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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/4/2025 has been entered.
2. Claims 1, 3, 5, 7, 10 and 15-16 and SEQ ID NO: 365 and 1224 are examined on the merits.
3. The rejections and objections not recited in this action are withdrawn.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.
Written Description
4. Claims 1, 3, 5, 7, 10 and 15-16 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(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to a method for causing mortality or stunting in insect pest using silencing element comprises an RNA strand identical or complementary to at least 21 contiguous nucleotides of an insect target gene that has the DNA sequence of SEQ ID NO: 365/1224 and a second strand is the complement thereof.
The specification teaches SEQ ID NO: 365/1224 encoding Rpn8 from Phyllotreta cruciferae (Specification, Table 1). The specification further teaches that feeding of dsRNA targeting SEQ ID NO: 365 results in mortality for the Phyllotreta cruciferae (Tables 2-3, Example 5).
Instant claims read on insect target gene comprising the SEQ ID NO: 365/1224, the insect gene is still not fully described in that neither the specification nor the prior art teaches the other part of the insect target gene in addition to SEQ ID NO: 365/1224. The only structure disclosed is the nucleotide sequence of SEQ ID NO: 365/1224. Without adequate description of full-length gene sequence comprising SEQ ID NO: 365/1224, it is also impossible to perform meaningful prior search for 21 contiguous nucleotides from such full-length gene sequence or the complement thereof.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Applicants fail to describe a representative number of polynucleotide sequences falling within the scope of the claimed genus, which is at least 21 contiguous nucleotides of the target gene comprising the sequence of SEQ ID NO: 365/1224. Applicants only describe at least 21 contiguous nucleotides of the sequence of SEQ ID NO: 365/1224. Furthermore, Applicants fail to describe structural features common to members of the claimed genus of polynucleotides. Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Furthermore, given the lack of description of the necessary elements essential for the insect targeting gene, it remains unclear what features identify at least 21 contiguous nucleotides of the insect target gene. Since said genus has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claims.
Applicants traverse in the paper filed 9/4/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that claim amendment should overcome the rejection (response, page 6).
The Office contends that while the amendment partially overcome the rejection, for the reason as discussed above the rejection is still maintained in that the full length of the target gene is not described.
Conclusion
No claim is allowed.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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 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
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