IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`INITIATIVE FOR RESPONSIBILITY IN DRUG PRICING, LLC
`Petitioner
`v.
`CELGENE CORPORATION
`Patent Owner
`
`
`
`U.S. Patent No. 6,315,720 to Williams et al.
`Issue Date: November 13, 2001
`Title: Methods For Delivering A Drug To A Patient While Avoiding The
`Occurrence Of An Adverse Side Effect Known Or Suspected
`Of Being Caused By The Drug
`
`
`_____________________
`
`
`
`Inter Partes Review No. Unassigned
`
`_____________________
`
`
`
`Petition For Inter Partes Review Of U.S. Patent No. 6,315,720
`Under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Page 1 of 66
`
`CELGENE EXHIBIT 2045
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
`
`

`
`
`
`Table Of Contents
`
`I. INTRODUCTION ............................................................................................. 1
`
`II. OVERVIEW ....................................................................................................... 1
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`STATEMENTS .................................................................................................. 6
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ....................................... 6
`
`V. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. §42.22(A)) ............................................. 9
`
`VI. OVERVIEW OF U.S. PATENT NO. 6,315,720 ...........................................10
`
`VII. PROSECUTION HISTORY .........................................................................15
`
`VIII.CLAIM TERMS REQUIRING CONSTRUCTION .................................19
`
`IX. IDENTIFICATION OF THE GROUNDS FOR CHALLENGE (37 C.F.R.
`§ 42.104(B)) .......................................................................................................27
`
`A. The Petition Establishes A Reasonable Likelihood That At Least One
`Challenged Claim Is Obvious ......................................................................27
`
`(i) Challenge 1: Claims 1-32 ..........................................................................30
`
`(iii) Challenge 2: Claims 1-32 ........................................................................48
`
`X. CONCLUSION ................................................................................................59
`
`CERTIFICATE OF SERVICE ............................................................................61
`
`
`
`ii
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`Page 2 of 66
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`

`
`Table of Authorities
`
`Cases
`
`Al-Site Corp. v. VSI Int’l, Inc.,
`174 F.3d 1308, 1323-24 (Fed. Cir. 1999) .............................................................26
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251, 1257 (Fed. Cir. 1989) ..................................................................32
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .............................................................................................2, 28
`
`In re Am. Acad. of Sci. Tech. Ctr.,
`367 F.3d 1359, 1364 (Fed. Cir. 2004) ..................................................................18
`
`In re GPAC Inc.,
`57 F.3d 1573, 1578 (Fed. Cir. 1995) ....................................................................26
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc.,
`381 F.3d 1111, 1116 (Fed. Cir. 2004) ..................................................................18
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 26, 27
`
`Multiform Desiccants, Inc. v. Medzam, Ltd.,
`133 F.3d 1473, 1477 (Fed. Cir. 1998) ..................................................................18
`
`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd.,
`357 F.3d 1319, 1334 (Fed. Cir. 2004) ..................................................................26
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................18
`
`State Contracting & Eng. Corp. v. Condotte America Inc.,
`346 F.3d 1057, 1069 (Fed. Cir. 2003) ..................................................................26
`
`Teleflex, Inc. v. Ficosa North America Corp,
`299 F. 3d 1313, 1325 (Fed. Cir. 2001) .................................................................19
`
`
`
`
`
`iii
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`Page 3 of 66
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`

`
`Statutes
`
`35 U.S.C. § 102(b) ........................................................................................ 2, 29, 46
`
`35 U.S.C. § 103(a) ........................................................................................ 1, 25, 46
`
`35 U.S.C. §§311-319.................................................................................................. 1
`
`
`
`Other Authorities
`
`M.P.E.P. § 2111.01 (IV) ..........................................................................................19
`
`M.P.E.P. § 2111.02 ..................................................................................................32
`
`M.P.E.P. § 2141 .......................................................................................................27
`
`M.P.E.P. §2143. .......................................................................................................28
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ..18
`
`
`Rules
`
`37 C . F .R . § 42.10(b) .............................................................................................. 6
`
`37 C.F.R. § 42.104(a) ................................................................................................. 6
`
`37 C.F.R. § 42.104(b) ..............................................................................................25
`
`37 C.F.R. § 42.108(c) ................................................................................................. 1
`
`37 C.F.R. § 42.6(d) ..................................................................................................28
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(4) .............................................................................................. 7
`
`37 CFR § 42.106(a) .................................................................................................. 6
`
`
`
`iv
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`Page 4 of 66
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`Exhibit 1001 - U.S. Patent No. 6,315,720
`
`Exhibits
`
`Exhibit 1002 - Powell et al., Guideline for the clinical use and dispensing of
`thalidomide, Postgrad. Med. J. 70:901 (1994)
`
`Exhibit 1003, Office Action, U.S. Patent Application Serial No. 09/694,217,
`January 18, 2001, Paper 2
`
`Exhibit 1004 Amendment, U.S. Patent Application Serial No. 09/694,217, March
`23, 2001
`
`Exhibit 1005 Amendment, U.S. Patent Application Serial No. 09/694,217, June 25,
`2001
`
`Exhibit 1006 - Dishman et al., Pharmacists’ role in clozapine therapy at a Veterans
`Affairs medical center, Am. J. Hosp. Pharm 51: 899 (1994)
`
`Exhibit 1007 - Bastani et al., Development of the Clozaril Patient Management
`System, Psychopharmacology 99:S122 (1989)
`
`Exhibit 1008(a) and (b) - The 47th Meeting of the Dermatologic and Ophthalmic
`Advisory Board (September 4-5, 1997, (the “FDA Meeting”)
`
`Exhibit 1009 - CDC Meeting, Centers for Disease Control, Preventing Birth
`Defects, March 26, 1997
`
`Exhibit 1010 - Mitchell et al., A Pregnancy-Prevention Program in Women of
`Childbearing Age Receiving Isotrertinoin, New England J. Med.
`333(2):101 (1995)
`
`Exhibit 1011 - Honigfeld, Effects of the Clozapine National Registry System on
`Incidence of Deaths Related to Agranulocytosis, Psychiatric
`Services 47:52 (1996)
`
`Exhibit 1012 - Declaration Matthew W. Davis M.D. RhP.
`
`
`
`v
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`Page 5 of 66
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`

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`I.
`
`INTRODUCTION
`
`The Initiative for Responsibility in Drug Pricing, LLC (the “Petitioner” or
`
`“IRDP”) hereby petitions for Inter Partes Review (“IPR”) (the “Petition”) under
`
`35 U.S.C. §§311-319 seeking cancellation of claims 1-32 of U.S. Patent No.
`
`6,315,720 (the “‘720 Patent”, Exhibit 1001). Based on the evidence presented in
`
`this Petition, the Patent Trial and Appeal Board (the “Board”) should institute an
`
`IPR because there is a reasonable likelihood that at least one of the claims
`
`challenged in the petition is unpatentable. 37 C.F.R. § 42.108(c).
`
`
`
`II. OVERVIEW
`
`Under 35 U.S.C. § 103(a), a patent is invalid “if the differences between the
`
`subject matter . . . patented and the prior art are such that the subject matter as a
`
`whole would have been obvious at the time the invention was made to a person
`
`having ordinary skill in the art to which said subject matter pertains.” To support a
`
`conclusion of obviousness based on the rationale of "combining prior art elements
`
`according to known methods to yield predictable results", the following must be
`
`articulated: (1) a finding that the prior art included each element claimed, although
`
`not necessarily in a single prior art reference, with the only difference between the
`
`claimed invention and the prior art being the lack of actual combination of the
`
`elements in a single prior art reference; (2) a finding that one of ordinary skill in
`
`
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`1
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`the art could have combined the elements as claimed by known methods, and that
`
`in combination, each element merely performs the same function as it does
`
`separately; (3) a finding that one of ordinary skill in the art would have recognized
`
`that the results of the combination were predictable; and, (4) whatever additional
`
`findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1 (1966))
`
`factual inquiries may be necessary, in view of the facts of the case under
`
`consideration, to explain a conclusion of obviousness. See also, M.P.E.P. §2143.
`
`The claims of the ‘720 patent are obvious over Powell et al. ((Postgrad.
`
`Med. J. 70:901 (1994), (“Powell”), Exhibit 1002) in view of Dishman et al. ((Am.
`
`J. Hosp. Pharm 51: 899 (1994), (“Dishman”), Exhibit 1006)), Bastani et al.
`
`((Psychopharmacology 99:S122 (1989), (Bastani”), Exhibit 1007)), the 47th
`
`Meeting of the Dermatologic and Ophthalmic Advisory Board ((September 4-5,
`
`1997, (the “FDA Meeting”), Exhibit 1008 (a) and (b))), and the CDC Meeting
`
`((Centers for Disease Control, Preventing Birth Defects, March 26, 1997, (Exhibit
`
`1009) (the “CDC Meeting”)). Each and every element of the claims can be found
`
`in the prior art. None of these prior art references were cited during prosecution of
`
`the ‘720 patent and all of the references are 35 U.S.C. § 102(b) pre-AIA prior art
`
`having been published more than one year before the effective date of the ‘720
`
`patent, October 23, 2000. Moreover, one of ordinary skill at the time of the
`
`invention, would have been motivated to combine the elements together and the
`
`
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`2
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`combination of these elements together would have yielded nothing more than
`
`entirely predictable results. See, Declaration, Dr. Matthew Davis, Exhibit 1012.
`
`A brief overview of claim 1 of the ‘720 patent clearly illustrates why this claim
`
`is obvious. For clarity, the claim is shown in italics.
`
`1. 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 suspected of being
`
`caused by said drug, wherein said method is of the type in which prescriptions
`
`for said drug are filled only after a computer readable 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 registered in said medium
`
`and qualified to fill the prescription for said drug, and the patient is registered
`
`in said medium and approved to receive said drug, the improvement
`
`comprising:
`
`Comment - Powell sets forth methods for delivering a drug to patients in need
`
`of the drug while avoiding the occurrence of adverse side effects by limiting
`
`dispensation to patients that avoid pregnancy. Exhibit 1002. Dishman discloses a
`
`computerized program for registering prescribers such as physicians, pharmacies
`
`and patients which is tied to the outpatient pharmacy dispensing software so that
`
`clozapine prescriptions are only processed when certain clinical criteria are met.
`
`Exhibit 1006.
`
`
`
`3
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`Page 8 of 66
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`(a) defining a plurality of patient risk groups based upon a predefined set of
`
`risk parameters for said drug;
`
`Comment: Powell provides guidelines for the definition of patient risk groups
`
`based on a set of risk parameters with respect to thalidomide, such as women of
`
`childbearing potential versus others, at risk of potential adverse side effects and
`
`birth defects in the case of pregnancy. Exhibit 1002 at 901-902.
`
`(b) defining a set of information to be obtained from said patient, which
`
`information is probative of the risk that said adverse side effect is likely to
`
`occur if said drug is taken by said patient; Id.
`
`(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;
`
`Comment: Dishman discloses patient risk group assignment based on white
`
`blood cell counts, and inputting that information into a computer database. Exhibit
`
`1006 at 900. Based on the information provided by the patients and the risk group
`
`assignments, both Powell and Dishman disclose that a determination is made
`
`regarding the acceptability of the risk of prescribing the drug. Exhibit 1002 at 901;
`
`Exhibit 1006 at 900, respectively. Only after a review of the documentation and
`
`approval of the NCCC (in the case of clozapine), is the pharmacist approved to
`
`begin clozapine therapy (i.e., fill the prescription). Id.
`
`
`
`4
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`(d) based upon said information and said risk group assignment, determining
`
`whether the risk that said adverse side effect is likely to occur is acceptable;
`
`Comment: In Bastani, if the patient’s white blood cell count is normal, i.e., the
`
`risk that the patient could develop a lethal agranulocytopenia is low, then clozapine
`
`may be dispensed. Exhibit 1007 at S123.
`
`(e) upon a determination that said risk is acceptable, generating a prescription
`
`approval code to be retrieved by said pharmacy before said prescription is
`
`filled. Id.
`
`In summary, each and every element of claim 1 is set forth in the prior art
`
`references. According to Dr. Matthew Davis, one of ordinary skill in the art at the
`
`time of filing, would have combined Powell with Dishman and Bastani, in view of
`
`the FDA and CDC Meetings. Exhibit 1012 at ¶17. The dangers of drugs such as
`
`thalidomide, clozapine, and others, were well known in the 1990s, and
`
`computerized systems were already in-place for the tracking of patients, physicians
`
`and pharmacies with respect to dispensing a potentially dangerous drug.
`
`Therefore, it would have been obvious to one of ordinary skill in the art to develop
`
`a computerized method to avoid the occurrence of adverse events in patients in
`
`need of such drugs by combining various aspects of existing, well-known, control
`
`systems. Id. In short, the computerized systems developed for thalidomide were
`
`the product not of innovation, but of ordinary skill and common sense.
`
`
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`5
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`
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`
`STATEMENTS
`
`Petitioner certifies that the ‘720 patent is available for IPR and that the
`
`Petitioner is not barred or estopped from requesting an IPR of any claim of the
`
`‘720 patent on the grounds identified herein. This Petition is filed in accordance
`
`with 37 CFR § 42.106(a). Powers of Attorney are filed concurrently as well
`
`as an Exhibit List per 37 C . F .R . § 42.10(b) and § 42.63(e), respectively. The
`
`required fee is paid via online credit card payment. The Office is authorized to
`
`charge fee deficiencies and credit overpayments to Deposit Acct. No. 50-5798
`
`(Customer ID No. 27571).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`The Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) is: Initiative for
`
`Responsibility in Drug Pricing, LLC (“Petitioner” or “IRDP”), 1020 Shark
`
`Reef Road, Lopez Island Washington 98261. IRDP seeks to improve
`
`Americans’ access to low-cost generic pharmaceuticals by invalidating patents
`
`that are unjustifiably delaying generic competition. IRDP is not affiliated with
`
`any pharmaceutical company, and is therefore not susceptible to the
`
`considerations that often result in settlements between brand-name and generic
`
`pharmaceutical companies that, in IRDP’s view, do not serve the public interest.
`
`
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`6
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`The Founder and President of the Initiative for Responsibility in Drug
`
`Pricing, LLC is Dr. Albert Berger. Professor Berger is the former Vice-Dean of
`
`the University of Washington Medical School and former Chair of the
`
`Department of Physiology & Graduate Education at the University of
`
`Washington. He holds grants and awards including the Ford Fellowship
`
`Foundation, Guggenheim Foundation Fellowship, Fogarty Fellowship, and two
`
`Javits Awards from the National Institutes of Health. Professor Berger holds
`
`PhDs in Chemical Engineering and Physiology from Princeton University and
`
`University of California – San Francisco. Professor Berger is the author of more
`
`than 125 medical research papers.
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)):
`
`Judicial matters: The ‘720 patent (Exh. 1001) is the subject of five court
`
`cases. Celgene Corporation v. Natco Pharma Limited, 2-10-cv-05197 (D.N.J.);
`
`Celgene Corporation et al. v. Barr Laboratories, Inc. et al., 2-08-cv-03357
`
`(D.N.J.); Celgene Corporation v. Barr Laboratories, Inc. et al., 2-07-cv-05485
`
`(D.N.J.); Celgene Corporation v. Barr Laboratories, Inc. et al., 2-07-cv-04050
`
`(D.N.J.); Celgene Corporation v. Barr Laboratories, Inc. et al., 2-07-cv-00286
`
`(D.N.J.). Petitioner is not a party to any of the above referenced matters.
`
`The ‘720 patent is an Orange Book listed patent for Celgene’s branded
`
`pharmaceutical drugs Thalomid and Revlimid. In Mylan Pharmaceuticals, Inc.
`
`
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`7
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`v. Celgene Corporation, 14-cv-2094 (D.N.J.), generic drug maker Mylan alleges
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`that Celgene unlawfully maintains monopolies over its two “lead” products—
`
`Thalomid and Revlimid—by preventing lower-priced generic competition from
`
`entering the market. Mylan alleges Celgene prevents generic manufactures from
`
`obtaining product samples for Thalomid and Revlimid, thus preventing a generic
`
`drug maker from demonstrating bioequivalence as required in an Abbreviated
`
`New Drug Application (“ANDA”). The Federal Trade Commission (“FTC”)
`
`filed an amicus brief expressing its disapproval of Celgene’s conduct. IRDP is
`
`not a party to this matter.
`
`Administrative matters: (1) In a petition filed concurrently herewith,
`
`Petitioner seeks IPR of the ‘720 patent as anticipated and (2) in a petition filed
`
`concurrently herewith, Petitioner seeks IPR of U.S. Pat. No. 6,045,501, which is
`
`against the same Patent Owner.
`
`
`
`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):
`
`Lead Counsel
`
`Back-Up Counsel
`
`8
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`Page 13 of 66
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`Michael A. Davitz M.D. J.D.
`
`Tarek N. Fahmi, Esq.
`
` D
`
` +1 408 389 3537
`T +1 866 877 4883
`F +1 408 773 6177
`
`tarek.fahmi@ascendalaw.com
`
`Ascenda Law Group
`84 W. Santa Clara St.
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`
`
`T: +1 866-877-4883
`C: +1 914-582-8817
`F: +1 408-773-6177
`
`michael.davitz@ascendalaw.com
`
`Ascenda Law Group
`84 W. Santa Clara St.,
`Suite 550

`San Jose, CA 95113-1812
`1-914-582-8817
`
`
`
`
`
`
`Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please direct
`
`all correspondence to lead counsel at the above address. Petitioners consent to
`
`
`email service at: michael.davitz@ascendalaw.com and
`
`tarek.fahmi@ascendalaw.com.
`
`
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`
`REASONS THEREFOR (37 C.F.R. §42.22(a))
`
`
`
`Petitioners request IPR and cancellation of claims 1-32 of the ‘720 patent. A
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`summary of the reasons for the relief is set forth in §II and in greater detail below.
`
`
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`9
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`VI. OVERVIEW OF U.S. PATENT NO. 6,315,720
`
`
`
`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 been consulted to
`
`confirm that the prescribers, pharmacies, and patients are registered in a computer
`
`database. Patients may be assigned to risk groups based on the degree of risk that
`
`taking the drug will lead to a side effect. Periodic surveys as well as diagnostics
`
`tests can also be obtained prior to approving dispensing the drug. Exhibit 1001 at
`
`Abstract.
`
`There are 32 claims with two independent claims. Claim 1 is representative
`
`and is reproduced below.
`
`Claim 1. 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 suspected of
`
`being caused by said drug, wherein said method is of the type in which
`
`prescriptions for said drug are filled only after a computer readable 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 registered in said
`
`medium and qualified to fill the prescription for said drug, and the patient is
`
`
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`10
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`registered in said medium and approved to receive said drug, the improvement
`
`comprising:
`
`a. defining a plurality of patient risk groups based upon a predefined set of
`
`risk parameters for said drug;
`
`b. defining a set of information to be obtained from said patient, which
`
`information is probative of the risk that said adverse side effect is likely to occur if
`
`said drug is taken by said patient;
`
`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;
`
`d. 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
`
`e. upon a determination that said risk is acceptable, generating a prescription
`
`approval code to be retrieved by said pharmacy before said prescription is filled.
`
`The dependent claims, claims 2-27, recite the following limitations:
`
` “in response to said risk group assignment, said patient is counseled as to
`
`the risks of taking said drug and advised as to risk avoidance measures” (claim 2);
`
`“wherein said counseling comprises full disclosure of said risks” (claim 3);
`
`“wherein said prescription is filled only following said full disclosure and informed
`
`consent of said patient” (claim 4); “wherein said risk group assignment and said
`
`informed consent is verified by said prescriber at the time that said patient is
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`11
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`registered in said computer readable storage medium” (claim 5); “wherein said risk
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`group assignment and said informed consent is transmitted to said computer
`
`readable storage medium by facsimile and interpreted by optical character
`
`recognition software” (claim 6); “wherein said set of information includes the
`
`results of diagnostic testing” (claim 7); “wherein said diagnostic testing is
`
`probative of the onset of said adverse side effect” (claim 8); “wherein said
`
`diagnostic testing is probative of the concentration of said drug in a tissue of said
`
`patient” (claim 9); “wherein said diagnostic testing comprises genetic testing”
`
`(claim 10); “wherein said side effect is likely to arise in said patient” (claim 11);
`
`“wherein said side effect is likely to arise in a foetus carried by said patient” (claim
`
`12); “wherein said side effect is likely to arise in a recipient or a foetus carried by a
`
`recipient of the bodily fluid of said patient” (claim 13); “wherein said recipient is a
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`sexual partner of said patient” (claim 14).
`
`Claim 15 adds additional steps to claim1: “[t]he method of claim 1 further
`
`comprising: f. defining for each said risk group a second set of information to be
`
`collected from said patient on a periodic basis; g. obtaining said second set of
`
`information from said patient; and h. entering said second set of information in
`
`said medium before said patient is approved to receive said drug”. Claim 16 adds
`
`“wherein said second set of information comprises a survey regarding said patient's
`
`behavior and compliance with said risk avoidance measures”; “wherein said survey
`
`
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`12
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`is conducted telephonically using an integrated voice response system” (claim 17);
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`“wherein said patient is a female of childbearing potential and said second set of
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`information comprises the results of a pregnancy test” (claim 18); “wherein said
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`periodic interval comprises about 28 days” (claim 19). Claim 20 adds to claim 1:
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`“further comprising providing said patient with a contraceptive device or
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`formulation”; “wherein said adverse side effect comprises a teratogenic effect”
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`(claim 21); “wherein said drug is thalidomide” (claim 22); “wherein said
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`teratogenic effect is likely to arise in a foetus carried by said patient” (claim 23);
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`“wherein said teratogenic effect is likely to arise in a foetus carried by a recipient
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`of the bodily fluid of said patient” (claim 24); “wherein said recipient of the bodily
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`fluid of said patient is a sexual partner of said patient” (claim 25); “wherein said
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`set of 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 following
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`limitation: “wherein said adverse side effect is likely to arise in patients who take
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`said drug in combination with at least one other drug.”
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`The claims which depend from claim 28 recite the following limitations:
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`“wherein said set of information is also probative of the likelihood that said patient
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`may take said drug and said other drug in combination” (claim 29); “wherein said
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`set of information includes the results of diagnostic testing” (claim 30); “wherein
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`said diagnostic testing comprises testing for evidence of the use of said other drug”
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`(claim 31); “wherein said diagnostic testing comprises testing for evidence which
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`is 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, especially
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`teratogenic drugs, to patients.” Exhibit 1001 at 3:31-34.
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`According to the specification, the methods of the present invention may be
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`“advantageously employed” in order to avoid taking drugs that can cause adverse
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`side effects in patients “for whom the drug is contraindicated”. Id. at 4: 1- 5.
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`The prescriber must be registered in a computer readable medium. In order
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`to be registered in the computer readable medium, prescribers may be required to
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`comply with various requirements, including, providing patient counseling and
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`education. Id. at 4: 49-54. Registration can be achieved by mail, facsimile or on-
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`line transmission and the prescriber may be asked to provide certain information as
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`part of the registration, including, name, address and health care institution
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`affiliation. Id. at 4:54-59; Id. at 5:1-5. A pharmacy that can fill the prescription
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`for the drug can also become registered in a computer readable medium in a
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`similar manner. Id. at 5:17-60.
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`Patients are also registered in the computer readable storage medium. Id. at
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`5: 61-63. Registration of the patient can take place at a registered pharmacy. Id. at
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`6: 3-7. Registration will involve filling in a registration card of form and providing
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`information such as name, sex, mailing address, date of birth, etc. Id. at 6:11-14.
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`Information that is probative of the risk of known side effects will also be
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`collected. Id. at 6:30-33. Once collected this information can then be compared
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`with a predefined set of risk parameters for the drug which allows for assignment
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`of the patient to particular risk 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 Serial
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`No. 09/694,217 (the “‘217 application”)). There are two named inventors, Bruce
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`Williams and Joseph K. Kaminiski. There were 32 claims as filed, including two
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`independent claims. On January 18, 2001, the USPTO issued an Office Action,
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`rejecting claims 1-27 as obvious Exhibit 1002, Office Action, U.S. Patent
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`Application Serial No. 09/694,217, January 18, 2001, Paper 2, at pg 2 (Note;
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`portions of the file copy are unreadable). However, in the readable portions of the
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`Office Action, the Examiner stated that Elsayed et al. (U.S. Patent No. 6,045,501,
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`hereinafter, Elsayed) suggests the “use of the information to evaluate the risk
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`levels, but do not teach the specific implementation of this procedure.” Exhibit
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`1002 at 62. The Examiner also stated that Schauss et al. (U.S. Patent No.
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`6,063,026, hereinafter, Schauss) teaches a medical diagnostic analysis system that
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`evaluates patient data obtained from medical testing or patient questioning for
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`drugs contraindications. Id. According to the Examiner, “it would have been
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`obvious to one of ordinary skill in the art at the time of the invention to implement
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`the screen for drug contraindications suggested in Elsayed et al, with the method of
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`Schauss et al., since Schauss et al. teach the particular steps for performing the
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`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,
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`while 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 which prescriptions
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`for said drug are filled only after a computer readable storage medium has been
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`consulted to assure that the prescriber is registered in said medium and qualified to
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`prescribe said drug, that the pharmacy registered in said medium and qualified to
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`fill the prescription for said drug, and the patient is registered in said medium and
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`approved to receive said drug, the improvement comprising:
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`a. defining a plurality of patient risk groups based upon a predefined set of
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`risk parameters for said drug;
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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 likely to occur if
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`said drug is taken by said patient;
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`c. in response to said information set, assigning said patient to at least one of
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`said risk groups; and
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`d. entering said risk group assignment in said medium before said patient is
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`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 code
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`as recited in amended Claim 1. Nor is there any explicit description in Elsayed of
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`the benefits and attributes which flow from the inclusion of this step…the
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`inventors have found that improved compliance with the drug delivery methods of
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`the present invention may be achieved when the patient’s risk group assignment
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`and all required information is entered in the computer readable storage medium,
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`and it is determined that the risk is acceptable, prior to generation of the
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`prescription approval code.” Exhibit 1002 Amendment, March 23, 2001, at 82.
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`The Applicants only amen