Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/11/26 has been entered.
Applicant’s amendment and response filed 5/11/26 is acknowledged and has been entered. Applicant’s terminal disclaimer filed 4/13/26 is acknowledged and has been entered. The amendment to the specification filed 4/13/26 has been entered.
2. The terminal disclaimer filed on 4/13/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US10,988,544, US8,518,410, US9,562,104, US9,567,401, US10,683,361,
US10,08,256, or US11,267,895 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the prior double patenting rejections of record over these said US patent applications are overcome.
3. Applicant is reminded of Applicant's election without traverse of Group I and species of 12E12 anti-dendritic cell antibody having specificity for CD40, HIV gag viral antigen, and Flex-v1 linker (SEQ ID NO: 145) in Applicant’s amendment and response filed 1/12/23. In addition, Applicant’s election (without traverse) of the species SEQ ID NO: 3 as the HIV polypeptide in a voicemail made on 3/5/24 by Applicant’s representative Ms. Laurie Stellman was acknowledged (see attached Examiner-initiated interview summary).
Applicant is reminded that upon consideration of the prior art, examination had been extended to include the humanized or human anti-DC targeting antibody recited in dependent claim 66 as well as SEQ ID NO: 1, 2, 4, 5 and 11.
Claims 57-60, 66 and 67 are presently being examined as they read upon the elected species, a humanized antibody, SEQ ID NO: 1-5 and 11. Claim 57 is independent.
4. Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57-60, 66 and 67 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.
Applicant has amended instant base claim 57 to delete recitation of “DC-targeting”.
5. Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57-60, 66 and 67 under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 20100135994 A1 (of record, pgPUB of application serial no. 12/504,463) or US 9,109,011 (of record, issued from said application serial no. 12/504,463), as evidenced by US20230212231A1 (of record).
Applicant has amended the claims to recite a specific peptide antigen that consists of either or both of SEQ ID NO: 3 and/or SEQ ID NO: 4, limitations that the art reference does not teach.
6. Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57-60, 66 and 67 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 9,234,040 (of record) in view of US 20100135994 A1 (of record) or US 9,109,011 (of record), as evidenced by US20230212231A1 (of record).
Applicant has amended the claims to recite a specific peptide antigen that consists of either or both of SEQ ID NO: 3 and/or SEQ ID NO: 4, limitations that the art references do not teach.
7. 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.
8. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
9. Claims 57-60, 66 and 67 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 9,234,040 (of record) in view of US 20100135994 A1 (of record) or US 9,109,011 (of record), and US 5,993,823, as evidenced by US20230212231A1 (of record).
The applied reference has a common inventor with the instant 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. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
Instant base claim 57 as presently amended recites:
An antibody-antigen fusion protein comprising:
an anti-CD40 antibody or antigen binding fragment thereof;
one or more viral antigenic peptide(s) from the gag antigen,
wherein the one or more antigenic peptides from the gag antigen consist of the amino acid sequence of SEQ ID NO:3 and/or SEQ ID NO:4; and
one or more flexible linkers between the anti-CD40 antibody or antigen binding fragment thereof and the antigenic peptide(s); and
wherein the anti-CD40 antibody comprises:
a heavy chain variable domain (VH) which comprises in sequence hypervariable regions CDR1H, CDR2H and CDR3H, the CDR1H having the amino acid sequence GFTFSDYYMY (SEQ ID NO.:44), the CDR2H having the amino acid sequence YINSGGGSTYYPDTVKG (SEQ ID NO.:45), and the CDR3H having the amino acid sequence RGLPFHAMDY (SEQ ID
NO.:46); and
a light chain variable domain (VL) which comprises in sequence hypervariable regions CDR1L, CDR2L and CDR3L, the CDR1L having the amino acid sequence SASQGISNYLN (SEQ ID NO.:41), the CDR2L having the amino acid sequence YTSILHS (SEQ ID NO.:42), and the CDR3L having the amino acid sequence QQFNKLPPT (SEQ ID NO.:43).
US 9,234,040 discloses a fusion protein comprising a DC (dendritic cell)-binding antibody or antigen binding fragment thereof fused to an antigen that may be any viral antigen or epitope thereof, including from HIV, such as gag, pol, env and nef, and vaccine/composition thereof. US 9,234,040 discloses that the antibody may have specificity for CD40. US 9,234,040 discloses that the antibody may be humanized. US 9,234,040 discloses that as dendritic cells are antigen presenting cells that play a key role in regulating antigen-specific immunity, delivering antigens directly to dendritic cells improves vaccines with anti-dendritic cell antibody-targeting of antigen. US 9,234,040 discloses various antigens expressed as fusions to the C-terminus of antibodies. US 9,234,040 discloses that the fusion constructs may be delivered in association with co-administered or linked adjuvant for eliciting therapeutic immune responses (see entire reference, especially column 3 at lines 20-36, paragraph spanning columns 5-6, column 8 at lines 28-67, column 10 at lines 11-25, claims, paragraph spanning columns 15-16, column 26 at lines 42-49, column 6 at lines 23-45 and abstract).
Although US 9,234,040 discloses an antibody-antigen fusion protein/composition thereof that comprises an anti-CD40 dendritic cell targeting antibody and an antigen/epitope of HIV such as gag, pol, env and/or nef, it does not disclose an epitope of HIV gag that consists of the sequence of amino acid residues 253-284 thereof (that is identical to the sequence of instantly recited SEQ ID NO: 4) and an epitope of HIV nef that consists of the sequence of amino acid residues 66-97 thereof (that is identical to the sequence of instantly recited SEQ ID NO: 1), nor does it disclose that the anti-CD40 antibody has the CDRs recited in instant base claim 57 (that are from the anti-CD40 antibody 12E12), nor does it disclose wherein the peptide of HIV gag is fused via a flexible linker to an anti-CD40 antibody or antigen binding fragment thereof.
US 20100135994 A1 discloses fusion proteins comprising dendritic cell (DC, an antigen presenting cell)-specific antibodies and fragment thereof, including anti-CD40 antibodies, including the 12E12 antibody (e.g., [0035], [0058], [0111]-[0115], [0125], [0130], [0008]-[0011], [0025]-[0046], [0035], [0037], [0058], [0111]-[0138], [0148]-[0151]) as well as various recombinant forms of said antibody (e.g., see claims, [0054]-[0062]), flexible linkers between the DC-specific antibody or fragment thereof and the antigen,, including the Flex-v1 linker (that is identical to instantly recited SEQ ID NO: 145, e.g., [0007]-[0015], [0080]-[0114], [0125], [0099], [0100], and claims), and viral antigens or epitopes thereof, including HIV gag, nef, pol, env, and cyclin D1 (e.g., abstract, [0012],[0056] [0059]), and vaccine compositions comprising the fusion proteins (e.g., page 1 at the title, [0010], [0011]) and further comprising a pharmaceutically acceptable carrier and/or adjuvant ([0064]). US 20100135994 A1 discloses that the DC-specific antibody or fragment thereof may be humanized (e.g., [0012],[0015], [0054],[0062]). US 20100135994 A1 discloses that targeting antigen to DCs advantageously results in dramatic dose-sparing, protective responses from a single vaccination, and expansion of antigen-specific T cells in both the CD8 and CD4 compartments, including the latter providing long-lived T cell help for antibody responses ([0051],[0079]). See entire reference.
US 9,109,011 (patent) has identical disclosure to US 20100135994 A1 (pgPUB), as it issued from the same application. See entire reference, including the claims.
US 5,993,823 discloses that a HIV gag antigenic peptide consists of the amino acid sequence of SEQ ID NO: 9 (amino acid residues 253-284 of HIV gag) of the art reference (that is identical to instantly recited SEQ ID NO: 4) and that a HIV nef antigenic peptide consists of the amino acid sequence of SEQ ID NO: 5 (amino acid residues 66-97 of HIV nef) of the art reference (that is identical to instantly recited SEQ ID NO: 1) (see entire reference, especially column 5 at lines 60-65).
It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the anti-CD40 12E12 antibody sequence in the fusion protein disclosed by US 20100135994 A1 or by US 9,109,011 as the anti-CD40 antibody or antigen binding fragment thereof in the fusion protein of the primary art reference US 9,234,040 that also comprises a generic HIV gag and a generic nef antigen/epitope, and to have used the specific HIV gag and nef antigenic peptides disclosed by US 5,993,823 (i.e., SEQ ID NO: 9 of the art reference that is identical to instantly recited SEQ ID NO: 4 and SEQ ID NO: 5 of the art reference that is identical to instantly recited SEQ ID NO” 1). It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the Flex-v1 linker disclosed by the secondary art reference US 20100135994 A1 interposed between the antibody and the antigen, and to have placed the fusion protein in a vaccine composition.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, because the anti-CD40 antibody in the fusion protein of US 9,234,040 is generic, while US 20100135994 A1 or US 9,109,011 discloses that the 12E12 antibody is an anti-CD40 dendritic cell-specific antibody that is useful in vaccines and that flexible linkers interpose components of the fusion protein, and US 5,993,823 discloses useful antigenic peptides from HIV gag and nef.
Evidentiary reference US20230212231A1 discloses the sequences for anti-CD40 antibody 12E12 at claim 83 thereof. Note that these sequences are identical to those that are recited in instant base claim 57. (The instant application also discloses this said antibody throughout the specification, and also has one mention of “12E12” with no disclosure of CDRs of said antibody). Therefore, the claimed fusion protein appears to be similar to the fusion protein of the prior art absent a showing of unobvious differences. Since the Patent Office does not have the facilities for examining and comparing the method of the instant invention to those of the prior art, the burden is on Applicant to show an unobvious distinction between the composition of the instant invention and that of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
10. 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.
11. Claims 57-60, 66 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,109,011 (of record) in view of US 7,118,751 (of record), US20080226667 A1 (of record), and US 5,993,823, as evidenced by an admission the specification of ‘011 at the paragraph spanning columns 9-10 and column 34, lines 5-end and continuing onto column 35 at lines 1-9.
The claims of US 9,109,011 are drawn to a composition comprising a fusion protein comprising a dendritic cell-specific antibody and at least one HIV Gag antigen and at least one HIV Nef antigen, wherein said antigens may be separated by one or more flexible linkers. Note that the heavy chain is selected from one of SEQ ID NO: 29 or 30, while the light chain is selected from one of SEQ ID NO: 24-28.
The admission in the specification of ‘011 at the paragraph spanning columns 9-10 is that the term “antigen” refers to a molecule that is carried to and/or into a cell or target by the antibody of the fusion protein, including peptides from viral antigens.
The admission in the specification of ‘011 at column 34, lines 5 to the end and continuing onto column 35 at lines 1-9 of ‘011 is that the 12E12 antibody as well as variants thereof are represented by the said light chain sequences, while the 12E12 antibody as well as variants thereof are represented by the said heavy chain sequences. Note that these said sequences comprise the CDR sequences that are recited in instant base claim 57. The admission the specification of ‘011 is that SEQ ID NOs: 24-28 therein are anti-CD40 12E12 (“seqa”) anti-CD4012E12 variant (“seqb-seqe”) light chain sequences, while SEQ ID NOs 29 and 30 are heavy chain sequences, sequence b from 12E12 and sequence a, a variant thereof (column 34).
The claims of US 9,109,011 do not recite wherein there is a flexible linker between the antibody and the viral antigen such as the Flex-V1 linker that is identical to instantly recited SEQ ID NO: 145, nor wherein the gag and nef antigens correspond to peptides consisting of the amino acid sequence of instantly recited SEQ ID NO: 4 and 1, respectively.
US 7,118,751 discloses a polypeptide that encodes a fusion protein that comprises: an HIV polypeptide or epitope followed by a flexible linker such as (Gly4Ser) and followed by an (activating or agonist) antibody or an antibody fragment such as an scFv or VHH having specificity for CD40 (see entire reference, especially abstract, Fig. 1C/D, col. 6 at lines 61-65, col. 7 at lines 8-15, 24-29, 34-46, col. 9 at lines 64-67, and 57, claims 1-3, 6, 7, 10) and vaccine comprising the said fusion protein (e.g., col. 8 at lines 44-47. (See entire reference, including claims.)
US20080226667 A1 discloses that a linker peptide may be inserted between the components of a fusion protein to prevent or alleviate steric hindrance between two domains (e.g., [0148], [0204], and [0109]). See entire reference.
US 20100135994 A1 discloses fusion proteins comprising dendritic cell (DC, an antigen presenting cell)-specific antibodies or fragment thereof, including anti-CD40 antibodies, including the 12E12 antibody (e.g., [0035], [0058], [0111]-[0115], [0125], [0130], [0008]-[0011], [0025]-[0046], [0035], [0037], [0058], [0111]-[0138], [0148]-[0151]) as well as various recombinant forms of said antibody (e.g., see claims, [0054]-[0062]), flexible linkers between the DC-specific antibody or fragment thereof and the antigen, including the Flex-v1 linker (that is identical to instantly recited SEQ ID NO: 145, e.g., [0007]-[0015], [0080]-[0114], [0125], [0099], [0100], and claims), and viral antigens or epitopes thereof, including HIV gag, nef, pol, env, and cyclin D1 (e.g., abstract, [0012],[0056] [0059]), and vaccine compositions comprising the fusion proteins (e.g., page 1 at the title, [0010], [0011]) and further comprising a pharmaceutically acceptable carrier and/or adjuvant ([0064]). US 20100135994 A1 discloses that the DC-specific antibody or fragment thereof may be humanized (e.g., [0012],[0015], [0054],[0062]). US 20100135994 A1 discloses that targeting antigen to DCs advantageously results in dramatic dose-sparing, protective responses from a single vaccination, and expansion of antigen-specific T cells in both the CD8 and CD4 compartments, including the latter providing long-lived T cell help for antibody responses ([0051],[0079]). See entire reference.
US 5,993,823 discloses that a HIV gag antigenic peptide consists of the amino acid sequence of SEQ ID NO: 9 (amino acid residues 253-284 of HIV gag) of the art reference (that is identical to instantly recited SEQ ID NO: 4) and that a HIV nef antigenic peptide consists of the amino acid sequence of SEQ ID NO: 5 (amino acid residues 66-97 of HIV nef) of the art reference (that is identical to instantly recited SEQ ID NO: 1) (see entire reference, especially column 5 at lines 60-65).
It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used a flexible linker such the (Gly4Ser) flexible linker disclosed by US 7,118,751 or the Flex-V1 linker that is identical to instantly recited SEQ ID NO: 145 that is disclosed by US 20100135994 A1 as the linker sequence in the construct recited in the claims of ‘011.
One of ordinary skill in the art would have been motivated to use any suitable linker to separate components of the fusion protein, and with a reasonable expectation of success in doing so, as the art reference US 7,118,751 discloses a similar construct to that recited in the claims of ‘011 having such a linker and US20100135994 A1 also discloses a suitable linker to be disposed between the DC-targeting antibody or fragment thereof and the antigen, and also in light of the disclosure of US20080226667 A1 that linkers can be used to prevent or alleviate steric hindrance between two domains.
It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the HIV gag and nef peptides that are disclosed by US 5,993,823 that are identical to instantly recited SEQ ID NO: 4 and 1, respectively as the HIV gag and nef peptides in the construct recited in the claims of ‘011.
One of ordinary skill in the art would have been motivated to use any suitable linker to separate components of the fusion protein, and with a reasonable expectation of success in doing so, as claims 1, 2 and 4 of ‘011 are silent as to the identity of the gag and nef antigens.
Applicant’s arguments in the amendment and response filed 5/11/26 (of record on page 6 thereof) are moot in view of this new ground of rejection.
12. Claims 57-60, 66 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8 and 11-14 of US Patent No. 9,234,040 (of record) in view of US 20100135994 A1 (of record) or US 9,109,011 (of record), and US 5,993,823.
Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file application 14/045,454 that issued as US 9,234,040 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
The claims of US 9,234,040 are drawn to a method for increasing the effectiveness of antigen presentation by a dendritic cell comprising targeting a composition comprising a dendritic cell immunoreceptor (DCIR)-specific antibody or antigen binding fragment thereof to the dendritic cell, wherein an antigen that is one or multiple viral antigens, such as an antigen from HIV gag, pol, or nef is attached to the antibody or fragment thereof in the form of the fusion protein.
US 9,234,040 does not disclose wherein a flexible peptide linker is interposed between the antibody and the antigen(s) in the fusion protein, nor wherein the CDRs are those that are recited in instant base claim 57, nor wherein the gag and nef antigens correspond to instantly recited SEQ ID NO: 4 and SEQ ID NO: 1, respectively.
US 20100135994 A1 discloses fusion proteins comprising dendritic cell (DC, an antigen presenting cell)-specific antibodies and fragment thereof, including anti-CD40 antibodies, including the 12E12 and 9A11 anti-CD40 antibodies (e.g., [0035], [0058], [0111]-[0115], [0125], [0130], [0008]-[0011], [0025]-[0046], [0035], [0037], [0058], [0111]-[0138], [0148]-[0151]) as well as various recombinant forms of said antibodies (e.g., see claims, [0054]-[0062]), flexible linkers between the DC-specific antibody or fragment thereof and the antigen, including the Flex-v1 linker (that is identical to instantly recited SEQ ID NO: 145, e.g., [0007]-[0015], [0080]-[0114], [0125], [0099], [0100], and claims), and viral antigens or epitopes thereof, including HIV gag, nef, pol, env, and cyclin D1 (e.g., abstract, [0012],[0056] [0059]), and vaccine compositions comprising the fusion proteins (e.g., page 1 at the title, [0010], [0011]) and further comprising a pharmaceutically acceptable carrier and/or adjuvant ([0064]). US 20100135994 A1 discloses that the DC-specific antibody or fragment thereof may be humanized (e.g., [0012],[0015], [0054],[0062]). US 20100135994 A1 discloses that targeting antigen to DCs advantageously results in dramatic dose-sparing, protective responses from a single vaccination, and expansion of antigen-specific T cells in both the CD8 and CD4 compartments, including the latter providing long-lived T cell help for antibody responses ([0051],[0079]). See entire reference.
US 9,109,011 (patent) has identical disclosure to US 20100135994 A1 (pgPUB), as it issued from the same application. See entire reference, including the claims.
US 5,993,823 discloses that a HIV gag antigenic peptide consists of the amino acid sequence of SEQ ID NO: 9 (amino acid residues 253-284 of HIV gag) of the art reference (that is identical to instantly recited SEQ ID NO: 4) and that a HIV nef antigenic peptide consists of the amino acid sequence of SEQ ID NO: 5 (amino acid residues 66-97 of HIV nef) of the art reference (that is identical to instantly recited SEQ ID NO: 1) (see entire reference, especially column 5 at lines 60-65).
It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the anti-CD40 12E12 antibody sequence portion of the fusion protein disclosed by US 20100135994 A1 or by US 9,109,011 as the dendritic cell immunoreceptor-specific antibody or antigen binding fragment thereof in the fusion protein that also comprises HIV gag antigen(s) recited in the method claims of US 9,234,040. It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the Flex-v1 linker disclosed by the secondary art reference US 20100135994 A1 or US 9,109,011 interposed between the antibody and the antigen, and to have placed the fusion protein in a vaccine composition. It would have been prima facie obvious to one of ordinary skill in the art before the time the invention was made to have used the gag and nef peptide antigens disclosed by US 5,993,823 in the fusion protein used in the method recited in the claims of ‘040.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, because the antibody in the fusion protein of US 9,234,040 is generic, while the secondary reference discloses that the 12E12 antibody is an anti-CD40 dendritic cell-specific antibody is useful in vaccines and the secondary art reference discloses that flexible linkers interpose components of the fusion protein. One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, because the claims of ‘040 recite generic HIV gag and nef peptide antigens, while US 5,993,823 discloses useful gag and nef peptide antigens.
Evidentiary reference US20230212231A1 discloses the sequences for anti-CD40 antibody 12E12 at claim 83 thereof. Note that these sequences are identical to those that are recited in instant base claim 57. (The instant application also discloses this said antibody throughout the specification, and also has one mention of “12E12” with no disclosure of CDRs of said antibody). Therefore, the claimed fusion protein appears to be similar to the fusion protein of the prior art absent a showing of unobvious differences. Since the Patent Office does not have the facilities for examining and comparing the method of the instant invention to those of the prior art, the burden is on Applicant to show an unobvious distinction between the composition of the instant invention and that of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Applicant’s argument (of record in the amendment and response filed 5/11/26 on page 6) is moot in light of this new rejection.
13. Claims 57-60, 66 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US 9,416,186 (of record).
Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file application 13/975,786 that issued as US 9,416,186 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
The claims of US 9,416,186 are drawn to a method of eliciting an immune response in a subject comprising administering a composition comprising a fusion protein that comprises an antibody, including a humanized antibody or fragment thereof, that binds CD40 and has the same CDRs as are recited in instant base claim 57, and further comprises a peptide linker, and at least one viral antigen (that are identical to SEQ ID NO: 1-5 recited in instant claims 57 and 60). The antibody may comprise SEQ ID NO: 37 and 38. The specification of US 9,416,186 evidences that these said sequences comprise the anti-CD40 heavy chain of 12E12.3F3 and comprising the Flex-V1 flexible linker (identical to SEQ ID NO: 145 that is recited in instant dependent claim 58), and the light chain of 12E12.3F3 (a humanized anti-CD40 antibody having the same said CDRs) (see column 55 at lines 48-66 and column 56 at lines 1-12 and 38-52). In addition, the antigen portion is at least one of SEQ ID NO: 1-5 which are identical to those that counterparts that are instantly recited. The antibody may be humanized.
Applicant’s argument that US 9,146,186 does not disclose (that is, does not recite) SEQ ID NO: 3 or 4 is moot, as both are recited in the claims of ‘186. See Applicant’s amendment and response filed 5/11/26 on page 6 thereof.
14. Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57, 59, 60, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,610,585 (of record) as evidenced by an admission in the specification at column 46 of ‘585.
The claims of ‘585 require a polypeptide with at least 80% sequence identity to SEQ ID NO: 1 (the entire HIV env gp140 protein). The instant claims as presently amended require that the antigenic peptides consist of instantly recited SEQ ID NO: 3 and/or 4 (HIV gag peptides).
15. Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57-60, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of US Patent No. 10,772,572 (of record).
The claims of ‘572 require a polypeptide with at least 80% sequence identity to SEQ ID NO: 1 (the entire HIV env gp140 protein). The instant claims as presently amended require that the antigenic peptides consist of instantly recited SEQ ID NO: 3 and/or 4 (HIV gag peptides).
16. In light of the abandonment of application serial no. 17/687,971 on 4/1/26, the prior rejection of record of claims 57-60, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 57-60, 65-68 and 65-74 of copending Application No. 17/687,971 (of record) is hereby withdrawn.
17. Applicant is reminded:
a) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 59-62, 66 and 67 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,961,991 in view of US 7,118,751 and US20080226667 A1.
The claims of ‘991 do not recite the CDRs recited in presently amended claim 57 (they recite variable regions from different antibodies).
b) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 59-62, 66 and 67 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,219,683 in view of US 7,118,751 and US20080226667 A1, as evidenced by an admission the specification of ‘683 at column 47 at the 1st entry.
The claims of US 11,219,683 do not recite the CDRs that are recited in presently amended instant base claim 57. (Also, upon reconsideration, the construct that is administered appears to be an HIV antigen-anti-CD40 heavy chain fusion protein in concert with a separate anti-CD40 light chain.)
c) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 59-62, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US Patent No. 9,234,040 (of record) in view of US 7,118,751 (of record) and US20080226667 A1(of record).
The claims of US 9,234,040 do not recite the CDRs recited in presently amended instant base claim 57.
d) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 59, 61, 62, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16-21, 23-30, 32-37, and 39-43 of US Patent No. 8,236,934 in view of US 7,118,751 and US20080226667 A1.
The claims of US 8,236,934 do not recite the CDRs recited in presently amended instant base claim 57.
e) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 59, 61, 62, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. 8,586,052 in view of US 7,118,751 and US20080226667 A1.
The claims of US 8,586,052 do not recite the CDRs that are recited in presently amended instant base claim 57.
f) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of record of claims 57, 61, 62 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US 9,885,017 in view of US 7,118,751 and US20080226667 A1, as evidenced by an admission in the specification of ‘017 at column 12, lines 60-62.
The claims of US 9,885,017 do not recite the CDRs recited in presently amended instant base claim 57, nor the recited HIV gag antigens (they recite HCV antigens). Instant dependent claims 61 and 62 are presently canceled.
g) Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 61-63, 66 and 67 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 76-93 of copending Application No. 17/927,804.
Applicant has amended instant base claim 57 to recite that the one or more viral antigens comprise one or both of specific gag antigens, limitations the claims of 17/927,804 do not recite (they recite an antigen from the N protein of SARS-CoV-2 virus).
h) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 58, 61-63, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US Patent No. 9,102,734 in view of US 7,118,751 and US20080226667 A1.
The claims of US 9,102,734 do not recite gag and nef antigens; rather they recite at least one antigen from HPV E6 and E7.
i) Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 61-63, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patent No. 10,286,058 in view of US 7,118,751 and US20080226667 A1.
The claims of US 10,286,058 do not recite HIV gag and nef antigens; rather they recite at least one antigen from HPV E6 and E7.
j) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 61-63, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-7 of US Patent No. 10,980,869 in view of US 7,118,751 and US20080226667 A1.
Applicant has amended instant base claim 57 to recite that the one or more viral antigens comprise one or both of specific gag antigens, limitations the claims of US 10,980,869 do not recite (they recite at least one antigen from HPV E6 and E7).
k) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 58, 61-63, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US Patent No. 11,717,567 in view of US 7,118,751 and US20080226667 A1.
Applicant has amended instant base claim 57 to recite that the one or more viral antigens comprise one or both of specific gag antigens, limitations the claims of US 11,717,567 do not recite (they recite at least one antigen from HPV E6 and E7).
l) Applicant is reminded that Applicant’s amendment filed 10/30/25 has overcome the prior rejection of claims 57, 58, 61-63, 66 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent No. 12,214,034 in view of US 7,118,751 and US20080226667 A1.
Applicant has amended instant base claim 57 to recite that the one or more viral antigens comprise one or both of specific gag antigens, limitations the claims of US 12,214,034 do not recite (they recite at least one antigen from HPV E6 and E7).
m) The terminal disclaimer filed on 4/13/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US10,988,544, US8,518,410, US9,562,104, US9,567,401, US10,683,361, US10,08,256, or US11,267,895 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the prior double patenting rejections of record over these said US patent applications are overcome.
n) Applicant’s amendment filed 5/11/26 has overcome the prior rejection of record of claims 57, 61, 62, 66 and 67 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-63 of copending Application No. 18/036,237 in view of US 7,118,751 and US20080226667 A1, as evidenced by an admission in the specification of ‘237 at page 11, lines 16-22.
The claims of 18/036,237 recite that the antigen portion is an antigen from SARS-CoV-2 virus (i.e., an RBD polypeptide). Presently amended base claim 57 recites that the one or more antigens of the fusion protein comprise a gag antigen selected from SEQ ID NO: 3 and SEQ ID NO: 4 (HIV gag polypeptides), which are not recited in the claims of ‘237.
18. Claim 57 is objected to because of the following informalities: The sequence numbers of the CDRs are recited with both a period and a colon between “NO” and the numeral, for example “SEQ ID NO.: 44”. There should only be a colon between the “NO” and the numeral. Appropriate correction is required.
19. No claim is allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights