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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/7/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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 2 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 2 recites the limitation "a plurality of the converting means". There is insufficient antecedent basis for this limitation in the claim as no “converting means” has been previously defined in the claims. For the purposes of examination, the phrase” converting means” is interpreted to recite “converting units” and refer to the “converting units” previously defined in claim 1.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites, “wherein the converting units has…” and should be corrected to recite “wherein the converting units have” to be in better grammatical form when referring to a plurality of converting “units”.
Appropriate correction is required.
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)(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.
(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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melsheimer (US 2007/0016281 A1).
Regarding claim 1, Melsheimer discloses:
A catheter (introducer system shown in Fig. 1 which includes a guide catheter through which the introducer (10) in inserted as recited in Para. [0035]-[0036]; this remains consistent with the disclosed invention in which the “catheter” is comprised of multiple tubular elements, forming an overall catheter assembly as shown in Figs. 1A-1B and Para. [0017] of the Specification) for delivering a tubular indwelling device (stent 36, see Fig. 1) to be placed in a biological lumen, comprising:
a sheath (guide catheter through which the introducer device (10) is inserted to a target site as recited in Para. [0035]-[0036]);
a long shaft-like member (introducer body 40, see Fig. 3) configured to be movable in the sheath in an axial direction (see Para. [0027] and [0035]-[0036] mentioning wherein the shaft (12), to which the introducer body is attached (see Fig. 1), is inserted through the guide catheter and thus moveable relative thereto); and
converting units (control members 24, see Figs. 4-5) configured to be capable of maintaining at least a portion of the tubular indwelling device in the axial direction in a contracted state in a state in which the tubular indwelling device is released from the sheath and converting the portion from the contracted state to an expanded state (see Para. [0027], [0029] and [0031]);
wherein the shaft-like member is provided with a holding portion (support rings 41, see Figs. 3-5) that holds the converting units (see Figs. 3-4 and Para. [0028]-[0029]), and the holding portion is formed to be able to position the tubular indwelling device in the contracted state in an axial direction of the shaft-like member (see Para. [0027]-[0031] and Fig. 4).
Regarding claim 2, Melsheimer discloses the invention of claim 1, Melsheimer further discloses wherein a plurality of the holding portions are provided (see Figs. 2-5) spaced apart in the axial direction of the shaft-like member (see Figs. 2-4 showing wherein a plurality of support rings are spaced apart along a longitudinal axis of the introducer body), and a plurality of the converting means are provided corresponding to the plurality of holding portions (see Figs. 2-5 showing a plurality of support rings and control members connected thereto).
Regarding claim 3, Melsheimer discloses the invention of claim 1, Melsheimer further discloses wherein the holding portion has an engagement portion that is engageable with the tubular indwelling device in the contracted state (see Para. [0028]-[0029] and Figs. 2-4 showing wherein the stent is positioned within the radial confines of the plurality of support rings which prevent the stent from expanding until removed therefrom).
Regarding claim 4, Melsheimer discloses the invention of claim 1, Melsheimer further discloses wherein the converting units has at least one linear member (see Figs. 2-5 showing a plurality of linear control members), and the holding portion is a guide rib (support rings are formed as guide ribs as shown in Figs. 2-5) having an attachment portion to which the shaft-like member is attached (see Para. [0028] and [0030] mentioning wherein the support rings are connected to one-another and form the introducer body via a series of struts 43; the portions of the support rings contacting the struts are defined to be the ”attachment portions” as shown in Examiner’s Diagram of Fig. 3 below) and a guide portion through which the linear member is inserted (see Figs. 4 and 6 showing wherein control wires (24) are inserted through portions (i.e., lobes 42) of the support rings; the portions of the support rings contacting the control wires are defined to be the “guide portions” as shown in Examiner’s Diagram of Fig. 4 below).
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Examiner’s Diagram of Fig. 3
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Examiner’s Diagram of Fig. 4
Regarding claim 5, Melsheimer discloses the invention of claim 4, Melsheimer further discloses wherein the attachment portion is provided eccentrically with respect to a circumscribed circle of the guide rib in a cross section perpendicular to the axial direction (see Figs. 3-6 showing wherein the “attachment portion” is provided eccentrically along the peripheral edge of the circumferential support rings).
Regarding claim 6, Melsheimer discloses the invention of claim 4, Melsheimer further discloses wherein the guide rib has an engagement portion that is engageable with the tubular indwelling device in the contracted state (see Fig. 4 showing wherein the radially-inward portion of the support rings contact the stent while in a compressed form to prevent expansion until the support rings are withdrawn), and the guide portion is provided in the engagement portion (see Figs. 3-6 showing wherein the radially-inward portion(s) of the support rings receiving the struts (43) therein are the same radially-inward portions that would be contacting the stent in the compressed form; this is shown better in Fig. 6).
Regarding claim 7, Melsheimer discloses the invention of claim 5, Melsheimer further discloses wherein a notch is provided in part of the attachment portion (see Figs. 2-4 showing a plurality of notches forming the support rings that form lobes 42 along the circumferential edge of the support rings).
Regarding claim 8, Melsheimer discloses the invention of claim 4, Melsheimer further discloses wherein the guide rib is a molded product made of one member (see Figs. 2-4 showing wherein the support rings comprises a molded ring-shape (i.e., a specific shape formed with a plurality of lobes) and are each comprised of a single member).
Regarding claim 9, Melsheimer discloses:
A delivery system (see Fig. 1) comprising:
a tubular indwelling device to be placed in a biological lumen (stent 36, see Fig. 1); and
a catheter for delivering the tubular indwelling device into the biological lumen (introducer system shown in Fig. 1 which includes a guide catheter through which the introducer (10) in inserted as recited in Para. [0035]-[0036]; this remains consistent with the disclosed invention in which the “catheter” is comprised of multiple tubular elements, forming an overall catheter assembly as shown in Figs. 1A-1B and Para. [0017] of the Specification);
wherein the catheter includes:
a sheath (body of the guide catheter; see Para. [0035]-[0036]);
a long shaft-like member (introducer body 40, see Fig. 3) configured to be movable in the sheath in an axial direction (see Para. [0027] and [0035]-[0036] mentioning wherein the shaft (12), to which the introducer body is attached (see Fig. 1), is inserted through the guide catheter and thus moveable relative thereto); and
converting units (control members 24, see Fig. 4) configured to be capable of maintaining at least a portion of the tubular indwelling device in the axial direction in a contracted state in a state in which the tubular indwelling device is released from the sheath and converting the portion from the contracted state to an expanded state (see Para. [0027], [0029] and [0031]);
the shaft-like member is provided with a holding portion (support rings 41, see Figs. 3-4) that holds the converting units (see Figs. 3-4 and Para. [0028]-[0029]), and the holding portion is formed to be able to position the tubular indwelling device in the contracted state in an axial direction of the shaft-like member (see Para. [0027]-[0031] and Fig. 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 2011/0295288 A1 to Khosrovaninejad, US 2010/0324651 A1 to Holzer, US 2008/0294231 A1 to Aguilar, US 8118852 B2 to Melsheimer, US 2006/0190070 A1 to Dieck, JP 2005000569 A to Takahashi, US 2008/0071343 to Mayberry, US 5372600 A to Beyar, US 2014/0000112 A1 to Braido, US 2020/0246161 A1 to Worrel, US 2014/0277332 A1 to Slazas, US 6520983 B1 to Colgan, US 2013/0268048 to Watson, US 2018/0280171 A1 to Gloss, US 2012/0316636 A1 to Young, US 2023/0225864 A1 to Pham and US 2012/0059450 A1 to Chiang all disclose stent delivery devices comprising a wound, wire-like stent retention mechanism connected to one or a plurality of holding portions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771