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
The claims filed on September 16th, 2026, have been entered. Claims 1-3, 6-7, 11-12, and 14-15 remain pending in the Application.
Response to Arguments
The rejection of claims 1-3, 6-7, 11-12, and 14-15 under 103 over Turjman et al. (Pub. No. 2014/0155980) in view of Zaidat et al. (Pub. No. 2024/0398412), Carter (U.S. Patent No. 6,663,614), Kim et al. (Pub. No. 2011/0178594), Yoshiyuki et al. (Japanese Patent App. No. 2016/185206), and Alonso et al. (Pub. No. 2019/0314177) has been withdrawn in light of Applicant’s amendment made September 16th, 2026; specifically, none of the cited references teaches that the hydrophilic material of the smooth cover potion is only composed of MPC polymer.
Applicant’s arguments with respect to claim(s) 1-3. 6-7, 11-12, and 14-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Applicant argues that the newly added claim limitation is not taught by the cited references; however, as discussed below, the newly added reference Fujita et al. (Pub. No. 2013/0190690) teaches said limitation.
Specification
The disclosure is objected to because of the following informalities: on Page 8, the Specification states that “such a hydrophilic fluid layer may be made of, for example, hyaluronic acid, an MPC polymer, or the like.” The abbreviation of “MPC polymer” should be written out in the first use of the abbreviation to clarify that 2-methacryloyloxy ethyl phosphorylcholine polymer is being referred to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-7, 11-12, and 14-15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1, “the hydrophilic material of the smooth cover portion covering the pusher wire is only composed of 2-methacryloyloxy ethyl phosphorylcholine (MPC) polymer” (emphasis added) constitutes new matter because the Specification only mentions MPC polymer once on page 8, “such a hydrophilic fluid layer may be made of, for example, hyaluronic acid, an MPC polymer, or the like.” The Specification does not have support for the limitation that the hydrophilic material is only composed of MPC polymer.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turjman et al. (Pub. No. 2014/0155980) in view of Zaidat et al. (Pub. No. 2024/0398412), Kim et al. (Pub. No. 2011/0178594), and Fujita et al. (Pub. No. 2013/0190690).
Regarding claim 1, Turjman et al. discloses a wire-equipped stent comprising:
a pusher wire ([0089] push wire 106; see FIG. 2) configured to be inserted in a catheter ([0089] 106 can be pushed through 102; see FIGs. 1A-1B) including an undulating inner surface (the functional language “configured to” means that 106 only has to be capable of being inserted into a catheter with an undulating inner surface, and if the inner surface of 102 were altered to be undulating without changing the diameter, 106 would still be insertable, thereby satisfying the claim limitation);
a stent ([0089] clot capture member 108; see FIG. 2) connected to a distal end portion of the pusher wire ([0089] 106 and 108 are connected at the distal end of 106 by attachment ring 110; see FIG. 2); and
a smooth cover portion provided at a distal portion of the pusher wire, and covering an outer surface of the distal portion of the pusher wire ([0098] an exterior coating can be provided on the outer surface of the push wire, as the push wire is indicated to be the guidewire; [0006], [0039], [0043]) to form a smooth surface to reduce sliding resistance when contacting with the undulated inner surface of the catheter ([0098] the exterior coating is used to help reduce friction with the microcatheter 102; FIG. 2), wherein a proximal portion of the pusher wire is exposed from the smooth cover portion ([0098-99] and FIG. 1A: a proximal portion of 106 goes back to the delivery handle, which is outside the body and would not have an exterior coating to reduce friction because that proximal portion would never go into the body);
wherein a distal side end portion of the smooth cover portion is connected to a proximal side end portion of the stent ([0091] the exterior coating would have its distal side end portion connected to the proximal side end portion of 108 due to the direct connection between 106 and 108 secured by 110; see FIG. 2), wherein a diameter of the distal side end portion of the smooth cover portion is smaller than a diameter of a proximal side end portion of the smooth cover portion ([0097] guidewire 106 can taper in the 200 region, and the exterior coating is on the outer surface of 106, so the exterior coating will also have a smaller diameter of its distal portion than the diameter of its proximal portion; see FIG. 2), and
a marker (110, which acts as a visual marker of the attachment between 106 and 108 outside of the body) which is connected to the proximal end portion of the stent (FIG. 2: 110 is attached to the proximal end portion of 108) and which is connected to the distal end portion of the smooth cover portion (FIG. 2: 110 is attached to the distal end portion of 106, which can have the coating to make the smooth portion), and the marker is configured to indicate a position of the proximal end portion of the stent when the stent is inserted into a blood vessel ([0245] and [0261] other attachment rings 3502 and 3002 are made of steel, which is a radiopaque material that can be observed from outside of the body);
wherein the smooth cover portion comprises a hydrophilic material covering the outer surface of the distal portion of the pusher wire ([0091] the exterior coating on the distal surface of the pusher wire can be a hydrophilic coating).
Turjman et al. is silent regarding the distal end portion of the smooth cover portion and the marker are bonded with each other with an adhesive, though Turjman et al. discloses that similar markers in other embodiments are attached to the distal portion of the pusher wire and the coating on that portion by swaging (3502 in [0245] and 3002 in [0261]).
Zaidat et al. teaches in the same field of endeavor of cerebral clot removal ([0125]) and discloses attaching a radiopaque marker band to the proximal end (120) of an occlusion device (100) by swaging or adhesive bonding ([0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the bonding of Turjman et al. (swaging) for the bonding of Zaidat et al. (adhesives) because both bonding methods are disclosed as equivalent methods of securing the distal end portion of the smooth cover portion and the marker to each other, and the substitution of one for the other would have had the predictable result of bonding the distal end portion of the smooth cover portion to the marker.
Turjman et al. as modified does not disclose the hydrophilic material comprises a 2-methacryloyloxy ethyl phosphorylcholine (MPC) polymer.
Kim et al. discloses using a layer of MPC and PLLA to coat the surface of a stent ([0011]) for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation ([0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to make the hydrophilic layer in Turjman et al. out of MPC and PLLA, as taught by Kim et al., for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation. Furthermore, the substitution of one material known in the art (MPC) for another would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire.
Turjman et al. as modified by Kim et al. does not disclose that the hydrophilic material is only comprised of MPC polymer, though Kim et al. notes that MPC provides a higher fraction of free water to prevent protein denaturation and adsorption, as well as suppresses platelet adhesion, blood coagulation, and inflammation, when compared to general hydrophilic polymers ([0011]).
Fujita et al. discloses a layer of just MPC can be used to coat the outermost surface of a balloon inserted into a blood vessel ([0035] the known polymers listed, including MPC, can be used singly, as well as in admixture).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the outermost layer in Turjman et al. to be made out of only MPC, as taught by Fujita et al., as the substitution of one material known in the art (MPC) for another (MPC and PLLA blend) would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire. Furthermore, it would have been obvious to one of ordinary skill in the art to use MPC alone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Turjman et al. further discloses where the smooth cover portion includes no coiled member (the exterior coating of Turjman et al. is not disclosed as having a coiled member, and none of the modifications would add a coiled member).
Regarding claim 3, Turjman et al. further discloses where the smooth cover portion has an outer surface with a surface roughness Ra of 0.5 nm or more and less than 2.0 nm ([0091] the guidewire 106 is coated with PTFE, which is a material recited in the application as an example of the materials which can make up the highly smooth portion and therefore is understood to have the claimed surface roughness).
Regarding claim 6, Turjman et al. further discloses wherein the stent is adapted to be delivered together with a catheter (102) to a region at or downstream of MI region in a skull and to be used together with the catheter in the skull ("adapted to be" constitutes functional language reciting an intended use of the device. Because apparatus claims are limited to structural features of the invention, the prior art device need not disclose use of the device in the claimed manner. Turjman et al. teaches in [0259] that the device can be used in a neurovascular procedure, and therefore is interpreted as being at least " adapted to be delivered together with the catheter to a region at or downstream of MI region in a skull and to be used together with the catheter in the skull " because it comprises the claimed structure and a size that is appropriate for accessing some area of the brain).
Regarding claim 7, Turjman et al. further discloses where the stent is adapted for use to retrieve a blood clot formed in a cerebral blood vessel in a region at or downstream of the MI region ("adapted for use" constitutes functional language reciting an intended use of the device. Because apparatus claims are limited to structural features of the invention, the prior art device need not disclose use of the device in the claimed manner. Turjman et al. teaches in [0259] that the device can be used in a neurovascular procedure, and therefore is interpreted as being at least "adapted for use in a cerebral blood vessel in a region at or downstream of the M1 region" because it comprises the claimed structure and a size that is appropriate for accessing a blood vessel within some area of the brain).
Claim(s) 11-12 /are rejected under 35 U.S.C. 103 as being unpatentable over Turjman et al. in view of Zaidat et al., Kim et al., Fujita et al., and Yoshiyuki et al. (Japanese Patent App. No. 2016/185206).
Regarding claims 11-12, Turjman et al. discloses a catheter-stent system (100; FIGs. 1A-2) comprising:
a wire-equipped stent (106 and 108); and
a catheter ([0089] the assembly can include microcatheter 102; see FIGs. 1A-B).
wherein the wire-equipped stent comprises:
a pusher wire ([0089] push wire 106; see FIG. 2);
a stent ([0089] clot capture member 108; see FIG. 2) connected to a distal end portion of the pusher wire ([0089] 106 and 108 are connected at the distal end of 106 by attachment ring 110; see FIG. 2); and
a smooth cover portion provided at a distal portion of the pusher wire, and covering an outer surface of the distal portion of the pusher wire ([0098] an exterior coating can be provided on the outer surface of the push wire, as the push wire is indicated to be the guidewire; [0006], [0039], [0043]) to form a smooth surface to reduce sliding resistance when contacting with the undulated inner surface of the catheter ([0098] the exterior coating is used to help reduce friction with the microcatheter 102; FIG. 2), wherein a proximal portion of the pusher wire is exposed from the smooth cover portion ([0098-99] and FIG. 1A: a proximal portion of 106 goes back to the delivery handle, which is outside the body and would not have an exterior coating to reduce friction because that proximal portion would never go into the body);
wherein a distal side end portion of the smooth cover portion is connected to a proximal side end portion of the stent ([0091] the exterior coating would have its distal side end portion connected to the proximal side end portion of 108 due to the direct connection between 106 and 108 secured by 110; see FIG. 2), wherein a diameter of the distal side end portion of the smooth cover portion is smaller than a diameter of a proximal side end portion of the smooth cover portion ([0097] guidewire 106 can taper in the 200 region, and the exterior coating is on the outer surface of 106, so the exterior coating will also have a smaller diameter of its distal portion than the diameter of its proximal portion; see FIG. 2), and
a marker (110, which acts as a visual marker of the attachment between 106 and 108 outside of the body) which is connected to the proximal end portion of the stent (FIG. 2: 110 is attached to the proximal end portion of 108) and which is connected to the distal end portion of the smooth cover portion (FIG. 2: 110 is attached to the distal end portion of 106, which can have the coating to make the smooth portion), and the marker is configured to indicate a position of the proximal end portion of the stent when the stent is inserted into a blood vessel ([0245] and [0261] other attachment rings 3502 and 3002 are made of steel, which is a radiopaque material that can be observed from outside of the body);
wherein the smooth cover portion comprises a hydrophilic material covering the outer surface of the distal portion of the pusher wire ([0091] the exterior coating on the distal surface of the pusher wire can be a hydrophilic coating).
Turjman et al. is silent regarding the distal end portion of the smooth cover portion and the marker are bonded with each other with an adhesive, though Turjman et al. discloses that similar markers in other embodiments are attached to the distal portion of the pusher wire and the coating on that portion by swaging (3502 in [0245] and 3002 in [0261]).
Zaidat et al. teaches in the same field of endeavor of cerebral clot removal ([0125]) and discloses attaching a radiopaque marker band to the proximal end (120) of an occlusion device (100) by swaging or adhesive bonding ([0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the bonding of Turjman et al. (swaging) for the bonding of Zaidat et al. (adhesives) because both bonding methods are disclosed as equivalent methods of securing the distal end portion of the smooth cover portion and the marker to each other, and the substitution of one for the other would have had the predictable result of bonding the distal end portion of the smooth cover portion to the marker.
Turjman et al. as modified does not disclose the hydrophilic material comprises a 2-methacryloyloxy ethyl phosphorylcholine (MPC) polymer.
Kim et al. discloses using a layer of MPC and PLLA to coat the surface of a stent ([0011]) for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation ([0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to make the hydrophilic layer in Turjman et al. out of MPC and PLLA, as taught by Kim et al., for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation. Furthermore, the substitution of one material known in the art (MPC) for another would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire.
Turjman et al. as modified by Kim et al. does not disclose that the hydrophilic material is only comprised of MPC polymer, though Kim et al. notes that MPC provides a higher fraction of free water to prevent protein denaturation and adsorption, as well as suppresses platelet adhesion, blood coagulation, and inflammation, when compared to general hydrophilic polymers ([0011]).
Fujita et al. discloses a layer of just MPC can be used to coat the outermost surface of a balloon inserted into a blood vessel ([0035] the known polymers listed, including MPC, can be used singly, as well as in admixture).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the outermost layer in Turjman et al. to be made out of only MPC, as taught by Fujita et al., as the substitution of one material known in the art (MPC) for another (MPC and PLLA blend) would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire. Furthermore, it would have been obvious to one of ordinary skill in the art to use MPC alone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Turjman et al. as modified does not disclose a catheter, including an undulated inner surface, a core material portion, and a resin layer covering the core material portion, wherein the core material portion includes a structure including a mesh coil and a spiral coil which overlap each other and the resin layer includes an undulated surface which is provided by the core material portion.
Yoshiyuki et al. teaches in the same field of endeavor of catheters, and discloses a catheter ([0007] discloses catheter 1) comprising:
a core material portion ([0026] discloses reinforcing body 6; see FIG. 3); and
a resin layer covering the core material portion ([0020] inner layer 22 may be made of synthetic resin, see Fig. 2),
wherein the core material portion includes a structure including a mesh coil ([0026] discloses a braided portion 7; see FIG. 3) and a spiral coil ([0026] discloses coil portion 8 which is spirally wound; see FIG. 3) which overlap each other (FIG. 3), and the resin layer includes an undulated surface which is provided by the core material portion ([0026] 7 and 8 are both wires which create an undulated surface, and [0034] 22 is on that surface, which would give 22 an undulated surface).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Turjman et al. to substitute a catheter with the characteristics taught by Yoshiyuki et al., in place of those disclosed by Turjman et al. since the catheter of Yoshiyuki et al. provides the advantage of increasing the flexibility of the distal end of the catheter while increasing the pushability of the proximal end and also allowing for high torque transmission (Yoshiyuki et al. [0037]). As discussed above, the resin layer is the inner layer 22 in FIG. 2 of the catheter of Yoshiyuki et al., and provides an undulated surface by the core material portion being made of the mesh coil and the spiral coil, thereby providing a catheter including an undulated inner surface.
Claim(s) 1 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turjman et al. in view of Zaidat et al., Fujita et al., and Alonso et al. (Pub. No. 2019/0314177).
Regarding claims 1 and 14, Turjman et al. discloses a wire-equipped stent comprising:
a pusher wire ([0089] push wire 106; see FIG. 2) configured to be inserted in a catheter ([0089] 106 can be pushed through 102; see FIGs. 1A-1B) including an undulating inner surface (the functional language “configured to” means that 106 only has to be capable of being inserted into a catheter with an undulating inner surface, and if the inner surface of 102 were altered to be undulating without changing the diameter, 106 would still be insertable, thereby satisfying the claim limitation);
a stent ([0089] clot capture member 108; see FIG. 2) connected to a distal end portion of the pusher wire ([0089] 106 and 108 are connected at the distal end of 106 by attachment ring 110; see FIG. 2); and
a smooth cover portion provided at a distal portion of the pusher wire, and covering an outer surface of the distal portion of the pusher wire ([0098] an exterior coating can be provided on the outer surface of the push wire, as the push wire is indicated to be the guidewire; [0006], [0039], [0043]) to form a smooth surface to reduce sliding resistance when contacting with the undulated inner surface of the catheter ([0098] the exterior coating is used to help reduce friction with the microcatheter 102; FIG. 2), wherein a proximal portion of the pusher wire is exposed from the smooth cover portion ([0098-99] and FIG. 1A: a proximal portion of 106 goes back to the delivery handle, which is outside the body and would not have an exterior coating to reduce friction because that proximal portion would never go into the body);
wherein a distal side end portion of the smooth cover portion is connected to a proximal side end portion of the stent ([0091] the exterior coating would have its distal side end portion connected to the proximal side end portion of 108 due to the direct connection between 106 and 108 secured by 110; see FIG. 2), wherein a diameter of the distal side end portion of the smooth cover portion is smaller than a diameter of a proximal side end portion of the smooth cover portion ([0097] guidewire 106 can taper in the 200 region, and the exterior coating is on the outer surface of 106, so the exterior coating will also have a smaller diameter of its distal portion than the diameter of its proximal portion; see FIG. 2), and
a marker (110, which acts as a visual marker of the attachment between 106 and 108 outside of the body) which is connected to the proximal end portion of the stent (FIG. 2: 110 is attached to the proximal end portion of 108) and which is connected to the distal end portion of the smooth cover portion (FIG. 2: 110 is attached to the distal end portion of 106, which can have the coating to make the smooth portion), and the marker is configured to indicate a position of the proximal end portion of the stent when the stent is inserted into a blood vessel ([0245] and [0261] other attachment rings 3502 and 3002 are made of steel, which is a radiopaque material that can be observed from outside of the body);
wherein the smooth cover portion comprises a hydrophilic material covering the outer surface of the distal portion of the pusher wire ([0091] the exterior coating on the distal surface of the pusher wire can be a hydrophilic coating), and
the distal end portion of the pusher wire includes a tapered area (200; FIG. 2; [0097]), and
the smooth cover portion is provided on the tapered area ([0098] the exterior coating is on at least part of 106).
Turjman et al. is silent regarding the distal end portion of the smooth cover portion and the marker are bonded with each other with an adhesive, though Turjman et al. discloses that similar markers in other embodiments are attached to the distal portion of the pusher wire and the coating on that portion by swaging (3502 in [0245] and 3002 in [0261]).
Zaidat et al. teaches in the same field of endeavor of cerebral clot removal ([0125]) and discloses attaching a radiopaque marker band to the proximal end (120) of an occlusion device (100) by swaging or adhesive bonding ([0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the bonding of Turjman et al. (swaging) for the bonding of Zaidat et al. (adhesives) because both bonding methods are disclosed as equivalent methods of securing the distal end portion of the smooth cover portion and the marker to each other, and the substitution of one for the other would have had the predictable result of bonding the distal end portion of the smooth cover portion to the marker.
Turjman et al. as modified does not disclose the hydrophilic material comprises a 2-methacryloyloxy ethyl phosphorylcholine (MPC) polymer.
Kim et al. discloses using a layer of MPC and PLLA to coat the surface of a stent ([0011]) for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation ([0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to make the hydrophilic layer in Turjman et al. out of MPC and PLLA, as taught by Kim et al., for the purpose of providing a biocompatible surface which has no substantial interaction with surface water and thereby prevents protein denaturation and adsorption as well as suppresses platelet adhesion, blood coagulation, and inflammation. Furthermore, the substitution of one material known in the art (MPC) for another would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire.
Turjman et al. as modified by Kim et al. does not disclose that the hydrophilic material is only comprised of MPC polymer, though Kim et al. notes that MPC provides a higher fraction of free water to prevent protein denaturation and adsorption, as well as suppresses platelet adhesion, blood coagulation, and inflammation, when compared to general hydrophilic polymers ([0011]).
Fujita et al. discloses a layer of just MPC can be used to coat the outermost surface of a balloon inserted into a blood vessel ([0035] the known polymers listed, including MPC, can be used singly, as well as in admixture).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the outermost layer in Turjman et al. to be made out of only MPC, as taught by Fujita et al., as the substitution of one material known in the art (MPC) for another (MPC and PLLA blend) would have had the predictable result of providing a hydrophilic layer of material on the outermost layer of the pusher wire. Furthermore, it would have been obvious to one of ordinary skill in the art to use MPC alone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Turjman et al. does not disclose a proximal end portion of the tapered area of the pusher wire is exposed from the smooth cover portion.
Alonso et al. teaches a wire (212; FIG. 2; [0339]) with a proximal portion (204) and a distal portion (206) where the distal portion is covered by a smooth cover portion (218; [0339] 218 is made of PTFE and is a lubricious layer) and the proximal portion is exposed from the smooth portion ([0339] and FIG. 2: 204 is exposed from 218) for the purpose of allowing fluorosafe markers to mark the proximal portion of the wire ([0339]; the markers are not pictured).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the smooth cover portion of Turjman et al. to only cover the distal portion and not the proximal portion, as taught by Alonso et al., for the purpose of allowing fluorosafe markers to mark the proximal portion of the wire.
Regarding claim 15, Turjman et al. as modified by Alonso et al. further discloses the smooth cover portion extends from the distal end portion of the tapered area of the pusher wire to the proximal end portion of the tapered area of the pusher wire (Alonso et al. FIG. 2: 218 covers a portion of the tapered area of 212, and the proximal end portion can be defined as the portion not covered by 218 while the distal end portion can be defined as the portion covered by 218, thereby meaning that the smooth portion extends from the distal end to the proximal end; furthermore, 212 is disclosed as potentially being tapered along its entire length, so the proximal portion of 212 can be tapered and uncovered while the distal end portion of 212 can be tapered and covered), and the proximal end portion of the tapered area of the pusher wire is exposed from the smooth cover portion (Alonso et al. FIG. 2: 218 does not cover the proximal end portion of the tapered area), while the distal end portion of the tapered area of the pusher wire is covered by the smooth cover portion (Alonso et al. FIG. 2: 218 covers the distal end portion of the tapered area).
Conclusion
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/JAMES R MCGINNITY/Examiner, Art Unit 3771