UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BIOEQ IP AG,
`
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`
`Patent Owner.
`
`Case IPR2016-01608
`
`Patent No. 6,716,602
`
`TRANSMITTAL OF PATENT OWNER'S EXHIBIT 2009,
`REGARDING REQUEST FOR CERTIFICATE OF CORRECTION
`
`

`
`To the Attention of the Patent Trial and Appeal Board:
`
`The undersigned counsel for Patent Owner in the above-
`
`captioned inter partes review ("IPR") proceeding received e-mail
`
`correspondence dated today from Maria Vignone, Paralegal Operations
`
`Manager, on behalf of the Patent Trial and Appeal Board ("the Board"),
`
`authorizing Patent Owner to file a Request for Certificate of Correction
`
`Under 35 U.S.C. § 254 as follows:
`
`(1)
`
`Patent Owner is authorized to file a Request for
`
`Certificate of Correction Under 35 U.S.C. § 254 ("§ 254
`
`Request") with the Director. The § 254 Request must be
`
`filed no later than Friday, December 2, 2016. A copy of
`
`that filing shall be entered as an exhibit in the record of
`
`this proceeding by no later than Friday, December 2,
`
`2016.
`
`In accordance with the foregoing instruction that a copy of the
`
`filing be entered as an exhibit in this IPR proceeding, Patent Owner herewith
`
`submits Exhibit 2009, comprising copies of the § 254 Request and the
`
`proposed Certificate of Correction. The original § 254 Request and
`
`proposed Certificate of Correction are being sent to the Commissioner of
`
`Patents via United States Postal Service Express Mail today, December 1,
`
`2016.
`
`

`
`Dated: December 1, 2016
`
`Respectfully submitted
`
`/J^rmifer Gor^m
`/
`Reg. No. 3Q053:
`PAUL, WMSS, RIFKIND,
`WHARTON & GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Tel: (212) 373-3716
`Fax:(212)492-0716
`
`Counsel for Patent Owner
`Genentech, Inc.
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Inventors:
`
`Dana ANDERSEN et al.
`
`Docket No:
`
`3118/1G804US1
`
`: 6,716,602
`Patent No.
`
`Confirmation
`
`9446
`
`No.:
`
`Issued:
`
`April 6, 2004
`
`Group Art
`
`1636
`
`Unit:
`
`Examiner:
`
`SULLIVAN, Daniel
`
`For:
`
`METABOLIC RATE SHIFTS
`IN FERMENTATIONS
`EXPRESSING
`RECOMBINANT
`PROTEINS
`
`REQUEST FOR CERTIFICATE OF CORRECTION UNDER 35
`U.S.C. § 254
`
`Commissioner for Patents
`Office of Data Management Attention: Certificates of Correction Branch
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Madam Director:
`
`The Patent Owner respectfully requests a certificate of
`
`correction under 35 U.S.C. § 254 to correct the Patent Office's mistake in
`
`issued claims 14, 16, 21, 25, 28, and 38 of U.S. Patent No. 6,716,602 (the
`
`'602 Patent). Accompanying this request is Form PTO/SB/44, a proposed
`
`GNE 2009
`Page 1
`
`

`
`Certificate of Correction. This patent is the subject of IPR2016-01608. In
`
`an email from Maria Vignone, Paralegal Operations Manager, dated
`
`December 1, 2016, the Patent Trial And Appeal Board authorized the filing
`
`of this request under 37 C.F.R. § 42.22, no later than December 2, 2016.
`
`The requested Correction adds no new matter and is clearly disclosed by the
`
`'602 Patent's prosecution history in the records of the Patent Office.
`
`During prosecution of the '602 patent, an amendment, dated
`
`August 1, 2003, was submitted and received by the Patent Office on August
`
`4, 2003 (the "Amendment"). The Amendment was acknowledged in the
`
`Notice of Allowability that issued on November 10, 2003. In issuing the
`
`claims, however, the Patent Office failed to include changes that were made
`
`by the Amendment to those claims that issued as claims 14, 16, 21, 25, 28,
`
`and 38.
`
`In particular, the Amendment included the addition of wherein
`
`clauses and other changes to each of pending claims 15 (issued claim 16)
`
`and 24 (issued claim 25):
`
`Doc#:USl:10929887v5
`
`GNE 2009
`Page 2
`
`

`
`Claim 15 (currently amendod): A method of increasing product yield of a
`
`properly folded antibody, growth factor, or jnaramalian protease produced by a
`recombinant E. coli host ceil, wherein expression of the antibody, growth
`factor, or protease is regulated by an inducible system, which method
`
`comprises
`
`(a)
`
`culturing the host cells under conditions of high metabolic
`
`and growth rate; and
`
`(b)
`
`reducing th_e metabolic rate of the cultured recombinant host
`
`cells at the time of induction of antibody, growth factor, or
`
`protease expression, wherein the_reductiorT in metabolic rate
`
`results in increased yield of properly folded antibody,
`
`growth factor, or protease.
`
`Amendment at 11-12.
`
`Claim 24 (currently amended!: A method for increasing product yield of a
`
`properly folded mammalian polypeptide of interest produced by recombinant
`
`host cells, wherein expression of the polypeptide by the recombinant host
`
`cells is regulated by an inducible system, which method comprises
`
`(a)
`
`culturing the recombinant host cells under conditions of
`
`high metabolic and growth rate; and
`
`(b)
`
`reducing the metabolic rate of the Cultured recombinant
`
`host cells at the time of induction of polypeptide
`
`expression, wherein the reduction in metabolic rate results
`
`in increased yield of properly folded mainaalian p.olyEgEtido.
`
`Amendment at 12-13.
`
`The Amendment also included the following amendments to
`
`pending claim 13 (issued claim 14), pending claim 20 (issued claim 21),
`
`pending claim 27 (issued claim 28), and pending claim 36 (issued claim 38),
`
`adjusting claim dependencies and removing "or other form of antibody":
`
`Doc#:US1.10929887v5
`
`GNE 2009
`Page 3
`
`

`
`Claim 13 (currently amended!: The method according to claim 4? 3§, wherein the
`
`polypeptide is selected from the group consisting of an Fab'j antibody and -an
`
`Fab antibody og other 'form &f antibody.
`
`Claim 20 {currently amended): The method according to claim 1$ 19, wherein
`
`the carbon/energy source is glucose.
`
`Claim 21 {currently araendod): The method according to claim *4 26, wherein
`
`the carbon/energy source is glucose.
`
`Claim 36 {currently amended): The method according to claim 54 .39, wherein
`
`the polypeptide is selected from the group consisting of an Fab'2 antibody and
`
`an Fab antibody'or other form of antibody.
`
`Following the Amendment, the Examiner issued a Notice of
`
`Allowability, mailed November 10, 2003, which acknowledged the
`
`Amendment by stating: "This communication is responsive to the
`
`amendment filed 4 August 2003." Notice of Allowability (November 10,
`
`2003) at 1 (emphasis in original).
`
`Upon payment of the issue fee, all of the pending claims issued.
`
`New claim 38 became issued claim 13, thereby incrementing the claims that
`
`followed by one number. New claim 39 became issued claim 37,
`
`incrementing claims that followed that claim by two numbers.
`
`As a result, pending claim 13 became issued claim 14, pending
`
`claim 15 became issued claim 16, pending claim 20 became issued claim 21,
`
`Doc#- US 1 10929887v5
`
`4
`
`GNE 2009
`Page 4
`
`

`
`pending claim 24 because issued claim 25, pending claim 27 became issued
`
`claim 28, and pending claim 36 became issued claim 38.
`
`Accordingly, issued claims 14, 16, 21, 25, 28, and 38 should be
`
`corrected to reflect the Amendment, as shown in the accompanying
`
`proposed Certificate of Correction.
`
`Conclusion
`
`For the stated reasons, the Patent Owner respectfully requests a
`
`certificate of correction under 35 U.S.C. § 254 as to claims 14, 16, 21, 25,
`
`28, and 38.
`
`Dated: December 1, 2016
`
`Respectfully submitted,
`
`./
`
`/ Xennifer (Jordon
`'/keg. No. 30,753
`/' PAUL, WEISS, RIFKIND,
`'
`WHARTON & GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Tel: (212) 373-3716
`Fax: (212) 492-0716
`
`Counsel for Patent Owner
`Genentech, Inc.
`
`/
`/
`
`Doc# US1 10929887v5
`
`GNE 2009
`Page 5
`
`

`
`I hereby certify that this correspondence is
`being deposited with the U.S. Postal Service
`as First Class Mail in an envelope addressed
`to: Mail Stop AMENDMENT,
`Commissioner for Patents, P.O. Box 1450,
`Alexandria, VA 22313-1450 on August 3,
`2015.
`
`Eileen Woo
`Registration No. 67,881
`
`Doc# US1 10929887v5
`
`GNE 2009
`Page 6
`
`

`
`PTO/SB/44 (09-07)
`Approved for use through 08/31/2013 OMB 0651-0033
`U S Patent and Trademark Office; U S DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 199S no persons are required to respond to a collection of information unless it displays a valid OMB control number
`(Also Form PTO-10S0)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`Page 1 of 1
`
`PATENT NO
`
`6,716,602
`
`APPLICATION NO. 10/000,655
`
`ISSUE DATE
`
`. April 6, 2004
`
`INVENTORY)
`
`D a na A n c l e r s e ni
`
`jo hn
`
`j0|yi Bradley R. Snedecor
`
`It is certified that an error appears or errors appear in the above-identified patent and that said Letters Patent
`is hereby corrected as shown below:
`
`In the claims:
`
`In col. 18, line 53, claim 14, please delete " 1" and substitute "13".
`
`In col. 18, line 55, claim 14, please delete "or other form of antibody".
`
`In col. 18, line 66, claim 16, please insert "the" after "reducing" and "cultured" before "recombinant host cells."
`
`In col. 18, line 68, claim 16, please delete"." and substitute ", wherein the reduction in metabolic rate
`results in increased yield of properly folded antibody, growth factor, or protease."
`
`In col. 19, line 11, claim 21, please delete "19" and substitute "20".
`
`In col. 19, line 27, claim 25, please insert "the" after "reducing" and "cultured" before "recombinant host cells."
`
`In col. 19, line 28, claim 25, please delete "." and substitute ", wherein the reduction in metabolic rate results
`in increased yield of properly folded mammalian polypeptide."
`
`In col. 20, line 1, claim 28, please delete "25" and substitute "27".
`
`In col. 20, line 24, claim 38, please delete "25" and substitute "37".
`
`In col. 20, line 27, claim 38, please delete "or other form of antibody".
`
`MAILING ADDRESS OF SENDER (Please do not use customer number below):
`Jennifer Gordon
`Paul, Weiss, Rifkind, Wharton & Garrison LLP
`1285 Avenue of the Americas, New York, NY 10019
`ThK collection of information re rpqmrpd by 37 CFR 1 322, 1 323, and 1 324 Th? Information w rsqnirpd to obtain or retain a hpnpflt by the public which is tn file
`(and by the USPTO to process) an application Confidentiality is governed by 35 U S C 122 and 37 CFR 1 14 This collection is estimated to take 1 0 hour to
`complete, including gathering, preparing, and submitting the completed applicaton form to the USPTO Time will vary depending upon the individual case Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer,
`US Patent and Trademark Office, US Department of Commerce, P O. Box 1450, Alexandna, VA 22313-1450 DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS SEND TO: Attention Certificate of Corrections Branch, Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2
`
`GNE 2009
`Page 7
`
`

`
`PTO/SB/92 (07-16)
`Approved for use through 07/31/2016 OMB 0651-0031
`U S Patent and Trademark Office, U S DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number
`
`Certificate of Mailing or Transmission under 37 CFR 1.8
`
`I hereby certify that this correspondence is being1
`
`1. [ /] Deposited with the United States Postal Service with sufficient postage as first class mail in an envelope addressed to:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`„„ 12/01/2016
`Date
`
`2. Q Facsimile transmitted to the United States Patent and Trademark Office, or
`
`3. O EFS-Web transmitted to the USPTO.
`
`OR
`
`Signature
`
`Dec. 1, 2016
`
`Date
`
`Eileen Woo, Reg. No. 67,881 212-373-3167
`
`Typed or printed name
`
`Telephone number
`
`Note. Each paper must have its own certificate of mailing or transmission, or this certificate must identify each submitted paper
`
`Request for Certificate of Correction (6 pages)
`Certificate of Correction (1 page)
`
`This collection of information is required by 37 CFR 1 8 The information is required to obtain or retain a benefit by the public, which is to file (and by the USPTO to
`process) an application Confidentiality is governed by 35 U S C 122 and 37 CFR 1 11 and 1 14 This collection is estimated to take 1 8 minutes to complete,
`including gathenng, preparing, and submitting the completed application form to the USPTO Time will vary depending upon the individual case Any comments on
`the amount of time you require to complete this form and/or suggestions for reducing this burden should be sent to the Chief Information Officer, U S Patent and
`Trademark Office, U S Department of Commerce, P O Box 1450, Alexandna, VA 22313-1450 DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2
`
`GNE 2009
`Page 8
`
`

`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that
`
`on December 1, 2016, a true and correct copy of the foregoing PATENT
`
`OWNER’S EXHIBIT 2009 was served by email on the following counsel of
`
`record for Petitioner:
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, NW
`Washington, DC 20005
`202.772.8679 (telephone)
`202.371.2540 (facsimile)
`
`Lead Counsel: Deborah A. Sterling (Reg. No. 62,732)
`Back-up Counsel: Timothy J. Shea (Reg. No. 41,306)
`Back-up Counsel: Jeremiah B. Frueauf (Reg. No. 66,638)
`Back-up Counsel: Olga A. Partington (Reg. No. 65,326)
`
`dsterlin-PTAB@skgf.com
`tshea-PTAB@skgf.com
`jfrueauf-PTAB@skgf.com
`opartington-PTAB@skgf.com
`
`/Eileen Woo/
`
`Eileen Woo
`Reg. No. 67,881
`
`
`
`
`
`Email: