• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

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

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

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

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

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

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

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

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 10, 2023 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–30 were not proven unpatentable because Petitioner failed to establish a reason to combine the Travers references with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that a person of ordinary skill in the art by March 20, 2012 would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields. Pet. 11 (citing Ex. 1002 ¶¶ 46–47). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 5 (citing Ex. 2014 ¶¶ 28–30). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner

    “Patent Owner argues that, in a few instances, the ’127 patent discloses “sequence reads” as corresponding to “multiple and distinct sequencing reactions.” Id. (citing Ex. 1001, 4:12–18, 4:45–49, 9:5–9, 9:11–12). Those disclosures, however, relate to “only one method for making the invention and do[] not automatically lead to finding a clear disavowal of claim scope.” Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 797 (Fed. Cir. 2019). Patent Owner does not point to, and we cannot find, any intrinsic evidence that would limit “sequence reads” as Patent Owner contends. Patent Owner also relies on Travers as extrinsic evidence that supports its argument. PO Resp. 9. Specifically, Patent Owner contends that Travers “refers to the sense and antisense target DNA sequences as subreads, which are distinct from the ‘raw read sequence’ or ‘raw read’ that comprises all of the subreads physically linked together.” Id. (citing Ex. 1021, 2). Patent Owner, however, ignores that Travers ’075 refers to the sequence of a sense or antisense strand as a “sequence read,” and not a subread. See Ex. 1018 ¶ 61. As a result, we find insufficient evidence to support Patent Owner’s proposed construction of “sequence read” as requiring “multiple and distinct sequencing reactions.”7 Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Based on the complete record, we see no need to expressly address any other claim term.” slip op. at 11

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

    “We are not persuaded by Petitioner’s arguments. First, the prior art references Petitioner relies on relate to sequencing SMRTbell templates; specifically, they teach two polymerase binding sites in the two hairpin adapters per SMRTbell molecule, one on each end of the target molecule. See Ex. 1021, Fig. 1. They do not speak to concatemers with multiple polymerase binding sites interspersed along the molecule. Second, as explained above, a two-round RCR already generates three polymerase binding sites. See Ex. 2014 ¶ 178. Thus, even if we were to agree with Petitioner that the optimal stoichiometric ratio for SMRTbell templates applies to RCR produced concatemers, the polymerase to concatemer template ratio is at least three, i.e., 50% higher than the number Petitioner points to.11 See Reply 16 (citing Ex. 1035, 34). 11 The product of one round of RCR replication has only two polymerase binding sites. But, with only one copy of A and A each, it would not satisfy Third, and most importantly, the prior art does not support Petitioner’s arguments. The SMRT sequencing “approach is based on eavesdropping on a single DNA polymerase molecule working in a continuous, processive manner.” Ex. 2021, 1 (“Within each [ZMW] chamber, a single DNA polymerase molecule is attached to the bottom surface.”). Indeed, in SMRT sequencing, polymerase molecules are randomly distributed among the ZMWs, leading to a Poisson distribution of occupancy. At optimal loading, the distribution is 36.8% empty ZMWs, 36.8% with just one polymerase, and 26.4% with two or more. In this experiment, ~35% of the ZMWs produced traces indicative of single DNA polymerase occupancy, of which 82% produced full-length reads.” slip op. at 33

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

    “3. Summary In sum, Petitioner has not met its burden to show that an ordinarily skilled artisan would have had a reason to sequence RCR replicated concatemers on PacBio’s sequencing platform with a reasonable expectation of success. Thus, Petitioner has not shown the Travers references render the claims 1–10, 12, and 15–28 obvious.12 F. Other Grounds Claim 11 depends from claim 1. Petitioner asserts that claim 11 would have been obvious over the combination of Travers ’075, Travers 2010, and NEB Expressions. Pet. 58–60. 12 The parties dispute whether there are objective indicia to support a conclusion of nonobviousness. PO Resp. 68–74; Reply 23–27; Sur-reply 27–29. We do not address this issue because we determine Petitioner has not met its burden in showing the reason to combine/modify the Travers references or the reasonable expectation of success.” slip op. at 45

  Patent outcomesUS 10,760,127 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,760,127
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Oct 2, 2023 · IPR2022-00794 · APJ Daniel J Galligan · IPR · Final written decision

  Claims 1, 2, and 6–8 were not shown unpatentable because the prior art combinations did not establish the claimed messaging through the server system.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Tr. 78:6–10. Patent Owner responded “I don’t think it makes any difference for this panel’s determination.” Tr. 78:13–14. We agree and determine that the differences in the level of skill offered by the parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems.” See Inst. Dec. 10. We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ289 Patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art).” slip op. at 9

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

    “1. media player Patent Owner contends that, based on the “intrinsic record . . . an ordinary artisan would have understood the ordinary and customary meaning of ‘media player’ in the ’289 patent refers to application software and does not encompass hardware devices.” PO Resp. 14 (citing Ex. 2022 ¶¶ 92–93). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player.’” Pet. Reply 1. Rather, Petitioner states the media players relied upon in the Petition are all application software. Pet. Reply 1–2. Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 24–27)—are application software. The third ‘media player’ is likewise not a hardware device.” Pet. Reply 2 (alteration in original). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Muthukumarasamy “controls delivery of selected media content and selects and controls the media devices that deliver the selected media content according to a media type of the selected media content.” Because Muthukumarasamy teaches that the media device displays media content from various disparate sources depending on the media type and media source, a [person of ordinary skill in the art] would have understood the media device loads an appropriate media player depending on the media type and source. Pet. 23–24 (citing Ex. 1008 ¶ 47; Ex. 1005 ¶¶ 66–67). Petitioner, however, proffers insufficient evidence or argument that the content choices described in paragraph 47 of Muthukumarasamy would have led an ordinarily skilled artisan to understand a media player is obtained and loaded in the content presentation device. Rather, Dr. Bederson makes conclusory statements without providing evidence to support the assertions (Ex. 1005 ¶¶ 66–67).” slip op. at 33

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “Muthukumarasamy discussed above. In particular, Petitioner has not explained how Hayward teaches receiving the one or more messages in a system server. Rather, Petitioner relies on Hayward to teach “identify a particular media player for playing content from the file,” and “identify a location of the particular media player.” Pet. 41–45. More specifically, Petitioner contends that a person of ordinary skill in the art “would have been motivated by and found it obvious from Hayward to implement the DBCS (e.g., the RCIBS) to facilitate control of internet content presented at the content presentation device using any number of media players through embedded media player pages, as described in Hayward.” Pet. 65. However, to the extent Petitioner’s assertions rely on “implement[ing] the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the content presentation device” (Pet. Reply 22), we determine Petitioner has not shown the combined process of Muthukumarasamy and Hayward would include the required messages being received by the server (e.g., zHub/zNode), as opposed to directly by the RCIBS as discussed above. Additionally, Petitioner has not shown, for the zHub/zNode process, that Hayward cures the deficiencies of Muthukumarasamy as set forth above. Accordingly, Petitioner has not shown that the combination of Muthukumarasamy and Hayward teaches “receiving, in a server system, one or more messages from a personal computing device . . . wherein the one or more messages, . . . identify a particular media player for playing content from the file wherein the media player is a computer application operable to present content and control presentation of the content,” as recited in claim 1 and commensurately recited in independent claim 6. Additionally, because claim 2 depends from claim 1 and claims 7 and 8 depend from claim 6, we conclude that Petitioner has not established by a preponderance of evidence that the subject matter of claims 2, 7, and 8 would have been obvious over the combination of Muthukumarasamy and Hayward.” slip op. at 37

  Patent outcomesUS 8,904,289 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,904,289
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Sep 27, 2023 · IPR2022-00795 · APJ Debra K Stephens · IPR · Final written decision

  Claims 1, 2, and 5–9 were not shown unpatentable over Muthukumarasamy alone or with Hayward because the claimed signals identifying a media player were not shown to pass through the asserted server system.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “(Tr. 78:6–10). Patent Owner responded: “I don’t think it makes any difference for this panel’s determination” (Tr. 78:13–14). We agree and determine that the differences in the level of skill offered by the Parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems” (see Inst. Dec. 10). We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ251 Patent and the prior art of record (cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art)).” slip op. at 11

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

    “1. Media player Patent Owner contends, based on the “intrinsic record . . . an ordinary artisan would have understood the ordinary and customary meaning of ‘media player’ in the ’251 Patent refers to application software and does not encompass hardware devices” (PO Resp. 13 (citing Ex. 2022 ¶¶ 81–92, 95)). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player’” (Pet. Reply 1). Rather, Petitioner states the media players relied upon in the Petition are all software (Pet. Reply 1–2). Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 23–26)—are application software. The third ‘media player’ is likewise not a hardware device” (Pet. Reply 1–2). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 12

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

    “2. Additional Terms In light of the record and our findings, reasonings, and conclusions discussed below, we determine that no other terms or phrases in the claims require express construction (see Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)))).” slip op. at 13

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

    “We determine that Hayward does not cure the deficiencies of Muthukumarasamy discussed supra. In particular, Petitioner has not explained how Hayward teaches receiving the one or more signals in a system server. Rather, Petitioner relies on Hayward to teach “identify a particular media player for playing the video content” (Pet. 38–41). More specifically, Petitioner contends “a [person of ordinary skill in the art] would have been motivated by and found it obvious from Hayward to implement the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the display device using any number of media players through embedded media player pages, as described in Hayward” (Pet. 15, 40 (citing Ex. 1005 ¶¶ 60, 102)). However, to the extent Petitioner’s assertions rely on “implement[ing] the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the display device . . .” (Pet. Reply 22 (emphasis omitted)), we determine Petitioner has not shown the combined process of Muthukumarasamy and Hayward would include the required signals being received by the server (e.g., zHub/zNode), as opposed to directly by the RCIBS as discussed above. Additionally, Petitioner has not shown, for the zHub/zNode process, that Hayward cures the deficiencies of Muthukumarasamy as set forth above.” slip op. at 39

  Patent outcomesUS 8,356,251 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,356,251
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Sep 27, 2023 · IPR2022-00793 · APJ Debra K Stephens · IPR · Final written decision

  Claims 1–5, 8, 11, 12, 14, 15, 27, and 28 were not shown unpatentable as obvious over Muthukumarasamy alone or with Hayward.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “(Tr. 78:6–10). Patent Owner responded: “I don’t think it makes any difference for this panel’s determination” (Tr. 78:13–14). We agree and determine that the differences in the level of skill offered by the Parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems” (see Inst. Dec. 10). We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ528 Patent and the prior art of record (cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art)).” slip op. at 10

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

    “‘media player’ in the ’528 patent refers to application software and does not encompass hardware devices” (PO Resp. 16 (citing Ex. 2022 ¶¶ 83–91, 94)). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player’” (Pet. Reply 1). Rather, Petitioner states the media players relied upon in the Petition are all application software (Pet. Reply 1–2). Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 21–24)—are application software. The third ‘media player’ is likewise not a hardware device” (Pet. Reply 1–2). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 12

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

    “2. Additional Terms In light of the record and our findings, reasonings, and conclusions discussed below, we determine that no other terms or phrases in the claims require express construction (see Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)))).” slip op. at 12

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

    “We are not persuaded. Even if the zHub and the zNode would be used to control the volume on the TV on which the streamed content is displayed, this device cooperation does not show the particular messaging recited in the claim. More specifically, even under Petitioner’s scenario that the “Volume Up” command flows from the IED (“personal computing device”) through the zHub/zNode (“server system”) to the TV (“content presentation device”), this command does not “identify a particular media player for playing content from the file.” Petitioner has not shown any messages in Muthukumarasamy that “identify a particular media player for playing content from the file” and flow from the IED through the zHub/zNode to the content presentation device. Thus, Petitioner’s assertions about devices working together fall short of proving by preponderant evidence that Muthukumarasamy discloses the particular messaging contents and path recited in claim 1.” slip op. at 30

  Patent outcomesUS 8,782,528 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,782,528
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Aug 25, 2023 · IPR2022-00556 · APJ John G New · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

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

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

  Patent outcomesUS 10,987,236 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,987,236
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

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

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

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

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Mar 24, 2023 · IPR2022-00034 · APJ John G New · IPR · Final written decision

  Petitioner failed to show claim 6 unpatentable because none of the seven asserted grounds established the required absence of an outer graft covering between the fibers and outer frame.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “November 2012 would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses.” slip op. at 11

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

    “We determine that, as the plain language of the claim term suggests, an “outer graft covering” must circumferentially cover some, or all, of the metallic outer frame of the prosthetic heart valve. See Merriam-Webster, Cover, available at: https://www.merriam-webster.com/dictionary/cover (last visited March 2, 2023) (defining “cover,” relevantly, as “something that is placed over or about another thing”). See Ex. 3004. Consequently, we understand an “outer graft covering” to be a structure, such as a cloth or fabric or other material, that circumferentially covers all or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the intervals between those struts and members. Consequently, we construe the limitation reciting “free of an outer graft covering between the fibers and the outer frame” to mean that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 40

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

    “Reply to Patent Owner’s Response, or otherwise provide any additional argument or evidence to demonstrate that the outer skirt of Levi does not constitute the outer graft covering prohibited by claim 6. Consequently, our initial determinations stand. Furthermore, our definition of outer graft covering herein as “a material or structure that circumferentially covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the 45 interstices between those struts and members, is covered by the outer graft covering” reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by claim 6. We consequently conclude that Petitioner has not met its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 45

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

    “Both the descriptions and Figure 22 of Spenser II show a cloth covering the proximal outer surface of the metallic outer frame of the prosthetic heart valve, including the spaces between the struts and members of the frame. Furthermore, the reference discloses that any fibers extending outwardly from the cloth arise from the surface of the cloth, and are not attached directly to the frame, as depicted in Figure 11 of the ’846 Specification. Thus, even were such fibers made of the same material as the cloth, which is not clear from the reference’s disclosure, the cloth would be between the surface-residing fibers and the metallic outer frame. We conclude that a person of ordinary skill in the art would have recognized that the sleeve-like cloth or fabric of Spenser II corresponds to an outer graft covering between its fibers and its outer frame, and such a covering would be between Spencer II’s surface fibers and its metallic outer frame. Such an outer graft cover is expressly prohibited by the language of claim 6, even if it and associated extending fibers are of the same material.” slip op. at 48

  Patent outcomesUS 10,966,846 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,966,846
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision

  The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41

  Patent outcomesUS 10,702,385 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,702,385
• Platinum Optics Technology Inc. v. Viavi Solutions Inc.No claims unpatentable
  PTAB · Oct 3, 2022 · IPR2021-00631 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 1–3, 5–8, 10–12, 14, 16–21, and 23 were not shown unpatentable because the asserted combinations did not establish the claimed hydrogenated silicon properties.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Supported by Mr. Willey’s testimony, Petitioner proposes that a person of ordinary skill in the art would have had “a Bachelor’s degree or equivalent in physics, or in a related science or engineering field, along with at least 5 years of experience in optical coating design and the manufacturing of optical filters, including various deposition techniques.” Pet. 13 (citing Ex. 1002 ¶¶ 66–68). According to Petitioner, “[a]dditional education (e.g., a Master’s degree with exposure to coating design and manufacturing) may substitute for some industrial experience in optical thin film design, and more industrial experience can substitute for a different educational background. Id. (citing Ex. 1002 ¶ 66). Patent Owner neither directly addresses Petitioner’s proposal nor provides its own proposal. See Tr. 35:15–18 (Patent Owner confirming for the record that it has not proposed a different level of ordinary skill than Petitioner’s proposal). Petitioner’s proposal is reasonable and consistent with the prior art presented. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We accordingly adopt Petitioner’s proposal.” slip op. at 11

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “Based on the statements Dr. Clemens made under oath in his Declaration, we find that he qualifies as a person having at least ordinary skill in the art according to our adopted definition. The questions Petitioner raises about Dr. Clemens’s qualifications were insufficiently explored on cross-examination to impeach that testimony. With respect to Petitioner’s further complaint that Dr. Clemens “did not review all the evidence in rendering his opinions, did not select the materials he reviewed, and did no independent research on the question of enablement,” we agree with Patent Owner that Petitioner cites no authority for the propositions that expert witnesses must review all exhibits or perform independent research. Sur-reply 27. Indeed, we do not find it particularly unusual for an expert witness to focus his analysis and opinions on specific issues identified by counsel, and Dr. Clemens properly discloses the underlying facts and data upon which his opinions are based. See 37 C.F.R. § 42.65(a). We thus accord due weight to Dr. Clemens’s testimony.” slip op. at 15

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

    “Petitioner contends that “the claims do not need an express construction to resolve the issues presented in this proceeding” but nevertheless “provides its proposed interpretations of two terms [namely, ‘center wavelength’ and ‘passband’] to clarify how Petitioner is applying the prior art to the claims.” Pet. 13. Patent Owner does not directly address Petitioner’s proposed constructions for these terms, and appears generally to treat the terms in a manner consistent with Petitioner’s proposals. We conclude that no express claim construction is necessary for any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 16

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

    “One difficulty with Petitioner’s position is that it treats the refractive index and extinction coefficient as independent variables in its argument. But the prior art is clear that the adjusting the hydrogen content of Si:H to achieve a desired extinction coefficient necessarily affects the refractive index—and, as we discuss above, that such adjustments do so in a direction counterproductive to the combination of parameters the inventors sought. And we agree with Patent Owner that the refractive index and extinction coefficient “are not parameters subject to simple adjustment, but properties resulting from the parameters of the fabrication process.” PO Resp. 52 (citing Ex. 2001 ¶¶ 121–122; Ex. 1016, Figs. 2–3). At the Oral Hearing, Petitioner conceded that Patent Owner’s characterization is accurate when considering the hydrogenated silicon material. See Tr. 65:7– 12. When Petitioner refers to the refractive index and extinction coefficient as result-effective variables, Petitioner means that those parameters are variables that can affect the properties of the claimed optical filter. See id. at 64:6–65:12. As we note above, Petitioner’s argument thus presumes that the refractive index and extinction coefficient can be independently adjusted to achieve desired filter properties—but the asserted prior art teaches against such independence because the known method of adjusting the hydrogen content of Si:H not only affects both the refractive index and extinction coefficient, but does so in a manner counterproductive to the inventors’ objective.” slip op. at 35

  Patent outcomesUS 9,354,369 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,354,369

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.