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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 9-15 in the reply filed on 12 June 2026 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 June 2026.
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.
Claims 9-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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, ron sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasuda (WO 2015053393)1.
With respect to claim 9, Yasuda discloses an apparatus for monitoring a monitor material of a process, such as a manufacturing process. The apparatus includes a contaminant identification device having an imaging system comprising a light source and a detector (see Fig. 33). Yasuda states that the imaging system is configured to detect an interference pattern based on object light having interacted with the sample and reference light of the illumination light (“In the module of FIG. 4A, a light source 201 such as a pulse laser or a high-intensity LED light source, a light detection element 208 such as a photodiode that detects passage of cells with scattered light, and fluorescence are detected for cells passing through the cell sorter chip 209. A plurality of pieces of information can be detected simultaneously by a high-sensitivity light detection element 206 such as a photomultiplier, a high-speed camera 207, or the like. As for the light emitted from the light source, continuous light may be emitted, but in order to increase the spatial resolution of the image without blurring, pulse light is generated in synchronization with the shutter cycle of the high-speed camera 207. Thus, it is possible to acquire an image having a higher term time resolution with shorter light irradiation”). In the alternative, it is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (here, recitations relating to how the imaging system operates) does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. Yasuda further teaches that a diverter in the form of a cell sorter (see Figs. 45A-C) selectively diverts an identified suspicious particle (e.g., cell) from the flow of the sample to an analysis flow. A nucleic acid test (NAT) device, such as a PCR device, is configured to be activated based on the detection of the suspicious particle.
With respect to claim 10, Yasuda discloses the apparatus as described above. Yasuda further teaches a sample collector in the form of a reservoir, pump, syringe, port, or other similar device (‘the sample solution is introduced from the inlet 212 into the microchannel 211 by a syringe pump or cell introduction means that does not generate a pulsating flow such as air pressure”).
With respect to claims 11-13, Yasuda discloses the apparatus as described above. Yasuda further teaches that the NAT device includes a droplet generator, and that a droplet generator imaging system is configured to monitor encapsulating of the suspicious particle in the droplet (“an imaging cell sorter that observes and separates cells in water droplets. The apparatus shown in FIG. 44A produces and drops water droplets of an optimal size by discharging cells in the sample solution from the thin tube at the tip of the water droplet forming module 4401 with a cell reservoir at a constant pressure…The formed charged water droplet 4403 is dropped on an optically transparent water-repellent insulating substrate having a Teflon resin processed surface such as glass, and rolls down in the tilt direction of the substrate. A high-speed camera capable of measuring bright field images and fluorescent images and an optical measurement module 4405 capable of measuring scattered light intensity, fluorescent intensity, etc. are arranged on the back of the substrate on the path where the water drops fall, and the acquired information is analyzed. By analyzing with the control module 4410, it can be determined whether the target cell is in a water droplet”). Yasuda teaches that a NAT imaging system is configured to track the droplet and evaluate the progress of the NAT.
With respect to claims 14 and 15, Yasuda discloses the apparatus as described above. Yasuda further states that a dielectrophoresis device is configured to subject the suspicious particle to an electric field in the analysis flow between the diverter and the NAT device (‘The electrodes of the electrostatic field guides for controlling each water droplet movement direction are arranged in the lower stage of the substrate 4404, and each of these electrodes is connected to the electric field switching mechanism 4409 for electrostatic field guides for controlling the water droplet movement direction. A control charge from 4410 can be applied. The analysis control module analyzes the acquired image and calculates the cell (cluster) area and perimeter, the nucleus area and the number in the cell cluster by calculation, and the calculation result obtained (for example, a computer). It can be configured by a mechanism (for example, a computer and a power source) that identifies the types of cells to be collected in combination and applies an electric field to an electrode of a specific guide to give an electric charge. The switching mechanism can be composed of a removable inset groove for fixing the substrate and an array of electrical contacts for applying electric charges from the analysis control module, which are aligned with the position of the electrode line of the substrate guide”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Cayer (US 20210107004), Beer (US 20120196288), Durack (US 20110001963) and Yossifon (US 20240408599) references disclose the state of the art regarding contaminant identification devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
1 See provided English translation
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