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. The Applicant’s response to the office action filed on April 01, 2026 is acknowledged.
Status of the Application
2. Claims 1-2, 8-10, 13-18, 20-22 and 24-27 are pending under examination. Claims 1, 10, 16 are amended. Claims 3-7, 11-12, 19 and 23 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in view of the amendment. The allowability of claims 1-2, 8-10 and 13-15 has been withdrawn in view of the amendment. The action is made final necessitated by the amendment.
Response to Arguments:
3. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Colston et al. has been withdrawn in view of the amendment.
4. The rejection of claims under obviousness type of double patenting has been withdrawn in view of the amendment.
New Rejections necessitated by the Amendment
Claim Rejections - 35 USC § 102
5. 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 1, 2, 8-9, 13-17, 20-22, 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ismagilov et al. (WO 2010/111265).
Ismagilov et al. teach a method of claims 1, 9, 14, 16, comprising: providing a microfluidic device comprising a substrate, an inlet port (main channel), an inlet channel coupled to the inlet port, a set of chambers formed within and defined by a material of the substrate, the set of chambers (areas) arranged as an array and coupled to the inlet channel and an outlet channel downstream of the set of chambers (para 0014-0016, 0091-0094);
delivering a biological sample comprising nucleic acids through inlet port (para 0296-0314, 0127-0130);
distributing the biological sample and reagents among the set of chambers thereby retaining the nucleic acids in one or more chambers of the set of chambers (para 0296-0314, 0127-0130);
transmitting a displacement fluid comprising oil and forming a displacement layer across the set of chambers by flowing oil into channel, wherein displacement layer separates contents of one or more chambers (para 0297-0310);
transmitting heat to the substrate with a variable temperature profile and thereby amplifying said nucleic acids of the biological sample at the set of chambers (para 0299-0310: indicating heat by thermal amplification cycles); and
analyzing amplified nucleic acids derived from the biological sample through imaging the set of chambers (para 0305-0314).
With reference to claims 2, 17, Ismagilov et al. teach that the set of chambers comprises 100,000 chambers (para 0151).
With reference to claim 8, Ismagilov et al. teach that the amplifying comprises whole genome amplification (para 0184).
With reference to claim 13, Ismagilov et al. teach that the method further comprises sealing the substrate with a laminate (para 0177, 0122).
With reference to claim 15, 21, Ismagilov et al. teach that each of the set of chambers has a depth from 5-200microns (para 0305).
With reference to claim 20, 22, Ismagilov et al. teach that the nucleic acid of the biological sample is associated with one or more target genes, and wherein analyzing the amplified nucleic acids comprises quantitation of gene expression of said one or more target genes (para 0185, 0601).
With reference to claims 24-25, Ismagilov et al. teach that the nucleic acid of the biological sample comprises RNA and DNA molecules (para 0302).
With reference to claim 26, Ismagilov et al. teach that the reagents comprise affinity molecules for binding nucleotide sequences (para 0128). For all the above the claims are anticipated.
Claim Rejections - 35 USC § 103
6. 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 1-2, 8-10, 13-18, 20-22 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (WO 2010/111265) in view of Chen (US 2003/0096277).
Ismagilov et al. teach a method as discussed above in section 5. However, Ismagilov et al. did not teach use of two forward primer and one common reverse primer to detect single nucleotide polymorphism mutations and allele-specific amplification.
Chen teaches a method of claims 10, 18, 27, for genotyping by allele specific PCR wherein the method comprises allele-specific amplification of the target nucleic acid comprising SNP locus comprising alleles by using two forward primers and one reverse primer (para 0032-0035, 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Ismagilov et al. with allele-specific amplification using primers as taught by Chen to develop an improved method for detecting SNP or multiple alleles in a DNA target. The ordinary person skilled in the art would have motivated to combine the method of Ismagilov et al. with allele-specific amplification using primers as taught by Chen and have a reasonable expectation of success that the combination would improve the sensitivity of the method because Chen explicitly taught use of two forward primers and a reverse primer to detect gene variation in SNP locus having alleles (para 0035) and such a modification of the method of the claims is considered obvious over the cited 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.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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