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 .
Drawings
The drawings are objected to because Figures 5A and 5C have dark shading that obscures the structures of the claimed invention. Drawings should be black and white line drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) 12-14, 17-19 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,510,962 (Aoba et al.).
Aoba discloses a method of assembling a stent-deployment apparatus of Fig. 1, the method comprising:
providing a stent-conveyance tube (10) comprising a distal guidewire-retaining segment (the distal portion in which the guidewire is received generally indicated at callout 11; the Examiner notes that the term “guidewire retaining segment” is significantly broad to encompass any structure in which a guidewire is retained and does not require any particular features), the stent-conveyance tube (10) having a first locking member (40) of a proximally-withdrawable locking mechanism engaged with the stent-conveyance tube (the locking member 40 is engaged with (or coupled with) the stent-conveyance tube 10 via connection to respective handle components (61 and 62));
b. arranging a pushing tube (20) around a first stent-conveyance tube segment (proximal segment);
c. arranging a stent (1) around a second stent-conveyance tube segment that is proximally displaced from the guidewire-retaining segment (the distal portion end of the stent-conveyance tube extending distal to the stent in Fig. 1) and distally displaced from the first stent-conveyance tube segment (location of pusher tube 20); and
d. installing a second locking member (string 30), wherein the installing includes (i) engaging the second locking member (30) with the pushing tube (20) (via holes 21 and 22) and (ii) constraining a loop portion of the second locking member (30) within an interior volume of the stent (10 to be constrained therein by the presence of the first locking mechanism (40). (Note that the claim does not require the first locking member to be positioned within the interior of the stent, but only that the second locking member 30 is constrained within the stent).
Regarding claim 13, a guidewire (9) is passed through the distal guidewire-retaining segment (distal portion near callout 11) of the stent conveyance tube (10).
Regarding claim 14, Aoba discloses the guidewire is not assembled with the remainder of the assembly before use, as the guidewire (9) is introduced into the patient first (Fig. 4) and the stent delivery assembly is guided over the guidewire (Fig. 5), wherein the stent delivery assembly components are pre-assembled.
Regarding claim 17, the first locking member (40) is detachably attached to the stent-conveyance tube via handle members (61 and 62).
Regarding claim 18: Aoba discloses a stent-deployment assembly in Fig. 1 comprising:
a. an elongated stent-conveyance tube (10) comprising a hollow longitudinal lumen configured to have a guidewire (9) traverse longitudinally therethrough;
b. a stent (1) arranged to surround a first stent-conveyance tube segment;
c. a pushing tube (20) surrounding a second stent-conveyance tube segment that is proximally displaced from the first stent-conveyance tube segment;
d. a first locking member (40) engaged with the elongated stent-conveyance tube; and
e. a second locking member (string 30) comprising a first portion arranged to transversely traverse the pushing tube (20) (via holes 21 and 22) and a second portion constrained within an interior volume of the stent (1) by the presence of the first locking member (40) (note that the claim does not require the locking member to be positioned within the interior of the stent, but only that the second locking member 30 is constrained within the stent).
Regarding claim 19, wherein the first and second locking members (30 and 40) are effective in combination to constrain distal movement of the stent (1) relative to the pushing tube (20).
Regarding claim 23, the first locking member (40) is detachably attached to the elongated stent-conveyance tube (10) via the handle portions (61 and 62).
Allowable Subject Matter
Claims 1-11 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1: Prior art discloses stent-deployment assemblies having a guidewire that is configured to breach a laterally breachable portion of a guidewire retaining segment. USPAP 2019/0000652 (Einav et al.) discloses a stent deployment assembly have a stent (52) mounted on a stent conveyance tube (22) that has a guidewire retaining segment (122) (see region 55 in Figure 2), wherein proximal-direction withdrawal of the stent-conveyance tube is effective to (i) cause the guidewire (12) to breach the laterally-breachable portion (via slit 28) of the guidewire-retaining segment so as to decouple the guidewire from the tube without manipulation of the guidewire (see Figure 3A-3C; [0161-0175]). Einav fails to include a pushing tube proximal to the stent, with a proximally-withdrawable locking mechanism engaging the stent with the pushing tube, as a second stent (54) is positioned proximal to the first stent (52).
Prior art discloses the concept of a proximally withdrawable locking mechanism that engages a proximal end of a stent with a pushing tube, such that proximal movement of an internal stent conveyance tube disengages the locking mechanism. For example, USPAP 2005/0085891 (Goto) discloses a stent delivery device in Figures 1A-D with a stent conveyance tube (11), a stent (14) mounted on the stent-conveyance tube, a pushing shaft (15) positioned proximal to the stent, and a locking mechanism in the form of a ball (21) and detent (17), wherein proximal movement of the stent-conveyance tube is effective to disengage the locking mechanism [0051].
Further in regards to claim 1: Prior art fails to disclose or render obvious a stent deployment assembly wherein when movement of the stent is externally constrained, a proximal a proximal-direction withdrawal of the stent-conveyance tube is effective to (i) cause the guidewire to breach the laterally-breachable portion of the guidewire-retaining segment so as to decouple the guidewire from the tube without manipulation of the guidewire, and (ii) disengage the proximally- withdrawable locking mechanism. In other words, proximal movement of the stent conveyance tube causes the guidewire release from the guidewire retaining segment and the locking mechanism to release the stent from the pushing tube.
Claims 15, 16 and 20-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Aoba discloses the first locking member (40) is connected to and moves along with the slider (62), which moves relatively to the stent-conveyance tube (10) (see Figures 7-8; col 9, lines 1-10). Aoba fails to disclose or render obvious the first locking member fixed or integral with the stent conveyance tube, as such a modification would render the device inoperable for its intended purpose.
Regarding claim 20: the prior art fails to disclose or render obvious wherein when movement of the stent is externally constrained, a proximal-direction withdrawal of the stent-conveyance tube is effective to cause the second locking member (30) to no longer be constrained by the first locking member (40).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774