-·-·-..
`
`•
`
`PATENT DOCKET 100/1SOC1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of
`
`SHMUEL CABILLY ET AL.
`
`Serial No. 07/205,419
`
`Filed: 06/10/88
`
`For: RECOMBINANT
`IMMUNOGLOBULIN
`):IREPARATIONS
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Art Unit: 183
`
`Examiner: J. HULEATT
`
`SUPPLEMENTARY PRELIMINARY AMENDMENT
`AND REQUEST FOR INTERFERENCE
`
`Honorable Commissioner of Patents and Trademarks
`Washington, D.C. 20231
`
`Sir:
`
`Amendment
`
`~·":)
`)
`-,.,.
`
`.~ ~
`,.• ,A
`
`::J
`
`'-.
`
`c--:
`
`l
`
`/7)
`::::.;;
`c
`... ..,---;
`
`,. -- -. --
`_--.., -..
`
`;\)
`
`1-.!
`·~ .J
`c
`
`'~~-
`(:::::,
`C.....J
`
`~?
`Please further amend this application by cancelling claims 53-~ and
`
`adding the following new claims:
`
`0(
`
`--67.
`
`A process for producing
`
`or an immunologically
`
`functional Ig fragment comprising at
`
`e variable domains of the Ig
`
`heavy
`
`(i)
`
`o t cell, comprising the steps of:
`
`variable domain of the Ig heavy chain
`
`and a
`
`sequence encoding at least the variable
`
`of the Ig light chain, and
`
`LC48:x:086.mdh
`
`Merck Ex. 1013, pg 602
`
`
`
`•
`
`PATENT DOCKET 100/1SOC1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of
`
`SHMUEL CABILLY ET AL.
`
`Serial No. 07/205,419
`
`Filed: 06/10/88
`
`For: RECOMBINANT
`IMMUNOGLOBULIN
`):IREPARATIONS
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Art Unit: 183
`
`Examiner: J. HULEATT
`
`SUPPLEMENTARY PRELIMINARY AMENDMENT
`AND REQUEST FOR INTERFERENCE
`
`Honorable Commissioner of Patents and Trademarks
`Washington, D.C. 20231
`
`Sir:
`
`Amendment
`
`~·":)
`)
`-,.,.
`
`.~ ~
`,.• ,A
`
`::J
`
`'-.
`
`c--:
`
`l
`
`/7)
`::::.;;
`c
`... ..,---;
`
`,. -- -. --
`_--.., -..
`
`;\)
`
`1-.!
`·~ .J
`c
`
`'~~-
`(:::::,
`C.....J
`
`~?
`Please further amend this application by cancelling claims 53-~ and
`
`adding the following new claims:
`
`0(
`
`--67.
`
`A process for producing
`
`or an immunologically
`
`functional Ig fragment comprising at
`
`e variable domains of the Ig
`
`heavy
`
`(i)
`
`o t cell, comprising the steps of:
`
`variable domain of the Ig heavy chain
`
`and a
`
`sequence encoding at least the variable
`
`of the Ig light chain, and
`
`LC48:x:086.mdh
`
`Merck Ex. 1013, pg 602
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`(ii)
`
`•
`
`Page 2
`
`that said Ig heavy and light chains
`
`are
`
`arate molecules in said transformed
`
`--68.
`
`The process according to claim 67 wherein said
`
`rst and second
`
`DNA sequences are present in different vectors.-(cid:173)
`
`--69.
`
`The process according to claim 67 wherein s id first and second
`
`DNA sequences are present in a single vee or.--
`
`--70.
`
`A process according to claim 68 wherein he vector is a plasmid.-
`
`--71.
`
`A process according to claim 70 whe ein the plasmid is pBR322.-
`
`* 72.
`
`-
`
`A process according
`
`bacterium or yeast.-(cid:173)
`
`is a
`
`--73.
`
`A process according
`
`the host cell is E. coli
`
`is E. coli
`
`or S. cerevisiae.-(cid:173)
`
`--74.
`
`A process according
`
`strain Xl776.--
`
`--75.
`
`--76.
`
`LC48x08
`
`.mdh
`
`Merck Ex. 1013, pg 603
`
`
`
`~·
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 3
`
`(
`
`allowed
`
`to
`
`refold
`
`in solution
`
`to
`
`an
`
`immunologically
`
`functional Ig molecule or Ig fragment.--
`
`•. 77.
`
`A process according to claim 67 wherein
`
`e DNA sequences code for
`
`the compl~te Ig heavy and light chain .--
`
`A process according to claim 67 wher in said first or said second
`
`DNA sequence further encodes at lea t one constant domain, wherein
`
`the constant domain is
`
`same source as
`
`the
`
`variable domain to which
`
`ttached.--
`
`··79.
`
`A process according to claim
`
`wherein said first or said second
`
`DNA sequence further enc
`
`least one constant domain, wherein
`
`the constant domain
`
`rom a species or class different
`
`from that from
`
`is derived.-(cid:173)
`
`domain to which it is attached
`
`A process
`
`claim 67 wherein said first and second DNA
`
`sequences are
`
`from one or more monoclonal antibody
`
`producing
`
`. ·81.
`
`first DNA sequence encoding at least a
`
`variable
`
`of an Ig heavy chain and a second DNA sequence
`
`encoding at 1 ast a variable domain of an Ig light chain wherein
`
`said first
`
`sequence and said second DNA sequence are located
`
`at different insertion sites.--
`
`81 which is a plasmid.--
`
`ell transformed with a vector according to claim 81.--
`
`·-82.
`
`--83.
`
`A
`
`A
`
`LC48x:086.mdh
`
`Merck Ex. 1013, pg 604
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 4
`
`--84.
`
`A transformed host cell comprising
`
`at least
`
`one of said vectors comprising a
`
`encoding at least
`
`a variable domain of an
`
`and at least another one
`
`--85.
`
`--86.
`
`of said vectors
`
`variable domain
`
`sequence encoding at least the
`
`cell is a mammalian
`
`host cell of claim 84 wherein the host cell is a
`
`cell.--
`
`Specification Basis
`
`Main claim 67 is based at least on section E.l.9 of the instant
`
`specification and the disclosure noted below:
`
`Claim 67
`
`Specification page/line
`
`"A process for producing an Ig molecule
`
`pages 8-9
`
`or an immunologically functional Ig
`
`page 13, lines 24-28;
`
`comprising at least the variable domains
`
`page 14, lines 1-12;
`
`of the Ig heavy and light chains,
`
`page 30, lines 10-15;
`
`page 43, lines 27-31
`
`LC48x086.mdh
`
`Merck Ex. 1013, pg 605
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 5
`
`in a single host, comprising the steps of
`
`page 23, lines 5-8 and lines
`
`28-34; page 22,
`
`lines 30-
`
`34;
`
`page 43, line 27 et seq.;
`
`original claims 43 and 50.
`
`(i) transforming said single host cell
`
`page 22, lines 29-34; 23/8;
`
`with a first DNA sequence encoding at
`
`page 23, lines 5 and 8; page
`
`least the variable domain of the Ig
`
`6, line 6; page 43, line 28
`
`heavy chain and a second DNA sequence
`
`et seq.; original claims 43
`
`encoding at least the variable domain of
`
`and 50.
`
`Ig light chain, and
`
`(ii) independently expressing said first
`
`page 22, lines 30-34; page
`
`DNA sequence and said second DNA sequence
`
`23, lines 10-12 and lines 28
`
`so that said Ig heavy and light chains are
`
`34; page 44, lines 5-19; and
`
`produced as separate molecules in said
`
`page 45, line 34.
`
`transformed single host cell.
`
`The basis for the remaining new claims is at least as follows:
`
`Claim
`
`Specification page/line
`
`68
`
`page 22, lines 32-33; section E.1.9
`
`LC48x086.mdh
`
`Merck Ex. 1013, pg 606
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 6
`
`69, 70, 81, 82 and 83
`
`page 22, lines 33-34; section E.l.9
`
`71
`
`72, 73, 74
`
`75
`
`76
`
`77
`
`78
`
`79
`
`80
`
`84
`
`page 16, line 15; section E.l.9
`
`pages 15-16; section E.l.9
`
`page 23, lines 21-34; section E.l. 9
`
`page 23, lines 18-21; sections 0.2, E.S and
`
`E.l. 9
`
`page 24, lines 2-3; section E.l.9
`
`page 11, line 27 -page 12, line 26; section
`
`E.l. 9
`
`page 11, line 27 - page 12, line 26; section
`
`0.6; section E.l.9
`
`page 21, line 7; section E.l. 9
`
`Same as claim 67
`
`85 and 86
`
`page 18, lines 1-30
`
`Interfering Patent
`
`New claims 67 - 84 (excepting claims 70, 71, 73, 74, 76 and 79)
`
`are verbatim replicates of claims 1- 18 of U.S. patent 4,816,397 to Boss
`
`et al.
`
`("Boss").
`
`Attached as Appendix 1 is a proposed count for
`
`interference.
`
`The proposed count is identical to claim 1 of the Boss
`
`patent. Claims 1-18 of Boss, all of the claims therein, correspond to the
`
`proposed count. Claims 67-86 of the instant application, all pending
`
`LC48X086.mdh
`
`Merck Ex. 1013, pg 607
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 7
`
`claims, correspond to the proposed count.
`
`The present application claims the benefit under 35 U~C 120 of
`
`U.S.S.N. 06/483,587, filed April 8, 1983. The Boss patent claims foreign
`
`priority under 35 USC 119 of a United Kingdom application filed March 25,
`
`1983.
`
`Thus,
`
`the present application has an effective filing date
`
`subsequent to the filing date of the foreign application.
`
`In accordance
`
`with the instructions in the first paragraph of MPEP 2308.01 and the last
`
`sentence of the sixth paragraph of MPEP 2309.02, Boss should not be
`
`accorded the benefit of the foreign application in the Declaration of
`
`Interference. Instead, Boss should be limited to their actual U.S. filing
`
`date of November 14, 1984, or at the earliest, March 23, 1984,
`
`the
`
`international filing date of the PCT application which ultimately matured
`
`into the Boss patent. Accordingly,
`
`the present applicants should be
`
`designated the senior party.
`
`Reference to Related Patent
`
`The parent to the instant application, U.S.S.N. 06/483,587, has
`
`issued as U.S. patent 4,816,567 (attached as Appendix 2) ("Cabilly"). The
`
`Cabilly patent is directed to novel forms of antibodies termed chimeric
`
`immunoglobulins, as well as vectors and methods for making same. These
`
`antibodies are interspecies chimeras of variable and constant region
`
`LC48X086.mdh
`
`Merck Ex. 1013, pg 608
`
`
`
`•
`
`u.s.s.N. 07/205,4J.9
`
`•
`
`Page 8
`
`chimeras. While the method of newly submitted claim 67 (and Boss) can be
`
`used for making such chimeric immunoglobulins, it is not necessary to ttse
`
`this method since the chimeric immunoglobulin chains can be produced in
`
`host cells transformed only with heavy or light chain, but not both as is
`
`called for in claim 67. Similarly, claim 67 is applicable to all forms
`
`of antibodies, and not only chimeric forms. The pending claims and those
`
`of Boss accordingly are cross-dominating but are not directed to the same
`
`patentable invention. It also should be noted that Cabilly is completely
`
`devoid of any teaching to produce interspecies variable-constant region
`
`chimeras. The only possible relevant disclosure in the Cabilly patent is
`
`found at column 4, lines 59-60, where interclass chimeras are suggested.
`
`Immunoglobulins are divided into different isotypes or classes, but this
`
`has nothing to do with what species the immunoglobulins are from. Claim
`
`13 of the Cabilly patent calls for a constant chain "derived from a
`
`different source" than the variable domain. The specification does not
`
`define "source", but it must be interpreted in light of the specification
`
`as referring to interclass chimeras. Thus, the Cabilly patent and the
`
`Boss patent are directed to separate patentable inventions. Presumably,
`
`as much has already been recognized by the Office in deciding to grant
`
`both the Boss patent and the Cabilly patent.
`
`LC48x086.mdh
`
`Merck Ex. 1013, pg 609
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 9
`
`Response to Restriction Requirement Mailed March 6. 1990
`
`In response to this restriction requirement, applicants elect the
`
`invention of Group I with traverse. The newly submitted claims herein
`
`fall within Group I and should be considered in place of claims 53-63 and
`
`65-66, which have been cancelled. As an aside, the Examiner is thanked
`
`for her reminder to file a certificate of correction in the parent issue
`
`patent. This will be done in due course.
`
`Respectfully Submitted
`
`~-· FIII_N ..... C~.'VVIJ..Jl~iJ./
`
`Max D. Hensley
`Reg. No. 27,043
`
`March 9, 1990
`460 Point San Bruno Blvd.
`So. San Francisco, CA 94080
`(415) 266-1994
`
`LC48x086.mdh
`
`Merck Ex. 1013, pg 610
`
`
`
`•
`
`u.s.s.N. 07/205,419
`
`•
`
`Page 10
`
`Appendix 1
`
`Proposed Count
`
`A process for producing an Ig molecule or an
`
`immunologically
`
`functional Ig fragment comprising at least the variable domains of the Ig
`
`heavy and light chains, in a single host cell, comprising the steps of:
`
`(i)
`
`transforming said single host cell with a first DNA sequence
`
`encoding at least the variable domain of the Ig heavy chain and
`
`a second DNA sequence encoding at least the variable domain of
`
`the Ig light chain, and
`
`(ii) independently expressing said first DNA sequence and said second
`
`DNA sequence so that said Ig heavy and light chains are produced
`
`as separate molecules in said transformed single host cell.
`
`LC48x086.mdh
`
`Merck Ex. 1013, pg 611
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
