• 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
• 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
• Amneal Pharmaceuticals LLC v. Jazz Pharmaceuticals Ireland Ltd. And Jazz Pharmaceuticals, Inc.Institution denied
  PTAB · Jul 28, 2016 · IPR2016-00546 · APJ Christopher G Paulraj · IPR · Institution

  The Board denied institution for claims 1–34 because the asserted obviousness combinations did not overcome teaching away or establish a reasonable expectation of success.

  RulingsInstitution decision

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

    “prior art’s teaching away of the co-administration of GHB and valproate. A reference teaches away from a claimed invention if it “criticize[s], discredit[s], or otherwise discourage[s]” modifying the reference to arrive at the claimed invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[W]hen the prior art teaches away from combining certain known elements, discovery of a successful means of combining them is more likely to be nonobvious.”). Here, we find it particularly relevant that Petitioner acknowledges that both Xyrem (GHB) and Depakote (valprotate) are CNS depressants that can cause potential drug-drug interactions, but does not otherwise address the explicit black box warning in the Xyrem Label that GHB should not be taken with other CNS depressants. Ex. 1005, 1; Pet. 24– 25. Nor does Petitioner address the Xyrem Label’s contraindication of GHB in patients with SSADH deficiency, despite Petitioner’s acknowledgement that valproate was known to inhibit SSADH activity. Ex. 1005, 8; Pet. 26. Petitioner does not provide any reason why the skilled artisan would have ignored the black box warning and contraindication in the Xyrem Label and co-administer GHB, even at a reduced dose, when valproate is being concomitantly administered to the patient. Moreover, even if the prior art did not teach away from reducing the effective dosage of GHB by at least 5% when valproate is co-administered, Petitioner has not demonstrated sufficiently that a skilled artisan would have had a reasonable expectation of success in treating the claimed sleep disorders with such a reduced dosage of GHB. Petitioner’s reliance upon the Xyrem Label’s teaching that GHB doses should be “titrated to effect,” which is based on the administration of GHB alone, does not necessarily suggest that a lower dose of GHB could effectively compensate for any increase in endogenous GHB levels caused by valproate administration as discussed in Hechler (Ex. 1006) or Shinka (Ex. 1007) when treating the claimed sleep disorders. Patent Owner points to evidence of record showing that GHB is eliminated from the body through alternate pathways that are not inhibited by valproate, and these alternate elimination pathways may actually decrease GHB levels. Prelim. Resp. 10–13. Petitioner does not account for these other pathways by which GHB may be eliminated. Petitioner, therefore, has not identified a sufficient basis on this record to conclude that any increased brain levels of endogenous GHB caused by valproate could have been predictably compensated for by a corresponding decrease of at least 5% in the amount of GHB orally administered to patients.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundNot shown unpatentable

    “prior art’s teaching away of the co-administration of GHB and valproate. A reference teaches away from a claimed invention if it “criticize[s], discredit[s], or otherwise discourage[s]” modifying the reference to arrive at the claimed invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[W]hen the prior art teaches away from combining certain known elements, discovery of a successful means of combining them is more likely to be nonobvious.”). Here, we find it particularly relevant that Petitioner acknowledges that both Xyrem (GHB) and Depakote (valprotate) are CNS depressants that can cause potential drug-drug interactions, but does not otherwise address the explicit black box warning in the Xyrem Label that GHB should not be taken with other CNS depressants. Ex. 1005, 1; Pet. 24– 25. Nor does Petitioner address the Xyrem Label’s contraindication of GHB in patients with SSADH deficiency, despite Petitioner’s acknowledgement that valproate was known to inhibit SSADH activity. Ex. 1005, 8; Pet. 26. Petitioner does not provide any reason why the skilled artisan would have ignored the black box warning and contraindication in the Xyrem Label and co-administer GHB, even at a reduced dose, when valproate is being concomitantly administered to the patient.” slip op. at 11

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

    “Moreover, even if the prior art did not teach away from reducing the effective dosage of GHB by at least 5% when valproate is co-administered, Petitioner has not demonstrated sufficiently that a skilled artisan would have had a reasonable expectation of success in treating the claimed sleep disorders with such a reduced dosage of GHB. Petitioner’s reliance upon the Xyrem Label’s teaching that GHB doses should be “titrated to effect,” which is based on the administration of GHB alone, does not necessarily suggest that a lower dose of GHB could effectively compensate for any increase in endogenous GHB levels caused by valproate administration as discussed in Hechler (Ex. 1006) or Shinka (Ex. 1007) when treating the claimed sleep disorders. Patent Owner points to evidence of record showing that GHB is eliminated from the body through alternate pathways that are not inhibited by valproate, and these alternate elimination pathways may actually decrease GHB levels. Prelim. Resp. 10–13. Petitioner does not account for these other pathways by which GHB may be eliminated. Petitioner, therefore, has not identified a sufficient basis on this record to conclude that any increased brain levels of endogenous GHB caused by valproate could have been predictably compensated for by a corresponding decrease of at least 5% in the amount of GHB orally administered to patients. Petitioner asserts that “routine pharmacokinetic studies” could be conducted to identify the dosage adjustment needed to safely co-administer GHB and valproate. Pet. 28. Petitioner, however, does not provide any further explanation or evidence concerning what type of pharmokinetic studies could be conducted, and why any such studies would have been considered either “routine” or have provided a reasonable expectation of success with a lower dose of GHB concomitantly administered with valproate. Cf. In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (“While it may have been obvious to experiment with the use of the same PK profile when contemplating an extended-release formulation, there is nothing to indicate that a skilled artisan would have had a reasonable expectation that such an experiment would succeed in being therapeutically effective.”).” slip op. at 12

  § 103 obviousnesscites KSR
  Patents in suitUS 8,772,306
• Tissue Transplant Technology Ltd. / Human Biologics Of Texas, Ltd. v. Mimedx Group, Inc.All claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00420 · APJ Lora M Green · IPR · Final written decision

  Claims 1–7 are unpatentable under § 103(a) over Nigam and Hariri, and over Dua and Hariri.

  RulingsFinal written decision

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “A prior art reference qualifies as prior art under 35 U.S.C. § 103(a) if its subject matter is analogous to the claimed invention. Innovation Toys LLC v. MGA Entertainment, Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed.Cir.1992). In other words, “familiar items may have obvious uses beyond their primary purposes.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, [402], 127 S.Ct. 1727, 1742 (2007).” slip op. at 13

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

    “We are not persuaded by any of Patent Owner’s arguments here. Nigam not only teaches laser engraving, but also teaches labeling with indelible ink. Ex. 1013, 12:27–28. In addition, Hariri teaches a biofabric comprising a grid pattern that was embossed into the biofabric by drying the fabric on a mesh grid. Ex. 1015 ¶ 121. We, therefore, conclude that Petitioner has established by a preponderance of the evidence that the ordinary artisan would have understood that a variety of means could be used to impart the asymmetric mark of Nigam onto a placental tissue graft, including embossing the graft with a pattern during a drying step as taught by Hariri.” slip op. at 24

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

    “Like our reviewing court, “[w]e will not read into a reference a teaching away from a process where no such language exists.” DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). Under the proper legal standard, a reference will teach away when it suggests that the developments flowing from its disclosures are unlikely to produce the objective of the invention. “A statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination.” Syntex (USA) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). “The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (citations omitted).” slip op. at 13

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

    “We also disagree with Patent Owner that Petitioner’s combination of Nigam and Hariri is based on impermissible hindsight analysis. As noted by Petitioner, Nigam teaches the use of asymmetric labels to differentiate the sides of a tissue lens implant, and Hariri teaches molding a grid into a placental tissue graft during the drying step, which also allows for differentiation of the two sides of the graft. Pet. 33. The Supreme Court has emphasized that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. Id. Under the correct obviousness analysis, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Here, a problem addressed by both Nigam and Hariri is differentiating two sides of a tissue graft, thus, providing a reason for their combination.” slip op. at 32

  Patent outcomesUS 8,597,687 unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,597,687
• Genzyme Corporation v. Genentech, Inc. And City Of HopeInstitution denied
  PTAB · Jun 23, 2016 · IPR2016-00383 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner failed to show a reasonable likelihood that claims 1–4, 9, 11, 12, 14–20, and 33 were unpatentable over the asserted grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “35 U.S.C. § 325(d) states, in relevant part (emphasis added), that “[i]n determining whether to institute or a proceeding under this chapter . . . the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We have considered the Patent Owner’s arguments, along with the facts and circumstances of the instant proceeding, and we decline to exercise our discretion to deny the Petition under 35 U.S.C. 325(d).” slip op. at 7

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

    “establishes a reasonable likelihood that Petitioner would prevail in any of its challenges of claims 1–4, 9, 11, 12, 14–20, and 33. ORDER In consideration of the foregoing, it is hereby ordered that the Petition is denied.” slip op. at 30

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

    “ii. Analysis “Anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” SynQor, Inc. v. Artesyn Techs., Inc., 709 F.3d 1365, 1375 (Fed. Cir. 2013) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Nonetheless, “a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)); see also In re Preda, 401 F.2d 825, 826 (CCPA 1968) (noting that “in considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom”). “Thus, it is not enough that the prior art reference discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole, or that it includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). “The requirement that the prior art elements themselves be ‘arranged as in the claim’ means that claims cannot be ‘treated . . . as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims and that give the claims their meaning.’” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (quoting Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1459 (Fed. Cir. 1984)).” slip op. at 9

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

    “We agree with Patent Owner that Petitioner has not sufficiently established that the combination of Salser and Ochi renders challenged claims 1–4, 9, 11, 12, 15–20, and 33 obvious. Petitioner’s reason to combine is premised on its assertion that in view of the globulin species of Salser, the ordinary artisan would have looked at Ochi, who teaches the recombinant production of a species of globulin, that is, an immunoglobulin. As noted by Patent Owner (Prelim. Resp. 53–54) and admitted by Petitioner (Pet. 27), the focus of Salser is on gene therapy (Ex. 1002, 1:24–28). Thus, Salser discusses providing a genetic capability, such as the production of a normal gene product when a cell produces an abnormal one, or the production of enzymes that protect the host from cytotoxic agents. Ex. 1002, 2:29–35. In particular, Salser notes that its method may be used to treat human genetic diseases such as hemoglobinopathes. Id. at 17:13–14. Salser does not specifically discuss the use of the method for the production of an immunoglobulin. Ochi looks at the ability of a cloned light chain that is expressed in immunoglobulin-producing hybridoma cells to restore specific antibody production. Ex. 1003, Abstract. The antibody studied is an IgM specific for TNP. Id. at 340. There is no discussion of any therapeutic use of that antibody, nor is there a discussion of therapeutic uses of antibodies in general. Except for its statement that because Salser teaches the globulin genus, and an immunoglobin as taught by Ochi is a species of that genus, Petitioner does not provide a reason why the ordinary artisan would have looked to the anti-TNP IgM of Ochi for use in the gene therapy methods of Salser. At best, Petitioner’s expert makes the statement, when discussing the anticipation challenge over Salser, that “immunoglobulins were inarguably the most important of the globulins from a medical and therapeutic standpoint.” Ex. 1058 ¶ 65. Petitioner’s expert, however, provides no support for that statement. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, neither Petitioner nor its expert point to any evidence that at the time of invention of the ’415 patent that the ordinary artisan was looking at immunoglobulins as targets of gene therapy. As for a reasonable expectation of success, Petitioner contends that is provided by Ochi, who teaches that introduction of an exogenous light chain into an immunoglobulin producing cell allows for assembly with the endogenous heavy chain to produce a functioning antibody. That teaching of Ochi, however, does not provide a reasonable expectation of success of introducing both an exogenous light chain and heavy chain into a cell to produce a therapeutic antibody in vivo as required by Salser.6 We determine, therefore, that Petitioner has not sufficiently demonstrated that the ordinary artisan would have had a reason to combine the immunoglobulin of Ochi with the gene therapy methods of Salser with a reasonable expectation of success of achieving the subject matter of challenged claims 1–4, 9, 11, 12, 15–20, and 33.” slip op. at 24

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 6,331,415
• Coalition For Affordable Drugs V LLC v. Hoffman-Laroche Inc.Institution denied
  PTAB · Mar 11, 2016 · IPR2015-01792 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution on claims 1–10 because Petitioner did not show a reasonable likelihood of proving obviousness over Smith, Capon, and Seed.

  RulingsInstitution decision

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

    “partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we conclude that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any challenged claim of the ’522 patent. Therefore, we do not institute an inter partes review for any challenged claim of the ’522 patent.” slip op. at 2

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

    “reasonable likelihood to prevail on any challenged claim. Petitioner has failed to show an articulated reason with a rational underpinning why one of skill in the art would have combined the teachings of Smith, Capon, and Seed to arrive at the claimed invention.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusNot shown unpatentable

    “The challenged method claims, however, address purifying a fusion protein “expression product” encoded by the polynucleotide set forth in the claim, see Ex. 1001, 45:45–67, 46:59–48:4, and the remaining challenged claims address the polynucleotides encoding the fusion proteins. See id. at 46:44– 58; see also Ex. 1023, 13–143 (addressing presented unexpected results after noting that the claimed inventions were “drawn to nucleic acids, not proteins” (emphasis omitted)). The evidence of unexpected results is commensurate in scope with the claims. During the prosecution of the ’522 patent, Patent Owner offered expert testimony concerning the unexpected results of improved TNF binding affinity, potency, kinetic stability, and reduced antibody effector function and aggregation ability. See Ex. 1020, 27–36; Ex. 1022, 25–39; Ex. 1024, 9–13; Ex. 2017. We agree with Patent Owner that the unrebutted objective indicia of nonobviousness presented in the prosecution history of the ’522 patent, and apparently relied upon by the Examiner, at least in part, in allowing the claims of the ’522 patent, see Ex. 1026, 6, supports the nonobviousness of the challenged claims. The Petition, moreover, should have addressed the evidence of unexpected results as part of Petitioner’s showing of a reasonable likelihood of success on the merits.4 See Praxair Distrib., Inc. v. INO Therapeutics, Inc., Case Nos. IPR2015-00522, -00524, -00525, - 00526, slip op. at 16–17 (PTAB July 29, 2015).” slip op. at 18

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

    “soluble or non-soluble proteins, or fragments thereof which bind TNF, in homogenous form.” Pet. 13 (citing Ex. 1004 ¶ 21 (citing Ex. 1001, 4:14– 18)). Patent Owner responds that the passage from the Specification of the ’522 patent cited by Petitioner’s Declarant, Dr. James J. Greene, see Ex. 1001, 4:14–18, refers to “proteins of the present invention,” or TNF fusion proteins and not to TNF receptors. Prelim. Resp. 20–21. Patent Owner offers that “TNF receptor” should be given its plain and ordinary meaning of a receptor that binds TNF. Id. at 21. We agree that “TNF receptor” should be given its ordinary meaning, but we are not persuaded that this claim limitation needs an express construction at this stage of the proceeding. slip op. at 5

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,163,522
• Coalition For Affordable Drugs Xi LLC v. Insys Pharma, Inc.Institution denied
  PTAB · Mar 10, 2016 · IPR2015-01800 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–3 obvious over the asserted combinations.

  RulingsInstitution decision

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

    “In sum, the information presented does not show sufficiently that an ordinary artisan would have modified the formulation of Ross GB’s Example 1 to include propylene glycol in a weight-percent amount that satisfies claims 1, 2, or 3. Both grounds asserted in the Petition depend upon that modification. Pet. 31–33. On this record, the Petition fails to establish a reasonable likelihood of prevailing with respect to claim 1, 2, or 3. III. CONCLUSION Taking account of the information in the Petition and Preliminary Response, we decline to institute review because the information presented does not demonstrate a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314(a). IV. ORDER For the reasons given, it is ORDERED that the Petition is denied.” slip op. at 8

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

    “Critically lacking is any objective evidence—for example, a suggestion in the prior art—that a person of ordinary skill in the art would have understood that the amount of propylene glycol, optimized for use in an aerosol nitroglycerin formulation, would match the optimal amount of propylene glycol, useful in a propellant-free fentanyl formulation. Id. at 32–34. The Petition fails to address adequately how the compositional differences between the disparate formulations of Ross GB and Klokkers-Bethke would have informed that understanding. Compare Ex. 1003, 11:1–9 (Example 1 of Ross GB includes fentanyl, saccharin, ethanol, menthol, and citrate buffer), with Ex. 1004, 3:65–4:8 (Klokkers-Bethke’s formulation includes nitroglycerin, ethanol, propylene glycol, and propellant).” slip op. at 7

  § 103 obviousness
  Patents in suitUS 8,486,972
• Coalition For Affordable Drugs Xi LLC v. Insys Pharma, Inc.Institution denied
  PTAB · Mar 10, 2016 · IPR2015-01799 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–5 unpatentable over the asserted obviousness grounds or McCoy anticipation.

  RulingsInstitution decision

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

    “III. CONCLUSION Taking account of the information in the Petition and Preliminary Response, we decline to institute review because the information presented does not demonstrate a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314(a). IV. ORDER For the reasons given, it is ORDERED that the Petition is denied.” slip op. at 13

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

    “The broadest reasonable interpretation of “discrete liquid droplets” requires express construction. That term is not defined, but is closely associated with the term “spray,” in the ’460 patent specification. Ex. 1001, 3:17–20 (invention is directed to “a liquid spray formulation in the form of discrete liquid droplets”). Based on the information presented, we accept Petitioner’s view that the broadest reasonable interpretation of “discrete liquid droplets” is “water or other liquid broken up into minute droplets and blown, ejected into, or falling through the air.” Pet. 14 (quoting Ex. 1008) (dictionary definition of “spray”). That interpretation is reasonable in view of the claim wording, the specification, and the dictionary definition of “spray” advanced by Petitioner. No other claim term requires express construction for the purposes of this decision.” slip op. at 5

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

    “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If identification of each claimed element in the prior art were sufficient to negate patentability, very few patents would ever issue.” In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). Obviousness can be established when the prior art, itself, would have suggested the claimed subject matter. In re Rinehart, 531 F.2d 1048, 1051 (CCPA 1976). But the Petition identifies no persuasive reason why the prior art would have recommended modifying Ross GB’s spray to alter the size, or mean diameter, of the droplets. Instead, the Petition selects elements from compositionally-different formulations and, without addressing those differences, argues that it would have been obvious to combine the selected elements in the manner that is specified in the challenged claims. Petitioner first argues that reducing the droplet size in Ross GB’s spray, to a size comparable to the droplets disclosed in McCoy or Whittle, would have been understood to provide “a higher surface area to be absorbed by the mucosa of the intra-oral cavity.” Pet. 22 (discussing McCoy) (quoting Ex. 1002 ¶ 22); see id. at 42 (discussing Whittle) (quoting Ex. 1002 ¶ 67). The Petition, however, fails to direct us to any disclosure in the asserted prior art, or any other credible evidence, from which we can reasonably conclude that an “ordinary artisan would have perceived the droplet sizes disclosed in” McCoy or Whittle to be smaller than those in Ross GB’s spray. Prelim. Resp. 20. That deficiency, standing alone, warrants denial of the obviousness grounds stated in the Petition. The Petition also fails to direct us to persuasive information that the mean diameter of droplets was of any concern in Ross GB’s spray—much less that one would have understood that Ross GB’s sublingual fentanyl spray would benefit from a modification to droplet surface area for the purpose of providing “a higher surface area to be absorbed by the mucosa of the intra-oral cavity.” Pet. 22, 42. In that regard, McCoy’s disclosure of droplet sizes is presented in the context of an intra-oral formulation that comprises an oral-absorption enhancer. Ex. 1005 ¶ 19. Whittle’s disclosure of droplet sizes is presented in the context of a formulation containing cannabinoids, and is not shown on this record to address increasing the surface area for absorption by mucosa. Pet. 42; see Ex. 1007, Abstract, 4:40–53 (disclosure of preferred range of particle sizes for “delivering cannabinoids”). The Petition directs us to no credible information that links a concern— about droplet size, mean diameter, or droplet surface area—to Ross GB’s spray, which includes no absorption enhancer and no cannabinoid. See Pet. 21–22, 42–43 (failing to establish that link, and directing us to no disclosure in Ross GB of a formulation comprising an absorption enhancer or a cannabinoid). That aspect of the Petition rests on bare opinion testimony that is not tethered adequately to objective evidence, tending to show that one would have combined the teachings of the references. Id. (citing Ex. 1002 ¶¶ 22–24, 67–68). slip op. at 9

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

    “The Petition directs us to McCoy’s teaching that the liquid droplets will be “sized within the range of about 1 to 200 microns, more preferably within the range of 10–100 microns.” Id. at 54 (quoting Ex. 1005 ¶ 19). Significantly, the Petition ignores that McCoy does not teach a “mean diameter” value or range for liquid droplets. Id. As Patent Owner points out, the Petition does not “explain how one of ordinary skill [in the art] would identify a particular range for mean diameter of droplets from a spectrum of possible droplet sizes that is about 2–5 times broader” than the mean diameter range “of from about 30 to about 70 microns” that is specified in claims 1, 4, and 5. Prelim. Resp. 51. In that regard, the Petition directs us to conclusory opinion testimony that McCoy’s preferred droplet sizes encompass the claimed “mean diameter” range of claim 1. Pet. 54 (citing Ex. 1002 ¶ 21). Patent Owner responds, and we agree, that the Petition fails to adequately explain how McCoy’s preferred droplet sizes correspond to a mean diameter value, which “would require information regarding distribution of droplet diameters across the broad spectrum of droplet sizes” disclosed in McCoy. Prelim. Resp. 51. Critically lacking is a cogent explanation of how an ordinary artisan “would have predicted a particular range for mean diameter of droplets from a spectrum of possible droplet sizes” disclosed in McCoy. Id. at 17. We agree with Patent Owner that Dr. Park’s sweeping, but unsupported, opinion that “there is no reasonable difference in how the claimed range operates over the range” disclosed in McCoy is insufficient to support a successful anticipation challenge. Id. at 18– 19 (quoting Ex. 1002 ¶ 21).” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,835,460

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.