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 .
Election/Restrictions
Applicant’s election without traverse of Group II claims 46-54 in the reply filed on 12/01/2025 is acknowledged. Claims 35-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/01/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/03/2024 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 46-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersen et al (US20010012612A1 published 08/09/2001; hereinafter Petersen).
Regarding claim 46, Petersen a method of performing sample homogenization, nucleic acid fragmentation, and nucleic acid detection using an integrated cartridge, the method comprising:
moving a sample fluid from a sample inlet (introducing the sample into a cartridge having a sample flow path – paragraph 5 and Fig. 3) and through a filter positioned on a main housing of the integrated cartridge (forcing the sample to flow through the first filter on a middle section 24 of the cartridge 20 – paragraph 7 and Fig. 6);
moving the sample fluid from the filter and into a sonication feature that is suspended from the main housing (forcing the sample to flow through the second filter located the lysing chamber – paragraph 7);
transmitting ultrasonic energy to the sample fluid within the sonication feature (the lysing chamber may be sonicated as the sample is forced to flow through the chamber – paragraph 7);
fragmenting nucleic acids within the sample fluid (transducer 92 is preferably an ultrasonic horn for sonicating the lysing chamber 86 – paragraph 149 and Fig. 5) (lysing chamber 86 comprising beads 96, 99 to shear the nucleic acid released from the sample – paragraph 71 and Fig. 6);
moving the sample fluid from the sonication feature and to a detection chamber positioned on the main housing (an analyte flow path extending from the lysing chamber 86 for carrying the analyte separated from the fluid sample to the reaction vessel 40 for chemical reaction and optical detection – paragraph 105); and
detecting nucleic acids within the detection chamber (at least 1 ml of sample should be analyzed to detect low concentration analytes such as nucleic acid – paragraph 158).
Regarding claim 47, Petersen teaches the method of claim 46, wherein moving the sample fluid from the filter and into the sonication feature comprises moving the sample fluid to a position below the sample inlet (the cartridge 20 has an inlet formed in the top piece 22; therefore, the sample in the lysing chamber 86 in the middle piece 24 is below the inlet – Fig. 4 and paragraph 56).
Regarding claim 48, Petersen teaches the method of claim 46, wherein moving the sample fluid from the filter and into a sonication feature comprises moving the sample fluid vertically through a conduit of a coupling between the sonication feature and the main housing (when the sample first flows from the first filter 94 and into the lysing chamber 86 with beads 96, 99, the sample moves vertically through a conduit of a gasket 93 between the lysing chamber and the middle section 24 – Fig. 6 and paragraph 65).
Regarding claim 49, Petersen teaches the method of claim 46, further comprising inserting the integrated cartridge into a nucleic acid detection reader (the cartridge 20 is inserted into an instrument 140, and the instrument having modules for thermal processing and optical detection of target analyte – paragraph 117 and Fig. 11).
Regarding claim 50, Petersen teaches the method of claim 46, wherein the method further comprises regulating the temperature of a sample fluid within the sonication feature (the cells or viruses are disrupted by heating the lysis chamber to a high temperature (e.g., 95.degree. C.) to disrupt the cell walls – paragraph 172).
Regarding claim 51, Petersen teaches the method of claim 46, wherein the method further comprises inserting the sonication feature into a sonotrode (the lysing chamber 86 of the cartridge 20 is placed into a cartridge nest 141 of the instrument 140, and the cartridge nest 141 comprising a transducer 92 e.g., an ultrasonic horn – paragraph 108 and Figs. 10-11).
Regarding claim 52, Petersen teaches the method of claim 46, wherein transmitting ultrasonic energy to the sample fluid further comprises dissipating ultrasonic energy using inert beads housed within the sonication chamber (the transducer 92 a velocity to the liquid in the chamber 86, creating a pressure wave in the chamber 86, and the beads 96, 99 (Fig. 6) in the filter stack 87 are agitated by the pressure waves in the chamber 86 – paragraph 151 and Fig. 6) (the transducer 92 e.g., an ultrasonic horn (paragraph 108) transfer energy to the beads 96, 99; therefore, the beads 96, 99 are deemed to dissipate ultrasonic energy via conservation of energy).
Regarding claim 53, Petersen teaches the method of claim 46, wherein transmission of ultrasonic energy to the sample fluid occurs as the sample fluid moves continuously through the sonication feature (the lysing chamber 86 may be sonicated (e.g., using an ultrasonic horn coupled to a wall of the chamber) as the sample is forced to flow through the chamber – paragraph 146).
Regarding claim 54, Petersen teaches the method of claim 46, wherein sample fluid is subjected to ultrasonic energy in bulk volumes (the transducer 92 a velocity to the liquid in the chamber 86, creating a pressure wave in the chamber 86, and the transducer 92 is an ultrasonic horn – paragraphs 108 and 151) which are then routed from the sonication feature to the detection chamber (an analyte flow path extending from the lysing chamber 86 for carrying the analyte separated from the fluid sample to the reaction vessel 40 for chemical reaction and optical detection – paragraph 105).
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796