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 November 19th, 2025, have been entered. Claims 2-18 remain pending in the Application. Claims 1, 19, 35, and 39 have been canceled by the Applicant. The claim amendments overcome the previous claim objection and 112(b) rejection.
Response to Arguments
Applicant's arguments filed November 19th, 2025, have been fully considered but they are not persuasive.
Applicant argues that Kuhn (Pub. No. 2022/0167990) does not disclose the newly added limitation “the pivot aperture…maintain[s] engagement with the first pin after deployment of the distal clip assembly from the proximal delivery catheter” because Kahn discloses the pivot pin 9 pulls out of through-hole 10 when the clamp arms 8a and 8b are closed and released. Examiner respectfully disagrees. The claim language only requires that the pivot aperture is engaged with the first pin after the distal clip assembly is deployed from the proximal delivery catheter, not when the distal clip assembly has been fully released to be within the body. In Kahn FIG. 6, 9 and 10 are still in engagement after 8a and 8b have been closed, which occurs after the distal clip assembly (3) has been pushed out of the proximal delivery catheter (1, 2). Therefore, the pivot pin 9 is still engaged with the pivot aperture 10 after the clamp device 3 has been deployed from the sheath device 2, and Kuhn satisfies the claim language.
Applicant further argues that Kuhn does not disclose a jaw adapter yoke because clamp base 7 is part of clamp housing 6 and is not slidably positioned within the distal clip assembly 3. Examiner respectfully disagrees. First, Examiner described coupling head 11 as being the jaw adapter yoke in claim 1, which was canceled and moved into claim 9. The coupling head 11 slides within the distal clip assembly 3 to allow for disengagement of 2 and 3, as shown in FIGs. 7-8. Second, while 7 was described as being the proximal receiving portion of the jaw adapter yoke, the claim language does not require the proximal receiving portion to specifically be slidably positioned within the distal clip assembly. Since coupling head 11 can be slidably positioned within the distal clip assembly 3 and clamp base 7 does not need to be slidably positioned, Kuhn satisfies the claim language.
Applicant finally argues that Kuhn does not disclose a spring tube between a proximal end of the distal clip assembly and a distal end of the catheter body because sheath 19 and connect tube 20 are not disclosed as having spring portions. Examiner respectfully disagrees. In [0064] of Kuhn, 19 is described as a coiled sheath, where the coils of 19 allow for elastic movement of 19 while the connect tube is rotated in either radial direction through engagement with ring groove 21 and engagement members 22. Therefore, coiled sheath 19 qualifies as a spring tube.
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) 2-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kuhn (Pub. No. 2022/0167990).
Regarding claim 3, Kuhn discloses a device for applying a hemostatic clip assembly ([0057] medical device; FIGs. 1-13), the device comprising:
a proximal delivery catheter (1, 2) including a proximal handle assembly (1) and an elongated catheter body (2) extending distally from the proximal handle assembly (FIG. 1), the elongated catheter body defining a longitudinal axis (FIG. 1: 2 defines a longitudinal axis);
a distal clip assembly (3) removably connected to a distal end of the elongated catheter body ([0069] 3 can be disconnected from 2 by the disconnection of the arms 8a and 8b from the control wire 4, which runs through 2), the distal clip assembly including a distal clip housing (6), a jaw adapter yoke (11) slidably positioned within the distal clip assembly ([0058] 11 slides within 6; FIGs. 7-8), and a jaw assembly (FIG. 1: the jaws 8a and 8b) having a pair of cooperating jaw members (8a, 8b) fixed to the jaw adapter yoke by a first pin (9; FIG. 3), the first pin oriented orthogonally relative to the longitudinal axis (FIG. 3: 9 is orthogonal to the axis defined by 2), wherein the proximal delivery catheter is configured and adapted to transmit linear motion along the longitudinal axis and torsion about the longitudinal axis to at least a portion of the distal clip assembly ([0060] control wire 4 can be moved distally or proximally to move and rotate the clamp arms around 9 to open or close them, and can be rotated to rotate to cause 8a and 8b to rotate), wherein at least one of the jaw members is configured and adapted to rotate about the first pin and to rotate about the longitudinal axis ([0060] the clamp arms rotate about the pivot pin to open or close; the jaws are capable of being rotated around the axis defined by 2 if the device is rotated about 2),
wherein the distal clip assembly includes a second pin (13; [0061]; FIG. 3) connecting between the jaw members and the distal clip housing, wherein each jaw member includes a proximal body portion (FIG. 9: each of 8a and 8b includes a proximal portion containing the connections to 9 and 13) and a distal end effector (FIG. 9: each of 8a and 8b includes a distal jaw), wherein the proximal body portion of each jaw member includes a respective cam slot (12; [0060]) configured and adapted to receive the second pin ([0061] 13 goes within 12; FIG. 13) and a pivot aperture (10; [0059]; FIG. 8) configured and adapted to receive the first pin ([0059] 9 is held by and extends through 10; FIG. 3) and to rotate about the longitudinal axis (FIGs. 3-5: 10 rotates about the longitudinal axis as 8a and 8b rotate on the longitudinal axis), and maintain engagement with the first pin after deployment of the distal clip assembly from the proximal delivery catheter ([0062] the first pin 9 and the pivot aperture 10 remain engaged with each other after the clamp arms 8a and 8b have been closed and deployed out of 1 and 2; FIGs. 1 and 6).
Regarding claim 2, Kuhn discloses the distal clip housing includes a pair of spaced apart arms (14a, 14b; FIG. 11) defining a slot (FIG. 11: the space between 14a and 14b is a slot) configured and adapted to provide clearance for respective proximal portions of the jaw members to rotate relative the first pin ([0061] 14a and 14b hold the guide pin 13 to allow 8a and 8b to rotate relative to 9 for opening and closing).
Regarding claim 4, Kuhn discloses the cam slots are configured and adapted to translate along the second pin to move axially relative to the distal clip housing ([0061] 13 translates within 12 as 4 is pulled in a direction which is along the axis defined by 2 and thereby relative to 6) and to move the jaw members between an open configuration where respective distal tips of the jaw members are moved away from one another ([0061] when 13 is at the most proximal position within 12, 8a and 8b are open; FIG. 3), a closed configuration where the respective distal tips of the jaw members are approximated towards one another to grasp tissue ([0061] when 13 has moved partially distally within 12, 8a and 8b are closed but not locked, as 13 has not passed over holding nose 31 shown in FIG. 9), and a locked configuration ([0069] when 13 passes 31 to be at the most distal position within 12, 8a and 8b are locked to prevent movement in either direction).
Regarding claim 5, Kuhn discloses each cam slot defines a distal portion (12a; [0069]; FIG. 9) and a proximal portion (FIG. 9: the proximal portion of 12 closest to the proximal end of the clamp arm) with a middle portion therebetween (FIG. 9: the middle portion of 12 between 12a and the proximal end of the clamp arm), wherein the middle portion of each cam slot is angled relative to the proximal and distal portions of each cam slot (FIG. 9: the middle portion of 12 is at an angle relative to the axially straight portions at either end of 12).
Regarding claim 6, Kuhn discloses the proximal portion of each cam slot defines a proximal axis extending in a first direction (FIG. 9: the proximal portion of 12 closest to the pivot point defines a proximal axis extending along the longitudinal axis defined by 2), the middle portion of each cam slot defines a middle axis extending at an oblique angle relative to the proximal axis (FIG. 9: the axis of the middle portion is at an angle to the longitudinal axis defined by the proximal portion and by 2).
Regarding claim 7, Kuhn discloses each cam slot includes a distal locking neck (31) projecting into the cam slot defining a distal locking area (12a), wherein the jaw members are in the locked configuration when the second pin is distal relative to the distal locking neck in the distal locking area ([0069] when 13 is distal to 31 within 12, the clamp arms are locked).
Regarding claim 8, Kuhn discloses the distal locking neck includes at least one of a protrusion projecting into the cam slot ([0069] 31 is a protrusion into 12a; FIG. 9).
Regarding claim 9, Kuhn discloses a device for applying a hemostatic clip assembly ([0057] medical device; FIGs. 1-13), the device comprising:
a proximal delivery catheter (1, 2) including a proximal handle assembly (1) and an elongated catheter body (2) extending distally from the proximal handle assembly (FIG. 1), the elongated catheter body defining a longitudinal axis (FIG. 1: 2 defines a longitudinal axis);
a distal clip assembly (3) removably connected to a distal end of the elongated catheter body ([0069] 3 can be disconnected from 2 by the disconnection of the arms 8a and 8b from the control wire 4, which runs through 2), the distal clip assembly including a distal clip housing (6), a jaw adapter yoke (11) slidably positioned within the distal clip assembly ([0058] 11 slides within 6; FIGs. 7-8), and a jaw assembly (FIG. 1: the jaws 8a and 8b) having a pair of cooperating jaw members (8a, 8b) fixed to the jaw adapter yoke by a first pin (9; FIG. 3), the first pin oriented orthogonally relative to the longitudinal axis (FIG. 3: 9 is orthogonal to the axis defined by 2), wherein the proximal delivery catheter is configured and adapted to transmit linear motion along the longitudinal axis and torsion about the longitudinal axis to at least a portion of the distal clip assembly ([0060] control wire 4 can be moved distally or proximally to move and rotate the clamp arms around 9 to open or close them, and can be rotated to rotate to cause 8a and 8b to rotate), wherein at least one of the jaw members is configured and adapted to rotate about the first pin and to rotate about the longitudinal axis ([0060] the clamp arms rotate about the pivot pin to open or close; the jaws are capable of being rotated around the axis defined by 2 if the device is rotated about 2),
wherein the distal clip assembly includes a second pin (13; [0061]; FIG. 3) connecting between the jaw members and the distal clip housing, wherein each jaw member includes a proximal body portion (FIG. 9: each of 8a and 8b includes a proximal portion containing the connections to 9 and 13) and a distal end effector (FIG. 9: each of 8a and 8b includes a distal jaw), wherein the proximal body portion of each jaw member includes a respective cam slot (12; [0060]) configured and adapted to receive the second pin ([0061] 13 goes within 12; FIG. 13) and a pivot aperture (10; [0059]; FIG. 8) configured and adapted to receive the first pin ([0059] 9 is held by and extends through 10; FIG. 3) and to rotate about the longitudinal axis (FIGs. 3-5: 10 rotates about the longitudinal axis as 8a and 8b rotate on the longitudinal axis),
wherein the jaw adapter yoke includes a proximal receiving portion (7; [0058]; FIG. 3) and the proximal delivery catheter includes a spring release (23; [0065]; FIG. 7) having a distal portion configured and adapted to be received within the proximal receiving portion of the jaw adapter yoke to transmit axial and rotational force to the jaw adapter yoke (FIG. 7: 23 are received within 6 and transmit forces to 6 from 2 and 4), wherein a portion of the spring release between a terminal distal end of the spring release and an outwardly extending flange portion is a constant diameter (FIG. 7: 23 has a constant outer diameter, which extends between the distal end of 23 and 14a).
Regarding claim 10, Kuhn discloses the proximal delivery catheter includes a drive wire (4) coupled to a proximal portion of the spring release to transmit linear and rotational motion from the drive wire to the jaw adapter yoke (FIG. 7: 4 is coupled to the proximal portion of 23, and transmits motion to 8a and 8b through 23).
Regarding claim 11, Kuhn discloses the proximal handle assembly includes an actuation portion (5) coupled to a proximal end of the drive wire ([0057] the proximal end of 4 is connected to 5), and a grasping portion (FIG. 1: the proximal-most ring of 1), wherein the actuation portion is configured and adapted to translate relative to the grasping portion to apply axial force to the drive wire ([0057] and FIG. 1: 5 is slidingly held on 1, which means 5 can move axially relative to the proximal-most ring on 1 to move 4 axially).
Regarding claim 12, Kuhn discloses a device for applying a hemostatic clip assembly ([0057] medical device; FIGs. 1-13), the device comprising:
a proximal delivery catheter (1, 2) including a proximal handle assembly (1) and an elongated catheter body (2) extending distally from the proximal handle assembly (FIG. 1), the elongated catheter body defining a longitudinal axis (FIG. 1: 2 defines a longitudinal axis);
a distal clip assembly (3) removably connected to a distal end of the elongated catheter body ([0069] 3 can be disconnected from 2 by the disconnection of the arms 8a and 8b from the control wire 4, which runs through 2), the distal clip assembly including a distal clip housing (6), a jaw adapter yoke (11) slidably positioned within the distal clip assembly ([0058] 11 slides within 6; FIGs. 7-8), and a jaw assembly (FIG. 1: the jaws 8a and 8b) having a pair of cooperating jaw members (8a, 8b) fixed to the jaw adapter yoke by a first pin (9; FIG. 3), the first pin oriented orthogonally relative to the longitudinal axis (FIG. 3: 9 is orthogonal to the axis defined by 2), wherein the proximal delivery catheter is configured and adapted to transmit linear motion along the longitudinal axis and torsion about the longitudinal axis to at least a portion of the distal clip assembly ([0060] control wire 4 can be moved distally or proximally to move and rotate the clamp arms around 9 to open or close them, and can be rotated to rotate to cause 8a and 8b to rotate), wherein at least one of the jaw members is configured and adapted to rotate about the first pin and to rotate about the longitudinal axis ([0060] the clamp arms rotate about the pivot pin to open or close; the jaws are capable of being rotated around the axis defined by 2 if the device is rotated about 2),
wherein the distal clip assembly includes a second pin (13; [0061]; FIG. 3) connecting between the jaw members and the distal clip housing, wherein each jaw member includes a proximal body portion (FIG. 9: each of 8a and 8b includes a proximal portion containing the connections to 9 and 13) and a distal end effector (FIG. 9: each of 8a and 8b includes a distal jaw), wherein the proximal body portion of each jaw member includes a respective cam slot (12; [0060]) configured and adapted to receive the second pin ([0061] 13 goes within 12; FIG. 13) and a pivot aperture (10; [0059]; FIG. 8) configured and adapted to receive the first pin ([0059] 9 is held by and extends through 10; FIG. 3) and to rotate about the longitudinal axis (FIGs. 3-5: 10 rotates about the longitudinal axis as 8a and 8b rotate on the longitudinal axis),
wherein the proximal delivery catheter includes a spring tube (19 and 20; [0065]) between a proximal end of the distal clip assembly and a distal end of the elongated catheter body (FIG. 7: 19 and 20 connects the proximal end of 3 to the distal end of 2).
Regarding claim 13, Kuhn discloses the spring tube includes at least one cantilever arm (22) removably coupled to the distal clip housing ([0064] 22 are part of 19, which is removably coupled to 3).
Regarding claim 14, Kuhn discloses the at least one cantilever arm includes an inwardly extending flange that removably engages with a circumferential slot defined about a periphery of a proximal end of the distal clip housing ([0064] and FIG. 7: 22 have radially inwardly projecting portions to fit within ring groove 21 to secure 19 and 20 to 6).
Regarding claim 15, Kuhn discloses the proximal delivery catheter includes a spring release (23) positioned at least partially within the spring tube (FIG. 7), wherein the spring tube includes an inward projection (25), wherein the spring release includes an outwardly extending flange portion (24) configured and adapted to interact with the inward projection of the spring tube ([0065] 24 engage 25 to keep 19 connected to 6) to selectively deflect the at least one cantilever arm of the spring tube ([0067] when desired, 22 can be deflected inward to press on 24) and release the inwardly extending flange of the at least one cantilever arm from the circumferential slot of the distal clip housing ([0067] pressing on 24 allows 22 to disengage from 21).
Regarding claim 16, Kuhn discloses the spring release includes a distal portion (FIG. 7: 23 have distal portions) configured and adapted to be received within a receiving portion of the jaw adapter yoke to transmit linear and rotational motion to the jaw adapter yoke (FIG. 7: the distal portions of 23 are capable of being received within 11 to send motion from 4 to 8a and 8b).
Regarding claim 17, Kuhn discloses the distal portion of the spring release is divided into at least two tines (FIG. 7: 23 are two different projections), wherein each tine has a mating surface selectively engageable with an inner surface of the receiving portion of the jaw adapter yoke (FIG. 7: the surfaces of 23 can engage with the inner surface of 11).
Regarding claim 18, Kuhn discloses each tine is configured and adapted to deflect inwardly and release from the receiving portion when an axial force in a proximal direction is applied to the spring release (FIGs. 7-8: 23 can deflect inwardly to release 11 when 4 is pulled proximally).
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