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 .
Application Status
This action is written in response to applicant’s correspondence received on 5/05/2026. Claims 1-17 were filed on 5/05/2026, with claims 9-11 cancelled and claims 12-13, 16-17 were withdrawn. Claims 1- 8, 14-15 are under examination in this Office action.
Prior prosecution included a restriction on 6/25/2025, with Group I (nucleic acid operably linked to a transgene; claims 1-8, 14 and 15), and Group II method of producing transgene (claims 12,13, 16-17). An election of Group I, without traverse was made on 8/25/2025, such that claims 1-8, 14-15 were elected.
Any rejection or objection not reiterated herein has been overcome by amendment.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency: The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the terms “BODIPY”, “Tween”, “Lipofectamine-2000”, and “Stop & Glo”, which is/are trade names or marks used in commerce, are noted in this application at, at least: Pg 20, Pg 23, and Pg 24, paragraph 1)
The term(s) should be accompanied by the generic terminology; furthermore the term(s) should be capitalized if not, wherever it/they appear(s) or, where appropriate, include a proper symbol(s) indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claims 1, 4-5,14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Vona (Di Vona et al, 2015 Molecular Cell 57, 506-520).
Re: claim 1, An isolated nucleic acid comprising at least two copies of SEQ ID NO: 3 operably linked to a heterologous transgene, where SEQ ID NO:3 is “tctcgcgaga”,
DiVona, disclosed the putative regulatory region of the RSP11 gene (an isolated nucleic acid) that harbours two motifs of “TCTGCGAGA” (SEQ ID NO: 3), was cloned upstream of the luciferase gene (a heterologous transgene) (Pg 511, right col, para 2; Pg 512, FIG 4G) where the fragment drove luciferase expression (an operable link), including the motif consensus sequence alone (Pg 511, right col, para 2; FigS4G).
Re: claims 4, 5, 14 DiVona disclosed that cells were co-transfected with a luciferase reporter vector and with the effector plasmids, encompassing the two copies of SEQID NO 3 and the luciferase gene….. (motif copies and luciferase: Pg 511, right col, para 2, Fig 4 pGL2 is Promega luciferase reporter plasmid vector Pg 518, left col, paras 3-4).
Claims 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Vona (Di Vona et al, 2015 Molecular Cell 57, 506-520) in view of Tanaka (US10822392 B2; filed 5/14/19).
The teachings of DiVona relevant to claim 1 are discussed above.
Di Vona does not teach a chimeric antigen receptor in a nucleic acid.
Tanaka teaches a nucleic acid comprising a chimeric antigen receptor (CAR) (claim 1), indicating, for example, that it could be linked to other regulatory elements to attain efficient transcription.
Prior to effective filing date it would have been prima facie obvious to one of ordinary skill in the art to have conducted a routine substitution of one transgene for another in a nucleic acid, using the CAR of Tanaka in place of the luciferase reporter transgene of DiVona. In the absence of evidence to the contrary, this substitution would be expected to yield predictable activation results with the CAR transgene. One of ordinary skill would be motivated to try to use a transcription enhancing system for CAR genes, since one goal of Tanaka was treating/preventing disease by administering cells expressing a CAR, or a composition thereof, and increased expression could benefit this (Col 4).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Vona (Di Vona et al, 2015 Molecular Cell 57, 506-520) in view of Feldman (Feldman S. et al., 2014, Hum Gene Ther Methods 25:253-260).
The teachings of DiVona as related to claim 1 have been discussed.
DiVona does not address stable integration into the genome of a cell.
Feldman teaches use of a piggyBac transposon to generate stably integrated constructs, efficiently, into (mammalian) cells (Abstract, Fig 1, Pg 254, para 2, Pg 256 right col, para 2).
Prior to effective filing date it would have been prima facie obvious to one of ordinary skill in the art to have combined the method of Feldman with the construct of DiVona as a simple substitution for the cassette of Feldman, to have obtained the predictable result of stable integration of the nucleic acid of DiVona. One of ordinary skill would have has a reasonable expectation of success with the teachings of DiVona and Feldmen and have been motivated to use this combination because the generation of stable cell lines would have allowed DiVona benefits of a cell line with known persistent expression of reporter and have eliminated the possibility of conducting experimentation with transient expression, which also provided the benefit of reduced variability of results, while providing for long-term monitoring of regulation by expression in cells and animals recognizing that transient integration could have affected the understanding and accuracy of experimental results.
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 1-8 and 14-15 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/255,296 (publication US20240035034A1). This is a single-reference obviousness-type double patenting rejection.
Re: instant claim 1, An isolated nucleic acid comprising at least two copies of SEQ ID NO: 3, where SEQ ID NO:3 is the motif “tctcgcgaga” in both applications. is taught by copending ‘296 (claim 1 preamble and claim 1b and sequence listing)
Claim 1 does not teach that this is operably linked to a heterologous transgene
Operably linked to a heterologous transgene is taught by ‘296 (claim 2).
Prior to effective filing date it would have been prima facie obvious to one of ordinary skill in the art to have included the heterologous transgene of ‘296 claim 2, in the isolated molecule comprising two copies of a motif of claim 1, because this would have merely combined elements of known types according to known methods to yield predictable results, absent evidence to the contrary. Motivation would come from the fact that the nucleic acid molecule with motif(s) would be more valuable/useful in combination with the transgene, since the molecule could provide more information related to motif function when used as a combination. For example, the addition of a heterologous transgene as simple as a reporter would benefit testing functionality of the molecule by allowing for detection of (e.g.) luciferase brightness as a measure of regulation by motif(s) of, e.g. gene expression and/or transcription activation. Replacing a reporter with a transgene to be regulated by motif(s) in some direct or indirect manner would also provide potential benefits such as therapeutic gene expression regulation.
The teachings of ‘296 regarding claim 1 are discussed above.
Rejections for claims 2-8, 14-15 are anticipatory-type double patenting rejections.
Re claim 2, the isolated nucleic acid of claim 1 further comprising a further sequence encoding for protein BANP, or for a fragment or variant of protein BANP retaining transcription factor activity, operably linked to a constitutive promoter or to an inducible promoter (copending ‘296, claim 3).
Re: claim 3, the isolated nucleic acid of claim 1, wherein the heterologous transgene is a chimeric antigen receptor (copending ‘296, claim 4).
Re: claims 4-5, a vector comprising the isolated nucleic acid of claim 1 (copending ‘296 claim 5), the vector is a plasmid (copending ‘296 claim 6).
Re: claim 6, a kit comprising the isolated nucleic acid of claim 1 and a second molecule comprising sequence encoding BANP or a fragment or variant of protein BANP retaining transcription factor activity, linked to constitutive or inducible a promotor (copending ‘296, claim 7).
Re: claim 7, the kit of claim 6, wherein both isolated nucleic acids are in the same vector (copending ‘296, claim 8)
Re: claim 8, the kit of claim 6, comprising two vectors, both nucleic acids within different vectors (copending ‘296, claim 9)
Re: claim 14, An isolated cell comprising the isolated NA of claim 1 (copending ‘296, claim 14)
Re: claim 15, The cell of claim 14, comprising at least two copies of SEQ ID NO:3 and the heterologous transgene is stably integrated into said cell genome (‘295, claim 15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-8, 14, 15 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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, Neil Hammell can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LISA HORTH/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
Prosecution Insights