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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Response to Amendment
The amendment filed 01/02/2026 has been entered. Claims 1-2, 4-5, 18, 20, 22, and 24-27 are currently pending in the application. Claims 3, 6-17, 19, 21, and 23 have been canceled. Claims 1, 5, and 18 have been amended. Claims 25-27 are newly added.
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 01/02/2026, with respect to the previously rejected claims have been considered but are moot because of Applicant’s amendments to the independent claims. Applicant has amended the independent claims with the newly added limitation to state, “the rails comprises a plurality of grooves or notches incrementally spaced apart along the rail,… the ring configured to releasably couple with the plurality of grooves or notches,” thus changing the scope of the claims. Therefore, the previous claim rejections and claim objections identified in the final office action dated 08/01/2025 have been withdrawn. A new ground of rejection are presented below. Please see the rejections under 35 U.S.C §103 below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 5, 18, 20, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Aubrey Palestrant (US4832055) hereinafter Palestrant in view of Reger et al. (US5108419) hereinafter Reger.
Regarding claim 1, Palestrant discloses a system, comprising:
a retractor (Figs. 1-4F mesh 52) movable between a radially-collapsed configuration (Fig. 4A mesh 52) and a radially- expanded configuration (Fig. 4B-F mesh 52) , the retractor (Figs. 1-4F mesh 52) comprising a plurality of retractor elements (Figs. 1-4F each of the retractor elements – portions of wires 28-38 that make up the mesh 52) coupled to a distal coupler (Figs. 1-4F connector 40), the distal coupler (Figs. 1-4F first connector 40) comprising a port (Portion of connector 40 that holds wires 26-38, [col. 6 line 61 – col. 7 line 2] “ Connector 40 serves to connect together a first end of each of peripheral wires 28-38, and attaches such peripheral wires about the first end of central core wire 26 at a first connection point. Connector 40 is welded, crimped or otherwise attached to the first end of central core wire 26 and to the first ends of peripheral wires 28-38 so that a fixed connection is achieved between the central core wire and the six peripheral wires.”);
a rail (Figs. 1-4f and 18A-C, wire 26) coupled to the distal coupler (Figs. 1-4F first connector 40) and configured to stabilize the retractor (Figs. 1-4F mesh 52) when in the radially-expanded configuration;
a ring (Figs. 1-4F connector 42) slidably disposed ([col. 7 lines 3-18] “…it will be noted that central core wire 26 passes freely through the interior space defined by tubular collar 42 and the peripheral wire secured therein, thereby allowing second connector 42 to slide along central core wire 26.”[ col. 10 lines 3-33] ) over the rail (Figs. 1-4f wire 26), and
an anchor (Fig. 1 feet 54, 56, 58, 60); and
a tether (Fig. 1 leg portion of peripheral wires 28, 30, 32, 34) coupling the ring (Figs. 1-4F connector 42) to the anchor (Fig. 1 feet 54, 56, 58, 60).
Palestrant is silent at expressly disclosing wherein the rail comprising a plurality of grooves or notches incrementally spaced apart along the rail, and wherein the ring is configured to releasably couple with the plurality of grooves or notches.
However Reger, in the same field of endeavor, teaches the rail (Reger – Figs. 19-21 core 206) comprising a plurality of grooves or notches (Reger – Figs. 19-21 fins/ribs 216) incrementally spaced apart along the rail (Reger – Figs. 19-21 core 206), and wherein the ring (Reger – Rigs. 19-21 collars 210) is configured to releasably couple with the plurality of grooves or notches (Reger – Figs. 19-21 fins/ribs 216) [col. 12 lines 24-40] “A fin or rib 216 extends along a portion of the core 206 extending proximally from each of the detent collars 210 for a short distance, and as may be seen with reference to FIG. 21, grooves 218 extend longitudinally through the locking rings 214 at a plurality of angularly separated locations about the locking rings 214. The grooves 218 permit sliding passage of the ribs 216 as the core member 206 is moved longitudinally within the outer member 204 as indicated by the arrow 220, with the core 206 in the proper angular alignment. Enough space is provided as at 222, between one of the ribs 216 and the next one of the locking rings 214, in a proximal direction along the core 206, to permit the core 206 to be rotated within the outer member 204 when all of the detent collars 210 are disengaged from a locking position between the pair of locking rings 214.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant with the teachings of Reger to include the rail comprising a plurality of grooves or notches incrementally spaced apart along the rail, and wherein the ring is configured to releasably couple with the plurality of grooves or notches for the benefit of ensuring the ring is in a “proper angular alignment” (Reger - [col. 12 lines 24-40]).
Regarding claim 2, Palestrant in view of Reger teaches the system of claim 1, further including an overtube (Palestrant - Fig. 4C-E catheter 70) having a lumen configured to receive an endoscope (Palestrant - Fig. 4C-F catheter 80), wherein the retractor (Palestrant - Figs. 1-4F mesh 52) is disposed at or adjacent to a distal end (Palestrant - Figs. 4C-E) of the overtube (Palestrant - Fig. 4C-F catheter 70).
Regarding claim 4, Palestrant in view of Reger teaches the system of claim 1, wherein the retractor (Palestrant - Figs. 1-4F mesh 52) includes the rail (Palestrant - Figs. 1-4f wire 26).
Regarding claim 5, Palestrant in view of Reger teaches the system of claim 1, wherein the plurality of grooves or notches are incrementally spaced apart longitudinally (Reger – Figs. 19-21 fins/ribs 216) [col. 12 lines 24-40] “A fin or rib 216 extends along a portion of the core 206 extending proximally from each of the detent collars 210 for a short distance, and as may be seen with reference to FIG. 21, grooves 218 extend longitudinally through the locking rings 214 at a plurality of angularly separated locations about the locking rings 214. The grooves 218 permit sliding passage of the ribs 216 as the core member 206 is moved longitudinally within the outer member 204 as indicated by the arrow 220, with the core 206 in the proper angular alignment. Enough space is provided as at 222, between one of the ribs 216 and the next one of the locking rings 214, in a proximal direction along the core 206, to permit the core 206 to be rotated within the outer member 204 when all of the detent collars 210 are disengaged from a locking position between the pair of locking rings 214.”). along the rail (Reger – Figs. 19-21 core 206).
Regarding claim 18, Palestrant discloses a method of treating a patient, the method comprising:
radially expanding a retractor (Figs. 1-4F mesh 52) while the retractor (Figs. 1-4F mesh 52) is adjacent to a target area (abstract, blood clot) in a body lumen of the patient (abstract), the retractor (Figs. 1-4F mesh 52) comprising:
a distal coupler comprising a port (Portion of connector 40 that holds wires 26-38, [col. 6 line 61 – col. 7 line 2] “ Connector 40 serves to connect together a first end of each of peripheral wires 28-38, and attaches such peripheral wires about the first end of central core wire 26 at a first connection point. Connector 40 is welded, crimped or otherwise attached to the first end of central core wire 26 and to the first ends of peripheral wires 28-38 so that a fixed connection is achieved between the central core wire and the six peripheral wires.”);
a plurality of retractor elements (Figs. 1-4F each of the retractor elements – portions of wires 28-38 that make up the mesh 52) coupled to a distal coupler(Figs. 1-4F connector 40),
a rail (Figs. 1-4f wire 26) coupled to the distal coupler (Figs. 1-4F first connector 40);
grasping tissue with a tissue-engaging element (Fig. 1 feet 54, 56, 58, 60); and
tensioning the tissue by securing an anchor-engaging element (Figs. 1-4F connector 42).
Palestrant is silent at expressly disclosing wherein the rail comprising a plurality of grooves or notches incrementally spaced apart along the rail, and coupling the anchor-engaging element to one of the plurality of grooves or notches.
However Reger, in the same field of endeavor, teaches the rail (Reger – Figs. 19-21 core 206) comprising a plurality of grooves or notches (Reger – Figs. 19-21 fins/ribs 216) incrementally spaced apart along the rail (Reger – Figs. 19-21 core 206), and coupling the anchor-engaging element (Figs. 19-21 collar 210) to one of the plurality of grooves or notches (Reger – Figs. 19-21 fins/ribs 216) [col. 12 lines 24-40] “A fin or rib 216 extends along a portion of the core 206 extending proximally from each of the detent collars 210 for a short distance, and as may be seen with reference to FIG. 21, grooves 218 extend longitudinally through the locking rings 214 at a plurality of angularly separated locations about the locking rings 214. The grooves 218 permit sliding passage of the ribs 216 as the core member 206 is moved longitudinally within the outer member 204 as indicated by the arrow 220, with the core 206 in the proper angular alignment. Enough space is provided as at 222, between one of the ribs 216 and the next one of the locking rings 214, in a proximal direction along the core 206, to permit the core 206 to be rotated within the outer member 204 when all of the detent collars 210 are disengaged from a locking position between the pair of locking rings 214.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant with the teachings of Reger to include the rail comprising a plurality of grooves or notches incrementally spaced apart along the rail, and coupling the anchor-engaging element to one of the plurality of grooves or notches for the benefit of ensuring a “proper angular alignment” of an anchor-engaging element (Reger - [col. 12 lines 24-40]).
Regarding claim 20, Palestrant in view of Reger teaches the method of claim 18, wherein, before the radially expanding step, the method includes: positioning a distal end of an endoscope (Palestrant - Fig. 4C-F catheter 80) adjacent to the target area in the body lumen (Palestrant - abstract); and extending an overtube (Palestrant - Fig. 4C-E catheter 70) including the retractor (Palestrant - Figs. 1-4F mesh 52) over the endoscope (Palestrant - Fig. 4C-F catheter 80) so that the retractor (Palestrant - Figs. 1-4F mesh 52) is adjacent to the target area (Palestrant - abstract, blood clot).
Regarding Claim 25, Palestrant in view of Reger teach the method of claim 18, wherein the anchor-engaging element (Palestrant - Figs. 1-4F connector 42) is a ring slidably disposed over the rail (Palestrant Figs. 1-4f wire 26).
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Palestrant in view of Reger in view of Smith et al. (US2018/0035997) hereinafter Smith 997.
Regarding claim 22, Palestrant in view of Reger teach the system of claim 1, but fails to explicitly state wherein the anchor is a tissue clip.
However Smith 997 teaches the anchor being a tissue clip ([0041]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant in view of Reger with the teachings of Smith 997 to configure the anchor to be a tissue clip to have the benefit grasping tissue and being “…any mechanism capable of grasping, securing, and/or manipulating tissue. For example, the target tissue anchor may be a clip, suture, corkscrew, spike, hook, grasper, staple, adhesive, simple loop (e.g., loop 620 of FIG. 6), spiral loop, helical loop, etc. The attachment of the target tissue anchor to the target tissue may need to be proximal of the proximalmost portion of a stabilizing anchor, so that the entire target tissue may be retracted distally from the cutting zone until the entire target tissue has been excised” [0041] .
Regarding claim 24, Palestrant in view of Reger teach the method of claim 18, but fails to explicitly state wherein the tissue-engaging element is a tissue clip.
However Smith 997 teaches the tissue-engaging element being a tissue clip ([0041]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant in view of Reger with the teachings of Smith 997 to configure the tissue-engaging element to be a tissue clip to have the benefit grasping tissue and being “…any mechanism capable of grasping, securing, and/or manipulating tissue. For example, the target tissue anchor may be a clip, suture, corkscrew, spike, hook, grasper, staple, adhesive, simple loop (e.g., loop 620 of FIG. 6), spiral loop, helical loop, etc. The attachment of the target tissue anchor to the target tissue may need to be proximal of the proximalmost portion of a stabilizing anchor, so that the entire target tissue may be retracted distally from the cutting zone until the entire target tissue has been excised” [0041] .
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Palestrant in view of Reger in view of Farley et al. (US6014589) hereinafter Farley.
Regarding Claim 26, Palestrant in view of Reger teaches the method of claim 18, but is silent whether the method further comprises positioning a tool adjacent to the target area of the body via the port in the distal coupler.
However Farley, in the same field of endeavor, teaches further comprises positioning a tool (Farley – Figs. 2, 4-8, 13, guide wire 38) adjacent to the target area of the body(Farley abstract) via the port (Farley – Figs. 2, 4-8, 13, guide wire port 36) in the distal coupler (Farley – Figs. 2, 4-8, 13, distal tip 34).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant in view of Reger to further comprises positioning a tool adjacent to the target area of the body via the port in the distal coupler, as taught by Farley, for the benefit of having a guide wire “advance into the vasculature of the patient” (Farley – col. 7 lines 24-35).
Regarding Claim 27, Palestrant in view of Reger teaches the system of claim 1, but is silent at explicitly teaching furthering comprising a tool disposed through the port of the distal coupler.
However Farley, in the same field of endeavor, teaches further comprises a tool (Farley – Figs. 2, 4-8, 13, guide wire 38) disposed through the port (Farley – Figs. 2, 4-8, 13, guide wire port 36) in the distal coupler (Farley – Figs. 2, 4-8, 13, distal tip 34).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Palestrant in view of Reger to further comprise a tool disposed through the port of the distal coupler., as taught by Farley, for the benefit of having a guide wire “advance into the vasculature of the patient” (Farley – col. 7 lines 24-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795