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 .
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 1, 5, 7-9, 11-13, 15, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jina et al. (US 2009/0099427A1) in view of Voskanyan (US 2012/0046533) and Kamath et al. (US 2005/0143635).
As to claim 1, Jina et al. discloses a process for forming a wearable monitoring device (see 600/602 of Fig. 16, 0101) comprising: cutting at least one semiconductor structure to form at least one microneedle array comprising individual microneedles having a plurality of tapered surfaces (see 0017, 0019, 0022, 0050, 0053, 0110 and Fig. 19); forming sensing features of the microneedle array (see 0104), where at least one microneedle array is configured to access interstitial fluid in a user and configured for in-vivo detection a plurality of analytes in the fluid (see 0020, 0042-0043 and 0104-0108); generating signals associated with the detection of the analyte (see 0066); and coupling an electronics module (see 0101) to receive signals and analyze the signal to determine analyte information for the user (see 0101-0102). Jina et al. states the height of the needle is 250-450 microns (see 0109 of Jina et al.).
As to claim 5, Jina et al. discloses a wearable monitoring device (see 600/602 of Fig. 16, paragraph 0101) for monitoring of a user that comprises an electrochemical microsensor (see 0066 and 0090) including at least one analyte sensing microneedle array (see 0104) that’s configured to access interstitial fluid in the user and in vivo detection of analytes in the fluid (see 0020, 0042-0043 and 0104-0108) where the electrochemical microsensor is configured to generate one or more signals associated with detection of the analyte (see 0066). The device comprises multiple microneedles that have a main body having a pointed tip region defined by cut faces tapering to a point (see 0017, 0019,0110 and Fig. 19).The device further comprises an electronics module in communication with the electrochemical microsensor (see 0101) that’s configured to receive the signal and analyze the signal to determine analyte information for the user (see 0101-0102).
As to claim 15, Jina et al. discloses a wearable monitoring device (see 600/602 of Fig. 16, paragraph 0101) for monitoring of a user that comprises an microsensor (see 0066 and 0090) including at least one analyte sensing microneedle array (see 0104) that’s configured to access interstitial fluid in the user and in vivo detection of analytes in the fluid (see 0020, 0042-0043 and 0104-0108) where the microsensor is configured to generate one or more signals associated with detection of the analyte (see 0066). The device comprises multiple microneedles that have a main body having a pointed tip region defined by cut faces tapering to a point (see 0017, 0019,0110 and Fig. 19).The device further comprises an electronics module in communication with the electrochemical microsensor (see 0101) that’s configured to receive the signal and analyze the signal to determine analyte information for the user (see 0101-0102).
Jina et al. fails to disclose detection of a plurality of analytes, a multi-analyte electronics module that is configured to calibrate the monitoring device based on one or more calibration signals associated with a functional calibration material of the at least one microneedle array; after calibrating the device receiving signals to determine a first and second analyte information as required by claims 1, 5 and 15.
Voskanyan et al. discloses an electrochemical analyte sensor having a working electrode, reference electrode, and counter electrode (see 0170). Voskanyan et al. states multiple working electrodes can be used in order to increase sensor accuracy or can be used to measure multiple analytes. Voskanyan et al. states that multiple analytes such as oxygen, hydrogen peroxide, glucose, lactate, potassium etc. can be measured (see 0174).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Jina et al. to include multiple working electrodes in the electrochemical microsensor as taught by Voskanyan et al. One would have been motivated to do so since both are directed to forming biosensors for detecting an analyte by using electrochemical methods where Voskanyan et al. discloses the addition of multiple electrodes in order to detect multiple analytes which can provide the patients heath using multiple factors.
As to the calibration, Kamath et al. teaches that a continuous analyte monitoring system may be calibrated using one or more signals obtained from electrodes associated with the sensor. Kamath et al. states that these signals provide baseline and/or sensitivity information for calibration of the analyte sensor (see abstract). The sensor system comprises a working electrode (for measuring the analyte – see 0010) and additional electrodes or sensing structures that generate secondary signals (see 0057, 0064). The secondary sigma is dependent upon the electrode/material (see 0010, 0077-0080). The electrode material produces electrochemical behavior and generates signals used for baseline and sensitivity correction (calibration).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Jian et al. and Voskanyan et al. to include the calibration techniques of Kamath et al. One would have been motivated to do so since both are directed to sensing electrodes where Kamath et al. teaches an alternative calibration system that improves calibration accuracy and enhances the reliability of the continuous monitoring system.
As to claims 7 and 12, the device is configured to detect a physiological parameter (body temperature, see 0079-0082) and at least one analyte parameter (glucose 0020, 0042) and identifies/outputs health problem or health even based on the parameters (see 0079, 0081, 0101 and 0102).
As to claim 8, the concentration of the analytes is determined (see 0101 of Jina et al.).
As to claim 9, the analyte information includes presence of a biomarker (see 0098).
As to claim 11, the electrochemical sensor can monitor continuously (see 0042).
As to claims 13 and 16, the use of multiple electrodes would result in signals for different analytes and the module determining the presence based on such signals.
As to claim 18, the device is configured to detect a physiological parameter (body temperature, see 0079-0082) and at least one analyte parameter (glucose 0020, 0042) and identifies/outputs health problem or health even based on the parameters (see 0079, 0081, 0101 and 0102).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jina et al. (US 2009/0099427A1) in view of Voskanyan (US 2012/0046533) and Kamath et al. (US 2005/0143635) as applied to claim 5 above and in further view of Zander (US 2006/0264716).
The teachings of Jina et al. and Voskanyan as applied to claim 5 are as stated above.
Jina et al. modified by Voskanyan fail to teach at least one insulating layer along one or more needle bodies of the microneedle array as required by claim 3.
Zander discloses a monitoring device for monitoring blood for a patient (see abstract). The device comprises an electrochemical sensor that includes an analyte for in vivo detection in interstitial fluid (see abstract, 0017, 0019, 0022). The array comprises microneedles each having a detection portion (see 0018-0019) and a non-detection electrically insulated needle body (see 0019; silicon oxide layer applied to the sides of the microneedle). The device generates signals at the end of the needle in the user’s skin causing less irritation and cross signaling.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Jina et al. and Voskanyan to include application of the electrically insulating layer on the microneedle bodies as taught by Zander. One would have been motivated to do so since both are directed to forming sensors using microneedle arrays to detect analytes in the body of a user and Zander further teaches the application of the insulating layer allows for detection at the tip of the needle for ease with user and better readings.
Claim(s) 1, 2, 5-6, 8-11 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2013/0225956) in view of Jina et al. (US 2009/0099427A1) and Kamath et al. (US 2005/0143635).
As to claim 1, Huang teaches a process for forming a monitoring device comprising etching (cutting) a structure to form a microneedle array (see 0022); forming sensing features on the microneedle array where the array can access interstitial fluid in the user and detect a plurality of analytes in the fluid (see 0029 and 0033-0035; the sensor detects glucose, cortisol, or fatty acids or a pharmaceutical molecule); the sensor is connected to detection electronics to generate signals associate with detection of the analytes (see 0037); and coupling the detection electronics to a module in communication with the microsensor that is configured to receive the signal and analyze the received signal to determine analyte information for the user (see 0037). Huang et al. states when simultaneous detection of multiple molecules is required then multiple sensors can be combined (see 0040).
As to claims 5 and 15, Huang et al. discloses a wearable monitoring device for monitoring a user (see abstract, 0038) comprising an electrochemical microsensor (see 0033) including at least one sensing microneedle array (see 0033) configured to access interstitial fluid in the user and detect in vivo an analyte (the sensor can detect glucose, cortisol, or fatty acids or a pharmaceutical molecule, see 0029) where the sensor generates one or more signals associated with the detection of the analyte (see 0037) and an electronics module in communication with the microsensor that is configured to receive the signal and analyze the received signal to determine analyte information for the user (see 0037). Huang et al. states when simultaneous detection of multiple molecules is required then multiple sensors can be combined (see 0040).
Huang fails to teach each microneedle of the array has a plurality of tapered surfaces at the tip region or the length of the microneedles are 150-500 microns as required by claims 1, 5 and 15.
Huang states the length of the microneedles can be 50-3000 microns.
Jina et al. discloses a process for forming a wearable monitoring device (see 600/602 of Fig. 16, 0101) comprising: cutting at least one semiconductor structure to form at least one microneedle array comprising individual microneedles having a plurality of tapered surfaces (see 0017, 0019, 0022, 0050, 0053, 0104, 0110 and Fig. 19). Jina states the microneedle array is configured to access interstitial fluid in a user and configured for in-vivo detection a plurality of analytes in the fluid (see 0020, 0042-0043 and 0104-0108)Jina et al. states the needles allow for painless and non-invasive sensing (see 0042) and stretching of the skin making penetration of the needle easy (see 0107). Jian et al state the needles can have a length of 250-450 microns (see 0109).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Huang to include the needles having tapered surfaces at the tip region as taught by Jina et al. One would have been motivated to do so since both are directed to forming wearable monitoring devices having a microneedle array that is painless for the user where Jina et al. teaches an alternative needle shape that offers the painless penetration of the microneedles into the patient’s skin.
As to the calibration, Kamath et al. teaches that a continuous analyte monitoring system may be calibrated using one or more signals obtained from electrodes associated with the sensor. Kamath et al. states that these signals provide baseline and/or sensitivity information for calibration of the analyte sensor (see abstract). The sensor system comprises a working electrode (for measuring the analyte – see 0010) and additional electrodes or sensing structures that generate secondary signals (see 0057, 0064). The secondary sigma is dependent upon the electrode/material (see 0010, 0077-0080). The electrode material produces electrochemical behavior and generates signals used for baseline and sensitivity correction (calibration).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Huang et al. and Jian et al. to include the calibration techniques of Kamath et al. One would have been motivated to do so since both are directed to sensing electrodes where Kamath et al. teaches an alternative calibration system that improves calibration accuracy and enhances the reliability of the continuous monitoring system.
As to claim 2, Huang teaches a semiconductor substrate and the multiple microneedles within the array would require multiple cutting of the surface.
As to claim 6, the tips of the microneedles can be coated so the analyte can be detected (see 0034-0035) and the needle body (acting as the electrode) transmits the signals (See 0034-0035).
As to claim 8, the module is programmed to determine the concentration of the analytes (see abstract, 0040).
As to claim 9, the information can include presence of a biomarker or drug concentration (see 0035, 0040 and 0043).
As to claim 10, the microneedle array includes multi-analyte microneedles that independently detect analytes (see 0040).
As to claim 11, the microsensor is configured for continuous monitoring (see 0009).
As to claims 13 and 16, the first analyte would produce different signals than the second analyte and the concentration of the two is determined (see 0040).
As to claims 14 and 17, the needle array comprises a first needle array for the first analyte and a second needle array for a second analyte (see 0040).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 5-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mir et al. (US 2011/0224515) discloses a microneedle array that has a calibration position where the microneedle at the calibration position is coated (see 0081, 0097).
Yang et al. (US 2004/0106190) discloses a calibration working electrode coated with an antibody (see 0068).
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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/CACHET I. PROCTOR/
Examiner
Art Unit 1712
/CACHET I PROCTOR/Primary Examiner, Art Unit 1712