• 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
• 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
• 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
• Neptune Generics, LLC v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Feb 10, 2020 · IPR2018-01494 · APJ David Cotta · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under any asserted § 103 ground because the evidence did not establish the claimed serum-level testing and dose adjustment would have been obvious.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner has not met this burden here because the Petition does not clearly articulate why an optimization rationale would have led the skilled artisan to “adjust[] the daily dose of the patient to achieve mifepristone blood levels greater than 1300 ng/mL.” slip op. at 14

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner contends that the person of ordinary skill in the art (“POSA”) would have: either a Pharm. D. or a Ph.D. in organic chemistry, pharmacy, pharmacology, or a related discipline; or a Bachelor’s or Master’s degree in organic chemistry or a related field with at least four years of experience relating to the study of pharmacokinetics or dosing of drugs, their detection and quantification, or their metabolism. Pet. 12. Patent Owner does not challenge Petitioner’s definition. Accordingly, we accept Petitioner’s definition, which is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 9

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

    “Although the parties propose constructions for several claim terms (Pet. 12–15; PO Resp. 17–18), we determine that no explicit construction of any claim term is necessary to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); 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’”).” slip op. at 10

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

    “Finally, Petitioner asserts that it would have been obvious that “the daily dosing of the patient could be adjusted to optimize mifepristone blood level, whatever level that might be.” Pet. 30. This argument is not persuasive for several reasons. First, Petitioner must do more than show that the ordinary artisan could have done what was claimed. Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 15

  Patent outcomesUS 8,921,348 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,921,348
• Aurobindo Pharma USA, Inc.No claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-01648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–25 were not shown unpatentable over Timmins and Cheng because Petitioner did not establish that the combination would have targeted the claimed mean Tmax range.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “In the Patent Owner Response, Patent Owner acknowledged the Board’s characterization of the knowledge of an ordinarily skilled artisan as consistent with the proposals of both parties (PO Resp. 12–13), and neither party further addressed the proper level of ordinary skill in the art or disagreed with our characterization from the Institution Decision. See PO Resp., Reply. Our determination regarding the patentability of the challenged claims does not turn on the differences between the parties’ definitions. We adopt Petitioner’s assessment, but note that our conclusions would be the same under Patent Owner’s assessment. C. Testimony of Dr. Akhlaghi” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We agree with Petitioner that Dr. Akhlaghi’s qualifications and deposition testimony, when read in context, indicate that Dr. Akhlaghi is sufficiently experienced to opine on the knowledge of one of skill in the art at the time of the ’866 patent. As noted in the August 13, 2018 update to our Trial Practice Guide: An expert witness must be qualified as an expert by knowledge, skill, experience, training, or education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). See Notice of Update to Office Patent Trial Practice Guide, 83 Fed. Reg. 156, (Aug. 13, 2018) (text of update available at https://www.uspto.gov/sites/default/files/documents/2018_Revised_Trial_Pr actice_Guide.pdf). In addition, we are well able to consider the value of an expert opinion and afford it appropriate weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) D. Claim Interpretation” slip op. at 9

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

    “Tmax” In our Institution Decision, we noted that the term “Tmax” appears in each of the challenged claims, and that both parties agreed that Tmax should be construed as stated in the Specification: “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours).” Inst. Dec. 7 (citing Pet. 24; Prelim Resp. 18; Ex. 1001, col. 7, ll. 49–53). We concluded that the proposed definition was consistent with the Specification and defined the claim term with reasonable clarity, deliberateness, and precision, and we adopted the parties’ construction. Neither party addressed the issue of construction of Tmax in further briefing, but the parties disagree about how Dr. Akhlaghi applied the definition in her testimony. See, eg., Pet. Reply 9–10. For purposes of analyzing the patentability of the challenged claims, we continue to interpret the term as “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours),” because that definition is consistent with the Specification, and because the parties themselves agreed to the definition of Tmax. Inst. Dec. 7. E. Overview of the Prior Art slip op. at 11

  • BurdenNot shown unpatentable

    “Based on our review of the record, we determine that Petitioner has not shown sufficiently that combining the teachings of Timmins and Cheng as Petitioner contends would have resulted in a dosage form that provides a mean Tmax of metformin from 5.5 to 7.5 hours after administration.” slip op. at 19

  Patent outcomesUS 6,866,866 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,866,866
• Rimfrost As v. Aker Biomarine Antarctic AsNo claims unpatentable
  PTAB · Aug 10, 2018 · IPR2017-00748 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–19 were not shown unpatentable under § 103 because the petitioner did not establish that the cited combinations disclosed or suggested the claimed ether phospholipid range.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not address the level of ordinary skill in its Response; however, Patent Owner’s declarant, Dr. Hoem opines that the definition proposed by Petitioner “is consistent with the literature, credentials of individuals working on lipid extractions, and the skill necessary to perform these extractions and interpret their results” Ex. 2001 ¶ 15. Based on that assessment, Dr. Hoem adopts the definition of the level of ordinary skill in the art advanced by Petitioner. Id. We agree with Petitioner, Dr. Tallon, and Dr. Hoem, and find that Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’877 patent is consistent with 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. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

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

    “unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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)). Although both Petitioner (Pet. 19‒29) and Patent Owner (PO Resp. 11‒14) offer several claim constructions, we determine that no explicit construction of any claim term is necessary for purposes of this Decision. In reaching this conclusion, we observe that the parties’ proposed constructions are largely coextensive with each other, and to the extent those constructions differ, they do so in ways that do not impact our analysis. For example, our 11 analysis below remains the same irrespective of whether we apply Petitioner’s construction of “krill oil” as meaning “lipids extracted from krill” (Pet. 21) or Patent Owner’s interpretation, “oil produced from krill” (PO Resp. 11). Similarly, our analysis is unaffected by whether we apply Petitioner’s definition of “to denature lipases and phospholipases,” i.e., “to alter the conformational structure of lipases and phospholipases to reduce lipid and phospholipid decomposition” (Pet. 24), or Patent Owner’s construction, “to treat the lipases and phospholipases to rupture hydrogen bonds thereby changing the molecular structure of the lipases and phospholipases” (PO Resp. 12–13).3” slip op. at 11

  • BurdenNot shown unpatentable

    “We agree with Patent Owner that Petitioner has not carried its burden to establish by a preponderance of the evidence that the combination of Grantham, Fricke 1984, and Tanaka I teaches or suggests a krill oil “with from about 3% to about 10% w/w ether phospholipids” (Ex. 1001, 34:64–65, 36:2–3), as required by the challenged claims. Petitioner does not rely on a direct measurement of the ether phospholipids present in krill oil to satisfy this claim element. Instead, as explained above, Petitioner’s declarant, Dr. Tallon estimates the amount of ether phospholipids present in the krill extract of Fricke 1984 based on Tanaka I’s disclosure that 23% of the total phosphatidylcholine extracted from krill is AAPC, and Fricke 1984’s disclosure that phosphatidylcholine comprises approximately 34% w/w of krill oil extract. Ex. 1006 ¶ 102. But Petitioner does not adequately explain why an ordinarily skilled artisan would have turned to Tanaka I to discern the ether phospholipid content of Fricke 1984, when Tanaka I did not use the then-preferred method for ether phospholipid analysis, and when more accurate measurements of krill oil ether phospholipid content were known in the art.” slip op. at 29

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1086 ¶¶ 72–73)), and the fact that NMR measurements of krill oil ether phospholipid content were known in the art (id. at 7 (citing Ex. 1009, 14; Ex. 1006 ¶ 94)), however, we are not persuaded that an ordinarily skilled artisan would have looked to Tanaka I to determine the phospholipid content of Fricke 1984 (Reply 9 (citing Ex. 1006 ¶¶ 134–136)). Tanaka I measures the percentages of the PC subclasses present in krill oil using a process of “successive degradations of PC with mild alkali and acid.” Ex. 1014, 2. Petitioner fails to adequately explain why an ordinarily skilled artisan would have turned to Tanaka I, which, like Fricke 1986, discloses a degradation process for measuring ether phospholipid levels, when more reliable NMR analyses were available. Even if, as Petitioner contends, the method of Tanaka I is more accurate than that of Fricke 1986 because it involves fewer degradation steps (Reply 9), Petitioner has not sufficiently established the reliability of Tanaka I’s degradation analysis for purposes of this Decision. 31 In particular, Petitioner does not adequately explain how the results obtained by Tanaka I compare to results acquired using other methods, such as 31P NMR, or why an ordinarily skilled artisan would have relied on Tanaka I when NMR analyses of krill oil ether phospholipid levels were available. The absence of evidence sufficient to establish the reliability of Tanaka I is of particular importance where, as here, Petitioner and its declarant, Dr. Tallon, go to great lengths both to tout the superiority of a quantification technique different from that used by Tanaka I––NMR (Reply 7–9; Ex. 1086 ¶¶ 71–74)––as well as to disparage the accuracy of other degradation-based analyses––namely, that used by Fricke 1986 (Reply 5–7; Ex. 1086 ¶¶ 67, 69).” slip op. at 31

  Patent outcomesUS 9,028,877 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,028,877
• Rimfrost As v. Aker Biomarine Antarctic AsNo claims unpatentable
  PTAB · Aug 10, 2018 · IPR2017-00747 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–20 were not shown unpatentable under § 103 because the evidence did not establish that the cited combinations taught the claimed ether phospholipid ranges.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We agree with Petitioner, Dr. Tallon, and Dr. Hoem, and find that Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’905 patent is consistent with 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. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “Although both Petitioner (Pet. 18‒25) and Patent Owner (PO Resp. 11‒12) offer several claim constructions, we determine that no explicit construction of any claim term is necessary for purposes of this Decision. In reaching this conclusion, we observe that the parties’ proposed constructions are largely coextensive with each other, and to the extent those constructions differ, they do so in ways that do not impact our analysis. For example, our 10 analysis below remains the same irrespective of whether we apply Petitioner’s construction of “krill oil” as meaning “lipids extracted from krill” (Pet. 20) or Patent Owner’s interpretation, “oil produced from krill” (PO Resp. 11). Similarly, our analysis is unaffected by whether we apply Petitioner’s definition of “effective amount of krill oil,” i.e., “at least the range of between 0.2 grams to 10 grams of krill oil” (Pet. 21), or Patent Owner’s construction, “0.2 grams to 10 grams of krill oil” (PO Resp. 12).3” slip op. at 10

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

    “Ex. 1086 ¶¶ 72–73)), and the fact that NMR measurements of krill oil ether phospholipid content were known in the art (id. at 6 (citing Ex. 1009, 14; Ex. 1006 ¶ 90)), however, we are not persuaded that an ordinarily skilled artisan would have looked to Tanaka to determine the phospholipid content of Fricke 1984 (Reply 8 (citing Ex. 1006 ¶¶ 130–131)). Tanaka measures the percentages of the PC subclasses present in krill oil using a process of “successive degradations of PC with mild alkali and acid.” Ex. 1014, 2. Petitioner fails to adequately explain why an ordinarily skilled artisan would have turned to Tanaka, which, like Fricke 1986, discloses a degradation process for measuring ether phospholipid levels, when more reliable NMR analyses were available. Even if, as Petitioner contends, the method of Tanaka is more accurate than that of Fricke 1986 because it involves fewer degradation steps (Reply 8), Petitioner has not sufficiently established the reliability of Tanaka’s degradation analysis for purposes of this Decision. In particular, Petitioner does not adequately explain how the results obtained by Tanaka compare to results acquired using other methods, such as 31P NMR, 27 or why an ordinarily skilled artisan would have relied on Tanaka when NMR analyses of krill oil ether phospholipid levels were available. The absence of evidence sufficient to establish the reliability of Tanaka is of particular importance where, as here, Petitioner and its declarant, Dr. Tallon, go to great lengths both to tout the superiority of a quantification technique different from that used by Tanaka––NMR (Reply 6–8; Ex. 1086 ¶¶ 71–74)– –as well as to disparage the accuracy of other degradation-based analyses–– namely, that used by Fricke 1986 (Reply 4–6; Ex. 1086 ¶¶ 67, 69). Accordingly, having reviewed Petitioner’s evidence and arguments, we determine that Petitioner has failed to demonstrate by a preponderance of the evidence that independent claims 1, 12, and 18 are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984. We have also reviewed Petitioner’s evidence and arguments as to dependent claims 2–4, 6, 9, 10, 15, and 16, and determine, for the reasons set forth with respect to the independent claims, that Petitioner has failed to demonstrate by a preponderance of the evidence that those claims are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984. Thus, Petitioner has failed to demonstrate by a preponderance of the evidence that claims 1–4, 6, 9, 10, 12, 15, 16, and 18 are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984.” slip op. at 27

  • Expert testimonyPetitioner expert creditedOther

    “We find Petitioner’s arguments concerning the superior accuracy and reliability of 31P NMR relative to other ether phospholipid quantification techniques persuasive. We likewise credit Petitioner’s assertions that an ordinarily skilled artisan would have had “compelling reason” to use NMR to measure krill oil ether phospholipid content. Indeed, Dr. Hoem, Patent 26 Owner’s declarant, also recognizes NMR as the preferred method for analyzing the components of krill oil. Ex. 1079, 1, 3‒4, 11; Ex. 1090, 97:23–98:5; Ex. 1086 ¶¶ 72‒74). Moreover, as set forth in the accompanying Final Written Decision in IPR2017–00745, we determine that claims 1–20 of the ’905 patent would have been obvious over combinations that rely on Catchpole, which discloses the use of 31P NMR to quantify krill oil ether phospholipids as disclosing a krill oil extract that meets the required ether phospholipid ranges.” slip op. at 26

  Patent outcomesUS 9,078,905 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,078,905
• Resmed Limited / Resmed Inc. et al. v. Fisher & Paykel Healthcare LimitedNo claims unpatentable
  PTAB · Mar 7, 2018 · IPR2016-01724 · APJ Rama G Elluru · IPR · Final written decision

  Claims 1, 2, 5–8, 11–13, 21, 22, 26, and 27 were not shown unpatentable under § 103 because motivation to combine and reasonable expectation of success were not established.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had “a bachelor’s degree in electrical engineering or biomedical engineering or a related discipline with an understanding of circuit design principles, and a reasonable amount of relevant product design experience to develop a level of competence in the field of respiratory therapy, or an equivalent advanced education.” Pet. 18; Ex. 1003 ¶ 22. Patent Owner does not dispute Petitioner’s definition of a person of ordinary skill in the art. PO Resp. 9. We adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. 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” slip op. at 6

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

    “For the purposes of this Decision, we determine that no claim term needs express interpretation. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 7

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

    “Tempered against Petitioner’s evidence of an alleged motivation to combine MR810, Gradon, and Edirisuriya is the uncertainty of operability of the proposed combination. With respect to each of the proposed circuit designs that Petitioner contends a skilled artisan would have been aware of to implement the combined teachings, a skilled artisan would have been faced with the real-world fact that there was uncertainty as to the operability of the design. First, the circuit designs that Petitioner proposes a skilled artisan would have utilized are not based on disclosure in the prior art. See Pet. Reply 5–7; Ex. 1032 ¶¶ 13–22. Petitioner does not rely on any prior art showing a circuit that allows a heater wire also to carry measurement signals. Pet. Reply 5–7; Ex. 2018, 19:6–21:17 (Petitioner’s expert, Mr. Bath, confirms that he did not locate any prior art references disclosing a circuit design in which the heater wire is utilized to carry electrical signals from measuring sensors). Moreover, Petitioner does not otherwise sufficiently rely on evidence that any of the proposed circuit designs would have been reasonably expected to be operable in any device, much less a humidification system. See Pet. Reply 5–7. Furthermore, Mr. Bath admits that these proposed designs are incomplete and would require additional non-trivial components. Ex. 2018, 89:13–90:21. He stated, “An engineer designing this system would need to take into account one change in the system by adjusting the rest of it to suit.” Id. at 89:16–18.” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner

    “We further find that Petitioner’s challenges rest on impermissible hindsight reconstruction of the disclosure in the ’641 patent. See Grain Processing Corp. v. Am.-Maize Prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (“Care must be taken to avoid hindsight reconstruction by using ‘the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.’” (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir. 1983))). All of the circuit designs Petitioner proposes a skilled artisan could have used to implement the asserted combination are hindsight reconstructions based on the disclosure in the ’641 patent. The ’641 patent describes switching the heater wire between two modes of use— carrying temperature measurement signals and heating the gas delivery tube —by inserting a component in parallel with a temperature measuring thermistor to switch the current path of the heater wire between the thermistor and the parallel-connected component. Specifically, the ’641 patent discloses switching the current flowing in heater wire 21, 28 between the parallel paths of thermistor 23 and diode 22, depending on whether heater wire 21, 28 is being used to carry temperature measurement signals or heat gas delivery tube 3, respectively. Ex. 1001, 4:8–21. Each of Petitioner’s proposed circuits, drawn solely from the testimony of Mr. Bath and not supported by the prior art, has a similar purpose. Petitioner’s first proposed circuit contains a capacitor connected in parallel with a thermistor to switch the path of the heating wire current between the thermistor, when the heating wire is being used to carry temperature measurement signals, and the capacitor, when the heating wire is being used to heat the breathing tube. Ex. 1032 ¶¶ 15–16. Petitioner’s second proposed circuit contains a gate-todrain connected MOSFET connected in parallel with a thermistor to switch the path of the heating wire current between the thermistor, when the heating” slip op. at 25

  Patent outcomesUS 8,453,641 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,453,641

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.