- Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentablePTAB · Dec 12, 2014 · IPR2013-00404 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–14 and 26 are unpatentable over Grangaud and/or Grangaud with Dowling; claims 15, 21, and 22 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureUnpatentableNot shown unpatentableMixed
“To establish inherent disclosure, the evidence must show that a feature necessarily is described in the reference, and that it would be recognized by persons of ordinary skill. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999); cf. EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1351 (Fed. Cir. 2001) (“Theoretical mechanisms or rules of natural law that are recited in a claim, that themselves are not patentable, however, do not need to be recognized by one of ordinary skill in the art for a finding of inherency.”). The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency. In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). Inherency may not be established by probabilities or possibilities. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“As to secondary considerations, we note that factual inquiries for an obviousness determination include secondary considerations based on evaluation and crediting of objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Notwithstanding what the teachings of the prior art would have suggested to one with ordinary skill in the art at the time of the University’s invention, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that the claimed invention would not have been obvious to one with ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471-1472 (Fed. Cir. 1984). However, such a conclusion requires the finding of a nexus to establish that the evidence relied upon traces its basis to a novel element in the claim and not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). All types of objective evidence of nonobviousness must be shown to have nexus. In re GPAC Inc., 57 F.3d at 1580 (nexus generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); In re Antor Media Corp., 689 F.3d 1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (copying); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); and In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (unexpected results). As discussed above, we conclude that claims 1, 3, and 8–12 are anticipated by Grangaud, as evidenced by Dowling. Because anticipation is the epitome of obviousness, a disclosure that anticipates under 35 U.S.C. § 102 also renders the claim unpatentable under 35 U.S.C. § 103. See In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982) (“[E]vidence establishing lack of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24
Patent outcomesUS 5,527,533 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 5,527,533 - Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentablePTAB · Dec 12, 2014 · IPR2013-00401 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–14 and 26 are unpatentable as anticipated by Grangaud and obvious over Grangaud alone or with Dowling; claims 15, 21, and 22 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInherency not foundMixed
“In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24
Patent outcomesUS 5,527,533 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 5,527,533 - Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentablePTAB · Dec 9, 2014 · IPR2013-00371 · APJ Scott E Kamholz · IPR · Final written decision
Claims 1–13 and 17–20 were not shown unpatentable as obvious over Ashley ’932 and Sheth because Sheth did not disclose a delayed-release portion or the claimed IR:DR ratios.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’405 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’405 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1007, 7:56. The ’405 patent discloses formats other than enteric coated pellets, such as an “uncoated matrix tablet,” as being delayed-release components. Id. at 5:38–40 (“delayed-release portion can be . . . uncoated matrix tablet.”). Consequently, properties of enteric coated pellets do not address the full scope of “delayed release” as that term is used in the ’405 patent. We will not read the limitations of an embodiment, even a preferred embodiment, into the construction of a claim term that is plainly used elsewhere in the specification more broadly. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). As Supernus concedes, Tr. 42:7–9, the ’405 patent does not provide an express definition of “delayed release.” We turn, therefore, to other evidence of how the term is understood and used by persons of ordinary skill in the art. We find, upon consideration of this evidence, that the term “delayed release” is used, more-or-less uniformly, to refer to formats that allow for release of a drug only after some delay following oral administration. See, e.g., Ex. 2058, 30 (quoted supra); Ex. 2047, 7 (defining “delayed release” as “release of a drug (or drugs) at a time other than promptly after administration”);4 Ex. 2016 ¶ 106 (citing definition of “delayed release” in Ashley ’854, quoted supra, with approval). Those definitions are consistent with one another, both parties and their experts cite them with favor, and we discern nothing in the use of the term “delayed release” in the ’405 patent specification that is inconsistent with those definitions or more limiting than them. For these reasons, we determine that the broadest reasonable construction of “delayed release,” consistent with the ’405 patent, is “release of a drug at a time other than immediately following oral administration.” See Ex. 2058, 30; Ex. 2047, 7; Ex. 1003, 11:4–6.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“water-soluble polymer in the coating of Sheth’s secondary loading portion results in release of drug promptly after administration. See Ex. 2016 ¶ 172. Amneal does not cite credible evidence to refute Dr. Rudnic’s testimony. Although Dr. Rudnic conceded that there must be some lag while the polymer hydrates, we further credit his testimony that this lag, essentially the time required to wet the material, would not be considered a “delay.” See Ex. 1052, 248:3–5. We agree with Dr. Rudnic that dissolution, however rapid, necessarily requires some finite amount of time to allow interaction of the solvent and the solute. See Ex. 1005, 5:1–2. Amneal does not explain why we should not credit all of Dr. Rudnic’s testimony on this point. Because we credit Dr. Rudnic’s testimony, we agree with Supernus that Sheth’s secondary loading portion is not a “delayed release” portion. A “delayed release” format, when that term is construed to mean “release of a drug at a time other than immediately following oral administration,” specifically excludes formats that result in release of drug starting immediately after oral administration. To conclude otherwise would read the phrase “delayed release” out of the claim. See In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) (all limitations of a claim must be considered when considering patentability over prior art). Amneal has not explained how there is any appreciable delay in the onset of drug release from the secondary loading portion once water in the patient’s saliva or gastric fluid has begun to solubilize the pH-insensitive polymer in the coating.6” slip op. at 13
- ExcludeMotion to exclude, deniedDenied
“MOTION TO EXCLUDE EVIDENCE Amneal moves to exclude Supernus Exhibits 2028, 2029, 2032–2034, 2039, 2049, 2050, 2147, 2149–2154, and 2156. Pet. Motion to Exclude 1. We dismiss Amneal’s motion as moot, because we do not rely on any of the objected-to evidence in our final decision. IV.” slip op. at 15
Patent outcomesUS 8,394,405 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,394,405 - Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentablePTAB · Dec 9, 2014 · IPR2013-00372 · APJ Scott E Kamholz · IPR · Final written decision
Claims 1–12 and 16–21 were not shown unpatentable over Ashley ’932 and Sheth because Sheth’s secondary loading portion was not a delayed-release portion.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’406 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’406 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1009, 7:56. The ’406 patent discloses formats other than enteric coated pellets, such as an “uncoated matrix tablet,” as being delayed-release components. Id. at 5:38–40 (“delayed-release portion can be . . . uncoated matrix tablet.”). Consequently, properties of enteric coated pellets do not address the full scope of “delayed release” as that term is used in the ’406 patent. We will not read the limitations of an embodiment, even a preferred embodiment, into the construction of a claim term that is plainly used elsewhere in the specification more broadly. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).” slip op. at 7
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We credit Dr. Rudnic’s declaration testimony that inclusion of a water-soluble polymer in the coating of Sheth’s secondary loading portion results in release of drug promptly after administration. See Ex. 2016 ¶ 176. Amneal does not cite credible evidence to refute Dr. Rudnic’s testimony. Although Dr. Rudnic conceded that there must be some lag while the polymer hydrates, we further credit his testimony that this lag, essentially the time required to wet the material, would not be considered a “delay.” See Ex. 1052, 248:3–5. We agree with Dr. Rudnic that dissolution, however rapid, necessarily requires some finite amount of time to allow interaction of the solvent and the solute. See Ex. 1005, 5:1–2. Amneal does not explain why we should not credit all of Dr. Rudnic’s testimony on this point.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“that Sheth’s secondary loading portion is not a “delayed release” portion. A “delayed release” format, when that term is construed to mean “release of a drug at a time other than immediately following oral administration,” specifically excludes formats that result in release of drug starting immediately after oral administration. To conclude otherwise would read the phrase “delayed release” out of the claim. See In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) (all limitations of a claim must be considered when considering patentability over prior art). Amneal has not explained how there is any appreciable delay in the onset of drug release from the secondary loading portion once water in the patient’s saliva or gastric fluid has begun to solubilize the pH-insensitive polymer in the coating.6” slip op. at 13
Patent outcomesUS 8,394,406 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,394,406 - Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentablePTAB · Dec 9, 2014 · IPR2013-00368 · APJ Scott E Kamholz · IPR · Final written decision
Amneal did not prove claims 1, 2, 5–15, and 19–22 unpatentable as obvious over Ashley ’932 and Sheth because Sheth did not disclose a delayed-release portion.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’740 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’740 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1001, 7:47. The ’740 patent discloses formats other than enteric coated pellets, such as an “uncoated matrix tablet,” as being delayed-release components. Id. at 5:29–31 (“delayed-release portion can be . . . uncoated matrix tablet.”). Consequently, properties of enteric coated pellets do not address the full scope of “delayed release” as that term is used in the ’740 patent. We will not read the limitations of an embodiment, even a preferred embodiment, into the construction of a claim term that is plainly used elsewhere in the specification more broadly. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). As Supernus concedes, Tr. 42:7–9, the ’740 patent does not provide an express definition of “delayed release.” We turn, therefore, to other evidence of how the term is understood and used by persons of ordinary skill in the art. We find, upon consideration of this evidence, that the term “delayed release” is used, more-or-less uniformly, to refer to formats that allow for release of a drug only after some delay following oral administration. See, e.g., Ex. 2058, 30 (quoted supra); Ex. 2047, 7 (defining “delayed release” as “release of a drug (or drugs) at a time other than promptly after administration”);3 Ex. 2016 ¶ 105 (citing definition of “delayed release” in Ashley ’854, quoted supra, with approval). Those definitions are consistent with one another, both parties and their experts cite them with favor, and we discern nothing in the use of the term “delayed release” in the ’740 patent specification that is inconsistent with those definitions or more limiting than them. For these reasons, we determine that the broadest reasonable construction of “delayed release,” consistent with the ’740 patent, is “release of a drug at a time other than immediately following oral administration.” See Ex. 2058, 30; Ex. 2047, 7; Ex. 1003, 11:4–6.” slip op. at 7
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We credit Dr. Rudnic’s declaration testimony that inclusion of a water-soluble polymer in the coating of Sheth’s secondary loading portion results in release of drug promptly after administration. See Ex. 2016 ¶ 175. Amneal does not cite credible evidence to refute Dr. Rudnic’s testimony. Although Dr. Rudnic conceded that there must be some lag while the polymer hydrates, we further credit his testimony that this lag, essentially the time required to wet the material, would not be considered a “delay.” See Ex. 1052, 248:3–5. We agree with Dr. Rudnic that dissolution, however rapid, necessarily requires some finite amount of time to allow interaction of the solvent and the solute. See Ex. 1005, 5:1–2. Amneal does not explain why we should not credit all of Dr. Rudnic’s testimony on this point.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“For this reason, we determine that Amneal has failed to show that Sheth discloses a “delayed release” portion. Amneal’s argument that Sheth discloses the claimed IR:DR ratio (or makes the claimed ratio reachable through routine experimentation) thus becomes untenable. Dr. Van Buskirk’s evidence concerning ratios in Sheth is premised on an assumption that Sheth’s secondary loading portion is a delayed release portion. See, e.g., Ex. 1022 ¶ 59 (“Additionally, the secondary loading coated pellets (the DR component) described in the ’748 patent . . .”). That assumption is unwarranted, for the reasons given above. Consequently, Sheth’s disclosure of ratios involving the secondary loading portion does not constitute disclosure of ratios involving a delayed release portion. Put another way, Amneal has failed to persuade us that the prior art it cites for disclosure of IR:DR ratios actually discloses such ratios. Without evidence that the claimed IR:DR ratio was known or could have been reached through routine experimentation, Amneal’s challenge fails. For the reasons discussed above, we conclude that Amneal has not” slip op. at 14
- ExcludeMotion to exclude, deniedDenied
“We dismiss Amneal’s motion as moot, because we do not rely on any of the objected-to evidence in our final decision. IV.” slip op. at 15
Patent outcomesUS 8,206,740 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,206,740 - Trivascular, Inc. v. Shaun L.W. SamuelsNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 6,007,575 - Sequenom, Inc. v. The Board Of Trustees Of The Leland Stanford Junior UniversityNo claims unpatentablePTAB · Nov 25, 2014 · IPR2013-00390 · APJ Francisco C Prats · IPR · Final written decision
Claims 1–17 were not shown unpatentable because the Board found they were reduced to practice before Lo II’s filing date, so Lo II was not prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“when it is successfully performed.” Shurie v. Richmond, 699 F.2d 1156, 1159 (Fed. Cir. 1983). “In order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence. . . . [A] ‘rule of reason’ analysis is applied to determine whether an inventor’s testimony regarding reduction to practice has been sufficiently corroborated.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (citation omitted). This “rule of reason” analysis “requires an evaluation of all pertinent evidence when determining the credibility of an inventor’s testimony.” Id. Under that analysis, “to corroborate a reduction to practice, it is not necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement.” Id. Corroborating evidence may be “testimony of a witness, other than an inventor, to the actual reduction to practice or it may consist of evidence of surrounding facts and circumstances independent of information received from the inventor.” Hahn v. Wong, 892 F.2d 1028, 1032–33 (Fed. Cir. 1989). Corroboration, however, “is not necessary to establish what a physical exhibit before the [B]oard includes. Only the inventor’s testimony requires corroboration before it can be considered.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993) (citation omitted).” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“In sum, for the reasons discussed, non-inventor corroborating evidence reasonably supports Patent Owner’s assertion that, on June 19, 2008, inventor Dr. Fan sent to Dr. Blumenfeld the draft of the PNAS paper appearing in Exhibits 2111 and 2113. As also discussed above, the evidence reasonably supports Patent Owner’s assertion that that document describes an actual reduction to practice of the processes recited in claims 1–17 of the ’415 patent. We are persuaded, therefore, that Patent Owner has shown that the subject matter of the challenged claims was reduced to practice before Lo II’s July 23, 2008 filing date. Accordingly, because the evidence does not support Petitioner’s position that Lo II constitutes prior art to the challenged claims under 35 U.S.C. § 102(e), and because Lo II is relied upon in every ground on which trial was instituted, Petitioner has not shown by a preponderance of the evidence that any of the challenged claims is unpatentable, based on any of the asserted grounds of unpatentability. III. CONCLUSION” slip op. at 14
- Expert testimonyPatent owner expert creditedDecided for patent owner
Patent outcomesUS 8,195,415 not shown unpatentable§ 102 anticipationPatents in suitUS 8,195,415 - Ariosa Diagnostics v. The Board Of Trustees Of The Leland Stanford Junior UniversityAll claims unpatentablePTAB · Nov 19, 2014 · IPR2013-00308 · APJ Lora M Green · IPR · Final written decision
Claims 1–13 are unpatentable: claims 1–5, 7–9, 12, and 13 as anticipated by Lo; claims 10–11 and 6 as obvious over Lo with Brenner and Li, respectively.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“recites (emphasis added) “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences.” Thus, the claim language associates “sequencing predefined sequences” with obtaining “sequence tags.” The Specification of the ’076 patent discusses sequence tags in the context of shotgun sequencing. See, e.g., Ex. 1001, col. 14, ll. 56–66. As Petitioner notes, there is no discussion in the Specification of the term “targeted sequencing.” Reply 1. Instead, the ’076 patent also discloses the use of a large number of windows of defined length created along the chromosome, such that the windows cover each chromosome in question, except for the non-informative regions of the chromosome, such as centromere and repetitive regions, may be omitted. Id. at col. 4, ll. 56–62. Thus, “[v]arious average numbers, i.e., median values, are calculated for different windows and compared. By counting sequence tags within a series of predefined windows of equal lengths along different chromosomes, more robust and statistically significant results may be obtained.” Id. at col. 4, ll. 62–67 (emphasis added). As taught by the ’076 patent, “[e]ach autosome (chr. 1–22) is computationally segmented into contiguous, non-overlapping windows,” although sliding windows could also be used. Id. at col. 5, ll. 4–9. In addition, as noted above, the ’076 patent also provides examples that describe “direct sequencing of cell-free DNA from plasma of pregnant women with high throughput shotgun sequencing technology,” wherein sequences were mapped to specific chromosomal regions, allowing for the measurement of over- and under-representation of chromosomes from an aneuploid fetus. Id. at col. 20, ll. 30–36. Thus, the Specification does not disclose sequencing only the defined sequences as Patent Owner would have us construe this phrase, but instead, it discloses sequencing the predefined sequences along with other sequences, and then using various techniques to locate the predefined sequences in the material that has been sequenced. Thus, we conclude that the broadest reasonable interpretation of the phrase “sequencing predefined subsequences” is that the subsequences may be predefined through comparison with the predefined windows that are created along the length of the chromosome. The predefined subsequences may walk along the entire length of the chromosome. Thus, although one predefined subsequence would not include the entire chromosomal sequence, two or more subsequences may include the entire length of the chromosomal sequence. That interpretation encompasses the preferred embodiment of the ’076 patent, whereas Patent Owner’s proffered construction limiting the method of claim 1 to “targeted” sequencing, as Patent Owner defines that term, would not” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“may then be sequenced, for example, by using massively parallel sequencing methods. Id. ¶¶ 55–56. As taught by Lo, sequence tags are generated, aligned to each chromosome, and tags identified as originating from a potentially aneuploid chromosome are compared quantitatively to tags originating from a reference chromosome, to allow for the identification of chromosomal gains or losses. Id. ¶ 70. That falls within the scope of the limitation of step (b) of claim 1 of “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences, wherein said sequence tags are of sufficient length to be assigned to a specific predefined subsequence.” That is, as construed above, the sequencing step is not limited to sequencing only the predefined subsequences, but encompasses sequencing other portions of the genome. And, as Lo teaches that the sequence tags are aligned to a chromosome to allow for the identification of chromosomal gains or losses (id. ¶ 70), the tags generated must necessarily be of sufficient length to be assigned to a specific predefined subsequence. See, e.g., Ex. 1008 ¶ 60 (noting that although Lo “does not describe specifically that the sequence tags were of sufficient length to be assigned to a specific region of the genome, one skilled in the art would understand this to be the case, because the sequence tags used to identify chromosomal origin must have been of sufficient length to allow assignment to a particular genomic region”).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“us, Petitioner has not demonstrated that the ordinary artisan would have combined Quake and Kapur as set forth in the Petition (29–39) to arrive at the method of challenged claim 1. In particular, Petitioner relies on Figures 6 and 7 of Kapur as teaching “a method for sequence determination of randomly generated DNA fragments using arrays having oligonucleotides of known sequence. Sequencing of a randomly generated genomic fragment via binding to a predefined sequence on an array aligns a random sequence to a probe indicative of a specific genomic region.” Pet. 31. The evidence relied upon by Petitioner does not explain, however, why one would have a used a method for detecting SNPs as taught by Kapur to perform the sequencing of Quake. That is, what is lacking in the Petition and accompanying Declarations is an “articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988. Petitioner responds that the “sequencing by array technology of Balasubramanian (US 2003/0022207 A1, published Jan. 30, 2003, Ex. 1040) is cited in all of Kapur (Ex. 1005 ¶ 163), Quake (Ex. 1006 ¶ 120), and the ‘076 patent (Ex. 1001 at col. 10, lines 50–56).” Paper 34 ¶ 19. Figures 6 and 7 relied upon by Petitioner, however, are drawn to methods of detecting SNPs, and not to the sequencing array technology of Balasubramanian. In fact, Petitioner first relies on paragraph 163 of Kapur, which it contends cites the sequencing array technology of Balasubramanian, in its challenge of claim 3, which is drawn to the use of massively parallel sequencing. Petitioner cannot rely upon Balasubramanian in its Reply to make up for the deficiencies in its Petition. See, e.g., 37 C.F.R. § 42.23(b) (noting that “[a]ll arguments for the relief requested in a motion must be made in the motion,” and that a “reply may only respond to arguments raised in the corresponding opposition or patent owner response”).” slip op. at 32
- ExcludeMotion to exclude, deniedDenied
“Patent Owner’s objections go more to the weight that paragraph 15 of Exhibit 1043 should be afforded, rather than to its admissibility. It is within our discretion to assign the appropriate weight to be accorded to Dr. Morton’s testimonial evidence. The Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented. Gnosis S.P.A. v. S. Alabama Medical Science Foundation, IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64). See also Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). We thus decline to exclude paragraph 15 of Exhibit 1043.” slip op. at 36
Patent outcomesUS 8,296,076 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,296,076 - PTAB · Oct 31, 2014 · IPR2013-00450 · APJ Scott E Kamholz · IPR · Order
The Board granted the parties’ joint motion to terminate IPR2013-00450 as to all parties and granted confidential treatment of the settlement agreement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“In view of the parties’ settlement agreement made in connection with the termination in accordance with 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(b), we determine that it is appropriate to terminate the involvement of Petitioner. Moreover, we determine that it also is appropriate to terminate the proceeding with respect to Patent Owner, because we have not yet decided the merits of this proceeding. As a result, it is appropriate to enter judgment in the form of termination. See 37 C.F.R. § 42.2. Accordingly, it is ORDERED that the joint motion to terminate IPR2013-00450 is granted, and this proceeding is hereby terminated as to all parties, including Petitioner Clio USA, Inc. and Patent Owner The Procter & Gamble Company; and” slip op. at 2
NonePatents in suitUS 7,122,199 - PTAB · Oct 31, 2014 · IPR2013-00448 · APJ Scott E Kamholz · IPR · Order
The Board granted the parties’ joint motion and terminated the proceeding as to all parties before deciding the merits.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“The parties filed a joint motion to terminate the instant proceeding (Paper 55 (“Mot.”)), and a true copy of their written settlement agreement (Ex. 2037) made in connection with the termination, in accordance with 35 U.S.C. § 317 and 37 C.F.R. § 42.74(b). The parties also jointly requested that their settlement agreement be treated as business confidential information under 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c). Paper 56. For the reasons provided below, the joint motion to terminate is granted. The joint request that the settlement agreement be treated as business confidential information is also granted.” slip op. at 2
NonePatents in suitUS 5,891,453
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.