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
Responsive to claim set of 5/8/2026
Claims pending 1-22
Claims withdrawn 19-22 and 12,15
Claims currently under consideration 1-11,13,14,16-18
Priority
This application has a filing date of 11/01/2022 and has
PRO 63/394,075 of 08/01/2022; and
PRO 63/274,168 of 11/01/2021.
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 5/8/2026 is acknowledged.
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse therein said reply.
Applicant’s species election without traverse of: the second structure set forth in claim 13 as fluorophore; and ethylene glycol as linker in the reply is further acknowledged.
Claims 12 & 15 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse further therein said reply.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1,5,6,9-11,13,14,17,18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyun et al (2019 Organic Letters 21:4439-42 including supporting information).
Hyun et al teach throughout the document and especially the abstract, trifunctional fluorogenic probes for cell imaging, etc. More particularly in scheme 1 and figures 1,2 & 4 as detailed from the last paragraph at p S9 to S12 Hyun et al: provide a target protein; provide various first fluorescent molecule labels; introduce to a cell a second fluorescent molecule, such that the second fluorescent molecule is modified so that it interacts with the target protein, and wherein the second fluorescent molecule is spectrally orthogonal to the first fluorescent molecule; measure interaction between the second fluorescent molecule and the target protein; introduce to a cell a non-fluorescent test compound; measure interaction between the second fluorescent molecule and the target protein in the presence of the test compound; and measure (necessarily calculate) a difference in interaction of the second fluorescent molecule with the target protein when the test compound is present and when the test compound is not present using competition assay(s) monitored by confocal microscopy and thereby determines binding any affinity of target protein for the test compound. The foregoing reads on claims 1;5,6 (before and after labeling respectively); applicant’s elected species of claims 9,10, 11, second structure of claim 13 & 14 when Fl is coumarin, L is diethylene glycol, PBM is a sugar (derivative of a therapeutic agent) and n is 1; as well as claims 17-18. See also Hyun figure 3 and/or figures S1-S5.
Claim Rejections - 35 USC § 103
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 1,5,6,9-11,13,14,17,18 and 2-4,7,8,16 are rejected under 35 U.S.C. 103 as being unpatentable over Hyun et al (2019 Organic Letters 21:4439-42 including supporting information) in view of Caruso et al (US AppPub 20090098648) as evidenced by Kokoris et al (2002 Protein Science 11:2767-72)
Hyun et al is relied on as above.
Hyun et al do not explicitly teach GFP and a kinase target protein both encoded in a same vector and separated by an IRES per claims 2-4,7,8 and 16.
Caruso et al teach throughout the document and especially the abstract and paragraph 0059+, high-titer packaging cells for safe production of gene therapy retroviruses. More particularly and like claims 2,3,4,7,8 and 16 (and further reading on claim 5), in paragraph 0039, Caruso et al discloses GFP and thymidine kinase (TK) both encoded in a same vector and separated by an IRES therefor.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the trifunctional probe approach suggested by Hyun et al with transformed cells expressing TK concomitantly marked with GFP of Caruso et al.
One of ordinary skill in the art would have been motivated to have employed trifunctional probe approach suggested by Hyun et al with transformed cells expressing TK concomitantly marked with GFP of Caruso et al for the benefits of having tracible cell(s) and or introducing TK as a “prodrug kinase” (rendered sensitive to low levels of acyclovir or ganciclovir) thereby, advantages detailed in the Kokoris et al abstract.
One of ordinary skill in the art would have had a reasonable expectation of success in utilizing Caruso’s cells expressing GFP and TK with Hyun’s trifunctional probes since substituting one cell line for another is not challenging, as well as art recognized robustness of such proteins, having been in molecular biology and clinically for decades.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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