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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/31/2024 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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-15, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Browning et al. (US 2010/0160779; hereafter Browning).
In regard to claim 1, Browning discloses a method for disrupting a blood clot with ultrasound and at least one cavitation enhancing agent (see at least the abstract), the method comprising: administering at least one cavitation enhancing agent (“microbubble contrast agent”) into a blood vessel of a subject (see par. [0021]); monitoring the at least one cavitation enhancing agent to determine when at least a portion of the at least one cavitation enhancing agent has reached a blood clot (see par. [0021]-[0024]); and controlling application of ultrasound energy to the at least one cavitation enhancing agent within the blood vessel of the subject such that, during a first time period, cavitation-enhancing ultrasound energy is not applied to the at least one cavitation enhancing agent within the blood vessel (see par. [0021]-[0024]- diagnostic ultrasound is used to find a clot) and, during a second time period after the first time period, cavitation enhancing ultrasound energy is applied to the at least one cavitation enhancing agent within the blood vessel (see par. [0023]-[0024]- a therapeutic ultrasound is used to agitate the microbubbles at the stenosis once the stenosis is found), wherein the first time period is based on results of the monitoring to determine when the at least a portion of the at least one cavitation enhancing agent reaches the blood clot (the first period is based on the time it takes to locate the stenosis) and the second time period is based on a time for the at least one cavitation enhancing agent to initiate disruption of the blood clot (the second period is based on the time it takes to disrupt the blood clot).
In regard to claim 2, Browning discloses wherein administering the at least one cavitation enhancing agent includes administering a mixture of nanodroplets and microbubbles of the at least one cavitation enhancing agent into the blood vessel (see par. [0004] and [0021]).
In regard to claim 3, Browning discloses wherein administering the at least one cavitation enhancing agent includes separately administering nanodroplets and microbubbles of the at least one cavitation enhancing agent into the blood vessel (see par. [0004] and [0021]).
In regard to claim 4, Browning discloses wherein monitoring the at least one cavitation enhancing agent includes transmitting ultrasound energy into the blood vessel, detecting ultrasound energy scattered by the at least one cavitation enhancing agent, and determining a location of the at least one cavitation enhancing agent within the blood vessel based on the detected ultrasound energy (see par. [0021]-[0025]).
In regard to claim 5, Browning discloses wherein transmitting ultrasound energy into the blood vessel includes transmitting ultrasound energy at a power level selected so as not to cause a phase change in particles of the at least one cavitation enhancing agent (see par. [0021]-[0026]).
In regard to claim 6, Browning discloses wherein transmitting ultrasound energy into the blood vessel includes transmitting ultrasound energy at a power level selected to cause a phase change in particles of the at least one cavitation enhancing agent from a liquid phase to a gaseous phase and form bubbles and to cause the bubbles to burst and wherein monitoring the at least one cavitation enhancing agent includes detecting ultrasound energy scattered by the bursting of the bubbles (see par. [0021]-[0025]).
In regard to claim 7, Browning discloses wherein the first time period ends if a detected location of the bursting of the bubbles is determined to correspond to a location of the blood clot (see par. [0023]-[0024]).
In regard to claim 8, Browning discloses comprising ceasing transmission of the ultrasound energy and extending the first time period if a detected location of the bursting of the bubbles is determined to be upstream from a location of the blood clot (see par. [0021]-[0025]).
In regard to claim 9, Browning discloses wherein the first time period is estimated based on an estimated flow rate of the at least one cavitation enhancing agent through the blood vessel (see par. [0021]-[0025]).
In regard to claim 11, Browning discloses wherein the at least one cavitation enhancing agent comprises nanodroplets (see par. [0004]) and the second time period is based on a time for a portion of the nanodroplets to convert to microbubbles and oscillate in diameter (see par. [0023]-[0026]).
In regard to claim 12, Browning discloses wherein controlling the application of the ultrasound energy comprises applying the cavitation enhancing ultrasound energy to the at least one cavitation enhancing agent for a third time period after the second time period, wherein the third time period is based on a time for a portion of the microbubbles to fragment (see par. [0021]-[0026]- the time periods can be divided into N number of periods).
In regard to claim 13, Browning discloses comprising monitoring results of application of the cavitation enhancing ultrasound energy to the at least one cavitation enhancing agent and wherein controlling application of the ultrasound energy includes controlling the application based on the results (see par. [0021]-[0026]).
In regard to claim 14, Browning discloses wherein monitoring results of the application of the cavitation enhancing ultrasound energy includes using an ultrasound transducer (10a, 10b) to monitor ultrasound energy scattered by the at least one cavitation enhancing agent proximal to the blood clot, generating an image of the scattered ultrasound energy, and displaying the image to a user (see par. [0017]).
In regard to claim 15, Browning discloses wherein monitoring results of the application of the cavitation enhancing ultrasound energy includes generating a feedback control signal based on ultrasound energy scattered by the at least one cavitation enhancing agent and automatically controlling at least one of the administering of the at least one cavitation enhancing agent and the application of the cavitation enhancing ultrasound energy using the feedback control signal (see par. [0021]-[0026]).
In regard to claim 29, see the rejection of claim 1 as the same steps are encompassed.
Allowable Subject Matter
Claims 16-28 are allowed.
Claims 10 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: In regard to claim 16, Browning fails to disclose or suggest the recited timing controller for controlling the application of ultrasound energy. The Browning device relies on the physician performing the monitoring steps to determine a stenosis is reached and the step of activating the therapeutic ultrasound as opposed to the recited timing controller and receiver of claim 16. There is no teaching reference to modify Browning to cure the stated deficiencies.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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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