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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the inner sheath comprises wires having a ribbon shaped profile". Claim 18 from which claim 20 depends recites “the wires… have a diameter of about 100 to about 300 um”. It is unclear how the wires can have a “ribbon shaped profile”, which is substantially flat (see spec [0096], while having a diameter. Therefore, the limitation is rendered indefinite. Claim 21 is also rendered indefinite due to its dependency from indefinite claim 20.
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 1-17, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hermann (US5630822) in view of Kelly (US2023/0137418), Vale (US2017/0105743), and Phouasalit (US2019/0274810).
Regarding claim 1, Hermann discloses a system for transforming a linear pulling force at one end of a catheter device to a radial compressive force at an opposite end of said catheter device that is substantially perpendicular to said linear pulling force comprising:
an outer sheath (41, C3:L56-60) having a lumen;
an inner sheath (21/26, C2:L62-65) that is adapted for insertion into the outer sheath; and,
a wire woven distal end (distal extremity 18, C3:L31) at a terminal extremity (the terminal extremity of inner sheath is interpreted as the section near the extremity 28, see Fig. 1) of the inner sheath that is formed from wires and includes a substantially cylindrical main body section comprising a leading end, a trailing end, and a middle portion extending between the leading end and the trailing end and defining a longitudinal axis of the main body section (see annotated Fig. 1);
a flare (see annotated Fig. 1) defining a mouth of the wire woven distal end that projects circumferentially (mouth is interpreted as the opening of the flared portion, see annotated Fig. 1);
a tapered section (see annotated Fig. 1) at the trailing end of the main body section; and
an attachment portion (portion between the distal extremity 28 and the sheath 26, see Fig. 1, C3:L31) that is affixed to the terminal extremity of the inner sheath (see Fig. 1), wherein the main body section has a compressed state and an expanded state, the main body section adopting the compressed state when the wire woven distal end is housed within the lumen of the outer sheath (C4:L60-65 ), and adopting the expanded state when the wire woven distal end of the inner sheath is advanced beyond a distal end of the outer sheath by moving the wire woven distal end of the inner sheath forward relative to the distal end of the outer sheath (C5:L1-5, see Fig. 1),
wherein the main body section has a diameter of about 22-38 mm in the expanded state (C3:L51-55),
wherein when said inner sheath in the expanded state is at least partially withdrawn into the outer sheath, said linear force is imposed on said tapered section, and then said main body section produces a radial compressive force within the wire woven distal end (capable of producing a radially compressive force when the distal extremity 28 is drawn within outer sheath 41 by a linear force).
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Hermann is silent regarding the main body section includes 11-21 picks per centimeter. Kelly teaches a clot retrieval catheter having a distal braided supported tip. The braided section can have a range of picks per inch from 120 to 170 (12 to 17 picks per centimeter) ([0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to modify the pick count of the main body section of Hermann to be 12 to 17 picks per centimeter, which falls within the claimed range of 11-21 picks per centimeter, as taught by Kelly in order to provide good pushability, kink resistance, and bending properties ([0021] of Kelly).
Hermann is silent regarding the mouth of the wire woven distal end defines a flare that projects circumferentially from the leading end of the main body section. Vale teaches a system for retrieval with a flare and a flare angle (a) for the purpose of facilitating aspiration of an obstruction and improving the approach angle of the obstruction ([0329]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hermann to provide a flare that projects circumferentially from the leading end of the main body section as taught by Vale in order to improve the angle of approach of the obstruction ([0329]).
Hermann as modified by Vale does not explicitly disclose the mouth projects at an angle of about 30º to 60º relative to the longitudinal axis. Applicant has not disclosed that the mouth project at an angle of about 30º to 60º relative to the longitudinal axis provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0092] of the specification. One of ordinary skill in the art would have expected the mouth projection of the invention of Hermann as modified by Vale and Applicant’s invention to perform equally well with either the angle of projection as taught by the invention of Hermann as modified by Vale or the claimed mouth projecting at an angle of about 30º to 60º relative to the longitudinal axis because both angles of mouth projection would perform the same function of capturing an object within the body equally well considering the desire to capture an object at the opening. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the flare angle of Hermann as modified by Vale such that the angle is from about 30º to 60º relative to the longitudinal axis as an obvious matter of design choice within the level of skill in the art.
Hermann is silent regarding the mouth of the wire woven distal end has a length of about 2.75 to 3 mm. However, Applicant has not disclosed that the flare having a length of 2.75 to 3mm provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0080] of the specification. One of ordinary skill in the art would have expected Hermann’s main body section and Applicant’s invention to perform equally well with either outer diameter taught by Hermann or the claimed 2.75-3mm because both dimensions would perform the same function of capturing an object within the body equally well considering the relative dimensions disclosed. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare of Hermann to have a length of about 2.75 to 3mm as an obvious matter of design choice within the skill of the art.
Hermann is silent regarding wherein the wires of the wire woven distal end have a diameter of about 100 to about 300um. Phouasalit teaches a clot removal device having a braided wire section, where the wire section has wires with a diameter in the range of 0.008 to 0.03 inches (203 to 762um) ([0042]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the wires of the woven distal end of Hermann for the wires of Phouasalit having a diameter of about 100 to about 300um because it would have yielded the same predictable result of providing wires of a certain size to be woven together for retrieving an obstruction.
Regarding claim 2, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1, Hermann further discloses wherein the inner sheath comprises a lumen extending from a proximal end of the inner sheath to the wire woven distal end. However, the modified invention does not explicitly disclose the lumen housing a suture line that is configured to transition the mouth of the wire woven distal end between closed and opened states. Hermann discloses in an alternative embodiment as shown in Figure 13, a suture line (draw string 241) housed in a lumen that is configured to transition the mouth of the wire woven distal end between closed and opened states (C8:L62-67, C9:L1-31). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the closing of the expandable sheath (C6:L29) of Hermann for the closing of the expandable sheath using the suture line (draw string 241) housed within the lumen of the sheath in order to close the distal end of the inner sheath with a pulling motion according to another embodiment of Hermann, since the substitution would have yielded the same predictable result of closing the expandable sheath around the tissue to prevent the captured tissue from being prematurely released.
Regarding claim 3, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1, Hermann further discloses wherein the main body section of the wire woven distal end produces a radial compressive force when said inner sheath in the expanded state is withdrawn into the outer sheath irrespective of whether any portion of an endovascular device within the wire woven distal end has been withdrawn into the outer sheath (the main body section is capable of producing a radial compressive force when contracted into the outer sheath 41).
Regarding claim 4, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1; yet, does not explicitly disclose wherein the flare has a length of about 2.8 mm. Applicant has not disclosed that the flare having a length of 2.8mm provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0080] of the specification. One of ordinary skill in the art would have expected the modified inventions main body section and Applicant’s invention to perform equally well with either outer diameter taught by the modified invention or the claimed 2.8mm because both dimensions would perform the same function of capturing an object within the body equally well considering the relative dimensions disclosed. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare of Hermann to have a length of about 2.8mm as an obvious matter of design choice within the skill in the art.
Regarding claims 5-11, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 4; yet, does not explicitly disclose wherein the flare projects circumferentially from the leading end of the main body section at an angle of about 30º or 35º or 40º or 45º or 50º or 55º or 60º relative to the longitudinal axis. Applicant has not disclosed that the flare projects at an angle of about 30º or 35º or 40º or 45º or 50º or 55º or 60º relative to the longitudinal axis relative to the longitudinal axis provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0092] of the specification. One of ordinary skill in the art would have expected the mouth projection of the invention of Hermann as modified by Vale and Applicant’s invention to perform equally well with either the angle of projection as taught by the invention of Hermann as modified by Vale or the claimed flare projecting at an angle of about 30º or 35º or 40º or 45º or 50º or 55º or 60º relative to the longitudinal axis because the angles of mouth projection would perform the same function of capturing an object within the body equally well considering the desire to capture an object at the opening. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the flare angle of Hermann as modified by Vale such that the angle is from about 30º or 35º or 40º or 45º or 50º or 55º or 60º relative to the longitudinal axis as an obvious matter of design choice within the level of skill in the art.
Regarding claim 12, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1; yet does not explicitly disclose wherein the mouth defined by the flare has a diameter that is about 107 to 122% larger than the diameter of the main body section when the main body section is in the expanded state. Applicant has not disclosed that the mouth of the flare having a diameter 107 to 122% larger than the main body section in the expanded state provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0082] of the specification. One of ordinary skill in the art would have expected the modified invention’s main body section and Applicant’s invention to perform equally well with either diameter of the mouth of the flare as taught by the modified invention or the claimed diameter of the mouth of the flare being a percentage larger than the main body section because both dimensions would perform the same function of capturing an object within the body equally well considering the relative dimensions disclosed. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare of Hermann to have the mouth have a diameter that is 107 to 122% larger than the diameter of the main body section in the expanded state as an obvious matter of design choice within the skill in the art.
Regarding claim 13, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1; yet, does not explicitly disclose wherein the inner sheath comprises a wire weave embedded in a thermoplastic or elastomeric material. Kelly further teaches jacket materials made of a thermoplastic material ([0111]) that are extruded on the sheath body 110 to cover the braid ([0111]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the wire weave of the modified invention embedded in a thermoplastic material in order to reinforce the sheath and ensure there is no exposed braid for catching on the obstruction ([0111]).
Regarding claims 14 and 15, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 13; yet, does not explicitly disclose wherein the wire weave of the inner sheath has a braiding angle of about 20-55º or about 30-40º. Kelly further teaches the braid angle being variable for the capability of conforming to the clot or tissue as its injected and more or less resistance to collapsing ([0086]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the braiding angle of the modified invention in order to provide the capability of conforming to the clot or tissue as its injected and more or less resistance to collapsing ([0068]).
Further, Applicant has not disclosed that the wire weave of the inner sheath having a braiding angle of about 20-55º or about 30-40º provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0095] of the specification. One of ordinary skill in the art would have expected the modified invention’s wire weave and Applicant’s invention to perform equally well with either the braiding angle as taught by the modified invention or the claimed braiding about 20-55º or about 30-40º because both braiding angles would perform the same function of providing desirable characteristics of a mesh for capturing an obstruction. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified invention of Hermann/Kelly/Vale/Phouasalit to have the wire weave of the inner sheath have a braiding angle of about 20-55º or about 30-40º as an obvious matter of design choice within the skill in the art.
Regarding claim 16, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 1, Hermann further discloses comprising an introductory sheath (introducer 13, C3:L22) having an introductory lumen that is sized such that the outer sheath and inner sheath can be translated through the introductory lumen pursuant to delivering the outer sheath and inner sheath from an environment external to a subject to a void space within the subject (C4:L63-66).
Regarding claim 17, Hermann/Kelly/Vale/Phouasalit makes obvious the system according to claim 16, Hermann further discloses wherein the introductory sheath can be disengaged from the outer sheath following translation of the outer sheath through the lumen of the introductory sheath by separating the introductory sheath into two or more parts (can be another introducer 118 used with introducer 13 in the assembly 12, C4:L55-56).
Regarding claim 22, Hermann discloses a system for transforming a linear pulling force at one end of a catheter device to a radial compressive force at an opposite end of said catheter device that is substantially perpendicular to said linear pulling force comprising:
an outer sheath (41, C3:L56-60) having a lumen;
an inner sheath (21/26, C2:L62-66) that is adapted for insertion into the outer sheath; and,
a wire woven distal end (distal extremity 28, C3:L31) at a terminal extremity (the terminal extremity of the inner sheath is interpreted as the sheath section near the extremity 28, see Fig. 1) of the inner sheath that is formed from wires and includes a substantially cylindrical main body section comprising a leading end, a trailing end, and a middle portion extending between the leading end and the trailing end and defining a longitudinal axis of the main body section (see annotated Fig. 1 from the rejection of claim 1);
a flare (see annotated Fig. 1) defining a mouth of the wire woven distal end that projects circumferentially from the leading end of the main body section (mouth is interpreted as the opening of the flared portion, see annotated Fig. 1);
a tapered section (see annotated Fig. 1) at the trailing end of the main body section; and
an attachment portion (portion between the distal extremity 28 and the sheath 26, see Fig. 1, C3:L31) that is affixed to the terminal extremity of the inner sheath, wherein the main body section has a compressed state and an expanded state, the main body section adopting the compressed state when the wire woven distal end is housed within the lumen of the outer sheath (C4:L60-65), and adopting the expanded state when the wire woven distal end of the inner sheath is advanced beyond a distal end of the outer sheath by moving the wire woven distal end of the inner sheath forward relative to the distal end of the outer sheath (C5:L1-5, see Fig. 1),
wherein the main body section has a diameter of about 22-38 mm in the expanded state (C3:L51-55), and, wherein when said inner sheath in the expanded state is at least partially withdrawn into the outer sheath, said linear force is imposed on said tapered section, and then said main body section produces a radial compressive force within the wire woven distal end (capable of producing a radially compressive force when the distal extremity 28 is drawn within outer sheath 41 by a linear force).
Hermann is silent regarding the mouth of the wire woven distal end defines a flare that projects circumferentially from the leading end of the main body section. Vale teaches a system for retrieval with a flare and a flare angle (a) for the purpose of facilitating aspiration of an obstruction and improving the approach angle of the obstruction ([0329]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hermann to provide a flare that projects circumferentially from the leading end of the main body section as taught by Vale in order to improve the angle of approach of the obstruction ([0329]).
Hermann does not explicitly disclose the main body section includes 11-21 picks per centimeter. Kelly teaches a clot retrieval catheter having a distal braided supported tip. The braided section can have a range of picks per inch from 120 to 170 (12 to 17 picks per centimeter) ([0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pick count of the main body section of Hermann to be 12 to 17 picks per centimeter, which falls within the claimed range of 11-21 picks per centimeter, as taught by Kelly in order to provide good pushability, kink resistance, and bending properties ([0021] of Kelly).
Hermann does not explicitly disclose wherein the mouth defined by the flare has a diameter that is about 107 to 122% larger than the diameter of the main body section when the main body section is in the expanded state. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare of Hermann to have the mouth have a diameter that is 107 to 122% larger than the diameter of the main body section in the expanded state as a matter of design choice. Applicant has not disclosed that the mouth of the flare having a diameter 107 to 122% larger than the main body section in the expanded state provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0082] of the specification. One of ordinary skill in the art would have expected the Hermann’s main body section and Applicant’s invention to perform equally well with either diameter of the mouth of the flare as taught by Hermann or the claimed diameter of the mouth of the flare being a percentage larger than the main body section because both dimensions would perform the same function of capturing an object within the body equally well considering the relative dimensions disclosed.
Hermann does not explicitly disclose wherein the wires of the wire woven distal end have a diameter of about 100 to about 300um. Phouasalit teaches a clot removal device having a braided wire section, where the wire section has wires with a diameter in the range of 0.008 to 0.03 inches (203 to 762um) ([0042]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the wires of the woven distal end of Hermann for the wires of Phouasalit having a diameter of about 100 to about 300um because it would have yielded the same predictable result of providing wires of a certain size to be woven together for retrieving an obstruction.
Regarding claim 23, Hermann discloses a device for use with a system for retrieving an object from a void space within a human subject (C5:L10-20) comprising:
a wire weave (26, C2:L62-66) forming (i) a substantially cylindrical main body section (distal extremity 28) comprising a leading end, a trailing end, and a middle portion extending between the leading end and the trailing end and defining a longitudinal axis (see annotated Fig. 1 from the rejection of claim 1);
(ii) a flare (see annotated Fig. 1 from the rejection of claim 1) defining a mouth of the device that projects circumferentially from the leading end of the main body section (mouth is interpreted as the opening of the flared portion, see annotated Fig. 1 from the rejection of claim 1);
(iii) a tapered section (see annotated Fig. 1 from the rejection of claim 1) at the trailing end of the main body section; and,
(iv) an attachment portion (portion between the distal extremity 28 and the sheath 26, see Fig. 1, C3:L31; alternatively the adhesive band 32, C3:L12-13) for affixing the device to a catheter (21, C3:L8-10) for manipulating the position of the device within the void space (capable of manipulating the position of the device within the void space at least when moving the entire of the device), wherein the main body section has a compressed state and an expanded state, the main body section adopting the compressed state when the wire woven distal end is housed within a lumen of a delivery sheath (C4:L60-65), and adopting the expanded state when the wire woven distal end of the inner sheath is advanced beyond a distal end of the delivery sheath by moving the wire woven distal end of the inner sheath forward relative to the distal end of the delivery sheath (C5:L1-5, see Fig. 1), wherein the main body section has a diameter of about 22-38 mm in the expanded state (C3:L51-55),
wherein when said inner sheath in the expanded state is at least partially withdrawn into the delivery sheath, said linear force is imposed on said tapered section, and then said main body section produces a radial compressive force within the device (capable of producing a radially compressive force when the distal extremity 28 is drawn within outer sheath 41 by a linear force).
Hermann is silent regarding the mouth of the wire woven distal end defines a flare that projects circumferentially from the leading end of the main body section. Vale teaches a system for retrieval with a flare and a flare angle (a) for the purpose of facilitating aspiration of an obstruction and improving the approach angle of the obstruction ([0329]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hermann to provide a flare that projects circumferentially from the leading end of the main body section as taught by Vale in order to improve the angle of approach of the obstruction ([0329]).
Hermann as modified by Vale does not explicitly disclose the mouth projects at an angle of about 30º to 60º relative to the longitudinal axis. Applicant has not disclosed that the mouth project at an angle of about 30º to 60º relative to the longitudinal axis provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0092] of the specification. One of ordinary skill in the art would have expected the mouth projection of the invention of Hermann as modified by Vale and Applicant’s invention to perform equally well with either the angle of projection as taught by the invention of Hermann as modified by Vale or the claimed mouth projecting at an angle of about 30º to 60º relative to the longitudinal axis because both angles of mouth projection would perform the same function of capturing an object within the body equally well considering the desire to capture an object at the opening. Therefore, 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 flare angle of Hermann as modified by Vale such that the angle is from about 30º to 60º relative to the longitudinal axis as an obvious matter of design choice within the level of skill in the art.
Hermann does not explicitly disclose the circumferential projection of the mouth has a length of about 2.75 to 3mm. However, Applicant has not disclosed that the flare having a length of 2.75 to 3mm provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0080] of the specification. One of ordinary skill in the art would have expected Hermann’s main body section and Applicant’s invention to perform equally well with either outer diameter taught by Hermann or the claimed 2.75-3mm because both dimensions would perform the same function of capturing an object within the body equally well considering the relative dimensions disclosed. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare of Hermann to have a length of about 2.75 to 3mm as an obvious matter of design choice within the skill in the art.
Hermann does not explicitly disclose the main body section includes 11-21 picks per centimeter. Kelly teaches a clot retrieval catheter having a distal braided supported tip. The braided section can have a range of picks per inch from 120 to 170 (12 to 17 picks per centimeter) ([0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pick count of the main body section of Hermann to be 12 to 17 picks per centimeter, which falls within the claimed range of 11-21 picks per centimeter, as taught by Kelly in order to provide good pushability, kink resistance, and bending properties ([0021] of Kelly).
Hermann does not explicitly disclose wherein the wires of the wire weave have a diameter of about 100 to about 300 µm. Phouasalit teaches a clot removal device having a braided wire section, where the wire section has wires with a diameter in the range of 0.008 to 0.03 inches (203 to 762um) ([0042]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the wires of the woven distal end of Hermann for the wires of Phouasalit having a diameter of about 100 to about 300um because it would have yielded the same predictable result of providing wires of a certain size to be woven together for retrieving an obstruction.
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hermann (US5630822) in view of Kelly (US2023/0137418) and Wallace (US2022/0257269)
Regarding claims 18-21, Hermann discloses a system for transforming a linear pulling force at one end of a catheter device to a radial compressive force at an opposite end of said catheter device that is substantially perpendicular to said linear pulling force comprising:
an outer sheath (41, C3:L56-60) having a lumen;
an inner sheath (21/26, C2:L62-66) that is adapted for insertion into the outer sheath; and,
a wire woven distal end (distal extremity 28, C3:L31) at a terminal extremity (the terminal extremity of the inner sheath is interpreted as the sheath section near the extremity 28, see Fig. 1) of the inner sheath that is formed from wires and includes a substantially cylindrical main body section comprising a leading end, a trailing end, and a middle portion extending between the leading end and the trailing end and defining a longitudinal axis (see annotated Fig. 1 from the rejection of claim 1);
a tapered section (see annotated Fig. 1) at the trailing end of the main body section; and an attachment portion (portion between the distal extremity 28 and the sheath 26, see Fig. 1, C3:L31) that is affixed to the terminal extremity of the inner sheath, wherein the main body section has a compressed state and an expanded state, the main body section adopting the compressed state when the wire woven distal end is housed within the lumen of the outer sheath (C4:L60-65), and adopting the expanded state when the wire woven distal end of the inner sheath is advanced beyond a distal end of the outer sheath by moving the wire woven distal end of the inner sheath forward relative to the distal end of the outer sheath (C5:L1-5, see Fig. 1), wherein the main body section has a diameter of about 22-38 mm in the expanded state (C3:L51-55),
wherein when said inner sheath in the expanded state is at least partially withdrawn into the outer sheath, said linear force is imposed on said tapered section, and then said main body section produces a radial compressive force within the wire woven distal end (capable of producing a radially compressive force when the distal extremity 28 is drawn within outer sheath 41 by a linear force).
Hermann does not explicitly disclose wherein the inner sheath comprises a wire weave embedded in a thermoplastic or elastomeric material. Kelly teaches jacket materials made of a thermoplastic material ([0111]) that are extruded on the sheath body 110 to cover the braid ([0111]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the wire weave of the modified invention embedded in a thermoplastic material in order to reinforce the sheath and ensure there is no exposed braid for catching on the obstruction ([0111]).
Hermann does not explicitly disclose wherein the wire weave has a braiding angle of about 20-55º or about 30-40º. Kelly further teaches the braid angle being variable for the capability of conforming to the clot or tissue as its injected and more or less resistance to collapsing ([0086]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the braiding angle of the modified invention in order to provide the capability of conforming to the clot or tissue as its injected and more or less resistance to collapsing ([0068]).
Further, Applicant has not disclosed that the wire weave of the inner sheath having a braiding angle of about 20-55º or about 30-40º provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0095] of the specification. One of ordinary skill in the art would have expected the modified invention’s wire weave and Applicant’s invention to perform equally well with either the braiding angle as taught by the modified invention or the claimed braiding about 20-55º or about 30-40º because both braiding angles would perform the same function of providing desirable characteristics of a mesh for capturing an obstruction. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified invention to have the wire weave of the inner sheath have a braiding angle of about 20-55º or about 30-40º as an obvious matter of design choice within the skill of the art.
Hermann does not explicitly disclose wherein the main body section includes 11-21 picks per centimeter. Kelly teaches a clot retrieval catheter having a distal braided supported tip. The braided section can have a range of picks per inch from 120 to 170 (12 to 17 picks per centimeter) ([0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pick count of the main body section of Hermann to be 12 to 17 picks per centimeter, which falls within the claimed range of 11-21 picks per centimeter, as taught by Kelly in order to provide good pushability, kink resistance, and bending properties ([0021] of Kelly).
Hermann does not explicitly disclose wherein the wires of the wire woven distal end have a dimension of about 100 to about 300 um (0.004-0.012 inches), wherein the wire weave of the inner sheath comprises wires having a ribbon-shaped profile, wherein the wires of the wire weave of the inner sheath have dimensions of 0.001-0.003 inches by about 0.003-0.007 inches. Wallace teaches a device for capturing clots having a funnel shaped device. The device is formed of ribbon shaped wires with dimensions of 0.002 inches by 0.004 inches ([0083]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the wires of the woven distal end and inner sheath of Hermann for the ribbon wires with the dimensions taught by Wallace because it would have yielded the same predictable result of providing wires of a certain size to be woven together for retrieving an obstruction.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774