• Amerigen Pharmaceuticals Limited v. Shire LLCRehearing denied
  PTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied Amerigen’s rehearing request, leaving claims 1–3, 5, 8, 9, and 11 uninstituted because Mehta did not disclose the claimed release limitation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the 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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Amerigen’s arguments with these principles in mind.” slip op. at 2

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

    “These arguments are not persuasive. First, Petitioner cites no authority for the proposition that a generic disclosure, such as that discussed above, is an express disclosure of every possible permutation of that generic disclosure. Second, even if we were to accept, for the sake of argument, that Mehta’s combined disclosures constitute an express disclosure of a composition capable of delayed release of “essentially all [of the drug] . . . within about 60 minutes,” non-instituted claims 1–3, 5, 8, 9, and 11 further require that the delayed release is enteric (i.e., the composition releases the second dose of the drug in the intestines, not the stomach). As we noted in the Decision, however, Mehta does not use the word “enteric,” nor does Mehta discuss delivery of the delayed dose to the intestines. Dec. 28. Nevertheless, we considered the possibility that Mehta might inherently disclose a composition that releases into the intestine not less than 80% of the second dose of the drug within about 60 minutes of the delayed release. Accordingly, we turned to Mehta’s Examples 1–5, but determined that not one of the exemplified delayed release compositions achieved a release of “essentially all” of the drug from a delayed release coating within about 60 minutes—regardless of whether the delay was long enough to be considered enteric.3 Id. at 24. As we noted in the Decision,” slip op. at 6

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

    “This argument is not persuasive. We considered, for example, Dr. Elder’s testimony that one of ordinary skill in the art would expect “that the number of variables and number of experimental runs to optimize the coating for the amphetamine would present no unusual problems of technology or expense” because one “can use statistical experimental design to optimize a formulation within the 21 trials that Mehta discloses to design one for amphetamine salts” (Ex. 1005 ¶ 471), as well as Dr. Elder’s testimony that one would expect “that routine optimization of the coating using the parameters identified by Mehta would provide enough guidance for controlling the release timing” (id. ¶ 512). Nevertheless, we found the actual results reported by Mehta to be more compelling. As we stated in the Decision: [N]one of Mehta’s delayed release formulations that could be considered to be enteric by virtue of their delay periods (i.e., those with delays of 4 or 5 hours) had release rates of “essentially all” of the drug anywhere near the required time period. Even if Mehta could be read to suggest that a delay of 4 or 5 hours followed by a release of essentially all of the delayed dose within 60 minutes would be desirable, we are not persuaded that Mehta’s disclosure that “the amount of drug released is influenced by: amount of coating, ratio of the two 4 Amerigen supported its challenges with the Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph., executed September 30, 2015 (“Elder Declaration”) (Ex. 1005). polymers, amount of talc, and curing time” is adequate guidance for one of ordinary skill in the art to achieve such a dosage form. In general, Mehta demonstrates that longer delays are accompanied by longer release times, with formulations that could be considered to provide enteric release (i.e., a release after a 4 or 5 hour [delay]) having 85% release times of 8 or more hours. Dec. 33–34 (citing Ex. 1003, Table 1).” slip op. at 8

  § 102 anticipation§ 103 obviousness
• Amerigen Pharmaceuticals Limited v. Shire LLCRehearing denied
  PTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied Shire’s rehearing request and confirmed claim 25 is in the trial only through its dependency from claims 18–20, not claims 2 or 13.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We are not persuaded and decline to alter the Order concluding the Decision of April 19, 2016 in any way. Claim 25 would fall should Petitioner prevail in its obviousness challenge—so long as claim 25’s dependency from claims 18–20 remains. However, we take this opportunity to confirm that claim 25 is part of the trial only to the extent it depends from claims 18–20, and not to the extent it depends from non-instituted claims 2 and 13.” slip op. at 4

  None
• TC Heartland LLC v. Kraft Foods Group Brands LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01131 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–29 were not shown unpatentable under § 103 over Lohrman and Ackilli because the petitioner did not explain why a skilled artisan would modify Ackilli’s ranges to reach the claimed pH range.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “having a pH of about 1.9 to about 2.4,” “flavoring,” and “drip index value.” Pet. 21–23. Patent Owner asserts that we need construe no claim term. PO Resp. 19–20. We agree with Patent Owner that no claim term requires 9 express construction for purposes of rendering a final written decision in this trial.” slip op. at 9

  • Skill levelSkill level board ownOther

    “Ms. Ferruzzi states that one of skill in the art included at least the ability to make the subject matter disclosed in Ackilli. Ex. 1010 ¶¶ 12–13; Pet. 24–25. Ms. Ferruzzi also states that one of skill in the art at the time of the invention also would have the ability “to make predictable use of the compositions and materials described” in Ackilli, and also have the education and experience in food chemistry to have knowledge of the information in Ackilli. Ex. 1010 ¶¶ 12–13; Pet. 25 (adding the ability to make predictable use of the containers described in the art such as Lohrman). Dr. Marvin J. Rudolph, Patent Owner’s declarant, disagrees with Ms. Ferruzzi’s assessment of the level of skill. Ex. 2012 ¶¶ 20–22. Dr. Rudolph asserts that one of skill in the art at the time of the invention would have “at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products” and “a Bachelor of Science in a packaging science or Mechanical Engineering or at least five years of experience in the design and manufacture of consumer product packaging.” Ex. 2012 ¶ 21. It is not apparent that Ms. Ferruzzi’s and Dr. Rudolph’s definitions relating to flavored beverage liquid concentrates are necessarily disparate. In reviewing the ’557 patent and Ackilli and applying the factors set forth above from Custom Accessories, we find that one of skill in the art who has the education and experience in food chemistry to understand Ackilli and the ’557 patent and can make predictable use of such 16 information, would have at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” slip op. at 16

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

    “overlap or are encompassed by disclosed ranges in the prior art. See Peterson, 315 F.2d at 1329–30 (“Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range.”). The overlap itself of the disclosed ranges and the claimed ranges provides sufficient motivation to optimize the ranges because of the “normal desire of scientists or artisans to improve upon what is already generally known.” See Peterson, 315 F.3d at 1330. Here, Ackilli, which addresses optimizing dispersion of its flavoring composition concentrates in water, does not mention pH, much less disclose a pH range for the flavoring compositions. See Ex. 1003, 1:10–13. Also, it is clear that Ackilli did not recognize pH as a result-effective variable for compositions as it did not discuss pH. Only if a variable is known to be result-effective is the optimization of the variable within the grasp of one of ordinary skill in the art. Applied Materials, Inc., 692 F.3d at 1295 (citing Antonie, 559 F.2d at 620); In re Boesch, 617 F.2d 272, 276 (CCPA 1980)). Because the Peterson presumption does not apply here, we need to identify where Petitioner offered some articulated reasoning with some rational underpinning to support a conclusion of obviousness. See KSR, 550 U.S. at 418.” slip op. at 30

  • Strike new argumentNew argument disregardedOther

    “We rejected this inherency theory in our Decision on Institution. We recognized that Ackilli does not disclose the pH of any of its disclosed concentrations, and Petitioner had not established that the pH of any of Ackilli’s working samples met the requirements of the challenged claims. Dec. Instit. 18–19. Therefore, we agreed with Patent Owner that Ackilli does not expressly or inherently disclose concentrations meeting the pH range of the challenged claims. Id. In the Declaration submitted with Petitioner’s Reply, Mr. Ackilli offers a new theory for how Ackilli teaches the claimed pH range. Mr. Ackilli testifies that the pH of a beverage is driven by the desired taste profile of the finished beverage and relies on alleged commercial embodiments of the Ackilli reference to prove that the beverage concentrates described in Ackilli included beverage concentrates with a pH in the claimed range. Ex. 1202 ¶¶ 55–61. Including such a new theory and new evidence concerning what a reference teaches is inappropriate at the reply stage. See 35 U.S.C. 312(a)(3); 37 C.F.R. § 41.104. Also, the evidence of the pH of alleged embodiments of the Ackilli reference on sale before the critical date, such as the peach and orange-flavored Water Sensations, is beyond the scope of this inter partes 28 proceeding because such evidence is not a patent or printed publication. See 35 U.S.C. § 311(b) (stating the scope of an inter partes review is limited to challenges under §§ 102 or 103 and “only on the basis of prior art consisting of patents or printed publications”); Tr. 32:24–33:14 (asserting that Water Sensations evidence is beyond scope of Petition).” slip op. at 28

  Patent outcomesUS 8,603,557 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,603,557
• TC Heartland LLC v. Kraft Foods Group Brands LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01128 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–22 were not shown unpatentable under § 103 over Ackilli because the petitioner did not explain why a skilled artisan would modify Ackilli’s compositions to reach the claimed pH range.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “improved taste (including a lasting taste impression and desirable body), improved palatability, improved keeping qualities, and stabilized flavor and color may be achieved by modifying the compositions of Ackilli to include higher amounts of citric acid and lower amounts of sodium citrate or potassium citrate buffers that result in compositions falling within the scope of the claim. 23 Ex. 1010 ¶ 24. Ms. Ferruzzi, however, cites only two references in support, references that we found a person of ordinary skill would not look to when seeking to modify Ackilli’s beverage concentration. Dec. Instit. 19; see PO Resp. 36 n.8. Without further support as to what one of skill in the art would have known, we do not credit this testimony.” slip op. at 23

  • Strike new argumentNew argument disregardedDecided for patent owner

    “recognize in Ackilli should have been in the Petition.” Tr. 34:23–25. We agree; Petitioner’s assertion of and reliance on Mr. Ackilli’s testimony to establish what one or ordinary skill in the art would have gleaned from Ackilli should have been in the Petition. See 35 U.S.C. § 312(a)(3) (stating that the petition must identify in writing and with particularity the evidence that supports the grounds for the challenge to each claim including affidavits or declarations of supporting evidence and opinions that petitioner relies upon). The fact that an argument may be responsive to Patent Owner’s arguments set forth in its Response does not relieve the Petitioner of its initial burden to identify “with particularity” the “evidence that supports the grounds for the challenge to each claim.” Maxlinear, Inc. v. Cresta Tech. Corp., Case IPR2015-00594, slip op. at 29 (PTAB Aug. 15, 2016) (quoting Intelligent Bio-Systems, 821 F.3d 1359, 1367–68 (Fed. Cir. 2016)); see also 37 C.F.R. § 42.104 (describing required content of the Petition).” slip op. at 19

  • ExcludeMotion to exclude, deniedDenied

    “As Patent Owner notes, we are “well positioned to determine and assign appropriate weight to evidence presented” to us. We agree that the arguments presented in Petitioner’s Motion to Exclude go to the weight that we give the evidence, and therefore, are an improper basis for excluding evidence. For this reason, we dismiss Petitioner’s Motion to Exclude.” slip op. at 25

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Dr. Marvin J. Rudolph, Patent Owner’s declarant, disagrees with Ms. Ferruzzi’s assessment of the level of skill. Ex. 2012 ¶¶ 20–22. Dr. Rudolph asserts that one of skill in the art at the time of the invention would have “at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” Ex. 2012 ¶ 21. It is not apparent that Ms. Ferruzzi’s and Dr. Rudolph’s definitions are necessarily disparate. In reviewing the ’299 patent and Ackilli and applying the factors set forth above from Custom Accessories, we find that one of skill in the art who has the education and experience in food chemistry to understand Ackilli and the ’299 patent and can make predictable use of such information, would have at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” slip op. at 10

  Patent outcomesUS 8,293,299 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,293,299
• 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
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Indivior UK LimitedRehearing denied
  PTAB · Nov 1, 2016 · IPR2016-01113 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied Indivior UK Limited’s request for rehearing, finding it had not shown the decision denying additional discovery should be modified.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “response to the first Request for Production that none of the requested agreements, or drafts thereof executed on or before May 31, 2016 existed. Opp. 17. May 31, 2016 is the date that Petitioner filed its Petition in this proceeding. In the Decision, we explained, among other things, that, generally, the Board has considered the relationship between entities alleged to be in privity at the time of the service of the complaint and that Patent Owner has not alleged privity existed between Petitioner and Teva at that time. Dec. 6–7. We explained further that “[e]ven accepting arguendo that Petitioner’s acquisition of Teva’s ANDAs . . . established privity between Petitioner and Teva, Patent Owner has not proffered persuasive evidence that indicia of privity existed at any time prior to the filing of the present Petition.” Id. at 7 (citing Taylor v. Sturgell, 553 U.S. 880, 893–95 (2008)). Those reasons alone support our determination that Patent Owner has failed to demonstrate that the proposed additional discovery would uncover something useful in support of its contention that Petitioner and Teva were in privity at the relevant time. Thus, we are not persuaded that our Decision should be modified based upon Patent Owner’s assertion that Petitioner’s response to the second Request for Production leaves open the possibility that correspondence or communications, dated prior to May 31, 2016, relating to the later-executed agreements, or drafts thereof, may exist and provide something useful to support Patent Owner’s contention that privity existed between Petitioner and Teva on or before the filing date of the Petition. Reh’g. Req. 6. As we stated in the Decision, “Patent Owner’s evidence and argument in support of its discovery requests fail to demonstrate more than a mere possibility or mere allegation that something useful will be found.” Dec. 6.” slip op. at 4

  • Additional discoveryAdditional discovery, deniedDenied

    “response to the first Request for Production that none of the requested agreements, or drafts thereof executed on or before May 31, 2016 existed. Opp. 17. May 31, 2016 is the date that Petitioner filed its Petition in this proceeding. In the Decision, we explained, among other things, that, generally, the Board has considered the relationship between entities alleged to be in privity at the time of the service of the complaint and that Patent Owner has not alleged privity existed between Petitioner and Teva at that time. Dec. 6–7. We explained further that “[e]ven accepting arguendo that Petitioner’s acquisition of Teva’s ANDAs . . . established privity between Petitioner and Teva, Patent Owner has not proffered persuasive evidence that indicia of privity existed at any time prior to the filing of the present Petition.” Id. at 7 (citing Taylor v. Sturgell, 553 U.S. 880, 893–95 (2008)). Those reasons alone support our determination that Patent Owner has failed to demonstrate that the proposed additional discovery would uncover something useful in support of its contention that Petitioner and Teva were in privity at the relevant time. Thus, we are not persuaded that our Decision should be modified based upon Patent Owner’s assertion that Petitioner’s response to the second Request for Production leaves open the possibility that correspondence or communications, dated prior to May 31, 2016, relating to the later-executed agreements, or drafts thereof, may exist and provide something useful to support Patent Owner’s contention that privity existed between Petitioner and Teva on or before the filing date of the Petition. Reh’g. Req. 6. As we stated in the Decision, “Patent Owner’s evidence and argument in support of its discovery requests fail to demonstrate more than a mere possibility or mere allegation that something useful will be found.” Dec. 6.” slip op. at 4

  • PTAB / AIA Trials › Real party in interest / privityOther

    “response to the first Request for Production that none of the requested agreements, or drafts thereof executed on or before May 31, 2016 existed. Opp. 17. May 31, 2016 is the date that Petitioner filed its Petition in this proceeding. In the Decision, we explained, among other things, that, generally, the Board has considered the relationship between entities alleged to be in privity at the time of the service of the complaint and that Patent Owner has not alleged privity existed between Petitioner and Teva at that time. Dec. 6–7. We explained further that “[e]ven accepting arguendo that Petitioner’s acquisition of Teva’s ANDAs . . . established privity between Petitioner and Teva, Patent Owner has not proffered persuasive evidence that indicia of privity existed at any time prior to the filing of the present Petition.” Id. at 7 (citing Taylor v. Sturgell, 553 U.S. 880, 893–95 (2008)). Those reasons alone support our determination that Patent Owner has failed to demonstrate that the proposed additional discovery would uncover something useful in support of its contention that Petitioner and Teva were in privity at the relevant time.” slip op. at 4

  None
  Patents in suitUS 8,475,832
• Flotek Industries, Inc. / Turbeco, Inc. et al. v. National Oilwell DHT, L.P.All claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01239 · APJ James J Mayberry · IPR · Final written decision

  Claims 1, 4, and 8 are unpatentable as obvious over Bielstein and Nelson; claim 7 is unpatentable as anticipated by Sims.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “a. Level of Ordinary Skill in the Art Flotek contends that the level of ordinary skill associated with the ’317 patent “is a person who has, through formal education or extensive practical experience, a Bachelor’s Degree in Mechanical Engineering or a similar degree, or 2–3 years of experience in designing, using or making downhole tools having various applications.” Pet. 3 (referencing the Declaration of Dr. Smith, Ex. 1002 ¶¶ 9–11). NOV does not dispute this definition of the level of ordinary skill associated with the ’317 patent. See PO Resp. (failing to discuss the level of ordinary skill in the art); Ex. 2004 (providing the Declaration of Dr. Akin, which fails to define the level of ordinary skill for the ’317 patent).4” slip op. at 19

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

    “requirements of 35 U.S.C. § 112, paragraph 6,3 and provides a construction consistent with our rules. See Pet. 4; 37 C.F.R. § 42.104(b)(3). We construe means-plus-function limitations by determining what the claimed function is and identifying the structure disclosed in the specification that corresponds to the means for performing that function. See Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1360 (Fed. Cir. 2000); see also In re Donaldson Co., 16 F.3d 1189, 1193 (Fed. Cir. 1994) (“[P]aragraph six applies regardless of the context in which the interpretation of means-plus-function language arises, i.e., whether as part of a patentability determination in the PTO or as part of a validity or infringement determination in a court.”). Flotek identifies the function for this claim element as “rotating the first [valve] member.” See Pet. 4. Flotek contends that the structures disclosed in the ’317 patent corresponding to this function are “turbines, rotary drill motors, positive displacement motors, or Moineau motors.” Id. NOV did not dispute Flotek’s construction of this term, including the identified structures, in its Preliminary Response and, as we determined that Flotek’s construction is reasonable, we adopted it in our Decision to Institute. See Dec. on Inst. 11. Neither party offers, expressly or implicitly, an alternative construction for this term and, based on the record developed during trial, we discern no reason to alter the meaning we previously determined, including identified structures. See PO Resp. 8 (“This response” slip op. at 10

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

    “We construe means-plus-function limitations by determining what the claimed function is and identifying the structure disclosed in the specification that corresponds to the means for performing that function. See Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1360 (Fed. Cir. 2000); see also In re Donaldson Co., 16 F.3d 1189, 1193 (Fed. Cir. 1994) (“[P]aragraph six applies regardless of the context in which the interpretation of means-plus-function language arises, i.e., whether as part of a patentability determination in the PTO or as part of a validity or infringement determination in a court.”). Flotek identifies the function for this claim element as “rotating the first [valve] member.” See Pet. 4. Flotek contends that the structures disclosed in the ’317 patent corresponding to this function are “turbines, rotary drill motors, positive displacement motors, or Moineau motors.” Id. NOV did not dispute Flotek’s construction of this term, including the identified structures, in its Preliminary Response and, as we determined that Flotek’s construction is reasonable, we adopted it in our Decision to Institute. See Dec. on Inst. 11. Neither party offers, expressly or implicitly, an alternative construction for this term and, based on the record developed during trial, we discern no reason to alter the meaning we previously determined, including identified structures. See PO Resp. 8 (“This response” slip op. at 10

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

    “In our Decision instituting trial, we determined that the ordinary and customary meaning of the term “axial flow opening” under a broadest reasonable interpretation is “an aperture or open width that permits flow in the axial direction.” Dec. on Inst. 13–14 (referencing Ex. 3001). Neither party offers, expressly or implicitly, an alternative construction for this term and, based on the record developed during trial, we discern no reason to alter the above construction.” slip op. at 11

  Patent outcomesUS 6,508,317 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,508,317
• Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Institution denied
  PTAB · Sep 29, 2016 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–22 were unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “we find that Petitioner has failed to show a reasonable likelihood of success that any of the challenged claims are unpatentable. The key limitation missing from any teaching or suggestion of the combination is “3% to 16% (w/w) cyphenothrin” (or any narrower range therein) combined with fipronil. Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 11

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

    “Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 12

  • PTAB / AIA Trials › Real party in interest / privityNot reached

    “E. Real Parties-In-Interest Patent Owner asserts that Merial Limited, Merial LLC, and Sanofi had a measure of control over this proceeding requiring them to be named as real parties-in-interest. Pet. 9–17. Because we have found that Petitioner has failed to show a reasonable likelihood that it would prevail on any challenged claim, we need not address whether these parties constitute real parties-in-interest. Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00731, slip op. at 5 (PTAB March 2, 2016) (holding satisfying the requirements of 35 U.S.C. § 312(a) is not jurisdictional). Any real party-ininterest issue is moot.” slip op. at 14

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

    “Neither party believes that any claim term or phrase needs to be expressly interpreted. See Pet. 10; Prelim. Resp. 5–39 (offering no express 1 PCT App. WO 2008/080542 A2, published Jul. 10, 2008 (Ex. 1004, “Sirinyan”). The Sirinyan reference is a German-language reference. Petitioner provided a certified English-language translation (Ex. 1005). 2 US Patent 4,902,510, issued Feb. 20, 1990 (Ex. 1006, “Garden”). 3 Mark Suarez, EPA Product Performance/Efficacy Review for Sergeant’s Cyphenothrin Squeeze-On for Dogs, Sergeant’s Cyphenothrin + IGR Squeeze-On for Dogs, and Sergeant’s Cyphenothrin + Methoprene Squeeze- On for Dogs, Nov. 7, 2006 (Ex. 1007, “the EPA Review”). constructions). We agree that we do not need to interpret expressly any claim term or phrase to resolve whether a trial should be instituted. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 4

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,614,244
• 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

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.