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 .
Response to Amendment
This action is in response to the remarks filed on 12/11/2025. The amendments
filed on 12/11/2025 are entered.
The previous rejections of claims 36-37 under 35 U.S.C. 112(b) have been withdrawn in light of the applicant’s remarks/amendments.
Information Disclosure Statement
The information disclosure statement filed 9/02/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the information disclosure statement fails to comply with 37 CFR 1.97(c) as it lacks a fee of 37 CFR 1.17(p) or a timing statement as specified in 37 CFR 1.97(e). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings were received on 12/11/2025. These drawings are acceptable.
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 Olympus Medical Systems (JP4436805B2) hereinafter Olympus (see attached FOR reference English translation 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 having a distal end 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’).
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 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 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:
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 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 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 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 and Olympus teach all of the limitations of claim 21. Primary reference Ewers further teaches:
wherein the anchor comprises a first end, a second end, and a middle portion, and the distal end of the wire suture is coupled to the middle portion of the anchor (col 12, line 63 through col 13, line 64, anchors 82 and 84 include a first end, second end, and then a middle portion between the ends. The wire suture distal end portion is attached/coupled to all parts of the anchor, and therefore is also coupled to the middle portion of the anchor element).
Regarding claim 27, the combined references of Ewers 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 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 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 and Olympus teach all of the limitations of claim 21. Primary reference Ewers, in 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 coupling 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); 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 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 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 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 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 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 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 and Olympus teach all of the limitations of claim 27. Primary reference Ewers further teaches:
the anchor is arranged and disposed to hinge around the coupling with the wire suture once exiting the outer cannula (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).
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 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 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 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 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, 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, 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 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 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 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.
Claims 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers, in 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 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 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 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 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 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, 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 coupled 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 coupled 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)
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, 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, 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, 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 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 (housing 62 on the proximal end of needle body 72 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).
Primary reference Ewers 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 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 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 filed 12/11/2025 have been fully considered but they are not persuasive. Responses to each of the applicant’s arguments are detailed below.
Regarding the applicant’s arguments on pages 8-9, the applicant argues that the Ewers reference disclosures of the anchor assembly 68’ that includes anchors 82, 84, and knot 133 fail to teach to the distal end of the suture being coupled to the anchor. The applicant argues that the anchors can move along the suture which would render the anchor not coupled to the suture. As depicted in figure 13 of Ewers reproduced by the applicant in the remarks, the current interpretation of the claims in the rejections above is that the suture is coupled to each anchor of the anchor assembly 68’ as the suture travels through the middle of each anchor. The claims do not require that the anchors are to be fixed a particular location on the suture, merely that the wire suture is “coupled to the anchor”. The broadest reasonable interpretation of “coupled” can include the anchors that are moveable along the suture, because they still remain coupled to the suture during use, as the anchors are completely attached to the suture between locking mechanism 136 and knot 133. As depicted in figure 13, locking mechanism 136 through knot 133 all are within the distal end of the suture, and located at the distal end opening of the overall cannula system. The claim does not require fixed coupling at the terminal distal tip of the suture, and therefore the teachings of Ewers are sufficient to teach to the broadest reasonable interpretation of the claim.
Regarding the applicant’s arguments on page 12 of the remarks, the applicant argues that housing 62 is positioned on the needle body 72 which cannot be considered part of the inner cannula which was claimed mapped in the present rejections to pusher 76. In the current rejections, housing 62 is a proximal stop shoulder at a proximal end of the device that has a diameter larger than a diameter of the outer cannula center bore (figure 13-15, the housing 62 is clearly larger than the bore even if not drawn exactly to scale) and in conjunction with the actuation member 78 enable the inner cannula to be stopped at a proximal end of the device and prevent entry into the outer cannula. While the present cited portions of the Ewers reference fully support this interpretation, one of ordinary skill in the art would look to other parts of the Ewers reference to determine whether this interpretation is reasonable. Ewers in col 8, lines 30-49 and figure 5B shows a detailed exploded assembly view of the system 60, which is referenced in conjunction with assembly 60’ that is cited with figures 13 and 14 (see col 12, lines 65-66). In figure 5B, housing 62 is coupled to pusher 76 as well as actuation member 78, and is also coupled to the tubular sheath 64 when in use as in figure 5A via interlock element 70. This more detailed depiction of the assembly 60 variation matches the current interpretation of the cited portions of the Ewers reference that includes figures 13-15 and col 12, line 63 through col 13, line 64. In light of both the initial interpretation of the cited portion of the reference alone, and the supporting teachings of the primary embodiment of the device, the current interpretation of the Ewers teachings remains sufficient to teach to the broadest reasonable interpretation of the claim. The applicant further argues that the actuation member 78 and housing 62 are illustrated as generic boxes and therefore cannot be used to support a specific cross-section profile. As discussed above, the broad recitation of “a cross-sectional profile larger than a diameter of the outer cannula central bore” does not require a specific disclosure within the prior art reference other than that the element is clearly larger than the diameter. In this instance, the figures and associated teachings to a housing are sufficient to teach that the housing (even when indicated with a box representation) is larger than the central bore of the outer catheter. As discussed above, when referencing the primary embodiment of the invention upon which the figures 13-15 embodiment is derived from, the figure 5B teachings of housing 62 and actuation member 78 match the examiner’s interpretation of a shoulder stop capability as in the other cited portions of the reference (see for example, figure 15C). For these reasons, the applicant’s arguments directed to the Ewers reference teachings are not persuasive.
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.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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. The proximal control end of the interventional systems can be similarly improved across interventional cannula/catheter procedures, and it would have been obvious to one of ordinary skill in the art to apply the features of Perkins-Neaton to that of Ewers to obtain an improvement to the device. For these reasons, the applicant’s arguments directed to the combination of references are not persuasive.
For these reasons, the applicant’s arguments have been considered but are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798