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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 29, 2026 has been entered.
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.
Claims 1-4, 7, 9, 10, 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst et al. (US 5,269,809 A) in view of Grafton (US 20050192631 A1).
Regarding claim 1, Hayhurst discloses a suture-to-button assembly (Figs. 1-12) for performing surgical procedures, comprising: a button 10 including an oblong-shaped body (Fig. 1) that includes a top surface (i.e., which 18 extends through; see Figs. 1 and 2), a bottom surface (i.e., opposing top surface; see Fig. 10), a first end wall located a first longitudinal extent of the oblong-shaped body (i.e., at 16; Fig. 1), a second end wall located at a second longitudinal extent of the oblong-shaped body (i.e., at 14; Fig. 1), and a first hole that opens through the first end wall (Fig. 1); and a suture construct 20 (i.e., 25 of Fig 1) received through the first hole (Figs. 1-3), a tail portion (i.e., at 22) adapted for fixating the suture construct to the button (Fig. 1).
Hayhurst doesn’t specifically disclose: wherein the suture construct includes a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button.
In the same field of endeavor, namely high strength suture tape, Grafton discloses a similar suture anchoring system including two suture strands 6,4.
Grafton also discloses the suture construct includes a primary suture strand 6 and a filler suture strand 4 spliced through the primary suture strand (para. [0023]), wherein the filler suture strand is a different strand of suture from the primary suture strand (paras. [0022]-[0023]); an adhesive (i.e., such as Loctite 4014 as disclosed by para. [0026]) that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand (para. [0026]), wherein the inter-strand bond creates a stiffened tail portion (para. [0026]) that functions as a hard stop for preventing separation of the suture construct from the button (para. [0026]).
Note also that the adhesive of Grafton is fully capable of securing the filler suture strand relative to the primary suture strand and the tail portion functions as a hard stop for preventing separation of the suture construct from the button, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
It would have been obvious to one of ordinary skill in the art to modify the device of Hayhurst to have a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button as disclosed by Grafton for purposes of creating a suture capable of a tight attachment (paras. [0026], [0029]).
Regarding claim 2, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses wherein the tail portion 22 establishes a thickened portion of the suture construct (i.e., at least by having a knot).
Regarding claim 3, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses wherein the tail portion includes a first outer diameter (i.e., around 22), and the first hole of the button through which the suture construct is received includes a second outer diameter (i.e., at 14), and further wherein the first outer diameter is larger than the second outer diameter (Fig. 1).
Regarding claim 4, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses wherein a second hole opens through the second end wall (Fig. 1).
Regarding claim 7, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 4. Hayhurst also discloses the second hole is configured to receive a tip portion of an inserter 32 of the suture-to-button assembly (i.e., during deployment of the button as shown in Fig. 2).
Regarding claim 9, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Grafton also discloses wherein the primary suture strand includes a suture tape (para. [0026] and the filler suture strand includes a round suture (Fig. 1; para. [0022]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Hayhurst such that the primary suture strand includes suture tape for the purposes of having a suture comprising a high strength (para. [0006]).
Regarding claim 10, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. The resulting device of Hayhurst and Grafton would also disclose wherein the filler suture strand is accommodated within a lumen of an outer jacket of the primary suture strand (i.e., see paras. [0022]-[0026] of Grafton).
Regarding claim 21, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses the first hole extends through an interior section of the button that is spaced from the top surface and the bottom surface (Fig. 1).
Regarding claim 22, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 21. Hayhurst also discloses the first hole does not open through either the top surface or the bottom surface of the button (Fig. 1).
Regarding claim 23, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses wherein the first end wall is slanted relative to the top surface and the bottom surface (i.e., at 16 of Fig. 1).
Regarding claim 24, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst also discloses wherein the tail portion includes a cut line that establishes a terminal end of the tail portion (Fig. 1).
Regarding claim 25, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 24. Hayhurst and Grafton don’t directly disclose wherein the cut line is located at a distance of about 0.5 mm to about 5 mm outside of the first hole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hayhurst and Grafton to have the cut line located at a distance of about 0.5 mm to above 5mm outside of the first hole since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777(Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hayhurst and Grafton would not operate differently with the claimed distance outside the first hole since the suture construct is only required to be a sufficient length to extend through the first hole of the button and the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is between 0.5mm and 5mm or 2mm and 5 mm or about 2 mm or about 5 mm (para. [0043]).
Regarding claim 32, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 1. Hayhurst doesn’t directly disclose the adhesive penetrates through an outer jacket of the primary suture strand to establish the inter-strand bond, and further wherein the stiffened tail portion provides the hard stop without tying any knots.
Grafton also discloses the adhesive penetrates through an outer jacket of the primary suture strand to establish the inter-strand bond, and further wherein the stiffened tail portion provides the hard stop without tying any knots (paras. [0022]-[0026].
The adhesive tail of Grafton is fully capable of establishing the inter-strand bond, and further wherein the stiffened tail portion provides the hard stop without tying any knots, if one desired to do so - note that the limitations of claim 32 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Claims 1, 4, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hiernaux et al. (US 2017/0095363 A1) in view of Grafton.
Regarding claim 1, Hiernaux discloses a suture-to-button assembly (Figs. 1-13) for performing surgical procedures, comprising: a button 32 including an oblong-shaped body (Fig. 2, para. [0049]) that includes a top surface (i.e., at 121’), a bottom surface (i.e., at 121), a first end wall located a first longitudinal extent of the oblong-shaped body (i.e., at 32), a second end wall located at a second longitudinal extent of the oblong-shaped body (i.e., opposite of 32), and a first hole that opens through the first end wall (i.e., para. [0062] discloses the anchor is hollow or tubular); and a suture construct 13, 14 received through the first hole (i.e., note that the first hole may extend through the middle of the button and may extend the entire distance, or halfway, or extend until meeting a second hole such that 13, 14 would be accommodated through the hole), a tail portion (i.e., as shown in Fig. 3) adapted for fixating the suture construct to the button (para. [0056]).
Hayhurst doesn’t specifically disclose: wherein the suture construct includes a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button.
In the same field of endeavor, namely high strength suture tape, Grafton discloses a similar suture anchoring system including two suture strands 6,4.
Grafton also discloses the suture construct includes a primary suture strand 6 and a filler suture strand 4 spliced through the primary suture strand (para. [0023]), wherein the filler suture strand is a different strand of suture from the primary suture strand (paras. [0022]-[0023]); an adhesive (i.e., such as Loctite 4014 as disclosed by para. [0026]) that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand (para. [0026]), wherein the inter-strand bond creates a stiffened tail portion (para. [0026]) that functions as a hard stop for preventing separation of the suture construct from the button (para. [0026]).
Note also that the adhesive of Grafton is fully capable of securing the filler suture strand relative to the primary suture strand and the tail portion functions as a hard stop for preventing separation of the suture construct from the button, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
It would have been obvious to one of ordinary skill in the art to modify the device of Hayhurst to have a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button as disclosed by Grafton for purposes of creating a suture capable of a tight attachment (paras. [0026], [0029]).
Regarding claim 4, Hiernaux and Grafton disclose the suture-to-button assembly as recited in claim 1. Hiernaux also discloses a second hole opens through the second end wall (i.e., opposite of the first end wall and extending longitudinally until meeting the first hole as shown in Fig. 3; para. [0062]).
Regarding claim 6, Hiernaux and Grafton disclose the suture-to-button assembly as recited in claim 4. Hiernaux also discloses the first hole is connected to a third hole 121/121’ of the button, (Fig. 3) and further wherein the third hole opens through the top surface and the bottom surface of the button (Fig. 3; para. [0061]-[0065]).
Claims 11, 12, 26, 27, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst in view of Grafton and further in view of Niver et al. (US 2021/0068806 A1).
Regarding claim 11, Hayhurst and Grafton disclose the suture-to-button assembly of claim 1. Grafton discloses the suture construct of the suture-to button assembly is spliced through the suture loop construct (paras. [0022]-[0026]).
Hayhurst and Grafton don’t directly disclose a second button; and a suture loop construct connected to the button and the second button.
In the same field of endeavor, namely orthopedic stabilization devices, Niver discloses a similar device to Hayhurst and Grafton including a button 102 and a suture construct 106. Niver also discloses a second button 104; and a suture loop construct 106 connected to the button (i.e., in this case 102, but the resulting device of the combination of Hayhurst and Grafton would be the elongated button of Hayhurst) to the second button (Fig. 14A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device of Hayhurst and Grafton to have a second button for purposes of inhibiting separation between two anatomical structures (para. [0034]).
Regarding claim 26, Hayhurst and Grafton disclose the suture-to-button assembly as recited in claim 4. Gayhurst and Grafton fail to directly disclose: wherein the first hole is a non-threaded opening and the second hole is a threaded opening.
Niver discloses the first and second holes being non-threaded (Figs. 14A-14E) or alternately, that they may be threaded holes (para. [0048]). Niver and Bachmaier1 fail to directly disclose: wherein the first hole is a non- threaded opening and the second hole is a threaded opening
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of wherein the first hole is a non- threaded opening and the second hole is a threaded opening since the only four choices are [1) wherein the first hole is a non- threaded opening and the second hole is a threaded opening, or 2) wherein the first hole and second hole are non- threaded openings, or 3) wherein the first hole and second hole are threaded openings, or 4) wherein the first hole is a threaded opening and the second hole is a non-threaded opening]. These are the only four options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at wherein the first hole is a non- threaded opening and the second hole is a threaded opening.
Regarding claim 27, Hayhurst, Grafton, and Niver disclose the suture-to-button assembly as recited in claim 26. The resulting device of Hayhurst, Grafton, and Niver as modified above with regard to claim 26 would also disclose comprising an inserter 32 (i.e., of Hayhurst) that includes a threaded shaft that is detachably engageable with the threaded opening (i.e., at least since in order to thread the inserter through the buttons, the inserter would also need to be threaded).
Regarding claim 29, Hayhurst discloses a suture-to-button assembly for performing surgical procedures (Figs. 1-12), comprising: a button 10 including an oblong-shaped body (Fig. 1) that includes a first end wall 16 located a first longitudinal extent of the oblong-shaped body (Fig. 1), a second end wall 14 located at a second longitudinal extent of the oblong-shaped body (Fig. 1), a first hole that opens through the first end wall, (Fig. 1) and a second hole that opens through the second end wall (Fig. 1); a suture construct 20, 25 received through the first hole (Fig. 1) a tail portion 24 adapted for fixating the suture construct within the first hole (i.e., via knot; Fig. 1); and an inserter 32.
Hayhurst fails to directly disclose:
wherein the suture construct includes a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button.
inserter including a threaded shaft that is detachably engageable to the second hole.
Regarding (i):
Grafton discloses the suture construct includes a primary suture strand 6 and a filler suture strand 4 spliced through the primary suture strand (para. [0023]), wherein the filler suture strand is a different strand of suture from the primary suture strand (paras. [0022]-[0023]); an adhesive (i.e., such as Loctite 4014 as disclosed by para. [0026]) that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand (para. [0026]), wherein the inter-strand bond creates a stiffened tail portion (para. [0026]) that functions as a hard stop for preventing separation of the suture construct from the button (para. [0026]).
Note also that the adhesive of Grafton is fully capable of securing the filler suture strand relative to the primary suture strand and the tail portion functions as a hard stop for preventing separation of the suture construct from the button, if one desired to do so - note that the limitations of claim 29 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
It would have been obvious to one of ordinary skill in the art to modify the device of Hayhurst to have a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button as disclosed by Grafton for purposes of creating a suture capable of a tight attachment (paras. [0026], [0029]).
Regarding (ii):
Niver discloses the first and second holes being non-threaded (Figs. 14A-14E) or alternately, that they may be threaded holes (para. [0048]). Niver fails to directly disclose: wherein the first hole is a non- threaded opening and the second hole is a threaded opening.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of wherein the first hole is a non- threaded opening and the second hole is a threaded opening since the only four choices are [1) wherein the first hole is a non- threaded opening and the second hole is a threaded opening, or 2) wherein the first hole and second hole are non- threaded openings, or 3) wherein the first hole and second hole are threaded openings, or 4) wherein the first hole is a threaded opening and the second hole is a non-threaded opening]. These are the only four options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at wherein the first hole is a non- threaded opening and the second hole is a threaded opening.
The resulting device of Hayhurst, Grafton, and Niver as modified above would also disclose comprising an inserter 32 (i.e., of Hayhurst) that includes a threaded shaft that is detachably engageable with the threaded opening (i.e., at least since in order to thread the inserter through the buttons, the inserter would also need to be threaded).
Claim 28, 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmaier2 (WO2020/092048 A1—previously presented) in view of Grafton.
Regarding claim 28, Bachmaier2 discloses a suture-to-button assembly (Figs. 1-2; paras. [0039]-[0054]) for performing surgical procedures, comprising: a button 12; and a suture construct 14, 26, 28 fixated to the button (Fig. 1), the suture construct including a primary suture strand 28, a filler suture 30 strand spliced through the primary suture strand to establish a tail portion that fixates the suture construct to the button (para. [0052], [0054]; Fig. 1). Bachmaier2 fails to directly disclose an adhesive that adheres to a portion of the filler suture strand that is spliced through the primary suture strand to secure the filler suture strand in place relative to the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand.
Grafton discloses the suture construct includes a primary suture strand 6 and a filler suture strand 4 spliced through the primary suture strand (para. [0023]), wherein the filler suture strand is a different strand of suture from the primary suture strand (paras. [0022]-[0023]); an adhesive (i.e., such as Loctite 4014 as disclosed by para. [0026]) that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand (para. [0026]), wherein the inter-strand bond creates a stiffened tail portion (para. [0026]) that functions as a hard stop for preventing separation of the suture construct from the button (para. [0026]).
Note also that the adhesive of Grafton is fully capable of securing the filler suture strand relative to the primary suture strand and the tail portion functions as a hard stop for preventing separation of the suture construct from the button, if one desired to do so - note that the limitations of claim 28 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
It would have been obvious to one of ordinary skill in the art to modify the device of Hayhurst to have a primary suture strand and a filler suture strand spliced through the primary suture strand, wherein the filler suture strand is a different strand of suture from the primary suture strand; an adhesive that forms an inter-strand bond that secures the filler suture strand relative to the primary suture strand, wherein the inter-strand bond creates a stiffened tail portion that functions as a hard stop for preventing separation of the suture construct from the button as disclosed by Grafton for purposes of creating a suture capable of a tight attachment (paras. [0026], [0029]).
Regarding claim 30, Bachmaier2 and Grafton disclose the suture-to-button assembly as recited in claim 28. Grafton also discloses wherein the adhesive penetrates through an outer jacket of the primary suture strand to establish an inter-strand bond that allows the tail portion to function as a hard stop for preventing the suture construct from separating from the button (paras. [0022]-[0026]).
Regarding claim 31, Bachmaier2 and Grafton disclose the suture-to-button assembly as recited in claim 30. Grafton also discloses wherein the tail portion provides the hard stop without tying any knots (paras. [0022]-[0026]).
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-7, 9-11, 21-32 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.
Conclusion
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771