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
Restriction/Election
1. Applicant’s election without traverse of the following species in the reply filed on 06/30/2026 is acknowledged: (i) drug candidates as recited in claim 2; (ii) microbial infections as recited in claim 5; (iii). viral receptors as recited in claim 7; (iv). SEQ ID NO: 3 as recited in claim 15.
2. Claims 1-3, 5, 7, 9, 12-22, 24-26, and 28-32 are pending and currently under consideration.
Information Disclosure Statement
3. The information disclosure statement filed on 05/18/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 05/18/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
5. The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 14 and 32 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i). Claim 14 recites “wherein the second peptide further comprises a cell membrane insertion domain”. Claim 14 also recites “wherein the cell membrane insertion domain is separated from the second peptide by the flexible amino acid linker: The two limitations are inconsistent, rendering the claim indefinite. It is suggested to amend the limitation “wherein the second peptide further comprises a cell membrane insertion domain” to ““wherein the second peptide is fused (or linked) to a cell membrane insertion domain”.
(ii). Claim 32 recites “wherein the method is utilized to characterize the pharmacological properties of the binding agent”. However, the claim does not set forth steps to characterize the pharmacological properties of the binding agent.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-3, 5, 7, 12-22, 24-26, 28, and 32 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 20170313762 A1 (or US 10,584,159 B2).
US 20170313762 A1 teaches a method of determining whether an agent binds and induces the trafficking of a cell surface receptor of interest in a cell to an endosomal compartment, wherein the method comprises binding the agent with the cell surface receptor of interest in the cell, wherein the cell surface receptor of interest, such as G-protein coupled receptors (GPCRs), is indirectly linked to Renilla luciferase protein (Renilla Luc) via a flexible amino acid linker, wherein the Renilla Luc as bioluminescence resonance energy transfer (BRET) donor generates BRET signal upon interaction with Renilla GFP as BRET acceptor (Fig. 1B); detecting a presence or an absence of the trafficking of the cell surface receptor of interest to the endosomal compartment, wherein the trafficking is characterized by the presence of the BRET signal, and wherein the absence of the trafficking is characterized by the absence of the BRET signal; and determining whether the agent induces the trafficking of the cell surface receptor of interest in the cell to the endosomal compartment, based on the BRET signal (see abstract; paragraphs [0004], [0160], [0203]-[0204], [0218]; claims 1-3, 8, 25, 42; Figure 1B). The agent refers to any molecules, such as proteins, small organic molecules to be tested for bioactivity, wherein the agent is evaluated whether the agent is useful in the treatment of diseases (see paragraphs [0004], [0235]-[0236], [0249]). The flexible amino acid linker comprises at least 18 amino acid residues (page 16, paragraph [0204]).
US 20170313762 A1 further teaches that Renilla GFP is indirectly linked to an endosomal targeting moiety comprising a FYVE domain via a polyglycine linker, wherein the FYVE domain has an amino acid sequence of SEQ ID NO: 20, which has 98.6% of homology to SEQ ID NO: 7 of the present invention (see paragraphs [0203], [0273]; claims 8, 25).
Thus, the teachings of US 20170313762 A1 meet the limitations of claims 1-3, 5, 7, 12-22, 24-26, 28, and 32.
Claim Rejections under 35 USC § 103(a)
9. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
10. Claims 9 and 29-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 20170313762 A1 as applied to claims 1-3, 5, 7, 12-22, 24-26, 28, and 32 above, and further in view of Laschet et al. (J. Biol. Chem. 294 (11): 4079-4090, 2019).
US 20170313762 A1 teaches a method as applied to claims 1-3, 5, 7, 12-22, 24-26, 28, and 32 above.
US 20170313762 A1 does not teach the limitations of claims 9 and 29-31.
Laschet et al. teach drug screening using SmBiT bound to the GPCR as a cell membrane receptor and LgBiT bound to the G protein as an intracellular protein, wherein the SmBiT and LgBiT as NanoLuc complementation system form a complete NanoLuciferase by the interaction between GPCR and G protein, and induce light emission, wherein amino acid sequences of the SmBiT and LgBiT are identical to the SEQ ID NOs: 1-2 of the present invention (see abstract; page 4080, right column; page 4088, left column; Figure 1).
It would have been obvious to one having ordinary skill in the art at the time the invention was made, as an alternative, to detect the luminescent signal using SmBiT and LgBiT taught by Laschet et al. with a reasonable expectation of success. One would have been motivated to do because SmBiT and LgBiT are well-known in the art and routinely practiced in the field by one of skill in the art.
It would also have been obvious to one having ordinary skill in the art at the time the invention was made, as an alternative, to screen a single binding agent or a plurality of different binding agents against a single type of cell membrane protein or a plurality of different types of cell membrane proteins associated with the cell with a reasonable expectation of success. One would have been motivated to do because such a screening method is well-known in the art and routinely practiced in the field by one of skill in the art.
Conclusion
11. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
August 14, 2026
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