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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March has been entered.
Status of Objections and Rejections
All rejections under 35 U.S.C. 112 from the previous office action are withdrawn in view of Applicant’s amendment.
Other rejections under 35 U.S.C. 103 from the previous office action 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) 1-5, 7-10, and 12-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin (US 2019/0017954) in view of Doris (US 2023/0097591), supported by Johnson (US 2017/0226037) as evidence for claim 3 and Kozulic (US 5,319,046) for claim 21.
Regarding claim 1, Shin teaches a system (Fig. 1; ¶34: a biosensor provided as a single-step ELISA system 100) comprising:
a sensing assembly (Fig. 1: system 100) comprising:
a sensing element comprising a sensing surface (Fig. 1; ¶35: upper surface 148 of the electrode 140), a capture species (Fig. 1; ¶46: the capture agent 166 attached/bound to the upper surface 148) configured to specifically bind with a portion of an analyte in a sample provided on the sensing surface (¶41: the capture agent 166 is any molecule and/or compound that immobilizes the target substance 158; the binding portion of the target substance 158 is deemed to be the recited portion), and at least one measurement electrode (Fig. 1; ¶35: a first electrode 140, i.e., the bottom electrode; the system includes any suitable number of the electrodes 140) configured to provide a measurement signal (¶66: detecting an output signal of the detection agent 170); and
a modification unit comprising a set of modification electrodes with at least a first modification electrode (Fig. 1; ¶35: a second electrode 144, i.e., the side electrode) provided adjacent or on the sensing element (Fig. 1: indicating electrode 144 is adjacent to the electrode 140), wherein the set of modification electrodes is configured to modify a property of at least a portion of the sample received on the sensing surface in a region adjacent the sensing surface (¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144; ¶48: modulating the pH of only a select portion of the reagent solution 150, e.g., the portion of the reagent solution 150 located below the modulation line 184), and
a control unit (Fig. 1; ¶34: controller 132) comprising one or more microprocessors (Fig. 1; ¶50: the controller 132 is provided as at least one microcontroller and/or microprocessor) programmed using software (¶50: to execute the software).
Shin further discloses the controller is configured to modulate a pH of a portion of the reagent solution in which the bound detection agent is located using the electrode, and the modulated pH causing changes of the pH-sensitive donor molecule and the acceptor molecule, which are used to detect the presence and/or concentration of the target substance (¶9). The detection agent is configured to form a complex with the target substance, and forming a complex includes absorbing, linking, and/or otherwise binding to the target substance (¶44). Shin does not explicitly disclose the microprocessors being programmed to (i) switch the modification unit between a measurement configuration and a debinding configuration, and (ii) determine a property of the analyte based on a parameter relating to a change in the measurement signal during a switch from the measurement configuration to the debinding configuration, wherein the measurement configuration modifies the property of at least the portion of the sample received on the sensing surface in the region adjacent the sensing surface such that binding between the capture species and the analyte is promoted, and wherein the debinding configuration modifies the property of at least the portion of the sample received on the sensing surface in the region adjacent the sensing surface such that disassociation between the capture species and the analyte is promoted.
However, Doris teaches affinity sensors may exhibit advantaged regeneration behavior when pH is changed in proximity to a sensing element, which comprise at least one sensing element comprising a recognition moiety that interacts with an analyte by reversibly forming an analyte complex ([Abstract]). By locally altering pH in proximity to a sensing element capable of forming an analyte complex, the recognition moiety associated with the sensing element and/or the analyte itself may experience one or more changes, which may alter the rate at which the recognition moiety releases an analyte bound in an analyte complex (¶14). Formation of the analyte complex is pH-dependent, and the at least one sensing element provides a signal that changes when the analyte complex reversibly forms (¶17). A change in magnitude of the signal is correlatable to an amount of analyte interacted with the at least one sensing element (¶17). Here, the interaction between the analyte and the sensing element are between the two configuration of bound analytes and the unbound analytes. Doris further discloses the change in magnitude of the signal between the first state and the second state may be correlated to the amount of analyte that is interacted with the sensing element (¶52). Thus, Doris teaches switching the modification unit between a measurement configuration and a debinding configuration ([Abstract]: pH changed in proximity to a sensing element; ¶17: the formation of the analyte complex is pH-dependent) and determining a property of the analyte based on a parameter relating to a change in the measurement signal during a switch from the measurement configuration to the debinding configuration (¶¶17, 52). Here, Doris teaches the affinity sensor is regenerated by actuating the working electrode to promote analyte decomplexation (¶36). Once a sufficient amount of decomplexation has taken place, further measurements of the analyte may be conducted, like determination of the analyte concentration (¶36).
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 Shin by activating the modification unit to switch the measurement configuration and debinding configuration and determine the property of the analyte during the switch as taught by Doris because the detection are pH-sensitive (Shin, ¶65) and the reversible binding as the analyte complex would undergo the binding and debinding between the capture species and the analyte, which provide a signal that changes when the analyte complex reversibly forms, e.g., from the measurement configuration to the debinding configuration, and the change in magnitude of the signal is correlatable to the amount of the analyte interacted with the sensing element (Doris, [Abstract], ¶¶17, 52). 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).
Further, the designation “wherein the measurement configuration modifies the property of at least the portion of the sample received on the sensing surface in the region adjacent the sensing surface such that binding between the capture species and the analyte is promoted, and wherein the debinding configuration modifies the property of at least the portion of the sample received on the sensing surface in the region adjacent the sensing surface such that disassociation between the capture species and the analyte is promoted” is deemed to be functional limitation in apparatus claims regarding intended result. 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, Shin in view of Doris teaches all structural limitations of the presently claimed sensor assembly, including the modification unit adjusting pH and measuring a signal during the switch from the measurement configuration to the debinding configuration, and thus it is capable of modifying the property of the sample adjacent the sensing surface, such that binding is promoted at the measurement configuration and disassociation is promoted during the debinding configuration.
Regarding claim 2, Shin teaches wherein the property of at least the portion of the sample is pH (¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144).
Regarding claim 3, Shin teaches wherein the modification unit (Fig. 1: electrode 144) is configured to actuate the set of modification electrodes to modify the property of at least the portion of the sample (¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144) received on the sensing surface in the region adjacent the sensing surface (¶48: modulating the pH of only a select portion of the reagent solution 150, e.g., the portion of the reagent solution 150 located below the modulation line 184) so as to modify a binding relationship between the capture species and the analyte (as evidenced by Johnson, ¶266: the variation of the local pH at the electrode, and in particular in the vicinity of the biomolecular probe allows for modulating the binding efficiency of the biomolecular probe and an analyte to be tested).
Further, the designation “so as to modify a binding relationship between the capture species and the analyte” is deemed to be functional limitation in apparatus claims regarding intended result. 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, Shin teaches all structural limitations of the presently claimed sensor assembly, including the modification unit adjusting pH, and thus it is capable of modifying a binding relationship between the capture species and the analyte.
Regarding claim 4, Shin in view of Doris discloses all limitations of claim 3, but fails to teach wherein the binding relationship modified by the modification unit is selected from at least one of a rate of binding between the capture species and the analyte (Kon), the rate of debinding between the capture species and the analyte (Koff), and/or the binding affinity (KD).
However, Doris teaches affinity sensors may exhibit advantaged regeneration behavior when pH is changed in proximity to a sensing element, which comprise at least one sensing element comprising a recognition moiety that interacts with an analyte by reversibly forming an analyte complex ([Abstract]). By locally altering pH in proximity to a sensing element capable of forming an analyte complex, the recognition moiety associated with the sensing element and/or the analyte itself may experience one or more changes, which may alter the rate at which the recognition moiety releases an analyte bound in an analyte complex (¶14). Thus, Doris teaches the local pH alteration would modify the binding relationship, e.g., the rate of debinding between the capture species and the analyte (Koff).
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 Shin by modifying the rate of debinding between the capture species and the analyte (Koff) as taught by Doris because the debinding rate would be caused by pH alteration in proximity to the sensing element (Doris, ¶14)). 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).
Regarding claim 5, Shin teaches wherein the capture species comprises at least one aptamer, i.e., a peptide (¶41: capture agents 166 include peptides).
Regarding claim 7, Shin teaches wherein the modification unit is configured to actuate the set of modification electrode so as to electrolyse water within the sample and thereby modify the pH of the sample (¶57: causing an in situ oxidation and/or reduction of the portion of the reagent solution 150 located near the electrode 140 in the modulation zone 182; the oxidation and/or reduction either (i) liberates hydrogen ions (H+) which bond to water molecules of the aqueous reagent solution 150 to form hydronium cations (H3O+) that acidify the reagent solution 150 (i.e. locally decreasing the pH), or (ii) increases the concentration of hydroxide anions (OH-) that alkalize the reagent solution 150 (i.e. locally increasing the pH)).
Regarding claim 8, Shin teaches wherein the at least one measurement electrode of the sensing element defines the sensing surface (Fig. 1; ¶41: the upper surface 148 of the bottom electrode 140).
Regarding claim 9, Shin teaches the sensor assembly further comprising a substrate (Fig. 1; ¶35: a bottom surface of the well 108) on which the sensing element is provided (Fig. 1; ¶35: the electrode 140 is located on the bottom surface 136); and wherein the first modification electrode of the set of modification electrodes is provided on or in the substrate (Fig. 1: indicating the side electrode 144 is on the bottom surface 136).
Regarding claim 10, Shin teaches wherein the modification unit is configured to modify the portion of the sample received on the sensing surface in a localised region adjacent the sensing surface ( Fig. 1; ¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144; ¶48: modulating the pH of only a select portion of the reagent solution 150, i.e., the portion of the reagent solution 150 located below the modulation line 184), the localised region having a maximum distance from the sensing surface of 10 x length of the capture species (Fig. 1; ¶41: the molecules of the capture agent 166 defines an average upper level 172; ¶48: modulating the pH of only a select portion of the reagent solution 150, i.e., the portion of the reagent solution 150 located below the modulation line 184; Fig. 1: indicating the height of the modulation line 184 is less than 10 x length of the capture agent, i.e., the height of 172).
Regarding claim 12, Shin teaches wherein the control unit is further configured to operate the modification unit to actuate the set of modification electrodes (Fig. 1; ¶48: the power source 116 outputs AC or DC power to the electrode 144 through the controller 132) to modify the property of at least the portion of the sample received on the sensing surface in a region adjacent the sensing surface (¶57: the pH of the reagent solution 150 is locally modulated by exciting the electrode 144) and subsequently determine the property of the analyte (¶51: the controller 132 is configured to execute the method 300 for determining or detecting the presence of the target substance 158 in the sample 134 and/or the concentration of the target) based on the measurement signal from the sensing element (¶44: the detection agent 170 that are bound to the electrode 140; Fig. 3: 312: detect output of detection agent).
Regarding claim 13, Shin teaches a method for determining a property of an analyte in a sample (Fig. 3; ¶6: a method for detecting a presence and/or a concentration of a target substance), the method comprising:
providing a sensor assembly for determining the property of the analyte in the sample (Fig. 3: 304 – prepare test well and control well; Fig. 4: both test well and control well each includes the disclosed biosensor), the sensor assembly comprising a sensing surface (Fig. 1; ¶35: upper surface 148 of the electrode 140), a capture species (Fig. 1; ¶46: the capture agent 166 attached/bound to the upper surface 148) configured to specifically bind with a portion of the analyte provided on the sensing surface (¶41: the capture agent 166 is any molecule and/or compound that immobilizes the target substance 158), and at least one measurement electrode (Fig. 1; ¶35: a first electrode 140, i.e., the bottom electrode; the system includes any suitable number of the electrodes 140) configured to provide a measurement signal (¶66: detecting an output signal of the detection agent 170);
providing the sample to the sensing surface (¶35: the upper surface 148 of the electrode 140 is positioned to contact directly the sample 134);
modifying the property of at least a portion of the sample in a region adjacent the sensing surface (¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144; ¶48: modulating the pH of only a select portion of the reagent solution 150, i.e., the portion of the reagent solution 150 located below the modulation line 184); and
determining a property of analyte in the sample on the sensing surface based on a parameter relating to a change in the measurement signal (¶10: to detect the presence of and/or the concentration of a target substance in a test sample).
Shin further discloses the controller is configured to modulate a pH of a portion of the reagent solution in which the bound detection agent is located using the electrode, and the modulated pH causing changes of the pH-sensitive donor molecule and the acceptor molecule, which are used to detect the presence and/or concentration of the target substance (¶9). The detection agent is configured to form a complex with the target substance, and forming a complex includes absorbing, linking, and/or otherwise binding to the target substance (¶44). Shin does not explicitly disclose so as to switch from a measurement configuration in which binding between the capture species and the analyte is promoted to a debinding configuration in which dissociation between the capture species and the analyte is promoted or determining a property of analyte in the sample on the sensing surface based on the measurement signal during the switch from the measurement configuration to the debinding configuration.
However, Doris teaches affinity sensors may exhibit advantaged regeneration behavior when pH is changed in proximity to a sensing element, which comprise at least one sensing element comprising a recognition moiety that interacts with an analyte by reversibly forming an analyte complex ([Abstract]). By locally altering pH in proximity to a sensing element capable of forming an analyte complex, the recognition moiety associated with the sensing element and/or the analyte itself may experience one or more changes, which may alter the rate at which the recognition moiety releases an analyte bound in an analyte complex (¶14). Formation of the analyte complex is pH-dependent, and the at least one sensing element provides a signal that changes when the analyte complex reversibly forms (¶17). A change in magnitude of the signal is correlatable to an amount of analyte interacted with the at least one sensing element (¶17). Here, the interaction between the analyte and the sensing element are between the two configuration of bound analytes and the unbound analytes. Doris further discloses the change in magnitude of the signal between the first state and the second state may be correlated to the amount of analyte that is interacted with the sensing element (¶52). Thus, Doris teaches switching the modification unit between a measurement configuration and a debinding configuration ([Abstract]: pH changed in proximity to a sensing element; ¶17: the formation of the analyte complex is pH-dependent) and determining a property of the analyte based on a parameter relating to a change in the measurement signal during a switch from the measurement configuration to the debinding configuration (¶¶17, 52). Here, Doris teaches the affinity sensor is regenerated by actuating the working electrode to promote analyte decomplexation (¶36). Once a sufficient amount of decomplexation has taken place, further measurements of the analyte may be conducted, like determination of the analyte concentration(¶36).
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 Shin by activating the modification unit to switch the measurement configuration and debinding configuration and determine the property of the analyte during the switch as taught by Doris because the detection are pH-sensitive (Shin, ¶65) and the reversible binding as the analyte complex would undergo the binding and debinding between the capture species and the analyte, which provide a signal that changes when the analyte complex reversibly forms, e.g., from the measurement configuration to the debinding configuration, and the change in magnitude of the signal is correlatable to the amount of the analyte interacted with the sensing element (Doris, [Abstract], ¶¶17, 52). 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).
Further, the limitation “so as to switch from a measurement configuration in which binding between the capture species and the analyte is promoted to a debinding configuration in which dissociation between the capture species and the analyte is promoted” does not further limit the method as claimed because it is the intended result of the step “modifying a property of at least a portion of the sample in a region adjacent the sensing surface.” Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. In method claims, it is the overall method steps that are given patentable weight not the intended result thereof because the intended result does not materially alter the overall method. Here, this designation is not given patentable weight when it simply expresses the intended result of a process step positively recited. MPEP 2111.04.
Regarding claim 14, Shin teaches wherein modifying a property of the sample in a region adjacent the sensing surface is carried out using a modification unit comprising a set of modification electrodes with at least a first modification electrode (Fig. 1: electrode 144) provided adjacent the sensing surface (Fig. 1: indicating electrode 144 is adjacent to the upper surface 148 of electrode 140) and wherein the set of modification electrodes is configured to modify the property of at least the portion of the sample (¶38: to modulate the pH of at least a portion of the reagent solution 150 in response to an electrical signal coupled to the electrode 144).
Regarding claim 15, Shin teaches wherein the property of at least the portion of the sample in the region adjacent the sensing surface is pH of the sample (¶38: to modulate the pH of at least a portion of the reagent solution 150).
Regarding claim 16, Shin teaches wherein modifying the property of at least the portion of the sample received on the sensing surface in the region adjacent the sensing surface comprises modifying a binding relationship between the capture species and the analyte (as evidenced by Johnson, ¶266: the variation of the local pH at the electrode, and in particular in the vicinity of the biomolecular probe allows for modulating the binding efficiency of the biomolecular probe and an analyte to be tested).
Regarding claim 17, Shin discloses all limitations of claim 16, but fails to teach wherein the binding relationship modified by the modification unit is selected from at least one of a rate of binding between the capture species and the analyte (Kon), the rate of debinding between the capture species and the analyte (Koff), and/or the binding affinity (KD).
However, Doris teaches affinity sensors may exhibit advantaged regeneration behavior when pH is changed in proximity to a sensing element, which comprise at least one sensing element comprising a recognition moiety that interacts with an analyte by reversibly forming an analyte complex ([Abstract]). By locally altering pH in proximity to a sensing element capable of forming an analyte complex, the recognition moiety associated with the sensing element and/or the analyte itself may experience one or more changes, which may alter the rate at which the recognition moiety releases an analyte bound in an analyte complex (¶14). Thus, Doris teaches the local pH alteration would modify the binding relationship, e.g., the rate of debinding between the capture species and the analyte (Koff).
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 Shin by modifying the rate of debinding between the capture species and the analyte (Koff) as taught by Doris because the debinding rate would be caused by pH alteration in proximity to the sensing element (Doris, ¶14)). 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).
Regarding claim 18, Shin teaches wherein the capture species are an aptamer, i.e., a peptide (¶41: capture agents 166 include peptides).
Regarding claim 19, Shin teaches wherein modifying the property of at least the portion of the sample in the region adjacent the sensing surface comprises modifying a pH of the sample to a pH of between 6.5 and 8 (¶47: FAM appears to glow brightly to an observer when the pH of the reagent solution 150 is about 6.5 to 9.0).
Regarding claim 20, Shin teaches wherein the region adjacent the sensing surface is a localised region adjacent the sensing surface, the localised region having a maximum distance from the sensing surface of 10 x length of the capture species (Fig. 1; ¶41: the molecules of the capture agent 166 defines an average upper level 172; ¶48: modulating the pH of only a select portion of the reagent solution 150, i.e., the portion of the reagent solution 150 located below the modulation line 184; Fig. 1: indicating the height of the modulation line 184 is less than 10 x length of the capture agent, i.e., the height of 172).
Regarding claim 21, Shin teaches wherein the capture species comprises a polynucleotide (¶41: nucleic acids; here, nucleic acids are chains of polynucleotides, as evidenced by Kozulic, the term “nucleic acids” include both small and large molecules, e.g., oligonucleotides and polynucleotides, and fragments thereof (col. 3, ll. 39-41)).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Doris, and further in view of O’Sullivan (B. O’Sullivan, A simulation and experimental study of electrochemical pH control at gold interdigitated electrode arrays, Electrochimica Acta, 2021 (395), 139113, pp. 1-9).
Regarding claim 6, Shin in view of Doris discloses all limitations of claim 1, but fails to teach the set of modification electrodes are interdigitated.
However, Doris teaches the pH-modulating element may be electrochemical in nature and comprise a working element and at least one additional electrode, e.g., a counter-reference electrode or separate counter and reference electrodes (¶20). The at least one additional electrode may promote oxidation or reduction of a solvent (e.g., water) or a sample component in response to a current produced during pH modulation (¶21). Further, O’Sullivan teaches an electrode array device comprised of two combs of interdigitated electrodes were employed for in-situ pH control (p. 3, col. 1, para. 2).
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 Shin by incorporating additional electrodes into the pH-modulating element as taught by Doris because the at least one additional electrode may promote oxidation or reduction of a solvent (e.g., water) or a sample component in response to a current produced during pH modulation (¶21). Further, 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 Shin and Doris by substituting the set of modification electrodes with two interdigitated electrodes as taught by O’Sullivan because the interdigitated electrodes are alternative electrode configuration for pH modulation, and the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant amends Doris does not disclose “debinding between capture species and the analyte would provide a signal” or the signal “is correlatable to the amount of the analyte interacted with the sensing element” because the change in signal is exclusively when the analyte complex reversibly forms (Response, p. 8, last para.). Applicant asserts no disclosure that any property of an analyte that is correlatable to a signal “during a switch from the measurement configuration to the debinding configuration” (bridging para. of pp. 8-9). Applicant argues the altering the pH is made purely in the context of regenerating affinity sensors (p. 9, para. 2). These arguments are unpersuasive. Doris not only discloses regenerating the affinity sensor by actuating the working electrode to promote analyte decomplexation, but once a sufficient amount of decomplexation has taken place, further measurements of the analyte may be conducted (Doris, ¶36). Applicant fails to consider the mechanism of “further measurement” (see Response, p. 10, para. 2). Doris discloses since the formation of the analyte complex is pH-dependent, and the at least one sensing element provides a signal that changes when the analyte complex reversibly forms, the change in magnitude of the signal is correlatable to an amount of analyte interacted with the at least one sensing element (¶17). Applicant asserts the signal is used solely to confirm regeneration, not to derive the claimed analyte property (p. 10, last para.; Doris ¶44), but fails to address Doris teaches there is a regeneration pH and a measurement pH while the affinity sensor is being continuously measured (Doris, ¶44). Doris teaches both regenerating the affinity sensor and the measurement by the affinity sensor.
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795
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