I. Applicant’s election without traverse of Species λ (claims 4-5) is acknowledged. Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant’s election without traverse of Species A (Fig. 3A: threads, suture anchor) is acknowledged. Claims 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 8-11 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. Claim 8 is indefinite because claim 8 could be interpreted in mutually exclusive ways: 1. not requiring an attachment, i.e. headless screw is configured for use with an attachment per lines 8-10, or 2. requiring an attachment, i.e. system per line 1 requires a headless screw per lines 2-8 and an attachment per lines 8-10. For examination purposes, interpretation 2 will be assumed.
III. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 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.
Claims 1, 2, 4, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehl et al. (US 2016/0287301; “Mehl” 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 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).
IV. 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl, 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).
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 the 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.
V. 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 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 11918264 (hereinafter ‘264). The following is provided to assist with mapping:
this application
‘264
claim 1
claim 1
claim 2
claim 2
claim 3
claim 4
claim 8
claim 1
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the claims of ‘264 is that the claims of ‘264 are more specific. Thus the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
Claims 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘264, as above, in view of Cox.
‘264 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.
VI. Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable after resolution of the above matters, positive recitation of the attachment, and rewriting the claim in independent form including all of the limitations of the base claim and any intervening claims.
VII. The following is an examiner’s statement of reasons for allowance or the indication of allowable subject matter: Claim 11 would distinguish over closest prior art cited in the 892. In an exemplary prior art reference, Mehl discloses an apparatus involving 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, but fails to disclose at least an attachment wherein the attachment is fully within the interior channel when coupled to the headless compression screw, and relationships thereof as claimed. There would have been no obvious reason(s) to modify the Mehl apparatus to satisfy at least this/these and/or each of applicant’s claimed limitations without the use of impermissible hindsight reasoning. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
VIII. 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
Prosecution Insights