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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 02, 2026 has been entered.
Claim Status
2. Claims 51, 55-56, 58-62, and 66 are pending and under examination to the extent of the elected species of the amino acid serine.
Claims 68-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 03, 2025.
Claims 1-50, 52-54, 57, 63-65, are 67 are cancelled.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
3. Applicant’s arguments and amendments filed February 02, 2026 have been fully considered but are not persuasive and do not overcome the rejections of record.
In traversing the rejection, Applicant argues primarily that knockout of an endogenous MFT gene in an elite soybean line would result in increased oil content as exemplified in the instant specification (p. 03, second paragraph), that the teachings of Cai were conducted in a non-elite soybean variety (p. 03, first paragraph), and the claims have been amended to further limit the claimed soybean cell to one obtained from an elite soybean line.
Applicant’s arguments are not persuasive to overcome the rejection of record because even though the scope of the claims have been limited to cells obtained from an elite soybean line, the specification still does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims. The claims encompass any elite soybean line comprising an amino acid sequence that is at least 95% identical to SEQ ID NO:2. Applicant provides only one working example of an elite soybean line comprising an amino acid sequence that is at least 95% identical to SEQ ID NO:2 wherein modification of position L140 of said amino acid sequence results in an increase in seed oil content (i.e., 93Y21; pp. 37-39, Example 5).
Given that the state of the art (Cai et al., New Phytologist. 2023; 239(3):905-919 (previously cited)) teaches that MFT loss-of-function mutations result in decreased seed oil content in contrast to Applicant’s disclosure of increased seed oil content in an elite soybean line a modified SEQ ID NO:2 (Abstract; p. 906, right column, first full paragraph; p. 908, right column, first full paragraph; p. 911, left column, “GmMFT simultaneously regulates oil and protein content, as well as seed size”) the result of mutating or reducing the activity soybean MFT is not predictable. Though Applicant suggests that the presence of a leucine at position 106 of SEQ ID NO:2 is the causative mutation resulting in the increased oil content phenotype (pp. 35-36, Example 3), neither Applicant nor the state of the art confirm any impact of position 106 on seed oil content, nor do either Applicant or the state of the art provide any list comprising of soybean lines comprising the required alleles of MFT and wherein modification of position L140 of SEQ ID NO:2 results in an increase in seed oil content. It is unclear which elite soybean accessions will comprise the requisite genotype and oil content suitable for the claimed invention. Without further guidance as to which soybean accessions comprise an allele of soybean MFT encoding an MFT having at least 95% sequence identity to SEQ ID NO:2, wherein substitution of the residues encoding of position L140 result in increased seed oil content, one of ordinary skill in the art could not predict which elite soybean lines are amenable to the claimed invention without, at minimum, performing genome sequencing and/or sequencing analysis to generate a list of putative soybean lines comprising variations in SEQ ID NO:2 wherein the variant protein retains at least 95% sequence identity to SEQ ID NO:2, assessing seed oil content in the putative lines, outcrossing the putative lines to identify any correlations between the identified variations and seed oil content, and further validating any correlations between the variations and seed oil content, which would ultimately result in extensive and undue experimentation.
Accordingly, the claims remain rejected under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112(a)
4. 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.
Enablement
5. Claims 51, 55-56, 58-62, and 66 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 the elite soybean line 93Y21, does not reasonably provide enablement for any elite soybean plant comprising an endogenous MFT gene encoding a polypeptide having at least 95% sequence identity to SEQ ID NO:2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims.
When determining whether a claimed invention complies with the enablement
requirement, factors to consider include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as previously set forth and will be summarized herein as necessary (see: Non-Final Rejection dated 03/14/2025, pp. 05-11; Final Rejection dated 10/02/2025, pp. 4-5). The claimed invention is not enabled for the following reasons.
Applicant has not provided sufficient guidance for one of ordinary skill in the art to identify elite soybean lines comprising an endogenous MFT gene encoding a polypeptide having at least 95% sequence identity to SEQ ID NO:2, wherein mutation of position L140 or loss-of-activity of the polypeptide results in increased seed oil content.
The MFT gene “Glyma.05g244100” comprises a soybean MFT-like gene located on chromosome 5 as disclosed by Applicant[0135], [0138-0140] (p. 33, Table 6). Applicant provides working examples of increased oil content in only one elite soybean line comprising mutations at position L140 of SEQ ID NO:2 or MFT loss-of-function mutations (i.e., 93Y21; pp. 37-39, Example 5)[0151]. Applicant describes the presence of multiple single nucleotide polymorphisms (SNPs) and small insertions and deletions within the promoter and coding sequence of the MFT allele isolated from an elite soybean line[0139]. However, Applicant suggests the presence of only a single mutation, V106L, as responsible for the increased oil content of the elite soybean line[0139]. While the loss-of-function mutations provide some guidance as to which regions of the MFT polypeptide are required for function, Applicant does not disclose increased oil content in any plants comprising a knockout (i.e., a total deletion) of the endogenous MFT gene.
Cai et al. (New Phytologist. 2023; 239(3):905-919 (previously cited)) teaches that the expression level of Glyma.05g244100 is positively correlated with seed oil content (p. 906, right column, first full paragraph; p. 908, right column, first full paragraph); that loss of MFT results in decreased seed oil content and seed weight in both soybean and Arabidopsis (Abstract); and that MFT also negatively regulates seed protein content (p. 911, left column, “GmMFT simultaneously regulates oil and protein content, as well as seed size”). Thus, the state of the art teaches that MFT loss-of-function mutations decrease seed oil content, which is in contrast to Applicant’s disclosure of increased seed oil content in soybean plants expressing SEQ ID NO:2. The state of the art further teaches that protein chemistry is one of the most unpredictable areas of biotechnology. For example, substitution of Tyr-38 of growth factor α with Phe or Trp did not abolish protein activity while replacement of Tyr-38 with Ala, Ser, His, or Thr severely reduced or abolished protein activity (Lazar et al., Molecular and Cellular Biology, 1989; 9(2):860-864 (previously cited)).
When viewed together with Applicant’s disclosure, the above examples teach that the effects of substitutions and loss-of-function mutations are not predictable with regard to MFT protein function and seed oil content. It is unclear if knocking out the endogenous MFT gene will result in an increase in seed oil content as claimed by Applicant or a decrease in seed oil content as taught by Cai. It is unclear what genotype is required in the recite elite lines to confer the claimed oil phenotype. Thus, substitutions or loss-of-function mutations in MFT gene alleles are not predictably functional with regard to seed oil content in elite soybean cell lines, and so, are not enabled.
In making this determination, the Office has weighed each of the Wands factors. The breadth of the claims is a soybean cell and/or plant comprising increased oil content and a loss-of-function mutation in an endogenous MFT polypeptide. The nature of the invention comprises a soybean cell/plant having increased oil content. The level of skill in the plant biotechnology art is high. The state of the art teaches MFT loss-of-function mutations as increasing seed oil content and does not teach SEQ ID NO:2 as increasing seed oil content. Applicant provides only one working example of an elite soybean line comprising a substitution or mutation at position L140 of a polypeptide having at least 95% sequence identity to SEQ ID NO:2 and having increased seed oil. Given these difficulties, notwithstanding the relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all of the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Because dependent claims 55-56, 58-62, and 66 do not address the recitations regarding a any elite soybean line comprising a polypeptide having at least 95% sequence identity to SEQ ID NO:2, they also are not enabled.
Response to Arguments – Claim Rejections - 35 USC § 103
6. Applicant’s arguments and amendments filed February 02, 2026 have overcome the rejections of record.
Conclusion
7. No claim is allowed.
8. The closes prior art, Li et al. (Plant Science. 2018; 266:95–101 (previously cited)), teaches a soybean plant, seed, and cell having increased oil content and comprising a genetic modification at a genomic locus encoding an endogenous MFT polypeptide (GmMFT; Abstract; p. 96, left column, “2.1. Plant materials and phenotyping data collection”; p. 98, left column, first full paragraph), which, encodes an amino acid sequence that has 100% sequence identity with SEQ ID NO:2 and discloses: that GmMFT regulates oil content in soybean (p. 98. left column, first and second full paragraphs); a negative correlation between seed oil and protein content (p. 97, right column, second full paragraph); and that Map-6077 of GmMFT is a SNP that is strongly associated with increased oil and increased protein content in soybean (Abstract; p. 97, right column, first full paragraph; p. 98, left column, first full paragraph). Li does not teach mutation of L140, knockout of an endogenous MFT polypeptide, or elite soybean lines.
Examiner’s Contact Information
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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