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 December 31st, 2025, have been entered. Claims 1-6, 18, and 21-32 remain pending in the Application. Claims 9-17 and 19-20 have been canceled by the Applicant. Claims 21-32 have been added by the Applicant. The claim amendments overcome the previous claim objections and some of the 112(b) rejections.
Response to Arguments
The rejection of claims 1-6 and 18 under 102(a)(1) and 103 over Nguyen et al. (Pub. No. 2020/0390456) in view of Cabiri (Pub. No. 2013/0304034) and Davis et al. (Pub. No. 2016/0089170) has been withdrawn in light of Applicant’s amendments made December 31st, 2025; specifically, none of the cited references disclose advancing movements of the control wire cause the basket tip to advance away from a distal end of the steerable sheath, while the plurality of wires, trailing behind the basket tip, project out of the distal end of the steerable sheath and expand.
Applicant’s arguments with respect to claim(s) 1-6, 18, and 21-32 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the steerable tool" in line 16. There is insufficient antecedent basis for this limitation in the claim. No steerable tool has been previously introduced in the claim, though a steerable sheath was previously introduced in line 2. Applicant should amend line 16 to “the steerable sheath” or otherwise correct the antecedent basis. For the purposes of examination, that interpretation will be used. Claims 2-6 and 21-23 are rejected for their dependency on claim 1.
Claim Rejections - 35 USC § 102
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) 18 and 24-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avellanet (U.S. Patent No. 6,264,664).
Regarding claim 18, Avellanet discloses an endoscopic apparatus (10; FIGs. 1-3b), comprising:
a steerable sheath (20) that is actuable to form a bend (FIG. 1: 20 can bend);
a control wire (14) disposed within the steerable sheath (FIG. 2: 14 is within 20) and movable therein along a longitudinal axis of the steerable sheath (FIGs. 2-3: 14 moves within 20 in a longitudinal direction); and
a basket (16) disposed on the control wire and positioned at least partially within the steerable sheath (FIG. 2: 16 is attached to 14 and is positioned within 20 during delivery), the basket including a basket tip (61) and a plurality of wires (28) that each have a pre-formed curvature (C5:L59-C6:L14: 28 are made from shape memory materials to have a pre-formed shape which is achieved when 16 is moved out of 20),
wherein the plurality of wires are coupled at their distal ends to the basket tip (FIG. 2: 28 are coupled distally within 61) and are coupled at their proximal ends to a distal end of the control wire (FIG. 2: 28 are coupled proximally to the distal end of 14),
wherein advancing movements of the control wire cause the basket tip to advance away from a distal end of the steerable sheath, while the plurality of wires, trailing behind the basket tip, project out of the distal end of the steerable sheath and expand (FIGs. 2-3 and C5:L59-C6:L14: 61 is advanced out of 20 by advancement of 14, which deploys 28 out of the distal end of 20 and allows 28 to expand to the basket shape),
wherein retreating movements of the control wire cause the basket to retract into the distal end of the steerable sheath and contract (FIGs. 3a-b and C6L10-14: when 14 is retracted, 16 compresses into a contracted delivery shape), and
wherein the basket is shaped to retain an object between the plurality of wires when the basket is contracted (C4:L54-58: 16 can be retracted to retain calculi 42 for removal from the body).
Regarding claim 24, Avellanet further discloses a basket tip member (66) disposed on the basket tip (FIG. 2: 66 is on the tip of 61), wherein the plurality of wires are attached at their distal ends to the basket tip member (FIG. 2: 28 are attached to 61).
Regarding claim 25, Avellanet further discloses the basket tip member is a cylindrical member (FIG. 2: 66 is cylindrical).
Regarding claim 26, Avellanet further discloses the basket tip member is a joining disc (C6:L35-45: 66 can be a crimp band welded to 28, which forms a joining disc).
Regarding claim 27, Avellanet further discloses when the basket tip is retracted, the basket tip member is retracted towards the distal end of the steerable sheath until the basket tip member makes contact with the distal end of the steerable sheath (FIGs. 2-3: 61 can be retracted into 20, which will bring 66 in contact with 32).
Regarding claim 28, Avellanet further discloses when the basket is retracted, the plurality of wires are withdrawn into the steerable sheath while the basket tip, trailing behind the plurality of wires, is retracted towards the distal end of the steerable sheath (FIGs. 2-3: as 16 is retracted, 28 are retracted into 20 before 66 is retracted towards 32).
Regarding claim 29, Avellanet discloses an endoscopic apparatus (10; FIGs. 1-3b), comprising:
a steerable sheath (20) that is actuable to form a bend (FIG. 1: 20 can bend);
a control wire (14) disposed within the steerable sheath (FIG. 2: 14 is within 20) and movable therein along a longitudinal axis of the steerable sheath (FIGs. 2-3: 14 moves within 20 in a longitudinal direction); and
a basket (16) disposed on a distal end of the control wire and positioned at least partially within the steerable sheath (FIG. 2: 16 is attached to the distal end of 14 and is positioned within 20 during delivery), the basket including a basket tube (FIG. 2: the body of 16 including 28 and 61), the basket tube having a cylindrical basket tip (61) and a plurality of linear slots (FIG. 2: the spaces between 28) forming a plurality of spines (28) extending axially along a length of the basket tube (FIG. 2: 28 extend along the length of the body of 16), the plurality of spines coupled at their distal ends to the cylindrical basket tip (FIG. 2: 28 are coupled proximally to the distal end of 14),
wherein advancing movements of the control wire cause the basket to project out of the distal end of the steerable sheath and expand (FIGs. 2-3 and C5:L59-C6:L14: 61 is advanced out of 20 by advancement of 14, which deploys 28 out of the distal end of 20 and allows 28 to expand to the basket shape), and
wherein retreating movements of the control wire cause the basket to retract into the distal end of the steerable sheath and contract (FIGs. 3a-b and C6L10-14: when 14 is retracted, 16 compresses into a contracted delivery shape).
Regarding claim 30, Avellanet further discloses the basket is shaped to retain an object between the plurality of spines when the basket is contracted (C4:L54-58: 16 can be retracted to retain calculi 42 for removal from the body).
Regarding claim 31, Avellanet further discloses the basket projecting out of the distal end of the steerable sheath and expanding includes the cylindrical basket tip to advancing away from a distal end of the steerable sheath, while the plurality of spines, trailing behind the cylindrical basket tip, project out of the distal end of the steerable sheath and expand (FIGs. 2-3 and C5:L59-C6:L14: 61 is advanced out of 20 by advancement of 14, which deploys 28 out of the distal end of 20 and allows 28 to expand to the basket shape).
Regarding claim 32, Avellanet further discloses when the basket is retracted, the plurality of spines are withdrawn into the steerable sheath while the cylindrical basket tip, trailing behind the plurality of spines, is retracted towards the distal end of the steerable sheath (FIGs. 2-3: as 16 is retracted, 28 are retracted into 20 before 66 is retracted towards 32).
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) 1-6 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet in view of Cabiri (Pub. No. 2013/0304034).
Regarding claim 1, Avellanet discloses an endoscopic apparatus (10; FIGs. 1-3b), comprising:
a steerable sheath (20) including a first flexible tube (34) concentrically nested within a second flexible tube (36);
a control wire (14) disposed within the steerable sheath (FIG. 2: 14 is within 20) and movable therein along a longitudinal axis of the steerable sheath (FIGs. 2-3: 14 moves within 20 in a longitudinal direction); and
a basket (16) disposed on a distal end of the control wire (32) and positioned at least partially within the steerable sheath (FIG. 2: 16 is attached to 14 and is positioned within 20 during delivery), the basket including a basket tip (61) and a plurality of wires (28) coupled at their distal ends to the basket tip (FIG. 2: the distal ends of 28 are coupled at 61),
wherein the steerable sheath is actuable to form a bend (FIG. 1: 20 can form a bend),
wherein the plurality of wires are coupled at their distal ends to the basket tip (FIG. 2: 28 are coupled distally within 61) and are coupled at their proximal ends to a distal end of the control wire (FIG. 2: 28 are coupled proximally to the distal end of 14),
wherein advancing movements of the control wire cause the basket tip to advance away from a distal end of the steerable sheath, while the plurality of wires, trailing behind the basket tip, project out of the distal end of the steerable sheath and expand (FIGs. 2-3 and C5:L59-C6:L14: 61 is advanced out of 20 by advancement of 14, which deploys 28 out of the distal end of 20 and allows 28 to expand to the basket shape),
wherein retreating movements of the control wire cause the basket to retract into the distal end of the steerable sheath and contract (FIGs. 3a-b and C6L10-14: when 14 is retracted, 16 compresses into a contracted delivery shape), and
wherein the basket is shaped to retain an object between the plurality of wires when the basket is contracted (C4:L54-58: 16 can be retracted to retain calculi 42 for removal from the body).
Avellanet does not disclose the first flexible tube includes a first deflectable portion, the second flexible tube includes a second deflectable portion, the first and second deflectable portions being selectively weakened portions of the first and second flexible tubes that are angularly oriented, relative to the longitudinal axis in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees, the first and second flexible tubes are joined at a location distal to the first and second deflectable portions, and the steerable sheath is actuable to form a bend by relative axial translation between the first flexible tube and the second flexible tube.
Cabiri teaches in the same field of endeavor of steerable tools (Abstract) and discloses a steerable sheath (10; [0022]; FIGs. 1A-1C) comprising a first flexible tube (12) and a second flexible tube (14), where the first flexible tube includes a first deflectable portion (FIG. 1A: distal portion of 12 with slots 16), the second flexible tube includes a second deflectable portion (FIG. 1B: distal portion of 14 with slots 16), the first and second deflectable portions being selectively weakened portions of the first and second flexible tubes ([0022] 12 and 14 have slots 16, which are selectively weakened compared to the portions without slots; FIGs. 1A-1C) that are angularly oriented, relative to a longitudinal axis of the steerable sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees ([0028] the open ends 18 of the slots 16 are oriented in opposite directions at an angle of approximately 180 degrees), wherein the first and second flexible tubes are joined at a location distal to the first and second deflectable portions ([0022] 12D is fixedly joined to 14D; FIG. 1C) and the steerable sheath is actuable to form a bend by relative axial translation between the first flexible tube and the second flexible tube (FIGS. 1A-1C: 10 bends by relative axial translation between 12 and 14) for the purpose of selectively increasing the flexibility of the distal end to improve steerability and controlled manipulation of the tubes ([0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the flexible tubes of Avellanet to have deflectable portions made of selectively weakened portions that are angularly oriented in offset directions, as taught by Cabiri, for the purpose of selectively increasing the flexibility of the distal end to improve steerability and controlled manipulation of the tubes.
Regarding claim 2, Avellanet as modified by Cabiri further discloses the first and second deflectable portions each include a serpentine profile of material removed from the first and second flexible tubes (Cabiri [0028] the slots can be shaped differently to provide bending in three dimensions, which would create a serpentine pattern in the open ends 18).
Regarding claim 3, Avellanet as modified by Cabiri further discloses the first and second deflectable portions each include a series of cutout sections spaced along the longitudinal axis (Cabiri [0026] the slots are formed by taking material out of 12 and 14 in sections spaced out along 14).
Regarding claim 4, Avellanet as modified by Cabiri further discloses the plurality of wires each have a pre-formed curvature (Avellanet C5:L59-C6:L14: 28 are made from shape memory materials to have a pre-formed shape which is achieved when 16 is moved out of 20) wherein the plurality of wires are coupled to each other at their distal ends (Avellanet FIG. 2: 28 are coupled together distally at 61) and are coupled, at their proximal ends, to a distal end of the control wire (Avellanet FIG. 2: 28 are coupled together proximally at the distal end of 14).
Regarding claim 5, Avellanet as modified by Cabiri further discloses a basket tip member (Avellanet 66) disposed on the basket tip (Avellanet FIG. 2: 66 is on the tip of 61), wherein the plurality of wires are attached at their distal ends to the basket tip member (Avellanet FIG. 2: 28 are attached to 61), and wherein the basket tip member is a cylindrical member (Avellanet FIG. 2: 66 is cylindrical).
Regarding claim 6, Avellanet as modified by Cabiri further discloses a basket tip member (Avellanet 66) disposed on the basket tip (Avellanet FIG. 2: 66 is on the tip of 61), wherein the plurality of wires are attached at their distal ends to the basket tip member (Avellanet FIG. 2: 28 are attached to 61), and the basket tip member is a joining disc (C6:L35-45: 66 can be a crimp band welded to 28, which forms a joining disc).
Regarding claim 21, Avellanet as modified by Cabiri further discloses a basket tip member (Avellanet 66) disposed on the basket tip (Avellanet FIG. 2: 66 is on the tip of 61), wherein the plurality of wires are attached at their distal ends to the basket tip member (Avellanet FIG. 2: 28 are attached to 61).
Regarding claim 22, Avellanet as modified by Cabiri further discloses when the basket tip is retracted, the basket tip member is retracted towards the distal end of the steerable sheath until the basket tip member makes contact with the distal end of the steerable sheath (Avellanet FIGs. 2-3: 61 can be retracted into 20, which will bring 66 in contact with 32).
Regarding claim 23, Avellanet as modified by Cabiri further discloses when the basket is retracted, the plurality of wires are withdrawn into the steerable sheath while the basket tip, trailing behind the plurality of wires, is retracted towards the distal end of the steerable sheath (Avellanet FIGs. 2-3: as 16 is retracted, 28 are retracted into 20 before 66 is retracted towards 32).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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