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
2. This Office Action is responsive to Applicant’s Amendment and Remarks, filed August 4, 2025. The amendment, filed August 4, 2025, has been entered, wherein claims 1, 26, 51, and 77 are amended, claims 2 – 12, 15 – 25, 27 – 37, 40 – 50, 52 – 70, 72 – 76, and 78 – 100 are canceled, and claims 13 – 14, 38 – 39, and 71 are withdrawn.
Claims 1, 13 – 14, 26, 38 – 39, 51, 71, and 77 are pending in this application and claims 1, 26, 51, and 77 are currently examined.
Priority
3. This application is a domestic application, filed February 8, 2022, which claims benefit of provisional application 63/148,490, filed February 11, 2021.
The following are maintained / modified grounds of rejection necessitated by Applicant’s Amendment and Remarks, filed August 4, 2025, wherein claims 1, 26, 51, and 77 are amended. Previously cited reference has been used to establish the maintained / modified grounds of rejection.
Maintained / Modified 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.
Claims 1, 26, 51, and 77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneider et al. (Molecular Cell Research, 2001, Vol. 1538, Issue 2 – 3, page 190 – 205, cited in the previous Office Action mailed May 2, 2025).
a. Independent claims 1, 26, 51, and 77 are directed to a method for treating cancer in a subject, wherein the method comprises contacting a cancer cell with an agent in an amount sufficient to change the endogenous baseline ratio of purine:pyrimidine nucleotides in the cancer cell, resulting in a change in the ratio of purine:pyrimidine nucleotides in the cancer cell, wherein the agent is adenosine; and wherein the cancer cell is inhibited from proliferating.
Schneider et al. disclose a study performed to investigate the molecular mechanisms underlying ATP-mediated cytotoxicity in the well-known human leukemic cell line U-937 (page 200, Right Col., para. 2). Adenosine is tested for the ability to inhibit cell proliferation. The results show that adenosine inhibits cell growth at a concentration of 300 μM. In untreated medium, adenosine shows a cell growth inhibitory effect on U-937 cells in a dose-dependent manner with reduced exponential cell growth in concentration below approximately 1000 μM (page 194, Right Col., para. 1). Schneider et al. teach that the experiments monitoring extracellular nucleotide metabolism confirmed the assumption that the long-term production and continuous uptake of adenosine, which is extracellularly generated by degradation of ATP, lead to an intracellular nucleotide imbalance with pyrimidine starvation (Abstract).
For these reasons, Schneider et al. anticipates the claimed invention.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed August 4, 2025, have been fully considered and are found to be not persuasive.
Regarding Schneider et al., Applicant argues that Schneider et al. teach that the mechanism of adenosine-mediated cytotoxicity strongly depends on the cell type used. However, the claims do not require universal efficacy across all cancers, but only contacting a cancer cell with adenosine to change the purine:pyrimidine ratio and inhibit proliferation. Schneider et al. explicitly disclose that adenosine, a purine nucleoside, when contacted with U937 human leukemia cancer cells, results in intracellular nucleotide imbalance due to pyrimidine starvation and inhibits proliferation in dose-dependent manner. These disclosures directly correspond to the limitations of the claims.
Applicant also argues that Schneider et al. teach that adenosine exhibited lower cytotoxicity than other purine nucleotides due to its own further metabolism. The fact that adenosine is metabolized or less effective is irrelevant in this case because anticipation does not require being the best or most effective agent, but only disclosure of the claimed elements.
Applicant further argues that Schneider et al. teach away from the claimed invention. However, anticipation under 35 U.S.C. 102 requires only a single reference discloses each and every element of the claimed invention, not that the reference discloses universal efficacy across all cell types.
Conclusion
No claim is found to be allowable.
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.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693