IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant
`
`Title
`
`Dayton T. Reardan et al.
`SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`Docket No.
`Filed
`
`Examiner
`
`101.031US1
`December 17 2002
`Lena Najarian
`
`Serial No. 10/322348
`Due Date July 28 2007
`Group Art Unit 3626
`
`MS Appeal Brief - Patents
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`We are transmitting herewith the following attached items as indicated with anX
`
`X Substitute Appeal Brief Under 37 C.F.R.
`Substitute Appeal Brief.
`
`41.37 32 pgs. including 1-page table of contents and 31-page
`
`If not provided for in a separate paper filed herewith Please consider this a PETITION FOR EXTENSION OF TIME for
`sufficient number of months to enter these papers and please charge any additional
`fees or credit overpayment to
`posit
`Account No. 19-0743.
`
`is
`
`SCHWEGMAN LUNDBERG WOESSNER
`Customer Number 21186
`
`KLUTH P.A.
`
`By.
`
`Atty
`R
`
`3
`
`aý
`
`CERTIFICATE UNDER 37 CFR 1.8 The undersigned hereby certifies that this correspondence is being filed using the USPTOs
`filing system EFS-Web and is addressed to Commissioner for Patents P.O. Box 1450 Alexandria VA 22313-1450
`on
`day of July 2007.
`
`electro
`
`this
`
`Name
`
`AreA
`
`SCHWEGMAN LUNDBERG WOESSNER
`
`KLUTH P.A.
`GENERAL
`
`EXHIBIT
`
`JAZZ EXHIBIT 2011
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`
`41.37
`
`is
`
`TABLE OF CONTENTS
`
`1. REAL PARTY IN INTEREST ..................................................................................
`
`2. RELATED APPEALS AND INTERFERENCES ...................................................
`
`3. STATUS OF THE CLAIMS ......................................................................................
`
`4. STATUS OF AMENDMENTS ..................................................................................
`
`5. SUMMARY OF CLAIMED SUBJECT MATTER .................................................
`
`Page
`
`2
`
`3
`
`4
`
`5
`
`6
`
`6. GROUNDS OF REJECTION TO BE REVIEWED ON APPEAL .....................
`
`12
`
`7. ARGUMENT ....................................
`
`8. SUMMARY ...............................................................................................................2
`
`CLAIMS APPENDIX ....................................................................................................
`
`EVIDENCE APPENDIX ...............................................................................................
`
`RELATED PROCEEDINGS APPENDIX
`
`25
`
`30
`
`Page 2 of 33
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`
`In re Application of. Dayton T. Reardan et al. Examiner Lena Najarian
`
`Serial No. 10/322348
`
`Group Art Unit 3626
`
`Filed December 17 2002
`
`Docket
`
`101.031US 1
`
`For SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`SUBSTITUTE APPEAL BRIEF UNDER 37 CFR $ 41.37
`
`Mail Stop Appeal Brief- Patents
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313--1450
`
`Sir
`
`This Substitute Appeal Brief is presented in support of the Notice of Appeal
`
`to the Board
`
`of Patent Appeals and Interferences filed on March 19 2007 from the Final Rejection of claims
`
`32-42 of the above-identified application as set forth in the Final Office Action mailed on
`
`October 26 2006 and further in response to the Notice of Non-Compliant Appeal Brief mailed
`
`June 28 2007.
`
`The Commissioner of Patents and Trademarks is hereby authorized to charge Deposit
`
`Account No. 19-0743 in the amount of $250.00 which represents the requisite fee set forth in 37
`
`C.F.R. 41.20b2.
`
`The Appellants respectfully request consideration and reversal of the
`
`Examiners rejections of pending claims.
`
`Page 3 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 2
`Dkt 101.031US1
`
`1. REAL PARTY IN INTEREST
`
`The real party in interest of the above-captioned
`
`patent application is the assignee Jazz
`
`Pharmaceuticals.
`
`Page 4 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 3
`Dkt 101.031 US I
`
`2. RELATED APPEALS AND INTERFERENCES
`
`There are no other appeals or interferences known to Appellant
`
`that will have a bearing
`
`on the Boards decision in the present appeal.
`
`Page 5 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 4
`101 .43 US 1
`
`Dkt
`
`3. STATUS OF THE CLAIMS
`
`The present application was filed on December 17 2002 with claims 1-25. A
`Preliminary Amendment was filed on September 30 2004 adding claims 26-31. A non-final
`Office Action was mailed June 29 2005. A response was filed September 29 2005. A Final
`Office Action was mailed December 29 2005. A Request
`
`for Continued Examination was filed
`
`with an Amendment and Response to Final Office Action on March 29 2006 in which claims
`11-31 were cancelled and new claims 32-37 were added. A non-final Office Action was mailed
`June 19 2006. A response was filed August 8 2006 in which claims 1-10 were cancelled and
`new claims 38-42 were added. A second Final Office Action was mailed October 18 2006. A
`
`response to Final Office Action was filed January 17 2007. An Advisory Action was mailed
`February 5 2007. Claims 32-42 stand finally rejected remain pending and are the subject of the
`
`present appeal.
`
`Page 6 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 5
`Dkt 101.031US1
`
`4. STATUS OF AMENDMENTS
`
`Claims 32-34 and 38-42 were amended in a filing by Appellant on January 17 2007
`
`following the Final Office Action mailed October 18 2006. These amendments were entered as
`
`indicated in the Advisory Action mailed February 5 2007. No further amendments have been
`to the Advisory Action dated February 5 2007.
`
`made subsequent
`
`Page 7 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 6
`Dkt 101.031US1
`
`5. SUMMARY OF CLAIMED SUBJECT MATTER
`
`Independent Claim 32
`A method of distributing a sensitive drug under exclusive control of an exclusive central
`
`32.
`
`pharmacy the method comprising
`
`receiving all prescription requests at the exclusive central pharmacy from a medical
`
`doctor containing information identifying a patient the sensitive drug and various credentials of
`
`the doctor page 5 line 22 -page 6 line 11 fig. 2A 202 204 206 210
`
`requiring entering of the information into an exclusive computer database associated with
`
`the exclusive central pharmacy for analysis of potential abuse situations page 5 lines 11-12
`
`17-20 page 6 lines 6-9 FIG. 1 140 FIG. 2A 206
`
`checking the credentials of the doctor page 7 lines 5-22 FIG. 2B 270 274 276 278
`
`284 286 288 290
`
`confirming with the patient that educational material has been read prior to shipping the
`sensitive drug page 7 lines 1-5 page 7 line 24 -page 8 line 2 FIG. 2A 208 FIG. 2C 242
`
`244 246 248
`
`checking the exclusive computer database for potential abuse of the sensitive drug page
`
`11 lines 10-22 FIG. 8 800 810 820 830 840
`
`only mailing the sensitive drug to the patient if no potential abuse is found by the
`
`checking of the exclusive computer database page 9 lines 12-22 FIG. 4B 436 438 440 442
`
`confirming receipt by the patient of the sensitive drug and page 2 line 14
`
`generating periodic reports via the exclusive computer database to evaluate potential
`diversion patterns. page 2 lines 24-27 page 11 lines 10-22 page 9 lines 12-19 FIG. 4 436
`FIG. 8 800 810 820 830 840
`
`33.
`
`A method of distributing a sensitive drug under exclusive control of an exclusive central
`
`Independent Claim 33
`
`pharmacy the method comprising
`
`Page 8 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 7
`Dkt 101.031US1
`
`receiving prescription requests from a medical doctor containing information identifying
`
`a patient the sensitive drug and various credentials of the doctor page 5 line 22 -page 6 line
`
`11 fig. 2A 202 204 206 210
`
`entering the information into an exclusive computer database associated with the
`
`exclusive central pharmacy for analysis of potential abuse situations page 5 lines I1- 2 17-20
`
`page 6 lines 6-9 FIG. 1 140 FIG. 2A 206
`
`checking the credentials of the doctor page 7 lines 5-22 FIG. 2B 270 274 276 278
`
`284 286 288 290
`
`checking the exclusive computer database for potential abuse of the sensitive drug page
`
`11 lines 10-22 FIG. 8 800 810 820 830 840
`
`only mailing the sensitive drug to the patient if no potential abuse is found by the
`
`checking of the exclusive computer database page 9 lines 12-22 FIG. 4B 436 438 440 442
`
`confirming receipt by the patient of the sensitive drug and page 2 line 14
`
`generating periodic reports via the exclusive computer database to evaluate potential
`
`diversion patterns. page 2 lines 24-27 page 11 lines 10-22 page 9 lines 12-19- FIG. 4 436
`
`FIG. 8 800 810 820 830 840
`
`38.
`
`A method of distributing a sensitive drug under control of an exclusive central pharmacy
`
`Independent Claim 38
`
`the method comprising
`
`receiving prescription requests at the central pharmacy from an authorized prescriber
`
`containing information identifying a patient the sensitive drug and various credentials of the
`
`authorized prescriber page 5 line 22 - page 6 line 11 fig. 2A 202 204 206 210
`
`entering the information into an exclusive computer database under exclusive control of
`
`the central pharmacy for analysis of potential abuse situations wherein the use of the exclusive
`
`computer database is required for distribution of the sensitive drug page 5 lines 11-12 17-20
`
`page 6 lines 6-9 FIG. 1 140 FIG. 2A 206
`
`checking of the credentials of the authorized prescriber page 7 lines 5-22 -FIG. 2B 270
`
`274 276 278 284 286 288 290
`
`Page 9 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 8
`Dkt 101.031 USI
`
`that educational material has been read prior to providing the
`confirming with the patient
`sensitive drug to the patient page 7 lines 1-5 page 7 line 24 -page 8 line 2 FIG. 2A 208
`FIG. 2C 242 244 246 248
`
`requiring checking of the exclusive computer database for potential abuse associated with
`
`the patient and/or
`
`the authorized prescriber page 11 lines 10-22 FIG. 8 800 810 820 830
`
`840
`
`only providing the sensitive drug to the patient provided information in the exclusive
`
`computer database is not indicative of potential abuse page 9 lines 12-22 FIG. 4B 436 438
`
`440 442
`
`confirming receipt by the patient of the sensitive drug and page 2 line 14
`
`generating periodic reports via the exclusive computer database to evaluate potential
`
`diversion patterns. page 2 lines 24-27 page 1 lines 10-22 page 9 lines 12-19 FIG. 4 436
`FIG. 8 800 810 820 830 840
`
`39.
`
`Independent Claim 39
`A method of distributing gamma hydroxy butyrate GHB under control of an exclusive
`central pharmacy the method comprising
`receiving prescription requests for GHB at the central pharmacy from an authorized
`
`prescriber containing information identifying a patient and various credentials of the authorized
`
`prescriber page 4 lines 11-18 page 5 line 22 -- page 6 line 1 fig. 2A 202 204 206 210
`
`entering the information into an exclusive computer database under exclusive control of
`
`the central pharmacy for analysis of potential abuse situations wherein the use of the exclusive
`computer database is required for distribution of GHB page 5 lines 11-12 17-20 page 6 lines
`6-9 FIG. 1140 FIG. 2A 206
`
`checking of the credentials of the authorized prescriber page 7 lines 5-22 FIG. 2B 270
`
`274 276 278 284 286 288 290
`
`confirming with the patient
`providing GHB to the patient a first
`time page 7 lines 1-5 page 7 line 24 -page 8 line 2
`FIG. 2A 208 FIG. 2C 242 244 246 248
`
`that GHB educational material has been read prior to
`
`Page 10 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`17 2002
`Filing Date December
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 9
`Dkt 101 .03 US 1
`
`requiring checking of the exclusive computer database for potential GHB abuse
`
`associated with the patient page 11 lines 10-22 FIG. 8 800 810 820 830 840
`only providing GHB to the patient provided information in the exclusive computer
`database is not indicative of potential abuse page 9 lines 12-22 FIG. 4B 436 438 440 442
`confirming receipt by the patient of the GHB and page 2 line 14
`
`generating periodic reports via the exclusive computer database to evaluate potential
`GHB diversion patterns. page 2 lines 24-27 page 11 lines 10-22 page 9 lines 12-19 FIG. 4
`
`436 FIG. 8 800 810 820 830 8401
`
`40.
`
`Independent Claim 40
`A method of distributing gamma hydroxy butyrate GHB under control of an exclusive
`central pharmacy the method comprising
`receiving prescription requests for GHB at the central pharmacy from an authorized
`
`prescriber containing information identifying a patient and various credentials of the authorized
`prescriber page 4 lines 11-18 page 5 line 22 - page 6 line 11 fig. 2A 202 204 206 210
`entering the information into an exclusive computer database under exclusive control of
`
`the central pharmacy for analysis of potential abuse situations wherein the use of the exclusive
`computer database is required for distribution of GHB page 5 lines 11-12 17-20 page 6 lines
`
`6-9 FIG. 1 140 FIG. 2A 206
`
`checking of the credentials of the authorized prescriber page 7 lines 5-22 FIG. 2B 270
`
`274 276 278 284 286 288 290
`confirming with the patient that GHB educational material has been read prior to
`providing GHB to the patient a first time page 7 lines 1-5 page 7 line 24 -page 8 line 2
`FIG. 2A 208 FIG. 2C 242 244 246 248
`requiring checking of the exclusive computer database for potential GHB abuse
`associated with the patient page 11 lines 10-22 FIG. 8 800 810 820 830 840
`mailing GHB to the patient provided information in the exclusive computer database is
`
`not indicative of potential abuse page 9 lines 12-22 FIG. 4B 436 438 440 442
`confirming receipt by the patient of the GHB and page 2 line 14
`
`Page 11 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 10
`Dkt 101 .03 US 1
`
`generating periodic reports via the exclusive computer database to evaluate potential
`GHB diversion patterns. page 2 lines 24-27 page 11 lines 10-22 page 9 lines 12-19 FIG. 4
`436 FIG. 8 800 810 820 830 840
`
`41.
`
`Independent Claim 41
`A method of distributing gamma hydroxy butyrate GHB under control of an exclusive
`central pharmacy the method comprising
`manufacturing GHB page 4 line 25 page 5 line 2
`only providing manufactured GHB to the exclusive central pharmacy page 4 line
`5 line 2
`receiving prescription requests for GHB at the central pharmacy from an authorized
`
`25-page
`
`prescriber containing information identifying a patient and various credentials of the authorized
`
`prescriber page 4 lines 11-18 page 5 line 22 -- page 6 line 11 fig. 2A 202 204 206 210
`
`entering the information into an exclusive computer database under exclusive control of
`
`the central pharmacy for analysis of potential abuse situations wherein the use of the exclusive
`computer database is required for distribution of GHB page 5 lines 11-12 17-20 page 6 lines
`
`6-9 FIG. 1 140 FIG. 2A 206
`
`checking of the credentials of the authorized prescriber page 7 lines 5-22 FIG. 2B 270
`
`274 276 278 284 286 288 290
`
`confirming with the patient that GHB educational material has been read prior to
`providing GHB to the patient a first time page 7 lines 1-5 page 7 line 24 -page 8 line 2
`FIG. 2A 208 FIG. 2C 242 244 246 248
`requiring checking of the exclusive computer database for potential GHB abuse
`
`associated with the patient page 11 lines 10-22 FIG. 8 800 810 820 830 840
`mailing GHB to the patient provided information in the exclusive computer database is
`
`not indicative of potential abuse page 9 lines 12-22 FIG. 4B 436 438 440 442
`confirming receipt by the patient of the GHB and page 2 line 14
`
`generating periodic reports via the exclusive computer database to evaluate potential
`
`GHB diversion patterns. page 2 lines 24-27 page 1 lines 10-22 page 9 lines 12-19 FIG. 4
`436 FIG. 8 800 810 820 830 840
`
`Page 12 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 11
`Dkt 101.031 US 1
`
`Independent Claim 42
`A method of distributing a sensitive drug under control of an exclusive central pharmacy
`
`42.
`
`the method comprising
`
`receiving prescription requests at the central pharmacy from an authorized prescriber
`
`containing information identifying a patient the sensitive drug and various credentials of the
`
`authorized prescriber page 4 lines 11-18 page 5 line 22 -page 6 line 11 fig. 2A 202 204
`
`206 210
`
`entering the information into an exclusive computer database under exclusive control of
`
`the central pharmacy for analysis of potential abuse situations wherein the use of the exclusive
`
`computer database is required for distribution of the sensitive drug page 5 lines 11-12 17-20
`
`page 6 lines 6-9 FIG. 1140 FIG. 2A 206
`
`checking of the credentials of the authorized prescriber page 7 lines 5-22 FIG. 2B 270
`
`274 276 278 284 286 288 290
`
`confirming with the patient that educational material has been read prior to providing the
`sensitive drug to the patient page 7 lines 1-5 page 7 line 24 -page 8 line 2 FIG. 2A 208
`
`FIG. 2C 242 244 246 248
`
`requiring checking of the exclusive computer database for potential abuse associated with
`
`the patient and/or
`
`the authorized prescriber page 11 lines 10-22 FIG. 8 800 810 820 830
`
`840
`
`only providing the sensitive drug to the patient provided information in the exclusive
`
`computer database is not indicative of potential abuse and page 9 lines 12-22 FIG. 4B 436
`
`438 440 442
`
`confirming receipt by the patient of the sensitive drug. page 2 line 14
`
`Page 13 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 12
`Dkt 101.031USI
`
`6. GROUNDS OF REJECTION TO BE REVIEWED ON APPEAL
`
`Claims 32-42 were rejected under 35 U.S.C.
`
`112 second paragraph as being indefinite
`
`for failing to particularly point out and distinctly claim the subject matter which applicant
`
`regards as the invention.
`
`103a as being unpatentable over
`Claims 32 38 and 42 were rejected under 35 U.S.C.
`Moradi et al. U.S. Patent Publication No. 2004/0019794 Al in view of Lilly et al. U.S. Patent
`Publication No. 2004/0176985 Al in view of Califano et al. U.S. Patent Publication No.
`2003/0033168 Al and further in view of Ukens Specialty Pharmacy.
`
`103a as being unpatentable over Moradi
`Claims 33-36 were rejected under 35 U.S.C.
`et al. U.S. Patent Publication No. 2004/0019794 Al in view of Lilly et al. U.S. Patent
`
`Publication No. 2004/0176985 Al.
`
`103a as being unpatentable over Moradi et al.
`Claim 37 was rejected under 35 U.S.C.
`U.S. Patent Publication No. 2004/0019794 Al in view of Lilly et al. U.S. Patent Publication
`No. 2004/0176985 Al and further in view of Melker et al. U.S. Patent Publication No.
`
`2002/0177232 Al.
`
`Claims 39-41 were rejected under 35 U.S.C.
`
`103a as being unpatentable over Moradi
`et al. U.S. Patent Publication No. 2004/0019794 Al in view of Lilly et al. U.S. Patent
`Publication No. 2004/0176985 Al in view of Califano et al. U.S. Patent Publication No.
`2003/0033168 Al and further in view of Talk About Sleep An Interview with Orphan Medical
`
`about Xyrem.
`
`Page 14 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 13
`Dkt 101.031USI
`
`7. ARGUMENT
`
`A The Applicable Law
`1 35 U.S.C.
`112 second paragraph
`
`With regard to 35 U.S.C.
`
`112 second paragraph the Board of Patent Appeals and
`
`Interferences has stated
`
`In rejecting a claim under the second paragraph of 35 U.S.C. 112 it
`is incumbent
`in the pertinent art when reading
`on the examiner to establish that one of ordinary skill
`the claims in light of the supporting specification would not have been able to ascertain
`with a reasonable degree of precision and particularity the particular area set out and
`circumscribed by the claims. Ex parte Wu 10 USPQ 2d 2031 2033 B.P.A.I.
`1989citing In re Moore 439 F.2d 1232 169 USPQ 236 C.C.P.A. 1971 In re
`Hammack 427 F.2d 1378 166 USPQ 204 C.C.P.A. 1970.
`
`The M.P.E.P. adopts this line of reasoning stating that
`
`is whether the claims set out
`The essential inquiry pertaining to this requirement
`and circumscribe a particular subject matter with a reasonable degree of clarity and
`particularity. Definiteness of claim language must be analyzed not in a vacuum but in
`light of
`1 The content of the particular application disclosure
`2 The teachings of the prior art and
`3 The claim interpretation that would be given by one possessing the
`ordinary level of skill
`in the pertinent art at the time the invention was made. MP.E.P.
`2173.02.
`
`2 35 U.S.C. 103a
`
`The determination of obviousness under 35 U.S.C.
`
`103 is a legal conclusion based on
`
`factual evidence. See Princeton Biochemicals
`
`Inc. v. Beckman Coulter Inc. 411 F.3d 1332
`
`1336-37 Fed.Cir. 2005. The legal conclusion that a claim is obvious within
`
`103a depends
`
`on at least four underlying factual
`
`issues set forth in Graham v. John Deere Co. ofKansas City
`383 U.S. 1 17 86 S.Ct. 684 15 L.Ed.2d 545 1966 1 the scope and content of the prior art
`2 differences between the prior art and the claims at issue 3 the level of ordinary skill
`pertinent art and 4 evaluation of any relevant secondary considerations.
`
`in the
`
`Page 15 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`4137
`
`Page 14
`Dkt 101.031US1
`
`The Examiner has the burden under 35 U.S.C.
`
`103 to establish a primafacie case of
`
`obviousness.
`
`In re Fine 837 F.2d 1071 1074 5 USPQ2d 1596 1598 Fed. Cir.1988. To
`
`establish prima facie obviousness of a claimed invention all the claim limitations must be taught
`or suggested by the prior art. In re Royka 490 F.2d 981 180 USPQ 580 CCPA 1974 MPEP
`
`2143.03. All words in a claim must be considered in judging the patentability of that claim
`the prior art. In re Wilson 424 F.2d 1382 1385 165 USPQ 494 496 CCPA 1970
`
`against
`
`MPEP
`
`2143.03. As part of establishing a prima facie case of obviousness the Examiners
`
`analysis must show that some objective teaching in the prior art or some knowledge generally
`
`available to one of ordinary skill
`
`in the art would lead an individual to combine the relevant
`
`teaching of the references. Id. To facilitate review this analysis should be made explicit. KSR
`
`Intl Co. v. Teleflex Inc. 550 U.S.
`
`2007slip opinion at 14citing In re Kahn 441 F. 3d
`
`977 988 Fed. Cir. 2006.
`
`The court in Fine stated that
`
`Obviousness is tested by what the combined teaching of the references
`would have suggested to those of ordinary skill
`in the art. In re Keller
`642 F.2d 413 425 208 USPQ 871 878 CCPA 1981. But it cannot be
`established by combining the teachings of the prior art to produce the
`claimed invention absent some teaching or suggestion supporting the
`combination. ACS Hosp. Sys. 732 F.2d at 1577 221 USPQ at 933. And
`teachings of references can be combined only if there is some suggestion
`or incentive to do so. Id. emphasis in original.
`
`The M.P.E.P. adopts this line of reasoning stating that
`
`In order for the Examiner to establish a prima facie case of obviousness
`three base criteria must be met. First there must be some suggestion or
`motivation either in the references
`themselves or in the knowledge
`generally available to one of ordinary skill
`in the art to modify the
`reference or to combine reference teachings. Second there must be a
`reasonable expectation of success. Finally the prior art reference or
`references when combined must teach or suggest all
`the claim limitations.
`The teaching or suggestion to make the claimed combination and the
`reasonable expectation of success must both be found in the prior art and
`not based on Appellants disclosure. In re Vaeck 947 F.2d 488 20
`USPQ2d 1438 Fed. Cir. 1991. MPEP
`2142.
`
`The test for obviousness under
`
`103 must take into consideration the invention as a
`
`whole that is one must consider the particular problem solved by the combination of elements
`
`that define the invention.
`
`Interconnect Planning Corp. v. Feil 774 F.2d 1132 1143 227 USPQ
`
`Page 16 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 15
`Dkt 101.031USI
`
`543 551 Fed. Cir.1985. The Examiner must as one of the inquiries pertinent
`
`to any
`
`obviousness inquiry under 35 U.S.C.
`
`103 recognize and consider not only the similarities but
`
`also the critical differences between the claimed invention and the prior art. In re Bond 910 F.2d
`
`831 834 15 USPQ2d. 1566 1568 Fed. Cir. 1990 rehg denied 1990 U.S. App. LEXIS 19971
`
`Fed. Cir.1990. The fact that a reference teaches away from a claimed invention is highly
`
`probative that the reference would not have rendered the claimed invention obvious to one of
`
`ordinary skill
`
`in the art. Stranco Inc. v. Atlantes Chemical Systems Inc. 15 USPQ2d 1704 1713
`
`Tex. 1990. When the prior art teaches away from combining certain known elements
`discovery of a successful means of combining them is more likely to be nonobvious. KSR Intl
`
`Co. 550 U.S.
`
`2007slip opinion at 12citing United States v. Adams 383 U.S. 39 51-51
`
`1966.
`
`Further the Office Action must provide specific objective evidence of record for a
`
`finding of a suggestion or motivation to combine reference teachings and must explain the
`
`reasoning by which the evidence is deemed to support such a finding. See KSR Intl Co. 550
`
`U.S.
`
`2007slip opinion at 14citing In re Kahn 441 F. 3d 977 988 Fed. Cir. 2006 In
`
`re Sang Su Lee 277 F.3d 1338 61 USPQ2d 1430 Fed. Cir. 2002. Finally the Examiner must
`
`avoid hindsight.
`
`In re Bond at 834.
`
`Additionally there must be a rational underpinning grounded in evidence to support the
`
`legal conclusion of obviousness. See In re Kahn 78 USPQ2d 1329 Fed. Cir. 2006 which states
`
`that rejections on obviousness grounds cannot be sustained by mere conclusory statements
`
`instead there must be some articulated reasoning with some rational underpinning to support the
`
`legal conclusion of obviousness.
`
`In re Kahn citing In re Lee 61 USPQ2d 1430 Fed. Cir.2002.
`
`Additionally mere identification in the prior art of each element is insufficient to defeat
`
`the
`
`patentability of the combined subject matter as a whole. In re Kahn.
`
`B Discussion of the rejection of claims 32-42 under 35 U.S.C.
`being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`112 second paragraph as
`
`which applicant
`
`regards as the invention.
`
`Page 17 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 16
`Dkt 101.031USI
`
`Claims 32-42 were rejected under 35 U.S.C.
`
`112 second paragraph as being indefinite
`
`for failing to particularly point out and distinctly claim the subject matter which applicant
`
`regards as the invention.
`
`In the response to the Final Office Action claims 32-42 were amended
`
`to clarify the claims in view of the
`
`112 rejections and not in response to art. These
`
`amendments as indicated in the Advisory Action mailed February 5 2007 were entered.
`
`The Advisory Action did not include any direct mention of the status of these Section 112
`
`rejections. Thus Applicant respectfully submits that the Section 112 rejections have been over
`
`come by these amendments.
`
`If the Examiner believes otherwise Applicant reserves the right to
`
`submit further argument against the 35 U.S.C.
`
`112 Second paragraph rejections in a reply to
`
`the Examiners Answer.
`
`C Discussion of the 35 U.S. C. 103a rejections.
`1 Discussion ofthe rejection of claims 32 38 and 42 under 35 U.S.C.
`103a as
`being unpatentable over Moradi et al. U.S. Patent Publication No. 2004/0019794 Al
`hereinafter Moradi in view of Lilly et al. U.S. Patent Publication No. 200410176985 Al
`hereinafter Lilly in view of Califano et al. U.S. Patent Publication No. 2003/0033168 Al
`hereinafter Califano9 and further in view of Ukens Specialty Pharmacy hereinafter
`
`Ukens.
`
`Applicant
`
`respectfully traverses the rejection of claims 32 38 and 42 because the
`
`proposed combination of Moradi Lilly Califano and Ukens fails to teach or suggest each of the
`
`claim elements and because Ukens teaches away from the combination.
`
`a. Failure to teach or suggest an exclusive computer database
`
`Each of the claims 32 38 and 42 all refer to an exclusive computer database. The Final
`
`Office Action indicates that Moradi discloses checking
`
`the exclusive central database for
`
`potential abuse of the drug and only mailing the drug to the patient
`by the checking of the exclusive central database para. 43 para. 45 para. 6 and FIG. 3 items
`
`if no potential abuse is found
`
`318 and 322 of Moradi.
`
`Page 18 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number
`10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 17
`Dkt 101.031USI
`
`The method of claims 32 38 and 42 utilize the exclusive computer database to
`
`implement strict control over distribution of sensitive drugs. These controls allow for tracking of
`
`who is prescribing these drugs and who is receiving them. These controls further ensure proper
`
`education about
`
`the sensitive drugs is provided to patients and understood. Without
`
`this
`
`exclusive computer database such controls are much more difficult
`
`to implement.
`
`The cited portions of Moradi are repeated below and it
`
`is clear that there is no teaching
`
`of an exclusive computer database as claimed.
`
`fill
`
`Paragraph 43
`If the prescription is verified as OK the processing continues in the
`the prescription and enter
`exemplary embodiment by having the pharmacist
`the prescription data into the pharmacists existing Pharmacy Management System
`PMS. The PMS system assigns the prescription a prescription number and the
`pharmacist enters that prescription number and the number of refills into the
`PODP 216 which then communicates that data back to the CSS 102 with an
`then gives at step 322 the
`identification of the prescription. The pharmacist
`ordered medicine and a copy of the prescription image to a prescription deliverer
`which is a delivery person in the exemplary embodiments for delivery to the
`patient. The CSS 102 is notified that the delivery person is in the process of
`delivering the medication and the status of the prescription is changed to
`delivery within the CSS database 204. The exemplary embodiment
`further
`includes providing the delivery person with a Route Slip that has printed
`directions to the patients address along with the scanned prescription image. The
`if and only if the
`delivery person hand-delivers the medicine to the recipient
`is holding the original copy of the prescription that is identical
`to the
`recipient
`image provided to the delivery person. This ensures that the proper patient gets
`the medicine and that the medicine is delivered only once. After the medicine is
`delivered the delivery person receives at step 324 the patients signature to
`certify a correct delivery. The delivery person can also stamp the original
`prescription to signify that the medicine specified in that prescription has been
`the prescription has already been filled. The delivery person
`delivered and that
`then returns also at step 324 to the POD system 106 and the POD operator
`updates the order status to Done in the PODP 212 so that this information is
`communicated as a confirmation to the CSS 102 and the CSS Database 204. The
`exemplary embodiment supports status designations of. delivered no one at the
`address prescription mismatch or one of a number of other potential
`reasons for
`non-delivery. Embodiments of the present invention provide the delivery person
`with a wireless communication device that initiates communication of the
`delivery status immediately upon delivery of the medication to the patient without
`return to the POD 106. These devices also
`requiring the delivery person to first
`
`Page 19 of 33
`
`

`
`APPEAL BRIEF UNDER 37 C.F.R.
`Serial Number 10/322348
`Filing Date December 17 2002
`Title SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`
`41.37
`
`Page 18
`Dkt 101 .03 US I
`
`include a written signature digitizer that is able to capture and