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 June 18, 2024 has been entered and the references cited therein have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 10, the last paragraph referring to “no more than a value obtained by dividing an amount of the liquid discharged by the agitator from the liquid flow path by a cross-sectional area of the liquid flow path” is vague and indefinite. None of the “value”, the “amount” or the “cross-sectional area” are defined in the claim.
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)(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, 2, 3/1, 3/2, 4/1, 4/2, 4/3, 5/1, 5/2, 5/3, 5/4, 6/1, 6/2, 6/2, 6/4, 6/4, 9/1, 9/1, 9/3, 9/4, 9/5 and 9/6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsukuma et al. (U.S. Patent Application Publication No. 2007/0149963).
In regard to claims 1, 4/1, 4/2, 4/3, Matsukuma et al. teach a balloon catheter 1 comprised of an outer cylindrical shaft 3, an inner cylindrical shaft 4 provided inside the outer cylindrical shaft 3 and a balloon 2 that is attached as its front (distal) end 2F to the front (distal) end 4F of the inner cylindrical shaft 4 and at its rear (proximal) end 2R to the front (distal) end 3F of the outer cylindrical shaft 3 (see paras. 0092-0093 and Fig. 1). A first electrode 5A and a second electrode 5B (collectively the heating unit) are positioned in the balloon 2 (see Fig. 1). Figures 1 and 2 show that the electrodes 5A, 5B are distributed over an outer circumferential surface of the inner cylindrical shaft 3. A liquid supply passage 6A for supplying liquid into the balloon 2 is formed in the clearance between the outer cylindrical shaft 3 and the inner cylindrical shaft 4 and the rear end 2R of the balloon 2 has a liquid introducing port 2A communicating with the liquid supply passage 6A (see Fig. 1 and para. 0095). A temperature sensor 9 is disposed in the balloon 2 and temperature information deriving leads 11 for deriving the temperature information detected by the temperature sensor 9 are connected with the high-frequency power supply apparatus 10 containing a temperature information processor (see para. 0121 and Figs. 1 and 4). The high frequency power supplied from the high frequency power supply apparatus 10 to the electrodes 5A, 5B is quantitatively adjusted in response to the measurement result of the temperature sensor 9 (see para. 0121). In regard to claim 2, see para. 0105. In regard to claims 3/1 and 3/2, Figures 1 and 2 show that the length of an area in which the electrodes 5A, 5B are located is half or more than half of a length of the inner cylinder shaft 3 inside the balloon 2. In regard to claims 5/1, 5/2, 5/3 and 5/4, Matsukuma et al. teach that the surface area of the electrodes 5A, 5B is 20mm2 or more, indicating that the length of each electrode 5A, 5B is greater than 3 mm (since area would be length x width) (see paras. 0096 and 0106). In regard to claims 6/1, 6/2, 6/3, 6/4 and 6/5, see para. 0108. In regard to claims 9/1, 9/2, 9/3, 9/4, 9/5 and 9/6, Matsukuma et al. teach a liquid supply device 6 where the liquid supplied passes through the liquid supply passage 6A and an agitator 8 disposed with the liquid supply device 6 to reciprocate the liquid in the balloon 2 between the inside of the balloon 2 and the liquid supply passage 6A (see Fig. 1 and para. 0120). As noted above, the high frequency power supplied from the high frequency power supply apparatus 10 (control unit) to the electrodes 5A, 5B is quantitatively adjusted in response to the measurement result of the temperature sensor 9 (see para. 0121).
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) 7/1, 7/2, 7/3, 7/4, 7/5, 7/6 and 9/7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsukuma et al. (U.S. Patent Application Publication No. 2007/0149963).
In regard to claims 7/1, 7/2, 7/3, 7/4, 7/5, 7/6 and 9/7, Matsukuma et al. are silent as to a distance between a distal end of the outer cylindrical shaft 3 and a proximal end of the electrodes 5A, 5B. However, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make a distance between the distal end of the outer cylindrical shaft 3 and a proximal end of the electrodes 5A, 5B between 0 and 5 mm as the device is disclosed in terms of mm (see, e.g., paras. 0106-0109 and 0147) and such a modification is within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 8, 9/8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsukuma et al. (U.S. Patent Application Publication No. 2007/0149963) in view of Panescu et al. (U.S. Patent No. 6,030,379).
In regard to claims 8, 9/8 and 10, Matsukuma et al. are silent as to a liquid flow path temperature sensor. However, Panescu et al. teach a similar catheter with a temperature sensing element 106 that is located to sense the temperature of cooling medium as it enters the electrode cavity 78 (see Fig. 9A and col. 12, lines 52-60). Panescu et al. thus demonstrate that temperature sensors placed in a liquid flow path are well known in the art for the purpose of sensing the temperature of the incoming fluid. 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 balloon catheter 2 of Matsukuma et al. with a temperature sensor in the liquid flow path 6A in order to sense the temperature of the incoming fluid. In addition, Matsukuma et al. are silent as to a distance between a distal end of the outer cylindrical shaft 3 and a proximal end of the electrodes 5A, 5B. However, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make a distance between the distal end of the outer cylindrical shaft 3 and a proximal end of the electrodes 5A, 5B between 3 and 5 mm as the device is disclosed in terms of mm (see, e.g., paras. 0106-0109 and 0147) and such a modification is within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant should note the following prior art examples of balloon catheters with heating electrodes: Satake, PCT Publication No WO 2010/070766; Chang et al., U.S. Patent Application Publication No. 2022/0110669; Zhao et al., U.S. Patent Application Publication No. 2022/0008111; Nguyen et al., U.S. Patent Application Publication No. 2019/0343580; Migawa et al., U.S. Patent Application Publication No. 2017/0119450; Wittenberger et al., U.S. Patent Application Publication No. 2015/0164570; and Lalonde et al., U.S. Patent Application Publication No. 2013/0197499.
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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