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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/16/2026 has been entered.
Claim Status
Claims 1, 4-5, 8-10, 12-15 and 53-54 are pending and being examined.
All previous objections and rejections in previous Office action and not set forth below have been withdrawn in view of applicant’s amendments to the claims (dated 03//20/2026).
Claim Objections
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 12. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1, 4-5, 8-10, 12-15 and 53-54 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 “… and flowering that is both early and synchronous….”.
The Applicant does not define the term “synchronous”. It is known in the art that “Flowering synchrony (or synchronous flowering) is the amount of overlap between flowering periods of plants in their mating season compared to what would be expected to occur randomly under given environmental conditions” (source: Synchronous flowering - Wikipedia, p.1, para 1). It is unclear, however, what period of days is encompassed by “synchronous flowering” in the claims, for flowering to start and finish. The declaration under 37 C.F.R 1.132 submitted on 6/22/2026 describes, “Flowers were observed in two edited lines as early as day 15 after planting and were clearly present in all edited lines by day 24” while the wild-type plants also showed flowering “by day 24, with substantial flowering observed only by day 32” (p. 10, para 1, line 1-4). Fig. 5A shows flowering in mutant lines C and F appeared 9 days later than for lines A and B. Moreover, Fig. 5A in the declaration shows that flowering in all the edited lines continued till day 32 when all the wild type plants also completed flowering. Therefore it is unclear what time range for flowering, to start and finish, is encompassed by the instant claims, for flowering to be considered synchronous.
In addition to the same data described in declaration under 37 C.F.R 1.132 submitted on 6/22/2026, the response by the Applicant submitted on 6/22/2026 (relied on the declaration under 37 C.F.R 1.132 submitted on 6/22/2026) asserts “… pods were observed in two edited lines as early as day 24 after planting and were clearly present in all four edited lines by day 32, whereas wild-type plants began showing only initial pod formation at day 32, with more substantial pod appearance occurring only by day 38. This earlier and more uniform timing of first flower and first pod appearance across the independent edited lines is (directly) consistent with the synchronous and early flowering phenotype…” (response, p.13, para 1, line 5-10).
The data presented by the Applicant show early flowering. But it is not clear how pod formation is related to or indicative of synchronous flowering. This adds further confusion to what is meant by “synchronous flowering” in the context of the claimed invention.
All the claims directly or indirectly depending from instant claim 1 inherit the infiniteness.
To provide better customer service and compact prosecution, the Examiner, nonetheless, examined the claims by interpreting the term “synchronous” flowering as its face value, as described by the current status of the art, as discussed below.
Claim Rejections - 35 USC § 112(a)
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.
Scope of Enablement
Claims 1, 4-5, 8-10, 12-15 and 53-54 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 early flowering, does not reasonably provide enablement for synchronous flowering. 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 and use the invention commensurate in scope with these claims.
Claim 1 recites, “… and flowering that is both early and synchronous….”.
The Applicant does not define the term “synchronous”. The applicant does not provide any example or drawing to show synchronous flowering in the instant description. Later, as part of the Declaration under 132 (submitted on 6/22/2026), the Applicant provided Fig. 5A-B. The figures show early flowering. However, there is no synchronous flowering.
For example, the CRISPR/Cas edited line A, only about 22% of the plants show first flowering while less than 5% plants show flowering for line B at day 15 while mutant lines C and F did not start flowering at 15 days, but at 24 days (Fig. 5A). These two lines show 60% and less than 60% flowering, respectively, at day 24. The same divergence is observed on day 24 for all the genome-edited lines on day 24 while all the plants including the wild type control plants show 100% flowering on day 32. Clearly, there is no synchronous flowering in these lines. The Applicant does not provide any guidance for a skilled artisan to make and use the invention to achieve the gain-of-function trait of synchronous flowering by mutating the SELF PRUNING 2 gene in cowpea (VuSP2).
Undue trial and error experimentations would be needed to achieve the gain-of-function trait of synchronous flowering along with early flowering by mutating the SELF PRUNING 2 gene in cowpea (VuSP2).
Based on breadth of the claims, lack of any working example, lack of guidance in the instant description or in prior art, the specification at the time of the application filed would not have taught one skilled in the art how to make and use the full scope of the claimed invention without performing undue experiments.
Claim Rejections - 35 USC § 103
Claims 1, 4-5, 8-10, 12-15 and 53-54 are rejected under 35 U.S.C. 103 being unpatentable over
Krylova et al. (Determinate Growth Habit of Grain Legumes: Role in Domestication and Selection, Genetic Control, 2020, Ėkologicheskai͡a︡ genetika, 18:43-58) in view of GenBank Accession No. KJ569524 (published on 09/02/2014), Lemmon et al. ((U) Rapid improvement of domestication traits in an orphan crop by genome editing, 2018, Nature Plants, 4:766-770), and (V) (Supplemental Information, 2018, Suppl. Pages 1-7)), Che et al. (Developing a rapid and highly efficient cowpea regeneration transformation and genome editing system using embryonic axis explants, 2021, The Plant Journal, 106:817–830; published online on 17th Feb. 2021), Vicente et al. (Semi-determinate growth habit adjusts the vegetative-to-reproductive balance and increases productivity and water-use efficiency in tomato (Solanum lycopersicum), 2015, Journal of Plant Physiology, 177:11-19), Hirano et al. (Structural Basis for the Altered PAM Specificities of Engineered CRISPR-Cas9, 2016, Molecular Cell, 61:886–894). This is a new rejection with new prior art references necessitated by the claim amendments, as discussed below.
Claim 1 is drawn to a method for producing a modified cowpea (Vigna unguiculata) plant exhibiting determinant plant architecture with synchronous and early flowering, wherein said method comprises the step of introducing (by targeted genome editing using a gRNA consisting pf SEQ ID NO: 123) a gene disruption mutation in Vigna unguiculata SELF PRUNING 2 (VuSP2) gene comprising the nucleic acid sequence SEQ IDNO:113.
Krylova et al. describes that many wild relatives of legumes are characterized by an indeterminate growth habit while the cultivated plants are characterized by both indeterminate and determinate type (abstract, line 3-5). In plants with a determinate growth habit type, terminal inflorescence is formed by transitioning from the vegetative phase to the reproductive phase and are characterized by several gain-of-function traits including simultaneous maturation of pods (which is a consequence of synchronous flowering) and resistance to lodging (abstract, line 5-7). Krylova et al. teaches that mutation in homologues of Arabidopsis TLF1 gene in soybean (G. max), pea (P. sativum), bean (P. vulgaris) and cowpea (Vigna unguiculala) results in transforming indeterminate growth habit to determinate type with early flowering and synchronous pod (i.e., fruit) maturity (p.52, Table titled “Homologs of main regulators of inflorescence development in legumes”). It is well-known in the art that determinate plants/cultivars have synchronized flowering and fruit (i.e., pod) production (Vicente et al., abstract, line 3-4).
However, Krylova et al. does not describe targeted genome editing or the instant SEQ ID NO: 114 and/or instant SEQ ID NO: 113.
GenBank Accession No. KJ569524 describes the TFL1 protein sequence from V. unguiculata comprising 100% sequence identity to instant SEQ ID NO: 114 (which is encoded by instant SEQ ID NO: 113), as shown below.
Title: US-18-279-761-114
Perfect score: 912
Sequence: 1 MARMPLEPLIVGRVIGEVLD..........GLPVAAVYFNAQRETAARRR 173
Searched: 1 seqs, 173 residues
Total number of hits satisfying chosen parameters: 1
Database : AASEQ2_07282025_122435.pep:*
RESULT 1
AASEQ2_07282025_122435
Query Match 100.0%; Score 912; DB 1; Length 173; Best Local Similarity 100.0%;
Matches 173; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MARMPLEPLIVGRVIGEVLDSFTTSTKMTVSYNKKQVYNGHEFFPSSINIKPKVEIEGGD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MARMPLEPLIVGRVIGEVLDSFTTSTKMTVSYNKKQVYNGHEFFPSSINIKPKVEIEGGD 60
Qy 61 MRSFFTLIMTDPDVPGPSDPYLREHLHWIVTDIPGTTDATFGKELVSYEIPKPNIGIHRF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 MRSFFTLIMTDPDVPGPSDPYLREHLHWIVTDIPGTTDATFGKELVSYEIPKPNIGIHRF 120
Qy 121 VFVLFKQKRRQCVTPPSSRDHFNTRNFAAQNELGLPVAAVYFNAQRETAARRR 173
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VFVLFKQKRRQCVTPPSSRDHFNTRNFAAQNELGLPVAAVYFNAQRETAARRR 173
The name of the cowpea gene (VuSP2) in the instant invention is different than VuTFL1. However, as the two genes encode the same polypeptide as described above, these two genes are essentially the same. Instant SEQ ID NO: 123 comprises 100% sequence identity to the VuTFL1/VuSP2 coding region, starting at position 25, as discussed below.
Lemmon et al.(U) describes targeted genome editing (abstract) in the (CENTRORADIALIS, TERMINAL FLOWER 1, SELF-PRUNING) CETS gene family comprising SELF PRUNING gene(s), in tomato and groundcherry (page 767, Fig. 1; page 768, Fig. 2). Lemmon et al.(U) asserted that the method would be valid for crops including cowpea (page 769, left column, last para, line 12-16).
Che et al. specifically describes CRISPR/Cas based targeted genome editing, efficient plant transformation and regeneration of transgenic plants in cowpea (abstract).
Before the effective filing date of the invention, it would have been obvious to one ordinarily skilled artisan to down-regulate the expression of the VuTFL1/VuSP2 gene, as taught by Krylova et al. and GenBank Accession No. KJ569524, to produce a cowpea plant exhibiting determinate plant architecture comprising synchronous flowering.
Use of CRISPR/Cas based targeted gene editing to downregulate a specific gene is now a routine and standard process in the art, as described by Lemmon et al.(U), and genome edited cowpea plant can be regenerated, as described by Che et al. Downregulating a specific gene can be done in many ways including deleting the gene itself (knockout) or to get out-of-frame indel mutation(s) that either introduce frame-shift mutation producing a very different protein or by creating a nonsense mutation(s) in the coding region, preferably in the first exon and after the start ATG codon so that the translation is terminated early. Targeted genome editing using CRISPR/Cas followed by regeneration of the mutant plants (as described by Lemmon et al. and Che et al.) is well known in the art as being faster and avoids off-target mutations in a significant way.
Given that cowpea is a commercially important legume crop, one of ordinary skill would have been motivated to mutate, including by downregulating or knocking out, the TFL1/SP2 gene in other indeterminate cowpea varieties, given that determinate growth habit comprises synchronous early flowering and exhibits several other advantages including simultaneous maturation of pods and resistance to lodging (Krylova et al, abstract, line 5-7) and is more suitable for mechanized cultivation (Krylova et al, abstract, line 11-12).
Cowpea transformation and regeneration is described by Che et al. (abstract). It is a standard and well-known practice to delete any gene, its regulatory elements including the immediate upstream promoter sequence, and/or part of the gene to generate loss of function mutant(s) using CRISPR-Cas technique.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to use CRISPR/Cas9 gene editing technique using a suitable gRNA including SEQ ID NO:123 with a reasonable expectation of success to silence or downregulate expression of the functional VuTFL1/VuSP2 protein encoded by the VuTFL1/VuSP2 gene for developing determinate cowpea plants in elite and indeterminate (or semi-determinate) cowpea plants. Using any specific gRNA sequence in the first exon and/or the promoter sequence ((the gRNAs including SEQ ID NO: 123 span the first exon/coding region of the VuSP2 gene which is from position 92 to 292 of SEQ ID NO: 113 (data not shown)), to downregulate/silence the expression of a functional VuTFL1/VuSP2 protein is within the experimental design choice of the ordinary skilled artisan.
Regarding claim 4, Lemmon et al. (U) describes expressing Cas9 polypeptide in a plant (page 3, Fig. 2). Lemmon et al.(V) describes cloning polynucleotide encoding Cas9 and two guide RNAs (gRNAs) in a vector (supplementary information, page 2, last para; page 3, para 1). The vectors are introduced in plants using Agrobacterium infiltration method (supplementary information, page 2, para 2). Expressed endonuclease (Cas9) protein and the gRNA(s) interact to produce a ribonucleoprotein (RNP) complex(es) comprising the Cas9 protein and the gRNA(s).
It is a well-known and standard practice to undertake screening the genome of genome edited plant cells to identify the cells/plants having the targeted mutation(s) followed by regenerating plants carrying the mutation(s); and then screening regenerated plants for desired trait(s) which are determinate plant architecture and early flowering in this case.
Regarding claim 5, an ordinarily skilled artisan would have screened the genome of the T0 transformants developed from the targeted genome editing leading to insertion and/or deletion in cowpea, as described above, using well-known nucleic acid amplification or PCR technique, as also described by Lemmon et al. (V) (Supplementary information, page 3, para 2), to confirm presence of the mutation(s) in the transformants.
Regarding claims 8-9, Being an important agricultural crop, an ordinarily skilled artisan would have introduced mutations in cowpea SELF-PRUNING (SP) gene using CRISPR/Cas9 system of gene editing in the plants for several reasons, as described above. All these mutations are stably integrated in the host genome and, thus, are heritable.
Regarding claim 10, Lemmon et al. (U) describes multiple chimeric mutant T0 plants comprising several insertion and deletion mutant alleles (page 767, left column, para 1, line 2-3).
Regarding Claims 12-13, Krylova et al. and GenBank Accession No. KJ569524 describe a cowpea (Vigna unguiculata) Terminal Flower 1 (VuTFL1) gene), as discussed above. Instant SEQ ID NO: 123 comprises 100% sequence identity to the VuTFL1/VuSP2 coding region, starting at position 25, as shown below.
Title: US-18-279-761-123
Perfect score: 20
Sequence: 1 cttatagtggggagagtcat 20
Searched: 1 seqs, 1291 residues
Database : NASEQ2_07282025_190514.seq:*
RESULT 1
NASEQ2_07282025_190514
Query Match 100.0%; Score 20; DB 1; Length 1291; Best Local Similarity 100.0%;
Matches 20; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTTATAGTGGGGAGAGTCAT 20
||||||||||||||||||||
Db 25 CTTATAGTGGGGAGAGTCAT 44
The SEQ ID NO: 123 (within the highlighted box) is in the coding region of the VuTFL1/VuSp2 gene (within the first exon), as shown below (brown highlighted areas are different exons).
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567
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Regarding claims 14 and 53, Lemmon et al. (U), teaches using Cas9 protein and the NGG Protospacer Adjacent Motif (PAM) (page 768, Fig. 2b and 2h). It is well known in the art that Cas9 protein recognizes the 3’-NGG-5’ Protospacer Adjacent Motif (PAM), as taught by Hirano et al. (summary; page 866, right column, para 1, line 13-15). The method for targeted genome editing, as described above, would include a 3’ NGG PAM sequence in the gRNA, as taught by Lemmon et al. (U) (page 768, Fig. 2b and 2h) and Lemmon et al. (V) (page 6, Supplementary Fig. 1a), while using Cas9 endonuclease.
Regarding claims 15 and 54, Targeted genome editing to silence/downregulate specific VuTFL1/VuSP2 gene, requires plant transformation to introduce the polynucleotide sequence encoding Cas9 protein and the gRNA(s). Plant transformation using agrobacterium-mediated infiltration is a well-known method which is also described by Lemmon et al. (U) (page 766, right column, para 2, line 2-4) and Che et al. (abstract).
Response to Applicant’s Arguments
The declaration under 37 C.F.R 1.132 Applicant submitted on 6/22/2026 are fully considered as it may apply to the new obviousness rejection above, but not found persuasive.
Citing declaration under 37 C.F.R 1.132, the Applicant argues about “unexpected results” (response, p.12, para 2) of achieving “synchronous and early flowering phenotype” (response, p.12, para 1, line 10).
In the CRISPR/Cas edited line A, only about 22% of the plants show first flowering while less than 5% plants show flowering for line B at day 15 while mutant lines C and F did not start flowering at 15 days, but at 24 days (Fig. 5A). These two lines (A and B) show about 60% and less than 60% flowering, respectively, at day 24. The same divergence is observed on day 24 for all the genome-edited lines on day 24 while all the plants including the wild type control plants show 100% flowering on day 32. Clearly, there is no synchronous flowering in these lines.
The declaration also describes field trials showing yield (p.10, para 2; Fig. 6) and photographs of the VuSP2 edited lines (Fig. 7). The photographs are not clear. Its relevance is also not clear to the Examiner. Moreover, the claims do not recite any yield.
Conclusion
No claim is allowed.
Contact Information
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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J.C.
/Jay Chatterjee/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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