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
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) 1-3, 5-8, 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wack et al. US 2012/0296345.
Regarding claim 1, Wack et al. discloses a method for fixing a tendon of a subject to an attachment surface (paragraph 0003, 0071), comprising: passing a single strand of suture 12 through the tendon in a single helical pass having multiple turns to form a helical suture construct having multiple loops and a longitudinal axis within the tendon of the subject (figure 11, paragraph 0073, suture 12 engaged with tissue 90 in a spiral, helical, or otherwise similar manner), wherein the tendon has a longitudinal axis along which the tendon undergoes tension under normal physiological conditions (tissue repairs for a tendon functioning under normal physiological conditions would necessarily undergo tension as an inherent property of the tendon in normal conditions), and wherein the longitudinal axis of the helical suture construct within the tendon is oriented parallel to the longitudinal axis of the tendon (figure 11, center of helical structure parallel to the longitudinal axis of tendon 90), but fails to explicitly disclose securing the suture to an anchor secured to the attachment surface, wherein the anchor is positioned to align the suture to direct and distribute tension along the longitudinal axis of the tendon.
However, Wack et al. further teaches a suture 12 being inserted into the tendon, and wherein any of the flexible member systems may be used in combination (paragraph 0071), and in a different embodiment disclosed the single strand of suture being connected to an anchor 160 (figure 17) to fix a tendon to an attachment surface such as a bone using the suture anchor (paragraph 0082) anchoring the suture to bone would be positioned to direct and distribute at least a minimal amount of stress and tension along the longitudinal axis of the tendon, as it would inherently tension the suture within the tendon when the anchor is attached, pulled or tensioned to secure with the tissue as it is placed in the same longitudinal manner as claimed.
Regarding claim 2, Wack et al. discloses wherein the attachment surface comprises a bone, tendon, soft tissue, allograft material, xenograft material, or a synthetic material. (paragraph 0071, tissue engaging member may be used to fix the tissue 90 an attachment surface, such as other soft tissue or bone).
Regarding claim 3, Wack et al. discloses the helical suture construct comprising a turn angle, but fails to explicitly disclose the turn angle between approximately 20 degrees and approximately 70 degrees. However, it would be "Obvious to Try" to result in the claimed ranges for the helical suture construct comprising a turn angle between approximately 20 degrees and approximately 70 degrees or a varied angle to optimize the angle that will be optimal pull-out strength for the tissue, specifically a tendon. There are a finite number of angles between 0 and 180 degrees and one having ordinary skill in the art at before the effective filing date of the invention would have been expected to succeed in trying any of those angles for securing the suture in a tendon as desired by Wack et al. Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to provide a turn angle between approximately 20 degrees and approximately 70 degrees to provide the optimal strength in a particular procedure.
Regarding claim 5, Wack et al. discloses wherein the helical suture construct is a first helical suture construct, but fails to explicitly disclose wherein the helical suture construct is a first helical suture construct and the method further comprises passing a second strand of suture through the tendon in a single helical pass having multiple turns to form a second helical suture construct having multiple loops and a longitudinal axis within the tendon.
However, Wack et al. discloses suture 12 being inserted into the tendon in a spiral or helical manner (figure 11, paragraph 0073), and further wherein any of the flexible member system may be used in combination (paragraph 0071). Wack et al. in a different embodiment discloses the single strand of suture being connected to an anchor 160 (figure 17) to fix tendon to an attachment surface such as bone using the suture anchor (paragraph 0082). Wack et al. in a different embodiment discloses more or less sutures or tissue engaging members being used to attach tissue to bone (paragraph 0108, figures 31-35 show an anchor 344 with multiple sutures 346 extending into the tissue 338 for attachment to the bone 340).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wack et al. with a second suture, as taught in various embodiments, for attaching tissue to bone. Additionally, adding a second helical construct in a similar manner into tissue would have been obvious to one having ordinary skill in the art at the time the invention was made strengthen or attach the tissue as one more or less sutures may be used (paragraph 0108) .
Regarding claim 6, Wack et al. discloses further comprising securing the second helical strand of suture to the attachment surface (paragraph 0071, tissue engaging member may be used to fix the tissue 90 to an attachment surface, such as other soft tissue or bone, figure 32A or 35A, for example, shows multiple sutures attached to the anchor 344 which is securing the tissue 338 to the attachment surface or bone 340).
Regarding claim 7, Wack et al. discloses a method for fixing a tendon of a subject to an attachment surface (paragraph 0003, 0071, 0108; , suture may be used to fix the tissue to an attachment surface, such as other soft tissue or bone, embodiments of suture construct for example, sutures 12, 346 or 366), comprising: inserting a suture having a longitudinal axis in the tendon of the subject (see annotated figure 35A below, for example), wherein the tendon has a longitudinal axis and wherein the longitudinal axis of the suture in the tendon is oriented parallel to the longitudinal axis of the tendon (see annotated figure 35A below) and securing the suture 366 to the attachment surface comprising securing the suture to an anchor 364 secured to the attachment surface (figure 35A, paragraph 0112), a longitudinal axis of the second suture construct is oriented substantially parallel to the longitudinal axis of the first suture construct (first and second sutures 366, figure 35A).
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Regarding claim 8, Wack et al. discloses the longitudinal axis of the second suture construct is oriented non-parallel to the longitudinal axis of the first suture construct (as annotated in figure 35A below, the suture may be substantially parallel, for example, the longer sutures, or non-parallel, such as the shorter sutures extending farther outward from the first suture), or alternatively, suture construct 12 being inserted into the tendon in a spiral or helical manner (figure 11, paragraph 0073), and further wherein any of the flexible member system may be used in combination (paragraph 0071). Therefore, providing multiple sutures, as suggested in figures 31-35, with the helical or spiral configuration of suture construct 12, as suggested in figure 11, also results in the claimed configuration.
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Regarding claim 11, Wack et al. discloses wherein the first helical suture and the second helical suture constructs overlap (multiple sutures that overlap along the longitudinal axis, or overlap near anchor 364, figure 35A; Examiner also notes the claim language does not limit how the sutures constructs overlap, and may simply overlap along an axis or a tissue tear).
Regarding claim 16, Wack et al. discloses wherein the suture has two free ends, and the two free ends are secured to the anchor (paragraph 0082, free ends are secured to the anchor as the suture is secured to the anchor).
Claim(s) 4 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wack et al. US 2012/0296345 in view of Pierson, III US 2004/0147957.
Regarding claim 4, Wack et al. discloses the method as discussed above, but fails to disclose wherein the turn angle varies along a length of the helical suture construct.
However, Pierson, III discloses a suture having a varied turn angle along a selected curvilinear path along the tendon, or a variety of shapes of helical elements to optimize the desired repair (paragraph 0084, for example, figure 1G). It would have been “Obvious to Try” to result in the claimed helical shape for the helical suture construct comprising a varied turn angle to optimize the pull-out strength for the tissue, specifically a tendon. There is a finite number of angles between 0 and 180 degrees and a one having ordinary skill in the art at before the effective filing date of the invention would have been expected to succeed in trying any of those angles for securing the suture in a tendon.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wack et al. with the desired varied turn angles along a selected curvilinear path along the tendon forming the desired different shaped helical sutures, as taught by Pierson, III, to provide the optimal desired repair.
Regarding claims 12-14, Wack et al. discloses wherein inserting the suture in the tendon with a suture passer and needle (for example, figure 30), but does not explicitly disclose inserting a suture with a helix-shaped needle having a tip into the tendon; and rotating the helix-shaped needle to provide a helical channel in the tendon advancing the helix shaped needle through the tendon; securing or coupling the suture material to the tip of the helix-shaped needle; and reversing a direction of rotation of the helix-shaped needle thereby inserting the helical suture in the tendon to form the helical suture construct.
Pierson, III discloses a first and second helical suture (figure 1K, for example), passing a helix shaped needle 20 having a tip into the tendon (figure 1A), rotating the helix shaped needle to provide a helical channel in the tendon (figure 1A); securing or coupling the suture material to the tip of the helix shaped needle (secured as it is positioned within the walls of the lumen 21 after the channel is provided), rotating the helix shaped needle to pass the suture into the tendon and forming a helix construct (figure 1A, paragraph 0078), and reversing a direction of rotation of the helix shaped needle thereby passing the helical suture in the tendon to form the helical suture construct (unscrewing motion, paragraph 0078, leaving the helix construct in position), rotating the helix shaped needle to advance the needle through the tendon to form a helix (figure 1A, paragraph 0078), withdrawing the insertion needle 20 to leave the suture in place (paragraph 0078).
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wack et al. with a helix shaped needle for insertion of the helical sutures where desired for attachment, as it is taught by Pierson, III that the configuration may be adapted to particular situations and further teaches inserting the helical sutures by use of a helix shaped needle to pass through tissue to provide a smaller wound or reduce additional trauma insertion through tissue (paragraph 0024).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wack et al. US 2012/0296345 in view of Yoon et al. US 5782844.
Regarding claims 9 and 10, Wack et al. discloses a method essentially as claimed including inserting a first and second suture (Wack et al., figures 11 and 35A, for example). Wack et al. discloses suture 12 being inserted into the tendon in a spiral or helical manner (figure 11, paragraph 0073). Wack et al. in a different embodiment discloses the single strand of suture being connected to an anchor 160 (figure 17) to fix soft tissue to an attachment surface such as bone using the suture anchor (paragraph 0082). Wack et al. in a different embodiment discloses more or less sutures or tissue engaging members being used to attach tissue to bone (paragraph 0108, figures 31-35 show an anchor 344 with multiple sutures 346 extending into the tissue 338 for attachment to the bone 340). Wack et al. further discloses wherein any of the flexible member system may be used in combination (paragraph 0071), which may include multiple helical suture constructs to attach tissue to bone.
Wack et al. fails to explicitly disclose a first and second helical suture being inserted specifically having the opposite or the same direction of rotation.
Yoon et al. teaches a method of fixating tissue, comprising a helical suture coil and insertion element, the direction of rotation may be modified depending on the necessary application, including clockwise or counterclockwise when being advanced with the helical suture coil (column 19, lines 28- 44). Examiner further notes that the claim requires only that two suture constructs, but does not require any connection or relationship between the two constructs. Adding a second helical construct in a similar manner into tissue would have been obvious to one having ordinary skill in the art before the effective filing of the invention, to strengthen or attach the tissue as one more or less sutures may be used for attachment (paragraph 0108). Adding the second helical construct in the direction as appropriate or optimal in a specific direction for a particular procedure, as further taught by Yoon et al., would be known for inserting helical constructs into tissue for attachment, the helical constructs necessarily being either the same or different rotational direction.
In combination, Wack et al. discloses multiple suture constructs, while Yoon teaches insertion in either the counterclockwise or clockwise directions as appropriate. Adding a second helical construct in a similar manner into tissue would have been obvious to one having ordinary skill in the art for strengthening the attachment site of the tissue at a particular location. Additionally, adding a second helical construct in a similar manner into tissue would have been obvious to one having ordinary skill in the art at the time the invention was made strengthen or attach the tissue as one more or less sutures may be used (Yoon, paragraph 0108).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wack et al. to close a tendon tear and provide a direction as desired, as taught by Yoon et al. for advancing the helical sutures into the tissue as necessary for a particular application.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wack et al. US 2012/0296345 in view of Pierson, III US 2004/0147957 as discussed above, and further in view Yoon et al. US 5782844.
Regarding claim 15, Wack et al. and Pierson, III discloses rotating the helix-shaped needle to insert a helical suture as discussed above, but fails to disclose linearly translating a slide component of an insertion instrument comprising the helix- shaped needle, wherein the linear translation of the slide component causes rotation of the helix- shaped needle.
Yoon et al. teaches a method of fixating tissue, comprising a slide component (pusher 26), wherein linear translation of the slide component causes rotation of the helix shaped needle and linearly translation of the slide component comprises linearly translating a trigger lever along the longitudinal axis to cause translation of the slide component (trigger handle 68"' is squeezed to move collar 214 and thus flange 200 of the inner member, the inner member thereby moving and rotating the helix shaped needle, fig. 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Wack et al. and Pierson, III to include an insertion instrument, as taught by Yoon et al. as a known method of precisely placing the suture within tissue with an insertion device and linear translation to cause rotation of the helix shaped needle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
