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 .
Please note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action is in reply to Applicants’ correspondence of 6/8/2026. Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put this application in condition for allowance. New grounds of rejection, necessitated by amendments, are presented in this Office Action. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action. This Action is FINAL.
Claim Status
Claims 1-3 and 6-30 are pending.
Claims 18-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/3/2025.
Claims 1-3, 6-17, and 30 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement (see paragraphs [0038, 0044, and 0071-0072]). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Remarks
The IDS supplied with the Remarks of 6/8/2026 is acknowledged. The provided IDS also does not include all of the references in the specification, as indicated above. Therefore, the references not found in any IDS remain unconsidered unless cited by the Examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c) (see Figure 22). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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.
Response to Remarks
Applicant’s amendment to the specification to include an incorporation by reference paragraph and provide an updated Sequence Listing XML is acknowledged.
The above specific deficiency regarding identification of SEQ ID NOs for depicted sequences remains. The amendment to the specification in paragraph [0013] to list SEQ ID NOs: 84-87 for Figure 18 and SEQ ID NOs: 88-98 does not adequately identify the sequences in the drawings. There are multiple sequences per drawing and it is not clear from the disclosure with SEQ ID NO corresponds to which sequence in the Figures.
Abstract
The objection to the abstract is withdrawn in light of Applicant’s amendment to the abstract to remove typos from sentence one.
Specification
Applicant’s amendment to the specification to properly denote trade names or marks used in commerce is acknowledged. This was not a formal objection (as indicated by box 10 on PTO-326 being left blank) and therefore there is no objection to withdraw.
Claim Rejections - 35 USC § 112b - Indefinite
Withdrawn:
The rejection of claim 3 as described in the Office Action of 1/9/2026 is withdrawn in light of Applicant’s amendment to the claim.
New (Necessitated by Amendments):
Claim 3 is 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 3 recites the limitation "the 5’-side region" in line 5. There is insufficient antecedent basis for this limitation in the claim. There is a 5’-side of a gene sequence encoding a protein defined in lines 3-4 but there is no “5’-side region” defined which makes it unclear what all is included in said region. For the purposes of examination, it is being interpreted the 5’-side region only comprises the 5’ side of a gene sequence encoding a protein (only a portion of a full gene sequence encoding a protein, specifically a 5’ portion). However, further clarification is required.
Withdrawn Claim Rejections - 35 USC § 102 and 103
The rejections of claims under 35 USC § 102 and 103, as outlined in the Office Action of 1/9/2026, are withdrawn in light of Applicant’s amendments to the claims.
New Claim Rejections - 35 USC § 102
Necessitated by Amendments
Claims 1-3, 7, 9-10, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu (Hu et al., The EMBO Journal 2019).
Regarding claim 1: Hu teaches a nucleic acid construct comprising a promoter region (Cdkn1A) and a 5’-side region and a 3’-side region of a gene sequence encoding a protein (GFP; Fig 7, presented below for reference). The 5’-side region has a first homologous region linked downstream thereof and the 3’-side region has a second homologous region linked upstream thereof, wherein the homologous regions are homologous to each other (Fig 7A, represented by the light grey). The 5’ side region and the 3’ side regions are created by dividing the gene sequence encoding the protein (GFP) into two parts and including an overlapping region in each side region (Materials and Methods – Generation of RMD reporter cell lines). Hu teaches constructs wherein the homology between the first homologous region and the second homologous region is less than 100% (1% and 3% divergence, or 99% homology and 97% homology).
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Regarding claim 2: Hu teaches that the nucleic acid construct is stably integrated into the genome of mES cells (Materials and Methods – Generation of RMD reporter cell lines). This read on a linear nucleic acid construct comprising, downstream of the promoter region, the 5’ side region and the 3’ side region.
Regarding claim 3: Hu teaches linearized vectors (nucleic acid constructs) comprising a promoter region (Cdkn1A) and a 5’-side region and a 3’-side region of a gene sequence encoding a protein (GFP; Fig 7A, presented above for reference). The 5’-side region has a first homologous region linked downstream thereof and the 3’-side region has a second homologous region linked upstream thereof, wherein the homologous regions are homologous to each other (Fig 7A, represented by the light grey). The 5’ side region and the 3’ side regions are created by dividing the gene sequence encoding the protein (GFP) into two parts and including an overlapping region in each side region (Materials and Methods – Generation of RMD reporter cell lines). Hu teaches cleaving the linear vector that has been stably integrated into the mES genome with a restriction enzyme I-SceI between the 5’side region and the 3’ side region. This necessarily creates two different nucleic acid molecules, one part of the linear chromosome containing the 5’ side region and the other part of the linear chromosome containing the 3’ side region. This reads on the regions being placed in two different nucleic acid molecules.
Regarding claims 7: Hu teaches that the first homologous region and the second homologous region each have a chain length of 315 bp and that the homology between the two sequences is 100%, 99%, or 97% (Fig 1A and Fig 7A).
Regarding claims 9 and 10: Hu teaches that the gene sequence encodes a protein whose intracellular expression in detectable and is a fluorescent protein gene (GFP, Fig 7A).
Regarding claim 13: Hu teaches the nucleic acid construct of claim 1. Given that the structure as described by Hu teaches the exact structure as defined in claim 1, the structure of Hu can necessarily act as a diagnostic agent. MPEP 2111.02 II states that
“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim).
In the instant case, the preamble of “A diagnostic agent for mismatch repair-deficient cancer” is not a structural limitation of the nucleic acid construct of claim 1 and therefore this intended use is not further limiting of the nucleic acid construct as taught by Hu.
Regarding claim 14: Hu teaches that the gene sequence encodes a protein whose intracellular expression in detectable (GFP, Fig 7A).
Regarding claim 15 and 16: Hu teaches the nucleic acid construct of claim 1. Given that the structure as described by Hu teaches the exact structure as defined in claim 1, the structure of Hu can necessarily act as a companion diagnostic agent (see citation of MPEP 2111.02 II above). In the instant case, the preamble of “A companion diagnostic agent for predicting an effect of an anticancer drug for mismatch repair-deficient cancer” is not a structural limitation of the nucleic acid construct of claim 1 and therefore this intended use is not further limiting of the nucleic acid construct as taught by Hu. And, because the “anticancer drug” is merely part of an intended use of the construct of claim 1, claim 16 is also rejected.
Regarding claim 17: Hu teaches that the gene sequence encodes a protein whose intracellular expression in detectable (GFP, Fig 7A).
New Claim Rejections - 35 USC § 103
Necessitated by Amendments
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (Hu et al., The EMBO Journal 2019) as applied to claims 1-3, 7, 9-10, and 13-17, and further in view of Taylor-Parker (AddGene, 2016; cited on PTO-892 of 1/9/2026).
The teachings of Hu are outlined above. Relevant to the instantly rejected claim, Hu teaches a nucleic acid construct that comprises a promoter, a 5’ side region and a 3’ side region which are composed of a divided gene sequence and each of which contain a first homologous region and a second homologous region which are not 100% homologous, respectively. Hu does not teach that the nucleic acid construct contains a poly-A addition signal downstream of the 3’-side region.
However, use of poly-A addition signals at the 3’ end of nucleic acid constructs was known in the art, as taught by Taylor-Parker.
Taylor-Parker teaches that in many expression plasmids, mammalian terminators are used which “include the sequence motif AAUAAA which promotes both polyadenylation and termination” (Eukaryotic termination and polyadenylation).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the nucleic acid construct of Hu to include the polyA sequence as taught by Taylor-Parker. One would be motivated to do so given the assertion by Taylor-Parker that “The addition of the poly(A) tail is important for stability of the mRNA, protection from degradation, and is integral to the nuclear export and translation processes as well.” (Eukaryotic termination and polyadenylation). One would have a reasonable expectation of success given that Taylor-Parker discusses the successful integration into mammalian expression plasmids to promote translation of genes within said vector.
Claims 8 and 30 are rejected as being unpatentable over Hu (Hu et al., The EMBO Journal 2019) as applied to claims 1-3, 7, 9-10, and 13-17, and further in view of Evans (Evans et al., Molecular and Cellular Biology 2000).
The teachings of Hu are outlined above. Relevant to the instantly rejected claim, Hu teaches a nucleic acid construct that comprises a promoter, a 5’ side region and a 3’ side region which are composed of a divided gene sequence and each of which contain a first homologous region and a second homologous region which are not 100% homologous, respectively. Hu teaches that sequence divergence of 1% to 3% inhibits SSA in an MMR dependent manner.
Hu does not teach less than 97% homology between the first homologous region and the second homologous region. However, the ability of MMR to prevent recombination between divergent sequences up to 90% divergent is known in the art, as taught by Evans.
Evans teaches that recombination between divergent sequences between 90%-99% homology is prevented by MMR. Evans teaches that greater than 10% sequence divergence leads to an inability of sequences to anneal (MMR AND THE REJECTION OF MISMATCHED RECOMBINATION INTERMEDIATES, paragraph 3). 90% homology reads on claim 8 (40% to 95%) and claim 30 (68% to 90%).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the nucleic acid construct of Hu to include up to 10% sequence divergence, as taught by Evans. One would be motivated to do so given that Hu is studying the effects of sequence divergence on a form of recombination as it relates to MMR. Evans teaches that MMR imposes a barrier to recombination at sequence divergence up to 10%. Therefore, the modification of Hu to incorporate a sequence divergence of 90% in the first and second homology regions would produce the predicted result of inhibiting SSA in an MMR dependent manner, as taught by Evans.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (Hu et al., The EMBO Journal 2019) in view of Chen (Chen et al., Cell Death & Disease 2018; cited on PTO-892 of 1/9/2026).
Hu teaches a nucleic acid construct comprising a promoter region (Cdkn1A) and a 5’-side region and a 3’-side region of a gene sequence encoding a protein (GFP; Fig 7, presented below for reference). The 5’-side region has a first homologous region linked downstream thereof and the 3’-side region has a second homologous region linked upstream thereof, wherein the homologous regions are homologous to each other (Fig 7A, represented by the light grey). The 5’ side region and the 3’ side regions are created by dividing the gene sequence encoding the protein (GFP) into two parts and including an overlapping region in each side region (Materials and Methods – Generation of RMD reporter cell lines). Hu teaches constructs wherein the homology between the first homologous region and the second homologous region is less than 100% (1% and 3% divergence, or 99% homology and 97% homology).
Hu does not teach that the gene sequence encoding a protein is one which acts to decrease cell survival rate. However, usage of reporter genes that induce an easily measurable phenotype, such as cell death, is known in the art, as taught by Chen.
Chen teaches using a nucleic acid construct which comprises a promoter upstream of a reporter construct, which is either luciferase (a gene sequence encoding a protein whose intracellular expression is detectable) or DTA (a gene sequence encoding a protein that acts to decrease cell survival rate, more specifically, a suicide gene; Abstract). Chen teaches using a promoter for the gene XRCC2, which is specifically overexpressed in cancer cells relative to non-cancer cells (Abstract). Chen teaches contacting the nucleic acid construct with cancer cells and decreasing cell survival of cancer cells (Figure 4 and 5).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the nucleic acid construct of Hu to include a gene that acts to decrease cell survival, as taught by Chen. One would be motivated to do so given the assertion by Chen that this allows for high selectivity and efficacy in treating cancer cells. One would have a reasonable expectation of success given that DTA could reasonably be expected to work in the construct of Hu, providing an alternative reporter that would work specifically in a DNA damage repair context.
Hu in view of Chen does not teach using this construct as a therapeutic agent specifically against mismatch repair-deficient cancer. However, Hu teaches that functional mismatch repair proteins suppress SSA between divergent sequences (Fig 7A-B).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the nucleic acid construct of Hu and Chen to apply them as a therapeutic agent specifically against mismatch repair deficient cells. One would be motivated to do so given the teaching by Hu that by inclusion of 1-3% sequence divergence within the overlapping regions, SSA is prevented (and thus no functional DTA would be created) in cells that have a functional mismatch repair system, while SSA would be allowed to occur and create a functional DTA gene to decrease cell survival rate specifically in cells that are deficient for mismatch repair, enabling selective killing of mismatch repair deficient cells. One would have a reasonable expectation of success given that the SSA system construct as taught by Hu, with successful SSA leading to expression of DTA, as taught by Chen for selective killing of cancer cells, could readily be employed to distinguish between mismatch proficient and mismatch deficient cells.
Response to Remarks
Applicant traversed the rejections of claims under 35 USC 102 and 103 as outlined in the Office Action of 1/9/2026 in the Remarks of 6/8/2026. These rejections have been withdrawn in light of Applicant’s amendments to the claims and thus the arguments against said rejections are moot. New claim rejections addressing the new claim rejections are presented above.
Double Patenting
Maintained – Modified as Necessitated by Amendments
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 1-3, 6-7, and 9-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87-89, 90-93, 95, 107-109, 113, 115-116, 129, 136-137, 140-142, and 146-148 of copending Application No. 19/130,810 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of the '810 claims are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks
Applicant has traversed the rejection of claims 1-3 and 6-17 over double patenting over claims 87-89, 90-93, 95, 107-109, 113, 115-116, 129, 136-137, 140-142, and 146-148 of copending Application No. 19/130,810 in the Remarks of 6/8/2026 (pg 15-16). Applicant's arguments have been fully considered but they are not persuasive.
The double patenting rejection has been amended in light of Applicant’s amendments to the claims but is maintained against claims 1-3, 6-7, and 9-17. Applicant argues that, because the present application has a much earlier priority date and a much earlier PCT filing date than the co-pending application, that the issue of double patenting should only be raised in the related application (pg 16 of Remarks). However, as stated in MPEP 804(I)(1)(b)(i):
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. (Emphasis added)
The double patenting rejection raised above is not the only remaining rejection in the application having the earlier patent term filing date. Therefore, the double patenting rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILEY E CASH whose telephone number is (571)272-0971. The examiner can normally be reached Monday-Friday 8:30am-6pm ET.
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, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAILEY ELIZABETH CASH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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