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 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, 7-9, 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laufer (US PGPub 2016/0206345).
Regarding Claim 1, Laufer teaches a medical device for creating elongated incisions within a pericardium (Figure 2A), the device comprising:
an incision device (114) operably coupled to a distal end of an elongate catheter (110; Figure 2A; Paragraph 0043), wherein the incision device (140) comprises an incision channel (124) defined along a lateral side of the elongate catheter (110; Figure 2A-2C; Paragraph 0046); and
a retractable cutting apparatus (140) disposed within the incision channel (124), wherein the retractable cutting apparatus (140) comprises a blade (142) structured to move between a retracted position (Figure 2B) and a deployed position (Figure 2C),
wherein upon movement of the blade (142) into the deployed position (Figure 2C), the retractable cutting apparatus (140) is structured to move along the incision channel (124) while the incision device (114) remains stationary (Figures 2B-2C; Paragraphs 0045-0046) .
Regarding Claim 5, Laufer teaches the medical device of Claim 1, further comprising:
a translation body (150) operably coupled to the blade (142) ; and
a retractable cutting apparatus movement actuator (148) attached to the translation body (150), wherein the retractable cutting apparatus movement actuator (148) is movable to move the retractable cutting apparatus (140) along the incision channel (as seen in Figures 2B-2C).
Regarding Claim 7, Laufer teaches the medical device of Claim 1, further comprising an introducer (120) positioned near a distal end of the incision device (see Figure 2A)
Regarding Claim 8, Laufer teaches the medical device of Claim 7, wherein at least a portion of the introducer (120) is radiopaque (Paragraph 0042).
Regarding Claim 9, Laufer teaches the medical device of Claim 1, wherein a cutting surface of the blade (142) when laterally projected, faces away from the distal end and towards a proximal end of the catheter (Figure 2C).
Regarding Claim 12, Laufer teaches the medical device of Claim 1, wherein at least a portion of a cutting surface of the blade (140) is reversibly adjustable laterally relative to a longitudinal axis of the catheter between a range of angles (Paragraph 0062).
Regarding Claim 15, Laufer teaches the medical device of Claim 1, further comprising a controller (130) engaged to the incision device, wherein the controller provides at least one of: (i) movement of the blade between the retracted position and the deployed position, (ii) movement of the retractable cutting apparatus along the incision device, (iii) energy to the incision device, or (iv) movement of one or more stabilizing members associated with said medical device (Paragraph 0049 and 0053).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer (US PGPub 2016/0206345) as applied to claim 1 above, and further in view of Orbay (US PGPub 2008/0195128)
Regarding Claim 4, Laufer teaches the medical device of Claim 1, but fails to disclose wherein the blade of the cutting apparatus is curved in a direction of rotation from the retracted position to the deployed position.
Orbay teaches a medical device for creating incisions having a deployable blade (165) having a retracted position (Figure 7A) and a deployed configuration (Figure 7B), the blade of the cutting apparatus is curved in a direction of rotation from the retracted position to the deployed position (see Figures 8A-8C).
It would have been obvious to one ordinary skill in the art to modify the flat blade of Laufer to be a curved blade for the advantage that curved blades assist in keeping tissue within the curve while cutting, while a flat blade may allow tough cartilaginous tissue to slide off.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer (US PGPub 2016/0206345) as applied to claim 1 above, and further in view of Laufer (US PGPub 2017/0164968 now referred to as Laufer-2)
Regarding Claims 10-11, Laufer teaches the medical device of Claim 1, but fails to disclose further comprising one or more stabilizing members structured to maintain the catheter at a given location (Claim 10) and wherein the one or more stabilizing members are structured to move between a stabilizing retracted position and a stabilizing deployed position (Claim 11).
Laufer-2 discloses a medical device for creating incisions (Figure 2A), further comprising one or more stabilizing members (182) structured to maintain the catheter at a given location (Figures 5A-5B; Paragraph 0065-0066) and wherein the one or more stabilizing members (182) are structured to move between a stabilizing retracted position and a stabilizing deployed position (Paragraph 0066).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Laufer with the stabilizing member teachings of Laufer-2 for the advantage of providing a biasing force against an opposing wall of tissue, such that the opposing force assist in maintaining the cutting element within tissue (Paragraph 0065; Luafer-2).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer (US PGPub 2016/0206345) as applied to claim 1 above, and further in view of Sherman (US Patent 6,010,500)
Regarding Claim 13, Laufer teaches the medical device of Claim 1, but fails to disclose wherein a plurality of radiopaque markers is provided along an edge of the incision channel, wherein a position of the blade can be determined based on the radiopaque markers.
Sherman teaches an apparatus for linear lesion ablation (abstract) comprising a incision device (14) and a retractable cutting apparatus (12), the incision device (14) a window (36; which is analogous to the incision channel of Laufer), wherein a plurality of radiopaque markers (38a and 38b; Figure 1) are provided along an edge of the incision channel (window 36), wherein a position of the blade (16) can be determined based on the radiopaque markers (28a and 38b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the incision channel of Laufer to include a plurality of markers, as taught by Sherman, for the advantage of tracking the position of the blade relative to the incision channel.
Allowable Subject Matter
Claims 2, 3, 6 and 14 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.
Regarding Claim 2, the prior art fails to disclose
a translation body operably coupled to the blade;
a blade rotation pin rotatably connecting the blade to the translation body, wherein the blade rotates about the blade rotation pin; and
an actuation pin attached to a cutting apparatus actuation mechanism structured to move the blade between the retracted position and the deployed position, wherein the actuation pin moves along a blade slot defined on the blade, wherein the movement of the actuation pin along the blade slot causes the blade to move between the retracted position and the deployed position, wherein in an instance in which the blade is in the retracted position, the blade is disposed within the incision channel, and wherein in an instance in which the blade is in the deployed position, the blade at least partially protrudes from the incision channel.
Claims 3 and 6 incorporate the allowable subject matter of Claim 2 by dependency.
Regarding Claim 14, the prior art fails to disclose:
a translation body operably coupled to the blade, wherein the translation body defines a translation body slot;
a blade movement pin attached to the blade, wherein the blade movement pin is positioned to move within the translation body slot, wherein at a first position within the translation body slot, the blade is in the retracted position and at a second position within the translation body slot, the blade is in the deployed position; and
a cutting apparatus casing defining a translation body channel that allows the translation body to move within the translation body channel;
wherein the blade is rotatably attached to the cutting apparatus casing, wherein the blade is structured to rotate based on the movement of the translation body,
wherein upon moving the translation body in a first direction, the blade movement pin moves along the translation body slot causing the blade to rotate from a clockwise direction in the retracted position to the deployed position,
wherein in an instance in which the blade is in the retracted position, the blade is disposed within the incision channel, and
wherein in an instance in which the blade is in the deployed position, the blade at least partially protrudes from the incision channel.
Claims 16-20 are allowed.
Regarding Claim 16, the prior art fails to disclose:
a translation body operably coupled to the blade;
a blade rotation pin rotatably connecting the blade to the translation body, wherein the blade rotates about the blade rotation pin; and
an actuation pin attached to a cutting apparatus actuation mechanism structured to move the blade between the retracted position and the deployed position, wherein the actuation pin moves along a blade slot defined on the blade, wherein the movement of the actuation pin along the blade slot causes the blade to move between the retracted position and the deployed position, and
wherein upon movement of the blade into the deployed position, the retractable cutting apparatus is structured to move along the incision channel while the incision device remains stationary.
Claims 17-18 are allowed for incorporating allowable subject matter by dependency.
Regarding Claim 19, the prior art fails to disclose:
a translation body operably coupled to the blade, wherein the translation body defines a translation body slot;
a blade movement pin attached to the blade, wherein the blade movement pin is positioned to move within the translation body slot, wherein at a first position within the translation body slot, the blade is in the retracted position and at a second position within the translation body slot, the blade is in the deployed position; and
a cutting apparatus casing defining a translation body channel that allows the translation body to move within the translation body channel,
wherein the blade is rotatably attached to the cutting apparatus casing,
wherein the blade is structured to rotate based on the movement of the translation body, and
wherein upon moving the translation body in a first direction, the blade movement pin moves along the translation body slot causing the blade to rotate from a clockwise direction in the retracted position to the deployed position.
Claims 20 is allowed for incorporating allowable subject matter by dependency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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