• TC Heartland LLC v. Kraft Foods Group Brands LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01131 · APJ Toni R Scheiner · IPR · Final written decision

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

  RulingsFinal written decision

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

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

  • Skill levelSkill level board ownOther

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

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

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

  • Strike new argumentNew argument disregardedOther

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

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

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

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

  • Strike new argumentNew argument disregardedDecided for patent owner

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

  • ExcludeMotion to exclude, deniedDenied

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

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

  Patent outcomesUS 8,293,299 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,293,299
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2016-00283 · APJ Toni R Scheiner · IPR · Final written decision

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

  RulingsFinal written decision

  • BurdenNot shown unpatentable

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

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

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

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

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

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

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

  • Expert testimonyDecided for petitioner

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

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012
• Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.No claims unpatentable
  PTAB · Jul 22, 2015 · IPR2014-01365 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1, 2, 6, 12–14, 17, 21–51, and 54–71 were not held unpatentable over Maloney or Oshlack and the Handbook.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “inter partes review of claims 1, 2, 6, 12–14, 17, 21–43, 45–51, and 54–82 of U.S. Patent No. 8,329,216 (“the ’216 patent”). Paper 1 (“Pet.”). Endo Pharmaceuticals Inc. (“Patent Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). As authorized (Paper 9), Petitioner filed a Reply to the Preliminary Response addressing the issue of whether Petitioner was served with a complaint alleging infringement of the ’216 patent more than one year before the Petition was filed, and, therefore, subject to a bar under 35 U.S.C. § 315(b). Paper 11. Patent Owner filed a Surreply on this issue. Paper 14. We determined that § 315(b) did not bar institution in this case. Paper 15, 10.” slip op. at 2

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted in part

    “Meanwhile, Petitioner filed a second Petition requesting inter partes review of claims 5, 16, 44, 46, 47, and 72–82 of the ’216 patent. IPR2014-01365, Paper 2 (“Second Petition”). On the same day, Petitioner filed a Motion for Joinder, requesting joinder of the Second Petition with the Petition in the instituted proceeding. IPR2014-01365, Paper 3 (“Joinder Motion”), 1–2. We granted Petitioner’s Motion for Joinder in relation to the ground that claims 44 and 47 of the ’216 patent would have been obvious over Oshlack and the Handbook, but not in relation to any asserted grounds regarding claims 5, 16, 46, and 72–82 in the Second Petition. IPR2014-00360, Paper 64, 2, 15.6 4 Oshlack et al., U.S. Patent No. 5,958,452, “Extruded Orally Administrable Opioid Formulations,” filed Apr. 10, 1997, issued Sept. 28, 1999 (Ex. 1007). 5 William A. Hanson, HANDBOOK OF DISSOLUTION TESTING, v-xii, 1–13, 26–53, 69–91, 111–23 (2d ed. 1991) (Ex. 1008). 6 In our Decision granting Petitioner’s Motion for Joinder In-Part and Instituting Inter Partes Review, we note “[r]egarding claims 46 and 47, as noted by Petitioner, ‘[d]ue to an unintentional inconsistency in claim numbering in the First Petition, trial was instituted for claims 46 and 47 without Petitioner’s specific analysis of these claims in the First Petition.’” Paper 64, 7.” slip op. at 3

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

    “light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). There is a “heavy presumption” that a claim term carries its ordinary and customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Petitioner offers claim construction of the phrases “controlled release” and “about.” Pet. 4–5. Petitioner notes that the ’216 patent defines “controlled release” as encompassing formulations that “release no more than about 80% of their active pharmaceutical ingredients within 60 minutes” under the claimed dissolution conditions. Id. (citing Ex. 1001, 3:31–33). Petitioner contends that “about” encompasses “at least the standard statistical error” for dissolution testing values. Id. at 5. Patent Owner responds that no claim construction is necessary. PO Resp. 7–8. Based on the record before us, we determine that Petitioner’s proposed constructions are the broadest reasonable construction of the above-mentioned phrases.” slip op. at 9

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

    “by Petitioner ignores the fact that Petitioner has the burden to establish by a preponderance of the evidence that the “two or three peaks” limitation of claim 1 is inherent to any oxymorphone formulation, as Petitioner asserts when making its case. Pet. 17; Reply 7. We are not persuaded that Petitioner has met its burden in this regard. In pointing to evidence regarding Study A, Patent Owner provides evidence indicating that certain oxymorphone formulations, as tested in Study A, do not present more than one peak of oxymorphone plasma concentration. PO Resp. 19 (citing Ex. 2013, Fig. 1). By contrast, Petitioner and its experts rely on data presented in Figures 5–7 in the ’216 patent to show that all oxymorphone formulations, including IR compositions, exhibit multiple peaks. Pet. 17–19 (discussing Figs. 6 and 7); Ex. 1003 ¶ 84 (stating that “Figure 6 shows peaks at about 3 hours and about 12 hours after administration” for an IR formulation), ¶ 95; Reply 7–8 (citing Ex. 1031 ¶¶ 34–39 (discussing Fig. 5)). The ’216 patent, when discussing Figures 5 and 6, describes IC formulations as showing “a classical curve, with a high and relatively narrow peak, followed by an exponential drop in plasma concentration,” while stating that CR formulations exhibited “triple peaks in blood plasma concentration.” Ex. 1001, 12:58–67 (Fig. 5); 14:47–3 (Fig. 6). Thus, it is not clear from the ’216 patent itself that IC formulations always present a second “peak” at 12 hours, or that the alleged “peak” at 12 hours for the IC formulations, as asserted by Petitioner and its experts, actually signifies a “peak” as it relates to the “two or three peaks within about 12 hours” recited in claim 1.” slip op. at 15

  Patent outcomesUS 8,329,216 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,329,216
• Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.No claims unpatentable
  PTAB · Jul 22, 2015 · IPR2014-00360 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1, 2, 6, 12–14, 17, 21–51, and 54–71 were not held unpatentable over Maloney or Oshlack and the Handbook.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “inter partes review of claims 1, 2, 6, 12–14, 17, 21–43, 45–51, and 54–82 of U.S. Patent No. 8,329,216 (“the ’216 patent”). Paper 1 (“Pet.”). Endo Pharmaceuticals Inc. (“Patent Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). As authorized (Paper 9), Petitioner filed a Reply to the Preliminary Response addressing the issue of whether Petitioner was served with a complaint alleging infringement of the ’216 patent more than one year before the Petition was filed, and, therefore, subject to a bar under 35 U.S.C. § 315(b). Paper 11. Patent Owner filed a Surreply on this issue. Paper 14. We determined that § 315(b) did not bar institution in this case. Paper 15, 10.” slip op. at 2

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted in part

    “Meanwhile, Petitioner filed a second Petition requesting inter partes review of claims 5, 16, 44, 46, 47, and 72–82 of the ’216 patent. IPR2014-01365, Paper 2 (“Second Petition”). On the same day, Petitioner filed a Motion for Joinder, requesting joinder of the Second Petition with the Petition in the instituted proceeding. IPR2014-01365, Paper 3 (“Joinder Motion”), 1–2. We granted Petitioner’s Motion for Joinder in relation to the ground that claims 44 and 47 of the ’216 patent would have been obvious over Oshlack and the Handbook, but not in relation to any asserted grounds regarding claims 5, 16, 46, and 72–82 in the Second Petition. IPR2014-00360, Paper 64, 2, 15.6 4 Oshlack et al., U.S. Patent No. 5,958,452, “Extruded Orally Administrable Opioid Formulations,” filed Apr. 10, 1997, issued Sept. 28, 1999 (Ex. 1007). 5 William A. Hanson, HANDBOOK OF DISSOLUTION TESTING, v-xii, 1–13, 26–53, 69–91, 111–23 (2d ed. 1991) (Ex. 1008). 6 In our Decision granting Petitioner’s Motion for Joinder In-Part and Instituting Inter Partes Review, we note “[r]egarding claims 46 and 47, as noted by Petitioner, ‘[d]ue to an unintentional inconsistency in claim numbering in the First Petition, trial was instituted for claims 46 and 47 without Petitioner’s specific analysis of these claims in the First Petition.’” Paper 64, 7.” slip op. at 3

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

    “light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). There is a “heavy presumption” that a claim term carries its ordinary and customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Petitioner offers claim construction of the phrases “controlled release” and “about.” Pet. 4–5. Petitioner notes that the ’216 patent defines “controlled release” as encompassing formulations that “release no more than about 80% of their active pharmaceutical ingredients within 60 minutes” under the claimed dissolution conditions. Id. (citing Ex. 1001, 3:31–33). Petitioner contends that “about” encompasses “at least the standard statistical error” for dissolution testing values. Id. at 5. Patent Owner responds that no claim construction is necessary. PO Resp. 7–8. Based on the record before us, we determine that Petitioner’s proposed constructions are the broadest reasonable construction of the above-mentioned phrases.” slip op. at 9

  • BurdenNot shown unpatentable

    “by Petitioner ignores the fact that Petitioner has the burden to establish by a preponderance of the evidence that the “two or three peaks” limitation of claim 1 is inherent to any oxymorphone formulation, as Petitioner asserts when making its case. Pet. 17; Reply 7. We are not persuaded that Petitioner has met its burden in this regard. In pointing to evidence regarding Study A, Patent Owner provides evidence indicating that certain oxymorphone formulations, as tested in Study A, do not present more than one peak of oxymorphone plasma concentration. PO Resp. 19 (citing Ex. 2013, Fig. 1). By contrast, Petitioner and its experts rely on data presented in Figures 5–7 in the ’216 patent to show that all oxymorphone formulations, including IR compositions, exhibit multiple peaks. Pet. 17–19 (discussing Figs. 6 and 7); Ex. 1003 ¶ 84 (stating that “Figure 6 shows peaks at about 3 hours and about 12 hours after administration” for an IR formulation), ¶ 95; Reply 7–8 (citing Ex. 1031 ¶¶ 34–39 (discussing Fig. 5)). The ’216 patent, when discussing Figures 5 and 6, describes IC formulations as showing “a classical curve, with a high and relatively narrow peak, followed by an exponential drop in plasma concentration,” while stating that CR formulations exhibited “triple peaks in blood plasma concentration.” Ex. 1001, 12:58–67 (Fig. 5); 14:47–3 (Fig. 6). Thus, it is not clear from the ’216 patent itself that IC formulations always present a second “peak” at 12 hours, or that the alleged “peak” at 12 hours for the IC formulations, as asserted by Petitioner and its experts, actually signifies a “peak” as it relates to the “two or three peaks within about 12 hours” recited in claim 1.” slip op. at 15

  Patent outcomesUS 8,329,216 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,329,216
• Organik Kimya As v. Rohm And Haas CompanyNo claims unpatentable
  PTAB · Jun 26, 2015 · IPR2014-00350 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–7 were not shown unpatentable because the cited combinations did not establish a qualifying swelling agent under the Board’s construction.

  RulingsFinal written decision

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

    “We disagree with Petitioner that the Specification’s use of the term “include,” when describing suitable swelling agents, “mak[es] clear” that bases that are not capable of permeating the shell and swelling the core also fall within the scope of the invention. Id. Rather, the Specification’s use of the word “include,” in this instance, is modified by the phrase immediately following it, i.e., “are those which,” suggesting that suitable swelling agents include only those which exhibit the functional characteristic thereafter described. See Ex. 1001, 8:44. In contrast, the subsequent paragraph of the Specification describes the structural requirement for suitable swelling agents using the word “include,” without modifying it with a restrictive phrase. Instead, when disclosing the volatile, fixed and permanent bases, the word “include” is coupled with the phrases “such as” and “and the like,” signaling open-ended or inclusive categories of these bases. See id. at 8:49– 56. Further, we agree with Patent Owner that the Specification describes a swelling agent not merely as being capable of permeating a shell and swelling the core of a multistage emulsion polymer in the abstract, but specifically under the conditions of the specific process for which the agent is to be used. Indeed, the Specification explains that in its process for preparing emulsion polymers, the core polymer of the multistage emulsion polymer swells when it “is subjected to a basic swelling agent that permeates the shell to at least partially neutralize the hydrophilic-functionality of the core.” Ex. 1001, 9:14–17. Based on the foregoing discussion, in light of the ’004 patent Specification, we construe the claim term “swelling agent” as expressing a structural element, i.e., “an aqueous or gaseous, volatile or fixed base, or combinations thereof,” in functional terms, i.e., “capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used.” See Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. 1996) (structural elements, e.g., “filter” and “brake,” may be expressed in functional terms).” slip op. at 8

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

    “After considering the arguments and evidence, we find that Patent Owner has established that a person of ordinary skill in the art would not have been motivated to substitute cresol for toluene in step 2A of Touda’s Example 2. Although cresol and toluene are both solvents, Patent Owner has established with persuasive evidence that cresol’s additional function as a polymerization inhibitor would have defeated the purpose of the solvent in Touda’s step 2A. That step is directed to the production of a filled polymer latex (multi-stage polymer). Ex. 1003, 7:35–56. During step 2A, toluene was added to a monomeric mixture over the course of 6 hours. Id. at 7:49– 50. Then the mixture was maintained at 80 °C for 2 hours to complete the polymerization reaction. Id. at 7:51–52. Dr. Schork attempted to replicate Example 2 with cresol substituting for toluene during step 2A, as proposed by Petitioner. Ex. 2005 ¶¶ 92–95 (citing Declaration Ex. I, “Synthesis Procedure for Touda ’320 Example 2 Modified”). Dr. Schork explained that the result observed from using cresol during step 2A was not surprising: “monomer was only 2.5% converted to polymer after the required eight hours.” Id. ¶ 95. Dr. Schork stated, “[i]n my opinion, these results show that the modified process of Example 2A does not make a core-shell emulsion polymer having a core stage and a shell stage because the cresol inhibits polymerization during the phase intended to make the shell.” Id. Petitioner’s assertion to the contrary—that Dr. Schork’s experiment produced “a meaningful amount of shell stage polymer,”—is merely attorney argument unsupported by any persuasive evidence. Pet. Reply 13. Indeed, Petitioner’s Declarant, Marek W. Urban, Ph.D., did not attempt to replicate Example 2 with the modifications proposed by Petitioner, i.e., substituting cresol for toluene in Step 2A. Accordingly, we conclude that Petitioner has not established that it would have been obvious to modify Touda’s Example 2 to include a polymerization inhibitor.” slip op. at 15

  • Expert testimonyPatent owner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Moreover, we agree with Patent Owner that Touda’s Example 2 also does not include a swelling agent, as required by claim 1 of the ’004 patent. PO Resp. 28. In particular, as Patent Owner asserts, Touda does not disclose expressly sodium hydroxide, or any other base, as a “swelling agent,” i.e., being capable of permeating the shell and swelling the core of the emulsion polymer under the conditions of Example 2. Id. Petitioner asserts that even if our construction of “swelling agent” requires a base that permeates the shell and swells the core, Petitioner “has established a prima facie case of inherency under Office practice.” Pet. Reply 10 (citing In re Best, 562 F.2d 1252, 1254 (C.C.P.A. 1977); In re Spada, 911 F.2d 705, 707–08 n.3 (Fed. Cir. 1990); In re Mousa, 479 F. App’x. 348, 353 (Fed. Cir. 2012)), 14. According to Petitioner, sodium hydroxide inherently permeates the shell and swells the core of the polymer particles in Touda because the same polymer particles are described in the ’004 patent as suitable for swelling. Pet. Reply 14. However, Dr. Schork explains that in Touda’s Example 1S, the core is only 5 parts (5%) methacrylic acid and the shell in Example 2A is only 6 parts (6%) acrylic acid, such that the core and the shell are only slightly acidic. Ex. 2005 ¶ 77. Dr. Schork states that a person of skill in the art “would understand that under these conditions, NaOH would at best neutralize the shell, not the core.” Id. According to Dr. Schork, “[g]iven the low levels of acid, the NaOH would be unlikely to permeate and neutralize any part of the particle. Certainly, NaOH would not permeate the shell and swell the core. Instead, to the extent that any swelling occurred, it would take place in the shell.” Id. Again, we are persuaded by Dr. Schork’s testimony and do not find that Petitioner has provided persuasive evidence contradicting Dr. Schork’s opinion. Accordingly, after considering the arguments and evidence, and based upon our construction of the term “swelling agent,” we find that Petitioner has not established that Touda discloses sodium hydroxide as a “swelling agent” in the process of Example 2.” slip op. at 16

  Patent outcomesUS 6,252,004 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 6,252,004
• Organik Kimya As v. Rohm And Haas CompanyNo claims unpatentable
  PTAB · May 27, 2015 · IPR2014-00185 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–5 were not shown unpatentable: Toda did not disclose the claimed swelling agent, and Touda did not teach or suggest it.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “We disagree with Petitioner. We have construed the claim term “swelling agent” as encompassing a structure, i.e., a base, and a function, i.e., being capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used. Petitioner has neither asserted nor shown that Toda expressly teaches that potassium hydroxide permeates the shell and swells the core of the multi-stage polymer in Toda’s Example 9. Instead, Petitioner asserts that potassium hydroxide permeates the shell and swells the core of the polymer particles in Toda because the same polymer particles are described in the ’435 patent as suitable for swelling. Pet. Reply 14 (citing Ex. 1002 ¶¶ 62–66). In other words, Petitioner’s argument is that Toda inherently discloses that potassium hydroxide is capable of permeating the shell and swelling the core of the polymer particles in Toda’s Example 9. With respect to Petitioner’s inherency argument, what is missing is some consideration of the reaction conditions in the process of Toda’s Example 9. In Toda’s Example 9, the potassium hydroxide was added to the mixture after the temperature of the mixture was lowered to 20° C and styrene was added to soften the polymer particles. Ex. 1003, 12:35–42. Patent Owner provides persuasive evidence, through the Declaration of Dr. Schork, that a person of ordinary skill in the art would have understood that the shell would be too hard at this temperature for potassium hydroxide to be capable of permeating the shell and swelling the core. PO Resp. 39 (citing Ex. 2011 ¶ 92). Petitioner has not argued persuasively otherwise. See, e.g., Pet. Reply 13–14.” slip op. at 14

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “some consideration of the reaction conditions in the process of Toda’s Example 9. In Toda’s Example 9, the potassium hydroxide was added to the mixture after the temperature of the mixture was lowered to 20° C and styrene was added to soften the polymer particles. Ex. 1003, 12:35–42. Patent Owner provides persuasive evidence, through the Declaration of Dr. Schork, that a person of ordinary skill in the art would have understood that the shell would be too hard at this temperature for potassium hydroxide to be capable of permeating the shell and swelling the core. PO Resp. 39 (citing Ex. 2011 ¶ 92). Petitioner has not argued persuasively otherwise. See, e.g., Pet. Reply 13–14. Further, in Toda’s Example 9, after adding the potassium hydroxide, the mixture is heated to 80 °C. Ex. 1003, 12:41–44. Patent Owner provides persuasive evidence, also through the Declaration of Dr. Schork, that, based on the teachings of Toda, a person of ordinary skill in the art would not expect potassium hydroxide to permeate the shell and swell the core at that temperature either. PO Resp. 39 (citing Ex. 2011 ¶¶ 86, 92); see also Ex. 2011 ¶ 93 (explaining why a person of ordinary skill would not consider potassium hydroxide a “swelling agent” when the reaction temperature of Toda Example 9 is increased to 80 °C). Here again, Petitioner has not argued persuasively otherwise. See, e.g., Pet. Reply 13–14. Additionally, Patent Owner provides persuasive experimental evidence that the potassium hydroxide solution used in Toda’s Example 9 is not capable of permeating the shell and swelling the core. See PO Resp. 38. Dr. Schork attempted to replicate Toda’s Example 9 twice and observed each time that potassium hydroxide was not capable of permeating the shell and swelling the core of the multi-stage emulsion polymer. Ex. 2011 ¶¶ 89– 94). According to Dr. Schork, results of those replications did not provide any swelling during the base treatment of Example 9, suggesting that potassium hydroxide did not perform as a swelling agent under the conditions of Toda’s Example 9, as required by claims 1–5 of the ’435 patent. See id. ¶¶ 94, 102–103.” slip op. at 15

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

    “We disagree with Petitioner that the Specification’s use of the term “include,” when describing suitable swelling agents, “makes clear” that bases that are not capable of permeating the shell and swelling the core also fall within the scope of the invention. Rather, the Specification’s use of the word “include,” in this instance, is modified by the phrase immediately following it, i.e., “are those which,” suggesting that suitable swelling agents include only those which exhibit the functional characteristic thereafter described. See Ex. 1001, 8:40. In contrast, the following paragraph of the Specification describes the structural requirement for suitable swelling agents using the word “include,” without modifying it with a restrictive phrase. Instead, when disclosing the volatile, fixed and permanent bases, the word “include” is coupled with the phrases “such as” and “and the like,” signaling open-ended or inclusive categories of these bases. See id. at 8:45– 52. Further, we agree with Patent Owner that the Specification describes a swelling agent not merely as being capable of permeating a shell and swelling the core of a multistage emulsion polymer in the abstract, but specifically under the conditions of the specific process for which the agent is to be used. Indeed, the Specification explains that in its process for preparing emulsion polymers, the core polymer of the multistage emulsion polymer swells when it “is subjected to a basic swelling agent that permeates the shell to at least partially neutralize the hydrophilic-functionality of the core.” Ex. 1001, 9:10–15. Based on the foregoing discussion, in light of the ’435 patent Specification, we construe the claim term “swelling agent” as expressing a structural element, i.e., “an aqueous or gaseous, volatile or fixed base, or combinations thereof,” in functional terms, i.e., “capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used.” See Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. 1996) (structural elements, e.g., “filter” and “brake,” may be expressed in functional terms).” slip op. at 8

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

    “We disagree with Petitioner. We have construed the claim term “swelling agent” as encompassing a structure, i.e., a base, and a function, i.e., being capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used. Petitioner has neither asserted nor shown that Toda expressly teaches that potassium hydroxide permeates the shell and swells the core of the multi-stage polymer in Toda’s Example 9. Instead, Petitioner asserts that potassium hydroxide permeates the shell and swells the core of the polymer particles in Toda because the same polymer particles are described in the ’435 patent as suitable for swelling. Pet. Reply 14 (citing Ex. 1002 ¶¶ 62–66). In other words, Petitioner’s argument is that Toda inherently discloses that potassium hydroxide is capable of permeating the shell and swelling the core of the polymer particles in Toda’s Example 9. With respect to Petitioner’s inherency argument, what is missing is some consideration of the reaction conditions in the process of Toda’s Example 9. In Toda’s Example 9, the potassium hydroxide was added to the mixture after the temperature of the mixture was lowered to 20° C and styrene was added to soften the polymer particles. Ex. 1003, 12:35–42. Patent Owner provides persuasive evidence, through the Declaration of Dr. Schork, that a person of ordinary skill in the art would have understood that the shell would be too hard at this temperature for potassium hydroxide to be capable of permeating the shell and swelling the core. PO Resp. 39 (citing Ex. 2011 ¶ 92). Petitioner has not argued persuasively otherwise. See, e.g., Pet. Reply 13–14. Further, in Toda’s Example 9, after adding the potassium hydroxide, the mixture is heated to 80 °C. Ex. 1003, 12:41–44. Patent Owner provides persuasive evidence, also through the Declaration of Dr. Schork, that, based on the teachings of Toda, a person of ordinary skill in the art would not expect potassium hydroxide to permeate the shell and swell the core at that temperature either. PO Resp. 39 (citing Ex. 2011 ¶¶ 86, 92); see also Ex. 2011 ¶ 93 (explaining why a person of ordinary skill would not consider potassium hydroxide a “swelling agent” when the reaction temperature of Toda Example 9 is increased to 80 °C). Here again, Petitioner has not argued persuasively otherwise. See, e.g., Pet. Reply 13–14.” slip op. at 14

  Patent outcomesUS 6,020,435 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,020,435
• Trivascular, Inc. v. Shaun L.W. SamuelsNo claims unpatentable
  PTAB · Dec 3, 2014 · IPR2013-00493 · APJ Richard E Rice · IPR · Final written decision

  Claims 1, 2, and 4–24 were not shown unpatentable over either instituted §103 combination because the references did not establish the required inflatable protrusions.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “not proved that claims 1, 2, 6–15, and 18–24 would have been obvious over Samuels ’851 and Todd, or that claims 1, 4–6, 9–11, 13, 14, 16, 17, and 19– 21 would have been obvious over Lazarus and Todd. Accordingly, Dr. Samuels’s Motion to Amend, which is contingent on claims 1, 14, and 23 being found unpatentable, is moot. IV. ORDER For the reasons given, it is ORDERED that claims 1, 2, and 4–24 of U.S. Patent No. 6,007,575 are not determined to be unpatentable; and FURTHER ORDERED that Dr. Samuels’s Motion to Amend is dismissed as moot.” slip op. at 24

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

    “TriVascular argues that “inflatable protrusions can be ‘solid’ structures such as barbs or[,] in the case of [] some of the prior art examples, solid circumferential ridges.” Reply 10 (citing Clark. Dep., Ex. 1021, 135:6–16 (discussing Samuels ’851 (Ex. 1002))). TriVascular’s proposed claim construction, however, does not accord with the plain meaning of “inflatable” as used in the Specification, i.e., expandable by being filled with fluid. See, e.g., Ex. 1001, Abstr. 3–4, 3:55 (“inflatable chamber”), 1:30 (“inflatable balloon”), 2:33, 38, 3:30 (“inflatable cuff”), 3:33–34 (“inflatable ridges”). Under the plain meaning of “inflatable” as used in the Specification, solid ridges are not “inflatable,” because they are not capable of being filled with fluid. See Resp. 5–8; In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (holding that the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification). Further, under TriVascular’s proposed claim construction, there is no meaningful difference between “protrusions” disposed on an inflatable cuff and “inflatable protrusions” disposed on an inflatable cuff. See Tr. 10:7–14. Trivascular’s proposed claim construction, therefore, fails to give any meaning to “inflatable” in “inflatable protrusions,” and by not giving effect to all words of the claim, runs afoul of a cardinal rule of claim construction. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye toward giving effect to all terms in the claim,” so that physical structures and characteristics described specifically in a claim are not rendered “merely superfluous.”).” slip op. at 7

  • Expert testimonyPetitioner expert discountedOther

    “inflatable balloon protuberances, including “inflatable ridges.” Pet. 22 (citing Ex. 1008, Figs. 5–9), 41 & 51 (claim chart) (quoting Ex. 1008, 7:35– 39, citing Ex. 1008, Fig. 7). At oral argument, TriVascular clarified its analysis of Todd’s disclosure, and asserted that the protuberances disclosed in Todd are hollow, and themselves inflatable. Tr. 6:5–12:20. TriVascular cited in support of its position the statement in column 7 of Todd that: “When inflated, the spiral ridge 48 contacts and tightly grips the walls of a body passageway in which it is inserted.” Id. at 6–7; Ex. 1008, 7:37–39 (emphasis added); see Pet. 40–41 (Claim Chart II, element 1a-3, quoting Ex. 1008, 7:35–39). TriVascular, however, has not provided a declaration, or any other evidence, to establish that a person of ordinary skill in the art would understand Todd to disclose protuberances that are hollow, and themselves inflatable. Dr. Samuels does not agree that Todd discloses “inflatable protrusions.” Resp. 12. Dr. Samuels asserts that “the region between the inner and outer surfaces of balloon 26 of Todd is solid . . . and any provided roughened surfaces or protuberances are also solid.” Id. (citing Ex. 1008, Figs. 4 & 8; Ex. 2004). On the record before us, TriVascular has failed to show that Todd discloses “inflatable protrusions,” i.e., protrusions that are expandable by being filled with fluid. See section II.A.5 supra. The protuberances disclosed in Todd project outwardly “from the outer surface” of inflatable balloon 26. See Ex. 1008, 6:58–59, 62–63. As such, the protuberances are disposed on the exterior surface of the inflatable balloon, and are not in fluid communication with the balloon’s inner chamber 32. See Resp. 12; Ex. 1008, 7:15–16, Figs. 2, 4 & 5 (describing knobs 40 as solid structures on the outer surface of the balloon), 7:32–34, Fig. 6 (describing “cross-hatched pattern 44 projecting outwardly from the exterior surface of balloon 26”), 7:35–39, Fig. 7 (describing “outwardly projecting spiral ridge 48 wound about the exterior surface of balloon 26”), 7:40–46, Fig. 8 (describing “outwardly projecting annular rings 52 wound about the exterior surface of balloon 26”). Todd discloses expansion means in fluid communication with inner chamber 32 for inflating balloon 26 (id. at 7:53–60), but does not disclose expansion means for inflating the protuberances, either separately or in conjunction with inflation of the balloon. Todd discloses, simply, that “when balloon 26 is inflated, the gripping means [i.e., the protuberances] on the exterior of the balloon contact and grip the walls of the body passageway.” Id. at 8:14–16. Trivascular has not persuaded us, moreover, that a person of ordinary skill in the art would have understood Todd’s statement “[w]hen inflated, the spiral ridge 48 contacts and tightly grips the walls of a body passageway in which it is inserted” (id at 7:37–39 (emphasis added)), to teach or suggest that spiral ridge 48 is expandable by being filled with fluid. See Tr. 6–7. Other than that isolated statement, there is no suggestion, indication, or hint in Todd that any of the disclosed protuberances is hollow such that it can be filled with fluid and inflated. To the contrary, as discussed above, Todd” slip op. at 15

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

    “We determine that Trivascular has not provided a sufficient rationale to support substituting the ridges of Todd for just the barbs of Samuels ’851. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). TriVascular also contends that it would have been obvious to eliminate both the recesses and barbs of Samuels ’851, and to substitute “a circumferential ridge, similar to the one that is in Todd.” See Tr. 15:24– 17:15. TriVascular asserts three reasons why combining the references in that fashion would satisfy the requirement for “inflatable protrusion(s) including at least one circumferential ridge disposed about the inflatable cuff”: (1) the ridges are “inflatable” in the combination simply because they are riding on an inflatable cuff; (2) the ridges in Todd are themselves inflatable; and (3) use of ridges that are themselves inflatable would have been obvious, as they would take up less volume and be easier to insert in blood vessels than ridges that are not themselves inflatable. See id. at 17:16–18:14. None of those reasons is persuasive. The first reason is not persuasive because it does not satisfy the requirement for “inflatable protrusions,” i.e., protrusions that are expandable by being filled with fluid. See section II.A.5 supra. The second reason is not persuasive because we do not agree that Todd discloses ridges that are themselves inflatable. See section II.B.1.b supra. Lastly, the third reason is not persuasive because TriVascular has not established that a person of ordinary skill in the art would have known to use, on an inflatable cuff, circumferential ridges that are themselves inflatable. The evidence is to the contrary. See, e.g., Ex. 2002 (Samuels Decl.) ¶ 4.c (“No one else in the medical field, to the best of my knowledge, ever proposed or suggested an inflatable ridge-based sealing arrangement prior to my invention, ever.”); Ex. 1020 (Samuels Dep.), 138:20–140:7 (affirming testimony in ¶ 4.c of Samuels Decl.), 187:11–14 (testifying that inflatable ridges were not known in the medical field); Ex. 2003 (Clark Decl.) ¶ 8 (“[B]eing able to reduce the overall diameter by just deflating the fluid chamber and, correspondingly, the ridges is an intriguing concept, one which was not known, to the best of my knowledge, in the medical field prior to Samuels ’575.”); Ex. 1021 (Clark Dep.), 82:19–21 (“I’m not aware of any inflatable protrusions to support an endograft prior to Samuels [’575].”).” slip op. at 19

  Patent outcomesUS 6,007,575 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 6,007,575

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.