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
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 DECEMBER 2025.
Applicant’s election without traverse of Group I: Claims 1-10, 19 and 20 in the reply filed on 05 DECEMBER 2025 is acknowledged.
Status of Claims
In the election on 05 DECEMBER 2025, Applicant has elected Group I: Claims 1-10, 19 and 20 are current pending claims are Claims 1-10, 19 and 20 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08 FEBRUARY 2023 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.
Specification
The disclosure is objected to because of the following informalities:
There is a period missing at end of [0040].
The use of the term BLUETOOTH®, [0116], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A “computing device adapted to be communicatively coupled…” in claim 19; “computing device is configured to at least one of display measurements…store the measurements…transmit the measurements” in claim 20. .
A “device” does not connote any particular structure. The “computing device” is defined in the specification as a “laptop, smartphone, desktop, etc.” in [0063].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 and 19-20 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].
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 6: wherein the assay device of claim 1, 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. ; 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 8: wherein the assay device of claim 1 further comprising 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.; 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.
Applicant’s invention is directed to a system.
Regarding Claim 19, the LOWE reference discloses a system comprising:
a computing device adapted to be communicatively coupled to an electrochemical assay device, [0605, 0794], 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].
and wherein the computing device is configured to receive measurements from the electrode, [0605, 0794].
Additional Disclosure Included is: Claim 20: wherein the system of claim 19, wherein the computing device is configured to at least one of 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].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. GINDILIS, US Publication No. 2019/0255504 A1 discloses an assay device, abstract, comprising : an electrochemical testing assembly, abstract, Figure 1A-3, including : test surface including a capture reagent selected to capture a target analyte, Figure 1A-3, [0147], ; an electrode, Figure 1A, 1B, electrodes 108/110, [0147], in communication with the test surface.
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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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