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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 8th, 2026, has been entered.
Response to Amendment
The claims entered on July 8th, 2026, have been entered. Claims 2-18 remain pending in the Application.
Response to Arguments
Applicant's arguments filed July 8th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that Kuhn (Pub. No. 2022/0167990) does not disclose the amended limitation in claim 3 that the pivot aperture is configured and adapted to maintain engagement with the first pin after separation of the distal clip assembly from the proximal delivery catheter because the through-hole 10 is not configured to maintain engagement with the pivot pin 9 after separation of the clamp device 3 from the handle 1 and sheath 2, as Kuhn [0062] states that the pivot pin 9 can be pulled out of the through-holes 10 to uncouple control wire 4 from the clamp device 3. Examiner respectfully disagrees. The separation of the distal clip assembly (clamp device 3) and the proximal delivery catheter (handle 1 and sheath 2) is described in [0065] and shown in FIGs. 7-8 as being based on the clamp housing 6 being disconnected from the two connecting elements 23, which is further described in [0071] as the control wire 4 being pulled proximally to cause the protrusion 30 of coupling head 11 to come out of engagement from the inwardly bulged sections 29 of the connecting elements 23 to cause them to come out of engagement, thereby uncoupling 6 from 2.
Second, Applicant argues that Kuhn does not disclose the limitation in claim 9 that the jaw adapter yoke comprises a proximal receiving portion and the proximal delivery catheter includes a spring release having a distal portion configured to be received within the proximal receiving portion of the jaw adapter yoke to transmit axial and rotational force to the jaw adapter yoke because the coupling head 11 (jaw adapter yoke) is a completely separate element from the clamp base 7 (receiving portion), and thereby 11 cannot comprise 7. While Examiner understands with this statement, the rejection below has been updated to reflect that the coupling head 11 has a proximal receiving portion in the protrusion 30 described in [0067] and shown in FIG. 10, where the distal portion of the connecting elements 23 (spring release) is received within 30 to transmit axial and rotational force. Therefore, the rejection stands.
Third, Applicant argues that Kuhn does not disclose the spring tube includes an inward projection because the engagement means 24 are not inward projections, but are instead through-holes. While Examiner understands with this statement, the rejection below has been updated to refer to the engagement portions 24 which pass through the engagement means 25 and the apertures 26 to be an inward projection in the spring tube 20. Therefore, the rejection stands.
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 further configured to maintain engagement with the first pin after separation 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; [0071] the separation of 1 and 2 from 3 occurs when 30 uncouples from 29, and 9 and 10 are capable of staying in engagement when that uncoupling happens; 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 comprises a proximal receiving portion (30; [0067]; FIG. 10) 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 30 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),
wherein the spring tube includes an inward projection (24; FIG. 7).
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 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
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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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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