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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 27, 2025 has been entered.
Status of the Application
2. Claims 1-2, 8-10, 13-18, 20-22 and 24-27 are pending under examination. Claims 3-7, 11-12, 19 and 23 are canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Claim Rejections - 35 USC § 102-maintained
3. 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 16-18, 20-22 and 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colston et al. (US 2010/0173394).
Colston et al. teach a method of claim 16, comprising: providing a microfluidic device comprising a substrate (cartridge or array) an inlet port, an inlet channel fluidly coupled to the inlet port, a set of chambers fluidly coupled to the inlet channel along the length of the inlet channel, wherein the set of chambers is a set of parallel chambers wherein set of chambers (para 0183-0184, 0492-0498, 0514-0517, 0620, 0692-0694, 0059-0060, 0283-0311, 0396-0398); delivering a biological sample and reagents to set of chambers upon receiving the biological sample into the inlet channel and retaining nucleic acids of the biological sample within the set of chambers (para 0517-0522, 0567-0572, 0184, 0549-0563, 0620);
forming a displacement layer (forming droplets) along the length of the inlet channel and over the set of chambers via a pump pressure an oil into the inlet channel (para 0183-0184, 0216, 0249-0256, 0381-0382, 0564-0567, 0655, 0517-0523, 0492-0498, 0514-0517, 0620, 0692-0694);
transmitting heat to the substrate with a variable temperature profile (para 0257-0291, 0520-0553, 0705-0713);
amplifying said nucleic acids of the biological sample at the set of chambers with said reagents (para 0291-0292, 0378-0380, 0495-0499, 0524-0536);
analyzing amplified nucleic acids derived from the biological sample through imaging the set of chambers (para 0292-0317, 0381-0382).
With reference to claim 17-18, 22, Colston et al. teach the set of chambers comprising 100,000 chambers (para 0856); nucleic acids of the biological sample comprises a set of single nucleotide polymorphisms (SNPs) (para 0178, 1137), wherein reagents comprise two allele-specific forward primers and a common reverse primer for each of the SNPs and the method further comprises detection of SNPs upon analyzing the amplified products (para 0178 indicates use of primer-probes and a common reverse primer).
With reference to claim 20, Colston et al. teach that the nucleic acids of the biological sample are associated with one or more target genes and analyzing amplified nucleic acids comprises performing quantitation of gene expression of said target genes (para 0389-0390).
With reference to claim 21, Colston et al. teach that each of the set of chambers has a depth from 5-200 microns (para 0565, 0690).
With reference to claims 24-25, Colston et al. teach that the nucleic acids of the biological sample comprise RNA and DNA molecules (para 0138).
With reference to claim 26-27, Colston et al. teach that that the reagents comprise affinity molecules for binding oligonucleotide sequences, performing allele specific PCR in coordination with amplifying said nucleic acids (para 0518-0519, 0528-0529, 0543, 0167, 1145). For all the above the claims are anticipated.
Response to Arguments:
A. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Linton has been withdrawn in view of the amendment and persuasive arguments.
B. With reference to the rejection of claims under 35 USC 102(a)(1) as being anticipated by Colston et al. the Applicant’s arguments were found unpersuasive. Colston et al. teach a microfluidic device comprising a substrate, inlet and outlet channels fluidly connected as recited in the amended 16. With reference to the Applicant’s arguments drawn to pump-driven oil flow, the arguments were found unpersuasive. As discussed in the rejection, Colston et al. teach the limitations of the amended claim 16 as discussed in the rejection. The rejection has been maintained and restated to address the amendment.
Double Patenting
4. 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 16-18, 20-22 and 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent 11,865,542 (hereafter the ‘542) in view of Colston et al. (US 2010/0173394). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 16-18, 20-22 and 24-27 are generic to all that is recited in claims 1-20 of the patent ‘542. That is, the claims 16-18, 20-22 and 24-27 fall entirely within the scope of claims 1-20 of the patent ‘422, or in other words, claims 16-18, 20-22 and 24-27 are anticipated/ obvious over the claims 1-20 of the patent ‘542. Specifically, the method steps comprising providing a microfluidic device comprising substrate comprising an inlet port coupled to an inlet channel, a set of chambers comprising at least 10,000 chambers coupled to the inlet channel along the length of the inlet channel; delivering a biological sample, retaining nucleic acid targets within the set of chambers, receiving reagents comprising PCR reagents at the set of chambers, transmitting oil, amplifying said nucleic acids by transmitting heat and analyzing contents of set of chambers upon imaging the set of chambers with fluorescent detection of said contents of the claims 16-18, 20-22 and 24-27 are within the scope of the claims 1-20 of the patent ‘542. The claims 16-18, 20-22 and 24-27 recite amplifying within the set of chambers, which is considered as an obvious variation over the claims in the patent ‘542. However, the claims in the patent do not disclose use of a microfluidic device as recited in claim 16.
Colston et al. teach a method of claim 16, comprising: providing a microfluidic device comprising a substrate (cartridge or array) an inlet port, an inlet channel fluidly coupled to the inlet port, a set of chambers fluidly coupled to the inlet channel along the length of the inlet channel, wherein the set of chambers is a set of parallel chambers wherein set of chambers (para 0183-0184, 0492-0498, 0514-0517, 0620, 0692-0694, 0059-0060, 0283-0311, 0396-0398); delivering a biological sample and reagents to set of chambers upon receiving the biological sample into the inlet channel and retaining nucleic acids of the biological sample within the set of chambers (para 0517-0522, 0567-0572, 0184, 0549-0563, 0620); forming a displacement layer (forming droplets) along the length of the inlet channel and over the set of chambers via a pump pressure an oil into the inlet channel (para 0183-0184, 0216, 0249-0256, 0381-0382, 0564-0567, 0655, 0517-0523, 0492-0498, 0514-0517, 0620, 0692-0694); transmitting heat to the substrate with a variable temperature profile (para 0257-0291, 0520-0553, 0705-0713);amplifying said nucleic acids of the biological sample at the set of chambers with said reagents (para 0291-0292, 0378-0380, 0495-0499, 0524-0536);analyzing amplified nucleic acids derived from the biological sample through imaging the set of chambers (para 0292-0317, 0381-0382).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the invention to combine the method of the claims in the patent ‘542 with the use of a microfluidic device as taught by Colston et al. to develop an improved method for analyzing a biological sample. The ordinary person skilled in the art would have motivated to combine the method of the claims in the patent ‘542 with a microfluidic device as taught by Colston et al. and have a reasonable expectation of success that the combination would result in improved method for analyzing target nucleic acids in a biological sample because Colston et al. explicitly taught use of a microfluidic device comprising an inlet and outlet channels fluidically connected to a set of chambers on a substrate (cartridge) for performing integrated analysis of a biological sample in microdroplets that provides a simple and economical method for a sample analysis and reduces cross-contamination (para 0620-0622) and such a modification of the method is considered obvious over the prior art. Therefore, the instant claims are obvious over the claims in the patent ‘542.
Response to Arguments:
With reference to the rejection of claims under obviousness type of double patenting, the Applicant’s arguments and the amendment have been fully considered and the rejection has been withdrawn in view of the amendment. However, rejection is reapplied to address the amendment.
Conclusion
Claims 1-2, 8-10, 13-15 are free of art.
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.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681