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 .
DETAILED ACTION
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.
Claims 1, 4-7 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feng (US 20210046295 (provided in the IDS)).
Addressing claim 1, Feng discloses a catheter system comprising:
an elongate body configured to be positioned within a blood vessel of a patient (see Fig. 1, [0022] and [0035]; 160 and 170 balloon catheter inserts inside blood vessel);
a balloon defining an interior volume (see Fig. 1, [0022] and [0035]; balloon 170);
a sensor configured to generate a pressure signal indicative of a pressure of a fluid within a flow path, the flow path including the interior volume and at least one lumen defined by the elongate body (see Fig. 1 and [0035]; pressure sensor 140 and flow rate sensor 150);
a valve fluidically coupled to the flow path and configured to define a flow area for the fluid (see Fig. 1 and [0045]; elements 120 and 130; also safety valve 201);
control circuitry configured to: determine a pressure setpoint, receive the pressure signal from the sensor, and position the valve to adjust the flow area based on the pressure setpoint and the pressure indicated by the sensor signal (see Fig. 1 and [0045-0049]; element 110; safety range is the pressure setpoint; pressure sensor sense the real-time pressure).
Addressing claims 4-7 and 22, Feng discloses:
addressing claim 4, wherein the catheter system is configured to receive an input indicative of the pressure setpoint and determine the pressure setpoint using the input (see Fig. 3 and [0077-0079]; element 182 allow user to enter pressure information).
addressing claim 5, wherein the valve includes: a restricting element configured to define the flow area; and a valve actuator configured to position the restricting element, wherein the control circuitry is configured to position the valve to adjust the flow area by at least causing the valve actuator to position the restricting element (see Figs. 1-2 and [0019], safety valve has restricting element to limit and define flow area; valve to open or close to stop flow is done by valve actuator).
addressing Claim 6, wherein the pressure signal is indicative of pressure of the fluid upstream of the restricting element (see Fig. 2 and [0019-0021]; pressure of liquid in the balloon upstream of safety valve)
addressing claim 7, a pump configured to cause the fluid to flow through the flow path, wherein the control circuitry is configured to adjust, using the pump, a flow rate of the fluid through the flow path based on the pressure setpoint and the pressure indicated by the sensor signal, and wherein the pump defines a pump outlet configured to discharge the fluid into the inlet lumen defined by the elongate body to cause the fluid to flow through the flow path (see Fig. 1, the pump is inherent include in order to feed fluid and evacuate fluid to inflate and deflate balloon).
addressing claim 22, the catheter system in claim 1 perform the method in claim 22 therefore claim 22 is being rejected for the same reason as claim 1. The safety valve 201 throttle a flow of fluid in fluid path when sensing pressure is different from safety pressure.
Claims 14, 15-21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber et al. (US2015/0105773).
Addressing claim 14, Weber discloses a catheter system comprising:
an elongate body (see Figs. 3-4 and abstract);
a balloon defining an interior volume (see Figs. 3-4; element 304);
a therapeutic element mechanically supported by the elongate body, wherein the therapeutic element is configured to emit energy (see [0028] and Figs. 3-4; electrode 312a-c);
control circuitry configured to: receive an input indicative of a pressure within the interior volume of the balloon, determine a power level based on the indicated pressure, and cause the therapeutic element to emit the energy based on the determined power level (see Figs. 1, 3 and [0035]).
Addressing claims 15-21, Weber discloses:
wherein the input includes a pressure setpoint, the catheter system further comprising a user interface configured to receive the pressure setpoint from a user, wherein the control circuitry is configured to determine the power level based on the pressure set point (see Figs. 3, [0023] and [0033-0035]; 312a-c are electrode that emit energy; energy can be ultrasound energy produce by ultrasound electrodes; adjust/determine power level base on pressure sensor feedback; the power level cause therapeutic element emit energy at a certain level; avoid too high pressure and over expansion of a balloon that implicit indicate of pressure setpoint and regular power level base on sensing pressure that is within or below the safety/set point pressure; reduce inflation implicitly indicate pressure setpoint; basically adjust pressure setpoint; he operator's ability to inflate the balloon to a pressure (set point pressure) in order to achieve the appropriate contact with the vessel wall; operator stop or reduce inflation indicate there is a user interface; operate the catheter through a user interface);
addressing claim 16, a sensor configured to generate a pressure signal indicative of a pressure of a fluid within a flow path defined at least in part by the elongate body, wherein the pressure of the fluid within the flow path is indicative of the pressure within the interior volume of the balloon, and wherein the control circuitry is configured to: receive the pressure signal from the sensor, and determine the power level based on the pressure signal (see Figs. 3-4, [0023] and [0033-0035]; 310a-b are sensors to sense pressure of inflate and deflate balloon by fluid);
addressing claim 17, wherein the therapeutic element is configured to emit ultrasound energy, further comprising a generator configured to provide energy to the therapeutic element (see Figs. 3-4 and [0023]; element 312a-c are electrodes; energy can be ultrasound energy produce by ultrasound electrodes; generator is implicit in order to produce power for ultrasound energy);
addressing claim 18, wherein the therapeutic element comprises energy control circuitry configured to cause the therapeutic element to emit the energy, and wherein the control circuitry is configured to control the energy control circuitry to cause the therapeutic element to emit the energy at the power level (see Figs. 1, 3-4, [0023] and [0033-0035];16 is control circuitry);
addressing claim 19, wherein a dimension of the balloon varies based on the pressure within the interior volume of the balloon, and wherein the input indicative of the pressure within the interior volume of the balloon is indicative of the dimension of the balloon (see [0033]; balloon is inflated with increase pressure and the pressure sensing enable user to determine if the balloon in contact with vessel wall; pressure increase indicate the balloon is inflate which is increase in diameter);
addressing claim 20, wherein the elongate body defines a longitudinal axis, and wherein the dimension of the balloon is a cross-sectional dimension of the balloon perpendicular to the longitudinal axis (see [0033]; inflate balloon to touch vessel wall is increase in the dimension of the balloon that is a cross-sectional of the balloon perpendicular to the longitudinal axis).
address claim 21, wherein the therapeutic element is positioned within the interior volume of the balloon (see Figs. 3-4; 312a-c are electrodes).
8. Addressing claim 23, the catheter system in claim 14 perform the method in claim 23 therefore claim 23 is being rejected for the same reason as claim 14.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Feng (US 20210046295 (provided in the IDS)) and in view of Lee (US 6,176,844).
Addressing claim 2, Feng does not explicitly disclose wherein the at least one lumen comprises an inlet lumen and an outlet lumen; wherein the flow path is defined through the inlet lumen, the interior volume, and the outlet lumen; and wherein a diameter of the outlet lumen is greater than a diameter of the inlet lumen. However, this only require routine skill in the art and it is a designer choice. Lee explicitly discloses wherein the at least one lumen comprises an inlet lumen and an outlet lumen; wherein the flow path is defined through the inlet lumen, the interior volume, and the outlet lumen; and wherein a diameter of the outlet lumen is greater than a diameter of the inlet lumen (see abstract and Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to have wherein the at least one lumen comprises an inlet lumen and an outlet lumen; wherein the flow path is defined through the inlet lumen, the interior volume, and the outlet lumen; and wherein a diameter of the outlet lumen is greater than a diameter of the inlet lumen as taught by Lee because this allow fast evacuation of fluid.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Feng (US 20210046295 (provided in the IDS)), in view of Lee (US 6,176,844) and further in view of Harshman et al. (US 2016/0310210).
Addressing claim 3, Feng does not disclose wherein the pressure signal is indicative of the pressure of the fluid within the outlet lumen. Harshman discloses wherein the pressure signal is indicative of the pressure of the fluid within the outlet lumen (see [0072] and Fig.13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to have wherein the pressure signal is indicative of the pressure of the fluid within the outlet lumen as taught by Harshman because this help detect fluid pressure downstream (see [0072]).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Feng (US 20210046295 (provided in the IDS)) and in view of Satake (US 2020/0038672).
Addressing claim 8, Feng does not explicitly disclose a positive displacement pump. Satake explicitly discloses a positive displacement pump (see [0017] and [0065]; perfusion and transfusing pump are positive displacement pump). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to have a positive displacement pump as taught by Satake because this provides good constant flow.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Feng (US 20210046295 (provided in the IDS)) and in view of Weber et al. (US 2015/0105773).
Addressing claims 9-12, Feng does not discloses the catheter system further comprising a therapeutic element mechanically supported by the catheter system, wherein the therapeutic element is configured to emit energy in a direction away from the longitudinal axis; wherein: the therapeutic element is configured to emit ultrasound energy; or a distal portion of the elongate body supports the therapeutic element; or the therapeutic element is positioned within the interior volume of the balloon; wherein the control circuitry is configured to: determine a power level, and cause the therapeutic element to emit the energy based on the determined power level; wherein the control circuitry is configured to determine the power level based on at least one of the pressure setpoint or the pressure signal indicative of the pressure of the fluid within the flow path. Weber discloses wherein the elongate body defines a longitudinal axis, the catheter system further comprising a therapeutic element mechanically supported by the catheter system, wherein the therapeutic element is configured to emit energy in a direction away from the longitudinal axis; wherein: the therapeutic element is configured to emit ultrasound energy; or a distal portion of the elongate body supports the therapeutic element; or the therapeutic element is positioned within the interior volume of the balloon; wherein the control circuitry is configured to: determine a power level, and cause the therapeutic element to emit the energy based on the determined power level; wherein the control circuitry is configured to determine the power level based on at least one of the pressure setpoint or the pressure signal indicative of the pressure of the fluid within the flow path (see Figs. 3, [0023] and [0033-0035]; 312a-c are electrode that emit energy; energy can be ultrasound energy produce by ultrasound electrodes; adjust/determine power level base on pressure sensor feedback; the power level cause therapeutic element emit energy at a certain level; Feng discloses pressure safety level which is input of pressure setpoint; Weber also discloses avoid too high pressure and over expansion of a balloon that implicit indicate of pressure setpoint and regular power level base on sensing pressure that is within or below the safety/set point pressure; 310a is pressure sensor within flow path; Feng also discloses pressure sensor within flow path that sense pressure of a fluid). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feng to have the catheter system further comprising a therapeutic element mechanically supported by the catheter system, wherein the therapeutic element is configured to emit energy in a direction away from the longitudinal axis; wherein: the therapeutic element is configured to emit ultrasound energy; or a distal portion of the elongate body supports the therapeutic element; or the therapeutic element is positioned within the interior volume of the balloon; wherein the control circuitry is configured to: determine a power level, and cause the therapeutic element to emit the energy based on the determined power level; wherein the control circuitry is configured to determine the power level based on at least one of the pressure setpoint or the pressure signal indicative of the pressure of the fluid within the flow path as taught by Weber because this help improve treatment procedure.
No art rejection for claim 13.
Response to Arguments
Applicant's arguments filed 03/23/26 have been fully considered but they are not persuasive. Applicant argues Feng does not expressly state that its pressure relief module 130, pressurization module 120, or safety valve 201 define a flow area for the fluid. Applicant’s argument is not persuasive the reference does not have to expressly state. When the valve open and close to allow fluid to flow into the balloon or stop fluid flow into the balloon is when the valve define a flow area for the fluid. When the valve is closed then it defines that the fluid flow area is the area where to fluid is store and flow to the valve and that does not include the balloon. When the valve is open then it defines the fluid flow area is the area that include the fluid reservoir flow all the way inside and include the balloon. The valve work in with the pressurization module and pressure relief module to open and close their together they define a fluid flow area. Applicant argues for example, opening and closing the safety valve may mean that fluid flows through the valve or that it does not flow at all, with no variable between the open and closed status and the path of the fluid flow may be an entirety of a lumen of where the valve is located (in open status) or nothing at all (in closed status), without a flow area that is separately adjustable from the size of the lumen and thus, opening and closing a valve may affect whether there is flow or not but does not adjust flow area as an amount of flow is not adjustable merely by opening and closing the valve. Applicant’s argument is not persuasive because when the valve is closed this just prevent fluid from enter the balloon, this does not prevent fluid flow in the lumen and the fluid reservoir. When the valve is closed the lumen and fluid reservoir is the flow area. When the valve is open the flow area is reservoir, lumen and the balloon. For example, when a person turns off the water faucet to the bathtub water still flow in the water tank and pipe. Regarding claim 22, this claim is being rejected for the same reason as claim 1 and as examiner explained in claim 1 how the valve controls the fluid area. The same explanation applied to claim 22. Claim 22 limitation is “positioning, using the control circuitry, a valve configured to throttle a flow of the fluid through the flow path based on a difference between a pressure setpoint and the pressure indicated by the sensor input”. The word throttle means controlling the flow. Feng discloses a valve position near the opening of the balloon to control the flow of fluid into the balloon based on a difference between a pressure setpoint and the pressure indicated by the sensor input. Feng discloses a valve that control fluid flow and define a flow area that include or exclude the balloon. Applicant argues Weber does not teach “an input indicative of a pressure within an interior volume of the balloon”. Applicant argues Weber discloses that its pressure sensors 310a and 310b “may be configured to sense contact between an outer surface of the compliant balloon 304 and a target tissue”. Applicant’s argument is not persuasive because as see in Fig. 3, the sensors 310a and 310b are inside the balloon 304. The sensors can determine if the outer surface of the compliant balloon in contact with the tissue by sensing the pressure changes inside the balloon (see [0033]; The pressure sensors 310a and 310b may be configured to sense contact between an outer surface of the compliant balloon 304 and a target tissue (e.g., via sensing increased resistance to further inflation); the resistance to further inflation cause by contact with tissue causes pressure changes in the balloon; sensing increased resistance to further inflation by sensors inside balloon is sensing pressure inside the balloon). When one squeeze the balloon by hand from the outside the pressure inside the balloon changes. The sensors sensing balloon surface contact by sensing pressure changes in the balloon. Regarding claim 2, applicant argues Lee does not provide any specifics about the size of the lumens. Applicant’s argument is not persuasive because as see in Fig. 1 and abstract major lumen 12 is a lot bigger than minor lumen 14. Applicant argues Lee does not disclose outlet lumens for the balloon. Applicant’s argument is not persuasive because lumen 12 is the outlet lumen.
Conclusion
THIS ACTION IS MADE FINAL. 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 HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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 Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights