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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-27), drawn to a locking catheter system, in the reply filed on 1/5/2026 is acknowledged.
Claims 28-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of locking one or more catheters, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/16/2023, 2/22/2024, 7/25/2024, 10/28/2024, 11/4/2025 and 1/5/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 10, 12-14, 17-18, 21 and 26-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houde (US 2003/0229295 A1).
Regarding claim 1, Houde discloses:
A locking catheter system (see Figs. 1 and 15) comprising:
a first catheter (sheath 14, see Fig. 15);
a second catheter (shaft 12, see Fig. 15) movably coupled with the first catheter (see Para. [0029], [0034] and [0055]; when not secured, shaft 12 may axially move relative to sheath 14); and
a locking mechanism (lock system 11, see Fig. 1 and Para. [0029]) coupled with the first and second catheters (see Para. [0029] mentioning wherein a splitter (16/716) of the lock system is coupled to both sheath 14 and shaft 12), the locking mechanism includes:
a lock body (body of splitter 716 extending proximally into main branch 764, see Fig. 15 and Para(s). [0029] and [0053]);
a system lumen (lumen 734, see Fig. 15) extending through the lock body (see Fig. 15 and Para. [0054]), wherein the first and second catheters are received in the system lumen (see Fig. 15 and Para. [0054]);
a system channel (main lumen 766, see Fig. 15) extending from the system lumen (see Fig. 15 and Para. [0054]), the system channel configured to receive one or more of the first or second catheters (see Fig. 15 showing wherein sheath 14 is disposed within main lumen 766);
a locking channel (side lumen 770, see Fig. 15) extending from the system lumen (see Fig. 15 and Para. [0054]), the locking channel configured to receive one or more of the first or second catheters (see Fig. 15 and Para. [0054] mentioning wherein shaft 12 is disposed within side lumen 770); and
a lock element (lock member 740, see Fig. 15 and Para. [0055]) coupled with the locking channel (see Fig. 15 and Para. [0055]), the lock element configured to statically couple one or more of the first or second catheters in the locking channel to the lock body (see Para. [0054]-[0055] mentioning wherein the locking member 740 may clamp down upon and lock shaft 12).
Regarding claim 2, Houde discloses the invention of claim 1, Houde further discloses wherein the system lumen extends between a proximal open end and a distal open end (see Fig. 15 showing wherein lumen 734 has an open proximal end that branches out to lumens 766 and 770; lumen 734 also comprises an open distal end to allow shaft 12 and sheath 14 to extend therefrom as shown in Fig. 1), and the system lumen is enclosed between the proximal and distal open ends (lumen 734 is enclosed between the open proximal and distal ends within the splitter and outer sheath as shown in Fig. 15).
Regarding claim 10, Houde discloses the invention of claim 1, Houde further discloses wherein the lock element includes one or more biasing elements (locking member 740 includes a collet that clamps down on shaft 12, see Fig. 15 and Para. [0055]).
Regarding claim 12, Houde discloses the invention of claim 1, Houde further discloses wherein the system channel is aligned with the system lumen (see Fig. 15); and the locking channel is angled relative to the system lumen (see Fig. 15).
Regarding claim 13, Houde discloses the invention of claim 1, Houde further discloses wherein the lock body includes an integral lock body (see Fig. 15 showing wherein the body of splitter 716 and y-adapter 738 are integral components with one-another).
Regarding claim 14, Houde discloses the invention of claim 1, Houde further discloses wherein the first and second catheters are longitudinally movable within the system channel relative to the lock body (see Para. [0029], [0034] and [0055] mentioning that, when not secured, shaft 12 and sheath 14 may axially move relative to both one-another and the static locking member 740).
Regarding claim 17, Houde discloses:
A locking catheter system (see Fig. 1 and 15) comprising:
a first catheter (sheath 14, see Fig. 15);
a second catheter (shaft 12, see Fig. 15);
a locking mechanism (lock system 11, see Fig. 1) coupled with the first and second catheters (see Para. [0029] mentioning wherein a splitter (16/716) of the lock system is coupled to both sheath 14 and shaft 12), the locking mechanism includes:
a lock body (body of splitter 716 extending proximally to main branch 764, see Fig. 15 and Para(s). [0029] and [0053]) having a system lumen (lumen 734, see Fig. 15) extending through the lock body (see Fig. 15 and Para. [0054]), wherein the first and second catheters are received in the system lumen (see Fig. 15 and Para. [0054]);
a system channel (main lumen 766, see Fig. 15) extending from the system lumen (see Para. [0054] and Fig. 15), the system channel configured to receive one or more of the first or second catheters (see Fig. 15 showing wherein sheath 14 is disposed within main lumen 766);
a locking channel (side lumen 770, see Fig. 15) extending from the system lumen (see Fig. 15 and Para. [0054]), the locking channel including a lock element (locking member 740, see Fig. 15 and Para. [0055]), the locking channel configured to receive one or more of the first or second catheters (see Para. [0054] and Fig. 15 showing wherein sheath 14 is disposed within main lumen 766); and
wherein the locking mechanism includes locked and unlocked configurations (see Para. [0029], [0035] and [0055] mentioning wherein locking member 740 (as a part of the locking assembly comprising the splitter), is configured to axially lock either the shaft 12 or sheath 14):
in the unlocked configuration the first and second catheters are received in the system channel (see Examiner’s Diagram of Fig. 15 below showing wherein lumen 770 meets up with lumen 766 before both lumens extend into lumen 734; at this transition point, the distal end of shaft 12 extends into lumen 766 as shown in the annotated Fig. 15 below), and the first and second catheters are movable relative to the lock body (see Para. [0029], [0034] and [0055]; when not secured, shaft 12 and sheath 14 may axially move relative to the static lock member 740); and
in the locked configuration at least the second catheter is received in the locking channel (see Fig. 15), the second catheter is statically coupled with the lock body (see Fig. 15 and Para. [0029], [0035] and [0055]), and the first catheter is movable relative to the lock body (see Fig. 15 and Para. [0029], [0035] and [0055]).
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Examiner’s Diagram of Fig. 15
Regarding claim 18, Houde discloses all of the limitations of claim 17, Houde further discloses wherein movement of the lock body correspondingly moves the second catheter relative to the first catheter (see Para. [0029] mentioning wherein the splitter can selectively couple to and lock either shaft 12 or sheath 14 thereto; when the shaft 12 is locked onto the splitter while the sheath 14 is free, movement of the splitter (i.e., the elongate tubular body of the device) correspondingly moves the shaft 12 therewith, while sheath 14 may remain stationary if held by a user).
Regarding claim 21, Houde discloses the invention of claim 17, Houde further discloses wherein the system lumen extends between a proximal open end (see Fig. 15 showing wherein lumen 734 has an open proximal end that branches out to lumens 766 and 770) and a distal open end (lumen 734 also comprises an open distal end to allow shaft 12 and sheath 14 to extend therefrom as shown in Fig. 1), and the system lumen is enclosed between the proximal and distal open ends (lumen 734 is enclosed between the open proximal and distal ends within the splitter and outer sheath as shown in Fig. 15).
Regarding claim 26, Houde discloses the invention of claim 17, Houde further discloses wherein the lock element includes one or more biasing elements (locking member 740 includes a collet that clamps down on shaft 12, see Fig. 15 and Para. [0055]).
Regarding claim 27, Houde discloses the invention of claim 17, Houde further discloses wherein the system channel is aligned with the system lumen (see Fig. 15); and the locking channel is angled relative to the system lumen (see Fig. 15).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 3-7, 9 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houde (US 2003/0229295 A1) in view of Graham (US 2011/0077621 A1).
Regarding claim 3, Houde discloses the invention of claim 1, Houde further discloses wherein the lock body includes a lock access cleft extending along the locking channel (guide wire 772 extending along lumen 770, see Fig. 15 and Para. [0054]; the guidewire may receive shaft 12 within a lumen thereof, thus serving as a cleft); and at least one of the first or second catheters is selectively positioned through each of the system access cleft or the lock access cleft (see Fig. 15 and Para. [0054] mentioning wherein shaft 12 may extend into guidewire 772) into the respective system or locking channels (shaft 12 extends from guidewire 772 and into lumen 770, see Fig. 15 and Para. [0054]).
However, Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock body includes a system access cleft extending along the system channel.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the elongate member is disposed within an access cleft (tubular member 54, see Fig. 5) extending along a length of the internal channel of the handpiece of the device (see Fig. 5) to provide a guiding means within which the elongate member is disposed (see Para. [0038]; elongate member 40 is disposed within and thus guided by tubular member 54).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the splitter of Houde to include an outer elongate member therein, configured to house the sheath 14 of Houde therein, as disclosed and suggested by Graham to, in this case, provide a guide means for which the sheath of Houde may be disposed within (see Graham Para. [0038]).
Regarding claim 4, the combination of Houde and Graham discloses the invention of claim 3, Houde, as modified by Graham, further discloses wherein the lock access cleft and the system access cleft includes cleft spacing (see Graham Fig. 5 which wherein the tubular member 54 comprises a cleft spacing within which the sheath of Houde is disposed; see also Houde Fig. 15 showing wherein guidewire 772 comprises a spacing within which shaft 12 is disposed), the locking channel includes a locking channel diameter (see Houde Fig. 15) and the system channel includes a system channel diameter (see Houde Fig. 15), and the locking and system channel diameters are greater than the cleft spacing (diameter of lumen 770 and lumen 766 of Houde are greater than diameter of guidewire 772 of Houde and the tubular member 54 of Graham so as to allow tubular member 54 of Graham and the guidewire 772 of Houde to be disposed therein).
Regarding claim 5, the combination of Houde and Graham discloses the invention of claim 3, Houde further discloses wherein the lock body includes an access intersection (intersection where sheath 14 and shaft 12 meet, see Fig. 15): the system lumen extends to the access intersection (see Fig. 15); and the system channel and the locking channel extend from the access intersection (see Figs. 15).
Regarding claim 6, Houde discloses all of the limitations of the invention of claim 1.
However, while Houde discloses, in an alternative embodiment, wherein the locking member may comprise a pinching wedge portion 876 (see Fig. 16 and Para. [0056]), Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock element includes a wedge brake.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a wedge locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the locking element is in the form of a locking wedge (actuator 52 includes cam portion 70 which wedges against the elongate shaft member, providing a locking mechanism therefore, see Fig. 5) that applies a closing pressure to the elongate member (see Para. [0042]-[0043] and Fig. 5).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see SR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the locking mechanism of Houde (i.e., locking member 740) be in the form of an actuatable locking wedge as disclosed by Graham. Since Houde already teaches a locking wedge as an alternative locking embodiment to the locking members 740 (see Fig. 16 and Para. [0056]), one of ordinary skill in the art would have understood that these two configurations were interchangeable with one-another in accomplishing the common task of locking the axial position of the shaft and sheath elements. Since Houde discloses both systems as alternative, interchangeably arrangements with one-another, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Houde would functional equally well with either the current locking members 740 or a wedge-type locking mechanism as disclosed by Graham.
Regarding claim 7, the combination of Houde and Graham discloses the invention of claim 6, Houde further discloses wherein the wedge brake includes a tapered track (tapered track defined by the angled nature of the branch 768 within which shaft 12 is disposed, see Fig. 15) and a wedge within the tapered track (cam portion 70 of actuator 52 of Graham (see Graham Figs. 5-6) is disposed within the lumen 770 of Houde, see Houde Fig. 15, in order to contact and compress the shaft 12), the wedge in communication with the locking channel (the cam portion of the actuator of Graham would extend into the lumen 770 of Houde in order to contact and compress the shaft 12 therein).
Regarding claim 9, Houde discloses all of the limitations of the invention of claim 1.
However, while Houde discloses, in an alternative embodiment, wherein the locking member may comprise a pinching cleat portion 876 (see Fig. 16 and Para. [0056]), Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock element includes one or more cleats.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the locking element comprises a cleat (cam portion 70, see Fig. 5) that is disposed within a lumen of the handle (see Fig. 5) to apply a closing pressure to the elongate member (see Para. [0042]-[0043]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see SR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the locking mechanism of Houde (i.e., locking member 740) be in the form of an actuatable locking cleat as disclosed by Graham. Since Houde already teaches a locking wedge having a pinching cleat as an alternative locking embodiment to the locking members 740 (see Fig. 16 and Para. [0056]), one of ordinary skill in the art would have understood that these two configurations were interchangeable with one-another in accomplishing the common task of locking the axial position of the shaft and sheath elements. Since Houde discloses both systems as alternative, interchangeably arrangements with one-another, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Houde would functional equally well with either the current locking members 740 or a wedge-type cleat locking mechanism as disclosed by Graham. The resulting combination would have the cam portion of the locking mechanism extend into the lumen 770 in order to contact shaft 12.
Regarding claim 22, Houde discloses the invention of claim 17, Houde further discloses wherein the lock body includes a lock access cleft extending along the locking channel (guide wire 772 extending along lumen 770, see Fig. 15 and Para. [0054]; the guidewire may receive shaft 12 within a lumen thereof, thus serving as a cleft); and in the locked configuration, the second catheter is selectively positioned through the lock access cleft into the locking channel (see Fig. 15 and Para. [0054] mentioning wherein shaft 12 may extend into guidewire 772) into the respective system or locking channels (shaft 12 extends from guidewire 772 and into lumen 770, see Fig. 15 and Para. [0054]).
However, Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock body includes a system access cleft extending along the system channel.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the elongate member is disposed within an access cleft (tubular member 54, see Fig. 5) extending along a length of the internal channel of the handpiece of the device (see Fig. 5) to provide a guiding means within which the elongate member is disposed (see Para. [0038]; elongate member 40 is disposed within and thus guided by tubular member 54).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the splitter of Houde to include an outer elongate member therein, configured to house the sheath 14 of Houde therein, as disclosed and suggested by Graham to, in this case, provide a guide means for which the sheath of Houde may be disposed within (see Graham Para. [0038]).
Regarding claim 23, the combination of Houde and Graham discloses the invention of claim 22, Houde, as modified by Graham, further discloses wherein the lock access cleft and the system access cleft includes cleft spacing (see Graham Fig. 5 which wherein the tubular member 54 comprises a cleft spacing within which the sheath of Houde is disposed; see also Houde Fig. 15 showing wherein guidewire 772 comprises a spacing within which shaft 12 is disposed), the locking channel includes a locking channel diameter (see Houde Fig. 15) and the system channel includes a system channel diameter (see Houde Fig. 15), and the locking and system channel diameters are greater than the cleft spacing (diameter of lumen 770 and lumen 766 of Houde are greater than diameter of guidewire 772 of Houde and the tubular member 54 of Graham so as to allow tubular member 54 of Graham and the guidewire 772 of Houde to be disposed therein).
Regarding claim 24, Houde discloses all of the limitations of the invention of claim 17.
However, while Houde discloses, in an alternative embodiment, wherein the locking member may comprise a pinching wedge portion 876 (see Fig. 16 and Para. [0056]), Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock element includes a wedge brake.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a wedge locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the locking element is in the form of a locking wedge (actuator 52 includes cam portion 70 which wedges against the elongate shaft member, providing a locking mechanism therefore, see Fig. 5) that applies a closing pressure to the elongate member (see Para. [0042]-[0043] and Fig. 5).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see SR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the locking mechanism of Houde (i.e., locking member 740) be in the form of an actuatable locking wedge as disclosed by Graham. Since Houde already teaches a locking wedge as an alternative locking embodiment to the locking members 740 (see Fig. 16 and Para. [0056]), one of ordinary skill in the art would have understood that these two configurations were interchangeable with one-another in accomplishing the common task of locking the axial position of the shaft and sheath elements. Since Houde discloses both systems as alternative, interchangeably arrangements with one-another, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Houde would functional equally well with either the current locking members 740 or a wedge-type locking mechanism as disclosed by Graham.
Regarding claim 25, Houde discloses all of the limitations of the invention of claim 17.
However, while Houde discloses, in an alternative embodiment, wherein the locking member may comprise a pinching cleat portion 876 (see Fig. 16 and Para. [0056]), Houde does not expressly disclose, within the embodiment of Fig. 15, wherein the lock element includes one or more cleats.
In the same field of endeavor, namely catheter devices comprising a locking mechanism, Graham teaches a catheter (see Fig. 1) comprising a locking element (actuator 52, see Fig. 5) configured to lock an elongate shaft member (elongate member 40, see Fig. 5) in an axial position (see Para. [0042]-[0043]), wherein the locking element comprises a cleat (cam portion 70, see Fig. 5) that is disposed within a lumen of the handle (see Fig. 5) to apply a closing pressure to the elongate member (see Para. [0042]-[0043]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see SR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the locking mechanism of Houde (i.e., locking member 740) be in the form of an actuatable locking cleat as disclosed by Graham. Since Houde already teaches a locking wedge having a pinching cleat as an alternative locking embodiment to the locking members 740 (see Fig. 16 and Para. [0056]), one of ordinary skill in the art would have understood that these two configurations were interchangeable with one-another in accomplishing the common task of locking the axial position of the shaft and sheath elements. Since Houde discloses both systems as alternative, interchangeably arrangements with one-another, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Houde would functional equally well with either the current locking members 740 or a wedge-type cleat locking mechanism as disclosed by Graham. The resulting combination would have the cam portion of the locking mechanism extend into the lumen 770 in order to contact shaft 12.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houde (US 2003/0229295 A1) in view Graham (US 9339631 B2), further in view of Melker (US 5431655 A).
Regarding claim 8, the combination of Houde and Graham disclose all of the limitations of the invention of claim 7.
However, while Graham discloses wherein the wedge actuator may include either a lever, button, toggle, switch or knob (see Para. [0036]), Graham does not expressly disclose a shape for the knob embodiment and thus does not expressly disclose wherein the wedge includes a ball (i.e., spherical shape).
In the field of endeavor of medical devices comprising an actuation handle knob configured to be gripped by a user, Melker teaches wherein a knob of a surgical instrument (see Fig. 3 and Abstract) may be in the form of a ball (see Fig. 3 and Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substation for one known actuation knob shape for another (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the actuation knob of the wedge actuator of Graham, as incorporated into the device of Houde, be in the form of a ball as disclosed by Melker. Since none of either Graham or Melker disclose any inherent or specific function to the shape of the respective actuation knobs, one of ordinary skill in the art would have expected the knob of the actuation wedge of Graham to function properly should the shape be modified to that of a ball, with a reasonable expectation of success.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houde (US 2003/0229295 A1) in view of Scopton (US 2007/0293719 A1).
Regarding claim 11, Houde discloses all of the limitations of the invention of claim 10.
However, Houde does not expressly disclose wherein the one or more biasing elements include one or more magnets.
In the same field of endeavor, namely catheter devices comprising a means for clamping and locking an internal wire disposed therein, Scopton teaches wherein a catheter device (see Fig. 1) comprising an internal guidewire within a lumen thereof (guidewire 22, see Figs. 18-19) further comprising a guidewire locking mechanism (see Figs. 18-19) comprised of a plurality of pinching elements (clamping members 852a-852c, see Figs. 18-19) that are configured to, upon actuation, pinch and clamp against the guidewire so as to lock the guidewire in-place at a desired location (see Para. [0062]), wherein the pinching elements may be magnetized to further secure the guidewire (see Para. [0062]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see SR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having collet of the locking member of Houde comprise magnetic functionality as disclosed by Scopton. Since Scopton teaches wherein a magnetized securement and a physical clamping securement are interchangeable securement methods known in the art to secure a guidewire/elongate body, one of ordinary skill in the art would have understood that these two configurations were interchangeable with one-another in accomplishing the common task of locking the axial position of the shaft with a reasonable expectation of success.
Claim(s) 15-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houde (US 2003/0229295 A1) in view of Spenser (US 2018/0280128 A1).
Regarding claim 15, Houde discloses all of the limitations of the invention of claim 1, Houde further discloses wherein the second catheter includes a basket catheter (shaft 12 includes a basket filer 18 at the distal end thereof, see Fig. 1 and Para. [0031]); the basket catheter is received in the locking channel (see Fig. 15) and statically coupled with the lock body (see Para. [0029], [0035] and [0055] mentioning wherein the splitter, is configured to axially lock either the shaft 12 or sheath 14 thereto, which would lock either shaft 12 and/or sheath 14 statically with the splitter).
However, Houde does not expressly disclose
wherein the first catheter includes a procedural guidewire;
in a locked configuration, the procedural guidewire is received in the system channel; and
wherein movement of the lock body correspondingly moves the basket catheter relative to the procedural guidewire.
In the same field of endeavor, namely nested multi-catheter medical devices axially aligned with one-another within an outer tubular member, Spenser teaches a catheter device (see Fig. 1A) comprising a first catheter (locking tube 110, see Fig. 1A) and a second catheter (actuator tube 140, see Fig. 1A); wherein the second catheter is disposed within a lumen of the first catheter (see Fig. 1A) during navigation to a surgical site (see Fig. 1A and Para. [0105]-[0108]); the first catheter comprising a guidewire extending through a lumen thereof (guidewire 10, see Fig. 1A) and alongside the second catheter within the lumen of the first catheter (see Fig. 1A) to guide the first catheter along a length thereof to a target surgical site (see Para. [105]-[0108]).
Since Houde discloses wherein the second catheter is disposed within a lumen of the first catheter (see Fig. 1), similar to the configuration disclosed by Spenser, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the sheath 14 of Houde to comprise a guidewire extending within and along the lumen thereof as taught and suggested by Spenser to, in this case, provide a guidewire to navigate the sheath of Houde along an insertion path during navigation to a surgical site (see Spenser Para. [0105]-[0108]). In the resulting configuration, since Houde discloses wherein the splitter can selectively couple to and lock either shaft 12 or sheath 14 thereto (see Houde Para. [0029]), when the shaft 12 is locked by the splitter while the sheath 14 and corresponding guidewire disposed therein are free, movement of the splitter (i.e., the elongate tubular body of the device) correspondingly moves the shaft 12 therewith, while guidewire may remain stationary if held by a user.
Regarding claim 16, the combination of Houde and Spenser disclose the invention of claim 15, Houde, as modified by Spenser, further disclose a retrieval catheter (guide catheter 13, see Fig. 1) coupled with the locking mechanism (see Figs. 1 and 15; the locking mechanism is attached to the proximal end of the guide catheter), the procedural guidewire and basket catheter extend through the retrieval catheter (sheath 14, shaft 12 and the guidewire, as incorporated from Spenser, all extend through the outer guide catheter as shown in Houde Fig. 1); and in the locked configuration, movement of the lock body correspondingly moves the retrieval catheter and basket catheter relative to the procedural guidewire. Since Houde discloses wherein the splitter can selectively couple to and lock either shaft 12 or sheath 14 thereto (see Houde Para. [0029]), when the shaft 12 is locked by the splitter while the sheath 14 and corresponding guidewire disposed therein are free, movement of the splitter (i.e., the elongate tubular body 13 of the device) correspondingly moves the shaft 12 and outer catheter 13 therewith, while guidewire and sheath 14 may remain stationary if held by a user.
Regarding claim 19, Houde discloses all of the limitations of the invention of claim 17, Houde further discloses wherein the second catheter includes a basket catheter (shaft 12 includes a basket filer 18 at the distal end thereof, see Fig. 1 and Para. [0031]); the basket catheter is received in the locking channel (see Fig. 15) and statically coupled with the lock body (see Para. [0029], [0035] and [0055] mentioning wherein locking member 740 (as a part of the locking assembly comprising the splitter), is configured to axially lock either the shaft 12 or sheath 14, which would lock either shaft 12 or sheath 14 statically with the splitter).
However, Houde does not expressly disclose
wherein the first catheter includes a procedural guidewire;
in a locked configuration, the procedural guidewire is received in the system channel; and
wherein movement of the lock body correspondingly moves the basket catheter relative to the procedural guidewire.
In the same field of endeavor, namely nested multi-catheter medical devices axially aligned with one-another within an outer tubular member, Spenser teaches a catheter device (see Fig. 1A) comprising a first catheter (locking tube 110, see Fig. 1A) and a second catheter (actuator tube 140, see Fig. 1A); wherein the second catheter is disposed within a lumen of the first catheter (see Fig. 1A) during navigation to a surgical site (see Fig. 1A and Para. [0105]-[0108]); the first catheter comprising a guidewire extending through a lumen thereof (guidewire 10, see Fig. 1A) and alongside the second catheter within the lumen of the first catheter (see Fig. 1A) to guide the first catheter along a length thereof to a target surgical site (see Para. [105]-[0108]).
Since Houde discloses wherein the second catheter is disposed within a lumen of the first catheter (see Fig. 1), similar to the configuration disclosed by Spenser, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the sheath 14 of Houde to comprise a guidewire extending within and along the lumen thereof as taught and suggested by Spenser to, in this case, provide a guidewire to navigate the sheath of Houde along an insertion path during navigation to a surgical site (see Spenser Para. [0105]-[0108]). In the resulting configuration, since Houde discloses wherein the splitter can selectively couple to and lock either shaft 12 or sheath 14 thereto (see Houde Para. [0029]), when the shaft 12 is locked by the splitter while the sheath 14 and corresponding guidewire disposed therein are free, movement of the splitter (i.e., the elongate tubular body of the device) correspondingly moves the shaft 12 therewith, while guidewire may remain stationary if held by a user.
Regarding claim 20, the combination of Houde and Spenser disclose the invention of claim 19, Houde, as modified by Spenser, further disclose a retrieval catheter (guide catheter 13, see Fig. 1) coupled with the locking mechanism (see Figs. 1 and 15; the locking mechanism is attached to the proximal end of the guide catheter), the procedural guidewire and basket catheter extend through the retrieval catheter (sheath 14, shaft 12 and the guidewire, as incorporated from Spenser, all extend through the outer guide catheter as shown in Houde Fig. 1); and in the locked configuration, movement of the lock body correspondingly moves the retrieval catheter and basket catheter relative to the procedural guidewire. Since Houde discloses wherein the splitter can selectively couple to and lock either shaft 12 or sheath 14 thereto (see Houde Para. [0029]), when the shaft 12 is locked by the splitter while the sheath 14 and corresponding guidewire disposed therein are free, movement of the splitter (i.e., the elongate tubular body 13 of the device) correspondingly moves the shaft 12 and outer catheter 13 therewith, while guidewire and sheath 14 may remain stationary if held by a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2017/0348019 A1 to Nakano, US 2020/0001055 A1 to Pigott, US 2014/0277564 A1 to Windheuser, US 2019/0069973 A1 to Isaacson, US 2017/0259043 A1 to Chan, US 2019/0307483 A1 to Flury, US 2015/0359487 A1 to Coulombe, US 2017/0259048 A1 to Matlock, US 2014/0379006 A1 to Sutherland, US 2023/0309878 A1 to Burkholz and US 2023/0309877 A1 to Harding all disclose catheter devices comprising one or more catheters and an associated locking mechanism for locking one or more catheters in a relative axial location.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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