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 .
Status
Claim 1 is presently pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over cited references CHANDRARATNA US 20060241522 A1 in view of SVERDLIK et al., WO 2017212489 A2 hereinafter “SVERDLIK”.
CHANDRARATNA discloses a method of treating peripheral vascular disease by stimulating angiogenesis within a patient (a method of treating ischemia in the legs by stimulating angiogenesis in a patient - [0012], [0032]), comprising: providing a wearable non-invasive device comprising a flexible housing material and an array of ultrasound transducers operably attached to the flexible housing material (an ultrasound device comprising a flexible substrate and an array of ultrasound transducers attached to the flexible substrate is worn on the leg, Fig. 3 - [0013], [0043-0044]); positioning the device and the array of transducers proximate a skin surface of a patient over at least one target site angiosome where angiogenesis is desired (the ultrasound device is positioned on the calf 7 of the patient for treatment of vessel and tissue disorders and for promotion of angiogenesis, and thus is positioned over a target site angiosome, Fig. 3, [0044], [0055], [0057]), and such that the flexible housing material and the array of ultrasound transducers substantially conforms to the skin surface of one or more of the thigh, calf, ankle, and foot of the patient (illustration Fig.3, [0044]); causing a therapeutically effective amount of ultrasonic energy over a set time period to be directed toward the target site angiosome (a therapeutic amount of ultrasound energy is delivered for a prolonged period of time toward the calf - [0055], [0057]), thereby stimulating cavitation and shear stress within tissue at the target site angiosome, thereby promoting angiogenesis within the patient (power to the ultrasound transducer elements can be adjusted to bring about the desired ultrasound-induced effects, wherein the delivered ultrasound energy to the target site promotes angiogenesis, thus the delivered ultrasound energy would cause cavitation and shear stress within the tissue at the target site – [0033], [0055]-[0056]).
CHANDRARATNA does not disclose determining the power delivered through the array of transducers; and comparing the determined power delivered to a reference value to determine proper coupling to the patient's skin surface. However, SVERDLIK in the same field of endeavor of applying ultrasound energy to a tissue volume, discloses various methods for assessing contact between an ultrasound applicator and skin (page 13, 3-4), specifically, discussion associated with Fig. 16D1 in page 57, from line 25, determining the power delivered through an array of transducers (at 1615); and comparing the determined power delivered to a reference value to determine proper coupling to the patient's skin surface (at 1617 and “a change in power above a certain threshold is indicative of loss of contact”). In view of these teachings, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic treatment method of CHANDRARATNA, to include determining power delivered through the array of transducer and compare the determined power delivered to a reference value or threshold, to determine proper coupling to the patient's skin surface, as taught by SVERDLIK, to increase efficiency in treatment since improper coupling or poor contact between a transducer and patient’s skin would result with attenuation of ultrasound which would reduce efficiency of treatment.
Conclusion
This is a continuation of applicant's earlier Application No. 17/048357. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached on (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797