• K/S Himpp v. III Holdings 4, LLCNo claims unpatentable
  PTAB · Jun 28, 2018 · IPR2017-00496 · APJ James T Moore · IPR · Final written decision

  Claims 1–17 were not shown unpatentable under § 103 over Topholm and Michael because the cited art did not teach adjusting a hearing aid profile.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The problem we find with this position is that the Petitioner is reading claim elements into the description of these references. Patent Owner points out that the profiles are not being adjusted, but rather being selected from twenty-four previously stored profiles. Resp. 30–31. While the ear module operational profile changes, we observe that this is because it is using a different profile, which was just uploaded from the control unit. The act of moving the finger around on the screen to us perhaps appears to change the profile, when it is in fact moving through a set of preexisting profiles and uploading them to the hearing aid instead, changing operation of the hearing aid itself but not adjusting the profile itself. Michael states: This permits the user to select a hearing profile by simply moving visual indicator 924 over main region 922 while listening to a sound stream broadcast by ear 35 module 10; the sound stream being heard by the user reflects the hearing profile corresponding to the current position of the visual indicator 924 in real-time. Ex. 1005, 8:32–37.” slip op. at 21

  • Expert testimonyPetitioner expert creditedOther

    “4 Petitioner also relies upon the declaration testimony of Dr. Robert E. Morley, Jr. (Ex. 1002). Both references appear to be prior art under 35 U.S.C. § 102(b). We find Dr. Morley, by virtue of his education and experience, qualified to testify to the subject matter of this proceeding. Ex. 1002 ¶¶ 2–14 and Exhibit A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. PO Resp. 34–36. We give Dr. Morley’s testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2006. We decline to assign generally no weight to his testimony, however.” slip op. at 3

  • Skill levelSkill level petitioner adoptedOther

    “These underlying factual considerations consist of: (1) the “level of ordinary skill in the pertinent art,”5 (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of non-obviousness such as “commercial success, long felt but unsolved needs, failure of others, etc.”6 KSR, 550 U.S. at 406 (quoting Graham, 383 U.S. at 17–18). 5 Petitioner defines the level of ordinary skill in the art as someone with a B.S. degree in electrical or computer engineering, or the equivalent, and at least two years of experience in the design of audiological products. Pet. 7-8 (citing Ex. 1002, ¶ 32). Patent Owner does not challenge this level. PO Resp., passim. The references in the record tend to support a finding that this is the appropriate level.” slip op. at 12

  Patent outcomesUS 8,761,421 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,761,421
• K/S Himpp v. III Holdings 4, LLCOther
  PTAB · Jun 28, 2018 · IPR2017-00414 · APJ James T Moore · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under § 103 over either Cohen and Martin or Holmes and Martin because the combinations did not establish the claimed separate shaping before mixing.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “As used herein, the term “hearing aid profile” refers to a collection of acoustic configuration settings for hearing aid 102, which are used by a processor 110 to shape electrical signals related to sounds to compensate for the user's hearing loss. Ex. 1001, 3:11–15. Petitioner states that Patent Owner defined this term in the ’538 patent as “a collection of acoustic configuration settings for hearing aid 102, which are used by processor 110 to shape electrical signals related to sounds to compensate for the user’s hearing loss.” Pet. 15. According to Petitioner, this construction is consistent with the plain and ordinary meaning of the term, relying upon the testimony of its witness Dr. Les Atlas. Pet. 15 (citing Ex. 1003 ¶ 38).10 Patent Owner does not dispute Petitioner’s proposed construction. Resp. 10–11. 10 Dr. Les Atlas is the Petitioner’s witness in this matter. We find him qualified to testify as to the subject matter of this proceeding, by virtue of his education and experience. See Ex. 1003 ¶ 4, and Appendix A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. Resp. 31–34. We give Dr. Atlas’ testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2005. We decline to assign generally no weight to his testimony, however. supports, and is consistent with, Petitioner’s proposal. Ex. 1001, 3:12–16. Accordingly, we determine that the broadest reasonable construction, in light of the specification of the ’538 patent, of the term “hearing aid profile” is a “collection of acoustic configuration settings for hearing aid, which are used by a processor to shape electrical signals related to sounds to compensate for a user’s hearing loss.”” slip op. at 8

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

    “For the purposes of our decision, we determine that no other claim terms need explicit construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (citation omitted).” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “11 Petitioner defines the level of ordinary skill in the art as someone with a Bachelor’s degree in electrical engineering and at least two years of experience in the field of audio engineering. Pet. 14 (citing Ex. 1003 ¶ 25). Patent Owner does not challenge Petitioner’s definition. Resp. passim. The references in the record support a finding that this is the appropriate level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of skill in the art). 12 The record contains no allegations or evidence of secondary considerations.” slip op. at 10

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “We find the testimony of Dr. Atlas on the key point of obviousness of pre-mixing processing to be less persuasive than that of Mr. Brown. We also find Dr. Atlas’ testimony falls short of adequately explaining how the combination of Cohen and Martin teaches a nexus (i.e., the “based on both the first [shaped] output signal and the second [shaped] output signal” (emphasis added) (hereinafter, “based on both limitation”) limitation recited in claim 1) between the claim 1 requirements of: (1) a condition precedent of shaping both a first output signal and a second output signal; and (2) a subsequent result of using both the first shaped output signal and the second shaped output signal if the hearing aid is in a third mode. Dr. Atlas assumes that one of ordinary skill in the art would process separately each signal and then mix them. Ex. 1003 ¶ 66. We find Dr. Atlas’ assumption is flawed. Specifically, in making this assumption, Dr. Atlas does not address adequately how the combination of Cohen and Martin opines “it would have been obvious to a person of ordinary skill in the art” (emphasis added), his later sentences appears to base his opinion principally on the reason one of ordinary skill in the art could do it. Id. In particular, he testifies: Because Cohen’s hearing aid applies different hearing aid profiles to different input sources, it would have been obvious to a person of ordinary skill in the relevant art to add the functionality of the combination mode as taught by Martin to Cohen’s hearing aid such that the speaker would produce an audible sound based on the output signals of the processor. Combining two signals such that both signals are sent to a speaker to an audible combination of sounds, that is where each signal is sufficiently perceived, was well within the technical ability of a person of ordinary skill in the art. To accomplish this would require that each one of the two signals is passed through an appropriate hearing aid profile. For example, it would have been obvious to a person of ordinary skill in the art that a different hearing aid profiles could be used for an audio coil inputs and that of a neighboring conversation and environmental sounds through a microphone. Namely, it is commonly known that the different frequency sensitivity of an audio telecoil versus a microphone can be beneficially compensated for. (Rodriquez, Ex. 1011, Abstract)” slip op. at 24

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,649,538
• Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentable
  PTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision

  Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9

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

    “1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (citing 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.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 11

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

    “In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12

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

    “3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28

  Patent outcomesUS 7,009,034 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,009,034
• Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing denied
  PTAB · Jan 22, 2018 · IPR2017-01262 · APJ Robert A Pollock · IPR · Rehearing

  The Board denied rehearing, leaving institution denied because Petitioner did not show the prior art disclosed or enabled access to the mammalian FUT8 gene sequence required by claims 1–6.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “6, 2000 concerning the means and methods for creating cells in which the gene for the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 12. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6- fucosyltransferase, focusing, instead, on the “basic enabling techniques described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 14 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269(20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 73. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 17. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how that the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 6

  None
  Patents in suitUS 7,425,446
• Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing denied
  PTAB · Jan 22, 2018 · IPR2017-01254 · APJ Robert A Pollock · IPR · Rehearing

  The Board denied Petitioner’s rehearing request, leaving in place the denial of institution on claims 1–5 because Petitioner did not show an abuse of discretion.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

  • BurdenDecided for patent owner

    “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Because Petitioner raised none 1 Genbank entry AB025198.1. “Mus musculus mRNA for alpha-1,6- fucosyltransferase, complete cds,” https://www.ncbi.nlm.nih.gov/nuccore /%20AB025198. 2 Yanagidani et al., Purification and cDNA Cloning of GDP-i-Fuc:N-acetyl- β-d-glucosaminyl fucosyltransferase (α1-6FucT) from Human Gastric CancerMKN45 Cells, 121 J. Biol. Chem. 626-632 (1997). 3 Naofumi Uozumi, Purification and cDNA Cloning of Porcine Brain GDPL-Fuc:N-Acetyl-β-D-Glucosaminide α1→6Fucosyltransferase, 271 J. Biol. Chem. 27810-27817 (1996). of the above arguments in the Petition, nor timely submitted any of Exhibits 1039, 1042, and 1043, Petitioner has not established that we misapprehended or overlooked this evidence. Cf. DeSilva v. DiLeonardi, 181 F.3d 865, 866– 67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archeologist with the record.”). slip op. at 4

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “of Drs. Van Ness and Jefferis. Req. Reh’g 12–14 (citing Ex. 1007 ¶¶ 18–20, 40–43, 77; Ex. 1026 ¶¶ 11–13). With respect to the latter, Petitioner points to Dr. Jefferis’s statement that a person of ordinary skill in the art “would have had knowledge of the scientific literature no later than October 6, 2000 concerning the means and methods for creating cells in which the gene for the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 11. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6-fucosyltransferase, focusing, instead, on the “basic enabling techniques described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 13 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269(20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 68. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 16–17. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 5

  None
  Patents in suitUS 8,067,232
• Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing denied
  PTAB · Jan 22, 2018 · IPR2017-01252 · APJ Robert A Pollock · IPR · Rehearing

  The Board denied the petitioner’s rehearing request, leaving in place the denial of institution on claims 1–12 because the petition did not establish access to the necessary mammalian FUT8 genetic material.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “isolated fucosyltransferase knock-out host cell.” Consistent with Patent Owner’s position, we construed the fucosyltransferease knock-out as “a disruption of FUT8, the gene encoding α1,6-fucosyltransferase.” Dec. 13. In denying the Petition, we found that Petitioner did not establish that the prior art disclosed or rendered obvious the challenged claims because it failed to present sufficient evidence that one of ordinary skill in the art would have had access to the necessary genetic starting material. Dec. 19– 24. In particular, we determined that “Petitioner fails to establish adequately that DNA encoding a mammalian α1,6-fucosyltransferase was either available, or could be routinely obtained by those of ordinary skill in the art.” Id. at 24. According to Petitioner, our finding is “clearly erroneous” and based on “misunderstandings about the record evidence, as well as a failure to weigh, in full, unrebutted expert testimony before the Board.” Req. Reh’g 1. We do not find Petitioner’s argument persuasive.” slip op. at 3

  • Strike new argumentNew argument disregardedDecided for patent owner

    “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Because Petitioner raised none of the above arguments in the Petition, nor timely submitted any of Exhibits 1 Genbank entry AB025198.1. “Mus musculus mRNA for alpha-1,6- fucosyltransferase, complete cds,” https://www.ncbi.nlm.nih.gov/nuccore /%20AB025198. 2 Yanagidani et al., Purification and cDNA Cloning of GDP-i-Fuc:N-acetyl- β-d-glucosaminyl fucosyltransferase (α1-6FucT) from Human Gastric CancerMKN45 Cells, 121 J. Biol. Chem. 626-632 (1997). 3 Naofumi Uozumi, Purification and cDNA Cloning of Porcine Brain GDPL-Fuc:N-Acetyl-β-D-Glucosaminide α1→6Fucosyltransferase, 271 J. Biol. Chem. 27810-27817 (1996). 1038, 1041, and 1042, Petitioner has not established that we misapprehended or overlooked this evidence. Cf. DeSilva v. DiLeonardi, 181 F.3d 865, 866– 67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archeologist with the record.”). slip op. at 4

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 11. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6-fucosyltransferase, focusing, instead, on the “basic enabling techniques to create the modified-antibody-producing mammalian cells described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 13 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269 (20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 77. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 20–21. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of the α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 6

  None
  Patents in suitUS 6,946,292
• Michael J. Sindoni, Jr. v. Deyan Ninov, Joseph S. Dehner, And Gregory A. HowellInstitution denied
  PTAB · Nov 7, 2017 · DER2016-00003 · APJ Jameson Lee · DER · Institution

  The Board denied institution because the petition lacked substantial evidence of derivation for any challenged claim, including sufficient proof of conception, communication, and the required claim comparisons.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “The threshold showing for institution of a derivation proceeding is whether the petition demonstrates substantial evidence that, if unrebutted, would support the assertion of derivation.4 35 U.S.C. § 135(a); 37 C.F.R. § 42.405(c). A petitioner must show that the respondent, without authorization, filed an application claiming a derived invention. 35 U.S.C. § 135(a); 37 C.F.R. § 42.405(b)(2). The party asserting derivation must establish prior conception of an invention and communication of that conception to an inventor of the other party. Cooper v. Goldfarb, 154 F.3d 1321, 1332 (Fed. Cir. 1998); Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993); Hedgewick v. Akers, 497 F.2d 905, 908 (CCPA 1974). The showing of communication must be corroborated. 37 C.F.R. § 42.405(c). Assuming that corroborated conception and communication both are established, a petitioner would be able to regard as a derived invention those” slip op. at 3

  • BurdenDenied

    “B. The Alleged Invention – Conception and Communication First, Petitioner has not sufficiently specifically identified the features of an invention that he allegedly conceived. The closest the Petitioner comes to doing that are these two statements in the Petition: (1) “Petitioner Sindoni conceived of a major advance in the pickup truck equipment field”; and (2) “[T]his invention, which in brief is a ramp system for a pickup truck, was communicated to Respondent by Sindoni before Respondent filed the ’123 application.” Pet. 3, 16. We do not understand the position of Petitioner to be that Mr. Sindoni conceived of the very first ramp system for a pickup truck. An Information Disclosure Statement submitted by Petitioner during prosecution of the ’548 Application identifies three prior art references disclosing a ramp system for a pickup truck, i.e., U.S. Patent Nos. 3,976,209; 4,624,619; and 7,445,268. Ex. 3002. Also, Petitioner’s ’548 Application generally refers to preexisting ramps for pickup trucks and characterizes them as unsatisfactory. Ex. 1002 ¶ 5. Yet, neither the Petition nor the Declaration of Mr. Sindoni sets forth any particular feature of the “ramp system for a pickup truck” that Petitioner allegedly conceived, much less the entirety of what Petitioner has conceived. This deficiency alone dooms the Petition, because we do not know what was conceived by Petitioner. Second, Petitioner has not sufficiently identified the features of any invention that he allegedly communicated to Respondent. The closest the Petitioner comes to doing that are these two statements in the Petition: (1) “[T]his invention, which in brief is a ramp system for a pickup truck, was communicated to Respondent by Sindoni before Respondent filed the ’123 application”; and “Petitioner disclosed the invention to Respondent to this end, and Respondent acknowledged receipt of the disclosure.” Pet. 3, 16. The Petition does not, however, point to corroborating evidence of communication or evidence of how Respondent has acknowledged receipt of Petitioner’s conceived “invention” at any time. The Declaration of Mr. Sindoni, the Petitioner, is no better. Mr. Sindoni testifies: “Details of the invention were communicated to FCA US LLC by me more than a year before FCA US LLC filed the Chrysler application and more than two years before the Sindoni application was filed.” Ex. 1003 ¶ 7 (emphasis added). However, Mr. Sindoni in his Declaration nowhere identifies or explains the referenced “[d]etails of the invention.” Submitted by Petitioner as Exhibit 1006 is a document that appears to be signed by Mr. Sindoni and a representative of an entity named “U.S. Patent Commission,” that pertains to disclosure by Mr. Sindoni of an invention to U.S. Patent Commission at some time. But that document has not been addressed in the declaration testimony of Mr. Sindoni. Nor is there a declaration from Angela Stevens, the individual who signed on behalf of U.S. Patent Commission, addressing the document. Thus, it has not been authenticated. Also, although the Petition generally refers to Exhibit 1006 as “Petitioner’s Invention Disclosure,” (Pet. 9–14), we do not know specifically what subject matter the Petitioner possibly had conceived because the Petitioner makes no averment in that regard. Furthermore, the content of Exhibit 1006 has not been explained either in the Petition or in the Declaration of Mr. Sindoni. Pages 4 and 5 of Exhibit 1006 appear to contain technical illustrations but are substantially illegible. On May 3, 2017, we issued an Order (Paper 7) stating: “[I]f Petitioner can provide a more legible copy of the last two pages of Exhibit 1006, then another full copy of Exhibit 1006, including the more legible last two pages, shall be filed within two weeks of the date of this communication.” Paper 7, 3. Petitioner filed no replacement copy of Exhibit 1006. We note also that the signature of Angela Stevens, on behalf of U.S. Patent Commission, on page 1 of Exhibit 1006, is undated, and Petitioner submitted no declaration of Angela Stevens to substantiate and explain her signature, e.g., when she received the document. In any event, Petitioner makes no explanation as to the relationship, if any, between U.S. Patent Commission and Respondent. We decline to assume that they are the same entity. Thus, we will not assume communication with U.S. Patent Commission is the same as communication with Respondent. For the foregoing reasons, the Petition is fatally deficient with regard to the” slip op. at 5

  None
  Patents in suitUS 9,067,525
• Argentum Pharmaceuticals LLC v. Cipla Ltd.Rehearing denied
  PTAB · Oct 31, 2017 · IPR2017-00807 · APJ Kristi L R Sawert · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in declining to construe the terms or in reserving disputed motivation and reasonable-expectation issues for trial.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 4

  • Expert testimonyOther

    “osmolality, poor spray quality, and unacceptable settling and caking” resulting from the attempted formulation of Cramer’s Example III. Id. at 8– 10; see also Prelim. Resp. 25. The Board, however, addressed those issues in the Institution Decision and determined that “Patent Owner’s arguments and expert testimony highlight disputed issues of fact about whether the skilled artisan would have been motivated to combine the teachings of Hettche, Phillipps, and Segal to arrive at the claimed subject matter, and would have had a reasonable expectation of success.” Instit. Dec. at 20 (citing Ex. 1002, 268–87; Ex. 2007 ¶¶ 40–47; Ex. 2111, 1; Ex. 2044, 1–2). The Board concluded that those “issues are best resolved following trial with the benefit of a full record.” Id. We are still of that view. Accordingly, we are not persuaded that the Board misapprehended or overlooked the issue of reasonable expectation of success.” slip op. at 5

  • BurdenOther

    “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes the Board misapprehended or overlooked and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review 1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992) (“Hettche”). Ex. 1007. 2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15, 1982) (“Phillipps”). Ex. 1009. 3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5, 1998) (“Segal”). Ex. 1012. 4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product Information (Dec. 1998) (“Flonase Label”). Ex. 1010. the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “In the Institution Decision, the Board determined that “no claim term requires express interpretation for purposes of this Decision.” Instit. Dec. 7. In its Rehearing Request, Patent Owner argues that the Board “misapprehended or overlooked the importance of construing the terms ‘nasal spray’ and ‘suitable for nasal administration’” found in all the challenged claims. Reh’g Req. 2. In particular, Patent Owner asserts that those terms mean “pharmaceutical formulations that are tolerable to patients, homogeneous, and can be suitably deposited onto the nasal mucosa.” Id. (citing Paper 7, Preliminary Response (“Prelim. Resp.”), 9). Patent Owner alleges that, had the Board construed “nasal spray” and “suitable for nasal administration,” then the Board would have denied the obviousness grounds because “none of the combinations of cited art teach a person of ordinary skill in the art how to make the claimed fixed-dose combination ‘nasal spray’ or formulation ‘suitable for nasal administration’ with a reasonable expectation of success.” Id. at 2–3 (citing Prelim. Resp. 9). We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 3

  Claim construction§ 103 obviousness
  Patents in suitUS 8,168,620
• Edwards Lifesciences Corporation v. Boston Scientific Scimed, Inc.Institution denied
  PTAB · Oct 25, 2017 · IPR2017-01294 · APJ James T Moore · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “challenged claim contains a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6, Petitioner is required to construe the limitation and “must identify the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function.” 37 C.F.R. § 42.104(b)(3). (Emphasis added). Here, the Petition fails to identify any portion of the ’962 patent Specification that describes the structure, material, or acts that correspond to the functions recited in the above-referenced limitations, and references a different document. See Pet. 24–25; see also 37 C.F.R. § 42.6(a)(3). It is not this panel’s responsibility to identify the portions of the Specification upon which it believes Petitioner may rely to support its positions with respect to 35 U.S.C. § 112 ¶ 6. Our Rules place this burden on Petitioner, so that the panel may evaluate effectively the challenged claims vis-à-vis the asserted prior art, as discussed below. B. Asserted Grounds of Unpatentability To show that a challenged claim containing a means-plus-function limitation is unpatentable over the asserted prior art, Petitioner must show that the structure that corresponds to a claimed function, or its equivalent, is found in, or obvious over, the applied prior art. See Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1299–1300 (Fed. Cir. 2009) (“It is firmly established in our precedent that a structural analysis is required when means-plus-function limitations are at issue; a functional analysis alone will not suffice.” (emphases added)). In this case, Petitioner’s failure to construe the claims in accordance with our Rules is determinative. By failing to identify the structure, material, or acts in the ’962 patent Specification that correspond to the claimed functions, Petitioner necessarily has not shown where that structure, material, acts, or their equivalents are disclosed in the applied prior art. Compare Pet. 24–25, with id. at 37 (discussing “expandable inflatable means”), 37–38 (discussing “mounting and retaining means”), 45–46 (discussing “means for inflating”).” slip op. at 11

  • BurdenDecided for patent owner

    “challenged claim contains a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6, Petitioner is required to construe the limitation and “must identify the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function.” 37 C.F.R. § 42.104(b)(3). (Emphasis added). Here, the Petition fails to identify any portion of the ’962 patent Specification that describes the structure, material, or acts that correspond to the functions recited in the above-referenced limitations, and references a different document. See Pet. 24–25; see also 37 C.F.R. § 42.6(a)(3). It is not this panel’s responsibility to identify the portions of the Specification upon which it believes Petitioner may rely to support its positions with respect to 35 U.S.C. § 112 ¶ 6. Our Rules place this burden on Petitioner, so that the panel may evaluate effectively the challenged claims vis-à-vis the asserted prior art, as discussed below.” slip op. at 11

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner

    “With respect to these limitations, Petitioner contends that these limitations in some instances do and in others do not invoke 35 U.S.C. § 112 ¶ 6. Pet. 24–25. Petitioner, however, does not discuss the presumption associated with use of the word “means” in these limitations and does not provide a single citation to persuasive intrinsic or extrinsic evidence to suggest that the presumption is either warranted or unwarranted in any case. Instead, Petitioner incorporates by reference a letter between counsel in the co-pending district court litigation. Id. (citing Ex. 1007). Even if Petitioner’s incorporation of counsel’s positions in litigation by reference were proper,5 the cited letter also fails to explain how or why applicable intrinsic or extrinsic evidence warrants in selected instances only deviating from the presumption that use of the term “means” invokes 35 U.S.C. § 112 ¶ 6. Although this letter suggests that the parties may agree that § 112 ¶ 6 should or should not apply to these limitations, a non-binding agreement 5 See 37 C.F.R. § 42.6(a)(3), prohibiting incorporation by reference of arguments. between parties does not constitute persuasive evidence and does not suspend operation of our Rules requiring the Petitioner to identify the corresponding structure and function, or explain otherwise. Further, claim construction, and whether § 112 ¶ 6 applies, is a legal determination made based on a hierarchy of evidence––intrinsic evidence being the most persuasive. Lawyer argument is among the least persuasive.” slip op. at 10

  Claim constructioncites Phillips
  Patents in suitUS 6,371,962
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · Jun 9, 2017 · IPR2016-00189 · APJ James T Moore · IPR · Final written decision

  Claims 1 and 2 are unpatentable as obvious over Kempeni and van de Putte because the combined teachings would have motivated the claimed biweekly 40 mg subcutaneous regimen with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Dr. Baughman describes the ordinarily skilled artisan physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 26; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled artisan pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 26–27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101–103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding without challenge, and it is consistent with the level of ordinary skill in the art as reflected by the prior art of record.” slip op. at 5

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “Owner asserts that “[a]s of June 2001, a treating physician who satisfied the definition of a POSA[4] would have understood the claims to require meaningful therapeutic efficacy.” Resp. at 61 (citing Ex. 2065 ¶¶ 20, 92– 93). As support, Patent Owner points to the ’987 patent specification’s disclosure that “administration of D2E7 produces a meaningful improvement in a variety of clinical outcome measures” such as ACR20, ACR50, and SJC.5 Id. at 62. Patent Owner also contends that the specification of the ’987 patent provides “clinically meaningful outcome parameters” for the treatment of RA. Id. (citing Ex. 2065, ¶¶ 92–93). Patent Owner, therefore, again asserts that we should construe the phrase to mean that the treatment has “meaningful therapeutic efficiency.” We again decline to interpret the claim in this manner. Such a construction would add much uncertainty to the 4 We understand POSA to be used as shorthand for a Person of Ordinary Skill in the Art. 5 ACR is shorthand for the American College of Rheumatology improvement criteria. SJC stands for swollen joint count. Ex. 1001, 28:23;30:22. claim. Meaningful is a highly subjective term, depending on the outcome sought by a treating physician and what he or she might regard as meaningful as regards that outcome.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed

    “Petitioner does not carry its burden to show that a person of ordinary skill in the art would have been so motivated. As explained above, in the Petition Petitioner asserts that the ordinary artisan would have doubled van de Putte’s 20 mg dose to 40 mg and weekly dosing interval to biweekly based on the single PK parameter of half-life. In support of that assertion, Dr. Baughman testifies that “half-lives are routinely used to develop the appropriate dosing frequency.” Ex. 1006 ¶ 66. Dr. Baughman’s testimony in that regard may be valid, but the record in this case does not include sufficient persuasive evidence from which we can make that determination. That is, neither Petitioner nor Dr. Baughman directs us to a monoclonal antibody drug with a dosing interval that corresponds to its particular half-life, or to other evidence supporting the assertion that skilled artisans routinely use half-lives to develop a dosing schedule. Accordingly, Dr. Baughman’s testimony on those issues is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “We see the evidence somewhat differently. A reference teaches away from the claimed invention if it criticizes, discredits, or would have RA, the 40 mg subcutaneous dose also is insufficient, given the lower bioavailability of a drug after subcutaneous administration. Tr. 46:16–21. We address that contention below in discussing Patent Owner’s argument that Kempeni, and the prior art as a whole, teach away from the 0.5 mg/kg dose. See infra §§ II.C.3.b.(2)(ii)–(2)(iii). discouraged a person of ordinary skill in the art from “following the path set out in the reference,” or if a person of ordinary skill “would [have been] led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). The mere disclosure of alternative designs, however, does not teach away. In re Mouttet, 686 F.3d 1322, 1333–34 (Fed. Cir. 2012). Kempeni discloses several clinical studies that utilized different dosing protocols. DE003 was one of those clinical studies. In the DE003 study, patients received 0.5 to 10 mg/kg of D2E7 intravenously “every two weeks” until DAS (Disease Activity Score) responses could be rated as “good.” Ex. 1003, 2 (emphasis added). Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, as explained above, Kempeni expressly discloses such dosing frequency.11 We agree with Patent Owner that, for some portion of the treatment period, patients were treated only on flare up. Resp. 49; Ex. 1003, 2. That disclosure, however, does not negate Kempeni’s teaching of biweekly dosing. Nor does it fairly teach away from biweekly dosing. We also agree that some patients were “updosed” for “inadequate clinical response.” Resp. 50; Ex. 1003, 2–3. 11 Additional prior art references support the finding regarding Kempeni’s disclosure. For example, one reference describes the DE003 study as a clinical trial in which “D2E7 was given in doses of 0.5–10 mg/kg [intravenously] over 3–5 minutes every two weeks over a time period of now 1½ years.” Ex. 2114, 4. We find that such disclosure represents, at most, an alternative dosing schedule to the biweekly dosing Kempeni discloses, with patient variability accommodated. In any event, we find that persons of ordinary skill were not led in a direction divergent from that taken by Patent Owner. To the contrary, evidence in the record demonstrates that skilled artisans conducted studies dosing D2E7 subcutaneously in fixed doses, and on a biweekly schedule. Ex. 1004, 1 (disclosing that D2E7 was administered subcutaneously in fixed doses of 20, 40, and 80 mg); Ex. 1005, 3 (describing the DE010 study, in which patients initially were treated with 1 mg/kg D2E7 intravenously, 1 mg/kg D2E7 subcutaneously, or placebo, but thereafter received subcutaneous injections of 1 mg/kg D2E7 biweekly in the open label portion of the study).” slip op. at 24

  Patent outcomesUS 9,073,987 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,073,987

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.