UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS, LLC and PAR
`PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`_____________________
`
`Case CBM: Unassigned
`_____________________
`
`PETITION FOR COVERED BUSINESS METHOD PATENT REVIEW OF
`U.S. PATENT NO. 8,457,988 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
`
`
`
`
`
`

`

`
`
`
`
`TABLE OOF CONTTENTS
`
`
`
`
`OF RELLIEF REQ
`
`
`
`
`INNTRODUCCTION AAND STATTEMENT
`UESTED
`
`
`
`
`
`.................(337 C.F.R. § 42.22(a))) ................................
`
`..................................
`................
`
`OVERVIEWW .............
`
`..................................
`
`..................................
`................
`A. 
`
`Backkground ....
`
`..................................
`
`..................................
`B. 
`
`
`
`
`The ’’988 patent .................................................
`
`..................................
`C. 
`
`
`
`
`Summmary of Arrgument .....................................
`
`..................................
`
`
`
`
`
`
`
`III.  GGROUNDSS FOR STAANDING ((37 C.F.R.. § 42.104((a)) .............................
`
`
`
`
`
`
`A.  Amnneal and Paar have staanding andd are not eestopped (337 C.F.R.
`
`
`
`
`§ 42.302) ...........................................................
`
`..................................
`
`
`
`
`The ’’988 patent is directeed to a coveered busin
`
`ess methodd ...............
`
`
`
`
`The Pateent Claims Cover a “FFinancial PProduct or
`Service” ..
` 1.
`
`ogical Inveention”.....
` 2.
`
`
`
`The Pateent Does Not Claim aa “Technol
`a) 
`
`
`
`
`
`Thhe claimedd subject mmatter doees not conntain any
`
`
`
`
`
`noovel or unoobvious tecchnologicall features ...................
`
`Thhe claims
`
`
`
`do not adddress anyy technicall problem
`
`
`
`
`
`using any kinnd of a techhnical soluution ..........................
`
`
`
`
`
`IV.  CCLAIM COONSTRUCCTION .......................................
`
`..................................
`
`
`and “Exxclusive CComputer
`A. 
`
`
`
`“Exclusive Ceentral Phharmacy”
`
`
`
`
`Databbase” ..........................................................
`
`..................................
`
`
`
`
`
`
`“Gennerating wiith the commputer proccessor periiodic reporrts via the
`
`
`
`
`excluusive compputer databbase” ..........................
`
`..................................
`
`
`C. 
`
`
`
`
`“Disppensed to tthe narcoleeptic patiennt by anothher pharmaacy” ..........
`
`
`
`EACH OF TTHE REFEERENCESS CITED I
`
`
`S AVAILAABLE PRIIOR ART .
` “printed
`A. 
`The
`
`
`
`
`ACA (AMMN1003 –– AMN10006) qualiifies as a
`
`
`
`
`publiication” ......................................................
`
`..................................
`OF THE
`
`
`
`
`
`
`VI.  PPERSON OOF ORDINNARY SKILL IN THHE ART && STATE
`................
`
`..................................
`
`
`AART ...........................
`
`..................................
`
`
`
`
`
`IDDENTIFICCATION OOF CHALLLENGE .....................
`
`..................................
`
`
`likely thaan not unppatentable
`
`
`
`AA.  Grouund 1: Claaims 1-15
`are more
`
`
`underr 35 U.S.CC. § 101 because theyy recite me
`
`
`
`re abstractt ideas .......
`
`b) 
`
`O A B C
`
`A B
`
`B. 
`
`A B C
`
`B. 
`
`E A
`
`I. 
`
`II. 
`
`V. 
`
`VII. 
`
`..... 1 
`..... 1 
`...... 3 
`...... 6 
`...... 8 
`..... 9 
`
`...... 9 
`.... 10 
`... 11 
`... 16 
`
`... 17 
`
`... 20 
`... 21 
`
`.... 22 
`
`.... 22 
`.... 23 
`... 23 
`
`.... 24 
`
`... 29 
`... 30 
`
`.... 31 
`
`-i-
`
`

`

`
`
`
`
`
`Claims 11-15 are noot statutoryy subject mmatter undder § 101,
`
`
`
`because tthey recite mere absttract ideas.
`
` .................................
`
`Even AAssuming
`
`
`
`these Meethod Claaims Appply
`to a
`
`
`
`
`
`Computeer Systemm, They OOnly Implliedly Refference a
`
`
`
`General PPurpose Computer ....................
`
`..................................
`Not
`
`
`Innclude MMeaningful
`
`
`The Meethod Claaims Do
`
`
`
`
`
`Limitatioons Beyondd the Abstrract Idea Ittself ...........................
`
`
`
`
`
`
`Grouund 2: Claimms 1, 3-9, and 11-155 are anticippated by thhe ACA ....
`
`
`
`Grouund 3: Claiims 1, 3-99, and 11-
`15 would
`
`have beenn obvious
`
`
`over the ACA ....................................................
`
`
`
`..................................
`
`
`D.  Grouund 4: Claiims 2 and
`
`
`
`10 wouldd have beeen obviouss over the
`f Elsayed.
`
`ACAA in view o
`
`..................................
`
`..................................
`
`
`Grouund 5: Claiims 2 and
`
`
`
`10 wouldd have beeen obviouss over the
`
`
`f Korfhagee. ...............................
`
`ACAA in view o
`
`..................................
`
`
`Seconndary conssiderationss do not rebbut the primma facie ca
`ase. ..........
`
`
`F. 
`
`
`
`
`
`
`VIII.  MMANDATOORY NOTTICES (37 C.F.R. § 442.8(a)(1))
`
`..................................
`................
`
`
`IX.  CCONCLUSSION .........
`
`..................................
`
`..................................
`
`
`
`B C D E F
`
`B. 
`C. 
`
`E. 
`
`... 32 
`
`... 40 
`
`... 43 
`.... 47 
`
`.... 66 
`
`.... 72 
`
`.... 73 
`.... 74 
`... 79 
`... 80 
`
` 1.
`
` 2.
`
` 3.
`
`-ii-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`I.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37
`C.F.R. § 42.22(a))
`
`Amneal Pharmaceuticals, LLC and Par Pharmaceutical, Inc. (collectively,
`
`“Petitioners”) petition for covered business method patent (“CBM”) review and
`
`seek cancellation of claims 1-15 of U.S. Patent No. 8,457,988 (“the ’988 patent”)
`
`(AMN1001). According to Office records, the ’988 patent is assigned to Jazz
`
`Pharmaceuticals, Inc. Jazz is currently asserting the ’988 patent against
`
`Petitioners. (AMN1024; AMN1026.)
`
`II. OVERVIEW
`Claims 1-15 of the ’988 patent are unpatentable because they: (i) claim
`
`ineligible subject matter under 35 U.S.C. § 101; (ii) are anticipated in 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 that encompasses
`
`steps such as interfacing with financial businesses such as insurance companies in
`
`order to secure payment for the prescription, 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
`
`-1-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`technological solution. CBM review is, therefore, appropriate.
`
`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 ’988 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 1-15 are directed to the abstract idea
`
`of centralizing distribution of hazardous or abuse-prone drugs to reduce the abuse
`
`risks associated with the drug without any meaningful limitations. And, the
`
`claimed steps can be performed by a human intermediary without any computer
`
`operation. (AMN1007, ¶¶45-46.)
`
`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 at least claims 1, 3-9, and 11-15 more
`
`than a year before the ’988 patent’s earliest effective filing date. Accordingly, at
`
`least claims 1, 3-9, and 11-15 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 the view of any available
`
`-2-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`alleged objective indicia of nonobviousness.
`
`The Grounds raised herein demonstrate that it is more likely than not that
`
`Petitioners will prevail with respect to at least one challenged claim, and CBM
`
`review of the ’988 patent is warranted. To find otherwise and to maintain the ’988
`
`patent would allow for patenting of an abstract idea, and would withdraw that
`
`which was in the public domain.
`
`A. Background
`The ’988 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’988 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. (AMN1007, ¶47.) 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.
`
`Not only were the ’988 patent’s claimed methods taught in the prior art, the
`
`mitigation of risks associated with the distribution of potentially hazardous drugs
`
`-3-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`generally was also well-established in the prior art. 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. (AMN1007, ¶23.) Under pressure to respond, Roche developed a
`
`Pregnancy Prevention Program Kit for Accutane®. (Id.) The kit 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.
`
`(AMN1007, ¶24.) 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 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
`
`-4-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`took corrective action, such as contacting and re-educating the prescribing
`
`physician and/or discontinuing supply of the prescription to the patient. (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., ¶25.)
`
`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®, called STEPS. (Id., ¶26.) 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
`
`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., ¶¶27, 28.) Computerized systems were helpful in generating reports
`
`tracking patients who were receiving excessive supplies of controlled substances.
`
`-5-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`(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 before the earliest effective filing date of the ’988 patent—discloses
`
`every limitation of at least claims 1, 3-9, and 11-15.
`
`The ’988 patent
`
`B.
`Against this backdrop, Jazz obtained the ’988 patent. The ’988 patent
`
`relates to “[a] drug distribution system and method [that] utilizes a central
`
`pharmacy and database to track all prescriptions for a sensitive drug.” (AMN1001,
`
`Abstract.) According to the ’988 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., 1:52-60.) Before shipping the prescription
`
`-6-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`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 and prescribing doctor. (Id., 1:63-67 and 9:4-8.) Reports are
`
`then generated to evaluate potential diversion patterns. (Id., 2:23-25.)
`
`During prosecution of the ’988 patent’s great-grandparent 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 (AMN1016, 442 (Amdt. & Reply filed Nov. 2,
`
`2009); see also AMN1016, 241-248 (Amdt. & Reply filed Aug. 8, 2006) and 303-
`
`334 (Appeal Brief filed July 18, 2007).) Applicants argued that these limitations
`
`were not taught by the cited prior art. (AMN1016, 449-456 (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 258-262 (Final Rejection, Oct. 18, 2006) and at 420-
`
`433 (Decision on Appeal, Aug. 31, 2009).)
`
`In the Notice of Allowance for the ’988 patent’s great-grandparent
`
`application, the Examiner relied on these limitations: “the closest prior art of
`
`1 Emphasis added throughout unless otherwise noted.
`
`-7-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`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
`
`475-476
`
`(Notice
`
`of Allowance)
`
`(emphasis
`
`in
`
`original).) Patentability of
`
`the ’988 patent claims,
`
`too, hinge on
`
`these
`
`limitations. But, as this petition demonstrates, all of these allegedly “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 Amneal and Par, both individually and collectively, have
`
`standing to seek CBM review of the ’988 patent, and the ’988 patent is eligible for
`
`CBM review. Supported by the Declaration of Dr. Robert Valuck, Ph.D., R.Ph.
`
`(“Valuck Dec.”) (AMN1007), an expert in the fields of drug safety, drug abuse
`
`prevention, and prescription drug distribution, this petition asserts five different
`
`grounds of unpatentability: (1) Claims 1-15 are unpatentable under 35 U.S.C.
`
`-8-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`§ 101 because they recite mere abstract ideas; (2) Claims 1, 3-9, and 11-15 are
`
`anticipated by the ACA; (3) Claims 1, 3-9, and 11-15 would have been obvious in
`
`view of the ACA; (4) Claims 2 and 10 would have been obvious over ACA in
`
`view of Elsayed; and (5) Claims 2 and 10 would have been obvious over ACA in
`
`view of Korfhage. In support of those stated grounds, this petition proposes terms
`
`for construction, and identifies each prior art reference relied upon.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`The undersigned and Amneal and Par certify that the ’988 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).
`
`A. Amneal and Par have standing and are not estopped (37 C.F.R.
`§ 42.302)
`
`Amneal and Par are eligible to make this petition. “A petitioner may not file
`
`… a petition to institute a covered business method patent review of the patent
`
`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
`
`-9-
`
`

`

`CBM Petition of U.S. Patent No. 8,457,988
`
`Jazz has sued Amneal and Par in the District of New Jersey and has accused them
`
`of infringing claims 1-15 of the ’988 patent. See § IX. Also, Amneal and Par are
`
`not estopped from bringing this challenge under 37 C.F.R. § 42.302(b).
`
`The ’988 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. The Office has
`
`recognized 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 ’988 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. 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., 1364-1365. Only
`
`-10-
`
`

`

`
`
`
`
`57,988 nt No. 8,45CBM PPetition of U.S. Paten
`
`
`
`
`
`
`
`one CBM-eligiblee claim rennders an en
`
`
`
`
`
`tire patent
`
`
`
`eligible foor CBM revview.2
`
`
`
` 1.
`
`
`
`
`
`The Pateent Claim
`s Cover a
`
`
`
`
`
`
`
`“Financiaal Productt or Servicce”
`
`
`
`TThe ’988 paatent is dirrected to a
`
`es a
`that] utilizystem… [t“drug disttribution sy
`
`
`
`
`
`
`
`central
`
`
`
`pharmacy and databbase to traack all prrescriptionss for a se
`
`
`
`
`
`
`
`
`
`
`
`nsitive druug.”
`
`
`
`(AMN11001, Abstrract.) The
`
`
`
`
`
`
`
`
`
`
`
`claimed syystem is ussed in commmerce. Forr example,, the
`
`
`
`
`
`claimedd methods
`
`
`
`have partiicular appllication invvolving anncillary acttivities relaated
`
`
`
`
`
`
`
`
`
`
`
`
`
`to a finnancial prooduct or seervice.3 Thhe ’988 paatent spec
`
`
`
`
`
`
`
`
`
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`CBM-eligibility oof the claimms, explainning how thhe claimedd activities
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`ification eestablishes
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`the
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`to a finnancial actiivity. Priorr Board deecisions haave lookedd to the sppecificationn, in
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`encompasssed activitties that wwere incideental
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`to finanncial activitty, which wwas sufficiient to deemm the entirre patent elligible.5
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`Transitionnal Programm for Covvered Businness Methhod Patentss—Definitiions
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`of Coveered Businness Methood Patent aand Technoological Innvention; FFinal Rule
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`, 77
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`Fed. Reeg. 48734, 48736 (Auug. 14, 2012) (Responnse to Commment 8).
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`cision, p. 111
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`013.
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`3 See SalesFForce.Comm v. VirtuallAgility, CCBM2013-000024, De
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`4 See CBM22012-000005, Paper NNo. 17, Jannuary 23, 2
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`See CBMM2014-000002, Paper NNo. 16, AApril 1, 20114; See alsso CBM20014-
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`00003, PPaper No. 12, April 1, 2014.
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`-11-
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`

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`CBM Petition of U.S. Patent No. 8,457,988
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`Here, the ’988 patent specification demonstrates how the ’988 patent is
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`incidental to financial activities—verifying insurance coverage and patient
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`payment. See Liberty Mutual Insurance Co. v. Progressive Casualty Insurance
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`Co., CBM2012-00002 (PTAB, Jan. 23, 2014) (determining an invention that
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`relates to a method of determining a premium for automobile insurance based on
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`data concerning a vehicle's monitored operational characteristics … to be eligible
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`CBM subject matter.); Gillman v. Stoneeagle Servs., Inc., CBM2013-00047
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`(Paper 11), at *8 (Board Feb. 18, 2014) (determining that a patent was eligible for
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`CBM review because “claim 1 is directed to … [a]djudicating an insurance claim
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`and processing payment for that claim [which] are inherently financial activities,”
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`thus meeting the “financial product or service” component of § 18(d)(1) of the
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`AIA.) For example, in order to provide the prescription drug, the ’988 patent
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`explains that “the insurance provider [of the patient] is contacted…to verify
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`coverage and benefits…[A] determination is [then] made regarding coverage for
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`the drug. If it is not available, it is determined…whether the patient is willing and
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`able to pay. If not, a process is performed for handling patients who are uninsured
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`or underinsured … If the patient is willing and able to pay, the patient is
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`informed of the cost of the product and is given payment options … [O]nce
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`payment is received, the intake reimbursement specialist submits a coverage
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`approval form with the enrollment form to the pharmacy team as notification to
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`-12-
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`

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`CBM Petition of U.S. Patent No. 8,457,988
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`process the patient’s prescription.” (AMN1001, 4:55-67.) The actions of
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`contacting the insurance provider, verifying coverage and benefits, determining
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`payment, informing the patient of the cost, and providing payment options are
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`clearly activities that are financial in nature. Further, these activities are necessary
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`in order to perform the step of “providing the company’s prescription drug to the
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`narcoleptic patient…,” as recited by independent claims 1 and 9. It therefore
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`follows that the claimed steps of the ’988 patent cover ancillary activities related
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`to a financial product or service.
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`Additionally, the ’988 patent’s specification provides other examples of
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`how it is used in commerce and encompasses activities that are financial in nature,
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`incidental to a financial activity or complementary to a financial activity. For
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`example, where there is an early prescription refill, “cash payers are also
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`identified … [and] if the physician approves … [t]he pharmacist notifies an intake
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`reimbursement specialist to contact the patient’s insurance provider to verify
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`coverage for the early refill .… If the insurance provider will pay … the specialist
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`submits the coverage approval form as notification that the refill may be
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`processed.” (AMN1001, 6:44-58.) Moreover, the ’988 patent provides “if the
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`insurance provider will not pay ... it is determined whether the patient is willing
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`and/or able to pay .… If it was determined … that the patient was willing and
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`able to pay, the patient is informed of the cost of the product and is given
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`-13-
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`

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`CBM Petition of U.S. Patent No. 8,457,988
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`payment options .… Once payment is received … the specialist submits a
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`coverage approval form to the pharmacy team as notification that the refill request
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`can be processed.” (AMN1001, 6:62-7:4.) The ’988 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
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`funds are available for paying for prescriptions where neither insurance will, nor
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`the patient can pay.” (AMN1001, 7:7-10.)
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`Additionally, claims 1 and 9 both recite activities such as “receiving … all
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`prescription requests…,” “checking … the credentials of any and all doctors…,”
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`and “providing the company’s prescription drug….” These claimed steps comprise
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`the core activities of running the very business of an exclusive (single) mail order
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`pharmacy that direct ships to consumers (AMN1007, ¶¶43-44.), once again
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`demonstrating that the multiple claims of the ’988 patent are CBM-eligible.
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`The ’988 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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`’988 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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`anticipated that patents subject to CBM would be “typically classifiable in Class
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`705.” 77 Fed. Reg. 48,680, 48,711 (Aug. 14, 2012). Further, the ’988 patent was
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`-14-
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`

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`CBM Petition of U.S. Patent No. 8,457,988
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`specifically classified under subclass 2, titled “Health care management (e.g.,
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`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. Billing systems
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`encompassed within the ’988 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 ’988 patent’s great-grandparent
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`application (U.S. Patent No. 7,668,730 “the ’730 patent”), the main prior art cited
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`by the Office against the ’730 patent—U.S. Patent Publication No. 2004/0019794
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`(“Moradi”) and U.S. Patent Publication No. 2004/0176985 (“Lilly”)—also
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`perform processing and operations that are used in the practice, administration, or
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`management of a financial product or service. For example, Moradi discusses
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`making payment arrangements before dispensing a prescription drug, and Lilly
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`discusses contacting insurance companies monitoring prescription information.
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`(See, e.g., AMN1030, ¶¶7, 32; AMN1031, ¶56, 62.) Whether considering the
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`claims themselves, the disclosure and embodiments in the specification, or the
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`Office’s own classification, the conclusion is the same: the ’988 patent performs
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`processing and operations that are used in the practice, administration, or
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`management of a financial product or service, qualifying it for CBM review .
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`-15-
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`CBM PPetition of U.S. Patennt No. 8,4557,988
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`The Pateent Does NNot Claim a “Technnological Innvention””
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`TThe AIA exxcludes “paatents for ttechnologiccal inventiions” fromm the definiition
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`of CBMM patents.
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`AIA § 18(d)(2). To
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`determinee if a patennt is for a
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`technologgical
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`inventioon, “the foollowing wwill be conssidered on
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`a case-byy-case basiss: whetherr the
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`claimedd subject mmatter as a
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`whole recites a technnological ffeature thaat is novel
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`unobvioous over thhe prior aart; and soolves a tecchnical prooblem usinng a technnical
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`solutionn.” 37 C.F.R. § 42.3301(b). Whhen first pproposed, ccommentattors asked
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`Office tto revise thhe definitioon to clarifyfy that a tecchnologicaal inventionn was one
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`met eithher of thesse definitioons, or to pprovide a wwholly diffferent testt. See, e.g.
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`Fed. Reeg. 48,734,, 48736-377 (Aug. 14,, 2012). Buut the Offiice declineed, decidinng to
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`maintainn the limitted scope oof the “techhnological
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`invention”” exceptionn. In so dooing,
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`a narroww exceptioon is conssistent witth the AIIA’s
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`legislatiive historyy and repressents “the best policyy choice.” IId. at 487335-36.
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`UUnder that
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`frameworkk, to be exeempt fromm CBM revview, the cllaimed subbject
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`matter
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`as a whoole must:
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`(1) have
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`a technol
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`ogical feaature that
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`and
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`unobvioous; and (22) solve a
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`technical
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`problem uusing a tecchnical sollution. If eeven
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`one claim of a paatent is nott directed tto a “technnological innvention,”
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`does noot apply. Idd. at 48,7336. The ’988 patent
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`claims do
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`not meet
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`the excep
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`tion
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`becausee its compputer proccessor andd computeer databasse componnents are
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`the excep
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`not
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`technoloogical feattures that aare novel aand non-obbvious, andd these feaatures are uused
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`-16-
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`CBM Petition of U.S. Patent No. 8,457,988
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`to address a 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 ’988 patent claims do not recite a technological feature that is novel
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`and unobvious. Claim 1, for example, covers an abstract idea with limited
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`references, at best, to a computer processor and a computer database. Given that a
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`human intermediary could perform all of the steps of claim 1, there is nothing
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`remotely technological or inventive in claim 1. Claim 1 merely recites the use of a
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`known generic processor interacting with a known generic database to perform
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`some of the steps of claim 1. Moreover, the recited processing could be done by a
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`non-technical implementation, such as the human mind. The technological
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`invention exception was not intended to immunize such a technology-generic data
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`processing 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