Prosecution Insights
Last updated: April 19, 2026
Application No. 17/620,077

DIGITAL PCR MEASUREMENT METHOD AND MEASUREMENT DEVICE

Non-Final OA §103§DP
Filed
Dec 16, 2021
Examiner
VANN-OJUEKAIYE, KENDRA RAYCHELL
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hitachi, Ltd.
OA Round
3 (Non-Final)
0%
Grant Probability
At Risk
3-4
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 8 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
61 currently pending
Career history
69
Total Applications
across all art units

Statute-Specific Performance

§101
13.1%
-26.9% vs TC avg
§103
41.9%
+1.9% vs TC avg
§102
8.9%
-31.1% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 8 resolved cases

Office Action

§103 §DP
DETAILED ACTION The amendment to the claims filed on 12/05/2025 have been entered. Claims 9 and 11-14 were withdrawn without traverse as being drawn to nonelected inventions. Claims 1-3, 5 and 7-8 are currently under examination. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered. Priority This application 17/620,077 is a 371 national phase of PCT/JP2020/020998 filed on 05/27/2020, which claims priority of JP 2019-118981 filed on 06/26/2019. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of JP2019-118981 has been submitted of the record on 12/16/2021. An English translation of the foreign application JP2019-118981 is required for the record to be considered for the priority date of 06/26/2019. Accordingly, the priority date of instant claims is determined to be 05/27/2020, the filing date of PCT/JP2020/020998. Claim Rejections - 35 USC § 103 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 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. Claims 1-3, 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shimazaki et al. (“Shimazaki”; (2017 cite in previous PTO 892). Parallel Evaluation of Melting Temperatures of DNAs in the Arrayed Droplets through the Fluorescence from DNA Intercalators. Analytical chemistry, 89 (12), 6305–6308.) in view of Zhong et al. (“Zhong”; (2011). Multiplex digital PCR: breaking the one target per color barrier of quantitative PCR. Lab on a Chip, 11(13), 2167-2174). Shimazaki discloses parallel evaluation of melting temperatures (Tm’s) of DNA molecules in multiple floating droplets (20 μm in diameter) was demonstrated. The Tm values were evaluated from the melting curves which were observed through the fluorescence from the DNA intercalators. The Tm values measured in the droplets corresponded well to those measured in the bulk, indicating the validity of the measurement. The parallel evaluation of Tm’s was realized by observing melting curves of DNAs in the different droplets at the same time using the “droplet guide”, which guided and fixed the floating droplets to the designated points in the observing plane. This demonstration would pave the way for the improvement of the precision of droplet digital PCR (ddPCR) whose state-of-the-art ascribes color and intensity of fluorescence to the base sequence of DNA in the droplet (Abstract). Regarding claim 1, Shimazaki teaches a method comprising “Digital PCR (dPCR) and droplet digital PCR (ddPCR) are the potential techniques to realize liquid biopsy. In ddPCR, each single DNA molecule in a sample is partitioned and amplified in a droplet. The existence of targeted DNA molecules in the droplet is indicated by fluorescence from dyes” (e.g., Pg. 6305 col. 1 para. 1). Shimazaki teaches “ddPCR has the potential for a single mutant DNA molecule in the sample to be detected” (e.g., Pg. 6305 col. 1, para. 1). Shimazaki also teaches “three types of double-stranded DNAs (dsDNAs) were used” (e.g., Pg. 6305 col. 2, para. 2). Thus, Shimazaki teaches “A method for detecting DNA by digital PCR, comprising the steps of: transferring a DNA solution containing different types of DNAs to be detected and fluorescent dye in a plurality of compartments. Regarding claim 1, Shimazaki teaches a method comprising “in the droplets (e.g., Pg. 6305 col. 2, para. 2). Shimazaki suggests that the method disclosed “in the droplet could be distinguished in terms of the Tm’s, which would lead to the contribution to the reduction of errors in detecting targeted DNA molecules in the ddPCR format.” (Pg. 6307, last para., last sent.) Thus, Shimazaki suggests a method comprising carrying out PCR in the plurality of compartments. PNG media_image1.png 502 637 media_image1.png Greyscale Regarding claim 1, Shimazaki teaches a method comprising “evaluation of melting curves of dsDNAs in different floating droplets was demonstrated by measuring the temperature dependence of fluorescence intensity” (e.g., Pg. 6306 col. 2 para. 2). Shimazaki teaches a method comprising “The Tm value of the dsDNA was evaluated by (1) fitting the melting curve with the sixth polynomial function (solid line in Figure 3), (2) taking a derivative for the fitting curve (dashed line in Figure 3), and (3) reading the temperature at which the derivative took the maximum value” (e.g., Pg. 6306 col. 2 para. 3; Figure 3 (shown below)). Shimazaki teaches the “The Tm value evaluated from Figure 3 was 74.1 °C, which was a little smaller than that measured in the bulk (80.1 °C) using a commercial real-time PCR system (QuantStudio (Thermo Fisher Scientific)).” (e.g., Pg. 6306 col. 2 para. 3). Thus, Shimazaki teaches a method comprising measuring a fluorescence intensity in association with a change in temperature; calculating a melting temperature of a DNA double strand from a change in fluorescence intensity, associated with a change in temperature of the DNA solution and calculating a temperature difference between two points wherein the two points have a predetermined slope value, on a melting curve indicating a change in the fluorescence intensity over temperature. Regarding claim 1, Shimazaki teaches a method wherein “Tm’s obtained through the same analysis in Figure 3 for the sample with the 16 and 23 bp dsDNAs ” and “two distinctive peaks were observed; one was centered at 53.4 °C and the other at 59.4 °C , which corresponded to the Tm’s of the 16 bp (57.1 °C) and 23 bp (64.0 °C) dsDNAs in bulk” (e.g., Pg. 6307 col. 1 para. 3, col. 2 para. 1; Fig. 6). Thus, Shimazaki wherein the difference between the melting temperature of the different type of DNAs is 10° C or less. However, Shimazaki does not explicitly teach the limitation “fluorescent-labeled probes” and “wherein the different types of fluorescent-labeled probes are labeled with a same fluorescent, and wherein each of the different types of fluorescent-labeled probes is capable of binding to a respective type of DNA among the different types of DNAs” and “different types of the fluorescent probes”. Zhong discloses “Quantitative polymerase chain reactions (qPCR) based on real-time PCR constitute a powerful and sensitive method for the analysis of nucleic acids. However, in qPCR, the ability to multiplex targets using differently colored fluorescent probes is typically limited to 4-fold by the spectral overlap of the fluorophores. Furthermore, multiplexing qPCR assays requires expensive instrumentation and most often lengthy assay development cycles. Digital PCR (dPCR), which is based on the amplification of single target DNA molecules in many separate reactions, is an attractive alternative to qPCR. Here we report a novel and easy method for multiplexing dPCR in picolitre droplets within emulsions-generated and read out in microfluidic devices-that takes advantage of both the very high numbers of reactions possible within emulsions (>106) as well as the high likelihood that the amplification of only a single target DNA molecule will initiate within each droplet. By varying the concentration of different fluorogenic probes of the same color, it is possible to identify the different probes on the basis of fluorescence intensity. Adding multiple colors increases the number of possible reactions geometrically, rather than linearly as with qPCR. Accurate and precise copy numbers of up to sixteen per cell were measured using a model system. A 5-plex assay for spinal muscular atrophy was demonstrated with just two fluorophores to simultaneously measure the copy number of two genes (SMN1 and SMN2) and to genotype a single nucleotide polymorphism (c.815A>G, SMN1). Results of a pilot study with SMA patients are presented.” (Abstract). Regarding claim 1, Zhong teaches a method wherein “dPCR was performed in aqueous droplets separated by oil using a microfluidics system” (Pg. 2168 Col. 1, para.3). Zhong teaches a method wherein “dPCR using probes with the same fluorophore (FAM)” (Pg. 2169 Col. 2, last line, Pg. 2170 Col. 1 first line; Table 1-SMN1 and SMN2). Zhong teaches a method wherein “different reactions with different efficiencies can be discriminated on the basis of end point fluorescence intensity alone even if they have the same color” (Pg. 2168 Col. 1 last para.). Thus, Zhong teaches a method “dPCR”, “fluorescent labeled probes” and “wherein the different types of fluorescent-labeled probes are labeled with a same fluorescent, and wherein each of the plurality of types of fluorescent-labeled probes is capable of binding to a respective type of DNA among the different types of DNAs; and different types of the fluorescent probes. Regarding claim 1, Shimazaki teaches a method wherein “The Tm value obtained would reduce errors in detecting targeted DNA molecules in ddPCR because the Tm value is inherent to the base sequence of DNA molecules and helps one to precisely determine the DNA molecules in the droplet.” (e.g., Pg. 6305 col. 1 para. 2). Shimazaki teaches a method wherein “dsDNAs. A DNA intercalator (Eva-Green) was used for the melting curve measurements of the dsDNA in the droplets. The melting curves can be measured with the DNA intercalator because its fluorescence intensity increases with the increase in the number of dsDNA molecules” (e.g., Pg. 6305 col. 2 para. 2). Thus, Shimazaki and Zhong teach a method wherein melting temperature is a melting temperature of a double strand formed between the fluorescent-labeled probes and the DNA to be detected. Shimazaki and Zhong are both considered to be analogous to the claimed invention because they are in the same field of detecting DNA by digital PCR. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for detecting different types of DNA by measuring the fluorescence intensity of dsDNA and calculating the difference in Tm as taught by Shimazaki to incorporate the method comprising dPCR using fluorescent labeled probes, wherein the different types of fluorescent-labeled probes are labeled with a same fluorescent, and wherein each of the plurality of types of fluorescent-labeled probes is capable of binding to a respective type of DNA among the different types of DNAs and different types of fluorescent-labeled probes that are labeled with a same fluorescent as taught by Zhong and provide a method according to the limitations of claim 1. Doing so would increase the throughput, reaction efficiency and alleviate barriers in measurements assessed in methods for the detection of different types of DNA by digital PCR. The teachings of Shimazaki and Zhong are documented above in the rejection of claim 1 under 35 U.S.C. 103. Claims 2-5 and 7-8 depend on claim 1. Regarding claim 2, Shimazaki teaches a method wherein “The bright spots were also observed from the droplets containing the DNA intercalator and the dsDNAs (16 and 23 bp)” (e.g., Pg. 6306 col. 2 para. 1). Shimazaki teaches a method wherein “Tm’s obtained through the same analysis in Figure 3 for the sample with the 16 and 23 bp dsDNAs ” and “two distinctive peaks were observed; one was centered at 53.4 °C and the other at 59.4 °C, which corresponded to the Tm’s of the 16 bp (57.1 °C) and 23 bp (64.0 °C) dsDNAs in bulk” (e.g., Pg. 6307 col. 1 para. 3, col. 2 para. 1; Fig. 6). Thus, Shimazaki and Zhong teach a method further comprising the step of identifying a compartment, in which the temperature difference is equal to or greater than a predetermined threshold, as a compartment containing two types of DNAs to be detected. Regarding claim 3, Shimazaki teaches a method wherein “The droplets contained the dsDNA (78 bp, 0.4 μM) and the DNA intercalator (1.2 μM), and these images were observed using the inverted fluorescence microscope (IX70, Olympus Corporation) with the excitation and observed wavelength being 490 and >500 nm, respectively. Bright spots were observed from the positions where the droplets were captured, indicating that the DNA intercalators were inserted in the dsDNA and emitted fluorescence” (e.g., Pg. 6306 col. 1 para. 2). Shimazaki teaches a method wherein Tm’s of the 78 bp dsDNA, which is a result of the analyses of all the valid melting curves obtained through the parallel evaluation (N = 1588). The Tm values centered at 74.3 °C, which corresponded to the bulk Tm value (80.1 °C)” (e.g., Pg. 6306 col. 2 para. 3). Thus, Shimazaki and Zhong teach a method further comprising the step of identifying a compartment, in which the temperature difference is less than a predetermined threshold, as a compartment containing one type of DNA to be detected. Regarding claim 5, Zhong teaches a method wherein “FAM” and ““MGBNFQ” is the minor groove binder non-fluorescent quencher” (Pg. 2173, Table 1). FAM reads on fluorescent-labeled probe. Thus, Shimazaki and Zhong teach a method wherein the fluorescent-labeled probe has a fluorescent dye and a quencher thereof. Regarding claim 7, Shimazaki teaches a method wherein “the “droplet guide”, which guided and fixed the floating droplets to the designated points in the observing plane” (e.g., Pg. 6305 col. 1 Para 2; Figure 1 a and b). Thus, Shimazaki and Zhong teach a method wherein the plurality of compartments are arranged in a plane. Regarding claim 8, Shimazaki teaches a method wherein droplets floating on the oil surface. (e.g., Pg. 6305 col. 1 Para 1;). Shimazaki also teaches a method wherein “the “droplet guide”, which guided and fixed the floating droplets to the designated points in the observing plane” (e.g., Pg. 6305 col. 1 Para 2; Figure 1 a and b). Thus, Shimazaki and Zhong teach a method wherein the DNA solution is divided into the plurality of compartments by droplets or wells. Response to Arguments Applicant' s arguments filed 12/05/2025 (Pg.5-6) with respect to claim 1-3, 5 and 7-8 have been considered but are not persuasive. To clarify some instances argued in the response filed 12/05/2025 see responses to each argument made by Applicant below: Applicants’ argument: “Shimazaki and Zhong do not teach or suggest the instant claim limitations… Applicant respectfully submits that one of ordinary skill in the art would not have had a reasonable expectation of success in applying Shimazaki to PCR or any motivation or reasonable expectation of success in applying Zhong to Shimazaki, that attempting to apply Zhong to Shimazaki would change the principle of operation of Shimazaki, and that Zhong actually would have led one of ordinary skill in the art away from Shimazaki.” (Pg. 6) Response: Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive, because the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Shimazaki and Zhong are both considered to be analogous to the claimed invention because they are in the same field of detecting DNA by digital PCR. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for detecting different types of DNA by measuring the fluorescence intensity of dsDNA and calculating the difference in Tm as taught by Shimazaki to incorporate the method comprising dPCR using fluorescent labeled probes, wherein the different types of fluorescent-labeled probes are labeled with a same fluorescent, and wherein each of the plurality of types of fluorescent-labeled probes is capable of binding to a respective type of DNA among the different types of DNAs and different types of fluorescent-labeled probes that are labeled with a same fluorescent as taught by Zhong and provide a method according to the limitations of claim 1. Doing so would increase the throughput, reaction efficiency and alleviate barriers in measurements assessed in methods for the detection of different types of DNA by digital PCR. Applicants’ argument: “Shimazaki does not teach droplet PCR with a reasonable expectation of success.” (Pg. 6) Response: Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive, because as recited on Pg. 4 of the Final Office action, “Shimazaki teaches a method comprising “Digital PCR (dPCR) and droplet digital PCR (ddPCR) are the potential techniques to realize liquid biopsy. In ddPCR, each single DNA molecule in a sample is partitioned and amplified in a droplet. The existence of targeted DNA molecules in the droplet is indicated by fluorescence from dyes” (e.g., Pg. 6305 col. 1, para. 1). Thus, Shimazaki does teach droplet PCR and suggests the DNA with the different base sequence in the droplet could be distinguished in terms of the Tm’s, which would lead to the contribution to the reduction of errors in detecting targeted DNA molecules in the ddPCR format. (Pg. 6307, last sentence of last para.) Applicants’ argument: “Applicant respectfully submits that this combination of references is incorrect. Zhong and Shimazaki are drawn to entirely different analytical techniques.” (Pg. 7) Response: Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Shimazaki and Zhong are both considered to be analogous to the claimed invention because they are in the same field of ddPCR. Applicants’ argument: “The remaining dependent claims, including claim 5, depend, either directly or indirectly, from independent claim 1. They are believed to be patentably distinguished for at least the same reasons as expressed above in relation to the independent claim from which each depends, as well as for the additional elements recited therein and in any intervening claim.” (Pg. 10) Response: Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive, because of the reasons stated above in response to the arguments against the rejection of Claim 1 under 35 U.S.C 103. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-3, 5 and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,018,319 (16/973,990) issued on 06/25/2024 in view of Shimazaki et al. (“Shimazaki”; (2017). Parallel Evaluation of Melting Temperatures of DNAs in the Arrayed Droplets through the Fluorescence from DNA Intercalators. Analytical chemistry, 89 (12), 6305–6308.) and Zhong et al. (“Zhong”; (2011). Multiplex digital PCR: breaking the one target per color barrier of quantitative PCR. Lab on a Chip, 11(13), 2167-2174). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims of U.S. Patent 12,018,319 in view of Shimazaki and Zhong. The claims of U.S. Patent No. ‘319 are drawn to: “1. A DNA detection method comprising the steps of: partitioning a DNA solution comprising a fluorescent-labeled probe or a DNA intercalator and a target DNA to be detected into a plurality of compartments; carrying out a nucleic acid amplification reaction in the compartments; for each of the compartments, measuring a fluorescence intensity in association with a temperature change; for each of the compartments, calculating, in association with the temperature change, a melting temperature of a DNA double strand based on a change in the fluorescence intensity; calculating, in association with the temperature change, for each of the compartments a ratio of a fluorescence intensity at a second temperature to a fluorescence intensity at a first temperature, the second temperature being lower than the first temperature.” Dependent claims: “2. The DNA detection method according to claim 1, further comprising the step of specifying a compartment for which the calculated ratio of the fluorescence intensity is equal to or lower than a predetermined threshold as a compartment that does not contain the target DNA to be detected. 3. The DNA detection method according to claim 1, further comprising the step of specifying a compartment for which the calculated ratio of the fluorescence intensity falls within a predetermined range as a compartment that contains the target DNA to be detected. 4. The DNA detection method according to claim 1, wherein the DNA solution comprises a fluorescent-labeled probe and the melting temperature is a melting temperature of a double strand formed between the fluorescent-labeled probe and the target DNA to be detected. 5. The DNA detection method according to claim 4, wherein the fluorescent-labeled probe has a fluorescent dye and a quencher for the fluorescent dye. 6. The DNA detection method according to claim 1, wherein the DNA solution comprises a DNA intercalator and the melting temperature is a melting temperature of a double strand of the target DNA to be detected. 7. The DNA detection method according to claim 1, wherein the plurality of compartments are arranged planarly. 8. The DNA detection method according to claim 1, wherein the DNA solution is partitioned into the plurality of compartments in a form of droplets or by using wells.” The teachings of Shimazaki and Zhong are documented above in the rejection of claims 1-3, 5 and 7-8 under 35 U.S.C. 103. Therefore, the invention as recited in claims 1-3, 5 and 7-8 are prima facie obvious over the prior art U.S. Patent No. 12,018,319 in view of Shimazaki and Zhong. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to detect DNA by digital PCR according to the limitations of the instant application claims 1-5 and 7-8 based on U.S. Patent No. 12,018,319 in view of Shimazaki and Zhong. Response to Arguments Applicants’ argument: “Applicant respectfully submits that these references do not teach or suggest the limitations of the present claims” (Pg. 5) and “the Office Action withdrew the previous rejection over U.S. Patent No. 12,018,319 alone and now adds Shimazaki and Zhong to assert double patenting. As discussed below, however, Shimazaki and Zhong do not teach or suggest the claim limitations” (Pg. 6). Response: Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive, because of the reasons stated above in response to the arguments against the rejection of Claim 1 under 35 U.S.C 103. Conclusion of Response to Arguments Applicant’s arguments with respect to claim(s) 1-3, 5 and 7-8 have been considered but are not persuasive. The rejection of claim(s) 1-3, 5 and 7-8 under 35 U.S.C. 103 and Double Patenting remain for the reasons stated in the responses to the arguments above. No claims are in condition for allowance. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Patent App. Pub. No: Dube et al. WO 2010088288 A2, Aug. 5, 2010 (Para. 10, 30, 41, 51, 57, 68 83, 99 and 121-122) Claims 1-3, 5 and 7-8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM. 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, Winston Shen can be reached at (571)272-3157. 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. /KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682 /WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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Prosecution Timeline

Dec 16, 2021
Application Filed
Apr 07, 2025
Non-Final Rejection — §103, §DP
Jun 27, 2025
Response Filed
Sep 08, 2025
Final Rejection — §103, §DP
Dec 05, 2025
Response after Non-Final Action
Jan 08, 2026
Request for Continued Examination
Jan 13, 2026
Response after Non-Final Action
Feb 03, 2026
Non-Final Rejection — §103, §DP (current)

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