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 Election/Restrictions
Applicant’s election of Group 1, Claims 1-12, in the reply filed on 9/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 102
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 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 1-2 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by McKim (US 2013/0252270).
McKimdiscloses a method for determining the cytotoxicity of a compound of interest (para [0132]), the method comprising: providing a first sample of living cells in a first test well (para [0132}); providing a second sample of living cells in a second test well (para [0174]); treating the first sample of living cells with the compound of interest (para [0132]); treating the second sample of living cells with a suitable control compound (para [0174]); selecting a luminescing detection agent (para [0286]: luciferase), adding the luminescing detection agent to said first sample of living cells (para [0286]: luciferase) measuring the resulting luminescence produced by the first sample of living cells (para [0269)); measuring the resulting luminescence produced by the second sample of living cells (para [0300]: control); the difference between the luminescence of the first sample of living cells and the luminescence of the second sample of living cells reflects a reduction in ATP levels in the first sample of living cells (para [0300], [0268]) which is indicative of the cytotoxicity of the compound of interest (para [0468]: Table 1: General Cytotoxicity - ATP).
Applicants assert the Written Opinion of the ISA suggests the claims are allowable, but this is based on the assertion that Ceetox does not disclose determining the time period for exposure of the first sample of living cells to the compound of interest which must pass prior to addition of the selected luminescing detection agent to said first sample of living cells and said second sample of living cells based on the selected luminescing detection agent; or adding agent over a period of time as determined by the selected luminescing detection agent and adding said luminescing detection agent to said second sample of living cells over a period of time as determined by the selected luminescing detection agent; or wherein said step of treating the first sample of living cells with the compound of interest does not result in cell death.
Examiner disagrees with the ISA based on US practice because the step of determining the period of time based on the luminescing detection agent is inherent in the process. Given an administered agent must have a time period of administration, this step must be satisfied. Additionally, where the prior art does not teach that the cell dies, the result is not cell death is also inherently met and the result of the testing would be recognizing the maximum level for cytotoxicity has not been met.
Claims 1-2, 6, 8-11, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopkins et al (Org. Biomol. Chem, Vol.17, (2019), pages 8391 to 8402).
Hopkins et al describes an in vitro toxic screening method for a compound in which cells (including a pancreatic cancer cell strain BxPC3) are exposed to a target compound and a control compound (DMSO) for about 24 hours, a luminescent detection agent (resazurin) is added, and the cells are cultured for 1 to 4 hours to measure living cells, and describes that the target compound is a N-benzyl sulfone amido having an indole heteroaromatic group. Table 3 (p. 8394) and Table 4 (p. 8395) of Hopkins et al further describe a N-benzyl sulfone amido having the structure of Formula I recited in the instant claims. Since each of these N-benzyl sulfone amido has shown an IC50 value using living cells and is understood to be a composition for the test, it can be said that a composition containing the N-benzylsulfonamide is described. Scheme 1 of Hopkins et al (the left column on page 8392) further describes a method for preparing the N-benzylsulfonamide.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abebe (Screening of Heteroaromatic N-Benzyl Sulfonamides for Novel Chemotherapeutic Drugs, The University of Tulsa ProQuest Dissertations & Theses, 2019. 27665704).
Abebe (see, in particular, p.8-11,p.14-16,p.39,p.40-56 ) describes that each assay method of CellTiter - Blue,CellTiter - Glo and BacTiter - Glo is performed as a cytotoxic assay of the target compound (p. 14-16), that in the ATP evaluation method using CellTiter - Glo, the target compound is incubated with cells for 1 hour or longer, a luminescent agent is added, the mixture is stirred for 5 minutes, and then the cells are allowed to stand for 5 minutes or longer to evaluate luminescence (p. 15), and that 2-deoxyglucose (2-DG) is added as a metabolic inhibitor to living cells 1 hour before the target compound is added (p. 40-56, 39), the target compound is a N-benzyl sulfone amido having an indole heteroaromatic group (p. 8-11), and the results of a toxicity test using the pancreatic cancer cell strain BxPC3 (p. 41, Fig. 28) are described.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Abebe (Screening of Heteroaromatic N-Benzyl Sulfonamides for Novel Chemotherapeutic Drugs, The University of Tulsa ProQuest Dissertations & Theses, 2019. 27665704).
Abebe is discussed above and appears to be anticipatory, but for this rejection only, it is presumed that the selection of treating the cells must be determined and timing is not explicitly taught.
It would have been obvious to one of ordinary skill in the art to utilize known methods and steps for testing for toxicity when doing a dual sample test, as suggested by Abebe. Further, the timing would be obvious where each component must be administered at some point in the process and such timing would reasonably be expected to be determined by the component to be added.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon-Fri (8am-5pm with occasional mid-day flex).
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612