Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Claims 33, 36 and 44-45 are pending and have been examined.
Priority
This application, Serial No. 18/448,631 (PGPub: US2023/0393069) was filed 08/11/2023. This application is a CONTINUATION of 16/780,508, filed 02/03/2020, now US Patent 11,754,499, which is a CONTINUATION of 16/199,822, filed 11/26/2018, now US Patent 10,551,382, which is a CONTINUATION of Serial No. 15/415,290, filed 01/25/2017 and now US Patent 10,139,411, which is a CONTINUATION of 14/122,766 filed 04/18/2017, now US Patent 9556470, which is a 371 of PCT/US2012/040543 filed 06/01/2012, which claims benefit of U.S. Provisional Patent Application 61/492,602 filed 06/02/2011.
Information Disclosure Statements
The Information Disclosure Statements filed 06/20/2024, 06/18/2025, 11/25/2025 have been considered by the Examiner.
Claim Objections
Claims 33, 36 and 44-45 are objected to because of the following informalities:
Claim 33 should include the word “and” after the “amplifying said nucleic acid” limitation.
Claims 36 and 44-45 should include the word “The” at the beginning of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 44-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 (and it’s dependent claim 45) is indefinite because it recites that determining an amount of nucleic acid is based upon a localized concentration of the detectable label. However, claim 33 has not provided any link or correlation between the nucleic acid and the label and thus it is unclear how concentration of the label could be related to the amount of nucleic acid.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 33, 36 and 44-45 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Link et al. (US 2010/0022414, Pub Date: 01/28/2010, hereinafter “Link”).
Regarding claim 33, Link teaches a method for quantifying amplified nucleic acids (paragraph 0158, concentration of a substance such as a nucleic acid; paragraphs 0227-0228, amplification by PCR in droplets), the method comprising: partitioning nucleic acid obtained in a biological sample partitions, wherein the partitions comprise PCR reagents and a detectable label; amplifying said nucleic acid; quantifying the nucleic acid molecules based upon the detectable label (see paragraphs 0300-0320).
Regarding claim 36, Link teaches the method wherein the quantifying step comprises a digital readout (paragraphs 0318-0320).
Regarding claim 44, Link teaches the method wherein the quantifying step comprises determining an amount of the nucleic acid based upon a localized concentration of the detectable label (paragraphs 0319-0320).
Regarding claim 45, Link teaches the method wherein the localized concentration is detected within the partitions (paragraphs 0319-0320).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 33 and 44-45 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wu (US 2011/0048951, Pub Date: 03/03/2011).
Regarding claim 33, Wu teaches a method for quantifying amplified nucleic acids (abstract and paragraph 0012, real time quantitative PCR), the method comprising: partitioning nucleic acid obtained in a biological sample partitions, wherein the partitions comprise PCR reagents and a detectable label; amplifying said nucleic acid; quantifying the nucleic acid molecules based upon the detectable label (see paragraphs 0029, reagents for nucleic acid amplification include primers, labels, dyes, etc.; paragraphs 0043-0051).
Regarding claim 44, Wu teaches the method wherein the quantifying step comprises determining an amount of the nucleic acid based upon a localized concentration of the detectable label (paragraph 0012, real-time quantitative PCR based on the change in fluorescence associated with the accumulation of amplification products).
Regarding claim 45, Wu teaches the method wherein the localized concentration is detected within the partitions (paragraph 0013, droplet of PCR product has fluorescence measured).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677