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 Arguments
Applicant's arguments filed 08/26/2025 have been fully considered but they are not persuasive. Applicant states that the elements 226, 244 and 254 of Fischell being relied on as the claimed barbs are referred to as ribs and are not a plurality of outwardly projecting angled barbs as claimed. However, the prior art’s choice of terminology does not change the structure that is depicted. A barb as known in the art is also referred to is an extension, projection, hook. As such, the structure depicted by Fischell broadly reads on the term barb. Regarding claims 19 and 20, as indicated in the rejection below, Fischell does disclose the hub including a key plate to restrict rotation in any directions along with a recess to receive the key plate.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and are rejected under 35 U.S.C. 103 as being unpatentable over Mendelson in view of Fischell (US PGPub 2019/0255299).
With respect to claim 1 Mendelson discloses:
A delivery device (see Fig. 2, [0070]) comprising: an inner shaft assembly including an inner shaft (130) having a proximal end and a distal end and a lumen [0070]; the inner shaft further including a spindle (140) connected to the distal end of the inner shaft, the spindle including a body and a side lumen (see Fig. 3, [0070]) offset with respect to a central axis of the spindle; and a spine wire (136) that can slide within both the lumen of the inner shaft and the side lumen of the spindle [0070].
Mendelson does not disclose a hub interconnecting the spindle and the inner shaft.
However, Fischell discloses a coupling mechanism (160 Fig. 4A) equivalent to the claimed hub for the purposes of providing a catheter extension to assist with manipulation of the delivery device through the vessels. The coupling mechanism includes plurality of outwardly projecting angled barbs that retain the inner shaft to the hub (see for example 244 in Fig 18C are angled and project outwardly as they circumferentially surround to the inner shaft or 272).
It would have been obvious to one of ordinary skill the art before the effective filing date to incorporate a hub that is a coupling mechanism having the claimed features as noted above for the purpose of providing an extension to the shaft to aid in navigation
Claim 2: Mendelson further discloses comprising a stented prosthesis (100) positioned on the spindle.
Claim 3: Mendelson discloses wherein the body includes a plurality of cuts (320, 322, 326 in Fig 14b or 456a-c in Fig. 27).
Claim 4: Mendelson discloses wherein the side lumen is formed within the body (see Fig. 3).
Claim 5: Mendelson discloses wherein the spindle includes a plurality of features extending from the body (holes described in [0080] and see in 320, 322, 326 in Fig 14b or 456a-c in Fig. 27) through which a plurality of elongated tension members (132a-c) are routed.
Claim 6: Mendelson discloses wherein the side lumen is positioned about 180 degrees from the plurality of features (see Fig. 3.
Claim 9: Fischell discloses the spindle includes a key plate that restricts rotation (186/202, Fig. 15A-E or 212 in Fig. 18C).
Claim 19: Fischell discloses the spindle includes a key plate that restricts rotation in any direction with respect to the inner shaft (212 in Fig. 18c).
Claim 20: Fischell disclose the hub includes a recess to receive the key plate (see Fig. 18C depicting a recess or space between the barbs for receiving the key plat 212)
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 ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kiesha Bryant can be reached at 571-272-8734. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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