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 .
Status of the Claims
The Amendment filed July 23, 2026 has been entered. Claims 24, 26, 31-32, 38-39 have been amended; and claims 1-23 have been withdrawn. Claims 24-39 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection previously set forth in the Non-Final Office Action mailed April 23, 2026.
The claim interpretation under 35 U.S.C. § 112(f) for claims 31 and 38 are maintained.
New grounds of claim objection are necessitated by the amendment as outlined below.
New grounds of rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendment as outlined below.
All rejections under 35 U.S.C. § 103 are withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/4/2026 has been considered by the examiner.
Claim Objection
Claims 24, 31-32, and 38-39 are objected to because of the following informalities:
Claim 24: please amend “may be tuned” to -- is tuned--; “EV particle” to -- EV biomarker of the plurality of biomarkers of interest--; “a different biomarker of interest or their respective tags” to -- a different biomarker of interest or [[their]] its respective tags--.
Claim 31: please amend “a plurality of extracellular vesicle-derived (EV-derived) biomarker of interest” to -- a plurality of extracellular vesicle-derived (EV-derived) biomarkers of interest--; “may be tuned” to -- is tuned--;“EV particle” to -- EV biomarker of the plurality of biomarkers of interest--; “a plurality of biomarkers of interest of the extracellular vesicles are tagged” to –[[a]] the plurality of biomarkers of interest of the extracellular vesicles are tagged--; “a different biomarker of interest or their respective tags” to -- a different biomarker of interest or [[their]] its respective tags--; “the binding of each of the biomarkers of interest or their respective tags” to --the binding of each of the plurality of biomarkers of interest or their respective tags--.
Claim 32: please amend “EV particle” to -- EV biomarker of the plurality of biomarkers of interest--; “assigning a tag to each of the biomarkers of interest within the plurality of biomarkers of the extracellular vesicles” to -- assigning a tag to each each detector chamber detects each attachment of the plurality of biomarkers of interest of the extracellular vesicles or their respective tags--; “each of the plurality of biomarkers of interest of the extracellular vesicles” to -- each
Claim 38: please amend “EV particle” to -- EV biomarker of the plurality of biomarkers of interest--; “assigning a tag to each of the biomarkers of interest within the plurality of biomarkers” to -- assigning a tag to each each detector chamber detects an attachment of each its respective tags --; “each of the plurality of EV-derived biomarkers of interest” to -- each of the plurality of
Claim 39: please amend “may be tuned” to -- is tuned --; “or their respective tags” to -- or [[their]] its respective tags--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites “wherein the sensor chamber comprises an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags; and digitally sensing the plurality of biomarkers of interest of the extracellular vesicles or their respective tags through changes in ion concertation near the plurality of gate surfaces of the electrode array, which are digitized using an analog-to-digital converter”. The instant specification and Fig.7 disclose “the one or more biological samples may be passed from the one or more tagging chambers 640, 644 to one or more detector arrays 710, 720, 730 via DMF channel 630. In particular embodiments, each of a plurality of detector arrays may be programmed to detect a particular biomarker. As an example and not by way of limitation, detector array 710 may be specifically programmed for a particular biomarker, such as “biomarker 1.” Similarly, detector array 720 may be programmed for “biomarker 2” and detector array 730 may be programmed for “biomarker N.” In this example, each detector array may be programmed to operate with a different detector chemistry, wherein each detector chamber may detect attachment of one distinct and specific labeled biomarker” [para. 0102] in PG-Pub. The specification does not disclose that each detector array is an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags, and digitally sensing the plurality of biomarkers of interest of the extracellular vesicles or their respective tags through changes in ion concertation near the plurality of gate surfaces of the electrode array, which are digitized using an analog-to-digital converter. The specification discloses electrode array in the DEP chamber instead of in the sensor chamber. The specification discloses “In particular embodiments, the working electrode surface 124 may function as a detector of one or more biomarkers 104” [Para. 0058] in PG-Pub; “In particular embodiments, digital sensing may occur when EV biomarkers of interest 104 are detected by changes in ion concentration near the gate surface of working electrode surface 124, mediated by, for example, antibody binding events, nucleic acid hybridization events, and/or enzymatic reactions” [para. 0059] in PG-Pub. But the specification does not disclose that the working electrode surface is an electrode array comprises an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags. Thus, claim 24 and its dependent claims 25-30 are new matters.
Claim 31 recites “wherein the sensor chamber comprises an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags”. As explained in claim 24 above, the specification/drawings do not support that the sensor chamber comprises an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags. Thus, claim 31 is a new matter.
Claim 32 recites “wherein the detector chamber detects each attachment of the plurality of biomarkers of interest of the extracellular vesicles or their respective tags”. The specification discloses “wherein each detector chamber may detect attachment of one distinct and specific labeled biomarker” [para. 0102] in PG-Pub. The specification does not support the detector chamber detects attachment of their respective tags. Claim 32 further recites “wherein the binding each of the biomarkers of interest or their respective tags changes a capacitance of surface chemistry or increases a number of charge carriers near one or more surfaces of the one or more field effect transistors”. The specification only discloses “when binding event 110 occurs, the observed event may either change the capacitance of surface chemistry 122 or increase the number of charge carriers, either of which event may be electronically measured” [para. 0053] in PG-Pub. In the above disclose, it does not disclose that the sensor is a field effect transistor, and the change occurs “near one or more surfaces of the one or more field effect transistors”. Thus, claim 32 and its dependent claims 33-37 are new matters.
Claim 38 recites “wherein the detector chamber detects an attachment of each of the biomarkers of interest, of the extracellular vesicles or their respective tags”. The specification discloses “wherein each detector chamber may detect attachment of one distinct and specific labeled biomarker” [para. 0102] in PG-Pub. The specification does not support the detector chamber detects attachment of their respective tags. Claim 38 further recites “wherein the binding of each of the biomarkers of interest or their respective tags changes a capacitance of surface chemistry or increases a number of charge carriers near one or more surfaces of the one or more field effect transistors”. The specification only discloses “when binding event 110 occurs, the observed event may either change the capacitance of surface chemistry 122 or increase the number of charge carriers, either of which event may be electronically measured” [para. 0053] in PG-Pub. In the above disclose, it does not disclose that the sensor is a field effect transistor, and the change occurs “near one or more surfaces of the one or more field effect transistors”. Thus, claim 38 is a new matter.
Claim 39 recites “wherein one or more surfaces of the one or more field effect transistors are each functionalized to bind to a different biomarker of interest or their respective tags, and wherein the binding of each of the biomarkers of interest or their respective tags changes a capacitance of surface chemistry or increases a number of charge carriers near the one or more surfaces of the one or more field effect transistors, which are electronically measured”. Fig.7 and [para. 0102] in PG-Pub do not disclose that the detector array that is functionalized to binding to a different biomarker is one or more surfaces of the one or more field effect transistors. The specification only discloses “when binding event 110 occurs, the observed event may either change the capacitance of surface chemistry 122 or increase the number of charge carriers, either of which event may be electronically measured” [para. 0053] in PG-Pub. In the above disclose, it does not disclose that the sensor is a field effect transistor, and the change occurs “near one or more surfaces of the one or more field effect transistors”. Thus, claim 39 is a new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31 and 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claim 31, claim 31 recites “wherein the sensor chamber comprises an electrode array comprising a plurality of gate surfaces that are each functionalized to bind to a different biomarker of interest or their respective tags; and one or more field effect transistors and an analog-to-digital converter for digitally determining a quantity of multiple biomarkers of interest, within the plurality of biomarkers of interest, of the extracellular vesicles or their respective tags, wherein the binding of each of the biomarkers of interest or their respective tags changes a capacitance of surface chemistry or increases a number of charge carriers near the one or more surfaces of the one or more field effect transistors, which are electronically measured”. Firstly, “the one or more surfaces” lack antecedent basis. Secondly, it is unclear what is the relationship between the electrode array and the one or more field effect transistors. It is unclear if the plurality of gate surfaces wherein the bindings occur are the same as or different than one or more surface of the one or more field effect transistor since the binding changes a capacitance of surface chemistry or increases a number of charge carriers near the one or more surfaces of the one or more field effect transistors. Thus, the scope of claim 31 is indefinite.
Regarding claim 38, “the binding” lacks antecedent basis. It is also unclear what is binding with the biomarkers of interest or their respective tags to result in the change. Thus, the scope of claim 38 is indefinite.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 13-21, filed 7/23/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered, and but are moot in view of the new grounds of rejection under 112(a) above. The prior art rejections from the previous office action are withdrawn in view of many new features that are not supported by the specification/drawings.
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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