- Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · Jan 7, 2026 · PGR2024-00043 · APJ Ryan H Flax · PGR · Final written decision
Claims 1–39 are unpatentable under Grounds 1–10; Petitioner did not prove lack of enablement under Ground 11, and Patent Owner’s motion to exclude was denied.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“REAL PARTIES-IN-INTEREST Petitioner identifies Avation Medical, Inc. as the real party-in-interest. Pet. x. Patent Owner identifies EMKinetics, Inc. as the real party-in-interest. Paper 5, 1; Paper 6, 1. Neither party contests the other’s assertions on this. C.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSA at the time of the claimed invention would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices. Additional work experience could substitute for a formal degree and vice versa. Ex.1003, ¶21. Pet. 20 (citing Ex. 1003). Patent Owner does not contest this proposed definition or offer an alternative. See generally Resp. We accept and use Petitioner’s uncontested definition of the ordinarily skilled artisan, which appears to comport with the level of skill in the art reflected in the prior art of record and the ’943 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may]” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.200(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that, “no terms require construction for purposes of this Petition.” Pet. 21. Patent Owner presents no express position on claim construction. See generally Resp. We do not expressly construe any claim terms. E.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“question, based on factual findings. VidStream, 981 F.3d at 1063–64. Moreover, public accessibility is the touchstone in determining whether a reference is a printed publication and such depends on whether the reference was available to interested, ordinarily skilled persons exercising reasonable diligence, which is determined on a case-by-case basis. Id. at 1065. Particularly pertinent here is that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” Id. Hulu (which cites VidStream on this issue) concerned, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. Hulu, 2021 WL 487622. Hulu holds that, although testimonial evidence is one way to prove public accessibility, there are also a variety of hallmarks of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at *10–13, 21. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established, and whether the reference’s “purpose of publishing . . . was ‘dialogue with an intended audience.’” Id. at *10–21 (citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)).” slip op. at 30
Patent outcomesUS 11,844,943 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 11,844,943 - 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 - Precision Planting LLC v. Maschio Gaspardo S.P.A.No claims unpatentablePTAB · Mar 21, 2025 · IPR2024-00008 · APJ Benjamin D M Wood · IPR · Final written decision
Claims 1–5, 7–14, and 16 were not shown unpatentable because the asserted anticipation and obviousness grounds failed to establish the claimed thrust-bearing element and its required location.
RulingsFinal written decision- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“We determine that the evidence of record overcomes the presumption that § 112, para. 6 does not apply because “thrust-bearing element” does not recite sufficiently definite structure in this case. See, e.g., Pet. 22 (the term is not used here according to its common meaning). First, the word “element” is a “[g]eneric term[]” or “verbal construct[]” often “used in a claim in a manner that is tantamount to using the word ‘means’” because it does not “connote sufficiently definite structure.” Williamson, 792 F.3d at 1350. We find nothing in the ’121 patent or elsewhere in the record suggesting that “element” in the term “thrust-bearing element” should be considered other than a generic placeholder term. Second, although the term “thrust bearing” may connote certain structure, “thrust-bearing element” does not. A “thrust bearing” is “a well-known term of art in engineering and is ‘a bearing which sustains axial loads and prevents axial movement of a loaded shaft.’” Ex. 1003 ¶ 46 (citing Ex. 1017, 2147). “The balls of traditional thrust bearings are positioned inline with the axial force, as thrust bearings are designed specifically to transmit axial load.” Id. Here, however, “thrust-bearing” is hyphenated, and is therefore a phrasal adjective modifying “element” rather than the noun phrase “thrust bearing.”8 Further, there are “substantial differences”” slip op. at 15
- Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Term construed board ownDecided for patent owner
“We largely agree with Petitioner. “[S]tructure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.” B. Braun Med. Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed.Cir.1997). The Specification of the ’121 patent “clearly links or associates” two components with the function of bearing axial thrust from the sowing disc: shaft 27 with flanging 30, and thrust-bearing plate 31. Ex. 1001, 3:25–35. Thrust-bearing plate 31 is expressly described as “bear[ing] on that surface of the disc which faces seal 24 . . . in order to withstand at least some of the axial load produced by the disc 16 on the seal 24. Ex. 1001, 3:28–31. Rotatably-mounted shaft 27 with flanging 30 is “fixed” to thrust-bearing plate 31 and therefore bears the axial load from the disc via the thrust-bearing plate. Id. at 3:25–28.10 10 Drive element 32 is described as part of thrust-bearing element 26 and permits thrust-bearing element 26 to be driven in rotation with sowing disc 16. Ex. 1001, 3:36–40. It is not described as bearing any axial load, however. Further, it is not necessary for the thrust-bearing element to rotate with the sowing disc for that element to bear axial load from the sowing disc. See id. at 3:58–59 (“Provision is also made for the thrust-bearing element 26 to be made idle and not driven in rotation by the [drive] shaft 20.”). Ultimately, however, whether drive element 32 is properly considered as part of the corresponding structure is not relevant to the outcome of this case. We disagree with Patent Owner that bearings 28 and seat 29 should be considered corresponding structure. The Specification does not associate these structures with any axial load-bearing function. Instead, bearings 28 and seat 29 are described as the means by which, and the location in which, shaft 27 is rotatably mounted. Ex. 1001, 3:25–27. Regardless, whether or not bearings 28 and seat 29 are considered corresponding structure does not affect the outcome of this case. In summary, we construe “thrust-bearing element” as a means-plus- function claim term under 35 U.S.C. § 112, para. 6. Its recited function is to bear thrust, or more specifically to “withstand at least some of the axial load produced by the disc on the seal.” The structure described in the Specification as corresponding to this function is shaft 27 with flanging 30, and thrust-bearing plate 31. We construe the limitation as directed to this structure, and equivalent structures.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“The question is not whether the patentee disclaimed coverage over structures in which the thrust-bearing element is not located entirely in the movable portion of the housing. Instead, we must simply ascertain what the patentee meant by “supported rotatably in the movable portion.” To answer this question, we look to the Specification, which “is the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315. “The construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention will be, in the end, the correct construction.” Id. at 1316. Here, it is undisputed that in the sole embodiment described by the ’121 patent, the thrust-bearing element is supported by and entirely within the movable portion of the housing. Ex. 1001, Figs. 1, 2; Pet Post-Hearing Resp. 1; PO Post-Hearing Resp. 2. Construing “in the movable portion” to require the thrust-bearing element to be entirely within the movable portion both “stays true to the claim language and most naturally aligns” with the sole disclosed embodiment. Such a construction does not import the word “entirely” from the sole embodiment into the claims because the construction “arises from the claim language itself.” See SharkNinja Operating LLC v. iRobot Corp., 2024 WL 1132219, *2–*3 (Fed. Cir. 2024) (construing “primary brush assembly disposed within the round housing perimeter” to require that the primary brush assembly be “entirely within” the round housing perimeter is not an improper incorporation of “entirely” from embodiments into the claims because the construction “arises from the claim language itself”). Accordingly, having reviewed the complete record and the parties’ pre- and post-hearing briefing, we determine that “supported rotatably in the movable portion” means supported rotatably entirely in the space defined by the movable portion.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“b. When “Thrust-Bearing Element” is Construed as a Means-Plus-Function Claim Limitation, there is Insufficient Evidence in the Record to Support a Finding that VenHuizen Discloses a Thrust- Bearing Element that is Supported Rotatably in the Movable Portion As noted above, Petitioner contends that VenHuizen’s shaft 55, retaining hub 56, and handle 58 together constitute the claimed thrust-bearing element “under a proper means-plus-function definition.” Pet. Reply 18–19.12 We do not discern sufficient evidence of record or persuasive technical reasoning from Petitioner to support a finding that these elements together are “supported rotatably in the movable portion” of the housing, as claim 1 requires. Ex. 1001, 4:38–39. We construed this limitation to require the thrust-bearing element to be supported rotatably entirely in the space defined by the movable portion (the space defined by VenHuizen’s second housing member 90). Petitioner does not contend, much less show, that these components are supported rotatably entirely in the movable second housing member 90. On the contrary, of the three components constituting VenHuizen’s thrust-bearing element, all of retaining hub 56 and most of shaft 55 are located in the fixed portion of the housing (first housing member 50), not the movable portion 90. See Ex. 1001, Fig. 6. Only handle 58 is ever located in the movable portion (when the fixed and movable portions are joined together). See id. Accordingly, Petitioner has not shown that VenHuizen discloses a thrust-bearing element rotatably supported in the movable portion.” slip op. at 35
Patent outcomesUS 8,770,121 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,770,121 - 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 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. 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)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - PTAB · Aug 22, 2024 · IPR2024-00521 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all grounds challenging claims 13 and 29, finding a reasonable likelihood that both claims would be shown unpatentable as obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“the prior art asserted in Petition 3 at the time it filed Petition 1, and had in hand both Patent Owner’s preliminary response to Petition 1 and the Board’s institution decision on Petition 1. See, e.g., Pet. 9; Prelim. Resp. 7–8. Nevertheless, we find that factors 2 and 3, considered in combination with factor 1, do not favor discretionary denial. See Code200, Paper 18, 5 (“General Plastic factor 1 must be read in conjunction with factors 2 and 3.”). We agree with Petitioner that the grounds and arguments presented by Petition 3 are not informed by the Board decisions or Patent Owner arguments in the first two IPRs. Petitioner’s arguments are unchanged as to the overlapping claim elements found in claim 1, from which challenged claims 13 and 29 depend. As to those overlapping elements, Petitioner repeats without substantive modification the mapping from Ground 1 of Petition 1 and is using neither the Petition 1 POPR [Patent Owner Preliminary Response] nor the institution decision to modify arguments that were previously unsuccessful, nor shifting its prior art arguments for this petition. Pet. 11. Stated differently, we find no “road-mapping” concerns or “shifts in the prior art asserted and the related arguments” in the later petition, like those found in General Plastic. See General Plastic at 17.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the challenged claims. 35 U.S.C. § 314(a).” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“a Bachelor of Science degree in biomedical engineering, or a similar field, such as electrical, or software, or computer engineering, and two years of industry experience or research working with medical devices and systems for measuring biomedical signals. Such systems might include those for determining levels of blood analytes, such as glucose, in a 9 See infra Section III.B. 10 Patent Owner does not presently assert any objective indicia of nonobviousness. See generally Prelim. Resp. 11 For purposes of this Decision, we apply a priority date in the 2009–2010 timeframe. See supra page 3 n.1. On the present record, it does not appear that the level of ordinary skill changed during this timeframe. patient and transmitting indications of such levels to a receiving device for reporting the measurements. Additional education, such as a Master’s degree could substitute for the industry experience, or vice versa. Pet. 23 (citing Ex. 1208 (Gross Decl.) ¶ 51).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having reviewed the arguments and evidence of record, we determine that no construction of any claim term is needed to decide whether to institute this Petition. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record. Should the parties argue for any specific claim interpretations at trial, they should do so in a separately designated section of their briefing to highlight their proposed claim interpretations. See, e.g., Consolidated Trial Practice Guide (Nov. 21, 2019), 44–49.12 Claim construction arguments should not be merely asserted within arguments over the merits of patentability challenges.” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,298,056 - Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - PTAB · Jun 13, 2024 · IPR2024-00269 · APJ Robert J Silverman · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7, 8, 10, 12, 17, and 18 based on both § 103 grounds, finding a reasonable likelihood of success.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Provisur proposes, and Weber does not dispute, that a person of ordinary skill in the art of the ’823 patent, at the time relevant for the analysis herein, would have possessed the following background and qualifications: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 13–14. Provisur’s proposed definition appears to be consistent with the problems and solutions addressed in the ’823 patent and the prior art of 3 US 2016/0023370 A1, pub. Jan. 28, 2016 (Ex. 1004, “Müller”). 4 US 2019/0329438 A1, pub. Oct. 31, 2019 (Ex. 1005, “GEA438”). 5 US 2009/0159631 A1, pub. June 25, 2009 (Ex. 1006, “DePoi”). record. Therefore, for the purposes of this Decision, we adopt Provisur’s characterization of the level of ordinary skill in the art.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Weber’s Preliminary Response does not manifest any claim construction dispute that would bear upon this Decision. Therefore, we need not expressly construe any claim terms at this preliminary stage. 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.”)” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“[I]n evaluating the factors,” set forth in Fintiv, “the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv 6 (emphasis added). In view of the following discussion of these factors, under the circumstances as they appear from the present record, the efficiency and integrity concerns, referenced in Fintiv, are best served by not exercising our discretion to deny the Petition without considering the merits. slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary 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.” For the reasons that follow, and solely for the purposes of this Decision, we determine that Grounds 1 and 2 of the Petition (as identified below) satisfy this standard.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,331,823
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.