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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/27/2025 has been entered. Claims 1-4, 8, 15-20, 26, 27, 30, 36-38, 41, and 42 are currently pending in this application. Claims 1-4, 8, and 15 are withdrawn.
Response to Arguments
Applicant's arguments filed 8/27/2025 have been fully considered but they are not persuasive.
With regard to applicant’s first argument, on page 6, that there is not sufficient motivation to modify Evans’ implant to have a distal end that faces an articular surface of a subject’s joint, the examiner disagrees. Table 8 of Evans clearly shows examples of tissues that would benefit from the implant, including hip, knee, hand, foot, ankle, wrist, elbow, and shoulder reconstructions, all of which would benefit from a distal end that matches the curvature of the articular surface defect of the joint, such as a convex curvature, as taught by Chen.
In response to applicant's argument, on page 7, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., surface region of the molded implant that has a higher density and is smoother and more consistent than would otherwise be possible by stacking layers or simply cutting away parts of certain layers) 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).
With regard to applicant’s argument, on pages 6 and 7, that the molded limitation results in a structurally different implant than the prior art, the examiner disagrees. The implant of Evans in view of Chen meets the structural limitations of the claim, particularly including a body having a formed shape that includes a convex first end, a second opposite end, and a cylindrical body periphery with a circular cross-sectional shape, wherein the body comprises lyophilized and compressed tissue layers that are formed of a single sheet of tissue that has been rolled to form a plurality of tissue layers, as explained in the rejection. Therefore, the examiner maintains that because the product of the product by process claim is the same as or obvious from the product of the prior art, the limitations are met, regardless of how the convex first end is imparted.
With regard to applicant’s argument, on page 7, that if the first end is formed by stacking and bonding discs of material on an end of Evans’ implant as disclosed by Chen, the result would not be an implant wherein the lyophilized and compressed tissue layers are formed of a single sheet of tissue that has been rolled to form a plurality of tissue layers that are formed of a single sheet of tissue that has been rolled to form a plurality of tissue layers about and extending substantially parallel to the longitudinal axis, the examiner disagrees. The examiner notes that the claim requires the body, which can be interpreted as any portion of the body, to be formed of the lyophilized and compressed tissue layers formed of a single sheet of tissue that has been rolled to form a plurality of tissue layers about and extending substantially parallel to the longitudinal axis. Therefore, implementing the method of forming the convex first end of the body as disclosed by Chen would not affect the formation of at least the body periphery portion of the body of Evans. Further, the examiner maintains that regardless of the process of forming the convex end, the implant of Evans in view of Chen meets the structural limitations as claimed.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the formed shape in which the body substantially remains that includes the lyophilized and compressed tissue layers formed of a single sheet of tissue that has been rolled to form a plurality of tissue layers about and extending substantially parallel to the longitudinal axis, as recited in claim 16, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that the formed shape is shown within the mold in fig. 1A, for example, however, the implant body is not shown as remaining substantially in the formed shape, i.e., outside of the mold, in any of the figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 19 is objected to because of the following informalities: Claim 19 recites “The of claim 16”, in the preamble, which appears to be missing the word – allograft – between the words “The” and “of”. Appropriate correction is required.
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.
Claims 16-20, 26, 27, 30, 36-38, 41, and 42 are 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 16, lines 19-20, recites “the chamber configured to receive a tissue of the lyophilized and compressed tissue layers”. It is unclear how the chamber receives a tissue of the lyophilized and compressed tissue layers, when the claim earlier recites that the lyophilized and compressed tissue layers are rolled to form a plurality of tissue layers. For the purpose of further examination, the examiner interprets this limitation as referring to the chamber receiving the plurality of tissue layers of the lyophilized and compressed tissue layers.
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 is/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 a tissue of the lyophilized and compressed tissue layers (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
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
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774