• Lupin Ltd. / Lupin Pharmaceuticals, Inc. v. Horizon Therapeutics, Inc.All claims unpatentable
  PTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15

  • Skill levelSkill level board ownOther

    “Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “at least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent necessary to resolve the controversy.’ Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11

  Patent outcomesUS 9,095,559 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,095,559
• Osi Pharmaceuticals, LLC / Genentech, Inc. v. Arch Development Corp.All claims unpatentable
  PTAB · Sep 11, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–3, 5, and 6 are unpatentable: claims 1–3, 5, and 6 as obvious over Akinaga, Seynaeve, Friedman, and Tam; claim 6 also over Honma.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art as of the effective filing date of the ’512 patent, “would have held an M.D. or Ph.D. in molecular biology, biochemistry, pharmacology, or a related field and have had several years of experience working in cancer research.” Pet. 17 (citing Ex. 1002 ¶ 19); PO Resp. 4. This level of ordinary skill is consistent with the prior art asserted in the Petition. See Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 779 n.2 (Fed. Cir. 1983) (indicating that the prior art itself may reflect the appropriate level of ordinary skill in the art). Accordingly, we adopt the parties’ definition for the purpose of this Decision. C.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningTerm construed board ownDecided for patent owner

    “which defines a “therapeutically effective amount” as “an amount of a DNA damaging agent and tyrosine kinase inhibitor that, when administered to an animal in combination, is effective to kill cells within the animal.” Id. at 5. The challenged claims, however, use “therapeutically effective amount” in a context different from the express definition set forth in the Specification. As noted by Petitioner, the definition at column 4, lines 16 to 19 of the Specification refers to “a combined amount of the DNA damaging agent and the tyrosine kinase inhibitor, while the claims require that only the tyrosine kinase inhibitor be administered in a ‘therapeutically effective amount.’” See Pet. 20.” slip op. at 9

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

    “Specification suggest that the inventors contemplated the induction of a differentiation pathway. See Ex. 2011 ¶ 4. To the contrary, and as discussed above in Section 1(C), the Specification focuses on the use of DNA damaging agents in combination with tyrosine kinase inhibitors to force damaged cells to override the G2 arrest checkpoint and enter mitosis before completing DNA repairs. See, e.g., Ex. 1001, 3:46–48 (“By preventing delays in G2, cells will enter mitosis before the DNA is repaired and therefore the daughter cells will likely die.”). Accordingly, we agree with Patent Owner that, in light of the Specification, one of ordinary skill in the art would not understand the terms “enhanc[ing] cell death” and “enhancing apoptosis” to encompass the a process by which cancer cells are differentiated, become mortal, and, subsequently, “live out their days and die.” See Pet. 29; Ex. 1002, ¶ 127.” slip op. at 14

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

    “The parties agree that the preamble of each challenged claim, as well as the “thereby” clause of claims 1–3 (“thereby improving chemotherapeutic intervention”), are non-limiting. Pet. 17–18, 21–22; Prelim. Resp. 5, 8; Ex. 2001, 15. On the present record, we adopt the parties’ proposed Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (instructing that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). D.” slip op. at 16

  Patent outcomesUS 7,838,512 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,838,512
• Topgolf International, Inc. v. Amit AgarwalRehearing denied
  PTAB · Sep 5, 2017 · IPR2017-00928 · APJ Lora M Green · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left in place institution of inter partes review of claims 1 and 6 based on the reasonable likelihood of obviousness over Bertoncino and Foley.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs 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). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 2

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

    “most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end.” We note that the term “significantly lower” is a relative term, and Patent Owner does not offer a construction of that term.1 Nor does Patent Owner point us to anything in the prosecution history as providing a construction for that term. In addition, we note further that the Specification of the ’389 patent also does not define the relative term “significantly lower.” The Specification of the ’389 patent, however, teaches that each target green includes a target flag and a receptacle hole that is located near the front section of the green. Ex. 1001, 4:29‒32. According to the Specification of the ’389 patent, the target green is sloped downhill and has the general shape of a concave surface so that the receptacle hole is at the lowest portion of the green. Id. at 4:32‒35. Figure 4C of the ’389 patent is reproduced below: 1 We acknowledge that the ’389 patent expired as of September 2012, and we are, thus, guided by the principle that the words of a claim “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (internal citation omitted). But, “[i]n determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Figure 4C shows a cross-sectional view of a target green. Id. at 3:28‒29. As taught by the ’389 patent, “[t]arget green 30 would appear to the golfer at the teeing area to have a sudden drop off near the front portion of the green, and then a gradual slope upwardly toward the back of the green.” Id. at 4:37‒40. Thus, at best, the Specification of the ’389 patent appears to support a construction of the claim limitation of a target green profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end” as a green that has a sudden drop off near the front portion of the green and then a gradual slope upward toward the back of the green.” slip op. at 10

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

    “established sufficiently a reasonable likelihood that the challenged claims were rendered obvious by the combination of Bertoncino and Foley. Dec. 22. In particular, as to the limitation that the target green has a profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end,” for purposes of institution, we determined: that Petitioner has shown a reasonable likelihood that this claim limitation is rendered obvious by Bertoncino. In particular, Figure 5 of Bertoncino clearly shows that the front ends of the target green on the driving range are substantially lower than the back ends. Ex. 1004, Fig. 5. In addition, we determine that to the extent they are not, Petitioner has reasonably demonstrated that Bertoncino makes such a green obvious by teaching that the ability to see the lie of the ball is dependent on the ability to visually follow the path of the ball (id. at 1:26‒ 29), as well as teaching a “sloped driving range” (id. at 4:12‒ 13; see also id. at 5:37‒39 (“Each target . . . preferably comprises a surface generally sloped towards the tee stands area)). Id. at 19.” slip op. at 3

  • BurdenDecided for petitioner

    “Pet. 49. Figure 5 of Bertoncino, as addressed above, is a schematic perspective of a sloped driving range of Bertoncino. Petitioner also relied on its version of Figure 4 of Bertoncino, which was altered in line with the teaching of that reference that the target green may have only the inner section 22 (Ex. 1004, 6:61–65), and including the slope of the driving range shown in Figure 5 of Bertoncino, reproduced below: Pet. 49 (citing Ex. 1003 ¶ 92). Figure 4 of Bertoncino is a cross-sectional view of the sloped circular target of Figure 3. Ex. 1004, 4:8‒9. That is supported by Petitioner’s expert, Mr. Robbins, who declares that “[a] person of skill in the art would interpret Bertoncino to disclose a range with a plurality of target greens, each of which is composed of a single section with the slope profile of inner section 22” as depicted above. Ex. 1003 ¶ 92. Thus, as we concluded in the Decision on Institution (Dec. 17‒18), Petitioner in its Petition has established reasonably that Bertoncino teaches a target green having a profile wherein the “profile’s forward most end located at the forward portion of the target green having an elevation that is significantly lower than at its rearmost end.” That is, Petitioner has established reasonably for purposes of institution that the target green of Bertoncino meets the “significantly lower” limitation as construed above, as it has as a green that has a sudden drop off near the front portion of the green due to the concave shape of the target green and then a gradual slope upward toward the back of the green. See Ex. 1004, 6:3‒11, 12:6‒12, Figure 4.” slip op. at 12

  Claim constructioncites Phillips
  Patents in suitUS 5,370,389
• L’Oréal USA, Inc. v. Liqwd, Inc.Institution denied
  PTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution

  The Board denied institution of PGR on claims 1–10 because Petitioner did not show that any claim was more likely than not unpatentable under § 112.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless the Director determines . . . it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “Moreover, “[a]pplicants can define . . . claim scope during prosecution,” just as they can in a patent specification. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343 (Fed. Cir. 2015). Here, during prosecution of the ’419 patent, the applicant stated that “[t]he term ‘hair coloring agent’ refers to a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” Ex. 1005, 7. To define specific terms used to describe an invention, the applicant need only set out the definition “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). On the present record, the definition of the term “hair coloring agent” set out in the prosecution history of the ’419 patent is sufficiently clear, deliberate, and precise to give a person of ordinary skill in the art notice that the term is used in the ’419 patent in a manner that does not include substances other than “colorant[s] or pigment[s] that [are] customarily used in hair care products,” even if those other substances might be described as “hair coloring agents” outside the context of the ’419 patent. Ex. 1005, 7. Accordingly, we should give effect to that definition. Because Patent Owner’s proposed construction of “wherein the mixture does not contain a hair coloring agent” gives effect to the prosecution history’s definition of “hair coloring agent,” we adopt Patent Owner’s proposed construction for purposes of the present decision. Thus, on the present record, and for purposes of the present decision, we construe “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.”” slip op. at 6

  • Disclosure Requirements (§112) › Definiteness (Nautilus)Not shown unpatentable

    “to determine the scope of the claims. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown that it is more likely than not that claims 1–10 of the ’419 patent are indefinite.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “wherein the mixture does not contain a hair coloring agent.” Pet. 36–39; Prelim. Resp. 39–40. If “a hair coloring agent” encompasses bleaching agents, then the claims all require a bleaching formulation and simultaneously exclude a bleaching agent, a scope that Petitioner argues is not described in the specification of the ’419 patent. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown it is more likely than not that claims 1–10 of the ’419 patent lack written description support. slip op. at 12

  Claim construction§ 112 disclosure
  Patents in suitUS 9,498,419
• Generico, LLC / Flat Line Capital LLC et al. v. Dr. Falk Pharma GmbHAll claims unpatentable
  PTAB · May 19, 2017 · IPR2016-00297 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1 and 16 are unpatentable as obvious over the Sept. 2007 Press Release, Endonurse, and Davis-1985 in view of either Marakhouski or Brunner.

  RulingsFinal written decision

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

    “is an express definition for the term “remission.” In the Specification, the term, “DAI score,” is expressly defined in the following passage: Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12. Ex. 1001, 17:7–12.4 When the express definitions for “remission” and “DAI score” are read together, the claim 1 phrase “remission is defined as a DAI” slip op. at 9

  • Skill levelSkill level board ownOther

    “The ’688 patent relates to a method for administering granulated mesalamine to treat ulcerative colitis. The claimed method is the result of pharmacokinetic studies and clinical studies conducted by the inventors. Ex. 2036 ¶¶ 7, 10–12, 19, 21 (inventor declaration describing pharmacokinetic and clinical studies); Exs. 2029, 2045, 2048–2050 (reports and protocol for pharmacokinetic and clinical studies). Most of the written description of the ’688 patent relates to these studies. Ex. 1001, 6:27–35, 6:43–7:25, 16:1–45, 17:1–35, 21:17–33:64, Figs. 1–3 (clinical studies); id. at 7:26–31, 14:5–15:67, 16:47–67, 17:38–21:15 (pharmacokinetic, in vitro, and animal studies). According to Dr. Johnson’s testimony, neither of the inventors is a medical doctor, and neither has experience treating patients. Ex. 1067, 16:23–17:8, 22:19–23:3. Co-inventor William Forbes has a doctorate in pharmacy (“Pharm.D.”) and was Vice President of Research and Development for Salix at the relevant time. Ex. 1012, 1; Ex. 1067, 24:14– 25:17. Co-inventor Lorin Johnson5 has a Ph.D. in molecular biology and” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

  Patent outcomesUS 8,865,688 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,865,688
• Steadymed Ltd. v. United Therapeutics CorporationAll claims unpatentable
  PTAB · Mar 31, 2017 · IPR2016-00006 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–22 are unpatentable under § 102(b) and § 103(a), based on the Board’s anticipation and obviousness grounds.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “proposed construction (PO Resp. 17). Indeed, if any conclusion can be drawn from the specification excerpts highlighted by UTC, it is that the claim term “product” is defined solely by the recited claim limitations. See Ex. 1001, 5:45–46 (referring to the purportedly improved impurity of the “product of the process according to the present invention.”).” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “2. Discussion Each of the challenged claims, including independent claims 1 and 9,” slip op. at 24

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

    “below, we are persuaded by SteadyMed’s showing that an ordinarily skilled artisan, at the time of invention of the ’393 patent, would have had reason to combine, and a reasonable expectation of success in combining, Moriarty and Phares. “[T]he skilled artisan need not be motivated to combine [the prior art] for the same reason contemplated by [the inventor].” In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006). In this regard, we note that in addition to teaching that intermediate purification is unnecessary to the production of treprostinil diethanolamine salt by the disclosed process (Ex. 1005, 40–42), Phares explicitly describes the Moriarty process in disclosing the production of (-)-treprostinil, the enantiomer of (+)-treprostinil (id. at 42). Ex. 1009 ¶¶ 50, 77–78. Accordingly, we are persuaded that an ordinarily skilled artisan would have modified the process of Moriarty to incorporate the step of adding and dissolving diethanolamine to treprostinil as taught by Phares (Ex. 1005, 24) to eliminate the requirement for intermediate purification, thus, improving synthetic efficiency and reducing cost.” slip op. at 47

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for patent owner

    “minimize all impurities in all pharmaceuticals to the extent possible, such a general agency preference for improved purity is insufficient to establish a long-felt but unmet need for improved treprostinil, in particular. See Tex. Instruments v. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.”). Indeed, adherence to UTC’s position would dictate a conclusion of nonobvious for any pharmaceutical product exhibiting any improvement in purity over prior art versions of that same product.” slip op. at 61

  Patent outcomesUS 8,497,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,497,393
• Green Cross Corporation v. Shire Human Genetic Therapies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-00258 · APJ Robert A Pollock · IPR · Final written decision

  The Board held claims 1–3, 16, and 17 not shown unpatentable under § 103 because Jin was not prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner

    “are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. 35 U.S.C. § 316(e); see Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that the challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). However, because Petitioner offered Jin into evidence, which qualifies on its face as prior art under §102(e), Patent Owner bears the burden of producing evidence supporting a date of invention prior to the critical date of Jin. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015). As discussed below, Patent Owner elected to antedate, and thereby remove, Jin as prior art by showing that the inventor actually reduced the claimed invention to practice prior to Jin’s 102(e) priority date(s). As a result, the burden of production returned to Petitioner to demonstrate that the invention set forth in the challenged claims was not actually reduced to practice as of the date alleged. Id. at 1380. In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). “Sufficiency of corroboration is determined by using a ‘rule of reason’ analysis, under which all pertinent evidence is examined when determining the credibility of an inventor's testimony.” Id. at 1170 (citation omitted). “[I]t is not[, however,] necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement. Furthermore, an actual reduction to practice does not require corroboration for every factual issue contested by the parties.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (internal citations omitted). “[E]ach corroboration case must be decided on its own facts with a view to deciding whether the evidence as a whole is persuasive.” Id. at 1331 (citation omitted),” slip op. at 11

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

    “provided sufficient evidence to show that it reduced to practice an embodiment encompassing all elements of the challenged claims prior to the critical date of Jin, and Petitioner does not convince us otherwise. Accordingly, we find that Jin is not § 102(e) prior art, as Petitioner contends. Because Petitioner’s ground for challenging the ’556 Patent as obvious depends on Jin, we conclude that Petitioner has not proven by a preponderance of the evidence that the challenged claims are unpatentable. F.” slip op. at 24

  • ExcludeMotion to exclude, deniedDenied

    “Motions i. Patent Owners Motion to Exclude Evidence (Paper 74) Patent Owner moves to exclude Exhibits 1035, 1036, 1037, 1038, 1039, 1400, 1049, and 1051, each of which relates to Petitioner’s obviousness case. As discussed above, Petitioner has failed to satisfy the threshold issue of demonstrating that Jin, the primary reference relied upon in its obviousness ground, is prior art to the ’556 Patent. Accordingly, we do not address the substance of Petitioner’s obviousness arguments and, thus, do not rely on the challenged exhibits in our analysis. Accordingly, we deny Patent Owner’s Motion as moot. ii. Petitioner’s Motion to Exclude Evidence (Paper 75) Petitioner moves to exclude Exhibit 2207 (“Webb Exhibit 4”) which is purportedly an unredacted version of the TKT report (Exhibit 2115). See Paper 81, 1. As we have no need to rely on the challenged exhibit or associated testimony in our analysis, Petitioner’s motion is denied as moot.” slip op. at 24

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

    “iii. Petitioner’s Request for Expungement of Papers 71 and 72 In its Response to Patent Owner’s Motions for Observations Regarding Cross-Examination of Drs. Carbonell and Webb, Petitioner requests that we expunge, or accord no weight to, Patent Owner’s Motions for Observations because Patent Owner “made no effort to faithfully quote any testimony, and its ‘observations,’ which are often crammed with multiple citations, improperly narrate and mischaracterize the testimony cited, are rife with legal argument, and include references to unauthorized exhibits.” Paper 80, 1–3 (footnotes omitted); Paper 82, 1–3 (same). Although we are not convinced that Patent Owner “color[s] so far outside the lines” as Petitioner contends, we do not rely in our analysis on Patent Owner’s Motions for Observations. Accordingly, Petitioner’s request is denied as moot.” slip op. at 25

  Patent outcomesUS 9,051,556 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 9,051,556
• The Gillette Company v. Shavelogic, Inc.Rehearing denied
  PTAB · Mar 16, 2017 · IPR2016-00699 · APJ Richard H Marschall · IPR · Rehearing

  The Board denied Gillette’s rehearing request and left intact the denial of institution on claims 1–6 because the petition did not show that Ohtsubo disclosed the construed limitation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “for Rehearing could have been made, but were not, in the Petition. Despite relying almost exclusively on Figure 7E for its construction, which shows the longitudinal axis of inertia passing through the center of mass of the handle, the Petition never addresses the center of mass or explains why the limitation should not be construed to require an axis passing through the center of mass. Pet. 10. Petitioner addresses the issue for the first time in the Request for Rehearing. We cannot misapprehend or overlook arguments never made in the Petition.” slip op. at 3

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

    “inertia,” a limitation found in claim 1, the only independent claim. In our Decision, we noted that Petitioner argued “longitudinal axis of inertia” did not have a defined meaning to one of ordinary skill in the art, and that Figure 7E of the ’282 patent discloses the longitudinal axis of inertia. Dec. 6. We agreed that Figure 7E discloses the limitation, and that the figure, for purposes of the Decision, was controlling on the meaning of the term given the absence of any textual description of the term in the specification and the parties’ reliance on Figure 7E. Id. at 8. We concluded that because Figure 7E discloses the longitudinal axis of inertia passing through the center of mass of the handle, and specifically labels the center of mass in the figure, that “at a minimum” the limitation “requires a longitudinal axis that passes through the center of mass of the handle.” Id. at 9. Based on that construction, we agreed with Shavelogic, Inc. (“Patent Owner”) that Petitioner failed to establish that the prior art discloses the limitation, and we denied institution. Id. at 11–13.” slip op. at 2

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

    “Our conclusion as to the claim construction did not purport to construe the entire phrase “longitudinal axis of inertia of the handle” and only concluded that, “at a minimum,” the phrase requires a longitudinal axis that passes through the center of mass of the handle. Dec. 9. We did not suggest that the center of mass alone defined the axis, or further define the scope of “longitudinal axis of inertia.” Our limited construction was sufficient to address the issues raised by the Petition because Petitioner did not adequately establish that the prior art disclosed the limitation, so construed. Ohtsubo” slip op. at 6

  Claim construction§ 103 obviousness
  Patents in suitUS 8,789,282
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

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

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

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

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01850 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703 patent were not shown unpatentable because S-1 was not prior art under § 102(a) or (b), defeating each instituted § 103 ground.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14” slip op. at 14

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

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

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

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  Patent outcomesUS 8,440,703 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,440,703

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.