- PTAB · Jun 3, 2025 · IPR2025-00055 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–42 on all asserted grounds, finding a reasonable likelihood that Dohil renders claim 35 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record and for purposes of institution, we find Petitioner’s analysis persuasive and adopt it as our own. Thus, we find Petitioner has established a reasonable likelihood of prevailing on its assertion that Dohil renders claim 35 obvious. We thus institute an inter partes review as to all challenges raised in the Petition. See SAS Institute, Inc. v. Iancu, 584 U.S. 357, 365–71 (2018); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner notes that the ’407 patent defines (1) “orally disintegrating tablet,” “orally dispersing tablet,” or “ODT;” (2) “about;” and (3) “having no significant systemic glucocorticoid or mineralocorticoid activity.” Pet. 17–19 (citing Ex. 1001, 2:46–49; 2:62–3:3, 3:16–21). We adopt the express definitions of these terms as set forth in the ’407 patent Specification. See Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998) (“When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.”).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe these or any other claim terms.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends that a POSA would have been motivated to follow the FDA Guidance (i.e., the guidance on the matter from the U.S. regulatory agency concerned with pharmaceuticals) in formulating Dohil’s rapidly dissolving lozenge or tablet containing budesonide. Id. at 25. According to Petitioner, a POSA seeking to formulate budesonide into an orally disintegrating pharmaceutical composition would have been motivated to follow the FDA Guidance that such a composition should disintegrate within thirty seconds or less when tested using the USP <701> Disintegration Test. Id. (citing Ex. 1053 ¶ 128). Petitioner also argues that a POSA would have had a reasonable expectation of success in doing so based on Dohil’s detailed description of how to formulate budesonide into a rapidly disintegrating lozenge or tablet. Id. (citing Ex. 1002 ¶¶ 27–41). According to Petitioner, formulating orally disintegrating tablets that dissolve within “several seconds to about a minute” would have been a routine exercise by 2009, the earliest possible priority date of the ’407 patent. Id. at 26 (citing Ex. 1005, 2; Ex. 1018, 434). Petitioner contends that, at that time, there were many orally disintegrating systems and products that were commercially available, which would have bolstered a POSA’s expectation of success. Id. (citing Ex. 1017, 179–181; Ex. 1018, 436–439; Ex. 1053 ¶ 129). Thus, Petitioner concludes that Dohil would have suggested to a POSA limitation 35[iv]. Id.” slip op. at 9
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,486,407 - PTAB · Jun 3, 2025 · IPR2025-00056 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–30 and all three grounds, finding a reasonable likelihood that at least one claim would have been obvious over Perrett.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted if the information presented by a petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSA”) related to the ’061 patent would have a Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2-3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development. The 8 See infra Section II.C. 9 At this stage of the proceeding, there is no evidence of objective indicia of obviousness or non-obviousness. POSA would also have had access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects. EX1070 ¶30. Pet. 5. At this stage of the proceeding, Patent Owner neither contests Petitioner’s proposed definition of the ordinarily skilled artisan nor provides an alternative definition. See generally Prelim. Resp. For the purposes of this Decision, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the high level of skill in the art reflected in the prior art of record and the ’061 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). D.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownNo construction neededOther
“When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). The Specification expressly states that “[t]he terms ‘orally disintegrating tablet’, ‘orally dispersing tablet’, or ‘ODT’ refer to a solid dosage form of the present invention, which disintegrates rapidly in the oral cavity of a patient after administration, without chewing.” Ex. 1001, 5:12–15. At this stage of the proceeding, we interpret the language “orally disintegrating tablet” / “orally dispersing tablet” / “ODT” to have the meaning as expressly set forth in the Specification, as noted above. slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,260,061 - PTAB · May 23, 2025 · IPR2025-00196 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–16 under both § 103 grounds, finding a reasonable likelihood that at least one claim would have been obvious over Best-2008 and Osada.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Under our current guidance, the filing of a Sotera-type stipulation is not conclusive, but remains “highly relevant” and will be considered “as part of [our] holistic analysis” here. See Guidance Memo. Whether Petitioner has other bases for invalidating the ’457 patent, such as the CarnoJet prior art product identified in the district court, is not a consideration here if such bases could not be asserted in this proceeding (and are not being used to argue over the asserted prior art here as a loop hole from the stipulation, of which there is no evidence).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“satisfied that Petitioner has met its burden for institution. No argument by Patent Owner persuades us otherwise. Petitioner has shown that each limitation and element of claim 1 is taught or suggested by the combination of Best-2008 and Osada. Moreover, Petitioner’s asserted reason to combine the references is supported by the references’ disclosures: Best-2008 suggests filtration of its coolant is desirable, but provides no specific means for doing so; Osada teaches a way of filtering fluid from an open-top tank, similar to Best-2008’s.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSITA[12]in the field of the ’457 patent at the time of the earliest possible effective filing date (December 14, 2012) would have had Bachelor of Science degree in mechanical or chemical engineering and at least two years of experience relating to the design and/or implementation of fluid circulation systems involving application of fluid dynamics and heat transfer principles. Additional education may serve as a substitute for a lack of experience and vice versa. (Ex-1003- Dahm at ¶¶36-41, 63-70.) Pet. 18–19. Patent Owner applies this same definition. Prelim. Resp. 6–7. At this stage of the proceeding, we accept and use Petitioner’s proposed and unopposed definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ‘457 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Although either of the district court proceedings’ definitions of the term “weir” appears to accurately describe the feature, at this stage of the proceeding, we do not find it necessary to expressly interpret this claim language.” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,405,457 - PTAB · May 16, 2025 · IPR2024-01487 · APJ Julia Heaney · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Nakazawa and Glaug.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . 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). Upon consideration of the Petition in view of the record at this stage, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. We also determine that the arguments and evidence of record do not support discretionary denial of the Petition under 35 U.S.C. § 314(a). Accordingly, we grant institution of an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“person of ordinary skill would modify either Nakazawa’s diffusion sheet or Glaug’s fluid acquisition system, but rather Petitioner argues “various layers in absorbent articles are invariably interchangeable.” Prelim. Resp. 41–42. Contrary to Patent Owner’s argument, as discussed above, Petitioner explains why and how a person of ordinary skill would modify Nakazawa’s diffusion sheet, and provides reasons for doing so. On this record, we find Petitioner’s reasoning sufficient.” slip op. at 24
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner further argues Nakazawa teaches away from Petitioner’s asserted modification in which Glaug’s lower non-perforated layer is added to Nakazawa’s diffusion sheet. Prelim. Resp. 42. Specifically, Patent Owner argues Nakazawa teaches that its embodiment in which the second absorbent material is wrapped in a hydrophilic sheet has the advantage of preventing leakage of super absorbent polymer (“SAP”) from the second absorbent material without impeding permeation of excretory fluid through the hydrophilic sheet. Id. at 43 (citing Ex. 1008 ¶ 85, Fig. 15). Patent Owner further relies on Petitioner’s argument that Nakazawa’s hydrophilic layer is analogous to the lower non-perforated layer in Glaug. Id. (citing Pet. 93–94). Therefore, Patent Owner argues, Nakazawa teaches that Glaug’s fluid acquisition system would impede permeation of fluid rather than promote it. Id. Patent Owner’s teaching away argument is unavailing based on the current record. Patent Owner improperly relies on Petitioner’s contention in its anticipation challenge based on Nakazawa, and characterizes it as an argument about Glaug. As further discussed in Section II.G below, Petitioner’s anticipation challenge is based on analogizing Nakazawa’s hydrophilic sheet to a core wrap feature identified in Patent Owner’s infringement contention in parallel district court litigation. See Pet. 92–93. Contrary to Patent Owner’s argument, Petitioner’s obviousness contention does not argue Nakazawa’s hydrophilic layer is analogous to Glaug’s nonperforated fibrous layer. Because Patent Owner is not properly characterizing Petitioner’s obviousness contention, Patent Owner’s teaching away argument is not persuasive.” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Under Fintiv, we consider the following factors: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv at 5–6.” slip op. at 35
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,308,138 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - PTAB · Jan 13, 2025 · IPR2024-00186 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review on all challenged claims and all grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Office (“USPTO”) issued a Memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings With Parallel District Court Litigation” (“Memorandum”)11, which states, among other things, that “the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have 11 Available at www.uspto.gov/sites/default/files/documents/interim_proc_ discretionary_denials_aia_parallel_district_court_litigation_memo_2022 0621_.pdf. reasonably been raised before the PTAB.” Memorandum 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). By email dated November 25, 2024, Petitioner requested leave to file a Reply to Patent Owner’s Preliminary Response to address, inter alia, its proposed submission of a Sotera stipulation. Ex. 3001. We denied Petitioner’s request for briefing, but granted its request to submit the stipulation. Id. The Sotera stipulation avers that “if IPR Nos. IPR2024- 00183, IPR2024-00185, and IPR2024-00186 are instituted, National Beef will not pursue in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat’ / Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023), any ground National Beef raised or reasonably could have raised in the aforementioned IPRs,” and that the stipulation “binds National Beef in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat'l Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023).” Ex. 1064. Applying the guidance provided in the Memorandum, we decline to exercise our discretion to deny institution in this proceeding under Fintiv because Petitioner submitted a Sotera stipulation.” slip op. at 20
- BurdenInstituted
“Thus, Petitioner has accounted for each step/element of independent claims 1 and 37 as taught by the combination of ICMSF and Gombas, and has also provided a reason why, with rational underpinnings, the prior art would have been combined and modified, with a reasonable expectation of success. On the current record, including Patent Owner’s arguments that we considered and are addressed in detail below, Petitioner’s evidence for this ground is sufficient to provide a reasonable likelihood of success in demonstrating unpatentability of at least one claim.” slip op. at 31
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. We also agree with Patent Owner that the ’771 patent provides definitions that guide the understanding of the term “lots” including: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of products of a production process, etc.), where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g., proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1003, 5:43‒54. The ’771 patent similarly provides definitions for “product portion,” “test lot sample,” and “composite lot-unit” that provide significant guidance and clarity as to the meaning of these terms. Ex. 1003, 5:60‒6:4, 6:12‒29, 7:49‒63. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). We decline to expressly interpret this term at this time.” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,637,771 - PTAB · Jan 13, 2025 · IPR2024-00185 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–7, 11, 12, 14–20, 22–24, 26, and 29–36 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION After considering the evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’143 Patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least one claim is rendered obvious by the asserted combinations of ICMSF, Hughes, and Price, we institute inter partes review on all grounds set forth in the Petition. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim or the construction of any claim term. Thus, our view with regard to any conclusion reached in the foregoing could change upon consideration of Patent Owner’s merits response and completion of the record.” slip op. at 54
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). We also agree with Patent Owner that the ’143 patent provides definitions that guide the understanding of the term “lots” including teaching: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of product of a production process, etc.) where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g. proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1002, 5:34–45. The Specification similarly provides definitions for “product portion,” “test lot sample,” and “single-unit production lot” that provide significant guidance and clarity as to the meaning of these terms. Id. at 5:52–63, 6:2–20.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“validation” as used herein with respect to production lots refers to determining that a particular sample tests negative using the detection assay. Where a modular composite sample tests negative, all single-unit production lot samples comprising the composite sample are validated along with the respective single-unit production lots, which are thus cleared for release. Where a modular composite sample tests positive, individual single unit production lots may nonetheless yet be validated if particular respective single-unit production lot samples test negative. Ex.1002, 7:15–24 (emphasis added). The above text expressly equates “validation” to a determination that “a particular sample tests negative.” The initial definitional sentence makes no mention of “cleared for release” as necessary for “validation.” The subsequent sentence refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and, even then, the “cleared for release” language indicates a separate step that may happen after the samples are “validated.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“On the current record, we are not persuaded that Petitioner has insufficiently articulated a motivation to combine or modify the asserted references. With respect to Ground 1, for example, Petitioner contends that one of ordinary skill in the art would have been motivated to modify ICMSF based on Gombas under the teaching-suggestion-motivation test so portions of the enriched, retained samples are further tested after a positive test of a composite sample by the same protocol, with a reasonable expectation of success for efficient validation. See § XII-A-1-h supra; Dickson ¶¶ 417-19. Pet. 53–54. Petitioner further argues that ordinarily skilled artisan would have sought to improve[] ICMSF with the similar methods of Gombas to yield efficient validation, which is a predictable result. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In this combination, a POSA would have simply substituted steps of ICMSF, as described above, with those of Gombas so portions of the enrichment cultures are retained and are further tested after a positive test of a composite sample by the same protocol for predictably efficient validation. MPEP § 2143(I)(B); Dickson ¶ 420. Id. at 53. As such, the Petition provides specific reasons to combine ICMSF and Gombas that are consistent with the flexible test recited in KSR, including the benefit of efficient validation of the test and that the combination is a simple substitution of steps. As KSR notes, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 US at 417. Here, Petitioner has made its reasons to combine explicit. See Pet. 53–” slip op. at 47
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,822,143 - PTAB · Jan 13, 2025 · IPR2024-00183 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–6, 10, 11, 13–20, 22, 23, and 26–33 because the asserted combinations of ICMSF, Hughes, and Price showed a reasonable likelihood that at least one claim was obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . 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). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’584 patent is unpatentable. Accordingly, we institute an inter partes review as to the challenged claims of the ’584 patent on the grounds of unpatentability set forth in the Petition. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (POSA/POSITA), “would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies.” Pet. 11. (citing Ex. 1041 ¶¶ 22–24). Petitioner further contends that a person of ordinary skill in the art would have had “a working knowledge of microbiology,” “would have been involved in developing sampling and testing methodologies for analysis of food products (“validation methodologies”),” and “would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” Id.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction impacts the decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“This definition requires that a “validation” determines that “a particular sample tests negative.” The initial definition sentence makes no mention of “cleared for release” as necessary for “validation.” Rather, the definition only refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and even then, the “cleared for release” is a separate step that occurs after the samples are “validated.”” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 7,534,584 - PTAB · Oct 16, 2024 · PGR2024-00028 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 1–10 because Petitioner showed it was more likely than not to prevail on obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate 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) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of at least one of claims 1–10 of the ’737 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person having ordinary skill in the art (“PHOSITA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have been someone with a medical degree and sufficient experience with interventional procedures, specifically with endovascular procedures including extensive use of both angioplasty balloons and occlusion devices. A[nd that a] busy interventionalist could conceivably acquire an adequate level of experience having a minimum of ten years of post-graduate experience as an interventional radiologist, vascular surgeon, interventional cardiologist, or other endovascular interventionist. Such a person would be familiar with various occlusion balloon catheters and their use in performing vascular occlusion procedures including occlusion procedures throughout the vascular system, including occlusion procedures within the aorta. Pet. 10–11 (citing Ex. 1003 ¶ 18). Patent Owner states that: “Solely for purposes of this Preliminary Response, Patent Owner does not object to Petitioner’s definition of a PHOSITA. Patent Owner reserves the right to assert an alternative definition for a PHOSITA in this or another proceeding involving the ‘737 Patent, where appropriate.” Prelim. Resp. 12.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“• “proximal”: “a portion or component of the preferred vascular occlusion catheter system that is oriented away from the body into which the system is or is intended to be placed.” Ex-1001, 21:52-56. • “distal”: “a portion or component of the preferred balloon catheter system that is oriented toward the body into which the system is or is intended to be placed.” Ex- 1001, 21:56-60.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“We find that the evidence currently of record reasonably supports an interpretation where the claimed proximal hub and flow valve may be in an element/sub-element relationship where the recited flow valve is a portion of the recited proximal hub.” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,857,737 - PTAB · Oct 9, 2024 · IPR2024-00733 · APJ Matthew S Meyers · IPR · Institution
The Board instituted IPR on claims 1–14 and all asserted grounds, finding a reasonable likelihood of success based on anticipation by Liddell and obviousness over Simpson and Liddell.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2020). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.”” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingTerm construed petitioner constructionDecided for petitioner
“preamble term “hand carriable” does not limit the claimed apparatuses. “[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Catalina Marketing, 289 F.3d at 808 (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). This rule against giving effect to intended-use language in the preamble “reflects a longstanding substantive aspect of the patent statue—specifically, the ‘well settled’ fundamental principle ‘that the recitation of a new intended use for an old product does not make a claim to that old product patentable.’” Arctic Cat Inc. v. GEP Power Products, Inc., 919 F.3d 1320, 1328 (Fed. Cir. 2019) (quoting In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). In this case, we view the phrase “hand carriable,” as it appears in the preamble, to be indicative of an intended use of the claimed apparatuses, rather than a structural limitation, and as such, we do not see it to be limiting based on the current record. Patent Owner does not point to any particular structural limitation required by the preamble term “hand carriable.” See Prelim. Resp. 2–10. Although the independent claims each recite “a handle,” the claims do not explicitly tie this limitation to the “hand carriable” language in the preambles. In any case, to the extent the handle recited in the claims may be used for carrying the claimed apparatus, the claims need not rely on the preamble term “hand carriable” for antecedent basis, as the handle limitation is introduced in the body of the claims. In other words, with respect to the functionality of carrying the apparatus by hand, the claim bodies recite “a structurally complete invention.” Catalina Marketing, 289 F.3d at 808.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“reasonable likelihood that it would prevail in challenging the patentability of independent claim 1. In our view, Petitioner’s analysis, on this record, adequately identifies where all the elements of claim 1 are found in Liddell.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“On the current record, we find that the Petition provides sufficient rationale to modify Simpson in view of Liddell. See Pet. 57–61 (citing Ex. 1002 ¶¶ 250–267). For example, Petitioner contends that one of ordinary skill in the art would have been motivated to incorporate Liddell’s cyclonic separating apparatus into Simpson’s vacuum cleaner in order to reap “the benefits of cyclonic separation, including maintaining steady suction as the separator fills with dirt.” Id. at 59 (citing Ex. 1002 ¶¶ 256– 259). Petitioner explains that Organ establishes that “bagless vacuums like ‘cyclonic’ vacuums were ‘becoming increasingly popular’” in the prior art because they are able “to maintain a consistently high level of suction, even as the collecting chamber fills with dirt” (id. (citing Ex. 1006, 1:8–13)), and relying on the declaration testimony of Dr. Giachetti, argues that one of ordinary skill in the art would have “would have been motivated to substitute Simpson’s dust separation system with a bagless cyclonic separator for the same reason” (id. (citing Ex. 1002 ¶ 281)).” slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,327,607
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.