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 entered in response to Applicant's amendment and reply filed 11/29/25. The claims 1-11, 13-26 are pending. Claims 12, 27-36 were previously cancelled.
Response to Arguments
Applicant’s arguments, filed in the pre-appeal dated 6/9/26 with respect to the rejections of claims 1-5 under 35 U.S.C. 103 as being unpatentable over Perkins (US2009/0248142) in view of Falwell (US2008/0039918) and McGuckin (US2018/0360607) have been fully considered and the arguments have been found persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, filed in the pre-appeal dated 6/9/26 with respect to the rejections of claims 13 and 14 under 35 U.S.C. 103 as being unpatentable over Perkins (US2009/0248142) in view of McGuckin (US2018/0360607) have been fully considered and the argument that has been found persuasive. However, a new grounds of rejection has been made in view of McGuckin (US2018/0360607).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin (US2018/0360607).
Regarding claim 13, McGuckin discloses an implantable coil for restoring venous valve function (see Abstract), comprising:
a coil body (10) defining a first diameter (diameter defined by loops of the coil, see Fig. 7C) and having a non-coiled configuration in a first state of the implantable coil (first state is when the coil extends longitudinally through the sheath 60 in a straightened state, [0063], see Fig. 7A) and a coiled configuration in a second state (second state is when the coil is released from the sheath 60 and assumes the coiled shape, [0063]) of the implantable coil for coiling around an abluminal surface of a vein and constricting a valve area thereof to bring leaflets within the valve area closer together (see Abstract, where the implantable coil is capable of being delivered in this manner around the vein to constrict the valve), and
a locking bead (36) at a proximal end of the coil body opposite a distal end thereof (see Fig. 7C), the locking bead aligned axially with a central axis of the coil body (see Fig. 7C, bead 36 is aligned along the central axis by being on an axis radially outward from the central axis) and defining a second diameter (diameter defined by the largest part of the bead 36 and around the coil that would be a larger diameter than just the coil itself, see Fig. 7C, [0055]) larger than the first diameter, the locking bead configured to anchor the implantable coil to a luminal surface of the vein by way of an opening of a wall of the vein (the bead 36 is capable of performing the claimed function by being a ball or hook structure that would make additional contact with a wall of a vessel when the coil is positioned around a vessel, [0055]).
Regarding claim 14, McGuckin discloses the implantable coil of claim 13, McGuckin further teaches wherein the locking bead is configured to seal the opening in the wall of the vein and prevent migration of the implantable coil (the bead 36 is capable of preventing migration of the coil and sealing an opening in the wall of the vein by being an enlargement at the end of the coil that could be inserted through and opening and prevented from backing out by the shape of the coil and also enlargement at the distal end, see Fig. 7C).
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 of this title, 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 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin (US2018/0360607) in view of Case (US2007/0100432).
Regarding claim 15, McGuckin discloses the implantable coil of claim 14; yet, is silent regarding wherein the locking bead is formed of a bioresorbable material. Case teaches a frame for venous valve insufficiency (see Abstract). Where the frame can be coated or formed from bioabsorbable materials ([0055]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the entirety of the coil including the bead of McGuckin to be coated with bioabsorbable materials as taught by Case in order to have the coil be partially absorbed by the body after a period of time to eliminate some of the structure from the vessel, before, during, or after the remodeling process ([0075]).
Regarding claim 16, McGuckin/Case makes obvious the implantable coil of claim 15, McGuckin further discloses wherein the implantable coil is a shape-set nitinol implantable coil ([0046]).
Regarding claim 17, McGuckin/Case makes obvious the implantable coil of claim 16, McGuckin further discloses wherein the coil body is shaped into a circular cylinder with circular coils in the second state of the implantable coil (see Fig. 7C).
Regarding claim 18, McGuckin/Case makes obvious the implantable coil of claim 16; yet, does not explicitly disclose wherein the coil body is shaped into an elliptic cylinder with elliptical coils in the second state of the implantable coil. It would have been an obvious matter of design choice to a person of ordinary skill in the art to have the coil body be shaped into an elliptic cylinder with elliptical coils in the second state, since applicant has not disclosed that having the elliptical shape provides an advantage, solves any stated problem, or is used for any particular purpose, it appears that the device would perform equally well with other designs as stated in the instant specification Paragraph [0076], and a person having ordinary skill in the art, being faced with modifying the shape of the coil body and coils of McGuckin/Case would have a reasonable expectation of success in making such a modification.
Regarding claim 19, McGuckin/Case makes obvious the implantable coil of claim 16; yet, does not explicitly disclose wherein the coil body is shaped into a cone with circular coils of increasing diameter from the proximal end to the distal end of the coil body in the second state of the implantable coil. It would have been an obvious matter of design choice to a person of ordinary skill in the art to have the coil body be shaped into a cone, since applicant has not disclosed that having the cone shape provides an advantage, solves any stated problem, or is used for any particular purpose, it appears that the device would perform equally well with other designs as stated in the instant specification Paragraph [0076], and a person having ordinary skill in the art, being faced with modifying the shape of the coil body and coils of McGuckin/Case would have a reasonable expectation of success in making such a modification.
Regarding claim 20, McGuckin/Case makes obvious the implantable coil of claim 16; yet, does not explicitly disclose wherein the coil body is shaped into an hourglass with circular coils of decreasing diameter from both the proximal and distal ends of the coil body in the second state of the implantable coil. It would have been an obvious matter of design choice to a person of ordinary skill in the art to have the coil body be shaped into an hourglass, since applicant has not disclosed that having the hourglass shape provides an advantage, solves any stated problem, or is used for any particular purpose, it appears that the device would perform equally well with other designs as stated in the instant specification Paragraph [0076], and a person having ordinary skill in the art, being faced with modifying the shape of the coil body and coils of McGuckin/Case would have a reasonable expectation of success in making such a modification.
Regarding claim 21, McGuckin/Case makes obvious the implantable coil of claim 16; yet, does not explicitly disclose wherein the coil body is shaped into a barrel with circular coils of increasing diameter from both the proximal and distal ends of the coil body in the second state of the implantable coil. It would have been an obvious matter of design choice to a person of ordinary skill in the art to have the coil body be shaped into a barrel, since applicant has not disclosed that having the barrel shape provides an advantage, solves any stated problem, or is used for any particular purpose, it appears that the device would perform equally well with other designs as stated in the instant specification Paragraph [0076], and a person having ordinary skill in the art, being faced with modifying the shape of the coil body and coils of McGuckin/Case would have a reasonable expectation of success in making such a modification.
Regarding claim 22, McGuckin/Case makes obvious the implantable coil of claim 21, McGuckin further discloses wherein the coil body is formed of a single wire (coil body is interpreted as only the body of portion 15 which is a single wire, [0051]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin (US2018/0360607) in view of Case (US2007/0100432) as applied to claim 21, and further in view of Bieneman (US2008/0009883).
Regarding claim 23, McGuckin/Case makes obvious the implantable coil of claim 21, yet, does not explicitly disclose wherein the coil body is formed of a number of wires braided together. Bieneman teaches a snare device having a guide element 12 that is formed of a wire that has various configurations known in the medical device art ([0027]). Where the configurations of the wire are a single strand, braid, and coil/core configuration ([0027]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the single strand coil body of McGuckin/Case for the braided coil body as taught by Bieneman, since the substitution would have yielded the same predictable result of providing a wire with desired characteristics for use in a vessel.
Regarding claim 24, McGuckin/Case makes obvious the implantable coil of claim 21, yet, does not explicitly disclose wherein the coil body is formed of a number of wires wound around a common core wire. Bieneman teaches a snare device having a guide element 12 that is formed of a wire that has various configurations known in the medical device art ([0027]). Where the configurations of the wire are a single strand, braid, and coil/core configuration ([0027]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the single strand coil body of McGuckin/Case for the coil around a core wire as taught by Bieneman, since the substitution would have yielded the same predictable result of providing a wire with desired characteristics for use in a vessel.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin (US2018/0360607) in view of Case (US2007/0100432), and Bieneman (US2008/0009883) as applied to claim 24, and further in view of Griffin (US2020/0163767).
Regarding claim 25, McGuckin/Case/Bieneman makes obvious the implantable coil of claim 24; yet, is silent regarding wherein the implantable coil includes one or more echogenicity-enhancing features for ultrasound visualization of the implantable coil. Griffin teaches methods for treating a valve in the human body, where components 120 of the device used for performing the procedure may comprise one or more markers 124, disposed thereon for identifying a location of retractable and extendable member 120 during a venous valve repair procedure, for example, by using markers 124 with external imaging, internal imaging, or both. Where markers 124 can include radiopaque markers to enhance visualization by X-ray, or etched grooves to enhance visualization by ultrasound imaging ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have modified the coil of McGuckin/Case/Bieneman to include echogenicity enhancing features such as grooves for ultrasound visualization as taught by Griffin in order to identify the location of the coil during implantation to ensure proper placement ([0078] of Griffin).
Regarding claim 26, McGuckin/Case/Bieneman/Griffin makes obvious the implantable coil of claim 25; yet, is silent regarding wherein the implantable coil includes one or more radiopacity-enhancing feature for X-ray visualization of the implantable coil. Griffin further teaches methods for treating a valve in the human body, where components 120 of the device used for performing the procedure may comprise one or more markers 124, disposed thereon for identifying a location of retractable and extendable member 120 during a venous valve repair procedure, for example, by using markers 124 with external imaging, internal imaging, or both. Where markers 124 can include radiopaque markers to enhance visualization by X-ray, or etched grooves to enhance visualization by ultrasound imaging ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have modified the coil of McGuckin/Case/Bieneman/Griffin to include radiopacity enhancing features for X-ray visualization as taught by Griffin in order to identify the location of the coil during implantation to ensure proper placement ([0078] of Griffin).
Allowable Subject Matter
Claims 1-11 are allowed.
The following is an examiner’s statement of reasons for allowance: no prior art of record teaches or disclose “a locking bead coupled to the proximal end of the coil body” in combination with the other elements of claim 1.
The closest prior art rejection of record, Perkins (US2009/0248142) in view of Falwell (US2008/0039918) does not teach all the claimed limitations as addressed below.
Regarding claim 1, Perkins discloses a system for restoring venous valve function, comprising:
an implantable coil (94) having a non-coiled configuration in a first state (first state is when the coil 94 extends longitudinally through the penetrator 85 in a straightened state, [0073]) and a coiled configuration in a second state (second state is when the coil 94 is released from the penetrator and assumes the coiled shape, [0073]), the implantable coil having a coil body (body of the coil 94) extending between a distal end and a proximal end and defining a first diameter therebetween (proximal end and distal end of the coil 94 are interpreted as the two ends of the structure, see Fig. 8D); and
a deployment device, comprising;
a handle (19);
an outer sheath (11) extending from the handle, the outer sheath including a side opening (opening that the penetrator 85 extends from, see Fig. 5A, [0073]) proximate a distal end;
a needle (85); and
a mandrel (mandrel 96) operatively coupled to the second actuator, the mandrel configured to push the implantable coil through a needle tip of the needle (the mandrel 96 and clip member 94 are advanced together through the lumen of penetrator 85, [0073]; where the mandrel is capable of pushing the clip member 94 by the clip conforming to the shape of the mandrel, [0073]), thereby allowing the implantable coil to transition from the first state within the deployment device to the second state outside of the deployment device ([0073]), wherein the implantable coil is disposed distal of a distal end of the mandrel (the coil 94 is disposed distal a distal end of the mandrel 96 when the mandrel 96 is removed, see Fig. 8D).
Perkins is silent regarding the handle including a first actuator and a second actuator, the needle operatively coupled to the first actuator and the mandrel operatively connected to the second actuator. However, Perkins further discloses advancing and retracting the needle 85 with the handle 19 by some actuation mechanism ([0054]). Falwell teaches a handle having three actuators 122, 124, and 124a for controlling movement of the tip assembly 140 ([0137]). Where the thumbwheel actuator 122 may be used to change the orientation of the tip assembly 140 relative to the longitudinal axis of the shaft of the catheter 100 dependent on the cables/pull wires attached ([0137]) a first slide actuator 124 or a thumbwheel actuator and a second slide actuator ([0137]). The first slide actuator 124 can be used to increase or decrease the curvature of the distal end and the second slide actuator 124A may be used to move a sliding electrode proximally and distally (interpreted as the coil). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have incorporated the handle assembly and three actuators of Falwell into the system of Perkins in order to provide a handle with actuation structures for operation of the mandrel and needle as desired by Perkins and also provide an actuation structure for changing the curvature at the tip of the catheter for orienting the implant in a desired manner for delivery ([0137]).
However, Perkins as modified by Falwell fails to disclose nor would it have been obvious to modify the combination to teach a locking bead coupled to the proximal end of the coil body and aligned axially therewith, the locking bead extending radially from a central axis of the coil body to define a second diameter, larger than the first diameter, wherein the locking bead is configured to anchor the implantable coil to a luminal surface of a vein by way of an opening of a wall of the vein.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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