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 .
Claim Objections
Claim 1 is objected to because of the following informalities: lines 6- 7- “a disengaging portion configured to disengage vascular debris from a vessel wall” should be amended to - - a disengaging portion configured to disengage the vascular debris from a vessel wall - - to correct an apparent typographical error. Appropriate correction is required.
Claims 2- 17 are objected to because they depend off claim 1.
Claim 1 is objected to because of the following informalities: line 8- “a collecting portion configured to collect vascular debris” should be amended to - - a collecting portion configured to collect the vascular debris - - to correct an apparent typographical error. Appropriate correction is required.
Claims 2- 17 are objected to because they depend off claim 1.
Claim 15 is objected to because of the following informalities: lines 2- 3 – “in addition to the lumen for conveying vascular debris” should be amended to - - in addition to the lumen for conveying the vascular debris - - to correct an apparent typographical error. Appropriate correction is required.
Claim 16 is objected to because it depends off claim 15.
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.
Claim(s) 1- 5 and 7- 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruzzi et al. (US Pub. No. 2017/0333076 A1).
Regarding claim 1, Bruzzi discloses a vascular device comprising a catheter (8) (Fig. 2) having a lumen for conveying vascular debris (22) (Figs. 3(a)- 3(e), 12), the lumen having an opening for receiving the vascular debris (22), the catheter (8) defining a longitudinal axis, the device further comprising:
a structure (3) (Figs. 1, 3- 9, 11- 13(B)) provided at a distal part of the catheter (8), the structure (3) comprising;
a disengaging portion (10) (Figs. 1, 12- 13(B)) configured to disengage the vascular debris (22) from a vessel wall (20) (Fig. 3(a)), and
a collecting portion (11) (Figs. 1, 12- 13(B)) configured to collect the vascular debris (22) (P. [0080] - - a thrombus capture body in the form of a cage 3 having an inwardly tapering trailing end 11 having a fine mesh and the inwardly tapering leading end 10 having a coarse mesh that is adapted for receipt of thrombus into the cage), and
a moveable macerator (13) (Fig. 2) located at least partially within the structure (3), the moveable macerator (13) located distal to the opening and configured to macerate vascular debris (22) (Ps. [0055], [0081] - - The leading end is inwardly tapering and is connected to the control arm at or close to its apex, such that movement of the control arm pushes or pulls (depending on whether the capture body is located distally or proximally of the blocking body) the capture body axially along the body lumen; Referring to FIG. 2 … the cage 3 is located proximally of the blocking body 5, and a macerator in the form of wires 13 is provided on a rotatable control arm 4 forward of the extractor tube 8, whereby rotation of the control arm 4 causes the wires to rotate and macerate thrombus within the cage in the proximity of the wires. In this embodiment, suction means or rotation of a screw (not shown) is provided to extract macerated thrombus from the cage through the extractor tube 12. The control 4 is operably connected to the leading end 10 of the cage 3 for movement of the cage again ensuring that the cage is pushed from its leading end 10; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed).
Regarding claim 2, Bruzzi further discloses wherein the structure (3) is expansible and compressible (Ps. [0085], [0087] - - FIG. 3A: … At this stage, both the blocking body 5 and the cage (capture body) 3 are in a non-deployed configuration; FIG. 3C: In the third step, the cage 3 and blocking body 5 are deployed on each side of the thrombus segment 22).
Regarding claim 3, Bruzzi further discloses wherein the macerator (13) is rotatable around the longitudinal axis (P. [0081] - - a macerator in the form of wires 13 is provided on a rotatable control arm 4 forward of the extractor tube 8, whereby rotation of the control arm 4 causes the wires to rotate and macerate thrombus within the cage in the proximity of the wires).
Regarding claim 4, Bruzzi further discloses wherein the macerator (13) is axially moveable in the direction of the longitudinal axis (P. [0081] - - The control 4 is operably connected to the leading end 10 of the cage 3 for movement of the cage again ensuring that the cage is pushed from its leading end 10; it is noted that the control arm on which the macerator (13) is disposed is axially moveable in the direction of the longitudinal axis to push the cage).
Regarding claim 5, Bruzzi further discloses wherein the macerator (13) is expandable in a radial direction substantially perpendicular to the longitudinal axis (A) (See Figs. 2, 3(A) - - wires 13 expand substantially perpendicularly to the longitudinal axis as shown in Fig. 2 from the collapsed delivery configuration shown in Fig. 3(A)).
Regarding claim 7, Bruzzi further discloses wherein the structure (3) comprises struts, optionally representing a stent-like configuration (See Fig. 2).
Regarding claim 8, Bruzzi further discloses wherein the disengaging portion (10) comprises a first region of struts and the collecting portion (11) comprises a second region of struts, wherein the first region of struts differs from the second region of struts (Ps. [0080], [0081] - - a thrombus capture body in the form of a cage 3 having an inwardly tapering trailing end 11 having a fine mesh and the inwardly tapering leading end 10 having a coarse mesh that is adapted for receipt of thrombus into the cage; Referring to FIG. 2 … the cage 3 is located proximally of the blocking body 5, and a macerator in the form of wires 13 is provided on a rotatable control arm 4 forward of the extractor tube 8, whereby rotation of the control arm 4 causes the wires to rotate and macerate thrombus within the cage in the proximity of the wires. In this embodiment, suction means or rotation of a screw (not shown) is provided to extract macerated thrombus from the cage through the extractor tube 12; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed)).
Regarding claim 9, Bruzzi further discloses wherein the first region of struts is less dense than the second region of struts and/or struts in the first region of struts are further spaced apart from each other than struts in the second region of struts (See Fig. 2) (P. [0080] - - a thrombus capture body in the form of a cage 3 having an inwardly tapering trailing end 11 having a fine mesh and the inwardly tapering leading end 10 having a coarse mesh that is adapted for receipt of thrombus into the cage; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed).
Regarding claim 10, Bruzzi further discloses wherein the first region of struts comprises struts having leading edges (Ps. [0080], [0081] - - a thrombus capture body in the form of a cage 3 having an inwardly tapering trailing end 11 having a fine mesh and the inwardly tapering leading end 10 having a coarse mesh that is adapted for receipt of thrombus into the cage; The control 4 is operably connected to the leading end 10 of the cage 3 for movement of the cage again ensuring that the cage is pushed from its leading end 10; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed; it is further noted that since the disengaging portion (10) comprising the first region of struts being pushed into the thrombus (22) is interpreted as having leading edges).
Regarding claim 11, Bruzzi further discloses wherein the collecting portion (11) comprises a basket (See Fig. 2) (Ps. [0029], [0080], [0090] - - the cage comprises an open leading end comprising a braid or mesh with a mesh size dimensioned to allow thrombus pass into the cage and a substantially closed trailing end comprising a braid or mesh having a mesh size dimensioned for capture of thrombus).
Regarding claim 12, Bruzzi further discloses wherein the disengaging portion (10) at least partially comprises a conical shape (See Fig. 1) (P. [0080] - - a thrombus capture body in the form of a cage 3 having an … inwardly tapering leading end 10 having a coarse mesh that is adapted for receipt of thrombus into the cage; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed).
Regarding claim 13, Bruzzi further discloses wherein the structure (3) is tethered to the distal end of the catheter (8) (See Fig. 2) (P. [0081] - - a macerator in the form of wires 13 is provided on a rotatable control arm 4 forward of the extractor tube 8 … The control 4 is operably connected to the leading end 10 of the cage 3 for movement of the cage again ensuring that the cage is pushed from its leading end 10).
Regarding claim 14, Bruzzi further discloses wherein the macerator (13) is configured to be actively moveable by way of rotation of a driving bar/wire (4) (Fig. 2) (P. [0081] - - a macerator in the form of wires 13 is provided on a rotatable control arm 4 forward of the extractor tube 8, whereby rotation of the control arm 4 causes the wires to rotate and macerate thrombus within the cage in the proximity of the wires … control 4 is operably connected to the leading end 10 of the cage 3 for movement of the cage again ensuring that the cage is pushed from its leading end 10; it is noted that control arm 4 is interpreted as a driving bar/wire).
Regarding claim 15, Bruzzi further discloses herein the catheter (8) comprises, in addition to the lumen for conveying the vascular debris (22), a lumen for receiving and/or handling the macerator (13) (See Fig. 2).
Regarding claim 16, Bruzzi further discloses wherein the lumen for receiving the vascular debris (22) and the lumen for receiving and/or handling the macerator (13) are arranged coaxially to each other (See Fig. 2).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruzzi et al. (US Pub. No. 2017/0333076 A1) in view of Hauser et al. (US Pub. No. 2007/0208370 A1).
Regarding claims 6, Bruzzi discloses the apparatus of claim 1, but Bruzzi does not disclose
(claim 6) wherein the macerator comprises at least one of a hook and angled bar as claimed.
However, Hauser teaches a vascular device for capturing and breaking apart particles in the blood in the same field of endeavor (Abstract)
(claim 6) wherein the macerator (904) comprises an angled bar (910, 912) (Ps. [0065], [0067] - - With reference now to FIG. 15, the filter device 800A of FIG. 14 is shown during use. After being advanced through a vessel 830 to a treatment site, negative pressure is applied at a proximal end of the aspiration catheter 820 to create a fluid flow into the mouth of the filter body 802. The inner catheter 854 may then be rotated for causing the agitation member 804 to rotate. While the agitation member is rotating, it may be advanced toward a thrombus 200 (or other particle) for macerating the thrombus and thereby removing the occlusion. During the maceration of the thrombus, resulting particles are drawn into the interior volume 816 of the filter body 802. Particles small enough to pass through the filter body are drawn into the aspiration catheter. As can be seen, this embodiment provides a very safe and effective mechanism for removing a thrombus from a blood vessel without any danger of distal embolization. It can further be seen that the filter helps center the agitation member such that the inner wall of the vessel is not damaged. At the end of the procedure, the inner catheter 854, outer catheter 852 and filter body 802 may all be withdrawn into the aspiration catheter 820 (or sheath) for safe removal from the patient's vasculature. It may be desirable to continue applying negative pressure along the proximal end of the aspiration catheter during removal such that the particles are not released from the filter; With reference now to FIGS. 17A through 17C, an alternative agitation member 904 is illustrated wherein the diameter of the distal end is controllable. In this embodiment, the agitation member 904 may be disposed at the distal end of a rotatable inner catheter 906, similar to the device described above with reference to FIG. 15. However, in this embodiment, the agitation member comprises two flexible members 910, 912 disposed along the distal end of the inner catheter 906. In the illustrated embodiment, the flexible members further comprise weighted tips 920, 922. As the inner catheter 906 rotates, centrifugal forces cause the flexible members 910, 912 to flex outward away from the axis of rotation, thereby effectively increasing the diameter of the agitation member 904. Therefore, it can be seen that the diameter of the agitation member can be controlled by varying the rotational velocity ω (omega) of the inner catheter. For example, at ω1 the diameter of the agitation member is D1, as shown in FIG. 17A. ω2 the diameter of the agitation member is D2, as shown in FIG. 17B. Finally, at ω3 the diameter of the agitation member is D3, as shown in FIG. 17).
The radially expanding angled bars taught by Hauser perform the same function of coming into contact with thrombus and dislodging and/or breaking up the thrombus into smaller particles (Hauser - - P. [0065] - - While the agitation member is rotating, it may be advanced toward a thrombus 200 (or other particle) for macerating the thrombus and thereby removing the occlusion) as the macerator in the form of wires 13 provided on a rotatable control arm disclosed by Bruzzi (Bruzzi - - P. [0081]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (radially expanding angled bars) for another (macerator in the form of wires 13 provided on a rotatable control arm) since the substitution would have yielded predictable results, namely, coming into contact with thrombus and dislodging and/or breaking up the thrombus into smaller particles. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruzzi et al. (US Pub. No. 2017/0333076 A1) in view of Daniel et al. (US Pub. No. 2001/0044632 A1).
Regarding claim 17, Bruzzi discloses the apparatus of claim 1, Bruzzi further disclosing wherein a fine mesh is provided in and/or over the collecting portion (11) (P. [0080] - - a thrombus capture body in the form of a cage 3 having an inwardly tapering trailing end 11 having a fine mesh as shown in Fig. 1; it is noted that the embodiment of Fig. 2 is similar to the embodiment of Fig. 1 except for a macerator in the form of wires 13 and since cage 3 is proximal with blocking body 5 and suction is provided to extract macerated thrombus, the leading end 10 and trailing end 11 are reversed), but Bruzzi does not explicitly disclose
(claim 17) wherein a membrane is provided in and/or over the collecting portion and/or distal to the collecting portion.
However, Daniel teaches a vascular device that captures emboli in a body lumen (Abstract)
(claim 17) wherein a membrane is provided in and/or over the collecting portion (22) (Figs. 1- 2, 4, 12) (P. [0034] - - Mesh 22 is preferably formed of woven or braided fibers or wires, or a microporous membrane, or other suitable filtering or netting-type material. In one preferred embodiment, mesh 22 is a microporous membrane having holes therein with a diameter of approximately 100 μm).
Daniel further disclosing that a membrane is a structural equivalent of a mesh. Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (membrane) for another (mesh) since the substitution would have yielded predictable results, namely, providing a suitable filtering or netting-type material (Daniel - - P. [0034]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KANKINDI RWEGO/Primary Examiner, Art Unit 3771