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 .
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, the “tracks” and “a pair of stopping surfaces” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2023/0285020) in view of Chen (US 2009/0253998).
Regarding claim 1, an invention relating to tissue fastener devices, Rogers discloses (Figs. 1-4, 7C) a system for closing one or more incisions or wounds of a patient (Abstract), the system comprising: a suture insertion device (100), the suture insertion device configured to deploy bioabsorbable fasteners to close an incision or wound in tissue of a patient (Abstract), the suture insertion device comprising: a body (110) comprising a pair of tissue holders (130a-b) positioned adjacent to a distal end of the body and operably coupled to first and second actuators (125a-b; Par. 0056), each of the first and second actuators being configured to move the respective tissue holder to effectively pinch and fold one edge of the incision or wound in preparation for deployment of a fastener (Par. 0067-0068); and a fastener delivery mechanism (140) operably coupled to an insertion actuator (40) and configured to deploy one or more of a plurality of bioabsorbable fasteners (Par. 0056 & 0058), wherein the fastener delivery mechanism comprises: an insertion device comprising one or more insertion needles [i.e. two needles (65a-b)], said insertion device being guided within tracks [i.e. needle guide tubes (146)] and configured to move in response to movement of the insertion actuator to cause the one or more insertion needles to releasably engage and deploy each one of the plurality of fasteners in a one-by-one fashion in response to repeated movements of the insertion actuator (Par. 0061); an introducer (135) positioned at, and extending from, a distal end of the fastener delivery mechanism, the introducer configured to directly contact opposing edges of the wound or incision and having an opening (290) through which a fastener exits the distal end of the introducer during deployment (Par. 0056 & 0063); and a pair of stopping surfaces (295a-b) configured to directly contact a respective one of the pair of tissue holders to thereby position the outer skin surfaces of each edge of the incision or wound at locations relative to the opening at a distal end of the introducer (Par. 0068). However, Rogers fails to disclose an automated system for closing one or more incisions or wounds of a patient, the system comprising: a movable platform; a suture insertion device releasably coupled to a portion of the movable platform, first and second actuators associated with the movable platform, an insertion actuator associated with the movable platform; and a controller operably coupled to the movable platform and the suture insertion device, the controller comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the controller to effect electro-mechanical control over: movement of the platform to thereby cause corresponding movement of the suture insertion device relative to the incision or wound; actuation of the first and second actuators to thereby cause movement of the pair of tissue holders; and actuation of the insertion actuator to thereby cause deployment of one or more of the plurality of fasteners via the fastener delivery mechanism.
In the same field of endeavor, which is tissue fastening devices, Chen teaches (Fig. 1) an automated system for closing one or more incisions or wounds of a patient (Abstract), the system comprising: a movable platform (129); a suture insertion device (141) releasably coupled to a portion of the movable platform (Par. 0051, 0062, 0119, 0122), first and second actuators [i.e. electro-mechanical actuators located in or near the joint between each of the branch arms and the main arm] associated with the movable platform (Par. 0046 & 0048), an insertion actuator [i.e. actuators that cause tools and other devices that are described herein to perform each of the functions] associated with the movable platform (Par. 0048 & 0054); and a controller (111) operably coupled to the movable platform and the suture insertion device (Par. 0048-0049 & 0077), the controller comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the controller to effect electro-mechanical control over: movement of the platform to thereby cause corresponding movement of the suture insertion device relative to the incision or wound; actuation of the first and second actuators to thereby cause movement of the pair of tissue holders; and actuation of the insertion actuator to thereby cause deployment of one or more of the plurality of fasteners via the fastener delivery mechanism (Par. 0048-0049, 0054-0055, 0095, 0111).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rogers to have an automated system for closing one or more incisions or wounds of a patient, the system comprising: a movable platform; a suture insertion device releasably coupled to a portion of the movable platform, first and second actuators associated with the movable platform, an insertion actuator associated with the movable platform; and a controller operably coupled to the movable platform and the suture insertion device, the controller comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the controller to effect electro-mechanical control over: movement of the platform to thereby cause corresponding movement of the suture insertion device relative to the incision or wound; actuation of the first and second actuators to thereby cause movement of the pair of tissue holders; and actuation of the insertion actuator to thereby cause deployment of one or more of the plurality of fasteners via the fastener delivery mechanism. Doing so would automate tissue fastening (Abstract), as taught by Chen.
Regarding claim 2, Rogers, as modified by Chen, discloses wherein the controller is programmed to coordinate movements of the pair of tissue holders until each tissue holder contacts a respective stopping surface with substantially the same predetermined force [see Chen paragraphs 0055 & 0105].
Regarding claim 3, Rogers, as modified by Chen, discloses wherein the controller is further programmed to sequentially actuate the insertion actuator to thereby actuate the fastener delivery mechanism to deliver one of the plurality of fasteners to a controlled distance relative to the opening at the distal end of the introducer and subsequently return first and second actuators and the insertion actuator to initial positions in preparation for deploying additional fasteners (Par. 0056, 0060, 0067, 0069).
Regarding claim 4, Rogers, as modified by Chen, discloses the system of claim 3. Rogers further discloses wherein the controlled distance to which the fastener delivery mechanism moves relative to the distal end of the introducer is determined via real-time analysis of a force applied by the insertion actuator (Par. 0058 & 0069).
Regarding claim 5, Rogers, as modified by Chen, discloses the system of claim 2. Rogers further discloses wherein the predetermined force to which each tissue holder contacts a respective stopping surface is between about 8 Lbf and about 15 Lbf (Par. 0064).
Regarding claim 6, Rogers, as modified by Chen, disclose the system of claim 2. Rogers further discloses wherein the predetermined force to which each tissue holder contacts a respective stopping surface provides sufficient resistance to reverse movement of each tissue holder (Par. 0058, 0064, 0069).
Regarding claim 7, Rogers, as modified by Chen, discloses the system of claim 6. Rogers further discloses wherein the resistance to reverse movement is greater than about 20 Lbf/mm (Par. 0064).
Regarding claim 8, Rogers, as modified by Chen, discloses the system of claim 1. Rogers further discloses wherein the tracks for guiding the insertion device and the pair of tissue holders comprise a movable relationship with one another (Par. 0060-0061 & 0068-0069).
Regarding claim 9, Rogers, as modified by Chen, discloses the system of claim 8. Rogers further discloses wherein the pair of tissue holders are configured to allow the tracks to move in response to forces applied upon the introducer such that the tracks are substantially centered between the pair tissue holders (Par. 0061-0063).
Regarding claim 10, Rogers, as modified by Chen, discloses the system of claim 1. Rogers further discloses wherein the opening in the introducer through which the bioabsorbable fastener passes is configured to adjust in size during and after deployment of a fastener (Par. 0063, 0068, 0077).
Regarding claim 11, Rogers, as modified by Chen, discloses the system of claim 10. Rogers further discloses wherein the opening is configured to change from a first size when a fastener is moving within the opening during deployment thereof, in which the sides of the opening directly contact the fastener, to a second different size after the fastener has been deployed, in which the opening is larger than the first size (Par. 0063, 0068, 0077).
Regarding claim 12, Rogers, as modified by Chen, discloses the system of claim 1. Rogers discloses (Fig. 6) further comprising one or more tissue graspers (335) operably coupled to the movable platform and configured to engage patient tissue and lift edges of the incision or wound to temporarily position each edge on opposite sides of the introducer of the suture insertion device in close proximity to the respective tissue holder on said given side of the introducer (Par. 0066 & 0068).
Regarding claim 13, Rogers, as modified by Chen, discloses further wherein the controller is operably coupled to the one or more tissue graspers and configured to effect electro-mechanical control over the one or more tissue graspers [see Chen paragraphs 0055 & 0105].
Regarding claim 14, Rogers, as modified by Chen, discloses further wherein the controller is configured to control opening and closing of jaws of each respective tissue grasper and movement of the one or more tissue graspers [see Chen paragraphs 0055 & 0105].
Regarding claim 15, Rogers, as modified by Chen, discloses the system of claim 13. Rogers further discloses wherein the system comprises three tissue graspers (Par. 0066).
Regarding claim 16, Rogers, as modified by Chen, discloses the system of claim 14. Rogers further discloses wherein a first tissue grasper is configured to pinch tissue at an apex at a distal end of the incision or wound and the second and third tissue graspers are configured to pinch a respective opposing edge of the incision or wound closer to a proximal end of the incision or wound (Par. 0066 & 0068).
Regarding claim 17, Rogers, as modified by Chen, discloses further comprising a camera positioned to capture one or more images of an operating field, including capturing one or more images of tissue surrounding the incision or wound, the one or more tissue graspers, the edges of the incision or wound, and the introducer of the suture insertion device [i.e. element 135, see Chen paragraphs 0046, 0052-0053, 0081, 0083].
Regarding claim 18, Rogers, as modified by Chen, discloses further wherein the controller is operably coupled to the camera and configured to receive image data therefrom and, based on analysis of said image data, the controller is configured to effect electro-mechanical control over at least one of: movement of the one or more tissue graspers; control over the opening and closing of a jaw of a given tissue grasper; movement of the platform to thereby cause corresponding movement of the suture insertion device relative to the incision or wound; actuation of the first and second actuators to thereby cause movement of the pair of tissue holders; and actuation of the insertion actuator to thereby cause deployment of one or more of the plurality of fasteners via the fastener delivery mechanism [see Chen, paragraphs [see Chen paragraphs 0046, 0052-0053, 0081, 0083].
Regarding claim 19, Rogers, as modified by Chen, discloses the system of claim 1. Rogers further discloses wherein the suture insertion device is a single use device (Par. 0062).
Regarding claim 20, Rogers, as modified by Chen, discloses further wherein the movable platform is configured to receive and releasably retain interchangeable suture insertion devices (Par. 0051, 0062, 0119, 0122).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 22, 2026
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