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 .
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 30, 33-46 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Solomon (US Patent No 20170209695).
Regarding claim 30, Solomon teaches a system for electrical stimulation of a body tissue (system 100 for delivering energy to a tissue, [0092]) comprising: (a) an array of microneedles, said microneedles formed from an electrically conductive material and configured for puncturing a surface of the tissue and creating micropores at a location of one or more of the microneedles (see microneedles 154 in which there may be multiple arrays of microneedles and they are composed of a semi-conductive or conductive material configured to be pressed into the tissue surface, [0098]); (b) a power unit (see power source 128, [0094]); (c) one or more surface electrodes configured for delivering electrical stimulation to the body tissue from said power unit (see the applicator unit 157 for placement on the skin surface which contains the microneedles 154 which are connected to the power source via circuitry connections 136 and 130), and a processing unit configured for determining if said tissue surrounding one or more of said microneedles has been ablated (see [0102], for the processor 140 which monitors all the electrical parameters applied to the tissue in order to determine the extent of the puncturing or the ablation delivered) to ensure that the micropores remain open when one or more of the microneedles are removed from the tissue (see in which the ablation of the tissue around the microneedles allows for the micropores to remain open after ablation, [0098].
Regarding claim 33, Solomon teach the system according to claim 30, wherein 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 (see from Solomon [0099], 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, [0111], in which there are multiple contact electrodes which may be individually activated with the power source, therefore containing switching circuitry).
Regarding claim 34, Solomon 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 from the power source 128 and supplied through the electrodes 40 to one or more of the clusters of microneedles for treatment, [0111]).
Regarding claim 35, Solomon 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 processor 140 is in communication with the electrical circuitry component 136 is in electric communication with the microneedle clusters 154 which leads to ablation around the microneedle, [0114]).
Regarding claim 36, Solomon 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, Solomon 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, [0102], 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, Solomon 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, [0114], 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, Solomon 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, [0102]).
Regarding claim 40, Solomon 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, [0112], thereby overlapping the claimed range).
Regarding claim 41, Solomon 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, [0112], thereby overlapping the claimed range).
Regarding claim 42, Solomon teaches the system according to claim 30, wherein said predetermined position of said microneedles is through a stratum corneum layer of a skin (the micro-needle ablation occurs on the tissue surface, for example the stratum corneum, [0098]).
Regarding claim 43, Solomon teaches the system according to claim 30, wherein said one or more surface electrodes is a wettable electrode (wherein the surface electrode portion may be comprised of a hydrogel, [0058], which is a known form of wettable electrode structure).
Regarding claim 44, Solomon teaches a method for electrical stimulation of a body tissue (system 100 for delivering energy to a tissue, [0092]) 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 at a location of one or more of the microneedles (see microneedles 154 in which there may be multiple arrays of microneedles and they are composed of a semi-conductive or conductive material configured to be pressed into the tissue surface, [0098]); (b) determining if said microneedles in said microneedle array are in a predetermined position in the tissue (see [0095], for the steps to determine if the array was placed in the correct position for treatment), ablating the tissue surrounding at least a subset of said microneedles of said array to ensure that the micropores remain open when one or more of the microneedles are removed from the tissue (see from Solomon, in which electric signals may be generated and supplied through one or more of the clusters of microneedles for treatment and see in which the ablation of the tissue around the microneedles allows for the micropores to remain open after ablation, [0098]); (d) removing said array of microneedles from said tissue (see from Solomon, the microneedle plate 318 may be removable, [0104]); 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, [0111], in which the microneedles act as the puncturing device and then the electrodes 24 are used to apply direct electrical stimulation over the micropores).
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, [0105], 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, [0112], 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, [0112], thereby overlapping the claimed range).
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) 31-32 is/are rejected under 35 U.S.C. 103 as being anticipated by Solomon (US Patent No 20170209695) in view of Afanasewiez (US Patent No 20130023749).
Regarding claim 31, Solomon teaches the system according to claim 30.
Solomon does not teach 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 and to generate an electrical signal indicative of said pressure.
However, the analogous force regulating microneedle array taught by Afanasewiez does disclose a system 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]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the stimulation array system taught by Solomon to contain the force detection and pressure response system taught by Afanasewiez, in order to regulate the pressure applied to the treatment region to allow for effective micro-punctures and needle treatment, as taught by Afanasewiez, [0075].
Regarding claim 32, the combination 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 (from Afanasewiez, 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]).
Response to Arguments
Applicants’ arguments with respect to claim(s) 30 and 44 as well as all relevant dependent claims 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 30 and 44 that the previous prior art of Afanasewiez alone does not teach or disclose the specific microneedle ablation techniques to open micro-pores to help with stimuli and therefore could not be analogously combined with the previous prior art of Toth, 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 ablation and stimulation systems taught by Solomon does disclose the newly amended claim limitations as well as the previous deficiencies of the prior art of Afanasewiez. Specifically, the new prior art of record of Solomon does go on to teach the microneedle system array for ablation and stimulation as shown in the present office action and is now being analyzed as the primary prior art with the previous art of Afanasewiez becoming the supporting reference within the rejection. Therefore, as the amended limitations are taught by the new prior art of record, claim 30 and 44 remain rejected under the new prior art of record rejection of Solomon in view of Afanasewiez set forth in the present office action.
As no further arguments or remarks have been made in regard 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
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
