DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT AND TRIAL APPEAL BOARD
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`
`
`
`
`[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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`CELGENE EXHIBIT 2037
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
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`

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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 ....................................................................................................... 6
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................. 7
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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)) ................................................... 8
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`VI. OVERVIEW OF U.S. PATENT NO. 6,045,501 ........................................ 8
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`VII. PROSECUTION HISTORY ..................................................................... 14
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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.
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`The Petition Establishes a Reasonable Likelihood that at Least One
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`Challenged Claim is Obvious. ............................................................................. 27
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`(i)
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`(ii)
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`Challenge 1: Claims 1-32 ......................... Error! Bookmark not defined.
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`Challenge 2: Claims 1-32 ........................................................................ 30
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`X. CONCLUSION .............................................................................................. 60
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`CERTIFICATE OF SERVICE ........................................................................... 61
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`Cases
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`DRAFT – ATTORNEY-CLIENT
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`Table of Authorities
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`Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1323-24 (Fed. Cir. 1999) ............. 29
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`Graham v. John Deere Co., 383 U.S. 1 (1966) .................................................. 2, 31
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`In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) ............. 19
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`In re GPAC Inc., 57 F.3d 1573, 1578 (Fed. Cir. 1995) .......................................... 29
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`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111,
`1116 (Fed. Cir. 2004) .......................................................................................... 20
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) ......................................... 29, 30
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`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)
` ............................................................................................................................. 20
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`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1334 (Fed. Cir.
`2004) ................................................................................................................... 28
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005 ......................................... 19
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`State Contracting & Eng. Corp. v. Condotte America Inc., 346 F.3d 1057, 1069
`(Fed. Cir. 2003) ................................................................................................... 29
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`Teleflex, Inc. v. Ficosa North America Corp, 299 F. 3d 1313, 1325 (Fed. Cir. 2001)
` ............................................................................................................................. 20
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`Statutes
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`35 U.S.C. § 102(b) ........................................................................................ 2, 32, 51
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`35 U.S.C. § 103(a) .............................................................................................. 1, 28
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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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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`M.P.E.P. § 2111.01 (IV) ......................................................................................... 20
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`M.P.E.P. § 2141 ...................................................................................................... 30
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) . 19
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`Rules
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`37 C.F.R. § 42.10(b) and § 42.63(e) .................................................................... 6
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`37 C.F.R. § 42.6(d) ................................................................................................. 31
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`37 C.F.R. § 42.8(a)(1) .............................................................................................. 6
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`37 C.F.R. § 42.8(b)(1) .............................................................................................. 6
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`37 C.F.R. § 42.8(b)(3) .............................................................................................. 7
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`37 CFR § 42.106(a) ................................................................................................ 6
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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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`II. OVERVIEW
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`Under 35 U.S.C. § 103(a), a patent is invalid “if the differences
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`between the subject matter . . . patented and the prior art are such that the
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`subject matter as a whole would have been obvious at the time the invention
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`was made to a person having ordinary skill in the art to which said subject
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`matter pertains.” To support a conclusion of obviousness based on the
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`rationale of "combining prior art elements according to known methods to
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`yield predictable results", the following must be articulated: (1) a finding
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`that the prior art included each element claimed, although not necessarily in
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`a single prior art reference, with the only difference between the claimed
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`invention and the prior art being the lack of actual combination of the
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`1
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`elements in a single prior art reference; (2) a finding that one of ordinary
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`skill in the art could have combined the elements as claimed by known
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`methods, and that in combination, each element merely performs the same
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`function as it does separately; (3) a finding that one of ordinary skill in the
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`art would have recognized that the results of the combination were
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`predictable; and, (4) whatever additional findings based on the Graham
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`(Graham v. John Deere Co., 383 U.S. 1 (1966)) factual inquiries may be
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`necessary, in view of the facts of the case under consideration, to explain a
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`conclusion of obviousness. M.P.E.P. §2143.
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`The claims of the ‘720 patent are obvious over Powell et al.
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`((Postgrad. Med. J. 70:901 (1994), (“Powell”), Exhibit 1002) in view of
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`Dishman et al. ((Am. J. Hosp. Pharm 51: 899 (1994), (“Dishman”), Exhibit
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`1003)), Bastani et al. ((Psychopharmacology 99:S122 (1989), (Bastani”),
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`Exhibit 1004)), the 47th Meeting of the Dermatologic and Ophthalmic
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`Advisory Board ((September 4-5, 1997, (the “FDA Meeting”), Exhibit 1005
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`(a) and (b))), and the CDC Meeting ((Centers for Disease Control,
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`Preventing Birth Defects, March 26, 1997, (Exhibit 1006) (the “CDC
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`Meeting”)). Each and every element of the claims can be found in the prior
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`art. None of these prior art references were cited during prosecution of the
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`‘720 patent and all of the references are 35 U.S.C. § 102(b) pre-AIA prior art
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`having been published more than one year before the effective date of the
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`‘720 patent, October 23, 2000. Moreover, one of ordinary skill at the time
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`of the invention, would have been motivated to combine the elements
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`together and the combination of these elements together would have yielded
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`nothing more than entirely predictable results. See, Declaration, Dr.
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`Matthew Davis, Exhibit 1009.
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`A brief overview of claim 1 of the ‘720 patent clearly illustrates why this
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`claim is obvious. 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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`Comment - Powell sets forth methods for delivering a drug to patients in
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`need of the drug while avoiding the occurrence of adverse side effects by
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`limiting dispensation to patients that avoid pregnancy. Exhibit 1002.
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`Dishman discloses a computerized program for registering prescribers such
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`DRAFT – ATTORNEY-CLIENT
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`as physicians, pharmacies and patients which is tied to the outpatient
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`pharmacy dispensing software so that clozapine prescriptions are only
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`processed when certain clinical criteria are met. Exhibit 1003.
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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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`Comment: Powell provides guidelines for the definition of patient risk
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`groups based on a set of risk parameters with respect to thalidomide, such as
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`women of childbearing potential versus others, at risk of potential adverse
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`side effects and birth defects in the case of pregnancy. Exhibit 1002 at 901-
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`902.
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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; Id.
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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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`Comment: Dishman discloses patient risk group assignment based on
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`white blood cell counts, and inputting that information into a computer
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`database. Exhibit 1003 at 900. Based on the information provided by the
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`patients and the risk group assignments, both Powell and Dishman disclose
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`that a determination is made regarding the acceptability of the risk of
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`prescribing the drug. Exhibit 1002 at 901; Exhibit 1003 at 900. Only after a
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`review of the documentation and approval of the NCCC (in the case of
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`clozapine), is the pharmacist approved to begin clozapine therapy (i.e., fill
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`the prescription). Id.
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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;
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`Comment: In Bastani, if the patient’s white blood cell count is normal,
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`i.e., the risk that the patient could develop a lethal agranulocytopenia is low,
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`then clozapine may be dispensed. Exhibit 1004 at S123.
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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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`prior art references. According to Dr. Matthew Davis, one of ordinary skill
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`in the art at the time of filing, would have combined Powell with Dishman
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`and Bastani, in view of the FDA and CDC Meetings. Exhibit 1009 at ¶17.
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`The dangers of drugs such as thalidomide, clozapine, and others, were well
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`known in the 1990s, and computerized systems were already in-place for the
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`DRAFT – ATTORNEY-CLIENT
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`tracking of patients, physicians and pharmacies with respect to dispensing a
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`potentially dangerous drug. Therefore, it would have been obvious to one of
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`ordinary skill in the art to develop a computerized method to avoid the
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`occurrence of adverse events in patients in need of such drugs by combining
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`various aspects of existing, well-known, control systems. Id. In short, the
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`computerized systems developed for thalidomide were the product not of
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`innovation, but of ordinary skill and common sense.
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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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`credit overpayments to Deposit Acct. No. 50-5798 (Customer ID No.
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`27571).
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`DRAFT – ATTORNEY-CLIENT
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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.
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` D
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` +1 408 389 3537
`T +1 866 877 4883
`F +1 408 773 6177
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`tarek.fahmi@fseip.com
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`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
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`Lead Counsel
`Michael A. Davitz M.D. J.D.
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`T: +1 866-877-4883
`C: +1 914-582-8817
`F: +1 408-773-6177
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`michael.davitz@fseip.com
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`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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`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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`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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`VI. OVERVIEW OF U.S. PATENT NO. 6,315,720
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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. The patent describes methods for delivering
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`a drug to a patient, while avoiding the occurrence of adverse side effects.
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`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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`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
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`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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`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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` “in response to said risk group assignment, said patient is counseled
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`as to the risks of taking said drug and advised as to risk avoidance measures”
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`(claim 2); “wherein said counseling comprises full disclosure of said risks”
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`(claim 3); “wherein said prescription is filled only following said full
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`disclosure and informed consent of said patient” (claim 4); “wherein said
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`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” (claim 5); “wherein said risk group assignment and said
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`informed consent is transmitted to said computer readable storage medium
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`by facsimile and interpreted by optical character recognition software”
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`(claim 6); “wherein said set of information includes the results of diagnostic
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`testing” (claim 7); “wherein said diagnostic testing is probative of the onset
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`of said adverse side effect” (claim 8); “wherein said diagnostic testing is
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`probative of the concentration of said drug in a tissue of said patient” (claim
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`9); “wherein said diagnostic testing comprises genetic testing” (claim 10);
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`“wherein said side effect is likely to arise in said patient” (claim 11);
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`“wherein said side effect is likely to arise in a foetus carried by said patient”
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`(claim 12); “wherein said side effect is likely to arise in a recipient or a
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`foetus carried by a recipient of the bodily fluid of said patient” (claim 13);
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`“wherein said recipient is a sexual partner of said patient” (claim 14).
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`Claim 15 adds additional steps to claim1: “[t]he method of claim 1
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`further comprising: f. defining for each said risk group a second set of
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`information to be collected from said patient on a periodic basis; g.
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`obtaining said second set of information from said patient; and h. entering
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`said second set of information in said medium before said patient is
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`approved to receive said drug”. Claim 16 adds “wherein said second set of
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`information comprises a survey regarding said patient's behavior and
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`compliance with said risk avoidance measures”; “wherein said survey is
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`conducted telephonically using an integrated voice response system” (claim
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`17); “wherein said patient is a female of childbearing potential and said
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`second set of information comprises the results of a pregnancy test” (claim
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`18); “wherein said periodic interval comprises about 28 days” (claim
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`19).Claim 20 adds to claim 1: “further comprising providing said patient
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`with a contraceptive device or formulation”; “wherein said adverse side
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`effect comprises a teratogenic effect” (claim 21); “wherein said drug is
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`thalidomide” (claim 22); “wherein said teratogenic effect is likely to arise in
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`a foetus carried by said patient” (claim 23); “wherein said teratogenic effect
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`is likely to arise in a foetus carried by a recipient of the bodily fluid of said
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`patient” (claim 24); “wherein said recipient of the bodily fluid of said patient
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`is a sexual partner of said patient” (claim 25); “wherein said set of
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`information includes the results of a pregnancy test” (claim 26); “wherein
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`said prescription is filled for no more than about 28 days” (claim 27).
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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: “wherein said set of information is also probative of the
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`likelihood that said patient may take said drug and said other drug in
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`combination” (claim 29); “wherein said set of information includes the
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`results of diagnostic testing” (claim 30); “wherein said diagnostic testing
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`comprises testing for evidence of the use of said other drug” (claim 31);
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`“wherein said diagnostic testing comprises testing for evidence which is
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`indicative of the onset of said adverse side effect” (claim 32).
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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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`address and health care institution affiliation. Id. at 4:54-59; Id. at 5:1-5. A
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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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`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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`1002 at 61 (Note; the file copy is unreadable at the bottom of page 61).
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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
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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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`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
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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:
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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
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`d. entering said risk group assignment in said medium before said
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`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
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`invention, contains no disclosure of the generation of a prescription approval
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`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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`step…the inventors have found that improved compliance with the drug
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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
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`acceptable, prior to generation of the prescription approval code.” Exhibit
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`1002 Amendment, March 23, 2001, at 82.
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`The Applicants only amended steps c and d, and added new step e to
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`claim 1 as follows:
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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; and
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`d. [entering said risk group assignment in said medium before said
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`patient is approved to receive said drug] based upon said information and
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`said risk group assignment, determining whether the risk that said adverse
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`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
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`(e) which is unreadable).
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`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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`Examiner also cited to Boyer et al. as teaching “a step for generating a
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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).
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`In June, the Applicants responded stating that “[a]s the Examiner has
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`not maintained the previous rejection of Claims 1 to 27 over the combination
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`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
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`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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`Amendment, June 25, 2001, at 96. The Applicants also submitted an
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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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`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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`(Fed. Cir. 2005. The “ordinary and customary meaning of a claim term is the
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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