Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 17
`Entered: December 19, 2013
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`CYANOTECH CORPORATION
`Petitioner
`
`v.
`
`THE BOARD OF TRUSTEES OF THE UNIVERSITY OF ILLINOIS
`Patent Owner
`____________
`
`Case IPR2013-00401
`Patent 5,527,533
`____________
`
`Before SCOTT E. KAMHOLZ, SHERIDAN K. SNEDDEN, and
`GEORGIANNA W. BRADEN, Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`
`Institution of Inter Partes Review and
`Consolidation with Case IPR2013-00404
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 17
`Entered: December 19, 2013
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`CYANOTECH CORPORATION
`Petitioner
`
`v.
`
`THE BOARD OF TRUSTEES OF THE UNIVERSITY OF ILLINOIS
`Patent Owner
`____________
`
`Case IPR2013-00401
`Patent 5,527,533
`____________
`
`Before SCOTT E. KAMHOLZ, SHERIDAN K. SNEDDEN, and
`GEORGIANNA W. BRADEN, Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`
`Institution of Inter Partes Review and
`Consolidation with Case IPR2013-00404
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`Case IPR2013-00401
`Patent 5,527,533
`
`
`I.
`
`INTRODUCTION
`
`In Case IPR2013-00401, Cyanotech Corporation (“Cyanotech”) filed a
`corrected petition (Paper 9, “Pet. ’401”) to institute an inter partes review of
`claims 1-27 of U.S. Patent No. 5,527,533 (“the ’533 patent”). Patent Owner, the
`Board of Trustees of the University of Illinois (“the University”), filed a
`preliminary response (Paper 15, “Prelim. Resp. ’401”).
`In Case IPR2013-00404, Cyanotech filed a corrected petition (Paper 8, “Pet.
`’404”) to institute an inter partes review of claims 1-27 of the ’533 patent. The
`University filed a preliminary response (Paper 13, “Prelim. Resp. ’404”).
`Case IPR2013-00401 and Case IPR2013-00404 involve the same patent and
`parties, and there is overlap in the asserted prior art and additional evidence
`submitted by Cyanotech. As discussed in detail below, we conclude that, under the
`present circumstances, securing the just, speedy, and inexpensive resolution of the
`instant proceeding would best be served by consolidating these proceedings.
`The Board has jurisdiction under 35 U.S.C. § 314. The standard for
`instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which states:
`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director
`determines that the information presented in the petition
`filed under section 311 and any response filed under
`section 313 shows that there is a reasonable likelihood
`that the petitioner would prevail with respect to at least 1
`of the claims challenged in the petition.
`Upon consideration of the above-mentioned petitions and preliminary
`responses, we conclude that Cyanotech has established that there is a reasonable
`likelihood that it will prevail with respect to at least one of the challenged claims.
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`Therefore, we grant the petition to institute an inter partes review as to claims 1-
`15, 21, 22, and 26, but deny the petition as to claims 16-20, 23-25, and 27.
`
`A. Related Proceedings
`
`The parties represent that the ’533 patent was involved in a declaratory-
`judgment civil action, Cyanotech Corporation v. U.S. Nutraceuticals, LLC d/b/a
`Valensa International and The University of Illinois (Civ. No. 1:12-cv-00352) (D.
`Hawaii) (hereinafter “Hawaii Action”). Pet. ’401, 2; Prelim. Resp. ’401, 2.
`Cyanotech filed the action on June 20, 2012, and challenged the validity of claims
`of the ’533 patent (Ex. 1037 and Ex. 2001).
`The University moved for dismissal from the Hawaii Action on the basis of
`sovereign immunity. Prelim. Resp. ’401, 2. The court in the Hawaii Action
`granted the motion and dismissed the action under FRCP 41(b) for failure to join
`an indispensable party. Id. The dismissal was without prejudice to Cyanotech
`bringing its claims in a co-pending parallel proceeding styled U.S. Nutraceuticals
`LLC d/b/a Valensa International; and The Board of Trustees of the University of
`Illinois v. Cyanotech Corporation, and Nutrex Hawaii, Inc. Civ. 5:12-cv-366-OC-
`10TBS (M.D. Fla), filed June 29, 2012. Ex. 1038, 2.
`
`B. The ’533 Patent (Ex. 1001)
`
`The ’533 patent relates “to methods of treating central nervous system and
`eye insult resulting from disease or injury” comprising the administration of
`astaxanthin. Ex. 1001, col. 1, ll. 9-11. Astaxanthin “ameliorates neuronal damage
`to the retina, wherein the neuronal damage is a result of photic injury, or ischemic,
`inflammatory or degenerative insult.” Id. at col. 6, ll. 67 to col. 7, ll. 2. “With
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`respect to damage from photic injury, astaxanthin decreases the loss of
`photoreceptor cells. With respect to damage from ischemic insult, astaxanthin
`ameliorates the loss of ganglion cells and the inner layers of the retinal neuronal
`network.” Id. at col. 8, ll. 54-56.
`Additionally, “[b]ecause astaxanthin is a highly-effective antioxidant and
`ameliorates free radical-induced eye damage, the administration of astaxanthin also
`provides a method of treating free radical-induced disease or injury to the central
`nervous system in general.” Id. at col. 15, ll. 56-60. Thus, “astaxanthin can be
`administered to stroke victims to ameliorate the ischemic insult-related injury
`attributed to the stroke” and “can be administered to individuals suffering from a
`traumatic injury to the spinal cord which leads to free radical-induced damage.”
`Id. at col. 15, ll. 60-65.
`Astaxanthin, unlike other carotenoids studied, can cross the blood-retinal
`brain barrier readily (unlike β-carotene) without accumulating pathologically in the
`eye. Id. at col. 10, ll. 18-22. Comparative studies with β-carotene demonstrate that
`astaxanthin is more effective than β-carotene at protecting rats from photic injury.
`Id. at col. 13, l. 60 to col. 14, l. 50.
`
`C. Independent Claims
`
`The challenged claims encompass nine independent claims, reproduced
`below, with emphasis added:
`1. A method of treating an individual suffering from retinal
`damage or
`retinal disease,
`said method comprising
`administering a therapeutically effective amount of astaxanthin
`to the individual to improve the vision of the individual.
`13. A method of
`treating an
`individual comprising
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`administering a therapeutically effective amount of astaxanthin
`to the individual to protect neurons in a retina of the individual
`from free-radical induced retinal injury.
`14. A method of treating an individual suffering from neuronal
`damage to a retina comprising administering a therapeutically-
`effective amount of astaxanthin to the individual to improve the
`condition of the retina.
`16. A method of treating an individual suffering from age-
`related macular degeneration comprising administering a
`therapeutically-effective amount of astaxanthin to the individual
`to retard the progress of age-related macular degeneration.
`17. A method of treating an individual suffering from an
`ischemic or intraocular pressure-related disease of a retina
`comprising administering a therapeutically-effective amount of
`astaxanthin to the individual to improve the condition of the
`retina and to prevent further damage to the retina.
`19. A method of treating an individual suffering from an
`inflammatory disease of a retina comprising administering a
`therapeutically effective amount of astaxanthin to the individual
`to improve the condition of the retina and to prevent further
`damage to the retina.
`21. A method of treating an individual suffering from a free
`radical-induced injury to a central nervous system, said method
`comprising administering a therapeutically-effective amount of
`astaxanthin to the individual to improve the condition of the
`central nervous system.
`26. A method of treating an individual suffering from a
`degenerative
`retinal disease,
`said method comprising
`administering a therapeutically effective amount of astaxanthin
`to the individual to retard the progress of the disease.
`27. A method of treating an individual suffering from a
`degenerative central nervous system disease of a brain or spinal
`cord, said method comprising administering a therapeutically
`effective amount of astaxanthin to the individual to retard the
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`progress of the disease.
`D. Consolidation
`
`35 U.S.C. § 315(d) governs consolidation of inter partes and provides:
`(d) MULTIPLE PROCEEDINGS.—Notwithstanding
`sections 135(a), 251, and 252, and chapter 30, during the
`pendency of an inter partes review, if another proceeding
`or matter involving the patent is before the Office, the
`Director may determine the manner in which the inter
`partes review or other proceeding or matter may proceed,
`including providing for stay, transfer, consolidation, or
`termination of any such matter or proceeding.
`
`
`37 C.F.R. § 42.122(a) provides that “[w]here another matter involving the
`patent is before the Office, the Board may during the pendency of the inter partes
`review enter any appropriate order regarding the additional matter including
`providing for the stay, transfer, consolidation, or termination of any such matter.”
`The Board’s rules for AIA proceedings “shall be construed to secure the just,
`speedy, and inexpensive resolution of every proceeding.” 37 C.F.R. § 42.1(b); see
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,758 (August 14, 2012).
`We conclude that, under the present circumstances, it is appropriate to
`consolidate this proceeding with that of Case IPR2013-00404. The proceedings
`were filed on subsequent days, involve the same patent and parties, and there is
`significant overlap in the asserted prior art. Therefore, decisions to institute inter
`partes review are entered concurrently in both proceedings.
`Petitioner will be required to re-file any exhibits unique to Case IPR2013-
`00404 under Case IPR2013-00401.
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`E. The Prior Art
`
`Petitioner relies on the following prior art:
`Ex. 1021
`Baranowitz et al. US 5,310,764
`10 May 1994
`René Grangaud, “Research on Astaxanthin, a New Vitamin A Factor”
`(1951) (unpublished doctorate dissertation, University of Lyon) (Ex. 1003,
`the English translation of which is Ex. 1002).
`
`J.E. Dowling & I.R. Gibbons, The effect of vitamin A deficiency on the fine
`structure of the retina, in The Structure of the Eye, 85-99 (C.K. Smelser ed.,
`New York, Academic Press, Inc. 1961) (Ex. 1026).
`
`Renée Massonet, “Research on Astaxanthin’s Biochemistry” (1958)
`(unpublished doctorate dissertation, University of Lyon) (Ex. 1005, the
`English translation of which is Ex. 1004).
`
`F. The Asserted Grounds
`
`In Pet. ’401, Cyanotech challenges claims 1-27 of the ’533 patent on the
`following grounds:
`Reference[s]
`
`Claims challenged
`
`Basis
`
`Grangaud
`
`§ 102
`
`1, 3, 8-24, and 26
`
`Grangaud and Baranowitz § 103
`
`Grangaud and Dowling
`
`Grangaud
`
`
`
`§ 103
`
`§ 103
`
`1-27
`
`1-27
`
`1, 3, and 8-27
`
`In Pet. ’404, Cyanotech also challenges claims 1-27 of the ’533 patent on the
`following grounds:
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`Reference[s]
`
`Massonet
`
`Basis
`
`§ 102
`
`Claims challenged
`
`1, 3, 8-24, and 26
`
`Massonet and Baranowitz
`
`§ 103
`
`Massonet and Dowling
`
`Massonet
`
`
`G. Claim Interpretation
`
`§ 103
`
`§ 103
`
`1-27
`
`1-27
`
`1, 3, and 8-27
`
`In an inter partes review, claim terms in an unexpired patent are interpreted
`according to their broadest reasonable construction in light of the specification of
`the patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
`Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Claim terms are
`given their ordinary and customary meaning, as would be understood by one of
`ordinary skill in the art in the context of the entire disclosure. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a
`claim term must be set forth in the specification with reasonable clarity,
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`In its Petition, Cyanotech sets forth what it considers to be the ordinary
`meaning for claim terms: “treating,” “damage,” “injury,” “disease,” and
`“individual.” Pet. ’401, 12-13; see also Ex. 1033 ¶ 20. The University does not
`address Cyanotech’s proposed constructions. The ’533 patent does not set forth
`specific definitions, and we have no basis to conclude that the words of the claims
`should not be given their ordinary meaning. Cyanotech’s proposed constructions
`are reasonable at this stage of the proceeding. Therefore, we adopt them for the
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`purposes of this decision.
`Claim 1 recites a method of treating an individual suffering from retinal
`damage or retinal disease. Claims 8-12 recite particular types of retinal damage,
`but do not exclude treatment of retinal disease. For example, claim 12
`encompasses a method of treating an individual suffering from age-related macular
`degeneration or retinal disease.
`
`II. ANALYSIS
`
`A. Whether Petitioner is Barred Under Section 315
`
`Section 315 of title 35 proscribes the relation of other proceedings or actions
`to inter partes review proceedings. 35 U.S.C. § 315(a)(1) states:
`INTER PARTES REVIEW BARRED BY CIVIL ACTION.—An
`inter partes review may not be instituted if, before the date on which
`the petition for such a review is filed, the petitioner or real party in
`interest filed a civil action challenging the validity of a claim of the
`patent.
`
`Cyanotech asserts that it is not barred or estopped from requesting inter
`partes review challenging the ’533 Patent claims, because the Hawaii Action was
`dismissed without prejudice and has no preclusive effect. Pet. 3 (citing FED. R.
`CIV. P. 41(b)). The University argues that § 315(a)(1) is clear on its face: The
`operative event is filing a civil action, and the ultimate disposition of that civil
`action is not relevant. Prelim. Resp. ’401, 6. We decline to adopt the University’s
`interpretation of § 315(a)(1), because such an interpretation fails to consider
`adequately relevant case law and legislative intent.
`Federal courts treat dismissals without prejudice as an action that de jure
`never existed. Holloway v. United States, 60 Fed. Cl. 254, 261 (Fed. Cl. 2004)
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`aff’d, 143 Fed. App’x 313 (Fed. Cir. 2005); see also Beck v. Caterpillar, Inc., 50
`F.3d 405, 407 (7th Cir. 1995) (“[Plaintiff’s] suit was voluntarily dismissed
`pursuant to Fed. R. Civ. P. 41(a), and is treated as if it had never been filed.”). The
`action is a nullity and the parties are left in the same legal position as if the civil
`action had never been filed. Bonneville Assocs., Ltd. P’ship v. Barram, 165 F.3d
`1360, 1364 (Fed. Cir. 1999); see also Graves v. Principi, 294 F.3d 1350, 1356
`(Fed. Cir. 2002) (“The dismissal of an action without prejudice leaves the parties
`as though the action had never been brought.”). Thus, when a lawsuit is dismissed
`without prejudice, the parties are free to litigate the matter in a subsequent action,
`as though the dismissed action had never existed. Univ. of Pittsburgh v. Varian
`Med. Sys., Inc., 569 F.3d 1328, 1333 (Fed. Cir. 2009) (“‘[D]ismissals for lack of
`jurisdiction are not decisions on the merits and therefore have no res judicata effect
`on subsequent attempts to bring suit in a court of competent jurisdiction.’”
`(quoting Kasap v. Folger Nolan Fleming & Douglas, Inc., 166 F.3d 1243, 1248
`(D.C. Cir. 1999)). A dismissal for failure to join a party typically is made without
`prejudice. See Univ. of Pittsburgh, 569 F.3d at 1332.
`We are guided by federal case law for our interpretation of § 315(a)(1). The
`Hawaii Action was dismissed without prejudice and, therefore, is a nullity. In the
`context of § 315(a)(1), the action was never filed.
`The University notes correctly that Congress placed clear “procedural
`limits” on the new post-grant review proceedings to “prevent abuse of these
`proceedings for the purposes of harassment or delay.” 157 CONG. REC. S1374
`(daily ed. March 8, 2011) (statement of Sen. Kyl). Specifically, the AIA imposes
`time limits on starting an inter partes review after litigation is commenced and
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`estops relitigating in court those issues that a petitioner raised, or reasonably could
`have raised, during an inter partes review. 35 U.S.C. §§ 315(b), 315(e)(1).
`The legislative history of § 315(a), however, indicates that inter partes
`review was intended to replace inter partes reexamination with an adjudicative
`process1 that, in addition to being a faster and more efficient alternative to civil
`litigation,2 would require parties to coordinate their validity challenges with civil
`litigation.3 It was not the intent of Congress, however, to bar a petitioner under §
`315(a) and force him to bring his claims in civil litigation. That interpretation
`would frustrate the Congressional intent of creating an adjudicative process as an
`alternative to civil litigation, and would lead to the unjustified scenario where a
`party could challenge a patent in civil litigation but not in inter partes review.
`Under § 315(a), parties have a choice of forum to challenge the invalidity of a
`patent. We are, therefore, not persuaded by the University’s arguments to the
`contrary. Prelim. Resp. ’401, 4-9.
`For the reasons stated above, the dismissal of the Hawaii Action without
`prejudice does not trigger the statutory bar against instituting an inter partes
`
`
`1 157 CONG. REC. S1041 (daily ed. March 1, 2011) (statement of Sen. Kyl) (“The
`present bill . . . repeal[s] requirements that inter partes be run on an examinational
`model and allow[s] the PTO to adopt an adjudicative model.”).
`2 157 CONG. REC. S936-S953 (daily ed. February 28, 2011) (statement of Sen.
`Grassley) (“These new procedures would also provide faster, less costly
`alternatives to civil litigation to challenge patents.”).
`3 157 CONG. REC. S1034-S1051 (daily ed. March 1, 2011) (statement of Sen. Kyl)
`(“The present bill does coordinate inter partes and post-grant review with
`litigation, barring use of these proceedings if the challenger seeks a declaratory
`judgment that a patent is invalid.”)
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`review under 35 U.S.C. § 315(a). Excluding an action that de jure never existed
`from the scope of § 315(a)(1) is consistent with both relevant case law and
`legislative history.
`
`B. Anticipation of Claims 1, 3, 8-24, and 26 by Grangaud
`
`Summary of Grangaud
`1.
`Grangaud discloses the results of experiments conducted on rats fed a
`vitamin A-deficient diet. Ex. 1002, 43. The animals developed complications of
`vitamin A deficiency that included xerophthalmia (“dry eye”) and death. Visible
`signs of xerophthalmia were described as ocular lesions. See e.g., id. at 44, 49.
`The restoration of vitamin A or astaxanthin to the vitamin A-deficient diet was
`sufficient to heal the ocular lesions. Id. Grangaud concluded that astaxanthin has
`vitamin A activity. Id. at 56. Grangaud further noted that the antioxidant strength
`of astaxanthin is comparable to that of vitamin A, and that astaxanthin shares the
`antixerophthalmic activity of vitamin A. Id.
`Grangaud is silent as to the mechanism of the disease pathogenesis for
`vitamin A deficiency. Grangaud provides no evidence tending to establish that the
`vitamin A-deficient rats exhibited retinal damage.
`
`Claims 1, 3, 8-15, 21, 22, and 26 in view of Grangaud
`2.
`Cyanotech relies on the Declaration of Florian J. Schweigert (“Schweigert
`declaration”) (Ex. 1033) to establish that vitamin A-deficient rats exhibiting dry
`eye necessarily have damage to the retina and retinal cells. For example,
`Schweigert states that severe vitamin A deficiency causes degeneration in the
`retina that precedes dry eye. Ex. 1033 ¶ 27. According to Schweigert, these types
`of retinal damage were reversed upon restoring vitamin A in the rats’ diets. Id. at ¶
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`42 (citing Figure 10 of Dowling). Schweigert then testifies that the types of retinal
`damage resulting from vitamin A deficiency include free radical-induced damage
`and injury. Id. at ¶ 88. Schweigert concludes that the astaxanthin administration
`by Grangaud necessarily treats retinal damage as well as dry eye. Id. at ¶ 67.
`The evidence presented by Cyanotech tends to demonstrate that retinal
`damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia
`and Grangaud discloses that administration of astaxanthin to vitamin A-deficient
`rats treats ocular lesions, a visible sign of xerophthalmia, thereby improving the
`vision of the rats. Pet. ’401, 14-16; Grangaud, 44. In view of this evidence, we
`conclude that there is a reasonable likelihood that Cyanotech will prevail in
`proving unpatentability of claim 1 for anticipation by Grangaud. See Perricone v.
`Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005) (“‘Under the
`principles of inherency, if the prior art necessarily functions in accordance with, or
`includes, the claims limitations, it anticipates.”’ (citation omitted)).
`We have considered fully Cyanotech’s arguments and evidence concerning
`anticipation by Grangaud of claims 3, 8-15, 21, 22, and 26, and are persuaded by
`Cyanotech of a reasonable likelihood that it will prevail in showing that these
`claims were anticipated by Grangaud. Accordingly, we institute inter partes
`review of claims 1, 3, 8-15, 21, 22, and 26 for anticipation by Grangaud.
`
`Claims 16-20 and 23-24 in view of Grangaud
`3.
`The ’533 patent presents two types of claims: A first set directed to the
`treatment of a certain type of damage and a second set directed to the treatment of
`conditions presenting a certain type of damage. Cyanotech seeks to establish that
`the type of damage recited in the first set of claims is inherent in the conditions
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`recited by the second set of claims. Pet. ’401, 23-28. However, even if successful,
`Cyanotech would not prevail in establishing that Grangaud anticipates claim 16-20,
`and 23-24, because Cyanotech has failed to provide sufficient and credible
`evidence of an inherent link between a patient population having dry eye, such as
`the population disclosed in Grangaud, and the patient populations having the
`conditions recited in claims 16-20 and 23-24. See Perricone, 432 F.3d at 1378-79.
`Cyanotech’s identification of a possible common mechanism of disease
`pathogenesis is insufficient to establish anticipation of these claims. Grangaud
`does not teach that all patients with severe vitamin A deficiency necessarily
`develop the specific indications or conditions set forth in these claims. For
`example, Cyanotech fails to point out sufficient and credible evidence of record
`that the patient population of individuals suffering from severe vitamin A
`deficiency is the same population of patients as the population of patients suffering
`from, for example, stroke (claim 23) and spinal cord injury (claim 25). For these
`reasons, we determine that evidence presented by Cyanotech does not present a
`reasonable likelihood that claims 16-20 and 23-24 are anticipated by Grangaud.
`
`C. Obviousness of Claims 1-27 over Grangaud and Dowling
`
`Summary of Dowling
`1.
`Dowling describes the effects of vitamin A-deficiency on the fine structure
`of the retina. Ex. 1026, 85-86. Figures 2b to 2d show the retinal degeneration of
`rats on a vitamin A-free diet supplemented with vitamin A acid as compared to rats
`on a vitamin A-free diet with vitamin A (alcohol) supplementation (Fig. 2a). Id. at
`88-89. Figure 10c shows the recovery of degenerated rat retinal layers by
`administration of vitamin A after retinal injury. Id. at 94-95.
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`Claims 1-15, 21, 22, and 26
`2.
`As summarized above, there is a reasonable likelihood Cyanotech can
`establish that severe vitamin A deficiency necessarily causes retinal damage or
`disease, as recited in claim 1. Cyanotech relies on Grangaud and evidence
`provided in Dowling and the Schweigert declaration to establish that astaxanthin
`shares the antixerophthalmic activity of vitamin A, and that vitamin A-deficient
`rats exhibiting dry eye necessarily have damage to the retina and retinal cells.
`Pet.’401, 15-17. Cyanotech has, thus, demonstrated a reasonable likelihood of
`establishing that it would have been obvious to substitute astaxanthin for vitamin A
`for the purposes of treating complications caused by vitamin A-deficiency.
`Accordingly, we determine that evidence presented in the record by Cyanotech
`establishes a reasonable likelihood that claims 1, 3, 8-11, 13-15, 21, 22 and 26
`would have been obvious over the combination of Grangaud and Dowling for the
`reasons discussed above.
`Claims 2 and 4-7 are directed to administration routes and dosages for
`administrating astaxanthin according to the method of claim 1. We determine that
`evidence presented by Cyanotech reasonably supports a finding that applying
`Grangaud’s effective administration routes and dosages of astaxanthin in rats to the
`administration routes and dosages encompassed by claims 2 and 4-7 would have
`been a predictable variation that could have been implemented by one of ordinary
`skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007) (“If a
`person of ordinary skill can implement a predictable variation, § 103 likely bars its
`patentability.”). Accordingly, we determine that the evidence presented by
`Cyanotech presents a reasonable likelihood that claims 2 and 4-7 would have been
`
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`obvious over Grangaud and Dowling.
`
`Claims 16-20, 23-25, and 27
`3.
`As summarized above, Cyanotech has failed to provide sufficient and
`credible evidence establishing an inherent link between a patient population having
`dry eye, such as the population disclosed in Grangaud, and the patient populations
`having the conditions recited in claims 16-20, 23-25, and 27. Dowling discloses
`that vitamin A deficiency causes retinal damage, but does not cure the deficiencies
`of Grangaud. Thus, the evidence set forth by Cyanotech does not reasonably
`support a conclusion that a person of ordinary skill in the art could have modified
`the teachings Grangaud with Dowling to arrive at the subject matter of claims 16-
`20, 23-25, and 27.
`
`D. Obviousness of Claims 1-27 over Grangaud and Baranowitz
`
`Summary of Baranowitz
`1.
`Baranowitz relates to methods for treating age-related macular degeneration
`(ARMD) in a mammal with β-carotene. Ex. 1021, abstract. Baranowitz discloses
`that administration of β-carotene may reduce the number or size of drusen (see
`e.g., id. at col. 7, ll. 43-54), the earliest and most obvious clinical sign of ARMD
`(id. at col. 1, l. 52).
`Baranowitz discloses that β-carotene is converted in mammals to give two
`equivalents of the aldehyde retinol, and that biochemical reduction of the aldehyde
`carbon yields vitamin A. Id. at col. 5, ll. 10-13. Baranowitz, however, does not
`disclose the treatment of age-related macular degeneration with vitamin A and
`makes no experimental determination as to whether vitamin A is capable of fading
`drusen.
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`Analysis
`2.
`Cyanotech relies on Baranowitz (Ex. 1021) for the disclosure that the use of
`retinal carotenoids confers antioxidant protection against highly reactive singlet
`oxygen created by exposure to light (Pet. ’401, 28) and that the administration of
`appropriate amounts of β-carotene can treat successfully age-related macular
`degeneration (id. at 34-35). Cyanotech contends it would have been obvious to
`substitute astaxanthin for β-carotene in the method of Baranowitz because both
`astaxanthin and vitamin A were known as effective retinal antioxidants (id. at 28).
`We are not persuaded for the reasons explained below.
`A determination of obviousness is appropriate when the prior art “contain[s]
`detailed enabling methodology for practicing the claimed invention, a suggestion
`to modify the prior art to practice the claimed invention, and evidence suggesting
`that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988).
`Here, there is insufficient evidence of record to establish that β-carotene is the
`functional equivalent of vitamin A, such that the simple substitution of vitamin A
`for β-carotene would produce the same desired results. Cyanotech fails to address
`whether β-carotene is effective for treating age-related macular degeneration due to
`its own antioxidant activity, or that of its downstream metabolites aldehyde retinol
`and vitamin A. See Ex. 1021, col. 5, ll. 10-12
`Moreover, the ’533 patent discloses that astaxanthin, unlike β-carotene,
`“surprisingly” was found to be able to cross the blood-retinal brain barrier to reach
`the retina. Ex. 1001, col. 10, ll. 17-20. Though the ’533 patent provides no
`objective factual evidence to explain why the finding was surprising, or by whom
`the finding was made, the finding nevertheless suggests that β-carotene and
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`astaxanthin are not functional equivalents. Cyanotech offers no credible evidence
`to show that this finding was not unexpected or that astaxanthin would have been
`regarded as a simple substitute for β-carotene that would have yielded predictable
`results. In the face of the disclosure suggesting that β-carotene and astaxanthin are
`not functional equivalents, Cyanotech’s assertion that it would have been obvious
`to substitute one for the other does not amount to sufficient “articulated reasoning
`with some rational underpinning” to support its assertion of obviousness. See KSR
`Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).
`Accordingly, we determine that the evidence presented by Cyanotech does
`not present a reasonable likelihood that at least one of claims 1-27 would have
`been obvious over Grangaud and Baranowitz. Therefore, this ground is denied.
`
`E. Obviousness of Claims 1, 3, and 8-27 over Grangaud
`
`Cyanotech makes no meaningful distinction between this ground and the
`grounds on which we granted the Petition to institute inter partes review for the
`same claims. Therefore, this ground is denied as redundant.
`
`F. Rejections relying on Massonet
`
`Cyanotech’s asserted grounds in Pet. ’401 rely primarily on Grangaud, while
`Cyanotech’s asserted grounds in Pet. ’404 rely primarily on Massonet. Cyanotech
`relies on Grangaud and Massonet to establish identical facts and the Schweigert
`declaration treats Grangaud and Massonet as providing factual equivalents. See
`e.g., Ex. 1033, ¶¶ 22, 45, 51-63, and 67. Finally, Cyanotech makes no meaningful
`distinction between the grounds that rely on Grangaud and the grounds that rely on
`Massonet. Accordingly, we deny the grounds that rely on Massonet as redundant
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`over the grounds that rely on Grangaud on which the petition to institute inter
`partes review has been granted. Where we deny grounds that rely on Grangaud
`due to deficiencies with Grangaud, we deny also the grounds that rely on Massonet
`because Massonet has the same deficiencies as Grangaud.
`
`G. Conclusion
`
`We conclude that Petitioner has demonstrated a reasonable likelihood of
`prevailing on the following grounds of unpatentability asserted in the Petition:
`(i) Claims 1, 3, 8-15, 21, 22, and 26 as anticipated under § 102(b) by
`Grangaud; and
`(ii) Claims 1-15, 21, 22, and 26 as obvious under § 103(a) over the
`combination of Grangaud and Dowling.
`We conclude that Petitioner has not demonstrated a reasonable likelihood of
`prevailing on the following grounds of unpatentability asserted in the Petition:
`Claims 16-20 and 23-24 as anticipated under § 102 by Grangaud;
`Claims 16-20 and 23-24 as anticipated under § 102 by Massonet;
`Claims 16-20 23-25, and 27 as obvious under § 103 over the
`combination of Grangaud and Dowling;
`Claims 16-20, 23-25, and 27 as obvious under § 103 over the
`combination of Massonet and Dowling;
`Claims 1-27 as obvious under § 103 over the combination of
`Grangaud and Baranowitz; and
`Claims 1-27 as obvious under § 103 over the combination of
`Massonet and Baranowitz.
`We decline to institute on the following grounds as they are redundant to the
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`above-mentioned grounds for which the Petition to institute inter partes review has
`already been grant
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