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 .
Status of the Claims
The amendments filed 16June2026, 03September2025, and 12August2025 are acknowledged and have been fully considered. Claims 1-4 (filed 12August2025) are pending, original, and examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63033273 filed 02June202] and 35 U.S.C. 121 [divisional of 17335264 filed 01June2021, now US Pat. No. 12410438].
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claim(s) 1 (therefore, also claims 2-3 which refer thereto and do not correct the issue) is/are 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 1 is directed toward a “guide” nucleic acid (i.e., a nucleic acid molecule), but then says that the nucleic acid binds to a target site in an endogenous CORYNE gene. The word “endogenous” does not have meaning when the nucleic acid molecule is outside of a cell (= which is why claim 4 is not rejected here). To exemplify the issue, please consider that “endogenous” in these claims leaves one to ask “endogenous to what?”—what is the genome to which the CRN is “endogenous” to?
Claims 1-4 are 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.
Lines 1-2 of claim 1 (to which claims 2-4 refer) say that the claimed nucleic acid molecule binds to a target site within a CORYNE (CRN) gene. However, the references to sub-sequences/fragments make the claims indefinite. To be clear, these claims say that the endogenous CRN gene may consist of just SEQ ID NO: 125 (78 nucleotides long), 124 (93 nucleotides long), or 123 (133 nucleotides long) or encode the sequence SEQ ID NO: 119 (44 amino acids long), 120 (64 amino acids long), or 121 (84 amino acids long). In view of the specification and prior art, a gene consisting of SEQ ID NO: 123, 124, or 125 or that encodes SEQ ID NO: 119, 120, or 121 would not be recognized as an “endogenous CRN” gene because those sequences are only sub-sequences/fragments of a full-length CRN sequence.
Please clarify in the claims that the targeted full length endogenous corn CRN gene comprises a nucleotide sequence having at least 95% sequence identity to SEQ ID NO: 122 or comprises a nucleotide sequence that encodes an amino acid sequence comprising at least 95% sequence identity to SEQ ID NO: 118. Thereafter, Applicant may say (e.g., in a “wherein” clause or dependent claim) that the endogenous corn CRN gene also comprises a fragment characterized by comprising one of SEQ ID NOs: 123-125 or by encoding one of SEQ ID NOs: 119-121.
Claim Rejections - 35 USC §§ 101 & 112 - Utility
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by a specific and substantial asserted utility or a well-established utility.
These claims are directed toward any nucleic acid (i.e., any nucleic acid molecule) that can bind to a CORYNE (CRN) gene. There is no other structural requirement in these claims. To that end, please note that “guide” in this context is an intended use and, therefore, not limiting. Please note also that the presence of a guide nucleic acid (even one that is targeted to a specific sequence via a spacer) does not mean that a mutation, or a particular mutation, is introduced into the target sequence.
The specification explains guide RNAs which comprise one of the spacer sequences SEQ ID NO: 126-130 may be used, within a CRISPR/Cas editing system and within a corn plant cell, to edit corn’s endogenous CRN and, thereby, to arrive at a corn plant/part with agronomically beneficial phenotypes (see pages 81-84).
There is no disclosed, nor well-recognized, specific or substantial use of one such nucleic acid (1) which [RE claim 1] does not comprise a spacer sequence (please note that a nucleic acid molecule that does not comprise a spacer would not be recognized as being useful as a “guide nucleic acid”, i.e. a nucleic acid that binds to a specific target site) and (2) which [RE claim 2] is outside of a CRISPR/Cas editing system.
It would be remedial of issues (1) and (2) for the recitations of claims 1, 2, and 3 to be combined into one claim.
As summarized at MPEP § 2103 (I)(A): “the claimed invention as a whole must be useful. The purpose of [the Utility] requirement is to limit patent protection to inventions that possess a certain level of ‘real world’ value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research” (internal citations omitted). See MPEP §§ 2164.01(c) and 2107.01-.03, e.g., 2107.02(III)(A) (“… a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.”).
Claims 1-2 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over JE et al. (“The CLAVATA receptor FASCIATED EAR2 responds to distinct CLE peptides by signaling through two downstream effectors” 2018 7: e35673 (21 total pages); of record IDS 12August2025) and HAZAK et al. (“Perception of root-active CLE peptides requires CORYNE function in the phloem vasculature” 2017 EMBO Reports 18(8): 1367-1381).
JE et al. teach mutant endogenous corn CORYNE (CRN) genes (ZmCRN) and the association between mutant ZmCRN genes with changes in Kernel Row Number (KRN) (see pages 3, 5, and Figure 2 thereof).
JE et al. do not teach the use of CRISPR/Cas gene editing to generate mutant ZmCRN genes (i.e., JE et al. do not teach guide nucleic acid molecules). In particular, JE et al. teach Mutator transposon insertion and a premature stop codon at residue Glutamine (Gln) Q357 (see Figure 2 on page 6).
HAZAK et al. teach mutant Arabidopsis CRN genes obtained using CRISPR/Cas gene editing (see the right column of page 1370).
Absent evidence to the contrary, it would be obvious to a person with ordinary skill in the art at the time this application was filed (a “POSA”) to utilize CRISPR/Cas gene editing (as taught by HAZAK et al.) to generate the ZmCRN mutants taught by JE et al. at least because CRISPR/Cas gene editing is known and efficient means to generate mutant sequences; and with the motivation of impacting KRN. This is believed to be true because it would be no more than “using a known technique [CRISPR/Cas gene editing] to improve similar products [ZmCRN] in the same way” (MPEP § 2143(I)(C)), “applying a known technique [CRISPR/Cas gene editing] to a known method [Mu transposon and premature stop codon mutation] ready for improvement to yield predictable results” (MPEP § 2143(I)(D)), or, at the very least “obvious to try” (MPEP § 2143(I)(E)).
It would be remedial of this rejection to incorporate claim 2 into the rejected claims. This is recommended because the Office is not aware of evidence showing that JE et al. or HAZAK et al. teach or suggest targeting the specific CRN gene sites which would be targeted by a guide nucleic acid comprising the spacer sequence SEQ ID NO: 126, 127, 128, 129, or 130.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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