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 on 4/22/2026 has been entered. Claims 1, 6, 7, 11, 14, 17 and 19 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection and objection previously set forth in the non-final Office Action mailed 10/22/2025.
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, 6, 7, 11, 12, 17 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2015/0018226, hereinafter Hansen.
Regarding claim 1, Hansen teaches a microfluidic device (figures 1, 2 and 7) for single or multicell capture comprising: a substrate (paragraph [0137]); one or more microgrooves or microtubes (the channels as seen in figure 1) disposed within the substrate (figures 1 and 2), each of the one or more microgrooves or microtubes having: a first end and a second end (figure 1, 2 and 7); a width between about 1 µm and 100 µm (paragraph [0137]), wherein the width of the microgrooves or microtubes corresponds to a diameter of a target cell or a group of target cells (functional limitation MPEP § 2114); one or more chambers (RT Reaction chamber or Pre-Amplification Reaction Chamber, figure 7) configured for retention, culture, or biological analysis of the target cell or group of target cell (intended use MPEP § 2114 (II) and is taught in paragraph [0150]); a constricted end (item 12) having a width less than the diameter of the target cell (functional limitation MPEP § 2114), the constricted end positioned between the first end and the second end (figures 1, 2 and 7) and configured to physically retain the target cell within the microgroove or microtube (functional limitation MPEP § 2114); a micropillar (item 20) positioned within the microgroove or microtube (figures 1 and 2) and configured to bifurcate a fluid flow to direct the target cell or a groups of cells toward the constricted end for capture (functional limitation MPEP § 2114); a fluid input (reagent injection, figure 7) disposed within the substrate in fluid communication with the first end of the one or more microgrooves or microtubes (figure 7); and a fluid output (elution output, figure 7) disposed within the substrate in fluid communication with the second end of at least one of the one or more microgrooves or microtube (figure 7), or the one or more chambers (figure 7), wherein the fluid output is configured to receive an aspiration force to draw target cells from the fluid input through the one or more microgrooves or microtubes for capture at the constricted end (functional limitation MPEP § 2114), wherein one or more cells captured in one of the microgrooves or microtubes are individually analyzable as a single cells (intended use MPEP § 2114 (II) and is taught in paragraph [0150]).
Regarding claim 6, Hansen teaches further comprising an imaging device, wherein the imaging device detects one or more cells captured in the one or more microgroove (paragraph [0168]).
Regarding claim 7, Hansen teaches wherein the substrate is silicon (paragraph [0134]).
Regarding claim 11, Hansen teaches the one or more microgrooves or microtubes further comprise a portion that narrows to a size that is less than a diameter of a target cell to trap the target cell (functional limitation MPEP § 2114 and is taught in paragraph [0139]).
Regarding claim 12, Hansen teaches the fluid output is in fluid communication with a vacuum source or a pipette aspirator (microfluidic peristaltic pump, figure 7), the vacuum source or pipette aspirator configured to generate an aspiration force that drives target cells from the fluid input, through the one or more microgrooves or microtubes, and into capture at the constricted end of the one or more microgrooves or microtubes (functional limitation, MPEP § 2114). The examiner notes that the vacuum source or pipette aspirator are not positively recited and the fluid output only needs to be capable of connecting to the vacuum source or pipette aspirator as they are not required structures for the device.
Regarding claim 17, Hansen teaches the micropillar defines a pillar gap between the micropillar and an adjacent wall of the microgroove or microtube (figures 1 and 2), the pillar gap having a width adjusted to permit capture of cells at or above a predetermined size while permitting passage of cells below the predetermined size (cells above the pillar gap would not be able to get through the gap), thereby enabling size-selective sorting of a mixed cellular population (intended use MPEP § 2114 (II)).
Regarding claim 18, Hansen teaches the fluid input comprises a first buffer exchange/feeding port or fluid reservoir (figure 7), and wherein er the fluid output port comprises a reservoir or a site for aspiration site for aspiration of a fluid in the device (figure 7).
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 4/22/2026, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments, see pages 7-14, filed 4/22/2026, with respect to the rejection(s) of claim(s) 1, 6, 7, 11, 14, 17 and 19 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hansen.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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