fe
`
`• '.^U
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`
`EXAMINERIN CHIEF
`
`w
`
`ft#cx'
`
`^ m ^
`
`•j
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`s
`
`OKAJW/ZOJ
`INTERFERENCE
`• ». M Ml*|*a« <•••»»»« » 5.
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`ft-i-igtiffim*,
`/(.•<•? •. •:•?, A
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`
`Sawai Ex 1006
`Page 1 of 359
`
`
`
`• '.^U
`
`i
`
`EXAMINERIN CHIEF
`
`w
`
`ft#cx'
`
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`
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`INTERFERENCE
`• ». M Ml*|*a« <•••»»»« » 5.
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`ft-i-igtiffim*,
`/(.•<•? •. •:•?, A
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`
`Sawai Ex 1006
`Page 1 of 359
`
`
`
`Interference No. 102,975
`
`The cases involved in this interference are:
`Junior Party
`Applicant: Sompong Wattanasin
`Address: 11 Divito Trail Hopatcong, New Jersey 07843
`Serial No.:
`07/498,301 filed 03/23/90
`For: Quinoline Analogs Of Mevalonolactone And Derivatives Thereof
`Assignees: None
`Attorneys of Record:
`
`Gerald D. Sharkin, Robert S. Honor,
`Richard E. Villa, Walter F. Jewell, Thomas
`O. McGovern, Thomas C. Doyle, Melvyn M.
`Kassenoff, Joseph J. Borovian, Joanne M.
`Giesser and Diane E. Furman
`Associate Attorney: None
`Accorded Benefit of: U.S. Serial No. 07/318,773 filed 03/03/89
`Gerald D. Sharkin
`Address:
`Sandoz Corp.
`59 Route 10 •
`E. -Hanover, NJ 07936
`
`Junior Party
`Applicants: Yoshihiro Fujikawa, Mikio Suzuki, Hiroshi Iwasaki,
`Mitsuaki Sakashita and Masaki Kitahara
`Addresses: Nissan Chemical Industries, Ltd, Chuo Kenkyusho,
`. 722-1, Tsuboi-cho, Funabashi-shi, Chiba-ken, Japan
`Respectfully
`Serial No.: 07/483,720 filed 02/23/90, Patent No. 5,011,930
`issued 04/30/91
`•
`For: Quinoline Type Mevalonolactones
`Assignees: Nissan Chemical Industries Ltd., Tokyo, Japan
`Attorneys of Record: Norman F. Obion, Stanley P. Fisher, Marvin
`J. Spivak, C. Irvin McClelland, Gregory J.
`Maier, Arthur I. Neustadt, Robert C.
`Miller, Richard D. Kelly, James D.
`Hamilton, Eckhard H. Kuesters, Robert T.
`
`"-.A
`
`Sawai Ex 1006
`Page 2 of 359
`
`
`
`Interference No. 102,975
`
`Pous, Charles L. Gholz, Vincent J.
`Sunderdick, William E. Beaumont and Steven
`6« Kelber
`Associate Attorney: None
`Accorded Benefit of: Japan Serial Nos. 207224 filed 08/20/87,
`15585 filed 01/26/88 and U.S. Serial No.
`07/233,752 filed 08/19/88
`Steven B. Kelber
`Obion, Fisher, Spivak,
`McClelland & Maier
`1755 S. Jeff, Davis Hwy.
`Crystal Square 5, Ste. 400
`Arlington, VA 22202
`
`Address:
`
`Senior Party
`Applicants: Yoshihiro Fujikawa, Hikio Suzuki, Hiroshi Iwasaki,
`Mitsuaki Sakashita and Masaki Kitahara
`Addresses: Nissan Chemical Industries, Ltd, Chuo Kenkyusho,
`722-1, Tsubox-cho, Funabashi-shi, Chiba-ken, Japan
`Respectfully
`Serial No.: 07/233,752 filed 08/19/88
`For: Quinoline Type Mevalonolactones
`Assignees: Nissan Chemical Industries Ltd., Tokyo, Japan
`Attorneys of Record: Norman F. Obion, Stanley P. Fisher, Marvin
`J. Spivak, C. Irvin McClelland, Gregory J.
`Maier, Arthur I. Neustadt, Robert C.
`Miller, Richard D. Kelly, James D.
`Hamilton, Eckhard H. Kuesters, Robert T.
`Pous, Charles L. Gholz, Vincent J.
`Sunderdick, William E. Beaumont and Steven
`B. Kelber
`Associate Attorney: None
`Accorded Benefit of: Japan Serial Nos. 207224 filed 08/20/87 and
`15585 filed 01/26/88
`
`i pif&Jl
`i
`
`1
`
`nut
`Ittf
`
`/v/c'
`
`Sawai Ex 1006
`Page 3 of 359
`
`
`
`Interference No. 102,975
`
`Address:
`
`Obion, Fisher, Spivak,
`McClelland & Maier
`1755 S. Jeff. Davis Hwy.
`Crystal Square 5, Ste. 400
`Arlington, VA 22202
`
`Count 1
`
`A compound of the formula:
`
`R*
`
`R'
`
`R6
`
`R2
`
`R1
`
`V—2,
`
`R-
`
`wherein
`
`R1, R2, R*5, R4 and R6 are independently
`hydrogen,
`C-^g alkyl,
`g cycloalkyl,
`alkoxy,
`n-butoxy,
`i-butoxy,
`sec-butoxy,
`are
`R7R8N- (wherein R7 and R8
`hydrogen or
`alkyl),
`
`independently
`
`• •
`
`Sawai Ex 1006
`Page 4 of 359
`
`
`
`Xnterference No. 102,975
`
`-4-
`
`trifluoromethyl,
`trifluoromethoxy,
`difluoromethoxy,
`fluoro,
`chloro,
`bromo,
`phenyl,
`phenoxy,
`benzyloxy,
`hydroxy,
`hydroxymethyl,
`-0(CH2)a0R19 (wherein R1^'" is hydrogen or
`and a is 1, .2 or 3),
`or when located at the ortho position to each
`other,
`and R^ together optionally form
`-CH=CH-CH=CH-?
`
`hydrogen,
`Cl-6
`£-2-3 alkenyi,
`C-s c cycloalkyl,
`•• phenyl substituted by R (wherein R is hydro
`Q
`q
`gen, Cj^alkyl, C^_^alkoxy, fluoro, chloro, bromo
`or trifluoromethyl),
`phenyl-(CI^^- (wherein m is 1, 2 or 3),
`-(CH2)nCH(CH3)-phenyl or phenyl-(CH2)nCH(CH3)-
`(wherein n is 0, 1 or 2).
`
`R5 is
`
`Y is
`
`-c h2- '
`
`-CH2CH2-,
`-CH=CH-,
`-CH2-CH=CH-,
`or
`-CH=CH-CH2-;
`
`. -
`
`Sawai Ex 1006
`Page 5 of 359
`
`
`
`Interference No. 102,975
`
`-5-
`
`2 is
`
`.ii
`
`HO
`
`0 r
`R" o
`or RH-T
`o
`
`o
`
`o
`
`R "
`I
`
`C02Rl2
`
`Q is
`
`W is
`
`or -Q-CH2WCH2-CO2R
`12 (where
`R14);
`
`is hydrogen or
`
`-CH(OH)-.
`••0(0}-, cr
`13
`-C(0R-')2-;
`
`-CfR11)(OH)- (where R11 is hydrogen
`alkyl).
`
`-0(0)-, or
`-C(ORl3)2-;
`
`or
`
`Cl-3
`
`the two R13 are independently primary or secondary
`13
`together form -(CH2)2- or -(CH2)2-;
`alkyl; or two R
`physiologically hydrolyzable alkyl or M (wherein M
`R14 is
`is NH4, sodium, potassium, 1/2 calcium or a hydrate
`or
`di-lower alkylamine
`lower alkylamine,
`of
`tri-lower alkylamine); and
`18
`17
`R and R are independently hydrogen or
`
`alkyl?
`
`Sawai Ex 1006
`Page 6 of 359
`
`
`
`Interference No. 102,975
`
`- 6 -
`
`The claims of the parties which correspond to Count 1
`
`are:
`Wattanasin
`Claims 1-7 and 10
`Fujikawa et al. '930 : Claim 1
`Fujikawa et al.: Claims 1-9, 11-34, 36, 39 and 40
`
`gjh
`
`Michael Sofa61eous
`Examiner-in-Chief
`(703) 557-4066
`
`Sawai Ex 1006
`Page 7 of 359
`
`
`
`All coMMvnicatioM mpeeling this
`ease should idtntify it by number
`and names of parties.
`
`tfSGt
`
`U.S. DEPARTMENT OF COMMERCE
`Patent and Trademark Office
`
`Paper No. 2
`
`Address: BOX INTERFERENCE
`Commissioner of Patents end Trademarks
`Washington, D.C. 20231
`
`f/iAtLXD
`
`AUG i 9 1W
`
`PAT. A i.M.OfFlCE
`BOARD OF PArew* APPEALS
`AND INTEM-'EflfcNCES
`
`Telephone:
`(703)557-4007
`Facsimile:
`(703)557-8642
`Interference No. 102,975
`Wattanasin
`v.
`Fujikawa et al.
`
`V.
`Fujikawa et al.
`
`This interference is declared as a result of a decision on
`preliminary motions in related Interference No. 102,648.
`No time is being set for filing motions. A time was set
`for filing preliminary statements concerning this interference in the
`related interference and such statements will be transferred to this
`interference. Times for taking testimony will be set concurrently
`with the related interference.
`
`MichaelcSofdcleous
`Examiner-in-Chief
`(703) 557-4066
`
`Sawai Ex 1006
`Page 8 of 359
`
`
`
`IN TWW UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`
`it??
`
`BOARD OF PATENT
`APPEALSS
`INTERFERENCES
`/M 21 1992
`
`HATTANASIN
`v.
`FUJIKAWA et al
`v.
`FUJIKANA et al
`
`INTERFERENCE NO. s 102,975
`EXAMINER—IN—CHIEF :
`MICHAEL SOFOCLEOUS
`
`PRELIMINARY STATEMENT OF FUJIKANA ET AL
`BOX INTERFERENCE
`HONORABLE COMMISSIONER OF PATENTS AND TRADEMARKS
`WASHINGTON, D.C. 20231
`SIR:
`With respect to both the Fujikawa '930 patent involved, and
`the Fujikawa application involved, Fujikawa relies, with respect to
`the Count of the Interference, solely on the filing dates of
`Japanese Patent Applications 207224/1987, 15585/1988 and
`193606/1988, filed August 20, 1987, January 26, 1988 and August 3,
`1988, respectively, to prove a constructive reduction to practice
`of the Count of the Interference. Any necessary extensions of time
`have been sought in the Request for Reconsideration filed in
`Interference 102,648.
`
`Respectfully submitted/
`OBLON, SPIVAK, McCLELLAND,
`MAIER & NEUSTADT^.C.
`
`B. Kelber
`:&ecflstration No.: 30,073
`Attorney for Fujikawa et al
`
`Fourth Floor
`1755 Jefferson Davis Highway
`Arlington, Virginia 22202
`(703) 521-5940
`
`• '—A
`
`Sawai Ex 1006
`Page 9 of 359
`
`
`
`2
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true copy of the foregoing PRELIMINARY
`STATEMENT OF FUJIKAWA ET AL was served by first class mail, postage
`prepaid, on counsel for the Party Wattanasin, as follows:
`Diane E. Furman
`SANDOZ CORP.
`59 Route 10
`E. Hanover, New Jersey 07936
`this 21st day of AUGUST, 1992.
`
`^Steverf B. Kelber
`
`Sawai Ex 1006
`Page 10 of 359
`
`
`
`Case No. 600-7101/CONT/In£.
`Patent
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`SOG 3 I 1992
`RECEIVED IN
`BOX JNT— .'ERBNCE
`Interference No. 102,975
`Examiner-in-Chief: M. Sofocleous
`
`WATTANASIN
`•y m
`FUJIKAWA et al.
`•y #
`FUJIKAWA et al.
`
`NOTICE OF THE FILING OF THE PRELIMINARY STATEMENT
`OF THE PARTY WATTANASIN
`
`Appended is the Preliminary Statement of the party Wattanasin
`
`for the subject interference.
`
`SANDOZ CORPORATION
`59 Route 10
`E. Hanover, NJ 07936
`DEF:rmf
`August 27, 1992
`
`Respectfully submitted,
`
`/iLCtnart
`Diane E. Furman
`Attorney for the Party Wattanasin
`Registration No. 31,104
`201-503-7332
`
`I toreby certify that this correspondence is being
`deposited with the United States Postal Service as
`first dass mail in an envelope addressed to: Comrms-
`atoner of Patents and Trademarks, Washington, D.C.
`20231,00
`ftngnsl-
`992
`(Date of Deposit)
`tfia.^E^^.S.urin a
`...
`M of applicam, assignee, or
`legistered Mpreseniative
`
`nat 12J.XZ
`
`ture
`
`of
`
`Sawai Ex 1006
`Page 11 of 359
`
`
`
`CERTIFICATE OF SERVICE
`
`it is hereby certified that a true copy of the papers
`entitled:
`
`NOTICE OF THE FILING OF THE PRELIMINARY STATEMENT
`OF THE PARTY WATTANASIN
`and
`PRELIMINARY STATEMENT OF THE PARTY WATTANASIN
`
`were served on counsel for the party Fujikawa et al., this 27th
`day of August 1992, by postage pre-paid first-class mail addressed
`to the followingi
`
`Obion, Spivak, McClelland, Maier & Neustadt, P.C.
`Attn: Steven B. Kelber, Esq.
`1755 South Jefferson Davis Highway
`Crystal Square 5, Ste. 400
`Arlington, VA 22202
`
`Diane E. Furman
`
`Sawai Ex 1006
`Page 12 of 359
`
`
`
`I
`
`!
`Case No. 600-71ui/CONT/Int.
`Patent
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`WATTANASIN
`v.
`Fujikawa et al.
`v •
`FUJIKAWA et al.
`
`Interference No. 102,975
`Examiner-in-Chief.: M. Sofocleous
`
`PRELIMINARY STATEMENT OF THE PARTY WATTANASIN
`
`In accordance with 37 CFR 1.622 and 1.623, the party
`Wattanasin hereby states as follows:
`
`(1) That the invention of each of Counts 1 and 2 was made in
`the- United States by Sompong Wattanasin.
`
`That the invention of each of Counts
`1 and 2 was first
`(2)
`disclosed
`by Dr. Sompong Wattanasin, to Dr. Faizulla Kathawala of
`Sandoz Pharmaceuticals Corporation, by November 28
`1983.
`
`L
`
`(3) That the invention was first conceived no later than
`November 28/ 1983.
`
`(4) That the first drawing or written description of the
`invention of each of Counts 1 and 2 also occurred by November 28
`1983, when Dr. Wattanasin proposed to Dr. Kathawala to synthesize
`compounds of the invention of Counts 1 and 2 from previously
`synthesized intermediates and commercially available compounds for
`formulation into compositions for use as HMG-CoA reductase
`inhibitors.
`
`L
`
`• •
`
`Sawai Ex 1006
`Page 13 of 359
`
`
`
`Wattanasin
`Preliminary Statement
`page - 2
`Exhibits A-B1 document the
`description of the invention.
`
`Int. No, 102,975
`
`first drawing or written
`
`Exhibit A comprises a true copy of a research
`proposal of Sompong Wattanasin, the last page of which lists a
`compound designated 14/ as follows:
`
`P \r_ ~v
`
`NJ'
`
`and "L" indicates either of the following side chains:
`
`OK
`
`OH
`
`0
`
`and
`
`R2
`
`2
`where R is an acid, a salt or an ester.
`
`O
`
`OH
`
`The documents appended as exhibits hereto correspond to
`1.
`certain of the exhibits already provided with Wattansin's Request
`for Interference of May 25, 1990, with the exception that the
`dates are left unmasked. A detailed explanation of the exhibits
`is provided in the Request.
`
`- •• v.*
`
`Sawai Ex 1006
`Page 14 of 359
`
`
`
`Wattanasin
`Preliminary Statement
`page - 3 -
`
`Int. No. 102,975
`
`Exhibit B comprises a true copy of another research
`proposal submitted by Dr. Wattanasin to Dr. Kathawala which
`indicates a drawing or written description of the
`further
`Page 1 thereof contains • the
`invention on November 19, 1984.
`following compounds:
`
`T^r
`I ~
`
`S"'
`
`u
`
`p
`
`L
`
`u vr •* •
`
`t r
`
`P
`wherein L and R2 have the significances mentioned above.
`
`That the date after conception
`when active exercise of
`(5)
`reasonable diligence began was no later than May 31, 1984.
`
`(6) That the first synthesis of a compound within the scope
`of Count 1, and an active agent of a method of Count 2, was
`performed by Sompong Wattanasin and was completed on November 15,
`1984, when Compound 1079-111-19 (subsequently redesignated
`Compound 63-366), comprising, an erythro racemate, was prepared,
`and recorded in his laboratory notebook.
`
`Sawai Ex 1006
`Page 15 of 359
`
`
`
`Wattanasin
`Preliminary Statement
`page - 4 -
`
`Int. No. 102,975
`
`Exhibits C-D comprise true copies of laboratory pages from
`the notebook of Sompong Wattanasin followed by copies of NMR
`2
`spectra for the final product synthesized :
`
`Exhibit C comprises a true copy of Laboratory Notebook
`No. 1049, pages 231, 241, 248, 251, and Laboratory Notebook No.
`1079, pages 22, 24, 27, 30, 33, 34, 39, 105, 106, 110 and 111,
`corresponding to the synthesis of Compound 63-366 and its
`non-commercially available intermediates. The NMR spectrum of
`Compound 63-366 was taken on November 21, 1984.
`
`Exhibit D comprises copies of Laboratory Notebook No.
`1127, pages 5, 9, and 11 (together with copies of spectra)
`corresponding to Compound 1127-11-34 of the invention (later
`redesignated Compound 63-548) and Compound 1127-11-37 (later
`redesignated Compound 63-549) of the invention and their
`non-commercially available intermediates. Both compounds also
`comprise erythro racemates.
`
`That the date of first actual reduction to practice was
`(7)
`no later than December 31, 1984, when Compound 63-366 was known to
`have in vitro activity as an HMG-CoA reductase inhibitor.
`
`On some of the notebook pages, microanalysis data were
`2 .
`affixed subsequent to the date the actual synthesis was perform©
`
`Sawai Ex 1006
`Page 16 of 359
`
`
`
`Wattanasin
`Preliminary Statement
`page - 5
`
`Int. No. 102,975
`
`Exhibits E-F comprise true copies of portions of bioassay
`data sheets which were prepared by Dr. Terence J. Scallen, an
`outside consultant for Sandoz. The bioassay data sheets were
`prepared concurrently with the tests, and then sent to Dr. Robert
`E. Damon of Sandoz. (The sheets bear the handwritten notations of
`Dr. Damon after he received them from Dr. Scallen.)
`
`The bioassay data show that a composition containing Compound
`63-366, i.e., a dimethylacetamide solution of Compound 63-366, was
`tested for HMG-CoA reductase inhibition activity on December 13,
`The test demonstrated that Compound 63-366 achieved a 50%
`1984.
`inhibition of HMG-CoA reductase at a concentration of < 1x10"^
`U/1.
`
`Additionally, dimethylacetamide solutions of, respectively,
`Compounds 63-548 and 63-549, were each tested for HMG-CoA
`reductase inhibition activity on June 13, 1985.
`
`Sawai Ex 1006
`Page 17 of 359
`
`
`
`Wattanasin
`Preliminary Statement
`page - 6 -
`
`Int. No. 102 1975
`
`Exhibit E comprises a true copy, of the protocol which
`was followed, and Scallen's Laboratory Notebook pages which
`recorded the data for 63-366.
`
`Exhibit F comprises a true copy, of the description of
`the procedure and the printout showing the data for 63-548 and
`63-549
`
`Respectfully submitted.
`
`r/v/f
`Diane E. Furman
`Attorney for the Party Wattanasin
`Registration No. 31,104
`201-503-7332
`
`SANDOZ CORPORATION
`59 Route 10
`E. Hanover, NJ 07936
`DEFrrmf
`August 27, 1992
`
`Exhibits A,B,C,D,E,F
`
`• •
`
`• ••.
`
`Sawai Ex 1006
`Page 18 of 359
`
`
`
`A
`
`'T
`
`Sawai Ex 1006
`Page 19 of 359
`
`
`
`<-o
`
`pKD p o^gJi
`
`^ oYvi
`
`t0o^-"tt"0—il If
`
`NoN^bjiv-
`
`Duv* plo-i^
`
`coo—j crgo-yw^-cJ.
`
`\r\-hz
`
`our
`
`o.txA.^
`
`cr^-
`
`\h cfj!-cx<; it-«j_
`
`d-*
`
`cc*-ltij_ ,
`
`UJs-
`
`Ui Coh<=iuc-i^"
`
`h£_i_
`
`toork
`
`ih KLt. cupprc)Ju"M«x*-
`
`0y^A-fc-x
`
`p
`
`ji-iA
`
`bjuloco ,
`
`, o n v-
`
`Lu o / tc
`
`Y^-Stulk~s
`b<j
`^Oi<AxA
`UJJL U-J i l l u <ijL-
`
`b-iolo
`
`CfiJ
`
`\v\ fuv^-cc^'ou^
`
`a.^Satjc.
`O-^
`
`Uu t* 11 b J2—
`CXKJL
`
`Lo-tljL.
`
`VxD
`
`OLDr
`
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