• Mylan Pharmaceuticals Inc. v. Astrazeneca ABInstitution denied
  PTAB · Dec 14, 2016 · IPR2016-01325 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Mylan did not show a reasonable likelihood of proving claims 1–20 obvious over McLeskey alone or with Howell 1996.

  RulingsInstitution decision

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

    “is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rely on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 19

  • Skill levelSkill level board ownDecided for patent owner

    “Person of Ordinary Skill in the Art. The parties’ propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 14–15; Prelim. Resp. 11–12. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 15

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

    “patentable weight, the term “therapeutically significant” should be construed to mean “any blood plasma fulvestrant concentration greater than or equal to at least 2.5 ngml-1 that is achieved for at least 4 weeks after injection.” Pet. 17–18. Patent Owner does not argue that Petitioner’s proposed interpretation is unreasonable, but contends that the meaning of the term is clear from the Specification and context of the claim phrase itself. See Prelim. Resp. 16 (citing Ex. 2003 ¶ 68; Ex. 1001, 9:24–27 (expressly defining “therapeutically significant” fulvestrant blood plasma levels as “at least 2.5 ngml-1, ideally at least 3 ngml-1, at least 8.5 ngml-1, and up to 12 12 Our reasoning extends to the wherein clauses of dependent claims 2 and 10, also challenged by Petitioner at page 16, footnote 9, of the Petition. ngml-1 of fulvestrant [] achieved in the patient.”). We agree with Patent Owner. No express construction of this term is required.” slip op. at 17

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

    “and 9, “wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks,” is merely a statement of intended result entitled to no patentable weight. Pet. 16–17. For the reasons set forth at pages 12–16 of Patent Owner’s Preliminary Response, we do not find Petitioner’s argument persuasive.12 For example, rather than merely stating the result of intramuscularly administering the recited formulation, as Petitioner argues, the wherein clause dictates both the administration duration and dose of the formulation, i.e., an amount sufficient to provide a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks. See Prelim. Resp. 15 (relying on Exhibits 2002 ¶ 37–39, Ex. 2001 ¶¶ 33–37, and citations therein). That these parameters are further limited in claims 2, 10 (“the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml-1”) further indicates that the wherein clauses provide defining characteristics. See Prelim. Resp. 15 (citing Ex. 2003 ¶ 60).” slip op. at 16

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,329,680
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution denied
  PTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

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

    “[U]nless a reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . 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)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10

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

    “references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “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.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,667,061
• Roxane Laboratories, Inc. v. Vanda Pharmaceuticals Inc.Rehearing denied
  PTAB · Nov 4, 2016 · IPR2016-00690 · APJ Robert A Pollock · IPR · Rehearing

  The Board denied rehearing, finding no abuse of discretion in its determination that Petitioner failed to show claim 1 unpatentable because the claimed dose reduction was unpredictable.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We concluded that the record as a whole, including FDA Guidance 1999, supported a mere invitation to experiment as rejected in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1073 (Fed. Cir. 2012). Dec. at 19, 22–23; see id. at 22 (“Such invitations to experiment do not, in light of the present record, predict the dosage reduction of the subject claim.”). The Decision, including our citation to Cylobenzaprine, makes clear our implicit rejection of Petitioner’s argument that, “to arrive at the claimed dosages, a POSA need only have followed FDA Guidance 1999’s comprehensive guidelines for the performance of drug interaction and dose regimen studies” using only “routine experimentation” and with “predictable results.” Pet. 54–55, 58; Reh’g Req. 4–5. Petitioner’s reliance on Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989) and Genzyme” slip op. at 3

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

    “Unlike in Merck and Genzyme, the present case does not involve predictable results that may be confirmed or fine-tuned by routine experimentation. Rather, upon careful consideration of the asserted prior art as a whole, we determined that, “it could not be predicted whether a change in iloperidone metabolism would have increased, decreased, or had no effect on the risk of QT prolongation” and, thus, the amount of dose reduction (if any) was unpredictable and would need to be determined empirically. Dec. at 22–23 (quoting Prelim. Resp. 15–16); see also id. at 22 (stating that, “the art as a whole taught a careful evaluation of [drugs such as iloperidone] for evidence of clinically-relevant drug-drug interactions, which may or may not be addressed with dose reductions”).1 Thus, our determination rejects Petitioner’s contention that one of ordinary skill in the art would have arrived at the claimed dosage reduction by routine experimentation. See Coherus Biosciences, Inc., v. Abbvie Biotechnology LTD., Case IPR2016- 00189, slip op. at 2 (PTAB July 14, 2016) (Paper 27) (“The Board is not obligated to respond in writing to every unpersuasive argument made before it.”). Accordingly, we are not persuaded we misapprehended or overlooked any of Petitioner’s arguments.” slip op. at 4

  § 103 obviousness
  Patents in suitUS 9,138,432
• 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
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

  RulingsFinal written decision

  • Expert testimonyOther

    “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

  • ExcludeMotion to exclude, deniedOther

    “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

  • Strike new argumentNew argument disregardedOther

    “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

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

    “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

  Patent outcomesUS 8,846,112 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,846,112
• 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

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.