Trials@uspto.gov Paper 14
`Tel: 571-272-7822
`
`Entered: February 9, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ROXANE LABORATORIES, INC. and PAR PHARMACEUTICAL, INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)1
`
`______________
`
`Before LORA M. GREEN, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`
`MURPHY, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Covered Business Method Patent Review
`37 C.F.R. § 42.208
`
`
`
`
`
`1 This Decision addresses the same jurisdictional issue raised in both cases.
`The patents at issue in CBM2014-00161 and CBM2014-00175 are related,
`and the jurisdictional arguments by Petitioners and Patent Owner are largely
`the same in each case. Therefore, we issue one Decision to be entered in
`each case. See Par Pharm., Inc. v. Jazz Pharms., Inc., Case CBM2014-
`00149/150/151/153, slip op. (PTAB Jan. 13, 2015) (Paper 12).
`
`
`
`

`

`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
`
`
`
`INTRODUCTION
`
`I.
`
`Roxane Laboratories, Inc. (“Roxane”), and Par Pharmaceutical, Inc.
`
`(“Par”) (together, “Petitioner”) filed a Petition requesting covered business
`
`method (“CBM”) patent review of claims 1–8 (all claims) of US Patent No.
`
`7,765,106 B2 (Ex. 1001, “the ’106 patent”),2 pursuant to 35 U.S.C. § 321
`
`and § 18 of the Leahy-Smith America Invents Act (Pub. L. No. 112-29, 125
`
`Stat. 284 (2011)) (“AIA”). Paper 6 (“Pet.”). Jazz Pharmaceuticals, Inc.
`
`(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 13
`
`(“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 324, which
`
`provides that a post-grant patent review, such as a CBM patent review, may
`
`not be instituted unless information presented in the Petition “would
`
`demonstrate that it is more likely than not that at least 1 of the claims
`
`challenged in the petition is unpatentable.”
`
`Petitioner challenges claims 1–8 of the ’106 patent as unpatentable
`
`under 35 U.S.C. §§ 101, 102(b), and 103(a). Pet. 34–35. Based on the
`
`information presented in the Petition and Preliminary Response, we
`
`determine Petitioner has not demonstrated that the ’106 patent is a “covered
`
`business method patent” pursuant to the statutory definition in § 18(d)(1) of
`
`the AIA. Therefore, for the reasons given below, we deny the Petition.
`
`
`2 For clarity and expediency, we treat CBM2014-00161 as representative of
`both cases. All citations are to CBM2014-00161 unless otherwise noted. In
`CBM2014-00175, Petitioner challenges claims 1–6 of US Patent No.
`7,765,107 B2 (“the ’107 patent”), which claims a “computerized method to
`control abuse of a prescription drug” followed by a series of control steps,
`including “determining . . . current and anticipated patterns of potential
`prescription abuse . . . from periodic reports generated only by the central
`database based on prescription request data . . . .” CBM2014-00175, Ex.
`1001, 8:36–9:25 (claim 1).
`
`
`
`2
`
`

`

`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
`
`
`A. Related Proceedings
`
`The parties identify the following as related district court proceedings
`
`regarding the ’106 patent: Jazz Pharms., Inc. v. Roxane Labs., Inc., 2:10-cv-
`
`6108 (D.N.J.); Jazz Pharms., Inc. v. Amneal Pharms., LLC, 2:13-cv-391
`
`(consolidated with 2:13-cv-7884) (D.N.J.); and Jazz Pharms., Inc. v.
`
`Ranbaxy Labs. Ltd., 2:14-cv-4467 (D.N.J.). Pet. 79; Paper 11, 2–3.
`
`The parties identify the following as petitions for covered business
`
`method review of patents related to the ’106 patent: Amneal Pharms., LLC v.
`
`Jazz Pharms., Inc., Case CBM2014-00149 (filed June 24, 2014) (US
`
`7,895,059 B2); Amneal Pharms., LLC v. Jazz Pharms., Inc., Case
`
`CBM2014-00150 (filed July 7, 2014) (US 8,457,988 B1); Par Pharm., Inc.
`
`v. Jazz Pharms., Inc., Case CBM2014-00151 (filed July 9, 2014)(US
`
`7,668,730 B2), and Amneal Pharms., LLC v. Jazz Pharms., Inc., Case
`
`CBM2014-00153 (filed July 9, 2014) (US 8,589,182 B1). Pet. 79; Paper 11,
`
`3.
`
`Patent Owner identifies the following pending US patent applications
`
`claiming priority benefit from US Patent Application No. 10/322,348, from
`
`which the ’106 patent also claims priority benefit: US Patent Application
`
`No. 14/196,603, filed March 4, 2014; US Patent Application No.
`
`14/219,904, filed March 19, 2014; and US Patent Application No.
`
`14/219,941, filed March 19, 2014. Paper 11, 3.
`
`B. The ’106 Patent
`
`The ’106 patent, titled “Sensitive Drug Distribution System and
`
`Method,” issued July 27, 2010 from an application filed November 2, 2004.
`
`
`
`3
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`

`

`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
`
`Ex. 1001.3 The ’106 patent is directed to a method for treating a patient with
`
`a sensitive prescription drug and controlling access to the sensitive
`
`prescription drug, which is prone to potential abuse, misuse, or diversion, by
`
`utilizing a central pharmacy and database to track all prescriptions for the
`
`sensitive drug. Id. at Abstract, 1:44–46. Information regarding all
`
`physicians authorized to prescribe the drug and all patients receiving the
`
`drug is maintained in the database. Id. at 1:46–48. Abuses are identified by
`
`monitoring the database for prescription patterns by physicians and
`
`prescriptions obtained by patients. Id. at Abstract, 1:48–50.
`
`Figures 2A, 2B, and 2C comprise flow charts representing “an initial
`
`prescription order entry process for a sensitive drug . . . .” Id. at 4:13–14. In
`
`overview, a physician submits prescriber, patient, and prescription
`
`information for the sensitive drug to a pharmacy team, which enters the
`
`information into a computer database. Id. at 4:13–39, Fig. 2A (steps 202–
`
`210). The pharmacy team then engages in “intake reimbursement” (Fig.
`
`2A), which includes verification of insurance coverage or the patient’s
`
`willingness and ability to pay for the prescription drug. Id. at 4:51–55.
`
`Steps 226–230 and 234–238 of Figure 2A are reproduced below:
`
`
`3 The ’107 patent issued from a divisional application of US 10/322,348
`(“the ’348 application”). CBM2014-00175, Ex. 1001, 1:6–9.
`
`
`
`4
`
`

`

`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`
`
`
`Figure 2A depicts steps for verifying insurance coverage or ability to pay.
`
`Id. at 2:28–30, 4:51–67. The “pharmacy” workflow includes verifying
`
`prescribing physicians’ credentials. Id. at 5:7–19, Fig. 2B (steps 274–280).
`
`Filling the prescription includes confirming the patient has read sensitive
`
`drug educational materials, confirming the patient’s receipt of the sensitive
`
`drug, and daily cycle counting and inventory reconciliation. Id. at 5:31–6:4.
`
`Figure 2C steps 240, 242, 246, and 258–266 are reproduced below.
`
`
`
`5
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`

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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`. . .
`
`
`
`
`
`Figure 2C depicts a portion of a prescription fulfillment flow diagram.
`
`Id. at Fig. 2C. The “CHiPS” system, referenced in steps 260 and 266, is an
`
`application database “used to maintain a record of a client home infusion
`
`
`
`6
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`

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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`program (CHIP) for Xyrem®.”4 Id. at 4:37–39. If a patient requests an
`
`early prescription refill, for example, the pharmacist generates a report
`
`evaluating “the patient’s compliance with therapy or possible product
`
`diversion, misuse or over-use.” Id. at 6:39–41, Fig. 4B (step 436).
`
`C. Illustrative Claim
`
`The ’106 patent contains multiple independent claims (1, 3, 5, and 7)
`
`and several dependent claims, of which claim 1 is illustrative and
`
`reproduced below:
`
`The invention claimed is:
`
`1. A therapeutic method for treating a patient with a prescription
`drug that is effective for therapeutic purposes, but is
`also a drug that has potential to be abused, misused, or
`diverted, comprising:
`
`receiving, only into an exclusive central computer system,
`all prescriptions for any and all patients being prescribed
`the prescription drug and from any and all doctors
`allowed to prescribe the prescription drug, the prescriptions
`containing information identifying the patient, the
`prescription drug, and various credentials of the medical
`doctor who is prescribing the prescription drug;
`
`requiring entering of the information into an exclusive
`computer database associated with the exclusive central
`computer system for analysis of potential abuse, misuse,
`or diversion of the prescription drug, such that all prescriptions
`for the prescription drug are processed for
`authorization only using the exclusive central computer
`system and the exclusive computer database;
`
`
`4 Xyrem is the brand name for gamma hydroxy butyrate, indicated for the
`treatment of cataplexy (excessive daytime sleepiness) in narcoleptic patients.
`Ex. 1001, 3:20–26. Xyrem is a sensitive prescription drug prone to potential
`abuse or diversion. Id.
`
`
`
`7
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`

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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`
`
`controlling the distribution of said prescription drug using
`the exclusive central computer system that tracks all
`prescriptions of said prescription drug and analyzes for
`the potential abuse, misuse, or diversion of the prescription
`drug by determining current and anticipated patterns
`of potential prescription abuse, misuse, or diversion
`of said prescription drug from periodic reports
`generated by the exclusive central computer system and
`the exclusive computer database based on prescription
`data from a medical doctor, wherein said prescription
`data contain information identifying the patient, the
`drug prescribed, and credentials of the doctor; and
`
`selecting multiple controls for distribution using said
`exclusive central computer system, the controls selected
`from the group consisting of communicating prescriptions
`from a physician to the exclusive central computer
`system; identifying the physician's name, license, and
`DEA (Drug Enforcement Agency) registration information;
`verifying the prescription; obtaining patient information; verifying the
`physician is eligible to prescribe
`the prescription drug by consulting the National Technical
`Information Services to determine whether the
`physician has an active DEA number and to check on
`whether any actions are pending against the physician;
`providing comprehensive printed materials to the physician;
`contacting the patient's insurance company if
`any; verifying patient registry information; providing
`comprehensive education information to the patient;
`verifying the patient has received and/or reviewed the
`educational materials; verifying the home address of the
`patient; shipping via US postal service or a commercial
`shipping service; receiving the name of an at least
`year old designee to receive the drug; confirming receipt
`of an initial shipment of the drug to the patient; returning
`the drug to a pharmacy after two attempts to deliver;
`launching an investigation when a shipment is lost; shipping
`to another pharmacy for delivery; requiring manufacture
`
`
`
`8
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`

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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`
`at a single location; authorizing release of inventory
`in a controlled manner; questioning early refills;
`flagging repeat instances of lost, stolen, destroyed, or
`spilled prescriptions; limiting the prescription to a one
`month supply; requiring rewriting of the prescription
`periodically; and making the database available to the
`DEA for checking for abuse, misuse, or diversion patterns in the data,
`for cash payments, and for inappropriate
`questions;
`
`authorizing the filling, using the exclusive central computer
`system, of a prescription for the prescription drug
`that has been subjected to said multiple controls and has
`been approved for shipment to the patient;
`
`noting, based on one or more of the analysis of the potential
`abuse, misuse, or diversion of the prescription drug and
`the periodic reports, that there is a potential for abuse,
`misuse, or diversion by the patient to whom the prescription drug is
`prescribed; and
`
`delivering the prescription drug to the patient in order to
`treat the patient with the prescription drug.
`
`
`II. ANALYSIS
`
`A. Covered Business Method Review
`
`Section 18 of the AIA governs the transitional program for “covered
`
`business method patent” reviews. Section 18(a)(1)(B) limits such reviews to
`
`a person, or the person’s real party-in-interest or privy, who has been sued
`
`for infringement or charged with infringement of the patent at issue. As
`
`indicated above, the parties both represent that Petitioner has been sued for
`
`infringement of the ’106 patent. Pet. 79; Paper 8, 2.
`
`Section 18(a)(1)(E) states that a transitional proceeding may be
`
`instituted only for a “covered business method patent,” which is “a patent
`
`
`
`9
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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`that claims a method or corresponding apparatus for performing data
`
`processing or other operations used in the practice, administration, or
`
`management of a financial product or service, except that the term does not
`
`include patents for technological inventions.” AIA § 18(d)(1) (emphasis
`
`added). The Office considered the legislative intent and history behind the
`
`AIA’s definition of “covered business method patent” when it promulgated
`
`rules for CBM patent review. See 37 C.F.R. § 42.301(a) (definition of CBM
`
`patent); see also Transitional Program for Covered Business Method Patents
`
`— Definitions of Covered Business Method Patent and Technological
`
`Invention, 77 Fed. Reg. 48,734, 48,735 (Aug. 14, 2012) (Response to
`
`Comment 1: “[T]he legislative history explains that the definition of
`
`covered business method patent was drafted to encompass patents ‘claiming
`
`activities that are financial in nature, incidental to a financial activity or
`
`complementary to a financial activity.’ 157 Cong. Rec. S5432 (daily ed.
`
`Sept. 8, 2011) (statement of Sen. Schumer).” (emphasis added)).
`
`Petitioner bears the burden of demonstrating that the ’106 patent
`
`claims a method “used in the practice, administration, or management of a
`
`financial product or service.” AIA § 18(d)(1); 37 C.F.R. § 42.304(a). In
`
`making this determination, our focus is firmly on the claims. See 77 Fed.
`
`Reg. at 48,736 (Response to Comment 4: “[T]he definition . . . is based on
`
`what the patent claims.”); see also Int’l Sec. Exch., LLC v. Chicago Bd.
`
`Options Exch., Case CBM2013-00050, slip op. 9 (PTAB Mar. 4, 2014)
`
`(Paper 16) (“For purposes of determining whether a patent is eligible for a
`
`covered business method patent review, the focus is on the claims.”). A
`
`patent needs only one claim directed to a covered business method to be
`
`eligible for review. Id. For the reasons explained below, we conclude
`
`
`
`10
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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`Petitioner has not demonstrated that the ’106 patent is a “covered business
`
`method patent” under AIA § 18(d)(1).
`
`B. Financial Product or Service
`
`1. The ’106 patent claims
`
`Claim 1 of the ’106 patent claims a method of treating a patient and
`
`“controlling the distribution of said prescription drug using the exclusive
`
`central computer system that tracks all prescriptions of said prescription
`
`drug and analyzes for the potential abuse, misuse, or diversion of the
`
`prescription drug.” Ex. 1001, 8:54–58. The claimed method requires
`
`entering the physician, patient, and prescription information into an
`
`“exclusive computer database,” which then tracks all prescriptions and
`
`utilizes a series of checks and controls to prevent “potential abuse.” Id. at
`
`8:47–9:32. The series of checks and controls are claimed as a Markush
`
`group of approximately 25 control steps, but Petitioner emphasizes the
`
`following controls for purposes of establishing the statutory “financial
`
`product or service” requirement: “contacting the patient’s insurance
`
`company,” “shipping via US postal service or a commercial shipping
`
`service,” “requiring manufacture at a single location,” “authorizing release
`
`of inventory in a controlled manner,” and “checking . . . for cash payments.”
`
`Pet. 16 (citing Ex. 1001, 8:67–9:32 (emphasis omitted)). The claimed
`
`method steps correspond to portions of the intake, pharmacy, and
`
`prescription fulfillment workflows described in the patent. The claim, as a
`
`whole, recites a method for treating a patient and controlling access to the
`
`prescription drug used for treatment to guard against potential abuse, misuse,
`
`or unauthorized diversion.
`
`
`
`11
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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
`
`
`2. Analysis of whether a patent claim satisfies the statutory
`“financial product or service” requirement
`
`a. Petitioner’s arguments
`
`Petitioner argues that at least claim 1 of the ’106 patent is CBM-
`
`eligible because the claimed method “is used in commerce,” i.e., the claimed
`
`method steps recite “incidental activities related to a financial product or
`
`service – verifying insurance coverage and patient payment.” Pet. 16.
`
`Petitioner further argues that, because the claims recite “receiving . . . all
`
`prescriptions,” “identifying the physician’s name, license, and DEA (Drug
`
`Enforcement Agency) registration information,” “contacting the patient’s
`
`insurance company if any,” and “confirming receipt of an initial shipment of
`
`the drug to the patient,” 5 the claimed method comprises “the core activities
`
`of running the business of an exclusive (single) mail order pharmacy that
`
`direct ships to patients.” Pet. 18. Petitioner relies on the Declaration
`
`testimony of Dr. Robert J. Valuck as evidence that filling a prescription
`
`necessarily involves checking a patient’s insurance coverage or ability to
`
`pay, which “ultimately relate[s] to the financial transaction of providing a
`
`prescription drug.” Id. (citing Ex. 1007 ¶¶ 45–46).
`
`b. The language of the patent claims
`
`The patent claims recite a method for treating a patient and controlling
`
`access to the prescription drug used for treatment to guard against “potential
`
`abuse, misuse, or diversion” of the prescription drug; they do not recite a
`
`financial product or service. The issue in dispute is whether the claim
`
`language recites method steps used in the practice, administration, or
`
`
`5 Claims 1, 3, 5, and 7 recite the quoted limitations. Ex. 1001, 8:36–14:8.
`12
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`

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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`management of a “financial” 6 product or service. Petitioner does not
`
`analyze the claim language, in detail or in context, to explain how the claim
`
`language recites method steps involving the movement of money or
`
`extension of credit in exchange for a product or service, e.g., the sale of a
`
`prescription drug. Pet. 16–19. Petitioner’s argument that the ’106 patent
`
`claims a “financial product or service” is conclusory and not supported by
`
`persuasive evidence or analysis.
`
`The claim limitations quoted by Petitioner, particularly “contacting
`
`the patient’s insurance company,” “shipping via . . . a commercial shipping
`
`service,” and “checking . . . for cash payments” (Pet. 16), when considered
`
`in the context of the claim as a whole, do not recite or require an activity
`
`involving the movement of money or extension of credit in connection with
`
`the sale of a prescription drug. Prelim. Resp. 21. As noted by Patent
`
`Owner, Petitioner’s argument implies the control steps in claim 1 are
`
`equivalent to “verifying” insurance coverage or a patient’s ability to pay for
`
`the prescription drug, but such verification steps are not recited or required
`
`by the actual claim language. Id. at 22–23. Petitioner also quotes the
`
`phrases “contacting the patient’s insurance company” and “checking for
`
`cash payments” out of context. Id. at 23–24. Petitioner omits, for example,
`
`that checking for cash payments is claimed in the context of “making the
`
`database available to the DEA for checking for abuse, misuse, or diversion
`
`patterns in the data, for cash payments, and for inappropriate questions.” Id.
`
`
`6 “Finance” is “the way in which money is used and handled; . . . 2: the
`system that includes the circulation of money, the granting of credit, the
`making of investments, and the provision of banking facilities.” Finance
`Definition, MERRIAM-WEBSTER, available at http://www.merriam-
`webster.com/dictionary/finance (last visited February 9, 2015). Ex. 3001.
`
`
`
`13
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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`at 24 (emphasis added). The language omitted by Petitioner makes very
`
`clear that the claimed control step recites a step in the process of preventing
`
`abuse, misuse, or diversion of the prescription drug, not verifying payment
`
`by a patient. Id. at 24–25.
`
`The claims also do not recite a product or service particular to or
`
`characteristic of financial institutions such as banks, insurance companies,
`
`and investment houses. For example, the claim language does not recite or
`
`require (i) the sale of a prescription drug, (ii) processing of payments,
`
`benefits, or insurance claims related to the sale of a prescription drug, (iii) a
`
`method of insuring a patient or determining the cost of insurance, (iv) a
`
`method of determining the cost of prescription benefits, (v) a method of
`
`facilitating payment of health care benefits, or (vi) the extension of credit for
`
`the purchase of a prescription drug. Prelim. Resp. 20–21. We agree with
`
`Patent Owner that the activities recited in the claim language, in the context
`
`of the claim as a whole, constitute checks (“checking”) and controls
`
`(“verifying” information or “confirming receipt” of the drug) on
`
`“delivering” a prescription drug to an authorized “patient” to treat the patient
`
`and prevent “the potential abuse, misuse, or diversion of the prescription
`
`drug.”
`
`Therefore, for the reasons given above, we are unpersuaded by
`
`Petitioner’s argument that the ’106 patent claims recite method steps “used
`
`in the practice, administration, or management of a financial product or
`
`service.”
`
`c. The written description of the ’106 patent
`
`The claim limitations of the ’106 patent cited by Petitioner also do not
`
`recite or require the act of verifying a patient’s insurance coverage or ability
`
`
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`14
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`to pay for the prescription drug. Petitioner and Dr. Valuck do not explain, in
`
`detail or with specific analysis of the claim language, why the claimed
`
`method steps recite or require verifying insurance coverage or a patient’s
`
`ability to pay as described in Figures 2A, 4B, or 5 of the patent. Pet. 17–18
`
`(citing Ex. 1007 ¶¶ 45–46); Prelim. Resp. 25–27. Petitioner and Dr. Valuck
`
`also do not explain why any of the claimed method steps should be
`
`considered “financial” when considered in the context of the claim language
`
`as a whole. Their reasoning is circular—“[t]hese claimed steps are all
`
`financially related activities that are performed daily by pharmacies because
`
`they are required to provide prescription drugs to consumers and are part of
`
`the purchase process” (Ex. 1007 ¶ 45)—and unpersuasive. We agree with
`
`Patent Owner; the act of verifying a patient’s insurance coverage or ability
`
`to pay is not a claimed method step in the ’106 patent. Prelim. Resp. 26–27.
`
`In the context of the claims as a whole, the reference to “contacting
`
`the patient’s insurance company” is one of many controls for checking the
`
`patient’s information and identity. Prelim. Resp. 26. The claimed step of
`
`“checking . . . for cash payments” also is a control for preventing a patient
`
`from having multiple prescriptions filled by multiple pharmacies using cash
`
`payments. Id. Making the database available for the DEA to check for cash
`
`payments furthers this initiative. Id. The ’106 patent makes clear that the
`
`other elements Petitioner cites (“shipping via US postal service or a
`
`commercial shipping service;” “requiring manufacture at a single location;”
`
`and “authorizing release of inventory in a controlled manner”) are also
`
`controls to prevent “the potential abuse, misuse, or diversion of the
`
`prescription drug.” Id. The quoted claim limitations do not recite or require
`
`
`
`15
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`Case CBM2014-00161 (Patent 7,765,106 B2)
`Case CBM2014-00175 (Patent 7,765,107 B2)
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`a method step “used in the practice, administration, or management of a
`
`financial product or service.”
`
`We also agree with Patent Owner that in the three CBM decisions
`
`cited by Petitioner (Pet. 17, n. 3, 4), the Board relied on the written
`
`description of the respective patents to support the “financial product or
`
`service” requirement because the claim limitations recited method steps used
`
`in the embodiments described in the relied-upon portions of the
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`specifications. Prelim. Resp. 30–31 (citing CRS Advanced Tech., Inc. v.
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`Frontline Tech., Inc., Case CBM2012-00005, slip. op. 8 (PTAB Jan. 23,
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`2013) (Paper 17) (claimed method for substitute teller fulfillment system
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`used in embodiment for retail banking system); Google Inc. v. Inventor
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`Holdings, Case CBM2014-00002, slip op. 8–9 (PTAB Apr. 1, 2014) (Paper
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`16) (claimed method of facilitating exchange of identities between two
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`anonymous parties used in embodiment for matching employment
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`candidates with employer); Google Inc. v. Inventor Holdings, Case
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`CBM2014-00003, slip op. 8–9 (PTAB Apr. 1, 2014) (Paper 12) (same).
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`Petitioner has not made a comparable or persuasive argument based on a
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`close analysis of the claim language, considered in context as a whole, in
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`view of the embodiments described in the ’106 patent. Therefore, we find
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`the cited authority inapposite to the facts of the present case.
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`For the reasons given above, we are not persuaded by Petitioner’s
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`argument that the written description of method steps for verifying insurance
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`coverage or a patient’s ability to pay are recited or required by the ’106
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`patent claims.
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`16
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`d. Petitioner’s “used in commerce” argument
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`We agree with Patent Owner that Petitioner improperly attempts to
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`expand CBM review to cover a claimed business method because it is “used
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`in commerce.” Pet. 16–17; Prelim. Resp. 11–12. Petitioner’s argument is
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`not supported by the plain language of the statute or the legislative history.
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`Prelim. Resp. 11–12 (citing Conn. Nat’l Bank v. Germain, 503 U.S. 249,
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`253–54 (1992) (“[I]n interpreting a statute a court should always turn first to
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`one, cardinal canon before all others . . . courts must presume that a
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`legislature says in a statute what it means and means in a statute what it says
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`there.”). Petitioner does not provide a cogent argument or rationale for why
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`the statutory phrase “financial product or service” should be interpreted to
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`include a method for controlling access to a prescription drug that may be
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`used in commerce. Pet. 16–19. Contrary to Petitioner’s argument, Congress
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`did not say in the statute that a business method patent “used in commerce”
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`or covering “core activities” of running a business7 is eligible for CBM
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`review. AIA § 18(d)(1); Prelim. Resp. 11–12, 17–18. To the contrary, the
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`language of the statute excludes such a business method from CBM review,
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`unless a petitioner demonstrates that the method is “used in the practice,
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`administration, or management of a financial product or service.” AIA
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`§ 18(d)(1). Petitioner does not address persuasively the language of the
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`statute or provide persuasive evidence or analysis from which we might
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`7 Petitioner argues that certain method steps recited in claims 1, 3, 5, and 7
`directed to “receiving” all prescriptions, “identifying” the prescribing
`physician, “contacting” the insurance carrier, and “confirming receipt” of the
`drug, comprise the “core activities of running the business of an exclusive
`(single) mail order pharmacy that direct ships to patients.” Pet. 18. That
`argument is part and parcel of Petitioner’s “used in commerce” argument.
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`17
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`conclude that the claimed method recites steps used in the practice,
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`administration, or management of a financial product or service.
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`The legislative history, taken in context as a whole, also does not
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`support Petitioner’s argument. As Patent Owner emphasizes, when an
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`adjudicator considers legislative intent, “the Supreme Court has cautioned
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`that the adjudicator must consider the legislative intent as a whole—not just
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`‘isolated fragments’ of congressional comments.” Prelim. Resp. 13. (citing
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`New England Power Co. v. New Hampshire, 455 U.S. 331, 342 (1982)
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`(“Reliance on such isolated fragments of legislative history in divining the
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`intent of Congress is an exercise fraught with hazards . . . .”); Offshore
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`Logistics, Inc. v. Tallentire, 477 U.S. 207, 220–21 (1986) (statements in the
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`legislative history must be read in light of the statutory language and
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`legislative history as a whole)). With such caution in mind, we observe that
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`members of Congress expressed varying views concerning the scope of a
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`“covered business method patent” during the debate leading up to passage of
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`the AIA on September 16, 2011. See Prelim. Resp. 14–17.
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`Those views are exemplified on the one hand by Senator Schumer, co-
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`sponsor of the transitional program for CBM patent review, who stated,
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`“Any business that sells or purchases goods or services ‘practices’ or
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`‘administers’ a financial service by conducting such transactions . . . .” 157
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`Cong. Rec. S5432 (daily ed. Sept. 8, 2011). On the other hand, Senator
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`Leahy, co-sponsor of the AIA, expressed a more limited view and stated that
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`the program was intended to cover “only those business method patents
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`intended to be used in the practice, administration, or management of
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`financial services or products, and not to technologies common in business
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`environments across sectors and that have no particular relation to the
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`18
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`financial services sector.” Id. at S5441. Senator Kyl, co-sponsor with
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`Senator Schumer of AIA Section 18, entered into the record the Senate
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`Manager’s Amendment, which described a covered business method patent
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`as “limited to data processing relating to just a financial product or service
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`(rather than also to an enterprise8).” Id. at S1367 (daily ed. Mar. 8, 2011).
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`The ’106 patent’s claimed method for treating a patient and
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`controlling access to a prescription drug does not recite method steps
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`involving the movement of money or extension of credit in connection with
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`the sale of a prescription drug. The claims are more limited and define a
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`decidedly different activity—controlling access to a prescription drug to
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`guard against potential abuse, misuse, or diversion. The claimed method,
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`moreover, has no particular relation to the financial services industry and
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`does not relate to just a financial product or service rather than to an
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`enterprise, i.e., a conventional business organization. Therefore, in the
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`absence of clear and compelling evidence of legislative intent to include any
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`business method “used in commerce” within the definition of a “covered
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`business method patent” pursuant to AIA § 18(d)(1), we are unpersuaded by
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`Petitioner’s argument.
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`e. Petitioner’s Class 705 argument
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`Petitioner relies on the classification of the ’106 patent