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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The examiner acknowledges the amendments made to the claims 30 and 44, with claims 1-29 previously canceled in prosecution. Claims 30-46 are currently pending in the present application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 30-32, 42-43 is/are rejected under 35 U.S.C. 103 as being anticipated by Afanasewiez (US Patent No 20130023749) in view of Toth (US Patent No 20160029960).
Regarding claim 30, Afanasewiez teaches a system for electrical stimulation of a body tissue (medical device configured to be applied to a subject, [0016]) comprising: (a) an array of microneedles, said microneedles formed from an electrically conductive material and configured for puncturing a surface of the tissue (the device may contain tines 11 which may be microneedles and are used as conductive contact portions to penetrate the skin, [0024]-[0025]); (b) a power unit (there is a connected cable which connects the device to a power source, [0065], or the equivalent power unit); (c) one or more surface electrodes configured for delivering electrical stimulation to the body tissue from said power unit (there is an intermediate contact portion 53 which may take the form of an active electrode to deliver treatment via a power source, [0032]).
Afanasewiez does not teach a processing unit configured for determining if said tissue surrounding one or more of said microneedles has been ablated.
However, the analogous microneedle stimulation system taught by Toth does teach a processing unit configured for determining if said tissue surrounding one or more of said microneedles has been ablated (see from Toth [0040] in which there are electrodes and sensors present within the microneedle array, in which the array of electrodes is connected to a control unit and configured to interface with the local tissues as to select ablation sights as well as validate ablation success within the localized tissue, [0159]. Therefore, validating if the surrounding tissue has been ablated).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrical stimulation system taught by Afanasewiez with that of control system to determine is the surrounding tissue has been ablated which is taught by Toth, in order to accurately interface with the surrounding tissue and sense the ablation success as to not deliver excess ablation energy to the tissue sight as taught by Toth, [0159].
Regarding claim 31, Afanasewiez teaches the system according to claim 30, further comprising one or more force detectors configured to detect application of a pressure exerted by the tissue on one or more of said microneedles in said array (see the force regulator 30, which detects when a predetermined amount of pressure has occurred on the device to actuate the tines or microneedles, [0075]) and to generate an electrical signal indicative of said pressure (see in which a piezoelectric electronic indicator may be attached to the force regulators as to generate an electric signal to deliver to the system, [0071]).
Regarding claim 32, Afanasewiez teaches the system according to claim 31, wherein said processing unit is configured to monitor said electrical signal over time so as to determine when said pressure exerted by said tissue on said microneedles is above a predetermined threshold (see the force regulator 30, which detects when a predetermined amount of pressure has surpassed the threshold value on the device to actuate the tines or microneedles, [0075]).
Regarding claim 42, Afanasewiez teaches the system according to claim 30, wherein said predetermined position of said microneedles is through a stratum corneum layer of a skin (microneedle tines 11 are configured to penetrate a patient’s stratum corneum, [0024]).
Regarding claim 43, Afanasewiez teaches the system according to claim 30, wherein said one or more surface electrodes is a wettable electrode (wherein conductive device layer may be formed of various hydrogel embodiments, [0066], which is a known form of wettable electrode structure).
Claim(s) 33-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Afanasewiez (US Patent No 20130023749) in view of Toth (US Patent No 20160029960) further in view of Solomon (US Patent No 10688301).
Regarding claim 33, Afanasewiez and Toth teach the system according to claim 30.
Afanasewiez nor Toth teach the system further comprising a switching circuit configured for intermittently connecting one or more subsets of said microneedles from said array to said power unit and for intermittently connecting one or more of said surface electrodes to said power unit.
However, the analogous electrical stimulation device taught by Solomon does teach a system further comprising a switching circuit configured for intermittently connecting one or more subsets of said microneedles from said array to said power unit (see from Solomon [0028], in which there are multiple clusters of microneedles which may be activated individually from the power source, therefore containing switching circuitry) and for intermittently connecting one or more of said surface electrodes to said power unit (see from Solomon, [0044], in which there are multiple contact electrodes which may be individually activated with the power source, therefore containing switching circuitry).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the device system taught by Afanasewiez and Toth, with that of the switching circuitry and individually activate-able microneedle clusters and contact electrodes taught by Solomon in order to achieve customizable ablation techniques to allow for different energy delivery methods dependent on what the type of treatment may be, as disclosed by Solomon, [0044].
Regarding claim 34, the combination teaches the system according to claim 33, further comprising a signal generator activatable by said processing unit to deliver an electrical signal between a selectable first subset of microneedles and a selectable second subset of microneedles or between a selectable first set of microneedles and at least one of the surface electrodes (see from Solomon, in which electric signals may be generated and supplied through one or more of the clusters of microneedles for treatment, [0034]).
Regarding claim 35, the combination teaches the system according to claim 34, wherein said processing unit is further configured to activate said signal generator to deliver an ablation signal to at least said subset of said microneedles of said array (from Solomon, see in which the electrical circuitry component 136 is in electric communication with the microneedle clusters 154 which leads to ablation around the microneedle, [0027]).
Regarding claim 36, the combination teaches the system according to claim 35, wherein said processing unit is further configured to activate the signal generator to deliver said ablation signal only after said processing unit has determined that said microneedle array is in the predetermined position (view Solomon fig 3, in which the flowchart shows that the stimulator device is positioned first and then activated to deliver treatment signal in step 36).
Regarding claim 37, the combination teaches the system according to claim 35, wherein said processing unit determines if tissue surrounding the microneedles has been ablated by analyzing a response of said tissue to a test signal (see from Solomon, [0034], in which electric signals may be applied through the microneedles, and the response may be measured as to adjust the energy delivery through the microneedles as needed, thereby resulting in a test signal).
Regarding claim 38, the combination teaches the system according to claim 30, wherein said processing unit is further configured for determining a number of said microneedles surrounded by ablated tissue (see from Solomon, [0040], in which the processor 140 controls the electrical circuit for individually energizing each electrode and microneedle as to maintain body and tissue control during treatment, therefore as the specific microneedles are known, the processor will also know which ones are next to ablated tissue).
Regarding claim 39, the combination teaches the system according to claim 35, wherein said ablation signal is a voltage signal (see in which the processor may adjust the voltage signal applied through the microneedles, from Solomon, [0031]).
Regarding claim 40, the combination teaches the system according to claim 39, wherein said ablation signal has an amplitude of 200 to 800 volts (from Solomon, see in which the voltage pulse delivery may reach up to 600 volts, [0041], thereby overlapping the claimed range).
Regarding claim 41, the combination teaches the system according to claim 39, wherein the ablation signal has a frequency of 1 KHz to 1,000 KHz (see from Solomon, in which the current energy pulses may have a stimulation frequency of up to 10 KHz, [0041], thereby overlapping the claimed range).
Claim(s) 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Afanasewiez (US Patent No 20130023749) in view of Solomon (US Patent No 10688301).
Regarding claim 44, Afanasewiez teaches a method for electrical stimulation of a body tissue (medical device configured to be applied to a subject, [0016]) comprising: (a) applying an array of microneedles to a surface of the body tissue, and puncturing the tissue surface to generate micropores in the tissue (the device may contain tines 11 which may be microneedles and are used as conductive contact portions to penetrate the skin, [0024]-[0025]); (b) determining if said microneedles in said microneedle array are in a predetermined position in the tissue (there may be a processing device located within the device which controls an electronic indicator to communicate with the rest of the system to notify if the device applicator was applied in the predetermined position or not, [0070]).
Afanasewiez does not explicitly teach ablating the tissue surrounding at least a subset of said microneedles of said array; (d) removing said array of microneedles from said tissue; and (e) applying one or more surface electrodes to a surface of said tissue over micropores formed by said microneedles and delivering electrical stimulation via said one or more surface electrodes.
However, the analogous electrical stimulation device taught by Solomon does teach ablating the tissue surrounding at least a subset of said microneedles of said array (see from Solomon, in which electric signals may be generated and supplied through one or more of the clusters of microneedles for treatment, [0034]); (d) removing said array of microneedles from said tissue (see from Solomon, the microneedle plate 318 may be removable, [0033]); and (e) applying one or more surface electrodes to a surface of said tissue over micropores formed by said microneedles and delivering electrical stimulation via said one or more surface electrodes (see from Solomon, [0040], in which the microneedles act as the puncturing device and then the electrodes 24 are used to apply direct electrical stimulation over the micropores).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the device system methodology taught by Afanasewiez, with that of the methodology to use microneedles and create microchannels in the skin for electrode treatment as taught by Solomon, in order to allow for more effective and prolonged microneedle treatment, as disclosed by Solomon, [0040].
Regarding claim 45, the combination teaches the method according to claim 44, further comprising determining if said tissue surrounding one or more of said microneedles of said array has been ablated prior to (d) (see from Solomon, [0034], in which electric signals may be applied through the microneedles, and the response may be measured as to adjust the energy delivery through the microneedles as needed, thereby resulting in a test signal to see if the tissue has been ablated).
Regarding claim 46, the combination teaches the method according to claim 44, wherein ablating said tissue is carried out with a voltage signal having an amplitude of 200 to 800 volts (from Solomon, see in which the voltage pulse delivery may reach up to 600 volts, [0041], thereby overlapping the claimed range) and a frequency of 1 KHz to 1,000 KHz (see from Solomon, in which the current energy pulses may have a stimulation frequency of up to 10 KHz, [0041], thereby overlapping the claimed range).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Specifically, the argument presented around the amended claim 1 that the previous prior art of Afanasewiez alone does not teach or disclose a processing unit configured for determining if said tissue surrounding one or more of said microneedles has been ablated, has been considered and found persuasive by the examiner. However, upon further search and consideration, necessitated by the amended claim limitation, it has been found that the analogous microneedle stimulation device taught by Toth does disclose the newly amended claim limitations. Specifically, Toth does teach a processing unit configured for determining if said tissue surrounding one or more of said microneedles has been ablated (see from Toth [0040] in which there are electrodes and sensors present within the microneedle array, in which the array of electrodes is connected to a control unit and configured to interface with the local tissues as to select ablation sights as well as validate ablation success within the localized tissue, [0159]. Therefore, validating if the surrounding tissue has been ablated). Therefore, as the amended limitation is taught by the prior art of record, claim 1 remains rejected under the new prior art of record rejection of Afanasewiez in view of Toth set forth in the present office action.
As no further arguments or remarks have been made in regards to the other dependent claims, they too remain rejected under the new prior art of record rejection set forth in the present office action.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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