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 and Amendment Filed
Applicant’s response and amendment, filed May 13, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed February 20, 2026) is as follows:
The objection to the drawings under 37 CFR 1.83(a) and 37 CFR 1.84(p)(5) has been overcome by amendments to the specification.
The objection to the specification has been overcome by amendments to the specification.
The 35 USC 112(b) rejection of claim 12 has been overcome by amendments to claim 12.
The 35 USC 103 rejection of claims 1-19 as being unpatentable over Maslin et al. (PCT Publication No. WO 2023/225110) in view if Ramakrisha et al. (U.S. Patent Application No. 2017/0215837) is hereby withdrawn.
The following new grounds of rejection are set forth:
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) 1-9 and 11-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhai et al. (U.S. Patent Application Publication No. 2023/0027712).
In regard to claims 1-9 and 11-18, Zhai et al. teach a tissue treatment system 100 comprised of a catheter 102, a controller 120, a connection cable 140, a balloon 112 coupled to the catheter 102, a fluid reservoir 110 and a fluid transfer cartridge 130 (pump) (see Fig. 1 and para. 0054). The controller 120 interfaces with the cartridge 130 to provide cooling fluid to the catheter 102 for selectively inflating and deflating the balloon 112 (see para. 0055). The balloon 112 is mounted on a catheter shaft 214 which is an elongated tubular structure and the shaft 214 includes one or more lumens that can be used as a fluid conduit to communicate inflation/cooling fluid from the proximal region 220 to the balloon 112 (see paras. 0058-0059 and Figs. 3A1-3B). The cartridge 130 includes a syringe pump 540 (see para. 0096). The controller 120 includes one or more processors 612 and a memory 612 and the processor 612 interfaces with the cooling fluid supply subsystem 630 to control the flow of cooling fluid into and out of the balloon 112 (see para. 0102). One or more sensors can be located on a distal portion of a guide sheath used to insert the distal portion of the catheter 102 or on a guidewire to enable blood pressure and/or blood flow at the proximal side of the balloon 112 to be monitored (see paras. 0146-0147). The sensors can also be used to monitor the blood flow rate distal to the balloon 112 (see para. 0148). Zhai et al. teach that a microphone can be used as the sensors or that an ultrasound transducer 111, positioned within the balloon 112, can be used as a microphone type of sensor made of a piezoelectric material (see para. 0149). While the balloon 112 is being inflated, one or more sensors (which can be microphones) is/are used to produce sensor measurements indicative of pressure and/or flow rate of blood within the body lumen (see para. 0154). The system 100 can take blood flow sound measurements during inflation of the balloon 112 and perform processing on the measurements and then comparing to a look-up table to detect apposition within the body lumen in order to more safely inflate the balloon 112 and ensure adequate contact with the body lumen for more efficient and even cooling of the body lumen and decrease the complexity of the procedure (see paras. 0166-0169). In regard to claim 20, see para. 0173 of Zhai et al.
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(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhai et al. (U.S. Patent Application Publication No. 2023/0027712) in view of Maslin et al. (PCT Publication No. WO 2023/225110).
In regard to claims 10 and 19, Zhai et al. teach that the inflation/cooling liquid may be a gas (see para. 0081). Maslin et al. teach a similar catheter 10 with an occlusion balloon 16, a distal pressure sensor 22 positioned distal to the balloon 16 and a proximal pressure sensor 24 positioned proximal to the balloon 16 (see Fig. 1 and para. 0038). A control hub 18 is in fluid communication with the balloon 16 and in fluid communication with a fluid reservoir 32 that stores fluid for supply to the balloon 16 to facilitate inflation and deflation of the balloon 16 based on control signals from a controller 34 in control hub 18 (see Figs. 1 and 10 and para. 0041). The fluid may be a biocompatible gas, such as carbon dioxide (see para. 0041). Maslin et al. thus demonstrate that the use of carbon dioxide to inflate an occlusion balloon is well known in the art. Accordingly, since Zhai et al. teach the use of a gas tin inflate balloon 112, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the carbon dioxide taught by Maslin et al. as the gas to inflate the balloon 112 of Zhai et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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