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 of Group III: Claims 19-30 in the reply filed on 31 JULY 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-18 and 31-32; Groups I, II and IV withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected methods and a system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 JULY 2026.
Status of Claims
In the election on 31 JULY 2026; Applicant has elected Group III: Claims 19-30.
Current pending claims are Claims 19-30 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 APRIL 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 17 APRIL 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 22 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 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.
Claims 19-30 are rejected under 35 U.S.C. 103 as being unpatentable over SLOUKA, Z. et al, Talanta (2015), http://dx.doi.org/10.1016/j.talanta.2015.04.083, submitted on the Information Disclosure Statement on 12 APRIL 2024; Non-Patent Literature Cite No. 50, BROSEL-OLIU, Analytica Chimica Acta 1088 (2019) 1-19.
Applicant’s invention is directed towards a system.
Regarding Claim 19, the SLOUKA reference discloses a system for simultaneous detection of multiple distinct microRNAs (miRNAs) in a biological sample from a subject, abstract, Figure 1, the system comprising:
an integration board, Figure 1, comprising:
a piezoelectric substrate, Figure 1, comprising:
a first inlet, a first outlet, Figure 1, page 3, section 2.3, and
a fluidic channel fluidly connecting the first inlet and the first outlet, Figure 1, page 3, section 2.3;
electrodes, Figure 1, page 3, section 2.3; and
one or more ion exchange arrays capable of detecting one or more distinct miRNAs, page 3-4, section 2.2-2.4, the one or more ion exchange arrays comprising:
a first cation exchange membrane (CEM) positioned across the fluidic channel proximate to the second inlet, page 4, section 3.1;
a positively charged reservoir fluidly connected to the fluidic channel by the first CEM, Figure 1, page 3;
a negatively charged reservoir fluidly connected to the fluidic channel by the CEM, Figure 1, page 3;
an anion exchange membrane (AEM) functionalized with a plurality of oligoprobes specific for a plurality of distinct miRNAs, fluidly connected to the fluidic channel and positioned between the first CEM, page 3, section 2.2-2.4
at least 2 source electrodes adapted to apply current across the AEM; and at least 2 sense electrodes adapted to measure voltage across the AEM; a
potentiostat, page 4, section 2.4;
a binary coding and decoding circuit to control and modulate the detection sensing for each distinct miRNA, page 6-7, section 3.3;
a plurality of probe selection switches, Figure 1;
a power source, Figure 1; and
a device for inducing fluid flow through the system, page 5 section 3.2.
SLOUKA discloses the claimed invention, but is silent in regards to a second inlet, a second outlet, and the fluidic channel fluidly connecting the first outlet, the second inlet, and the second outlet; and a second CEM.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the invention of SLOUKA so that there a second set of inlet, outlet fluidic channel and CEM to further process more than one sample at a time and increase the throughput of the overall device and mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
SLOUKA suggests the claimed invention, but is silent in regards to interdigitated electrodes, and a transducer that applies alternating current to the interdigitated electrodes.
BROSEL-OLIU discloses a system for detection of an analyte in a biological sample from a subject, abstract, Figure 4, the system comprising:
an integration board, Figure 4, comprising:
interdigitated electrodes, and a transducer that applies alternating current to the interdigitated electrodes, Figure 4, page 5-7, section 3, 4, 4.1.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the device of SLOUKA with the integration board of BROSEL-OLIU which comprises interdigitated electrodes, and a transducer that applies alternating current to the interdigitated electrodes to develop different systems for different analyte and provide selectivity for a specific target, page 7, section 4, 4.1.
Additional Disclosures Included are: Claim 20: wherein the system of claim 19, wherein a calibration curve is generated by inputting the voltage shift (V) measured from a current-voltage curve (CVC) into the equation:
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, wherein V is the voltage shift; R is the gas constant, 8.314 J (mol-1-K-1); T is the temperature, 25 0C = 298 K; F is Faraday's constant, 9.648 x 104 C mol-1; A is a coefficient that is approximately the theoretical value of 2 ln10(RT/F) ~ 0.12 V for every 10-fold decrease in bulk miRNA concentration; Cr is the reference concentration; and C is the concentration of the miRNA bound to the oligoprobe , SLOUKA page 6 Figure 5. ; Claim 22: wherein the system of claim 19, wherein the miRNA is free, contained in exosomes, or a combination thereof, SLOUKA page 5, section 3.1.; Claim 23: wherein the system of claim 19, wherein the system is used to determine the concentration of the miRNAs in the biological sample and the miRNA concentrations of a control or normal subject, SLOUKA Figure 6(a), (b), baseline, page 6 section 3.3; Claim 25: wherein the system of claim 19, wherein the system does not require miRNA isolation, reverse-transcription, or preamplification. The instant claim language is directed towards a manner in which the apparatus is intended to be employed when in use and a state of the miRNA, which is directed towards the intended use or the specific material handled does not, alone, define the scope or novelty of an apparatus claim. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The intended use or the specific material handled does not, alone, define the scope or novelty of an apparatus claim. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 26: wherein the system of claim 19, wherein the system detects the miRNA in from about 30 minutes to about 45 minutes. The instant claim is directed towards a method of intended use and a manner of operating the device, rather than a structural feature that accomplished its function. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). ; Claim 27: wherein the system of claim 19, wherein the system detects at least two miRNAs simultaneously. The instant claim is directed towards a method of intended use and a manner of operating the device, rather than a structural feature that accomplished its function. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). ; Claim 28: wherein the system of claim 22, wherein when the miRNA is contained in exosomes, the system lyses the exosomes in about 1 minute. The instant claim is directed towards a method of intended use and a manner of operating the device, rather than a structural feature that accomplished its function. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). ; Claim 29: wherein the system of claim 28, wherein the lysis is mechanical lysis, SLOUKA page 5, section 3.2, a filter is a mechanical means. ; and Claim 30: wherein the system of claim 19, wherein the volume of the biological sample is from about 20 mL to about 40 mL. The instant claim language is directed towards a manner in which the apparatus is intended to be employed when in use. The volume of the biological sample does not further define the system structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). However, SLOUKA teaches when in use, 50 mL of cancer cell lines are used, page 4, section 2.4.
Regarding Claim 21 the SLOUKA discloses a system where the miRNA is of microRNA (miRNA 146a).
SLOUKA is silent in regards to wherein the miRNA is one or more of miR-1-1 (SEQ ID NO: 1); miR-208b (SEQ ID NO: 4); miR-499 (SEQ ID NO: 7); miR-200b (SEQ ID NO: 10); miR-543 (SEQ ID NO: 13); miR-331 (SEQ ID NO: 16); miR-3605 (SEQ ID NO:19); miR-301a (SEQ ID NO: 22); miR-18a (SEQ ID NO: 25); miR-423 (SEQ ID NO: 28); miR-142 (SEQ ID NO: 31); or miR-132 (SEQ ID NO: 34).
The instant claim language is directed towards the material or article worked upon in the apparatus and use of the apparatus on a particular material is generally irrelevant to determining patentability of the apparatus itself. The intended use or the specific material handled does not, alone, define the scope or novelty of an apparatus claim. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding Claim 24 , the SLOUKA suggests the claimed invention, but is silent in regards to the conditions of when the system is in use or being operated or its intended use. The instant claim invention is directed towards a parameter of the material worked upon by the structure, thus “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935); and limitation directed towards ‘the subject is administered a treatment’ is directed towards what the system does once the concentration of the miRNA in the biological sample is increased by 10-100-fold as compared to the control or normal subject, which is interpreted by the Examiner to be method language when the system is in use. This language does not further define the system structurally but rather in how the system is to be used. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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