• Candela Corporation v. Nikolai TankovichNo claims unpatentable
  PTAB · Jun 5, 2024 · IPR2023-00234 · APJ Sheridan K Snedden · IPR · Final written decision

  The Board held claims 1–28 not shown unpatentable because the asserted combinations did not establish simultaneous delivery of overlapping and non-overlapping laser beams.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 19; Ex. 1002 ¶ 77. Patent Owner does not dispute this proposed level of skill, but offers that a “POSA may have alternatively held a degree in electrical engineering.” PO Resp. 10; Ex. 4–10, 13, 15–17. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record, and also consider Patent Owner’s additional proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed patent owner constructionDecided for patent owner

    “In this case, the Specification is devoted to the teaching simultaneous delivery of multiple laser beams. The Specification begins by stating that “[t]here are no lasers or laser handpieces on the market today that can simultaneously deliver two or more wavelengths of laser energy in spacial, fractional form.” Ex. 1001, 1:12–14. The Specification explains that “laser treatment usually requires different modalities of energy in order [to] successfully treat the pathologies to which they are applied,” but that “the sequential application of multiple wavelengths of laser energy compromises the treatment.” Id. at 1:16–25. The Specification then continues to explain various problems associated with the sequential application of multiple wavelengths. Id. at 1:25–52. The Specification concludes its introduction as follows: What is needed in the art therefore is an effective laser therapy system that can simultaneously deliver multiple wavelengths of laser energy through the use of a single laser unit without producing interference between the wavelengths within the treated tissue.” slip op. at 13

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

    “summarized above, we find Patent Owner to have the better position. In particular, we agree with Patent Owner that the combination of Hsia and Black fail to teach or suggest simultaneously delivering non-overlapping beams. The combination also fails to teach or suggest producing beam patterns that include both overlapping and non-overlapping beams. PO Resp. 34. To begin, while we recognize that Hsia discloses overlapping and non-overlapping treatment patterns, those patterns are achieved by the sequential delivery of laser beams as a user physically moves a single handpiece that delivers a single beam across the skin of a patient. Ex. 1004 ¶ 68, Figs. 8 and 9; Ex. 2001 ¶¶ 73–74. Black does not cure that deficiency as Black does not disclose treatment with non-overlapping beams. Ex. 2001 ¶ 99. Black discloses using a “refractive optics, mirror-based optical delivery device” for the simultaneous delivery of multiple overlapping laser beams. Ex. 1006 ¶¶ 12– 13. The beams align on an optical path and, using different laser beam parameters, deliver treatment at various depths within a combined beam path. Id. ¶¶ 54, 58–59. Thus, while Black may be characterized as creating overlapping beams, we do not find sufficient support for a finding that Black teaches or suggests creating non-overlapping beams for simultaneous delivery, and the claims require both. We also do not find sufficient support for Petitioner’s claim that a POSA would have found it obvious to combine Black and Hsia to simultaneously produce both overlapping beams and nonoverlapping beams, based on the disclosures in these references. See, e.g.,” slip op. at 31

  • BurdenFwd all claims patentableNot shown unpatentable

    “Claims Claims Not 35 U.S.C. § Reference(s)/ Claims Shown Shown Basis Unpatentable Unpatentable 1–28 103 Hsia, Black 1–28 Hsia, Black, 23 103 23 Negus Hsia, Black, 27, 28 103 27, 28 Altshuler Altshuler, 1–28 103 1–28 Black Altshuler, 23 103 23 Black, Negus Overall Outcome 1–28 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–28 of the ’481 patent are unpatentable; and” slip op. at 41

  Patent outcomesUS 10,675,481 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,675,481
• 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
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.No claims unpatentable
  PTAB · Jan 26, 2024 · IPR2022-01400 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–29 were not shown unpatentable over the asserted obviousness grounds because the prior-art combinations did not teach key limitations of claims 1, 17, and 29.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Having considered these arguments on the full trial record, we find Patent Owner has the better position because Petitioner’s showing that element 1(b) is taught by Schmitt is unpersuasive. We begin with Patent Owner’s argument concerning the distinction between the cfDNA molecules and the duplex tag comprising the molecular barcode found in the text of claim 1. Element 1(a) recites “a population of cell-free deoxyribonucleic acid (cfDNA) molecules.” Ex. 1001, 61:7–9. Element 1(b) recites “tagging a plurality of the cfDNA molecules in the population” of element 1(a) “with duplex tags comprising molecular barcodes to produce tagged parent polynucleotides . . . wherein the duplex tags are attached to both ends of a added). We agree with Patent Owner and credit the testimony of its declarant that this claim language distinguishes the duplex tags from the ends of the cfDNA molecule to which they are attached. Resp. 8; Ex. 2015 ¶¶ 38–39, 60, 61. That is, the duplex tag is not part of the cfDNA molecule itself, but rather is “attached to both the ends” of that molecule by “tagging” it as recited in element 1(b). We also agree with Patent Owner that given this distinction, claim 1 does not encompass Schmitt’s hybrid embodiment. Resp. 18–20. As Petitioner notes, “[i]n Schmitt’s hybrid-tag embodiment, the strands are grouped based on the combination of the short n-mer barcode and the end of the target DNA.” Pet. 11; see Resp. 17 (“[T]he combination of the endogenous shear sequence and exogenous 3-mer sequence together provide the SMI used for grouping and matching in Schmitt’s DCS process.”). Petitioner and its declarant illustrate the grouping in Schmitt’s hybrid embodiment with the following diagram. Pet. 12; Ex. 1002 ¶¶ 96–98. Petitioner’s diagram shows the PCR products produced from sequencing a “Target DNA” molecule that has been tagged with 3-mers X and Y according to Schmitt’s hybrid embodiment. See Ex. 1002 ¶ 98 (describing diagram). A portion of the endogenous sequence of the DNA molecule labeled L and R is used in combination with the 3-mer sequence to group the resulting strands into two families labeled the “X+L→R+Y Family” and the “R+Y→X+L Family.” Ex. 1002 ¶ 98; Ex. 2015 ¶ 62 (explaining that Petitioner’s diagram shows that “the relied upon hybrid SMI sequences of Schmitt include sequence from the sample DNA molecule not contained in the adapter or the duplex tags”). SMIs, differently label the strands and therefore are the recited “duplex tags.” See Pet. 27–28 (“duplex tags comprise both the fragment DNA end sequences and a shorter n-mer tag”) (emphasis added) (internal quotations omitted). However, we credit Dr. Quackenbush’s testimony that end sequences L and R are not “attached to both ends” of the cfDNA molecule by “tagging” it as recited in element 1(b). See Ex. 2015 ¶ 59–62 (explaining that Schmitt’s hybrid SMI sequences include a portion of the sample DNA molecule, which is “not contained in adapter molecules or duplex tags that are attached to the DNA molecules”). Rather, end sequences L and R are the pre-existing, endogenous ends of that molecule. Id. Thus, Petitioner’s theory of unpatentability does not account for the distinction the claim language draws between the cfDNA molecule and the duplex tags. Petitioner’s argument that the ’306 patent defines “duplex tag” as a” slip op. at 20

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

    “That is, although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner has not sufficiently explained why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, the Petition does not address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi degenerate bases) in the adaptor.” Ex. 1083 ¶ 30. sticky-end adapter-DNA litigation to be even more efficient than Meyer’s blunt-end adapter-DNA ligation” is also unpersuasive. See Pet. 60–61. The KAPA data sheet discloses sticky-end adapter DNA ligation, but KAPA teaches that only 0.5 to 15% tagging efficiency is expected when the starting sample is 100 pg–100 ng of “high quality DNA.” Ex. 1015, 4. Thus, the KAPA data suggests that the use of sticky-end adapters, such as what Schmitt discloses, does not in and of itself teach or suggest the tagging efficiency limitations. Moreover, the record shows that tagging efficiency depends on a variety of other factors, including the quality of the input DNA. The KAPA data sheet states that tagging efficiency “can be significantly lower for DNA of lower quality.” Ex. 1015, 4. Fisher also explains that “the efficiency of adaptor ligation varies between samples, probably because of variation in input DNA quality.” Ex. 1031, 5–6. Petitioner’s argument that the DNA the KAPA data sheet refers to as “lower quality” is “from formalin-fixed, paraffin-embedded (‘FFPE’) samples (well known for having chemically damaged DNA)” is unavailing. See Reply 25–26 (citing Ex. 1098 ¶¶ 96–98). First, neither Petitioner, nor its declarant, address the similar teaching in Fisher. Second, even if the specific type of lower quality DNA in the KAPA data sheet is different, the salient point, i.e., that tagging efficiency depends on DNA quality, remains unrebutted. This is significant because Petitioner does not sufficiently address how the quality of the cfDNA of Narayan compares to the quality of the genomic DNA samples of Meyer and Schmitt or how that would affect the expected tagging efficiency. Petitioner’s assertion that “significant quantities of cfDNA could be isolated from blood samples” (see Reply 26), fact that a significant quantity of cfDNA could be obtained does not show that the quality of that DNA is similar such that a POSA using such would have expected to achieve a tagging efficiency similar to that in Meyer.” slip op. at 40

  • Strike new argumentNew argument disregardedDenied

    “We are not persuaded. First, this is an inappropriate new argument. The Petition presents a different mapping, alleging that the “duplex tag” comprises both the endogenous end sequence of the cfDNA molecule and the 3-mer barcode of Schmitt’s hybrid tag embodiment. Pet. 27 (“the duplex tags comprise both the fragment DNA end sequences and ‘a shorter n-mer tag’ to serve as ‘unique molecular identifiers’”) (quoting Ex. 1083 ¶ 30, Ex. 1002 ¶¶ 162–163); see also Tr. 62:13–63:19 (Petitioner’s counsel noting he was unaware of any explicit statement in the Petition that Schmitt’s duplex tag comprised just the 3-mer without the end sequence). Nor did Petitioner regarding element 1(b). See Reply 8–10. Rather, consistent with the mapping in the Petition, the Reply identifies “Schmitt’s hybrid tags,” i.e., the combination of the endogenous end sequence and the n-mer, as the duplex tags in element 1(b). See Reply 8 (urging that “duplex tags” are “tags that differently label the complementary strands,” which “is precisely what Schmitt’s hybrid tags do”). Because this argument was not previously presented, Patent Owner has not been afforded a sufficient opportunity to address it. Thus, Petitioner’s new argument excluding the end sequences in Schmitt’s hybrid tag embodiment from the alleged “duplex tags comprising molecular barcodes” has been waived. Second, even if we were to consider it on the merits, Petitioner’s new mapping for element 1(b) is inconsistent with Petitioner’s allegations for element 1(e). Element 1(e) recites “reducing or tracking redundancy” in sequence reads “using at least sequencing information from the molecular barcodes of the duplex tags to determine distinct cfDNA molecules.” Ex. 1001, 61:26–30. For these limitations, the Petition points to Schmitt’s grouping of reads into families based on their SMI and asserts that Schmitt determines distinct cfDNA molecules based on “the complementary nature of the SMI on the two strands of the duplex.” See Pet. 30–32 (internal quotations omitted). Thus, like Petition’s mapping for element 1(b), Petitioner’s allegations for element 1(e) rely on a duplex tag that includes both the 3-mer and the end sequence of the cfDNA molecule. Petitioner has not sufficiently explained, much less shown by a preponderance of the evidence, that Schmitt teaches or suggests the limitations in element 1(e) based on its new mapping of the 3-mer alone as duplex tags.” slip op. at 25

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Motion to exclude, deniedDenied

    “We do not rely on any of these exhibits in rendering our decision on Petitioner’s grounds. Therefore, we dismiss as moot Petitioner’s motion to exclude Exhibits 1069, 1074, 1078, 1079, and 1085–1088.” slip op. at 46

  Patent outcomesUS 11,149,306 not shown unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,149,306
• 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
• Mylan Pharmaceuticals, Inc. / MSN Laboratories Private Ltd et al. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Sep 8, 2023 · IPR2023-00016 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–6 were not shown unpatentable: the unexpected results supporting claim 1 outweighed the evidence of obviousness, and the other grounds depended on that unestablished premise.

  RulingsFinal written decision

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Peterson, Petitioner” slip op. at 8

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

    “C. Claim Construction Petitioner asserts that “[t]he claim terms do not require construction to apply the grounds.” Pet. 14. Patent Owner does not respond to this contention, or otherwise address claim construction in its Response. Accordingly, neither party has identified any claim term for construction.” slip op. at 10

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

    “in which the pKa of aspartic acid’s R group was the same or even higher than that of glutamic acid when incorporated into a peptide, which directly undermines Petitioner’s position that the relative difference would be the same. Ex. 2045, 37 (Table 1). Petitioner dismisses this evidence, urging that it relates to “residues buried inside a peptide” that “are not analogous to the Asp3 or Glu3 pKas in plecanatide.” Reply 20. But that misses the point. The record shows there are interactions beyond just whether the residue is buried that can affect the pKa. See, e.g., Ex. 1012, 127 (“interactions with other peptide R groups, and other environmental factors can affect the pKa”); Ex. 2069, 96:19–97:2, 97:19–98:1 (Dr. Peterson acknowledging that intrachain hydrogen bonds can affect pKa). Neither Petitioner, nor Dr. Peterson, sufficiently address these other interactions, much less do they do so within the context of the particular amino acid sequences at issue here. Accordingly, we credit Dr. Davies’s testimony that a POSA “would have understood that the pKa values of amino side chain groups could not be predicted when the amino acid was incorporated into a peptide” and therefore would not have expected the Glu3 substitution to result in a peptide that would “remain protonated at a higher pH as compared to Asp or result in better activity in less acidic environments.” Ex. 2024 ¶¶ 178–186.” slip op. at 35

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusMixed

    “For these reasons, Patent Owner has established a sufficient nexus” slip op. at 40

  Patent outcomesUS 7,041,786 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,041,786
• Mylan Pharmaceuticals, Inc. / MSN Laboratories Private Ltd. et al. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Sep 8, 2023 · IPR2022-00722 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–6 were not shown unpatentable: the unexpected results evidence outweighed the obviousness showing for claim 1, and the other grounds depended on that unproven premise.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “above, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. Indeed, Patent Owner’s unexpected results showing is sufficiently strong that we would reach the same conclusion even if we had found the other rationales Petitioner offers for making the Glu3 substitution (i.e., higher side-chain pKa and avoiding aspartimide formation) to be persuasive. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 60

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “above, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. Indeed, Patent Owner’s unexpected results showing is sufficiently strong that we would reach the same conclusion even if we had found the other rationales Petitioner offers for making the Glu3 substitution (i.e., higher side-chain pKa and avoiding aspartimide formation) to be persuasive. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 60

  • ExcludeMotion to exclude, grantedGranted in part

    “Opp. at 4 (citing FRE 803(14)–(15), 804(b)(3) and 806). But even so, Petitioner’s argument plainly does not apply to the Currie submission, which is not a statement or admission from Patent Owner, but rather statements from an adverse party. Accordingly, we agree with Patent Owner that the Currie submission (i.e., pages 88–98 and 120–127 of Exhibit 1067) is hearsay without exception and therefore should be excluded under FRE 802.” slip op. at 69

  Patent outcomesUS 7,041,786 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 7,041,786
• 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
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of 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 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLCNo claims unpatentable
  PTAB · Feb 15, 2022 · IPR2020-01438 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 4 and 5 were not shown unpatentable because the evidence, including unexpected results, did not establish obviousness over the asserted prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “to the earliest effective filing date of June 6, 2015, the filing date of the ’063 provisional application, Allgenesis PCT thereby does not qualify as prior art against the ’820 patent. See above II.D. Accordingly, Petitioner has not met the burden of establishing that the claims are unpatentable as obvious over Allgenesis PCT. F.” slip op. at 59

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

    “the reasoning to combine the references, and the evidence of secondary considerations in the form of surprising unexpected results, we determine that Petitioner has not shown that claims 4 and 5 of the ’820 patent are unpatentable. III. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not established by a preponderance of the evidence that claims 4 and 5 of the ’820 patent are unpatentable.” slip op. at 78

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundNot shown unpatentable

    “equivalent for another. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). “Conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.” Hoffman-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014).” slip op. at 69

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “Ex. 1001, 11. Table 2 shows three observation days comparing 0.05% sunitinib TID with 0.05% nintedanib. On all three days, 0.05% nintedanib TID shows significant improvements over 0.05% sunitinib TID. For example, on day 12, the 0.05% nintedanib TID group had a negative value (indicating a reduction in neovascular area), while the 0.05% sunitinib TID group had a positive number (indicating a growth in neovascular area) and the difference between the two is also statistically significant with a P value of 0.016. The comparative data of measuring the reduction in neovascularization in an established animal model as shown the ’820 patent provides a sufficient nexus to the claimed method of reducing hyperemia. The data presented in Table 2 (shown above) shows that nintedanib functions unexpectedly better than sunitinib. The ’820 patent further explains that nintedanib inhibits three kinase targets, FGFR4, Lyn and Src, that are not inhibited by sunitinib, pazopanib, or other common kinases inhibitors. Ex. 1001, 12:14–17; see also id. at 11 (Table 1). In addition, “nintedanib’s potencies on FGFRl-3 are substantially higher than that of sunitinib that may also contribute to the superior efficacy of nintedanib in the cornea suture rabbit model.” Id. 12:17–20. Given these surprising and unexpected results that nintedanib has improved efficacy and a better safety profile compared to sunitinib as reported in the ’820 patent specification convinces us that on balance the weight of the evidence supports a finding that claims 4 and 5 have not been shown to be unpatentable.” slip op. at 77

  Patent outcomesUS 10,149,820 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 10,149,820
• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

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

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214

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.