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 .
Notice of Amendment
In response to the amendment filed on 1/14/2026, cancelled claim 1 and new claims 2-10 are acknowledged. Claims 2-10 are currently pending. The following new and reiterated grounds of rejection are set forth:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 and 4-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. (US Publication No. 2006/0089569 A1) (cited by Applicant), further in view of Hollett (US Publication No. 2013/0053766 A1) (cited by Applicant).
Regarding claim 2, Soukup et al. discloses a medical device comprising:
a first member (102) having a distal end and a longitudinal axis, a portion of the first member at, along or near the distal end comprising at least one feature (126) having a spiral or helical shape (see Figure 1 and [0032]);
wherein a length of the at least one feature is configured to change along the longitudinal axis (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]); and
a second member configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the second member relative to the first member is configured to increase the length of the at least one feature of the first member (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]).
It is noted Soukup et al. does not specifically teach linear movement along the longitudinal axis of the second member relative to the first member is configured to rotate the first member about the longitudinal axis. However, Hollett teaches linear movement along the longitudinal axis of the second member (18) relative to the first member (12) is configured to rotate the first member about the longitudinal axis (see Figure 1 and [0036] and [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. to include linear movement along the longitudinal axis of the second member relative to the first member is configured to rotate the first member about the longitudinal axis, as disclosed in Hollett, so as to rotate the distal end to selectively point toward the desired branch so that the desired branch may be efficiently cannulated (see Hollett: [0036]).
Regarding claim 4, neither Soukup et al. nor Hollett specifically teach the second member is not attached to the first member. However, it would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to have the second member not attached to the first member, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 5, Soukup et al. teaches the second member is coupled to the first member (see [0039]).
Regarding claim 6, Soukup et al. teaches at least one coating or layer (340) (see Figure 4 and [0039]).
Regarding claim 7, Soukup et al. teaches the first member comprises a coiled member (see [0013]).
Regarding claim 8, Hollett teaches the first member comprises a shape memory material (see [0047]).
Regarding claim 9, Hollett teaches the device comprises a guidewire (see [0030]).
Regarding claim 10, Soukup et al. teaches the device comprises a microcatheter or another type of catheter (see [0029]-[0030]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. and Hollett, further in view of Vrba (US Patent No. 8556,914 B2) (cited by Applicant).
Regarding claim 3, it is noted neither Soukup et al. nor Hollett specifically teach the at least one feature comprises an helical or helix angle of 10 to 80 degrees relative to the longitudinal axis. However, Vrba teaches the at least one feature comprises an helical or helix angle of 10 to 80 degrees relative to the longitudinal axis (see Figure 1 and col. 5, lines 21-48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. and Hollett to include the at least one feature comprises an helical or helix angle of 10 to 80 degrees relative to the longitudinal axis, as disclosed in Vrba, so as to aid a user of the device in crossing an occlusion in a vessel and/or increase the lateral flexibility of the tubular member (see Vrba: Abstract).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791