DETAILED ACTION
Applicant’s arguments, filed on 01/14/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 01/14/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-30 are the current claims hereby under examination.
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 .
Claim Objections
Claims 1-2, 4, 11-13, and 16-19 are objected to because of the following informalities:
In claim 1, line 8, “the surface area” should read “a surface area”, as there is a lack of antecedent basis in the claim
In claim 2, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 4, line 3, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 11, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 12, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 13, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 16, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 17, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 18, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
In claim 19, line 2, “the sample fluid” should read “a sample fluid”, as there is a lack of antecedent basis in the claim
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-3 and 11-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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 2, the claim recites the limitation “concentration of target analyte” in line 4. It is unclear if this is meant to refer to the concentration of target analyte from claim 1, lines 9-10, or a different concentration of a different target analyte. If it is meant to refer to the concentration of the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different concentration of a different target analyte, it needs to be distinguished from the concentration of target analyte from claim 1. For purposes of examination, it is being interpreted as referring to the concentration of target analyte from claim 1.
Further regarding claim 2, the claim recites the limitation “concentration of target analyte in µL” in line 4. It is unclear how a concentration can be measured in µL. Additionally, this is a change from the original claim 2 in the last set of claims, however it has not been marked as a change by an underline in the newest set of claims. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as concentration of target analyte in µM, as this is a proper measure of concentration.
Further regarding claim 2, the claim recites the limitation “a value” in line 4. It is unclear if this limitation is meant to refer to the value from claim 1, line 10, or a different value. If it is meant to refer to the value from claim 1, it needs to refer back to it. If it is meant to refer to a different value, it needs to be distinguished from the value from claim 1. For purposes of examination, it is being interpreted as referring to the value from claim 1.
Regarding claim 3, the claim recites the limitation “a surface area” in line 4. It is unclear if this limitation is meant to refer to the surface area from claim 1, line 8, or a different surface area. If it is meant to refer to the surface area from claim 1, it needs to refer back to it. If it is meant to refer to a different surface area, it needs to be distinguished from the surface area from claim 1. For purposes of examination, it is being interpreted as referring to the surface area from claim 1.
Regarding claim 11, the claim recites the limitation “an analyte” in line 2. It is unclear if this limitation is meant to refer to the target analyte from claim 1, line 10, or a different analyte. If it is meant to refer to the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different analyte, it needs to be distinguished from the analyte from claim 1. For purposes of examination, it is being interpreted as referring to the target analyte from claim 1.
Further regarding claim 11, the claim recites the limitation “a concentration” in line 3. It is unclear if this is meant to refer to the concentration of target analyte from claim 1, lines 9-10, or a different concentration. If it is meant to refer to the concentration of the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different concentration, it needs to be distinguished from the concentration of target analyte from claim 1. For purposes of examination, it is being interpreted as referring to the concentration of target analyte from claim 1.
Regarding claim 12, the claim recites the limitation “an analyte” in line 2. It is unclear if this limitation is meant to refer to the target analyte from claim 1, line 10, or a different analyte. If it is meant to refer to the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different analyte, it needs to be distinguished from the analyte from claim 1. For purposes of examination, it is being interpreted as referring to the target analyte from claim 1.
Further regarding claim 12, the claim recites the limitation “a concentration” in line 3. It is unclear if this is meant to refer to the concentration of target analyte from claim 1, lines 9-10, or a different concentration. If it is meant to refer to the concentration of the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different concentration, it needs to be distinguished from the concentration of target analyte from claim 1. For purposes of examination, it is being interpreted as referring to the concentration of target analyte from claim 1.c
Regarding claim 13, the claim recites the limitation “an analyte” in line 2. It is unclear if this limitation is meant to refer to the target analyte from claim 1, line 10, or a different analyte. If it is meant to refer to the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different analyte, it needs to be distinguished from the analyte from claim 1. For purposes of examination, it is being interpreted as referring to the target analyte from claim 1.
Further regarding claim 13, the claim recites the limitation “a concentration” in line 3. It is unclear if this is meant to refer to the concentration of target analyte from claim 1, lines 9-10, or a different concentration. If it is meant to refer to the concentration of the target analyte from claim 1, it needs to refer back to it. If it is meant to refer to a different concentration, it needs to be distinguished from the concentration of target analyte from claim 1. For purposes of examination, it is being interpreted as referring to the concentration of target analyte from claim 1.
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.
Claims 1-13, 16-19, 22-24, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heikenfeld (US 20180353748).
Regarding independent claim 1, Heikenfeld teaches a device (Abstract: “A device for sensing biofluid”) comprising:
at least one substrate ([0066]: “The device 100 includes polymer substrates 110”) that defines a microfluidic feature ([0057]: “A wicking collector can be a microfluidic component”) having a defined volume ([0067]: “The microreplicated polymer 114 contains a network or grid of biofluid wicking channels or pathways that collects biofluid from the skin”; [0009]: “the device area is 1 cm.sup.2 and a volume to be filled of 1 μL”);
at least one electrochemical aptamer sensor carried by the substrate ([0075]: “the sensor 124 is an electrochemical aptamer sensor”) and in fluid communication with the defined volume of the microfluidic feature ([0070]: “the wicking collector 136 has a wicking pressure greater than or equal to that of wicking pump 138 to ensure adequate wicking pressure by the wicking collector 136 and to maintain sufficient biofluid sample contact with the sensors … the device 100 may be configured with a wicking pump 138 that is in fluid communication with the wicking collector”), the at least one electrochemical aptamer sensor comprising at least one electrode ([0065]: “sensors require two or more electrodes”) and a plurality of aptamers associated with the at least one electrode ([0060]: “a sensor may be configured with a wicking surface or material that functions without a wicking coupler (e.g., an immobilized aptamer layer which is hydrophilic”; [0088]: “a sensor with an area of about 0.001 cm.sup.2 (about 300 μm×300 μm) with 5E12 aptamer probes/cm.sup.2”);
wherein the defined volume in µL is equal to C * the surface area of the electrode area in cm2 that is associated with the plurality of aptamers / concentration of target analyte in µM, and wherein C has a value chosen from less than 4, less than 0.4, less than 0.04, and less than 0.004 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”; [0009]: “the device area is 1 cm.sup.2 and a volume to be filled of 1 μL”. To determine concentration of the target analyte in µM in the defined volume, the concentration can be determined for 1 µL of the sample fluid (a volume of 14.1 nL with a concentration of 100 nM of cortisol (the analyte)), which is a concentration of 0.00141 µM of target analyte in the defined volume. Therefore, plugging in the known values (defined volume = 1 µL, surface area of the electrode = 0.1
c
m
2
, and the concentration of target analyte = 0.00141 µM, the C value is determined to be C = 0.0141, which is less than 0.04.).
Regarding claim 2, Heikenfeld teaches the device of claim 1, wherein the sample fluid has a volume in µL, that is equal to C * the surface area of the electrode area in cm2 that is associated with the plurality of aptamers / concentration of target analyte in µL, and wherein C has a value chosen from less than 4, less than 0.4, less than 0.04, and less than 0.004 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”. In light of the 112(b) rejection interpreting the concentration of target analyte meaning to be measured in µM, plugging in the known values (sample fluid volume = 14.1 nL, or 0.0141 µL, concentration of target analyte = 100 nM, or 0.1 µM, and the surface area of the electrode = 0.1
c
m
2
), the C value is determined to be C = 0.0141, which is less than 0.4.).
Regarding claim 3, Heikenfeld teaches the device of claim 1, wherein the at least one electrochemical aptamer sensor includes a plurality of aptamers on the at least one electrode at an aptamer density of >5E9/cm2, and wherein the at least one electrode has a surface area for association with the plurality of aptamers, the surface area being chosen from a surface area less than 0.5cm2, a surface area less than 0.05cm2, a surface area less than 0.005cm2, and a surface area less than 0.0005cm2 ([0088]: “a sensor with an area of about 0.001 cm.sup.2 (about 300 μm×300 μm) with 5E12 aptamer probes/cm.sup.2, which is 5E9 probes or about 8E-15 moles of probe.”).
Regarding claim 4, Heikenfeld teaches the device of claim 1, wherein the electrochemical aptamer sensor is physically continuous or connected and includes areas within the perimeter of the sensor that are not in contact with the sample fluid when sample fluid is present in the defined volume (Fig. 1A, reference character 124), such that a ratio of sensor area to substrate area is at least one of less than 0.3, less than 0.1, less than 0.03, less than 0.01, less than 0.003, less than 0.001 ( [0009]: “the device area is 1 cm.sup.2”; [0088]: “a sensor with an area of about 0.001 cm.sup.2 (about 300 μm×300 μm) with 5E12 aptamer probes/cm.sup.2”. The sensor area is 0.001
c
m
2
and the substrate area is 1
c
m
2
, therefore the ratio is 0.001, which is less than 0.003.).
Regarding claim 5, Heikenfeld teaches the device of claim 1, wherein the defined volume has a total volume (Vd) and wherein a subset (Vs) of that volume is adjacent to the electrode, and wherein Vs is definable geometrically by being the volume that is equidistant from the electrode (Figure 1A, Vs is the volume in the wicking collector adjacent to the aptamer sensor (124).), and wherein Vs has a value that is chosen from greater than 2% of Vd, greater than 5% of Vd, greater than 10% of Vd, greater than 20% of Vd, and greater than 50% of Vd ([0088]: “Exemplary sensor areas include less than 0.001 mm.sup.2, less than 0.01 mm.sup.2, less than 0.1 mm.sup.2, or less than 1 mm.sup.2.”. This illustrates that the sensor size can change, which can change the value of Vs and create the percentages of this limitation, therefore it teaches on this limitation).
Regarding claim 6, Heikenfeld teaches the device of claim 1, wherein the microfluidic feature has an interior space having the defined volume, the interior space including at least a first dimension ([0071]: “the wicking collector 136 may be comprised of a 5 μm thick layer”) and a second dimension ([0071]: “a wicking space between the wicking collector 136 and the skin 12 with an average height of 50 μm due to skin roughness”), said first dimension and said second dimension being chosen from height, width, depth, and diameter (thickness (depth) and height), wherein the first dimension is measured at a location that does not intersect the at least one electrode, and the second dimension is measured at a location that does intersect the at least one electrode (Figure 1A, wicking collector 136 does not include the electrode), and wherein the first dimension is less than 50 µm ([0071]: “the wicking collector 136 may be comprised of a 5 μm thick layer”) and the second dimension is chosen from greater than 50 µm, greater than 100 µm, greater than 200 µm, greater than 500 µm, or greater than 1000 µm ([0071]: “a wicking space between the wicking collector 136 and the skin 12 with an average height of 50 μm due to skin roughness”).
Regarding claim 7, Heikenfeld teaches the device of claim 1, wherein the device has less than 80% analyte depletion ([0088]: “the analyte will not be depleted in the sample”) with a sample volume chosen from less than 30 µL, less than 10 µL, less than 1 µL, less than 0.1 µL, and less than 0.01 µL ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 0.1 µL).
Regarding claim 8, Heikenfeld teaches the device of claim 1, wherein the device has less than 20% analyte depletion ([0088]: “the analyte will not be depleted in the sample”) with a sample volume chosen from less than 30 µL, less than 10 µL, less than 1 µL, less than 0.1 µL, and less than 0.01 µL ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 0.1 µL).
Regarding claim 9, Heikenfeld teaches the device of claim 1, wherein the device has less than 10% analyte depletion ([0088]: “the analyte will not be depleted in the sample”) with a sample volume chosen from less than 30 µL, less than 10 µL, less than 1 µL, less than 0.1 µL, and less than 0.01 µL ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 0.1 µL).
Regarding claim 10, Heikenfeld teaches the device of claim 1, wherein the device has less than 5% analyte depletion ([0088]: “the analyte will not be depleted in the sample”) with a sample volume chosen from less than less than 30 µL, 10 µL, less than 1 µL, less than 0.1 µL, and less than 0.01 µL ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 0.1 µL).
Regarding claim 11, Heikenfeld teaches the device of claim 1, wherein the device is able to measure an analyte in less than 30 µL of the sample fluid and with less than 50% analyte depletion ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”; [0088]: “the analyte will not be depleted in the sample”. 14 nL is 0.0141 µL, therefore less than 30 µL), wherein the analyte has a concentration that is chosen from less than 100 nM, less than 10 nM, less than 1 nM, less than 100 pM, and less than 10 pM ([0088]: “assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”).
Regarding claim 12, Heikenfeld teaches the device of claim 1, wherein the device is able to measure an analyte in less than 5 µL of the sample fluid and with less than 50% analyte depletion ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”; [0088]: “the analyte will not be depleted in the sample”. 14 nL is 0.0141 µL, therefore less than 5 µL), wherein the analyte has a concentration that is chosen from less than 100 nM, less than 10 nM, less than 1 nM, less than 100 pM, and less than 10 pM ([0088]: “assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”).
Regarding claim 13, Heikenfeld teaches the device of claim 1, wherein the device is able to measure an analyte in less than 1 µL of the sample fluid and with less than 50% analyte depletion ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”; [0088]: “the analyte will not be depleted in the sample”. 14 nL is 0.0141 µL, therefore less than 1 µL), wherein the analyte has a concentration that is chosen from less than 100 nM, less than 10 nM, less than 1 nM, less than 100 pM, and less than 10 pM ([0088]: “assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”).
Regarding claim 16, Heikenfeld teaches the device of claim 1, wherein the defined volume is filled with less than 10 µL of the sample fluid ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 10 µL).
Regarding claim 17, Heikenfeld teaches the device of claim 1, wherein the defined volume is filled with less than 3 µL of the sample fluid ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 3 µL).
Regarding claim 18, Heikenfeld teaches the device of claim 1, wherein the defined volume is filled with less than 1 µL of the sample fluid ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 1 µL).
Regarding claim 19, Heikenfeld teaches the device of claim 1, wherein the defined volume is filled with less than 0.3 µL of the sample fluid ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 0.3 µL).
Regarding claim 22, Heikenfeld teaches the device of claim 1, wherein the device is a microneedle test device ([0038]: “a microneedle is a pre-existing pathway if the microneedle uses reverse iontophoresis for analyte extraction”).
Regarding independent claim 23, Heikenfeld teaches a device (Abstract: “A device for sensing biofluid”) comprising:
at least one substrate ([0066]: “The device 100 includes polymer substrates 110”) that defines a microfluidic feature ([0057]: “A wicking collector can be a microfluidic component”) having a defined volume ([0067]: “The microreplicated polymer 114 contains a network or grid of biofluid wicking channels or pathways that collects biofluid from the skin”; [0009]: “the device area is 1 cm.sup.2 and a volume to be filled of 1 μL”));
at least one electrochemical aptamer sensor carried by the substrate ([0075]: “the sensor 124 is an electrochemical aptamer sensor”) and in fluid communication with the defined volume of the microfluidic feature ([0070]: “the wicking collector 136 has a wicking pressure greater than or equal to that of wicking pump 138 to ensure adequate wicking pressure by the wicking collector 136 and to maintain sufficient biofluid sample contact with the sensors … the device 100 may be configured with a wicking pump 138 that is in fluid communication with the wicking collector”), the at least one electrochemical aptamer sensor comprising at least one electrode ([0065]: “sensors require two or more electrodes”)and a plurality of aptamers associated with the at least one electrode ([0060]: “a sensor may be configured with a wicking surface or material that functions without a wicking coupler”);
wherein the defined volume is capable of containing a sample fluid ([0066]: “The device 100 may be configured or implemented to work with a biofluid”), wherein the sample fluid has a volume in µL that is equal to C * the surface area of the electrode area in cm2 that is associated with the plurality of aptamers / concentration of target analyte in µM, and wherein C has a value chosen from less than 4, less than 0.4, less than 0.04, and less than 0.004 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.” Plugging in the known values (sample fluid volume = 14.1 nL, or 0.0141 µL, concentration of target analyte = 100 nM, or 0.1 µM, and the surface area of the electrode = 0.1
c
m
2
), the C value is determined to be C = 0.0141, which is less than 0.4.).
Regarding independent claim 24, Heikenfeld teaches a method ([0022]: “various methods for integration of volume reducing components, sensors, chemical delivery components, and reverse iontophoresis components are provided.”) comprising:
bringing a sample fluid potentially including a target analyte into proximity with an electrochemical aptamer sensor ([0075]: “the sensor 124 is an electrochemical aptamer sensor”; [0070]: “the wicking collector 136 has a wicking pressure greater than or equal to that of wicking pump 138 to ensure adequate wicking pressure by the wicking collector 136 and to maintain sufficient biofluid sample contact with the sensors … the device 100 may be configured with a wicking pump 138 that is in fluid communication with the wicking collector”) comprising at least one electrode ([0065]: “sensors require two or more electrodes”) and a plurality of aptamers associated with the at least one electrode ([0060]: “a sensor may be configured with a wicking surface or material that functions without a wicking coupler”);
wherein the volume of the sample fluid in µL is equal to C * the surface area of the electrode in cm2 that is associated with the plurality of aptamers / concentration of the target analyte in µM; and wherein C has a value chosen from less than 4, less than 0.4, less than 0.04, and less than 0.004 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.” Plugging in the known values (sample fluid volume = 14.1 nL, or 0.0141 µL, concentration of target analyte = 100 nM, or 0.1 µM, and the surface area of the electrode = 0.1
c
m
2
), the C value is determined to be C = 0.0141, which is less than 0.4.).
Regarding claim 27, Heikenfeld teaches the method of claim 24, wherein bringing the sample fluid into proximity with the electrochemical aptamer sensor further comprises bringing less than 30 µL of the sample fluid into proximity with the electrochemical aptamer sensor ([0088]: “Now, assume for 14.1 nL of solution that flows past the sensors”. 14 nL is 0.0141 µL, therefore less than 30 µL).
Regarding claim 28, Heikenfeld teaches the method of claim 24, wherein bringing the sample fluid into proximity with the electrochemical aptamer sensor further comprises delivering the sample fluid into a defined volume of a microfluidic feature of a device ([0057]: “A wicking collector can be a microfluidic component”), the defined volume of the microfluidic feature being in fluid communication with the electrochemical aptamer sensor ([0070]: “the wicking collector 136 has a wicking pressure greater than or equal to that of wicking pump 138 to ensure adequate wicking pressure by the wicking collector 136 and to maintain sufficient biofluid sample contact with the sensors … the device 100 may be configured with a wicking pump 138 that is in fluid communication with the wicking collector”).
Regarding claim 29, Heikenfeld teaches the method of claim 28, further comprising bringing at least one microneedle associated with the device into contact with the epidermis, dermis, hypodermis, blood vessel, or capillary of a subject ([0038]: ““pre-existing pathways” refer to pores, pathways, or routes through skin through which interstitial fluid may be extracted.”), the at least one microneedle including a lumen in fluid communication with the microfluidic feature to deliver the sample fluid from the subject to the defined volume of the microfluidic feature ([0038]: “a microneedle is a pre-existing pathway if the microneedle uses reverse iontophoresis for analyte extraction”).
Claim Rejections - 35 USC § 103
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld as applied to claim 1 above, and further in view of Buck (US 2019025457).
Regarding claim 14, Heikenfeld teaches the device of claim 1, wherein the at least one electrode of the sensor is one of a plurality of electrodes of the sensor ([0065]: “sensors require two or more electrodes”), the plurality of electrodes being comprised of at least a working electrode and a counter electrode (Abstract: “The device further includes an iontophoresis electrode and a counter electrode”).
However, Heikenfeld does not teach the electrodes being interdigitated.
Buck discloses an electrochemical sensor. Specifically, Buck teaches the working electrode and counter electrode that are interdigitated ([0038]: “The working and counter electrodes 34 and 36 of sensor 20 depicted in FIGS. 1A and 1B each have multiple exposed electrode areas. These areas are formed in part by the conductive portion of the electrodes as shown in FIG. 1B, in which the counter electrode 34 includes several counter electrode segments 40 that are interdigitated with similar working electrode segments”). Heikenfeld and Buck are analogous arts as they are both sensors used to analyze analytes in a biofluid.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the electrodes being interdigitated from Buck into the device from Heikenfeld as it allows the electrodes to pick up more signals, making the measurement more accurate.
Claims 15, 21, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld as applied to claims 1 and 28 above, and further in view of Scott (US 20190274598).
Regarding claim 15, Heikenfeld teaches the device of claim 1, wherein the at least one electrode of the sensor is one of a plurality of electrodes of the sensor ([0065]: “sensors require two or more electrodes”), the plurality of electrodes being comprised of at least a working electrode and a counter electrode (Abstract: “The device further includes an iontophoresis electrode and a counter electrode”).
However, Heikenfeld does not teach the electrodes being coplanar.
Scott discloses a system to calibrate a medical device. Specifically, Scott teaches the working electrode and counter electrode that are coplanar ([0262]: “These coplanar electrodes include a counter electrode or a counter/reference electrode 1631 disposed in wrap-around configuration with reference to the working electrode 1632”). Heikenfeld and Scott are analogous arts as they are both sensors used to analyze analytes in a biofluid.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the electrodes being coplanar from Scott into the device from Heikenfeld as it allows the electrodes to measure different parameters that can be important in analysis, which can provide more information to the device and allow for an accurate result.
Regarding claim 21, Heikenfeld teaches the device of claim 1, wherein the device is a test strip ([0109]: “the wicking collector is negligible in volume or in impacting sampling interval (e.g., a thin strip leading over 50 μm wide sensors”).
However, Heikenfeld does not disclose that the device is measuring blood.
Scott teaches that the device measures blood ([0083]: “The sensor may be, for example, positionable through an exterior skin surface of a user for the continuous or periodic monitoring (periodic according to a regular interval, an irregular interval, a schedule, frequent repeats, etc.) of a level of an analyte in the user's bodily fluid (e.g., interstitial fluid, subcutaneous fluid, dermal fluid, blood … The sensor response may be correlated and/or converted to analyte levels in blood or other fluid”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include that the device measures blood from Scott into the device from Heikenfeld as it allows the device to monitor the blood of the user and analyze the analyte concentration in the blood, which can provide important health information to the user.
Regarding claim 30, Heikenfeld teaches the method of claim 28, further comprising placing a sample onto a material of the device in order for at least a portion of the blood sample to be transported into the defined volume of the microfluidic feature ([0038]: “a microneedle is a pre-existing pathway if the microneedle uses reverse iontophoresis for analyte extraction”, Fig. 1A).
However, Heikenfeld does not disclose that the device is measuring blood.
Scott teaches that the device measures blood ([0083]: “The sensor may be, for example, positionable through an exterior skin surface of a user for the continuous or periodic monitoring (periodic according to a regular interval, an irregular interval, a schedule, frequent repeats, etc.) of a level of an analyte in the user's bodily fluid (e.g., interstitial fluid, subcutaneous fluid, dermal fluid, blood … The sensor response may be correlated and/or converted to analyte levels in blood or other fluid”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include that the device measures blood from Scott into the method from Heikenfeld as it allows the method to monitor the blood of the user and analyze the analyte concentration in the blood, which can provide important health information to the user.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld as applied to claim 1 above, and further in view of Jing (“A Review of Methods for Measuring Aptamer-ProteinEquilibria”)(previously cited).
Regarding claim 20, Heikenfeld teaches the device of claim 1, wherein the plurality of aptamers is a solute in solution ([0060]: “a sensor may be configured with a wicking surface or material that functions without a wicking coupler (e.g., an immobilized aptamer layer which is hydrophilic, or polymer ionophore layer which is porous to the analyte)”).
However, Heikenfeld is silent on the aptamer concentration.
Jing discloses methods that use aptamers in analysis. Specifically, Jing teaches the concentration of the plurality of aptamers in the solution is chosen from less than 50%, less than 20%, less than 10%, less than 5%, less than 2%, and less than 1% of the analyte concentration in solution (Page 4: “If the aptamer is smaller than the target and the corresponding complex, only the aptamer can cross the membrane to the other compartment. Note that this method is only applicable in cases where the target is significantly larger than the aptamer.”. This includes the percentages stated.). Heikenfeld and Jing are analogous arts as they both use aptamers for measuring capabilities.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the aptamer concentration from Jing in the device from Heikenfeld as Heikenfeld is silent on the aptamer concentration, and Jing provides a suitable aptamer concentration in an analogous art.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld as applied to claim 24 above, and further in view of Wang (WO 2009097466).
Regarding claim 25, Heikenfeld teaches the method of claim 24.
However, Heikenfeld does not teach wherein at least one redox couple is associated with said aptamers, the method further comprising measuring an initial electrical current between the at least one electrode and the at least one redox couple.
Wang discloses an electrochemical sensor. Specifically, Wang teaches wherein at least one redox couple is associated with said aptamers, the method further comprising measuring an initial electrical current between the at least one electrode and the at least one redox couple ([0070]: “Said reagent layer functions to act on the analyte of interest in the biological sample to provide a signal (proportional to the concentration of analyte) which translates to an electrical current in the electrode tracks. In one embodiment, said reagent layer 34 spans the whole width of the electrode strip covering all electrode tracks. A redox mediator may also be used as the reference redox couple for the reference electrode 18”). Heikenfeld and Wang are analogous arts as they are both sensors used to measure parameters of a biofluid.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the redox couple from Wang into the method from Heikenfeld as it allows the method to have a more detailed structure for analysis, which can provide the method with more information and produce a more accurate result to the user.
Regarding claim 25, the Heikenfeld/Wang combination teaches the method of claim 25, further comprising detecting and/or measuring a change from the initial electrical current between the at least one electrode and the at least one redox couple following bringing the sample fluid into proximity with the electrochemical aptamer sensor (Wang, [0057]: “an aspect of the invention is a device that measures the conductivity of sample and control or standard solutions and automatically discriminates between control and sample solutions based on the difference in conductivity measured between sample and control.”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended the claims to overcome the claim objections and 112(b) rejections, however the amendments have introduced new objections and 112(b) rejections.
Applicant's arguments with regards to the 102 and 130 rejections have been fully considered but they are not persuasive. Applicant argues that Heikenfeld does not teach the defined volume of an area used to receive and hold sample volume, however as described in the 102 rejection above, Heikenfeld discloses this limitation for claim 1 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”; [0009]: “the device area is 1 cm.sup.2 and a volume to be filled of 1 μL”. To determine concentration of the target analyte in µM in the defined volume, the concentration can be determined for 1 µL of the sample fluid (a volume of 14.1 nL with a concentration of 100 nM of cortisol (the analyte)), which is a concentration of 0.00141 µM of target analyte in the defined volume. Therefore, plugging in the known values (defined volume = 1 µL, surface area of the electrode = 0.1
c
m
2
, and the concentration of target analyte = 0.00141 µM, the C value is determined to be C = 0.0141, which is less than 0.04.), as well as the volume of the sample fluid in claims 23 and 24 ([0086]: “the electrode 150 is in contact with the wicking collector 136, which is electrically conductive because it is filled with sweat, that has an electrical contact area with skin that is less than 0.1 cm.sup.2.”; [0088]: “Now, assume for 14.1 nL of solution that flows past the sensors includes 100 nM of cortisol.”. In light of the 112(b) rejection interpreting the concentration of target analyte meaning to be measured in µM, plugging in the known values (sample fluid volume = 14.1 nL, or 0.0141 µL, concentration of target analyte = 100 nM, or 0.1 µM, and the surface area of the electrode = 0.1
c
m
2
), the C value is determined to be C = 0.0141, which is less than 0.4.).
For these reasons, the rejection of claim 1 is proper.
The rejection of claims 23 and 24 are proper for similar and/or analogous reasons.
The rejection of the claims dependent from claims 1 and 24 are proper because the rejection of claims 1 and 24 are proper and the prior art teaches or suggests the features of these claims.
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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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