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 .
Claim Interpretation
In claim 1, applicants recite “capable of” producing a result. Applicants are reminded that the cited prior art teaching is not required to expressly carry out the recited result or function. The rejection is proper where the prior art teaches an element possessing the capability of performing the claimed function.
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 1-10 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. Applicants recite “for each measurement instant of a measurement period”, it is unclear what “a measurement instant” and “measurement period” is. Are applicants referring to a certain time period? Therefore, the metes and bounds of this claim cannot be determined. Clarification is needed.
Claims 1-10 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. Applicants recite “a plurality of measurement instants”. Are applicants referring to the same recited “measurement instant” or different? Therefore, the metes and bounds of this claim cannot be determined. Clarification is needed.
Claim 1 recites the limitation "each measurement instant". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turner (US 10,232,369).
Regarding claim 1, Turner teaches a fluidic cartridge an imager (camera/optics) defining a field of view, an analytical support (1) being introduced into the field of view of the analytical instrument (data analysis module), the analytical support (1) comprising at least one analysis chamber (4) configured to receive the biological sample and a plurality of reference chambers (4) configured to receive a reference liquid, the process first involving placing the biological sample in the analysis chamber (4) and reference liquid (null liquid or water) in the plurality of reference chambers (4), reference chambers (4) being provided with reference reagents and different concentrations of endotoxins, the reference reagents being capable of causing a luminescence reaction in the presence of the reference liquid as a function of the endotoxin concentration in the corresponding reference chamber (4) , the analysis chamber (4) being provided with analytical reagents that are capable of causing a luminescence reaction in the presence of endotoxins of the biological sample, the process comprising, for each measurement instant of a measurement period, the acquisition (S02) at the measurement instant of the image of the analytical support (1) and the determination, determination, from the image of the analytical support (1), of an analysis chamber light intensity value for the measurement instant, the process also comprises, for a plurality of measurement instants: the determination; from the image of the analytical support (1), of light intensity values of reference chambers (4) for said measurement instant, the determination, from the light intensity values of reference chambers (6) for said measurement instant, of a calibration relationship linking the light intensity value and the endotoxin concentration at the measurement instant; the process also comprising, for a plurality of measurement instants: the determination of at least one measurement of endotoxin concentration in the biological sample at the measurement instant from a calibration relationship for said measurement instant and the analysis chamber intensity value at the measurement instant; and the determination of a temporal evolution of the endotoxin concentration measurement in the biological sample over the measurement period from endotoxin concentration measurements for several measurement instants. (Refer to Col. 24, Lines 42-67 to Col. 25, Lines 1-3) (Refer to Col. 27, Lines 23-36)
Regarding claim 2, subsequently comprising the implementation of an action as a function of the temporal evolution of the endotoxin concentration measurement (S07) measurement. (Refer to Col. 24, Lines 42-67 to Col. 25, Lines 1-3)
Regarding claim 3, in which the action performed involves stopping the process or issuing an alert as a function of the stability of said temporal evolution of the endotoxin concentration measurement or of a decrease in the endotoxin concentration measurement. (Refer to Col. 24, Lines 15-40)
Regarding claim 4, a calibration relationship is determined for each measurement instant of the measurement period. (Refer to Col. 24, Lines 42-67 to Col. 25, Lines 1-3)
Regarding claim 5, the calibration relationship for a measurement instant is a calibration relationship determined from the light intensity values of the reference chambers of a preceding measurement instant. (Refer to Col. 24, Lines 42-67 to Col. 25, Lines 1-3)
Regarding claim 6, the temporal evolution of a measurement of endotoxin concentration in the biological sample is determined several times during the measurement period, each time following a measurement instant taken into account in said temporal evolution. (Refer to Col. 24, Lines 15-40)
Regarding claim 7, analytical reagents present in analysis chambers (4) and reference reagents (4) present in reference chambers (4) comprising a recombinant factor C and a fluorogenic substrate of the reference chambers comprising endotoxins at predetermined concentrations. (Refer to Col. 24, Lines 42-67 to Col. 25, Lines 1-3)
Regarding claim 8, at least one reference chamber (4) is free of endotoxin. (Refer to Col. 24, Lines 64-67)
Regarding claim 9, the analytical support (1) comprises a plurality of analysis chambers (4) chambers, and the determination of an analysis chamber light intensity value for said measurement instant comprises the determination of a statistically representative value of light intensity values of a plurality of the analysis chambers (4). (Refer to Col. 23, Lines 38-44)
Regarding claim 10, an imager (camera) defining a field of view, the analytical instrument (101) being configured to receive an analytical support (1) in the field of view of the imager (camera), the analytical support (1) comprising at least one analysis chamber (4) configured to receive a biological sample, and a plurality of reference chambers (4) configured to receive a reference liquid, the reference chambers (4) being provided with reference reagents and reference concentrations, the reference reagents being capable of causing a luminescence reaction in the presence of the reference liquid as a function of the endotoxin concentration in the corresponding reference chamber (4), the analysis chamber (4) being provided with analytical reagents that are capable of causing a luminescence reaction in the presence of endotoxins of the biological sample. (Refer to Figure 10A)
Conclusion
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/JYOTI Mutreja/Primary Examiner, Art Unit 1798
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