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. Applicant’s election without traverse of group I in the reply filed on November 18, 2025 is acknowledged. The withdrawal of claim 13 drawn to species is acknowledged.
Status of the Application
2. Claims 1-8, 10-12, 14-19 are considered for examination. Claims 13 and 20-21 have been withdrawn from further consideration as being drawn to nonelected group. Claim 9 is canceled.
Priority
3. This application field on February 24, 2023 is a 371 of PCT/EP2021/073427 fled on August 24, 2021 which claims foreign priority benefit to GB2014819.3 filed on September 21, 2020 and GR2020100509 filed on August 24, 2020.
Claim Rejections - 35 USC § 102
4. 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).
Claim Rejections - 35 USC § 103
5. 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.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681