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 .
Status of Application/Restriction/Claims
Applicant’s election without traverse of Group I (claims 16-25) and species (TSC2) in the reply filed on 12/15/2025 is acknowledged. Claims 16-33 are pending. Claims 17-20, 23-25 and 26-33 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. It is noted that claims 17-20 and 23-25 are directed to the non-elected growth-related gene species.
Claims 16, 21-22 and 25 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application JP 2020-179947 and 371 of PCT/JP2021/039717 filed on 10/27/2020 and 10/27/2021, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 10/27/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/26/2023 was received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Interpretation
With respect to the “optionally” language recited in claim 16, it is emphasized that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, see MPEP 2111.04.
Furthermore, applicant has elected TSC2 as the single specific combination of growth-related genes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16, 21-22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mykles et al. "Hormonal control of the crustacean molting gland: Insights from transcriptomics and proteomics." General and Comparative Endocrinology 294 (2020): 113493 (hereinafter Mykles) in view of Munkley et al. "A novel androgen-regulated isoform of the TSC2 tumour suppressor gene increases cell proliferation." Oncotarget 5.1 (2013): 131 (hereinafter Munkley) as evidenced by Cell signaling technology. SignalSilence. Way Back Machine. 11/21/2015.
Claims 16 and 21-22: Mykles describes the hormonal controls of crustacean molting and growth by examining the mechanisms of mTOR signaling (Mykles, abstract and Fig 1). Mykles discloses experiments using rapamycine to down-regulate mTOR signaling genes (Mykles, abstract and Fig 1). Similarly, Mykles discloses how Gl-TSC2a acts to down regulate and inhibit mTOR signaling (Mykles, pg 8 col 1 and Fig 6-7). Although Mykles discloses TSC2 as a growth-related gene which inhibits mTOR signaling and thus acts to limit crustacean molting and growth, Mykles does not disclose a method for inhibiting the function of TSC2 to improve crustacean molting and growth.
Claims 16 and 25: Munkley describes TSC2 as an important tumor suppressor gene which complexes with TSC1 to block the ability of Rheb GTPase to activate mTOR (Munkley, abstract, mechanism of action provided below as in Fig 4). Munkley discloses several approaches to knockdown TSC2 using siRNAs (Ambion S14437). Munkley was able to successfully inhibit TSC2 using siRNAs to activate cell growth (Munkley, pg 136). Furthermore, numerous other commercial providers like cell signaling technology supply siRNAs targeting TSC2.
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It would have been prima facie obvious to one of ordinary skill in the art to inhibit the function of TSC2 using a siRNA as described by Munkley in the methods for controlling crustacean molting and growth described by Mykles. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Munkley provides a mechanism for selectively inhibiting TSC2 using siRNAs to activate cell growth. In particular, one of ordinary skill would be motivated to knockdown TSC2 and increase mTOR to accelerate growth and molting in decapod crustaceans for improved aquaculture. One would have a reasonable expectation of success given that there are numerous commercial suppliers for siRNAs targeting TSC2 which offers a selective approach towards mTOR upregulation. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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