DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/6/25 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 11/6/25. As directed by the amendment: claims 1-4, 6-14, 18-20 and 23-24 are presently pending in this application. Claims 1, 4, 6, 18 are amended.
Response to Arguments
Applicant’s amendments filed 11/6/25 with respect to claim interpretation of claims 1 and 18 under 35 U.S.C. 112(f) provide structural features to the claimed “fixation device”. Therefore, the claim interpretation is withdrawn.
Applicant’s amendments filed 11/6/25 with respect to rejection of claims 1-16, 18-21, and 23-24 under 35 U.S.C. 101 have overcome the rejection.
Applicant's arguments filed 11/6/25 with respect to the rejection of claims 1, 2, 4, 5, 9-12, and 14 under 35 U.S.C. 103(a) as being unpatentable over Hagan (US2005/0255140) in view of Evans (US2003/0236573) and Ahlfors (US2005/0226856) have been fully considered but they are not found persuasive. Applicant incorporates previously rejected claims 15 and 16 into claim 1 and argues that the claim element “the scaffold is configured to partially fill the repair site when inserted and expand fill the repair site in the presence of blood” is not intended use. Examiner respectfully disagrees, apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647. MPEP 2114. Where structurally the features claimed are anticipated by Hagan as addressed in the rejection below. Applicant further argues, Hagan does not disclose a scaffold constructed of the same materials as recited in the present claims and fails to disclose the scaffold being compressible and expandable. Examiner makes notice, the scaffold of Hagan need not be constructed of the same materials as the claimed invention to perform the function, rather just have the capability of doing so. Where the scaffold of Hagan is made of tissue for movement as a natural ligament, and would therefore be compressible and expandable ([0056], [0069]).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation “at least one fixation device is a first fixation device… and a second fixation device". Claim 1 previously recited “the at least one fixation device comprises an eyelet”. It is unclear if the at least one fixation device comprises the eyelet, the first fixation device, and second fixation device; or if the first fixation device and second fixation device both comprise the eyelet. For examination purposes, the at least one fixation device is interpreted as a first fixation device with an eyelet and a second fixation device with an eyelet.
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, 2, 4, 9-12, and 14 are rejected 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).
Regarding claim 1, Hagan discloses a tissue healing device for positioning at or adjacent a first bone (scaffold is near a first bone 220 by repairing a ligament 200, [0068]) and configured to repair a tissue (ligament 200) connectable to a second bone (ligament 200 is connected to second bone 210, [0067]), the tissue healing device comprising:
a scaffold (scaffolding, [0068]) that is compressible and expandable (scaffold is made of tissue for movement as a natural ligament [0056], [0069], and therefore would be compressible and expandable), the scaffold configured to be positioned at or adjacent a repair site of the tissue ([0068]) and at or adjacent a first bone (bone 220), wherein the scaffold is configured to absorb blood at the repair site (scaffold is a matrix and is intended for tissue ingrowth and therefore would be capable of absorbing blood, [0064]), wherein the tissue is connected to a second bone (ligament 200 is connected to second bone 210, [0067]), 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 scaffold fully capable of performing this intended use since it expands and compresses by acting as a natural ligament, [0056], [0069]);
at least one fixation device configured to be secured to the first bone (bone blocks are interpreted as a fixation device and have eyelets/holes for fixation to bone; see Fig. 16C, [0074]), wherein the at least one fixation device comprises an eyelet (screw holes drilled through bone blocks, [0074]) at a first end of the fixation device (screw holes are made throughout the bone block and would therefore be at a first end as shown in Fig. 16C), and
at least one suture (60) configured to be threaded through the at least one fixation device (suture is capable of being passed through eyelets/holes of bone block, [0074]) and positioned along the scaffold (see Fig. 15, where the suture is stitched through and along the scaffold, see [0049], [0069]) and coupled to the tissue via the at least one fixation device (the suture is stitched to the ruptured tissue, where the suture is capable of being passed through the eyelets/holes by having a diameter sized to fit through the opening of the eyelet) to position the scaffold between the repair site of the tissue and the first bone and the second bone (see Fig. 15).
Hagan 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 Hagan 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 Hagan/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]).
Hagan/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 Hagan/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, Hagan/Evans/Ahlfors/Pachence makes obvious the device of claim 1, the modified invention discloses where the tissue is an anterior cruciate ligament (ACL) ([0065] of Hagan) and wherein the scaffold allows cell ingrowth ([0064] of Hagan, see C1:L31-36 of Chervitz).
Regarding claim 4, Hagan/Evans/Ahlfors/Pachence makes obvious the device of claim 1, Hagan further discloses wherein the at least one fixation device further comprises a second end opposite the first end of the fixation device (bone block has a first end and second end, see Fig. 16C).
Regarding claim 9, Hagan/Evans/Ahlfors/Pachence makes obvious the device of claim 4; yet, does not explicitly disclose the fixation device is selected from the group consisting of a screw. Hagan teaches the fixation device can be a screw having an eyelet ([0009]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the screw and eyelet fixation device for the bone block fixation device since the substitution would have yielded the same predictable result of providing fixation for a graft at its ends ([0009]).
Regarding claims 10 and 11, Hagan/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, Hagan/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, Hagan/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).
Claims 3, 6, and 7 are rejected 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) as applied to claim 1 above; and further in view of Chervitz (US6283996).
Regarding claims 3, Hagan/Evans/Ahlfors/Pachence makes obvious the claimed invention of claim 1; except for wherein the at least one fixation device is conical in shape.
However, Chervitz teaches a similar device (Fig. 1) comprising at least one fixation device 11 is conical in shape (pointed cone 14; Fig. 1).
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 Hagan by substituting the fixation device taught by Chervitz, since the substitution would have been predictable to one having ordinary skill in the art and have provided the added benefit of a barb fixation mechanism to secure the device against bone (C1:L31-36 of Chervitz).
Regarding claims 6 and 7, Hagan/Evans/Ahlfors/Pachence makes obvious the claimed invention of claim 1; except for wherein the at least one suture is attached to the at least one fixation device anchor through the eyelet; wherein the fixation device anchor includes a sharpened tip at the second end of the fixation device.
However, Chervitz teaches a similar device (Fig. 1) wherein the at least one fixation device includes an eyelet 19 at the first end of the fixation device (Fig. 1); wherein at least one suture 20 is attached to the at least one fixation device 11 through the eyelet 19 (as shown in Fig. 1); wherein the fixation device includes a sharpened tip at the second end of the fixation device (the sharpened tip of cone 14; Fig. 1).
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 Hagan by substituting the fixation device taught by Chervitz, since the substitution would have been predictable to one having ordinary skill in the art and have provided the added benefit of a barb fixation mechanism to secure the device against bone (C1:L31-36 of Chervitz). The substituted fixation device of Chervitz teaches an eyelet for the passage of a suture that is passed through a bone end 22 (C3:L26-30) and the fixation device of Hagan discloses an eyelet ([0073]), where the suture of the substituted fixation device would be passed through the scaffold matrix of Hagan in the same manner as disclosed in [0049]. The modification results in the fixation device including wherein the at least one suture is attached to the at least one fixation device anchor through the eyelet; wherein the fixation device anchor includes a sharpened tip at the second end of the fixation device.
Claim 8 is rejected 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), Chervitz (US6283996) as applied to claim 7 above; and further in view of Skiba (6689153).
Regarding claim 8, Hagan/Evans/Ahlfors/Pachence/Chervitz 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 Hagan/Evans/Ahlfors/Pachence/Chervitz 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 Hagan (US2005/0255140) 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, Hagan/Evans/Ahlfors/Pachence makes obvious the claimed invention of claim 1; except for the 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. 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 Hagan/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 Hagan (US2005/0255140) in view of Evans (US2003/0236573), Pachence (US5713374), and Severns (US2002/0173792).
Regarding claim 18, Hagan discloses a tissue healing device for positioning at or adjacent a femur (scaffold is near a bone 220 by repairing ligament 200, [0068], where the bone 220 is capable of being a femur) and configured to repair a ligament (ligament 200) connectable to a tibia (ligament 200 is connected to bone 210, [0067], where the bone 210 is capable of being a tibia and the device is configured to repair a ligament connectable to a tibia), the tissue healing device, comprising:
a scaffold (scaffolding, [0068]) that is compressible and expandable (scaffold is made of tissue for movement as a natural ligament [0056], [0069], and therefore would be compressible and expandable), the scaffold configured to absorb blood at the repair site (scaffold is a matrix and is intended for tissue ingrowth and therefore would be capable of absorbing blood, [0064]), 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 scaffold fully capable of performing this intended use since it expands and compresses by acting as a natural ligament, [0056], [0069]), and wherein the ligament is connectable to the tibia (ligament 200 connected to another bone 210, [0067]);
at least one fixation device configured to be secured to the femur (bone block having eyelets/holes for fixation to bone; see Fig. 16C, [0074]; thereby the bone blocks are configured to be secured to a femur as claimed), wherein the at least one fixation device comprises an eyelet at a first end of the fixation device (screw holes drilled through bone blocks, [0074]; screw holes are made throughout the bone block and would therefore be at a first end as shown in Fig. 16C); and
and at least one suture (60) configured to be threaded through the at least one fixation device (suture is capable of being passed through eyelets/holes 210 [0073]) and positioned along the scaffold (see Fig. 15, where the suture is stitched through and along the scaffold, see [0049], [0069]) and coupled to the ligament via the at least one fixation device (the suture is stitched to the ruptured tissue, where the suture is capable of being passed through the eyelets/holes by having a diameter sized to fit through the opening of the eyelets/holes) to position the scaffold between the repair site of the ligament and the femur and the tibia (see Fig. 15, thereby is configured to position the scaffold between the repair site and a femur and a tibia as claimed).
Hagan does not explicitly disclose the scaffold being hydrophilic. Evans, in the same field of endeavor teaches 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 scaffold that is compressible and expandable (the device 14 is a hydrophilic sponge-like scaffold 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 Hagan for the scaffold material of Evans (that teaches the scaffold being hydrophilic, made of 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.
Hagan 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 Hagan 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 Hagan/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 Hagan/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 Hagan/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.
The intended use of the preamble (“for positioning at or adjacent a femur”) has been considered but deemed not to impose any structural difference between the claimed invention and Hagan’s modified device. Hagan’s device as modified is structured as claimed and is capable of being used for positioning at or adjacent a femur as claimed.
Regarding claim 19, Hagan/Evans/Pachence/Severns makes obvious the device of claim 18, Hagan further discloses the ligament is an anterior cruciate ligament (ACL) ([0065] of Hagan).
Regarding claim 20, Hagan/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 Hagan/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 Hagan/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, Hagan/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, Hagan/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. 15, see [0053] of Hagan which discloses a cylindrical scaffold with a length that is greater than the width).
Conclusion
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, Melanie Tyson at (571)272-9062. 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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