DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group II, claims 11-20 in the reply filed on 16 January 2026 is acknowledged. Claims 1-10 and 21 have been withdrawn. Claims 11-20 are currently pending and under examination.
This application claims benefit of priority to U.S. Provisional Patent Application No. 63/332808, filed April 20, 2022.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fowler et al. (IDS; US 2018/0306683, Published 2018).
With regard to claim 11, Fowler et al. teach a method for partitioning multiple individual cells from a larger population of cells, including cells from a heterogenous population of cells, such as from a blood sample or clinical biopsy (Abs.; Para. 84, 106, 111, 207; claim 14; Fig. 19), which are biological samples. A microfluidic system is utilized and is configured for capturing multiple individual cells and processing them (Para. 212; Fig. 1, 19). Each capture configuration is configured to capture an individual cell when a population of cells is flowed through the respective capture configuration, where cells that are not captured by a specific capture configuration, may then flow to a subsequent capture configuration, and may be captured, and so on down through the series of capture configurations, wherein the capture configurations may be coupled in series, or daisy chained, with each other (Para. 219; Fig. 2). The individual cells are trapped in a channel, including by direct positioning, including by optical tweezing (Para. 129), wherein each individual cell is transported to, and deposited in, separate chambers (Fig. 2; claim 23). In the chambers, multistage processing of at least the first and second captured single cells is performed, including DNA analysis, wherein reaction products may then be placed in a harvest well and exported for additional analysis and/or processing (Para. 16, 213-214; Fig. 1, 2, 5A-B, 19).
As Fowler et al. teach the separation of multiple, single cells from a biological sample using a microfluidic system having multiple channels and multiple receiving and reaction chambers, wherein optical tweezing is utilized to trap at least a first and second individual cell, it would have been obvious to one of ordinary skill to perform the method as claimed, including trapping individual cells of a first cell type from a cell mixture in a first channel by optical tweezing; transporting the trapped individual cells of the first cell type down a second channel; depositing the transported individual cells of the first cell type in a first chamber; trapping individual cells of a second cell type from the cell mixture in the first channel by optical tweezing; transporting the trapped individual cells of the second cell type down a third channel; and depositing the transported individual cells of the second cell type in a second chamber.
Further, as Fowler et al. teach that each separated, individual cell is placed in a respective chamber that is separate from the flow channels of the microfluidic system, it would have been obvious to an ordinary artisan that the first and second chambers are separated from the first channel, and placed into non-microfluidic receptacles (i.e. harvest wells (230)) for the subsequent DNA analysis.
With regard to claim 12, Fowler et al. teach that the separated cells, including the first and second cells, are lysed; DNA is amplified; and identification of the captured cells is performed (Para. 45). The cells can be from selected members of the human population and can be forensic samples (Para. 112). As the cells are identified, and can be from a human, and can be forensic samples, it would have been obvious to an ordinary artisan that the method may be utilized for identification of a human from the DNA.
With regard to claim 13, Fowler et al. teach that the method may be performed on a single microfluidic chip (Para. 92).
With regard to claims 14-16, Fowler et al. teach that microfluid components may be punched or cut (Para. 94-95), which is excising/separating a respective piece of the microfluidic chip from the remainder of the chip.
With regard to claim 17, Fowler et al. teach that the sorted, single cells are placed out of the fluid flow in reaction chambers and harvest wells (see Fig. 2, 5A-B), wherein the reaction chambers and harvest wells are non-microfluidic receptacles and tubes.
With regard to claim 18, Fowler et al. teach flowing the plurality of cells through the microfluidic device such that individual cells from the plurality of cells are captured at individual capture sites of the microfluidic device (Para. 19), which is maintaining a flow of the cell mixture in the first channel during the trapping steps.
With regard to claims 19 and 20, Fowler et al. teach priming the microfluidic device utilizing one or more solutions prior to flowing multiple cells through the device and capturing the individual cells (Fig. 21), wherein priming the microfluidic device with solution as taught is flushing the first channel prior to the separating steps, and wetting the first, second, and third channels prior to the trapping steps.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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