I. Applicant’s arguments 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 arguments.
II. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 8, the limitation “an attachment including a threaded portion configured to engage a thread of a first trailing end portion the interior channel” can be indefinite because it can be unclear whether or not: 1. the interior channel is required to have a first trailing end portion; or 2. The interior channel is required to have a first trailing end portion and the first trailing end portion is required to have a thread. If these structures are required, they should be positively recited, e.g. “the interior channel comprises a first trailing end, and the first trailing end comprises a thread,” for example. For examination, the limitation will be interpreted in the broader sense, which is not requiring a first trailing portion or a thread of a first trailing portion, i.e. only the capability of use therewith is required.
III. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102/103 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1, 2, 4, and 5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Mehl et al. (US 2016/0287301; “Mehl” herein) or, in the alternative, under 35 U.S.C. 103 as obvious over Mehl in view of Ainsworth et al. (US 8747472; “Ainsworth” herein).
Regarding claim 1, Mehl discloses a headless compression screw (e.g. 400) comprising: a hollow root portion (e.g. 403) having a leading end and a trailing end and an interior channel (e.g. 412) extending from the leading end to the trailing end, and an exterior screw thread (e.g. 402) formed on at least a portion of an exterior of the hollow root portion between the leading end and the trailing end, wherein a first trailing end portion of the interior channel comprises a thread (e.g. 416) configured to engage with an attachment.
Regarding the limitation “a diameter of the interior channel is less than a diameter of the first trailing end portion,” Mehl may disclose a first trailing end portion (e.g. 415, 416) and a diameter of the interior channel (e.g. 412) is less than a diameter (e.g. at 415) of the first trailing end portion (e.g. Figs. 28-29). Alternatively, regarding the relative diameters of threaded portion 416 and channel 412, Ainsworth shows a diameter of a threaded portion 532 being larger than a channel 516 and such that delivery over a guidewire is facilitated (e.g. Fig. 3; col. 6, lines 6-11). It is considered obvious to have applied the teaching of a diameter of a threaded portion being larger than a channel per Ainsworth to the threaded portion and channel of Mehl in order to facilitate delivery over a guidewire, thereby enabling implantation of a device by a surgeon.
Regarding claim 2, Mehl discloses a pitch of the exterior screw thread changes from the leading end to the trailing end (e.g. pitch at 432 can be smaller or greater than external threads of any screw component; para. [0119], lines 3-7; Fig. 35; Fig. 32).
Regarding claim 4, Mehl further discloses the interior channel comprises a second trailing end portion (e.g. a portion near 409), wherein a shortest distance between the first trailing end portion and the trailing end is greater than a shortest distance between the second trailing end portion and the trailing end (e.g. a trailing end portion of 416 is located farther than a trailing end portion near 409; Fig. 29).
Regarding claim 5, Mehl further discloses an inside diameter of the second trailing end portion is greater than an inside diameter of the first trailing end portion (e.g. a portion near 409 at 415 has a wider diameter than a portion of 416; Fig. 29).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl or Mehl/Ainsworth, as above, in view of Jensen et al. (2006/0106390; “Jensen” herein).
Mehl is silent regarding the exterior screw thread being opposite of the thread of the first trailing end portion of the interior channel.
Jensen discloses a bone fastener wherein a thread may be left-handed or right-handed and may extend with the same or opposite handedness as another thread (para. [0022], lines 13-16).
It is considered obvious to have applied the teaching of a thread being left-handed or right-handed and extending with the same or opposite handedness as another thread per Jensen to the exterior screw thread and the thread of the first trailing end portion of the interior channel per Mehl, in order to provide a handedness combination suitable for providing securement functions.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mehl in view of Cox et al. (2004/0093030; “Cox” herein) and Ainsworth.
Mehl discloses a system comprising: a headless compression screw (e.g. 400) including: a hollow root portion (e.g. 403) having a leading end and a trailing end and an interior channel (e.g. 412) extending from the leading end to the trailing end, and an exterior screw thread (e.g. 402) formed on at least a portion of an exterior of the hollow root portion between the leading end and the trailing end, wherein a first trailing end portion of the interior channel comprises a thread (e.g. 416) configured to engage with an attachment.
Mehl does not disclose an attachment, the attachment including a threaded portion configured to engage the thread of the portion of the trailing end of the interior channel; the attachment comprises a suture anchor configured to couple suture to the headless compression screw; and the suture anchor includes an aperture configured to receive the suture.
Cox discloses a fastener (e.g. 30) having a head (at 42; Fig. 1) such that a channel (e.g. at 50) comprises a trailing end portion having threads (e.g. 46), the head comprises a drive connection (e.g. 40), a suture anchor (e.g. 32) comprises threads (e.g. 70) configured to mate with the threads (e.g. 46), and the suture anchor is configured to couple to and receive the suture via an aperture (e.g. 62).
It is considered obvious to have applied the teaching of a head such that a channel comprises a trailing end portion having threads; the head comprises a drive connection; a suture anchor comprises threads configured to mate with the threads of the trailing end portion, and the suture anchor is configured to couple to and receive suture via an aperture, per Cox to the head and channel per Mehl, in order to accommodate surgical procedures that may utilize sutures, such as attachment of anatomical structures to one another.
Regarding the limitation “a diameter of the interior channel is less than a diameter of the first trailing end portion,” Mehl may disclose a first trailing end portion (e.g. 415, 416) and a diameter of the interior channel (e.g. 412) is less than a diameter (e.g. at 415) of the first trailing end portion (e.g. Figs. 28-29). Alternatively, regarding the relative diameters of threaded portion 416 and channel 412, Ainsworth shows a diameter of a threaded portion 532 being larger than a channel 516 and that such a configuration allows delivery over a guidewire (e.g. Fig. 3; col. 6, lines 6-11). It is considered obvious to have applied the teaching of a diameter of a threaded portion being larger than a channel per Ainsworth to the threaded portion and channel of Mehl in order to facilitate delivery over a guidewire, thereby facilitating placement of an implant in a patient by a surgeon.
IV. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 11918264 (hereinafter ‘264) in view of Ainsworth.
The claims of the patent discloses all limitations including an interior channel and a trailing end portion thread but not that a diameter of the interior channel is less than a diameter of the trailing end portion thread. Ainsworth shows a diameter of a trailing end portion thread 532 being larger than a channel 516 and that such a configuration allows delivery over a guidewire (e.g. Fig. 3; col. 6, lines 6-11). It is considered obvious to have applied the teaching of a diameter of a threaded portion thread being larger than a channel per Ainsworth to the trailing end portion thread and the interior channel of the patent in order to facilitate delivery over a guidewire, thereby facilitating placement of an implant in a patient by a surgeon.
Claims 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘264 and Ainsworth, as above, in view of Cox.
‘264 further does not disclose the attachment comprises a suture anchor configured to couple suture to the headless compression screw; and the suture anchor includes an aperture configured to receive the suture.
Cox discloses a fastener (e.g. 30) having a head (at 42; Fig. 1) such that a channel (e.g. at 50) comprises a trailing end portion having threads (e.g. 46), the head comprises a drive connection (e.g. 40), a suture anchor (e.g. 32) comprises threads (e.g. 70) configured to mate with the threads (e.g. 46), and the suture anchor is configured to couple to and receive the suture via an aperture (e.g. 62).
It is considered obvious to have applied the teaching of a head such that a channel comprises a trailing end portion having threads; the head comprises a drive connection; a suture anchor comprises threads configured to mate with the threads of the trailing end portion, and the suture anchor is configured to couple to and receive suture via an aperture, per Cox to the attachment and interior screw thread per claim 1 of ‘264, in order to accommodate surgical procedures that may utilize sutures, such as attachment of anatomical structures to one another.
V. Claim 11 is allowed.
VI. 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.
VII. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN A. SEVILLA whose telephone number is (571)270-5621. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIAN A SEVILLA/ Primary Examiner, Art Unit 3775
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