DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on 3/31/26. As directed by the amendment: claims 1-4, 6-14, 18-20 and 23-24 are presently pending in this application. Claims 1, 7, 13, and 18 are amended.
Response to Arguments
Applicant's arguments filed 3/31/26 with respect to the rejection of claims 1, 2, 4, 9-12, and 14 under 35 U.S.C. 103(a) as being unpatentable over Hagan (US2005/0255140) in view of Evans (US2003/0236573), Ahlfors (US2005/0226856), Pachence (US5713374) have been fully considered and the amendment overcomes the previous rejection. However, a new grounds of rejection has been made in view of Chervitz (US6283996) in view of Evans (US2003/0236573), Ahlfors (US2005/0226856), and Pachence (US5713374).
Applicant further argues, Chervitz (US6283996) teaches away from the presently claimed tissue healing device. Applicant asserts the footing and strap arrangement of Chervitz is distinctly different from the fixation device as claimed. Examiner disagrees, where Applicant has provided no clear evidence how the arrangement of Chervitz teaches away from the claimed invention. Chervitz meets the claim limitations of a fixation device by being fixed within the bone hole and the ligament extends from the strap/footing arrangement. Examiner suggests Applicant clearly amend to state the differences between the claimed invention and Chervitz and how the fixation device is secured to the bone.
Applicant further argues, under the teachings of Pachence one having ordinary skill in the art would have been led away from a hydrophilic scaffold configured to absorb blood. Examiner disagrees with Applicants arguments. The rejection relies on Pachence, merely for a teaching of the scaffold having Type I collagen as required by the claim. Pachence teaches a scaffold with Type I collagen and is used for tissue repair (C4:L21-24). One having ordinary skill in the art with the teachings of Pachence to show a scaffold with Type I collagen would have arrived at the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7, 10-12, and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chervitz (US6283996) in view of Evans (US2003/0236573), Ahlfors (US2005/0226856), and Pachence (US5713374).
Regarding claim 1, Chervitz discloses a tissue healing device for positioning at or adjacent a first bone (first bone is where bone end 22 of ligament graft connects to, see Fig. 4) and configured to repair a tissue connectable to a second bone (end of ligament graft attached to second bone not shown in Figures), the tissue healing device comprising:
a scaffold (graft 21) that is compressible and expandable configured to be positioned at or adjacent a repair site of the tissue and at or adjacent a first bone (C3:L65-67), wherein the scaffold is configured to absorb blood at the repair site (the ligament graft is capable of absorbing blood, C3:L33-35), wherein the tissue is connected to a second bone (graft ligament is connected to second bone), and wherein the scaffold is configured to partially fill the repair site when inserted and expand to fill the repair site in the presence of blood (the graft fully capable of performing this intended use since it expands and compresses by acting as a natural ligament);
at least one fixation device (10) configured to be secured to the first bone, wherein the at least one fixation device comprises an anchor, screw, helical anchor, staple, clip, snap, or rivet (14) and an eyelet at a first end of the fixation device (eyelet 19); and
at least one suture (20) configured to be threaded through the at least one fixation device (see Fig. 1) and positioned along the scaffold (see Fig. 1) and coupled to the tissue via the at least one fixation device to position the scaffold between the repair site of the tissue and the first bone and the second bone (see Fig. 1), wherein the at least one suture is attached to the at least one fixation device through the eyelet (see Fig .1).
Chervitz does not explicitly disclose the scaffold being hydrophilic collagen scaffold. Evans, in the same field of endeavor discloses a tissue healing device 14 (Figs. 2A-2B) configured to repair a tissue (see [0002]-[0003] discloses tissue repair with graft scaffolds and [0116] discloses ligament repair), comprising a scaffold and teaches the scaffold comprises a hydrophilic collagen scaffold that is compressible and expandable (the device 14 is a hydrophilic sponge-like scaffold formed of collagen that expands and compresses as shown in Figs. 2A-2B and disclosed in [0126], [0127], [0130]; where hydrophilicity is discussed in [0011]), wherein the hydrophilic scaffold is configured to absorb blood at the repair site (the scaffold 14 is a porous hydrophilic expandable and compressible scaffold which is fully capable of absorbing fluid such as blood).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have substituted the scaffold material of Chervitz for the hydrophilic collagen scaffold material of Evans (that teaches the scaffold being hydrophilic, including plasma or platelet, growth factors, collagen and in the form of a sponge), since the substitution would have yielded the same predictable result of providing a scaffold for tissue ingrowth and repair of the ligament. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The modified hydrophilic collagen scaffold of Chervitz/Evans does not explicitly disclose the scaffold containing glycosaminoglycan and pepsin. Ahlfors teaches a collagen implant that includes glycosaminoglycans populated in the implant ([0056]) and collagen that is pepsin extracted ([0059]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the hydrophilic collagen scaffold contain glycosaminoglycan and pepsin, since the amount of glycosaminoglycan and pepsin derived collagen can be altered in order for different strength and characteristics of a collagen implant ([0217]); further, one having ordinary skill in art would have found it obvious to include pepsin for extraction of collagen and glycosaminoglycans to mimic the native tissue ([0217]).
Chervitz/Evans does not explicitly disclose the type of collagen in the scaffold being Type I collagen. However, Pachence teaches Type I Collagen scaffold for tissue repair (C4:L21-24). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the collagen in the scaffold of Chervitz/Evans to be Type I collagen, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, the modified invention discloses where the tissue is an anterior cruciate ligament (ACL) (C1:L16-17) and wherein the scaffold allows cell ingrowth (C1:L31-36 of Chervitz).
Regarding claims 3, Chervitz/Evans/Ahlfors/Pachence makes obvious the claimed invention of claim 1, Chervitz further discloses wherein the at least one fixation device is conical in shape (top cone 14 is conical, see Fig. 1).
Regarding claim 4, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Chervitz further discloses wherein the at least one fixation device further comprises a second end opposite the first end of the fixation device (10 has a first end and second end, see Fig. 1).
Regarding claim 7, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Chervitz further discloses wherein the fixation device includes a sharpened tip at the second end of the fixation device (top cone 14 is interpreted as sharp by extending to a point, see Fig. 1).
Regarding claims 10 and 11, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Evans further teaches where the scaffold further comprises a repair material and the repair material is a platelet or plasma ([0032] of Evans).
Regarding claim 12, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Evans further teaches one or more growth factors configured to be disposed within or on the scaffold ([0034] of Evans).
Regarding claim 14, Chervitz/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Evans further teaches wherein the scaffold consists essentially of a collagen sponge ([0126]-[0130] discusses a sponge-like porous scaffold made of collagen).
Claim 8 is rejected under 35 U.S.C. 103(a) as being unpatentable over Chervitz (US6283996) in view of Evans (US2003/0236573), Ahlfors (US2005/0226856), Pachence (US5713374) as applied to claim 7 above; and further in view of Skiba (6689153).
Regarding claim 8, Chervitz/Evans/Ahlfors/Pachence makes obvious the claimed invention of claims 7; except for wherein the fixation device is threaded. However, Skiba discloses a fastening device 101 having a threaded tip 103 (Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device in Chervitz/Evans/Ahlfors/Pachence to include the fixation device being threaded, as taught and suggested by Skiba, for securely anchoring the fastening device at the implantation site.
Claim 13 is rejected under 35 U.S.C. 103(a) as being unpatentable over Chervitz (US6283996) in view of Evans (US2003/0236573), Ahlfors (US2005/0226856), Pachence (US5713374) as applied to claim 1 above; and further in view of Li (5707395).
Regarding claim 13, Chervitz/Evans/Ahlfors/Pachence makes obvious the claimed invention of claim 1; except for the at least one fixation device further comprises is a first fixation device configured to be secured to the first bone and a second fixation device configured to secured to a second bone. However, Li teaches a similar device comprising at least one fixation device is a first fixation device configured to be secured to a first bone and a second fixation device configured to secured to a second bone (Fig. 2 discloses fixation devices 20 where the first fixation device is anchored to the Tibia and the second fixation device 20 is anchored to the femur). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Chervitz/Evans/Ahlfors/Pachence to include a first fixation device configured to be secured to a first bone and a second fixation device configured to secured to a second bone, as taught and suggested by Li, for securely anchoring the tissue repair device at both ends of the joints.
Claims 18-20 and 23-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chervitz (US6283996) in view of Evans (US2003/0236573), Pachence (US5713374), and Severns (US2002/0173792).
Regarding claim 18, Chervitz discloses a tissue healing device for positioning at or adjacent a femur (first bone is where bone end 22 of ligament graft connects to, see Fig. 4, where the bone is the femur, C1:L19) and configured to repair a ligament connectable to a tibia (C1:L19-20), the tissue healing device, comprising:
a scaffold (graft 21) that is compressible and expandable (graft is made of tissue for movement as a natural ligament, and therefore would be compressible and expandable, C3:L65-67), the scaffold configured to absorb blood at the repair site (graft is a matrix and is intended for tissue ingrowth and therefore would be capable of absorbing blood, C3:L33-35), wherein the scaffold is configured for partially fill the repair site when inserted and expand to fill the repair site in the presence of blood (the graft fully capable of performing this intended use since it expands and compresses by acting as a natural ligament), and wherein the ligament is connectable to the tibia (graft ligament is connected to second bone or tibia);
at least one fixation device (10) configured to be secured to the femur, wherein the at least one fixation device comprises an anchor, screw, helical anchor, staple, clip, snap, rivet (14) and an eyelet (eyelet 19) at a first end of the fixation; and
and at least one suture (20) configured to be threaded through the at least one fixation device (see Fig. 1) and positioned along the scaffold (see Fig. 1) and coupled to the ligament via the at least one fixation device (the suture is coupled to the ligament by the fixation device 10, by the graft capable of including some part of the ligament) to position the scaffold between the repair site of the ligament and the femur and the tibia (see Fig. 1), wherein the at least one suture is attached to the at least one fixation device through the eyelet (see Fig. 1).
Chervitz does not explicitly disclose the scaffold being hydrophilic collagen scaffold. Evans, in the same field of endeavor discloses a tissue healing device 14 (Figs. 2A-2B) configured to repair a tissue (see [0002]-[0003] discloses tissue repair with graft scaffolds and [0116] discloses ligament repair), comprising a scaffold and teaches the scaffold comprises a hydrophilic collagen scaffold that is compressible and expandable (the device 14 is a hydrophilic sponge-like scaffold formed of collagen that expands and compresses as shown in Figs. 2A-2B and disclosed in [0126], [0127], [0130]; where hydrophilicity is discussed in [0011]), wherein the hydrophilic scaffold is configured to absorb blood at the repair site (the scaffold 14 is a porous hydrophilic expandable and compressible scaffold which is fully capable of absorbing fluid such as blood).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have substituted the scaffold material of Chervitz for the hydrophilic collagen scaffold material of Evans (that teaches the scaffold being hydrophilic, including plasma or platelet, growth factors, collagen and in the form of a sponge), since the substitution would have yielded the same predictable result of providing a scaffold for tissue ingrowth and repair of the ligament. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Chervitz does not disclose the suture being bioabsorbable, but Pachence teaches bioresorbable sutures for use in combination with a matrix for tissue repair (C3:L36-37). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the tissue healing device of Chervitz to include a bioabsorbable suture, as taught and suggested by Pachence, as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The modified invention of Chervitz/Evans/Pachence does not explicitly disclose wherein the scaffold implanted at the repair site and secured in place with the at least one suture averages at least 50% of the intact tissue strength at the three months following implantation. Severns teaches bioresorbable spacer 46 (scaffold) that acts to replace tissue and after bone begins to heal, such as after several weeks, begins to deteriorate (therefore decreasing the strength) ([0098]). It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to modify the tissue healing device in Chervitz/Evans/Pachence to include the scaffold implanted at the repair site and secured in place with the at least one suture averaging at least 50% of the intact tissue strength at the three-months following implantation and wherein the scaffold, since the deterioration of the scaffold is a result effective variable, as suggested by Severns, that contributes to the overall tissue healing at the implantation site, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Modifying Chervitz/Evans/Pachence to include the scaffold implanted at the repair site and secured in place with the at least one suture averages at least 50% of the intact tissue strength at the three-months following implantation would allow for the scaffold to efficiently mimic natural tissue being repaired.
Regarding claim 19, Chervitz/Evans/Pachence/Severns makes obvious the device of claim 18, Chervitz further discloses the ligament is an anterior cruciate ligament (ACL) (C1:L16-17)
Regarding claim 20, Chervitz/Evans/Pachence/Severns makes obvious the device of claim 19; yet, does not explicitly disclose wherein the scaffold when implanted at the repair site, develops aligned structure in the tissue four weeks after implantation, which was indistinguishable from the tissue adjacent to the repair site. Severns further teaches bioresorbable spacer 46 (scaffold) that acts to replace tissue and after bone begins to heal, such as after several weeks, begins to deteriorate ([0098]). Before the deterioration, the space 46 is desired to act the same as the repaired tissue ([0097]-[0098]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue healing device in Chervitz/Evans/Pachence to have the scaffold develop aligned structure in the tissue four weeks after implantation, which would be indistinguishable from tissue adjacent to the repair site, since the implantation time before the scaffold beings to deteriorate is a result effective variable, as suggested by Severns, that contributes to the overall healing at the implantation site, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Modifying Chervitz/Evans/Pachence to develop aligned structure in the tissue four weeks after implantation, which was indistinguishable from the tissue adjacent to the repair site, would allow for the scaffold to efficiently mimic natural tissue being repaired.
Regarding claim 23, Chervitz/Evans/Pachence/Severns makes obvious the device of claim 19, the modified invention discloses wherein the scaffold consists essentially of a collagen sponge (see [0126]-[0130] of Evans which discloses a collagen sponge-like porous scaffold).
Regarding claim 24, Chervitz/Evans/Pachence/Severns makes obvious the device of claim 19, the modified invention discloses wherein the scaffold has a first end, a second opposite the first end, a length that extends from the first end to the second end, and a width that is perpendicular to the length, wherein the length is greater than the width, such that, the scaffold is configurable for implantation at the repair site (see Fig. 1, where Chervitz discloses a cylindrical scaffold with a length that is greater than the width).
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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached on M-F 10-6.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Thomas Barrett 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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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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