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 11 is objected to because of the following informalities:
In line 16, “the lumen tube” should be changed to “the tube” in order to maintain consistent terminology.
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.
Claim(s) 1-8 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sixto et al. (US 2007/0010715).
Regarding claim 1, Sixto discloses a tissue engagement device (1, [0093], FIG 1-9), comprising: a lumen tube (8, [0094]) having a maximum exterior width (FIG 7); a proximal end and an opposing distal end (Proximal end best shown in FIG 7 and distal end shown in FIGs 1-7); and at least two adjacent engagement arms (4) each including a piercing tip (44, [0104]) and a non-piercing edge (Curved portion of each arm immediately proximal to the needle ends), wherein the at least two adjacent engagement arms are configured to move between: a first orientation (FIG 5) in which the at least two adjacent engagement arms extend out beyond an end of the lumen tube (The arms extend past lumen of 8 and into tip 5. FIGs 1-3 show the openings the needle tips are seated in) such that the piercing tips of the at least two adjacent engagement arms face away from each other (FIG 5 shows the tips face away from each other), with the non-piercing edges of the at least two adjacent engagement arms at least partially overlapping each other (See annotated FIG 5 below) and oriented to pass over and deflect tissue, without penetrating the tissue when the distal end is pressed against the tissue (The device in this position is at least configured such that it can be inserted into tissue without penetrating), and a second orientation (FIGs 1-4) in which each non-piercing edge of the at least two adjacent engagement arms faces distally from the lumen tube (The segment annotated below faces in the distal direction of the lumen tube in this orientation) and the non-piercing edges of the at least two adjacent engagement arms do not overlap each other after a deployment transition (This portion is spaced apart in FIG s 1-4 and no longer overlaps), wherein the piercing tips of the at least two adjacent engagement arms face away and are spaced from each other by a distance greater than the maximum exterior width in the second orientation (FIGs 1-4 show the needle tips remain facing away from one another and are spaced apart by a distance greater than the width of the lumen tube).
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Regarding claim 2, Sixto discloses a puncture needle (62, FIG 9) that comprises a tip configured to puncture through a tissue layer after the tissue layer has been engaged by the piercing tips of the at least two adjacent engagement arms ([0114-0115]).
Regarding claim 3, Sixto discloses a pathway of the puncture needle is either parallel to or collinear with a central axis of the lumen tube (FIG 9 shows the pathway is parallel to a central axis of the lumen tube, which is not shown but is understood to extend along the same axis as coil 7).
Regarding claim 4, Sixto discloses the pathway extends between the at least two adjacent engagement arms (FIG 9).
Regarding claim 5, Sixto discloses the at least two adjacent engagement arms are actuated by a lever, a knob, or a sliding button ([0112-0113]) translation of actuation wire 2 is used to deploy the arms. This is interpreted as a sliding button).
Regarding claim 6, Sixto discloses the at least two adjacent engagement arms are actuated by an actuator rod (3, [0107-0109 and 0112-0113]).
Regarding claim 7, Sixto discloses the piercing tips of the at least two adjacent engagement arms are each sharpened along one or more bevel planes ([0104] discloses needle ends 44 that are tapered. The sharpened tapered end is interpreted as a bevel plane).
Regarding claim 8, Sixto discloses movement of the piercing tips of the at least two adjacent engagement arms includes rotational movement or pivotal movement (FIGs 4-6; [0100] “the needles 4 are connected movably to the actuation rod 3, preferably, pivotally to the rod 3 “).
Regarding claim 10, Sixto discloses the at least two adjacent engagement arms include more than two adjacent engagement arms ([0100] discloses “The preferred embodiment of the retractor 1 has two needles 4. However, the number of needles can be expanded to suit particular needs”).
Regarding claim 11, Sixto discloses a tissue engagement device (1, [0093], FIG 1-9), comprising:
a handle (100, FIG 57, [0176] discloses the handle is for used with device 1 or any of the disclosed embodiments); a tube having a lumen (8, [0094]) and a maximum exterior width at a distal device end (FIG 7), the tube operatively coupled to the handle (understood to be operatively coupled as a component of the assembled device); and a first engagement arm (one of 4) including a first piercing tip (44, [0104]) and a first non-piercing edge (Curved portion of each arm immediately proximal to the needle ends), and a second engagement arm (the other of 4) including a second piercing tip (44, [0104]) and a second non-piercing edge (Curved portion of each arm immediately proximal to the needle ends) wherein the first and second engagement arms are displacable between: a first orientation (FIG 5) in which the first and second engagement arms extend out beyond an end of the lumen at the distal device end (The arms extend past lumen of 8 and into tip 5. FIGs 1-3 show the openings the needle tips are seated in) such that the first piercing tip and second piercing tip face away from each other (FIG 5 shows the tips face away from each other), with the first non-piercing edge and the second non-piercing edge at least partially overlapping each other (See annotated FIG 5 above) and oriented to pass over and deflect tissue, without penetrating the tissue when the distal device end is pressed against the tissue (The device in this position is at least configured such that it can be inserted into tissue without penetrating), and a second orientation (FIGs 1-4) in which the first non-piercing edge and the second non-piercing edge face distally from the lumen tube (The segment annotated above faces in the distal direction of the lumen tube in this orientation) and do not overlap each other after a transition to a deployed position(This portion is spaced apart in FIG s 1-4 and no longer overlaps), wherein the first piercing tip and the second piercing tip face away and are spaced from each other by a distance greater than the maximum exterior width in the second orientation (FIGs 1-4 show the needle tips remain facing away from one another and are spaced apart by a distance greater than the width of the lumen tube).
Regarding claim 12, Sixto discloses a puncture needle (62, FIG 9) that comprises a tip configured to puncture through a tissue layer after the tissue layer has been engaged by the first and second piercing tips ([0114-0115]).
Regarding claim 13, Sixto discloses a pathway of the puncture needle is either parallel to or collinear with a central axis of the tube (FIG 9 shows the pathway is parallel to a central axis of the lumen tube, which is not shown but is understood to extend along the same axis as coil 7).
Regarding claim 14, Sixto discloses the pathway extends between the first and second engagement arms (FIG 9).
Regarding claim 15, Sixto discloses the first and second engagement arms are actuated by a lever, a knob, a sliding button, or an actuator rod (3, [0107-0109 and 0112-0113]).
Regarding claim 16, Sixto discloses the first piercing tip and the second piercing tip are each sharpened along one or more bevel planes ([0104] discloses needle ends 44 that are tapered. The sharpened tapered end is interpreted as a bevel plane).
Regarding claim 17, Sixto discloses movement of the first piercing tip and the second piercing tip include rotational movement or pivotal movement (FIGs 4-6; [0100] “the needles 4 are connected movably to the actuation rod 3, preferably, pivotally to the rod 3 “).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 9, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sixto et al. (US 2007/0010715).
Regarding claims 9 and 18, Sixto discloses the invention substantially as claimed, as set forth above for claims 1 and 11.
Sixto discloses the engagement arms are preferably pivotally attached to the actuation rod and can be crimped, bent, or otherwise fastened to the actuation rod ([0100]) but is silent regarding the first and second engagement arms each include a slot in which a fixed guide post slides to cam the first and second engagement arms during movement.
However, the alternative embodiment of FIGs 27-31 show an attachment between the arms and the actuation rod comprising the first and second engagement arms each include a slot (bore 41, [0124], FIG 27) in which a fixed guide post (distal end of each tie rod 32) slides to cam the first and second engagement arms during movement ([0142-0144]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first and second engagement arms to be pivotally attached to the actuation rod by means of a slot in which a fixed guide post slides to cam the first and second engagement arms during movement, as taught by the alternative embodiment, for the purpose of utilizing a technique commonly known in the art for achieving the predictable result of pivotally attaching the arms to the actuation rod.
Regarding claim 19, Sixto discloses the invention substantially as claimed, as set forth above for claim 11.
Sixto is silent regarding each of first and second engagement arms further include a flat shelf portion configured for a tissue layer to rest on during actuation.
However, the alternative embodiment of FIGs 27-31 show an alternative embodiment of the engagement arms wherein each arm includes a flat shelf portion (See top flat surface in FIG 31) configured for a tissue layer to rest on during actuation (This surface is a non-cutting edge and is at least configured for tissue to lay thereon during use).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first and second engagement arms to each include a flat shelf portion configured for a tissue layer to rest on during actuation, as taught by the alternative embodiment, for the purpose of utilizing an engagement arm shape commonly known in the art for achieving the predictable result of engaging the tissue in the desired manner for a particular procedure.
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
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