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 .
DEATILED ACTION
1. The Applicant’s response to the office action filed on September 30, 2025 is acknowledged.
Status of the Application
2. Claims 1-14, and 16-22 are pending under examination. Claim 15 is canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the following reasons.
Objection to the claims-withdrawn
3. The objection to the claims 1 and 21 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
4. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102-withdrawn
5. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Huang has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-withdrawn
6. The rejection of claims under 35 USC 103 as being unpatentable over Huang in view of Calvert has been withdrawn in view of the amendment.
New Rejections Necessitated by the Amendment
Claim Rejections - 35 USC § 103
7. 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 1-14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Compton et al. (WO 2015/121658) in view of Calvert (WO 2018/204175).
Compton et al. teach a method of claim 1, 21, comprising the steps of: providing a solution comprising a biological sample, a quinone is dissolved in the solution (page 4, line 4-29);
applying the solution to an electrode, wherein the electrode is three-electrode electrochemical cell (page 4, line 4-29, page 5, line 1-20, page 8, line 7-36, page 14, line 1-10, page 16, line 10-25);
measuring an electrochemical response of the electrochemical cell, wherein the electrochemical response (electric potential) measures a change in oxidation state of the quinone, quinone derivates thereof (page 4, line 4-29, page 8, line 7-36, page 9, line 1-32);
quantifying an amount of the target nucleic acid in the sample by the change of electrochemical response, wherein the method quantifies a change in pH of the solution as a function of the electrical response of the electrochemical cell (page 4, line 4-29, page 9, line 34 to line 20 on page 11).
With reference to claim 2, Compton et al. teach that the quinone is a 1,4-benzoquinone,
or derivatives thereof (page 19, line 10-28).
With reference to claims 4-6, 14, 16-18, Compton et al. teach that the electrochemical response measured is the potential of electrochemical cell, current or combination, wherein the potential is measured via cyclic voltammetry and the three-electrode comprises working electrode, reference electrode and counter electrode and the electrodes comprise carbon wire electrodes (page 4, line 4-29, page 8, line 7 to line 9 on page 10, page 14, line 1-10).
With reference to claim 7-8, Compton et al. teach quinone concentration is about 1uM to 1000uM and the solution comprises a buffer (page 18, line 6-16).
However, Compton did not specifically teach sample as biological sample, primers and amplification reagents.
Calvert teach a method of claims 1-14, 16-22, measuring pH of a solution comprising a biological sample and performing RT-LAMP amplification, wherein the method comprising a pH-sensitive indicator dye in the RT-LAMP reaction mixture, wherein the biological sample comprises a blood, urine, serum or plasma sample in the presence of a pH-sensitive indicator dye comprising cresol red, cresol purple, phenol red, thymol blue or naphtholphthalein; measuring pH of the solution change in color in response a change due to the presence or absence of a target polynucleotide in the biological sample and quantifying an amount of the target polynucleotide in the sample (paragraphs under the subheading RT-LAMP assay for detection of ZIKA RNA’ on page 11-17, page 2, 29-34, page 3, line 1-2, page 5, line 23-27).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filing date of the invention to modify the method as taught by Compton et al. with measuring a pH of a biological sample and amplification of the biological sample as taught by Calvert to improve the method of detecting a target nucleic acid in a biological sample in a point-of care setting (POC). The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would improve the method because Calvert taught use of a biological sample for detecting the presence or absence of a target polynucleotide in an amplification reaction an a POC setting by measuring a change in pH (page 2, line 29-34, page 3, line 1-2) and such a modification is considered obvious over the cited prior art. Further, it would be obvious to use a quinone or a phenol red as a pH indicator dye because both produce a color change in the electrochemical or redox reactions that is detectable in visible light (page 16, line14-21) and such a modification is considered obvious over the cited prior art.
Conclusion
No claims are 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.
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
Prosecution Insights