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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 21 of claim 1, “the occluders” should be changed to “the proximal and distal occluders” to maintain consistent terminology.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a cutter carried by the handle for severing the tensioning member” in claim 3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Examiner notes that FIG 73 shows a handle but the lever is operated to release retention tube 310E (not a filament as claimed) from the distal occluder 205E by unlocking a mechanical interlock ([0069]). This disclosure fails to show a cutter carried by the handle for severing the tensioning member.
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
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.
Claim(s) 1- 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz (US 2011/0082495).
Regarding claim 1, Ruiz discloses an apparatus (Device 70 and 45 as shown in FIGS 3-5C, or in the alternative, the device of FIGs 9-10C, [0065-0078]) for controlling blood loss from a blood vessel of a mammalian patient comprising (Although the device is shown being used to collapse and occlude an LAA, the device is at least capable of being used to collapse and occlude a blood vessel, thereby achieving the function of controlling blood loss from said blood vessel. Further, the device of Ruiz comprises all of the claimed structure and therefore is understood to be at least configured to achieve the same function as what is disclosed in the claim): a handle (Not shown, [0044] discloses outer sheath 100 comprises “a suitable proximal end (not shown) for manipulation by a clinician”. This is understood to be a handle. In the alternative embodiment, [0074] discloses that outer sheath 170 also includes “a suitable proximal end (not shown) for manipulation by a clinician” which is interpreted as the handle); a delivery tube (100, or in the alternative embodiment, 170) attached to the handle ([0044] or [0074]) and having proximal (Suitable proximal end not shown) and distal ends (Distal end shown in FIGs 4A-5C or alternatively, FIGS 10A-10C) and a lumen (101, [0044] or 171) with an axis (Longitudinal axis of the device as shown in FIGS 4A-5C and 10A-10C), the delivery tube being adapted to be advanced transversely through the walls of the blood vessel (The delivery tube is at least sized and shaped such that it could pass through the walls of a blood vessel if the blood vessel had apertures of an appropriate size); a proximal occluder (60, FIG 3, [0038, 0047, 0049-0052], or alternatively 130, FIG 9, [066, 0068, 0070, 0074-0078]) having an axis and being disposed coaxially within the lumen of the delivery tube in a low-profile configuration (FIG 5A. The alternative embodiment of FIG 9 does not show the delivery configuration but is it understood to be similar to what is previously disclosed), the proximal occluder being configurable to have at least a portion thereof assume a configuration oriented radially of the delivery tube axis when ejected out of the delivery tube (deployed shape of FIG 5C or alternative, FIG 10A-10C); a distal occluder (50, FIG 3, [0040, 0046-0047, 0049-0051], or alternatively 120, FIG 9, [0066, 0068, 0074-0078]) having an axis and being disposed coaxially in a low-profile configuration within the lumen of the delivery tube distally of the proximal occluder (FIG 5A shows the low profile delivery configuration aligned with the longitudinal axis and distal of the proximal occluder. The alternative embodiment of FIG 9 does not show the delivery configuration but is it understood to be similar to what is previously disclosed), the distal occluder being configurable to have at least a portion thereof assume a configuration oriented radially of the delivery tube axis when ejected out of the delivery tube (Deployed shape of FIG 5B and 5C, or alternatively FIGs 10A-10C); an elongate tensioning member (80, or alternatively 180) being detachably connected to the distal occluder ([0042 and 0047], or alternatively [0072, 0075-0077]) and extending proximally through the delivery tube (FIG 4A-5C, [0044], or alternatively FIG 10A-10C); the distal occluder being ejectable from the delivery tube separately from (Because movement of 80 is separate from 90, which deploys the proximal occluder. Alternatively, because movement of 180 is separate from 160 which deploys the proximal occluder) and before ejection of the proximal occluder (FIGs 5A-5B show distal occluder 50 is deployed prior to 60, [0046]. Although not shown in FIGs 10A-10C, it is understood that a partially deployed state exists where the distal occluder is ejected before the proximal occluder); an elongate member (90, or alternatively 160) extending through the delivery tube (FIG 4A-5C, [0044], or alternatively FIGS 10A-10C, [0074]) and operatively associated with the proximal occluder to urge the proximal occluder in a distal direction ([0046, 0050], or alternatively [0073-0076]); whereby, the occluders may be deployed, sequentially (FIGs 5A-5C, [0048-0050]), on opposite sides of the vessel (FIG 5B-5C show the occluders being deployed on opposite sides of wall 34 of the LAA, therefore they are at least capable of being deployed on opposite sides of a vessel. Operation of the device is similar for the embodiment of FIG 9-10C) and may be urged toward each other (FIGs 4B and 5C shows the step where 50 and 60 are brought closer together, [0046 and 0050]. FIGs 10A-10B show the step where 120 and 130 are brough closer together) to at least partially occlude the vessel in response to manipulation of the tensioning and elongate members (Manipulation of the tensioning and elongate members draws the proximal and distal occluder closer towards one another, to achieve the position of FIGs 4C and 5C. This position is shown to occlude the LAA and is at least configured to occlude a blood vessel if the occluders were deployed on opposed sides of a vessel).
Regarding claim 2, Ruiz discloses the tensioning member (80) is separable from the distal occluder (FIG 4C and 5C).
Regarding claim 3, Ruiz discloses in the alternative embodiment, the tensioning member comprises a filament (180, FIG 10A-10C, [0075-0077] discloses 180 is a suture or wire which is interpreted as a filament) and further comprising: a cutter carried by the handle for severing the tensioning member ([0077] discloses wire 180 is cut at the proximal end of the device, which is interpreted as meeting the limitation of a cutter carried by the handle).
Regarding claim 4, Ruiz discloses the elongate member (90) having a distal end engageable with the proximal occluder to enable the rotational position of the deployed proximal occluder to be adjusted relative to the distal occluder in response to rotation of the elongate member ([0047] the distal end of elongate member 90 comprises a projection 91 which mates with slot 67 of the proximal occluder, thereby permitting the rotational position to be adjusted via rotation of the elongate member).
Regarding claim 5, Ruiz discloses the tensioning member (80) having a distal end engageable with the distal occluder to enable the rotational position of the deployed distal occluder to be adjusted relative to the proximal occluder in response to rotation of the tensioning member ([0046-0047] the distal end of tensioning member 80 comprises threads 82 which mate with threads 58 of the distal occluder, thereby permitting the rotational position to be adjusted via rotation of the tensioning member).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771