DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on February 24, 2026. Claims 1-59 are pending in the application.
Status of Objections and Rejections
All objections from the previous office action are withdrawn in view of Applicant’s amendment.
All rejections under 35 U.S.C. §112 from the previous office action are withdrawn in view of Applicant’s amendment.
All rejections under 35 U.S.C. §103 are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-15, 24-30, 32, 35, 37-39, and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand (WO 2017/189122) in view of Lin (US 2020/0196925).
Regarding claim 1, Bertrand teaches a sensing device (¶6: use EAB sensors) for sensing at least one analyte (¶6: to detect target analytes in a sweater sample) comprising:
a sensor fluid (Fig. 3: fluid inside the concentration channel 380) including a plurality of aptamers (Fig. 1; ¶33: aptamer 140; ¶55: a plurality of aptamers may be chosen to cover the concentration range), one or more aptamers of the plurality of aptamers being configured to sense an analyte in a sample fluid (Fig. 1B; ¶¶33-34: the aptamer 140 is selected to specifically interact with a target analyte 160 so that when the aptamer captures a target analyte molecule, the aptamer undergoes a conformation change that partially disrupts the first configuration and forms a configuration; accordingly, the capture of the target analyte 160 moves the redox moiety 150 into a second position relative to the electrode 130 for the square wave voltammetry SWV measurement); and
at least one isolation element retaining the plurality of aptamers in the sensor fluid (Fig. 3; ¶37: pre-sensor membrane 394, concentrating membrane 390, and post-sensor membrane 392 retaining the aptamers in the fluid inside the concentration channel 380).
Bertrand discloses the sensing elements includes and analyte capture complex 140 that has a first end covalently bonded to a sulfur molecule (thiol) 120, which is in turn covalently bonded to a gold electrode base 130 (Fig. 1; ¶33), and fails to teach wherein the plurality of aptamers configured to freely diffuse in the sensor fluid.
However, Lin teaches a microdevice for monitoring a target analyte, including a field effect transistor and a microfluidic channel including graphene ([Abstract]). The aptameric graphene nanosensing integrates aptamer-based selective analyte enrichment, and then the sample target was released into a free aptamer solution for binding of the free aptamer to the standard target on graphene via competitive binding, thus changing the graphene conductance (¶109). The mixture of the free aptamer and released sample AVP was incubated with graphene functionalized with standard AVP (Fig. 38D), inducing the binding of the free aptamer to the standard AVP on graphene via competitive binding (Fig. 38E), thus changing the graphene conductance (¶454).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand by employing free aptamers in the sensor fluid for sensing as taught by Lin because it is a suitable detection method based on aptameric nanosensing due to specific binding between the aptamer and the analyte. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Examiner notes here that the designation “configured to freely diffuse in the sensor fluid” is functional limitation in apparatus claims rather than a structural limitation. MPEP 2114 (II). It is suggested to recite the plurality of aptamers as free, i.e., not immobilized on the electrode or somewhere else, in the sensor fluid.
Regarding claim 2, Betrand teaches wherein the at least one isolation element is a membrane (Fig. 3; ¶37: pre-sensor membrane 394, concentrating membrane 390, and post-sensor membrane 392).
Regarding claim 3, Betrand teaches wherein the one or more aptamers of the plurality of aptamers are configured to measure the analyte electrochemically (¶31) and the one or more aptamers each includes at least one redox tag (Fig. 1; ¶33: redox moiety 150) and the device includes at least one electrode (Fig. 1; ¶33: gold electrode base 130).
Regarding claim 5, Betrand teaches wherein the device further comprising a reservoir fluid that is in fluidic communication with the sensor fluid (Fig. 2; ¶35: a pump 230, which facilitates wicking or osmotic flow of the sweat sample to, across, and away from the sensors, and is a hydrogel, textile, salt, desiccant, or other suitable material; here the fluid would be contained in the pump 230 and thus deemed to be a reservoir fluid).
Regarding claim 6, Betrand and Lin disclose all limitations of claim 5 but fail to teach wherein a volume of reservoir fluid is at least one of 2X, 10X, 50X, 250X greater than a volume of the sensor fluid.
However, Betrand teaches the pump 330 would have a significantly greater volume than the concentration channel 380 to facilitate pH and salinity buffering of the sweat sample (¶38), rendering the volume of the reservoir fluid is a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by adjusting the volume of the reservoir fluid as recited because the volume of the reservoir fluid is a result-effective variable and can be optimized through routine experimentation to facilitate pH and salinity buffering of the sweat sample ad desired. MPEP 2144.05 (II)(B).
Regarding claim 7, the designation “wherein there is a first mass flow of aptamer through the at least one isolation element and a second mass flow of aptamer through a fluidic connection between the sensor fluid and the reservoir fluid, and the first mass flow is at least 2X, 10X, 50X, 250X less than the second mass flow” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus its isolation element is capable of having a first mass flow of aptamer through the isolation element at least 2X, 10X, 50X, 250X less than a second mass flow of aptamer through a fluidic connection between the sensor fluid and the reservoir fluid.
Regarding claim 8, the designation “wherein there is a first mass flow of analyte through the at least one isolation element and a second mass flow of analyte through a fluidic connection between the sensor fluid and the reservoir fluid, and the first mass flow is at least 2X, 10X, 50X, 250X greater than the second mass flow” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus its isolation element is capable of having a first mass flow of analyte through the isolation element at least 2X, 10X, 50X, 250X greater than a second mass flow of analyte through a fluidic connection between the sensor fluid and the reservoir fluid. Further, Betrand teaches the target analyte may be concentrated at least 10X, 100X, or 1000X higher than its original concentration in sweat (¶38).
Regarding claim 9, Betrand and Lin disclose all limitations of claim 7. Betrand does not disclose wherein the concentration of aptamer in the sensor fluid is within at least 50%, 10%, 2%, 0.4% of the concentration in the reservoir fluid.
However, Lin teaches a free aptamer solution at concentrations in the range of 0-1000 nM was incubated with the graphene nanosensor untiI Ids reached a saturated level, which was found to increase with the free aptamer concentration and saturate above 100 nM (¶457), which indicates that the aptamer concentration in the sensor fluid is at least 1% of the aptamer concentration in the reservoir fluid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Betrand and Lin by adjusting the ratio of aptamer concentration in sensor fluid and in the reservoir fluid as recited because it represents a suitable concentration ratio for the aptamer-based sensor for electrochemical detection. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 10, Betrand teaches wherein the concentration of analyte in the sensor fluid is within at least 50%, 10%, 2%, 0.4% of the concentration in the sample fluid ((¶38: the target analyte may be concentrated at least 10X, 100X, or 1000X higher than its original concentration in sweat).
Regarding claim 11, Betrand teaches wherein the membrane includes a backing material (Fig. 3; ¶37: pre-sensor membrane 394) and the backing material is facing the sample fluid (Fig. 3: pre-sensor membrane 394 facing the sample 14).
Regarding claim 12, the designation “wherein the membrane has a Deff/Δx that is greater than an amount selected from the group consisting of 5 m s-1 x 10-3, 0.5 m s-1 x 10-3, 0.05 m s-1 x 10-3, and 0.005m s-1 x 10-3” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus the membrane of the device is capable of having a Deff/Δx that is greater than an amount selected from the group consisting of 5 m s-1 x 10-3, 0.5 m s-1 x 10-3, 0.05 m s-1 x 10-3, and 0.005m s-1 x 10-3 as recited.
Regarding claim 13, Betrand and Lin disclose all limitations of claim 2. Betrand does not disclose wherein the membrane has a thickness that is less than an amount selected from the group consisting of ~ 100 nm, 1 µm, 10 µm and 100 µm thick.
However, Lin teaches the nanosensor is coated with a thin hydrogel layer which is permeable to the target analyte (¶199). The thickness of the hydrogel layer ranges from about 20-50 µm (¶201), which overlaps the claimed range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Betrand and Lin by adjusting the membrane thickness within the claimed range because they are suitable thickness of membrane of an electrochemical sensor. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 14, the designation “wherein the membrane has a change in retentivity/change in molecular weight that is greater than an amount selected from the group consisting 2X, 5X, 10X, and 20X” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus the membrane of the device is capable of having a change in retentivity/change in molecular weight that is greater than an amount selected from the group consisting 2X, 5X, 10X, and 20X as recited.
Regarding claim 15, the designation “wherein the device is configured to retain 90% of the initial aptamer concentration in the sensor fluid for a period of time selected from the group consisting of >16 months, >8 months, >4 months, >2 months, >1 month, >2 weeks, and >1 week” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus it is capable of retaining 90% of the initial aptamer concentration in the sensor fluid for a period of time as recited.
Regarding claims 24-25, the designation “wherein the analyte is a small molecule of molecular weight less than 1000 Da” in claim 24 and “wherein the analyte is a protein” in claim 25 are directed to a material or article worked upon. "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Young, 75 F.2d. 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). MPEP 2115.
Regarding claim 26, Betrand teaches wherein the device is a continuous sensing device (¶42: for continuous analyte monitoring).
Regarding claim 27, Betrand teaches wherein the device is a single-use device (¶4: for a single use).
Further, the designation “wherein the device is a single-use device” is deemed to be functional limitation regarding the intended use in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus it is capable of being a single-use device.
Regarding claim 28, the designation “wherein the device has a lag time, and the lag time to reach 90% of a sensor response is less than at least one of 180 min, 60 min, 20 min, 5 min, 2 min” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus it is capable of reaching 90% of the sensor response is less than at least one of 180 min, 60 min, 20 min, 5 min, 2 min.
Regarding claim 29, Betrand and Lin disclose all limitations of claim 1. Betrand further discloses wherein the device further comprises a surface opposite the at least one isolation element (Fig. 3: the top surface of the pump 330 with a cover 332), the surface defining a volume housing the sensor fluid (Fig. 3: concentration channel 380).
Betrand does not disclose a distance between the surface and the at least one isolation element is at least one of less than 100 µm, 10 µm, 1 µm, 0.1 µm, 0.01 µm.
However, Lin teaches an aptamer nanosensor (Fig. 36A; ¶448: 1500) including an enrichment chamber 1505 retaining microbeads 1512 and followed by a sensing microchamber 1506 (Fig. 36A; ¶393). A weir structure 1511 of the enrichment microchamber 1505 can be from about 1/5 to about 1/20 the height of the enrichment chamber, from about 10 µm to about 70 µm (Fig. 36A; ¶403), which overlaps the recited ranges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Betrand and Lin by adjusting the height of the enrichment chamber, e.g., the distance between the top surface and the isolation of Betrand, within the claimed range because they are suitable configuration for an electrochemical sensor. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 30, Betrand teaches wherein the at least one electrode has an area and the membrane has an area, and the electrode area and membrane area have a ratio of <1 (Fig. 3: indicating the area of the electrode 324 is less than the membrane area of the membrane 390).
Regarding claim 32, Betrand teaches wherein the redox tag is configured to move within the sensor fluid, and the movement of the redox tag results is a change of electron transfer between the redox tag and the at least one electrode (Fig. 1; ¶34: when the aptamer captures a target analyte molecule, the aptamer undergoes a conformation change and accordingly moves the redox moiety 150 relative to the electrode 130, producing a second electrical signal that is distinguishable from the first electrical signal).
Regarding claim 35, Betrand teaches wherein the aptamer is a folded aptamer (Fig. 1: indicating a folded aptamer 140).
Regarding claim 37, the designation “wherein the membrane has a Deff/Δx of between 5 m s-1 x 10-3 and 0.005 m s-1 x 10-3” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus the membrane of the device is capable of having a Deff/Δx of between 5 m s-1 x 10-3 and 0.005 m s-1 x 10-3 as recited.
Regarding claim 38, the designation “wherein the membrane has a Deff/Δx that is at least 0.005 m s-1 x 10-3” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus the membrane of the device is capable of having a Deff/Δx that is at least 0.005 m s-1 x 10-3 as recited.
Regarding claim 39, the designation “wherein the device is configured to measure 90% of the sample fluid concentration in at least <15 min” is deemed to be functional limitation regarding the intended use in apparatus claims. MPEP 2114 (II). "[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) (emphasis in original). 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). Here, Betrand in view of Lin teaches all structural limitations of the presently claimed device and thus it is capable of measuring 90% of the sample fluid concentration in at least <15 min.
Regarding claim 59, Betrand teaches wherein the sensor fluid includes at least one passivating solute (¶38: human serum albumin, which is retained in the fluid).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Plaxco (WO2017/164982).
Regarding claim 31, Bertrand and Lin disclose all limitations of claim 3 but fail to teach wherein a passivating layer is present on the at least one electrode.
However, Plaxco teaches an EAB sensor (Fig. 1; ¶14), including a working electrode functionalized with a recognition element such as an aptamer and a redox label 104 (Fig. 1; ¶30). After the electrode surface has been functionalized with recognition and signaling constructs, additional steps may be performed to passivate exposed electrode surface sites in order to reduce non-specific interactions with sample constituents (¶40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by incorporating a passivating layer on the electrode surface as taught by Plaxco because the passivating layer would reduce non-specific interactions (¶40). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Vallee-Belisle (WO 2019/232618).
Regarding claims 33-34, Bertrand and Lin disclose all limitations of claim 1 but fail to teach wherein the plurality of aptamers comprise a plurality of signaling aptamers and a plurality of anchor aptamers (claim 33) or wherein the plurality of redox tags are bound to the plurality of signaling aptamers, but are not bound to the plurality of anchor aptamers (claim 34).
However, Vasllee-Belisle teaches detection of a target using oligonucleotides (p. 1, ll. 7-8). The device includes a receptor aptamer (SEQ ID NO: 1), a signaling DNA (SEQ ID NO: 4), and an anchoring DNA (SEQ ID NO: 8) (Fig. 3; p. 5, ll. 33-35). The redox tag is bound to the signaling DNA, but not the anchor aptamer (Fig. 3(a), p. 28, ll. 13-14: redox-labeled signaling DNA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by incorporating a plurality of signaling aptamers labeled with redox tags for electrochemical detection upon hybridization of the signaling aptamers with the anchoring aptamers because it would provide kinetically controlled detection (p. 2, ll. 5-6). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues Lin describes a microdevice that includes at least one aptamer functionalized on a surface of the graphene (Response, p. 17, last para.), which requires aptamer that is bound, either directly or indirectly, to a graphene substrate (p. 18, para. 1). This argument is unpersuasive because Lin teaches the device comprising AVP (control sample 1708) functionalized graphene and free aptamers 1707 (Fig. 38D) in the sensor fluid, and the free aptamers may bind to the target analyte 1703 or the control sample 1708 (Fig. 38E), thus the competitive binding resulting in changing the graphene conductance (¶454). Further, the magnitude of the conductance difference increases with the free aptamer solution and saturates above 100 nM (Fig. 47, ¶457). In another word, Lin teaches the device comprising a plurality of aptamers that freely diffuses in the sensor fluid, free target analyte in the sensor fluid, and immobilized control sample on the graphene. The method of detection that includes binding of the free aptamer and the immobilized control sample does not teach away using free aptamers in the device.
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 extension fee 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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/C. SUN/Primary Examiner, Art Unit 1795
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