Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 29-31, 33, 36-42, 51, 60-61, and 74-79 are pending and under consideration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 29-31, 33, 36-42, 51, 60-61, and 74-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11774452 (Applicant’s IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to same anti-CEA antibody as used in the method claims of the current application.
Claim 1 of the patent is drawn to:
An isolated antibody or antibody fragment comprising, an (a) HCDR1 comprising the amino acid sequence of SEQ ID NO: 1; (b) HCDR2 comprising the amino acid sequence of SEQ ID NO: 2; (c) HCDR3 comprising the amino acid sequence of SEQ ID NO: 3; (d) LCDR1 comprising the amino acid sequence of SEQ ID NO: 4; (e) LCDR2 comprising the amino acid sequence of SEQ ID NO: 5; and (f) LCDR3 comprising the amino acid sequence of SEQ ID NO: 6.
Heavy Chain CDRs of US 11774452
GFSLTSNG- SEQ ID NO:1
IWAGGNT- SEQ ID NO:2
ARDDGYYYAMDY- SEQ ID NO:3
Light Chain CDRs of US 11774452
QDINKY-SEQ ID NO:4
YTS- SEQ ID NO:5
LQYDNT- SEQ ID NO:6
The above HCDRs and LCDRs are identical to those used in the methods of detecting cancer, and determining the status of a solid tumor, and methods of treating a cancer as currently claimed. The portion of the specification of the reference (e.g., the patent) that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. As such, the patent clearly teaches methods of detecting and treating solid tumors such as colorectal cancer, liver cancer, stomach cancer, ovarian cancer, thyroid cancer, lung cancer, breast cancer or pancreatic cancer. See column 7, lines 54+ and column 8, lines 8+.
Patented Claim 3 is drawn to:
The isolated antibody or antibody fragment of claim 1, wherein the antibody is a monoclonal antibody, a fully human antibody, or an antibody fragment selected from a Fab, Fab′, Fv, scFv and (Fab′)2.
While the current claims do not specify the structure of the antibody, they are broadly drawn to antibodies comprising a variable heavy region and a variable light region (SEQ IDs 7 and 8) and/or antibody fragments thereof which would encompass a monoclonal antibody or well-known and obvious fragments such as Fab, Fab’, Fv, scFv and (Fab’)2.
Patented Claim 5 is drawn to:
A kit for the immunohistochemical detection of a solid tumor cancer comprising cells expressing a CEA antigen comprising: (a) an antibody according to claim 1; and (b) a secondary antibody conjugated to a detectable label, wherein the secondary antibody binds to and is capable of detecting the antibody of (a) when bound to a CEA antigen.
This is similar in scope to currently pending claim 60 drawn to a composition comprising a tissue specimen and an antibody complex between the claimed anti-CEA antibody of Claim 1 and a CEA antigen. While the claim does not include a secondary antibody, it would be obvious to include a detectable label for the purpose of visualizing the anti-CEA antibody complex. Also, pending Claim 33 includes the labeling of specimens.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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