• Precision Planting LLC v. Maschio Gaspardo S.P.A.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,770,121
• Orthocision, Inc. v. PTL Opco LLCNo claims unpatentable
  PTAB · Sep 18, 2024 · IPR2023-00625 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1, 2, 9, and 10 were not shown unpatentable under any asserted § 103 ground because Petitioner did not adequately explain how or why the prior art would be combined.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not specifically address Petitioner’s proposed definition. See generally Resp. Patent Owner’s witness, Dr. Bovinet, uses a slightly different, but not materially so, definition of the ordinarily skilled artisan than Petitioner. See Ex. 2005 ¶ 13. Thus, the parties appear to agree on who the person of ordinary skill in the art would have been in terms of education and field of work experience. We accept and adopt Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’129 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[]” 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)). B.” slip op. at 13

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

    “3. Summary on Claim Construction We maintain our earlier constructions of “open tip” and “releasing means . . . .” See DI 16–24. We determine that no other express construction of any claim term is necessary for purposes of rendering this Decision. See Nidec Motor Corp., 868 F.3d at 1017. Although we maintain here our constructions of “open tip” and “releasing means . . . ,” we do so only for the sake of completeness. These claim constructions, ultimately, are not determinative of the outcome of this proceeding because, regardless of the meaning of any claim term, including these disputed terms, we find that Petitioner fails to adequately explain why any claim would have been obvious under the asserted grounds. We explain this in detail below. C.” slip op. at 29

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

    “Ex. 1001, 6:28–38 (emphasis added). However, the language of claim 1 is very clear on the functionality of the “open tip,” expressly reciting that “the open tip cuts bone tissue away from the sacrum or the ilium.” Id. at 13:19– 20. Thus, the claim language itself provides the required functionality of the “open tip,” and we do not agree with Petitioner that additional functionality relating to where bone tissue might go once cut, as discussed in the Specification, should be read into the claims as a limitation. Patent Owner’s newly proposed interpretation is similar to Petitioner’s in that it requests addition of functionality discussed as an example in the Specification, but not recited in the claim’s expressly recited functional language relating to the “open tip.” We disagree with Patent Owner that the concept of dislodged tissue entering a void defined by the open tip is necessary to understanding the claim element. And, once more, Patent Owner reads too much structure from the written description into the claim language as a limitation because it is not apparent that the recited “open tip” language requires that we further clarify that any interior void defined by the open tip is on the interior of the abrading head, and behind the exterior abrading surfaces, or between interior surfaces of a first pair of opposing sides, as proposed by Patent Owner. “[W]hile it is true that claims are to be interpreted in light of the specification . . . , it does not follow that limitations from the specification may be read into the claims. . . . [T]he claims define the invention.” Sjolund v. Musland, 847 F.2d 1573, 1581–82 (Fed. Cir. 1988).” slip op. at 18

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner

    “A claim limitation is presumed to invoke 35 U.S.C. § 112(f) (or pre- AIA § 112 ¶ 6) if, as here, it explicitly uses the term “means” and includes functional language; this presumption is overcome if the limitation further includes the structure, material, or acts necessary to perform the recited function. See Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). Here, the word “means” is recited, followed by functional language, and the claim recites no structure associated with the means or function. Moreover, the parties agree that this is a means plus function limitation. See Pet. 19–20; Resp. 9. We find “releasing means” is a means plus function limitation and, based on the plain language of the claim, the recited “releasing means” is a part of the also recited “slide hammer assembly,” as the above-quoted claim language defines. Ex. 1001, 13:10–17. Construing a claim term under 35 U.S.C. § 112(f) involves two steps: (1) identifying the claimed function; and then (2) determining what structure, if any, disclosed in the Specification corresponds to the claimed function. Williamson, 792 F.3d at 1351. In conducting this analysis, we may not incorporate structure from the written description beyond that which is necessary to perform the claimed function. See Micro Chemical, Inc. v. Great Plains Chemical Co., 194 F.3d 1250, 1258 (Fed. Cir. 1999).” slip op. at 20

  Patent outcomesUS 11,020,129 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,020,129
• Axonics, Inc. v. Medtronic, Inc.No claims unpatentable
  PTAB · May 30, 2024 · IPR2020-00712 · APJ James A Tartal · IPR · Remand

  Claims 3–6, 9–12, and 15–18 were not proven unpatentable because the petitioner failed to show the required two inputs in the asserted prior art.

  RulingsRemand decision

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

    “The Specification of the ’148 patent states that “an alignment measurement may be made by measuring a value, e.g., current or voltage, associated with, e.g., proportional to, the current passing through [the] rechargeable power source.” Id. at 21:3–6. We therefore find that the Specification expressly identifies “current or voltage” as examples of “a value.” Id. In the FWD, we stated that “[a]lthough the ’148 patent makes clear that ‘a value’ may include, for example ‘voltage,’ we agree with Patent Owner that the two independent limitations should be construed such that the Value Limitation does not render superfluous the Signal Limitation or the Measured Voltage Limitation.” FWD 26. We further determined that “the Value Limitation and the Signal Limitation, as well as the Value Limitation and the Measured Voltage Limitation both require two separate inputs to the external power source.” Id. That determination is not at issue here. See Axonics, 75 F.4th at 1379–80 (stating that Petitioner did “not argue the Board erred in adopting the two-input claim construction”). 2. Additional Claim Terms We find no additional claim term requires express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 22

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention. In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” Id. (citation omitted). Petitioner contends that a person of ordinary skill in the art at the time of the invention “would have had at least a bachelor’s degree in electrical the industry working with implantable medical devices such as cardiac pacemakers or defibrillators.” Pet. 8. Patent Owner argues that a person of ordinary skill “would have had at least a bachelor’s degree in a relevant field (e.g., electrical, mechanical, or biomedical engineering) with at least two years of experience with the design of components (e.g., circuitry) for implantable medical devices and associated external devices (e.g., a charging unit),” and that “[m]ore education can substitute for practical experience and vice versa.” PO Resp. 4–5 (citing Ex. 2002 ¶¶ 21–22). Our analysis here, as in the FWD, does not turn on which of the Parties’ competing definitions of ordinary skill is applied. See FWD 16. Moreover, the appropriate level of ordinary skill is not in dispute on remand. Consistent with the FWD and the Decision on Institution, we apply the level of ordinary skill in the art proposed by Petitioner. See Inst. Dec. 11 (stating that “the ’148 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references . . . is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner” (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001))); FWD 16.” slip op. at 18

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “By contrast, in his Rebuttal Declaration, Dr. Mihran disputes Dr. Panescu’s new description of the operation of Schulman, noting that the current through R9 is not increased as a result of the current regulator R8/Q7 turning on, but that “[i]nstead, it is the increase in current through R9 in excess of the desired 40 mA operating current that causes the current regulator R8/Q7 to turn on, which acts to shunt this excess current through Q7, thereby diverting it away from the battery to maintain the desired operating condition during charging.” Ex. 2010 ¶ 6 n.3 (citing Ex. 1005, 5:2–7, 5:15–38, 9:57–68). We credit the testimony of Dr. Mihran, as supported by the cited portions of Schulman, over the unsupported testimony of Dr. Panescu in regard to how Schulman operates to measure current at R9. See id. However, whether Schulman discloses automatically varying the output power of the external power source based on a value associated with current passing through the internal battery, as required by the Value Limitation, is not in dispute. Dr. Mihran, for example, states that “Schulman discloses that the sole input provided to the external power” slip op. at 34

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Patent Owner argues, and we agree, that the measured current through R9 is the only input to the external power source Schulman APO Sur-reply 14–15. Patent Owner further argues, and we further agree, that the voltage across output leads 51 and 52 of Schulman is not an input to the external power source separate from the measured current through R9 in Schulman. See APO Sur-reply 11–16 (citing, e.g., Ex. 1003 ¶ 75; Ex. 2002 ¶ 46; Ex. 1005, 6:35–38; Ex. 2010 ¶¶ 4–7). In support of Patent Owner, Dr. Mihran states that “[t]he voltage between nodes 51 and 52 is never provided to the external power source in Schulman.” Ex. 2010 ¶ 4. According to Dr. Mihran, “Schulman discloses that the sole input provided to the external power source that the external power source uses to automatically regulate its power output is the input that derives from the amount of current flowing through the current sampling resistor R9.” Id. ¶ 5 (emphasis omitted) (citing Ex. 1005, 4:45–53, 6:35–38; Ex. 2002 ¶ 46). Dr. Mihran further states as follows: My understanding of Dr. Panescu’s opinion is that he does not contend that the voltage between nodes 51 and 52 is ever sent to the external power source as an input, and instead simply asserts that if “the voltage across leads 51 and 52 exceeds a predetermined amount,” then the current through R9 increases, which in turn “causes the power supplied by the external power source to decrease.” (Ex. 1012 at ¶16.) This does not represent a separate input, however, because the input derived from the current flowing through the current sampling resistor R9 (i.e. the load modulation frequency of telemetry circuit 12, the components of which “form a free-running multivibrator”) is what Dr. Panescu also identifies as satisfying the first input, “a value associated with said current passing through said internal battery.” (Ex. 1012 at ¶14 (“when the current through the internal battery . . . increases above a predetermined target value, the current regulator turns on, increasing the current through current sampling resistor R9.”) operating conditions may influence the value” of the amount of current flowing through current sampling resistor R9, and the current through R9 is the “only value that is communicated to the external power source,” corresponding to a single input that “cannot satisfy both of the two inputs required by claims 3, 6, 9, 12, 15, and 18 of the ’148 patent.” Id. ¶ 6. Dr. Mihran further states as follows: I understand Dr. Panescu’s opinion to be that, because Schulman discloses that the current through R9 is used by the external charger to automatically vary its output, any “value” that influences the amount of current through resistor R9 is a “separate respective input[] used by the external power source as a basis for automatically varying its power output.” ([Ex. 1012 ¶14].) In other words, Dr. Panescu simply identifies a voltage across two points in the circuit that he claims affects the current through R9 and contends that that voltage satisfies one of the two required separate inputs based on its alleged indirect impact on the output of the external charger. This strained interpretation of the claims renders superfluous the two separate inputs to the external power source required by claims 3, 6, 9, 12, 15, and 18 of the ’148 patent: (1) “a value associated with said current passing through said internal battery” and (2) “a signal proportional to said current passing through said internal battery” (claims 3, 9, and 15) and “measured voltage associated with said current passing through said internal battery” (claims 6, 12, and 18). In any circuit, there may be multiple components (e.g., transistors, switches, diodes, etc.) that can influence the current through a particular resistor. For example, in Schulman the current drawn by the stimulation portion of the implant circuit will influence the amount of current through R9. Dr. Panescu’s interpretation that a voltage or current at these components represents a “separate input” in Schulman is incorrect, because the sole input that is telemetered back to the external charger is the input derived from the amount of current flowing through R9.” slip op. at 35

  Patent outcomesUS 8,738,148 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,738,148
• Axonics, Inc. v. Medtronic, Inc.No claims unpatentable
  PTAB · May 30, 2024 · IPR2020-00680 · APJ James A Tartal · IPR · Remand

  On remand, the Board determined that claims 1, 5, and 9 were not shown unpatentable as anticipated by Schulman, Fischell, or Baumann.

  RulingsRemand decision

  • BurdenNot shown unpatentable

    “consider for purposes of the FWD. We also consider Patent Owner’s Amended Sur-reply, as supported by the Rebuttal Declaration of Dr. Mihran, and the arguments and evidence advanced in the post remand briefs of the Parties. Based on the totality of the record in this case, we determine, for the reasons that follow, that Petitioner does not show by a preponderance of the evidence that any of claims 1, 5, or 9 is anticipated by Schulman, Fischell, or Baumann. A. Principles of Law A claim is anticipated if a single prior art reference either expressly or inherently discloses every limitation of the claim. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967, 975 (Fed. Cir. 2010). “A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “B. Level of Ordinary Skill in the Art The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention. In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” Id. (citation omitted). of the invention “would have had at least a bachelor’s degree in electrical engineering or an equivalent as well as at least five years of experience in the industry working with implantable medical devices such as cardiac pacemakers or defibrillators.” Pet. 7. Patent Owner argues that a person of ordinary skill “would have had at least a bachelor’s degree in a relevant field (e.g., electrical, mechanical, or biomedical engineering) with at least two years of experience with the design of components (e.g., circuitry) for implantable medical devices and associated external devices (e.g., a charging unit),” and that “[m]ore education can substitute for practical experience and vice versa.” PO Resp. 5 (citing Ex. 2002 ¶¶ 21, 22). Our analysis here, as in the FWD, does not turn on which of the Parties’ competing definitions of ordinary skill is applied. See FWD 16. Moreover, the appropriate level of ordinary skill is not in dispute on remand. Consistent with the FWD and the Decision on Institution, we apply the level of ordinary skill in the art proposed by Petitioner. See Inst. Dec. 11–12 (stating that “the ’758 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner” (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001))); FWD 16.” slip op. at 17

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedOther

    “By contrast, in his Rebuttal Declaration, Dr. Mihran disputes Dr. Panescu’s new description of the operation of Schulman, noting that the current through R9 is not increased as a result of the current regulator R8/Q7 turning on, but that “[i]nstead, it is the increase in current through R9 in excess of the desired 40 mA operating current that causes the current regulator R8/Q7 to turn on, which acts to shunt this excess current through Q7, thereby diverting it away from the battery to maintain the desired operating condition during charging.” Ex. 2010 ¶ 6 n.2 (citing Ex. 1005, 5:2–7, 5:15–38, 9:57–68). We credit the testimony of Dr. Mihran, as supported by the cited portions of Schulman, over the unsupported testimony of Dr. Panescu in regard to how Schulman operates to measure current at R9. See id. However, whether Schulman discloses automatically varying the output power of the external power source based on a measured current, as required by the challenged claims, is not in dispute. Dr. Mihran,” slip op. at 32

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We find that because it is largely unsupported and conclusory, the opinion of Dr. Panescu in his Supplemental Declaration that “Schulman teaches automatically varying the output power of the external power source based on a value, where the value is the voltage across the output leads 51 In his original declaration, Dr. Panescu made clear that, according to Schulman, the output of the external power source was lowered if the charging current, as measured at sampling resistor R9, “exceeds a maximum capacity,” not because of the voltage across output leads 51 and 52. See Ex. 1003 ¶ 127 (quoting Ex. 1005, 7:25–29). Petitioner does not allege that any measurement of voltage across output leads 51 and 52 in Schulman is conveyed to an external power source to automatically vary its power output. Instead, Petitioner’s argument is premised on the notion that if the voltage across leads 51 and 52 exceeds a predetermined amount, then it will affect the current sampled by resistor R9. We also find persuasive Dr. Mihran’s testimony that Petitioner’s strained interpretation renders the Value Limitation superfluous to the Measured Current Limitation because the voltage across leads 51 and 52 was not shown by Petitioner to be a separate input to the external power source. See Ex. 2010 ¶ 7 (explaining that “there may be multiple components (e.g., transistors, switches, diodes, etc.) that can influence the current through a particular resistor,” and that influencing the current measured at R9 does not constitute a separate input to the external charger from the measured current at R9). To be clear, we need not resolve whether the challenged claims require each separate input be separately conveyed to the external power source. Here, the burden to show anticipation is on Petitioner and Petitioner offers no persuasive evidence or explanation to establish by a preponderance of the evidence that a person of ordinary skill in the art would have understood the voltage across output leads 51 and 52 corresponds to “a value” based upon which the external power source “automatically” varies its power output, as required by the challenged claims. Nor does skill in the art would have understood the voltage across leads 51 and 52 in Schulman to be a separate input from the measured current at R9 when, at most, Petitioner alleges the voltage across leads 51 and 52 may, in certain circumstances, have some effect on the measured current at R9, itself. Thus, Petitioner does not show by a preponderance of the evidence that Schulman discloses to a person of ordinary skill in the art two separate inputs to the external power source, as Petitioner conceded is required by the Value Limitation and the Measured Current Limitation.” slip op. at 35

  Patent outcomesUS 8,457,758 not shown unpatentable
  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 8,457,758
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

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

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” 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 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Nespresso USA, Inc. v. K-Fee System GMHBNo claims unpatentable
  PTAB · Apr 10, 2024 · IPR2022-01574 · APJ James J Mayberry · IPR · Final written decision

  Claims 1–13 were not shown unpatentable because the asserted combinations did not teach or render obvious the claimed groove entirely to the side of the chamfered mandrel.

  RulingsFinal written decision

  • Skill levelSkill level board ownPatent owner expert discountedDecided for patent owner

    “The Federal Circuit has made clear that, “[t]o offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.” Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (emphasis added). “Without that skill, the witness’[s] opinions are neither relevant nor reliable.” Id. at 1377. The Federal Circuit reasons that “‘[a]dmitting testimony from a person . . . with no skill in the pertinent art serves only to cause mischief and confuse the factfinder.’ . . . That testimony would ‘amount[ ] to nothing more than advocacy from the witness stand.’” Id. (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)). possesses at least the level of ordinary skill in the art. Our level of ordinary skill in the art requires a bachelor’s degree in engineering plus five years of experience in design of mechanical beverage systems, or similar products, as well as experience with sensors for recognizing an identifier. Patent Owner does not persuasively account for how Dr. Howle’s experience, extensive as it may be, includes five years of experience in design of mechanical beverage systems, or similar products, as well as experience with sensors for recognizing an identifier. Cf. Kyocera, 22 F.4th at 1376 (“Dr. Pratt has advanced degrees in engineering and extensive experience in the design and manufacture of fastener driving tools. But he lacks experience in power nailer design.”).” slip op. at 21

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “The Federal Circuit has made clear that, “[t]o offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.” Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (emphasis added). “Without that skill, the witness’[s] opinions are neither relevant nor reliable.” Id. at 1377. The Federal Circuit reasons that “‘[a]dmitting testimony from a person . . . with no skill in the pertinent art serves only to cause mischief and confuse the factfinder.’ . . . That testimony would ‘amount[ ] to nothing more than advocacy from the witness stand.’” Id. (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)). possesses at least the level of ordinary skill in the art. Our level of ordinary skill in the art requires a bachelor’s degree in engineering plus five years of experience in design of mechanical beverage systems, or similar products, as well as experience with sensors for recognizing an identifier. Patent Owner does not persuasively account for how Dr. Howle’s experience, extensive as it may be, includes five years of experience in design of mechanical beverage systems, or similar products, as well as experience with sensors for recognizing an identifier. Cf. Kyocera, 22 F.4th at 1376 (“Dr. Pratt has advanced degrees in engineering and extensive experience in the design and manufacture of fastener driving tools. But he lacks experience in power nailer design.”).” slip op. at 21

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

    “Based on the information above, we conclude that the limitation “a groove that is laterally offset from the chamfered mandrel” requires the groove to be entirely to the side of any part of the mandrel. This construction is consistent with the words of the claim—the claim states that the groove is laterally offset from, or to the side of, the chamfered mandrel, not merely offset from a portion of or the centerline of the mandrel. This construction is also consistent with the one embodiment describing the relationship between the mandrel and groove containing the seal, which depicts the groove entirely to the side of the chamfered mandrel. We do not accept Mr. Jobin’s testimony that laterally offset is determined relative to the centerline of an object. Neither the intrinsic record nor other extrinsic evidence provides support for Mr. Jobin identifying the centerline of an object as the reference point for determining if a point is laterally offset from the object.” slip op. at 31

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We do not agree with Petitioner that Yoakim teaches a groove that is laterally offset from the chamfered mandrel. As we indicated in our claim construction section, we construe the claim term to require the groove to be entirely to the side of any part of the mandrel. We agree with Patent Owner that, as depicted in Yoakim’s Figure 35, the alleged groove is not entirely to the side of any part of the mandrel. See Pet. 69; see also Pet. Reply 19 (showing the alleged groove, in red, including a portion over the chamfered mandrel); PO Resp. 55 (same). Even if Petitioner’s position is that all of the groove must be to the side of the centerline of the mandrel, Petitioner fails to prove that Yoakim teaches such a structure. As seen in Petitioner’s illustration at page 19 of Petitioner’s Reply (reproduced above), a small portion of the groove (which Petition colorizes in red) is to the left of the centerline (shown in green). See Pet. Reply 19.” slip op. at 40

  Patent outcomesUS 11,254,491 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,254,491
• Axonics, Inc. v. Medtronic, Inc.No claims unpatentable
  PTAB · Mar 21, 2024 · IPR2020-00715 · APJ Brent M Dougal · IPR · Remand

  On remand, the majority determined claims 1, 2, 5, 7, 13–15, and 18 were not shown unpatentable under either of two §103 grounds, because the asserted combinations lacked sufficient support.

  RulingsRemand decision

  • Skill levelSkill level board ownOther

    “In view of the above, and the evidence of record, we find on remand that the relevant art is medical leads. We previously found that the level of ordinary skill in the art requires “experience researching and developing medical leads for sacral neuromodulation.” FWD 16. Consistent with the Federal Circuit decision and our finding of the relevant art, the experience of one of ordinary skill is not limited to “sacral neuromodulation.” Rather, the level of ordinary skill in the art requires experience in the relevant art, which is medical leads.” slip op. at 10

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

    “B. Claim Construction In an inter partes review, we construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). No terms require express construction. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “Gerber indeed suggests anchoring its lead by fibrosis. Namely, Gerber discloses: “Yet another anchoring mechanism 50 is to allow the medical lead 10 to fibrose in naturally using the human body’s natural reaction to a foreign body or healing.” Ex. 1010, 4:27–30. Moreover, there is no dispute that tines secure via fibrosis. Petitioner, however, acknowledges that any foreign object introduced into the body will cause fibrosis. Tr. 12:8– 13. Nonetheless, Petitioner maintains that Gerber’s disclosure of securing its lead by fibrosis would have led a POSITA to choose tines because tines were a leading candidate among the devices that anchor by fibrosis. Pet. 51 (citing Ex. 1003 ¶ 115) (emphasis added). Petitioner’s argument relies on Mr. Pless’s opinion that tines were a leading candidate for securement via fibrosis, and Mr. Pless’s opinion is based his review of the conventional uses of tines. Tr. 12:18–24 (Petitioner explaining that pages 13–16 of Mr. Pless’s Declaration provide support for his opinion that tines were most commonly used for fixation via fibrosis). According to Mr. Pless, “[b]efore 2001, tines were the most commonly used passive fixation, especially due to the predominant usage of tines in the cardiac space. Tines help to anchor the lead immediately after implantation by engaging with the body tissue, and then by fibrosis.” Ex. 1003, 15–16. Gerber’s lead, however, is for sacral nerve stimulation and is implanted in the sacral area via an open surgical procedure. Ex. 1010, 1:7–15, 5:32–39. We find credible Dr. Siegel’s testimony that Gerber’s device is implanted via an open surgical procedure in which the periosteum and soft tissues surrounding the implantation site are dissected, compromising their structural integrity and rendering tines, which initially anchor by engaging body tissue, ineffective. Thus, despite the prevalent use of tines in the cardiac space to secure leads by engaging body tissue and then by fibrosis, Petitioner has not persuaded us that Gerber’s disclosure of securing its lead by fibrosis would have led a POSITA to replace Gerber’s anchoring mechanism with tines. Regarding Petitioner’s reasoning for positioning tines according to Akerström’s arrangement, Lindegren attributes a manufacturing preference to tines integrally formed and evenly spaced on rings, not proximally extending tines that are adapted to be folded inwardly against the lead body without overlap. Ex. 1011, 5:17–20 (“From the manufacturing point of view, having the projections devised as an integral part of a one-piece ring-shaped means and evenly distributed around the circumference of the ring-shaped means, should be preferable.”). Moreover, according to Petitioner, a smaller profile is suited to percutaneous delivery (Pet. 51), but Gerber’s lead is implanted via an open surgical procedure (Ex. 1010, 1:7–15, 5:32–39). Accordingly, Petitioner has not persuaded us that a POSITA would have had a reason to include, in Gerber’s lead, Hauser’s tines situated according to Akerström’s arrangement.” slip op. at 24

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “We credit Dr. Slavin’s testimony that the trigeminal cistern is a fluid- filled cavity that does not contain tissue for the tines to “engage” with, or be damaged by. Ex. 2029 ¶ 54–55. Dr. Slavin testifies that he is “a board certified neurosurgeon and [has] been in active clinical practice that includes all aspects of neuromodulation, spinal surgery and surgery for pain, including implantation of electrical stimulation devices, surgery on vertebral column including sacrum, trigeminal nerve surgery and so forth.” Ex. 2029 ¶ 5. Thus, Dr. Slavin has extensive knowledge of the areas around the trigeminal nerve. In contrast, Mr. Pless, an electrical engineer and product designer for electrical stimulations device in various areas of the body (Ex. 1003 ¶¶ 3–16), testifies that he believes there is tissue in the area of implantation in Young, but states “I'm not exactly sure what that tissue would be.” Ex. 2026, 123:21–23. Thus, we do not credit Mr. Pless’s testimony that Young’s tines can be damaged because of the body tissue 16 Hauser, discussed in the next ground, teaches tines on the distal most end which impliedly would be advanced out of the introducer, before advancement and placement of the electrode. Ex. 1013, 4:1–3, 4:26–51, Figs. 1, 6. present in the area of implantation of Young. As noted previously, the Petition relies exclusively on Young for teaching this method step of claims 1 and 14.” slip op. at 16

  Patent outcomesUS 8,036,756 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,036,756
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41

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

    “Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15

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

    “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Aug 25, 2023 · IPR2022-00556 · APJ John G New · IPR · Final written decision

  Claims 1–4 were not shown unpatentable because the asserted references did not teach or suggest the limitation requiring no outer graft covering between the fibers and outer frame.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “As the plain language of the claim term suggests, an “outer graft covering” must cover some, or all, of the metallic outer frame of the prosthetic heart valve. Consequently, and according to the plain and ordinary meaning, we understand an “outer graft covering” to be a structure, 29 such as a cloth, fabric or other material, that covers all, or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, and specifically “between the first portion of fibers and the outer frame,” we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the spaces between those struts and members. Consequently, the ordinary and customary meaning of the limitation “free of an outer graft covering between the fibers and the outer frame” is that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 29

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “As an initial matter, there is little disagreement between the parties and their experts that PET can be a graft covering. However, the disputed limitation requires something more. Specifically, it requires that “the outer seal is free of an outer graft covering between the fibers and the outer frame.” We are not persuaded that Petitioner has demonstrated, by a preponderance of the evidence of record, that Levi, Spenser II, or Walther, upon which Petitioner relies, teaches or suggests the incorporated limitation of claim 1 reciting “wherein the valve assembly is free of an outer graft covering between the first portion of fibers and the outer frame.” In our analysis, we must first determine what is meant by the claim term “outer graft covering.”” slip op. at 29

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Furthermore, our understanding of an outer graft covering as a material or structure that covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the interstices between those struts and members, is covered by the outer graft covering, reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by challenged claim 1. We consequently conclude that Petitioner has not met 35 its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 35

  Patent outcomesUS 10,987,236 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,987,236
• Recor Medical, Inc. / Otsuka Medical Devices Co., Ltd. v. Medtronic Ireland Manufacturing Unlimited Co.No claims unpatentable
  PTAB · Jul 14, 2023 · IPR2022-00431 · APJ Eric C Jeschke · IPR · Final written decision

  Claims 1–4 and 8–12 were not shown unpatentable because Petitioner did not prove the asserted anticipation or obviousness grounds by a preponderance of the evidence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends, with accompanying declaration testimony, that [t]he level of ordinary skill encompassed a team of people, having a person with a Ph.D. or M.D. and five years of clinical and/or research experience treating diseases of the kidneys and circulatory systems and a person with at least a Bachelor’s degree in biomedical engineering or a related field and at least five years of experience designing catheter-based ablation systems. Pet. 40 (emphasis omitted) (citing Daft Pet. Decl. ¶¶ 64–68). Patent Owner responds that, “[f]or purposes of this proceeding, [Patent Owner] does not object to the definition of a person of ordinary skill in the art (‘POSITA’) proffered by Petitioner[] and adopted by the Board at institution as the result remains the same regardless of the definition—the Challenged Claims are valid.” PO Resp. 16; see also Dec. Inst. 15–17 (adopting, for purposes of institution, Petitioner’s proposed definition of the person of ordinary skill in the art). In addition, however, Patent Owner proposes a different level of ordinary skill in the art “should the Board believe that the difference in definition impacts the outcome” of this proceeding.8 PO Resp. 16. Both Petitioner and Patent Owner discuss how” slip op. at 9

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

    “to transmit ultrasound energy waves to target renal neural fibers” (claim 1, element 1d) and “configured to [perform certain functions] to the target neural fibers” (claims 3, 4, 8, and 9). See Pet. 23–25; PO Resp. 17–22; Pet. Reply 10; PO Sur-reply 1–2. Petitioner asserts that the phrase “configured to” should be construed as “able to.” Pet. 23; see Pet. 23–24 n.5 (discussing how “able to” has the same meaning as “capable of”). Patent Owner responds that “[t]he Board need not reach the construction of this term as Petitioner[’s] arguments fail under either construction, but to the extent a construction is required, ‘configured to’ should be construed as ‘designed to.’” PO Resp. 18. Based on the complete record, we do not discern a need to construe explicitly this phrase because doing so would not change the result of the analysis below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “the alleged motivation to use the device of Acker in Levin’s renal neuromodulation method. As noted by Patent Owner, after introducing Webster (by patent number), Levin states that “[s]imilar catheter based apparatus can be used to ablate the renal nerve with an intent to treat [Chronic Renal Failure].” Ex. 1004 ¶ 64 (emphasis added) (cited at PO Resp. 39 (discussing how “Levin explicitly qualif[ies] its statement by referring to ‘similar’ (not identical) catheters”)). But neither Petitioner nor its declarants have established that Acker’s ultrasound catheter is in fact “[s]imilar” to that in Webster in a manner that would support the view that one of ordinary skill in the art would have understood that Acker’s catheter could be used to “ablate the renal nerve with an intent to treat [Chronic Renal Failure]” as disclosed in paragraph 64 of Levin—i.e., to perform Levin’s renal neuromodulation method. See id. Dr. Mendelsohn states that Acker’s use of ultrasound-based ablation falls within the “any thermal means” disclosure in Webster (see Ex. 1052, 3:40–42), but Dr. Mendelsohn does not address why Acker’s ultrasound catheter is “[s]imilar” to the catheter in Webster (even after expressly noting the presence of that statement in Levin). See Mendelsohn Decl. ¶ 71 (“Moreover, Webster teaches transvascular nerve ablation using RF thermal ablation or ‘any thermal means’ and Levin teaches catheters similar to Webster’s can be used for renal denervation. Ultrasound ablation disclosed in Acker is a ‘thermal means’ of ablation.”).” slip op. at 21

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “(2) Objective Indicia of Nonobviousness We next turn to Patent Owner’s objective evidence of nonobviousness. Patent Owner alleges (1) unexpected results and skepticism, (2) copying, (3) praise, and (4) long-felt but unsolved need and failure of others. See PO Resp. 60–68; PO Sur-reply 25–27. Petitioner responds. See Pet. Reply 36–37. We have considered the evidence and argument presented by both parties, but do not address the issues in detail. See Alza Corp. v. Mylan Labs., Inc., 391 F.3d 1365, 1373 n.9 (Fed. Cir. 2004) (“Because [patent challenger] has not made a prima facie case of obviousness, we need not address the parties’ assertions regarding the district court’s discussion of secondary considerations.”).” slip op. at 31

  Patent outcomesUS 8,845,629 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 8,845,629

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.