`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC., and ROXANE LABORATORIES,
`INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`_____________________
`
`Case CBM: Unassigned
`_____________________
`
`PETITION FOR COVERED BUSINESS METHOD PATENT REVIEW OF U.S.
`PATENT NO. 7,668,730 UNDER 35 U.S.C. § 321 AND § 18 OF THE LEAHY-
`SMITH AMERICA INVENTS ACT
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`B.
`
`b)
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`(37 C.F.R. § 42.22(a)) ....................................................................................... 1
`OVERVIEW ..................................................................................................... 1
`A.
`Background ............................................................................................ 3
`B.
`The ’730 patent ....................................................................................... 7
`C.
`Summary of Argument ........................................................................... 9
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................ 10
`A.
`Par and Roxane have standing and are not estopped. (37 C.F.R.
`§ 42.302) ............................................................................................... 10
`The ’730 patent is directed to a covered business method ................... 11
`1.
`The Patent Claims Cover a “Financial Product or Service” ...... 12
`2.
`The Patent Does Not Claim a “Technological Invention” ........ 16
`a)
`The claimed subject matter does not contain any
`novel or unobvious technological features ...................... 17
`The claims do not address any technical problem
`using any kind of a technical solution ............................. 20
`IV. CLAIM CONSTRUCTION ........................................................................... 22
`A.
`“Exclusive Central Pharmacy” and “Exclusive Computer
`Database” .............................................................................................. 22
`“Generating with the computer processor periodic reports via
`the exclusive computer database” ........................................................ 22
`EACH OF THE REFERENCES CITED IS AVAILABLE PRIOR
`ART ................................................................................................................ 23
`A.
`The ACA (PAR1003 – PAR1006) qualifies as a “printed
`publication” .......................................................................................... 23
`VI. PERSON OF ORDINARY SKILL IN THE ART & STATE OF THE
`ART ................................................................................................................ 28
`IDENTIFICATION OF CHALLENGE ......................................................... 29
`A. Ground 1: Claims 1-11 are more likely than not unpatentable
`under 35 U.S.C. § 101 because they recite mere abstract ideas ........... 30
`
`B.
`
`V.
`
`VII.
`
`
`
`-i-
`
`

`

`3.
`
`4.
`
`B.
`
`CBM Petition of U.S. Patent No. 7,668,730
`
`
`1.
`
`2.
`
`Claims 1-11 are not statutory subject matter under § 101,
`because they recite mere abstract ideas. .................................... 31
`Even Assuming These Method Claims Apply to a
`Computer System, They Only Impliedly Reference a
`General Purpose Computer ........................................................ 39
`The Method Claims Do Not
`Include Meaningful
`Limitations Beyond the Abstract Idea Itself .............................. 42
`The Preliminary Examination Instructions in view of the
`Alice decision confirm that the ’730 Patent does not recite
`patentable subject matter. ........................................................... 45
`Ground 2: Claims 1-11 are anticipated by the ACA ............................ 47
`1.
`Claim 1 ....................................................................................... 50
`2.
`Claim 2 ....................................................................................... 62
`3.
`Claim 3 ....................................................................................... 62
`4.
`Claims 4 and 5............................................................................ 63
`5.
`Claim 6 ....................................................................................... 64
`6.
`Claim 7 ....................................................................................... 64
`7.
`Claim 8 ....................................................................................... 65
`8.
`Claim 9 ....................................................................................... 66
`9.
`Claim 10 ..................................................................................... 66
`10. Claim 11 ..................................................................................... 67
`Ground 3: Claims 1-11 would have been obvious over the ACA ....... 67
`C.
`Secondary considerations do not rebut the prima facie case. .............. 73
`D.
`VIII. IT IS MORE LIKELY THAN NOT THAT PETITIONER WILL
`PREVAIL WITH RESPECT TO AT LEAST ONE OF THE
`CHALLENGED CLAIMS ............................................................................. 78
`IX. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ..................................... 78
`X.
`CONCLUSION ............................................................................................... 79
`
`
`
`
`
`-ii-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`I.
`
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37
`C.F.R. § 42.22(a))
`
`
`
`Par Pharmaceutical, Inc. and Roxane Laboratories, Inc. (collectively,
`
`“Petitioners”) petition for covered business method patent (“CBM”) review and
`
`seek cancellation of claims 1-11 of U.S. Patent No. 7,668,730 (“the ’730 patent”)
`
`(PAR1001). According to USPTO records, the ’730 patent is assigned to Jazz
`
`Pharmaceuticals, Inc. Jazz is currently asserting the ’730 patent against
`
`Petitioners. (See PAR1025 and PAR1026.)
`
`II.
`
`OVERVIEW
`
`Claims 1-11 of the ’730 patent are unpatentable because they: (i) claim
`
`ineligible subject matter under 35 U.S.C. § 101; (ii) are anticipated by the prior art
`
`under 35 U.S.C. § 102(b); and (iii) are obvious over the prior art under 35 U.S.C. §
`
`103, even in view of secondary considerations of nonobviousness.
`
`The challenged claims simply recite methods for centralized distribution of
`
`retail goods, specifically drugs, through a central pharmacy, rendering them
`
`incidental to a financial product or service. And these claims are directed to
`
`methods and not any technological invention. The claims’ recitation of a generic
`
`computer processor does not change this conclusion. Moreover, the claimed
`
`distribution methods are not novel or nonobvious and do not solve a technological
`
`problem with any technological solution. CBM review is, therefore, appropriate.
`
`
`
`-1-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`
`By law, no patent should issue if it claims: “A prior art method X,” which is
`
`simply an abstract idea, and nothing more. Yet the ’730 patent claims just that.
`
`Even in their best possible light, the claims are merely drawn to abstract ideas, and
`
`nothing more, artfully drafted in an effort designed to monopolize the abstract idea
`
`itself, as warned against in Alice Corp. v. CLS Bank Int’l, No. 13-298, 573 U.S. __
`
`(2014) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289,
`
`1297 (2012). For example, challenged claims 1-11 are directed to the abstract idea
`
`of centralizing distribution of hazardous or abuse-prone drugs to reduce the abuse
`
`risks associated with the drugs without any meaningful limitations. And, the
`
`claimed steps can be performed by a human intermediary without any computer
`
`operation. (PAR1007, ¶50.)
`
`The challenged claims are also unpatentable as being anticipated by and
`
`obvious in view of the relevant prior art. For example, published materials that
`
`were used in an FDA Advisory Committee Meeting (the “Advisory Committee
`
`Art” or “ACA”) disclose every limitation of the challenged claims more than a
`
`year before the ’730 patent’s earliest effective filing date. Accordingly, the
`
`challenged claims are anticipated. Alternatively, the challenged claims would also
`
`have been obvious to a person of ordinary skill in the art (“POSA”) at the time of
`
`the invention over the same art, even in view of any available alleged objective
`
`indicia of nonobviousness.
`
`
`
`-2-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`
`The Grounds raised in this Petition amply demonstrate that it is more likely
`
`than not that Petitioners will prevail with respect to at least one of the challenged
`
`claims, and CBM review of the ’730 patent is warranted. To find otherwise and
`
`maintain the ’730 patent, allows for patenting of an abstract idea and would allow
`
`for patenting of an abstract idea, and would withdraw that which was in the public
`
`domain. The Board should institute CBM review and cancel each of challenged
`
`claims 1-11.
`
`A. Background
`The ’730 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’730 patent is listed in the United States Food
`
`and Drug Administration’s electronic publication known as the “Orange Book”
`
`(“OB”), in connection with the prescription drug product Xyrem®. The active
`
`ingredient
`
`in Xyrem®—sodium oxybate,
`
`the
`
`sodium
`
`salt of gamma
`
`hydroxybuyrate (“GHB”)—was well-known in the prior art as being susceptible to
`
`diversion and abuse. (PAR1007, ¶51.) So, as a prerequisite to FDA approval, the
`
`sponsor of Xyrem®, with assistance and direction from an FDA advisory
`
`committee, agreed to employ a centralized distribution program to attempt to
`
`reduce abusive and illicit uses of Xyrem®, now known as the Xyrem® Success
`
`Program. By listing the ’730 patent in the FDA’s OB for Xyrem®, Jazz is asserting
`
`
`
`-3-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`that the Xyrem® Success Program is an embodiment of at least one claim of the
`
`’730 patent.
`
`Aside from the explicit disclosure of the ’730 patent’s claimed methods in
`
`the prior art, the mitigation of risks associated with the distribution of potentially
`
`hazardous drugs was well-established in the art before the earliest effective filing
`
`date of the ’730 patent. For example, in 1982, Hoffman-La Roche (“Roche”)
`
`gained approval for Accutane® (isotretinoin), which became known to be a potent
`
`teratogen that was responsible for birth defects. (PAR1007, ¶22.) Under pressure to
`
`respond, Roche developed a Pregnancy Prevention Program for Accutane®. (Id.)
`
`The program included informed consent forms to be completed by the patient and
`
`prescriber, along with patient counseling on the teratogenic risk of Accutane®, the
`
`need to avoid pregnancy, and the use of proper birth control methods. Finally, this
`
`program required that women of childbearing potential must test serum negative
`
`for a pregnancy before beginning treatment. (Id.)
`
`
`
`Following in the footsteps of Accutane®, in 1990, Clozaril® (clozapine)
`
`entered the United States market for use with treatment-resistant schizophrenia.
`
`(PAR1007, ¶23.) However, Clozaril® use was associated with agranulocytosis, a
`
`potentially fatal blood disorder resulting in white blood cell loss. (Id.) To mitigate
`
`these risks and control the distribution of Clozaril®, the manufacturer implemented
`
`a national registry system that limited distribution of the drug. (Id.) The
`
`
`
`-4-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`distribution system required registration in an integrated computerized database—
`
`
`
`collecting information identifying the patient and the physician and measuring the
`
`patient’s white blood cell count before filling a prescription. (Id.) If a patient or
`
`physician was non-compliant with the program, the national registry took
`
`corrective action, such as contacting and re-educating the prescribing physician
`
`and/or discontinuing supply of the prescription to the patient. (Id.) Overall, the
`
`Clozaril® distribution system resulted in 97% compliance over its first five years
`
`of implementation. (Id.) While the use of a computer differentiated the Clozaril®
`
`system from the Accutane® system, the use of computers was not novel to
`
`prescription drug distribution, because by 1990 pharmacies had long been using
`
`computers to aid in filling prescriptions. (Id., ¶24.)
`
`
`
`Based on the experiences of patients and doctors with Accutane® and
`
`Clozaril®, in 1999, the manufacturers of prescription thalidomide—a known
`
`teratogen—developed a hybrid system, combining the computerized registry
`
`system of Clozaril® and the pregnancy monitoring/prevention, and informed
`
`consent requirements of Accutane®. (Id., ¶25.) This combination of computerized
`
`registry system and preventative testing served to monitor and control the
`
`distribution of the drug. (Id.)
`
`
`
`Thus, by 1999, at least three systems for the restricted distribution of
`
`effective, yet hazardous prescription drugs were known in the art and implemented
`
`
`
`-5-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`across the industry. Moreover, while risk management programs were developing
`
`during the 1980s through 1990s, pharmacies had already been using computerized
`
`systems for the distribution of controlled substances, i.e., drugs with potential for
`
`abuse. (Id., ¶¶26, 27.) Aiming to reduce time for dispensing, improve accuracy and
`
`accountability, and streamline record keeping, the distribution of controlled
`
`substances veered toward automation via the implementation of computerized
`
`systems of distribution. (Id., ¶27.) Computerized systems were helpful in
`
`generating reports tracking patients who were receiving excessive supplies of
`
`controlled substances. (Id.) Distribution of controlled substances could be tied to
`
`information identifying the patient, the prescribing doctor, the quantity of the drug
`
`dispensed, and the hospital inventory of a drug. (Id.) And, the systems could be
`
`queried to provide data, such as prescriptions by doctor and patient. (Id.) These
`
`systems allowed for detecting patterns of abuse. (Id.)
`
`
`
`Given the proclivity for diversion and abuse of GHB, the FDA held advisory
`
`committee meetings as a prerequisite to granting approval to the Xyrem® New
`
`Drug Application (“NDA”). A collection of materials that were used in that
`
`meeting (the “Advisory Committee Art” or “ACA”)—all of which published more
`
`than one year prior to the earliest effective filing date of the ’730 patent—discloses
`
`every limitation of the challenged claims.
`
`Consequently, prior to the earliest effective filing date of the ’730 patent, the
`
`-6-
`
`
`
`
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`prior art existed that would have led a POSA to develop the centralized distribution
`
`methods claimed in the ’730 patent to minimize the risks associated with the
`
`distribution of hazardous, but therapeutically beneficial, prescription drugs. (Id.,
`
`¶28.)
`
`The ’730 patent
`
`B.
`Against this backdrop, Jazz obtained the ’730 patent. The ’730 patent
`
`
`
`relates to “[a] drug distribution system and method [that] utilizes a central
`
`pharmacy and database to track all prescriptions for a sensitive drug.” (PAR1001,
`
`Abstract.) According to the ’730 patent, prescription patterns by physicians and
`
`patients are monitored for abuse using an exclusive central database. Further,
`
`physician eligibility to prescribe the drug is verified via a database, including
`
`determining whether any corrective or approved disciplinary actions have been
`
`brought against the physician. (Id., 1:44-50.) Prior to shipping the prescription
`
`drug, the central pharmacy confirms whether the patient has been educated about
`
`the prescription, and only ships the prescription drug when no abuse is found
`
`related to the patient or prescribing doctor. (See id., 1:52-63.) Reports are then
`
`generated to evaluate potential diversion patterns. (See id., 2:13-15.)
`
`
`
`The ’730 patent claims are directed to a method of distributing a prescription
`
`drug from an exclusive central pharmacy that comprises: (1) receiving in a
`
`computer processor all prescription requests for any and all patients only at the
`
`
`
`-7-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`exclusive central pharmacy, entering information from the prescription requests
`
`into an exclusive computer database associated with the exclusive central
`
`pharmacy and processing the prescription requests only by the exclusive central
`
`pharmacy using only the exclusive computer database; (2) checking for patterns of
`
`abuse using the exclusive computer database; (3) only providing the prescription
`
`drug to the patient if no abuse is found; and (4) generating periodic reports to
`
`evaluate potential diversion patterns.
`
`
`
`During prosecution of the application that led to the ’730 patent (U.S. Patent
`
`Application No. 10/322,348 (“the ’348 application”)), the independent claims were
`
`amended to add the following limitations to overcome prior art rejections: (1) “all
`
`prescriptions for the sensitive drug are processed only by the exclusive central
`
`pharmacy using only the exclusive computer database”; and (2) “mailing the
`
`sensitive drug to the patient only if no potential abuse is found by the patient to
`
`whom the sensitive drug is prescribed and the doctor prescribing the sensitive
`
`drug.”1 (PAR1002, 698 (Amdt. & Reply filed Nov. 2, 2009; see also PAR1002,
`
`401 (Amdt. & Reply filed Aug. 8, 2006) and 522 (Appeal Brief filed July 18,
`
`2007).) Applicants argued that these limitations were not taught by the cited prior
`
`art. (PAR1002, 699 (Amdt. & Reply, filed Nov. 2, 2009).) All other limitations of
`
`the claims were found to have been taught by the cited prior art. (Id. at 417-430
`
`
`1 Emphasis added throughout unless otherwise noted.
`
`
`
`-8-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`(Final Rejection, Oct. 18, 2006) and at 592-604 (Decision on Appeal, Aug. 31,
`
`2009).)
`
`
`
`Subsequently, in the Notice of Allowance for the ’348 application, the
`
`Examiner pointed to the above-noted limitations when allowing the claims, stating:
`
`“the closest prior art of record does not teach or fairly suggest that all prescriptions
`
`for GHB are processed only by the exclusive central pharmacy using only the
`
`exclusive computer database. The exclusive computer database is checked for
`
`potential GHB abuse and GHB is provided/mailed only if no potential abuse is
`
`found by the patient to whom GHB is prescribed and the doctor/authorized
`
`prescriber of the GHB.” (Id. at 790 (Notice of Allowance) (emphasis in original).)
`
`However, as demonstrated in this petition, all of these alleged “novel” limitations
`
`were, in fact, not novel. Use of an “exclusive central pharmacy” and “exclusive
`
`computer database” were well-known in the art. (See § VII.B.1.) And the same art
`
`also discloses checking the exclusive computer database for patterns of abuse by
`
`both the doctors and patients and only providing the prescription drug to the patient
`
`if no abuse is found. (Id.)
`
`Summary of Argument
`
`C.
`Petitioners Par and Roxane, both individually and collectively, have standing
`
`to seek CBM review of the ’730 patent, and the ’730 patent is eligible for CBM
`
`review. Supported by the Declaration of Dr. Robert Valuck, Ph.D., R.Ph. (“Valuck
`
`
`
`-9-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`Dec.”) (PAR1007), an expert in the fields of drug safety, drug abuse prevention,
`
`and prescription drug distribution, this petition asserts three different grounds of
`
`unpatentability: Claims 1-11 (1) are unpatentable under 35 U.S.C. § 101 because
`
`they recite mere abstract ideas; (2) are anticipated by the ACA; and (3) would have
`
`been obvious in view of the ACA. In support of those stated grounds, this petition
`
`proposes terms for construction, identifies each prior art reference relied upon, and
`
`provides mandatory notices.
`
`III.
`
`GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`
`The undersigned and Par and Roxane certify that the ’730 patent is available
`
`for post-grant review as a covered business method patent under § 18 of the
`
`Leahy–Smith America Invents Act (“AIA”). Pub. L. 112-29., § 18(a)(1)(A), 125
`
`Stat. 284, 329 (2011). A covered business method patent, as defined in the AIA,
`
`must claim 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 it does not include patents for technological
`
`inventions. AIA § 18(d)(1). Because the ’730 patent satisfies these requirements,
`
`it is eligible for post-grant, or CBM, review under § 18.
`
`A.
`
`Par and Roxane have standing and are not estopped. (37 C.F.R. §
`42.302)
`
`Par and Roxane are eligible to make this petition. “A petitioner may not file
`
`… a petition to institute a covered business method patent review of the patent …
`
`
`
`-10-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`unless the petitioner … has been sued for infringement of the patent or has been
`
`charged with infringement under the patent.” 37 C.F.R. § 42.302(a). Patent Owner
`
`Jazz has sued each of Par and Roxane in the District of New Jersey and has
`
`accused the Petitioners of infringing claims 1-11 of the ’730 patent. See § IX. As a
`
`result, Par and Roxane have standing to file this petition under 37 C.F.R. §
`
`42.302(a). Additionally, because neither Par nor Roxane has been a party to any
`
`other decided post-grant or inter partes review of the challenged ’730 patent
`
`claims under 37 C.F.R. § 42.302(b), Petitioners are not estopped from bringing this
`
`challenge.
`
`The ’730 patent is directed to a covered business method
`
`B.
`The AIA defines a CBM patent as “a patent 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….”
`
`AIA § 18(d)(1); see also 37 C.F.R. § 42.301. As the Office has recognized, the
`
`AIA’s legislative history establishes that “financial product or service” should be
`
`“interpreted broadly,” encompassing patents “claiming activities that are financial
`
`in nature, incidental to a financial activity or complementary to a financial
`
`activity.” See 77 Fed. Reg. 48734, 48735. Of particular applicability to the ’730
`
`patent, Sen. Schumer, co-author of § 18, stated that “[t]o meet this [eligibility]
`
`requirement, the patent need not recite a specific financial product or service.
`
`
`
`-11-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`Rather, the patent claims must only be broad enough to cover a financial product
`
`or service.” See 157 Cong. Rec. S1365 (daily ed. Mar. 8, 2011) (Sen. Schumer).
`
`Moreover, the language “practice, administration, or management” is “intended to
`
`cover any ancillary activities related to a financial product or service,
`
`including…customer
`
`interfaces, Web site management and functionality,
`
`transmission or management of data, [and] customer communications…” Id. at
`
`1364-1365.
`
`The Patent Claims Cover a “Financial Product or Service”
`
`1.
`The ’730 patent is directed to a “drug distribution system … [that] utilizes a
`
`central pharmacy and database to track all prescriptions for a sensitive drug.”
`
`(PAR1001, Abstract.) The claimed system would be used in commerce. As made
`
`clear in its Abstract, the ’730 patent “relates to distribution of drugs,” and claims a
`
`“computerized method of distributing a prescription drug.” (See id., 8:37-38.)
`
`Only one CBM-eligible claim is needed within a patent in order to deem an entire
`
`patent eligible for CBM review;2 here, at least claim 1 is CBM-eligible because
`
`the distribution of a prescription drug is financial in nature; and it is also incidental
`
`and complementary to financial activities.
`
`2 Transitional Program for Covered Business Method Patents – Definitions of
`
`Covered Business Method Patent and Technological Invention; Final Rule, 77 Fed.
`
`Reg. 48734, 48736 (Aug. 14, 2012) (Response to Comment 8).
`
`
`
`-12-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`
`The ’730 patent specification further supports CBM-eligibility, explaining
`
`how the claimed activities are incidental to a financial activity. Prior Board
`
`decisions have looked to the specification, in light of the claims, to determine that
`
`a patent is CBM-eligible even if its claims may not map directly or explicitly to a
`
`financial product or service.3 In those cases, the Board determined that the
`
`specification revealed that the claims encompassed activities that were incidental
`
`to financial activity, which was sufficient to deem the entire patent eligible for
`
`CBM review.4
`
`Here, the ’730 patent specification demonstrates how the ’730 patent is
`
`incidental to financial activities. For example, where there is an early prescription
`
`refill, “cash payers are also identified…[and] if the physician approves…[t]he
`
`pharmacist notifies an intake reimbursement specialist to contact the patient’s
`
`insurance provider to verify coverage for the early refill...If the insurance
`
`provider will pay…the specialist submits the coverage approval form as
`
`notification that the refill may be processed.” (PAR1001, 6:33-52.) Moreover, the
`
`’730 patent provides “if the insurance provider will not pay...it is determined
`
`whether the patient is willing and/or able to pay...If it was determined…that the
`
`3 See CBM2012-00005, Paper No. 17, (January 23, 2013).
`
`4 See CBM2014-00002, Paper No. 16, (April 1, 2014); see also CBM2014-00003,
`
`Paper No. 12, (April 1, 2014).
`
`
`
`-13-
`
`

`

`CBM Petition of U.S. Patent No. 7,668,730
`
`
`
`patient was willing and able to pay, the patient is informed of the cost of the
`
`product and is given payment options....Once payment is received…the specialist
`
`submits a coverage approval form to the pharmacy team as notification that the
`
`refill request can be processed.” (Id., 6:58-67.) The ’730 patent has additional
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`examples which demonstrate that its system is used in commerce, such as the
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`“NORD” process, which is “used to determine whether donated, third party funds
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`are available for paying for prescriptions where neither insurance will, nor the
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`patient can pay.” (Id., 7:3-6.)
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`Additionally, other claims of the ’730 patent, too, cover direct or ancillary
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`activities related to a financial product or service. For example, all claims recite
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`activities such as “receiving all prescription requests…,” “checking the credentials
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`of any and all doctors…,” and “mailing” or “providing” the prescription drug.
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`These claimed steps comprise the core activities of running the very business of a
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`mail order pharmacy that direct ships to consumers (PAR1007, ¶¶47-48.), once
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`again demonstrating that the multiple claims of the ’730 patent are CBM-eligible.
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`The ’730 patent’s support for claiming activities that are incidental to a
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`financial activity is not at all surprising in view of the Office’s classification of the
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`’730 patent within Class 705, titled “Data processing: financial, business practice,
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`management, or cost/price determination.” Though this fact alone might not
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`necessarily be dispositive, it is highly relevant given that the Office itself
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`-14-
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`CBM Petition of U.S. Patent No. 7,668,730
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`
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`anticipated that patents subject to CBM would be “typically classifiable in Class
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`705.” 77 Fed. Reg. 157, p. 48,680, 48,711 (Aug. 14, 2012). Further, the ’730
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`patent was specifically classified under subclass 2, titled “Health care management
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`(e.g., record management, ICDA billing).” Part of the definition for subclass 705/2
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`states that patents under this sub-category include “billing systems based on
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`entered medical codes, for example, ICDA codes.” See Manual of Classification,
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`United States Patent & Trademark Office, Class 705.
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` Billing systems
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`encompassed within the ’730 patent are activities that are financial in nature,
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`incidental to a financial activity or complementary to a financial activity.
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`Additionally, during the prosecution of the ’730 patent, the main prior art
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`cited by the Office—U.S. Patent Publication No. 2004/0019794 (“Moradi”) and
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`U.S. Patent Publication No. 2004/0176985 (“Lilly”)—also perform processing and
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`operations that are used in the practice, administration, or management of a
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`financial product or service. For example, Moradi discusses making payment
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`arrangements before dispensing a prescription drug, and Lilly discusses contacting
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`insurance companies monitoring prescription information. (See, e.g., PAR1030,
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`¶¶7, 32; PAR1031, ¶56, 62.)
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`Whether considering the claims themselves, the disclosure and embodiments
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`in the specification, or the Office’s own classification, the conclusion is the same:
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`the ’730 patent performs processing and operations that are used in the practice,
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`-15-
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`CBM Petition of U.S. Patent No. 7,668,730
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`
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`administration, or management of a financial product or service, qualifying it for
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`CBM review under the AIA.
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`The Patent Does Not Claim a “Technological Invention”
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`2.
`The AIA excludes “patents for technological inventions” from the definition
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`of CBM patents. AIA § 18(d)(2). To determine if a patent is for a technological
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`invention, “the following will be considered on a case-by-case basis: whether the
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`claimed subject matter as a whole recites a technological feature that is novel and
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`unobvious over the prior art; and solves a technical problem using a technical
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`solution.” 37 C.F.R. § 42.301(b).
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`When first proposed, commentators asked the Office to revise the definition
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`to clarify that a technological invention was one that met either of these
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`definitions, or to provide a wholly different test. See, e.g., 77 Fed. Reg. 48,734,
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`48736-37 (Aug. 14, 2012). But the Office declined to loosen the definition,
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`deciding to maintain the limited scope of the “technological invention” exception.
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`In so doing, the Office explained that a narrow exception is consistent with the
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`AIA’s legislative history and represents “the best policy choice.” Id. at 48735-36.
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`Under that framework, to be exempt from CBM review, the claimed subject
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`matter as a whole must: (1) have a technological feature that is novel and
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`unobvious; and (2) solve a technical problem using a technical solution. If even
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`one claim of a patent is not directed to a “technological invention,” the exception
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`-16-
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`

`

`CBM Petition of U.S. Patent No. 7,668,730
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`
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`does not apply. Id. at 48736. Here, the ’730 patent claims do not meet the
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`requirements of the narrow “technological invention” exception because its
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`computer processor and computer database components are not technological
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`features that are novel and non-obvious, and these features are used to address a
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`non-technical problem using a non-technical solution.
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`a)
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`The claimed subject matter does not contain any
`novel or unobvious technological features
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`The ’730 patent claims do not recite a technological feature that is novel and
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`unobvious. Claim 1, for example, covers an abstract idea with limited references,
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`at best, to a computer processor and a computer database. Given that a human
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`intermediary could perform all of the steps of claim 1, there is nothing remotely
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`technological or inventive in claim 1. Claim 1 merely recites the use of a known
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`generic processor interacting with a known generic database to perform some of
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`the steps of claim 1. Moreover, the recited processing could be done by a non-
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`technical implementation, such as the human mind. The technological invention
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`exception was not intended to immunize such a technology-generic data processing
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`claim from CBM review. As stated by Sen. Schumer:
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`[the technological invention exception] is not meant to exclude patents
`that use known technology to accomplish a business process or method of
`conducting business—whether or not that process or method appears to be
`novel.… In other words, a paten