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 .
This office action is in response to the amendment filed on June 30, 2025. Claims 1 and 2 have been cancelled. Claims 3 and 4 are currently pending and are under examination.
Any objections or rejections not reiterated below are hereby withdrawn.
Withdrawal of Rejections
The rejection of claims 3 and 4 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn based on the remarks filed on June 30, 2025 stating the transformation of a cell to produce a recombinant protein, wherein the recombinant protein satisfies a structural requirement based on formulas provided in the claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 11, 2025 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Pending Rejection(s)
Claim Rejections - 35 USC § 112
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 3 and 4 stand 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.
In claim 3, it is unclear what the designed DNA-binding protein is encompassed by. The metes and bounds of what is designed is unclear. What is the “designed” structure referring to? Claim 4 is rejected for depending on a rejected claim and failing to cure the indefiniteness.
Response to Remarks
Applicants respond to the 35 U.S.C. 112(b) rejection with the 35 U.S.C. 112(a), first paragraph rejection and state claim 3 as amended recites a specific combination of amino acids as the three amino acids of Number 1 AA, Number 4 AA, and Number “ii” (-2) AA that binds a target DNA base of a target DNA base sequence. Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive. The metes and bounds of the DNA-binding protein is unclear based on the formula provided. The three amino acids do not clearly define the DNA base selective manner of making a DNA-binding protein.
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 3 and 4 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection was explained in the office action mailed on April 4, 2025. The claims are rejected for failing to describe the structure of the genus of DNA-binding proteins that are encompassed by the claims. The method of determining the DNA-binding protein is not described.
Response to Remarks
Applicants respond to the 35 U.S.C. 112(b) rejection with the 35 U.S.C. 112(a), first paragraph rejection and state claim 3 as amended recites a specific combination of amino acids as the three amino acids of Number 1 AA, Number 4 AA, and Number “ii” (-2) AA that binds a target DNA base of a target DNA base sequence. Applicant states that given the common knowledge in the art and the guidance disclosed in the present specification, one of ordinary skill in the art would understand what is claimed. Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive.
MPEP § 2163 states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The specification aligns PPR domains and teaches a loose formula regarding if the PPR domain can bind to a DNA base in a selective manner. There is not a functional characteristics when coupled with a known or disclosed correlation between function and structure: One cannot follow the rules for determining PPR motif amino acids position number 1, position number 4 and position identified as (ii) in a PPR protein because the art does not recognize the amino acid numbering used in the specification to come up with the loosely achieved formula. There is nothing in Formula 1 that would tell anyone of skill in this art what comprises a Helix A- X- Helix B- L motif, no domain length, or conserved amino acid configuration.
As stated in the specification at page 3, para [0008], there are over 500 PPR protein and their PPR motifs have low conservation. Therefore, more identification of the motif must be provided to demonstrate that Applicants are in possession of the proteins as claimed by formula 1. Those working in this art are highly skilled. Predictability in the art: Based on the difficulty of determining formula 1 in any protein, or PPR protein, and then determining amino acids No 1, No. 4 and ii even if the sequence is provided in the prior art, it is not predictable what the protein that can bind in a DNA base selective manner could be. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species of the invention is sufficient (MPEP 2163). Claims 3 and 4 are broadly generic to all possible designed DNA-binding proteins encompassed by the claims. The possible variations are enormous to any class of polymeric amino acids.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 10:30-9:30 EST.
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/ANAND U DESAI/Primary Examiner, Art Unit 1656