• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • BurdenMixed

    “Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20

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

    “(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

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

    “Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19

  Patent outcomesUS 8,252,316 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,252,316
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • Skill levelSkill level board ownOther

    “The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16

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

    “water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  Patent outcomesUS 8,679,524 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,679,524
• Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyNo claims unpatentable
  PTAB · Dec 22, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 were not shown unpatentable as obvious over Cohen, Shire, and Carpenter because Petitioner did not establish a reasonable expectation of success.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedOther

    “suggests a trial-and-error approach to protein formulation. See Ex. 2011 (“Very often, proteins have to be evaluated individually and stabilized on a trial-and-error basis.”). Thus, we credit Dr. Staples’s testimony regarding the use of trial-and-error optimization because it appears that this was a known approach for formulating proteins. We do not agree that because the approach was known, it was necessarily expected to be successful. Petitioner cites to the statement in Carpenter that the authors were “quite confident” the generalized high throughput formulation procedure they describe “can be coupled successfully with high throughput screening strategies of protein drugs and facilitate drug development within the inherent time and resource constraints of the pharmaceutical industry.” Ex. 1004, 195. We note that, although in isolation Carpenter’s proclamation of being “quite confident” appears to demonstrate a reasonable expectation of success, when considered in context it refers to a general trend in the industry, not to the ability to formulate specific proteins. The full statement does not indicate that there was confidence that any particular drug could be successfully formulated as a liquid. Thus, this evidence is not persuasive.” slip op. at 7

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

    “parties, we determine, on balance, that Petitioner has not established sufficiently that an ordinary artisan would have had a reasonable expectation of success in formulating CTLA4Ig as a stable liquid formulation as recited in the challenged claims. Specifically, in the challenge to Patent Owner’s claims, Petitioner relies on Carpenter to show that an ordinarily skilled artisan would have known how to prepare a stable liquid formulation of CTLA4Ig for subcutaneous administration. Pet. 33–40. The statements in Carpenter are the most significant evidence of whether there would have been an expectation of success in achieving the claimed formulation. But Carpenter expressly states that “[i]t [could] be assumed that most proteins will not exhibit sufficient stability in aqueous solution to allow a liquid formulation to be developed.” Ex. 1004, 188; PO Resp. 16. Carpenter also states that although a stable liquid formulation is desirable, “for most proteins maintaining physical and chemical stabilities in aqueous solution for an extended period of time is extremely difficult.” Ex. 1004, 184. These statements indicate that there would not have been a reasonable expectation of success in achieving the claimed formulations. Dr. Staples’s testimony about routine trial-and-error optimization does not overcome these statements. Petitioner’s citation to Paborji (Ex. 1016) does not persuade us otherwise. Even though Paborji states that CTLA4Ig in phosphate buffer is “relatively stable,” without testimony to explain how this would be interpreted by a skilled artisan, the strong doubt about success expressed in Carpenter is not overcome.” slip op. at 13

  Patent outcomesUS 8,476,239 not shown unpatentable
  § 103 obviousnesscites KSR
  Patents in suitUS 8,476,239
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2016-00283 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–12 were not shown unpatentable because Par failed to establish that the prior art would have motivated a skilled artisan to dose based on about 60% conversion.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Horizon, on the other hand, contends that a person of ordinary skill in the art would have the following qualifications: (a) An M.D. or equivalent degree; (b) 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; and (c) At least five years of experience treating patients with nitrogen retention disorders, including UCDs. Corr. PO Resp. 26. Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “First, regardless of whether one of ordinary skill in the art would have understood Brusilow ’91 to teach 80% to 90% conversion, or something closer to 100% conversion, we credit Dr. Sondheimer’s testimony that one of ordinary skill in the art would have sought out prior art references “discuss[ing] the conversion of PAA to PAGN” (Ex. 1002 ¶ 42) if only “[b]ecause Brusilow ’91 involved a single subject and observed a range of conversion rates” (id. at 43). As for the parties’ diametrically opposed views on whether Dr. Brusilow preselected all three doses administered to the patient, or adjusted the dose in Period III to account for the 90% conversion observed in Period II (see Ex. 1012, Table 1), we find we need not resolve the controversy, because, even if we accept that the dose in Period III was adjusted based on the results in Period II, it would not change our ultimate disposition of the case.” slip op. at 27

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See 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)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9

  • Expert testimonyDecided for petitioner

    “several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See 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)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCAll claims unpatentable
  PTAB · Sep 29, 2016 · IPR2016-00284 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–11 are unpatentable under § 103 over the three combinations of references identified in the decision.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Petitioners argue that Patent Owner’s Exhibits 2022 and 2024 should be excluded because they are not prior art to the ’215 patent. Paper 25, 1–2. Even considering Exhibits 2022 and 2024, we are still persuaded that a preponderance of the evidence shows claims of the ’215 are unpatentable. Accordingly, Petitioners’ motion is dismissed as moot. Petitioners also argue that Patent Owner relies on attorney argument to rebut Petitioners’ challenges, effectively providing impermissible expert evidence, which Petitioners seek to exclude. (Paper 25, 2–6.) We dismiss Petitioners’ argument because attorney argument is not evidence. See Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977) (“Argument of counsel cannot take the place of evidence lacking in the record.”). Therefore, Petitioners’ argument is improperly presented in a motion to exclude evidence. Nevertheless, the issue of evidentiary support for Patent Owner’s arguments is addressed above. Patent Owner argues that evidence relied upon by Petitioners should be excluded. Paper 33. Specifically, Patent Owner seeks to exclude certain portions of Dr. Sondheimer’s cross-examination testimony and Exhibits 1031–1033. Patent Owner acknowledges that “[i]n its Reply (Paper 28), Petitioner has not attempted to rely upon the portions of Dr. Sondheimer’s deposition transcript or the documents Patent Owner seeks to exclude.” Paper 33, 2–3. We dismiss Patent Owner’s motion as being moot. Because Patent Owner cannot point to where Petitioners rely on the testimonial evidence, having apparently not relied on it, we have no basis on which to determine whether the evidence is inadmissible and no basis on which to exclude it. Furthermore, because Exhibits 1031–1033 have not been made of record in this proceeding (see Paper 33, 1), they cannot be excluded.” slip op. at 23

  • Skill levelOther
  • Expert testimonyPetitioner expert creditedOther

    “Petitioners rely on the testimony of Neal Sondheimer, M.D., Ph.D. (Ex. 1002). Dr. Sondheimer testifies that he currently holds several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies about the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. We find Dr. Sondheimer to be qualified to provide opinions on the subject matter at issue. Patent Owner does not present the testimony of its own witness to support its arguments.” slip op. at 5

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner

    “We look to the language of the claim itself and to language in the specification to determine the scope of a claim. To limit a claim beyond what its plain language appears to convey, the patentee “may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1365 (Fed. Cir. 2004) The plain language of independent claims 1–3 recites only the steps of “measuring,” “comparing,” and “administering.” The claims do not include a “targeting” step or steps such as repeated measuring, comparing, and administering, until the fasting blood ammonia level is less than half the upper limit of normal. See Pet. Reply 5–6. Although Patent Owner cites to evidence of the background of the invention, we have not been directed to evidence within the specification of the ’215 patent that clearly limits the claimed methods from being applied at any blood ammonia level greater than half the upper limit of normal. In addition, Patent Owner does not direct us to testimony or other evidence indicating that those skilled in the art would have considered the language of the claims to require “targeting” a certain blood ammonia level or to specify administering drug dosages only when the blood ammonia level is at about that targeted level. On the contrary, the plain terms of the claims contain no such limitations and are broad enough to embrace the administration of drug at higher blood ammonia levels. Accordingly, we conclude that the correct interpretation of Patent Owner’s claims is a method of measuring a fasting blood ammonia level, comparing this level to the upper limit of normal, and administering drug when the level is any level greater than half the upper limit of normal for blood ammonia level.” slip op. at 14

  Patent outcomesUS 8,404,215 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,404,215
• Adama Makhteshim Ltd. v. Finchimica S.P.A.Rehearing denied
  PTAB · Jun 16, 2016 · IPR2016-00577 · APJ Sally Gardner Lane · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left institution of review of claims 1–12 unchanged, finding Petitioner was not estopped from asserting the challenged grounds.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “Patent Owner requests “partial rehearing” of the Decision. Patent Owner argues that Decision was incorrect where the Board determined that Petitioner is not estopped from challenging the claims of the ’559 patent on grounds 1 and 3 asserted in the Petition. (Paper 9, Request, at 1). Patent Owner does not argue that the Board otherwise erred in determining that there is a reasonable likelihood that Petitioner would prevail.” slip op. at 2

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for petitioner

    “We do not agree. The record indicates that the Board did not authorize Petitioner’s original request to file motions for unpatentability based on references cited in grounds 1 and 3 which included EP ’117. Instead the Board indicated that the motions were not authorized at that time but that Petitioner could renew its request when the interference proceeded to a priority determination. (Interference 105,995, Paper 21 (Ex 1023), Levin Motions List, at 3:3–4:8 and Paper 38 (Ex 1026), Order Setting Times, at 4:12-15). An email communication dated 31 July 20151 that is cited in the” slip op. at 3

  None
  Patents in suitUS 8,304,559
• Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyRehearing denied
  PTAB · May 27, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving institution of inter partes review of claims 1–15 in place based on a reasonable likelihood of obviousness.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We are not persuaded that we overlooked or misapprehended a matter in relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2

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

    “[i]n general, we consider Petitioner’s argument to be persuasive based on the record before us because Cohen teaches a specific dosage of CTLA4Ig and it is reasonably likely that those of ordinary skill in the art would have been able to determine an effective concentration for a subcutaneously administered formulation from that dosage. Dec. 10. We noted further that given the effective dosage reported in Cohen, the absence of any specific information about CTLA4Ig indicating that an ordinary artisan could not have determined an effective concentration for subcutaneous administration using routine optimization, and the absence of evidence of secondary considerations, we are persuaded at this point in the proceeding that the recited concentration is likely to be an unpatentable modification. Id.” slip op. at 4

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “relation to our decision regarding claim 11. We are persuaded that there is a reasonable likelihood that Petitioner will prevail in showing that the claimed storage temperature range would have been obvious in view of Carpenter (Ex. 1004, 16), even if the reference does not mention expressly a specific temperature range. Dec. 13. As noted in our Decision, Carpenter teaches that proteins formulated under certain constraints would have been suitable for commercialization, i.e., have “a shelf life of 18 months.” Dec. 13; Ex. 1004, 16. At this point in the proceeding, we find the testimony of Petitioner’s witness, Dr. Staples, to be persuasive that the conditions recited in claim 11, including the temperature range of 2 to 8 oC for at least 12 months, were known to be the minimum requirements for commercialization of a protein formulation, and, therefore, an ordinary artisan would have understood Carpenter to suggest such conditions. Id. (citing Ex. 1006, ¶ 57).” slip op. at 2

  Discretionary denialcites KSR
  Patents in suitUS 8,476,239
• Sata GmbH & Co. KG v. Anest Iwata CorporationRehearing denied
  PTAB · May 17, 2016 · IPR2015-01790 · APJ Jennifer S Bisk · IPR · Rehearing

  The Board denied SATA’s rehearing request, leaving institution denied for claims 15–22 because the petition did not adequately explain how the evidence supported the proposed grounds.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision[,]” which party “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.” 37 C.F.R. § 42.71(d). slip op. at 2

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

    “Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4

  • BurdenDecided for patent owner

    “Moreover, as we noted in our Institution Decision, our determination to not institute trial was based, in-part, on inadequacies of the Petition in explaining suitably how the proffered evidence was applied to the proposed grounds. Pet. 5– 7. In that respect, we were not satisfied that Petitioner had met its burden of showing a reasonable likelihood of success in showing the unpatentability of claims 15–22 in view of the record that was before us.” slip op. at 4

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “35 U.S.C. § 311(b) states that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Petitioner does not explain how the Final Written Decision of IPR2013-00111 or “the bulk of the entire proceedings” of that case qualify as either a patent or a printed publication under the statute. In particular, to qualify as a printed publication under § 102, a reference “must have been sufficiently accessible to the public interested in the art” at the time the patent application at issue was filed. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009) (internal quotation marks omitted). The results of IPR2013-00111 were, by definition, not available until well after the ’387 patent issued.” slip op. at 3

  § 102 anticipation
  Patents in suitUS 6,494,387
• The Johns Hopkins University v. Biocon LimitedInstitution denied
  PTAB · May 12, 2016 · IPR2016-00175 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of proving claim 1 anticipated by or obvious over Bedi.

  RulingsInstitution decision

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

    “CONCLUSION Taking account of the information presented in the Petition and Preliminary Response, we determine that the Petition fails to show that there is a reasonable likelihood that Petitioner would prevail at trial with respect to claim 1 of the ’247 patent. ORDER It is ORDERED that the Petition is denied and no trial is instituted.” slip op. at 10

  • BurdenDenied

    “A. Anticipation by Bedi To establish anticipation, each and every element in a claim, “arranged or combined in the same way as recited in the claim,” must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Claim 1 requires a chimeric fusion protein comprising an “immunomodulating moiety” that “is SEQ ID NO: 4.” Ex. 1001, 69:45, 70:38. Claim 1 specifies that “SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Id. at 70:42–44. In claim 1, “the amino acid spacer is selected from SEQ ID NO: 3 or SEQ ID NO: 11.” Id. at 70:38–39.” slip op. at 5

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

    “The Petition fails to explain how, in spite of that difference, the “heavy chain” fusion protein depicted in Bedi’s Figure 3 anticipates claim 1. Pet. 17, 19. On that point, the Petition states that Bedi’s Figure 3 depicts a “construct comprising” the requisite components of the invention, but does not explain why Bedi’s disclosure of a lysine residue, on the C-terminus of the heavy chain sequence, teaches the specific fusion protein recited in claim 1. Id. at 19; see id. at 17 (admitting that Bedi’s heavy chain sequence includes a lysine residue, and that the addition of that residue distinguishes Bedi’s fusion protein from the fusion protein of claim 1); Prelim. Resp. 16– 19. We agree with Patent Owner that the Petition does not address adequately the differences between the “heavy chain” fusion protein depicted in Bedi’s Figure 3 and the claimed invention. Id. at 18. Nor does the Petition address adequately how Bedi’s Figure 3 depicts a fusion protein wherein the immunomodulating moiety “is attached via the amino acid spacer to the C-terminus of” the light chain sequence, specified in claim 1 as SEQ ID NO: 6. Ex. 1001, 70:43–44. We agree with Petitioner that Bedi depicts the same light chain sequence (identified as SEQ ID NO: 71 in Figure 3) as SEQ ID NO: 6 in claim 1. Ex. 1003, Fig. 3. The Petition, however, lacks supported analysis explaining how or why a person of ordinary skill in the art would understand Bedi to disclose in Figure 3 a fusion protein in which the immunomodulating moiety is attached via the amino acid spacer to the “light chain” sequence identified as SEQ ID NO: 71 in Bedi. Pet. 19 (arguing, without any evidentiary support, that Figure 3 depicts “attaching to anti-EGFR1 heavy or light chain (SEQ ID NO: 2 or 71, respectively)”). That attachment is not depicted in Figure 3, and the Petition directs us to no disclosure supporting the view that an ordinary artisan would have understood Figure 3 to illustrate an alternative fusion protein in which the immunomodulating moiety is attached via the amino acid spacer sequence to the C-terminus of the light chain sequence. “[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.” Net MoneyIN, Inc., 545 F.3d at 1371. On this record, we determine that the Petition does not direct us to information sufficient to show that Bedi anticipates claim 1.” slip op. at 6

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

    “Petitioner’s obviousness challenge is interlaced with unsupported factual contentions. Pet. 20–29. The Petition rests on bare argument to establish how two asserted background references (Ex. 1007 and Ex. 1008) would have informed the understanding of an ordinary artisan’s reading of Bedi. Pet. 24–27. A lack of evidence also undermines Petitioner’s attempt to explain why “[o]ne of skill in the art would have been motivated to take the teachings of Bedi and apply them to constructing a fusion protein” according to claim 1 (id. at 27), “wherein SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Ex. 1001, 70:42–44. The Petition, moreover, directs us to no support for the argument that “one of ordinary skill in the art would appreciate that the Fox3+CD25+CD4 Tregs described in (Ex. 1007 and 1008) will inherently express EGFR under inflammatory conditions, and that EGFR-positive Treg cells are more immunosuppressive than EGFR-negative Treg cells.” Pet. 27. Compounding that evidentiary deficit, the Petition advances bare attorney argument that “one so skilled would be motivated to use the EGFR targeting moiety of Bedi, to target the most immunosuppressive Treg populations set forth in Bedi and” a background reference. Id.” slip op. at 8

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,815,247

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.