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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/28/2022 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-22 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20100174301) in view of Slazas et al. (US 20140277078) [hereinafter Slazas].
Regarding claim 1, Wallace discloses an occlusive device (100, Fig. 1E) comprising:
an elongate polymer body 104 (Fig. 1E, para. 0051) including a cover 108 formed of a fiber (Fig. 1E, para. 0052, 0057), wherein the cover 108 is configured to closely conform to at least the polymer body 104 (Fig. 1D, 0049);
a shape memory wire 120 coupled with the polymer body 104 (Fig. 1E, para. 0062, 0064), wherein the shape memory wire 120 is secured to the elongate polymer body 104 (para. 0062); and
a pusher member 306 (Fig. 5B, para. 0078).
However, Wallace fails to disclose the pusher member includes a plurality of radial slots disposed along a length of the pusher member.
Slazas in the same field of endeavor teaches an occlusive device (5, Fig. 1A), comprising a pusher member 10 (Fig. 1A-B, para. 0036), wherein the pusher member 10 includes a plurality of radial slots 30 disposed along a length of the pusher member (Figs. 1A-B, para. 0037) for the purpose of enhancing flexibility and minimizing compression/buckling of the pusher member (para. 0037).
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 pusher member in Wallace to include the plurality of radial slots of Slazas in order to enhance flexibility and minimize compression/buckling of the pusher member (para. 0037).
Regarding claim 2, Modified Wallace discloses a coupler 300 at a proximal end (Fig. 5B of Wallace), the coupler 300 being coupled to the cover (best shown in Fig. 5D of Wallace, however the coupler is coupled to the cover by their common connection to the polymer body 104).
Regarding claim 3, Modified Wallace discloses wherein the fiber is braided (para. 0052 of Wallace).
Regarding claim 4, Modified Wallace discloses wherein the fiber is knitted (para. 0015, 0052 of Wallace).
Regarding claim 5, Modified Wallace discloses wherein the shape memory wire 120 is formed of an instilled non-straight shape (para. 0062 of Wallace).
Regarding claim 6, Modified Wallace discloses wherein the cover comprises a first and second fiber (para. 0052 of Wallace).
Regarding claim 8, Modified Wallace discloses wherein the cover 108 is formed to wrap around the shape memory wire 120 and the elongate polymer body 104 (Fig. 1E of Wallace).
Regarding claim 9, Modified Wallace discloses wherein the elongate polymer body 104, cover 108 and shape memory wire 120 are secured together (para. 0049, 0062 of Wallace).
Regarding claim 10, Modified Wallace discloses wherein the elongate polymer body, cover, and shape memory wire are secured together with adhesive (Fig. 1F-H, para. 0069-70 of Wallace).
Regarding claim 11, Modified Wallace discloses wherein the shape memory wire 120 extends over 1 or more segments along the length of the elongate polymer body 104 (Fig. 1E od Wallace illustrates the wire 120 extends throughout the entire length of polymer body 104).
Regarding claim 12, Modified Wallace discloses wherein the shape memory wire is a shape memory metallic alloy (para. 0064 of Wallace).
Regarding claim 13, Modified Wallace discloses wherein the shape memory metallic alloy is nitinol (para. 0064 of Wallace).
Regarding claim 14, Wallace discloses an occlusive device (100, Fig. 1E) comprising:
an elongate polymer body 104 including a cover 108 (Fig. 1E, para. 0051, 0052, 0057);
a shape memory wire 120 coupled with the polymer body 104 (Fig. 1E, para. 0062, 0064), wherein the shape memory wire 120 is secured to the elongate polymer body 104 and an engagement structure 314 formed at a proximal end of the elongate polymer body 104 (Fig. 5D, para. 0062, 0080), the engagement structure 314 configured to releasably attach with a pusher member (312, Fig. 5D, para. 0080), the engagement structure 314 comprising a tube 311 (Fig. 5D, para. 0080), wherein the tube 311 is coupled to the cover 108 [via, there common connection to the polymer body 104] (Fig. 1E, 5D).
However, Wallace fails to disclose the pusher member includes a plurality of radial slots disposed along a length of the pusher member.
Slazas in the same field of endeavor teaches an occlusive device (5, Fig. 1A), comprising a pusher member 10 (Fig. 1A-B, para. 0036), wherein the pusher member 10 includes a plurality of radial slots 30 disposed along a length of the pusher member (Figs. 1A-B, para. 0037) for the purpose of enhancing flexibility and minimizing compression/buckling of the pusher member (para. 0037).
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 pusher member in Wallace to include the plurality of radial slots of Slazas in order to enhance flexibility and minimize compression/buckling of the pusher member (para. 0037).
Regarding claim 16, Modified Wallace discloses wherein the polymer body 104 comprises a single polymer strand (para. 0051, para. 0062 of Wallace) [note: the polymer body 104 comprises a single helical coil formed or polymer].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20100174301) and Slazas et al. (US 20140277078) [hereinafter Slazas], as applied to claim 14 above, and further in view of Kadam (US 20160038151).
Regarding claim 15, Modified Wallace discloses all of the limitations set forth above in claim 14, including an electrolytic detachment structure (para. 0080-81 of Wallace) comprising an engagement structure 314 formed at a proximal end of the elongate polymer body 104 (Fig. 5D, para. 0062, 0080 of Wallace), the engagement structure 314 configured to releasably attach with a pusher member (para. 0080), the engagement structure 314 comprising a tube 311 (Fig. 5D, para. 0080 of Wallace), wherein the tube 311 is coupled to the cover 108 [via, there common connection to the polymer body 104] (Fig. 1E, 5D of Wallace). However, Modified Wallace fails to disclose wherein the tube is coupled to the cover with a girth hitch knot.
Kadam in the same field of endeavor teaches an occlusive device comprising an electrolytic detachment structure (para. 0008, 0052) comprising an engagement structure 94 configured to releasably attach with a pusher member 92 (para. 0050-51), the engagement structure 94 comprising a tube 50 (Figs. 1-2, 11A-C, para. 0050-51), wherein the tube 50 is coupled to a cover 26/28 with a girth hitch knot (para. 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the electrolytic detachment structure in Modified Wallace for the knotted electrolytic detachment structure in Kadam in order to yield the predictable result of detaching the occlusive device from the pusher member (para. 0080-0081).
Claims 17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20100174301) and Slazas et al. (US 20140277078) [hereinafter Slazas], as applied to claim 14 above, and further in view of Ferrera et al (US 7326225) [hereinafter Ferrera].
Regarding claim 17, Modified Wallace discloses all of the limitations set forth above in claim 14 including an elongate polymer body 104 including a cover 108 (Fig. 1E, para. 0051, 0052, 0057 of Wallace). Modified Wallace further discloses wherein the polymer body is radiopaque (para. 0051 of Wallace). However, Modified Wallace fails to disclose that the polymer body is also shape memory.
Ferrera in the same field of endeavor teaches an occlusive device comprising a coil formed of radiopaque and polyurethane shape memory polymer (col. 14 lines 13-16) for the purpose of providing the coil with super elastic properties (col. 2 lines 52-56).
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 polymer body in Modified Wallace to include the shape memory polymer of Ferrera in order to provide the proximal body with super elastic properties (col. 2 lines 52-56).
Regarding claim 20, Wallace discloses an occlusive device (100, Fig. 1E) comprising:
an elongate polymer body 104, the elongate polymer body including a cover 108 (Fig. 1E, para. 0051, 0052, 0057);
the cover 108 configured to closely conform to at least the polymer body 104 (Fig. 1E, para. 0049), the cover being formed of a fiber (Fig. 1E, para. 0052, 0057),
herein the polymer body 104 comprises radiopaque (para. 0051), and
a pusher member 306 (Fig. 5B, para. 0078).
However, Wallace fails to disclose that the polymer body is also shape memory.
Ferrera in the same field of endeavor teaches an occlusive device comprising a coil formed of radiopaque and polyurethane shape memory polymer (col. 14 lines 13-16) for the purpose of providing the coil with super elastic properties (col. 2 lines 52-56).
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 polymer body in Wallace to include the shape memory polymer of Ferrera in order to provide the proximal body with super elastic properties (col. 2 lines 52-56).
Wallace in view of Ferrera fails to disclose the pusher member includes a plurality of radial slots disposed along a length of the pusher member.
Slazas in the same field of endeavor teaches an occlusive device (5, Fig. 1A), comprising a pusher member 10 (Fig. 1A-B, para. 0036), wherein the pusher member 10 includes a plurality of radial slots 30 disposed along a length of the pusher member (Figs. 1A-B, para. 0037) for the purpose of enhancing flexibility and minimizing compression/buckling of the pusher member (para. 0037).
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 pusher member in Modified Wallace to include the plurality of radial slots of Slazas in order to enhance flexibility and minimize compression/buckling of the pusher member (para. 0037).
Regarding claims 21, Modified Wallace discloses wherein the elongate polymer body 104 comprises a proximal end, the proximal end comprising a coupler 300 (Fig. 5B, para. 0078 of Wallace).
Regarding claims 22, Modified Wallace discloses wherein the polymer body 104 is formed in an instilled non-straight shape (Fig. 1E, para. 0062 of Wallace).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20100174301) and Slazas et al. (US 20140277078) [hereinafter Slazas], as applied to claim 14 above, and further in view of Wilson et al. (US 20040034363) [hereinafter Wilson].
Regarding claims 18-19, Modified Wallace discloses all of the limitations set forth above in claim 14, including a shape memory wire 120 coupled with the polymer body 104 (Fig. 1E, para. 0062, 0064 of Wallace). Modified Wallace further discloses wherein the shape memory wire 120 is in an instilled non-straight form (Fig. 1E, para. 0062 of Wallace). However, Modified Wallace fails to disclose wherein the shape memory wire comprises a multifilament braided structure comprising a first filament and a second filament, the first filament and second filament each being formed in a different shape.
Wilson in the same field of endeavor teaches an occlusive device comprising stretch resistant member 18 (Fig. 1) (analogous to the shape memory wire interpreted as stretch resistant member 120 of Wallace), wherein the stretch resistant member may be formed as braid [which is known in the art to include two or more interlacing filaments, wherein each filament forms a different shape when being braided together] (para. 0027), and wherein the braid structure is taught as a known alternative to the single wire structure of Wallace (para. 0027 of Wilson, see para. 0062-63 of Wallace).
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 single shape memory wire in Modified Wallace to include the braid structure of Wilson, particularly since Wilson teaches that the braid structure is taught as a known alternative to the single wire structure of Wallace (para. 0027 of Wilson, see para. 0062-63 of Wallace). Furthermore, such a modification is a substitution for one stretch resistant member for another and would yield the predictable result of providing stretch resistance to the coil/polymer body, thereby reducing the risk of breakage (para. 0006).
Claims 1-10, 12-13, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hebert et al. (US 20180008274) in view of Slazas et al. (US 20140277078) [hereinafter Slazas].
Regarding claim 1, Herbert discloses an occlusive device (10’, Fig. 4A) comprising:
an elongate polymer body 27, 27’ (Figs. 1 and 4A, para. 0134-0135 discloses that the element 27, 27’ may be a core mandrel or permanent core element (shown in the embodiment of Fig. 4A), wherein the core element may be made of metal, wire, or polymers, and para. 0161) including a cover 12,12’ formed of a fiber (Figs. 1 and 4A, para. 0149), wherein the cover 12, 12’ is configured to closely conform to at least the polymer body 27, 27’ (Fig. 4A, 0161);
a shape memory wire 29 (para. 0161 discloses that the tube 29 is formed of Nitinol) coupled with the polymer body 27 (Fig. 4B, para. 0161 further discloses that the tube 29 is screwed/twisted into the coil windings of the core element 27, Fig. 4B), wherein the shape memory wire 29 is secured to the elongate polymer body 27 (para. 0161); and
a pusher member 186 (Fig. 5E-G, para. 0184).
However, Herbert fails to disclose the pusher member includes a plurality of radial slots disposed along a length of the pusher member.
Slazas in the same field of endeavor teaches an occlusive device (5, Fig. 1A), comprising a pusher member 10 (Fig. 1A-B, para. 0036), wherein the pusher member 10 includes a plurality of radial slots 30 disposed along a length of the pusher member (Figs. 1A-B, para. 0037) for the purpose of enhancing flexibility and minimizing compression/buckling of the pusher member (para. 0037).
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 pusher member in Herbert to include the plurality of radial slots of Slazas in order to enhance flexibility and minimize compression/buckling of the pusher member (para. 0037).
Regarding claim 2, Modified Herbert discloses a coupler 29a at a proximal end (Figs. 5F-G of Herbert, para. 0184), the coupler 29a being coupled to the cover (Figs. 5F-G of Herbert, para. 0184; the coupler is coupled to the cover by their common connection to the shape memory wire 29).
Regarding claim 3, Modified Herbert discloses wherein the fiber is braided (para. 0149 of Herbert).
Regarding claim 4, Modified Herbert discloses wherein the fiber is knitted (para. 0149 of Herbert).
Regarding claim 5, Modified Herbert discloses wherein the shape memory wire 29 is formed of an instilled non-straight shape (para. 0162 of Herbert discloses that the tube 29 is screwed/twisted into the coil windings of core element 27, therefore the tube 29 is formed of a coil shape).
Regarding claim 6, Modified Herbert discloses wherein the cover 12 comprises a first and second fiber (para. 0149 of Herbert).
Regarding claim 7, Modified Herbert discloses wherein the shape memory wire 29 is interacted with cover 12 (para. 0135 of Herbert discloses that the micrograft 10 can also include a permanent core element such as shown in the embodiment of FIG. 4A; para. 0161 of Herbert discloses that the micrograft/cover 12...is seated within proximal coils of the tube 29, preferably screwed or twisted into the coil windings of the helical core element 27. Therefore, Examiner understands that because the core element (elongate polymer body) is integral to the micrograft which is formed by the braid (cover), the tube 29 (shape memory wire) twisting into the windings of the core meet the limitation of having a wire interlaced in the cover as claimed)
Regarding claim 8, Modified Herbert discloses wherein the cover 12 is formed to wrap around the shape memory wire 29 and the elongate polymer body 27 (see Fig. 4A of Herbert).
Regarding claim 9, Modified Herbert discloses wherein the elongate polymer body 27, cover 12 and shape memory wire 29 are secured together (para. 0153 of Herbert).
Regarding claim 10, Modified Herbert discloses wherein the elongate polymer body 27, cover 12, and shape memory wire 29 are secured together with a band (para. 0153 of Herbert).
Regarding claim 12, Modified Herbert discloses wherein the shape memory wire 29 is a shape memory metallic alloy (para. 0161 of Herbert).
Regarding claim 13, Modified Herbert discloses wherein the shape memory metallic alloy is nitinol (para. 0161 of Herbert).
Regarding claim 20, Herbert discloses an occlusive device (10’, Fig. 4A) comprising:
an elongate polymer body 27, 27’ (Figs. 1 and 4A, para. 0134-0135 discloses that the element 27, 27’ may be a core mandrel or permanent core element (shown in the embodiment of Fig. 4A), wherein the core element may be made of metal, wire, or polymers, and para. 0161) including a cover 12,12’ formed of a fiber (Figs. 1 and 4A, para. 0149), the cover 12, 12’ configured to closely conform to at least the polymer body 27, 27’ (Fig. 4A, 0161), herein the polymer body 27,27’ comprises radiopaque and shape memory properties (para. 0157); and
a pusher member 186 (Fig. 5E-G, para. 0184).
However, Herbert fails to disclose the pusher member includes a plurality of radial slots disposed along a length of the pusher member.
Slazas in the same field of endeavor teaches an occlusive device (5, Fig. 1A), comprising a pusher member 10 (Fig. 1A-B, para. 0036), wherein the pusher member 10 includes a plurality of radial slots 30 disposed along a length of the pusher member (Figs. 1A-B, para. 0037) for the purpose of enhancing flexibility and minimizing compression/buckling of the pusher member (para. 0037).
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 pusher member in Herbert to include the plurality of radial slots of Slazas in order to enhance flexibility and minimize compression/buckling of the pusher member (para. 0037).
Regarding claims 21, Modified Herbert discloses wherein the elongate polymer body 27, 27’ comprises a proximal end (para. 0161), the proximal end comprising a coupler 29a (Fig. 5F-G, para. 0184 of Herbert).
Regarding claims 22, Modified Wallace discloses wherein the polymer body 27, 27’ is formed in an instilled non-straight shape (Fig. 4A, para. 0161 of Herbert).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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