CTNF 18/361,637 CTNF 97104 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 3, 10, 12, 14, 16 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Bishop et al. (US 2018/0185153 A1) . Regarding claim 1, Bishop discloses a system for delivering and deploying a tissue anchor in a person, comprising: an active puncturing tool including: a proximal control handle (para. [0274] discloses a handle of the delivery system) with a flexible sheath extending distally therefrom (para. [0274] discloses an outer sheath connected to the handle of the delivery system and includes a dilator; note also that it could be catheter 100), a flexible puncturing needle (i.e., needle is hollow and exhibits some amount of flexibility) extending through the sheath and linearly movable therein to a position beyond a distal tip of the sheath (para. [0274] discloses a hollow needle that extends through the dilator and can be advanced and retracted; see also para. [0286] and Figs. 35J1-J-3), the needle having a distal tip (Fig. 35J-1), and a tissue anchor 150 movable through the sheath (i.e., through needle as shown in Figs. 35J-1-35J-3) to a position beyond the distal tip of the needle (Fig. 35J-2). Regarding claim 3, Bishop discloses the system of claim 1. Bishop also discloses wherein the tissue anchor is an expandable disk-shaped anchor configured to abut tissue (Fig. 35J-3). Regarding claim 10, Bishop discloses the system of claim 1. Bishop also discloses wherein the needle is hollow (Figs. 35-J-1-35J-3) and the tissue anchor is positioned within and deployable from within the needle (Fig. 35J-2). Regarding claim 12, Bishop discloses a system for delivering and deploying a cardiac tissue anchor in a person, comprising: an active puncturing tool including: a proximal control handle (para. [0274] discloses a handle of the delivery system) with a flexible sheath extending distally therefrom (para. [0274] discloses an outer sheath connected to the handle of the delivery system and includes a dilator; note also that it could be catheter 100), a flexible puncturing needle (i.e., needle is hollow and exhibits some amount of flexibility) extending through and beyond the sheath (para. [0274] discloses a hollow needle that extends through the dilator and can be advanced and retracted; see also para. [0286] and Figs. 35J1-J-3), the needle having a distal tip (Fig. 35J-1), and a tissue anchor 150 movable through the sheath to a position beyond the distal tip of the needle i.e., through needle as shown in Figs. 35J-1-35J-3); and at least one lead of an EKG system in electrical contact with the needle for recording an electrical signal from the heart of the person (para. [0210], [0224], [0267]). Regarding claim 14, Bishop discloses the system of claim 12. Bishop also discloses wherein the tissue anchor is an expandable disk-shaped anchor configured to abut tissue (Fig. 35J-3). Regarding claim 16, Bishop discloses the system of claim 12. Bishop also discloses wherein the flexible puncturing needle is linearly movable within the sheath to a position beyond a distal tip of the sheath (para. [0274] discloses a hollow needle that extends through the dilator and can be advanced and retracted; see also para. [0286] and Figs. 35J1-J-3). Regarding claim 21, Bishop discloses the system of claim 12. Bishop also discloses wherein the needle is hollow (Figs. 35-J-1-35J-3) and the tissue anchor is positioned within and deployable from within the needle (Fig. 35J-2) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 2, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Sharma et al. (US 2015/0119646 A1) . Regarding claim 2, Bishop discloses the system of claim 1. Bishop also discloses wherein the system is for delivering and deploying cardiac anchors (Para. [0275]-[0276]), and the at least one lead is a lead of an EKG system connected so that one lead is in electrical contact with a proximal end of the needle (para. [0210], [0224], [0267]). Bishop doesn’t directly disclose: the flexible puncturing needle is electrically insulated except at the distal tip. However, in the same field of endeavor of lead implantation method, Sharma discloses a similar device to Sharma and includes a flexible sheath (i.e., laparoscope as disclosed in para. [0014]; a lead (para. [0014]); a needle attached to the lead (para. [0014]) and an anchor (para. [0015]). Sharma also discloses the flexible puncturing needle is electrically insulated (para. [0014]) except at the distal tip (i.e., where the insulation of the lead ends para. [0014]). 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 device of Sharma to have an insulated needle connected to a lead at least since it is generally known in the art that leads must be insulated to protect the conductor from electrical shorts, environmental damage, and mechanical stress while ensuring safe and reliable operation. Regarding claim 13, Bishop discloses the system of claim 12. Bishop also discloses the lead is in electrical contact with a proximal end of the needle (para. [0210], [0224], [0267]). Bishop doesn’t directly disclose: wherein the flexible puncturing needle is electrically insulated except at the distal tip, and the EKG being a 5-lead EKG. Regarding i: Sharma discloses a similar device to Sharma and includes a flexible sheath (i.e., laparoscope as disclosed in para. [0014]; a lead (para. [0014]); a needle attached to the lead (para. [0014]) and an anchor (para. [0015]). Sharma also discloses the flexible puncturing needle is electrically insulated (para. [0014]) except at the distal tip (i.e., where the insulation of the lead ends para. [0014]). 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 device of Sharma to have an insulated needle connected to a lead at least since it is generally known in the art that leads must be insulated to protect the conductor from electrical shorts, environmental damage, and mechanical stress while ensuring safe and reliable operation. Regarding ii: It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc ., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the EKG being a 5-lead EKG since there are a limited amount of EKG leads to choose from. As such, there is no undue experimentation and there being a reasonable expectation of success at arriving at the EKG being a 5-lead EKG . 07-21-aia AIA Claim s 4, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Forbes (US 2017/0035433 A1) . Regarding claim 4, Bishop discloses the system of claim 1. Bishop also discloses wherein the tissue anchor is configured to embed in tissue and comprises: a tubular barrel (i.e., barrel is defined inside of 134 as shown in Fig. 35J-1) defining a longitudinal axis having a plurality of distally-extending tines 152 configured to be embedded into tissue, the tines being biased toward a relaxed configuration where the tines splay radially outward from the axis (para. [0286]); a flexible proximal shaft 150 connected to the barrel (note: 150 is still proximal to the very tip of the device); and a suture connected to the tines and extending through the needle (para. [0286]), each tine extending outward from the barrel and along a respective tine to be fastened at a distal tip thereof (para. [0286]), wherein tension on the suture helps prevent the tines from bending toward the axis upon application of proximal forces on the anchor tending to pull the anchor from within tissue (para. [0286]; Fig. 35J-3). Bishop doesn’t directly disclose a plurality of sutures each connected to one of the tines and extending proximally through the shaft. In the same field of endeavor, namely left atrial appendage occlude device, Forbes discloses a similar device including and anchor 32 comprising self-expanding anchor tines 39 and wherein the anchor tines also include sutures (para. [0060]). 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 device of Bishop to have the tines include sutures for purposes of attachment (para. [0060]). Regarding claim 15, Bishop discloses the system of claim 12. Bishop also discloses wherein the tissue anchor is configured to embed in tissue and comprises: a tubular barrel (i.e., barrel is defined inside of 134 as shown in Fig. 35J-1) defining a longitudinal axis having a plurality of distally-extending tines 152 configured to be embedded into tissue, the tines being biased toward a relaxed configuration where the tines splay radially outward from the axis (para. [0286]); a flexible proximal shaft 150 connected to the barrel (note: 150 is still proximal to the very tip of the device); and a suture connected to the tines and extending through the needle (para. [0286]), each tine extending outward from the barrel and along a respective tine to be fastened at a distal tip thereof (para. [0286]), wherein tension on the suture helps prevent the tines from bending toward the axis upon application of proximal forces on the anchor tending to pull the anchor from within tissue (para. [0286]; Fig. 35J-3). Bishop doesn’t directly disclose a plurality of sutures each connected to one of the tines and extending proximally through the shaft. In the same field of endeavor, namely left atrial appendage occlude device, Forbes discloses a similar device including and anchor 32 comprising self-expanding anchor tines 39 and wherein the anchor tines also include sutures (para. [0060]). 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 device of Bishop to have the tines include sutures for purposes of attachment (para. [0060]) . 07-21-aia AIA Claim s 6-8, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Hamel (US 20100105979 A1) . Regarding claim 6, Bishop discloses the system of claim 1. Bishop doesn’t directly disclose wherein the control handle has a first slider movable thereon configured to axially displace the needle relative to the sheath, and the proximal control handle has a second slider movable thereon configured to axially displace the tissue anchor relative to the needle. In the same field of endeavor, namely surgical needle and anchor system with retractable features, Hamel discloses a similar device to Bishop including a handle assembly 18 and a retractable needle assembly 20 and an anchor 16. Hamel also discloses he control handle 18 has a first slider (i.e., one of 34a, 34b) movable thereon configured to axially displace the needle relative to the sheath (para. [0051]), and the proximal control handle has a second slider (i.e., one of 34a, 34b) movable thereon configured to axially displace the tissue anchor relative to the needle (paras. [0059]-[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 device of Bishop to have two sliders as disclosed by Hamel for the purposes of controlled delivery of the needle and anchor (paras. [0051], [0059]-[0060]). Regarding claim 7, Bishop and Hamel disclose the system of claim 6. Hamel also discloses wherein the first and second sliders are coupled for common movement (paras. [0051], [0059]-[0061]), and further including a lock 70 configured to be released to permit the second slider to move with respect to the first slider (i.e., lock 70 limits movement see para. [0063] such that lock 70 is also capable of permitting the second slider to move with respect to the first slider). Regarding claim 8, Bishop discloses the system of claim 6. Hamel also discloses wherein each of the first and second sliders includes an outer finger tab (Fig. 1) labeled with an indicator of the respective function of each (i.e., Hamel discloses an indication on the handle which can be an audible click that tells the user that the function of the slider has been accomplished). Regarding claim 17, Bishop discloses the system of claim 16. Bishop doesn’t directly disclose wherein the control handle has a first slider movable thereon configured to axially displace the needle relative to the sheath, and the proximal control handle has a second slider movable thereon configured to axially displace the tissue anchor relative to the needle. In the same field of endeavor, namely surgical needle and anchor system with retractable features, Hamel discloses a similar device to Bishop including a handle assembly 18 and a retractable needle assembly 20 and an anchor 16. Hamel also discloses he control handle 18 has a first slider (i.e., one of 34a, 34b) movable thereon configured to axially displace the needle relative to the sheath (para. [0051]), and the proximal control handle has a second slider (i.e., one of 34a, 34b) movable thereon configured to axially displace the tissue anchor relative to the needle (paras. [0059]-[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 device of Bishop to have two sliders as disclosed by Hamel for the purposes of controlled delivery of the needle and anchor (paras. [0051], [0059]-[0060]). Regarding claim 18, Bishop and Hamel disclose the system of claim 17. Hamel also discloses wherein the first and second sliders are coupled for common movement (paras. [0051], [0059]-[0061]), and further including a lock 70 configured to be released to permit the second slider to move with respect to the first slider (i.e., lock 70 limits movement see para. [0063] such that lock 70 is also capable of permitting the second slider to move with respect to the first slider). Regarding claim 19, Bishop and Hamel disclose the system of claim 17. Hamel also discloses wherein each of the first and second sliders includes an outer finger tab (Fig. 1) labeled with an indicator of the respective function of each (i.e., Hamel discloses an indication on the handle which can be an audible click that tells the user that the function of the slider has been accomplished) . 07-21-aia AIA Claim s 9, 11, 20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Sra (US 20050033287 A1) . Regarding claim 9, Bishop discloses the system of claim 1. Bishop doesn’t directly disclose wherein the control handle further includes an actuator for angling a tip of the sheath. In the same field of endeavor, namely epicardial left atrial appendage isolation, Sra discloses a similar device including a steering handle 12 with several actuators 44, 46, 48, 50 connected to catheter shaft 14. Sra also discloses control handle further includes an actuator 46 for angling a tip of the sheath (para. [0029]). 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 device of Bishop to have an actuator that deflects the sheath for purposes of allowing the sheath 10 to accommodate different orientations of devices (para. [0029]). Regarding claim 11, Bishop discloses the system of claim 10. Bishop doesn’t directly disclose wherein the control handle further includes a plurality of fluid ports connected thereto for introducing or withdrawing fluid or gas from concentric spaces within the system, including a space between the sheath and needle, and a space between the needle and tissue anchor. Sra discloses the control handle further includes a plurality of fluid ports (i.e., at least for delivering irrigation fluid and aspirating through the ports as disclosed by para. [0024]) connected thereto for introducing or withdrawing fluid or gas from concentric spaces within the system (para. [0024]), including a space between the sheath and needle, and a space between the needle and tissue anchor (i.e., by way of being delivered). 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 device of Bishop to have a plurality of fluid ports for the purposes of irrigating and aspirating (para. [0024]). Regarding claim 20, Bishop discloses the system of claim 12. Bishop doesn’t directly disclose wherein the control handle further includes an actuator for angling a tip of the sheath. In the same field of endeavor, namely epicardial left atrial appendage isolation, Sra discloses a similar device including a steering handle 12 with several actuators 44, 46, 48, 50 connected to catheter shaft 14. Sra also discloses control handle further includes an actuator 46 for angling a tip of the sheath (para. [0029]). 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 device of Bishop to have an actuator that deflects the sheath for purposes of allowing the sheath 10 to accommodate different orientations of devices (para. [0029]). Regarding claim 22, Bishop discloses the system of claim 21. Bishop doesn’t directly disclose wherein the control handle further includes a plurality of fluid ports connected thereto for introducing or withdrawing fluid or gas from concentric spaces within the system, including a space between the sheath and needle, and a space between the needle and tissue anchor. Sra discloses the control handle further includes a plurality of fluid ports (i.e., at least for delivering irrigation fluid and aspirating through the ports as disclosed by para. [0024]) connected thereto for introducing or withdrawing fluid or gas from concentric spaces within the system (para. [0024]), including a space between the sheath and needle, and a space between the needle and tissue anchor (i.e., by way of being delivered). 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 device of Bishop to have a plurality of fluid ports for the purposes of irrigating and aspirating (para. [0024]) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 5 is 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 5, Bishop and Forbes disclose the system of claim 4. Bishop also discloses wherein each of the tines is formed as a laser-cut portion of a tube that also forms the tubular barrel (para. [0286]). Bishop doesn’t directly disclose each tine has a plurality of cleats along its length through which the sutures pass before reaching the distal tip. There is no reason, suggestion, or motivation to modify Bishop to have the tines of Bishop 35J-1, 35J-3 to have cleats since they function as wires and do not have the width to accommodate cleats. Further, although 35D-G shows a ribbon with cleats, the ribbon cannot function as the tine as required by claim 1. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST. 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, Darwin Erezo can be reached at 5712724695. 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. /RACHAEL L GEIGER/ Examiner, Art Unit 3771 /BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771 Application/Control Number: 18/361,637 Page 2 Art Unit: 3771 Application/Control Number: 18/361,637 Page 3 Art Unit: 3771 Application/Control Number: 18/361,637 Page 4 Art Unit: 3771 Application/Control Number: 18/361,637 Page 5 Art Unit: 3771 Application/Control Number: 18/361,637 Page 6 Art Unit: 3771 Application/Control Number: 18/361,637 Page 7 Art Unit: 3771 Application/Control Number: 18/361,637 Page 8 Art Unit: 3771 Application/Control Number: 18/361,637 Page 9 Art Unit: 3771 Application/Control Number: 18/361,637 Page 10 Art Unit: 3771 Application/Control Number: 18/361,637 Page 11 Art Unit: 3771 Application/Control Number: 18/361,637 Page 12 Art Unit: 3771 Application/Control Number: 18/361,637 Page 13 Art Unit: 3771
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