DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 66-69 and 71-85 are pending in the application. Claims 1-65 and 70 have been canceled. Claims 66, 75, 78, 82, and 84 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/20/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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Claims 82, 84, and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 18, and 20 of U.S. Patent No. 12,201,291 B2 in view of Tornier (FR 2 900 561 A1, English Machine Translation provided in previous Office Action).
Regarding claim 82, US 12,201,291 B2 discloses a system for treating a patient, comprising: a bone anchor (claim 17) comprising: a proximal head portion comprising an eyelet comprising a first side and a second side (claim 17); a distal threaded portion extending distally from the proximal head portion (claim 17), the distal threaded portion configured for engaging bone (claim 17), wherein the proximal head portion comprises a larger diameter compared to a diameter of the distal threaded portion (claim 17); and a locking element (claim 17); and a suture comprising two free ends and configured to form two strands and a suture arc between the two strands (claim 17), wherein the locking element is configured to be advanced distally toward the distal threaded portion to secure the suture within the eyelet (claim 17), wherein the suture is configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet of the proximal head portion and the suture arc extends from the second side of the eyelet of the proximal head portion (claim 17). US 12,201,291 B2 fails to disclose that the locking element abuts a stop to be spaced apart from a distal surface of the eyelet.
In the same field of endeavor, Tornier teaches (Figure 4) a system for treating a patient, comprising: a bone anchor (2) comprising: a proximal head portion (31) comprising an eyelet (331) comprising a first side and a second side; a distal threaded portion (6) extending distally from the proximal head portion (Figure 4), the distal threaded portion configured for engaging bone (9), wherein the proximal head portion (31) comprises a larger diameter compared to a diameter of the distal threaded portion (Figure 4); and a locking element (61); and a suture (7) comprising two free ends, wherein the locking element is configured to be advanced distally toward the distal threaded portion to secure the suture within the eyelet (Figure 4), wherein the locking element (at 613) abuts a stop (333) to be spaced apart from a distal surface of the eyelet (Figure 4), wherein the suture is configured to extend through the eyelet (Figure 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the locking element to abut a stop to be spaced apart from a distal surface of the eyelet, as taught by Tornier. This modification would ensure better holding and immobilization of the suture threads between the locking element and the distal surface of the eyelet (page 9 of English Machine Translation).
Regarding claim 84, US 12,201,291 B2 as modified by Tornier teaches a distal surface of the locking element and a distal surface of the eyelet define a gap between 0.005 inches and 0.02 inches (claim 18).
Regarding claim 85, US 12,201,291 B2 as modified by Tornier teaches a suture passer configured to deliver the suture (claim 20).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 66, 71, 73, and 74 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gedebou (US 2005/0090827 A1) in view of Gerber et al. (US 2007/0203498 A1) ("Gerber").
Regarding claim 66, Gedebou discloses (Figure 4) a system for treating a patient, comprising: a bone anchor comprising: a longitudinal axis; a proximal head portion (32) comprising an eyelet comprising a first side and a second side, wherein the eyelet comprises a through axis extending from the first side to the second side; a distal threaded portion (14) extending distally from the proximal head portion, wherein the distal threaded portion extends on the longitudinal axis, the distal threaded portion configured to engage bone (12), wherein the proximal head portion comprises a larger cross-sectional dimension compared to a cross-sectional dimension of the distal threaded portion (Figure 4); a locking element (38); and a suture (18), wherein the locking element (38) is configured to advance distally within the proximal head portion to secure the suture within the eyelet (paragraph 0057), wherein the suture is configured to extend through the eyelet
Gedebou fails to explicitly disclose that the through axis of the eyelet intersects the longitudinal axis. Gedebou also fails to disclose that the suture is configured to form two strands and a suture arc between the two strands, wherein the suture is configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet of the proximal head portion and the suture arc extends from the second side of the eyelet of the proximal head portion.
In the same field of endeavor, Gerber teaches (Figures 1-3) a system for treating a patient comprising a suture with two free ends and configured to form two strands and a suture arc (61) between the two strands, wherein a locking element (32) is configured to advance distally within a cylindrical body (12) of the anchor element (10) to secure the suture within an eyelet (24), wherein the suture is configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet and the suture arc extends from the second side of the eyelet (Figure 3; paragraphs 0079 and 0081). Gerber teaches (Figures 1-3) that the bone anchor comprises a longitudinal axis (26) and the eyelet comprises a through axis extending from the first side to the second side of the anchor, wherein the through axis intersects the longitudinal axis (Figures 1 and 3).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the through axis of the eyelet to intersect the longitudinal axis and to modify the suture disclosed by Tornier such that it is configured to form two strands and a suture arc between the two strands and to modify the suture to be configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet of the proximal head portion and the suture arc extends from the second side of the eyelet of the proximal head portion, as taught by Gerber. These modifications would provide a loop via which the soft tissue is connected to the bone anchor, and without the need to tie a bulky knot (Gerber, paragraphs 0079 and 0081).
Regarding claim 71, Gedebou as modified by Gerber teaches (Gedebou, Figure 4) a distal surface of the locking element (38) and a distal surface of the eyelet define a gap capable of avoiding over-compression of the locking element on the suture (Gedebou, paragraph 0057).
Regarding claim 73, the system taught by Gedebou as modified by Gerber is capable of treating obstructive sleep apnea.
Regarding claim 74, the suture (18) taught by Gedebou is capable of being attached to a mandible with the bone anchor.
Claim 72 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gedebou (US 2005/0090827 A1) in view of Gerber et al. (US 2007/0203498 A1) ("Gerber") as applied to claim 66 above, and further in view of Kaplan (US 2008/0203498 A1).
Regarding claim 72, Gedebou as modified by Gerber teaches the invention substantially as claimed. However, the combined teaching fails to teach a suture passer.
In the same field of endeavor, Kaplan teaches (Figures 1-8) a system for treating a patient comprising a bone anchor (300), a suture (530) comprising two free ends and configured to form two strands and a suture arc between the two strands, wherein the suture is secured through the bone anchor such that the two strands of the suture extend from the first side of the anchor and the suture arc extends from the second side of the anchor; a suture passer (100) to pass and deliver the suture through the soft tissue (paragraph 0037).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system taught by Gedebou as modified by Gerber to further include a suture passer, as taught by Kaplan. This modification would provide a device to loop the suture through the soft tissue, before securing the soft tissue to bone (Kaplan, paragraph 0037).
Claims 82-84 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tornier (FR 2 900 561 A1), English Machine Translation provided in previous Office Action) in view of Gerber et al. (US 2007/0203498 A1) ("Gerber").
Regarding claim 82, Tornier discloses (Figure 4) a system for treating a patient, comprising: a bone anchor (2) comprising: a proximal head portion (31) comprising an eyelet (331) comprising a first side and a second side; a distal threaded portion (6) extending distally from the proximal head portion (Figure 4), the distal threaded portion configured for engaging bone (9), wherein the proximal head portion (31) comprises a larger diameter compared to a diameter of the distal threaded portion (Figure 4); and a locking element (61); and a suture (7) comprising two free ends, wherein the locking element is configured to be advanced distally toward the distal threaded portion to secure the suture within the eyelet (Figure 4), wherein the locking element (at 613) abuts a stop (333) to be spaced apart from a distal surface of the eyelet (Figure 4), wherein the suture is configured to extend through the eyelet (Figure 4).
Tornier fails to disclose that the suture is configured to form two strands and a suture arc between the two strands and the suture is configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet of the proximal head portion and the suture arc extends from the second side of the eyelet of the proximal head portion. However, Tornier discloses the eyelet may be provided for the passage of several suture threads, the number being able to be optimized according to the application (page 9 of English Machine Translation).
In the same field of endeavor, Gerber teaches (Figure 3) a system for treating a patient comprising a suture with two free ends and configured to form two strands and a suture arc (61) between the two strands, wherein a locking element (32) is configured to advance distally within a cylindrical body (12) of the anchor element (10) to secure the suture within an eyelet (24), wherein the suture is configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet and the suture arc extends from the second side of the eyelet (Figure 3; paragraphs 0079 and 0081).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the suture disclosed by Tornier such that it is configured to form two strands and a suture arc between the two strands and to modify the suture to be configured to extend through the eyelet such that the two strands of the suture extend from the first side of the eyelet of the proximal head portion and the suture arc extends from the second side of the eyelet of the proximal head portion, as taught by Gerber. This modification would provide a loop via which the soft tissue is connected to the bone anchor, and without the need to tie a bulky knot (Gerber, paragraphs 0079 and 0081).
Regarding claim 83, Tornier as modified by Gerber teaches that the locking element (61) is configured to advance by rotation (see pages 8-9 of English Machine Translation).
Regarding claim 84, Tornier as modified by Gerber teaches (Tornier, Figure 4) that a distal surface of the locking element (61) and a distal surface of the eyelet define a gap. However, the combined teaching fails to explicitly teach that the gap is between 0.005 and 0.02 inches. Tornier as modified by Gerber teaches the general conditions of the claim in that the suture is locked and immobilized within the gap (see Figure 4 and pages 8-9 of English Machine Translation).
It would have been obvious to one having ordinary skill in the art at the time the invention was made, to configure the bone anchor and suture, SO that the gap is between 0.005 inches and 0.02 inches, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 85 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tornier (FR 2 900 561 A1), English Machine Translation provided in previous Office Action) in view of Gerber et al. (US 2007/0203498 A1) ("Gerber") as applied to claim 82 above, and further in view of Kaplan (US 2008/0203498 A1).
Regarding claim 85, Tornier as modified by Gerber teaches the invention substantially as claimed. However, the combined teaching fails to teach a suture passer configured to deliver the suture.
In the same field of endeavor, Kaplan teaches (Figures 1-8) a system for treating a patient comprising a bone anchor (300), a suture (530) comprising two free ends and configured to form two strands and a suture arc between the two strands, wherein the suture is secured through the bone anchor such that the two strands of the suture extend from the first side of the anchor and the suture arc extends from the second side of the anchor; a suture passer (100) to pass and deliver the suture through the soft tissue (paragraph 0037).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system taught by Tornier as modified by Gerber to further include a suture passer configured to deliver the suture, as taught by Kaplan. This modification would provide a device to loop the suture through the soft tissue, before securing the soft tissue to bone (Kaplan, paragraph 0037).
Allowable Subject Matter
Claims 67-69 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 75-81 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Claim 67 recites that the locking element comprises a screw. This limitation, in combination with the limitations of claim 66 as amended, is not disclosed or suggested in the prior art of record. The newly cited Gedebou reference fails to disclose or suggest that the locking element comprises a screw. The Tornier reference discloses a locking element comprising a screw. However, the Tornier reference fails to disclose or suggest the new limitations in claim 66.
Claim 68 recites that the locking element comprises a hex opening. This limitation, in combination with the limitations of claim 66 as amended, is not disclosed or suggested in the prior art of record. The newly cited Gedebou reference fails to disclose or suggest that the locking element comprises a hex opening. The Tornier reference discloses that the locking element comprises a hex opening. However, the Tornier reference fails to disclose or suggest the new limitations in claim 66.
Claim 69 recites a screwdriver configured to advance the locking element. This limitation, in combination with the limitations of claim 66 as amended, is not disclosed or suggested in the prior art of record. The newly cited Gedebou reference fails to disclose or suggest a screwdriver configured to advance the locking element. The Tornier reference discloses a screwdriver configured to advance the locking element. However, the Tornier reference fails to disclose or suggest the new limitations in claim 66.
The following is an examiner’s statement of reasons for allowance: claim 75 has been amended to further recite that the distal threaded portion is integrally formed and extending distally from the proximal head portion and that the locking element is configured to rotate relative to the proximal head portion and the distal threaded portion. These limitations, in combination with the other limitations in claim 75, are not disclosed or suggested in the prior art of record. The Tornier reference fails to disclose or suggest the distal threaded portion integrally formed. The Tornier reference further fails to disclose that the locking element is configured to rotate relative to the proximal head portion and the distal threaded portion. Claims 76-81 are all dependent on claim 75, thus are also allowable over the prior art of record.
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.”
Response to Arguments
Applicant’s arguments with respect to claims 66, 71-74, and 82-85 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. The Gedebou reference is newly cited in the rejections of claims 66 and 71-74. An alternate embodiment (Figure 4) of the previously cited Tornier reference has been cited to reject claims 82-85.
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 CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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