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 .
Remarks
In response to communications sent April 18, 2022, claim(s) 1-15 are pending in this application; of these claims 1, 12, 13, and 14 are in independent form.
Response to Amendment
The preliminary amendment to the Specification filed April 18, 2022 is acknowledged and have been entered into the record.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawing(s) filed on April 18, 2022 are accepted by the Examiner.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: May 16, 2022.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities: The claim recites “a suitable therapy” in the preamble and again the last line of the body of the claim. However, in the body of the claim, it is unclear whether the term “a suitable therapy” is the same therapy-element as the one mentioned in the preamble. Claims 2-11 are objected to because they depend from an independent claim that is objected to. Appropriate correction is required. The Examiner suggests amending the body of the claim to recite “the suitable therapy” for clarity.
Claims 2 and 3 are objected to because of the following informalities: The claims recite “A method according to…” rather than “The method according to…”. Appropriate correction is required.
Claims 5-11 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim 13 is objected to because of the following informalities: The claim recites “a drug combination” in the preamble and again the last line of the body of the claim. However, in the body of the claim, it is unclear whether the term “a drug combination” is the same drug-element as the one mentioned in the preamble. Appropriate correction is required.
Claim Interpretation
The element “zero … or more candidate drugs” is not interpreted as indefinite. In the context of the claims, this is because “zero” drugs may still have “a response output,” albeit a trivial response output of “no response”. Hence the element is broad but not indefinite.
The claim 15 is further limiting of claim 14 because it introduces the term “administering.”
Claim Analysis - 35 USC § 101
No rejection is made under 35 U.S.C. § 101 despite involvement of a judicial exception of an abstract idea, specifically a mental process and mathematics. The mental process and mathematics of the “composite experimental design” (b) improves the later physical measurement process (c) to make the measurement process a more efficient measurement process, overcoming the complexity of the measurement process that normally results from the many combinatorial variations of compounds to test at different doses. The measurement step at (c) is a element beyond the abstract idea that is integrated with the abstract steps before it (b). The abstract step (b) improves the physical measurement process (c) by determining which combinations of compounds and which doses are chosen to be measured at step (c) to reduce the measurement complexity. The step (d) also involves some abstract ideas, but the claim as a whole includes the inventive concept of the integrated steps (a), (b), and (c).
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)(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.
Claim(s) 1-4 and 12-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0373535 A1 (“Nowak-Sliwinska”).
As to claim 1, Nowak-Sliwinska teaches a method for predicting a suitable therapy for treating a patient (Nowak-Sliwinska Para [0038]: a method for identifying low-dose multi-drug combinations for the treatment of cancer), the method comprising:
a) measuring a response output for each candidate drug (Nowak-Sliwinska Para [0040]: candidate compounds to be assayed) from an initial set of candidate drugs in a sample obtained from the patient (Nowak-Sliwinska Para [0039]: cancer cells) at one or more predetermined doses of the candidate drug (Nowak-Sliwinska Para [0041]: using various concentrations of the drug);
b) determining a minimum set of test combinatorial therapies from the initial set of candidate drugs (Nowak-Sliwinska Para [0042]: designing candidate compound combinations); wherein each test combinatorial therapy comprises zero, one or more candidate drugs at predetermined doses (Nowak-Sliwinska Para [0043]: the combinatorial therapies are tested a predetermined doses within therapeutic windows); wherein the minimum set of test combinatorial therapies is determined according to a composite experimental design (Nowak-Sliwinska Para [0042]: designing a candidate compound combination matrix by orthogonal array composite design, OACD);
c) measuring a response output for each test combinatorial therapy in the set in a sample obtained from the patient to determine a relationship between the response output and the corresponding predetermined doses of the candidate drugs, the relationship including one or more components indicative of respective drug-drug interactions (Nowak-Sliwinska Para [0044]: analyzing the anti-cancer efficacy for each candidate compound in the therapeutic window to determine the contribution of individual candidate compounds as individual agents within compound combinations by deriving a second-order linear regression analysis);
d) predicting a suitable therapy for treating the patient based on the derived relationship (Nowak-Sliwinska Para [0045]: predicting the suitable synergistic therapies using the significant parameters of the linear regression model).
As to claim 2, Nowak-Sliwinska teaches a method according to claim 1, wherein the composite experimental design is an orthogonal array composite design (OACD) (Nowak-Sliwinska Para [0042]: designing a candidate compound combination matrix by orthogonal array composite design, OACD).
As to claim 3, Nowak-Sliwinska teaches a method according to claim 2, wherein the composite experimental design is an OACD resolution IV design (Nowak-Sliwinska Para [0052]: a resolution IV design matrix for the orthogonal array).
As to claim 4, Nowak-Sliwinska teaches the method of any one of claims 1 to 3, wherein the candidate drugs are clinically approved drugs (Nowak-Sliwinska Para [0051]: clinically approved drugs).
As to claim 12, Nowak-Sliwinska teaches a method for selecting a suitable therapy for treating a patient (Nowak-Sliwinska Para [0038]: a method for identifying low-dose multi-drug combinations for the treatment of cancer), the method comprising:
a) measuring a response output for each candidate drug (Nowak-Sliwinska Para [0040]: candidate compounds to be assayed) from an initial set of candidate drugs in a sample obtained from the patient (Nowak-Sliwinska Para [0039]: cancer cells) at one or more predetermined doses of the candidate drug (Nowak-Sliwinska Para [0041]: using various concentrations of the drug);
b) determining a minimum set of test combinatorial therapies from the initial set of candidate drugs (Nowak-Sliwinska Para [0042]: designing candidate compound combinations); wherein each test combinatorial therapy comprises zero, one or more candidate drugs at predetermined doses (Nowak-Sliwinska Para [0043]: the combinatorial therapies are tested a predetermined doses within therapeutic windows); wherein the minimum set of test combinatorial therapies is determined according to a composite experimental design (Nowak-Sliwinska Para [0042]: designing a candidate compound combination matrix by orthogonal array composite design, OACD);
c) measuring a response output for each test combinatorial therapy in the set in a sample obtained from the patient to determine a relationship between the response output and the corresponding predetermined doses of the candidate drugs, the relationship including one or more components indicative of respective drug-drug interactions (Nowak-Sliwinska Para [0044]: analyzing the anti-cancer efficacy for each candidate compound in the therapeutic window to determine the contribution of individual candidate compounds as individual agents within compound combinations by deriving a second-order linear regression analysis); and
d) selecting a suitable therapy for treating the patient based on the derived relationship (Nowak-Sliwinska Para [0045]-[0046]: selecting compounds by process of elimination by predicting the suitable synergistic therapies using the significant parameters of the linear regression model).
As to claim 13, Nowak-Sliwinska teaches a method for screening a drug combination for treating a patient (Nowak-Sliwinska Para [0038]: a method for identifying low-dose multi-drug combinations for the treatment of cancer), the method comprises:
a) measuring a response output for each candidate drug (Nowak-Sliwinska Para [0040]: candidate compounds to be assayed) from an initial set of candidate drugs in a sample obtained from the patient (Nowak-Sliwinska Para [0039]: cancer cells) at one or more predetermined doses of the candidate drug (Nowak-Sliwinska Para [0041]: using various concentrations of the drug);
b) determining a minimum set of test combinatorial therapies from the initial set of candidate drugs (Nowak-Sliwinska Para [0042]: designing candidate compound combinations); wherein each test combinatorial therapy comprises zero, one or more candidate drugs at predetermined doses (Nowak-Sliwinska Para [0043]: the combinatorial therapies are tested a predetermined doses within therapeutic windows); wherein the minimum set of test combinatorial therapies is determined according to a composite experimental design (Nowak-Sliwinska Para [0042]: designing a candidate compound combination matrix by orthogonal array composite design, OACD);
c) measuring a response output for each test combinatorial therapy in the set in a sample obtained from the patient to determine a relationship between the response output and the corresponding predetermined doses of the candidate drugs, the relationship including one or more components indicative of respective drug-drug interactions (Nowak-Sliwinska Para [0044]: analyzing the anti-cancer efficacy for each candidate compound in the therapeutic window to determine the contribution of individual candidate compounds as individual agents within compound combinations by deriving a second-order linear regression analysis); and
d) selecting a drug combination for treating the patient based on the derived relationship (Nowak-Sliwinska Para [0045]-[0046]: selecting compound combinations by process of elimination by predicting the suitable synergistic therapies using the significant parameters of the linear regression model).
As to claim 14, Nowak-Sliwinska teaches a method of treating a patient (Nowak-Sliwinska Para [0038]: a method for identifying low-dose multi-drug combinations for the treatment of cancer), the method comprising:
a) measuring a response output for each candidate drug (Nowak-Sliwinska Para [0040]: candidate compounds to be assayed) from an initial set of candidate drugs in a sample obtained from the patient (Nowak-Sliwinska Para [0039]: cancer cells) at one or more predetermined doses of the candidate drug (Nowak-Sliwinska Para [0041]: using various concentrations of the drug);
b) determining a minimum set of test combinatorial therapies from the initial set of candidate drugs (Nowak-Sliwinska Para [0042]: designing candidate compound combinations); wherein each test combinatorial therapy comprises zero, one or more candidate drugs at predetermined doses (Nowak-Sliwinska Para [0043]: the combinatorial therapies are tested a predetermined doses within therapeutic windows); wherein the minimum set of test combinatorial therapies is determined according to a composite experimental design (Nowak-Sliwinska Para [0042]: designing a candidate compound combination matrix by orthogonal array composite design, OACD);
c) measuring a response output for each test combinatorial therapy in the set in a sample obtained from the patient to determine a relationship between the response output and the corresponding predetermined doses of the candidate drugs, the relationship including one or more components indicative of respective drug-drug interactions (Nowak-Sliwinska Para [0044]: analyzing the anti-cancer efficacy for each candidate compound in the therapeutic window to determine the contribution of individual candidate compounds as individual agents within compound combinations by deriving a second-order linear regression analysis);
d) selecting a suitable therapy for treating the patient based on the derived relationship (Nowak-Sliwinska Para [0045]-[0046]: selecting compound combinations by process of elimination by predicting the suitable synergistic therapies using the significant parameters of the linear regression model); and
e) treating the patient with the therapy (Nowak-Sliwinska Para [0057]: treating the patient with the combination therapy).
As to claim 15, Nowak-Sliwinska teaches the method of claim 14, wherein the method comprises administering the one or more drugs concurrently or sequentially to the patient (Nowak-Sliwinska Para [0068]: administering simultaneously or sequentially).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20210358636-A1: orthogonal array composite design (OACD)
Zhang, Ting, et al. "Orthogonal array composite design to study and optimize antioxidant combinations in the prevention of UVB-induced HSF damage." Journal of Photochemistry and Photobiology B: Biology 178 (2018): 568-576.
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/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 January 21, 2026