• 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
• 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
• Apple, Inc. v. Corephotonics Ltd.No claims unpatentable
  PTAB · Nov 8, 2021 · IPR2020-00906 · APJ John F Horvath · IPR · Final written decision

  Claims 19–22 were not shown unpatentable because Petitioner did not establish that Ogata’s lens could be scaled for Parulski’s camera with a reasonable expectation of success.

  RulingsFinal written decision

  • Expert testimonyDecided for patent owner

    “first embodiment lens and the data entered into the “Lens Editor Data” spreadsheet are noticeable. First, the Abbe number for the third lens element is 42.72 in Ogata’s first embodiment lens and 26.5 (i.e., 38% smaller) in the “Lens Data Editor” spreadsheet. Compare Ex. 1026, 7:46, with Ex. 1021, 36. Second, the data for the fourth and tenth aspherical surfaces are noticeably different. For example, the fourth order term (A4) for the fourth aspherical surface is 0.66 x 10-4 in Ogata’s first embodiment lens and 151.69 x 10-4 (i.e., 0.015) in the “Lens Data Editor” spreadsheet. Compare Ex. 1026, 7:55, with Ex. 1021, 36. Neither Petitioner nor Dr. Sasián explain these discrepancies.” slip op. at 15

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We agree with Patent Owner. The Petition contends that a person of ordinary skill in the art would have known that Ogata’s lens (using glass lens elements) could have been scaled to focus an image onto a 1/2.5” image sensor for use in Parulski’s camera. See Pet. 24–30; Ex. 1021, 36. Petitioner’s reply evidence and argument is not introduced to support that contention but a different contention—that a person of ordinary skill in the art would have known that Ogata’s lens could have been redesigned using aspheric plastic lens elements to focus an image onto a 1/3” image sensor. See n.11, supra. This is a new contention that does not support Petitioner’s 11 We note that Dr. Sasián’s analysis discloses how Kawamura’s lens can be modified by replacing the spherical glass lens elements with aspherical plastic lens elements, moving the aperture stop to the first lens element, changing the F number to 2.8, and reducing the effective focal length to focus an image onto a 1/3” image sensor rather than a 1/2.5” image sensor. See Ex. 1039 ¶¶ 25–30; App’x, 17–18. Dr. Sasián also opines that although this analysis illustrates how Kawamura’s lens could have been modified, a person skilled in the art “would have recognized that Ogata could have been similarly adjusted to yield a miniaturized form-factor.” Id. ¶ 25. because it is a new and untimely contention, we do not consider it further. See Consolidated Trial Practice Guide (Nov. 2019)12 (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g., to make out a prima facie case of unpatentability.”); see also Ariosa Diagnostics v. Verinata Heath, Inc., 805 F.3d 1359, 1368 (Fed. Cir. 2015) (“The Board must make judgments about . . . when a Reply contention crosses the line from the responsive to the new.”); Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d at 1359, 1369–70 (Fed. Cir. 2016) (affirming the Board’s rejection of a reply argument presenting an “entirely new rationale to explain why one of skill in the art would have been motivated to combine” prior art references); Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1330–31 (Fed. Cir. 2019) (affirming the Board’s rejection of a reply argument presenting an “entirely new rationale” for why a claim would have been obvious).” slip op. at 18

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

    “first embodiment lens and the data entered into the “Lens Editor Data” spreadsheet are noticeable. First, the Abbe number for the third lens element is 42.72 in Ogata’s first embodiment lens and 26.5 (i.e., 38% smaller) in the “Lens Data Editor” spreadsheet. Compare Ex. 1026, 7:46, with Ex. 1021, 36. Second, the data for the fourth and tenth aspherical surfaces are noticeably different. For example, the fourth order term (A4) for the fourth aspherical surface is 0.66 x 10-4 in Ogata’s first embodiment lens and 151.69 x 10-4 (i.e., 0.015) in the “Lens Data Editor” spreadsheet. Compare Ex. 1026, 7:55, with Ex. 1021, 36. Neither Petitioner nor Dr. Sasián explain these discrepancies.” slip op. at 15

  Patent outcomesUS 10,225,479 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 10,225,479
• Apple, Inc. v. Corephotonics Ltd.No claims unpatentable
  PTAB · Nov 8, 2021 · IPR2020-00905 · APJ John F Horvath · IPR · Final written decision

  Claims 1–16, 18, 23–38, and 40 were not shown unpatentable because the asserted obviousness combinations did not establish a fused image with both Wide perspective and position POV.

  RulingsFinal written decision

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

    “In a dual-aperture camera image plane, as seen by each sub-camera (and respective image sensor), a given object will be shifted and have different perspective (shape). This is referred to as point-of-view (POV). The system output image can have the shape and position of either sub-camera image or the shape or position of a combination thereof. If the output image retains the Wide image shape then it has the Wide perspective POV. If it retains the Wide camera position then it has the Wide position POV. The same applies for Tele images position and perspective. As used in this description, the perspective POV may be of the Wide or Tele sub-cameras, while the position POV may shift continuously between the Wide and Tele sub-cameras. In fused images, it is possible to register Tele image pixels to a matching pixel set within the Wide image pixels, in which case the output image will retain the Wide POV ("Wide fusion"). Ex. 1001, 5:10–26.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “We find Petitioner sets forth sufficient reasoning with rational underpinning to combine the teachings of Parulski and Konno. Parulski lenses, but fails to give lens prescription data for the two camera lenses. Konno discloses lens prescription data for a dual-lens camera utilizing two thin lenses. The combination, therefore, is one of familiar elements according to known methods to obtain predictable results or a substitution of one element for another known in the field to obtain a predictable result. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007).” slip op. at 17

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

    “We agree with Patent Owner. As we explain in § II.D.1, supra, claims 1 and 23 require generating a fused image having a Wide perspective POV and a Wide position POV. Petitioner’s only argument for how the combination of Parulski and Konno teaches this limitation is Parulski’s teaching of generating a fused image having a Wide position POV, i.e., having the field of view (FOV) of the Wide camera. See Pet. Reply 13 (“Parulski teaches . . . producing an output image that maintains the Wide position POV or the field of view of the Wide camera when the image was captured.”). Petitioner fails to demonstrate how Parulski’s image fusion method would also maintain the Wide perspective POV as required by independent claims 1 and 23. Accordingly, for the reasons discussed above, Petitioner has failed to demonstrate by a preponderance of evidence that claims 1 and 23 are unpatentable as obvious over the combination of Parulski and Konno.” slip op. at 21

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Patent Owner argues that Petitioner and Dr. Durand have failed to demonstrate that Parulski teaches “the ‘fused image with a point of view (POV) of the Wide camera’ limitation” because their “sole argument that Parulski meets this limitation is based on the output [image] having the ‘wide image’s field of view.’” PO Resp. 29 (citing Ex. 1003 ¶ 51). Patent Owner further argues that “[n]othing in Parulski suggests that whatever image data from the tele image that might be ‘fused’ into the output would be modified to have the shapes and positions from the wide image POV” and “nothing in Dr. Durand’s declaration even attempts to establish [that] this admitted during his deposition that he had not provided an opinion about whether Parulski generates a fused image having both a Wide perspective POV and a Wide position POV. See PO Sur-Reply 5 (citing Ex. 2041, 52:25–54:20). We agree with Patent Owner. As we explain in § II.D.1, supra, claims 1 and 23 require generating a fused image having a Wide perspective POV and a Wide position POV. Petitioner’s only argument for how the combination of Parulski and Konno teaches this limitation is Parulski’s teaching of generating a fused image having a Wide position POV, i.e., having the field of view (FOV) of the Wide camera. See Pet. Reply 13 (“Parulski teaches . . . producing an output image that maintains the Wide position POV or the field of view of the Wide camera when the image was captured.”). Petitioner fails to demonstrate how Parulski’s image fusion method would also maintain the Wide perspective POV as required by independent claims 1 and 23.” slip op. at 20

  Patent outcomesUS 10,225,479 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 10,225,479
• 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
• 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

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.