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 .
Response to Amendment
Applicant amendments filed 12/29/2025 have been entered. Applicant amendments overcomes the previous claim objection and 112(b) rejections set forth in the Office Action mailed 09/29/2025, the previous claim objection and 112(b) rejections are withdrawn.
Status of Claims
Claims 19-24, 26-32, and 35 remain pending in the application, with claims 19-24, 28-32, and 35 being examined and claims 26-27 being withdrawn pursuant to the election filed 10/07/2024.
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.
Claim(s) 19, 21, 28-29, 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US-2013/0071869-A1) in view of Sullivan (US-2017/0248573-A1).
Regarding claim 19, Wu teaches a method of holding a sample in a time dependent area of a test strip, the method comprising:
providing the test strip (test sensor 804) including ([0184], Figure 8):
a first flow path (reservoir 808 and channel 810) ([0186], Figure 8, where it is understood that both the reservoir 808 and channel 810 together make up a first flow path and herein when referring to the first flow path both 808 and 810 will be used);
the time dependent area (channel 810) in the first flow path (808 and 810) ([0186], Figure 8);
applying the sample to the test strip (804) ([0199] see introducing liquid to opening 812);
flowing the sample along the first flow path (808 and 810) ([0199] see liquid sample for analysis is transferred into the reservoir 808 by introducing the liquid to opening 812, where liquid sample flows through channel 810, filling the reservoir 808);
While Wu does teach where the reservoir 808 that has a working electrode 832 and counter electrode 834 from which an analytic output signal is measured, and is therefore a detection area (Wu; [0188]), Wu does not teach an e-gate that separates the channel 810 (time dependent area) from the reservoir 808 (detection area), where the e-gate is a Self Assembled Monolayer that regulates the residence in the time dependent area.
In the analogous art of systems, methods, and devices for analyzing small volumes of fluidic samples, Sullivan teaches where a device comprises a metering mechanism that controls flow of a volume (Sullivan; abstract, [0014]).
Specifically, Sullivan teaches where the metering mechanism can be an active valve that comprises an electrode having a hydrophobic coating (such as an alkanethiol self-assembled monolayer (SAM)) (Sullivan; [0014]). It is further described by [0032] that the application of a voltage to the electrode causes dissolution of the hydrophobic coating (understood to be the SAM described in [0014]) that permits the flow of at least a portion of the volume to a sample region. As seen in Figure 2 there is a microfluidic device 20 that includes an active valve as a metering mechanism that controls fluid flow, in particular active elements 202 constrain and/or arrest fluid flow between capillary channel 203 and detection substrate 204, where the active element is the electrodes with the alkanethiol self assembled monolayer (Sullivan; [0068], [0069] describes “an alkanethiol surface assembled monolayer (SAM)” which is understood to be a typo and should be “self assembled monolayer” as similarly described in [0014]).
It would have been obvious to one skilled in the art to modify the channel of Wu such that it includes the electrode with alkanethiol self assembled monolayer as taught by Sullivan because Sullivan teaches that it is beneficial to control the timing and/or rate of flow between different sample regions in order to ensure that sample volume is retained for an appropriate length of time and to prevent premature flow of sample volume into other regions, and that the active valve controls fluid flow between the two regions (Sullivan; [0062], [0068]).
It is understood that the electrode with alkanethiol SAM of Sullivan will be placed at the transition point between the channel 810 and reservoir 808 of Wu similar to where the active valve 202 is seen to be between capillary 202 and detection substrate 204 in Figure 2 of Sullivan. From [0062] of Sullivan which describes that it is beneficial to control the timing and/or rate of flow between the different sample regions and that the microfluidic devices described incorporate one or more metering mechanisms or other flow control elements in order to ensure that the sample volume is retained in the sample region for an appropriate length of time and to prevent premature flow of the sample volume into other regions, the SAM of Sullivan will hold the sample until a metric is reached, the metric selected from a list consisting of a measured time.
Regarding claim 21, modified Wu teaches the method of claim 19. Wu further teaches wherein the time dependent area (810) is a reaction holding area (Wu; [0186] see where reagents may be deposited in the channel 810).
Regarding claim 28, modified Wu teaches the method of claim 19. Sullivan further teaches wherein the e-gate is the Self Assembled Monolayer (SAM) (see claim 19 supra).
Regarding claim 29, modified Wu teaches the method of claim 28. Sullivan further teaches wherein an electric current opens the e-gate (see claim 19 supra).
Regarding claim 32, modified Wu teaches the method of claim 19. Wu further teaches further comprising a meter (measurement device 802), the meter (802) engaging the test strip (804) (Wu; [0184] see the measurement device 802 and test sensor 804 may be adapted to implement an electrochemical sensor system, Figure 8).
The channel 810 of the test sensor 804 of Wu has been modified such that it includes the electrode with a SAM as taught by Sullivan, where a voltage is applied to the electrode to actuate the valve. As described by [0188] of Wu, in the electrochemical system the sample interface 814 of test sensor 804 has conductors that are connected to a working electrode 832 and counter electrode 834. [0190] of Wu describes where electrical input signals may be transmitted by the sensor interface 818 of the measurement device 802 to the sample interface 814 to apply the electrical input to the sample of the biological fluid.
One skilled in the art would find it obvious that the electrode of Sullivan will similarly be connected to the sample interface 814 of the test sensor and will be receive electrical input signals from the measurement device 802 via sensor interface 818 to the sample interface 814, thus opening the e-gate.
Claim(s) 20, 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US-2013/0071869-A1) and Sullivan (US-2017/0248573-A1), and in further view of Schlautmann (US-2003/0226604-A1).
Regarding claim 20, modified Wu teaches the method of claim 19. Wu does not teach wherein the time dependent area is a heating area and includes a heating element in communication with the heating area of the first flow path, the method further comprising heating the sample with the heating element.
In the analogous art of microfluidic devices with a fluid channel, Schlautmann teaches integrated metal patterns disposed inside a micro fluidic conduit (Schlautmann; abstract, [0053]).
Specifically, Schlautmann teaches where the integrated metal patterns that are disposed inside the micro fluidic conduit can be used as heaters that enhance a chemical reaction (Schlautmann; [0053]).
It would have been obvious to one skilled in the art to modify the channel that includes reagents of Wu such that it has the integrated metal patterns that can be used as heaters as taught by Schlautmann because Schlautmann teaches that the heaters enhance chemical reactions (Schlautmann; [0053]).
Regarding claim 22, modified Wu teaches the method of claim 20. Wu further teaches wherein a reaction holding area includes reagents for causing a reaction.
As described by Wu [0186], the channel 810 can have reagents deposited in it. The location where the reagents are located within channel 810 is a reaction holding area.
Regarding claim 23, modified Wu teaches the method of claim 19. Wu does not teach wherein the time dependent area is a heating area and includes a heating element in communication with the heating area of the first flow path, for heating the sample in the first flow path.
In the analogous art of microfluidic devices with a fluid channel, Schlautmann teaches integrated metal patterns disposed inside a micro fluidic conduit (Schlautmann; abstract, [0053]).
Specifically, Schlautmann teaches where the integrated metal patterns that are disposed inside the micro fluidic conduit can be used as heaters that enhance a chemical reaction (Schlautmann; [0053]).
It would have been obvious to one skilled in the art to modify the channel that includes reagents of Wu such that it has the integrated metal patterns that can be used as heaters as taught by Schlautmann because Schlautmann teaches that the heaters enhance chemical reactions (Schlautmann; [0053]).
Regarding claim 24, modified Wu teaches the method of claim 19. Wu does not teach wherein the time dependent area is a temperature change area and includes a temperature change element in communication with the temperature change area of the first flow path, for changing the temperature of the sample in the first flow path.
In the analogous art of microfluidic devices with a fluid channel, Schlautmann teaches integrated metal patterns disposed inside a micro fluidic conduit (Schlautmann; abstract, [0053]).
Specifically, Schlautmann teaches where the integrated metal patterns that are disposed inside the micro fluidic conduit can be used as heaters that enhance a chemical reaction (Schlautmann; [0053]).
It would have been obvious to one skilled in the art to modify the channel that includes reagents of Wu such that it has the integrated metal patterns that can be used as heaters as taught by Schlautmann because Schlautmann teaches that the heaters enhance chemical reactions (Schlautmann; [0053]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US-2013/0071869-A1) and Sullivan (US-2017/0248573-A1), and in further view of Reid (US-2005/0067280-A1).
Regarding claim 30, modified Wu teaches the method of claim 19. Wu teaches where biosensor systems may use optical and/or electrochemical methods to analyze the biological fluid (Wu; [0005]), where [0008] describes where in an optical system the concentration of A1c is determined, and where for total hemoglobin (THb) the reflectance is inversely proportional to the THb (mg/dL) for the detection system. It is therefore understood that the electrochemical system will also be determining concentration of A1c and THb. [0188] of Wu describes where in the electrochemical system there is a working electrode 832 and counter electrode 834 that are disposed on a surface of base 806 that forms the reservoir 808. However, Wu does not teach wherein the detection area includes an interdigitated electrode for detecting A1C.
In the analogous art of electrochemical cells for detection and quantification of analytes in a liquid sample, Reid teaches where interdigitated electrodes are used in electrochemical cells (Reid; abstract, [0005]).
Specifically, Reid teaches where interdigitated electrodes can be formed, where the electrodes being in close proximity minimize the volume of sample required to perform an electrochemical measurement (Reid; [0005]). Further, Reid teaches where conventional biosensors have a working electrode and a dual-purpose reference/counter electrode on the same major surface of an insulating substrate (Reid; [0005]).
It would have been obvious to one skilled in the art to modify the working and counter electrode of Wu such that they are interdigitated electrodes as taught by Reid because Reid teaches that interdigitated electrodes minimize the volume of sample required to perform an electrochemical measurement (Reid; [0005]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US-2013/0071869-A1), Sullivan (US-2017/0248573-A1), and Reid (US-2005/0067280-A1), and in further view of Lee (US-2020/0182864-A1).
Regarding claim 31, modified Wu teaches the method of claim 30. Wu does not teach wherein the test strip further includes a second flow path, the second flow path including an interdigitated electrode for detecting hemoglobin.
In the analogous art of point-of-care micro biochips for disease diagnostics, Lee teaches a biochip with one or multiple channels that are connected to the same inlet through which sample flows (Lee; [0002], [0064]).
Specifically, Lee teaches where there are multiple biomarkers embedded or coated with the same or different biomarkers where it is seen in Figure 2A that there are two microchannels that include three gold nano interdigitated electrodes that are coated with a particular and unique antibody (Lee; [0064], [0071]). It is further described by [0071] of Lee that the advantage of this biochip is that several types of antigens can be detected simultaneously through a single drop, which offers improved specificity of results when compared with a biochip having a single electrode and single pair of contact pads.
It would have been obvious to one skilled in the art to modify the test strip of Wu such that there are two separate flow paths, where they are specific to a particular analyte as taught by Lee because Lee teaches that by having multiple channels with multiple IDEs that are specific to unique analytes, it improves specificity of results (Lee; [0071]).
It is understood that because the biosensor system of Wu is detecting A1c and total hemoglobin, when the channel 810 and reservoir 808 are split such that there are two channels and two reservoirs connected to a common inlet as taught by Lee, one of the channels will detect A1c and the other will detect hemoglobin. Further both channels will include interdigitated electrodes as taught by Reid.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US-2013/0071869-A1) and Sullivan (US-2017/0248573-A1), and in further view of Kylberg (US-2006/0083496-A1).
Regarding claim 35, modified Wu teaches the method of claim 32. Wu has been modified by Sullivan to include the electrode and SAM. While [0062] of Sullivan describes that the sample volume is retained in the sample region for an appropriate length of time, however it is unclear if this is opening the e-gate after the sample has undergone necessary digestion.
In the analogous art of performing a reaction, Kylberg teaches a method for performing a reaction at elevated uniform temperature in one or more reaction mixtures (Kylberg; [0077]).
Specifically, Kylberg teaches the steps of: providing a rotatable microfluidic disc, introducing one or more reaction mixtures into separate reaction volumes, supplying energy to the heating structure and maintaining the temperature at the elevated level for a sufficient time for the intended reaction to take place, and then transferring each reaction mixture further downstream in the micro channel linked to the reactor volume (Kylberg; [0078]-[0082]).
It would have been obvious to one skilled in the art to modify the measurement device of Wu such that it applies a voltage to the electrode that will open the valve after a sufficient time as taught by Kylberg because Kylberg teaches that it is desirable and effective to maintain a fluid in a specific location at an elevated temperature for a sufficient time for the intended reaction to take place and then transferring the reaction mixture downstream (Kylberg; [0080], [0082]).
It is understood that the sufficient time will be enough time for the reagent and sample to undergo necessary digestion.
Response to Arguments
Applicant arguments filed 12/29/2025 have been fully considered.
Applicant argues on page 5 that Huang is not in the same field as Wu and therefore there would be no motivation to combine the two. The rejection that applicant is arguing, Wu in view of Sullivan and Huang, was an alternative rejection where holding the sample in the time dependent area with the e-gate until a metric is reached, the metric being a temperature. As applicants have cancelled claims 33-34 which had the meter being configured to open the e-gate when the sample has reached a necessary temperature, the alternative rejection in view of Wu, Sullivan, and Huang has been withdrawn.
However, the rejection in view of Wu and Sullivan where the metric is a measured time still applies to the presently pending claims.
Additionally, applicant argues on page 6 that channel 810 of Wu is not disclosed as a time dependent area. Currently there is no additional structure given to the time dependent area in the claim, where although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the channel 810 of Wu is the time dependent area.
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 SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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, Elizabeth Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796