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 6 is objected to because of the following informalities: “wherein the membrane is coupled to one the outer layer and the inner layer” should be amended to - -wherein the membrane is coupled to one of the outer layer and the inner layer - - to correct an apparent typographical error. Appropriate correction is required.
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- 9, 11- 13 and 15- 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fulton, III (US Pub. No. 2015/0351775 A1).
Regarding claim 1, Fulton discloses a device comprising:
a catheter (100) (Figs. 1- 4, 8- 9) having a distal catheter end and defining a catheter lumen (P. [0058] - - The catheter 100 is essentially in a typical configuration of a standard catheter);
a containing element (200) (Figs. 1- 4) coupled to the catheter (100), wherein the containing element (200) is configured to be deployed from the distal catheter end of the catheter (100) and includes an outer wall portion including:
an inner layer (198) (Figs. 1, 3) defining an inner chamber in communication with the catheter lumen; and
an outer layer (206) (Figs. 1, 3, 8) coupled to the inner layer (198) such that, when the containing element (200) is deployed from the catheter (100), the inner layer (198) and the outer layer (206) form a distal folded edge (204) (Figs. 1, 3) defining a distal opening of the containing element (200) in communication with the inner chamber; and
a control element (196) extending through the catheter lumen and coupled to the containing element (200), wherein the control element (196) is longitudinally movable relative to the catheter (100) to selectively collapse the inner chamber defined by the inner layer (198) when the containing element (200) is deployed (P. [0059] - - Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter).
Regarding claim 2, Fulton further discloses wherein the containing element (200) is formed from a braided shape settable material (Ps. [0027], [0058] - - The mesh braid may comprise a plurality of wires … The plurality of wires may comprise a plurality of Nitinol wires; FIG. 1 is an illustration of a prior art occlusion device or funnel catheter 100 in which the proximal end 202 of the tubular mesh braid 200 is attached to the distal aspect of the outer sleeve 194 and the distal end 204 of the tubular mesh braid 200 is attached to the distal aspect 198 of the inner sleeve 196).
Regarding claim 3, Fulton further discloses wherein the containing element (200) is coupled to the catheter by the outer layer (206) (See Fig. 1).
Regarding claim 4, Fulton further discloses wherein the outer wall portion further includes a membrane (216) (Figs. 2, 4, 9) configured to prevent fluid flow through at least a portion of the outer wall portion (198, 206) (P. [0058] - - An impervious coating 216 covers the tubular mesh braid 200).
Regarding claim 5, Fulton further discloses wherein the membrane (216) is disposed between the inner layer (198) and the outer layer (206) (See Fig. 2).
Regarding claim 6, Fulton further discloses wherein the membrane (216) is coupled to the outer layer (206) (See Fig. 1).
Regarding claim 7, Fulton further discloses wherein the distal folded edge is configured to retain a predefined shape when deployed from the distal catheter end (See Fig. 2) (P. [0059] - - Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter).
Regarding claim 8, Fulton further discloses wherein the distal folded edge is formed by heat setting the containing element in a deployed shape (Ps. [0027], [0059], - - The mesh braid may comprise a plurality of wires … The plurality of wires may comprise a plurality of Nitinol wires; Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter; it is noted that Nitinol is a shape memory alloy formed by heat setting).
Regarding claim 9, Fulton further discloses wherein the control element (196) is a control catheter coupled to a proximal portion of the inner layer (198).
Regarding claim 11, Fulton further discloses wherein, when the containing element (200) is deployed, the outer layer (206) includes a proximal flow restriction portion (P. [0059] - - FIG. 2 is an illustration of a prior art device 100 placed into a blood vessel BV and with the inner sleeve 196 withdrawn. Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter. The margins of the funnel tip expand to contact the blood vessel wall 210 with a predetermined amount of radial force to occlude blood flow).
Regarding claim 12, Fulton further discloses wherein the proximal flow restriction portion is a proximally concave surface of the outer layer (206) (See Fig. 2) (P. [0059] - - it is noted outside surface of the funnel is a proximally concave surface of the outer layer).
Regarding claim 13, Fulton further discloses wherein the outer layer (206) proximally tapers (See Fig. 2).
Regarding claim 15, Fulton discloses a device comprising:
a catheter (100) (Figs. 1- 4, 8- 9) having a distal catheter end and defining a catheter lumen; and
a containing element (200) (Figs. 1- 4) coupled to the catheter (100), wherein the containing element (200) is configured to be deployed from the distal catheter end of the catheter (100) and includes an outer wall portion including:
an inner layer (198) (Figs. 1, 3) defining an inner chamber in communication with the catheter lumen; and
an outer layer (206) (Figs. 1, 3, 8) coupled to the inner layer (198) such that, when the containing element (200) is deployed from the catheter (100), the inner layer (198) and the outer layer (206) form a distal folded edge (204) (Figs. 1, 3) defining a distal opening of the containing element (200) in communication with the inner chamber;
wherein the outer layer (206) is configured to form a proximally concave surface when the containing element (200) is deployed from the distal catheter end (See Fig. 2) (P. [0059] - - it is noted outside surface of the funnel is a proximally concave surface of the outer layer).
Regarding claim 16, Fulton further discloses wherein the containing element (200) is formed from a braided shape settable material (Ps. [0027], [0058] - - The mesh braid may comprise a plurality of wires … The plurality of wires may comprise a plurality of Nitinol wires; FIG. 1 is an illustration of a prior art occlusion device or funnel catheter 100 in which the proximal end 202 of the tubular mesh braid 200 is attached to the distal aspect of the outer sleeve 194 and the distal end 204 of the tubular mesh braid 200 is attached to the distal aspect 198 of the inner sleeve 196).
Regarding claim 17, Fulton further discloses wherein the proximally concave surface includes a proximal folded edge and each of the distal folded edge (204) and the proximal folded edge are configured to retain a predefined shape when deployed from the distal catheter end (P. [0059] - - it is noted outside surface of the funnel is a proximally concave surface of the outer layer).
Regarding claim 18, Fulton further discloses wherein the distal folded edge and the proximal folded edge are formed by heat setting the containing element in a deployed shape (Ps. [0014], [0059] - - the flexible tubular sleeve comprises a shape memory material such as Nitinol. The shape memory material may be fashioned in a way to be biased to assume the funnel shape as described below; Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter; it is noted that the shape memory alloy, Nitinol is fashioned to form the predetermined funnel shape via heat setting).
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) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fulton, III (US Pub. No. 2015/0351775 A1) in view of Lund-Clausen et al. (US Pub. No. 2015/0005781 A1).
Regarding claim 10, Fulton discloses the apparatus of claim 1, but Fulton does not disclose
(claim 10) wherein the control element is a filament extending between the inner layer and the outer layer of the outer wall portion.
However, Lund-Clausen teaches a medical device for collecting objects using a basket wherein one end of the basket is inside a catheter and the other open end is everted over the distal end of the catheter in the same field of endeavor (Abstract)
(claim 10) wherein the control element (20) (Figs. 1- 3) is a filament extending between the inner layer and the outer layer of the outer wall portion (See Fig. 1) (P. [0042] - - By pulling back on the actuating element 20 the second end portion 18, the open end of the basket 14, is pulled into the distal end 12d of the inner catheter 12. This action causes the second end portion 18 of the basket 14 to roll inwardly, thus drawing, as if pulling or sucking, the thrombus 24 into the closing basket. The thrombus 24 is thus trapped bit-by-bit in the basket 14 and withdrawn into the inner catheter 12. As a result of the relative movement between the inner catheter 12 and the basket 14 from the first configuration to the second configuration the thrombus 24 is thus drawn into the inner catheter 12, inside the basket 14).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute the filament extending between the inner and outer layer of the outer wall portion according to the teachings of Lund-Clausen for the control catheter associated with Fulton because the filament would predictably perform the same function of causing the basket to roll inwardly, thus drawing thrombus within the basket and into the catheter, as Fulton’s control catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 14, Fulton discloses the apparatus of claim 1, but Fulton does not disclose
(claim 14) further comprising a delivery catheter within which the catheter is disposed.
However, Lund-Clausen teaches a medical device for collecting objects using a basket wherein one end of the basket is inside a catheter and the other open end is everted over the distal end of the catheter in the same field of endeavor (Abstract)
(claim 14) further comprising a delivery catheter (10) (Figs. 1- 3) within which the catheter (12) (Figs. 1- 3) is disposed (P. [0041] - - FIG. 2 shows the medical device of FIG. 1 after the outer catheter 10 has been withdrawn relative to the inner catheter 12. The outer catheter 10 is provided so as to cover the basket 14 and prevent it from springing open during introduction of the device. Once the outer catheter 10 has been withdrawn the second end portion 18 of the basket 14 is no longer constricted and is able to spring open outwardly).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus of Fulton in order to include a delivery catheter according to the teachings of Lund-Clausen because it would cover the basket and prevent it from springing open during introduction of the device (Lund-Clausen - - P. [0041]).
Claim(s) 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fulton, III (US Pub. No. 2015/0351775 A1) in view of Greenhalgh et al. (US Pub. No. 2017/0086864 A1).
Regarding claim 19, Fulton discloses a system comprising:
a catheter (100) (Figs. 1- 4, 8- 9), wherein the catheter includes a distal catheter end and defines a catheter lumen (P. [0058] - - The catheter 100 is essentially in a typical configuration of a standard catheter, albeit with an outer sleeve 194 and inner sleeve 196 comprising the catheter wall);
a containing element (200) (Figs. 1- 4) coupled to the catheter (100), wherein the containing element (200) is configured to be deployed from the distal catheter end of the catheter (100) and includes an outer wall portion including:
an inner layer (198) (Figs. 1, 3) defining an inner chamber in communication with the catheter lumen; and
an outer layer (206) (Figs. 1, 3, 8) coupled to the inner layer (198) such that, when the containing element (200) is deployed from the catheter (100), the inner layer (198) and the outer layer (206) form a distal folded edge (204) (Figs. 1, 3) defining a distal opening of the containing element (200) in communication with the inner chamber; and
a membrane (216) (Figs. 2, 4, 9) configured to restrict flow through the outer wall portion (198, 206) (P. [0058] - - An impervious coating 216 covers the tubular mesh braid 200); and
a control element (196) extending through the catheter lumen and coupled to the containing element (200), wherein the control element (196) is longitudinally movable relative to the catheter (100) to selectively collapse the inner chamber defined by the inner layer (198) when the containing element (200) is deployed (P. [0059] - - Withdrawal of the inner sleeve 196 may cause the flexible tubular mesh braid 200 to buckle in a predetermined manner because of the manner in which the tubular mesh braid 200 was formed so that the tubular mesh braid 200 creates a funnel shape on the distal catheter).
Fulton does not disclose
(claim 19) an aspiration source and delivery catheter as claimed.
However, Greenhalgh teaches a mechanical thrombectomy system in the same field of endeavor (Abstract)
(claim 19) an aspiration source (Ps. [0066], [0111], [0153] - - Any of the apparatuses described herein may also include a vacuum source. For example any of these apparatuses may include a guidewire vacuum pump coupled to a proximal end of the guidewire lumen and configured to apply vacuum therethrough. For example, any of these apparatuses may include an outer catheter vacuum pump coupled to a space between the catheter and the flexible tube and configured to apply a vacuum within a lumen of the catheter between an inner wall of the catheter and the flexible tube; FIGS. 35A-35C illustrate operation of an apparatus as shown in FIG. 34 in which the clot is drawn into the catheter by withdrawing the expandable first end region of the distal tractor region into the catheter (e.g., pulling on the puller region of the tractor assembly) which compresses the clot (FIGS. 35A-35B); releasing the tractor assembly and/or pushing it distally may further break up the clot and release it from the distal tractor region so that it may be suctioned up proximally with a manual or powered vacuum source (FIG. 35C); As mentioned, any of these apparatuses may include a vacuum source. The addition of the vacuum to the system may aid the ability of the distal tractor region to pull clot/emboli into the catheter. The vacuum applied may be stead/constant, ramped or pulsatile).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the system associated with Fulton in order to include an aspiration source according to the teachings of Greenhalgh because the addition of the vacuum to the system may aid the ability of the containing element associated with Fulton to pull clot/emboli into the catheter (Greenhalgh - - Ps. [0066], [0111], [0153]).
Modified Fulton does not disclose
(claim 19) a delivery catheter; a catheter disposed within the delivery catheter, wherein the catheter includes a distal catheter end and defines a catheter lumen in fluid communication with the aspiration source.
However, Greenhalgh teaches a mechanical thrombectomy system in the same field of endeavor (Abstract)
(claim 19) a delivery catheter (301) (Figs. 3A- 3C) (P. [0015] - - The apparatus may be pre-loaded for deployment of the distal tractor region and capture of an object within a vessel, or in some variations it may be loaded in vivo, after or during positioning a guidewire and/or the catheter within a blood vessel. For example, in some variations, the apparatus may be adapted for use in vivo by holding the distal tractor region retracted into the catheter until the catheter is within the vessel, and preferably near the object to be removed. Once positioned, the distal tractor region of the flexible tube within the catheter may be distally extended from the catheter, expanded to form the capture shape that can be drawn and inverted over the distal end of the catheter either with or without advancing the catheter distally. Thus, the distal tractor portion may be safely and securely delivered to the necessary site within the lumen without risk to damage to the apparatus or the body);
a catheter (340) (Figs. 3A- 3C) disposed within the delivery catheter (301), wherein the catheter (340) includes a distal catheter end and defines a catheter lumen in fluid communication with the aspiration source (described, not shown) (P. [0153] - - As mentioned, any of these apparatuses may include a vacuum source. The addition of the vacuum to the system may aid the ability of the distal tractor region to pull clot/emboli into the catheter. The vacuum applied may be stead/constant, ramped or pulsatile).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the system of Fulton in order to include a delivery catheter such that the catheter associated with Fulton is disposed in the delivery catheter according to the teachings of Greenhalgh because it would allow for the thrombectomy device to be safely and securely delivered to the necessary site within the lumen without risk to damage to the apparatus or the body (Greenhalgh - - P. [0015]).
Regarding claim 20, Fulton in view of Greenhalgh discloses the system of claim 19, Fulton further disclosing wherein the outer layer (206) is configured to form a proximally concave surface when the containing element (200) is deployed from the distal catheter end (See Fig. 2) (P. [0059] - - it is noted outside surface of the funnel is a proximally concave surface of the outer layer).
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