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 .
Application Status
Claims 1-20 are pending and examined on the merits herein.
Claim Rejections - 35 USC § 101
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-6 and 17-19 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6 and 9-11 of prior U.S. Patent No. 12,173,057. This is a statutory double patenting rejection.
Regarding claim 1, the patented claims teach an antibody, comprising:
a. a light chain variable domain comprising three complementarity determining regions (CDRs) comprising CDR1, CDR2, and CDR3, wherein the light chain CDR1 comprises an amino acid sequence selected from SEQ ID NOs: 12 and 13; the light chain CDR2 comprises an amino acid sequence of SEQ ID NO: 14, and the light chain CDR3 comprises an amino acid sequence of SEQ ID NO: 15; and
b. a heavy chain variable domain comprising three CDRs comprising CDR1, CDR2, and CDR3, wherein the heavy chain CDR1 comprises an amino acid sequence of SEQ ID NO: 16, the heavy chain CDR2 comprises an amino acid sequence of SEQ ID NO: 17, and the heavy chain CDR3 comprises an amino acid sequence selected from SEQ ID NOs: 18, 19, 20, and 21 (claim 1). SEQ ID NO: 12-21 have 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 2, the patented claims teach wherein the light chain CDR1 comprises SEQ ID NO: 13 and the heavy chain CDR3 comprises SEQ ID NO: 21 (claim 2). SEQ ID NO: 13 and 21 have 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 3, the patented claims teach wherein the light chain variable domain comprises SEQ ID NO:2 and the heavy chain variable domain comprises SEQ ID NO:7 (claim 3). SEQ ID NO: 2 and 7 have 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 4, the patented claims teach wherein the light and heavy chain variable regions are in a light-heavy orientation (claim 4).
Regarding claim 5, the patented claims teach wherein the light and heavy chain variable regions are in a heavy-light orientation (claim 5).
Regarding claim 6, the patented claims teach further comprising:
c. a light chain constant domain comprising SEQ ID NO:3; and
d. a heavy chain constant domain comprising SEQ ID NO:11 (claim 6). SEQ ID NO: 3 and 11 have 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 17, the patented claims teach an isolated polynucleotide DNA sequence that comprises a sequence encoding the antibody of claim 1 (claim 9).
Regarding claim 18, the patented claims teach an isolated vector comprising the polynucleotide of claim 9 (claim 10).
Regarding claim 19, the patented claims teach an isolated host cell comprising the vector of claim 10 (claim 11).
Non-Statutory 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 and 23 of U.S. Patent No. 12,173,057. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 7-8, the patented claims teach wherein the antibody is a human chimeric antibody, or a scFv (claim 7).
Regarding claim 9, the patented claims teach an intrabody, comprising:
(a) a light chain variable domain comprising three complementarity determining regions (CDRs) comprising CDR1, CDR2, and CDR3, wherein the light chain CDR1 comprises an amino acid sequence selected from SEQ ID NOs: 12 and 13; the light chain CDR2 comprises an amino acid sequence of SEQ ID NO: 14, and the light chain CDR3 comprises an amino acid sequence of SEQ ID NO: 15; and
(b) a heavy chain variable domain comprising three CDRs comprising CDR1, CDR2, and CDR3, wherein the heavy chain CDR1 comprises an amino acid sequence of SEQ ID NO: 16, the heavy chain CDR2 comprises an amino acid sequence of SEQ ID NO: 17, and the heavy chain CDR3 comprises an amino acid sequence selected from SEQ ID NOs: 18, 19, 20, and 21 (claim 23). SEQ ID NO: 12-21 have 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claims 10-16, the patented claims teach wherein the antibody binds filamin-A antigen, and wherein:
(a) said filamin-A antigen is a gene product encoded by the FLNA gene, or a homologue thereof;
(b) said filamin-A antigen is an approximately 280-kDa breast cancer cell secreted soluble filamin-A antigen;
(c) the antibody is capable of preferentially binding a breast cancer cell secreted soluble filamin-A antigen, wherein said preferential binding is relative to a non-breast cancer cell secreted soluble filamin-A antigen;
(d) the antibody is capable of binding to a breast cancer cell secreted soluble filamin-A antigen with a specific affinity of between 10−7 M and 10−11 M;
(e) said filamin-A antigen is an approximately 280-kDa breast cancer cell membrane associated filamin-A antigen;
(f) the antibody is capable of preferentially binding a breast cancer cell membrane associated filamin-A antigen, wherein said preferential binding is relative to a non-breast cancer cell membrane associated filamin-A antigen; and
(g) the antibody is capable of binding to a breast cancer cell membrane associated filamin-A antigen with a specific affinity of between 10−7 M and 10−11 M (claim 8).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 23 U.S. Patent No. 12,173,057 as applied to claims 1-19 above and further in view of Kunert (Appl Microbiol Biotechnol 100, 3451–3461 (2016); PTO-892).
Regarding claims 1-19, the teachings of the patented claims are detailed above.
The patented claims do not teach a method of producing the antibody.
Kunert teaches that the 1990s were dominated by the development of chimeric antibodies with human constant immunoglobulin regions and mouse variable regions (page 3452, col 1, para 2). Kunert further teaches that the dominating production system for mAbs is a recombinant expression in cellular systems and that the most prominent host cell lines for recombinant mAb expression are CHO, NS0, Sp2/0, HEK293, and PER.C6 (page 3452, col 2, para 3). Kunert further teaches that the process has been subjected to various improvements, which are often only empirically described, are escorted by achievements in vector design and genetic engineering of host cell lines (page 3454, col 1, para 2). Kunert further teaches that HEK293 cells are especially applied for transient gene expression to harvest a protein within a few days after DNA delivery (page 3461, col 2).
It would have been obvious to one of ordinary skill in the art to use established methods of monoclonal antibody production as taught by Kunert to produce the FLNA antibody as taught the patented claims. The ordinary artisan would have been motivated to do so because Kunert teaches that chimeric antibody production has been well established for over 30 years and further that the process involves DNA expression that can be through an engineered vector, in a host cell that is then harvested. The ordinary artisan has a reasonable expectation of success to produce the FLNA antibody using a host cell system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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