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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Specification
Figs. 2-4 disclose nucleotide or amino acid sequences, which are also disclosed in the sequence listing. Neither the figures nor the brief descriptions of those figures on page 7 refer to the sequences by their sequence identifiers, as required by 37 CFR 1.821(d).
The respective sequence identifiers should be inserted either into the figures or into the brief descriptions of those figures on page 7 while describing the figures.
Claim Status
Claims 7-10 and 13-17 are pending and being examined.
All previous objections and rejections not set forth below have been withdrawn in view of applicant’s amendments to the claims.
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 7-10 and 13-17 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “gene” in claims 7-8 is recited to describe SEQ ID NO: 4. Instant SEQ ID NO: 4 does not indicate the Dt2 gene but the cDNA sequence (spec, page 10, para 5, line 1-2) corresponding to the coding sequence of the gene. But the specification also refers to SEQ ID NO: 4 as a gene (p. 3, 6th paragraph), and also as a coding sequence of a gene (p. 2, 5th paragraph). The specification does not comprise a definition for “gene”. The accepted meaning of the term gene comprises promoters, enhancers, coding regions (exons), non-coding region (introns) and other regulatory elements, as applicable. The Dt2 gene surely encodes for the cDNA comprising SEQ ID NO: 4.
The term is indefinite because the specification does not clearly redefine the term. All the claims dependent from claims 7-8 also inherit the indefiniteness.
It is suggested to replace the term “having” in claims 7 (line 3) and claim 8 (line 3) with “encoding”. In an effort to provide a better customer service and compact prosecution, the Examiner interpreted the relevant claims in line of the suggestion mentioned above to continue examination.
Regarding claims 7 and 8, It is not clear to the examiner what the Applicant mean by “the legume is in DN50 background”. Does any plant species which is an offspring of or originating from a cross with the soybean variety DN50, qualify as “a legume in DN50 background”? What percentage of genotype or genes from DN50 soybean variety needs to be in the plant to qualify as “a legume in DN50 background”? The Applicant does not define the term “background” in the context of the invention. It is suggested to replace “in DN50 background” with “soybean variety DN50”.
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.
Claims 7-10 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ping et al. (Dt2 Is a Gain-of-Function MADS-Domain Factor Gene That Specifies Semideterminacy in Soybean, 2014, The Plant Cell, 26:2831–2842) in view of Kou et al. (Natural variation of the Dt2 promoter controls plant height and node number in semi‑determinant soybean, 2021, Mol. Breeding, 41: 40) and Jacobs et al. (Targeted genome modifications in soybean with CRISPR/Cas9, 2015, BMC Biotechnology, 15:1-10), in evidence of Wang et al. (GmSnRK1.1, a Sucrose Non-fermenting-1(SNF1)-Related Protein Kinase, Promotes Soybean Resistance to Phytophthora sojae, 2019, Front. Plant Sci. 10:996), Xu et al. (Responses of Branch Number and Yield Component of Soybean Cultivars Tested in Different Planting Densities, 2021, 11:69).
Claim 7 is drawn to a method for improving yield or increase in branch numbers of a legume in DN50 background by inactivating the function of a gene encoding the cDNA comprising SEQ ID NO: 4.
Ping et al. describes Soybean (Glycine max) stem growth habit is a key adaptation and
agronomic trait that directly affects soybean yield among many other traits (page 2831, left column, para 1, line 1-5). t Ping et al. teaches a Shoot Identity 2 (DT2) gene in soybean, which is a legume. The genomic DNA sequence encoding the MADS-box protein DT2 (GenBank Accession No. KF908015) encodes a mRNA sequence which is having 100% sequence identity to SEQ ID NO. 4, as discussed in the previous Office action dated 04/09/2025 (page 4-8). Ping et al. describe that Dt2 is a relatively new gain-of-function mutation which occurred after the domestication of cultivated soybeans (page 2838, left column, para 1, line 6-7) and Dt2 represses the expression of Dt1 (abstract, line 8-9; page 2838, left column, para 1, last 3 lines).
Kou et al. describes that lower expression of Dt2 gene in soybean releases the inhibition (repression) of Dt1 expression which increases number of nodes and grain yield (abstract).
Before the effective filing date of the invention, it would have been obvious to the ordinarily skilled artisan to downregulate or inactivate the Dt2 gene, as described by Kou et al., to relieve the Dt2-mediated repression of Dt1 gene, as described by Ping et al. and Kou et al, in the approved soybean variety DN50, which is routinely used for gene transformation experiments, as evidenced by Wang et al. (page 2, right column, para 3, line 5-6).
Before the effective filing date, an ordinarily skilled artisan would have been motivated to inactivate the Dt2 gene in the elite soybean variety DN50 to increase yield and increase branch number which is directly correlated to number of nodes, as described by Xu et al. (page 10, para 2, line 1-5).
Regarding claims 13-14, Ping et al. teaches a legume plant (soybean) belonging to the genus Glycine (Glycine soja) (abstract).
Regarding claim 8 and 15, gene inactivation by knocking out is a well-known standard process in the art, as described by Jacobs et al. (abstract).
Jacobs et al. describes a highly specific genome editing tool in soybean by using CRISPR-Cas9 based targeted gene editing technique comprising a guide RNA (sgRNA or gRNA) as (page 1, abstract; left column, last para). sgRNA reads on to sgRNA, as described by the Applicant (spec, page 5, para 4, line 1-2). Jacobs et al. also describes developing a vector system to simplify the production of CRISPR/Cas9 targeting vectors, which is applicable for targeting any gene in a plant including soybean (page 1, abstract) to produce a variety of mutations including deletions, SNPs, insertions, and replacements (page 3, left column, para 3, line 5-7) and, thus can inactive one (page 3, left column, para 3, line 1-3) (instant claim 8) or more (page 3, left column, para 4, line 1-9) (instant claim 9) target gene(s) in the plant using one or more gRNAs, as needed. In plants, such targeted genome editing is a standard practice and used to knockout genes, modify gene expression by disrupting promoter sequences, or insert transgenes at a specific location via homologous recombination (page 1, right column, para 2). Jacobs et al. also describes more than one gRNA target sequences (page 8, left column, para 1) cloned in expression vectors comprising Kanamycin (nptII) and Hygromycin (hpt) antibiotic resistance markers (Jacobs et al., 2015, additional file 6), used in Agrobacterium mediated transformation including using Agrobacterium tumefaciens (page 6, right column, para 1) (cf. instant claim 8). Jacobs et al. also describes the process and the requirements to design the gRNA sequence comprising about 20 bp, including 22-23 bp, sequence homology with the coding region of specific target gene(s) (page 1, right column, para 1; page 7, right column, last para). Choosing any specific sequence in the target gene within its coding region containing about a 20 nucleotide stretch of homology to design the guide RNA sequence, as described by Jacobs et al., is within the experimental design choice of an ordinarily skilled artisan without altering the outcome. It would have been obvious to a person of ordinary skill in the art to choose about 20 bp long gRNA sequence comprising instant SEQ ID NOs: 9 or 10 (as recited in claim 10) mutate and, thus, inactivate the Dt2 gene.
Moreover, designing specific gRNA sequence is a routine standard practice in the art especially if the target sequence comprising the coding sequence (cDNA sequence) of the target gene is already known. It is noted that instant SEQ ID NO: 4 encoding the cDNA of Dt2 gene has 100% sequence identity to instant SEQ ID NOs: 9-10 (data not shown).
Before the effective filing date of the invention, it would have been obvious to a person with ordinary skill in the art to inactivate the Dt2 gene encoding the cDNA sequence consisting of SEQ ID NO. 4 in DN50 soybean variety, as described by Ping et al. in view of Kato et al. and in evidence of Wang et al., by using CRISPER/Cas9 gene editing technique comprising a suitable gRNA, as taught by Jacobs et al., to transform the growth habit of the DN50 soybean plants to indeterminate type, as described by Ping et al. in view of Kato et al. and in evidence of Wang et al.
Before the effective filing date of the instant invention, a person with ordinary skill in the art would have been motivated to knockout or inactivate the Dt2 gene in the established DN50 soybean variety with a realistic goal to transform it into an indeterminate type to increase yield and branch number.
Regarding claims 16-17, Ping et al. teaches a legume plant, soybean (Glycine soja) (abstract).
Conclusion
All claims are rejected.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662