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 .
The examiner reviewing your application at the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to examiner Sarae Bausch.
Election/Restrictions
Applicant’s election of group I, claims 11-10, 18-19, and 21-22 and species small molecule inhibitor, dasatinib in the reply filed on 11/17/2025 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)).
Claims 11-13, 16-17, 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 in the reply filed on 11/17/2025.
Claims 1-10, 18-19 and 21-22 are under examination. Claim 5 is under examination with respect to elected species of small molecule inhibitor.
Claim Objections
Claim 1 objected to because of the following informalities: claim 1 recites TTP without the full form of the work. The claim should recite the full form followed by abbreviation in parenthesis when first recited. For example, tristetraprolin (TTP). Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 18-19 and 21-22 rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and law of nature without significantly more.
The claims recite an abstract idea, a mental process and a law of nature. Claim 1 recites determining whether one or more compounds reduce a level of phosphorylated TTP in a treated sample compared to a control. The broadest reasonable interpretation of determining is a step that can be accomplished mentally be evaluating data and includes critical think process. Additionally the claims encompasses a law of nature. The claims require the natural correlation between reduction of phosphorylated TTP and anti-aging activity. This correlation is required to determine if a compound is an anti-aging compound and thus decreased phosphorylated TTP is correlated to anti-aging activity which does not require the hand of man to occur.
This judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. The cited prior art demonstrate the additional steps were well established routine and conventional. Vasudevan (US2020/0101057 A1) teaches providing a sample of THP1 cells, treating with test compounds and measuring level of phosphorylated TTP (see fig 6K).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements for determining anti-aging compounds and phosphorylated TTP were well known, routine and conventional in the art as taught by Vasudevan.
Claim 2-4 recite a control level, reduced of 15% phosphorylated TTP, and using antibody to target phosphorylated TTP. Determining TTP levels and using control levels was well known, routine and conventional in the art as taught by Vasudevan.
Claim 5-6, 18, 21-22 limits the anti-aging compound. These agents were known in the art as taught by Vasudevan.
Claims 7-8 and 19 include additional step of determining SASP marker expression and phenotype. Determining SASP marker expression and phenotype was well known, routine and convention in the art as taught by Vasudevan.
Claims 9-10 limit the sample, which is a field of use limitation and does not amount to significantly more.
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 1-2, 4-10, 18-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vasudevan (US2020/0101057 A1).
With regard to claim 1-2, 5-6, 18, and 21, Vasudevan teaches methods for measuring phosphorylated TTP in samples comprising S+, SS and AraC treated cells in the absence or presence of alkaline phosphatase (see para 20, fig 3F-H). Vasudevan shows phosphorylated TTP levels are reduced, ARE levels are reduced in AraC-treated cells compared to S+ cells (see fig 4f, para 20) (claim 8) (AU rich mRNA is reduced). SS cells are leukemic cells induced by growth factor deprivation and exhibit chemoresistance, AraCS are chemo surviving cells, S+ cells are proliferating cells (see para 106). Vasudevan teaches contacting THP1 cells with AraC inhibitor (see para 73) (providing a sample comprising senescent cells, providing one or more compounds to be tested, treating sample with compound and determining level of phosphorylated TTP). Vasudevan teaches contacting THP1 cells with AraC, PFD, and LY2228820 reduce phosphorylated TTP, Vasudevan teaches this combination targets early inflammation for cell survival (anti-aging) and reduced chemoresistance by DNA damage and stress signaling (anti-aging). LY2228820 is a small molecule inhibitor and senomorphic comound (claim 5-6, 18, 21). Vasudevan teaches decreased phosphor-TTP in THP1 cells contacted with AraC (see fig 3F, 4F, 6K) compared to SS cells (reference sample) (claim 2).
With regard to claim 4, Vasudevan teaches western blot analysis using antibodies targeting phosphorylated TTP (See para 89).
With regard to claim 7-8, and 19, Vasudevan teaches expression levels of senescence-associated secretory phenotype (SASP) genes of AraCS and SS compared to S+ (see figure 11A). Vasudevan teaches determining reduced expression levels of SASP genes (see fig 11A).
With regard to claim 10, Vasudevan teaches SS THP1 cells and AraCS were THP1 cells treated with 5uM AraC (sample comprises monocytes and macrophages) (see para 73).
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.
Claims 1-7, 9-10, 18-19 and 21-22are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (CN110934873A) in view of Frasca (Mechanism of Ageing and Development, 2010, 131, 306-314).
Sun teaches administering dasatinib and SRT2104 to samples comprising PSC27 cells and mice (see pg. 3). Sun teaches eliminating senescent cells by administration of dasatinib and SRT 2104 (see pg. 3) (claim 5-6, 18, 21-22). Sun further teaches administering dasatinib eliminates activity of senescent cells and down regulation of gene targets. Sun teaches contacting anti-aging compound, dasatinib elements aged cells (see pg. 4). Sun teaches dasatinib and SRT2104 is used for reducing the level of SASP markers (see pg. 7). Sun teaches use of down regulated ABL for the preparation of medicament as the deletion of ABL caused significant decrease in senescent stromal cells (see pg. 7). Sun teaches screening compounds can be performed by one skilled in the art using routine screening methods in the art. Sun teaches contacting bleomycin to PSC27 cells (claim 9-10, providing sample comprising cells and inducing senescence, cells comprising macrophages). Sun teaches senescent cells were stained with SA-µ-gal positive (see pg. 8, ex 1) (claim 7, 19) Sun teaches PSC27 cells showed an increase in staining indicating increased gaining. Sun teaches pharmacodynamic screening analysis and teaches dasatinib survival rate of senescent PSC27 was reduced (See fig 9, 10, ex 2). While Sun teaches providing a sample comprising senescent cells, providing and contacting a compound to be tested, and treating a sample with compounds, dasatinib, Sun does not teach determining if one or more compounds reduce a level of phosphorylated TTP in the sample.
However it was well known in the art to determine phosphorylated levels of TTP in a sample. It was additionally known that TTP levels were correlated to gaining. Frasca teaches decreased phosphorylated TTP in old cells compared to young cells (see fig 8). Frasca teaches aging is a dysregulation between information and anti-inflammatory networks and teaches better characterization of inflammatory/immune pathways in aging lead to better regulation (see pg. 313). Frasca teaches B cells cultured and stimulated with LPS and inhibitor of PP2A (see 2.3 and 2.4). Frasca teaches western blotting for analysis for phosphorylated TTP by using antibody to TTP (see 2.6) (claim 4). Frasca teaches reduced levels of phosphor-TTP by 15% (see fig 4 and 5) (claim 3).
Therefore it would have been prima obvious to modify the teaching of Sun to include analysis of phosphorylated TTP in senescence cells as taught by Frasca. The ordinary artisan would have been motivated to include additional assays in the method of Sun because Sun teaches using known screening assays and Frasca teaches analysis of phosphorylated TTP in new versus old cells and teaches a difference in phosphorylated TTP in new versus old cells. The ordinary artisan would have had a reasonable expectation of success of using an assay of identifying anti-aging compounds by measuring phosphorylated TTP because Sun teaches anti-aging compounds and suggests the use of routine assays and Frasca teaches an assay that compares new versus old cells by measuring phosphorylated levels of TTP.
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699