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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 1, 2, 4, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (2009/0306711) in view of McKay (2010/0021516) and further in view of Dooney et al. (2015/0201929).
Stone discloses the following claimed limitations:
Claim 1: A fixation device (Fig. 23-24), comprising: a button (340) (Fig. 23-24) having a first surface (button surface of the button seen in Fig. 23-24) and a second surface (top surface of the button seen in Fig. 23-24) first and second inner apertures (in Fig. 23 it has two apertures 344) extending therethrough (Fig, 23-24); a length of suture (310) (Fig. 23-24) having a first limb (half of the suture 310 seen in Fig. 23-24 where the middle portion is at the flexible anchor 312) connected to a second limb (half of the suture 310 seen in Fig. 23-24 where the middle portion is at the flexible anchor 312), the first and second limbs both extending through the first inner aperture (Fig. 23-24 where the two limbs extend through both the apertures 344), forming a loop (Fig. 23-24) in the length of suture extending from the button (Fig. 23-24); a collapsible barb (312) (note that it is described with different configurations in Fig. 1-3a as part 101) connected to the loop (Fig. 23-24); a passing strand (250) connected to the loop (Fig. 9, [0048], and [0050] where it states that the auxiliary strand (250) can be used with the other embodiments), and configured to prevent relative motion between the collapsible barb and the loop (Fig. 9, [0048], and [0050] where it is capable of performing this function), wherein the passing strand and collapsible barb are configured to be positioned on a side of the first surface of the button in a first configuration and to be positioned on a side of the second surface of the button in a second configuration (Fig. 9 and [0048-50] where it states that the collapsible barb is pulled through an aperture of the anchor therefore the embodiment of Fig. 23-24 would also be capable of having the barb at a first surface and then passing it through the aperture in order to be in the second surface in the delivered configuration seen in Fig. 23-24); a mass of suture material or a protuberance (see figure below) having a first thickness (see figure below) and formed in a first terminal end of the first limb (see figure below) extending proximally from the button on the side of the second surface of the button (see figure below), wherein the first thickness is greater than any thickness of a second terminal end of the second limb extending proximally from the button on the side of the second surface of the button (see figure below where the thickness of the 2nd terminal end is the thickness of the suture while the mass is a knot that is formed by the 1st limb around the second limb therefore the mass has a larger thickness than the 2nd terminal end); and wherein pulling the second limb proximally from the button decreases the size of the loop (Fig. 23-24 where it is capable of reducing the loop size by pulling the ends).
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It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 4: wherein the protuberance is a knot in the first limb (Fig. 23-24).
Claim 7: Wherein the collapsible barb is composed of a hollow, braided tubular structure (Fig. 1-1c and [0030]).
Stone teaches all the claimed limitations discussed above however, Stone does not disclose that the mass of suture or the protuberance has a diameter larger than the diameter of the first inner aperture nor that a second terminal end of the second limb extending proximally from the button on the side of the second surface of the button does not form the mass of suture material or protuberance.
McKay discloses a suture anchor (Fig. 1a-4a) where the suture at its terminal ends has a mass of suture material and the protuberance (17, 18) (Fig. 1a-4a, [0019], and [0090]) have a diameter that is larger than a diameter of the first inner aperture (13) (Fig. 1a-4a and [0090]), and where a second terminal end (end with needle as seen in Fig. 2-2b) of the second limb extending proximally from the button on the side of the second surface of the button (Fig. 2-2b) does not form the mass of suture material or protuberance (18) (Fig. 2-2b).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Stone with a knot that is larger than the aperture in view of the teachings of McKay, in order to prevent the suture from being pulled through the aperture of the button ([0090]).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Stone with knot/protuberance that is not formed with the second limb in view of the teachings of McKay, in order to have a pre-knotted end that locks in place while the other end is free to be passed from one side to the other of the button as seen in Fig. 2-2b which would reduce the length of surgery by providing a pull and cut pre-knotted device ([0007] and [0019]).
Stone in view of Mckay teaches all the claimed limitations discussed above however, Stone in view of McKay does not disclose an adjustable loop with an eye-splice as claimed nor that the mass or protuberance is formed only by the first terminal end.
Dooney discloses a fixation device (Fig. 7), comprising: a fixation member (60) having first and second inner apertures (apertures 99 as seen in Fig. 5 which are meant to receive eyelet suture [0030]) extending therethrough (Fig. 5); a length of suture (10) having a first limb (starts from terminal end with knot 20 and extends until where the needle 15 connects to the suture in Fig. 1) connected to a second limb (extends from the point where the needle connects to the suture as seen in Fig. 1 until the terminal end 11) (Fig. 1), a mass or protuberance (20) (Fig. 1) is formed only by the first terminal end (Fig. 1), and an eye-splice (30) formed in first limb (Fig. 1 and [0026]), the second limb passing through the eye-splice and the eye-splice extending distally from the button (Fig. 1 and 7).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Stone in view of McKay with an eye-splice self-locking adjustable suture loop as claimed in view of the teachings of Dooney, in order to lock the suture in place ([0016] and [0026]).
Note that by changing the loop configuration to the self-looking adjustable loop disclosed by Dooney, the device of Stone in view of McKay would have a mass/protuberance (the knot) that is formed only by the first terminal end.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (2009/0306711) in view of McKay (2010/0021516) and Dooney et al. (2015/0201929) and further in view of Bojarski et al. (2005/0033363).
Stone in view of Mckay and Dooney teaches all the claimed limitations discussed above including that the fixation member can have any shape (last sentence of paragraph [0060] of Stone) however, Stone in view of McKay does not disclose the pair of outer apertures as claimed.
Bojarski discloses a fixation device (Fig. 118), comprising: a button (2805) having first and second inner apertures (2850) extending therethrough (Fig. 118); and a pair of outer apertures (2855) extending through the button (Fig. 118), wherein the first and second inner apertures are between the pair of outer apertures (Fig. 118).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Stone in view of McKay and Dooney with outer apertures as claimed in view of the teachings of Bojarski, in order to flip the retainer inside the bone after it has been delivered in a delivery profile ([0375]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (2009/0306711) in view of McKay (2010/0021516) and Dooney et al. (2015/0201929) and further in view of Stone et al. (2007/0185532).
Stone (‘711) in view of McKay and Dooney teach all the limitations discussed above, however Stone (‘711) does not disclose that the collapsible barb is flat, woven structure passed through at multiple passing locations by the length of suture.
Stone (‘532), discloses another well-known suture anchor device having a tubular hollow collapsible barb (100 in Fig. 2-7d) and a flat, woven collapsible barb structure (100 in Fig. 7e-k and [0051]) passed through at multiple passing locations by the length of suture (Fig. 7e-k where the suture passes through multiple apertures in the collapsible barb).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the collapsible barb of Stone (‘711) to be a woven, flat structure, as taught by Stone (‘532), since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive.
Applicant argues that the Stone does not teach that a second terminal end of the second limb extending proximally from the button on the side of the second surface of the button does not form the mass of suture material or protuberance, as claimed.
The examiner agrees; however, McKay does disclose that a second terminal end (end with needle as seen in Fig. 2-2b) of the second limb extending proximally from the button on the side of the second surface of the button (Fig. 2-2b) does not form the mass of suture material or protuberance (18) (Fig. 2-2b).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Stone with knot/protuberance that is not formed with the second limb in view of the teachings of McKay, in order to have a pre-knotted end that locks in place while the other end is free to be passed from one side to the other of the button as seen in Fig. 2-2b which would reduce the length of surgery by providing a pull and cut pre-knotted device ([0007] and [0019]).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771
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