Prosecution Insights
Last updated: April 19, 2026
Application No. 18/701,455

A SYNTHETIC GENE EXPRESSION REGULATOR AND A PROCESS FOR PRODUCING HYBRID CROPS USING THEREOF

Non-Final OA §103§112
Filed
Apr 15, 2024
Examiner
DEVEAU ROSEN, JASON
Art Unit
1662
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Szkola Glowna Gospodarstwa Wiejskiego W Warszawie
OA Round
1 (Non-Final)
80%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
96%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allow Rate
658 granted / 821 resolved
+20.1% vs TC avg
Strong +16% interview lift
Without
With
+16.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
32 currently pending
Career history
853
Total Applications
across all art units

Statute-Specific Performance

§101
5.7%
-34.3% vs TC avg
§103
20.2%
-19.8% vs TC avg
§102
17.7%
-22.3% vs TC avg
§112
43.3%
+3.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 821 resolved cases

Office Action

§103 §112
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 . Claim Status Claims 1-17 are pending and examined. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement (e.g., see p. 17). 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. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Required response – Applicant must provide: Replacement and annotated 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 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. Specification On page 11, paragraph 2, the specification refers to “Annex A”. It is not understood to what “Annex A” refers. The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use. Arrangement of the Specification As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading: (a) TITLE OF THE INVENTION. (b) CROSS-REFERENCE TO RELATED APPLICATIONS. (c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT. (d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. (e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM. (f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. (g) BACKGROUND OF THE INVENTION. (1) Field of the Invention. (2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98. (h) BRIEF SUMMARY OF THE INVENTION. (i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S). (j) DETAILED DESCRIPTION OF THE INVENTION. (k) CLAIM OR CLAIMS (commencing on a separate sheet). (l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet). (m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system. Here, Applicant has failed to provide a section for a brief description of the drawings. Moreover, it appears that Applicant has not provided descriptions for all of the drawings (i.e., descriptions for Fig. 5, 6, 7, 9, 12, 20, 32, 33 and 34 are missing). Appropriate action is advised. Claim Objections Claim 1 line 3 should recite the limitation --the-- as opposed to “a” phenotypic traits to properly refer back the previous instance of “phenotypic trait” in line 1. It is suggested throughout the claims that the limitation “characterized in that” be replaced with --wherein--. Wherein referring to sequence identifiers, it is suggested the limitation “shown as” be replaced with the limitation --as set forth in--. In line 6 of claim 13 Applicant should remove the limitation “,cells”. Appropriate action is advised. 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 1-17 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 recites the limitation a plant gene “related” to a phenotypic trait of male sterility. Here, the specification fails to define the limitation “related”, while one of skill in the art would understand the limitation “related” as being synonymous with meanings such as “associated” or connected by common ancestry. Therefore, the metes and bounds of the claim are indefinite because it is not clear if the claimed gene , in fact, confers a phenotypic trait, or, if it is merely associated with other genes that may confer the phenotypic trait, or, if the gene “related” to a phenotypic trait is a paralog or ortholog of a gene that actually confers said phenotypic trait. Claim 1 also recites the limitation “a protein binding domain of the plant gene” related to a phenotypic trait of male sterility (MS). Meanwhile, the specification defines a protein binding domain as DNA binding domains or transcription factors, endonucleases and Cas proteins (p. 5, ¶ 1). The figures reiterate this definition of “a protein binding domain” (e.g., see Fig. 1 A; see also p. 7, Example 1). Therefore, the metes and bounds of the claim are indefinite because it is not clear if “a protein DNA binding domain” of the plant gene related to a phenotypic trait of male sterility comprises nucleotides of the gene related to MS, or, if the “a protein DNA binding domain” does not comprise nucleotides of the gene related to a phenotypic trait of MS but is instead a protein that targets/binds to said gene. Claim 1 recites the limitation “the” gene linked with the former. There is no antecedent basis for this limitation because there is no “gene” in the synthetic expression regulator but rather domains and activators/repressors that are linked to the “protein DNA binding domain” (e.g., see Fig. 1 A). Finally, claim 1 recites the limitation “the” element that controls expression of the sterility gene. The metes and bounds of the claim are indefinite because it is not clear as to what “element” the claim refers (i.e., there is no antecedent basis for the limitation “the” element). A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation crop gene, and the claim also recites wheat gene which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Moreover, the metes and bounds of the claim are indefinite because it is not understood what is meant by the limitation “crop gene” as the specification fails to define said limitation. Claims 4 and 6 present the same issue by reciting the limitation “such as” and are therefore rejected for the same reason as claim 2. Claim 3 recites the limitation “selected from a group including”. The metes and bounds of the claim are indefinite because it is not clear if group is inclusive (i.e., a group comprising RNA molecules) or exclusive (i.e., a group consisting of RNA molecules). Claims 4 and 6 present the same issue and are therefore rejected for the same reason as claim 3. Claim 7 is drawn to a protein activator having the amino acid sequence as set forth in SEQ ID NO: 2. The metes and bounds of the claim are indefinite because it is not clear how the amino acid sequence of SEQ ID NO: 2 may simultaneously be a DNA protein binding domain (e.g., see claim 5) and a protein activator domain. Claim 10 is drawn to an expression cassette: there is insufficient antecedent basis for this limitation as the claim from which claim 10 depends is not directed to an expression cassette but a synthetic expression regulator. Claims 10 and 12 are drawn to an expression cassette or vector characterized by the nucleotide sequences of SEQ ID NO: 13 and 14, respectively. The metes and bounds of the claim are indefinite because the polynucleotide sequences are only 20 nucleotides in light. Thus, it is unclear how the claims may be drawn to an expression cassette or vector. This is interpretation is supported by the specification which discloses that SEQ ID NO: 13 and 14 are expression cassettes and vectors comprising more than 20 nucleotides (e.g., see p. 11, last ¶; see also Fig. 8). Claims 5, 8-9, 11 and 13-17 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness. 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 1-17 is/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 synthetic regulator such as tadCas9::VP128-M1 activator as exemplified in Examples 7 and 10 of the instant specification, does not reasonably provide enablement for synthetic expression regulators as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims. In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows: Here, the claims are broadly drawn to a synthetic regulator of a plant gene “related” to a phenotype trait of MS containing a protein DNA binding domain of the plant gene related to the trait of MS and a protein activator or repressor domain for the transcription process of the gene linked with the former wherein the protein DNA binding domain forms a complex with an RNA molecule having a sequence complementary to the element that controls expression of the sterility gene, a process of incorporating said expression regulator into plants cells in a process to produce MS plants regenerated from said cells and a process for producing a hybrid plant by breeding said MS plant with a distinct inbred line. To summarize, the “synthetic regulator” is comprised of (1) a protein binding domain (e.g., an inactive Cas9: see p. 7, ¶ 2); (2) a protein activator or repressor; and (3) a linker between the two. This synthetic regulator in conjunction with an RNA molecule having a sequence complementary to the element that controls expression of the sterility gene will bind to the promoter region of a gene related to MS and either (1) activate expression of the gene related to MS or (2) repress expression of a gene related to MS. Meanwhile, the specification teaches various known genes related to a phenotypic trait of male sterility and (MS) that more than 100 genic male sterility (GMS) genes are known in plants (p. 4, last ¶). Introduction of this synthetic regulator lead to activation of expression of the MS2 gene in wheat which is known to be a dominant sterility gene (Example 10; see also p. 2, last ¶). As proof of principle, the specification teaches that a synthetic regulator as described supra activated the promoter of the MS2 gene leading to expression a visual marker confirming the efficiency of the synthetic regulator (Example 7). Here, the claims encompass a vast genus of synthetic expression regulators for use in any conceivable plant yet the specification fails to teach or provide the requisite guidance for (1) identifying and using genes related to MS; and (2) identifying and using RNA molecules having sequences complementary to elements that control expression of MS genes (e.g., gRNA). Moreover, the specification fails to provide working examples of genes related to MS and further fails to provide working examples of RNA molecules having sequences complementary to elements that control expression of MS genes that are commensurate in scope with what is claimed. These teachings are critical in light of the state of the art, which provides that teach that in addition to GMS genes there are also cytoplasmic male sterility (CMS) genes, and that many genes involved in MS have not yet been characterized in many species (Farinati et al, 2023, Frontiers in Plant Science,14:1-20.doi:10.3389/fpls.2023.1223861; see p. 2, col. 1, ¶ 1 and 2). Here, the claims encompass both GMS and CMS genes yet the specification has failed to provide any guidance for forming complexes with CMS genes related to MS. Regarding the RNA molecules as broadly claimed, Li et al teach that not all gRNA (i.e., an RNA molecule having a sequence complementary to the element) predictably activate expression of the desired target gene when used with dCas9 (2017, Nat Plants, 3(12)930-936. doi:10.1038/s41477-017-0046-0; p. 2, ¶ 1). Or see Alerasool et al, which teaches that disrupting gene function with CRISPRi is more sensitive to guide RNA selection with gene silencing often incomplete (2020, Nature Methods, 17:1093-1096. doi.org/10.1038/s41592-020-0966-x; p. 1093, col. 1, ¶ 1). Therefore, in light of the breadth of the claims, the lack of working examples, the failure of the specification to teach synthetic expression regulators commensurate in scope with what is claimed, and the state of the art which teaches that many genes related to MS have yet to be identified and that gRNA use is not predictable, the skilled practitioner would resort to systematic screening and testing of synthetic expression regulators as claimed which is tantamount to excessive and impermissible undue trial and experimentation. Claims 1-17 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. Instant claims 1-17 are broadly drawn to a synthetic regulator of a plant gene “related” to a phenotype trait of MS containing a protein DNA binding domain of the plant gene related to the trait of MS and a protein activator or repressor domain for the transcription process of the gene linked with the former wherein the protein DNA binding domain forms a complex with an RNA molecule having a sequence complementary to the element that controls expression of the sterility gene, a process of incorporating said expression regulator into plants cells in a process to produce MS plants regenerated from said cells and a process for producing a hybrid plant by breeding said MS plant with a distinct inbred line. To summarize, the “synthetic regulator” is comprised of (1) a protein binding domain (e.g., an inactive Cas9: see p. 7, ¶ 2); (2) a protein activator or repressor; and (3) a linker between the two. This synthetic regulator in conjunction with an RNA molecule having a sequence complementary to the element that controls expression of the sterility gene will bind to the promoter region of a gene related to MS and either (1) activate expression of the gene related to MS or (2) repress expression of a gene related to MS. Meanwhile, the specification describes various known genes related to a phenotypic trait of male sterility and MS that more than 100 GMS genes are known in plants (p. 4, last ¶). Introduction of this synthetic regulator lead to activation of expression of the MS2 gene in wheat which is known to be a dominant sterility gene (Example 10; see also p. 2, last ¶). As proof of principle, the specification teaches that a synthetic regulator as described supra activated the promoter of the MS2 gene leading to expression a visual marker confirming the efficiency of the synthetic regulator (Example 7). The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406. Here, the claims encompass a vast genus of synthetic expression regulators for use in any conceivable plant yet the specification fails to describe either a representative number of species from this broad genus of (1) genes related to MS; or (2) RNA molecules having sequences complementary to elements that control expression of MS genes (e.g., gRNA). Moreover, the specification fails to describe working examples of genes related to MS and further fails to provide working examples of RNA molecules having sequences complementary to elements that control expression of MS genes that are commensurate in scope with what is claimed. This description is critical in light of the state of the art, which describes that in addition to GMS genes there are also CMS genes, and that many genes involved in MS have not yet been characterized in many species (Farinati et al, see p. 2, col. 1, ¶ 1 and 2). Here, the claims encompass both GMS and CMS genes yet the specification has not described any of the latter. Regarding the RNA molecules as broadly claimed, Li et al describe that not all gRNA (i.e., an RNA molecule having a sequence complementary to the element) predictably activates expression of the desired target gene when used with dCas9 (p. 2, ¶ 1). Or see Alerasool et al, which describes that disrupting gene function with CRISPRi is more sensitive to guide RNA selection with gene silencing often incomplete (p. 1093, col. 1, ¶ 1). Therefore, in light of the breadth of the claims, the lack of working examples, the failure of the specification to describe a representative number of species from the broad genus of either plant genes related to MS or RNA molecules as claimed, and the state of the art which describes that many genes related to MS have yet to be identified and that gRNA use is not predictable, the skilled practitioner not be of the opinion that Applicant was in possession of the genus of synthetic expression regulators or processes of using them as broadly claimed. Claim Rejections - 35 USC § 103 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. Claim(s) 1-4, 6, 9, 11 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al (2019, Plant Biotechnology Journal, 14:1905-1913) in view of Li et al (2017, Nat Plants, 3(12)930-936. doi:10.1038/s41477-017-0046-0) and Alerasool et al (2020, Nature Methods, 17:1093-1096. doi.org/10.1038/s41592-020-0966-x). 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. Instant claims 1-4, 6, 9, 11 and 13-17 are broadly drawn to a synthetic regulator of a plant gene “related” to a phenotype trait of MS containing a protein DNA binding domain of the plant gene related to the trait of MS and a protein activator or repressor domain for the transcription process of the gene linked with the former wherein the protein DNA binding domain forms a complex with an RNA molecule having a sequence complementary to the element that controls expression of the sterility gene, wherein the gene is a wheat gene, wherein the RNA molecule is sgRNA, wherein the protein activator is SunTag or TV, wherein the repressor domain is a KRAB repressor domain, an expression cassette or vector comprising said synthetic regulator, a process of incorporating said expression regulator into plants cells in a process to produce MS plants regenerated from said cells, wherein the vector is introduce by particle bombardment and identified, and a process for producing a hybrid plant by breeding said MS plant with a distinct inbred line wherein the regulator is used as a dominant sterility trait. Okada et al teaches a CRISPR/Cas9 system to generate heritable targeted mutations in the wheat male fertility gene Ms1 for the rapid generation of male sterility in commercial wheat cultivars for use in hybrid seed production which captures heterosis and increase yield of crop (see Abstract; see also p. 1905 bridging p. 1906, col. 1). Thus, while Okada et al teach the silencing of a gene related to MS in a plant, the issue is whether one of ordinary skill in the art would have modified the teachings of Okada et al to activate or repress an element that controls expression of said gene rather than introduce mutations into said gene to control expression. To this point, Li et al teach an efficient Cas9-based transcriptional activation platform TV as in instant claims 1, 3, 4, 9 and 11 (see Abstract; see also p. 2, last ¶). This system is used in conjunction with gRNA and has been used with SunTag (see Abstract). Li et al teach this system provides a promising alternative strategy for gene activation in plants by tethering an autonomous transcription activation domain (TAD) to an intended promoter at endogenous genomic loci to upregulate crop genes conferring beneficial traits (see Abstract; see p. 5, ¶ 1 and last ¶ bridging p. 6). Meanwhile, Alerasool et al teaches catalytically inactive dCas fused to a KRAB repressor domain that is used with a gRNA is known in the art to disrupt gene function as encompassed by instant claims 1, 3, 6, 9 and 11 (p. 1093, col. 1, ¶ 1). Known as “CRISPRi”, this method is beneficial as it lacks the toxicity of Cas9 caused by double stranded breaks (p. 1093, col. 1, ¶ 1). The KRAB domain is known in the art to be a particularly strong repressor (p. 1093, col. 2, ¶ 1). Therefore, prior to the effective filling date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify the teachings of Okada et al by instead using the expression regulators as taught by Li et al and Alerasool et al because to do so would avoid the toxicity associated with double stranded breaks caused by CRISPR. One would have reasonable expectation of success in doing to because the MS2 gene is known to be involved in wheat MS and because both Li et al and Alerasool et al teach the successful use of the expression regulator as instantly claimed. In this way, one could rapidly generate male sterility in commercial wheat cultivars for use in hybrid seed production and breeding which captures heterosis and increase yield of crop Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm. 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, Joe Zhou can be reached at (571)272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
Read full office action

Prosecution Timeline

Apr 15, 2024
Application Filed
Nov 21, 2025
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
80%
Grant Probability
96%
With Interview (+16.3%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 821 resolved cases by this examiner. Grant probability derived from career allow rate.

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