DETAILED ACTION
Claims 13 and 19 are amended. Claim 18 is cancelled. Claims 25 & 26 are newly added claims. A complete action on the merits of pending claims 13-17, 19, and 21-26 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 02/05/2026. With regards to the 35 USC 112(a) rejection documented in the Non-Final Office Action sent on 11/20/2025, it is overcome through applicant’s amendment to claim 13 and is withdrawn.
Claim Rejections - 35 USC § 103
Claim(s) 13-17 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bardsley (US PGPUB No. 2020/0229957 A1), in view of Wensel (US Patent No. 5895398 A).
Regarding claim 13, Bardsley discloses, implant delivery systems and devices that provide a rapid release of the implant at a desired implantation location. Bardsley teaches, a system (Figure 1, delivery system (10); Paragraph [0048]) for implanting a medical implant (Figure 3, coil implant (80); Paragraph [0058]) in a human or animal body (Paragraph [0047]), comprising:
a wire element (Figures 1 and 14, engagement wire (40)) for connecting the system to the medical implant (Paragraphs [0048] and [0088]-[0089]);
a guide tube (Figure 1 and 14, implant pusher shaft (20)) for the wire element (Paragraph [0048]), wherein the guide tube comprises an internal tube element (Figures 1 and 14, the internal wall forming/comprising lumen (22) under the Broadest Reasonable Interpretation (BRI) as best understood by a person of ordinary skill in the art is considered an “internal tube element”) forming a lumen of the guide tube (Figures 1 and 14, axial lumen (22); Paragraph [0048]); and
a handle (Figure 1, control mechanism (30)) for handling the system (Paragraphs [0048] and [0054]-[0055]);
wherein the medical implant (coil implant (80)) is arranged at a proximal end (Figure 1, distal end (26); Paragraph [0048]) of the guide tube (Figure 14) and the handle (control mechanism (30)) is arranged at a distal end (Figure 1, proximal end (24); Paragraph [0048]) of the guide tube (Figure 1; Paragraph [0054]),
wherein the wire element (wire (40)) is fixed with a first end (Figure 1, proximal end (44)) to the handle (Paragraph [0055]),
wherein a second end (Figure 1 or 14, distal end (46) or free end (202)) of the wire element (wire (40)) is guided through the lumen (axial lumen (22); Paragraph [0048]) of the guide tube (shaft (20)) to exit the proximal end (distal end (26)) thereof (Paragraph [0048], discloses, “… the implant engagement wire (40) is slidably disposed within the axial lumen (22) of the implant pusher shaft (20). According to one embodiment of present teachings, the implant engagement wire (40) is configured to extend distally or retract proximally independent of the implant pusher shaft (20).” As such it is fully capable of extending to exit distal end (26) of shaft (20)), wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) passes through an eyelet or loop (Figures 3 and 14, engagement loop (92); Paragraph [0058] and [0089]) of the medical implant (implant (80)) and is guided back through the lumen (axial lumen (22)) of the guide tube (shaft (20)) to the handle (control mechanism (30)) to form an exposed loop at the proximal end (distal end (26)) of the guide tube (shaft (20)) (Figure 14; Paragraph [0089]; As previously stated engagement wire (40) is fully capable of extending to exit distal end (26) of shaft (20), such that when it loops back it is indeed forming an exposed loop at distal end (26) of shaft (20)), and
wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) is detachably fixed to the handle (control mechanism (30); Paragraph [0089]).
Bardsley fails to teach, a double-lumen guide tube for the wire element, wherein the double-lumen guide tube comprises two internal tube elements forming a first lumen and a second lumen of the double-lumen guide tube; and wherein the second end of the wire element is guided back through the second lumen adjacent the first lumen of the double-lumen guide tube to the handle, as Bardsley discloses only a single 'axial lumen' (22) within the implant pusher shaft (20) through which the wire passes and returns.
Wensel discloses, a double lumen catheter. Wensel teaches, a double-lumen guide tube (Figure 9, double lumen catheter (56); Col. 6, line 10-12) for a wire element (Figure 9, insertion mandrel (16 and 16’)), wherein the double-lumen guide tube comprises two internal tube elements forming a first lumen and a second lumen of the double-lumen guide tube (Figure 9, lumens (58 and 60); Where the internal walls forming the lumen (58 & 60) are considered to be ‘internal tube elements’ under the Broadest Reasonable Interpretation (BRI) as best understood by a person of ordinary skill in the art) (Col. 6, line 12-14. Further, Col. 6, line 10-26, disclose, the "double lumen catheter" with two lumens (58 and 60), and states that the "lumens (58 and 60) each receive an insertion mandrel (16 and 16' )”. The reference further discloses that "as the helixes are withdrawn into the catheter, each one straightens out and is kept separate within the respective lumens").
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as both references and the claimed invention are directed to delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires.
Regarding claim 14, Bardsley further teaches, wherein the wire element (wire (40)) is made of a metal (Paragraph [0056]).
Regarding claim 15, Bardsley further teaches, wherein the wire element (wire (40)) has a diameter of 0.1 mm to 0.5 mm (Paragraph [0056], discloses, “In some embodiments, the implant engagement wire (40) has a general diameter between 0.001″ and 0.005″.” Converted to mm, 0.005in would equal to 0.127mm which falls within the claimed range of 0.1mm to 0.5mm).
Regarding claim 16, Bardsley further teaches, wherein the guide tube (implant pusher shaft (20)) is at least partially made of a plastic (Paragraph [0052]).
Bardsley fails to teach, the guide tube as a double-lumen guide tube.
Wensel teaches, the double-lumen guide tube (double lumen catheter (56)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as both references and the claimed invention are directed to delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires.
Regarding claim 17, Bardsley teaches, the guide tube (implant pusher shaft (20)).
Bardsley fails to teach, wherein the double-lumen guide tube has a diameter of 1.0 mm to 2.0 mm.
Wensel teaches, wherein the double-lumen guide tube (double lumen catheter (56)) has a diameter of 1.0 mm to 2.0 mm (Col. 4, line 7-9, discloses, “The outer diameter of the catheter can also vary. Typically the outer diameter will range from about 2 to about 10 French (one French=0.013 inch).” As such, diameters between 3 Fr and 6 Fr (inclusive) would fall within the claimed 1 mm to 2 mm range).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel which has a diameter of 1.0 mm to 2.0 mm to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as both references and the claimed invention are directed to delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel which has a diameter of 1.0 mm to 2.0 mm to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires.
Regarding claim 24, Bardsley teaches, further comprising an implantation catheter for guiding the guide tube (implant pusher shaft (20)) and the medical implant (coil implant (80)) connected thereto to an implantation site in the human or animal body (Paragraph [0223]).
Bardsley fails to teach, the guide tube as a double-lumen guide tube.
Wensel teaches, the double-lumen guide tube (double lumen catheter (56)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as both references and the claimed invention are directed to delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires.
Claim(s) 21-23 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bardsley, in view of Wensel, and further in view of Mody (US Patent No. 6454740 B1).
Regarding claim 21, Bardsley teaches, the first end (proximal end (44)) of the wire element (wire (40)) is fixed to the handle (control mechanism (30); Paragraph [0055]).
Bardsley fails to teach, wherein the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle.
Wensel teaches, aspects of the system according to claim 13 (See above rejection of claim 13).
Mody discloses a catheter having a loop-back wire design. Mody teaches, a wire element (Figure 2, thread (60)) that loops back and is guided through a lumen of the guide tube (Figure 2, tubular member (14)) back to the handle (Figure 2, hub (12)) and is detachably fixed to the handle with a second end (Figure 2, pulling end (64)) (Col. 4, line 38-57). Mody further teaches, a first end (Figures 1-2, fixed end (62)) of the wire element (thread (60)) comprises a nipple (As seen in Figure 2, fixed end (62) is protruding out of hub (12) thus it is indeed a “nipple” which is interpreted as a rounded or cylindrical projection) fixable in a corresponding recess of the handle (As seen in Figure 2 and disclosed in Col. 4, line 43-45, “In any event, the thread (60) has a fixed end (62) which is captured between the body (16) and the collar (22).” Thus, the “nipple” is indeed fixable in a corresponding recess of hub (12)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Bardsley such that the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as all the references and the claimed invention are directed to catheter assemblies to be used within the cavities of the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardsley such that the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as such a modification would have been predictable, namely, to provide secure yet releasable fixation.
Regarding claim 22, Bardsley teaches, the second end (free end (202)) of the wire element (wire (40)) releasably fixed to the handle (control mechanism (30); Paragraphs [0089]-[0090]).
Bardsley fails to teach, wherein the handle comprises a clamp for the second end of the wire element, for releasably fixing the second end of the wire element to the handle.
Wensel teaches, aspects of the system according to claim 13 (See above rejection of claim 13).
Mody teaches, the handle (hub (12)) comprises a clamp (Figure 2, pivotable locking member (24); Col. 3, line 62) for the second end (pulling end (64)) of the wire element (thread (60)), for releasably fixing the second end (pulling end (64)) of the wire element (thread (60)) to the handle (hub (12)) (Col. 3, line 8-11 and Col. 4, line 38-57).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Bardsley such that the handle comprises a clamp for the second end of the wire element, for releasably fixing the second end of the wire element to the handle as taught by Mody, as all the references and the claimed invention are directed to catheter assemblies to be used within the cavities of the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardsley such that the handle comprises a clamp for the second end of the wire element, for releasably fixing the second end of the wire element to the handle as taught by Mody, as such a modification would have been predictable, namely, providing the same controlled implant release function.
Regarding claim 23, Bardsley teaches, aspects of the system according to claim 22 (See above rejection of claim 22).
Bardsley fails to teach, wherein the clamp comprises a safeguard against unintentional actuation of the clamp.
Wensel teaches, other aspects of the system according to claim 13 (See above rejection of claim 13).
Mody teaches, the clamp (pivotable locking member (24)) comprises a safeguard against unintentional actuation of the clamp (Col. 2, line 24-29, Col. 4, line 54-57, and Col. 5, line 24-31, all disclose a safeguard against unintentional actuation of the pivotable locking member (24)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Eskridge such that the clamp comprises a safeguard against unintentional actuation of the clamp as taught by Bardsley, as all the references and the claimed invention are directed to catheter assemblies to be used within the cavities of the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardsley such that the clamp comprises a safeguard against unintentional actuation of the clamp as taught by Mody, as such a modification would have been predictable, namely, to ensure secure operation and prevent unintended movement unless manually operated.
Regarding claim 25, Bardsley teaches, a system (Figure 1, delivery system (10); Paragraph [0048]) for implanting a medical implant (Figure 3, coil implant (80); Paragraph [0058]) in a human or animal body (Paragraph [0047]), comprising:
a wire element (Figures 1 and 14, engagement wire (40)) for connecting the system to the medical implant (Paragraphs [0048] and [0088]-[0089]);
a guide tube (Figure 1 and 14, implant pusher shaft (20)) for the wire element (Paragraph [0048]); and
a handle (Figure 1, control mechanism (30)) for handling the system (Paragraphs [0048] and [0054]-[0055]);
wherein the medical implant (coil implant (80)) is arranged at a proximal end (Figure 1, distal end (26); Paragraph [0048]) of the guide tube (Figure 14) and the handle (control mechanism (30)) is arranged at a distal end (Figure 1, proximal end (24); Paragraph [0048]) of the guide tube (Figure 1; Paragraph [0054]),
wherein the wire element (wire (40)) is fixed with a first end (Figure 1, proximal end (44)) to the handle (Paragraph [0055]),
wherein a second end (Figure 1 or 14, distal end (46) or free end (202)) of the wire element (wire (40)) is guided through a lumen (Figures 1 and 14, axial lumen (22); Paragraph [0048]) of the guide tube (20) to exit the proximal end (distal end (26)) thereof (Paragraph [0048], discloses, “… the implant engagement wire (40) is slidably disposed within the axial lumen (22) of the implant pusher shaft (20). According to one embodiment of present teachings, the implant engagement wire (40) is configured to extend distally or retract proximally independent of the implant pusher shaft (20).” As such it is fully capable of extending to exit distal end (26) of shaft (20)), wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) passes through an eyelet or loop (Figures 3 and 14, engagement loop (92); Paragraph [0058] and [0089]) of the medical implant (implant (80)) and is guided back through the lumen (axial lumen (22)) of the guide tube (shaft (20)) to the handle (control mechanism (30)) to form an exposed loop at the proximal end (distal end (26)) of the guide tube (shaft (20)) (Figure 14; Paragraph [0089]; As previously stated engagement wire (40) is fully capable of extending to exit distal end (26) of shaft (20), such that when it loops back it is indeed forming an exposed loop at distal end (26) of shaft (20)), and
wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) is detachably fixed to the handle (control mechanism (30); Paragraph [0089]).
Bardsley fails to teach, a double-lumen guide tube for the wire element; and wherein the second end of the wire element is guided back through a second lumen adjacent the first lumen of the double-lumen guide tube to the handle, as Bardsley discloses only a single 'axial lumen' (22) within the implant pusher shaft (20) through which the wire passes and returns; and wherein the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle.
Wensel teaches, a double-lumen guide tube (Figure 9, double lumen catheter (56); Col. 6, line 10-12) for the wire element (Figure 9, insertion mandrel (16 and 16’); Col. 6, line 12-14. Further, Col. 6, line 10-26, disclose, the "double lumen catheter" with two lumens (58 and 60), and states that the "lumens (58 and 60) each receive an insertion mandrel (16 and 16' )”. The reference further discloses that "as the helixes are withdrawn into the catheter, each one straightens out and is kept separate within the respective lumens").
Mody teaches, a wire element (Figure 2, thread (60)) that loops back and is guided through a lumen of the guide tube (Figure 2, tubular member (14)) back to the handle (Figure 2, hub (12)) and is detachably fixed to the handle with a second end (Figure 2, pulling end (64)) (Col. 4, line 38-57). Mody further teaches, a first end (Figures 1-2, fixed end (62)) of the wire element (thread (60)) comprises a nipple (As seen in Figure 2, fixed end (62) is protruding out of hub (12) thus it is indeed a “nipple” which is interpreted as a rounded or cylindrical projection) fixable in a corresponding recess of the handle (As seen in Figure 2 and disclosed in Col. 4, line 43-45, “In any event, the thread (60) has a fixed end (62) which is captured between the body (16) and the collar (22).” Thus, the “nipple” is indeed fixable in a corresponding recess of hub (12)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, where the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as all the references and the claimed invention are directed to catheter assemblies to be used within the cavities of the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, where the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires. Furthermore, to provide secure yet releasable fixation.
Regarding claim 26, Bardsley teaches, a system (Figure 1, delivery system (10); Paragraph [0048]) for implanting a medical implant (Figure 3, coil implant (80); Paragraph [0058]) in a human or animal body (Paragraph [0047]), comprising:
a wire element (Figures 1 and 14, engagement wire (40)) for connecting the system to the medical implant (Paragraphs [0048] and [0088]-[0089]);
a guide tube (Figure 1 and 14, implant pusher shaft (20)) for the wire element (Paragraph [0048]), wherein the guide tube comprises an internal tube element (Figures 1 and 14, the internal wall forming/comprising lumen (22) under the Broadest Reasonable Interpretation (BRI) as best understood by a person of ordinary skill in the art is considered an “internal tube element”) forming a lumen of the guide tube (Figures 1 and 14, axial lumen (22); Paragraph [0048]); and
a handle (Figure 1, control mechanism (30)) for handling the system (Paragraphs [0048] and [0054]-[0055]);
wherein the medical implant (coil implant (80)) is arranged at a proximal end (Figure 1, distal end (26); Paragraph [0048]) of the guide tube (Figure 14) and the handle (control mechanism (30)) is arranged at a distal end (Figure 1, proximal end (24); Paragraph [0048]) of the guide tube (Figure 1; Paragraph [0054]),
wherein the wire element (wire (40)) is fixed with a first end (Figure 1, proximal end (44)) to the handle (Paragraph [0055]),
wherein a second end (Figure 1 or 14, distal end (46) or free end (202)) of the wire element (wire (40)) is guided through the lumen (axial lumen (22); Paragraph [0048]) of the guide tube (shaft (20)) to exit the proximal end (distal end (26)) thereof (Paragraph [0048], discloses, “… the implant engagement wire (40) is slidably disposed within the axial lumen (22) of the implant pusher shaft (20). According to one embodiment of present teachings, the implant engagement wire (40) is configured to extend distally or retract proximally independent of the implant pusher shaft (20).” As such it is fully capable of extending to exit distal end (26) of shaft (20)), wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) passes through an eyelet or loop (Figures 3 and 14, engagement loop (92); Paragraph [0058] and [0089]) of the medical implant (implant (80)) and is guided back through the lumen (axial lumen (22)) of the guide tube (shaft (20)) to the handle (control mechanism (30)) to form an exposed loop at the proximal end (distal end (26)) of the guide tube (shaft (20)) (Figure 14; Paragraph [0089]; As previously stated engagement wire (40) is fully capable of extending to exit distal end (26) of shaft (20), such that when it loops back it is indeed forming an exposed loop at distal end (26) of shaft (20)), and
wherein the second end (distal end (46) or free end (202)) of the wire element (wire (40)) is detachably fixed to the handle (control mechanism (30); Paragraph [0089]).
Bardsley fails to teach, a double-lumen guide tube for the wire element, wherein the double-lumen guide tube comprises two internal tube elements forming a first lumen and a second lumen of the double-lumen guide tube; wherein the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle; and wherein the second end of the wire element is guided back through the second lumen adjacent the first lumen of the double-lumen guide tube to the handle, as Bardsley discloses only a single 'axial lumen' (22) within the implant pusher shaft (20) through which the wire passes and returns.
Wensel teaches, a double-lumen guide tube (Figure 9, double lumen catheter (56); Col. 6, line 10-12) for a wire element (Figure 9, insertion mandrel (16 and 16’)), wherein the double-lumen guide tube comprises two internal tube elements forming a first lumen and a second lumen of the double-lumen guide tube (Figure 9, lumens (58 and 60); Where the internal walls forming the lumen (58 & 60) are considered to be ‘internal tube elements’ under the Broadest Reasonable Interpretation (BRI) as best understood by a person of ordinary skill in the art) (Col. 6, line 12-14. Further, Col. 6, line 10-26, disclose, the "double lumen catheter" with two lumens (58 and 60), and states that the "lumens (58 and 60) each receive an insertion mandrel (16 and 16' )”. The reference further discloses that "as the helixes are withdrawn into the catheter, each one straightens out and is kept separate within the respective lumens").
Mody teaches, a wire element (Figure 2, thread (60)) that loops back and is guided through a lumen of the guide tube (Figure 2, tubular member (14)) back to the handle (Figure 2, hub (12)) and is detachably fixed to the handle with a second end (Figure 2, pulling end (64)) (Col. 4, line 38-57). Mody further teaches, a first end (Figures 1-2, fixed end (62)) of the wire element (thread (60)) comprises a nipple (As seen in Figure 2, fixed end (62) is protruding out of hub (12) thus it is indeed a “nipple” which is interpreted as a rounded or cylindrical projection) fixable in a corresponding recess of the handle (As seen in Figure 2 and disclosed in Col. 4, line 43-45, “In any event, the thread (60) has a fixed end (62) which is captured between the body (16) and the collar (22).” Thus, the “nipple” is indeed fixable in a corresponding recess of hub (12)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, where the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as all the references and the claimed invention are directed to catheter assemblies to be used within the cavities of the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single lumen "implant pusher shaft" of Bardsley with the "double lumen catheter" of Wensel to use one of the two lumens of the guide tube to guide one end of the wire element to pass one end of the wire element through the implant's loop and guide it back through the second lumen to detachably fix the second end of the wire element to the handle to facilitate the release of the implant after deployment, where the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle as taught by Mody, as such a modification would have been predictable, namely, to prevent the wire from twisting and maintain the relative spatial relationship of the wires. Furthermore, to provide secure yet releasable fixation.
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 19 is allowable over the prior art of record. The prior art of record does not teach or suggest, nor would it have been obvious to a person of ordinary skill in the art, to modify the double-lumen guide tube of the Bardsley/Wensel combination such that “the two internal tube elements are each formed as a stainless steel helix,” as recited in claim 19.
While Duncan (US 2010/0137928 A1) discloses the use of a noble metal coil in the context of an electrophysiology lead, there is no reasonable motivation to incorporate stainless steel helical tube elements as the internal structures forming the two lumens of the guide tube in the device taught by Bardsley as modified by Wensel. The teachings of Duncan are directed to a fundamentally different structure and purpose (electrical conduction and insulation in an implantable lead), and a person of ordinary skill would not have been motivated to apply Duncan’s coil construction to the double-lumen guide tube of the claimed delivery/retrieval system without the benefit of impermissible hindsight.
Thus, dependent claim 19 contains allowable subject matter that distinguishes over the prior art of record.
Response to Arguments
Applicant's arguments filed on 02/05/2026 have been fully considered but they are not persuasive.
Applicant argues that the combination of Bardsley and Wensel fails to teach “the double-lumen guide tube comprises two internal tube elements forming a first lumen and a second lumen of the double-lumen guide tube.”
After consultation with the Primary Examiner Mohamed Gabr, the rejection of claim 13 is maintained. Under the broadest reasonable interpretation (BRI) consistent with the specification and in view of the understanding of a person of ordinary skill in the art, the claim language “two internal tube elements forming a first lumen and a second lumen” is reasonably interpreted as the structural walls that define and separate the two lumens within the double-lumen guide tube.
Wensel teaches a double-lumen guide tube (see Figure 9 and associated cited text as in the rejection above) having two internal lumens separated by a common wall, wherein each lumen is formed by its respective surrounding tube wall structure. This meets the claimed limitation under the broadest reasonable interpretation (BRI).
Accordingly, reliance on Duncan is not necessary. The rejection has been updated to reflect that Wensel alone teaches this feature in combination with Bardsley. The rejection of claims 13 under 35 U.S.C. 103 over Bardsley in view of Wensel is therefore maintained.
Applicant argues that Mody does not/fails to teach “the first end of the wire element comprises a nipple fixable in a corresponding recess of the handle.”
The Examiner disagrees. Under the broadest reasonable interpretation (BRI) consistent with the specification and as understood by a person of ordinary skill in the art, the term “nipple” is reasonably interpreted as a projecting or protruding end portion of the wire/thread, and a “corresponding recess” encompasses a space or cavity configured to receive and retain that end.
Mody clearly discloses a first end (fixed end (62)) of the thread (60) that is captured and fixed within the hub (12). Specifically, Mody states: “the thread (60) has a fixed end (62) which is captured between the body (16) and the collar (22)” (see also Figures 1–3 and Col. 4, lines 40–50). When the collar (22) is threaded onto the body (16), the fixed end (62) is securely received and retained in the interface space formed between these two hub components. This interface functions as the corresponding recess that fixes the protruding fixed end (62) in position.
Applicant’s argument that no “specific structure” is required is unpersuasive. The claim does not recite any particular shape, enlargement, or additional feature for the “nipple” beyond it being fixable in a corresponding recess. Mody’s captured fixed end satisfies the limitation under the broadest reasonable interpretation (BRI).
Accordingly, the combination of Bardsley, in view of Wensel, and further in view of Mody teaches all the recited limitations of newly added claims 25 and 26.
See updated rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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