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 argues in the response filed 06/09/2026 that prior art Kearns or Wright disclose the track portion comprising a series of gear teeth. It is to be noted, the claim does not state what the track portion does, or how it is spaced/engaged with the rest of the tamper body let alone the tamper. New rejections with respect to Kearns in view of Akerfeldt/Cantanese and Wright in view of Akerfeldt/Cantanese has been made below.
The applicant argues the double patent rejection be held in abeyance. The examiner acknowledges the request, but the double patenting rejections is still maintained below.
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 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 6,156,056 to Kearns in view of U.S. Patent 6,860,895 to Akerfeldt and/or U.S. Patent Publication 2007/0142846 to Cantanese.
As to claim 8, Kearns discloses a tamper (the device 12 with the suture buttress 200/400), comprising: a tamper body (402, col. 7 ll. 5-20, figure 23-25) that is elongate along a longitudinal direction, the tamper body defining a distal end, a proximal end opposite the distal end, and an outer surface; a tamper channel (406) that extends from the proximal end to the distal end along the longitudinal direction (figure 24), the tamper channel configured to receive a suture assembly therethrough (col. 7 ll. 5-20, figure 10, col. 4 ll. 33-53, the channel 406 is capable of being used with a system that can comprise a suture, therefore the channel can receive a suture assembly), at least one first cut (distal 418, figure 24, 25) at the distal end and that extends from the outer surface toward the tamper channel; and at least one second cut (distal 428, figure 24, 25) at the distal end opposite the first cut and that extends from the outer surface toward the tamper channel, wherein the at least one first cut and the least one second cut are configured to permit the distal end of the tamper to flex (figure 25). The specification does not define “tamper/tamper body” and there are no further claim limitations to the tamper body. Since the suture buttress reads on the structural limitations, can receive a suture assembly, would be able to push down something that is distal to the distal end, the suture buttress 400 can read on a tamper body.
However, Kearns is silent about the track portion comprising a series of gear teeth. It is noted that the track portion and series of gear teeth does not have any claim limitations linking it to the rest of the tamper and/or to the tamper body. Akerfeldt teaches a similar device (anchor delivery, abstract) having the track portion (161) comprising a series of gear teeth (163) for the purpose of driving distal parts of the device. Cantanese teaches a similar device (anchor delivery, abstract) having the track portion (paragraph 264, figure 15a-d) comprising a series of gear teeth (paragraph 264, figure 15a-d) for the purpose of assisting in anchor delivery. Both Akerfeldt and Cantanese teaches that is known that a track portion comprises a series of gear teeth can be a part of an actuation mechanism to help deliver a device. The claim does not state how the track portion engages and/or is spaced with the tamper body. Kearns does disclose that a distal part of the device can be moved. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the tamper of Kearns comprise the track portion comprising a series of gear teeth in order for assisting in actuation of the device.
As to claim 9, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the at least one first cut and the at least one second cut are configured to permit the distal end to flex more readily along a first plane than a second plane that is perpendicular to and intersects the first plane (figure 25). The buttress can more easily bend in the plane as seen in figure 25, then out of the plane based on the slits.
As to claim 10, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the at least one first cut and the at least one second cut extend only partially around the outer surface (figure 23, 24).
As to claim 11, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the first cuts and the second cut are separated by a portion of the outer surface (figure 23, 24).
As to claim 12, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the at least one first cut is a set of first cuts (figure 24, the set of slits 418), and the least one second cut is a set of second cuts (the set of 428), wherein the set of first cuts and the set of second cuts are offset with respect to each other along the longitudinal direction (figure 23-25).
As to claim 13, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the first cut is configured to open and the second cut is configured to compress when the tamper flexes along the plane (figure 25).
As to claim 14, with the device of Kearns and Akerfeldt/Cantanese above, Kearns discloses the first cut and the second cut are slits (col. 7 ll. 13-20).
Claims 8, 10, 11, 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 7,963,952 to Wright in view of U.S. Patent 6,860,895 to or U.S. Patent Publication 2007/0142846 to Cantanese.
As to claim 8, Wright discloses a tamper (10, the catheter can read on a tamper, see below), comprising: a tamper body (90/100, col. 6 ll. 30-col. 7 ll. 2, figure 3e-4a) that is elongate along a longitudinal direction, the tamper body defining a distal end, a proximal end opposite the distal end, and an outer surface; a tamper channel (lumen of catheter, figure 3e,g, 4a, 1, col. 3 ll. 66-col. 4 ll. 57) that extends from the proximal end to the distal end along the longitudinal direction (figure 1), the tamper channel configured to receive a suture assembly therethrough (col. 4 ll. 21-39, figure 1, the catheter is able to receive a medical instrument which can read on a suture assembly), at least one first cut (92, figure 3e; or 102/110, figure 3g, 4a ) at a distal portion and that extends from the outer surface toward the tamper channel; and at least one second cut (94, figure 3e; or 104/112, figure 3g, 4a) at the distal portion opposite the first cut and that extends from the outer surface toward the tamper channel (the second cut can be on the opposite side of the catheter, at least disclosed by figure 4a which can a slit orientation of previous slits), wherein the at least one first cut and the least one second cut are configured to permit the distal portion of the tamper to flex (col. 3 ll. 66-col. 4 10). The catheter can have different slit orientations/shapes that can read on the cuts as claimed, i.e. the wavy cuts of figure 3e, spiral cuts of figure 3g. The cuts as seen in figure 4a can be used as the cuts for the previous cuts, which can be the spiral cuts of figure 3g. Further the cuts allow the catheter to expand which can allow the “tamper to flex”. The specification does not define “tamper / tamper body” and there are no further limitations to the tamper body. Since the catheter reads on the structural limitations, can receive a suture assembly, would be able to manipulate something as the catheter expands, or manipulate something that is positioned within the catheter, the catheter can read on a tamper.
However, Wright is silent about the track portion comprising a series of gear teeth. It is noted that the track portion and series of gear teeth does not have any claim limitations linking it to the rest of the tamper body. Akerfeldt teaches a similar device (anchor delivery, abstract) having the track portion (161) comprising a series of gear teeth (163) for the purpose of driving distal parts of the device. Cantanese teaches a similar device (anchor delivery, abstract) having the track portion (paragraph 264, figure 15a-d) comprising a series of gear teeth (paragraph 264, figure 15a-d) for the purpose of assisting in anchor delivery. Both Akerfeldt and Cantanese teaches that is known that a track portion comprises a series of gear teeth can be a part of an actuation mechanism to help deliver a device. The claim does not state how the track portion engages and/or is spaced with the tamper body. Wright does disclose that the device can be used to deliver other devices, which would have an actuation mechanism. The device would then be a part of the “tamper”. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the tamper of Wright comprise the track portion comprising a series of gear teeth in order for assisting in actuation of the device.
As to claim 10, with the device of Wright and Akerfeldt/Cantanese above, Wright discloses the at least one first cut and the at least one second cut extend only partially around the outer surface (figure 3e,g).
As to claim 11, with the device of Wright and Akerfeldt/Cantanese above, Wright discloses the first cuts and the second cut are separated by a portion of the outer surface (figure 3e,g).
As to claim 14, with the device of Wright and Akerfeldt/Cantanese above, Wright discloses the first cut and the second cut are slits (col. 6 ll. 30 to col. 7 ll. 2).
As to claim 15, with the device of Wright and Akerfeldt/Cantanese above, Wright discloses the first cut and the second cut are spiral cuts (figure 3g).
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.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,089,828. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims a tamper (claim 1), comprising: a tamper body (claim 1) that is elongate along a longitudinal direction, the tamper body defining a distal end (claim 1), a proximal end (claim 1) opposite the distal end, and an outer surface (claim 1); a tamper channel (claim 1) that extends from the proximal end to the distal end along the longitudinal direction, the tamper channel configured to receive a suture assembly therethrough (claim 1, the suture assembly extends through the channel), at least one first cut (claim 1) at a distal portion and that extends from the outer surface toward the tamper channel (claim 1); at least one second cut (claim 1) at the distal portion opposite the first cut and that extends from the outer surface toward the tamper channel (claim 1), wherein the at least one first cut and the least one second cut are configured to permit the distal portion of the tamper to flex (claim 1), and a track portion (claim 4,5) comprising a series of gear teeth (claim 4,5, the track portion engages with a gear, so the track portion will have gear teeth).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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