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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 22, 2026 has been entered.
2. Applicant's amendment to claims 1 and 5 in the reply filed on 6/22/2026 are acknowledged.
Claims 1, 3, 5, 7, 10, 15 and 16 are pending and examined on the merits.
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.
Scope of Enablement
3. Claims 1, 3, 5, 7, 10, 15 and 16 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 a method for causing mortality or stunting in Phyllotreta species using dsRNA with a first strand that comprises at least 21 contiguous nucleotides of SEQ ID NO: 365 and a second strand that is the complementary sequence of the first strand, and wherein expression the dsRNA inhibiting the gene of SEQ ID NO: 365, does not reasonably provide enablement for any dsRNA with any size targeting SEQ ID NO: 365. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
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 SEQ ID NO: 365.
The specification teaches SEQ ID NO: 365 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 claim only defines one of the RNA strand as being identical or complementary to at least 21 contiguous nucleotides of SEQ ID NO: 365 without specifying that the second strand is the complement strand of the first one, therefore the dsRNA read on essentially any size in any plant. Thomas et al. (2001, The Plant Journal 25(4):417-425) teach that the lower size limit required for targeting reporter transgene mRNA de novo using PTGS was 21 nucleotides of complete identity, a size corresponding to that of small RNAs associated with PTGS in plant and RNAi in animals (abstract). Therefore, all of the DNA segments smaller than 21 nucleotides in instant claims are not enabled for silencing a target gene. As discussed above, instant claims only define one of dsRNA as containing at least 21 contiguous nucleotides of the SEQ ID NO: 365without defining the other strand as being the complement thereof. Therefore, the dsRNA as claimed would encompass dsRNA with less than the minimal size of 21 bp.
Therefore, given the claim breadth, lack of further guidance and additional working example, unpredictability of the art, undue experimentation would be required for a person skilled in the art to practice the invention.
Conclusion
No claim is allowed.
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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