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 .
Amendments
In the reply filed 3/30/2026, Applicant has amended Claims 1 and 2, cancelled claims 5-7, 14-18, 21 and added new claims, Claims 23-26.
Claims 1-4, 8-10, 13, 19-20, 22-26 are under consideration.
Withdrawn Objection to Drawings
The prior objection to Figure 2 of the Specification as not conforming to sequence rules, requiring the use of “SEQ ID NO:” is withdrawn in light of Applicant’s amendments.
Withdrawn Objection to Specification
The prior objection to the disclosure because it contained an embedded hyperlink and/or other form of browser-executable code is withdrawn in light of Applicant’s amendments.
Objection to Specification
Sequence Compliance
As stated in the Office action mailed 9/30/2025, where the description of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description of the patent application. 37 CFR 1.821 (d). Specifically, the peptide sequences of Tables 2, 4, 6 & 7, and nucleic acid sequences in Example 10, p. 111 of the disclosure indicate sequences are an unbranched sequence of 4 or more amino acids or an unbranched sequence of 10 or more nucleotides. Branched sequences are specifically excluded from this definition. Sequences with fewer than four specifically defined nucleotides or amino acids are specifically excluded from this section.
The applicant is reminded that the specification must be amended in order to comply with regulations cited above. All references to sequences in the specification should be referred to as “SEQ ID NO:1”, for example. To avoid all doubts of the examiner and to ensure correct interpretation of the specification, the identification of sequences with proper sequence identifiers is required.
Withdrawn Claim Objections
The objection to Claim 1 has been withdrawn due to applicant’s amendment.
Withdrawn Claim Rejections - 35 USC § 112(a)
(Written Description & Scope of Enablement)
The prior rejection of Claims 1-2, 4, 8-10, 13, 19-20, and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments of instant claims to describe zinc finger polypeptide sequences for binding a GGGGCC sequence.
(Scope of Enablement)
The prior rejection of Claims 1-2, 4, 8-10, 13, 19-20, and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s amendments of instant claims to recite zinc finger polypeptide sequences capable of binding a GGGGCC sequence.
Withdrawn Claim Rejections - 35 USC § 112(b)
The prior rejection of Claims 1-4, 8-10, 13, 19-20, and 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicant’s amendments of Claim 1 to consistently claim between 1-18 zinc finger domains, and Claim 2 to no longer recite “Table 2”.
New Claim Rejections - 35 USC § 112(a)
NEW MATTER
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 1-4, 8-10, 13, 19-20, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new limitations of “F2-F18” and “F3-F18” in independent claim 1 appears to represent new matter. MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen , 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” Although the basis for this limitation was identified in Applicant’s remarks filed 3/30/2026 as being supported by specification, claims and figures as originally filed, a review of the specification by the Examiner did find both literal and implicit support for the ranges of F2, F4, F6, F8, F10, F12, F14, F16, F18, as well as for F3, F5, F7, F9, F11, F13, F15, F17 in Applicant’s Tables; however, the Examiner did NOT find any specific basis for the recited range limitations of F2-F18 and F3-F18. As noted by MPEP 606.03(o), new matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. In instant case, one skilled in the art would NOT consider a series of every other F domain to be inherently or implicitly supported by the recited range of the entire series of F domains (see also MPEP 2163.05 (III) Range Limitations).
New 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 1-4, 8-10, 13, 19-20, and 22 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitations that a given SEQ ID NO corresponds to the zinc finger domains of “F2-F18” and “F3-F18”. Since the ranges of F domains are overlapping, a single F domain (e.g., F3) can correspond to two different SEQ ID NOs. The scope of the claim is unclear as to which SEQ ID NO corresponds to which F domain. Dependent Claims 2-4, 8-10, 13, 19-20, and 22 are included in the basis of this rejection because they do not clarify which SEQ ID NO corresponds to which F domain.
Claim 23 recites the limitations that a given SEQ ID NO corresponds to the zinc finger domains of F2, F4, F6, F8, F10 “etc” and F3, F5, F7, F9, F11 “etc”. The term “etc” renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "etc"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). It is recommended Applicant spell out the F series such as “F2, F4, F6, F8, F10, F12, F14, F16, F18”, and “F3, F5, F7, F9, F11, F13, F15, F17”. Dependent Claims 24-25 are included in the basis of this rejection because they do not clarify the F series.
Claim 24, instant claim recites the limitation that the zinc finger domain pattern is from “Table 2”. A claim may be rendered indefinite by reference to a table (see MPEP 2173.05(s)). Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Appropriate correction is required.
Allowable subject matter
Independent Claims 1 and 25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 1st paragraph and under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2nd paragraph, set forth in this Office action. Specifically, the prior art does not teaches or suggest the a zinc finger protein comprising the claimed arrangement of SEQ ID NOs, which were shown by Applicant to be capable of binding a GGGGCC motif and regulate a GGGGCC containing gene.
Conclusion
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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