DETAILED ACTION
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 .
Claims 1-17 are pending and will be examined.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63530450, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed ‘450 application provides broad support for the concepts of electrowetting on dielectric devices and combining the technology with qPCR for analysis, but it does not provide specific or general support for the steps of the method, where even in claim 1 the result of the first qPCR test must be determined as positive or negative or where specific concentration is determined within a subdroplet as in claim 2. Further, dependent claims include further testing incorporating technology such as DNA sequencing and none of these additional tests have support in the priority document. Therefore, the claims will be afforded the same priority date as the filing of the specification August 2, 2024.
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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marco Serra 2018 (Marco Serra. An innovative approach for magnetic solid supports handling in droplet microfluidics. Physics[physics]. Université Paris sciences et lettres, 2018. English).
With regard to claim 1, Serra teaches a method for molecule quantification, comprising:
(a) utilizing an electrowetting-on-dielectric (EWOD) device to split a target droplet into a plurality of sub-droplets (Figure 6e, where a subdroplet is formed on an EWOD device, p 129; see also Fig 7, p 130; see also p 77);
(b) performing a first quantitative polymerase chain reaction (qPCR) test on at least one of the plurality of sub-droplets within the EWOD device (p 49 and 82, where the concept is introduced; Fig 4 where qPCR is applied to droplets; see also p 91); and
(c) obtaining a result of the first qPCR test on the at least one of the plurality of sub-droplets to determine whether the result of the first qPCR test is positive or negative (p 49 and 82, where the concept is introduced; Fig 4 where qPCR is applied to droplets; see also p 91).
With regard to claim 2, Serra teaches a method of claim 1, wherein performing a first qPCR test comprises calculating a concentration of a target molecule within the at least one of the plurality of sub-droplets, if the concentration surpasses a preset threshold, the result of the first qPCR test on the at least one of the plurality of sub-droplets is positive (p 88, Fig 4, where qPCR is used).
With regard to claim 3, Serra teaches a method of claim 1, wherein, before utilizing an EWOD device to split a target droplet into a plurality of sub-droplets,
the method comprises:
performing an initial qPCR test on the target droplet within the EWOD device;
and obtaining a result of the initial qPCR test on the target droplet to determine whether the result of the initial qPCR test is positive or negative (p 49 and 82, where the concept is introduced; Fig 4 where qPCR is applied to droplets; see also p 91).
With regard to claim 4, Serra teaches a method of claim 1, wherein, after determining the result of the first qPCR test is positive, the method further comprises the following step:
performing a second qPCR test on another of the plurality of sub-droplets (p 49 and 82, where the concept is introduced; Fig 4 where qPCR is applied to droplets; see also p 91).
With regard to claim 5, Serra teaches a method of claim 1, wherein, after determining the result of the first qPCR test is positive, the method further comprises the following step:
performing a digital droplet polymerase chain reaction (ddPCR) test on the tested sub-droplets (p 34, p 84, where droplet digital microfluidics is described).
With regard to claim 6, Serra teaches a method of claim 1, wherein, after determining the result of the first qPCR test is positive, the method further comprises the following step: performing a diagnostics analysis, or biological applications on the tested sub-droplets (Abstract, Chapter 4, p 161-203; Figure 7, for example, where DNA sequencing occurs).
With regard to claim 7, Serra teaches a method of claim 6, wherein the biological applications comprise DNA synthesis, protein synthesis or DNA sequencing (Abstract, Chapter 4, p 161-203; Figure 7, for example).
With regard to claim 8, Serra teaches a method of claim 1, wherein, after determining the result of the first qPCR test is positive, the method further comprises:
utilizing the EWOD device to split the tested sub-droplets into a plurality of secondary sub-droplets (Figure 6e, where a subdroplet is formed on an EWOD device, p 129; see also Fig 7, p 130; see also p 77).
With regard to claim 9, Serra teaches a method of claim 8, wherein the method further comprises the following step:
performing a third qPCR test on at least one of the plurality of secondary sub-droplets (p 49 and 82, where the concept is introduced; Fig 4 where qPCR is applied to droplets; see also p 91).
With regard to claim 10, Serra teaches a method of claim 8, wherein the method further comprises the following step:
performing a digital droplet polymerase chain reaction (ddPCR) test on the secondary sub-droplets (p 34, p 84, where droplet digital microfluidics is described).
With regard to claim 11, Serra teaches a method of claim 8, wherein the method further comprises the following step:
performing a diagnostics analysis or biological applications on the secondary sub-droplets (Abstract, Chapter 4, p 161-203; Figure 7, for example, where DNA sequencing occurs).
With regard to claim 12, Serra teaches a method of claim 11, wherein the biological application comprises DNA synthesis, protein synthesis or DNA sequencing (Abstract, Chapter 4, p 161-203; Figure 7, for example, where DNA sequencing occurs).
With regard to claim 13, Serra teaches a method of claim 1, wherein,
after determining the result of the first qPCR test is positive, the method further comprises:
emerging at least a portion of the sub-droplets to form at least one target droplets (Figure 6e, where a subdroplet is formed on an EWOD device, p 129; see also Fig 7, p 130; see also p 77).
With regard to claim 14, Serra teaches a method of claim 13, wherein the method further comprises repeating steps (a), (b), and (c) as defined in Claim 1 (Figure 6e, where a subdroplet is formed on an EWOD device, p 129; see also Fig 7, p 130; see also p 77).
With regard to claim 15, Serra teaches a method of claim 13, wherein the method further comprises the following step:
performing a diagnostics analysis or biological applications on the target droplets (Abstract, Chapter 4, p 161-203; Figure 7, for example, where DNA sequencing occurs).
With regard to claim 16, Serra teaches a method of claim 15, wherein the biological application comprises DNA synthesis, protein synthesis or DNA sequencing (Abstract, Chapter 4, p 161-203; Figure 7, for example, where DNA sequencing occurs).
With regard to claim 17, Serra teaches a method of claim 1, wherein the volume of the sub-droplets is down to the nano-liter range (p 129-130, where the volume of the droplets is discussed as within the nanoliter range, perhaps even smaller).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Serra et al. (Lab Chip, 2017, 17:3979-3999).
Conclusion
No claims stand rejected. Claims stand rejected.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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