Roxane Laboratories, Inc.v.Jazz Pharmaceuticals Inc.

Patent Trial and Appeal Board

Feb 9, 2015

11097985 (P.T.A.B. Feb. 9, 2015)

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)

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I. INTRODUCTION
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).
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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.
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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.
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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.
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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
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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.
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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
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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
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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
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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.
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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.
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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.
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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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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
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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
specifications. Prelim. Resp. 30–31 (citing CRS Advanced Tech., Inc. v.
Frontline Tech., Inc., Case CBM2012-00005, slip. op. 8 (PTAB Jan. 23,
2013) (Paper 17) (claimed method for substitute teller fulfillment system
used in embodiment for retail banking system); Google Inc. v. Inventor
Holdings, Case CBM2014-00002, slip op. 8–9 (PTAB Apr. 1, 2014) (Paper
16) (claimed method of facilitating exchange of identities between two
anonymous parties used in embodiment for matching employment
candidates with employer); Google Inc. v. Inventor Holdings, Case
CBM2014-00003, slip op. 8–9 (PTAB Apr. 1, 2014) (Paper 12) (same).
Petitioner has not made a comparable or persuasive argument based on a
close analysis of the claim language, considered in context as a whole, in
view of the embodiments described in the ’106 patent. Therefore, we find
the cited authority inapposite to the facts of the present case.
For the reasons given above, we are not persuaded by Petitioner’s
argument that the written description of method steps for verifying insurance
coverage or a patient’s ability to pay are recited or required by the ’106
patent claims.

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d. Petitioner’s “used in commerce” argument
We agree with Patent Owner that Petitioner improperly attempts to
expand CBM review to cover a claimed business method because it is “used
in commerce.” Pet. 16–17; Prelim. Resp. 11–12. Petitioner’s argument is
not supported by the plain language of the statute or the legislative history.
Prelim. Resp. 11–12 (citing Conn. Nat’l Bank v. Germain, 503 U.S. 249,
253–54 (1992) (“[I]n interpreting a statute a court should always turn first to
one, cardinal canon before all others . . . courts must presume that a
legislature says in a statute what it means and means in a statute what it says
there.”). Petitioner does not provide a cogent argument or rationale for why
the statutory phrase “financial product or service” should be interpreted to
include a method for controlling access to a prescription drug that may be
used in commerce. Pet. 16–19. Contrary to Petitioner’s argument, Congress
did not say in the statute that a business method patent “used in commerce”
or covering “core activities” of running a business
7
is eligible for CBM
review. AIA § 18(d)(1); Prelim. Resp. 11–12, 17–18. To the contrary, the
language of the statute excludes such a business method from CBM review,
unless a petitioner demonstrates that the method is “used in the practice,
administration, or management of a financial product or service.” AIA
§ 18(d)(1). Petitioner does not address persuasively the language of the
statute or provide persuasive evidence or analysis from which we might

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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conclude that the claimed method recites steps used in the practice,
administration, or management of a financial product or service.
The legislative history, taken in context as a whole, also does not
support Petitioner’s argument. As Patent Owner emphasizes, when an
adjudicator considers legislative intent, “the Supreme Court has cautioned
that the adjudicator must consider the legislative intent as a whole—not just
‘isolated fragments’ of congressional comments.” Prelim. Resp. 13. (citing
New England Power Co. v. New Hampshire, 455 U.S. 331, 342 (1982)
(“Reliance on such isolated fragments of legislative history in divining the
intent of Congress is an exercise fraught with hazards . . . .”); Offshore
Logistics, Inc. v. Tallentire, 477 U.S. 207, 220–21 (1986) (statements in the
legislative history must be read in light of the statutory language and
legislative history as a whole)). With such caution in mind, we observe that
members of Congress expressed varying views concerning the scope of a
“covered business method patent” during the debate leading up to passage of
the AIA on September 16, 2011. See Prelim. Resp. 14–17.
Those views are exemplified on the one hand by Senator Schumer, co-
sponsor of the transitional program for CBM patent review, who stated,
“Any business that sells or purchases goods or services ‘practices’ or
‘administers’ a financial service by conducting such transactions . . . .” 157
Cong. Rec. S5432 (daily ed. Sept. 8, 2011). On the other hand, Senator
Leahy, co-sponsor of the AIA, expressed a more limited view and stated that
the program was intended to cover “only those business method patents
intended to be used in the practice, administration, or management of
financial services or products, and not to technologies common in business
environments across sectors and that have no particular relation to the
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financial services sector.” Id. at S5441. Senator Kyl, co-sponsor with
Senator Schumer of AIA Section 18, entered into the record the Senate
Manager’s Amendment, which described a covered business method patent
as “limited to data processing relating to just a financial product or service
(rather than also to an enterprise
8
).” Id. at S1367 (daily ed. Mar. 8, 2011).
The ’106 patent’s claimed method for treating a patient and
controlling access to a prescription drug does not recite method steps
involving the movement of money or extension of credit in connection with
the sale of a prescription drug. The claims are more limited and define a
decidedly different activity—controlling access to a prescription drug to
guard against potential abuse, misuse, or diversion. The claimed method,
moreover, has no particular relation to the financial services industry and
does not relate to just a financial product or service rather than to an
enterprise, i.e., a conventional business organization. Therefore, in the
absence of clear and compelling evidence of legislative intent to include any
business method “used in commerce” within the definition of a “covered
business method patent” pursuant to AIA § 18(d)(1), we are unpersuaded by
Petitioner’s argument.
e. Petitioner’s Class 705 argument
Petitioner relies on the classification of the ’106 patent in Class 705,
subclass 2, which includes “billing systems based on entered medical
codes,” in support of the argument that “[b]illing systems encompassed

8
An “enterprise” is distinguished from the more limited “financial product
or service” in the USPTO’s Manual of Classification, Class 705, which
defines an enterprise as, inter alia, a “conventional business organization.”
Prelim. Resp. 16; see
http://www.uspto.gov/web/offices/ac/ido/oeip/taf/def/705.htm.
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within the ’106 patent are activities that are financial in nature, incidental . . .
or complementary to a financial activity.” Pet. 18–19. Petitioner also relies
on the citation of prior art billing systems by the Examiner during
examination of the ’106 patent as further support for this argument. Id. at
19. Petitioner argues that, although not dispositive, the classification of the
’106 patent in Class 705 and citation of art regarding prescription drug
payment arrangements is persuasive evidence that the ’106 patent method
claims satisfy the statutory “financial product or service” requirement. Id. at
18–19.
Petitioner does not explain, however, how the claim language of the
’106 patent recites method steps used in medical code billing systems or
prior art payment systems. Id. As indicated by Patent Owner, the ’106
patent claims do not recite method steps used in billing systems, and the
patent does not even describe billing systems. Prelim. Resp. 35. In sum, in
the absence of a more detailed analysis and explanation of how the claim
language and prior art indicate that the claims recite method steps used in
billing systems, we are not persuaded that mere classification in Class 705
supports the inference that the patent claims satisfy the “financial product or
service” requirement of AIA § 18(d)(1).
3. Conclusion
For the reasons given above, based on the present record and
particular facts of this case, Petitioner has not demonstrated that at least one
claim of the ’106 patent recites or requires method steps “used in the
practice, administration, or management of a financial product or service” as
defined in Section 18(d)(1) of the AIA.

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III. CONCLUSION
For the reasons given above, based on the present record and
particular facts of these cases, we are not persuaded that the information
presented in the Petitions establishes that any claim in the ’106 and ’107
patents qualifies as a covered business method patent under Section 18 of
the AIA. Petitioner, therefore, has failed to satisfy the jurisdictional
requirements of Section 18.

IV. ORDER
Accordingly, it is ORDERED that the Petitions are denied.

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FOR PETITIONERS:
Alan B. Clement, Lead Counsel
Peter N. Fill, Backup Counsel
LOCKE LORD LLP
aclement@lockelord.com
pfill@lockelord.com

FOR PATENT OWNER:
F. Dominic Cerrito, Lead Counsel
QUINN EMANUEL URQUHART & SULLIVAN, LLP
nickcerrito@quinnemanuel.com

John V. Biernacki, Backup Counsel
JONES DAY
jvbiernacki@jonesday.com