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
Priority
This application is a continuation of U.S. Patent Application No. 17/851,905, filed June 28, 2022, which is continuation of U.S. Patent Application No. 17/008,025, filed August 31, 2020, now U.S. Patent No. 11,390,651, issued July 19, 2022, which is a continuation of U.S. Patent Application No. 16/335,099, filed March 20, 2019, now U.S. Patent No. 10,808,012, issued October 20, 2020, which is a national stage application under 35 U.S.C. 371 of PCT Application No. PCT/US2017/053047 having an international filing date of September 22, 2017, which designated the United States, which PCT application claimed priority to U.S. Provisional Application Serial No. 62/399,133, filed 09/23/2016, and U.S. Provisional Application Serial No. 62/400,476, filed 09/27/2016, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 06/28/2024 is acknowledged. Claims 1-23 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024 and 04/30/2026 arein compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 06/28/2024 are acknowledged and accepted by the Examiner.
Claim Objections
Claims 8 and 12 are objected to for the following informalities:
Claims 8 and 12 are duplicate claims. Correction is required.
Claims 9 and 13 are duplicate claims 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.
Claims 21-22 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 21-22 are rejected for containing a reference to tables. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim' .
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 Langi, 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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-20 of U.S. Patent No. 12054519. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The claims of the present invention are directed to an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a mutation in the L ORF at a position correspond to T1166 of the L protein in SEQ ID NO: 11.
The patented claims are directed to:
1. An isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a missense mutation in the L ORF at a position corresponding to T1166 of the L protein in SEQ ID NO:11 (instant claim 1).
3. The isolated polynucleotide molecule of claim 1, wherein the missense mutation is T11661 of the L protein in SEQ ID NO: 11 (instant claim 3).
4. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is further modified by a missense mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9, a missense mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9, a missense mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3, or a missense mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4, or any combination thereof (instant claim 2).
5. The isolated polynucleotide molecule of claim 4, wherein the missense mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9 is N88K, the missense mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9 is A73S, the missense mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3 is K136R, or the missense mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 is E114V, or any combination thereof (instant claim 4).
6. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is further modified by two or more of a missense mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9, a missense mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9, a missense mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3, and a missense mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 (instant claim 2).
8. The isolated polynucleotide molecule of claim 6, wherein the missense mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9 is N88K, the missense mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9 is A73S, the missense mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3 is K136R, or the missense mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 is E114V, or any combination thereof (instant claim 4).
9. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome comprises a deletion of one or more ORF codons resulting in a deletion of one or more amino acid deletions in at least one of the RSV proteins selected from M2-2, NS1 and NS2 (instant claim 5).
10. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is codon-pair deoptimized (instant claim 6).
11. The isolated polynucleotide molecule of claim 1, wherein the L ORF of the RSV genome or antigenome is codon-pair deoptimized (instant claim 7).
12. A vector comprising the isolated polynucleotide molecule of claim 1 (instant claims 8 and 12).
13. A cell comprising the isolated polynucleotide of claim 1 (instant claims 9 and 13).
14. A pharmaceutical composition comprising an immunologically effective amount of the recombinant RSV variant encoded by the isolated polynucleotide molecule of claim 1 (instant claims 10 and 14).
15. A method of vaccinating a subject against RSV comprising administering the pharmaceutical composition of claim 14 (instant claims 11 and 15).
16. A method of inducing an immune response comprising administering the pharmaceutical composition of claim 14 (instant claim 16).
17. The method of claim 16, wherein the pharmaceutical composition is administered intranasally (instant claim 17).
18. The method of claim 16, wherein the pharmaceutical composition is administered via injection, aerosol delivery, nasal spray, or nasal droplets, or any combination thereof (instant claim 18).
19. A live attenuated RSV vaccine comprising the recombinant RSV variant encoded by the isolated polynucleotide of claim 1 (instant claim 19).
20. A pharmaceutical composition comprising the RSV vaccine of claim 19 (instant claim 20).
In considering instant claims 1-23, there is no patentable difference between the claimed composition and methods and the patented composition and methods in that the U.S. Patent No. 11390651 discloses an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence having the same mutations and methods of use as the patented claims.
Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11390651. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The claims of the present invention are directed to an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a mutation in the L ORF at a position correspond to T1166 of the L protein in SEQ ID NO: 11.
The patented claims are directed to
1. An isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a mutation in the L ORF at a position corresponding to T1166 of the L protein in SEQ ID NO:11 and further modified by at least two mutations selected from the group consisting of:
i. a mutation in the M2-1 ORF at a position corresponding to N88 or A73 of the M2-1 protein in SEQ ID NO:9;
ii. a mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3;
iii. a mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4; and
iv. combinations thereof. (instant claims 1 and 4 corresponds to the patented claim 1 limitation of at least two mutations) (instant claims 1-3).
2. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is further modified by the following mutations:
i. a mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9;
ii. a mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3; and
iii. a mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 (instant claim 2).
3. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is further modified by the following mutations:
i. a mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9;
ii. a mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3; and
iii. a mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 (instant claim 2).
4. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is modified by corresponding mutations selected from the group consisting of (1) T1166I in the L protein, N88K in the M2-1 protein, K136R in the N protein and E114V in the P protein; and (2) T1166I in the L protein, A73S in the M2-1 protein, K136R in the N protein and E114V in the P protein (instant claim 4).
5. The isolated polynucleotide molecule of claim 4, wherein the RSV genome or antigenome comprises a deletion in at least one of the proteins selected from M2-2, NS1 and NS2 (instant claims 5 and 22).
6. The isolated polynucleotide molecule of claim 4, wherein the RSV genome or antigenome is codon-pair deoptimized (instant claim 6).
7. The isolated polynucleotide molecule of claim 4, wherein the L ORF of the RSV genome or antigenome is codon-pair deoptimized (instant claim 7).
8. A vector comprising the isolated polynucleotide molecule of claim 1 (instant claim 8).
9. A cell comprising the isolated polynucleotide of claim 1 (instant claim 9).
10. A pharmaceutical composition comprising an immunologically effective amount of the recombinant RSV variant encoded by the isolated polynucleotide molecule of claim 1 (instant claim 10).
11. A method of vaccinating a subject against RSV comprising administering the pharmaceutical composition of claim 10 (instant claim 11).
12. A method of inducing an immune response comprising administering the pharmaceutical composition of claim 10 (instant claim 16).
13. The method of claim 11, wherein the pharmaceutical composition is administered intranasally via injection, aerosol delivery, nasal spray or nasal droplets (instant claims 17 and 18).
14. A live attenuated RSV vaccine comprising the recombinant RSV variant encoded by the isolated polynucleotide of claim 4 (instant claim 19).
15. A pharmaceutical composition comprising the RSV vaccine of claim 14 (instant claim 20).
16. A method of making a live attenuated RSV vaccine comprising expressing the isolated polynucleotide molecule of claim 4.
17. An isolated polynucleotide molecule that is at least about 95% identical to the nucleotide sequence of SEQ ID NO:14 (instant claims 21 and 23).
18. The isolated polynucleotide molecule of claim 17, comprising the nucleotide sequence of SEQ ID NO:14 (instant claim 23).
19. A vector comprising the isolated polynucleotide molecule of claim 18 (instant claim 12).
20. A cell comprising the isolated polynucleotide of claim 18 (instant claim 13).
21. A pharmaceutical composition comprising an immunologically effective amount of the recombinant RSV variant encoded by the isolated polynucleotide molecule of claim 18 (instant claim 14).
22. A method of vaccinating a subject against RSV comprising administering the pharmaceutical composition of claim 21 (instant claim 15).
23. A method of inducing an immune response comprising administering the pharmaceutical composition of claim 21 (instant claim 16).
24. The method of claim 22, wherein the pharmaceutical composition is administered intranasally (instant claim 17).
25. The method of claim 24, wherein the pharmaceutical composition is administered via injection, aerosol delivery, nasal spray or nasal droplets (instant claim 18).
26. A live attenuated RSV vaccine comprising the recombinant RSV variant encoded by the isolated polynucleotide of claim 18 (instant claim 19).
27. A pharmaceutical composition comprising the RSV vaccine of claim 26 (instant claim 20).
In considering instant claims 1-23, there is no patentable difference between the claimed composition and methods and the patented composition and methods in that the U.S. Patent No. 11390651 discloses an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence having the same mutations and methods of use as the patented claims.
Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10808012.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The claims of the present invention are directed to an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a mutation in the L ORF at a position correspond to T1166 of the L protein in SEQ ID NO: 11.
The patented claims are directed to
1. An isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by a mutation in the L ORF at a position corresponding to T1166 of the L protein in SEQ ID NO:11 and further modified by at least two mutations selected from the group consisting of:
i. a mutation in the M2-1 ORF at a position corresponding to N88 or A73 of the M2-1 protein in SEQ ID NO:9;
ii. a mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3;
iii. a mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4; and
iv. combinations thereof (instant claims 1-2).
2. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is further modified by a mutation selected from the group consisting of:
i. a mutation in the M2-1 ORF at a position corresponding to N88 or A73 of the M2-1 protein in SEQ ID NO:9
ii. a mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3;
iii. a mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4; and
iv. combinations thereof (instant claim 2).
3. The isolated polynucleotide molecule of claim 1, wherein the mutation in the L ORF at a position corresponding to T1166 of the L protein in SEQ ID NO:11 is T1166I (instant claim 3).
4. The isolated polynucleotide molecule of claim 2, wherein
a. the mutation in the M2-1 ORF at a position corresponding to N88 of the M2-1 protein in SEQ ID NO:9 is N88K and the mutation in the M2-1 ORF at a position corresponding to A73 of the M2-1 protein in SEQ ID NO:9 is A73S;
b. the mutation in the N ORF at a position corresponding to K136 of the N protein in SEQ ID NO:3 is K136R; and
c. the mutation in the P ORF at a position corresponding to E114 of the P protein in SEQ ID NO:4 is E114V (instant claim 4).
5. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome comprises a deletion in at least one of the proteins selected from M2-2, NS1 and NS2 (instant claims 5 and 21-22).
6. The isolated polynucleotide molecule of claim 1, wherein the RSV genome or antigenome is codon-pair deoptimized (instant claim 6).
7. The isolated polynucleotide molecule of claim 1, wherein the L ORF of the RSV genome or antigenome is codon-pair deoptimized (instant claim 7).
8. A vector comprising the isolated polynucleotide molecule of claim 1 (instant claims 8 and 12).
9. A cell comprising the isolated polynucleotide of claim 1 (instant claims 9 and 13).
10. A pharmaceutical composition comprising an immunologically effective amount of the recombinant RSV variant encoded by the isolated polynucleotide molecule of claim 1 (instant claims 10 and 14).
11. A method of vaccinating a subject against RSV comprising administering the pharmaceutical composition of claim 10 (instant claims 11 and 15).
12. A method of inducing an immune response comprising administering the pharmaceutical composition of claim 10 (instant claim 16).
13. The method of claim 11, wherein the pharmaceutical composition is administered intranasally (instant claim 17).
14. The method of claim 13, wherein the pharmaceutical composition is administered via injection, aerosol delivery, nasal spray or nasal droplets (instant claim 18).
15. A live attenuated RSV vaccine comprising the recombinant RSV variant encoded by the isolated polynucleotide of claim 1 (instant claim 19).
16. A pharmaceutical composition comprising the RSV vaccine of claim 15 (instant claim 20).
In considering instant claims 1-22, there is no patentable difference between the claimed composition and methods and the patented composition and methods in that the U.S. Patent No. 10808012 discloses an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence having the same mutations and methods of use as the patented claims.
Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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