DETAILED ACTION
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C.
119 (a)-(d). Acknowledgment is made of Applicants' claim for benefit to foreign
applications EP21382441.0 filed 05/12/2021.
This application claims the benefit of priority to Patent Application PCT/EP2022/062990 Acknowledgement is made of Applicants' claim for benefit to prior filed to Patent
Application Number PCT/EP2022/062990, filed on 05/12/2022. This application is a
continuation of application 18/560053 filed on 11/09/2023.
Information Disclosure Statement
The IDS filed 03/06/2024 has been considered by the Examiner.
Status of Claims
Claims 19-28, 30-31 and 33-40 are under examination.
Claim 1-19, 29, and 32 are cancelled.
Claim Objections
Claim 35 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 34. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a recombinant adeno-associated viral genome comprising a nucleotide sequence encoding a telomerase reverse transcriptase (TERT) operably linked to a tissue-specific promoter, wherein the total length of the viral genome is less than 4700 nucleotides, and wherein the tissue-specific promoter consists of SEQ ID NO: 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the TERT encoding sequence is codon-optimized.
Claim 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a) the TERT encoding sequence comprises, essentially consists of, or consists of a nucleotide sequence encoding a polypeptide represented by an amino acid sequence having at least 60%, 70%, 80%, 90%, 95%, or 99% identity or similarity with any one of SEQ ID NOs: 4, 7, or 10, or; b) the TERT encoding sequence comprises, essentially consists of, or consists of a nucleotide sequence having at least 60%, 70%, 80%, 90%, 95%, or 99% identity with any one of SEQ ID NOs: 1, 2,3,5,6, 8, or 9, or; c) the TERT encoding sequence comprises, essentially consists of, or consists of a nucleotide sequence the sequence of which differs from the sequence of a nucleotide sequence of a) or b) due to the degeneracy of the genetic code.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the recombinant viral genome further comprises a Kozak consensus sequence operably linked to the nucleotide sequence encoding a TERT.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the recombinant viral genome further comprises a polyA sequence operably linked to the nucleotide sequence encoding a TERT
Claim 25 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require an adeno-associated viral vector comprising the recombinant adeno-associated virus genome.
Claim 26 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the viral vector is of serotype 1, 2, 3, 4, 5, 6, 7, 8, 9, rh10, rh8, Cb4, rh74, DJ, 2/5, 2/1, 1/2 or Anc80.
Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the viral vector is of serotype 6 or 9.
Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the viral vector is of serotype 6.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the viral vector is of serotype 9.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a pharmaceutical composition comprising the recombinant adeno-associated viral genome.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a method of treating or preventing a condition associated with shortened telomere length comprising administering a therapeutically effective amount of the recombinant adeno-associated viral genome.
Claims 34 and 35 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 39 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a method of treating or preventing pulmonary fibrosis comprising administering a therapeutically effective amount of the recombinant adeno- associated viral genome according to claim 20 to a subject via intratracheal administration.
Claim 36 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the TERT encoding sequence is codon-optimized for expression in a human cell.
Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the TERT encoding sequence comprises, essentially consists of, or consists of a nucleotide sequence encoding a polypeptide represented by an amino acid sequence having at least 60%, 70%, 80%, 90%, 95%, or 99% identity or similarity with any one of SEQ ID NOs:7, or 10.
Claim 38 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the TERT encoding sequence comprises, essentially consists of, or consists of a nucleotide sequence having at least 60%, 70%, 80%, 90%, 95%, or 99% identity with any one of SEQ ID NOs: 6 or 9.
Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 35 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a pharmaceutical composition comprising the adeno-associated viral vector.
Claim 40 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 37 of copending Application No. 19/051,949. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a method of treating or preventing a condition associated with shortened telomere length comprising administering a therapeutically effective amount of the adeno-associated viral vector to a subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Catherine L McCormick whose telephone number is (703)756-5659. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635