Control No.
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`Patent Under Reexamination
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`, Examiner
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`Art Unit
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`Ex Parte Reexamination Certificate
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`Notice of Intent to Issue
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`Padmashri Ponnaluri -
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
` 1. [Z Prosecution on the merits is (or remains) closed in this ex parte reexamination proceeding. This proceeding is
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`subject to reopening at the initiative of the Office or upon petition. Cf. 37 CFR 1.313(a). A Certificate will be
`issued in view of
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`(a) [Z Patent owner's communication(s) filed: 2/12/09 2/13/09.
`-
`(b)
`[:1 Patent owner’s late response filed:
`.
`(c) E] Patent owner’s’ failure to file an appropriate response to the Office action mailed:
`(d) E] Patent owner’s failure to timely file an Appeal Brief (37 CFR 41.31).
`(e) E] Other:
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`.
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`Status of Ex Parte Reexamination:
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`(f) Change in the Specification: C] Yes [Z No
`(g) Change in the Drawing(s):
`I] Yes E No
`(h) Status of the C|aim(s):
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`(1) Patent claim(s) confirmed: 1-20 and 33-36.
`(2) Patent claim(s) amended (including dependent on amended claim(s)): 21-32
`(3) Patent claim(s) cancelled:
`.
`(4) Newlypresented claim(s) patentable:
`(5) Newly presented cancelled claims:
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`2. IX] Note the attached statement of reasons for patentability and/or confirmation. Any comments considered
`necessary by patent owner regarding reasons for patentability and/or confirmation must be submitted promptly
`to avoid processing delays. Such submission(s) should be labeled: “Comments On Statement of Reasons for
`Patentability and/or Confirmation."
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`3. CI _Note attached NOTICE OF REFERENCES CITED (PTO-892).
`4. X Note attached LIST OF REFERENCES CITED (PTO/SB/08).
`5. D The drawing correction request filed on
`is:
`1:} approved D disapproved.
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`6. D Acknowledgment is made of the priority claim under 35 U.S.C. § '119(a)-(d) or (f).
`a)[:l All b)l:I Some*
`c)I:l None
`of the certified copies have
`[:1 been received.
`Elvnot been received.
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`[I been filed in Application No.
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`E] been filed in reexamination Control No.
`l_—_| been received by the International Bureau in PCT Application No.
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`* Certified copies not received:
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`7.’ [:1 Note attached Examiner's Amendment.
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`8. [Z Note attached Interview Summary (PTO-474).
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`9. El Other:
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` / A
`V
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`A
`'
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`PRIMARY EXAMla\lt:rl
`crzu SPE-AU 3991
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`cc: Re uestem .f~th_1rd
`jiieuester
`.
`,
`,
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`U.S. Patent and Trademark Office
`'
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`PTOL-469 (Rev.08-06)
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`Notice of Intent to Issue Ex Parte Reexamination Certificate
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`Part of Paper No 20090211
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`Genzyme Ex. 1025, pg 805
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`Genzyme Ex. 1025, pg 805
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`

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`Application/Control Number: 90/007,859 5} 70/0075,42
`Art Unit: 3991
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`I
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`Page 2
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`Reexamination
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`Procedural Posture
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`This is the merged Ex parte reexamination proceedings of 90/007,542 and 90/007,859.
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`This is merged reexamination of US Patent 6,331,415 (Cabilly II), issued on December 18, 2001.
`
`_ Decision merging reexamination ‘proceedings 90/007,542 and 90/007,859 was mailed on 6/6/06.
`
`_
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`A First Office Action in this merged proceedings was mailed on 8/16/06.
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`Patent Owner filed a response on 10/3 0/06.
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`Final Rejection was mailed on 2/16/07.
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`A Request for Continued Reexamination was filed on 5/21/07. The Request for
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`Continued Reexamination was granted on 6/10/07.
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`Final Rejection was mailed on 2/25/08.
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`Afier Final response was mailed on 6/6/08.
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`Advisory action was mailed on 7/19/08.
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`Notice of Appeal was filed on 8/22/08.
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`Appeal Brief was filed on 12/9/08.
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`A supplemental response and amendment are filed on 2/12/09. The amendment to claim
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`21 does not comply with Rule 1.530. A second supplemental amendment is filed on 2/ 13/09.
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`Amendment
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`Claims 21, 27 and 32 are amended by the amendment filed on 2/13/09.
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`Information Disclosure Statement
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`Genzyme Ex. 1025, pg 806
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`Genzyme Ex. 1025, pg 806
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`

`
`Application/Control Number: 90/007,859 Ei 79/£707» 542'
`Art Unit: 3991
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`'
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`Page 3
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`The Information disclosure statements (PTO/SB/08) filed on 2/11/09 and 6/6/08 have
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`been considered. The documents L11 to L30 related to the litigation (cited in the 6/6/08, IDs) are
`
`considered, however a line is drawn through the citations because these documents are not
`
`appropriate for printing on the face of the reexamination certificate.
`
`The Cabilly 6,331,415 Invention (Cabilly II Patent)
`
`The invention is drawn to a method for producing an immunologically functional
`
`immunoglobulin molecule or an immunologically functional immunoglobulin fragment by
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`transforming a single host cell with a first DNA sequence encoding immunoglobulin heavy chain "
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`and a second DNA sequence encoding immunoglobulin light chain and independently expressing
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`the first DNA sequence and second DNA sequence so that said immunoglobulin heavy chain and
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`light chain are produced as separate molecules in said transformed single host cell.
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`Claims 1, 21 and 33 are representative of the invention.
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`Based on the prosecution history of the patent at issue, and the interference record from
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`Interference No. 102,572, the term “immunoglobulin molecule” in claims 1 and 33 is considered
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`to be immunologically functional molecule and capable of binding to a known antigen.
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`Withdrawn Rejections
`
`The obviousness-_type double patenting rejection of claims 1-36 of U.S. Pat. No.
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`6,331,415 (Cabilly 2) over claims 1-7 of US. Patent No. 4,816,567 (Cabilly 1) in view of Axel et
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`al. U.S. Pat. No. 4,399,216 (8/83), Rice and Baltimore, PNAS USA 79 (12/82):7862-7865,
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`Kaplan et al. EP 0044722 (1/82), Builder et al U.S/Pat. No. 4,511,502 (issued 4/85), Accolla et
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`Genzyme Ex. 1025, pg 807
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`Genzyme Ex. 1025, pg 807
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`

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`Application/Control Number: 90/007,859 5, ?6/005’, §’49—~
`Art Unit: 3991
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`Page 4
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`al PNAS USA 77(1): 563,566 (1980), Dallas (WO 82/03088), Deacon (Biochemical. Society
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`Transactions, 4 (1976):818—820), 1981 Valle (Nature, 291 (May '81) pages 338-340; Ochi
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`(Nature, 302(3/24/83) pages 340-342 alone, or further in view of Moore et al.‘U.S. Pat. No.
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`5,840,545 (Nov. 24, 31998: effectively filed March 15, 1982) is withdrawn upon reconsideration
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`.and in view of Patent Owner’s response and Declarations presented in this reexamination
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`proceedings.
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`Cabilly I Patent (the ‘567 patent) claims are drawn to a method for preparing chimeric
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`immunoglobulin heavy chain or immunoglobulin light chain molecules separately from
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`transformed host cells. The host cell in the Cabilly I patent claims is transformed with either
`
`'
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`immunoglobulin heavy chain or immunoglobulin light chain. Cabilly I patent claims do not
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`recite a single host cell transformed with DNA sequences encoding both immunoglobulin heavy
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`chain and immunoglobulin light chain independently as required in the present Cabilly II claims.
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`Axel et al taught a process for inserting foreign DNA into eukaryotic cell by
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`cotransformation with the disclosed foreign DNA I and DNA 11 that encodes" a selectable marker.
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`Axel et al did not teach a single host cell transformed with immunoglobulin heavy chain and
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`‘immunoglobulin light chain independently. Axel et al did not teach co-expression of two foreign
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`DNA sequences (see Harris declaration, McKnight declaration, Botchan declaration, Rice
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`declaration, and Colman declaration).
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`Rice exogenously introduced a recombinant murine kappa light chain gene into a mutant
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`lymphoid cell line (8lA-2 cell line) that contains heavy chain (endogenous). Rice taught the co-
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`expression of immunoglobulin heavy and light chain in the mutanticells. However, Rice did not
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`teach that a single host cell is transformed with both immunoglobulin heavy chain and light
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`Genzyme Ex. 1025, pg 808
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`Genzyme Ex. 1025, pg 808
`
`

`
`Application/Control Number: 90/007,859 2 70/007, 542
`Art Unit: 3991
`
`’
`
`Page 5
`'
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`chain (see Rice Declarations, Colman declaration, Harris declaration, Botchan declaration, and
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`McKnight declaration). Rice taught the successfial expression of immunoglobulin light chain
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`a genes is linked to the ongoing ability of the cell to express its endogenous heavy chain gene (see
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`Harris declaration, and Rice declaration).
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`Kaplan taught a method for producing an immunoglobulin multimer, wherein the
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`individual immunoglobulin heavy chain and light chain are produced in separate cell culture.
`Kaplan did not teach producing immunoglobulin heavy chain and light chain in a single host cell
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`(see Harris declaration, McKnight declaration, Botchan declaration, Colman declaration, and
`Rice declaration).
`
`Dallas taught a method of making an E.coli vaccine by inserting into one E.coli cell
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`genes obtained from another strain of E.coli. Dallas did not teach a method for producing
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`multiple eukaryotic proteins from a single host cell (see Harris declaration, McKnight
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`declaration, Rice declaration, and Botchan declaration).
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`Moore patent disclosed a method for producing “rFv” binding molecule comprising
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`variable regions of immunoglobulin heavy chain and light chain. Moore patent taught producing
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`immunoglobulin heavy chain and light chain in separate host cells. Moore patent taught the
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`immunoglobulin heavy chain and light chain are inserted into two separate single-marker pGMl
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`based ‘plasmids, resulting in pGM1H and pGMlL. Since both pGM1H and pGMlL plasmids
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`contain the same selectable marker, two separate host cell cultures are transformed with each
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`plasmid (see Scott declaration, McKnight declaration, Altman declaration). Thus, the Moore
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`patent taught producing immunoglobulin heavy chain and light chain in separate host cells.
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`Genzyme Ex. 1025, pg 809
`
`Genzyme Ex. 1025, pg 809
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`

`
`Application/Control Number: 90/007,859
`An Unit: 3991
`
`70/00% 54'-7-
`
`-
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`Page 6
`’
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`Deacon and Valle introduced and expressed exogenous immunoglobulin heavy chain and
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`light chain in xenopus oocyte cells. Valle 1982 is cumulative in its teachings to Deacon and
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`Valle reference. The Deacon and Valle reference did not describe any experiment where a
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`eukaryotic host cell is transfected with DNA (see Rice Declarations, Colman declaration, Harris
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`declaration, ‘McKnight declaration and Botchan declaration).
`
`_ Ochi taught a method of producing antibody by cloning an immunoglobulin light chain
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`into a cell line endogenously producing an immunoglobulin heavy chain. Ochi did not teach that
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`a single host cell is transformed with both immunoglobulin heavy chain and light chain (see Rice
`Declarations, Harris declaration, McKnight declaration and Botchan declaration).
`
`Builder taught reconstitution techniques for recovering expressed polypeptides from
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`bacterial host cells. Builder did not teach assembly of immunoglobulin tetramer (see Harris
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`declaration).
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`Accolla described methods for making anti-CEA monoclonal antibodies. Accolla did not
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`teach a method for producing monoclonal antibodies that bind to the CEA antigen through
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`recombinant DNA techniques (see Harris declaration).
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`Upon reconsideration of the declarations by Harris, McKnight, Botchan, Colman, and
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`-Rice, a person of ordinary skill in the art at the time the invention was made would not have had
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`a reasonable expectation of success modifying the Cabilly I Patent claims in accordance to the
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`teachings of Axel, Rice, Kaplan, Builder, Accolla, Dallas, Moore patent, Deacon and Valle, and
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`Ochi references of record to produce an immunologically functional immunoglobulin molecule
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`by independently expressing immunoglobulin heavy chain and light chain in a single
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`transformed host cell.
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`Genzyme Ex. 1025, pg 810
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`Genzyme Ex. 1025, pg 810
`
`

`
`Application/Control Number: 90/007,859 :4 70/007, 542
`Art Unit: 3991
`
`Page‘7
`
`STATEMENT OF REASONS FOR PATENTABILITY AND/OR CONFIRMATION
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`The following is an examiner's statement of reasons for patentability and/or confirmation_of the
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`claims found patentable in this reexamination proceeding:
`
`The combination of the Cabilly I patent claims and the teachings of Axel, Rice, Kaplan,
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`Builder, Accolla, Dallas, Moore patent, Deacon and Valle and Ochi references do not suggest or
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`contain an enabling disclosure of a method to produce an immunologically functional
`
`. immunoglobulin molecule by independently expressing immunoglobulin heavy chain and light
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`chain in a single transformed host cell.
`
`Any comments considered necessary by PATENT OWNER regarding the above
`
`statement must be submitted promptly to avoid processing delays. Such submission by the
`
`patent ownershould be labeled: "Comments on Statement of Reasons for Patentability and/or
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`Confirmation" and will be placed in the reexamination file.
`
`Conclusion
`
`Claims 1-20, 33-36 are confirmed and amended claims 21-32 are allowed.
`
`Future Correspondences
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Padmashri Ponnaluri whose telephone number is 571-272-0809.
`
`The examiner can normally be reached on Monday through Friday between 7 AM and 3.30 PM.
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`If attempts to reach the examiner by telephone are unsuccessfiil, the examiner’s
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`supervisor Deborah Jones can be reached on 571-272-1535. The fax phone number for the -
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`organization where this application or proceeding is assigned is 571-273-9900.
`
`Genzyme Ex. 1025, pg 811
`
`Genzyme Ex. 1025, pg 811
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`

`
`Application/Control Number: 90/007,859 S 70/00 ?,54—2_
`
`i Page8 _
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`Art Unit: 3991
`
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval G’AIR) system. Status information for published
`applications may be obtained from either Private PAIR or Public PAIR. Status information
`for unpublished applications is available through Private PAIR only. For more information
`about the PAIR system, see http://pair-direct.uspto. gov. Should you have questions on access
`to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197
`(toll-free).
`
`All correspondence relating to this Ex parte Reexamination proceeding should be directed to:
`
`By EFS:
`
`Registered users may submit via the electronic filing system EFS-Web at
`
`ht_tps 2//sportal.usipto. gov/authenticate/authenticateuserlocalepf. html
`
`By Mail to:
`
`Attn: Mail Stop “Ex Parte Reexam”
`
`Central Reexamination Unit
`Commissioner for Patents
`P. O. Box 1450
`
`Alexandria VA 22313-1450
`
`g
`By FAX to:
`(571) 273-9900
`Central Reexamination Unit
`
`Hand—Deliver any communications to:
`Customer Service Window
`
`Attn: Central Reexamination Unit
`
`Randolph Building, Lobby Level
`401 Dulany Street
`Alexandria, VA 22314
`
`Conferee:
`
`AH D. JONES
`DE ‘
`CRU SPE-AU 3991
`
`
`«E.'i-"=’ N rm. 3-§UAi'\.!G
`_
`-'=«‘5MAFEV EXAl\/lii\5EFI
`':.‘.R.l,§ —. AH 399:
`
`P mashri Ponnaluri
`
`Primary Examiner
`Unit 3991
`
`13 February 2009
`
`Genzyme Ex. 1025, pg 812
`
`Genzyme Ex. 1025, pg 812