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 .
1. Original claim 1-20 are currently pending.
Election/Restrictions
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim, 1-19, drawn to a composition comprising the polynucleotide set forth by SEQ ID NO: 19, classified in C12N 15/102.
II. Claim 20, drawn to a composition comprising the polynucleotide set forth by SEQ ID NO: 18, classified in C12N 15/102.
The inventions are independent or distinct, each from the other because:
Inventions I and II are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are drawn to compositions having different biochemical structures and functions. Furthermore, inventions I and II are not disclosed as being capable of use together.
During a telephone conversation with applicant’s representative Peter Mikesell on 12/22/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19, drawn to a composition comprising the polynucleotide set forth by SEQ ID NO: 19. Affirmation of this election must be made by applicant in replying to this Office action.
Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention, specifically a composition comprising the polynucleotide set forth by SEQ ID NO: 18.
Claims 1-19 are under examination.
Claim Objections
3. Claims 1-19 should be rewritten as follows:
Claim 1
A composition comprising the polynucleotide set forth by SEQ ID NO: 19.
Claim 2
A plasmid comprising the polynucleotide set forth by SEQ ID NO: 19.
Claim 3
The composition of claim 1, wherein the composition consists of the polynucleotide set forth by SEQ ID NO: 19.
Claim 4
A composition comprising a polynucleotide comprising in 5’ to 3’ order: a first restriction site, a first polyA signal sequence, a promoter, the nucleotide sequence set forth by SEQ ID NO: 19, a second polyA signal sequence, and a second restriction site.
Claim 5
The composition of claim 4, wherein the polynucleotide consists of the first restriction site, the first polyA signal sequence, the promoter, the nucleotide sequence set forth by SEQ ID NO: 19, the second polyA signal sequence, and the second restriction site.
Claim 6
A plasmid comprising a polynucleotide consisting in 5’ to 3’ order of: a first restriction site, a first polyA signal sequence, a promoter, the nucleotide sequence set forth by SEQ ID NO: 19, a second polyA signal sequence, and a second restriction site.
Claim 7
The composition of claim 4, wherein the promotor is the DCP1A promoter set forth by SEQ ID NO: 29 or the shortened DCP1A promoter set forth by SEQ ID NO: 30.
Claim 8
The composition of claim 4, wherein the promotor is selected from the group consisting of the DCP1A promoter, the DCP2 promoter and the ZFP36 promoter.
Claim 9
The composition of claim 4, wherein the first restriction site and the second restriction site are different.
Claim 10
The composition of claim 4, wherein the first restriction site is a BstB1 restriction site.
Claim 11
The composition of claim 4, wherein the second restriction site is a BamH1 restriction site.
Claim 12
The composition of matter as recited in claim 4, wherein each of the first polyA signal sequence and the second polyA signal sequence contains between five and eleven nucleotide residues.
Claim 13
The composition of claim 5, wherein the first restriction site has a length of 4 to 7 nucleotide residues, the first polyA signal sequence has a length of 5 to 11 nucleotides, the promoter has a length of 140 to 170 nucleotides, the second polyA signal sequence has a length of 5 to 11 nucleotides, and the second restriction site has a length of 4 to 7 nucleotides.
Claim 14
The composition of claim 5, wherein the polynucleotide is set forth by SEQ ID NO: 17.
Claim 15
A plasmid comprising the polynucleotide set forth by SEQ ID NO: 17.
Claim 16
The composition of claim 4, wherein the polynucleotide further comprises a first digestion enhancing sequence 5’ to the first restriction site and a second digestion enhancing sequence 3’ to the second restriction site.
Claim 17
The composition of claim 16, wherein the polynucleotide consists of the first digestion enhancing sequence, the first restriction site, the first polyA signal sequence, the promoter, the nucleotide sequence set forth by SEQ ID NO: 19, the second polyA signal sequence, the second restriction site, and the second digestion enhancing sequence.
Claim 18
A plasmid comprising a polynucleotide consisting of: a first digestion enhancing sequence, a first restriction site, a first polyA signal sequence, a promoter, the nucleotide sequence set forth by SEQ ID NO: 19, a second polyA signal sequence, a second restriction site, and a second digestion enhancing sequence.
Claim 19
The composition of claim 16, wherein the first digestion enhancing sequence has a length of 5 to 100 nucleotides, the first restriction site has length of 4 to 7 four nucleotides, the first polyA signal sequence has a length of 5 to 11 nucleotides, the promoter has a length of 140 to 170 nucleotides, the second polyA signal sequence has a length of 5 to 11 nucleotides, the second restriction site has a length of 4 to 7 nucleotides, and the second digestion enhancing sequence has a length of 5 to 100 nucleotides.
Double Patenting
4. 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.
5. Claims 1, 2, 4-12, and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 19/315,085 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets encompass a DNA comprising a promoter operably linked the same nucleic acid sequence.
Instant claim 1 recites a composition comprising the polynucleotide set forth by SEQ ID NO: 19; claim 2 defines that the composition is a plasmid. Instant claims 4-12 and 16-18 encompass a composition comprising SEQ ID NO: 17 (see below); claim 6 defines that the composition is a plasmid. Instant claim 14 is drawn to SEQ ID NO: 17; claim 15 recites a plasmid comprising SEQ ID NO: 17.
The instant specification defines that the recited plasmid comprises SEQ ID NO: 17. The instant specification defines SEQ ID NO: 17 as being a DNA molecule consisting in 5’ to 3’ order of: a first digestion enhancing sequence, the BstB1 restriction site, a first polyA sequence (10 nucleotides), the short DCP1A promoter set forth by SEQ ID NO: 30 operably linked to SEQ ID NO: 19, a second polyA sequence (6 nucleotides), the BamH1 restriction site, and a second digestion enhancing sequence (see [0031]; [0035]; [0057]; [0077]; [0079]; Fig. 1, 7B, and 8).
As evidenced by the attached sequence alignments, SEQ ID NO: 19 is the same as SEQ ID NO: 12 recited in the application claim 20 (i.e., SEQ ID NO: 17 comprises SEQ ID NO: 12). Thus, the instant claims are drawn to a DNA comprising a promoter operably linked to a nucleic acid encoding the myc 3’ UTR substituted with a sequence selected from AUUUU, CCUC, CUGC, UAAGUUAU, UAACUUAU, and GUAAAUAG, as recited in the application claim 20. The application specification discloses that the promoter is the DCP1A promoter set forth by either SEQ ID NO: 29 or 30 (see [0411]; [0413], Table 4; [0750]).
Thus, the instant claims and the application claims are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 1, 2, 4-12, and 14-18 are rejected. Claims 1-19 are objected to.
Claims 1-19 are free of the prior art of record because SEQ ID NOs: 19 and 17 are not taught and are not rendered obvious by the prior art of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILEANA POPA/Primary Examiner, Art Unit 1633