DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed May 26, 2023. Currently, claims 1-20 are pending.
Priority
This application claims priority to
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The limitations SARS and MERS does not appear in the first provisional application. Therefore, they are provided benefit of October 27, 2020.
Drawings
The drawings are acceptable.
Claim Rejections - 35 USC § 102
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.
(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.
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 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.
Claim(s) 1, 4, 6-7, 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (Anal. Chem. Vol. 89, pages 745-750, 2017).
Hu teaches a method of producing droplets containing a sample within a microfluidic device, amplifying the nucleic acids in the droplets using digital droplet LAMP and determining fluorescence of the droplets for absolute quantification. Hu teaches the dLAMP method s tolerant to inhibitory substances and is robust and precise (abstract).
With respect to Claims 4, 12, Hu teaches human infection of avian influenza A H5N1 viruses were quantified (abstract).
With respect to Claim 6, Hu teaches obtaining a nasopharyngeal swab, i.e. a nasal swab (abstract Figure, page 746, col. 2 para 4).
With respect to Claim 7, Hu teaches incubation for amplification at 60-65 degrees (Figure 1b, page 747, col. 1).
With respect to Claim 9, Hu teaches droplet generation with primers in the droplets prior to amplifications (page 747, col .1) .
With respect to Claim 10-11, Hu illustrates taking samples, extracting RNA and reverse transcribing to cDNA for dLAMP assays (page 747, Figure 1a).
Claim(s) 1-5, 7- 9, 11-12, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xie et al. (WO2018/039969, March 8, 2018).
Xie teaches a method for producing droplets within a microfluidic device, amplifying nucleic acids in the droplets using LAMP and determining fluorescence of the droplets. Specifically, Example I, provides a single cell is lysed in lysis buffer, PCR products are added to the reaction mixture and droplets are formed in a microfluidic device (page 40). PCR amplification is performed (page 40). Xie teaches amplification may be performed using loop-medicated isothermal amplification (page 18). Xie teaches nucleic acid may be detected using fluorophore labels (page 58).
With respect to Claims 2-3, Xie teaches millions of small fragments are generated and the number of droplets exceeds the number of fragments to ensure that most of the droplets contain only one DNA fragment. Thus, millions of droplets are produced (page 23).
With respect to Claim 4, Xie teaches human cells are used (page 32 and Figure 7).
With respect to Claim 5 and 18, Xie teaches the sample may be saliva (page 32).
With respect to Claim 7, Xie teaches PCR reaction buffer and primers are added to the reaction mixture which is heated to 72C for 10 minutes (at least 65C)(Example I, page 40).
With respect to Claim 9, primers are in the droplets prior to amplifying (Example I, page 40).
With respect to Claim 11, Xie teaches the molecule may be RNA (page 27).
With respect to Claims 12 and 16, Xie teaches the sample may be a virus or bacteria (page 22).
Claim(s) 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walt et al. (WO 2020/037130, February 20, 2020).
Walt teaches a method for determining an attomolar concentration of a species in a fluid by providing an aqueous fluid having a volume of at least 1 ml and containing a species at a concentration of less than 1 fM (pages 23-24); forming a plurality of at least 1,000,000 droplets (page 24, lines 2-4), determining droplets of the plurality that contain the species and determining a concentration of the species in the fluid. The concentration of the target analyte in the sample ranges from about 0 aM to about 1 mM, e.g., about 1 aM to about 1 mM.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (WO2018/039969, March 8, 2018) in view of Wang et al. (CN111118225, March 3, 2020).
Xie teaches a method for producing droplets within a microfluidic device, amplifying nucleic acids in the droplets using LAMP and determining fluorescence of the droplets. Specifically, Example I, provides a single cell is lysed in lysis buffer, PCR products are added to the reaction mixture and droplets are formed in a microfluidic device (page 40). PCR amplification is performed (page 40). Xie teaches amplification may be performed using loop-medicated isothermal amplification (page 18). Xie teaches nucleic acid may be detected using fluorophore labels (page 58). Xie teaches the sample may be a virus or bacteria (page 22).
Xie does not teach the nucleic acid is COVID-19.
However, Wang teaches droplet digital PCR may be used to detect COVID-19.
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have detected additional viruses, such as COVID-19 using the method of Xie to allow detection of a clinically relevant virus.
Claims 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (WO2018/039969, March 8, 2018) in view of Morris et al. (US 2023/0323353, priority March 25, 2020).
Xie teaches a method for producing droplets within a microfluidic device, amplifying nucleic acids in the droplets using LAMP and determining fluorescence of the droplets. Specifically, Example I, provides a single cell is lysed in lysis buffer, PCR products are added to the reaction mixture and droplets are formed in a microfluidic device (page 40). PCR amplification is performed (page 40). Xie teaches amplification may be performed using loop-medicated isothermal amplification (page 18). Xie teaches nucleic acid may be detected using fluorophore labels (page 58). Xie teaches the sample may be a virus or bacteria (page 22).
Xie does not teach the nucleic acid is SARS.
However, Morris teaches droplet digital PCR may be used to detect MERS and SARS
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have detected additional viruses, such as SARS and MERS using the method of Xie to allow detection of a clinically relevant virus.
Conclusion
No claims allowable over the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
July 22, 2025