Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-38 were canceled.
Claims 39-56 are pending and under consideration.
Claim Objections
Claim 39 is objected to because of the following informalities: “wherein the antibody comprises“ in line 2-3 and line 10 should read “wherein the antibody or the antigen-binding fragment thereof comprises“ because “an antibody or an antigen-binding fragment thereof” was recited before.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 46-50 and 54-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 46 recites “the antigen-binding fragment” in line 10. There is insufficient antecedent basis for this limitation in the claim. Claim 46 does not recite “an antigen-binding fragment” before “the antigen-binding fragment” was recited in line 10.
Claim 50 recites “the antigen-binding fragment” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 46 does not recite “an antigen-binding fragment”.
Claim 50 recites “an Fsc fragment” in line 2-3. This notation is not known in the art and therefore it is not clear what fragment Applicant intends to recite.
Dependent claims do not remedy this deficiency.
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 39-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 9,902,775 (hereinafter patent’775; 6/20/2025 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 39 and 46, claim 1 of patent’775 claims “An antibody that specifically binds to human Blood dendritic cell antigen 2 (BDCA2) consisting of the amino acid sequence set forth in SEQ ID NO: 1, wherein the antibody comprises a variable heavy (VH) domain comprising VH complementarity determining region (CDR)1, VH CDR2, and VH CDR3, wherein:
the VH CDR1 comprises the amino acid sequence GFTFSTYTMS (SEQ ID NO:9);
the VH CDR2 comprises the amino add sequence TISPGDSFGYYYPDSVQG (SEQ ID NO: 10); and
the VH CDR3 comprises the amino add sequence DIYYNYGAWFAY (SEQ ID NO: 11); and
wherein the antibody comprises a variable light (VL) domain comprising VL CDR1, VL CDR2, and VL CDR3, wherein:
the VL CDR1 comprises the amino add sequence KASQSVDYDGDSYMN (SEQ ID NO:5);
the VL CDR2 comprises the amino add sequence AASTLES (SEQ ID NO:6); and
the VL CDR3 comprises the amino add sequence QQANEDPRT (SEQ ID NO:7).” Nucleic acid claimed by instant application is obvious from protein of parent patent because one of ordinary skill in the art would be able to create nucleic acid sequence from known protein sequence.
Regarding claim 40 and 47, claim 2 of patent’775 claims “The antibody of claim 1, wherein the VH domain comprises the amino add sequence set forth in SEQ ID NO:24.”
Regarding claim 41, claim 3 of patent’775 claims “The antibody of claim 1, wherein the antibody comprises a heavy chain and wherein the heavy chain comprises the amino add sequence set forth in SEQ ID NO:4.”
Regarding claim 42 and 48, claim 4 of patent’775 claims “The antibody of claim 1, wherein the VL domain comprises the amino add sequence set forth in SEQ ID NO:23.”
Regarding claim 43, claim 5 of patent’775 claims “The antibody of claim 1, wherein the antibody comprises a light chain and wherein the light chain comprises the amino acid sequence set forth in SEQ ID NO:3.”
Regarding claim 44 and 49, claim 6 of patent’775 claims “The antibody of claim 1, wherein the VH domain comprises the amino acid sequence set forth in SEQ ID NO:24 and the VL domain comprises the amino acid sequence set forth in SEQ ID NO:23.”
Regarding claim 45, claim 7 of patent’775 claims “The antibody of claim 1, wherein the antibody comprises a heavy chain and a light chain, and wherein the heavy chain comprises the amino acid sequence set forth in SEQ ID NO:4 and the light chain comprises the amino acid sequence set forth in SEQ ID NO:3.”
Regarding claim 50, claim 15 of patent’775 claims “The antigen-binding fragment of claim 11, wherein the antigen-binding fragment is: a single chain antibody, an Fab fragment, an F(ab′)2 fragment, an Fab′ fragment, an Fsc fragment, an Fv fragment, an scFv, an sc(Fv)2, or a diabody.”
Regarding claims 51-56, creating nucleic acid from known protein sequence, creating expression vector, transfecting expression vector into host cell, and producing protein by culturing the transfected host cell is conventionally performed and well-known routine experimentation in the art. Therefore, these claims are obvious from protein of parent patent.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
