DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2026 has been entered.
Response to Amendment
The amendment filed 07/14/2026 has been entered. Claims 1-9 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 04/14/2026.
Response to Arguments
Applicant's arguments with respect to claims 1-9 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. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Rejections - 35 USC § 102
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 1, 9 is rejected under 35 U.S.C 102(a)(1) as being anticipated by Harlev et al. (US 20090171274) herein referred to as Harlev.
Regarding claim 1, Harlev discloses A catheter (Figure 2B, 10) comprising: a shaft to be inserted into a body (Figure 3B, 34); and a plurality of splines connected to a distal end side of the shaft (Figure 3B, 50); wherein the plurality of splines include a first spline and a second spline, and a third spline (See annotated Figure 3B below), the first spline and the second spline are located adjacent to each other circumferentially (See annotated Figure 3B below), the second spline and the third spline are located adjacent to each other circumferentially (See annotated Figure 3B below), and motions of the first spline and the second spline are restrained by a first restraining member (Figure 14, 300; Paragraph [0099]), and motions of the second spline and the third spline are restrained by a second restraining member (Figure 14, 300; Paragraph [0099]).
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Regarding claim 9, Harlev discloses the catheter according to claim 1 further comprising a distal end member connected to a distal end side of the plurality of splines (Figure 3B, 53), wherein the first restraining member is provided separately from the distal end member and the shaft (Figure 14, 300).
Claim Rejections - 35 USC § 103
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.
Claim 2-7 is rejected under 35 U.S.C 103 as being unpatentable over Harlev in view of Just et al. (US 20130172715) herein referred to as Just.
Regarding Claim 2, Harlev discloses the catheter according to claim 1, wherein the first restraining member includes a first end and a second end (See annotated Figure 14 below), at least a portion on the first end side of the first restraining member is located within the first spline (See annotated Figure 14 below), at least a portion on the second end side of the first restraining member is located within the second spline (See annotated Figure 14 below). However, Harlev does not explicitly disclose wherein the first restraining member includes a protruding portion protruding such that the protruding portion is closer to a distal end of the catheter than a distal end of the first spline and a distal end of the second spline are.
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Just discloses a catheter (Figure 1) wherein the first restraining member includes a protruding portion protruding such that the protruding portion is closer to a distal end of the catheter than a distal end of the first spline and a distal end of the second spline are (Figure 13, 231). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the first restraining member taught by Harlev to be as taught by Just. The motivation being to form a single, one-piece, unitary, monolithic structure (Just, Paragraph [0059]).
Regarding claim 3, Harlev in view of Just disclose the catheter of claim 2. Harlev discloses a distal end member connected to a distal end side of the plurality of splines (Figure 3B, 43), wherein the distal end member covers a distal end portion of the first spline, a distal end portion of the second spline (Figure 10B; wherein splines are covered by the distal end member). Just also discloses a distal end member connected to a distal end side of the plurality of splines (Figure 3, 40), wherein the distal end member covers a distal end portion of the first spline, a distal end portion of the second spline, and the protruding portion of the first restraining member (Paragraph [0043]; wherein distal end member covers distal end portion of the splines 28, in which is 228 in Figure 13, which also includes the protruding portion 231). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end member taught by Harlev to include the covering the protruding portion of the first restraining member as taught by Just. The motivation being to radially and/or axially confine each of the plurality of splines (Just, Paragraph [0043]).
Regarding claim 4, Harlev in view of just disclose the catheter according to claim 3. Just also discloses wherein in plan view of a lower surface of the distal end member, a wall portion forming an inner surface of the distal end member includes a first recess portion and a second recess portion that are located adjacent to each other (Figure 3, 30; wherein recess portions are wherein splines 24 sit), at least a portion of the distal end portion of the first spline is located in the first recess portion, and at least a portion of the distal end portion of the second spline is located in the second recess portion (See annotated Figure 3 below). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end member taught by Harlev to include the covering the protruding portion of the first restraining member as taught by Just. The motivation being to radially and/or axially confine each of the plurality of splines (Just, Paragraph [0043]).
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Regarding claim 5, Harlev in view of Just disclose the catheter according to claim 4. Harlev also discloses wherein an interior of the distal end member is filled with an adhesive (Figure 5B, 74)
Regarding claim 6, Harlev in view of Just discloses the catheter according to claim 3. Just also discloses wherein the distal end member includes a bundling member bundling the protruding portion of the first restraining member (Figure 3, 30). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end member taught by Harlev to include a bundling member as taught by Just. The motivation being to radially and/or axially confine each of the plurality of splines (Just, Paragraph [0043]).
Regarding claim 7, Harlev in view of Just discloses the catheter according to claim 6, wherein the bundling member has a plate shape including a first surface and a second surface that is a back surface of the first surface (See annotated Figure 3 below), the second surface faces a distal end surface of the first spline and a distal end surface of the second spline (See annotated Figure 3 below), and the bundling member is provided with a through-hole which penetrates from the first surface to the second surface and into which the protruding portion of the first restraining member is inserted (Figure 3; wherein protruding portions 34 are inserted into the thru-holes which penetrate through both surfaces). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end member taught by Harlev to include a bundling member as taught by Just. The motivation being to radially and/or axially confine each of the plurality of splines (Just, Paragraph [0043]).
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Claim 8 is rejected under 35 U.S.C 103 as being unpatentable over Harlev in view of Kordis et al. (US 5904680) herein referred to as Kordis.
Regarding Claim 8, Harlev discloses the catheter according to claim 1. However, Harlev does not explicitly disclose wherein the first restraining member is wire.
Kordis discloses A catheter (Figure 1) wherein the first restraining member is wire (Column 8, lines 1-13). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the first restraining member taught by Harlev to be wire as taught by Kordis. The motivation being wire allows for a resilient and inert structure (Kordis, Column 8, lines 1-13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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