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 September 3rd, 2026, have been entered. Claims 1-6 and 8-13 remain pending in the Application. Claim 7 has been canceled by the Applicant. Claim 13 was previously withdrawn by the Applicant. The claim amendments overcome the previous claim objections.
Response to Arguments
The rejection of claims 1-6 and 8-12 under 103 over McArthur et al. (U.S. Patent No. 10,722,338) in view of Wilson et al. (Pub. No. 2004/0092989) has been withdrawn in light of Applicant’s amendment; specifically, Wilson et al. does not disclose the length of the first transition section is less than a length of the second transition section.
Applicant’s arguments with respect to claim(s) 1-6 and 8-12 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. It is noted that Applicant argues that the newly added claim limitation is not taught by Wilson et al.; however, as discussed below, the newly added reference Raijman et al. (Pub. No. 2019/0366059) teaches said limitation.
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 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McArthur et al. (U.S. Patent No. 10,722,338) in view of Wilson et al. (Pub. No. 2004/0092989) and Raijman et al. (Pub. No. 2019/0366059).
Regarding claim 1, McArthur et al. discloses a medical device (FIGs. 1-7B), comprising a delivery mechanism (100) and an implant (170), wherein the delivery mechanism comprises a delivery component (FIG. 1: the body of 100), and the implant is detachably connected to the delivery component (FIGs. 3-5A: 170 is releasably attached to 100); wherein the delivery mechanism is configured to deliver the implant to a predetermined position in a target lumen and release the implant (C4:L41-44: a user may use 100 to place 170 is a desired location such as in the IVC).
McArthur et al. does not disclose the delivery mechanism comprises an assistive component that is connected to the delivery component and configured to be expanded or shrunk in a radial direction of the delivery component, and the assistive component is radially expanded during the release of the implant so as to release the implant with a predetermined form in the predetermined position.
Wilson et al. teaches in the same field of endeavor of medical delivery devices (Abstract), and discloses a medical device (FIG. 1) comprising a delivery mechanism (50; FIGs. 5A-5B) and an implant (10), wherein the delivery mechanism comprises a delivery component (52, 54, and 56) and an assistive component (108; FIG. 16B; [0087]) that is connected to the delivery component ([0086-87] and FIG. 15B: 54 includes 92, which includes 104 and 106, which are attached to 108) and configured to be expanded or shrunk in a radial direction of the delivery component ([0089] 108 can be inflated, which FIGs. 15B and 16B illustrate causes radial expansion; [0111] 108 can also be deflated, illustrated by FIG. 17B), and the implant is detachably connected to the delivery component (FIG. 17B: when 108 is deflated, 10 remains in place); wherein the delivery mechanism is configured to deliver the implant to a predetermined position in a target lumen and release the implant ([0096] 10 is placed using 50), and the assistive component is radially expanded during the release of the implant so as to release the implant with a predetermined form in the predetermined position (FIGs. 15A-17B: 108 is expanded during deployment of 10 to place 10 in the deployed form) for the purpose of securing the implant in place during delivery ([0087]), wherein the assistive component comprises a first transition section (FIG. 16B: proximal end of 108), a main section (FIG. 16B: body of 108), and a second transition section (FIG. 16B: distal end of 108) which are axially connected successively (FIG. 16B), and an outer diameter of the first transition section and an outer diameter of the second transition section decrease in directions away from the main section (FIG. 16B: the proximal and distal ends of 108 decrease in their respective directions away from the body of 108), and the first transition section is closer to the implant (FIG. 16B: the proximal end of 108 is closer to 10 than the distal end of 108).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified McArthur et al. to include an assistive component, as taught by Wilson et al., for the purpose of securing the implant in place during delivery.
McArthur et al. as modified by Wilson et al. does not disclose a length of the first transition section is less than a length of the second transition section.
Raijman et al. discloses a balloon (204/304; FIGs. 10-12; [0099]) with a proximal transition section, a distal transition section, and a main body, where the proximal transition section can have a symmetrical shape or an asymmetrical shape compared to the distal transition section and the main body ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified McArthur et al. to have the assistive component be asymmetric, as taught by Raijman et al., because both shapes are disclosed as equivalent structures for expanding a frame, and the substitution of one for the other would have resulted in the predictable result of allowing for a frame to be expanded based on the area of operation that the frame is being deployed in.
Regarding claim 2, McArthur et al. as modified by Wilson et al. further discloses the delivery component comprises a tube assembly (McArthur et al. 110 and 130) and a backward release component (McArthur et al. 133), the tube assembly comprising at least a first tube (McArthur et al. 130), the backward release component having a distal structure that is partially connected to the first tube and coaxially to the first tube (McArthur et al. FIG. 5A: 133 is connected to 130 is a coaxial manner), the assistive component sleeved over the first tube and proximal to the distal structure (Wilson et al. FIG. 17B: 108 is over the guidewire 60, which is the equivalent of 130 in McArthur et al., and 108 is proximal to the distal end), the implant detachably connected to the distal structure of the backward release component (McArthur et al. FIGs. 3-5A: 170 is releasably coupled to the distal end of 130).
Regarding claim 3, McArthur et al. as modified by Wilson et al. further discloses the assistive component is configured to be at least partially movable in an axial direction of the first tube to radially expand the assistive component (Wilson et al. FIG. 16B: 108 expands away from 60).
Regarding claim 4, McArthur et al. as modified by Wilson et al. further discloses an outer diameter of at least some segments of the main section is greater than or equal to a maximum outer diameter of the first transition section and the second transition section (Wilson et al. FIG. 16B: the body of 108 has a greater outer diameter than the proximal and distal ends).
Regarding claim 5, McArthur et al. as modified by Wilson et al. further discloses the tube assembly further comprises a second tube (McArthur et al. 110) that is sleeved over the first tube (McArthur et al. FIG. 3A: 110 is sleeved over 130) and axially movable relative to the first tube and the distal structure (McArthur et al. FIGs. 2-3: 110 is retracted and thereby axially movable relative to both 130 and 133); wherein the assistive component has a distal end that remains stationary relative to the first tube (Wilson et al. FIGs. 15B-17B: 108 remains stationary relative to 60), and a proximal end that is connected to a distal end of the second tube and movable synchronously with the second tube (Wilson et al. [0087] and FIG. 15B: the proximal end of 108 is connected to 130 by 110).
Regarding claim 6, McArthur et al. as modified by Wilson et al. further discloses the delivery component further comprises a handle (McArthur et al. FIG. 1: the handle portion) provided with a first drive assembly (McArthur et al. 140) that is connected to a proximal end of the second tube (McArthur et al. C6:L42-57: 140 is connected to 110) and configured to drive the second tube to move axially relative to the first tube (McArthur et al. C6:L42-57: 140 is used to retract and deploy 110).
Regarding claim 8, McArthur et al. as modified by Wilson et al. further discloses the assistive component is a balloon (Wilson et al. [0087] 108 is a balloon) that is connected to and in communication with a perfusion channel defined in the first tube (Wilson et al. [0087] 108 is connected to a fluid passageway formed between 104 and 106) and the perfusion channel is configured to fill an agent into the balloon (Wilson et al. [0087] 108 is inflated by the fluid passageway; since “agent” is a broad term that just conveys an object which creates an effect, any fluid which causes the effect of inflating 108 can be considered an agent, and [0089] states that fluid is used to inflate 108).
Regarding claim 9, McArthur et al. as modified by Wilson et al. further discloses the backward release component comprises a limit sleeve (McArthur et al. 135), a restraint member (McArthur et al. 131), and a connector (McArthur et al. 132), wherein the limit sleeve and the restraint member constitute the distal structure of the backward release component (McArthur et al. FIG. 3A: 131 and 135 are the distal end of 133), the limit sleeve is connected to and in communication with the first tube (McArthur et al. FIG. 3A: the distal end of 130 are connected to 135), the limit sleeve is axially stationary relative to the first tube (McArthur et al. FIG. 3A: 135 is secured to the end of 130, and is thereby stationary relative to 130); the restraint member is configured to be received in the limit sleeve (McArthur et al. FIG. 5A: 133 is received within 135); the connector is inserted into the first tube and movable relative to the first tube (McArthur et al. FIG. 3A: 132 goes within 130 and moves relative to 130), and a distal end of the connector is connected with the restraint member (McArthur et al. FIG. 3A: 132 is connected to 131); wherein the restraint member is engaged with the limit sleeve (McArthur et al. FIG. 3A: 131 is connected to 135) and the restraint member is detachably connected to the implant when the restraint member is at least partially located inside the limit sleeve (McArthur et al. FIG. 5A: 131 detaches from 170 when within 135), and the backward release component is disconnected from the implant when the restraint member is at least partially exposed from a distal end of the limit sleeve (McArthur et al. FIG. 5A: 170 disconnects from 100 when 131 is exposed from 135) and the restraint member is disengaged with the limit sleeve (McArthur et al. FIG. 5A: 131 does not contact 135), resulting from a movement of the first tube relative to the connector (McArthur et al. FIG. 5A: 130 moves relative to 135 when 131 disengages 170 from 100).
Regarding claim 10, McArthur et al. as modified by Wilson et al. further discloses the delivery component further comprises a handle (McArthur et al. FIG. 1: the handle portion) provided with a second drive assembly (McArthur et al. 147; FIG. 6A), the handle connected to a proximal end of the connector (McArthur et al. FIGs. 6A-6A1: the handle portion is connected to the proximal end of 132), the second drive assembly connected to a proximal end of the first tube and configured to drive the first tube to move axially relative to the connector (McArthur et al. C12:L35-50: 147 is connected to 130 and used to move 130 relative to 132).
Regarding claim 11, McArthur et al. as modified by Wilson et al. further discloses wherein a retrieval part (McArthur et al. 178; FIG. 5A) is configured to detachably connect to the backward release component (McArthur et al. FIG. 5A: 178 is releasably attached to 133).
Regarding claim 12, McArthur et al. as modified by Wilson et al. further discloses the restraint member is a slider (McArthur et al. FIG. 5A: 131 slides according to the arrows) having a side wall defined therein with a groove (McArthur et al. 136); wherein the groove and an inner surface of the limit sleeve together limit a position of a proximal-to-heart end of the implant so as to connect the implant with the backward release component when the slider is at least partially received in the limit sleeve (McArthur et al. FIG. 5A: 135 and 136 limit the position of the proximal end of 170 while 131 is within 135), and the backward release component is disconnected from the implant when the slider moves axially relative to the limit sleeve to expose the groove from the limit sleeve (McArthur et al. FIGs. 3A and 5A: when 130 is moved proximally, 131 slides relative to 135 and 170 is disconnected from 100).
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
