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 .
DETAILED ACTION
Applicant's amendments and remarks filed on May 12, 2026 are acknowledged. Claims 6, 18-20, 27, 38-40, 47, 49-50, 52, and 62 have been canceled. Claim 26 was amended. Claims 1-5, 7-17, 21-26, 28-37, 41-46, 48, 51, 53-61, and 63-71 are pending. Claims 1-5, 7-17, 21-25, 43-46, 48, 51, 53-59, 61, and 71 are withdrawn.
Claims 26, 28-37, 41, 42, 60, and 63-70 are examined on the merits herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 12, 2026 has been entered.
Priority
This application claims priority to PCT/US2020/027541 filed on April 9, 2020 which claims priority to U.S. provisional application 62/877,810 filed on July 23, 2019 and U.S. provisional application 62/831,706 filed on April 9, 2019.
Withdrawn Objections
In view of Applicant’s amendments and response, the objections to the drawings and specification are withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments and response, the 35 U.S.C 112(d), 35 U.S.C 112(b), and 35 U.S.C 103 rejections are withdrawn.
Drawings
The drawings were received on April 15, 2026. These drawings are found acceptable by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26, 28-37, 41, 42, 60, and 63-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a polypeptide zinc-finger repressor construct comprising an engineered zinc finger DNA-binding domain coupled to a Kruppel-associated box (KRAB) transcription repressor, wherein the zinc finger DNA-binding domain comprises at least six zinc-finger sequences, wherein the zinc finger sequences bind to a target nucleic acid sequence in a gene encoding a gene product, wherein the gene product is SCN9A, wherein expression of the gene product is inhibited, and wherein the target nucleic acid sequence is SEQ ID NO: 116, 118, or 120; a polynucleotide encoding a polypeptide zinc-finger repressor construct comprising an engineered zinc finger DNA-binding domain coupled to a transcription repressor, wherein the zinc finger DNA-binding domain comprises at least six zinc-finger sequences, wherein the zinc finger sequences bind to a target nucleic acid sequence in a gene encoding a gene product, wherein the gene product is SCN9A, wherein expression of the gene product is inhibited, and wherein the target nucleic acid sequence is SEQ ID NO: 116, 118, or 120, does not reasonably provide enablement for any other claimed target nucleic acid sequences. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue". These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Breadth of claims and nature of the invention:
Claim 26 (and dependents) is drawn to a polypeptide zinc-finger repressor construct comprising an engineered zinc finger DNA-binding domain coupled to a Kruppel-associated box (KRAB) transcription repressor, wherein the zinc finger DNA-binding domain comprises at least six zinc-finger sequences, wherein the zinc finger sequences bind to a target nucleic acid sequence in a gene encoding a gene product, wherein the gene product is SCN9A, wherein expression of the gene product is inhibited, and wherein the target nucleic acid sequence is selected from any one of SEQ ID NOS: 108-122.
Claim 29 (and dependent) is drawn to a polynucleotide encoding a polypeptide zinc-finger repressor construct comprising an engineered zinc finger DNA-binding domain coupled to a transcription repressor, wherein the zinc finger DNA-binding domain comprises at least six zinc-finger sequences, wherein the zinc finger sequences bind to a target nucleic acid sequence in a gene encoding a gene product, wherein the gene product is SCN9A, wherein expression of the gene product is inhibited, and wherein the target nucleic acid sequence is selected from any one of SEQ ID NOS: 108-122.
Claim 31 (and dependents) is drawn to a vector containing the polynucleotide of claim 29.
Amount of direction provided by the inventor and existence of working examples:
Exhibit B (reproduced below) in the Declaration filed by Applicant on 9/8/2025 demonstrates HuH-7 and IMR-90 cells transduced with eleven zinc-finger designs wherein ZF 1 through ZF 11 correspond to SEQ ID NOS: 112 through 122 respectively. Specifically, a significant level of repression was observed only for ZF 5, 7, and 9 (SEQ ID NOS: 116, 118, and 120, respectively) in both HuH-7 and IMR-90 cell lines. Other ZF did not function to significantly repress transcription.
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State of the prior art, level of predictability in the art, and level of one of ordinary skill:
As evidenced by Exhibit B in the Declaration provided by Applicant, not all of the zinc fingers designed were capable of repression in all cell types because variable results were achieved. Furthermore, Exhibit B shows that instantly claimed SEQ ID NOS: 108 through 111 were not tested in either cell type. Therefore, it is evident that the level of unpredictability is high because Applicant provided evidence that shows that sequences besides SEQ ID NO: 116, 118, and 120 do not function as a repressor.
Quantity of experimentation:
In view of the breadth of the claims which embrace a target nucleic acid sequence from any one of SEQ ID NOS: 108-122, the state and level of unpredictability, the lack of working examples to show that sequences other than SEQ ID NOS: 116, 118, and 120 are capable of repression, one of skill would have to perform undue experimentation in order to practice the invention commensurate in scope with the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 recites the following:
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Claim 28 depends on claim 26 and claim 26 requires that the transcription repressor is KRAB; therefore, claim 28 does not further limit the claim which it depends on.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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