Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 57-75 are pending and under examination. In light of the updated search, a new ground of rejections is made.
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 57-75 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.
The issue is that claim 57 refers to the CDRs of the anti-CD40 antibody, but does not indicate what numbering system is being used to delineate the CDRs. It appears that the spec. does not provide a limiting definition for the CDRs contained within SEQ ID NOs: 1 and 2. For example, they could be the CDRs according to Kabat, the CDRs according to Chothia, or they could be numbered accord to other CDR boundary definitions that may not strictly follow one of Kabat or Chothia. Because it is unclear what numbering system or nomenclature is being used, it is unclear what amino acid residues are required for the claims. Claims 58-75 are being rejected as being dependent from claim 57.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 57-74 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Banchereau et al. (US2010/0135994, Patent No. 9109011B2, earliest effective priority date is 07/16/2008 (based on provisional application).
Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
With respect to claims 57 and 68, Banchereau teaches antibodies that bind dendritic cells, including anti-CD40 antibodies, including recombinant antibodies (e.g., humanized, antigen-binding fragments) and compositions thereof (e.g., see paragraphs [0059]-[0070]), including the potent activating anti-CD40 12E12 antibody (e.g., see paragraphs [0111]-[0138]). Banchereau teaches a composition comprising such an anti-CD40 antibody, which comprises a light chain sequence comprising e.g., SEQ ID NO: 24 and a heavy chain sequence comprising SEQ ID NO: 29. See, e.g., Banchereau’s claim 1.
Note that Banchereau’s SEQ ID NO: 24 comprises a sequence having 100% identity to residues 21-234 of the instant SEQ ID NO: 2. See sequence alignment, below. This identical sequence comprises the entire light chain variable region within the instant SEQ ID NO: 2. See the instant specification at p. 34, lines 3-8 (as filed). Thus, Banchereaus’s SEQ ID NO: 24 comprises the light chain CDRs within SEQ ID NO: 2 as required by the instant claim 57.
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Similarly, Banchereau’s SEQ ID NO: 29 comprises a sequence having 100% identity to residues 20-467 of the instant SEQ ID NO: 1. See sequence alignment, below. This identical sequence comprises the entire light chain variable region within the instant SEQ ID NO: 1. See the instant specification at p. 33, lines 30-35 (as filed). Thus, Banchereaus SEQ ID NO: 29 comprises the light chain CDRs within SEQ ID NO: 1 as required by the instant claim 57.
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Banchereau further teaches Gag antigen is attached to the form an antibody-antigen complex (see abstract), which would read on one or more antigens as recited by the instant claim 57.
With respect to claim 58, Banchereau teaches fungal antigens (see para. [0055]).
With respect to claim 59, Banchereau teaches hepatitis B virus (see para. [0056]).
With respect to claim 60, Banchereau teaches the claimed Nef SEQ ID NO:16 in sequence 31.
With respect to claim 61, Banchereau teaches anthrax (see para. [0077]).
With respect to claim 62, Banchereau teaches fungal antigen (see para. [0055]).
With respect to claim 63, Banchereau teaches lymphoma (see para. [0145]).
With respect to claim 64, Banchereau teaches PSA antigen (see para. [0129]).
With respect to claim 65, Banchereau teaches a flexible linker (see para. [0008]).
With respect to claim 66, Banchereau teaches SEQ ID NO:4 which reads on the claimed SEQ ID NO: 74.
With respect to claim 67, Banchereau teaches SEQ ID NOs: 24 and 29 above, which comprise all of the CDRs of this claim.
With respect to claim 69, Banchereau teaches isolated and purified nucleic acid (see para. [0016]).
With respect to claim 70, Banchereau teaches vector encoding (see para. [0018]).
With respect to claims 71-72, Banchereau teaches eukaryotic expression hosts (see para. [0093]).
With respect to claim 73, Banchereau teaches the claimed method of producing a polypeptide (see para. [0081]).
With respect to claim 74, Banchereau teaches the method for eliciting an immune response in a subject (see para. [0078]).
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 57-60 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 9109011B2 (‘011).
Patent ‘011 recites a composition comprising: a dendritic cell (DC)-specific antibody or fragment thereof comprising a light chain sequence selected from the group consisting of SEQ ID NO: 24, 25, 26, 27 and 28 and a heavy chain sequence selected from the group consisting of SEQ ID NO: 29 and 30, to which one or more engineered Gag antigens are attached to form an antibody-antigen fusion protein wherein the engineered Gag antigens are less susceptible to proteolytic degradation by eliminating one or more proteolytic sites; and a Nef antigen that is attached to the engineered Gag antigen wherein the composition is able to elicit a human immunodeficiency virus (HIV)-specific T cell immune response to Gag and Nef. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘011 recites SEQ ID NOs: 24 and 29 which comprise the CDR1L, CDR2L, and CDR3L from SEQ ID NO:2 and CDRIH, CDR2H, and CDR3H from SEQ ID NO:1. See prior art rejection, above.
With respect to instant claims 58-59, Patent claim 2 recites wherein the Gag and Nef antigens comprise a fusion protein separated by one or more flexible linkers.
With respect to instant claims 60 and 65, Patent claim 4 recites wherein the Gag and Nef antigens comprise a fusion protein separated by one or more flexible linkers.
Claims 57-59 and 65-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-13 of U.S. Patent No. 9102734B2 (‘734).
Patent No. ‘734 recites a fusion protein comprising the formula: Ab-(Ag-PL-Ag)x wherein Ab is an antibody or antigen binding fragment thereof; PL is at least one peptide linker comprising at least one glycosylation site; Ag is at least one cancer antigen; and x is an integer from 1 to 20, wherein the Ag is selected from tumor associated antigens selected from human papilloma virus (HPV) E6 and E7 and the PL is selected from SSVSPTTSVHPTPTSVPPTPTKSSP (SEQ ID NO.: 11), PTSTPADSSTITPTATPTATPTIKG (SEQ ID NO.: 12), TVTPTATATPSAIVTTITPTATTKP (SEQ ID NO.: 13) and TNGSITVAATAPTVTPTVNATPSAA (SEQ ID NO.: 14). Patent claims 6 and 10 recite wherein the Ab comprises at least the variable region of the antibody anti-CD40.sub.--12E12.3F3 (ATCC Accession No. PTA-9854). Patent claim 7 recites wherein the Ab comprises at least one variable domain having 100% sequence identity with a heavy chain variable domain of SEQ II) NOS.: 148 or a light chain variable domains of SEQ ID NOS.: 149 or both.
Although the claims at issue are not identical, they are not patentably distinct from each other because the specification of this application teaches that SEQ ID NOs: 1 and 2 are the heavy chain and light chain variable regions, respectively, of the anti-CD40 antibody 12E12.3F3. See the specification at, e.g., p. 33, line 27 – p. 34, line 9. Thus, Patent claims 6-7 and 10-11 require the 6 CDRs within SEQ ID NOs 1 and 2 as recited by claim 57 of this application since the patent claims require this same anti-CD40 antibody 12E12.3F3 and SEQ ID NOs: 148 and 149. Additionally, the '734 patent claims are directed to a fusion protein comprising an antibody comprising CDR1L, CDR2L, and CDR3L from SEQ ID NO:2 and CDR1H, CDR2H, and CDR3H from SEQ ID NO:1 and one or more cancer antigens from papilloma virus with at least one peptide linker, as in claims 57-59 and 65-66 of this application.
With respect to instant claim 67, Patent claims 8 and 12 recite the Ab comprises at least one light chain variable domain comprising the CDR1.sub.L having the amino acid sequence SASQGISNYLN (SEQ ID NO.:41), the CDR2.sub.L having the amino acid sequence YTSILHS (SEQ ID NO.:42) and the CDR3.sub.L having the amino acid sequence QQFNKLPPT (SEQ ID NO.:43); and one heavy chain variable domain comprising the CDR1.sub.H having the amino acid sequence GFTFSDYYMY (SEQ ID NO.:45), the CDR2.sub.H having the amino acid sequence YINSGGGSTYYPDTVKG (SEQ ID NO.:46), and the CDR3.sub.H having the amino acid sequence RGLPFHAMDY (SEQ ID NO.:47).
Claims 57-60 and 65-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8518410B2 (‘410).
Patent No. ‘410 recites a fusion protein comprising the formula: Ab-(PL-Ag); wherein Ab is an antibody or a fragment thereof; PL is selected from SEQ ID NO.: 11, 12, 13 or 14; Ag is at least one viral antigen. Claim 11 recites that Ab comprises SEQ ID NOS: 37 and 38. Claim 12 recites wherein the Ab comprises at least the variable region of the antibody anti-CD40-12E12.3F3 (ATCC Accession No. PTA-9854). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent claim 11 recites SEQ ID NOS: 37 and 38 which have the claimed variable regions and the specification of this application teaches that SEQ ID NOs: 1 and 2 are the heavy chain and light chain variable regions, respectively, of the anti-CD40 antibody 12E12.3F3. See the specification at, e.g., p. 33, line 27 – p. 34, line 9. Thus, patent claim 12 requires the 6 CDRs within SEQ ID NOs 1 and 2 as recited by claim 57 of this application.
With respect to claims 58-59, Patent claim 4 recites HIV antigen.
With respect to claim 60, Patent claim 5 recites the claimed sequences.
With respect to claim 65-66, Patent claim 17 recites the peptide linker.
With respect to claim 67, Patent claims 11, 13, and 22 recite the claimed CDRs.
Claims 57-58, 60,67 and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9416186B2 (‘186).
With respect to instant claims 57, 67, 74, Patent No. ‘186 recites a method of eliciting an immune response in a subject comprising administering to the subject an effective amount of a composition comprising a fusion protein with the formula: Ab-(PL-Ag)x; wherein Ab is an antibody or fragment thereof comprising the light chain hypervariable regions CDR1L having the amino acid sequence SASQGISNYLN (SEQ ID NO:41), CDR2L having the amino acid sequence YTSILHS (SEQ ID NO:42), and CDR3L having the amino acid sequence QQFNKLPPT (SEQ ID NO:43) and the heavy chain hypervariable regions CDR1H having the amino acid sequence GFTFSDYYMY (SEQ ID NO:44), CDR2H having the amino acid sequence YINSGGGSTYYPDTVKG (SEQ ID NO:45) and CDR3H having the amino acid sequence RGLPFHAMDY (SEQ ID NO:46); PL is at least one peptide linker comprising at least one glycosylation site; Ag comprises at least one of the following viral antigens: VGFPVTPQVPLRPMTYKAAVDLSHFLKEKGGL; Nef (116-145): (SEQ ID NO: 2). Because claim 74 eliciting an immune response with the fusion protein of claim 57, it would have been obvious to have use the claimed fusion protein.
With respect to claim 58, Patent claim 1 recites viral (see above).
With respect to claim 60, Patent claim 1 recites VGFPVTPQVPLRPMTYKAAVDLSHFLKEKGGL; Nef (116-145): (SEQ ID NO: 2) (see above).
With respect to claim 74, Patent claim 1 recites on a method for eliciting an immune response in a subject comprising administering.
Claims 57-58, 63-64 and 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11806390B2 (‘390).
With respect to claims 57 and 74, Patent No. ‘390 recites a method for inducing cytotoxic T-cell response against tumor cells in a human subject in need thereof, the method comprising administering to the subject an effective amount of a composition comprising a fusion protein, wherein the fusion protein comprises an anti-CD40 antibody or antigen-binding fragment thereof linked to one or more cancer antigens expressed by the tumor cells; wherein the anti-CD40 antibody or antibody-binding fragment thereof comprises a light chain variable region comprising a CDR1L, CDR2L, and CDR3L of SEO ID NO:41, 42, and 43, respectively, and a heavy chain variable region comprising a CDR1H, CDR2H, and CDR3H of SEO ID NO:44, 45, and 46, respectively, which would read on the claimed CDRs and antigen.
With respect to claims 58 and 63, Patent claim 5 recites leukemia and melanoma.
With respect to claim 64, Patent claim 3 recites PSA.
With respect to claim 75, Patent claim 2 recites MAGE 12.
Response to Arguments
Applicant’s arguments filed 06/25/2025 have been fully considered. In light of the updated search, a new ground of rejections has been made (see above).
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678