DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`[INSERT NAME OF PETITIONER]
`Petitioner
`v.
`CELGENE
`Patent Owner
`____________
`Case IPR2013-
`Patent 6,315,720
`____________
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 6,315,720
`UNDER 35 USC §§ 311-319 AND 37 CFR §42.100 ET SEQ.
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`
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`Page 1 of 48
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`CELGENE EXHIBIT 2039
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
`
`
`PRIVILEGED AND CONFIDENTIAL
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`[INSERT NAME OF PETITIONER]
`Petitioner
`v.
`CELGENE
`Patent Owner
`____________
`Case IPR2013-
`Patent 6,315,720
`____________
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 6,315,720
`UNDER 35 USC §§ 311-319 AND 37 CFR §42.100 ET SEQ.
`
`
`
`
`
`
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`Page 1 of 48
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`CELGENE EXHIBIT 2039
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
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`
`
`
`
`Contents
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II. OVERVIEW ..................................................................................................... 1
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
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`STATEMENTS ....................................................................................................... 5
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................. 6
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`V. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
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`REASONS THEREFOR (37 C.F.R. §42.22(a)) ................................................... 7
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`VI. OVERVIEW OF U.S. PATENT NO. 6,315,720 ........................................ 7
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`VII. PROSECUTION HISTORY ..................................................................... 13
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`VIII. CLAIM TERMS REQUIRING CONSTRUCTION ........................... 18
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`IX.
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`IDENTIFICATION OF THE GROUNDS FOR CHALLENGE (37
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`C.F.R. § 42.104(b)) ................................................................................................ 27
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`A. The Petition Establishes a Reasonable Likelihood that at Least One
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`Challenged Claim is Anticipated ..................................................................... 27
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`(i) Challenge 1: Claims 1-32 ........................................................................ 29
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`X. CONCLUSION .............................................................................................. 42
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`CERTIFICATE OF SERVICE ........................................................................... 43
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`
`ii
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`Page 2 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`Table of Authorities
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`Cases
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`Akzo N.V. v. U.S. Int’l Trade Comm’n, 808 F.2d 1471, 1479 (Fed. Cir. 1986) ..... 25
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`Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) ..... 24
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`Elan Pharms. Inc. v. Mayo Found., 346 F.3d 1051, 1057 (Fed. Cir. 2003) ........... 25
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`Helifix, Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000) ................... 25
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`In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) ............. 15
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`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111,
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`1116 (Fed. Cir. 2004) .......................................................................................... 15
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`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)
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` ............................................................................................................................. 15
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005 ......................................... 15
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`Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236 (Fed. Cir. 1989) ............... 24
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`Scripps Clinic & Research Found. V. Genentech, Inc., 927 F.2d 1565, 1576 (Fed.
`
`
`
`Cir. 1991) ............................................................................................................ 24
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`iii
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`Page 3 of 48
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`Teleflex, Inc. v. Ficosa North America Corp, 299 F. 3d 1313, 1325 (Fed. Cir. 2001)
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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` ............................................................................................................................. 16
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`Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987)
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` ................................................................................................................. 24, 26, 37
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`Statutes
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`35 U.S.C. § 314 ........................................................................................................ 1
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`35 U.S.C. §§311-319 ................................................................................................ 1
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`37 C.F.R. § 42.108(c) ............................................................................................... 1
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`Other Authorities
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`M.P.E.P. § 2111.01 (IV) ......................................................................................... 16
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`MPEP § 2131.02 ..................................................................................................... 24
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) . 14
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`Rules
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`37 C.F.R. § 42.10(b) and § 42.63(e) .................................................................... 1
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`37 C.F.R. § 42.6(d) ................................................................................................. 25
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`iv
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`Page 4 of 48
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`37 C.F.R. § 42.8(a)(1) .............................................................................................. 2
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`37 C.F.R. § 42.8(b)(1) .............................................................................................. 2
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`37 C.F.R. § 42.8(b)(3) .............................................................................................. 2
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`37 CFR § 42.106(a) ................................................................................................ 1
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`v
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`Page 5 of 48
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`I.
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`INTRODUCTION
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`[INSERT NAME OF PARTY] (the “Petitioner”) hereby petitions for
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`Inter Partes Review (“IPR”) (the “Petition”) under 35 U.S.C. §§311-319
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`seeking cancellation of claims 1-32 of U.S. Patent No. 6,315,720 (the “ ‘720
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`Patent”, Exhibit 1001). Based on the evidence presented in this Petition, the
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`Patent Trial and Appeal Board (the “Board”) should institute an IPR because
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`there is a reasonable likelihood that at least one of the claims challenged in
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`the petition is unpatentable. 37 C.F.R. § 42.108(c).
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`
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`II. OVERVIEW
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`“A claim is anticipated only if each and every element as set forth in
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`the claim is found, either expressly or inherently described, in a single prior
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`art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
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`631 (Fed. Cir. 1987), see also MPEP § 2131.02. “Extrinsic evidence may be
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`considered to explain, but not expand on, the meaning of an anticipatory
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`reference.” In re Baxter Travenol Labs, 952 F.2d 388, 390 (Fed. Cir. 1991).
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`The Federal Circuit has also held that extrinsic evidence may be used to
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`reveal the technical knowledge available to persons of ordinary skill in the
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`field, but may not be used to fill gaps in the reference. Continental Can Co.
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`USA, Inc. v. Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991).
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`1
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`Page 6 of 48
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`The ‘720 patent issued on November 13, 2001 and has an effective
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`filing date of October 23, 2000. Each and every element of the ‘720 patent
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`claims is found in the THALOMIDTM (thalidomide) Capsules Revised
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`
`Package Insert (15 July 1998), as appended to the “Thalomid Capsules
`(Celgene) 07/16/1998 Approval [Erythema Nodosum Leprosum:
`Approval Letter; Final Labeling; Supervisory Review” dated July 17,
`1998 (“Thalomid PI” or “PI”). Exhibit 1002. Because it was available
`more than one year before October 23, 2000, the PI constitutes 35
`
`U.S.C. § 102(b) pre-AIA prior art to the ‘720 patent.
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`A brief overview of claim 1 of the ‘720 patent clearly illustrates why
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`the claim is anticipated by the PI. For clarity, the claim is shown in italics.
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`1. In a method for delivering a drug to a patient in need of the drug, while
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`avoiding the occurrence of an adverse side effect known or suspected of
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`being caused by said drug, wherein said method is of the type in which
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`prescriptions for said drug are filled only after a computer readable
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`storage medium has been consulted to assure that the prescriber is
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`registered in said medium and qualified to prescribe said drug, that the
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`pharmacy is registered in said medium and qualified to fill the
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`prescription for said drug, and the patient is registered in said medium
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`and approved to receive said drug, the improvement comprising:
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`2
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`Page 7 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`Comment - The Thalomid PI is designed to provide a method for
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`delivering a drug, thalidomide, to a patient in need, while avoiding the
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`occurrence of an adverse side effect known or suspected of being caused by
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`the drug. Exhibit 1002 at 18. It provides that all prescribers (physicians) and
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`pharmacists must be registered with the “S.T.E.P.S.” Program, the restricted
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`distribution program for the product, and that all patients must agree to
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`comply with requirements of the program Id. at 1, 3, 4, 21. The S.T.E.P.S.
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`program was designed by Celgene, the manufacturer of Thalomid, and is
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`considered part of the Thalomid product label, or package insert. See
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`Keravich, et al., Am. J. Health-Syst. Pharm., 56: 1721 (1999) (“Keravich”),
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`Exhibit 1003 at 1721, describing aspects of the S.T.E.P.S. program,
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`including the computerized database maintained by Celgene’s customer
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`service division, that includes prescriber (physician) registration, pharmacy
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`registration, and patient registration. Id. at 1722; see also, Declaration of
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`Matthew W. Davis M.D. RhP, Exhibit 1004 which provides a further
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`explanation of aspects of the S.T.E.P.S. program. Note, the Keravich or the
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`Davis Declaration are simply referred to in order to explain the meaning of
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`the PI around the S.T.E.P.S. program and are not cited to either expand on or
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`fill in any gaps in the PI.
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`3
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`Page 8 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`a. defining a plurality of patient risk groups based upon a predefined set
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`of risk parameters for said drug;
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`The PI defines a plurality of patient risk groups based on a predefined set of
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`risk parameters, e.g. women of childbearing potential, men capable of
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`impregnating women. Exhibit 1002.
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`b. defining a set of information to be obtained from said patient, which
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`information is probative of the risk that said adverse side effect is
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`likely to occur if said drug is taken by said patient;
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`The PI lays-out a set of information to be obtained from the patient that is
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`probative of the risk of the drug’s potential side effects, e.g., a signed
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`informed consent form and pregnancy test; Id. at 20-21.
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`c. in response to said information set, assigning said patient to at least
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`one of said risk groups and entering said risk group assignment in
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`said medium;
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`The PI assigns the patient to one of the risk groups, which information is
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`entered into the S.T.E.P.S. database ; Id.; (see also Exhibit 1003 at 1722-23
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`(describing that patients are registered into Celgene’s S.T.E.P.S. database
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`based on their signed informed consent form).
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`4
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`Page 9 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`d. based upon said information and said risk group assignment,
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`determining whether the risk that said adverse side effect is likely to
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`occur is acceptable; Id.
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`e. upon a determination that said risk is acceptable, generating a
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`prescription approval code to be retrieved by said pharmacy before
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`said prescription is filled. Id.
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`In summary, each and every element of claim 1 is set forth in the
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`Thalomid PI, which incorporates the S.T.E.P.S. program, and the claim is
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`therefore, anticipated. A similar rationale applies for claims 2-32 as
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`discussed in greater detail below.
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`
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a));
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`PROCEDURAL STATEMENTS
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`Petitioner certifies that the ‘720 patent is available for IPR and
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`that the Petitioner is not barred or estopped from requesting an IPR of any
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`claim of the ‘720 patent on the grounds identified herein. This Petition is
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`filed in accordance with 37 CFR § 42.106(a). P owers of Attorney are
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`filed concurrently , as well as an Exhibit List per 37 C.F.R. § 42.10(b)
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`and § 42.63(e), respectively. The required fee is paid via online credit
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`card payment. The Office is authorized to charge fee deficiencies and
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`5
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`Page 10 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`credit overpayments to Deposit Acct. No. __________ (Customer ID No.
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`___________).
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
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`The Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) are:
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`[INSERT PARTY] (the “Petitioner.”)
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`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):
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`Back-Up Counsel
`Tarek N. Fahmi, Esq.
`
` D
`
` +1 408 389 3537
`T +1 866 877 4883
`F +1 408 773 6177
`
`tarek.fahmi@fseip.com
`
`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`Lead Counsel
`Michael A. Davitz M.D. J.D.
`
`
`
`T: +1 866-877-4883
`C: +1 914-582-8817
`F: +1 408-773-6177
`
`michael.davitz@fseip.com
`
`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.,
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`
`
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`Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please
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`direct all correspondence to lead counsel at the above address. Petitioners
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`6
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`Page 11 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`consent to email service at: michael.davitz@fseip.com and
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`tarek.fahmi@fseip.com.
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`V.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
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`THE REASONS THEREFOR (37 C.F.R. §42.22(a))
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`
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`Petitioners request IPR and cancellation of claims 1-32 of the ‘720
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`patent. A summary of the reasons for the relief is set forth in §II and in
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`greater detail below.
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`
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`VI. OVERVIEW OF U.S. PATENT NO. 6,315,720
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`
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`The ‘720 patent issued on November 13, 2001 and has an effective
`
`filing date of October 23, 2000. The patent describes methods for delivering
`
`a drug to a patient, while avoiding the occurrence of adverse side effects.
`
`Prescriptions are only filled after a computer readable storage medium has
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`been consulted to confirm that the prescribers, pharmacies, and patients are
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`registered in a computer database. Patients may be assigned to risk groups
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`based on the degree of risk that taking the drug will lead to a side effect.
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`Periodic surveys as well as diagnostics tests can also be obtained prior to
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`approving dispensing the drug. Exhibit 1001 at Abstract.
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`7
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`Page 12 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`There are 32 claims with two independent claims. Claim 1 is
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`representative and is reproduced below.
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`Claim 1. In a method for delivering a drug to a patient in need of the
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`drug, while avoiding the occurrence of an adverse side effect known or
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`suspected of being caused by said drug, wherein said method is of the type
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`in which prescriptions for said drug are filled only after a computer readable
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`storage medium has been consulted to assure that the prescriber is registered
`
`in said medium and qualified to prescribe said drug, that the pharmacy is
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`registered in said medium and qualified to fill the prescription for said drug,
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`and the patient is registered in said medium and approved to receive said
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`drug, the improvement comprising:
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`a. defining a plurality of patient risk groups based upon a predefined
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`set of risk parameters for said drug;
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`b. defining a set of information to be obtained from said patient,
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`which information is probative of the risk that said adverse side effect is
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`likely to occur if said drug is taken by said patient;
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`c. in response to said information set, assigning said patient to at least
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`one of said risk groups and entering said risk group assignment in said
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`medium;
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`Page 13 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`d. based upon said information and said risk group assignment,
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`determining whether the risk that said adverse side effect is likely to occur is
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`acceptable; and
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`e. upon a determination that said risk is acceptable, generating a
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`prescription approval code to be retrieved by said pharmacy before said
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`prescription is filled.
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`The dependent claims, claims 2-27, recite the following limitations:
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`Claim 2 adds the limitation of “in response to said risk group
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`assignment, said patient is counseled as to the risks of taking said drug and
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`advised as to risk avoidance measures” to claim 1. Claim 3 adds “wherein
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`said counseling comprises full disclosure of said risks” to claim 2. Claim 4
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`adds “wherein said prescription is filled only following said full disclosure
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`and informed consent of said patient” to claim 3. Claim 5 adds “wherein
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`said risk group assignment and said informed consent is verified by said
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`prescriber at the time that said patient is registered in said computer readable
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`storage medium” to claim4. Claim 6 adds “wherein said risk group
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`assignment and said informed consent is transmitted to said computer
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`readable storage medium by facsimile and interpreted by optical character
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`recognition software” to claim 7. Claim 7 adds “wherein said set of
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`information includes the results of diagnostic testing” to claim 1. Claim 8
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`9
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`Page 14 of 48
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`adds “wherein said diagnostic testing is probative of the onset of said
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`adverse side effect” to claim 7. Claim 9 adds “wherein said diagnostic
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`testing is probative of the concentration of said drug in a tissue of said
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`patient” to claim 7.
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`Claim 10 adds “wherein said diagnostic testing comprises genetic
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`testing” to claim 7. Claim 11 adds “wherein said side effect is likely to arise
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`in said patient” to claim 1. Claim 12 adds “wherein said side effect is likely
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`to arise in a foetus carried by said patient” to claim 1. Claim 13 adds
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`“wherein said side effect is likely to arise in a recipient or a foetus carried by
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`a recipient of the bodily fluid of said patient” to claim 1. Claim 14 adds
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`“wherein said recipient is a sexual partner of said patient” to claim 13.
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`Claim 15 adds “[t]he method of claim 1 further comprising: f. defining for
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`each said risk group a second set of information to be collected from said
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`patient on a periodic basis; g. obtaining said second set of information from
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`said patient; and h. entering said second set of information in said medium
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`before said patient is approved to receive said drug” to claim 1. Claim 16
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`adds “wherein said second set of information comprises a survey regarding
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`said patient's behavior and compliance with said risk avoidance measures” to
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`claim 15. Claim 17 adds “wherein said survey is conducted telephonically
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`using an integrated voice response system” to claim 16. Claim 18 adds
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`“wherein said patient is a female of childbearing potential and said second
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`set of information comprises the results of a pregnancy test” to claim 16.
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`Claim 19 adds “wherein said periodic interval comprises about 28 days” to
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`claim 18. Claim 20 adds “further comprising providing said patient with a
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`contraceptive device or formulation” to claim 1. Claim 21 adds “wherein
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`said adverse side effect comprises a teratogenic effect” to claim 1. Claim 22
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`adds “wherein said drug is thalidomide” to claim 1. Claim 23 adds “wherein
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`said teratogenic effect is likely to arise in a foetus carried by said patient” to
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`claim 21. Claim 24 adds “wherein said teratogenic effect is likely to arise in
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`a foetus carried by a recipient of the bodily fluid of said patient” to claim 21.
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`Claim 25 adds “wherein said recipient of the bodily fluid of said patient is a
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`sexual partner of said patient” to claim 24. Claim 26 adds “wherein said set
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`of information includes the results of a pregnancy test” to claim 21. Claim
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`27 adds “wherein said prescription is filled for no more than about 28 days”
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`to claim 26.
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`The other independent claim, 28, is identical to claim 1 with the
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`following limitation: “wherein said adverse side effect is likely to arise in
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`patients who take said drug in combination with at least one other drug.”
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`The claims which depend from claim 28 recite the following
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`limitations: claim 29 adds “wherein said set of information is also probative
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`DRAFT – ATTORNEY-CLIENT
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`of the likelihood that said patient may take said drug and said other drug in
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`combination” to claim 28. Claim 30 adds “wherein said set of information
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`includes the results of diagnostic testing” to claim 28. Claim 31 adds
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`“wherein said diagnostic testing comprises testing for evidence of the use of
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`said other drug” to claim 30. Claim 32 adds “wherein said diagnostic testing
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`comprises testing for evidence which is indicative of the onset of said
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`adverse side effect” to claim 30.
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`The drug delivery methods described are generally to “methods for
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`delivering drugs known or suspected of causing an adverse side effect,
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`especially teratogenic drugs, to patients.” Exhibit 1001 at 3:31-34.
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`According to the specification, the methods of the present invention
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`may be “advantageously employed” in order to avoid taking drugs that can
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`cause adverse side effects in patients “for whom the drug is
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`contraindicated”. Id. at 4: 1- 5.
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`The prescriber must be registered in a computer readable medium. In
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`order to be registered in the computer readable medium, prescribers may be
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`required to comply with various requirements, including, providing patient
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`counseling and education. Id. at 4: 49-54. Registration can be achieved by
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`mail, facsimile or on-line transmission and the prescriber may be asked to
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`provide certain information as part of the registration, including, name,
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`12
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`address and health care institution affiliation. Id. at 4:54-59; Id. at 5:1-5. A
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`pharmacy that can fill the prescription for the drug can also become
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`registered in a computer readable medium in a similar manner. Id. at 5:17-
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`60.
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`Patients are also registered in the computer readable storage medium.
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`Id. at 5: 61-63. Registration of the patient can take place at a registered
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`pharmacy. Id. at 6: 3-7. Registration will involve filling in a registration
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`card of form and providing information such as name, sex, mailing address,
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`date of birth, etc. Id. at 6:11-14. Information that is probative of the risk of
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`known side effects will also be collected. Id. at 6:30-33. Once collected this
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`information can then be compared with a predefined set of risk parameters
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`for the drug which allows for assignment of the patient to particular risk
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`group. Id. at 6:33-36.
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`
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`VII. PROSECUTION HISTORY
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`The ‘720 patent was filed October 23, 2000 (U.S. Patent Application
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`Serial No. 09/694,217 (the “‘217 application”)). There are two named
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`inventors, Bruce Williams and Joseph K. Kaminiski. There were 32 claims
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`as filed, including two independent claims. On January 18, 2001, the
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`USPTO issued an Office Action, rejecting claims 1-27 as obvious Exhibit
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`13
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`Page 18 of 48
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`
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`1002 at 61 (Note; the file copy is unreadable at the bottom of page 61).
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`PRIVILEGED AND CONFIDENTIAL
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`However, in the readable portions of the Office Action, the Examiner stated
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`that Elsayed et al. (U.S. Patent No. 6,045,501, hereinafter, Elsayed) suggests
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`the “use of the information to evaluate the risk levels, but do not teach the
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`specific implementation of this procedure.” Exhibit 1002 at 62. The
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`Examiner also stated that Schauss et al. (U.S. Patent No. 6,063,026,
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`hereinafter, Schauss) teaches a medical diagnostic analysis system that
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`evaluates patient data obtained from medical testing or patient questioning
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`for drugs contraindications. Id. According to the Examiner, “it would have
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`been obvious to one of ordinary skill in the art at the time of the invention to
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`implement the screen for drug contraindications suggested in Elsayed et al,
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`with the method of Schauss et al., since Schauss et al. teach the particular
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`steps for performing the analysis.” Id.
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`Claims 28-32 were objected to, but would be allowable if rewritten in
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`independent form. Id. at 63.
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`Claim 1 as originally filed read:
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`1.
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`In a method for delivering a drug to a patient in need of the
`
`drug, while avoiding the occurrence of an adverse side effect known or
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`suspected of being caused by said drug, wherein said method is of the type
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`which prescriptions for said drug are filled only after a computer readable
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`
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`14
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`Page 19 of 48
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`DRAFT – ATTORNEY-CLIENT
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`storage medium has been consulted to assure that the prescriber is registered
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`in said medium and qualified to prescribe said drug, that the pharmacy
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`registered in said medium and qualified to fill the prescription for said drug,
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`and the patient is registered in said medium and approved to receive said
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`drug, the improvement comprising:
`
`(a) defining a plurality of patient risk groups based upon a predefined
`
`set of risk parameters for said drug;
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`(b) defining a set of information to be obtained from said patient,
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`which information is probative of the risk that said adverse side effect is
`
`likely to occur if said drug is taken by said patient;
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`(c) in response to said information set, assigning said patient to at
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`least one of said risk groups; and
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`(d) entering said risk group assignment in said medium before said
`
`patient is approved to receive said drug.
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`On March 23, 2001, the Applicants responded arguing that “Elsayed,
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`although teaching a method which contains many of the steps of the present
`
`invention, contains no disclosure of the generation of a prescription approval
`
`code as recited in amended Claim 1. Nor is there any explicit description in
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`Elsayed of the benefits and attributes which flow from the inclusion of this
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`
`
`
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`step…the inventors have found that improved compliance with the drug
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`15
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`Page 20 of 48
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`DRAFT – ATTORNEY-CLIENT
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`delivery methods of the present invention may be achieved when the
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`patient’s risk group assignment and all required information is entered in the
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`computer readable storage medium, and it is determined that the risk is
`
`acceptable, prior to generation of the prescription approval code.” Exhibit
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`1002 Amendment, March 23, 2001, at 82.
`
`
`
`The Applicants only amended steps (c) and (d), and added new step
`
`(e) to claim 1 as follows:
`
` (c) in response to said information set, assigning said patient to at
`
`least one of said risk groups and entering said risk group assignment in said
`
`medium; and
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`(d) [entering said risk group assignment in said medium before said
`
`patient is approved to receive said drug] based upon said information and
`
`said risk group assignment, determining whether the risk that said adverse
`
`side effect is likely to occur is acceptable [.] and
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`(e) upon a determination that said risk is acceptable, generating a
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`prescription approval code to be retrieved by said pharmacy before said
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`prescription is filled. Id. at 80 (and 84, showing marked changes except for
`
`(e) which is unreadable).
`
`
`
`On April 12, 2001, the Examiner issued a final Office Action
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`
`
`
`
`maintaining the rejections of the claims over Elsayed and Schauss et al. The
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`16
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`Page 21 of 48
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`
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`Examiner also cited to Boyer et al. as teaching “a step for generating a
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`prescription approval number or code associated with said prescription by a
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`computer workstation….” Id. at 89. (Boyer et al. U.S. Patent No.
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`6,202,923).
`
`In June, the Applicants responded stating that “[a]s the Examiner has
`
`not maintained the previous rejection of Claims 1 to 27 over the combination
`
`of Elsayed and Schauss et al, it is apparently the Examiner’s position that
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`the amendment submitted on March 23, 2001 was sufficient to overcome the
`
`rejection, but that Boyer contains disclosure that teaches or suggest the
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`additional claim elements added by Applicants in that amendment…
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`Applicants respectfully disagree. Claim 1 defines an improved method for
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`delivering a drug to a patient in need of the drug while avoiding the
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`occurrence of an adverse side effect known or suspected of being caused by
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`the drug. In this method, the drug is to be delivered to the patient only after
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`a computer readable storage medium has been consulted to assure that
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`prescriber, the patient and the pharmacy have been registered in the
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`medium.” This method further involves the assignment of the patient to a
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`risk group, based upon the information gathered from the patient that is
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`probative of the risk that the adverse side effect will occur…” Exhibit 1002
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`
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`17
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`Page 22 of 48
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`
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`Amendment, June 25, 2001, at 96. The Applicants also submitted an
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`amended claim 28 which corresponded to claim 28 as issued.
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`On July 11, 2001, a Notice of Allowance issued. Exhibit 1002 at 105.
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`After allowance, the Applicants submitted a supplemental Information
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`Disclosure Statement and the Office issued a Supplemental Notice of
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`Allowability on September 28, 2001 without comment.
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`
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`VIII. CLAIM TERMS REQUIRING CONSTRUCTION
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`
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`Consistent with the statute and legislative history of the America
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`Invents Act, when considering whether to institute a patent trial the Board
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`has indicated that it will interpret the claims of a challenged patent using a
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`“broadest reasonable construction” approach. Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). In applying such a
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`standard, it is important to recognize that the broadest reasonable
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`construction of claim language is not one that permits any reading. Instead,
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`it is one that must be made “in light of the specification as it would be
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`interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech.
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`Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
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`Unless there are indications to the contrary, a claim term is accorded
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`its ordinary and customary meaning. Phillips v. AWH Corp., 415 F.3d 1303
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`
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`18
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`Page 23 of 48
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`
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`(Fed. Cir. 2005. The “ordinary and customary meaning of a claim term is the
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the
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`patent application.” Id. at 1313, citing Innova/Pure Water, Inc. v. Safari
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`Water Filtration Systems, Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004) (“A
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`court construing a patent claim seeks to accord a claim the meaning it would
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`have to a person of ordinary skill in the art at the time of the invention.”);
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`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir.
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`1998) (the court must interpret the claims “as they would be understood and
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`interpreted by a person in that field of technology”). Claims are first
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`construed according to intrinsic evidence, which consists of the language of
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`the claims themselves, the language of the other claims, the patent
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`specification and the prosecution history. Phillips, supra, 415 F.3d 1303;
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`see also Teleflex, Inc. v. Ficosa North America Corp, 299 F. 3d 1313, 1325
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`(Fed. Cir. 2001).
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`In the ‘720 patent, the patentee has acted in several instances as his
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`own lexicographer clearly defining the meaning the claim term in the
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`specification. M.P.E.P. § 2111.01 (IV).
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`Claims 1-4, which contain claim terms that we elect to construe, are
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`reproduced below. Those terms are underlined and in bold, as provided
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`19
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`Page 24 of 48
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`below. Unless otherwise stated, all other terms have their plain and ordinary
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`
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