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 .
DETAILED ACTION
1. Claims 1-5, 7, 9, 10, 12, 15, 17-21, 23, 25, 26, 28, 31 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 6/21/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities: The specification submitted 4/14/2023 has U.S. Patent No. 9675689 in the middle of it from pages 14-97, as well as WO2019/217922A1 from pages 98-205.
A substitute specification is required pursuant to 37 CFR 1.125(a).
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Diamond et al. (US20200316193)(cited in applicant’s IDS submitted 6/21/2024).
See claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 as submitted 6/24/2025.
Diamond et al. teaches: rMVA virus expressing on ore more heterologous foreign protein antigens (abstract); including fusion CMV protein antigen comprising nucleotide sequence encoding two or more antigenic portions of IE gene 1 or IE gene2, wherein the portions elicit an immune response (abstract); administering to human [0014](as recited in claims 1, 17, 23; reading on a dose as recited in claim 10); for transplant recipients [0073](as recited in claims 12, 23, 28); wherein subject is human stem cell donor (claim 30 of Diamond)(as recited in claims 1, 7, 26 (reading on a dose as recited in claims 10, 26)); the CMV antigen is selected from the group consisting of pp65, CMV pp150, IE1, IE1 exon 4 (IE1/e4), IEfusion, glycoprotein B (gB) and antigenic fragments thereof (as recited in claims 2, 3, 18, 19); comprising IE1 antigenic portion fused to IE2 (claim 23 of Diamond et al.)(as recited in claims 2, 3); promoter, mH5 [0019](as recited in claims 4, 5, 20, 21); as well as using pp65-IEfusion-MVA as a vehicle to expand cell populations from CMV positive donors of HCT, and infusing the amplified T cells into a transplant recipient with active viremia [0080].
Thus, Diamond et al. anticipates the instant claims.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claims 9, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Diamond et al. as applied to claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 above, and further in view of Diamond et al. (WO2004093905)(See PTO-892: Notice of References Cited)(hereinafter “Diamond et al.-2”).
See claims 9, 25 as submitted 6/24/2025.
See the teachings of Diamond et al. above.
Diamond et al. does not teach: intramuscular administration.
Diamond et al.-2 teaches: MVA expressing CMV antigens (abstract); including intramuscular administration [000108].
One of ordinary skill in the art would have been motivated to administer as taught by Diamond et al.-2 with the method as taught by Diamond et al. Diamond et al. teaches administration of MVA expressing CMV antigens, and Diamond et al.-2, which also teaches administration of MVA expressing CMV antigens, teaches such a method known in the art for administration of MVA expressing CMV antigens (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for administering as taught by Diamond et al.-2 with the method as taught by Diamond et al. There would have been a reasonable expectation of success given the underlying materials and methods (administering MVA expressing CMV antigens as taught by Diamond et al. and Diamond et al.-2) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
6. Claims 15, 31 are rejected under 35 U.S.C. 103 as being unpatentable over Diamond et al. as applied to claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 above, and further in view of Hsu et al. (WO2014151473A1)(See PTO-892: Notice of References Cited).
See claims 15, 31 as submitted 6/24/2025.
See the teachings of Diamond et al. above. It is reiterated Diamond et al. teaches using pp65-IEfusion-MVA as a vehicle to expand cell populations from CMV positive donors of HCT, and infusing the amplified T cells into a transplant recipient with active viremia [0080].
Diamond et al. does not teach: wherein the HCT is HLA-matched, or
wherein the HCT is haploidentical or mismatched.
Hsu et al. teaches: HCT [0004]; hematopoietic cell donors (abstract); including instances in which patient and donor are HLA matched [0028].
One of ordinary skill in the art would have been motivated to use HLA-matched HCT as taught by Hsu et al. with the method as taught by Diamond et al. Diamond et al. teaches use of HCT, and Hsu et al., which also teaches HCT, teaches a method known of HCT known in the art wherein patient and donors are HLA matched (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using HLA-matched HCT as taught by Hsu et al. with the method as taught by Diamond et al. There would have been a reasonable expectation of success given the underlying materials and methods (HCT as taught by Diamond et al. and Hsu et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
7. Claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. (cited above).
See claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 as submitted 6/24/2025.
Claims 1-9 of copending Application No. 19/212381 recite: a cytomegalovirus (CMV) vaccine comprising: an immunologically effective amount of a recombinant modified vaccinia Ankara (rMVA) virus, wherein the rMVA virus comprises a fusion nucleotide sequence which encodes an IEfusion CMV protein antigen, said fusion nucleotide sequence comprising a nucleotide sequence encoding an Immediate-Early Gene-1 (IE1) antigenic portion directly fused to a nucleotide sequence encoding an Immediate-Early Gene-1 (IE2) antigenic portion, wherein (i) the nucleotide sequence encoding the IE1 antigenic portion includes a nucleotide sequence encoding IE1 exon 4 (IE1/e4); (ii) the nucleotide sequence encoding the IE2 antigenic portion is a nucleotide sequence encoding IE2 exon 5 (IE2/e5); or (iii) both (i) and (ii).
Claims 1-9 of copending Application No. 19/212381 do not recite the method as claimed.
See the teachings of Diamond et al. above.
One of ordinary skill in the art would have been motivated to use the composition as recited in claims 1-9 of copending Application No. 19/212381 in the method of Diamond et al. Diamond et al. teaches CMV vaccine, and claims 1-9 of copending Application No. 19/212381 recite such a vaccine (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using the composition as recited in claims 1-9 of copending Application No. 19/212381 in the method of Diamond et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
8. Claims 9, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. as applied to claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 above and further in view of Diamond et al.-2 (cited above).
See claims 9, 25 as submitted 6/24/2025.
See the teachings of claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. above.
Claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. does not teach: intramuscular administration.
See the teachings of Diamond et al.-2 above.
One of ordinary skill in the art would have been motivated to administer as taught by Diamond et al.-2 with the method as taught by claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. Claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. teach administration of MVA expressing CMV antigens, and Diamond et al.-2, which also teaches administration of MVA expressing CMV antigens, teaches such a method known in the art for administration of MVA expressing CMV antigens (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for administering as taught by Diamond et al.-2 with the method as taught by claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
9. Claims 15, 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. as applied to claims 1-5, 7, 10, 12, 17-21, 23, 26, 28 above and further in view of Hsu et al. (cited above).
See claims 15, 31 as submitted 6/24/2025.
See the teachings of claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. above.
Claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. does not teach: wherein the HCT is HLA-matched, or wherein the HCT is haploidentical or mismatched.
See the teachings of Hsu et al. above.
One of ordinary skill in the art would have been motivated to use HLA-matched HCT as taught by Hsu et al. with the method as taught by claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. Claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. teaches use of HCT, and Hsu et al., which also teaches HCT, teaches a method known of HCT known in the art wherein patient and donors are HLA matched (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using HLA-matched HCT as taught by Hsu et al. with the method as taught by claims 1-9 of copending Application No. 19/212381 in view of Diamond et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672