DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/22/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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(s) 20 and 73-84 are rejected under 35 U.S.C. 103 as being unpatentable over University of Michigan Regents (WO 2019/200201; hereafter Michigan) in view of Cottone et al. (US 2021/0196932; hereafter Cottone) and conditionally in view of Tsukashima et al. (US 2011/0160647; hereafter Tsukashima).
In regard to claim 1, Michigan discloses an undulating balloon PTA system (1), comprising: a balloon catheter (16) comprising an inflatable balloon member (2) having a preset maximum inflation pressure (see Fig. 13 and par. [0074]-[0075] for peak inflation pressures); an oscillating fluid pressure source (14) communicating with the balloon catheter; and a controller (13) configured to cause the oscillating fluid pressure source (14) to deliver controlled pressure oscillations to the balloon catheter between a maximum pressure equal to the preset maximum inflation pressure and a set minimum pressure at a selected cycle time (see par. [0048], [0050], [0054], [0060], and [0074]- [0075].
Michigan discloses that the embodiments of the invention enable dynamic balloon angioplasty which in turn will "improve and control drug delivery for drug-coated balloons" which implies a drug coating (see par. [0010]) but Michigan fails to expressly disclose a drug-carrying nanoparticle matrix disposed on an outer surface of the balloon member as is recited in claim 1.
In a similar art, Cottone discloses a medical balloon (1.1) having a coating (2.2), wherein the coating comprises a pharmaceutical agent encapsulated in a plurality of microspheres, nanoparticles (e.g., nanogels), liposomes, or cyclodextran particles in the biocompatible matrix (see par. [0013]-[0014]), wherein the nanoparticle matrix comprises drug-carrying nanoparticles and interstitial bonding agent (see par. [0008], [0013]-[0014], [0037]), wherein the interstitial bonding agent is configured to release the drug-carrying nanoparticles in response to a predetermined “conditions” (expansion of the balloon; see par. [0035] or exposure to body temperature; see par. [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drug coating of Michigan with the equivalent drug coating of Cottone since the Cottone coating is capable of performing the same function of delivering drugs to achieve the same or substantially similar result of treating the affected area within the body.
The combination teaches the limitations as recited because Cottone does teach release in response to predetermined “conditions” (the claims currently recite an “or” option between the recited stimulus or conditions).
Even though not specifically required by the claims, the combination fails to teach “the stimulus is sonic energy and the system further comprises an external ultrasound transducer configured to deliver sonic energy at a frequency under 1 MHz”.
In a similar art, Tsukashima discloses an active drug eluting angioplasty balloon (10) which utilizes ultrasonic energy to facilitate the release of the bioactive drug (12) and further comprising an external ultrasound transducer (27) configured to deliver sonic energy at a frequency under 1 MHz (see par. [0012], [0014], [0025], [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drug release mechanism of Tsukashima in the combination system since the Tsukashima release mechanism is capable of performing the same function of delivering drugs in response to a stimulus/condition to achieve substantially similar result of releasing the drug at the appropriate location in the body. The examiner notes that “external” does not indicate any particular limitation or structural feature.
In regard to claim 73, Tsukashima teaches wherein the external ultrasound transducer is configured to deliver the sonic energy at a frequency under 100 KHz (see par. [0012], [0014], [0025], [0072]).
In regard to claim 74, Tsukashima teaches wherein the external ultrasound transducer (27) is configured to deliver ultrasound waves that degrade the interstitial bonding agent (see par. [0050]).
In regard to claim 75, Tsukashima teaches wherein the interstitial bonding agent comprises a sound-sensitive bonding agent configured to release the drug-carrying nanoparticles upon application of the sonic energy (see par. [0050]; a coating that releases in response to ultrasound is sound sensitive).
In regard to claim 76, Tsukashima teaches wherein the external ultrasound transducer (27) is configured to deliver the sonic energy at a level selected to disrupt the interstitial bonding agent while maintained below a level that would cause an effect on tissue of the vessel wall beyond the balloon and nanoparticle matrix adhered to the balloon substrate (see par. [0012], [0014], [0025], [0027], [0072]).
In regard to claim 77, Tsukashima teaches wherein the sonic energy comprises vibration configured to break a mechanical structure of the nanoparticle matrix (see par. [0050]).
In regard to claim 78, please see the rejection of claim 20 as the examiner believes all of the limitations are adequately addressed.
In regard to claim 79, Tsukashima teaches an external ultrasound source (27) (27 is external to some structures).
In regard to claim 80, Tsukashima teaches further comprising an internal ultrasound resonator (27) disposed in the balloon catheter configured to deliver said sonic energy (see at least Fig. 7).
In regard to claim 81, Tsukashima teaches wherein said internal ultrasound resonator (27) is disposed within the balloon (see at least Fig. 7).
In regard to claim 82, Tsukashima teaches wherein said internal ultrasound resonator comprises a piezo ultrasound resonator (see par. [0057]).
In regard to claim 83, Tsukashima teaches wherein said balloon is configured to deploy a stent (see at least Fig. 13).
In regard to claim 84, Tsukashima teaches wherein the interstitial bonding agent is configured to release the drug-carrying nanoparticles in response to sonic energy delivered at a frequency under 100 KHz (see par. [0012], [0014], [0025], [0027], [0072]).
Allowable Subject Matter
Claims 21-22 and 68-72 are allowed.
Response to Arguments
Applicant's arguments filed 6/3/2026 have been fully considered but they are not persuasive.
The examiner notes that claim 20 was not indicated as allowable and was rejected. The applicant did not provide arguments against the rejection.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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