- Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00224 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over Leary, Chan, and Liao; the Board also found claims 1–11 and 13–19 unpatentable over Leary.
RulingsFinal written decision- Skill levelDecided for petitioner
“B. Level of Ordinary Skill in the Art” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“7. Objective Indicia of Non-Obviousness Objective indicia of non-obviousness may include long-felt but unsolved need, failure of others, unexpected results, commercial success, copying, licensing, industry praise, and expert skepticism. Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1379 (Fed. Cir. 2012). “[O]bjective indicia ‘may often be the most probative and cogent evidence of nonobviousness in the record,’” and “help turn back the clock and place the claims in the context that led to their invention.” Id. at 1378. Evidence of objective indicia of non-obviousness “must always when present be considered en route to a determination of obviousness.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012); see also Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc). Such evidence, however, does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1372 (Fed. Cir. 2007). (“Here, the record establishes such a strong case of obviousness that Pfizer’s alleged unexpectedly superior results are ultimately insufficient.”)” slip op. at 53
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 9
Patent outcomesUS 11,384,394 unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,384,394 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - Micron Technology, Inc. v. Katana Silicon Technologies LLCAll claims unpatentablePTAB · May 13, 2024 · IPR2023-00071 · APJ Julia Heaney · IPR · Final written decision
Claims 3–5, 8, 11, 20–22, 27–29, 31, and 33 are unpatentable as obvious over the stated combinations of prior art and skilled-artisan knowledge.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“On the fully developed record, we find that Petitioner’s construction, “a layer that adheres,” is more strongly supported by the evidence than Patent Owner’s construction, “a pre-formed layer that is adhered.” Our analysis begins with the claim language. The term “adhesion layer” appears in each of the ’806 patent’s independent claims, which include both method and device claims. See, e.g., Ex. 1001, 13:44–63 (claim 1 directed to a “semiconductor device”); id. at 17:58–18:17 (claim 30 directed to a “method of manufacturing a semiconductor device”). Claim 1 recites “a first semiconductor chip having a first adhesion layer adhered to its back surface” and “a second semiconductor chip having a second adhesion layer adhered to its back surface.” Id. at 13:49–51, 13:54–56 (emphasis added). Claim 30 recites the steps of “forming a first insulating adhesion layer on a back surface of a first wafer” and “forming a second insulating adhesion layer on a back surface of a second wafer.” Id. at 17:60–62, 18:3–5 (emphases added). In the absence of contrary evidence, we must assume that the term “adhesion layer” has the same meaning in all claims of the ’806 patent. In re Varma, 816 F.3d 1352, 1363 (Fed. Cir. 2016) (“the principle that the same phrase in different claims of the same patent should have the same meaning is a strong one, overcome only if ‘it is clear’ that the same phrase has different meanings in different claims,” quoting Fin Control Sys. Pty, Ltd. v. OAM, Inc., 265 F.3d 1311, 1318 (Fed. Cir. 2001)). The language of claim 30 and similarly worded claims of the ’806 patent suggests strongly that an “adhesion layer” may be formed in situ on the back surface of a wafer and need not be pre-formed, as argued by Patent Owner. The testimony of Patent Owner’s expert, Mr. Elenius, supports this interpretation. See Ex. 2014 ¶¶ 43, 50 (testifying that a person of ordinary skill in the art “would recognize that there are multiple methods of forming an ‘adhesion layer’ on the back surface of the semiconductor chip” and that “[p]astes and other adhesives, adhesive agents, adhesive layers or other material that are dispensed onto a substrate or chip back are formed into a layer over time as they harden through curing” (emphasis added)). Thus, the language of claims 30 and 31 does not support Patent Owner’s construction that the “adhesion layer” must be a pre-formed layer that is adhered. Cf. PO Resp. 22–25 (arguing for that construction).” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Citing testimony from Dr. Suhling, Petitioner asserts that a person of ordinary skill in the art at the priority date of the ’806 patent would have had i) a bachelor-level degree in electrical engineering, mechanical engineering, material science, or a related subject and five or more years of experience working in the field of semiconductor packaging; ii) a Master’s-level degree in mechanical engineering, electrical engineering, material science, or a related field, and at least 1-3 years of experience in the design/development of semiconductor packages; or iii) a Ph.D.- level degree in mechanical engineering, material science, electrical engineering, or a related field, and at least some experience in the area of semiconductor packaging. Pet. 17–18 (citing Ex. 1002 ¶¶ 28–32). Petitioner further states that “[a]dditional education may substitute for professional experience, and significant work experience may substitute for formal education.” Pet. 18. Patent Owner’s declarant, Mr. Elenius, states that a person of ordinary skill in the art would have had “a bachelor’s degree in electrical, mechanical or materials engineering and two to three years of experience in the design or development of semiconductor manufacturing, or the equivalent.” Ex. 2014 ¶ 32. Mr. Elenius further states that “[a]dditional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education.” Id. For purposes of this Decision, we find no meaningful differences” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“3. Reasons to Combine Petitioner contends that it would have been obvious for a person of ordinary skill in the art to combine Ball’s teachings of stacking chips with Mostafazadeh’s process for applying adhesive to create individual chips with adhesive backsides. Pet. 28–29. Petitioner contends that a person of ordinary skill would have been motivated to combine the teachings of Ball and Mostafazadeh for several reasons, including to provide a more efficient manufacturing process for multichip modules and to simplify the stacking process. Pet. 28–31. Patent Owner argues that a person of ordinary skill would not have been motivated to combine Mostafazadeh with Ball because there would have been no reasonable expectation of success and the combination would not have resulted in a functioning semiconductor device. PO Resp. 39. Patent Owner asserts that Petitioner’s combination of Ball and Mostafazadeh would fail for multiple reasons and that Mostafazadeh does not describe multi-chip stacked mounting. Id. at 39–52. Having considered the evidence and arguments, we determine that the preponderance of the evidence favors Petitioner. Petitioner demonstrates persuasively that a person of ordinary skill in the art would have had reasons to combine Ball’s stacked multichip module with Mostafazadeh’s process for applying adhesive at the wafer stage and then dicing to create individual chips with adhesive backsides. Pet. 28–31. In particular, Petitioner shows that a person of ordinary skill in the art would have considered Mostafazadeh’s teaching of applying the adhesive to a wafer surface and then subsequently dicing the wafer in order to provide a more efficient manufacturing process for multichip modules and to simplify Ball’s process of stacking chips. Id.; see KSR, 550 U.S. at 417 (stating that the “mere application of a known technique to a piece of prior art ready for the improvement” suggests obviousness). The teachings of both Ball and Mostafazadeh support Petitioner’s combination. Ball teaches a stacked multichip module using flip-chip and wire bond interconnections, where a lower chip is flip-chip connected to a substrate using metal bumps, and an upper chip is wire bond connected to the substrate. Ex. 1005, Abstract, 3:42–64, 4:58–59, 5:3–12, 5:18–20, 5:23– 27, Fig. 1. Ball teaches that the upper chip is attached to the lower chip in a back-to-back arrangement with a layer of adhesive applied over a back side of the lower chip. Id. Mostafazadeh teaches a method for applying integrated circuit dies to support surfaces. Ex. 1003, Abstract. In Mostafazadeh’s method, an adhesive coating is formed on a surface of a semiconductor wafer, the adhesive coating is dried, and the semiconductor wafer is diced to form integrated circuit dies, each having an adhesive layer on its mounting surface, i.e., its back surface. Id. at 3:5–11, 5:20–25, 7:9–11, 7:29–8:2, Fig. 2 (steps 104–110). A selected die is then attached to an associated support surface by placing the adhesive layer of the selected die in contact with the associated support surface. Id. at 3:11–13, 8:10–12, Fig. 2 (steps 112–118).” slip op. at 33
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“After considering the parties’ arguments and evidence, we determine that Petitioner meets its burden of proof for claim element [3d]. Our finding is supported by Figure 1 of Ball, which depicts a second chip mounted to a first chip in a back-to-back arrangement. Ex. 1002 ¶ 158; Ex. 1005, Fig. 1. More particularly, Ball’s Figure 1 shows that back side 32 of upper die 12 (the claimed “second semiconductor chip”) is mounted to back side 30 of lower die 14 (the claimed “first semiconductor chip”) by adhesion layer 28. Ex. 1005, 5:18–20. Relying on Dr. Suhling’s testimony, Petitioner shows persuasively that “a circuit is formed on the front surface 34 of upper die 12 . . . , as evidenced by bonding pads 36 and wires 38 connecting the upper die’s circuitry to the wiring layer on substrate 16.” Pet. 41; Ex. 1002 ¶ 159. We credit Dr. Suhling’s unrebutted testimony that, “[b]ecause the circuitry is on the front side of upper die 12, a [person of ordinary skill in the art] would know that the back surface adhesive layer is ‘where a circuit is not formed.’” Ex. 1002 ¶ 159. Patent Owner argues that, to meet claim elements [3b] and [3d], “a reference must show that an adhesion layer extends to cover the entire back surface of the second semiconductor chip where a circuit is not formed.” PO Resp. 30. We find no support in the claim language or other intrinsic evidence for Patent Owner’s argument. In our view, the phrase “back surface where a circuit is not formed” identifies the back side of the chip as opposed to the front side, where a circuit is formed. Ex. 1001, 14:26–27 (claim element [3d]). Our interpretation is supported by the claim language as a whole. Claim element [3b], for example, recites “a first semiconductor chip having a circuit forming on its front surface and an adhesion layer adhered to its back surface.” Id. at 14:17–19 (emphasis added). In this” slip op. at 47
Patent outcomesUS RE38,806 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR - Micron Technology, Inc. v. Katana Silicon Technologies LLCAll claims unpatentablePTAB · May 13, 2024 · IPR2023-00072 · APJ Julia Heaney · IPR · Final written decision
Claims 1, 2, 6, 7, 9, 10, 12–19, 23–26, 30, and 32 are unpatentable as obvious over the asserted combinations of prior art.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Although the proposals for the level of skill in the art by the parties’ declarants have differences in wording, we find no meaningful differences between the parties’ respective definitions that would materially alter the outcome of this Decision. Nevertheless, based on our review of the ’806 patent, the types of problems and solutions described in the ’806 patent, and cited prior art, we adopt and apply Petitioner’s definition of the level of ordinary skill in the art.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionGranted
“On the fully developed record, we find that Petitioner’s construction, “a layer that adheres,” is more strongly supported by the evidence than Patent Owner’s construction, “a pre-formed layer that is adhered.”” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner shows persuasively that a person of ordinary skill in the art would have had a reasonable expectation of success in combining Mostafazadeh with Ball and Fogal. Pet. 32–33. The evidence discussed above concerning reasons to combine supports a reasonable expectation of success. We are also persuaded by Dr. Suhling’s testimony that the “combination of Ball, Fogal, and Mostafazadeh would require no modification of the multichip modules in Ball and Fogal: rather Mostafazadeh merely explains in more detail methods known in the art for creating chips with adhesive surfaces.” Ex. 1002 ¶ 239; see also id. ¶¶ 62– 69 (describing prior art methods for applying adhesive to the backside of a wafer). For the foregoing reasons, we find that Petitioner has demonstrated that a person of ordinary skill in the art would have had a reasonable expectation of successfully combining Ball, Fogal, and Mostafazadeh.” slip op. at 46
- ExcludeOther
“We do not discuss or cite any of these exhibits in this Decision, or rely on any of them in reaching our determination that all of the challenged claims are unpatentable. Because their presence in the record would not affect our analysis in this Decision, we dismiss as moot Petitioner’s motion with respect to these exhibits.” slip op. at 72
Patent outcomesUS RE38,806 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR - Micron Technology, Inc. v. Katana Silicon Technologies LLCAll claims unpatentablePTAB · May 13, 2024 · IPR2023-00073 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1–15 are unpatentable under §103: the Board found the asserted combinations taught the limitations, with motivation to combine and a reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The claim language, “forming” an “adhesion layer on a back surface,” suggests strongly that an “adhesion layer” may be formed in situ on the back surface of a wafer. The testimony of Patent Owner’s expert, Mr. Elenius, supports this interpretation. See Ex. 2014 ¶¶ 43, 50 (testifying that a person of ordinary skill in the art “would recognize that there are multiple methods of forming an ‘adhesion layer’ on the back surface of the semiconductor chip” and that “[p]astes and other adhesives, adhesive agents, adhesive layers or other material that are dispensed onto a substrate or chip back are formed into a layer over time as they harden through curing” (emphasis added)). Thus, the language of the claims of the ʼ879 patent does not support Patent Owner’s construction that the “adhesion layer” must be a preformed layer that is adhered. Cf. PO Resp. 21–23 (arguing for that construction).” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we find no meaningful differences between the parties’ respective definitions that would materially alter the outcome of this Decision. Nevertheless, based on our review of the ’879 patent, the types of problems and solutions described in the ’879 patent, and cited prior art, we adopt and apply Petitioner’s definition of the level of ordinary skill in the art.” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Mostafazadeh, could overflow.” PO Resp. 41, 42 (citing Ex. 2014 ¶ 121). According to Patent Owner, the downward pressure during mounting “could cause adhesive to squeeze out.” Id. at 41. We find that Patent Owner’s argument and the corresponding testimony of Mr. Elenius are speculative and do not outweigh Petitioner’s evidence of obviousness. The overflow issue was recognized and addressed by Mostafazadeh. Contrary to Patent Owner’s argument, Mostafazadeh provides explicitly that its adhesive layer “covers an entire mounting surface 190 of the selected integrated circuit dies 182 and does not extend beyond a boundary of the mounting surface 190.” Ex. 1003, 10:6–9 (emphasis added). Additionally, Mostafazadeh teaches that when “the adhesive layer is rolled on, it is exactly the same size as the mounting surface and is quite even. Thus, when the die is attached to its supporting surface the adhesive does not extend beyond the mounting surface of the die.” Id. at 9:15–18. Further, Mostafazadeh teaches that its process avoids the adhesive jutting around the edges of the die. Id. at 2:26–28. These teachings support that a person of ordinary skill in the art would have had a reasonable expectation of successfully applying Mostafazadeh’s die attachment method to Ball’s multichip device while avoiding adhesive overflow. Next, Patent Owner argues that Petitioner’s combination would fail” slip op. at 40
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“preponderance of the evidence favors Petitioner. Petitioner demonstrates persuasively that a person of ordinary skill in the art would have had reasons to combine Ball’s stacked multichip module using flip-chip and wire bond connections with Mostafazadeh’s process for applying adhesive to create individual chips with adhesive backsides. Pet. 25–28. In particular, Petitioner shows that a person of ordinary skill in the art would have considered Mostafazadeh’s teaching of applying the adhesive to a wafer surface and then subsequently dicing the wafer in order to provide a more efficient manufacturing process for multichip modules and to simplify Ball’s process of stacking chips. Id.; see KSR, 550 U.S. at 417 (stating that the “mere application of a known technique to a piece of prior art ready for the improvement” suggests obviousness). The teachings of both Ball and Mostafazadeh support Petitioner’s” slip op. at 33
Patent outcomesUS 6,352,879 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 6,352,879 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Mar 29, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 on all asserted §103 grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the Petition, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’803 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 17 (citing Ex. 1002 ¶¶ 15–16). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Claim Construction › Intrinsic evidence (Phillips canons) › Conventional terms ('about', 'substantially', 'a'/'an', 'configured to')Term construed petitioner constructionDecided for petitioner
“At this stage of the proceeding—and without a substantive response from Patent Owner—we determine Petitioner’s construction is consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the bio-alkene is “about 5 to about 20 carbons atoms.” Ex. 1001, claim 1 (emphasis added). We agree with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ is used as part of a numeric range, the use of the word ‘about,’ avoids a strict numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20 carbon atoms” does not require precisely 5 to 20 carbon atoms. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses a carbon chain length of 4 carbon atoms, and “about 20” at the upper end of the range encompasses a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the related ’902 Application—which also claims the benefit of the ’985 Provisional and shares a virtually identical specification as the ’803 Patent— supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8 to about 20” to “carbon chain length of 7 to 20.” See Ex. 1006, 335 see also id. at 16, 23–63. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 7
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,882,803 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01226 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“challenged claims are thus anticipated, we do not reach the additional Grounds 2–7 proposed in the Petition. Furthermore, Petitioner’s Motion to Exclude Evidence is granted-in-part, denied-in-part and dismissed-in-part. Patent Owner’s Motion to Exclude Evidence is denied-in-part and dismissed-in-part.” slip op. at 92
Patent outcomesUS 10,888,601 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601
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.