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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 4th, 2026, has been entered.
Response to Amendment
The claims filed on May 4th, 2026, have been entered. Claims 1-17 and 21-22 remain pending in the Application. Claims 18-20 have been canceled by the Applicant. Claims 21-22 have been added by the Applicant.
Response to Arguments
Applicant's arguments filed May 4th, 2026, have been fully considered but they are not persuasive.
Applicant argues that the newly added claim limitation “a first end region of the device spreader is mounted on the distal end of the flexible elongate member and a second end region of the device spreader is disposed proximally of the first end region of the device spreader” is not disclosed by Shuey et al. (Pub. No. 2021/0000599) in view of Marczyk et al. (Pub. No. 2016/0256188) because a first filament 630 is coupled to a slot 632 of the lever 636 ([0060]), and in FIG. 6, 632 is located near the distal end of the catheter 634 instead of being proximal of another end of 626. Examiner respectfully disagrees. The device spreader was identified as spreader 620 and the flexible elongate member was identified as catheter 634, and as shown in annotated FIG. 6 below, the second end region of 620 is proximal of the first end region of 620 while the first end region of 620 is mounted on the distal end of 634. While 630 does not share a direct connection to 620, 630 is coupled to 620 through 626.
PNG
media_image1.png
690
613
media_image1.png
Greyscale
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8, 12-17, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuey et al. (Pub. No. 2021/0000599) in view of Marczyk et al. (Pub. No. 2016/0256188).
Regarding claim 1, Shuey et al. discloses a delivery/deployment system ([0060]; FIG. 6) for delivering and/or deploying a medical device (600) having a first arm (602 within 622) and a second arm (602 within 626) shiftable between a closed configuration with the arms adjacent each other ([0060] 600 has a closed position where the arms are pressed close together) and an open configuration with the arms shifted apart from each other ([0060] 600 has an open position where the arms are spread open), said system comprising:
a control handle ([0062] the system can be connected to and controlled by a handle) having a control handle housing ([0062] the handle can have a housing for the pulley system) and an actuator controller ([0062] the handle can have pulleys for translating parts of the system such as 604);
a device spreader (620) configured to deliver and deploy the medical device ([0060] 620 deploys 600) and having a first arm (622) configured to engage the first arm of the medical device ([0060] 622 engages one of the 602) and the second arm (626) configured to engage a second arm of the medical device ([0060] 626 engages the other of the 602);
a flexible elongate member (634) having a distal end (FIG. 6) and a proximal end ([0062] the proximal end of 634 is attached to the handle), and extending distally from said control handle through a steerable flexible elongate member ([0062] 634 can be delivered through an outer delivery sheath);
wherein a first end region of the device spreader is mounted on the distal end of the flexible elongate member (Annotated FIG. 6 below) and a second end region of the device spreader is disposed proximally of the first end region of the device spreader (Annotated FIG. 6); and
an actuator (604) coupled to said spreader device ([0061] 604 is coupled to 620) and extending to and coupled to the actuator controller ([0061] 604 is coupled to the handle controlling the system through the pulley system), and wherein the actuator includes a wire (630) coupled to the second end region of the device spreader ([0060] 630 is coupled to the second end region of 620 through 626; Annotated FIG. 6) and extends to the proximal end ([0060] 630 extends proximally into 634 to the proximal end of the device to be handle by a medical professional).
PNG
media_image1.png
690
613
media_image1.png
Greyscale
Shuey et al. is silent regarding the actuator controller includes a lever handle pivotable with respect to said control handle to cause said actuator to shift the device spreader arms between closed and open configurations to shift the medical device between closed and open configurations, and where the wire extends to the lever handle. Shuey et al. does disclose that the handle can be used to translate one or more parts of the system, including by connections involving pulleys that translate the parts, to control the delivery system from outside of the body, and that the handle is connected to the wire ([0060]).
Marczyk et al. teaches a system (930; [0028]; FIGs. 1-6) comprising a control handle (940) having a control handle housing (942) and an actuator controller (946), an end effector (99) having a first arm (992) and a second arm (994), and an actuator (948) coupled to the end effector ([0029] 948 is coupled to 990; FIG. 1) and extending to and coupled to the actuator controller ([0030] 948 is coupled to 946), where the actuator controller includes a lever handle (944) pivotable with respect to said control handle (FIGs. 1 and 4: 944 pivots relative to 942) to cause said actuator to shift the end effector arms between closed and open configurations ([0032] 944 is pivoted to pull 948 proximally through 946), and wherein the actuator includes a wire ([0029] 948 acts as a wire) coupled to a distal end region of the device spreader ([0029] 948 is coupled to the end effector 990; FIG. 1) and extends to the lever handle ([0030] 948 is operatively coupled to 944 by 946; FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the handle of Marczyk et al. for the handle of Shuey et al. because both handles are considered equivalent structures for controlling the delivery system, and the substitution of one for the other would have the predictable result of allowing for manipulation of the delivery system.
Regarding claim 2, Shuey et al. as modified by Marczyk et al. further discloses said actuator is coupled to said first arm of said device spreader (Shuey et al. [0060] 630 is coupled to 622) and extends distally therefrom and then proximally to said actuator controller (Shuey et al. FIG. 6: 630 loops down from 622 and then up to the substituted handle of Marczyk et al.), and is guided around pulleys to be coupled with said lever handle (Shuey et al. [0062] the substituted handle of Marczyk et al. is coupled to 630 by one or more pulleys for translating 622).
Regarding claim 3, Shuey et al. as modified by Marczyk et al. further discloses a grasper limiter (Marczyk et al. 950; [0032]; FIGs. 1-3) operatively associated with said control handle to limit the extent to which said device spreader opens the medical device (Marczyk et al. [0032] 950 is operatively connected to 940 to limit how much 990 clamps; the substitution as the handle of Shuey et al. would therefore limit how much 620 opens 600).
Regarding claim 4, Shuey et al. as modified by Marczyk et al. further discloses said grasper limiter includes a limit stop (Marczyk et al. 970) movable with respect to said lever handle to limit the extent to which said lever handle is movable to cause said actuator to shift said device spreader to an open configuration (Marczyk et al. [0035] 970 is moved by 948 relative to 944 to lock 944 into position and prevent 990 from being moved into the open position).
Regarding claim 5, Shuey et al. as modified by Marczyk et al. further discloses said grasper limiter includes an adjustment gauge (Marczyk et al. 958 and 959) movable with respect to said control handle housing to indicate the degree to which said lever handle may open said device spreader to open the medical device (Marczyk et al. [0034] 958 and 959 allow for visual confirmation of how much 948 is allowed to move relative to 940 for opening 990; the substitution as the handle of Shuey et al. would therefore show how much 620 can open 600).
Regarding claim 6, Shuey et al. as modified by Marczyk et al. further discloses said actuator controller shifts said actuator from a neutral position to an actuated position (Shuey et al. [0062] the pulleys move 630 from the closed position to the open position), said system further comprising a spring assist (Marczyk et al. 950; [0032]; FIGs. 2-3) within said control handle housing configured to assist said actuator to return to the neutral position upon releasing said lever handle (Marczyk et al. [0039] when too much clamping force is being applied to 990, 950 acts against further compression through 953, so that if 944 were released, 953 would retract 948 back to the proximal position where 990 is open).
Regarding claim 7, Shuey et al. as modified by Marczyk et al. further discloses an actuator guide housing (Marczyk et al. 952) through which said actuator passes to extend to said actuator controller (Marczyk et al. FIG. 2: 948 passes through 952 to couple to 946), wherein: said spring assist comprises a spring (Marczyk et al. 953) and a spring plate (Marczyk et al. 949) within said actuator guide housing (Marczyk et al. FIG. 2: 949 is within 952); said spring plate is coupled with respect to said actuator (Marczyk et al. FIG. 2: 948 and 949 are coupled together); and said spring biases said spring plate to return said actuator to the neutral position (Marczyk et al. [0032] the force applied by 953 on 949 causes 948 to be pulled back towards the original position).
Regarding claim 8, Shuey et al. as modified by Marczyk et al. further discloses said spring assist comprises a resilient actuator guide housing (Marczyk et al. 952) configured to return said actuator to the neutral position (Marczyk et al. [0032] 952 helps to return 948 to the original position).
Regarding claim 12, Shuey et al. as modified by Marczyk et al. further discloses the proximal end of said flexible elongate member is fixed with respect to said control handle (Shuey et al. [0062] 634 is fixed to the handle); and said control handle is movably mounted on a connecting tube ([Shuey et al. [0062] the handle being substituted for Marczyk et al. can be mounted onto another catheter) to move said flexible elongate member and said device spreader axially with respect to the steerable flexible elongate member (Shuey et al. [0062] 620 and 634 can be moved by the handle within the outer delivery sheath, and thereby axially with respect to that sheath).
Regarding claim 13, Shuey et al. as modified by Marczyk et al. further discloses a handle lock (Marczyk et al. 970; [0040]) operably associated with said control handle to fix a position of said control handle and said device spreader with respect to a steerable flexible elongate member (Marczyk et al. [0035] 970 is a lock which prevents 990 from operating unless 970 is put into a particular position, which locks both the handle and 620 of Shuey et al. relative to 634 of Shuey et al.).
Regarding claim 14, Shuey et al. discloses a control handle ([0062] the system can be connected to an controlled by a handle) operably associated with a device spreader (620) configured to deliver and deploy a medical device ([0060] 620 deploys 600) and having a first arm (622) configured to engage a first arm of the medical device ([0060] 622 engages one of the 602) and a second arm (626) configured to engage a second arm of the medical device ([0060] 626 engages the other of the 602), said control handle comprising:
a control handle housing ([0062] the handle can have a housing for the pulley system);
wherein the device spreader has a first end region (Annotated FIG. 6 below) and a second end region disposed proximally of the first end region (Annotated FIG. 6) and
an actuator controller ([0062] the handle can have pulleys for translating parts of the system such as 604) movable with respect to said control handle housing ([0062] the pulley lines will move within the handle housing and thereby relative to the housing) and the actuator controller including a wire (630) coupled to the second end region of the device spreader ([0060] 630 is coupled to the second end region of 620 through 626; Annotated FIG. 6) and extends to the proximal end ([0060] 630 extends proximally into 634 to the proximal end of the device to be handle by a medical professional), the proximal end causing an actuator (604) operably engaged with the device spreader and said actuator controller to shift said device spreader arms between closed and open configurations ([0060] the arms 622 and 626 of 620 open and close to move 600) to shift the medical device between closed and open configurations ([0060] 600 has a closed position where the arms are pressed close together and 600 has an open position where the arms are spread open).
PNG
media_image1.png
690
613
media_image1.png
Greyscale
Shuey et al. does not disclose the actuator controller includes a lever handle pivotable with respect to the control handle housing, where the lever handle causes the actuator operably engaged with the device spreader and said actuator controller to shift said device spreader arms between closed and open configurations to shift the medical device between closed and open configurations, and the wire extending to the lever handle. Shuey et al. does disclose that the handle is connected to the wire ([0060]).
Marczyk et al. teaches a system (930; [0028]; FIGs. 1-6) comprising a control handle (940) having a control handle housing (942) and an actuator controller (946), an end effector (99) having a first arm (992) and a second arm (994), and an actuator (948) coupled to the end effector ([0029] 948 is coupled to 990; FIG. 1) and extending to and coupled to the actuator controller ([0030] 948 is coupled to 946), where the actuator controller includes a lever handle (944) pivotable with respect to said control handle (FIGs. 1 and 4: 944 pivots relative to 942) to cause said actuator to shift the end effector arms between closed and open configurations ([0032] 944 is pivoted to pull 948 proximally through 946), and wherein the actuator controller includes a wire ([0029] 948 acts as a wire) coupled to a distal end region of the device spreader ([0029] 948 is coupled to the end effector 990; FIG. 1) and extends to the lever handle ([0030] 948 is operatively coupled to 944 by 946; FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the handle of Marczyk et al. for the handle of Shuey et al. because both handles are disclosed as equivalent structures for controlling the system, and the substitution of one for the other would have the predictable result of allowing for manipulation of the delivery system.
Regarding claim 15, Shuey et al. as modified by Marczyk et al. further discloses a grasper limiter (Marczyk et al. 950; [0032]; FIGs. 1-3) operatively associated with said control handle to limit the extent to which the lever handle shifts the device spreader to open the medical device (Marczyk et al. [0032] 950 is operatively connected to 940 to limit how much 990 clamps; the substitution as the handle of Shuey et al. would therefore limit how much 620 opens 600).
Regarding claim 16, Shuey et al. as modified by Marczyk et al. further discloses said grasper limiter includes a limit stop (Marczyk et al. 970) movable with respect to said lever handle to limit the extent to which said lever handle is movable (Marczyk et al. [0035] 970 is moved by 948 relative to 944 to lock 944 into position and prevent 990 from being moved into the open position).
Regarding claim 17, Shuey et al. as modified by Marczyk et al. further discloses said grasper limiter includes an adjustment gauge (Marczyk et al. 958 and 959) movable with respect to said control handle housing to indicate the degree to which said lever handle may open the device spreader to open the medical device (Marczyk et al. [0034] 958 and 959 allow for visual confirmation of how much 948 is allowed to move relative to 940 for opening 990; the substitution as the handle of Shuey et al. would therefore show how much 620 can open 600).
Regarding claim 21, Shuey et al. discloses a medical device system ([0060]; FIG. 6), comprising:
a flexible elongate member (634) having a distal end (FIG. 6) and a proximal end ([0062] the proximal end of 634 is attached to the handle);
a medical device (600) coupled to the flexible elongate member ([0061] 634 moves 600 into position), the medical device having a first arm (602 within 622) and a second arm (602 within 626) shiftable between a closed configuration with the arms adjacent each other ([0060] 600 has a closed position where the arms are pressed close together) and an open configuration with the arms shifted apart from each other ([0060] 600 has an open position where the arms are spread open);
a control handle ([0062] the system can be connected to and controlled by a handle) coupled to the proximal end of the flexible elongate member ([0062] the handle can be connected to the catheter), the control handle having a control handle housing ([0062] the handle can have a housing for the pulley system) and an actuator controller ([0062] the handle can have pulleys for translating parts of the system such as 604) movable with respect to the control handle housing ([0062] the parts, such as the actuator controller, can be translated with respect to the handle);
a device spreader (620) configured to deliver and deploy the medical device ([0060] 620 deploys 600) and having a first spreader arm (622) configured to engage the first arm of the medical device ([0060] 622 engages one of the 602) and a second spreader arm (626) configured to engage the second arm of the medical device ([0060] 626 engages the other of the 602);
wherein a first end region of the device spreader is mounted on the distal end of the flexible elongate member (Annotated FIG. 6 below) and a second end region of the device spreader is disposed proximally of the first end region (Annotated FIG. 6); and
an actuator (604) coupled to the spreader device ([0061] 604 is coupled to 620) and extending to and coupled to the actuator controller ([0061] 604 is coupled to the handle controlling the system through the pulley system), and wherein the actuator includes a wire (630).
PNG
media_image1.png
690
613
media_image1.png
Greyscale
Shuey et al. is silent regarding the actuator controller includes a lever handle pivotable with respect to said control handle to cause said actuator to shift the device spreader arms between closed and open configurations to shift the medical device between closed and open configurations, and where the actuator includes a wire coupled to the second end region of the device spreader and extends to the lever handle. Shuey et al. does disclose that the handle can be used to translate one or more parts of the system, including by connections involving pulleys that translate the parts, to control the delivery system from outside of the body, and that the handle is connected to the wire ([0060]).
Marczyk et al. teaches a system (930; [0028]; FIGs. 1-6) comprising a control handle (940) having a control handle housing (942) and an actuator controller (946), an end effector (99) having a first arm (992) and a second arm (994), and an actuator (948) coupled to the end effector ([0029] 948 is coupled to 990; FIG. 1) and extending to and coupled to the actuator controller ([0030] 948 is coupled to 946), where the actuator controller includes a lever handle (944) pivotable with respect to said control handle (FIGs. 1 and 4: 944 pivots relative to 942) to cause said actuator to shift the end effector arms between closed and open configurations ([0032] 944 is pivoted to pull 948 proximally through 946), and wherein the actuator includes a wire ([0029] 948 acts as a wire) coupled to a distal end region of the device spreader ([0029] 948 is coupled to the end effector 990; FIG. 1) and extends to the lever handle ([0030] 948 is operatively coupled to 944 by 946; FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the handle of Marczyk et al. for the handle of Shuey et al. because both handles are considered equivalent structures for controlling the delivery system, and the substitution of one for the other would have the predictable result of allowing for manipulation of the delivery system.
Claim(s) 9-11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuey et al. in view of Marczyk et al., and in further view of Francischelli et al. (Pub. No. 2010/0145361).
Regarding claims 9 and 22, Shuey et al. as modified by Marczyk et al. discloses the system as claimed in claims 1 and 21, respectively, as discussed above, and further discloses the device spreader comprises a movable retention element (Shuey et al. 612) configured to shift between an engaged retention position retaining the medical device with respect to said device spreader (Shuey et al. [0060] 612 is coupled to locking pins 610, which prevent 600 from leaving 620, and 612 has an initial position where 610 are kept in place), and a disengaged position allowing the medical device to be released from said device spreader (Shuey et al. [0060] 612 can be pulled to remove 610 from 620, allowing for 600 to leave 620). Shuey et al. as modified does not disclose said control handle further comprising a release system configured to shift said movable retention element from the engaged retention position to the disengaged position.
Francischelli et al. teaches a system ([0148] a tool for placing a clip-style LAA occlusion device) comprising a control handle ([0148] a handle of the tool), a movable retention element ([0148] a suture attached to a stop on the distal end of the tool) configured to shift between an engaged retention position for retaining the medical device with respect to the tool ([0148] the stop prevents the clip from deploying) and a disengaged position allowing the medical device to be released from the tool ([0148] when the suture is pulled by actuation of knob 50, shown in FIG. 5, the stop is removed and the clip can be deployed), where the control handle further comprises a release system ([0148] the proximal end of the tool actuates the stop) configured to shift said movable retention element from the engaged retention position to the disengaged position ([0148] when the proximal end of the tool is actuated, the stop is removed, and the clip can be deployed) for the purpose of preventing early deployment of the clip before the clip is in the proper position ([0148]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the substituted handle from Marczyk et al. with the release system of Francischelli et al. for the purpose of preventing early deployment of the clip before the clip is in the proper position.
Regarding claim 10, Shuey et al. as modified by Francischelli et al. further discloses said release system comprises a clip release slider (Francischelli et al. 50; FIG 5 and [0148] 50 is on the proximal end of the tool as part of the handle 38) mounted with respect to said control handle housing (Francischelli et al. FIG. 5: 50 is mounted on the handle housing); said movable retention element extends from said device spreader to said clip release slider to be coupled to said clip release slider (Francischelli et al. [0148] a suture connects 50 to the clip); and withdrawal of said clip release slider from said control handle housing shifts said movable retention element to the disengaged position (Francischelli et al. FIG. 5 and [0148] when 50 is withdrawn out of the handle housing, the suture is pulled proximally, and the stop is pulled out of the clip to allow the clip to deploy).
Regarding claim 11, Shuey et al. as modified further discloses a safety button (Marczyk et al. 964) biased to retain said clip release slider with respect to said control handle housing (Marczyk et al. [0037] lockout 964 is biased in place to prevent lever 960 from operating until 964 is actuated).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES R MCGINNITY/Examiner, Art Unit 3771
Prosecution Insights