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 .
Claim Status
The amendment filed on 06/24/2026 is acknowledged. Claims 1-9 and 11-12 were cancelled, claims 10 and 13 were amended, and claims 17-26 were added.
Claims 10 and 13-26 are currently pending and under examination.
Priority
Applicant claims benefit to U.S. application number 63/379,573 filed on 10/14/2022 and U.S. application number 63/457,624 filed on 04/06/2023. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/07/2025, 12/18/2025, and 06/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn Rejections
35 U.S.C. 102 rejection over Janin et al. of claims 1-3, 5-6, and 8 is withdrawn in view of claims 1-3, 5-6, and 8 being cancelled.
35 U.S.C 103 rejection over Janin et al. of claims 1-11, 13, and 16 is withdrawn in view of claims 1-9 and 11 being cancelled and claims 10 and 13 being amended by narrowing the compounds of the Markush group of claim 10 to include two specific compounds and amending claim 13 to depend on claim 10 which has changed the scope of the claims 10, 13, and 16. Further regarding instant claim 10, this rejection is withdrawn because it was applied based on getting to the compound of instant claim 10
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(shown below) which is now cancelled.
35 U.S.C. 103 rejection over Janin et al. in view of Su et al. of claims 1-11 is withdrawn in view of claims 1-9 and 11 being cancelled and claim 10 being amended by narrowing the compounds of the Markush group of claim 10 to include two specific compounds which has changed the scope of the claim 10.
35 U.S.C. 103 rejection over Janin et al. in view of Su et al. further in view of Firefly Luciferase Assay Kit of claims 13-16 is withdrawn in view of claim 13 being amended to depend on claim 10 which has changed the scope of the claims 13-16.
35 U.S.C. 103 rejection over Janin et al. in view of Firefly Luciferase Assay Kit of claims 13-16 is withdrawn in view of claim 13 being amended to depend on claim 10 which has changed the scope of the claims 13-16.
Double Patenting rejection over U.S. Patent No. 11691976B2 in view of Su et al. of claims 1-4 and 6-11 is withdrawn in view of claims 1-4, 6-9, and 11 being cancelled and claim 10 being amended by narrowing the compounds of the Markush group of claim 10 to include two specific compounds which has changed the scope of the claim 10.
Double Patenting rejection over U.S. Patent No. 11691976B2 in view of Su et al. further in view of Janin et al. of claim 5 is withdrawn in view of claim 5 being cancelled.
Double Patenting rejection over U.S. Patent No. 11691976B2 in view of Su et al. further in view of Firefly Luciferase Assay Kit of claims 13-16 is withdrawn in view of claim 13 being amended to depend on claim 10 which has changed the scope of the claims 13-16.
New Rejections Necessitated by Amendments filed on 06/24/2026
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10 and 13-26 are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US20200062766A1, published 02/27/2020, PTO-892).
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Walker et al. teaches many known coelenterazine analogues have deficiencies, which limit their effectiveness as luciferase substrates and usefulness in luciferase-based assays. These deficiencies include cell toxicity, light sensitivity, thermodynamic instability, low aqueous solubility, and low cell permeability. Accordingly, there exists a need for coelenterazine analogues with improved properties and methods for synthesizing the analogues. Representative compounds include the compounds of formula (II) wherein for both representative species Y is hydroxyl, R3 is fluoro, and p is 1 (shown below). For the representative compound on the left, q is 0. For the representative compound on the right, q is 1 and R4 is fluoro (see pages 10 and 12 and shown below). Also disclosed are methods of making the compounds, kits comprising the compounds, and methods of using the compounds as luciferase substrates in luciferase-based assays (see 0054). The compounds of formula (II) may be provided as part of a kit. The kit may include one or more luciferases (in the form of a polypeptide, a polynucleotide, or both) and a coelenterazine analogue of formula (II), along with suitable reagents and instructions to enable a user to perform assays such as those disclosed herein. The kit may also include one or more buffers (see 0154).
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The teachings of Walker et al. differ from that of the instantly claimed invention in that the representative compounds, as taught by Walker et al., does not include compounds selected from the group consisting of:
and
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given as alternatives by instant claim 10 and as claimed in instant claims 17 and 22. Furthermore, Walker et al. does exemplify the alternatives of instant claims 10, 17, and 22 in a kit as required by instant claims 13-16, 18-21, and 23-26.
However, Walker et al. further teaches compounds of formula (II) wherein Y is selected from a Markush group including halogen and —ORy1 wherein Ry1 is selected from a Markush group including hydrogen, R3 is selected from a Markush group including halogen, p is 0-4, R4 is selected from a Markush group including halogen, and q is 0-5 (see 0030-0036 and shown below).
Regarding instant claims 10, 17, and 22, it would have been obvious before the effective filing date of the claimed invention to substitute the hydroxyl group of the representative species with a halogen such as fluorine to arrive at the instantly claimed invention. It
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would have been prima facie obvious for one of ordinary skill in the art to substitute the hydroxyl group of the representative compounds because Walker et al. teaches in the Markush formula (II) shown above that position Y can be selected from a Markush group that includes halogens and this substitution would therefore result in the claimed species.
In regard to instant claims 13, 18, and 23, the patentability of a kit using the compound of instant claims 10, 17, and 22 depends on the compound. Therefore, if the compounds of claims 10, 17, and 22 are made obvious, the kit is also found to be obvious.
Instant claims 16, 21, and 26, which depend on instant claims 13, 18, and 23 respectively, are being interpreted to be nonfunctional descriptive material that does not add more to the interpretation of instant claims 13, 18, and 23 (see MPEP 2111.05(I)(B)).
Regarding instant claims 14-15, 19-20, and 24-25, Walker et al. teaches the kit may include one or more luciferases (in the form of a polypeptide, a polynucleotide, or both) and a coelenterazine analogue of formula (II), along with suitable reagents and instructions to enable a user to perform assays such as those disclosed herein. The kit may also include one or more buffers such as those disclosed herein. This corresponds to the instant claims of the kit further comprising a luciferase, as required by instant claims 14, 19, and 24, a buffer reagent, as required by instant claims 15, 20, and 25, and instructions, as required by instant claims 16, 21, and 26.
Response to Arguments
Regarding claim objections, the selection of the objection checkbox in the Office Action Summary page of the office action filed on 04/06/2026 was made via inadvertent clerical error and should be disregarded. For clarification, no claims were objected to in the Office Action filed on 04/06/2026 regarding the instant application.
Applicant’s arguments filed on 06/24/2026 with respect to claim 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the arguments.
Conclusion
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 KRISTEN WEEKS BRADY whose telephone number is (571)272-5906. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571) 272-5960. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W BRADY/
Examiner, Art Unit 1692
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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