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 .
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 4 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.
Claim 4 recites the limitation "the portion of the marker member" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KISHIDA (JP 2011-010787).
Regarding claim 1, KISHIDA teaches a catheter (21) comprising: a tubular body (1) having a lumen (as shown in Fig. 4-5); a reinforcing body (3) provided on an outer periphery of the tubular body (as shown in Fig. 4-5); and a radiopaque marker member (4) disposed on the reinforcing body along a circumferential direction of the reinforcing body (as shown in Fig. 4-5; abstract; para. 0031), wherein in a longitudinal axis direction of the tubular body, a distal end of the reinforcing body is positioned at a same site as a distal end of the marker member (as shown in Fig. 4 below), and a distal end portion of the marker member is joined to the reinforcing body (by notch/cutout/hole 7 that is filled with melted material, or adhesive; para. 0022; 0041-0043), and a portion of the marker member other than the distal end portion of the marker member is not joined to the reinforcing body (para. 0022; 0041-0043; as shown in Fig. 3-4, the joining portion is only by the notch/cutout/hole 7; in the top portion of the marker member 4, the notch/cutout/hole 7 is located at the distal end of the marker member).
[AltContent: textbox (Distal end of marker body (same applies to the top portion of the cross-section))][AltContent: textbox (Distal end of reinforcing body (same applies to the top portion of the cross-section) )][AltContent: textbox (Same site)][AltContent: arrow][AltContent: rect][AltContent: arrow][AltContent: ][AltContent: arrow][AltContent: ]
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Regarding claim 3, KISHIDA teaches the catheter according to claim 1, wherein the reinforcing body is a braided body that is braided using a wire (para. 0027).
Regarding claim 4, KISHIDA teaches the catheter according to claim 1, wherein the distal end portion of the marker member that is joined to the reinforcing body extends for a first dimension in the longitudinal axis direction of the tubular body that is smaller than a second dimension for which the portion of the marker member other than the distal end portion extends in the longitudinal axis direction of the tubular body (as shown in Fig. 3-4, the joining portion is only by the notch/cutout/hole 7 which is smaller than the rest of the marker member).
Regarding claim 5, KISHIDA teaches the catheter according to claim 1, wherein the portion of the marker member other than the distal end portion is either in contact with the reinforcing body or spaced apart from the reinforcing body (as shown in Fig. 4-5).
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.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over KISHIDA (JP 2011-010787).
Regarding claim 6, KISHIDA teaches a production method of a catheter (21) provided with a tubular body (1) having a lumen (as shown in Fig. 4-5), a reinforcing body (3) provided on an outer periphery of the tubular body (as shown in Fig. 4-5), and a radiopaque marker member (4) disposed on the reinforcing body along a circumferential direction of the reinforcing body (as shown in Fig. 4-5; abstract; para. 0031), the method comprising: disposing, in a longitudinal axis direction of the tubular body, a distal end of the reinforcing body and a distal end of the marker member at a distal end side of the tubular body (as shown in Fig. 3-4), and a distal end portion of the marker member is joined to the reinforcing body (by notch/cutout/hole 7 that is filled with melted material; para. 0022; 0041-0043; in the top portion of the marker member 4, the notch/cutout/hole 7 is located at the distal end of the marker member); and welding a contact portion formed by the reinforcing body and the distal end portion of the marker member without applying a mechanical external force to the contact portion (as shown in Fig. 4-5; para. 0022; 0041-0043), and without welding a portion of the marker member other than the distal end portion of the marker member (para. 0022; 0041-0043; as shown in Fig. 3-4, the joining portion is only by the notch/cutout/hole 7; in the top portion of the marker member 4, the notch/cutout/hole 7 is located at the distal end of the marker member).
KISHIDA fails to disclose disposing, in a longitudinal axis direction of the tubular body, the distal end of the reinforcing body at a site further toward the distal end side of the tubular body than the distal end of the marker member.
However, it will be an obvious matter of design choice to provide the distal end of the reinforcing body at a site further toward the distal end side of the tubular body than the distal end of the marker member, since the applicant has not disclosed that doing so solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the positioning of the distal end of the reinforcing body and the distal end of the marker member with respect to the distal end side of the tubular body of KISHIDA.
Regarding claim 7, KISHIDA teaches the production method according to claim 6, wherein at the same time as welding the contact portion by heating, a site of the reinforcing body further toward the distal end side of the tubular body than the distal end of the marker member is detached from the contact portion (when viewed as modified by design choice; para. 0022; 0041-0043; as shown in Fig. 3-4, the joining portion is only by the notch/cutout/hole 7; in the top portion of the marker member 4, the notch/cutout/hole 7 is located at the distal end of the marker member).
Regarding claim 8, KISHIDA teaches the production method according to claim 6, wherein heating of the contact portion during welding is performed by irradiation of laser light (para. 0022; 0041-0043).
Response to Arguments
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues that “In rejecting claim 2, the Office Action indicates that the distal end of alleged reinforcing body 3 is located as the same site as the distal end of the alleged marker member 4. However, it is clearly shown in each of the figures of Kishida (e.g., Figure 4) that the distal end of the alleged marker member 4 is disposed further toward the distal end side of the tubular body (1 and 2) than the distal end of alleged reinforcing body 3 (see arrow annotations on Figure 4 of Kishida below). In other words, the distal end of the alleged reinforcing body 3 is not located as the same site as the distal end of the alleged marker member 4.” on remarks page 4, lines 19-24 and page 5, lines 1-2. In response to Applicant’s arguments, KISHIDA teaches wherein in a longitudinal axis direction of the tubular body, a distal end of the reinforcing body is positioned at a same site as a distal end of the marker member (as shown in Fig. 4 above).
Regarding claim 6, Applicant argues that “In rejecting claim 7, the Office Action does not address claim 7 because "this limitation does not apply as it is an alternative" (Office Action, page 7). The features of claim 7 are now incorporated into claim 6 and are not recited as an alternative. The cited art is deficient because the opposite arrangement is disclosed by Kishida. Specifically, as shown in Figure 4 of Kishida, the distal end of the alleged marker member 4 is disposed further toward the distal end side of the tubular body (1 and 2) than the distal end of alleged reinforcing body 3.” on remarks page 5, lines 5-11. In response to Applicant’s arguments, KISHIDA fails to disclose disposing, in a longitudinal axis direction of the tubular body, the distal end of the reinforcing body at a site further toward the distal end side of the tubular body than the distal end of the marker member. However, it will be an obvious matter of design choice to provide the distal end of the reinforcing body at a site further toward the distal end side of the tubular body than the distal end of the marker member, since the applicant has not disclosed that doing so solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the positioning of the distal end of the reinforcing body and the distal end of the marker member with respect to the distal end side of the tubular body of KISHIDA.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALBA T ROSARIO-APONTE whose telephone number is (571)272-9325. The examiner can normally be reached M to F; 8am-5pm.
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/ALBA T ROSARIO-APONTE/Examiner, Art Unit 3761 08/05/2026
/ELIZABETH M KERR/Primary Examiner, Art Unit 3761
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