DETAILED ACTION
Withdrawn Rejections
The rejection of record of claims 1, 3-11, 16-17, 19-20, and 26-30 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendment to the claims.
Maintained Rejections
Applicant’s arguments regarding the rejection of record of claims 1, 7-8, 16, 20, and 29-30 for non-statutory double patenting over claims 17, and 19-20 of copending Application No. 17/692,857 has been fully considered but is not persuasive. The rejection has been recast below. Response to arguments will follow the rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7-8, 16, 20, and 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17, and 19-20 of copending Application No. 17/692,857 (referenced herein as ‘857). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims would anticipate the instant claims if it were available as prior art.
Copending claim 17 of ‘857 recites, inter alia, “An introducing carrier for incorporating a target sequence into a cell genome comprising: lipid particle; and a modified piggyBac transposase polypeptide or a polynucleotide encoding the modified piggyBac transposase encapsulated in the lipid particle, wherein the modified piggyBac transposase polypeptide includes a piggyBac transposase amino acid sequence and a nuclear localization signal amino acid sequence, and the polynucleotide encoding the modified piggyBac transposase includes a base sequence encoding a piggyBac transposase and a base sequence encoding a nuclear localization signal.” Copending claim 19 of ‘857 recites, inter alia, “wherein donor DNA containing the target sequence is further encapsulated in the lipid particles.” Copending claim 20 of ‘857 recites, inter alia, “wherein the lipid particles contain, as a constituent component, a lipid compound represented by Formula (1-01) and/or a lipid compound represented by Formula (1-02).”
The combination of claims 17, and 19-20 would anticipate the instantly claimed “A nucleic acid delivery carrier suitable for the integration of a DNA sequence into a genome of cells, the nucleic acid delivery carrier comprising: a donor DNA comprising a DNA sequence that encodes a chimeric antigen receptor (CAR) and a promoter; an RNA agent comprising an RNA encoding a transposase or a CRISPR-Associated Protein 9 (Cas9) and a lipid particle encapsulating the donor DNA and the RNA agent, wherein the nucleic acid delivery carrier has a core-shell structure: wherein the core comprises the donor DNA and the shell comprises the RNA agent wherein the cells in the genome are human T-cells, and wherein the lipid particle comprises a lipid compound represented by a following formula 1-01 and/or 1-02” as in instant claim 1, “carrier of claim 1 or 3, wherein the protein is a transposase” of claim 7, “carrier of claim 7, wherein the protein is PiggyBac” of claim 8, “method of delivering a nucleic acid delivery method for integrating a DNA sequence into a genome of cells by using a nucleic acid delivery carrier, the method comprising: bringing the nucleic acid delivery carrier into contact with the cell, wherein the nucleic acid delivery carrier comprises a donor DNA comprising the DNA sequence, an RNA agent comprising an RNA encoding a protein capable of integrating the DNA sequence into the genome of cells, and a lipid particle encapsulating the donor DNA and the RNA, wherein the nucleic acid delivery carrier has a core-shell structure consisting of the donor DNA and the RNA agent in which the donor DNA is a core and the RNA agent is a shell, and the lipid particle comprises a lipid compound represented by following formula (1-01) and/or (1-02)” of claim 16, “nucleic acid delivery method for integrating a DNA sequence into a genome of cells by using a nucleic acid delivery carrier, the method comprising: bringing the nucleic acid delivery carrier into contact with the cell, wherein the nucleic acid delivery carrier comprises a donor DNA comprising the DNA sequence, an RNA agent comprising an RNA encoding a protein capable of integrating the DNA sequence into the genome of cells, and a lipid particle encapsulating the donor DNA and the RNA, wherein the nucleic acid delivery carrier has a core-shell structure consisting of the donor DNA and the RNA agent in which the RNA agent is a core and the donor DNA is a shell, encapsulating the RNA agent and the lipid particle comprises a lipid compound represented by following formula (1-01) and/or (1-02)” of claim 20, “wherein the protein is a transposase” of claim 29, and “wherein the protein is PiggyBac “of claim 30 if it were available as prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments regarding the double patenting rejection have been fully considered, however, the previously posited rejection, which was recast above, relied upon co-pending application 17/692,857 and NOT 17/195,357 as argued. Thus, the rejection has been maintained as set forth above.
New Grounds of Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-11, 16-17, 19-20, and 26-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the cells in the genome are human T-cells.” Cells contain genomes, not the other way around, thus the claim is indefinite.
Claim 3 recites “the lipid particle comprises a lipid compound represented by the formula 1- 01 and/or the formula 1-02 and DOPE and/or DOTAP, cholesterol or DMG-PEG.” It is unclear what combination of lipid compounds are required by the claims based on the multiple recitations of the “and/or”, rendering the claim prima facie confusing. Thus, the claim is indefinite.
Claim 4 recites “wherein the donor DNA further comprises a promoter sequence and a terminator sequence and has a length of 3 to 2,000 nucleotides”. It is unclear how a donor DNA (a CAR and promoter as in instant claim 1) or a promoter sequence and terminator in combination could have such a short length of 3 nucleotides as claimed. The claim is also written in a manner that is prima facie confusing as it is unclear whether the nucleotide length applies to the entire donor DNA or the combination of promoter sequence and terminator sequence. Thus, the claim is indefinite.
Please note that claims 3-11, 16-17, 19-20, and 26-30 are included in this rejection for being dependent on indefinite claims above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 7-3.
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, Peter Paras Jr can be reached at (571) 272-4517. 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.
/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632