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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/2026 has been entered.
Applicant's amendment to claim 33 in the reply filed on 12/1/2025 is acknowledged and entered.
As a result, claim 1-23 and 34-38 are withdrawn from consideration for being drawn to non-elected invention.
Claims 24, 26-27, 29-33 and SEQ ID NO: 9 and 18 are examined on the merits.
2. The rejections and objections not recited in this action are withdrawn.
Claim Rejections - 35 USC § 112
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.
3. Claim 33 remains rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
A review of the full content of the specification indicates that obtaining nucleotide sequences encoding a modified NSF that that has an amino acid sequence of SEQ ID NO:18 having one or a plurality of amino acid modification compared to SEQ ID NO:17 and has modification of R4Q/N21Y wherein the modified NSF is a growth promoting and survival variant is essential to the operation of the claimed invention.
The specification also teaches soybean gene of SEQ ID NO:9 encoding a NSF protein comprising SEQ ID NO:18 having both R4Q and N21Y modification. The specification further teaches homologous sequence listed in Table 6 majority of which is over 90% identical to SEQ ID NO:18.
The Federal Circuit has recently clarified the application of 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.” (See 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 a 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.
However, neither the specification nor the prior art discloses any polypeptide that is at least about 90% identical to SEQ ID NO: 18 except for SEQ ID NO: 18 itself having both R4Q and N21Y modifications. Furthermore, since SEQ ID NO:18 contains both R4Q and N21Y modifications, there is no evidence that a single modification would be sufficient for the modified NSF to be functioning as a growth promoting and survival variant. Therefore, given the breadth of the claims and the lack of further guidance, a person skilled in the art would conclude that applicant is not in possession of the claimed invention.
Applicants traverse in the paper filed 12/1/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that claim 33 has been amended to recite that the modified NSF polypeptide has the amino acid sequence of SEQ ID NO:18, where amino acid positions 4 and 21 are modified (response, page 17).
The Office contends that the amended claim only recites that the modified NSF polypeptide has an amino acid sequence of SEQ ID NO:18 (emphasis added), which reads on any fragment of SEQ ID NO:18 with any size.
To overcome the rejection, it is suggested to amend the claim to recite the modified NSF polypeptide has the amino acid sequence of SEQ ID NO:18.
Conclusion
Claims 24, 26-27, 29 are allowed and claim 33 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662