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 .
Priority
Acknowledgement is made of applicant’s claim for benefit under 35 U.S.C. 119(e). As such, the
effective filing date of Claims 1-2, 6-8, 11, 14, 17, 24, 30, 32-33, 48, 50, 60, 62, 100-103 is 03/02/2022.
Status of the Claims
Amendments dated 11/19/2025 have been entered.
Claims 1-2, 6-8, 11, 14, 17, 24, 30, 32-33, 48, 50, 60, 62, and 100-103 are pending.
Claims 1-2, 6-8, 11, 14, 17, 24, 30, 32-33, 48, 50, 60, and 103 are withdrawn from consideration for being directed to a non-elected invention.
Claims 62 and 100-102 are examined herein.
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.
---The following are new rejections from those set forth in the Office Action dated 08/26/2025 in view of Applicant’s amendments to the claims. Applicant’s Remarks dated 11/19/2025 have been reviewed and are deemed inapposite to the new rejections.---
Claims 62 and 100-102 remain 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.
Claims 62 and 101 recite the term “complementary” which renders the claims indefinite. Applicant does not define the term “complementary”, in reference the instantly claimed guide nucleic acid as a whole, in the claims or instant specification in such a way that one of ordinary skill in the art would be reasonable apprised of the meets and bounds of the claimed invention. Applicant defines the term “complementary” as “natural binding of polynucleotides under permissive salt and temperature conditions by base-pairing” (pg. 27, lines 1-2), wherein “complementarity between two single-stranded molecules may be "partial," in which only some of the nucleotides bind, or it may be complete when total complementarity exists between the single stranded molecules.” (pg. 27, lines 4-6) In view of the Applicant’s definition of the term “complementary”, it is unclear what degree of complementarity is required by the claims for a guide nucleic acid to be partially complementary to a target site in a soybean BRI1 gene, from about nucleotide 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69. In other words, what degree of complementarity is Applicant requiring the guide nucleic acids to be relative to the claimed target site, to be partially complementary nucleotides 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69 (i.e., 5%, 10%, 95%, or 99% complementary) and is only a portion of the guide nucleic acid required to be partially complementary? Additionally, it is unclear what is required for a guide nucleic acid to be fully complementary a target site in a soybean BRI1 gene, from about nucleotide 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69. Does that mean the guide nucleic acid must the 100% complementary across all of nucleotides 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69 or only certain portions of nucleotides 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69, and if so, what portions? This logic flows to the nucleotide sequences recited in Claim 101. As such, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention. For purposes of examination, the broadest reasonable interpretation of the term “complementary” will encompass any guide nucleic acids with any degree of complementarity to a target site in a soybean BRI1 gene, wherein the target site is in a region of the soybean BRI1 gene located from about nucleotide 2-213 with reference to nucleotide position numbering of SEQ ID NO: 69. This determination does not relieve Applicant from their duty to amend the claims in any further correspondence.
All dependent claims thereof are included in the rejection for the same reasons as given above.
Claim Rejections - 35 USC § 112
Written Description
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.
---The following are new rejections from those set forth in the Office Action dated 08/26/2025 in view of Applicant’s amendments to the claims. Applicant’s Remarks dated 11/19/2025 have been reviewed and are deemed inapposite to the new rejections.---
Claims 62 and 100-102 remain 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 Federal Circuit has clarified the written description requirement. The court stated that a
written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
The court also concluded that "naming a type of material generally known to exist, in the absence of
knowledge as to what that material consists of, is not description of that material". Id. Further, the court
held that to adequately describe a claimed genus, Patent Owner must describe a representative number
of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
Claims 62 and 100-102 are broadly directed to any guide nucleic acid known in the art that is complementary to a target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene, wherein the target site is in a region of the soybean BRI1 gene at positions that correspond to nucleotides 2-213 with reference to nucleotide position numbering of SEQ ID NO:69 (elected species).
As discussed in the 35 U.S.C. §112(b) rejection above, the specification does not define or adequately describe the claimed term “complementary” in such a way that one of ordinary skill in the art would be able to identify guide nucleic acids that are adequately complementary to the target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene from guide nucleic acid that are not adequately complementary to the target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene. Applicant does not describe the degree of complementarity required by the claims for a guide nucleic acid to be “complementary” to the claimed the target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene. Applicant does not describe whether the instant claims require the guide nucleic acids to be 100% complementary across the whole length of the target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene or if the sequences be only fully complementary to portions of the target site in a soybean Brassinosteroid Insensitive- 1 (BRI1) gene. Furthermore, if the sequences can be partially complementary to the claimed nucleic acid sequences, Applicant does not describe the degree of complementarity that is required by the instant claims (i.e., 5%, 10%, 95%, or 99% complementary), if it required to be partially complementary across the whole target site, or only portions of the target site.
Applicant describes a method of gene editing generating edits in the 5' regulatory region of the soybean BRI1 genes of Glyma.06gl47600 (SEQ ID NO:72) and Glyma.04g218300 (SEQ ID NO:83) to remove or modify upstream open reading frames which are present in the transcript of the BRI1 gene. To generate a range of alleles, Applicant designed CRISPR guide nucleic acids comprising one or more spacers (SEQ ID NOs: 99-103) having complementarity to targets within both of the BRI1 soybean genes placing the guide nucleic acids into a construct for editing (pg. 90, Example 1, lines 28-33). Applicant does not explicitly describe any guide nucleic acid with full complementarity relative to the instantly target site. Applicant does not explicitly describe any guide nucleic acid with any degree of partial complementarity to the instantly claimed target site. Applicant does not describe the degree of complementarity of the guide nucleic acids relative to the target site used in the working or prophetic examples. Applicant does not describe whether the guide nucleic acids are partially complementary or fully complementary to the target site. If the guide nucleic acids in the working examples are fully complementary to the target site, Applicant does not describe if the guide nucleic acid is 100% complementary across the whole target site or portions of the target site. If the guide nucleic acids are partially complementary to the target site, Applicant does not describe the degree of complementarity using sequence identity, if the partial complementarity is across the whole target site, or if the partial complementarity is only present over portions of the target site. Based on the Applicant’s disclosure, it is unclear if the only part of the guide nucleic acid that is complementary to the target site is the one or more spacers (SEQ ID NOs: 99-103, or 96-100 as instantly claimed). If the spacer is the only portion of the guide nucleic acid that is required to be complementary to the target site, Applicant does not describe what degree of complementarity is required (i.e., Full complementarity across the whole spacer sequence or only a part of the spacer? Partial complementarity across the whole spacer sequence, and to what degree? Partial complementarity across only a portion of the spacer sequence, and to what degree?). The instant application fails to provide guidance for which nucleic acids of the instantly claimed guide nucleic acids must be fully complementary to the instantly claimed target site for the guide nucleic acid to hybridize to the target site. The instant application fails to provide guidance for which nucleic acids of the instantly claimed guide nucleic acids can be partially complementary to the instantly claimed target site for the guide nucleic acid to hybridize to the target site.
Applicant has failed to describe a representative number of species of guide nucleic acids that have any degree of complementarity to the instantly claimed target site. Applicant has failed to describe a representative number of species of guide nucleic acids that have any degree of complementarity relative to the instantly claimed target site that hybridize to the target site.
Hence, Applicant has not, in fact, described the vast genus of guide nucleic acids that could have any degree of complementarity to the instantly claimed target site and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of exemplified species of the claimed guide nucleic acids and the lack of written description with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Closest Prior Art
Claims 62 and 100-102 appear to be free of the prior art. The closest prior art can be found in the combination of Zhang et al. ( Nature Biotechnology 36.9 (2018): 894-898; IDS Document) and Sun et al. (Scientific reports 5.1 (2015): 10342).
Zhang et al. teaches gene editing of upstream uORFs in a gene to enhance its translation, specifically disclosing methods of gene editing the uORF of AtBRI1 (AT4G39400). To generate mutants of uORFs in AtBRI1, Zhang teaches AtBRI1uORF-sgRNA, a guide nucleic acid that targets the uORF of BRI1 in Arabidopsis (ecotype Col-0) (Online Methods, Plasmid construction). Zhang teaches the target site of AtBRI1uORF-sgRNA (Figure 2(a); the uORF sequence (blue) is shown with the sgRNA target site underlined and the protospacer-adjacent motif shown in bold). When compared to SEQ ID NO: 69, the target site of the AtBRI1uORF-sgRNA (See Figure 2(a); WT) would have some degree of binding relative to instant SEQ ID NO: 69, as shown in the following sequence alignment.
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352
594
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Greyscale
The target site for the exemplified guide nucleic acid corresponds to nucleotides 2-213 relative to SEQ ID NO: 69. Specifically, the target site for AtBRI1uORF-sgRNA shows a degree of recognizable complementarity to nucleotides 97-121 relative to SEQ ID NO: 69.
Sun et al. teaches using the CRISPR-Cas9 system to efficiently perform targeted mutagenesis in soybean (pg. 2, Introduction, last paragraph). Sun also teaches that designing and implementing CRISPR-Cas9 gene editing components, which includes sgRNA compositions, is routine and well-known in the art and is used across a wide variety of plant species for crop improvement (pg. 2, Introduction, second to last paragraph). Specifically, Sun teaches designing sgRNA to create targeted mutations in endogenous soybean genes (pg. 8, Methods, Vector construction, second paragraph), including spacer elements to target endogenous genes of interest in soybean (See Figures S2-S7, S9-S10, and Table S2).
However, neither Zhang, Sun, nor any other disclosure in the prior art teach a guide nucleic acid or any genus of probe that specifically targets a soybean BRI1 gene or a motivation to target the soybean BRI1 gene for any method of gene editing or mutation of the endogenous soybean gene, wherein the guide RNA or probe has any degree of complementarity to a target site within the soybean BRI1 gene.
Conclusion
No claims are allowed.
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 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 KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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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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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663