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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10 October 2025 has been 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claims 10-12 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by US 2013/0190212 to Handique et al. (“Handique”).
With regard to Claim 10, Handique teaches an apparatus comprising a fluid inlet port 320, divided into a plurality of separate microfluidic paths 240 configured to transport a plurality of cells, each microfluidic path comprising a plurality of cell capture pores and chambers 220, 222, and an outlet port 420 to discharge merged output of cells from the capture chambers (see Abstract; FIG. 2; ¶¶ [0029]-[0031]). The apparatus features optical interrogation and detection of single cells, and the reference teaches inclusion of a plurality of sensors 130 configured to detect passage of cells in-and-out of the chambers (see FIGs. 11A-11D; ¶¶ [0029], [0055]).
With regard to Claims 11-12, Handique teaches functionalizing capture pores and chambers via introduction of antibodies therein and teaches that targeted capture on the basis of surface antigens is conventional within the art (see ¶¶ [0003], [0084]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
2. Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Handique as applied to Claim 12, and further in view of US 2016/0238623 to Sun et al. (“Sun”).
With regard to Claims 13-14, Handique teaches a parallelized microfluidic analytic device (see Abstract; ¶ [0043]); however the reference does not expressly teach an apparatus further comprising ports to facilitate receiving and delivering diverse capture antibodies among cell capture pores and chambers. Sun is similarly directed to analytical methods facilitated by devices comprising microfluidic chips, and teaches parallel microfluidic devices capable of conducting diverse simultaneous experiments without cross-talk via physical isolation of antibodies introduced to capture chambers via secondary inlets (see Abstract; ¶ [1159]). Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have incorporated additional ports in the microfluidic device of Handique in order to configured capture pores and chambers with diverse antibodies.
3. Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Handique as applied to Claim 12, and further in view of WO 2012/094642 to Skelley et al. (“Skelley”).
With regard to Claims 15-16, Handique does not teach capture chambers comprising a plurality of micropillars as claimed. Skelley is similarly directed to microfluidic cell capture devices, and teaches a device featuring chambers comprising a plurality of micropillars of about 60 µm in diameter and spaced 80 µm apart to provide structural support thereto while minimizing fluidic resistance (see Abstract; Pgs. 2, 32-33). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have incorporated support pillars as claimed in the device of Handique in order to confer support to the microfluidic chambers as taught by Skelley.
With regard To Claim 17, Handique does not teach Coulter sensors. Skelley teaches incorporation of Coulter sensors in a microfluidic device in order to distinguish among cell sizes (see Pg. 62). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have incorporated Coulter sensors in the microfluidic device of Handique, as taught by Skelley, in order to distinguish and count cells of varying sizes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael P Rodriguez whose telephone number is (571)270-3736. The examiner can normally be reached 9:00 - 6:00 Eastern M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Cleveland can be reached at 571-272-1418. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael P. Rodriguez/Primary Examiner, Art Unit 1712
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