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 .
Response to Arguments
Applicant argues in the response filed 06/30/2026 that the new drawings and claim amendments would overcome the prior objections and 112 rejections. The prior objections and 112 rejections have been withdrawn.
The applicant argues prior art Brown and Foerster does not disclose the “anchor and suture tensioner assemble to the suture during use, after coupling to tissue” (with respect to independent claims 22, 31, 39) and “the suture extending external to the shaft directly between the anchor and tensioner” (with respect to independent claim 22). It is to be noted the claims are a device claim and therefore cannot positively recite any method steps. The claims do not claim the specific mechanism or structure of how a suture will be assembled to the rest of the system. Further the claims do not claim different configurations of the system (pre/post “assembly”), just that the assembly to suture during use. Finally the claims do not further claim what encompasses the “use”. The examiner maintains the suture can be coupled to (or assembled) to the system during general use. The suture is coupled/attached to the system while the system is being used. The rejections with respect to independent claims 31 (both Brown and Forester) and 39 (Brown in view of Kruse) have been maintained below.
The previous rejections with respect to independent claim 22 have been withdrawn.
New rejections with respect to Wales, Whittaker, and Keane in view of Foerster have been made below.
Claim Rejections - 35 USC § 102
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 22, 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2011/0172701 to Wales.
As to claim 22, Wales discloses a tissue repair system (paragraph 7), including; a suture (50), and an anchor inserter (10, figure 1) including; a handle (35); a shaft (30) extending distally from the handle; an anchor (125, figure 2c) at a distal end of the shaft (figure 2c); and a suture tensioner (42, figure 1, paragraph 84), wherein the anchor and the suture tensioner configured to assembly to the suture during use (figure 8a), after the suture has been coupled to tissue (figure 8b), the suture extending external to the shaft directly between the anchor and the suture tensioner (figure 8b), wherein the suture tension includes an actuator (the surface of the tab the user grabs of the tab 42, figure 1) configured to be moved to adjust a tension along the suture (paragraph 124, 84, the tab can be pulled to adjust the tension), and wherein the suture tensioner is configured to move freely when the actuator is released (paragraph 91). The tab is removed and can be used to pull the suture 50.
As to claim 28, Wales discloses a second anchor inserter (second 10, paragraph 117) including handle (second 35), a suture tensioner (second 42) and a shaft (second 30) extending distally from the handle and an anchor (second 25) at a distal end of the shaft, the anchor and the suture tensioner of the second anchor inserter are also configured to assembly to the suture during use and wherein the suture tensioner of the second anchor insert is configured to adjust a tension along the suture (paragraph 117). Two devices can be used to deploy two implant system in an X configuration. Therefore one implant will be assembled or connected to the suture where they cross each other to form the X. Pulling on the tab of the assembly on the bottom of the X stich configuration, will adjust the tension on the other, or adjust the tension on the suture.
Claims 22, 29, 30, 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2008/0033486 to Whittaker.
As to claim 22, Whittaker discloses a tissue repair system (paragraph 8), including; a suture (300), and an anchor inserter (10, figure 1) including; a handle (20); a shaft (22) extending distally from the handle; an anchor (200) at a distal end of the shaft (figure 1); and a suture tensioner (26, figure 5, paragraph 48), wherein the anchor and the suture tensioner configured to assembly to the suture during use (figure 1, 17, paragraph 67, 70), after the suture has been coupled to tissue (paragraph 69, 70), the suture extending external to the shaft directly between the anchor and the suture tensioner (figure 17), wherein the suture tension includes an actuator (27) configured to be moved to adjust a tension along the suture (paragraph 48, 69), and wherein the suture tensioner is configured to move freely when the actuator is released (paragraph 48, 49, figure 3, 7). The claim does not state when the actuator is released. Once the pawl is released, the wheel can move. Alternatlvey, once the user lets go of the handle, the wheel can move freely.
As to claim 29, Whittaker discloses the suture tensioner is configured to rotate continuously to both increase and decrease tension along the suture (paragraph 48).
As to claim 30, Whittaker discloses the anchor includes an anchor body 220) and a plug (210), the plug configured to axially advance and lock the suture with the anchor body (paragraph 43), when the anchor body is located within bone and wherein the suture tensioner is configured to freely move and allow the suture to move with the plug while axially advancing (paragraph 43, 48). The claim is a device claim and cannot positively recite the method steps. The specific movement of freedom is further defined. The suture tensioner can be moved when the pawl is released. Further when the pawl is released, the anchor can be advanced.
As to claim 39, Whittaker discloses a tissue repair system (paragraph 8), including; a suture (300), and an anchor inserter (10, figure 1) including; a handle (20); a shaft (22) extending distally from the handle; an anchor (200) at a distal end of the shaft (figure 1), the anchor including an anchor body (220) and a plug (210), the anchor configured to assemble to the suture during use (figure 1, 17, paragraph 67, 70), and the plug configured to axially advance and push the suture distally against the anchor body to lock the suture, when the anchor is located within the bone (paragraph 43)and a suture tensioner (26) disposed on the anchor inserter configured to couple to the suture extending from the anchor and adjust tension on the suture before the plug is axially advanced (figure 17, paragraph 48, 49, 69 ), the suture tensioner configured to freely spin while axially advancing the plug (paragraph 48, 49, figure 3, 7). Once the pawl is released, the wheel can move. Alternatlvey, once the user lets go of the handle, the wheel can move freely. The wheel can move when the plug is advanced.
Claims 31-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2009/0069823 to Foerster.
As to claim 31, Foerster discloses a tissue repair system (paragraph 47), including; a suture (54), and an anchor inserter (10, figure 1, 2) including; a handle (12); a shaft (20) extending distally from the handle; an anchor (34) at a distal end of the shaft (figure 4b); and a suture tensioner (52, figure 1, 4a,b) adjacent the handle, wherein the anchor and suture tensioner are configured to assembly to the suture during use, after the suture has been coupled to tissue (figure 8a-k, 10b), and wherein the suture tensioner is configured to rotate to adjust a tension on the suture (paragraph 60), the suture tensioner including a shaft (general shaft that extends between knobs 50, figure 3, 6) with a suture holding slot (90, the slot defined between the two disc like elements, figure 6, and where the suture is seen in extend, figure 10b) disposed through an external surface of the shaft, and wherein the anchor inserter defines a bifurcating plane (a plane that bifurcates the device that generally extends along the longitudinal axis of the device, figure 1), and the suture holding slot is configured to hold the suture at a location coincident with the bifurcating plane (figure 1a).
As to claim 32, Foerster discloses the suture tensioner is configured to freely spin when not being held (paragraph 60).
As to claim 33, Foerster discloses the suture tensioner is configured to rotate continuously to both increase and decrease tension along the suture (paragraph 60).
As to claim 34, Foerster discloses the anchor includes a through-hole (figure 5a-d) for receiving the suture therethrough and wherein the through-hole extends along the bifurcating plane (figure 1, 6).
As to claim 35, Foerster discloses the anchor includes a recess (the recess that forms 64/64’ figure 5a, 8g) extending along an external surface of the anchor, the recess extending along the bifurcating plane (figure 5a, 8g).
As to claim 36, Foerster discloses the slot defines a circumferential slot with a notch (90, the suture attachment 90, enters the circumferential slot between the discs).
As to claim 37, Foerster discloses the circumferentially disposed slot with the notch are configured to slidingly release the suture by sliding the suture along the tensioner shaft axis (figure 6). The suture can be released from the attachment 90 by sliding the suture along an axis of the tensioner which can read on the “tensioner shaft axis”.
As to claim 38, Foerster discloses the anchor includes an anchor body (proximal portion of 72) and an plug (82), the plug configured to axially advance into and along the anchor body to engage the suture with the anchor body when the body is located in bone (figure 5c,d), and wherein the suture tensioner is configured to freely move and allow the suture to move with the plug while axially advancing (paragraph 59). If the ratchet release is activated, the reel can freely move as the plug is moved.
Claims 31-34, 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2013/0123810 to Brown.
As to claim 31, Brown discloses a tissue repair system (paragraph 70), including; a suture (120), and an anchor inserter (600, figure 19, with the tensioning mechanisms as seen in figure 22, 23, 24, 25) including; a handle (605); a shaft (602) extending distally from the handle; an anchor (160) at a distal end of the shaft (figure 21c); and a suture tensioner (any of the embodiments 606/631, 604, 637, 612, figure 23-25, paragraph 102-106, will be able to read on the suture tensioner) adjacent the handle, wherein the anchor and suture tensioner are configured to assemble to the suture during use, after the suture has been coupled to tissue (figure 22, 28-32, the suture can be assembled / coupled to the suture during use, after the suture has been coupled to tissue), and wherein the suture tensioner is configured to rotate to adjust a tension on the suture (paragraph 60), the suture tensioner including a shaft (shaft of 631/633/637/612) with a suture holding slot (the tab that defines the slot as seen in figure 22, the notches where the suture extends around in figure 23, the circumferential slot in figure 34, or slot that is defined by the suture path in figure 25) disposed through an external surface of the shaft, and wherein the anchor inserter defines a bifurcating plane (a plane that bifurcates the device that generally extends along the longitudinal axis of the device, as best seen in figure 19), and the suture holding slot is configured to hold the suture at a location coincident with the bifurcating plane (the suture can be held at a place in embodiments of figure 22-25 that is coincident of the plane).
As to claim 32, Brown discloses the suture tensioner is configured to freely spin when not being held (paragraph 103, 105).
As to claim 33, Brown discloses the suture tensioner is configured to rotate continuously to both increase and decrease tension along the suture (paragraph 103).
As to claim 34, Brown discloses the anchor includes a through-hole (figure 14) for receiving the suture therethrough and wherein the through-hole extends along the bifurcating plane (figure 21c).
As to claim 36, Brown discloses the slot defines a circumferential slot (the slot as seen in figure 25, where the suture extends, which can be along a portion of the circumference of the shaft) with a notch (641 can define the notch).
As to claim 37, Brown discloses the circumferentially disposed slot with the notch are configured to slidingly release the suture by sliding the suture along the tensioner shaft axis (paragraph 106). The suture can be released by sliding the suture along an axis of the tensioner shaft.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22-27, 29, 31-33, 35-37 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2003/0204195 to Keane in view of U.S. Patent Publication 2009/0069823 to Foerster.
As to claim 22, Keane discloses a tissue repair system (paragraph 6), including; a suture (6), and an anchor inserter (1, 8, 9, figure 2, 3) including; a handle (8); a shaft (9) extending distally from the handle; an anchor (10) at a distal end of the shaft (figure 2, 3); and a suture tensioner (1, figure 2, 3, paragraph 23), wherein the anchor and the suture tensioner configured to assembly to the suture during use (figure 2, 3, 7), after the suture has been coupled to tissue (figure 7), the suture extending external to the shaft directly between the anchor and the suture tensioner (figure 2-4, 7, paragraph 41), wherein the suture tension includes an actuator (the means of rotating the spool, paragraph 35) configured to be moved to adjust a tension along the suture (paragraph 35), and wherein the suture tensioner is configured to move freely when the actuator is released (paragraph 34, 35).
If it would not be known that the suture tensioner of Keane has an actuator, Foerster teaches a similar device having a suture tensioner (52) with an actuator (50, paragraph 42) in order for controlling the tension in the suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the suture tensioner of Keane have an actuator in order for controlling the tension in the suture.
As to claim 23, with the device Keane and Foerster above, Keane discloses the anchor inserter defines a bifurcating plane (figure 1-3a, paragraph 23, 26, 28, the device may not have the notches 20 and can have different amount of notches 4, for different amount of sutures, therefore the device can have a given bifurcating plane)) and wherein the suture tensioner includes a shaft (general middle shaft, figure 1) with a slot (3) for releasably coupling the suture, the slot disposed on the bifurcating plane (figure 1). Keane discloses the device may not have the notches 20 and the indentations 4 can be used to secure different numbers of sutures. Therefore the slot can be disposed on the bifurcating plane. If it would not be known that Keane can read on the slot being disposed on a bifurcating plane, Foerster teaches discloses the anchor inserter defines a bifurcating plane (figure 1a,c) and wherein the suture tensioner includes a shaft (the general shaft that extends between the knobs 50, figure 1, 6) with a slot (the slot of the reel 52 between the two disc like elements, figure 6, where the suture extends as seen in figure 10b) for releasably coupling the suture, the slot disposed on the bifurcating plane (figure 1a-c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the slot be disposed on the bifurcating plane in order for securing the suture in a balance manner to tension the suture.
As to claim 24, with the device Keane and Foerster above, Keane discloses the anchor includes a through-hole (figure 4) for receiving the suture therethrough and wherein the through-hole extends along the bifurcating plane. Foerster can further provide evidence on the through-hole to attach the suture to the anchor (figure 1, 5a-d, 6).
As to claim 25, with the device Keane and Foerster above, Keane discloses the anchor includes a recess (figure 4, the recess where the suture extends) extending along an external surface of the anchor, the recess extending along the bifurcating plane. Foerster can further provide evidence of an anchor recess extending along the bifurcating plane to help attach the suture to the anchor (figure 5a, 8g).
As to claim 26, with the device Keane and Foerster above, Keane discloses the suture tensioner includes a shaft with a circumferentially disposed slot (3) with a notch (4), configured to slidingly receive the suture to couple the suture to the suture tensioner (paragraph 26, figure 1).
As to claim 27, with the device Keane and Foerster above, Keane discloses the circumferentially disposed slot and the notch are configured to slidingly release the suture from the suture tensioner once a target tension has been achieved (paragraph 27, figure 1). Foerster can further provide evidence of a slot which can slidingly release the suture (paragraph 27, figure 1).
As to claim 29, with the device Keane and Foerster above, Keane discloses the suture tensioner is configured to rotate continuously to both increase and decrease tension along the suture (paragraph 28). Foerster can further provide evidence of the suture tensioner is configured to rotate continuously to both increase and decrease tension along the suture (paragraph 60).
As to claim 31, Keane discloses a tissue repair system (paragraph 6), including; a suture (6), and an anchor inserter (1, 8, 9, figure 2, 3) including; a handle (8); a shaft (9) extending distally from the handle; an anchor (10) at a distal end of the shaft (figure 2, 3); and a suture tensioner (1, figure 2, 3, paragraph 23), wherein the anchor and the suture tensioner configured to assembly to the suture during use (figure 2, 3, 7), after the suture has been coupled to tissue (figure 7), wherein the suture tensioner is configured to rotate (paragraph 28) to adjust tension on the suture, the suture tensioner including a shaft with a suture holding slot (3,4) disposed through an external surface of the shaft (figure 1), and wherein the anchor inserter defines a bifurcating plane (figure 1-3a, paragraph 23, 26, 28, the device may not have the notches 20 and can have different amount of notches 4, for different amount of sutures, therefore the device can have a given bifurcating plane) and the suture holding slot is configured to hold the suture at a location coincident with the bifurcating plane (figure 1). Keane discloses the device may not have the notches 20 and the indentations 4 can be used to secure different numbers of sutures. Therefore the slot can coincident on the bifurcating plane.
If it would not be known that Keane can read on the slot being coincident on a bifurcating plane, Foerster teaches discloses the anchor inserter defines a bifurcating plane (figure 1a,c) and wherein the suture tensioner includes a shaft (the general shaft that extends between the knobs 50, figure 1, 6) with a suture holding slot (the slot of the reel 52 between the two disc like elements, figure 6, where the suture extends as seen in figure 10b) for releasably coupling the suture, the slot coincident on the bifurcating plane (figure 1a-c) for the purpose of tension the suture in a balanced manner (paragraph 53). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the slot be coincident on the bifurcating plane in order for securing the suture in a balance manner to tension the suture.
As to claim 32, with the device Keane and Foerster above, Keane discloses the suture tensioner is configured to freely spin when not being held (paragraph 28).
As to claim 33, with the device Keane and Foerster above, Keane discloses the suture tensioner is configured to spin continuously to both increase and decrease tension along the suture (paragraph 28). The suture tensioner is a spool which therefore can continuously both increase and decrease tension along the suture. Foerster can provide evidence on the continuous spin to both increase and decrease tension along the suture (paragraph 60).
As to claim 35, with the device Keane and Foerster above, Keane discloses the anchor includes a through-hole (figure 4) for receiving the suture therethrough and wherein the through-hole extends along the bifurcating plane. Foerster can further provide evidence on the through-hole to help attach the suture to the anchor (figure 1, 5a-d, 6).
As to claim 36, with the device of Keane and Foerster above, Keane discloses the suture holding slot defines a circumferentially disposed slot with a notch (4, figure 1).
As to claim 37, with the device Keane and Foerster above, Keane discloses the circumferentially disposed slot and the notch are configured to slidingly release the suture by slidingly the suture along the tensioner shaft axis (figure 1). The suture will be released from the suture tensioner. The release will involve sliding the suture. The sliding can be along an axis which is “the tensioner shaft axis” since the tensioner shaft axis is not further defined.
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0123810 to Brown in view of U.S. Patent Publication 2020/0281580 to Kruse.
As to claim 38, Brown discloses the device above including the anchor includes an anchor body (body of 160) and an plug (358, the sliding knot can be used with the anchor 160), the plug configured to axially advance to engage and lock the suture with the anchor body (paragraph 121), and wherein the suture tensioner is configured to freely move and allow the suture to move with the plug while axially advancing (paragraph 121). As the knot is advanced, at least the hand held tensioner 631 can be moved. However, Brown is silent about the plug is advanced into and along the anchor body.
Kruse teaches a similar device (tensioning sutures) having an anchor comprising an anchor body (5/100) and a plug (9), where the plug is configured to axially advance into and along the anchor body to engage the and lock the suture, when the anchor is located within bone (paragraph 47 - 50, 93-95) for the purpose of helping to lock the tension of the suture. As the plug is advanced, the plug will push and secure the suture within the anchor. Further, the anchor can be located in bone (figure 31 of Brown). Using a plug that can push the suture of Brown distally against and into the anchor body can help secure the suture, and yield the predictable result of securing the tension of the suture as desired. Since the tensioner of Brown can be manually adjusted (paragraph 103), the tensioner can adjust the tension before/during the advancement of the plug. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have a plug in the system of Brown configured to axially advance the plug into and along the body to lock the suture in order for securely controlling the tension of the suture as desired.
As to claim 39, Brown discloses a tissue repair system (paragraph 70), including; a suture (120), and an anchor inserter (600, figure 19, with the tensioning mechanisms as seen in figure 22, 23, 24, 25) including; a handle (605); a shaft (602) extending distally from the handle; an anchor (160) at a distal end of the shaft (figure 21c), the anchor including an anchor body (body of 160) and a plug (358); the anchor configured to assemble to the suture during use (figure 28-31, during use, the suture is assembled/connected to the anchor) and a suture tensioner (any of the embodiments 606/631, 604, 637, 612, figure 23-25, paragraph 102-106) disposed on the anchor inserter and configured to couple to the suture extending from the anchor and adjust a tension on the suture before the plug is axially advanced (paragraph 60), the suture tensioner configured to freely spin while axially advancing the plug (figure 22, paragraph 103), but is silent about the plug is configured to axially advance an push the suture distally against the anchor body to lock the suture when the anchor is located in bone. Brown does disclose other anchor embodiments with plug like elements (106/107, figure 5).
Kruse teaches a similar device (tensioning sutures) having an anchor comprising an anchor body (5/100) and a plug (9), where the plug is configured to axially advance and push the suture distally against the anchor body to lock the suture, when the anchor is located within bone (paragraph 47 - 50, 93-95) for the purpose of helping to lock the tension of the suture. As the plug is advanced, the plug will push and secure the suture within the anchor. Further, the anchor can be located in bone (figure 31 of Brown). Using a plug that can push the suture of Brown distally against the anchor body can help secure the suture to the anchor, and yield the predictable result of securing the tension of the suture as desired. Since the tensioner of Brown can be manually adjusted (paragraph 103), the tensioner can adjust the tension before/during the advancement of the plug. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use a plug in the system of Brown configured to push the suture distally against the anchor body to lock the suture in order for securing the suture to bone and control the tension as desired.
As to claim 40, with the system of Brown and Kruse above, Brown discloses the suture tensioner includes a shaft (either the shaft of 625 or 612) with a suture receiving slot (where the slot is positioned in either figure 24 or 25) disposed on an external surface of the shaft, and wherein the anchor inserter defines a bifurcating plane, and the suture tensioner slot is coincident with the bifurcating plane (figure 19, 24, 25).
As to claim 41, with the system of Brown and Kruse above, Brown discloses the anchor includes a through-hole (figure 14) for receiving the suture therethrough and wherein the through-hole extends along the bifurcating plane, configured so that the suture extends from the through hole to the suture tensioner slot while remaining within the bifurcating plane (figure 21a-c, 24.)
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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