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
  Patents in suitUS 11,395,838
• Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentable
  PTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision

  Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13

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

    “As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under the AIA, a reference patent document need only meet the “ministerial requirements” of §§ 119 and 120, and the provisional or other earlier application(s) to which the reference patent document claims a right of priority must “describe[] the subject matter” relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30

  Patent outcomesUS 10,722,253 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,722,253
• Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentable
  PTAB · Mar 10, 2023 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Final written decision

  Claims 1–18 are unpatentable under §103: claims 1–12, 15, 16, and 18 over Teigen and Grey; claims 13–14 over Teigen, Grey, and Yang; claim 17 over Teigen, Grey, and Matteo.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Based on our consideration of the full record, we find that, overall, Patent Owner’s definition is more specifically tailored to the claimed subject matter of the ’883 patent. We also find that, a person with a biomedical engineering degree could have the required background in fluid mechanics. See Ex. 1031, 45:21–46:7. Therefore, we find that a person of ordinary skill in the art would have a B.S. in mechanical or biomedical engineering with at least three years of experience in designing systems for minimally invasive intravascular procedures for treating occluded vessels or the equivalent and in consultation with medical professionals such as interventional neurosurgeons. Although we agree with, and have primarily adopted Patent Owner’s definition for an ordinarily skilled artisan in this proceeding, our analysis and conclusions herein would not change even under Petitioner’s definition. The parties also do not indicate that the outcome would differ based on the definition of the person of ordinary skill in the art. See Pet. 15; PO Resp. 6; Pet. Reply 1.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “as adopted by the Board in the Institution Decision. The ’883 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 36:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’883 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 2:62–65. In the ’883 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’883 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1030 ¶¶ 13–14; Ex. 2001 ¶¶ 53, 62. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.”” slip op. at 14

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

    “As discussed above, we construed “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 33 (citing Ex. 1003 ¶¶ 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 34 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the disclosure of the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges which fall within the ’883 patent’s definition of no “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1030 ¶ 29; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).” slip op. at 21

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “AIA § 102 draws a distinction between actually being entitled to a right of priority to, or the benefit of, a prior-filed application according to the definition of “effective filing date” of a claimed invention in AIA 35 U.S.C. § 100(i)(1)(B), and merely being entitled to claim a right of priority to, or the benefit of, a prior-filed application for prior-art purposes according to the use of “effectively filed” in AIA 35 U.S.C. § 102(d). See 35 U.S.C. §§ 100(i)(1)(B), 102(a)(2), 102(d)(2); MPEP § 2154.01(b). USPTO guidance also indicates that AIA § 102 prior-art reference effective-filing-date determinations differ from pre-AIA law. For example, a 2018 Memorandum to the Patent Examining Corps states, in the context of prior-art determinations, that “[t]he requirement that one of the claims in the patent [document] . . . be supported by the written description of the provisional application in compliance with pre-AIA 35 U.S.C. § 112, first paragraph (or AIA 35 U.S.C. § 112(a)), is not applicable when examining an application subject to the first inventor to file provisions of the AIA.” Robert W. Bahr, Memorandum re: Critical Reference Date Under pre-AIA 35 U.S.C. §102(e) (Apr. 5, 2018), available at http://www.uspto.gov/sites/ default/files/documents/dynamic_memo_05apr2018_0.pdf (emphasis added) (citing Dynamic Drinkware, 800 F.3d at 1381 n.2; 157 Cong. Rec. 3423 (2011) (explaining the distinction between being entitled to claim priority or benefit in AIA 35 U.S.C. § 102(d) and actually being entitled to priority or benefit under 35 U.S.C. § 119, 120, or 365)). This Memorandum further indicates: The date subject matter was “effectively filed” under AIA 35 U.S.C. § 102(d) for purposes of considering a U.S. patent, a U.S. patent application publication, or an international application publication as prior art under AIA 35 U.S.C. § 102(a)(2) is discussed in MPEP § 2154.01(b), and is not affected by Dynamic Drinkware or [Amgen v. Sanofi, 872 F.3d 1367, 1380 (Fed. Cir. 2017)] and is not being modified by this memorandum. Id. at 2. MPEP § 2154.01(b) explicitly states, as a result of the distinction discussed above, in application of the AIA version of § 102, “the question of whether a patent or published application is actually entitled to priority or benefit with respect to any of its claims is not at issue in determining the date the patent or published application was ‘effectively filed’ for prior art purposes.” MPEP § 2154.01(b) (emphases added).” slip op. at 31

  Patent outcomesUS 10,531,883 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,531,883

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.