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 § 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) 1-2, 4, 7-12, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cindrich et al (US 20160256306 A1) “Cindrich”.
Regarding Claim 1, the first embodiment of Cindrich teaches a delivery device (deployment device 100, par. [0025], Fig. 1) for delivering a cardiac prosthesis to a target site, the delivery device comprising:
a sheath (outer sheath 150 and inner sheath 170, par. [0075], Figs. 2 and 10);
a shaft (shaft section 156, par. [0076], Fig. 9) at least partially positioned coaxially within the sheath;
a handle (handle assembly 102, par. [0075], Figs. 1 and 2) connected to the sheath and the shaft, the handle including:
a body (housing 110, par. [0029], Fig. 2) having an inner surface,
an actuator (actuator 120, par. [0030], Fig. 2) connected to the body and configured to control linear movement of the sheath relative to the shaft, the handle further including a feedback system having:
at least one ridge (ratchet lugs 136, par. [0044], Fig. 2), and a clip (carrier 140, par. [0044], Fig. 2) including a first flap (ratchet slide engaging arm 146, par. [0044], Fig. 2) extending from the sheath (par. [0075]), but does not teach a first flap traveling over a ridge and a feedback system that is audible and/or tactile.
However, another embodiment of Cindrich teaches the first flap being configured to contact and travel over the at least one ridge when the sheath moves longitudinally (pars. [0052] and [0059];
wherein the feedback system is configured to convey a first feedback indication when the first flap contacts and travels past the at least one ridge (pars. [0052] and [0059], Claims 11 and 12, feedback is provided at the end of the stroke, wherein the steps of the stroke include the first flap contacting and passing the at least one ridge);
further wherein the first feedback indication is selected from the group consisting of audible feedback, tactile feedback and a combination thereof that specifies a position of the sheath with respect to the shaft (pars. [0060] and [0061]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include a first flap traveling over a ridge and a feedback system that is audible and/or tactile, as taught by another embodiment of Cindrich, in order to gradually and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Regarding Claim 2, the first embodiment of Cindrich further teaches the delivery device of claim 1, wherein the feedback system includes a plurality longitudinally spaced ridges (ratchet lugs 136, par. [0046], Fig. 2).
Regarding Claim 4, the first embodiment of Cindrich does not teach varied longitudinal or vertical spacing of the plurality of ridges. However, another embodiment of Cindrich teaches the delivery device of claim 2, wherein at least three of the plurality of ridges are varied in one or more of longitudinal or vertical spacing with respect to adjacent ridges of the plurality of ridges (par. [0046], although there is an option for evenly spaced ridges, it is not required). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include varied longitudinal or vertical spacing of the plurality of ridges, as taught by another embodiment of Cindrich, in order to gradually and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Regarding Claim 7, the first embodiment of Cindrich does not teach the clip including a second flap. However, another embodiment of Cindrich teaches the delivery device of claim 1, wherein the clip includes a second flap (housing engaging arm 148, par. [0054], Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include the clip including a second flap, as taught by another embodiment of Cindrich, in order to help control the deployment of the prosthesis while tracking the stage of deployment (par. [0055]).
Regarding Claim 8, the first embodiment of Cindrich does not teach a second flap and first flap with different lengths. However, another embodiment of Cindrich teaches the delivery device of claim 7, wherein the second flap has a length that is different than a length of the first flap (Figs. 4 and 6, ratchet slide engaging arm 146 is shorter than the length of carrier 140, while the housing engaging arm 148 is approximately the length of carrier 140). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include a second flap and first flap with different lengths, as taught by another embodiment of Cindrich, in order to help control the deployment of the prosthesis while tracking the stage of deployment (par. [0055]).
Regarding Claim 9, the first embodiment of Cindrich further teaches the delivery device of claim 1, wherein the at least one ridge is configured such that the first flap provides the first feedback indication when the first flap travels over the at least one ridge in a first direction but not when the first flap travels over the ridge in a second direction (par. [0052], engaging arm 146 only moves over ratchet lugs 136 only proximally and not distally, resulting in the end of the stroke and the feedback indication).
Regarding Claim 10, the first embodiment of Cindrich teaches a method comprising: providing a delivery device (deployment device 100, par. [0025], Fig. 1) including: a sheath (outer sheath 150 and inner sheath 170, par. [0075], Figs. 2 and 10);
a shaft (shaft section 156, par. [0076], Fig. 9) coaxially positioned at least partially within the sheath and having a distal portion (par. [0076], Fig. 9, extends distally from carrier 140);
a cardiac prosthesis positioned on the distal portion (delivery catheter assembly 104 and delivery tip 174, pars. [0016] and [0028], Fig. 1, vascular prosthesis is placed on delivery catheter assembly, which extends distally from the handle assembly);
a handle (handle assembly 102, par. [0075], Figs. 1 and 2) connected to the sheath and the shaft, the handle including:
a body (housing 110, par. [0029], Fig. 2) having an inner surface, an actuator (actuator 120, par. [0030], Fig. 2) connected to the body and configured to control linear movement of the sheath,
the handle further including a feedback system having: at least one ridge (ratchet lugs 136, par. [0044], Fig. 2), and a clip (carrier 140, par. [0044], Fig. 2) including a first flap (ratchet slide engaging arm 146, par. [0044], Fig. 2) extending from the sheath (par. [0075]), but does not teach moving the sheath in a first direction to lead to a first feedback indication.
However, another embodiment of Cindrich teaches moving the sheath in a first direction to a first position with respect to a distal end of the shaft with the actuator until the first flap contacts and travels past one or more of the at least one ridge to produce a first feedback indication selected from the group consisting of audible feedback, tactile feedback and a combination thereof (pars. [0052], [0059], [0060-0061], and [0075]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include moving the sheath in a first direction to lead to a first feedback indication, as taught by another embodiment of Cindrich, in order to gradually and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Regarding Claim 11, the first embodiment of Cindrich further teaches the method of claim 10, wherein the first feedback indication conveys information indicating a deployment stage of the cardiac prosthesis (Abstract, par. [0019]).
Regarding Claim 12, the first embodiment of Cindrich does not teach the first feedback indication indicating the prosthesis compression. However, another embodiment of Cindrich teaches the method of claim 10, wherein the first feedback indication conveys information indicating compression of the cardiac prosthesis during a step of sheathing the cardiac prosthesis with the sheath (Abstract, par. [0019]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include the first feedback indication indicating the prosthesis compression, as taught by another embodiment of Cindrich, in order to gradually and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Regarding Claim 18, the first embodiment of Cindrich does not teach a static at least one ridge. However, another embodiment of Cindrich teaches the method of claim 10, wherein the at least one ridge is static with respect to the body during the step of moving the sheath in the first direction to produce the first feedback indication (pars. [0059] and [0075], the at least one ridge interacts with other components as a result of displacement of those components and not sole displacement of the ridge). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include a static at least one ridge, as taught by another embodiment of Cindrich, in order to securely and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Regarding Claim 20, the first embodiment of Cindrich does not teach moving the sheath in a second direction. However, another embodiment of Cindrich teaches the method of claim 10, further comprising moving the sheath in a second direction, opposite the first direction (par. [0091], outer sheath 150 may move distally as opposed to proximally);
wherein, while the sheath is moving in the second direction, the feedback system does not produce an audible or tactile indication as the flap contacts and travels over one or more of the at least one ridge (par. [0061], visual feedback may be used). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include moving the sheath in a second direction, as taught by another embodiment of Cindrich, in order to securely and controllably progress the deployment of the prosthesis while tracking the stage of deployment (pars. [0059] and [0060]).
Claim(s) 3, 5-6, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cindrich et al (US 20160256306 A1) “Cindrich” in view of Gloss et al (US 10743990 B2) “Gloss”.
Regarding Claim 3, Cindrich does not teach a first and second section of longitudinally spaced ridges. However, Gloss, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein the plurality longitudinally spaced ridges are positioned in a first section on the body (body 3024, par. (101), Fig. 40) including a first set of longitudinally spaced ridges (flexible section 3032, par. (101), Fig. 40) and a second section (second end 3028, par. (101), Fig. 40) on the body including a second set of longitudinally spaced ridges (flexible section 3048, par. (101), Fig. 40);
wherein a configuration of the first set differs from a configuration of the second set (par. (101), Fig. 40). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include a first and second section of longitudinally spaced ridges, as taught by Gloss, in order to have a more flexible and smoother deployment of the prosthesis (Gloss, par. (100)).
Regarding Claim 5, Cindrich does not teach at least two of the plurality of ridges with different widths. However, Gloss, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein at least two of the plurality of ridges have different widths (Fig. 40). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include at least two of the plurality of ridges having different widths, as taught by Gloss, in order to have a more flexible and smoother deployment of the prosthesis (Gloss, par. (100)).
Regarding Claim 6, Cindrich does not teach at least two of the plurality of ridges have different heights. However, Gloss, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein at least two of the plurality of ridges have different heights (Fig. 40). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include at least two of the plurality of ridges having different heights, as taught by Gloss, in order to have a more flexible deployment of the prosthesis and better indication of deployment stage (Gloss, par. (100)).
Regarding Claim 13, Cindrich does not teach the plurality of ridges at first and second sections and an actuator moving the sheath to a second position. However, Gloss, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein the at least one ridge is a plurality of ridges (flexible section 3032, par. (101), Fig. 40) arranged in a first section of the body (body 3024, par. (101), Fig. 40) and a plurality of ridges (flexible section 3048, par. (101), Fig. 40) arranged in a second section (second end 3028, par. (101), Fig. 40) of the body, the first position being at the first section;
wherein the method further includes using the actuator (part of handle assembly 18, par. (62), Fig. 1) to move the sheath (outer sheath assembly 12, par. (62), Fig. 1) to a second position with respect to the shaft (shaft assembly 16, par. (62), Fig. 1) until the first flap contacts and travels over one or more of the plurality of ridges of the second section to produce a second feedback indication (pars. (62) and (63). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include the plurality of ridges at first and second sections and an actuator moving the sheath to a second position, as taught by Gloss, in order to have a more flexible deployment of the prosthesis and better indication of deployment stage (Gloss, par. (100)).
Regarding Claim 14, Cindrich does not teach the plurality of ridges at the first section differing in construction compared to the plurality of ridges at the second section. However, Gloss, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein the plurality of ridges at the first section differs in construction as compared to the plurality of ridges at the second section (Fig. 40). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include the plurality of ridges at the first section differing in construction compared to the plurality of ridges at the second section, as taught by Gloss, in order to have a more flexible deployment of the prosthesis and better indication of deployment stage (Gloss, par. (100)).
Regarding Claim 15, the first embodiment of Cindrich does not teach a difference in sound between the first and second feedback indications. However, another embodiment of Cindrich teaches that the first feedback indication and the second feedback indication are audible and the first feedback indication differs in sound from the second feedback indication (par. [0062], Claim 11, audible feedback can be provided at the end of a stroke, which signals the feedback indication). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include a difference in sound between the first and second feedback indications, as taught by another embodiment of Cindrich, in order to signify the degree of deployment of a prosthesis (Abstract, See MPEP 2144.04(VD) - In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954)).
Regarding Claim 16, the first embodiment of Cindrich does not teach a different audible volume between the first and second feedback indications. However, another embodiment of Cindrich teaches wherein an audible volume of the first feedback indication differs from an audible volume of the second feedback indication (par. [0062], Claim 11, audible feedback can be provided at the end of a stroke, which signals the feedback indication). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Cindrich to include a different audible volume between the first and second feedback indications, as taught by another embodiment of Cindrich, in order to signify the degree of deployment of a prosthesis (Abstract, See MPEP 2144.04(VD) - In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954)).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cindrich et al (US 20160256306 A1) “Cindrich” in view of Gloss et al (US 10743990 B2) “Gloss”, in further view of Waldhauser et al (US 20210001116 A1) “Waldhauser”.
Regarding Claim 17, Cindrich in view of Gloss does not teach a number of audible clicks of the first feedback indication differs from a number of audible clicks of the second feedback indication. However, Waldhauser, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein a number of audible clicks of the first feedback indication differs from a number of audible clicks of the second feedback indication (par. [1047], there may be a various number of clicks to signify deployment of the device). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich in view of Gloss to include a number of audible clicks of the first feedback indication differs from a number of audible clicks of the second feedback indication, as taught by Waldhauser, in order for the user to have a clear indication of the system’s deployment status and therefore proceed with the procedure as necessary (Waldhauser, par. [1047]).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Cindrich et al (US 20160256306 A1) “Cindrich” in view of Waldhauser et al (US 20210001116 A1) “Waldhauser”.
Regarding Claim 19, Cindrich does not teach the first feedback indication including two audible clicks. However, Waldhauser, in the same field of art, teaches transcatheter stented prosthesis delivery device (Abstract), wherein the first feedback indication includes two audible clicks (par. [1047], there may be a various number of clicks to signify deployment of the device). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Cindrich to include the first feedback indication including two audible clicks, as taught by Waldhauser, in order for the user to have a clear indication of the system’s deployment status and therefore proceed with the procedure as necessary (Waldhauser, par. [1047]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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