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 Claims
The claim set submitted on 11 JUNE 2026 is acknowledged and considered. In the claim set, Claim 1 is ‘Currently Amended’; Claims 2-5, 7, 9 and 10 are ‘Original’; Claims 6, 8, 19 and 20 are ‘Cancelled’; Claims 11-18 are ‘Withdrawn’; and Claim 21 is ‘New’.
Current pending claims are Claims 1-5, 7, 7, 10 and 21 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 11 JUNE 2026, with respect to the objection to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant's arguments filed 11 JUNE 2026 have been fully considered but they are not persuasive.
In the REMARKS Applicant asserts that the applied reference to LOWE does not recite or suggest the use of a passive pump. In particular, the citations directed towards language of capillary action , Applicant does not teach this ‘passive pump’ and asserts that the only ‘pumping action’ occurring is described in [0515].
While LOWE does not specifically use the term ‘passive pump’ it is known in the art that fluid transport in for example an assay device that is moved by capillary action, is considered to be a passive pumping mechanism. As it is known in the art capillary action is the movement of a liquid through a narrow space (such as a capillary tube, porous material, or microchannel) without the need for external mechanical pumps or applied pressure. It is driven by intermolecular forces — specifically surface tension and adhesion between the liquid and the solid surfaces — which create a pressure difference across the liquid interface.
LOWE teaches that the ‘assay device can optionally be supplied with a blood separation membrane arranged between a sample inlet and the detection zone” , [0756, 0788], and the assay device and included reagents are typically provided in a dry state. Addition of a liquid sample to the assay device (i.e., to the capillary channel), [0757].
The device of LOWE does not use any external mechanical pumps or applied pressure and the capillary action described in disclosure of LOWE is a passive pump.
Applicant further asserts that the LOWE reference does not teach “wherein the detection reagent is a first detection reagent including a label, wherein the assay device further comprises a second detection reagent disposed within the microfluidic network, wherein the second detection reagent includes a substrate, the buffer fluid transports the first detection reagent to the test channel before the second detection reagent.”
Applicant asserts that the cited portion of LOWE does not teach two detection reagents in which the second detection reagent includes a substrate; Examiner respectfully disagrees.
In the mapped portion of Claim 6 in the prior Office Action, wherein the assay device further comprises a second detection reagent disposed within the microfluidic network, [0769], channel 150 includes one or more reagent zones , wherein the second detection reagent includes a substrate.
In the claim language, it recites ‘wherein the second detection reagent includes a substrate’. The term ‘includes’ or ‘including’ is synonymous with ‘comprising’.
A claim using “comprising” is presumed to allow for the addition of other elements or steps without limiting the claim’s coverage. Mars Inc. v. H.J. Heinz Co., Invitrogen Corp. v. Biocrest Manufacturing, and Genentech, Inc. v. Chiron Corp. See MPEP 2111.03.
The second detection reagent is not limited solely to the substrate and it is interpreted the portion of the channel on the substrate with a reagent is considered to be the second detection reagent.
Furthermore, the language which recites ‘the buffer fluid transports the first detection reagent to the test channel before the second detection reagent’ is language directed towards the intended use of the device and how it is intending to be operated. “[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 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.
Claims 1-5, 7, 9, 10 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by LOWE, US Publication No. 2018/0059105 A1, submitted on the Information Disclosure Statement on 08 FEBRUARY 2023, US Patent Application Publications Cite No. 1.
Applicant’s invention is directed to a device, an assay device.
Regarding Claim 1, the LOWE reference discloses an assay device, abstract, assay device, Figure 11A, comprising:
an electrochemical testing assembly, Figure 11A, [0230] including:
a test channel including a capture reagent selected to capture a target analyte, Figure 11A, [0758, 0762, 0766, 0767, 0772], device 100 has base 102 which includes an inlet 110 connected to channel 120 with one or more reagent zones; and
an electrode having a surface in communication with the test channel, Figure 11A, [0759, 0760];
a microfluidic network in communication with the test channel, [0759, 0797, 0445];
a buffer fluid inlet in communication with the microfluidic network, [0759, 0769, 0797]; and
a detection reagent disposed within the microfluidic network, [0759, 0769], wherein, when a buffer fluid is provided to the buffer fluid inlet, the buffer fluid transports the detection reagent to the test channel by capillary-driven flow, [0759, 0769, 0778], and wherein the electrode is configured to measure an electrical response indicating capture of the target analyte by the capture reagent after transportation of the detection reagent to the test channel, [0775, 0779], Figure 10a, b, 11A, [0778, 0769, 0782, 0760, 0171-0173];
a membrane in communication with the microfluidic network, Figure 11A, [0445, 0713, 0758, 0759, 0773, 0788, 0797], device includes base 102, which includes inlet 110 that is fluidically connected to channel 120, blood separation membrane arranged between inlet and detection zone, and a passive pump coupled to the membrane, [0788], assay device can have blood separation membrane arranged between inlet and detection zone such that when blood is available as sample, only blood plasma reaches the detection zone, [0773], Figure 9A, sample/blood is drawn by capillary action, [0759], wherein the passive pump facilitates capillary-driven flow of the buffer fluid through the microfluidic network when the buffer fluid is provided to the buffer fluid inlet, [0788], liquid flows along channel via capillary action to junction 130, [0759], it is interpreted by the Examiner that capillary action is a / provides a passive pump that drives the buffer solution through the device; and
wherein the detection reagent is a first detection reagent including a label, [0769], channel 150 includes one or more reagent zones including one or more reagents on surface of channel 150, wherein the assay device further comprises a second detection reagent disposed within the microfluidic network, [0769], channel 150 includes one or more reagent zones , wherein the second detection reagent includes a substrate, and wherein, when the buffer fluid is provided to the buffer fluid inlet, the buffer fluid transports the first detection reagent to the test channel before the second detection reagent, [0769], channel 150 includes one or more reagent zone including one or more reagents in a dry state on surface of channel 150, dry reagents can be resuspended upon contact with liquid, i.e. buffer, buffer can be introduced to channel 150 via inlet 140.
Additional Disclosure Included are: Claim 2: wherein the assay device of claim 1, wherein the detection reagent is an electrochemical mediator, [0769], channel 150 includes one or more reagent zones including one or more reagents in dry state, channel 150 can include a substrate for the redox enzyme and a redox mediator, and wherein the target analyte inhibits interaction between the electrochemical mediator and the electrode when the target analyte is captured by the capture reagent, [0464, 0465, 0525]. ; Claim 3: wherein the assay device of claim 1, wherein the detection reagent is a label selected to bind with the target analyte when the target analyte is captured by the capture reagent, and wherein the label is selected to react with a substrate when the label is bound to the target analyte to produce an electrochemically active product detectable by the electrode, [0422, 0452, 0460, 0466, 0560, 0561]. ; Claim 4: wherein the assay device of claim 1, further comprising a substrate inlet in communication with the microfluidic network, [0759], base 102 has inlet 140, inlet 140 is connected to channel 150, [0778], second liquid is then added to test strip at inlet 140, which contains sodium acetate buffer, hydrogen peroxide substrate and the redox mediator, wherein, when a substrate is provided to the substrate inlet, the substrate is transported by capillary-driven flow to the test channel, [0778], second liquid flows along channel 150 via capillary action to junction 130 where second fluid contact blood sample at meniscus 190 to for a liquid-liquid interface; Claim 5: wherein the assay device of claim 1, wherein the detection reagent is one of a dried label and a dried substrate disposed within the microfluidic network, [0769], channel 150 includes one or more reagent zones including one or more reagents on surface of channel 150, and wherein, when the buffer fluid is provided to the buffer fluid inlet, the buffer fluid rehydrates the detection reagent before transporting the detection reagent to the test channel, [0769], channel 150 includes one or more reagent zone including one or more reagents in a dry state on surface of channel 150, dry reagents can be resuspended upon contact with liquid, i.e. buffer, buffer can be introduced to channel 150 via inlet 140. ; Claim 7: wherein the assay device of claim 1, wherein the capture reagent is disposed on the surface of the electrode, [0762], Reagents may be deposited on one or more electrode and on one or more electrode set. The reagents can be deposited on any part of the channels that facilitates interaction with analytes in the sample before detection takes place. ; Claim 9: wherein the assay device of claim 1 further comprising a sample inlet in communication with the microfluidic channel, [0713, 0733, 0758, 0759], inlet 510 and Figure 11A device includes base 102, which includes inlet 110 that is fluidically connected to channel 120. ; and Claim 10: wherein the assay device of claim 1 further comprising a sample inlet in communication with the microfluidic channel, wherein the sample inlet includes a filtration membrane, [0713, 0756, 0758, 0759, 0773, 0788], Figure 11A, device 100 includes base 102, which includes inlet 110 that is fluidically connected to channel 120, blood separation membrane arranged between inlet and detection zone.; and Claim 21: wherein the assay device of claim 1, further including: a computing device coupled to the assay device, wherein the computing device is configured to receive measurements from the electrode and to display the measurements on a display of the computing device, store the measurements in a memory of the computing device, and transmit the measurements to a second computing device, [0605, 0676, 0793-0796], Figure 17, communication medium including a direct cable connection, a computer network, a wireless network, a satellite network, or the like.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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