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's arguments filed 01/12/2026 have been fully considered but they are not persuasive.
Applicant argued the use of Rogalski is improper due to its use of a screw instead of a flexible filament, not describing the pluralities of apertures position along opposing edges, and a lack of disclosure the central axis of the holes align when brought together. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Rogalski is incorporated to show the alignment of apertures. Brunelle teaches the apertures on opposing edges as well as the filament subjected to tension. Rogalski teaches the plurality of apertures overlap and the use of a straight screw shows the central axis of the circular holes would be aligned.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the choice of how to thread a filament to hold two edges together is within the skill The orientation of holes when the edges are held together is a matter of simple substitution of one known element for another (lined up adjacently or coaxially aligned) to obtain predictable results (see MPEP 2143).
Claim(s) 1, 8-9 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brunelle (US 2009/0018655 A1) in view of Guerra (US 2014/0277448 A1) and Rogalski (US 2003/0130735 A1).
Regarding claim 1, Brunelle discloses a bioactive scaffold (¶ [0007])for use in reconstruction of an anterior cruciate ligament of a patient (¶ [0030]), comprising:
a tissue matrix (4, scaffold, fig. 7A) circumferentially surrounding the first end of the graft and at least a portion of the body of the graft (¶ [0072] states the scaffold can be used as a wrap). Though Brunelle does not explicitly recite the scaffold surrounds the graft from the first end of the graft to a portion of the body of the graft, the scaffold of Brunelle is capable of surrounding the first end of the graft and at least a portion of the body of the graft.
wherein the tissue matrix includes collagen type I (¶ [0037]);
wherein the tissue matrix includes a first plurality of apertures (see annotated fig. 7A, below) extending through the tissue matrix along a first edge of the tissue matrix (see annotated fig. 7A, below) and a second plurality of apertures (see annotated fig. 7A, below)extending through the tissue matrix along a second edge of the tissue matrix (see annotated fig. 7A, below) ; and
a filament (3, suture, fig. 7A) configured to be laced through the first plurality of apertures and the second plurality of apertures (fig. 7A) and draw the first edge of the tissue matrix toward the second edge of the tissue matrix when the filament is subjected to tension thereby closing the tissue matrix around the graft (fig. 7A).
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Brunelle fails to teach a graft. However Guerra discloses a soft tissue graft that includes a graft (99, graft construct, fig. 5) including a first end (see annotated fig. 5, below), a second end (see annotated fig. 5, below), and a body (see annotated fig. 5, below) extending therebetween, wherein the graft is sized and configured to extend from a first bone of a joint (91, femur, fig. 5) to a second bone of the joint (92, tibia, fig 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly of Brunelle to include the teaching of a graft by Guerra since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Brunelle in view of Guerra fails to teach the edges of the tissue matrix circumferentially overlap aligning the first and second plurality of apertures. However, Rogalski discloses a graft device that includes the first edge of the tissue matrix circumferentially overlaps the second edge of the tissue matrix (figs. 12-13) when the filament is subjected to tension to close the tissue matrix around the graft such that a central axis of each of the first plurality of apertures is aligned with a corresponding central axis of each of the second plurality of apertures (figs. 12-13). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the alignment of apertures of Brunelle and Guerra to include the edges of the tissue matrix circumferentially overlap aligning the first and second plurality of apertures as taught by Rogalski since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 8, Brunelle fails to teach the graft is configured to extend into a first hole formed in the first bone. However, Guerra further discloses a first portion of the graft is configured to extend into a first hole formed in the first bone (91a, femoral tunnel, fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly of Brunelle to include the graft is configured to extend into a first hole formed in the first bone as taught by Guerra since it is combining prior art element according to known methods to yield predictable results.
Regarding claim 9, Brunelle further discloses a first portion of the tissue matrix (see annotated fig. 7A, below) is configured to extend into the first hole formed in the first bone (first portion of the tissue matrix, see annotated fig. 7A, below). The phrase “configured to extend into the first hole formed in the first bone” is a functional recitation (see MPEP 2114(II)). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing the recited function in order to meet the claim requirements. In this case, the first portion of the tissue matrix is capable of extending into the first hole formed in the first bone.
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Regarding claim 26, Brunelle further discloses the tissue matrix is impregnated with a therapeutic substance configured to promote or inhibit a particular response (¶ [0032]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brunelle in view of Guerra and Rogalski as applied to claim 1 above, and further in view of Paulos (US 2011/0282448 A1).
Regarding claim 2, Brunelle in view of Guerra and Rogalski fails to teach after the filament is subjected to tension to close the tissue matrix around the graft, the tissue matrix applies a compressive force to the graft. However, Paulos discloses scaffold (10c, cuff, fig. 8B) that includes after the filament is subjected to tension to close the tissue matrix around the graft, the tissue matrix applies a compressive force to the graft (¶ [0124]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the scaffold of Brunelle, Guerra and Rogalski to include after the filament is subjected to tension to close the tissue matrix around the graft, the tissue matrix applies a compressive force to the graft as taught by Paulos in order to provide protection of the tissue environment (Paulos, ¶ [0124]).
Claim(s) 15-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brunelle (US 2009/0018655 A1) in view of Guerra (US 2014/0277448 A1) and Rogalski (US 2003/0130735 A1).
Regarding claim 15, Brunelle discloses a bioactive scaffold assembly (¶ [0007]) for use in reconstruction of an anterior cruciate ligament of a patient (¶ [0030]), comprising:
a tissue matrix (4, scaffold, fig. 7A) circumferentially surrounding the first end of the graft and at least a portion of the body of the graft (¶ [0072] states the scaffold can be used as a wrap). Though Brunelle does not explicitly recite the scaffold surrounds the graft from the first end of the graft to a portion of the body of the graft, the scaffold of Brunelle is capable of surrounding the first end of the graft and at least a portion of the body of the graft.
wherein the tissue matrix includes collagen type I (¶ [0037]);
wherein the tissue matrix includes a first orifice proximate the first end of the graft (see annotated fig. 7A, below), the first tether extending axially through the first orifice (when the matrix is wrapped around the graft the tether would extend axially through the orifice);
wherein a cross-sectional area of the first orifice is less than a cross-sectional area of the graft proximate the first end of the graft (obvious to try, there are only 3 options, smaller, larger and same as for the cross sectional area relations, choosing the first orifice to be smaller than the cross sectional area of the graft would be obvious as it would ensure the graft stays securely within the scaffold as tension is applied during movement of the joint);
wherein the cross-sectional area of the first orifice is at least twice as great as a cross- sectional area of the first tether (the only difference between the prior art and the claims is the recitation of relative dimensions which does not make the claimed device patentably distinct from the prior art (MPEP 2144.04 IV A)); and
wherein the tissue matrix is configured to span a gap between the first bone and the second bone (4, scaffold, fig. 7A). The phrase “the tissue matrix is configured to span a gap between the first bone and the second bone” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the scaffold is considered to be capable of spanning a gap between the first bone and the second bone;
wherein the tissue matrix includes a first plurality of apertures (see annotated fig. 7A, below) extending through the tissue matrix along a first edge of the tissue matrix (see annotated fig. 7A, below) and a second plurality of apertures (see annotated fig. 7A, below)extending through the tissue matrix along a second edge of the tissue matrix (see annotated fig. 7A, below) ; and
at least one filament (3, suture, fig. 7A) configured to be laced through the first plurality of apertures and the second plurality of apertures (fig. 7A) and draw the first edge of the tissue matrix toward the second edge of the tissue matrix when the at least one filament is subjected to tension thereby closing the tissue matrix around the graft (fig. 7A).
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Brunelle fails to teach a graft. However Guerra discloses a soft tissue graft that includes a graft (99, graft construct, fig. 5) including a first end (see annotated fig. 5, below), a second end (see annotated fig. 5, below), and a body (see annotated fig. 5, below) extending therebetween, wherein the graft is sized and configured to extend from a first bone of a joint (91, femur, fig. 5) to a second bone of the joint (92, tibia, fig 5); wherein the graft includes a first tether extending axially from the first end of the graft (56, suture loops, fig. 10), the first tether being configured to secure the graft to the first bone (¶ [0022], fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly of Brunelle to include the teaching of a graft by Guerra since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Brunelle in view of Guerra fails to teach the central axis of the first plurality of apertures is aligned with a corresponding central axis of each of the second plurality of apertures. However, Rogalski discloses a graft device that teaches when the filament is subjected to tension to close the tissue matrix around the graft, a central axis of each of the first plurality of apertures is aligned with a corresponding central axis of each of the second plurality of apertures (figs. 12-13). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the alignment of apertures of Brunelle and Guerra to include the edges of the tissue matrix circumferentially overlap aligning the first and second plurality of apertures as taught by Rogalski since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 16, Brunelle further discloses the first edge of the tissue matrix is configured to abut a second edge of the tissue matrix after disposing the tissue matrix around the graft (fig. 7A).
Regarding claim 17, Brunelle further discloses the first edge of the tissue matrix is configured to circumferentially overlap a second edge of the tissue matrix (see annotated fig. 7A, below) after disposing the tissue matrix around the graft. The phrase “a first edge of the tissue matrix is configured to circumferentially overlap a second edge of the tissue matrix after disposing the tissue matrix around the graft” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the first edge is considered to be capable of overlapping the second edge of the tissue matrix.
Regarding claim 18, Brunelle further discloses the tissue matrix is configured to be disposed around the graft prior to implanting the graft into the joint (4, scaffold, fig. 7A). The phrase “the tissue matrix is configured to be disposed around the graft prior to implanting the graft into the joint” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the scaffold is considered to be capable of being disposed around the graft prior to implanting the graft into the joint.
Regarding claim 19, Brunelle further discloses the tissue matrix is configured to be disposed around the graft after implanting the graft into the joint (¶ [0036]).
Regarding claim 20, Brunelle further discloses the tissue matrix is configured to stimulate a healing response in the patient (¶ [0030], ¶ [0032] and ¶ [0036]).
Regarding claim 21, Brunelle further discloses the tissue matrix is configured to limit contact between the graft and synovial fluid within the joint (4, scaffold, fig. 7A). The phrase “the tissue matrix is configured to limit contact between the graft and synovial fluid within the joint ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the scaffold is considered to be capable of limiting contact between the graft and synovial fluid within the joint.
Regarding claim 22, Brunelle fails to teach the ends of the graft extend into holes in the bone. However, Guerra further discloses the first end of the graft is configured to extend into a first hole formed in the first bone (91a, femoral tunnel, fig. 5), and the second end of the graft is configured to extend into a second hole formed in the second bone (92a, tibial tunnel, fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly of Brunelle to include the ends of the graft extend into holes in the bone as taught by Guerra since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 23, Brunelle further discloses the tissue matrix is configured to extend into the first hole (see annotated fig. 7A, below). The phrase “the tissue matrix is configured to extend into the first hole” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the end is considered to be capable of extending into the first hole.
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Regarding claim 24, Brunelle further discloses the tissue matrix is configured to extend into the second hole (see annotated fig. 7A, below). The phrase “the tissue matrix is configured to extend into the second hole ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the end is considered to be capable of extending into the second hole.
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Regarding claim 25, Brunelle further discloses the tissue matrix is configured to extend into the first hole and the second hole (see annotated fig. 7A, below). The phrase “the tissue matrix is configured to extend into the first hole and the second hole” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the ends are considered to be capable of extending into the first hole and the second hole.
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Conclusion
THIS ACTION IS MADE FINAL. 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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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