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 (IDS) filed December 28, 2023 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 19 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 19, the phrase “wire rod portion” lacks proper antecedent basis in both claim 19 and in independent claim 17 (from which claim 19 depends).
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.
Claims 1-7 and 9-15 are is/are rejected under 35 U.S.C. 103 as being obvious over Takahashi et al. (U.S. Patent Application Publication No. 2021/0007791 – hereinafter Takahashi ‘791) in view of Takahashi et al. (U.S. Patent No. 11,950,836 – hereinafter Takahashi ‘836).
The applied references have a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, they constitute prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1-5 and 9-13 Takahashi ‘791 teaches a medical device 10 comprised of an elongated shaft portion 20 with an outer shaft 31 that holds an expansion body 21 at its distal end (see Fig. 1 and para. 0031-0032). Figure 1 shows that the outer shaft 31 has a distal end part to which a proximal end of the expansion body is fixed. Expansion body 21 includes a distal member 35 that may not be fixed to the expansion body and thus acts as a force receiving portion (see Fig. 2 and para. 0033). Expansion body 21 is expandable and contractible in a radial direction (see para. 0008). Takahashi ‘791 also teaches maintenance treatment elements 22, that are configured to be bipolar electrodes, disposed on the expansion body 21 (see Fig. 2 and para. 0046). Takahashi ‘791 also teaches a pulling shaft 33 disposed inside outer shaft 31 and inside expansion body 21 that connects to the distal member 35 by protruding from the distal end part of the outer shaft 31 where the pulling shaft 33 is slidable with respect to the outer shaft 31 (see Fig. 2 and para. 0033). The expansion body 21 includes a first, distal-side expansion portion extending radially outward from the distal member 35 and a distal-side top portion disposed on a proximal side of the distal side expansion portion and convexly curved radially outward (see Figs. 2 and 3). Similarly, the expansion body 21 includes a second, proximal-side expansion portion extending radially outward from the distal end part of the outer shaft 31 and a proximal-side top portion disposed on a distal side of the proximal-side expansion portion and convexly curved radially outward (see Figs. 2 and 3). Pulling shaft 33 functions to apply a compressive force to the distal-side expansion portion and the proximal-side expansion portion (see para. 0010). The expansion body 21 also includes a holding portion having a valley shape in the radial direction of expansion body (recessed radially inward) and serves to couple the proximal-side top portion with the distal-side top portion and the valley shape holds biological tissue (see Fig. 2 and para. 0035 and 0039). The holding portion 51 has a bottom portion, a proximal-side holding portion 52 and a distal-side holding portion 53 where the holding portions 52, 53 extend radially outward from to the distal-side top portion and the proximal-side top portion (see Figs. 2 and 3). The proximal-side holding portions 53 have projection portions 54 that hold the maintenance treatment elements 22 at regular intervals in a circumferential direction of the expansion body 21 (see Figs. 2 and 3 and para. 0036). Figures 2 and 3 show that the distal-side holding portions 52 include facing portions facing the plurality of maintenance treatment elements 22. Takahashi ‘791 teaches an expansion body 100 that has a plurality of strut structures on both the distal-side expansion portion and the proximal-side expansion portion (see Fig. 14 and para. 0068). Takahashi ‘791 is silent as to easy-to-deform portions on any part of the expansion body 21. However, Takahashi ‘836 teaches a similar medical device 10 with an expansion body 21 having a holding portion 51 that has a bending portion 54 that has a variety of forms for reducing the bending strength, such as a smaller diameter a slit portion 54a (Fig. 16A), a cutout portion (Fig. 16B), a plurality of small hole portions 54c (Fig. 16C) or a soft portion 54d formed from a softer material (Fig. 16E) (see also col. 12, lines 41-57). Takashi ‘836 thus demonstrates that the use of mechanical features and different materials to provide an easy-to-deform portion on an expansion body 21 was 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 any of the distal-side strut structures, proximal-side strut structures, projection portions 54 or the portions facing the projection portions 54 of Takahashi ‘791 with different mechanical structures (slits, cutouts, smaller diameter) or materials in order to make those portions easy-to-deform. With further respect to claim 9, see paras. 0053-0063 of Takahashi ‘791. In regard to claims 6, 7, 14 and 15, providing the mechanical structures or materials that cause easy-to-deform properties on the projection portions 54 or portions facing the projection portions 54 of Takahashi ‘791 would result in the easy-to-deform portion being sandwiched between more rigid portions with a higher bending rigidity and being a bent portion in a natural state.
Claims 8 and 16-20 are is/are rejected under 35 U.S.C. 103 as being obvious over Takahashi et al. (U.S. Patent Application Publication No. 2021/0007791 – hereinafter Takahashi ‘791) in view of Takahashi et al. (PCT Publication No. WO 2021/065873 – hereinafter Takahashi ‘873). The examiner will refer to the translation of Takahashi ‘873 as filed with the IDS on December 28, 2023.
The applied references have a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, they constitute prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 8, 16, 17 and 20, see the above rejection for claims 1 and 9. With further respect to claims 8, 16, 17 and 20, Takahashi ‘791 is silent as to a flexible portion on pulling shaft 33 that is bendable in the center with a distal end rigid portion and a proximal end rigid portion. However, Takahashi ‘873 teaches a similar medical device 10 with an expansion body 21 and an inner pipe 60 that effectuates the expansion of the expansion body 21 and extends from the second connecting portion 59 at the tip end portion of the expansion body 21 toward the proximal end side (see Fig. 2 and page 4). The inner pipe 60 has a flexible portion 62 that bends easier than an adjacent portion (see Figs. 3B and 3C and page 5). Figures 11A-11C show that the flexible portion 62 is disposed between a distal-end rigid portion and a proximal-end rigid portion. Takahashi ‘873 thus demonstrates that the use of flexible or bendable portions on a shaft within an expandable member are well known in the art so that the expandable portions can be more precisely placed. 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 Takahashi ‘791 with the inner pipe 60 and flexible portion taught by Takahashi ‘873 in order to more precisely place the expandable member. In regard to claim 18, see Fig. 11C of Takahashi ‘873. In regard to claim 19, see Figs. 11A-11E of Takahashi ‘873.
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