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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/08/2026 has been entered.
Response to Amendment
This action is in response to the remarks filed on 7/08/2026. The amendments
filed on 7/08/2026 are entered.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 7/08/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 21-25, 27, 35, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers et al. (U.S. Pat. No. 8298291) hereinafter Ewers, in view of Mitelberg et al. (U.S. Pub. No. 20210275166) hereinafter Mitelberg, in further view of Olympus Medical Systems (JP4436805B2) hereinafter Olympus (see attached FOR reference English translation of the office action of 6/12/2025 for citations).
Regarding claim 21, primary reference Ewers teaches:
an outer cannula defining an outer-cannula lumen (tubular sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, tubular sheath 64 forms an analogous teaching to an outer cannula defining an outer-cannula lumen);
an inner cannula translatable within the outer-cannula lumen and defining an inner- canula lumen (pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64);
an anchor that is disposed at a distal end of the inner cannula and is pushable by the inner cannula out of a distal end of the outer cannula (anchor assembly 68’ comprising anchors 82 and 84, figures 13-15; col 12, line 63 through col 13, line 64, anchor assembly 68’ forms the anchor disposed at the distal end of the pusher 76 (inner cannula) which includes the additional lumen 77, and is constructed as to push the anchor out of the distal end of the outer cannula); and
a wire suture translatable through the inner-cannula lumen (suture element 132’ is disposed between distal anchor 82 and proximal anchor 84, figures 13-15; col 12, line 63 through col 13, line 64, suture element 132’ forms a wire suture translatable through the inner-cannula lumen (pusher lumen 77)).
Primary reference Ewers further fails to teach:
a wire suture translatable through the inner-cannula lumen having a distal end affixed to the anchor
However, the analogous art of Mitelberg of a deployment system for a suture anchor tissue treatment system (abstract) teaches:
a wire suture translatable through the inner-cannula lumen having a distal end affixed to the anchor ([0010], anchor suture eyelet fixedly coupled to the suture; [0011], “While the distal end of the suture is fixedly secured to the first suture anchor, additional suture anchors are threaded onto the suture through the suture anchor eyelets.”; [0070], “suture anchor 42 also includes a collar 68 that is fixedly coupled to a suture eyelet 70.”; figures 3-6 further depict the distal anchor eyelet for attachment to the distal end of the suture; [0071]-[0074]; [0078], “the sheath is retracted revealing a first suture anchor 42 is fixedly coupled to suture 46 which is positioned near target tissue adjacent a gastrointestinal “GI” defect 142”; [0079]-[0080]; figures 7A-7H).
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 the cannula/needle anchor and suture system of Ewers to incorporate the wire suture with a distal end affixed to the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0078]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
Primary reference Ewers further fails to teach:
An endoscopic ultrasound (EUS) anchoring system comprising:
However, the analogous art of Olympus of an endoscopic puncture needle and puncture suture system (abstract) teaches:
An endoscopic ultrasound (EUS) anchoring system ([0008]-[0013], figure 2, ultrasound endoscope system that includes an inner needle tube; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus) comprising:
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 the cannula/needle anchor and suture system of Ewers and Mitelberg to be incorporated into the endoscopic ultrasound anchoring system as taught by Olympus because complex interventional procedures within the body require both sutures for sealing any incisions within a tissue region of interest, but also imaging to enable a physician to perform the procedure. By utilizing the anchor and suture system of Ewers in the endoscopic ultrasound anchoring system as taught by Olympus, higher quality targeting of regions of interest can occur, leading to improved clinical outcomes for patients (see Olympus, [0002]-[0004]).
Regarding claim 22, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further teaches:
further comprising:
a cinch mechanism translatable within the main lumen (col 12, line 63 through col 13, line 64 and figures 13-15; specifically, col 13, lines 45-56, including “the anchor assembly is cinched by retracting control element 134… thereby cinching anchor assembly 68'”; As depicted in the associated figures 13-15 of Ewers and the lumen of Olympus as in figures 3-5, the cinch mechanism is translatable within the main EUS lumen of the overall combined prior art device) and configured to:
cut the wire suture, forming a cut proximal end of the wire suture (specifically, col 13, lines 57-64, including “The needle assembly cuts the suture proximal of locking mechanism 136, as in FIG. 15F”; see also col 12, line 63 through col 13, line 64 and figures 13-15).; and
couple the cut proximal end of the wire suture to the cinch mechanism while the distal end of the wire suture remains coupled to the anchor (proximal end of suture element 132’ is coupled with locking mechanism 136, figure 15F; see also distal and proximal anchors 84 and 82, with distal end of wire suture coupled to the anchor; col 13, lines 57-64; see also col 12, line 63 through col 13, line 64 and figures 13-15).
Primary reference Ewers further fails to teach:
while the distal end of the wire suture remains affixed to the anchor
However, the analogous art of Mitelberg of a deployment system for a suture anchor tissue treatment system (abstract) teaches:
while the distal end of the wire suture remains affixed to the anchor ([0010], anchor suture eyelet fixedly coupled to the suture; [0011], “While the distal end of the suture is fixedly secured to the first suture anchor, additional suture anchors are threaded onto the suture through the suture anchor eyelets.”; [0070], “suture anchor 42 also includes a collar 68 that is fixedly coupled to a suture eyelet 70.”; figures 3-6 further depict the distal anchor eyelet for attachment to the distal end of the suture; [0071]-[0074]; [0078], “the sheath is retracted revealing a first suture anchor 42 is fixedly coupled to suture 46 which is positioned near target tissue adjacent a gastrointestinal “GI” defect 142”; [0079]-[0080]; figures 7A-7H).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the wire suture with a distal end affixed to the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0078]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
Primary reference Ewers further fails to teach:
an EUS scope defining a EUS lumen; and
However, the analogous art of Olympus of an endoscopic puncture needle and puncture suture system (abstract) teaches:
an EUS scope defining a EUS lumen ([0008]-[0013], figure 2, ultrasound endoscope system that includes an endoscopic lumen in which the needle tube transits; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system and EUS lumen in which the needle/cannula elements transit, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus).; and
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporated the EUS scope with an EUS lumen as taught by Olympus because complex interventional procedures within the body require both sutures for sealing any incisions within a tissue region of interest, but also imaging to enable a physician to perform the procedure. By utilizing the anchor and suture system of Ewers in the endoscopic ultrasound anchoring system with an EUS lumen as taught by Olympus, higher quality targeting of regions of interest can occur, leading to improved clinical outcomes for patients (see Olympus, [0002]-[0004]).
Regarding claim 23, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 22. Primary reference Ewers further teaches:
further comprising:
a plunger included in the cinch mechanism and configured to apply a compressive force on the wire suture (pusher 76 is coupled to the proximal end of needle body 72 and provides a compressive force on the wire suture, figures 13-15; see also col 12, line 63 through col 13, line 64, particularly col 13, lines 31-64).
Regarding claim 24, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 22. Primary reference Ewers further teaches:
wherein the cinch mechanism is housed within an anchor pusher handle (control element 134’ may be a handle disposed at the proximal end of suture 132’ of needle body 72, col 13, lines 18-19; figures 13-15; see also col 12, line 63 through col 13, line 64).
Regarding claim 25, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further fails to teach:
wherein the anchor comprises a first end, a second end, and a middle portion, and the distal end of the wire suture is affixed to the middle portion of the anchor
However, the analogous art of Mitelberg of a deployment system for a suture anchor tissue treatment system (abstract) teaches:
wherein the anchor comprises a first end, a second end, and a middle portion, and the distal end of the wire suture is affixed to the middle portion of the anchor ([0074], figures 6A and 6B show first and second ends of the anchor with a middle central interior portion in which the suture eyelet 216 is affixed to the wire suture).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the wire suture with a distal end affixed to the central portion of the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0074]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
Regarding claim 27, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further teaches:
wherein the outer cannula is translatable within the main lumen (col 12, line 63 through col 13, line 64 and figures 13-15; tubular sheath 64 is translatable within the main lumen (EUS lumen) in the combined invention with Olympus; As depicted in the associated figures 13-15 of Ewers and the lumen of Olympus as in figures 3-5, the outer cannula is translatable within the main EUS lumen of the overall combined prior art device).
Primary reference Ewers further fails to teach:
an EUS scope defining a EUS lumen;
However, the analogous art of Olympus of an endoscopic puncture needle and puncture suture system (abstract) teaches:
an EUS scope defining a EUS lumen ([0008]-[0013], figure 2, ultrasound endoscope system that includes an endoscopic lumen in which the needle tube transits; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system and EUS lumen in which the needle/cannula elements transit, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus); and
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporated the EUS scope with an EUS lumen as taught by Olympus because complex interventional procedures within the body require both sutures for sealing any incisions within a tissue region of interest, but also imaging to enable a physician to perform the procedure. By utilizing the anchor and suture system of Ewers in the endoscopic ultrasound anchoring system with an EUS lumen as taught by Olympus, higher quality targeting of regions of interest can occur, leading to improved clinical outcomes for patients (see Olympus, [0002]-[0004]).
Regarding claim 35, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further teaches:
wherein a length of the anchor is parallel to a length of the inner-cannula lumen when disposed within the outer cannula (pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64 and the anchors 82 and 84 are parallel to the inner-cannula lumen within the outer cannula, figures 13-15; col 12, line 63 through col 13, line 64, pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64).
Regarding claim 38, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers, in view of Mitelberg, in further view of Olympus further teaches:
A method for implanting an anchor using the EUS anchoring system of claim 21 (see rejection of claim 21 above), comprising the steps of:
(a) directing an EUS scope towards a first section of tissue, the EUS scope including an EUS lumen extending therethrough (Olympus: [0008]-[0013], figure 2, ultrasound endoscope system that includes an endoscopic lumen in which the needle tube transits; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system and EUS lumen in which the needle/cannula elements transit, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus and extended to a target tissue of interest);
(b) positioning the outer cannula, the inner cannula, the wire suture, and the anchor within the EUS lumen (Ewers: pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, suture element 132’ and anchor 84/82 are positioned within the overall device for use. In combination with Olympus: [0008]-[0013], figure 2, ultrasound endoscope system that includes an inner needle tube; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus);
(c) extending the inner cannula, the wire suture, and the anchor from the EUS scope, through the first section of tissue, and into a second section of tissue (Ewers: the inner cannula is extended to provide the wire suture and anchor into first and section sections of tissue as depicted and disclosed in figures 13-15; col 12, line 63 through col 13, line 64);
(d) hinging the anchor around the affixed distal end with the wire suture (Ewers: as depicted in figures 15B and 15C, the anchor forms a hinging around the coupling with the wire suture after extension; see further as depicted and disclosed in figures 13-15; col 12, line 63 through col 13, line 64; Mitelberg: [0010], anchor suture eyelet fixedly coupled to the suture; [0011], “While the distal end of the suture is fixedly secured to the first suture anchor, additional suture anchors are threaded onto the suture through the suture anchor eyelets.”; [0070], “suture anchor 42 also includes a collar 68 that is fixedly coupled to a suture eyelet 70.”; figures 3-6 further depict the distal anchor eyelet for attachment to the distal end of the suture; [0071]-[0074]; [0078], “the sheath is retracted revealing a first suture anchor 42 is fixedly coupled to suture 46 which is positioned near target tissue adjacent a gastrointestinal “GI” defect 142”; [0079]-[0080]; figures 7A-7H); and
(e) retreating the inner cannula from the tissue layers, thereby leaving the anchor and the wire suture in the second section of tissue (Ewers: the inner cannula is retreated to provide the wire suture and anchor into the section sections of tissue as depicted and disclosed in figures 13-15; col 12, line 63 through col 13, line 64).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the wire suture with a distal end affixed to the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0078]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to be incorporated into the endoscopic ultrasound anchoring system as taught by Olympus because complex interventional procedures within the body require both sutures for sealing any incisions within a tissue region of interest, but also imaging to enable a physician to perform the procedure. By utilizing the anchor and suture system of Ewers in the endoscopic ultrasound anchoring system as taught by Olympus, higher quality targeting of regions of interest can occur, leading to improved clinical outcomes for patients (see Olympus, [0002]-[0004]).
Regarding claim 40, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 38. Primary reference Ewers, in view of Olympus further teaches:
further comprising the steps of:
(f) feeding a cinch over the wire suture along with a pusher tube (col 12, line 63 through col 13, line 64 and figures 13-15; specifically, col 13, lines 45-56, including “the anchor assembly is cinched by retracting control element 134… thereby cinching anchor assembly 68'”; As depicted in the associated figures 13-15 of Ewers and the lumen of Olympus as in figures 3-5, the cinch mechanism is provided with the pusher tube 76 and locking mechanism 136);
(g) pulling the anchor tight against the tissue layers by pulling a proximal end of the wire suture (col 12, line 63 through col 13, line 64 and figures 13-15; specifically, col 13, lines 45-56, including “the anchor assembly is cinched by retracting control element 134… thereby cinching anchor assembly 68'”; As depicted in the associated figures 13-15 of Ewers and the lumen of Olympus as in figures 3-5, the cinch mechanism is provided with the pusher tube 76 and locking mechanism 136 pulling the anchor tight between each anchor 82 and 84);
(h) pushing the cinch against the tissue layers by the pusher tube (col 12, line 63 through col 13, line 64 and figures 13-15; specifically, col 13, lines 45-56, including “the anchor assembly is cinched by retracting control element 134… thereby cinching anchor assembly 68'”; As depicted in the associated figures 13-15 of Ewers and the lumen of Olympus as in figures 3-5, the cinch mechanism is provided with the pusher tube 76 and locking mechanism 136);
(i) cutting the wire suture via the cinch mechanism (specifically, col 13, lines 57-64, including “The needle assembly cuts the suture proximal of locking mechanism 136, as in FIG. 15F”; see also col 12, line 63 through col 13, line 64 and figures 13-15); and
(j) removing the pusher tube (col 12, line 63 through col 13, line 64 and figures 13-15, pusher tube is removed with the device once the anchors and suture are placed).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Olympus as applied to claim 21 above, and further in view of Carpenter et al. (U.S. Pub. No. 20210186481) hereinafter Carpenter.
Regarding claim 26, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further fails to teach:
further comprising:
a hooked wire translatable within a clamp lumen defined by a clamp, the hooked wire having a distal end comprising a hook, wherein the hooked wire is configured to:
couple to the wire suture via the hook; and
position the wire suture into the clamp lumen by translating the hook distally away from the anchor
However, the analogous art of Carpenter of a tissue anchor with a wire suture system (abstract) teaches:
further comprising:
a hooked wire translatable within a clamp lumen defined by a clamp, the hooked wire having a distal end comprising a hook ([0118], figure 29, portion 605 forms a hook element that is a clamp between the tissue anchor 600 and the suture 694. This portion of the device further forms a “clamp lumen” as the lumen where the clamp portion resides), wherein the hooked wire is configured to:
couple to the wire suture via the hook ([0118], figure 29, portion 605 forms a hook element that is a clamp between the tissue anchor 600 and the suture 694.); and
position the wire suture into the clamp lumen by translating the hook distally away from the anchor ([0118], figure 29, portion 605 forms a hook element that is a clamp between the tissue anchor 600 and the suture 694. Wire suture is positioned based upon the hook moving distally into 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 have modified the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the hook element as a clamp coupling the anchor and the suture as taught by Carpenter because it provides for a secure suture attachment feature, enabling suture connection to the target tissue of interest (Carpenter, [0118]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Olympus as applied to claim 27 above, and further in view of Binmoeller et al. (U.S. Pub. No. 20150366579) hereinafter Binmoeller.
Regarding claim 28, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 27. Primary reference Ewers, in view of Mitelberg, in further view of Olympus further teaches:
the anchor is arranged and disposed to hinge around the coupling with the wire suture once exiting the outer cannula (Ewers: as depicted in figures 15B and 15C, the anchor forms a hinging around the coupling with the wire suture after extension; see further as depicted and disclosed in figures 13-15; col 12, line 63 through col 13, line 64; Mitelberg: [0010], anchor suture eyelet fixedly coupled to the suture; [0011], “While the distal end of the suture is fixedly secured to the first suture anchor, additional suture anchors are threaded onto the suture through the suture anchor eyelets.”; [0070], “suture anchor 42 also includes a collar 68 that is fixedly coupled to a suture eyelet 70.”; figures 3-6 further depict the distal anchor eyelet for attachment to the distal end of the suture; [0071]-[0074]; [0078], “the sheath is retracted revealing a first suture anchor 42 is fixedly coupled to suture 46 which is positioned near target tissue adjacent a gastrointestinal “GI” defect 142”; [0079]-[0080]; figures 7A-7H).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the wire suture with a distal end affixed to the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0078]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
Primary reference Ewers further fails to teach
wherein:
the outer cannula comprises a first outer cannula and a second outer cannula;
the second outer cannula is translatable within the EUS lumen;
the inner cannula is arranged and disposed to pass from the first outer cannula to the second outer cannula, and is translatable within the second outer cannula
However, the analogous art of Binmoeller of a tissue treatment apparatus for deployment to a target region of interest (abstract) teaches:
wherein:
the outer cannula comprises a first outer cannula and a second outer cannula ([0030]-[0033], figures 4-7, outer catheter 90 teaches to the EUS lumen of the combined prior art device, and inner catheter 80 with inner reinforcement cannula 84 and cannula 45 forming first and second outer cannula. Main body 33 forms a teaching to the inner cannula in the combined prior art invention; see also [0034]-[0045]);
the second outer cannula is translatable within the EUS lumen ([0030]-[0033], figures 4-7, outer catheter 90 teaches to the EUS lumen of the combined prior art device, and inner catheter 80 with inner reinforcement cannula 84 and cannula 45 forming first and second outer cannula that are each translatable in the EUS lumen of the combined prior art invention (see catheter 90); see also [0034]-[0045]);
the inner cannula is arranged and disposed to pass from the first outer cannula to the second outer cannula, and is translatable within the second outer cannula ([0030]-[0033], figures 4-7, outer catheter 90 teaches to the EUS lumen of the combined prior art device, and inner catheter 80 with inner reinforcement cannula 84 and cannula 45 forming first and second outer cannula. Main body 33 forms a teaching to the inner cannula in the combined prior art invention and is disposed to pass from the first outer cannula and the second outer cannula and allows separation of the two pieces of the overall device as in figure 6; see also [0034]-[0045]); and
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the first and second outer cannula as taught by Binmoeller because it enables the cannula sections to be separated and deployed to the target region of interest, which provides for efficient retraction of elements after completing a procedure (Binmoeller, [0030]-[0045]).
Claims 29-30 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Olympus as applied to claims 21 or 38 above, and further in view of Nakao (U.S. Pat. No. 9713465) hereinafter Nakao.
Regarding claim 29, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further fails to teach:
wherein the outer cannula further defines a fluid injection port divergent from a distal portion of the outer cannula
However, the analogous art of Nakao of a surgical fastening assembly for delivering a fastener to a target tissue of interest (abstract) teaches:
wherein the outer cannula further defines a fluid injection port divergent from a distal portion of the outer cannula (col 13, lines 4-10; col 13, lines 58-62, “an alternative embodiment might deliver warm fluid to the anchors through fluid port 30 and passageway 15 to induce an austenitic state”; figure 2, fluid injection port 30 to introduce fluid 17).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the fluid injection port divergent from a distal portion of the outer cannula as taught by Nakao because it enables the delivery of fluid to a target region of interest, which can be utilized to achieve an austenitic state in the anchors deployed within a tissue (Nakao, col 13, lines 58-62). This provides for higher treatment efficacy, which leads to improved clinical outcomes.
Regarding claim 30, the combined references of Ewers, Mitelberg, Olympus, and Nakao teach all of the limitations of claim 29. Primary reference Ewers further fails to teach:
wherein the fluid injection port and the distal portion form a Y connect
However, the analogous art of Nakao of a surgical fastening assembly for delivering a fastener to a target tissue of interest (abstract) teaches:
wherein the fluid injection port and the distal portion form a Y connect (col 13, lines 4-10; col 13, lines 58-62, “an alternative embodiment might deliver warm fluid to the anchors through fluid port 30 and passageway 15 to induce an austenitic state”; figure 2, fluid injection port 30 to introduce fluid 17 forms a Y connect with the distal portion of the overall device).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, Olympus, and Nakao to incorporate the Y connect fluid injection port divergent from a distal portion of the outer cannula as taught by Nakao because it enables the delivery of fluid to a target region of interest, which can be utilized to achieve an austenitic state in the anchors deployed within a tissue (Nakao, col 13, lines 58-62). This provides for higher treatment efficacy, which leads to improved clinical outcomes.
Regarding claim 39, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 38. Primary reference Ewers further fails to teach:
further comprising the steps of:
extending the outer cannula from the EUS scope, through the first section of tissue, and into the second section of tissue;
then retreating the outer cannula from the second section of tissue
However, the analogous art of Olympus of an endoscopic puncture needle and puncture suture system (abstract) teaches:
further comprising the steps of:
extending the outer cannula from the EUS scope, through the first section of tissue, and into the second section of tissue (figures 3-5, include extending the outer cannula from the EUS scope and into the first and section sections of tissue; see also [0008]-[0013], figure 2, ultrasound endoscope system that includes an inner needle tube; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus);
then retreating the outer cannula from the second section of tissue (figures 3-5, include extending the outer cannula from the EUS scope and into the first and section sections of tissue and is removed from the tissue after the procedure occurs; see also [0008]-[0013], figure 2, ultrasound endoscope system that includes an inner needle tube; figures 3-5, and [0017]-[0021], endoscope insertion section 4 includes the ultrasound probe 15, needle tube 24, and the sheath 23 which form the combined endoscopic ultrasound anchoring system, wherein the multi-part anchoring system of Ewers would be provided within the endoscopic ultrasound lumen as taught by Olympus).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the endoscopic ultrasound anchoring system as taught by Olympus because complex interventional procedures within the body require both sutures for sealing any incisions within a tissue region of interest, but also imaging to enable a physician to perform the procedure. By utilizing the anchor and suture system of Ewers in the endoscopic ultrasound anchoring system as taught by Olympus, higher quality targeting of regions of interest can occur, leading to improved clinical outcomes for patients (see Olympus, [0002]-[0004]).
Primary reference Ewers further fails to teach:
flowing a fluid through the outer cannula and into the second section of tissue; and
However, the analogous art of Nakao of a surgical fastening assembly for delivering a fastener to a target tissue of interest (abstract) teaches:
flowing a fluid through the outer cannula and into the second section of tissue (col 13, lines 4-10; col 13, lines 58-62, “an alternative embodiment might deliver warm fluid to the anchors through fluid port 30 and passageway 15 to induce an austenitic state”; figure 2, fluid injection port 30 to introduce fluid 17 forms a Y connect with the distal portion of the overall device).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the fluid injection port for flowing a fluid into the tissue as taught by Nakao because it enables the delivery of fluid to a target region of interest, which can be utilized to achieve an austenitic state in the anchors deployed within a tissue (Nakao, col 13, lines 58-62). This provides for higher treatment efficacy, which leads to improved clinical outcomes.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Olympus as applied to claim 21 above, and further in view of Noda et al. (U.S. Pat. No. 9220532) hereinafter Noda.
Regarding claim 31, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further fails to teach:
wherein the outer cannula further defines a plurality of apertures along a distal portion of the outer cannula
However, the analogous art of Noda of a working cannula for use in interventional tissue treatment procedures (abstract) teaches:
wherein the outer cannula further defines a plurality of apertures along a distal portion of the outer cannula (col 4, lines 6-30, figure 1, through-holes 42 form a plurality of apertures of the distal end of the catheter system (cannula in the combined prior art invention with Ewers, and Olympus)).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the plurality of apertures as taught by Noda because it enables fluid communication between the device and the tissue region of interest (Noda, col 4, lines 6-30). This provides for additional treatment configurations, leading to improved specificity of treatment outcomes.
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Olympus as applied to claim 21 above, and further in view of Conlon et al. (U.S. Pub. No. 20090143794) hereinafter Conlon.
Regarding claim 32, the combined references of Ewers, Mitelberg, and Olympus teach all of the limitations of claim 21. Primary reference Ewers further fails to teach:
further comprising: a second anchor translatable within the outer lumen and egressable from the distal end of the outer lumen
However, the analogous art of Conlon of a surgical instrument for providing a suture applicator to a tissue of interest (abstract) teaches:
further comprising: a second anchor translatable within the outer lumen and egressable from the distal end of the outer lumen ([0038]-[0039], figure 15, “first and second suture anchors”).
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, and Olympus to incorporate the first and second suture anchors as taught by Conlon because a second suture anchor can then be ejected from the cannula and positioned relative to the tissue in order to capture the tissue between the first and second suture anchor (Conlon, [0039]). This provides for more complete suture deployment to a region of interest.
Regarding claim 33, the combined references of Ewers, Mitelberg, Olympus, and Conlon teach all of the limitations of claim 32. Primary reference Ewers further fails to teach:
further comprising a second wire suture translatable through the inner-cannula lumen having a distal end affixed to the second anchor
However, the analogous art of Conlon of a surgical instrument for providing a suture applicator to a tissue of interest (abstract) teaches:
further comprising a second wire suture translatable through the inner-cannula lumen having a distal end affixed to the second anchor ([0038]-[0039], figure 15, “first and second suture anchors” wherein the “suture anchor” forms both a second anchor and a second suture. Note that in the combined invention the combined references including Ewers, teaches to a “wire” suture and Mitelberg teaches to “affixed” to the distal end)
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, Olympus, and Conlon to incorporate the first and second suture anchors as taught by Conlon because a second suture anchor can then be ejected from the cannula and positioned relative to the tissue in order to capture the tissue between the first and second suture anchor (Conlon, [0039]). This provides for more complete suture deployment to a region of interest.
Regarding claim 34, the combined references of Ewers, Mitelberg, Olympus, and Conlon teach all of the limitations of claim 32. Primary reference Ewers further fails to teach:
wherein the anchor and the second anchor are predisposed at different positions along a length of the inner-cannula lumen
However, the analogous art of Conlon of a surgical instrument for providing a suture applicator to a tissue of interest (abstract) teaches:
wherein the anchor and the second anchor are predisposed at different positions along a length of the inner-cannula lumen ([0038]-[0039], figure 15, “first and second suture anchors” wherein the “suture anchor” forms both a second anchor and a second suture. With the second suture anchor “can then be ejected” from the cannula following deployment of the first anchor, this forms predisposition at different positions with the ejected second suture anchor being proximal to the distal region)
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 the cannula/needle anchor and suture system of Ewers, Mitelberg, Olympus, and Conlon to incorporate the first and second suture anchors as taught by Conlon because a second suture anchor can then be ejected from the cannula and positioned relative to the tissue in order to capture the tissue between the first and second suture anchor (Conlon, [0039]). This provides for more complete suture deployment to a region of interest.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in view of Mitelberg, in further view of Perkins-Neaton et al. (U.S. Pub. No. 20190314574) hereinafter Perkins-Neaton.
Regarding claim 36, primary reference Ewers teaches:
An anchor delivery system (abstract) comprising:
an anchor (anchor assembly 68’ comprising anchors 82 and 84, figures 13-15; col 12, line 63 through col 13, line 64, anchor assembly 68’ forms the anchor disposed at the distal end of the pusher 76 (inner cannula) which includes the additional lumen 77, and is constructed as to push the anchor out of the distal end of the outer cannula);
a wire suture coupled to the anchor (suture element 132’ is disposed between distal anchor 82 and proximal anchor 84, figures 13-15; col 12, line 63 through col 13, line 64, suture element 132’ forms a wire suture translatable through the inner-cannula lumen (pusher lumen 77) and has a distal end coupled to the anchor assembly 68’).;
an outer cannula defining an outer-cannula central bore (tubular sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, tubular sheath 64 forms an analogous teaching to an outer cannula defining an outer-cannula lumen).; and
an inner cannula defining an inner-cannula central bore, wherein the inner-cannula central bore has a cross-sectional dimension configured to accommodate the suture (pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, pusher 76 includes a lumen 77 which forms an inner cannula that is translatable within the outer cannula of sheath 64 and has a lumen capable of accommodating the wire suture element).;
the outer-cannula central bore has a cross-sectional dimension configured to accommodate the inner cannula (tubular sheath 64, figures 13-15; col 12, line 63 through col 13, line 64, tubular sheath 64 forms an analogous teaching to an outer cannula defining an outer-cannula lumen in which the pusher 76 can be fit within);
wherein the inner cannula further comprises a proximal stop shoulder at a proximal end, the proximal stop shoulder having a cross-sectional profile larger than a diameter of the outer-cannula central bore to prevent the proximal end from entering the outer cannula (actuation member 78 on the proximal end of pusher 76 has a larger profile than sheath 64 and therefore forms a proximal stop shoulder with a larger cross sectional profile than the outer cannula; figures 13-15; col 12, line 63 through col 13, line 64; col 8, lines 30-49 and figure 5B show the actuation member 78 further provided in a dimensional form that forms a proximal stop shoulder at a proximal end of the inner cannula; see also figure 19A-C, col 14, lines 26-41, further show variation that additionally has actuation member 78 in format of proximal stop shoulder that is moveable and larger in cross sectional progile than the outer cannula central bore of sheath 64).
Primary reference Ewers further fails to teach:
a wire suture affixed to the anchor
However, the analogous art of Mitelberg of a deployment system for a suture anchor tissue treatment system (abstract) teaches:
a wire suture affixed to the anchor ([0010], anchor suture eyelet fixedly coupled to the suture; [0011], “While the distal end of the suture is fixedly secured to the first suture anchor, additional suture anchors are threaded onto the suture through the suture anchor eyelets.”; [0070], “suture anchor 42 also includes a collar 68 that is fixedly coupled to a suture eyelet 70.”; figures 3-6 further depict the distal anchor eyelet for attachment to the distal end of the suture; [0071]-[0074]; [0078], “the sheath is retracted revealing a first suture anchor 42 is fixedly coupled to suture 46 which is positioned near target tissue adjacent a gastrointestinal “GI” defect 142”; [0079]-[0080]; figures 7A-7H).
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 the cannula/needle anchor and suture system of Ewers to incorporate the wire suture with a distal end affixed to the anchor as taught by Mitelberg because it enables precise initial positioning of the distal suture anchor directly in the tissue of interest at the target area within the patient (Mitelberg, [0078]). This provides higher quality interventional procedures, leading to improved clinical outcomes for patients.
Primary reference Ewers further fails to teach;
the inner cannula has a length greater than 1 m
However, the analogous art of Perkins-Neaton of a therapy drug delivery device for tissue treatment (abstract) teaches:
the inner cannula has a length greater than 1 m ([0064]; in the combined invention of Ewers and Perkins-Neaton, the inner cannula of Ewers with the interfaced cannula of Perkins-Neaton forms an inner cannula greater than 1 m;); and
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 the cannula/needle anchor and suture system of Ewers and Mitelberg to incorporate the longer inner cannula length as taught by Perkins-Neaton because it enables easier access to fluid ports related to the inner lumens and provides a user with more flexibility of placement of the lumen within the treatment space (Perkins-Neaton, [0063]-[0064]). This provides for better fluid delivery during combined treatment procedures, leading to improved clinical outcomes.
Regarding claim 37, the combined references of Ewers, Mitelberg, and Perkins-Neaton teach all of the limitations of claim 36. Primary reference Ewers further teaches:
further comprising a removable stopper adapted and configured to be removably mounted on an outer surface of the inner cannula to prevent advancement of the inner cannula and the anchor distal to the inner cannula from advancing within the outer cannula (figure 32, col 18, lines 49-67, “Retraction control element 280 may be removably connected via a coupling mechanism such as a threaded connection 282 to the proximal end of control or housing 272”, in combination with the first locking position 276 and the control positioning, this provides for a removable stopper that prevents movement (advancement) of the inner cannula and anchor system; col 19, lines 1-4).
Response to Arguments
Applicant’s arguments with respect to claims 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 7/08/2026 have been fully considered but they are not persuasive. Responses to each of the applicant’s arguments are detailed below.
In response to applicant's argument that Perkins-Neaton is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Perkins-Neaton teaches to a percutaneous therapy delivery system that involves analogous interventional access to target regions of interest within a patient. Whether a device is used in drug delivery or the application of a suture, one of ordinary skill in the art would look to advancements within interventional cannula or catheter systems and apply these features accordingly to analogous endeavors. The reference does not modify the Ewers reference in a way that teaches away from the intended purpose of tissue anchor placement, and therefore the stated motivation one of ordinary skill in the art would utilize to modify the primary reference would apply.
For these reasons, the applicant’s arguments have been considered but are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harari et al. (U.S. Pub. No. 20150320442) teaches to a delivery device for tissue anchor delivery and includes a suture attached to a distal anchor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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, Keith Raymond can be reached at 571-270-1790. 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.inseruspto.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.
/SEAN A FRITH/Primary Examiner, Art Unit 3798
Prosecution Insights