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 .
Response to Amendment
Claims 2-4, 6-24, 26, 28, 30, 32, 35-36, 38-39, 41-63, 71-87, 89 and 92-94 were cancelled. Claim 1 has been amended as requested in the amendment filed on 4 June 2026. Following the amendment, claims 1, 5, 25, 27, 29, 31, 33-34, 37, 40, 64-70, 88, and 90-91 are pending in the instant application.
Claims 25, 27, 29, 31, 33-34, 37, 40, 64-70, 88, and 90-91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions
Claims 1 and 5 are under examination in the instant office action.
Withdrawn Rejection
The rejection of Claims 1 and 5 under 35 U.S.C. 101 as being directed to a judicial exception(s) natural phenomenon/law of nature without significantly more is withdrawn. The Declaration under 37 C.F.R.1.132 of Ramani Kandasamy is persuasive to overcome the rejection of record because it states: “To my knowledge, there is no evidence that the complex of nanchung with water witch is naturally occurring. The publication cited by the Examiner does not show that this complex occurs endogenously in Drosophila. The single-nucleus transcriptomic atlas data referred to in Kandasamy et al. shows the presence of individual Nan and Wtrw transcripts within the same cell types. This dataset does not provide any evidence of protein-protein interaction or heteromeric complex formation in vivo, let alone that a functional Nan-Wtrw complex is naturally occurring. Instead, as explained in my previously submitted declaration in this case with reference to Liu et al. (Nature, 450:294-298, 2007), Wtrw and Nan exist in Drosophila in two separate channels as part of a hygrosensing system that responds to changes in either direction, not in a single complex. This is consistent with the statement in Liu et al. on page 296: "These data identify distinct roles for wtrw and nan; one is involved in sensing moist air and the other in sensing dry air” (see bullet 7, bridging pages 2-3 of Declaration).
Further, the Declaration provides evidence that the Nan and Wtrw complex of the instant claims, is significantly different from both its naturally-occurring components. For example, Fig. 2 of the application (corresponding to Kandasamy et al. Fig. 1) shows that both afidopyropen and pymetrozine evoke calcium signals in CHO-K1 cells CO- expressing Nan + Wtrw but not in cells expressing Wtrw alone. Similarly, Fig. 4A of the application (corresponding to Kandasamy et al. Fig. 3A) shows activation of calcium ion mobilization by nicotinamide in CHO-K1 cells co-expressing Nan + Wtrw but not in cells expressing Nan or Wtrw individually or in parental cells (i.e., cells prior to infection with the genes or proteins of interest); and application Fig. 5A (corresponding to Kandasamy et al. Fig. 4A) shows different respective binding affinities to afidopyropen for Nan, Wtrw, and Nan + Wtrw.
Therefore, in light of the evidence that this is not a naturally-occuring complex, and in view of the functional differences the co-expressed complex exhibits in relation to its separate natural components, the Examiner concludes that the claimed methods for determining whether or not a candidate compound is a modulator of a complex consisting of an insect transient receptor potential channel Nanchung protein and an insect transient receptor potential channel Water witch protein, wherein the complex is expressed from at least one vector that is transfected into the cell, does not rely upon merely testing a naturally occurring phenomenon, and the rejection is withdrawn.
Claim Rejections - 35 USC § 112 (New, Necessitated by Amendment)
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.
Claims 1 and 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As currently amended, Claim 1 recites, “wherein the complex is expressed from at least one vector that is transfected into the cell”. Thus, the claims rely upon a vector that appears to be novel and it is not disclosed within the specification as filed, that these materials have been made available to the public. As MPEP 2403.01 states, biological material includes material that is capable of self-replication either directly or indirectly. Self-replication after insertion in a host is one example of indirect self-replication. Examples of indirect replicating biological materials include viruses, phages, plasmids, symbionts, and replication defective cells. 37 CFR 1.801 states: “Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.” Thus, Deposit of a vector containing the genes of the claimed “complex” would enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation. There is no statement of Deposit within the disclosure as filed, therefore an artisan would not be able to make and/or use the invention of the claims without undue further experimentation.
A suitable deposit for patent purposes is required, and the specification does not contain the requisite statement of Deposit under the terms of the Budapest Treaty, or otherwise. It should be noted that mere mention alone does not ensure public access to that deposit under the terms of the Budapest Treaty. Applicant should note that the language stating that the deposited material will be irrevocably removed upon the granting of a patent is required if Deposit occurs under the Budapest Treaty or not, as outlined below.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that “the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent”, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or Declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803-1.809 for additional explanation of these requirements.
Since there is no statement of Deposit, then a person having ordinary skill in the art would have to perform undue further experimentation in order to make and/or use the invention as claimed. Given that the nature of the invention requires material that is capable of self-replication either directly or indirectly.
Allowable Subject Matter
There is nothing within the prior art to teach or suggest the method of claims 1 and 5. If the rejection under 35 U.S.C. 112(a) based upon lack of Deposit, can be overcome, then these claims will be deemed allowable subject matter.
The closest art of record Kandasamy et al.(2022) does not qualify as prior art. The formation of a functional Nan- Wtrw heteromeric calcium channel complex in was established through experimental, heterologous co-expression of both proteins in CHO-K1 cells. See Sections 2.2 and 2.3 and Fig. 2 (demonstrating formation of a complex by co-immunoprecipitation). The work by the co-authors of the publication therefore led to the formation of nanchung with water witch complex in mammalian cells under laboratory conditions.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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