- 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 · IPR2023-00532 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach Grounds 2–6.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. As an initial matter, we are not persuaded by Patent Owner’s reliance on Sanofi and Eli Lilly. See PO Resp. 9. In Sanofi, a non-precedential decision, the Federal Circuit held that the preamble to the claims at issue, reciting “[a] method of increasing survival comprising administering to a patient in need thereof” was limiting upon the claims, in conformance with the court’s prior decisions in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). Sanofi, 757 F. App’x at 992–93. Furthermore, the court held that, because the preamble was limiting, and recited a “method of increasing survival” the proposed claims would now clearly require “increasing survival.” Id. at 994. The preamble to claim 1 of the ’681 patent, however, recites no such “increase” with respect to efficacy, but merely recites “A method for treating an angiogenic eye disorder in a patient,” and the remainder of the claim requires no specific efficacy requirement. Nor does Eli Lilly support Patent Owner’s position. In Eli Lilly, the court upheld the Board’s conclusion that the preamble reciting “a method for treating headache in an individual” was limiting upon the claims. Eli Lilly, 8 F.4th at 1343. However, it noted, in upholding the Board’s conclusion, the Board also “found that while the claims encompass a clinical result, they do not require such a result.” Id. (emphasis added). We also find that the similar language of the preamble to challenged claim 1 of the ’681 patent, although encompassing clinical efficacy, does not require it, let alone a “high degree of efficacy.”” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“the preamble’s recitation of a “method for treating” requires a high level of efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar argument because it required improperly importing limitations into the claims. See Ex. 3001, 22. Specifically, the Board found that: [W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly, although the claims “encompass a clinical result, they do not require such a result.” Eli Lilly, 8 F.4th at 1343. We consequently reject” slip op. at 35
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration. Ex. 1001, col. 3 ll. 34–44. Petitioner also notes that the Specification further explains that “the immediately preceding dose” means “in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001, col. 3, ll. 54–59; Ex. 1002 ¶¶ 44–45). We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44.” slip op. at 37
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“As Petitioner states, Patent Owner relies upon these Exhibits as objective secondary evidence of non-obviousness. See, e.g., PO Resp. 65– 69. However, and as we explain below, because we find that the challenged claims are anticipated by Dixon, we do not reach Patent Owner’s arguments that the claims are non-obvious (Grounds 4–6) or its contentions regarding secondary considerations of non-obviousness. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (holding that “secondary considerations are not an element of a claim of anticipation”). Consequently, we dismiss Petitioner’s motion to dismiss the Financial Documents as moot.” slip op. at 10
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01225 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, …in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting.” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44.” slip op. at 37
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“If a claim limitation is directed to printed matter, the next step in the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 28. Petitioner asserts that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 28–29 (citing Ex. 1002 ¶¶ 27–29; Ex. 1003 ¶¶ 21–25). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), we adopt Petitioner’s definition.” slip op. at 52
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681
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.