DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Amendment filed 4/17/2026 has been entered. The previous objection to the drawings is withdrawn in light of applicant’s explanation. The previous objection to the claims is withdrawn in light of applicant’s amendments. The previous rejection under 35 USC 112 is withdrawn in light of applicant’s amendments. Claims 1-4, 8, 15-20, 26, 27, 30, 36-38, and 41-42 are currently pending. Claims 1-4, 8, and 15 are withdrawn.
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument, on page 7, that neither Evans nor Chen disclose a rolled layer of tissue, the examiner disagrees. Evans clearly discloses that the implant material may be composed of a wide variety of biocompatible materials (e.g., polymer, collagen) and preferably incorporating native fibrous collagen (paragraph 0129) and that the implant can be manufactured having architecture and mechanical properties (such as stiffness and compressibility; structure matched, integrity matched or compliance matched, respectively) to substantially match the architecture and/or mechanical properties of surrounding tissue into which the implant is placed (paragraph 0131), such as bone, cartilage, tendon, skin, ligament, arteries, etc. (paragraph 0116). Evans also teaches that the tissue implant can be modified to have porosity and mechanical properties to substantially match the properties of the tissue juncture region after implantation (bio-matching) (paragraph 0132). When given the broadest reasonable interpretation, the examiner maintains that the material of the implant of Evans is meets the limitation of a tissue since it has the architecture and mechanical properties, as well as the porosity, of surrounding tissue into which the implant is placed, and particularly since applicant has not specified a type of tissue (e.g., synthetic, natural, tendon, etc.). As explained in the previous action, Evans also teaches that the implant (54) is preferably formed of a sheet (53) which is reeled up about a mandrel (i.e., rolled). Therefore, it is also maintained that Evans meets the limitations of a rolled single sheet of tissue, as claimed.
With regard to applicant’s argument, on pages 8 and 9, that the previous rejection does not articulate a sufficient motivation to modify the first end of the implant of Evans to be convex or how one of ordinary skill would have imparted a structural shape to an end of the implant of Evans, the examiner disagrees. As explained in the previous action, Evans teaches that the implant can be manufactured having architecture to substantially match the architecture of surrounding tissue into which the implant is placed (paragraph 0131), as well as using a tool to reshape the end of the implant (paragraph 0154). Chen discloses a cylindrically-shaped articular cartilage graft (paragraph 0007) that can be contoured to match the curvature of the defect site via a mold that has a desired concave or convex curvature (paragraphs (paragraph 0094 and 0107; fig. 20). The examiner maintains that 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 implant of Evans, using a tool to reshape the end of the implant, as taught by Evans, such that the first end is convex, in order to match the architecture/curvature of the surrounding tissue at the defect site, as taught by Chen.
With regard to applicant’s argument, on pages 8-9, that the office does not explain why the claimed structure is not structurally different from that taught by Evans in view of Chen, the examiner disagrees. Applicant is reminded that the claims are directed toward an apparatus, not a method. According to MPEP 2114: 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 (Bd. Pat. App. & Inter. 1987). The previous office action clearly shows that the structural limitations of the claimed allograft body are met by Evans in view of Chen, as set forth in the rejection of claims 16-20, 26-27, 30, 36-38, and 41-42. Evans also discloses that the implant can be compressed to any degree to provide for a good fit within the delivery system and the tissue wound (paragraph 0128). Therefore, it is clear that the formed shape of the allograft of Evans in view of Chen is fully capable of being defined based on a shape of a chamber of a mold, the mold including a mold body having a first side and a second side, and a substantially cylindrical chamber periphery extending therebetween and defining the chamber, the chamber configured to receive the rolled single sheet of tissue such that the plurality of layers are compressed together to form the body. More specifically, the recitation with respect to the manner in which a claimed apparatus is intended to be employed (i.e., formed and/or compressed within a mold) does not differentiate the claimed apparatus from the prior art apparatus in this case. The examiner further maintains that since the mold is not positively recited in claim 16, it has not been given patentable weight. These limitations are product by process limitations - if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Therefore, because the product in the product-by-process claim is the same as or obvious from the product of the prior art, as set forth in the previous rejection, these limitations are met by Evans in view of Chen.
In response to applicant's argument, on pages 9-10, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the end caps form the end of the roll into the convex shape by compressing portions of the tissue to form that shape and/or a compressed convex end) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claim(s) 16-20, 26, 27, 30, 36-38, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2013/0236573 A1 to Evans et al. (Evans) in view of US Patent Application Publication No. 2008/0077251 A1 to Chen et al. (Chen).
Regarding at least claim 16
Evans teaches an implant for deployment in select locations or select tissue for regeneration of tissue (abstract).
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Evans meets the limitations of an allograft adapted for use in correction of one or more skeletal impairments comprising: a body (54) having a formed shape defining a first end (top end), a second end (bottom end), and a body periphery extending therebetween (as shown in fig. 2E), wherein the first end and the second end are disposed along a longitudinal axis of the body (as shown in fig. 2E), the first end and the second end are disposed on opposite sides of a plane that is orthogonal to the longitudinal axis (as shown in fig. 2E), wherein the body periphery is cylindrical with respect to the longitudinal axis and has a circular cross-sectional shape along the plane (the periphery of body 54 is tubular/cylindrical with a circular cross-sectional shape), and wherein the body comprises lyophilized and compressed tissue layers extending between the first end and the second end (paragraphs 0087 and 0089 disclose lyophilizing and compressing tissue layers of the body), wherein the lyophilized and compressed tissue layers are formed of a single sheet of tissue (53) that has been rolled to form a plurality of tissue layers about and extending parallel to the longitudinal axis (paragraph 0135 discloses that the sheet 53 is reeled up about a mandrel to form a tube); wherein the formed shape is defined based on a shape of a chamber of a mold, the mold including a mold body having a first side and a second side, and a substantially cylindrical chamber periphery extending therebetween and defining the chamber, the chamber configured to receive the rolled single sheet of tissue such that the plurality of layers are compressed together to form the body (these limitations are product by process limitations - MPEP 2113 states, “Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Further, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Since the mold is not positively recited in claim 16, it has not been given patentable weight. Therefore, because the product in the product-by-process claim is the same as or obvious from the product of the prior art, these limitations are met by Evans); and wherein the body of the allograft is resiliently compressible and flexible while remaining substantially as the formed shape (paragraph 0128 discloses that the implant can be compressed to any degree to provide for a good fit within the delivery system and the tissue wound).
Evans also teaches that the implant can be manufactured having architecture and mechanical properties (such as stiffness sand compressibility; structure matched, integrity matched or compliance matched, respectively) to substantially match the architecture and/or mechanical properties of surrounding tissue into which the implant is placed (paragraph 0131), as well as using a tool to reshape the end of the implant (paragraph 0154). However, Evans does not explicitly teach wherein the first end is convex in a first direction along the longitudinal axis from the plane to the first end and configured to correspond with an articular surface geometry of a subject's joint.
Chen discloses a cylindrically-shaped articular cartilage graft (paragraph 0007) that can be contoured to match the curvature of the defect site via a mold that has a desired concave or convex curvature (paragraphs (paragraph 0094 and 0107; fig. 20).
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 implant of Evans such that the first end is convex in a first direction along the longitudinal axis from the plane to the first end and configured to correspond with an articular surface geometry of a subject's joint, in order to match the curvature of the defect site, as taught by Chen.
Regarding at least claim 17
Evans in view of Chen teaches the allograft of claim 16. Chen clearly teaches the capability of using a mold to contour the ends of the graft to match the curvature of the defect site. However, Chen does not explicitly teach wherein a first surface of the first end is convex in the first direction along the longitudinal axis and a second surface of the second end is concave in a second direction along the longitudinal axis from the plane to the second end.
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 invention of Evans in view of Chen such that a first surface of the first end is convex in the first direction along the longitudinal axis and a second surface of the second end is concave in a second direction along the longitudinal axis from the plane to the second end, depending on the location and curvature of the defect in which the implant is intended to be placed. Further, the court has held that the configuration of a claimed device is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device was significant (see MPEP 2144.04). Since applicant has not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications of shape are a matter of design choice.
Regarding at least claim 18
Evans in view of Chen teaches the allograft of claim 16. Chen clearly teaches the capability of using a mold to contour the ends of the graft to match the curvature of the defect site. However, Chen does not explicitly teach wherein a first surface of the first end is convex in the first direction along the longitudinal axis and a second surface of the second end is convex in a second direction along the longitudinal axis from the plane to the second end.
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 invention of Evans in view of Chen such that a first surface of the first end is convex in the first direction along the longitudinal axis and a second surface of the second end is convex in a second direction along the longitudinal axis from the plane to the second end, depending on the location and curvature of the defect in which the implant is intended to be placed. Further, the court has held that the configuration of a claimed device is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device was significant (see MPEP 2144.04). Since applicant has not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications of shape are a matter of design choice.
Regarding at least claim 19
Evans in view of Chen teaches the allograft of claim 16. Chen clearly teaches the capability of using a mold to contour the ends of the graft to match the curvature of the defect site. However, Chen does not explicitly teach wherein the second end is concave in a second direction along the longitudinal axis from the plane to the second end.
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 invention of Evans in view of Chen such that the second end is concave in a second direction along the longitudinal axis from the plane to the second end, depending on the location and curvature of the defect in which the implant is intended to be placed. Further, the court has held that the configuration of a claimed device is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device was significant (see MPEP 2144.04). Since applicant has not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications of shape are a matter of design choice.
Regarding at least claim 20
Evans in view of Chen teaches the allograft of claim 16. Chen clearly teaches the capability of using a mold to contour the ends of the graft to match the curvature of the defect site. However, Chen does not explicitly teach wherein the second end is convex in a second direction along the longitudinal axis from the plane to the second end.
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 invention of Evans in view of Chen such that the second end is convex in a second direction along the longitudinal axis from the plane to the second end, depending on the location and curvature of the defect in which the implant is intended to be placed. Further, the court has held that the configuration of a claimed device is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device was significant (see MPEP 2144.04). Since applicant has not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications of shape are a matter of design choice.
Regarding at least claim 26
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches that the implants can be combined with other surgical devices such as sutures, for the purpose of enhancing the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) (paragraph 0115) and/or fix the implant in position after implantation (paragraph 0138). However, Evans does not explicitly teach wherein the body defines a plurality of suture passages extending transversely through the body and parallel to the plane.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify specify that the body defines a plurality of suture passages extending transversely through the body and parallel to the plane, in order to enhance the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) and/or fix the implant in position after implantation, as taught by Evans. The examiner notes that there is a lack of any disclosed criticality of the claimed limitation (see paragraph 0118 which states that the direction of extension of the suture passages can be transverse or longitudinal).
Regarding at least claim 27
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches that the implants can be combined with other surgical devices such as sutures, for the purpose of enhancing the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) (paragraph 0115) and/or fix the implant in position after implantation (paragraph 0138). However, Evans does not explicitly teach wherein the body defines a plurality of suture passages extending longitudinally through the first end and the second end and parallel to the longitudinal axis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify specify that the body defines a plurality of suture passages extending transversely through the body and parallel to the plane, in order to enhance the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) and/or fix the implant in position after implantation, as taught by Evans. The examiner notes that there is a lack of any disclosed criticality of the claimed limitation (see paragraph 0118 which states that the direction of extension of the suture passages can be transverse or longitudinal).
Regarding at least claim 30
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches wherein the body defines one or more channels (55) extending between and through the first end and the second end (paragraph 0135 discloses a central passageway 55 for accommodating a guide pin or other guiding element).
Regarding at least claims 36 and 37
With regard to the claim limitations directed toward the mold in each of claim 36 and claim 37, the examiner notes that these limitations are product by process limitations. MPEP 2113 states, “Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 USPQ 161 (CCPA 1964). Further, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It is further noted that since the mold is not positively recited in claim 16, it has not been given patentable weight. Therefore, since the product in the product-by-process claim is the same as or obvious from the product of the prior art, the limitations of claims 36 and 37 are met by Evans in view of Chen as explained above.
Regarding at least claim 38
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches that the implants can be combined with other surgical devices such as sutures, for the purpose of enhancing the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) (paragraph 0115) and/or fix the implant in position after implantation (paragraph 0138). However, Evans does not explicitly teach wherein: the body defines a first plurality of suture passages extending transversely through the body and parallel to the plane, and wherein the body defines a second plurality of suture passages extending longitudinally through the first end and the second end and parallel to the longitudinal axis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify specify that , wherein: the body defines a first plurality of suture passages extending transversely through the body and parallel to the plane, and wherein the body defines a second plurality of suture passages extending longitudinally through the first end and the second end and parallel to the longitudinal axis, in order to enhance the effectiveness of tissue repair (e.g. serve as a site for attachment of a second tissue) and/or fix the implant in position after implantation, as taught by Evans. The examiner notes that there is a lack of any disclosed criticality of the claimed limitation (see paragraph 0118 which states that the direction of extension of the suture passages can be transverse or longitudinal).
Regarding at least claim 41
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches wherein a radius of the body periphery at the first end and a radius of the body periphery at the second end are the same or less than a radius of the body periphery at any point between the first end and the second end (fig. 2E shows that the body periphery radius at the first end and at the second end are the same as the radius of the body periphery at any point between the two ends).
Regarding at least claim 42
Evans in view of Chen teaches the allograft of claim 16. Evans also teaches wherein the subject's joint is selected from a group consisting of a subtalar joint, a carpometacarpal joint, a lateral mid-foot joint, a 4th metatarsal-cuboid joint, a 5th metatarsal-cuboid joint, an ankle joint, a tibiotalar joint, an elbow joint, a radio-capitellar joint, a proximal femoral joint, an interphalangeal joint, one or more joints of the fingers, and any combination thereof (Table 8 shows examples of tissue that potentially benefit from the implant, including hip reconstruction/replacement, hand reconstructions, foot reconstructions, ankle reconstructions, etc.).
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 inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached 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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/M.A.H/ Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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