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`I SERIAL NUMBER
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`FILING DATE
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`UNITED ST'A~PAFrrMENT ~ COMMERCE
`
`,
`patent and Trade~ Office
`;AJc1Fess:' COMMISsiONER OF PATENTS AND TRADEMARKS
`_Washington. O.q. §!!2231
`- J ATTORNEY DOCKE"f: NO.
`FIRST NAMED INVENTOR
`
`o::::/266,, 1~:54
`
`06/27/•34
`
`t-It ORR I SOl'-1
`
`VIc~::: 1 s- VEENKER
`-
`FISH 8{--NEAVE~...---
`1251 AVENUE OF THE AMERICAS
`NEW YORK NY
`10020
`
`u:::M2/ 11 o 1
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`'-This-is a communicatiOn from the examiner in charge of your application.
`COMMISSIONER OF PATENTS AND TRADEMARKS
`
`BD1CIPFWCIII
`I NISBET I EXAMINER
`
`ART UNIT
`
`PAPER NUMBER
`
`1:306
`
`DATE MAILED:
`
`11/01/94
`
`9 This application has been .ixamlned
`~-shortened statutory period for response to this action .is set to expir~·~nth(s),
`says from the date of this letter.
`~ilure to respond within the period for response will cause the aPPlication to become abandoned. 35 U.S.C. 133
`-
`~
`~
`:~_frt I THE_ F~LLOWING ATTACHMENT(S) ARE PART OF THIS AC"nON:
`
`rs{ Responsive to communl.,.,.,.;n.filed on ... · ·-{j; /z J/r':f' .. D This action Is made final.
`
`: .;~ 1. 0 Notice of References Cit~ by Ex~iner, PT0-892.
`-- -<=-- 3. 0 Notice of Art Cited by Applicant, PT0-1449.
`.
`5. · 0 Information on How to Effect Drawing C~nges, PT0-1474~
`~rtll SUMMARY OF ACTION
`
`a
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`2. 0 Notice of Draftsman's Patent Drawing Review, PTQ-948.
`4. 0 Notice of Informal Patent APPlication, PTQ-152.
`6. 0 ------------------'
`;; 7-1 -qs;-
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`s=-:}---5" .q {J'.:J-(;9'_ • are pending in the application.
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`7
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`Of the above, c la ims - - - - - - - - - - - - - - - - - - - - . . . , - - - - - - - - - - are withdrawn fr()_m cqnsi9eration.
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`,,_ .:
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`'-=-~-:,.~s:i'FJ Claims
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`- -.-. ~-?~~~- J Sy
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`1
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`- have been eancelled.
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`are allowed.
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`:-..
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`~-,< ~::~::::"-~:411 q;-'-f!(; [lf-Ss-,
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`5. D C la ims - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - are objected to.
`6. 0 Claims. ________________________ ....;,.-____ are subject to restriction or election requirement:.
`7. 0 This application has been filed with -informal dr~ings und~r 37 C.F.R. 1.85 which.are acceptable for examination purposes.
`8. 0 Formal d~awings a~e required in response t~ this Offi_~;_:e action.
`9. 0 The-corrected or substitute drawings have been received on
`. Under 37 C.F.R. 1.84 these drawings----
`are D a~eptable; D not acceptable-(see.explanation or Notice of Draftsman's Patent D~!twing Review, PT0-948).
`.-r
`-
`10. D The propoSed additio~al or substitute sheet(s)-of drawings, filed on - - - - - - - - "
`- · examiner; D disapproved by the examiner (see explanation).
`11. 0 The proposed drav_.ring correction, filed _________ _, has been D approved; D disapproved (see .explanation).
`12. 0 Acknowledgement is made of the claim for priority under 35 U.S.C. 119.- The certified copy has D been received D not been received
`D been filed in parent application, serial no.
`; filed on - - - - - - - - - -
`13. D Since this application apppears to be in condition for allowance except for formal matters, prosec~tion as to the merits is closed in
`accordance with the practice under Ex parte Quayle, 1935 C. D. 11; 453 O.G. 213.
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`-
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`has (have) been· Oapp~oved by the
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`,. ..... ...,.,-F
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`14~ 00ther
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`EXAMINER'S A~ON
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`Merck Ex. 1048, pg 1285
`
`

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`-• -~
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`Serial No.: 08/266,154
`Art Unit: 1806
`
`- '
`
`III. DETAILED ACTION
`15. The text of those sections of Title 35, U.S. Code not
`included in this action can be found in a prior Office action.
`
`16. The filing of new claims 78-95 in the amendment filed
`6/27/94 is acknowledged.
`
`17. Applicant's limitation of the claims to recite the
`production of antibodies in lymphoid cell lines obviates the
`rejection under § 112. In addition, applicant's explanation of
`the apparent inconsistencies in the 131 declaration are
`sufficient. The fact that the reagent was replaced and the
`experiments were subsequently successful establishes that the
`said success was reproducible. Accordingly, said rejection is
`withdrawn.
`
`A
`
`/
`
`18. Claims 39-41, 43-48, 54-55, 57-58, 60-69, and 71-95 are
`rejected under 35 U.S.C. § 103 as being unpatentable over Cabilly
`(L,R, or 2A) or Boss (2b) in view of Gillies(S).
`
`Applicant's arguments filed 6/27/94 have been fully considered
`,~~i but they are not deemed to be persuasive.
`
`~~ Rejections are maintained for reasons of record, stated in papers
`5, 7, and 10, mailed November 29, 1988, May 24, 1989, and
`-~~ September 25, 1990.
`
`~
`
`,~''! The amendment and response filed 6/27/94 set forth the following
`~~ grounds of traversal. The first asserts that insufficient
`1
`' predictability existed at the priority date to allow coexpression
`""'
`of two antibody chains. Applicants urge that the Cabilly
`references do not have a teaching of specific coexpression of
`:;~ genes in a mammalian system and that Cabilly' s yield was not
`-~ nearly as good as that in the instant case. Gillies is criticized
`for the alleged failure to actually show functional antibody. In
`addition, the Gillies patent allegedly fails to asses the yeild
`of a functional antibody. Only raw, unassembled protein is shown.
`
`';;!:;'::
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`These arguments have been considered but are not deemed
`persuasive. The argument concerning Cabilly is not considered
`persuasive because of the aforementioned specific teaching of
`producing antibodies in mammalian cells. While applicants are
`correct in characterizing Cabilly's disclosure as non-enabling
`for myeloma cell production, Cabilly is only used to teach double
`transfection. Gillies shows the production of antibodies in
`myeloma cells. Morover, Gillies teaches the production of
`proteins in a yeilds approaching wild type. Therefore, such
`yields are considered approximating 100% in comparison to
`applicant's 32%. Accordingly, applicant's argued unexpected
`yields are not considered as such. As far as applicant's ~
`
`Merck Ex. 1048, pg 1286
`
`

`
`.. I
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`Serial No.: 08/266,154
`Art Unit: 1806
`
`regarding the fact that Gillie's yield is of unassembled protein,
`such is simply not supported by Gillies. Applicants have not
`pointed out the statement in Gillies where the routineer would
`learn that Gillies' protein is not assembled. Absent such a clear
`disclosure to the contrary, it is more reasonable to assume that
`Gillies' disclosed yield is functional. Ohterwise, Gillies would
`not be producing the protein. The protein/antibody is of no use
`when it is not functional. Accordingly~ the rejection
`is maintained and no claim is allowed.
`
`19. Any inquiry concerning this communication or earlier
`communications from the examiner should be directed to Examiner
`Nisbet whose telephone number is (703) 308-4204 from 9:00 am to
`5:00 pm weekdays with the exception of alternating Fridays. If
`the examiner cannot be reached, the supervisor may be contacted
`at phone number (703)308-3535.
`
`Any inquiry of a general nature or relating to the status of this
`~-application should be directed to the Group receptionist whose
`~]telephone number is (703) 308-0196.
`
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`:~f:October 31, 1994
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`0 -O!J.~
`-~
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`SUPERVISORY PA fEr~;, EX,;MINER
`GJ:::('i ID ·j ,.,J.
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`Merck Ex. 1048, pg 1287