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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 24th, 2026, has been entered.
Response to Amendment
The claims filed on August 24th, 2026, have been entered. Claims 1-2, 6, and 8-20 remain pending in the Application. Claims 8-20 were previously withdrawn by the Applicant.
Response to Arguments
The rejection of claims 1-2 and 6 under 103 over Wallace et al. (U.S. Patent No. 9,060,777) in view of Sharma (Pub. No. 2024/0108392) has been withdrawn in light of Applicant’s amendment made August 24th, 2026; specifically, a connection mechanism connecting the advancement mechanism to the therapeutic device, wherein a proximal end of the therapeutic device includes a receiving feature engaged with the distal linking feature of the pusher wire, wherein the receiving feature and the distal linking feature are positioned on overlapping tabs that extend from the therapeutic device and the advancement mechanism, respectively, and wherein the connection mechanism is maintained together by external pressure from the delivery sleeve while the connection mechanism is within the delivery sleeve and releases the therapeutic device from the advancement mechanism when the connection mechanism exits the delivery sleeve.
Applicant’s arguments with respect to claim(s) 1-2 and 6 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 § 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) 1-2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo (Pub. No. 2019/0008522) in view of Smith et al. (Pub. No. 2016/0199067).
Regarding claim 1, Lorenzo discloses an endovascular apparatus (10; FIG. 2) comprising:
a delivery sleeve (14) having a longitudinal lumen (15) extending between a proximal end and a distal end (FIG. 2);
a therapeutic device (20, 40) housed within and extending substantially an entire length of the delivery sleeve (FIGs. 4 and 6: 40 is very long and will take up the entirety of 14 during deployment);
wherein the therapeutic device includes one or more detachable polymer endovascular embolization coils ([0044] 40 is at least one embolic coil);
an advancement mechanism (14g) comprising a pusher wire ([0059] 14g is a pusher) having a distal linking feature (96);
a connection mechanism (98) connecting the advancement mechanism to the therapeutic device (FIGS. 13-14 and [0059] 98 connects 14g to the occlusion device), wherein a proximal end of the therapeutic device includes a receiving feature ([0059] detachment feature 98 has a connection with 96) engaged with the distal linking feature of the pusher wire ([0059] the connection of 98 links with 96), wherein the receiving feature and the distal linking feature are positioned on overlapping tabs that extend from the therapeutic device and the advancement mechanism, respectively ([0042] 30 has a set of overlapping tabs that hold on to 22 and while this is a separate embodiment, [0059] indicates that the connection between 96 and 98 can be a similar attachment as 30; FIG. 2), and wherein the connection mechanism is maintained together by external pressure from the delivery sleeve while the connection mechanism is within the delivery sleeve (FIG. 2: 30 grabs onto 20 while 30 is within 12) and releases the therapeutic device from the advancement mechanism while the connection mechanism exits the delivery sleeve (FIG. 5: 30 releases 22 when 30 exits 12); and
wherein an outside diameter of the delivery sleeve is sufficiently small such that the delivery sleeve is insertable into the catheter (FIG. 2: 14 fits within 12).
Lorenzo does not disclose a stop positioned on the proximal end of the delivery sleeve which limits a distance the delivery sleeve is inserted into a catheter, wherein the stop comprises an attachment mechanism to connect a proximal end of the catheter, wherein the attachment is a luer connection that engages an opposing luer connection on the proximal end of the catheter, wherein both an inner surface and an outer surface of the delivery sleeve are composed of a material with a low coefficient of friction.
Smith et al. discloses a delivery system (10; FIG. 1) comprising a pair of concentric tubes (16, 18), a stop (20) positioned on the proximal end of the inner sleeve which limits a distance the inner tube is inserted into the outer tube ([0069] 20 is at the proximal end of 16 and 18, and limits the distance 18 can go into 16), wherein the stop comprises an attachment mechanism to connect a proximal end of the outer tube (24, 26), wherein the attachment is a luer connection that engages an opposing luer connection on the proximal end of the outer tube ([0069] 24 and 26 can form a luer connector to link 16 and 18) for the purpose of preventing the inner tube from exiting the outer tube too far in the distal direction, and wherein both an inner surface and an outer surface of the inner tube are composed of a material with a low coefficient of friction ([0086-87] 18 can be made of PTFE or nitinol, while Lorenzo [0047] the delivery tube can be made of nitinol; the present spec [0028] discloses the delivery sleeve is made of PTFE).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the delivery sleeve and catheter of Lorenzo to have a stop with a luer connection for the purpose of preventing the inner tube from exiting the outer tube too far in the distal direction, as taught by Smith et al., and to further modify the delivery sleeve to be made of PTFE instead of nitinol because the substitution of one material known in the art for another would have resulted in the predictable result of providing a low-coefficient of friction material. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, Lorenzo as modified by Smith et al. further discloses the advancement mechanism is configured to engage the therapeutic device to advance the therapeutic device into a patient (Lorenzo [0059] 14g is used to engage and advance 20 into the aneurysm).
Regarding claim 6, Lorenzo as modified by Smith et al. further discloses the therapeutic device extends approximately to the distal end of the delivery sleeve (Lorenzo FIGs. 4 and 6: 40 is very long and will take up the entirety of 14 during deployment).
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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/JAMES R MCGINNITY/Examiner, Art Unit 3771
