PTAB
Advanced fields
51 decisions · 683msnewest first
  • PTAB · Mar 18, 2025 · IPR2023-01381 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 1–3 and 7–9 are unpatentable as obvious over Uemoto and Smith; the motion to amend is granted, and proposed substitute claims 13 and 14 are not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In order to determine whether an invention would have been obvious at the time the application was filed, we consider the level of ordinary skill in the pertinent art. Graham, 383 U.S. at 17. In assessing 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.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quotation omitted). Petitioner contends a person of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering, chemical engineering, physics, or material science, or a closely related field, and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies.” Pet. 5–6. Petitioner contends “[a]dditional education could substitute for professional experience and vice versa.” Id. at 6. Patent Owner contends that a person of ordinary skill in the art would have had “at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” PO Resp. 7 (citing Ex. 2009 ¶ 82). Upon review of the evidence of record and the parties’ arguments, we adopt Petitioner’s definition of the person of ordinary skill in the art as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). We note, however, that the conclusions reached in this Decision would be the same under either proposed definition of the ordinarily skilled artisan. See Ex. 2009 ¶ 83 (Dr. Schubert testifying that his opinions would be the same under either proposed definition); Ex. 1033 ¶ 9 (Dr. Shealy testifying that the differences in proposed definitions of the ordinarily skilled artisan “would not change the outcome of the invalidity analysis in any material manner”); PO Resp. 7; Pet. Reply 1.” slip op. at 9

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

      “compensated GaN layer above the barrier layer, and a gate contact above the compensated GaN layer.” Ex. 1001, 5:12–18. Petitioner contends the term “compensated” indicates that the step of compensating the GaN layer has already occurred, such that the term “compensated GaN layer” should be construed as a “‘[d]oped GaN layer formed with a step to passivate its impurities’ which is a ‘product-by-process’ limitation.”5 Pet. 12–14. And, because compensation with hydrogen was the “critical step” distinguishing the claims from the prior art, and because hydrogenation in as-grown III-nitride materials had been well known for over a decade by 2009, Petitioner contends “compensated” “cannot be interpreted as mere hydrogen presence in as-grown material, a well-known property of doped GaN.” Id. at 15. Patent Owner contends “compensated GaN material” should be construed as “a semiconductor GaN gate material in which one type of impurity (for example, donor) cancels the electrical effects of the other type of impurity (for example, acceptor).” PO Resp. 11 (citing Ex. 2009 ¶ 92) (emphasis added). Patent Owner contends this construction is consistent with the IEEE dictionary, which defines “compensated semiconductor” as 5 Given that product-by-process steps in a device claim are not entitled to patentable weight, Petitioner contends “the prior art only need show a material with passivated impurities to show unpatentability, not the step to achieve it.” Pet. 15–16. “[a] semiconductor in which one type of impurity or imperfection (for example, donor) partially cancels the electric effects of the other type of impurity or imperfection (for example, acceptor).” PO Resp. 14 (quoting Ex. 2004). Patent Owner contends its construction is also consistent with the written description of the ’294 patent, which explains that a compensated GaN material is part of the gate and includes a p-type impurity that imparts an electrical effect (i.e., conductivity), as well as a second impurity, e.g., hydrogen, that partially cancels the electrical effect of the p-type impurity, rendering the layer semi-insulating. Id. at 14–15 (citing Ex. 1001, 3:10–13, 3:43–45). On this record, we construe “compensated GaN layer” as “a GaN layer in which one type of impurity (for example, donor) partially cancels the electric effects of the other type of impurity (for example, acceptor).” This is consistent with the disclosures of the ’294 patent, the IEEE dictionary definition, and the construction ultimately adopted by the ITC. Ex. 2004, 3; Ex. 1049, 16–17 (ITC construing “compensated GaN layer” to mean “a GaN layer in which one type of impurity partially cancels the electrical effects of another type of impurity”); Ex. 1001, 3:43–45 (explaining that the compensated GaN layer of the ’294 patent is formed through the “passivation of a p-type impurity using hydrogen”). For the reasons set forth below, however, we decline to construe “compensated GaN layer” as a product-by-process claim term (as asserted by Petitioner), or to limit the compensated GaN layer to a gate material (as asserted by Patent Owner).” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

      “There are two exceptions to the general rule that we apply the ordinary and customary meaning of a claim term: (1) when a patentee sets out a definition and acts as his own lexicographer, or (2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution. See Thorner, 669 F.3d at 1365. The standards for lexicography and disclaimer, however, are “exacting.” Id. at 1366. There is no argument that the patentees acted as their own lexicographer to redefine the term “compensated GaN layer.” With respect to disavowal, a “patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Thorner, 669 F.3d at 1366 (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002)). As noted by Patent Owner, the title of the ’294 patent is, in part, “Compensated Gate MISFET” and much of the discussion of the ’294 patent is of a compensated GaN layer that is directly below the gate contact and above a barrier layer and operates in conjunction with the gate contact to control the on/off state of the transistor. PO Resp. 12–14. We are presented with insufficient argument or evidence to conclude, however, that these disclosures rise to the level of a disclaimer. For example, although the title of the ’294 patent is directed to a “Compensated Gate MISFET,” claim 1 is more broadly directed to “[a] column III Nitride transistor.” Ex. 1001, 5:12, code (54). Nor are we directed to an expression or statement of manifest exclusion in the ’294 patent that would serve to disclaim any “compensated GaN layer” that is not directly below the gate and/or that does not function in concert with the gate electrode to control the on/off state of the transistor. See Thorner, 669 F.3d at 1366. With respect to the stated goals of the invention, as noted by Patent Owner, one of the primary purposes of the compensated GaN layer of the ’294 patent is to reduce gate leakage and gate capacitance. Ex. 1001, 2:13– 19, 3:18–21 (“[U]sing a compensated semiconductor layer 38 leads to low gate leakage during device operation.”). We cannot use the goals of the invention, however, to rewrite the claims or insert terms that are not present. See Thorner, 669 F.3d at 1366. Moreover, the prior art of record indicates that a compensated GaN layer that is below the gate contact and above a barrier layer, but not part of the active gate structure, may also “decrease the leakage current between the gate and the drain.” Ex. 1006 ¶¶ 44 (“Even when a positive bias of 5 V or higher is applied to the gate electrode, no significant gate-leakage current is observed.”), 61. As such, evidence of record suggests that a person of ordinary skill in the art would have understood that one of the primary goals disclosed in the ’294 patent is achieved regardless of whether the compensated GaN layer is part of the gate, or simply in close vicinity to the gate. In view of the foregoing, we are not persuaded that the written description of the ’294 patent indicates that the “compensated GaN layer” must be part of the gate structure.” slip op. at 17

    • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

      “To be probative, Patent Owner must prove there is a nexus between the presented evidence and the merits of the claimed invention. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A rebuttable presumption of nexus applies when the “patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco, 851 F.2d at 1392). “That is, presuming nexus is appropriate ‘when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.’” Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). If the praise is not limited to the features of the claimed invention, the patent owner may still prove nexus “by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Patent Owner contends that the compensated gate of the ’294 patent “was a breakthrough invention and resulted in the first commercially viable enhancement-mode GaN transistor.” PO Resp. 60 (citing Ex. 2009 ¶¶ 192– 193, 197; Ex. 2021). Patent Owner further contends that this achievement required the counter-intuitive use of a compensated gate material in the gate structure, and represented “a technological leap that laid the foundation for viable enhancement-mode GaN transistors.” Id. at 61–62. For this achievement, Patent Owner contends the inventor, Dr. Alex Lidow, received the 2015 SEMI Award. Id. at 60 (citing Ex. 2021). Upon review of Patent Owner’s evidence and the parties’ arguments, we find that Patent Owner’s objective indicia evidence is entitled to little, if any, weight. The evidence of praise relied upon by Patent Owner is not clearly linked to the claimed invention or any particular product having each of the claimed features of the ’294 patent. Ex. 2021. For example, the 2015 SEMI award was provided to Dr. Lidow “for commercialization of GaN power devices.” Id. An article explaining the award indicates that “high cost” previously “limited [the] commercial success” of GaN technologies, but Dr. Lidow was able to overcome these issues, “from resolving packaging limitations to establishing a low-cost supply chain,” “through persistence.” Id. This praise is not demonstrably linked to the claimed invention or any particular device, and does not mention the use of a compensated gate, or any other relevant feature recited in the claims. In view of the foregoing, we determine that Patent Owner’s objective evidence of non-obviousness is entitled to little, if any, weight.” slip op. at 20

    Patent outcomesUS 8,350,294 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,350,294
  • PTAB · Nov 1, 2024 · PGR2024-00025 · APJ Jeffrey W Abraham · PGR · Institution

    The Board denied institution because Petitioner did not show that claims 1–20 were more likely than not unpatentable over either obviousness ground, for lack of utility, or as indefinite.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’033 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–22, 44–45). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’033 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level”” slip op. at 6

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

      “Petitioner does not offer a specific construction for any claim terms. Pet. 19–20. Rather, Petitioner contends that “the outer boundary of the Challenged Claims lacks reasonable certainty,” and, therefore, “the Challenged Claims are unpatentable as indefinite under §112(b).” Pet. 20. Petitioner further contends that the challenged claims are unpatentable as obvious “regardless of the outer boundary of the claims.” Pet. 21. Patent Owner disagrees with Petitioner’s arguments regarding indefiniteness, and does not construe any claim terms. See generally Prelim. Resp. As explained in detail below, based on the record before us, we are not persuaded by Petitioner’s indefiniteness arguments, and determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. 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” slip op. at 7

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

      “Patent Owner is correct that Petitioner focuses its obviousness challenge on 1PNZQ23’s phenotype, and does not address its genotype. Prelim. Resp. 41–42; see Pet. 26–32 (comparing 1PNZQ23’s phenotype with the phenotypes of the asserted prior art). Petitioner does not direct us to, nor do we discern, any information in the Petition or Reply regarding 1PNZQ23’s genotype that supports Petitioner’s arguments regarding obviousness. Furthermore, Patent Owner offers information suggesting that “the breeding of 1PNZQ23 was unpredictable even with both parents being known in the art.” Prelim. Resp. 47. Dr. Schnable addresses unpredictability in the breeding process, stating: distinct even when the F1 plant itself results from a cross of two inbreds. A [person of ordinary skill in the art] would not expect that a cross of the same parents will produce F2 or D1 progeny identical to 1PNZQ23. . . . [T]he genome of a progeny plant is the result of genetic segregation and recombination in the F1 plant of the two parental genomes and the chance of the exact same child resulting from that initial biparental cross is infinitesimally small. Ex. 2004 ¶ 123. This information undermines Petitioner’s arguments regarding an expectation of success in achieving the claimed invention.” slip op. at 13

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,707,033
  • PTAB · Oct 15, 2024 · PGR2024-00023 · APJ Jeffrey W Abraham · PGR · Institution

    The Board denied institution on claims 1–20 because the petition did not show they were unpatentable on any asserted obviousness, utility, written-description, or enablement ground.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’545 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist as along with genetics specialists) and field-side personnel.” Pet. 16 (citing Ex. 1003 ¶¶ 50–51). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 16. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’545 patent, and we adopt it for purposes” slip op. at 6

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

      “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).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 21. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. 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 7

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

      “additional reasons. For example, we agree with Patent Owner that Petitioner fails to demonstrate sufficiently that a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at PH4CYJ based on Smalley’s disclosure alone. Prelim. Resp. 51–52. According to the ’545 patent specification, the claimed PH4CYJ inbred maize variety is a cross between inbred line PH1VNA and inbred line PH1KTF. Ex. 1001, 37:62–64. In the simplest terms, PH1VNA and PH1KTF are the parents, and their cross ultimately resulted in the inbred variety PH4CYJ. The ’545 patent explains that after the initial crossing of the parental lines, the” slip op. at 14

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 11,696,545
  • PTAB · Sep 30, 2024 · PGR2024-00022 · APJ Michael G Mcmanus · PGR · Institution

    The Board denied institution on claims 1–24 because Voltage did not show that any challenged claim was more likely than not unpatentable under the asserted grounds.

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

      “We have authority to determine whether to institute a post-grant review. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). A post-grant review may not be instituted “unless. . . the information presented in the petition . . . if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Upon consideration of the evidence and arguments in the Petition (including its supporting testimonial evidence) and the evidence and arguments in the Preliminary Response (including its supporting testimonial evidence), we determine that Petitioner has not demonstrated that the ’153 patent is eligible for post-grant review. Accordingly, we decline to institute a post-grant review of claims 1–24 based on the grounds articulated in the Petition.” slip op. at 2

    • Skill levelOther

      “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.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We determine that no express finding is necessary, on the present record, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Further, for purposes of this institution decision, and on the present record, we determine that the adoption of either party’s proposal regarding requisite work experience would not change our analysis or conclusions. C. Claim Construction” slip op. at 12

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

      “The parties put forward several terms for construction. Pet. 14–17; Prelim. Resp. 9–12. With respect to Grounds I through VII, we have determined that no claim constructions are required in order to address the points at issue. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms that are in controversy, and only to the extent necessary to resolve the controversy” (internal citation omitted)). Claim construction is required to resolve certain issues arising in connection with Ground VIII. Accordingly, we construe certain terms in our discussion of that ground, infra.” slip op. at 13

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

      “through the undermold.” The term “aperture only partially extending through said undermold” was added to the claims of the ’254 parent application by amendment. Ex. 1021, 103–105; Ex. 1020, 6:60–8:47. With this amendment, the claims of the ’254 patent align with Figure 7, reproduced below. Figure 7 of the ’254 Patent (Figure 7 of the ’153 patent is identical to Figure 7 of the ’254 patent except for minor stylistic changes). As can be seen, the aperture occupied by drop line 12 extends partially through the undermold to compression lug 20 while the aperture occupied by feeder cable 14 extends completely through the undermold. This suggests a construction of “aperture extending partially through the undermold” where such aperture does not extend completely through the undermold. Such a construction of “aperture extending partially through the undermold” is consistent with the plain meaning of “extending partially.”” slip op. at 62

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham · Nautilus
    Patents in suitUS 11,689,153
  • PTAB · Sep 24, 2024 · PGR2024-00019 · APJ Ulrike W Jenks · PGR · Institution

    The Board denied institution of PGR on claims 1–20 because the Petition did not show they were more likely than not unpatentable on any asserted ground.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner failed to demonstrate that it is more likely than not that claims 1–20 of the ’803 patent are unpatentable. Accordingly, we deny institution of a post-grant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’803 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (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

      “Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 20. Patent Owner also does not construe and based on the record before us, we determine that none of the claim terms requires an explicit construction to determine whether to institute post-grant review. 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 7

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

      “their cross ultimately resulted in the inbred variety 1PFLQ21. The ’803 patent explains that after the initial crossing of the parental lines, the selection of the progeny was based on genetic analysis predicting disease, insect, and agronomic phenotypic performance. Id. 37:64–66. “Inbred 1PFLQ21 was developed by producing a doubled haploid from the F1 plants, selfing and using pedigree selection amongst the D1 lines, and selfing and bulking from the subsequent generations.” Id. 37:66–38:3. The ’803 patent specification, therefore, makes it clear that simply crossing both parental inbred maize lines is not reasonably expected to result in the claimed inbred maize variety; rather, it explains that more plant breeding work is required to arrive at the 1PFLQ21 inbred maize line than just having both parental inbred maize lines available.” slip op. at 15

    Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,659,803
  • PTAB · Sep 24, 2024 · PGR2024-00020 · APJ Jeffrey W Abraham · PGR · Institution

    Denied institution of PGR on claims 1–20 because Petitioner did not show a reasonable likelihood equivalent under § 324 that any challenged claim was unpatentable.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’020 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner asserts that a person of ordinary skill in the art “had a high level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist . . . along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–21). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art,” but “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’020 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6

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

      “Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 22. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. 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 7

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

      “Based on these disclosures in Smalley, we agree with Petitioner that a person of ordinary skill in the art would have understood that the parental line PH1D84 could have been used as a starting point to arrive at other inbred lines. See Pet. 41. Petitioner, however, fails to demonstrate sufficiently how or why a person of ordinary skill in the art would have had a reasonable expectation of success in developing 1PFHC43 specifically, when its other parent was not known in the art at the relevant time. As Dr. Schnable explains, 1PFHC43’s genome is derived from its parents. Ex. 2004 ¶ 115. Petitioner does not address how a person of ordinary skill in the art would have been able to produce the claimed seed, including its unique genotype, without having access to PH1VNA or its genomic and phenotypic information.” slip op. at 15

    Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,666,020
  • PTAB · Sep 10, 2024 · IPR2023-00485 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 1–10 are unpatentable as obvious over the combined disclosures of Yoakim, Jarisch, Rossi, and Castellani.

    RulingsFinal written decision
    • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

      “have a bachelor’s degree in engineering plus five years of experience in design of mechanical beverage systems, or similar products.” Pet. 31 (citing Ex. 1003 ¶ 40). In the Institution Decision, we preliminarily determined that a person of ordinary skill in the art “would have 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.” Inst. Dec. 8 (emphasis added). Neither party disputes this conclusion. PO Resp. 9; see generally Pet. Reply. As such, we adopt our preliminary definition of the ordinarily skilled artisan for purposes of this Final Written Decision.” slip op. at 8

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “designing medical devices and components, and that those experiences represent work designing products similar to mechanical beverage systems, Patent Owner fails to direct the Board to evidence sufficient to establish that this experience, in the aggregate, amounts to at least “five years” or involved “experience with sensors for recognizing an identifier.” Inst. Dec. 8 (adopting Patent Owner’s own proposed definition of one of ordinary skill in the art); see Sur-reply 3–4 (citing Ex. 1066, 34:16–35:9; Ex. 1067, 101:3– 12, 102:20–104:9; Ex. 2017 ¶¶ 3–4, 8–10) (failing to establish adequately, if at all, how Dr. Howle’s qualifications include the requisite minimum five-year period of relevant design experience). Accordingly, we determine that Dr. Howle is not qualified to offer expert testimony from the perspective of a person having ordinary skill in the art in this proceeding.10 See Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). The Federal Circuit has explained that “[t]o offer expert testimony from the perspective of a skilled artisan in a patent case,” including the issue of patent “validity,” the “witness must at least have ordinary skill in the art.” Id. (Board’s emphasis). “Without that skill, the witness’[s] opinions are neither relevant nor reliable.” Id. at 1377.” slip op. at 13

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

      “Second, Patent Owner and Dr. Howell assert that a person of ordinary skill in the art “would have understood upon reading the second German application that the capsule features described would be intended to be combinable with each of the described embodiments.” PO Resp. 40; Ex. 2017 ¶ 61. But Patent Owner and Dr. Howell do not explain how a barcode could be used in the devices depicted in Figures 16–18, which place the detection means 2.4.2 on the outer circumference of the flange (not its underside) and rely on toothed-rings physically interacting with either the chamber, retaining arms, or a pinion. Ex. 1047, 12:22–31, 13:8–18. Indeed, the second German priority application explains that means 2.4.2 physically interacts with retaining arms 30 (embodiments of Figures 16 and 17) or a pinon (embodiment of Figure 18), and if means 2.4.2 were not present in these embodiments the capsule would either “drop through into a waste container” or could not be inserted through the insertion shaft. Id. at 12:22– 27, 13:9–12, 13:16–35 (noting that in the embodiment disclosed in Figure 18 a pinon interacts with means 2.4.2 and only when means 2.4.2 “is formed complementary to the teeth of the means” can the capsule be inserted). At no point does the second German application identify means 2.4.2 as a barcode or suggest a barcode could be used as the detection means. The second German application also states that A person skilled in the art is also aware that for example the insertion shaft may also contain a sensor, for example a camera, clear, however, that element 27 is part of the brewing chamber, and not the capsule. Ex. 1047, 12:27–31, 13:5–8, 13:21–26, 15:36. Thus, we are not persuaded that the toothed ring is in fact on the bottom side of the flange. which senses the shape of the means 2.4.2. For example, it would be possible, in the present case, for the shape of the teeth and/or the spacing between the same to be sensed. This signal, in turn, is passed to a control means, which frees, for example, the brewing chamber if the capsule is the correct one. Ex. 1047, 14:11–19. Again, despite using a camera to determine if a capsule is “the correct one,” the second German application does not suggest using a barcode in place of the toothed-ring structure, or suggest moving the location of the detection means 2.4.2 from the outer surface to the underside of the flange. This reinforces that the inventors did not contemplate using a barcode in the embodiments depicted in Figures 16–18.” slip op. at 23

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

      “As asserted by Petitioner, Jarisch teaches how to move a code in a centrifugal brewing system to the bottom of the flange and how to configure a light-conductive material so that the detector’s light source will reach the bottom of the flange. Pet. 48–49; Pet. Reply 23–24 (Ex. 1003 ¶¶ 184–185; Ex. 1005 ¶¶ 82–84, Fig. 5). And, although Figure 61 of Yoakim discloses a flare in its brewing chamber, bodily incorporation is not required, and we are directed to no persuasive argument or evidence that Yoakim could not be configured with a straight chamber, as generally depicted in Figure 5 of Jarisch. Pet. Reply 24 (noting that Dr. Howle’s testimony on this subject is “conclusory” and depends on “bodily incorporation”). As such, we credit the testimony of Mr. Jobin that a person of ordinary skill in the art would have sought to place the code at the bottom of the flange and would have had a reasonable expectation of success in so doing.17 Ex. 1003 ¶ 184. Patent Owner further contends that Yoakim requires that the capsule holder be capable of receiving a set of multiple volume capsules and that 17 As discussed above, Mr. Jobin has extensive experience in the design of brewing devices. Conversely, Dr. Howle has limited experience in this field and is not one of ordinary skill in the art. Although Mr. Jobin’s testimony is more persuasive regardless of the discrepancy in experience between the two declarants, when this difference in design experience is considered, it only serves to increase the weight we give to Mr. Jobin’s testimony. there is a “snug fit” to avoid “unbalances.” PO Sur-reply 8 (citing Ex. 1004 ¶¶ 205, 479, 484, 507, 512). According to Patent Owner, Petitioner does not explain adequately how the use of Jarisch’s “straight chamber” with a capsule holder that does not engage with the side wall of the capsule would allow insertion of the multiple volume capsules or permit a “snug fit.” Id.; PO Resp. 28. Patent Owner’s assertion that Yoakim discloses the use of certain capsules that might not fit into a device with Jarisch’s non-flared structure is ineffective to undercut the sufficiency of Petitioner’s showing on this point. As noted by Patent Owner, Yoakim discloses the use of certain capsules which might not fit into a device with Jarisch’s non-flared structure. But Petitioner is not seeking a bodily incorporation of Yoakim and Jarisch, and other embodiments of Yoakim do not require the type of flared capsule identified by Patent Owner. Ex. 1004, Fig. 63. Moreover, we are directed to no persuasive evidence that Jarisch’s lack of contact between the capsule side wall and the holder would render the device inoperable or even less effective. Id. (citing Ex. 2019, 36:18–37:6; Ex. 1005 ¶ 23 (Jarisch explaining that its device includes a capsule holding means and that the capsule may be successfully driven in rotation). As such, we credit the testimony of Mr. Jobin that one of ordinary skill in the art would have understood how to design the chamber of Yoakim to allow reading of a barcode on the underside of the flange and that this design would allow for successfully receiving single-serve capsules and driving them in rotation. Ex. 1003 ¶¶ 182–184; Ex. 1005 ¶ 23.” slip op. at 39

    Patent outcomesUS 11,230,430 unpatentable
    § 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,230,430
  • PTAB · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with 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

      “With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written Decision. 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 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

      “Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17

    • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

      “The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22

    Patent outcomesUS 10,689,740 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · Nautilus
    Patents in suitUS 10,689,740
  • PTAB · 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 unpatentable
    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,278,505
  • 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
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