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
1. The Applicant’s response to the office action filed on June 15, 2026 is acknowledged.
Status of the Application
2. Claims 1-8, 10-12 and 14-19 are pending under examination. Claim 9 is canceled. Claims 13 and 20-21 are previously withdrawn from further consideration as being drawn to nonelected group. The Applicant’s arguments have been fully considered and found unpersuasive for the following reasons.
Claim Rejections - 35 USC § 102-maintained
3. 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 1-8, 10-11 and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ismagilov et al. (US 2018/0321137).
Ismagilov et al. teach a processor-implemented method of claims 1, 19, for determining a diagnostic outcome, method comprising: placing a biological sample from a subject in solution with an array of electro-chemical sensors (para 0149-0151, 0217-0241, 0186: indicating slipchip comprising electrochemical sensors and sample amplification in the slipchip device), receiving signals generated by an array of electro-chemical sensors in solution with a biological sample from a subject (para 0149-0151,
0217, 0241-0249, 0186, 0008-0018), each sensor of the array of electrochemical sensors configured to generate a signal in response to one or more amplification reactions occurring in the solution, the one or more amplification reactions being indicative of the presence of an RNA host response (para 0149-0151, 0217-0241, 0186, para 0008-0018); processing signals received from the array of electro-chemical
sensors (para 0241-0255, 0008-0018); based on the processing, assigning at least one value to the sample according to the likelihood of a diagnostic outcome (para 0241-0255, 0008-0018); and based on the at least one assigned value, determining the diagnostic outcome (positive signal or negative outcome) (para 0241-0255, 0008-0018).
With reference to claim 2, Ismagilov et al. teach that the electro-chemical sensors are chemically sensitive sensors (para 0186-0187).
With reference to claims 3-4, Ismagilov et al. teach that the nucleic acid amplification is an isothermal reaction, wherein the amplification is loop mediated isothermal amplification (para 0217, 0149-0151).
With reference to claim 5, Ismagilov et al. teach that the biological sample contains at least one of a DNA, RNA or protein sample (para 0021).
With reference to claim 6, Ismagilov et al. teach that the at least one value is assigned to the sample based on time-to-positive (para 0233, 0291).
With reference to claim 7-8, 10-11, Ismagilov et al. teach that the diagnostic outcome is a differentiation between a bacterial and a viral infection; a differentiation between a biological sample from a subject that has an infection and a biological sample from a subject that does not have an infection; a differentiation between a biological sample from a subject that is predisposed to an infection and a biological sample from a subject that is not predisposed to an infection; or a differentiation between an active form of an infection and a latent form of an infection (para 0222-0231)
With reference to claim 14-15, Ismagilov et al. teach that processing the signals comprises clustering the signals received from each sensor of the array of sensors in the time domain, each cluster generated by the clustering process comprises a subset of sensors of the array of sensors (para 0089-0096, 0241-0255, 0072).
With reference to claims 16-17, Ismagilov et al. teach that processing the signals comprises obtaining a feature associated with the amplification curve associated with an amplification reaction, the amplification curve describing a degree of amplification over time; and wherein the at least one value is assigned based on the feature associated with the amplification curve, wherein the feature associated with the amplification curve is melting curve (Ct) (para 0241-0255).
With reference to claim 18, Ismagilov et al. teach that processing the signals comprises obtaining a feature associated with a plurality of different amplification curves, each amplification curve being associated with a different amplification reaction and each describing a degree of amplification of a respective amplicon over time; and wherein the at least one value is assigned based on the plurality of features associated with the amplification curve (para 0241-0255, 0283).
Response to Arguments:
With reference to the rejection of claims under 35 USC 102(a)(1) as being anticipated by Ismagilov et al., the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to no teaching of an array of electrochemical sensors to generate amplification reaction signals indicative of an RNA host-response. The arguments were found unpersuasive. First, Ismogilov et al. teach an array (slipchip) comprising plurality of reaction areas for amplification of different target analytes or gene markers in a biological sample in response to cancer in a host, wherein the array comprises plurality of sensors (para 0176) which include CMOS sensors, camera, photon and other sensors. As discussed in the rejection para 0186 indicates electrochemical reaction signal detected by CMOS or camera sensors, wherein the array comprises 10 to 10, 000 reaction compartments (para 0183-0184) and the slipchip is electrically conductive material and the areas or compartments are connected to at least one electrode (para 0186-0187) which clearly indicate that more than one electrode sensors are connected to the reaction areas on the array. Further, with reference to no teaching of one or more amplification reactions in response to an RNA host-response, the arguments have been found unpersuasive because as discussed in the rejection Ismogilov et al. teach amplification signals of one or more gene expressions of RNA in response to host’s cancer condition or host’s HIV infection (para 0217-0226, 0149-0150), Further, Ismogilov et al. teach that target nucleic acid is an RNA molecule and the amplification comprises reverse transcribing RNA and the examiner cited para (para 0217, 0241-0249, 0255, 0149-0150) teach at least one RT-LAMP or dRT-LAMP amplification signals in response to at least one RNA target molecule which do not exclude more than one amplification reaction signals of RNA host-response to host infected by HIV or cancer. In addition, Ismagilov et al. teach pH indicators in amplification reactions and detecting color development though CMOS or other sensors which is within the scope of electrochemical sensor detection. For all the above, the rejection has been maintained.
Claim Rejections - 35 USC § 103-maintained
4. 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 1-8, 10-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 2018/0321137) in view of Steelman et al. (US 2017/0218455).
Ismagilov et al. teach a method for determining a diagnostic outcome as discussed above, however, Ismagilov et al. did not teach assigning the at least one value to the sample comprising a trained classifier.
Steelman et al. teach microfluidic chip with integrated into amplification chambers comprising detection units for quantitating amplification products, wherein detection unit comprises electrochemical sensors comprising detection probes with redox indicators for detecting a change in the electrical current, or potential, resulting in signal readouts for real-time monitoring of amplification products over a time period (para 0152-0161),
wherein the method utilizes machine learning methods to analyze training datasets for analyzing differentially expresses probes and ranking the selected sets and a trained classifier was used to test to set a mean average value for differentially expressed probes (para 0326-0328).
It would be prima facie obvious to an ordinary person skilled in the art before the effective filing date of the invention to modify the method of Ismagilov et al. with the trained classifier method as taught by Steelman et al. to develop an improved method for determining diagnostic outcome. The ordinary person skilled in the art would have motivated to combine the method of Ismagilov et al. with a trained classifier as taught by Steelman et al. and have a reasonable expectation of success that the combination would improve the diagnostic outcome because Steelman et al. explicitly taught trained
classifier would provide selection and ranking of differentially expressed gene markers and aid in cross-validation of test (para 0328) and such a modification is considered obvious over the cited prior art.
Response to Arguments:
4. With reference to the rejection of claims under 35 USC 103 as being obvious over Ismagilov et al. in view of Steelman et al., the Applicant’s arguments have been fully considered and found unpersuasive. As discussed above, Ismagilov et al. teach detection of amplification signals in response to RNA host-response (HIV infection or caner to the host) through sensors or array of sensors and as discussed in the rejection it would be obvious to modify the method of Ismagilov et al. with assigning at least one value of sample by trained classifier as taught by Steelman et al. to derive at the claimed method. For all the above the rejection has been maintained.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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