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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12 of U.S. Patent No. 12,364,496 in view of Yang (US 10,016,206).
Regarding the application claims 1 and 2, the patent claims 1 and 2 recite the invention as claimed but fail to recite that individual ones of the struts have a shape that undulates about the axis (application claim 1, line 4).
However Yang discloses a similar system for removing clots as described above having a clot treatment device (40C) having undulating struts (42) as claimed (Figure 5A) which perform equivalently to straight struts for removing unwanted material from a blood vessel (col. 6, lines 40-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the struts of the patent claims 1 and 2 with the undulating shape of Yang as a simple substitution of one known strut shape for another to obtain predictable results (MPEP 2143 (I)(B)).
Regarding the application claims 3-11, the patent claims 3-10 and 12 recite the limitations as claimed, respectively.
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.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 10,016,206).
Regarding claim 18, Yang discloses a clot treatment device (40C; Figure 1A; Abstract), compressing: a proximal end portion; a distal end portion; and a plurality of struts (42) extending generally axially along an axis between the proximal end portion and the distal end portion, wherein movement of the distal end portion toward the proximal end portion is configured to radially expand the struts to an expanded position (col. 7, lines 38-50).
Yang discloses that in the expanded position individual ones of the struts have either (a) a hook-like shape (44”) when viewed along the axis (Figure 4) or (b) a shape that undulates about the axis between the proximal end portion and the distal end portion (Figure 5A) but does not explicitly state that both (a) and (b) are embodied in one device.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the hook-like shape(s) of Figure 4 on the struts of Figure 5A in order to improve the ability of this embodiment to capture debris using the hooks (col. 11, lines 5-8).
Regarding claim 19, the clot treatment device does not include any cross-members interconnecting the struts (evident from Figures 4 and 5A).
Regarding claim 20, the hook-like shape extends radially away from the axis and at least partially curves back toward the axis (see left-most hooks in Figure 4).
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 10,016,206) in view of Bonnette et al. (US 2006/0229645).
Regarding claim 1, Yang discloses a system for removing clot material within a body vessel (Abstract), comprising: a clot treatment device (40C; Figure 1B) having a first end portion (proximal or distal end portion 42a), a second end portion (the other of the proximal or distal end portion 42a not designated as the first end portion), and a plurality of struts (42) extending along the axis between the first end portion and the second end portion, wherein the individual ones of the struts have a shape that undulates about the axis between the first end portion and the second end portion (as shown in Figure 5A); a first elongate member (30/40A/48/40B/48; alternatively, the system can have only one cage - col. 14, lines 23-24) coupled to one end portion and a second elongate member (wire - col. 7, lines 41-42) coupled to the other end portion.
Yang fails to disclose that the elongate members are coupled to a handle having an actuator as claimed.
Bonnette et al. disclose elongate members (14 and 54) having distal ends coupled to opposite end portions of a similar clot treatment device (18) and having proximal ends coupled to a handle (150/20; Figure 7), wherein actuation of an actuator (152) of the handle is configured to move one elongate member (54) relative to the other elongate member to reduce a distance between the end portions to radially expand the struts (¶[0065], [0066]). Alternatively, Bonnette et al. disclose a similar handle (58) having different actuator (12/30/32) mechanism (Figure 1; ¶[0056]). Bonnette et al. disclose that the handle and actuator mechanisms allow precise control over the amount and rate of expansion of the clot treatment device (¶[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted one of the above handle and actuator of Bonnette et al. to control movement of the elongate members of Yang as claimed in order to provide precise control over the amount and rate of expansion of the clot treatment device.
Regarding claim 2, the clot treatment device is configured to be radially expanded within a stent positioned within the body vessel (evident from Figure 9C of Yang when expanded within an appropriately sized stent and vessel).
Regarding claim 3, the first end portion is a proximal end portion of the clot treatment device, and wherein the second end portion is a distal end portion of the clot treatment device (when using the Figure 1 handle/actuator of Bonnette et al.).
Regarding claim 4, the second elongate member extends through a lumen of the first elongate member (14 extends through 58 in Bonnette et al., two analogous coaxial shafts would be provided to Yang in the above modification).
Regarding claim 5, the first end portion is a distal end portion of the clot treatment device, and wherein the second end portion is a proximal end portion of the clot treatment device (when using the Figure 7 handle/actuator of Bonnette et al.).
Regarding claim 6, actuation of the actuator (152 of Bonnette et al.) is configured to move both the first elongate member and the second elongate member relative to the handle (depending on which part of the handle is grasped; not both at the same time).
Regarding claim 7, the handle is rotatable to rotate the clot treatment device relative to the implant (either handle above could be grasped and rotated as claimed).
Regarding claim 8, the handle is longitudinally movable to move the clot treatment device longitudinally relative to the body vessel (either handle above could be grasped and moved longitudinally as claimed).
Regarding claim 9, the handle is rotatable and longitudinally movable to rotate and longitudinally move the clot treatment device relative to the implant (either handle above could be grasped and rotated and moved as claimed).
Regarding claim 10, the system further comprises a guide catheter (20 of Yang), wherein the clot treatment device is configured to be (a) covered within the guide catheter in a first state and (b) uncovered from the guide catheter and expanded to a second state (col. 8, lines 65-67 of Yang).
Regarding claim 11, the clot treatment device does not include any cross-members interconnecting the struts (evident from Figure 5A of Yang).
Regarding claim 12, the actuator is a rotatable knob (152 of Bonnette et al.) or a slider.
Regarding claim 13, the handle includes an indicator (168 of Bonnett et al.) configured to indicate an amount that the struts are radially expanded (¶[0066]).
Regarding claim 14, Yang discloses a system for removing clot material within a body vessel (Abstract), comprising: a clot treatment device (40C; Figure 1B) having a first end portion (proximal or distal end portion 42a), a second end portion (the other of the proximal or distal end portion 42a not designated as the first end portion), and a plurality of struts (42) extending along the axis between the first end portion and the second end portion; a first elongate member (30/40A/48/40B/48; alternatively, the system can have only one cage - col. 14, lines 23-24) coupled to one end portion and a second elongate member (wire - col. 7, lines 41-42) coupled to the other end portion; wherein in an expanded position individual ones of the struts have a hook-like shape (44”) when viewed along a longitudinal axis (Figure 4).
Yang fails to disclose that the elongate members are coupled to a handle having an actuator as claimed.
Bonnette et al. disclose elongate members (14 and 54) having distal ends coupled to opposite end portions of a similar clot treatment device (18) and having proximal ends coupled to a handle (150/20; Figure 7), wherein actuation of an actuator (152) of the handle is configured to move one elongate member (54) relative to the other elongate member to reduce a distance between the end portions to radially expand the struts (¶[0065], [0066]). Alternatively, Bonnette et al. disclose a similar handle (58) having different actuator (12/30/32) mechanism (Figure 1; ¶[0056]). Bonnette et al. disclose that the handle and actuator mechanisms allow precise control over the amount and rate of expansion of the clot treatment device (¶[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted one of the above handle and actuator of Bonnette et al. to control movement of the elongate members of Yang as claimed in order to provide precise control over the amount and rate of expansion of the clot treatment device.
Regarding claim 15, the hook-like shape extends radially away from the axis and at least partially curves back toward the axis (see left-most hooks in Figure 4 of Yang).
Regarding claim 16, the clot treatment device does not include any cross-members interconnecting the struts (evident from Figure 4 of Yang).
Regarding claim 17, the handle is rotatable and longitudinally movable to rotate and longitudinally move the clot treatment device relative to the implant with the struts in the expanded position (either handle above could be grasped and rotated and moved as claimed).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
