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 .
Response to Amendment
The amendment filed 05/04/2026 is entered. The amendment overcomes all previous grounds of rejection. A new issue has been identified resulting in new grounds of rejection. This Office action is NON-FINAL.
Claim Objections
Claims 11, 13, 14, 15, 16 and 17 are objected to because of the following informalities: In claims 11, 13, 14, 15, 16 and 17, the term “analyte” should be “analytes”. In claim 16, “wherein the the at least” should be “wherein the at least”. In claim 17, “wherein the is the at least” should be “wherein the at least”. 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 1, 2, 4-17 and 20-30 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.
Each of independent claims 1, 4 and 20 has the same issue. Each claim recites, as a first step, obtaining “a reference signature corresponding to a reference signal generated when one of the multiple distinct target nucleic acid analytes is amplified”.
Each claim later recites “comparing the kinetic signature [from the amplification of the biosample] to the reference signature; and determining if each of the multiple distinct target nucleic acid analytes is present based on a curve fit of the kinetic signature to the reference signature”.
There is a discrepancy between determining if each of the multiple distinct target nucleic acid analytes is present, and obtaining and comparing only “a” reference signature to the kinetic signature obtained from amplifying the sample. If the multiple distinct targets are targets a, b, c, d and e, and only the reference signature of target “a” is obtained and compared to the kinetic signature of the sample, the method would only be able to determine whether target “a” is present. One would not be able to tell whether a kinetic signature that does not match target “a” indicates target “b”, “c”, “d” or “e”, unless the kinetic signature were compared to the reference signatures of those targets.
Moreover, the preamble of each claim indicates a “method of detecting multiple distinct target nucleic acid analytes”, but by obtaining and comparing only one reference signature, the claims would only be able to determine whether the target nucleic acid analyte corresponding to that reference signature was present.
The examiner has drafted a potential amendment to claim 1 to circumvent this issue, and if acceptable to Applicant, could serve as a template for amendments to independent claims 4 and 20 as well. If, however, it is important to the Applicant to determine “if each of the multiple distinct target nucleic acid analytes is present”, then more extensive amendment may be needed.
A method of detecting a first one of multiple distinct target nucleic acid analytes, the method comprising:
obtaining, from a non-transitory computer readable storage medium, a reference signature corresponding to a reference signal generated when the first one of the multiple distinct target nucleic acid analytes is amplified with a primer set by a thermocycling reaction comprising a set of temperature cycles;
adding primer pairs to a bio-sample, wherein at least one primer pair comprises a limiting primer, and each of the primer pairs defines a region of a corresponding one of the multiple distinct target nucleic acid analytes to be amplified;
performing an amplification reaction on the bio-sample;
detecting, with a detector of a polymerase chain reaction (PCR) system, a signal generated during the amplification reaction;
determining a kinetic signature from the signal;
comparing the kinetic signature to the reference signature; and
determining if the first one of the multiple distinct target nucleic acid analytes is present based on a curve fit of the kinetic signature to the reference signature;
wherein the kinetic signature is plotted as a curve;
wherein the curve comprises at least one of an exponential region, a linear region, and a plateau region; and
wherein the at least one of the exponential region, the linear region, and the plateau region occurs over at least 4 cycles.
As all claims depend directly or indirectly from one of claims 1, 4 or 20, they are rejected for the same reason.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681
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