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 .
Preliminary Amendment
The preliminary amendment filed January 8, 2024 has been entered and made of record.
Information Disclosure Statements
The information disclosure statements (IDSs) filed January 8, 2024 and January 8, 2026 have been entered and the references cited therein have been considered by the examiner.
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) 1-3, 5-10 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Burnett et al. (U.S. Patent Application Publication No. 2021/0251677).
In regard to claims 1-7, 9 and 20, Burnett et al. teach a cryotherapy catheter or probe 102 with a cryotherapy balloon 1402 at its distal end where balloon 1402 is restricted by sheath 3202 with has openings 3204 (see Figs 32-35). Thus, the sheath 3202 has a lumen and a slot (opening 3204) where the balloon 1402 is disposed within the lumen and is configured to protrude outward from the opening 3204 with expanded with cryogenic fluid (see also para. 0069 and Figs. 36-38). Figures 33-35 show a plurality of openings 3204 and that the distal end of the sheath 3202 is biased to a linear configuration. Figures 33 and 34 show a plurality of openings 3204 that are longitudinally spaced along the sheath 3202, disposed at a same radial position, at least one longitudinal opening and are of a same size and evenly spaced along the sheath 3202 (see also paras. 0070 and 0071). In regard to claim 8, see Fig. 38 which shows additional lobes of the balloon 1402 which arise from additional openings on the sheath 3202. In regard to claim 10, Burnett et al. teach retainer 3502 that restricts the cryotherapy balloon longitudinally where the sheath 3202 may not be connected to the retainer and thus the retainer 3502 would be positioned within the lumen of sheath 3202 (see Fig. 35 and para. 0073).
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) 4 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (U.S. Patent Application Publication No. 2021/0251677) in view of Gnanashanmugam et al. (PCT Publication No. WO 2013/090848).
In regard to claim 4, Burnett et al. are silent as to the distal end of the sheath 3202 is biased to a spiral configuration. However, Gnanashanmugam et al. teach a similar apparatus for neural modulation comprised of a pair of catheters 222a, 222b having expandable distal sections 223a, 223b comprised of self-expanding helical electrodes 224a, 224b to facilitate and enhance contact with the vessel wall (see Fig. 20 and page 40, lines 14-27). Gnanashanmugam et al. thus demonstrate that the use of self-expanding devices for neural modulation 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 make the distal end portion of the sheath 3203 of Burnett et al. to bias into a spiral configuration in order to facilitate and enhance contact of the balloons 1402 carried by sheath 3202 with the vessel wall. In regard to claims 11, 12 and 14-19, see the above rejection for claims 1, 2, 5-7, 9 and 10. With further respect to claim 11 and in regard to claim 13, as noted above, Gnanashanmugam et al. teach first and second expandable distal sections 223a, 223b within a guide sheath 150 (see Fig. 20) for the purpose of for effectively treating the vasculature (see page 40, lines 14-27). Gnanashanmugam et al. thus demonstrate that providing two expandable distal sections was well known in the art. Furthermore, it is well settled that the duplication of parts is a design choice well within the skill of the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1955). 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 device of Burnett et al. with two probes 102 and two sheaths 3202 within a guide sheath, in the manner disclosed by Gnanashanmugam et al., in order to provide the device with a structure that effectively treats the bodily lumen.
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.
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, Linda Dvorak can be reached at 571-272-4764. 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.
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794