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 .
This is a NON FINAL rejection in response to applicant’s claim amendments and arguments filed June 29, 2026. Claims 15-20 have been canceled from consideration. Claims 1-14 are pending review in this correspondence.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 29, 2026 has been entered.
Response to Amendment
Rejection of claims 15-18 and 20 as being unpatentable over Xu et al (US 2005/0196746 A1) in view of Yue et al (US 2007/0014695 A1) is withdrawn in view of applicant’s claim cancelations.
Rejection of claim 19 as being unpatentable over Xu et al (US 2005/0196746 A1) and Yue et al (US 2007/0014695 A1) in view of Korpela (US 2003/0003023 A1) is withdrawn in view of applicant’s claim cancelations.
Allowance of claims 1-14 is withdrawn in view of the IDS submitted June 29, 2026.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4-10, and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown (US 2002/0164820 A1) (provided by applicant in IDS dated 6/29/2026).
With respect to claim 1 Brown discloses a method comprising:
providing a microfluidic device (analytical assembly, See Para. 0110 and Figs. 1-2; Para. 0013 describes that the apparatus is intended to isolate and retain fluid samples having volumes from about one microliter to about one picoliter or less) comprising:
a sample inlet (entrance openings 70, See Para. 0119),
an outlet channel (exit vent, See description in Para. 0119), and
a substrate (substrate 50) comprising a set of chambers (patterned layer 56 are formed a plurality of wells or holes therethrough defining bottom portions 60 of sample chamber, See Para. 0117) in fluid communication with the sample inlet, wherein each chamber of the set of chambers has a maximum cross-section at an opening into the chamber and wherein the opening defines an entry for material of a sample to enter the chamber (See Paras. 0119-0120);
receiving a sample into the sample inlet (See Para. 0122 for discussion of a sample of fluid medium being introduced to the flow-through channels through entrance openings 70); and
performing a set of processes upon the sample within the set of chambers at the substrate (See Para. 0122 for discussion of the introduction of a displacing fluid),
wherein the set of processes comprises flowing a continuous isolation layer through a space that is fluidly connected to the set of chambers, wherein the continuous isolation layer covers the openings having the maximum cross-section of the set of chambers as a continuous layer and seals the set of chambers (See Para. 0122 for discussion of how the displacing fluid flows through and fills the channels displacing sample from within the channels but without displacing sample from the sample chambers. The result is a plurality of discrete, isolated portions of the sample, held by the sample chambers).
With respect to claim 2 Brown discloses that the set of chambers comprises from 10,000 to 1,000,000 individual chambers (See Para. 0077).
With respect to claim 4 Brown discloses flowing the continuous isolation layer comprises introducing an isolation material into the microfluidic device and toward the outlet channel (See Fig. 2 and Para. 0122 for discussion of how a displacing fluid is caused to enter the flow-through channels through the entrance openings 70, and the displacing fluid flows through and fills the channels displacing sample from within the channels but without displacing sample from the sample chambers).
With respect to claim 5 Brown discloses that the continuous isolation layer comprises an oil (See Para. 0047 for discussion of the displacing fluid being mineral oil, silicon oil, fluorinated oils, and other fluids which are preferably substantially non-miscible with water).
With respect to claim 6 Brown discloses that performing the set of processes upon the sample comprises performing a nucleic acid analysis (See Para. 0108).
With respect to claim 7 Brown discloses that fluid flow reaches chambers of the set of chambers sequentially (See Para. 0122 for discussion of how a displacing fluid is caused to enter the flow-through channels through the entrance openings 70, and the displacing fluid flows through and fills the channels displacing sample from within the channels but without displacing sample from the sample chambers).
With respect to claim 8 Brown discloses that the set of processes further comprises a polymerase chain reaction (PCR) process (See Paras. 0114 and 0122).
With respect to claim 9 Brown discloses delivering PCR reagents into the set of chambers for the PCR process (See Paras. 0052 and 0144-0147).
With respect to claim 10 Brown discloses that performing the set of processes comprises performing a single cell molecular analysis (See Para. 0076).
With respect to claim 12 Brown discloses that the set of processes further comprises a thermocycling process with transmission of heat to the substrate (See Paras. 0140 and 0146).
With respect to claim 13 Brown discloses further wherein the set of processes comprises an optical detection process configured for detecting signals derived from the set of chambers (See Para. 0108 for discussion of how, after isolation, amplification, and quantification, the existence and quantitation of two or more different target sequences can be determined, for example by using a fluorescence energy transfer assay).
With respect to claim 14 Brown discloses that the optical detection process comprises detecting fluorescence from the set of chambers (See Paras. 0096 and 0108).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0164820 A1) in view of Xu et al (US 2005/0196746 A1).
Refer above for the disclosure of Brown.
With respect to claim 3, Brown fails to disclose that the sample comprises a bodily fluid.
Xu teaches a microfluidic device (device discussed in Fig. 13, Para. 0365) comprising a sample inlet (See Figs. 13A-D reproduced below), an outlet channel (See Figs. 13A-D reproduced below), and a substrate (See Figs. 13A-D reproduced below) comprising a set of chambers (microwells 1303) in fluid communication with the sample inlet (See Fig. 13A and Para. 0054 for discussion of how the upper opening of a well can be of any shape and can be of an irregular conformation; the walls of a well can extend upward from the lower surface of a well at any angle or in any way). Xu further teaches that the sample comprises a bodily fluid (See Paras. 0069, 0071 of Xu for discussion of the sourcing of cells; Para. 0109 discloses that samples of any tissue or organ can be used, with preferred types of cells coming from the heart and blood and that it can be from any source and can be a liquid).
It would have been obvious to one of ordinary kill in the art before the effective filing date of the claimed invention to incorporate a bodily fluid as the sample, as bodily fluid is a viable source of various substances that can be analyzed, and the ability to vary the type of sample can be another specific use of the device (See Paras. 0069 and 0071 of Xu).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0164820 A1) in view of Xu et al (US 2005/0009004 A1) (hereinafter referred to as Xu 2).
Refer above for the disclosure of Brown.
With respect to claim 11, Brown fails to disclose that the sample comprises material from cancer cells.
Xu 2 provides biochips and other fluidic components and apparatuses and methods of use that allow for the direct detection of ion transport function or properties using microfabricated structures that can allow for automated detection of ion transport function or properties These biochips and apparatuses and methods of use thereof are particularly appropriate for automating the detection of ion transport function or properties, particularly for screening purposes, including high-throughput screening purposes. In some aspects the present invention can be practiced using a wide variety of cells from different sources. For example, cancer cells can be interrogated as to their ion channel activity in the presence and absence of test compounds or in comparison to other cells such as non-cancerous cells or other cancer cells (See Paras. 0173-0174).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate cancer cells as the source cell for the sample of Brown, as taught by Xu 2, for the purpose of interrogating their ion channel activity in the presence and absence of test compounds or in comparison to other cells such as non-cancerous cells or other cancer cells (See Paras. 0173-0174 of Xu 2) and as another specific use for the device of Brown.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 July 11, 2026
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