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 66-85 are pending in the application. Claims 1-65 have been canceled. Claims 66-85 are new.
Claim Objections
Claim 78 is objected to because of the following informalities: in line 1, “the minimum” should read --a minimum--. Appropriate correction is required.
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 66, 67, 69, 70, 72, 75, 78, 79, 82, 84, and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 10, 12, 14, 17, 18, and 20 of U.S. Patent No. 12,201,291 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 66, US 12,201,291 B2 discloses a system for treating a patient, comprising: a bone anchor (claim 1) comprising: a proximal head portion comprising an eyelet comprising a first side and a second side (claim 1); a distal threaded portion extending distally from the proximal head portion, the distal threaded portion configured to engage bone, wherein the proximal head portion comprises a larger cross-sectional dimension compared to a cross-sectional dimension of the distal threaded portion (claim 1); and a locking element (claim 1); and a suture comprising two free ends and configured to form two strands and a suture are between the two strands, wherein the locking element is configured to advance distally within the proximal head portion to secure the suture within the eyelet (claim 1), 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 are extends from the second side of the eyelet of the proximal head portion (claim 1).
Regarding claim 67, US 12,201,291 B2 discloses the locking element comprises a screw (claim 1).
Regarding claim 69, US 12,201,291 B2 discloses a screwdriver configured to advance the locking element (claim 6).
Regarding claim 70, US 12,201,291 B2 discloses a longitudinal axis transverse to a longitudinal axis of the bone anchor (claim 2).
Regarding claim 72, US 12,201,291 B2 discloses a suture passer (claim.9).
Regarding claim 75, US 12,201,291 B2 discloses a system for treating a patient, comprising: a bone anchor (claim 10) comprising: a proximal head portion comprising an eyelet comprising a first side and a second side (claim 10); a distal threaded portion extending distally from the proximal head portion, the distal threaded portion configured to engage bone, wherein the proximal head portion is enlarged relative to the distal threaded portion (claim 10); and a locking element (claim 10), and a suture comprising two free ends and configured to form two strands and a suture are between the two strands (claim 10), wherein the locking element is configured to be rotated distally to secure the suture within the eyelet, 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 are extends from the second side of the eyelet of the proximal head portion (claim 10).
Regarding claim 78, US 12,201,291 B2 discloses the minimum pull-out force of the suture is between 4 kgf to 8 kgf when the suture is secured within the eyelet (claim 12).
Regarding claim 79, US 12,201,291 B2 discloses the bone anchor is configured to be implanted in a mandible (claim 14).
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).
Regarding claim 84, US 12,201,291 B2 discloses 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 discloses 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 and 73-84 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tornier (FR 2 900 561 A1), English Machine Translation attached) in view of Gerber et al. (US 2007/0203498 A1) (“Gerber”).
Regarding claim 66, Tornier discloses (Figures 1-4) a system for treating a patient, comprising: a bone anchor (1) comprising: a proximal head portion (31) comprising an eyelet (331) comprising a first side and a second side; a distal threaded portion (531) extending distally from the proximal head portion (Figure 3), the distal threaded portion configured to engage bone (9), wherein the proximal head portion comprises a larger cross-sectional dimension compared to a cross-sectional dimension of the distal threaded portion (Figure 3); and a locking element (51); and a suture (7) comprising two free ends, wherein the locking element (51) is configured to advance distally within the proximal head portion to secure the suture within the eyelet (Figure 2), wherein the suture is configured to extend through the eyelet (Figures 1-3).
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.
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 67, Tornier as modified by Gerber teaches (Tornier, Figure 1) that the locking element (51) comprises a screw (533).
Regarding claim 68, Tornier as modified by Gerber teaches (Tornier, Figure 1) that the locking element comprises a hex opening (511).
Regarding claim 69, Tornier as modified by Gerber teaches a screwdriver configured to advance the locking element (operating key, page 6 of English Machine Translation).
Regarding claim 70, Tornier as modified by Gerber teaches (Tornier, Figures 1-3) that the eyelet (331) comprises a longitudinal axis transverse to a longitudinal axis of the bone anchor.
Regarding claim 71, Tornier as modified by Gerber teaches (Tornier, Figure 3) a distal surface (51A) of the locking element (51) and a distal surface (31B) of the eyelet define a gap capable of avoiding over-compression of the locking element on the suture (see page 9 of English Machine Translation).
Regarding claim 73, the system taught by Tornier as modified by Gerber is capable of treating obstructive sleep apnea.
Regarding claim 74, the suture (7) taught by Tornier is capable of being attached to a mandible with the bone anchor (1).
Regarding claim 75, Tornier discloses (Figures 1-4) a system for treating a patient, comprising: a bone anchor (1) comprising: a proximal head portion (31) comprising an eyelet (331) comprising a first side and a second side; a distal threaded portion (531) extending distally from the proximal head portion (Figure 3), the distal threaded portion configured to engage bone (9), wherein the proximal head portion is enlarged relative to the distal threaded portion (Figure 3); and a locking element (51), and a suture (7) comprising two free ends, wherein the locking element (51) is configured to be rotated distally to secure the suture (7) within the eyelet, and wherein the suture is configured to extend through the eyelet (Figures 1-3).
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.
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 76, Tornier as modified by Gerber teaches (Tornier, Figures 1 and 3) that the locking element (51) comprises a threaded portion (533) configured to engage an internally threaded surface (351) of the proximal head portion.
Regarding claim 77, Tornier as modified by Gerber teaches (Tornier, Figure 3) that the locking element (51) does not entirely fill the eyelet (there is space for the suture to extend through, as shown in Figure 3).
Regarding claim 78, Tornier as modified by Gerber teaches that the suture is secured within the eyelet. However, the combined teaching fails to explicitly disclose a minimum pull-out force of the suture between 4 kgf to 8 kgf. Tornier as modified by Gerber teaches the general conditions of the claim in that the suture is locked and immobilized (see page 7 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 suture has a minimum pull-out force of between 4 kgf to 8 kgf, 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).
Regarding claim 79, the bone anchor (1) taught by Tornier as modified by Gerber is capable of being implanted in a mandible.
Regarding claim 80, Tornier as modified by Gerber teaches (Tornier, Figure 1) that the suture (7) is configured to be pulled through the bone anchor before securing the suture within the eyelet (Figure 3).
Regarding claim 81, Tornier as modified by Gerber teaches that the suture (7) is configured to suspend tissue (see pages 5-6 of English Machine Translation).
Regarding claim 82, Tornier discloses (Figures 1-4) a system for treating a patient, comprising: a bone anchor (1) comprising: a proximal head portion (31) comprising an eyelet (331) comprising a first side and a second side; a distal threaded portion (531) extending distally from the proximal head portion (Figure 3), 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 3); and a locking element (51); 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 3), wherein the suture is configured to extend through the eyelet (Figures 1-3).
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.
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 (51) is configured to advance by rotation (see pages 6-7 of English Machine Translation).
Regarding claim 84, Tornier as modified by Gerber teaches (Tornier, Figure 3) that a distal surface (51A) of the locking element (51) 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 3 and page 7 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).
Claims 72 and 85 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tornier (FR 2 900 561 A1), English Machine Translation attached) in view of Gerber et al. (US 2007/0203498 A1) (“Gerber”) as applied to claims 66 and 82 respectively, above, and further in view of Kaplan (US 2008/0077161 A1).
Regarding claims 72 and 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).
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771