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 filed August 2, 2024 has been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
Applicant’s preliminary amendment, filed July 12, 2024, has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 1, 4, 8, 10-13, 16, 18, 20 and 25-28 are amended; claims 2, 3, 5-7 and 9 remain as originally presented; claims 14, 15, 17, 19, 21-24 and 29-42 are canceled.
Specification
The disclosure is objected to because of the following informalities: In para. 0049, “process 602” seems to be an incorrect numeral as Figure 4 is being discussed.
Appropriate correction is required.
Claim Objections
Claim 11 is objected to because of the following informalities: In claim 11, “first rate” and “second rate” should be “first flow rate” and “second flow rate”, respectively, to align with the specification and the claims. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13, 16, 18, 20 and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (U.S. Patent Application Publication No. 2014/0371736) in view of Mon (U.S. Patent Application Publication No. 2003/0229384).
In regard to claims 1 and 25-28, Levin et al. teach a system comprised of a tissue treatment device 100 with a shaft 110 (elongate instrument) with a lumen 113 (first channel) and a lumen 160 (second channel) and a balloon 120 coupled to a distal portion of the shaft 110 (see Fig. 1 and para. 0128). The distal ends of lumens 113, 160 are positioned in balloon 120 and lumens 113 160 are in fluid communication with the balloon 120 (see Fig. 1 and para. 0128). Ports 161, 162, 162 are configured to deliver fluid to balloon 120 and/or to extract fluid from balloon 120 and a pump or negative pressure can be provided to perform a negative pressure priming procedure (see para. 0134). In addition, port 161 is attached to fluid delivery device 600, typically a pump or pressurized reservoir configured such that fluid flows from lumen 160 into balloon 120 and port 163 is attached to fluid extraction device 700, such as a pump or reservoir, configured such that fluid flows from balloon 120 into lumen 113 and out port 163 (see Fig. 4A and para. 0137). Figure 4B shows that these connections can be reversed. Levin et al. also teach the use of a heater 135 for heating the fluid (see Fig. 2 and paras. 0130 and 0166). Levin et al. are silent as to the fluid extraction device 700 being configured to restrict a drainage flow but do disclose using the lumens 113, 160 and fluid delivery device 600 and fluid extraction device 700 to precisely control the fluid to/from balloon 120 (see, e.g., para. 0137 and para. 0142). However, Mon teaches a similar catheter 100 with a balloon 112 where warmed fluid is pumped through lumens 120 into balloon 112 at one end to fill the balloon 112 and pumped out at the other end to remove the fluid (see Fig. 4 and para. 0042). Mon also teach that an outtake-fluid-side channel 115b is fitted with a restrictive orifice 116 to control the balloon 112 pressure and it may be opened to determine the amount of fluid flow (see para. 0042). Mon thus demonstrates that restrictive orifices for controlling the fluid flow through an outtake or draining channel are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the extraction device 700 of Levin et al. with the restrictive orifice of Mon in order to control the fluid flow to the extraction device 700 and thus control the pressure in the balloon 120, in the manner disclosed by Mon. Levin et al. also teach that the system may comprise a controller constructed and arranged to modify delivery of the temperature of a fluid delivered to the balloon 120 and the flow rate of a fluid delivered to the balloon 120 and the controller may modify temperature, flow rate and/or pressure (see para. 0043 and 0113). Levin et al. also teach thermal priming, which is pre-heating performed prior to balloon 120 inflation (see Fig. 6C and para. 0146), inflating the balloon 120 with heated fluid (see Fig. 6C and para. 0148), ablating an anatomic passage with the balloon 120 (see Fig. 19 and paras. 0127 and 0195) and deflating the balloon 120 (see para. 0123). In regard to claims 2 and 3, see paras. 0068, 0124, 0141 and 0142 of Levin et al. In regard to claim 4, see Figures 6C and 6D of Levin et al. In regard to claim 5, see paras. 0068, 0137, 0141 and 0146-0148 of Levin et al. In regard to claims 6-8, see paras. 0137, 0142 and 0146-0148 of Levin et al. In regard to claims 9-11, see Figs. 6A-6D and paras. 0137-0148 of Levin et al. In regard to claim 12, see para. 0118 of Levin et al. In regard to claim 13, see Fig. 13 and para. 166 of Levin et al. teaching fluid transport mechanism 800 with an impeller that constitutes an agitator system. In regard to claim 16, Levin et al. are silent as to either lumen 113 or lumen 160 having a plurality of sub-channels. However, Mon teaches a plurality of lumens 120 in catheter 100 (see Fig. 3a and para. 0042). Mon thus demonstrates that providing a plurality of fluid lumens on a catheter with a balloon is well known in the art for the purposes of increasing the fluid flow or distribution. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the catheter 100 of Levin et al. with a plurality of fluid flow lumens, in the manner disclosed by Mon, in order to equip the device with the ability to increase the fluid flow or distribution. In regard to claim 18, see Figs. 12A-!2c and para. 0159 of Levin et al. In regard to claim 20, see paras. 0064, 0121 and 0124 of Levin et al. In regard to claim 25, see Fig. 13 and para. 0166 of Levin et al.
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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