UNITED STATES pATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313·1450
`www.uspto.gov
`
`APPLICATION NO.
`
`90/007,859
`
`FILING DATE
`
`12/23/2005
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`6331415
`
`22338-10231
`
`6447
`
`02/23/2009
`
`7590
`47554
`SIDLEY AUSTIN LLP
`·ATTN: DC PATENT DOCKETING
`1501 K STREET, NW
`WASHINGTON, DC 20005
`
`EXAMINER
`
`ART UNIT
`
`PAPER NUMBER
`
`DATE MAILED: 02/23/2009
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PT0-90C (Rev. 10/03)
`
`1571
`
`GENENTECH 2019
`GENZYME V. GENENTECH
`IPR2016-00383
`
`1
`
`

`
`Control No.
`
`Patent Under Reexamination
`
`Notice of Intent to Issue
`Ex Parte Reexamination Certificate
`
`90/007,859 Z{ 1tJjorYI.!'ft2- 6331415
`Examiner
`Art Unit
`
`Padmashri Ponnaluri
`3991
`-- The MAILING DATE of this· communication appears on the cover sheet with the correspondence address --
`1. t8l Prosecution on the merits is (or remains) closed in this ex parte reexamination proceeding. This proceeding is
`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
`(a) t8l Patent owner's communication(s) filed: 2112109. 2113109.
`(b) 0 Patent owner's late response filed: __ .
`(c) D Patent owner's failure to file an appropriate response to the Office action mailed: __ .
`(d) D Patent owner's failure to timely file an Appeal Brief (37 CFR 41.31).
`(e) D Other: __
`Status of Ex Parte Reexamination:
`(f) Change in the Specification: D Yes t8] No
`D Yes t8l No
`(g) Change in the Drawing(s):
`(h) Status of the Claim(s):
`(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) Newly presented claim(s) patentable: __ .
`(5) Newly presented cancelled claims: __ .
`2. t8l 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.·
`3. 0 Note attached NOTICE OF REFERENCES CITED (PT0-892).
`4. t8J Note attached LIST OF REFERENCES CITED (PTO/SB/08). I I p jS'.
`5. D The drawing correction request filed on __ is: D approved D disapproved.
`6. D Ac~nowledgment is made of the priority claim under 35 U.S. C. § 119(a)-(d) or (f).
`a)D All b)O Some*
`c)O None
`of the certified copies have
`D been received.
`D not been received.
`D been filed in Appiication No. __ :
`D been filed in reexamination Control No.
`.
`D been received by the International Bureau in PCT Application No. __ .
`*Certified copies not received: __ ..
`7. D Note attached Examiner's Amendment.
`8. t8l Note attached Interview Summary (PT0-474).
`9. D Other: __ .
`
`·~ /)
`
`I
`
`1-'P..I
`
`·-· •
`
`,1 FUNNA.lurr
`PRIMARY EXA!vilf·JEP
`cc: Requester(OA.llird pljhy~t§<!J.'Qester)
`U.S. Patent and Trademark Office
`PTOL-469 (Rev.OB-06)
`
`I
`
`I YV'I
`EVELYN M. HUANG
`PRIMARY EXAM!NEF;
`l"f~l!
`1\
`,..,... •. ·'
`...,
`,...,
`,...., vvv l
`Notice of Intent to Issue Ex Parte Reexamination Certificate
`
`I
`
`(I /If\' A.
`DEBORAH D. JONES
`CRU SRE-AU 3991
`
`Part of Paper No 20090211
`
`1572
`
`2
`
`

`
`Application/Control Number: 90/007,859 ~ qojoo~5'4'L
`Art Unit: 3991
`
`Page2
`
`Reexamination
`
`Procedural Posture
`
`This is the merged Ex parte reexamination proceedings of90/007,542 and 90/007,859.
`
`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.
`
`A First Office Action in this merged proceedings was mailed on 8/16/06.
`
`Patent Owner filed a response on 10/30/06.
`
`Final Rejection was mailed on 2/16/07.
`
`A Request for Continued Reexamination was filed on 5/21/07. The Request for
`
`Continued Reexamination was granted on 6/10/07.
`
`Final Rejection was mailed on 2/25/08.
`
`After Final response was mailed on 6/6/08.
`
`Advisory action was mailed on 7/19/08.
`
`Notice of Appeal was filed on 8/22/08.
`
`Appeal Brief was filed on 12/9/08.
`
`A supplemental response and amendment are filed on 2/12/09. The amendment to claim
`
`21 does not comply with Rule 1.530. A second supplemental amendment is filed on 2/13/09.
`
`Amendment
`
`Claims 21, 27 and 32 are amended by the amendment filed on 2/13/09.
`
`Information Disclosure Statement
`
`1573
`
`3
`
`

`
`Application/Control Number: 90/007,859 t; 1tftJ01_, .~4-'L
`Art Unit: 3991
`
`Page 3
`
`The Information disclosure statements (PTO/SB/08) filed on 2/11/09 and 6/6/08 have
`
`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 oy
`
`transforming a single host cell with a first DNA sequence encoding immunoglobulin heavy chain
`
`and a second DNA sequence encoding immunoglobulin light chain and independently expressing
`
`the first DNA sequence and second DNA sequence so that said immunoglobulin heavy chain and
`
`light chain are produced as separate molecules in said transformed single host cell.
`
`Claims 1, 21 and 33 are representative of the invention.
`
`Based ~n the prosecution history of the patent at issue, and the interfe.rence record from
`
`Interference No. 102,572, the term "immunoglobulin molecule" in claims 1 and 33 is considered
`
`to be immunologically functional molecule and capable of binding to a known antigen.
`
`Withdrawn Rejections
`
`The obviousness-type double patenting rejection of claims 1-36 of U.S. Pat. No.
`
`6,331,415 (Cabilly 2) over claims 1-7 ofU.S. Patent No. 4,816,567 (Cabilly 1) in view of Axel et
`
`al. U.S. Pat. No. 4,399,216 (8/83), Rice and Baltimore, PNAS USA 79 (12/82):7862-7865,
`
`Kaplan etal. EP 0044722 (1182), Builder et al U.S. Pat. No. 4,511,502 (issued 4/85), Accolla et
`
`1574
`
`4
`
`

`
`Application/Control Number: 90/007,859 ~ c;ojoo'l, :)42-
`Art Unit: 3991
`
`Page4
`
`al PNAS USA 77(1): 563,566 (1980), Dallas (WO 82/03088), Deacon (Biochemical. Society
`Transactions, 4 (1976):818-820), 1981 Valle (Nature, 291 (May '81) pages 338-340; Ochi
`
`(Nature, 302(3/24/83) pages 340-342 alone, or further in view of Moore et al. U.S. Pat. No.
`
`5;840,545 (Nov. 24, 1998: effectively filed March 15, 1982) is withdrawn upon reconsideration
`
`and in view of Patent Owner's response and Declarations presented in this reexamination
`
`proceedings.
`
`Cabilly I Patent (the '567 patent) claims are drawn to a method for preparing chimeric
`
`immunoglobulin heavy chain or immunoglobulin light chain molecules separately from
`
`transformed host cells. The host cell in the Cabilly I patent claims is transformed with either
`
`immunoglobulin heavy chain or immunoglobulin light chain. Cabilly I patent claims do not
`
`recite a single host cell transformed with DNA sequences encoding both immunoglobulin heavy
`
`chain and immunoglobulin light chain independently as required in the present Cabilly II claims.
`
`Axel et al taught a process for inserting foreign DNA into eukaryotic cell by
`
`cotransformation with the disclosed foreign DNA I and DNA II that encodes a selectable marker.
`
`Axel et al did not teach a single host cell transformed with immunoglobulin heavy chain and
`
`immunoglobulin light chain independently. Axel et al did not teach co-expression of two foreign
`
`DNA sequences (see Harris declaration, McKnight declaration, Botchan declaration, Rice
`
`declaration, and Colman declaration).
`
`Rice exogenously introduced a recombinant murine kappa light chain gene into a mutant
`
`lymphoid cell line (81A-2 cell line) that contains heavy chain (endogenous). Rice taught the co-
`
`expression of immunoglobulin heavy and light chain in the mutant cells. However, Rice did not
`
`teach that a single host cell is transformed with both immunoglobulin heavy chain and light
`
`1575
`
`5
`
`

`
`Application/Control Number: 90/007,859 ~ rojotJ7i 54-2....
`Art Unit: 3991
`
`Page 5
`
`chain (see Rice Declarations, Colman declaration, Harris declaration, Botchan declaration, and
`
`McKnight declaration). Rice taught the successful expression of immunoglobulin light chain
`
`genes is linked to the ongoing ability of the cell to express its endogenous heavy chain gene (see
`
`Harris declaration, and Rice declaration).
`
`Kaplan taught a method for producing an immunoglobulin multimer, wherein the
`
`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
`
`(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
`
`genes obtained from another strain of E. coli. Dallas did not teach a method for producing
`
`multiple eukaryotic proteins from a single host cell (see Harris declaration, McKnight
`
`declaration, Rice declaration, and Botchan declaration).
`
`Moore patent disclosed a method for producing "rFv" binding molecule comprising
`
`variable regions of immunoglobulin heavy chain and light chain. Moore patent taught producing
`
`immunoglobulin heavy chain and light chain in separate host cells. Moore patent taught the
`
`immunoglobulin heavy chain and light chain are inserte~ into two separate single-marker pGMl
`
`based plasmids, resulting in pGMIH and pGMIL. Since both pGMIH and pGMIL plasmids
`
`contain the same selectable marker, two separate host cell cultures are transformed with each
`
`plasmid (see Scott declaration, McKnight declaration, Altman declaration). Thus, the Moore
`
`patent taught producing immunoglobulin heavy chain and light chain in separate host cells.
`
`1576
`
`6
`
`

`
`Application/Control Number: 90/007,859 ~ 90/00~ 54-2._
`Art Unit: 3991
`
`Page6
`
`Deacon and Valle introduced and expressed exogenous immunoglobulin heavy chain and
`
`light chain in xenopus oocyte cells. Valle 1982 is cumulative in its teachings to Deacon and
`
`Valle reference. The Deacon and Valle reference did not describe any experiment where a
`
`eukaryotic host cell is transfected with DNA (see Rice Declarations, Colman declaration, Harris
`
`declaration, McKnight declaration and Botchan declaration).
`
`Oc~i taught a method of producing antibody by cloning an immunoglobulin light chain
`
`into a cell line endogenously producing an immunoglobulin heavy chain. Ochi did not teach that
`
`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
`
`bacterial host cells. Builder did not teach assembly of immunoglobulin tetramer (see Harris
`
`declaration).
`
`Accolla described methods for making anti-CEA monoclonal antibodies. Accolla did not
`
`teach a method for producing monoclonal antibodies that bind to the CEA antigen through
`
`recombinant DNA techniques (see Harris declaration).
`
`Upon reconsideration of the declarations by Harris, McKnight, Botchan, Colman, and
`
`Rice, a person of ordinary skill in the art at the time the invention was made would not have had
`
`a reasonable expectation of success modifying the Cab illy I Patent claims in accordance to the
`
`teachings of Axel, Rice, Kaplan, Builder, Accolla, Dallas, Moore patent, Deacon and Valle, and
`
`Ochi references of record to produce an immunologically functional immunoglobulin molecule
`
`by independently expressing immunoglobulin heavy chain and light chain in a single
`
`transformed host cell.
`
`1577
`
`7
`
`

`
`Application/Control Number: 90/007,859 z; 9ojoo~ !:)4-2..
`Art Unit: 3991
`
`Page7
`
`STATEMENT OF REASONS FOR PATENTABILITY AND/OR CONFIRMATION
`
`The following is an examiner's statement of reasons for patentability and/or confirmation.ofthe
`
`claims found patentable in this reexamination proceeding:
`
`The combination of the Cabilly I patent claims and t~e teachings of Axel, Rice, Kaplan,
`
`Builder, Accolla, Dallas, Moore patent, Deacon and Valle and Ochi references do not suggest or
`
`contain an enabling disclosure of a method to produce an immunologically functional
`
`. immunoglobulin molecule by independently expressing immunoglobulin heavy chain and light
`
`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 owner·should be labeled: "Comments on Statement of Reasons for Patentability and/or
`
`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.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's ·
`
`supervisor Deborah Jones can be reached on 571-272-1535. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-9900.
`
`1578
`
`8
`
`

`
`Application/Control Number: 90/007,859 ~ t:tojoo 1-,54-2.
`Art Unit: 3991
`
`Page 8
`
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval (PAIR) 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
`
`https://sportal.uspto.gov/authenticate/authenticateuserlocalepf.html
`
`By Mail to:
`
`Attn: Mail Stop uEx Parte Reexam"
`Central Reexamination Unit
`Commissioner for Patents
`P. 0. Box 1450
`Alexandria VA 22313-1450
`
`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: DE~NES
`
`CRU SPE-AU 3991
`
`4A--
`p~~shri Ponnaluri
`Primary Examiner
`Unit 3991
`13 February 2009
`
`1579
`
`9