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 Status
Applicant’s Remarks and Amendments filed 30 January 2026 have been entered. Claim 21 is new. Claims 1-21 are pending.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive. Regarding Applicant’s argument that Speciner does not teach a graft support element separate from a suture (pg. 10 of remarks), Examiner respectfully disagrees. As rectified by Applicant’s new claim 21 which explicitly states that the graft support filament may not be a part of the suture, Applicant’s claim 1 language does not have the same broadest reasonable interpretation, and therefore the graft support filament and suture are not understood to be explicitly separate elements. Further, Applicant’s specification teaches that “the suture material may be aligned and secured to the graft support filament such that the suture material and the graft support filament are manipulated as a single device” [0007], and defines the graft support filament as “a suspension device used to connect and/or suspend the soft tissue graft to an anchoring site, whether a suture anchor, bone, other soft tissue, or the like” [0030]. Spenciner teaches that the free suture ends 216, 218 serve as a structural support that reinforces the graft 202 (col. 8, lines 28-29), and that an increased number of free sutures ends used for graft insertion and fixation improves the strength of the attachment of the graft to the surgical site (col. 9, lines 50-54). It would appear as though Spenciner’s free suture ends are performing a similar task to Applicant’s graft support filament and without additional definition by Applicant’s specification or further claim limitations, Examiner would continue to find the two analogous and therefore maintain the rejection.
Regarding Applicant’s argument that Jackson does not disclose, teach, or reasonably suggest a method comprising “positioning a first graft support filament having at least one adjustable filamentary loop at least partially against a soft tissue graft”, and “securing the first graft support filament against the soft tissue graft such that the at least one adjustable filamentary loop of the first graft support filament is slidable relative to the soft tissue graft”, as recited in pending claim 14 (pg. 13 of remarks), Examiner respectfully disagrees. Applicant’s specification discloses that “the at least one adjustable filamentary loop is adapted to be slidable alongside the soft tissue graft and through the spiral pattern of the suture material” [0010] and “wherein the at least one filamentary loop is slidable relative to the suture material and the soft tissue graft” [0013]. Merriam-Webster defines “slide” as “to move smoothly along a surface”. It is unclear to Examiner whether Applicant intends for the adjustable filamentary loop’s slidability to be “along” the graft or “through” the graft, as both are mentioned in the specification. Applicant’s current language for claim 14 teaches that “at least one adjustable filamentary loop of the…graft support filament is slidable relative to the soft tissue graft” which under broadest reasonable interpretation, Examiner comes to understand as any adjustability, through or along the graft, of the filamentary loop would qualify as being “slidable”. Jackson teaches a loop 14 that is adjustable in length and/or perimeter and may be pulled to reduce the size of the loop which is attached to the graft [0045] which under the current interpretation of “slidable” would meet the definition and therefore the claim limitation. The combination of this teaching of slidability by Jackson with the graft taught by Jackson would meet Applicant’s claim limitations, as stated in Page 16 of the NFOA. The later reasoning stating that Spenciner teaches adjustability appears to be a typo, for which Examiner apologizes. However, as the limitation has still been rejected in the Office Action and not gone unaddressed, the rejection in view of Jackson is maintained.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Spenciner (US Pat. No. 9622742 B2), “Spenciner”.
Regarding claim 1, Spenciner teaches
a method for preparing a soft tissue graft (Fig. 3A, graft 202), comprising: passing a suture material (Fig. 3A, suture 204) through the soft tissue graft (Fig. 3A, suture 204 is stitched into graft 202) adjacent to a graft support filament (Fig. 3B free suture ends 216, 218) at a first longitudinal location along the graft support filament and the soft tissue graft (Fig. 3C, first and second portions 213a, 213b of loop 210A of suture 204 overlay suture ends 216, 218 (col. 9, lines 3-9)),
such that the suture material passes through the soft tissue graft on a first side of the graft support filament (Fig. 3C, suture 204 passes through first surface 209 of graft 202 to a second, opposite surface 211 (cols. 7-8, lines 66-4));
passing the suture material over the graft support filament and back through the soft tissue graft adjacent to the graft support filament at a second longitudinal location spaced longitudinally along the graft support filament and the soft tissue graft from the first longitudinal location (Fig. 3D, needle 203 comprising suture 204 with attached first and second suture tails 206, 208 is repeatedly passed through graft 202 over suture ends 216, 218 at subsequent entry points longitudinally spaced apart from first and second entry points 212, 214 (col. 9, par. 3)),
such that the suture material passes through the soft tissue graft on the first side of the graft support filament (Fig. 3C, suture 204 passes through first surface 209 of graft 202 to a second, opposite surface 211 (cols. 7-8, lines 66-4));
and tensioning the suture material to secure the graft support filament to the soft tissue graft along a length of the suture material between the first longitudinal location and the second longitudinal location (Fig. 3D, suture ends 216, 218 are held on surface 209 of graft 202 between first entry point 212 and second entry point 214 (and further, final entry point 228) while tensioned prior to being inserted into the body (col. 8, lines 26-28)).
Regarding claim 2, Spenciner teaches
wherein the suture material includes a needle (Fig. 2, suture 204 is attached to needle 203),
wherein during the passing steps the needle pierces the soft tissue graft to pass the suture material through the soft tissue graft (Fig. 3C, needle 203 and suture 204 passes through first surface 209 of graft 202 to a second, opposite surface 211 (cols. 7-8, lines 66-4)).
Regarding claim 3, Spenciner teaches
wherein the passing steps and tensioning step are repeated at least twice at two more additional longitudinal locations along the graft support filament and the soft tissue graft (Fig. 3D, suture ends 216, 218 are held on surface 209 of graft 202 between first entry point 212 and final entry point 228 by numerous loops 210 while tensioned prior to being inserted into the body (col. 8, lines 26-28)).
Regarding claim 4, Spenciner teaches
wherein the graft support filament (Fig. 3C, free suture ends 216, 218) comprises a length of suture including at least one adjustable filamentary loop formed therein (Fig. 3D, suture 204 forms loops 210),
wherein the first and second longitudinal locations (Fig. 3C, first and second entry points 212, 214) are along a length of the at least one adjustable filamentary loop (Fig. 3C, entry points 212, 214 are along the length of graft 202 which loops 210 pass through).
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 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Jolly et al. (US Pat. No. 8591544 B2), “Jolly”.
Regarding claim 5, Spenciner teaches the suture material (Fig. 3C, suture 204) and the graft support filament (Fig. 3C, free suture ends 216, 218), but fails to teach wherein, prior to the first passing step, the suture material is aligned and secured to the graft support filament such that the suture material and the graft support filament are manipulated as a single device relative to the soft tissue graft.
Jolly teaches a method for tissue repair wherein, prior to the first passing step (Fig. 6, first stitch), the suture material (Fig. 6, suture 10) is aligned and secured to the graft support filament (Fig. 3, end 111 of the preparation area of tendon strand 30 (col. 4, lines 46-50)) such that the suture material (Fig. 6, suture 10) and the graft support filament (Fig. 3, end 111 of the preparation area of tendon strand 30 (col. 4, lines 46-50)) are manipulated as a single device relative to the soft tissue graft (Fig. 3, end 11 is a part of tendon strand 30 and functions with suture 10). Jolly discloses that this suture loop and needle construct provided comprises increased strength abilities (col. 2, lines 32-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the suture material and graft support filament taught by Spenciner with the steps and manipulation abilities taught by Jolly in order to provide a graft that withstands higher forces during implantation and use.
Regarding claim 9, Spenciner teaches the graft support filament (Fig. 3C, free suture ends 216, 218), the soft tissue graft (Fig. 3A, graft 202), and the tensioning step (Fig. 3D, suture ends 216, 218 are held on surface 209 of graft 202 between first entry point 212 and second entry point 214 (and further, final entry point 228) while tensioned prior to being inserted into the body (col. 8, lines 26-28)), but fails to teach wherein, after the tensioning step, the graft support filament is slidable relative to the soft tissue graft and the suture material.
Jolly teaches a method for tissue repair wherein, after the tensioning step (Fig. 6, suture 10 is tensioned after passing through tendon strand 30 (col. 5, lines 12-13)), the graft support filament (Fig. 3, end 111 of the preparation area of tendon strand 30 (col. 4, lines 46-50)) is slidable (Fig. 7, suture 10 passes through tendon regions 110, 120 forming stitches wherein the needle 20 can be readjusted if suture strands are uneven (col. 4, lines 64-67)) relative to the soft tissue graft (Fig. 6, tendon strand 30) and the suture material (Fig. 6, suture 10). Jolly discloses that this suture loop and needle construct provided comprises increased strength abilities (col. 2, lines 32-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft support filament, soft tissue graft, and tensioning step taught by Spenciner with the tensioning steps and sliding capabilities taught by Jolly in order to provide a graft that withstands higher forces during implantation and use.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Jolly et al. (US Pat. No. 8591544 B2), “Jolly” and further in view of Spenciner (US 2016/0157851 A1), “Spenciner 851”.
Regarding claim 6, Spenciner teaches wherein, the suture material (Fig. 3C, suture 204) is aligned and secured to the graft support filament (Fig. 3D, suture ends 216, 218 of suture 204 are held on surface 209 of graft 202), the method further comprising passing a first end of the suture material through the soft tissue graft (Fig. 3C, first and second suture tails 206, 208 are nearest needle 203 which passes through graft 202), passing the second end of the suture material through the soft tissue graft (Fig. 3C, suture ends 216, 218 are passed through graft 202), but Spenciner in view of Jolly fails to teach folding the suture material on itself and securing the suture material to the graft filament in a luggage-tag configuration, and pulling on the first end and the second end to position the luggage-tag configuration and the graft support filament against a surface of the soft tissue graft.
Spenciner 851 teaches an implant with adjustable filament coils comprising folding the suture material on itself and securing the suture material to the graft filament in a luggage-tag configuration (Fig. 1A, suture filament 50 forms self-locking knot 52), and pulling on the first end (Fig. 3E, first terminal end 54t) and the second end (Fig. 3E, second terminal end 55t) to position the luggage-tag configuration and the graft support filament against a surface of the soft tissue graft (Fig. 1B, tensioning ends 54t, 55t adjusts the circumference of coils 60 which couple to first and second ligament grafts 102’, 104’ (Fig. 6A)). Spenciner 851 discloses that the self-locking knot can be manipulated to allow for circumferential increases of the coils [0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to try utilizing the knot taught by Spenciner 851 to secure the soft tissue graft and filaments taught by Spenciner in order to allow for alterations after preparation.
Regarding claim 7, Spenciner teaches the soft tissue graft (Fig. 3A graft 202) and the first longitudinal location (Fig. 3D, first entry point 212) is closer to one end of the soft tissue graft (Fig. 3A, first entry point 212 is adjacent first end 202a of graft 202), but Spenciner in view of Jolly fails to teach a luggage-tag configuration.
Spenciner 851 teaches a luggage-tag configuration (Fig. 1A, suture filament 50 forms self-locking knot 52). Spenciner discloses that the self-locking knot can be manipulated to allow for circumferential increases of the coils [0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to try utilizing the knot taught by Spenciner to secure the soft tissue graft and filaments taught by Spenciner in order to allow for alterations after preparation.
Regarding claim 8, Spenciner teaches wherein the second longitudinal location (Fig. 3B, second entry point 214) is closer to the one end of the soft tissue graft than the first longitudinal location (Figs. 3A-B, second entry point 214 is nearer first end 202a than first entry point 212).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Jackson et al. (US 2019/0314143 A1), “Jackson”.
Regarding claim 10, Spenciner teaches wherein the suture material (Fig. 3C, suture 204) comprises a first portion (Fig. 3A, region of suture 204 comprising sutures tails 206, 208) and a second portion (Fig. 3A, region of suture 204 comprising suture ends 216, 218), and the passing and tensioning steps use the first portion of the suture material (Fig. 3D, suture ends 216, 218 are held on surface 209 of graft 202 between first entry point 212 and second entry point 214 (and further, final entry point 228) while tensioned prior to being inserted into the body (col. 8, lines 26-28)), the method further comprising: passing the second portion (Fig. 3A, region of suture 204 comprising suture ends 216, 218) of the suture material (Fig. 3C, suture 204) through the soft tissue graft (Fig. 3A graft 202) adjacent to the graft support filament (Fig. 3D, suture ends 216, 218 of suture 204) and the soft tissue graft (Fig. 3A graft 202), such that the suture material passes through the soft tissue graft on the first side of the graft support filament (Fig. 3C, suture 204 passes through first surface 209 of graft 202 to a second, opposite surface 211 (cols. 7-8, lines 66-4)), but fails to teach a third longitudinal location along the graft support filament and the third longitudinal location spaced laterally of the first and second longitudinal locations.
Jackson teaches a surgical fixation system comprising a third longitudinal location (Fig. 7, third stitched region 57) along the graft support filament (Fig. 7, reinforcement scaffold 22) and the third longitudinal location spaced laterally of the first and second longitudinal locations (Fig. 7, third stitched region 57 is spaced apart from first and second stitched regions 54, 56); and passing the second portion of the suture material (Fig. 3, loop 14) over the graft support filament (Fig. 7, reinforcement scaffold 22) and back through the soft tissue graft (Fig. 7, graft 16) adjacent to the graft support filament at a fourth longitudinal location (Fig. 7, stitching process may be repeated until desired number of stitched regions have been formed [0054]) spaced longitudinally along the graft support filament (Fig. 6, stitches occur in D1 direction and are repeated until desired number is reached (i.e., four lateral stiches along reinforcement scaffold 22 and graft 16)) and the soft tissue graft (Fig. 7, graft 16) from the third longitudinal location (Fig. 7, third stitched region 57), such that the suture material (Fig. 6, suture strand 52) passes through the soft tissue graft (Fig. 7, graft 16) on the first side of the graft support filament (Fig. 6, stitches begin on left side of reinforcement scaffold 22); and tensioning the suture material to secure the graft support filament (Fig. 7, reinforcement scaffold 22) to the soft tissue graft (Fig. 7, graft 16) along a length of the suture material (Fig. 6, suture strands 52 are tensioned after being stitched [0054]) between the third longitudinal location (Fig. 7, third stitched region 57) and the fourth longitudinal location (Fig. 6, stitches occur in D1 direction and are repeated until desired number is reached (i.e., fourth lateral stitch)).
Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period of time in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the soft tissue graft taught by Spenciner with the graft support filament and longitudinal locations taught by Jackson in order to increase the biocompatibility of the graft when implanted.
Claims 11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Jackson et al. (US 2019/0314143 A1), “Jackson” and further in view of Sengun (US Pat No. 10182903 B2), “Sengun”.
Regarding claim 11, Spenciner teaches a soft tissue graft (Fig. 3A, graft 202), first (Fig. 3A, first entry point 212) and second longitudinal locations (Fig. 3B, second entry point 214), and suture material (Fig. 3A, suture 204), but fails to teach passing a second suture material through the soft tissue graft adjacent to a second graft support filament at a third longitudinal location along the second graft support filament and the soft tissue graft, or such that the second suture material passes through the soft tissue graft on a first side of the second graft support filament.
Jackson teaches a surgical fixation system comprising third (Fig. 7, third stitched region 57) and fourth longitudinal locations (Fig. 7, stitching process may be repeated until desired number of stitched regions have been formed [0054]). Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the soft tissue graft taught by Spenciner with the graft support filament and longitudinal locations taught by Jackson in order to increase the biocompatibility of the graft when implanted. However, Spenciner in view of Jackson fails to teach passing a second suture material through the soft tissue graft adjacent to a second graft support filament along the second graft support filament and the soft tissue graft, or such that the second suture material passes through the soft tissue graft on a first side of the second graft support filament.
Sengun teaches preparing a ligament graft comprising passing a second suture material (Fig. 2, suture loops 250) through the soft tissue graft (Fig. 2, graft 222) adjacent to a second graft support filament (Fig. 2, reinforcement construct 234) along the second graft support filament and the soft tissue graft (Fig. 2, suture loops extend along reinforcement construct 234 and graft 222), or such that the second suture material (Fig. 2, suture loops 250) passes through the soft tissue graft (Fig. 2, graft 222) on a first side of the second graft support filament (Fig. 2, suture loops 250 are formed by passing the suture around the same side surface of graft 222 (col. 8, lines 4-9)); passing the second suture material over the second graft support filament (Fig. 2, suture loops 250) and back through the soft tissue graft adjacent to the second graft support filament along the second graft support filament and the soft tissue graft (Fig. 2, suture loops 250 are formed by passing a suture tail attached to reinforcement construct 234 through graft 222 (col. 7, lines 62-65)), such that the suture material (Fig. 2, suture loops 250 comprise suture tails 206, 208 (Fig. 1)) passes through the soft tissue graft (Fig. 2, graft 222) on the first side of the second graft support filament (Fig. 2, suture loops 250 are formed by passing the suture around the same side surface of graft 222 (col. 8, lines 4-9)); and tensioning the second suture material to secure the second graft support filament to the soft tissue graft along a length of the second suture material between the third longitudinal location and the fourth longitudinal location (Fig. 2, graft 222 is tensioned prior to being inserted into a bone tunnel (col. 1, lines 53-55)).
Sengun discloses that the ends of the graft are reinforced using other types of tissue repair constructs (col. 8, lines 9-20). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner in view of Jackson with the dual suture ends and stitching methods taught by Sengun in order to provide additional reinforcement of the graft to avoid rupture after implantation.
Regarding claim 13, Spenciner teaches the soft tissue graft (Fig. 3A, graft 202), but Spenciner in view of Jackson fails to teach wherein the graft support filament is positioned alongside the soft tissue graft and includes at least one adjustable filamentary loop, and the suture material is positioned to alternate between passing through the soft tissue graft and around the graft support filament along at least part of the length of the soft tissue graft and the graft support filament, wherein during the tensioning step, the at least one adjustable filamentary loop of the graft support filament slides alongside the soft tissue graft and through the suture material and the diameter of the at least one adjustable filamentary loop decreases.
Jackson teaches a surgical fixation system wherein the graft support filament (Fig. 7, reinforcement scaffold 22) is positioned alongside the soft tissue graft (Fig. 7, graft 16) and includes at least one adjustable filamentary loop (Fig. 7, loop 14), and the suture material (Fig. 6, suture strand 52) is positioned to alternate between passing through the soft tissue graft and around the graft support filament along at least part of the length of the soft tissue graft and the graft support filament (Fig. 6, needle 26 passes through reinforcement scaffold 22 and graft 16 to form stitched regions 54, 56, 57 [0054]), wherein during the tensioning step (Fig. 6, suture strands 52 are tensioned after stitching [0054]), the at least one adjustable filamentary loop (Fig. 7, loop 14) of the graft support filament (Fig. 7, reinforcement scaffold 22) slides alongside the soft tissue graft (Fig. 7, graft 16) and through the suture material (Fig. 6, suture strand 52) and the diameter of the at least one adjustable filamentary loop decreases (Fig. 7, loop 14 is adjustable in length and/or perimeter and may be pulled to reduce the size of loop 14 [0045]).
Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner with the graft support filament, positioning, and adjusting taught by Jackson in order to increase biocompatibility of the device.
Regarding claim 14, Spenciner teaches a method of preparing a soft tissue graft (abstract) and adjustable filamentary loops that are slidable relative to the soft tissue graft (Fig. 3D, loops 210 along graft 202), but fails to teach positioning a first graft support filament having at least one adjustable filamentary loop at least partially against a soft tissue graft, such that at least a portion of the at least one adjustable filamentary loop of the first graft support filament extends beyond a first end of the soft tissue graft; positioning a second graft support filament having at least one adjustable filamentary loop at least partially against the soft tissue graft, such that at least a portion of the at least one adjustable filamentary loop of the second graft support filament extends beyond a second end of the soft tissue graft; securing the first graft support filament against the soft tissue graft such that the at least one adjustable filamentary loop of the first graft support filament is slidable relative to the soft tissue graft; and securing the second graft support filament against the soft tissue graft such that the at least one adjustable filamentary loop of the second graft support filament is slidable relative to the soft tissue graft.
Jackson teaches a surgical fixation system comprising positioning a first graft support filament (Fig. 7, reinforcement scaffold 22) having at least one adjustable filamentary loop (Fig. 7, loop 14) at least partially against a soft tissue graft (Fig. 7, graft 16), such that at least a portion of the at least one adjustable filamentary loop of the first graft support filament extends beyond a first end of the soft tissue graft (Fig. 7, loop 14 is beyond the end of graft 16 and reinforcement scaffold 22); securing the first graft support filament against the soft tissue graft such that the at least one adjustable filamentary loop of the first graft support filament is slidable relative to the soft tissue graft (Fig. 7, loop 14 is adjustable in length and/or perimeter and may be pulled to reduce the size of loop 14 [0045]).
Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner with the graft support filament, positioning, and adjusting taught by Jackson in order to increase biocompatibility of the device. However, Spenciner in view of Jackson fails to teach positioning a second graft support filament having at least one adjustable filamentary loop at least partially against the soft tissue graft, such that at least a portion of the at least one adjustable filamentary loop of the second graft support filament extends beyond a second end of the soft tissue graft; and securing the second graft support filament against the soft tissue graft such that the at least one adjustable filamentary loop of the second graft support filament is slidable relative to the soft tissue graft.
Sengun teaches preparing a ligament graft comprising positioning a second graft support filament (Fig. 2, reinforcement construct 234) having at least one adjustable filamentary loop (Fig. 2, suture loops 250) at least partially against the soft tissue graft (Fig. 2, graft 222), such that at least a portion of the at least one adjustable filamentary loop of the second graft support filament extends beyond a second end of the soft tissue graft (Fig. 2, suture tails 206, 208 (Fig. 1) of suture loops 250 extend beyond end 222b of graft 222); and securing the second graft support filament (Fig. 2, reinforcement construct 234) against the soft tissue graft (Fig. 2, graft 222).
Sengun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft support filaments and positioning taught by Jackson, and the graft and adjustability taught by Spenciner with the second graft support filament and stitching methods taught by Sengun in order to save operating room costs.
Regarding claim 15, Spenciner teaches the soft tissue graft (Fig. 3A, graft 202), but fails to teach wherein the step of securing the first graft support filament against the soft tissue graft includes passing at least a first length of suture material through the soft tissue graft in at least a first location and passing around but not through the first graft support filament.
Jackson teaches a surgical fixation system wherein the step of securing the first graft support filament (Fig. 7, reinforcement scaffold 22) against the soft tissue graft (Fig. 7, graft 16) includes passing at least a first length of suture material (Fig. 7, adjustable eyesplice loops 32) through the soft tissue graft (Fig. 7, graft 16) in at least a first location (Fig. 7, first stitched region 54) and passing around but not through the first graft support filament (Fig. 4, needle 26 is passed through graft 16 to anchor reinforcement scaffold 22 to graft 16 [0051]). Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner with the graft support filament, positioning, and adjusting taught by Jackson in order to increase biocompatibility of the device.
Regarding claim 16, Spenciner teaches the soft tissue graft (Fig. 3A, graft 202), and first location (Fig. 3A, first entry point 212) spaced longitudinally from a second longitudinal location (Fig. 3B, second entry point 214), but fails to teach wherein the step of securing the second graft support filament against the soft tissue graft includes passing at least the first length of suture material through the soft tissue graft in at least a second location, spaced longitudinally from the first location, and passing around but not through the second graft support filament.
Jackson teaches a surgical fixation system comprising passing at least the first length of suture material (Fig. 7, adjustable eyesplice loops 32) through the soft tissue graft and passing around but not through the second graft support filament (Fig. 4, needle 26 is passed through graft 16 to anchor reinforcement scaffold 22 to graft 16 [0051]). Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner with the graft support filament, positioning, and adjusting taught by Jackson in order to increase biocompatibility of the device. However, Spenciner in view of Jackson fails to teach a second graft support filament against the soft tissue graft.
Sengun teaches preparing a ligament graft wherein the step of securing the second graft support filament (Fig. 2, reinforcement construct 234) against the soft tissue graft (Fig. 2, graft 222). Segun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft and longitudinal locations taught by Spenciner and the suture attachment methods taught by Jackson with the second graft support filament taught by Sengun in order to decrease operating room costs by simplifying the procedure.
Regarding claim 17, Spenciner teaches the soft tissue graft (Fig. 3A, graft 202), and a second location (Fig. 3B, second entry point 214), spaced longitudinally from the first location (Fig. 3A, first entry point 212), but fails to teach wherein the step of securing the second graft support filament against the soft tissue graft includes passing at least a second length of suture material through the soft tissue graft, and passing around but not through the second graft support filament.
Jackson teaches a surgical fixation system including includes passing at least a second length of suture material through the soft tissue graft and passing around but not through the second graft support filament (Fig. 4, needle 26 is passed through graft 16 to anchor reinforcement scaffold 22 to graft 16 [0051]). Jackson discloses that the reinforcement scaffold is bioabsorbable for resorbing away after a period in the body or can be provided with medicinal or therapeutic agents [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner with the graft support filament, positioning, and adjusting taught by Jackson in order to increase biocompatibility of the device. However, Spenciner in view of Jackson fails to teach securing the second graft support filament against the soft tissue graft.
Sengun teaches preparing a ligament graft comprising the second graft support filament (Fig. 2, reinforcement construct 234) against the soft tissue (Fig. 2, graft 222). Segun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft and longitudinal locations taught by Spenciner and the suture attachment methods taught by Jackson with the second graft support filament taught by Sengun in order to decrease operating room costs by simplifying the procedure.
Regarding claim 18, Spenciner in view of Jackson fails to teach the limitations of claim 18. Sengun teaches preparing a ligament graft wherein the first length of suture material passes around the first graft support filament (Fig. 2, suture loops 240 engage reinforcement construct 224) and not the second graft support filament (Fig. 2, reinforcement construct 234), and the second length of suture material passes around the second graft support filament and not the first graft support filament (Fig. 2, suture loops 250 engage reinforcement construct 234). Segun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner to comprise the suture material and graft filaments taught by Sengun in order to decrease operating room costs by simplifying the procedure.
Regarding claim 19, Spenciner in view of Jackson fails to teach the limitations of claim 19. Sengun teaches preparing a ligament graft wherein prior to positioning, the first graft support filament and positioning the second graft support filament, the method comprises connecting the first length of suture material to the first graft support filament (Fig. 2, suture loops 240 engage reinforcement construct 224) and connecting the second length of suture material to the second graft support filament (Fig. 2, suture loops 250 engage reinforcement construct 234). Segun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner to comprise the suture material and graft filaments taught by Sengun in order to decrease operating room costs by simplifying the procedure.
Regarding claim 20, Spenciner teaches a method for preparing reinforced grafts wherein prior to positioning, the first graft support filament and positioning the second graft support filament, the method comprises interconnecting the at least one filamentary loop (Fig. 5, suture ends 516, 518 partially overlap (col. 11, lines 61-67)), but Spenciner in view of Jackson fails to teach the first and second graft support filaments.
Sengun teaches preparing a ligament graft comprising at least one filamentary loop (Fig. 2, suture loops 240) of the first graft support filament (Fig. 2, reinforcement construct 224) and at least one filamentary loop (Fig. 2, suture loops 250) of the second graft support filament (Fig. 2, reinforcement construct 234). Segun discloses that the stitching method used for graft preparation is simplified and less labor intensive (col. 5-6, lines 60-14). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Spenciner in view of Jackson to comprise the suture material and graft filaments taught by Sengun in order to decrease operating room costs by simplifying the procedure. However, Spenciner in view of Jackson and Sengun fails to teach wherein prior to positioning, the first graft support filament and positioning the second graft support filament, the method comprises interconnecting the filamentary loops.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Jackson et al. (US 2019/0314143 A1), “Jackson” and further in view of Bachmaier et al. (US Pat. No. 10448945 B2), “Bachmaier”.
Regarding claim 12, Spenciner teaches a soft tissue graft (Fig. 3A, graft 202), but Spenciner in view of Jackson fails to teach a method of implanting a soft tissue graft in a bone tunnel.
Bachmaier teaches a surgical fixation system comprising a method of implanting a soft tissue graft in a bone tunnel formed in bone (Fig. 9, graft 16 is fixed within second bone tunnel 46), comprising the steps of: positioning the prepared soft tissue graft of claim 10 within the bone tunnel (Fig. 9, graft 16 and reinforcement material 18 are fixated to second bone tunnel 46), prepared soft tissue including a fixation member (Fig. 9, fixation device 12) connected to the graft support filament (Fig. 9, reinforcement material 18); positioning the fixation member (Fig. 9, fixation device 12) relative to the bone to secure the graft support filament relative to the bone (Fig. 9, fixation device 12 provides cortical bone fixation of graft 16 (col. 4, lines 26-28)); and tensioning the graft support filament to position the soft tissue graft within the bone tunnel (Fig. 9, separate tensions may be applied to graft 16 and reinforcement material 18 during implantation (col. 5, lines 30-33)), wherein upon tensioning, at least a portion of the graft support filament slides relative to the soft tissue graft and the suture material (Fig. 9, reinforcement material 18 is tensioned separately from graft 16 and different amounts of slack can be provided to each (col. 7, lines 16-20)).
Bachmaier discloses that the surgical fixation system can be used in a variety of reconstruction procedures, not just ACL reconstruction (col. 6, lines 34-38). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prepared soft tissue graft taught by Spenciner in view of Jackson with the implantation features and methods of the soft tissue graft taught by Bachmaier in order to increase the use of the system in a wider range of related repair fields.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Spenciner (US Pat. No. 9622742 B2), “Spenciner” in view of Sengun (US Pat No. 10182903 B2), “Sengun”.
Regarding claim 21, Spenciner teaches the graft support filament (Fig. 3B free suture ends 216, 218) but fails to teach it is a material that is separate from the suture material. Sengun teaches preparing a ligament graft wherein the graft support filament is a material that is separate from the suture material (Fig. 1, graft 202 comprises reinforcement material 204 and separate suture tail 208 is secured to graft 202 and reinforcement material 204 (col. 6, lines 29-35)). Sengun discloses that the reinforcement material and suture provide structural support to the graft (col. 6, lines 37-39). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft and suture taught by Spenciner with the graft support filament separate from the suture taught by Sengun in order to provide the graft with additional structural support.
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.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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