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 Objections
Claim 7 is objected to because of the following informalities: in line 3, the limitation “the distal end side” should read “the distal end side of the tubular body”. Appropriate correction is required.
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.
Claims 1-8 are 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 1 recites the limitation "the same site" in line 7. There is insufficient antecedent basis for this limitation in the claim.
In claim 1, the limitation “a distal end portion of the marker member” is unclear if it is referring to the “distal end of the marker member” or if it is a portion of the distal end of the marker member?
In claim 2, the limitation “wherein in the longitudinal axis direction of the tubular body, the distal end of the reinforcing body is positioned at the same site as the distal end of the marker member” is unclear because independent claim 1 gives the alternative of “a distal end of the reinforcing body is either positioned at the same site as a distal end of the marker member, or positioned at a site further toward a distal end side of the tubular body than the distal end of the marker member”, so if the second option (a site further toward a distal end side of the tubular body than the distal end of the marker member) is elected in independent claim 1, then the limitation of claim 2 is no longer a valid option, and therefore does not apply. Claim 2 will only be valid if the first option is elected in claim 1, and it will also be a repetitive limitation of what is already elected in independent claim 1. For examination purposes, this limitation will be considered an alternative as in claim 1.
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 6 recites the limitation "the same site" in line 6. There is insufficient antecedent basis for this limitation in the claim.
In claim 7, the limitation “the distal end of the reinforcing body is disposed at the site further toward the distal end side than the distal end of the marker member” is unclear because independent claim 6 gives the alternative of “disposing, in a longitudinal axis direction of the tubular body, a distal end of the reinforcing body at either the same site as a distal end of the marker member, or at a site further toward a distal end side of the tubular body than the distal end of the marker member, and at the same time as welding the contact portion by heating, a site of the reinforcing body further toward the distal end side than the distal end of the marker member is detached from the contact portion”, so if the first option (same site) is elected in independent claim 6, then the limitation of claim 7 is no longer a valid option, and therefore does not apply. Claim 7 will only be valid if the second option is elected in claim 6. For examination purposes, this limitation will be considered an alternative as in claim 6.
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 1-8 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 either positioned at the same site as a distal end of the marker member, or positioned at a site further toward a distal end side of the tubular body than the distal end of the marker member (same site; 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, 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).
Regarding claim 2, KISHIDA teaches the catheter according to claim 1, wherein in the longitudinal axis direction of the tubular body, the distal end of the reinforcing body is positioned at the same site as the distal end of the marker member (as shown in Fig. 4-5).
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).
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 at either the same site as a distal end of the marker member, or at a site further toward a distal end side of the tubular body than the distal end of the marker member (same site; 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).
Regarding claim 7, KISHIDA teaches the production method according to claim 6, wherein in the longitudinal axis direction of the tubular body, the distal end of the reinforcing body is disposed at the site further toward the distal end side than the distal end of the marker member, and at the same time as welding the contact portion by heating, a site of the reinforcing body further toward the distal end side than the distal end of the marker member is detached from the contact portion (this limitation does not apply as it is an alternative as already explained in 112b rejections section).
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2016/0279385, US 2017/0246425, US 2020/0330735 and US 2015/0314108.
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 02/03/2026
/STEVEN W CRABB/Supervisory Patent Examiner, Art Unit 3761