CONTROL NOS. 90/007,542 AND 90/007,859
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`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Control Nos.:
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`Confirmation Nos.:
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`90/ 007,542
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`90/ 007,859
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`7585 (’542)
`6447 (’859)
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`Filed:
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`13 May 2005
`23 December 2005
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`(’542)
`(’859)
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`Patent Owner:
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`Genentech, Inc. and
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`City of Hope
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`GTOUP A“ Unit
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`3991
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`Examiner:
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`P. Ponnaluri
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`For:
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`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly et al.)
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`Mail Stop Ex Parte Reexam
`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`SUPPLEMENTAL AMENDMENT UNDER 37 C.F.R.
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`1.550 b
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`Sir:
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`Further to the proposed amendment filed on 12 February 2009, Owners submit the
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`following page of amendments to the claims to address an informality.
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`Owners believe that no fee is due in connection with the present amendment. However,
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`any fee required for entry or consideration of this paper may be debited from our Deposit
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`Account No. 18-1260.
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`SUPPLEMENTAL AMENDMENT
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`13 FEBRUARY 2009 — PAGE 1
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`Mylan v. Genentech
`Mylan V. Genentech
`IPR2016-00710
`Genentech Exhibit 2014
`
`Genentech Exhibit 2014
`
`IPR2016-00710
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
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`AMENDMENT TO THE CLAIMS
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`Please amend claim 21, 27 and 32 as follows:
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`21.
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`(Amended)
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`A method comprising
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`a)
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`preparing a E DNA sequence [consisting essentially of DNA] encoding an
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`immunoglobulin [consisting of an immunoglobulin] heavy chain and a second DNA
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`seguence encoding an immunoglobulin light chain [or Fab region, said immunoglobulin
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`having specificity for a particular known antigen];
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`b)
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`inserting the DNA sequences of step a) into a replicable expression vector wherein each
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`seguence is operably linked to a suitable promoter;
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`c)
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`transforming a prokaryotic or eukaryotic microbial host cell culture with the vector of
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`step b);
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`d)
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`culturing the host cell so that said immunoglobulin heavy and light chains are produced
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`as separate molecules in said transformed host cell; and
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`e)
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`recovering the immunoglobulin from the host cell culture, said immunoglobulin being
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`capable of binding to a known antigen.
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`27. (Amended)
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`The method of claim 26 wherein the heavy chain and light chain [s or Fab
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`region] are deposited within the cells as insoluble particles.
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`32. (Amended)
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`The insoluble particles of heavy chain and light chains [or Fab region]
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`produced by the method of claim 27.
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`SUPPLEMENTAL AMENDMENT
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`13 FEBRUARY 2009 — PAGE 2
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`

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`CONTROL NOS. 90/007,542 AND 90/007,859
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`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
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`REMARKS
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`Interview Summary
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`On 13 February 2009, Examiner Ponnaluri advised the undersigned by telephone that the
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`amendment filed on 12 February 2009 was informal because the text deleted from the claims was
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`marked with both brackets and strikethrough text. She indicated that a supplemental amendment
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`using only brackets to indicate deleted text would be in proper form.
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`Amendments
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`The changes to the text of the claims set forth above are identical to the changes
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`presented in the paper filed on 12 February 2009. Deleted text is indicated solely by the use of
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`brackets.
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`Conclusion
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`Owners request that the Office enter the present amendment to the claims and consider
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`the remarks set forth in the paper filed on 12 February 2009.
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`Respectfully submitted,
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`/David L. Fitzgerald/
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`David L. Fitzgerald, Reg. No. 47,347
`Attorney of Record
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`13 February 2009
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`SIDLEY AUSTIN LLP
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`1501 K Street, N.W.
`Washington, DC 20005
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`tel. (202) 736-8818
`fax (202)736-8711
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`SUPPLEMENTAL AMENDMENT
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`13 FEBRUARY 2009 — PAGE 3
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`

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`
`Ex Parte Reexamination Interview Summary
`Art Unit p_
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`Control No.
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`Patent Under Reexamination
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`Examiner
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`
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`All participants (USPTO personnel, patent owner, patent owner's representative):
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`
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` (1) £<maM
`(2) Jeffrey Kushan
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`(3) __
`(4)
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`
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`Date of Interview: 13 February 2009
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`b)I:l Video Conference
`Type: a)|Z Telephonic
`c)l:] Personal (copy given to:' 1)l] patent owner
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`2)I:I patent owner's representative)
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`d)l:I Yes
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`e)IZ No.
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`Exhibit shown or demonstration conducted:
`If Yes, brief description:
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`
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`Agreement with respect to the claims 01] was reached. g)I:] was not reached. h)® N/A.
`Any other agreement(s) are set forth below under “Description of the general "nature of what was agreed to..."
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`Claim(s) discussed: 21 27 and 32.
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`Identification of prior art discussed: none.
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`
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`Description of the general nature of what was agreed to if an agreement was reached, or any other comments:
`Examiner has informed that the amendment filed on 2/12/09 does not comglv with 37 CFR 1.530. The deleted subiect
`matter has to be bracketed, no striking out. Patent Owner's representative has agreed to file amendment according to
`37 CFR 1.530.
`'
`
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`(A fuller description, if necessary, and a copy of the amendments which the examiner agreed would render the claims
`‘patentable, if available, must be attached. Also, where no copy of the amendments that would render the claims
`patentable is available, a summary thereof must be attached.)
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`A FORMAL WRITTEN RESPONSE TO THE LAST OFFICE ACTION MUST INCLUDE PATENT OWNER'S
`STATEMENT OF THE SUBSTANCE OF THE INTERVIEW. (See MPEP § 2281). IF A RESPONSE TO THE
`LAST OFFICE ACTION HAS ALREADY BEEN FILED, THEN PATENT OWNER IS GIVEN ONE MONTH FROM THIS
`INTERVIEW DATE TO PROVIDE THE MANDATORY STATEMENT OF THE SUBSTANCE OF THE INTERVIEW
`(37 CFR 1.560(b)). THE REQUIREMENT FOR PATENT OWNER’S STATEMENT CAN NOT BE WAIVED.
`EXTENSIONS OF TIME ARE GOVERNED BY 37 CFR 1.550(6).
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`cc: Requester (if third party requester)
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`U.S. Patent and Trademark Office
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`PTOL-474 (Rev. 04-01)
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`Ex Parte Reexamination Interview Summary
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`Paper No. 20090211
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`PAGE 4
`PAGE 4