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 .
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 64 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. Regarding claim 64, the term, “preferably,” renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
Claims 54-61, and 64-66 rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. (3,613,242) in view of Bleyer et al. (8,049,059), and further in view of Whitson et al. (5,755,791). With respect to claims 54-62, 64, and 66, Hill et al. disclose the invention substantially as claimed. Hill et al. disclose, in figures 1-6 and col. 1, line 64 to col. 2, line 61; an apparatus for preparing a tissue graft (G) from fascia tissue comprising fascia lata or rectus sheath fascis (Note: The introductory statement of intended use (“for preparing a tissue graft (G) from fascia tissue comprising fascia lata or rectus sheath fascis”) has been carefully considered but deemed not to impose any structural limitations on the claims patentably distinguishable over the device of Hill et al.), which is capable of being used as claimed if one desires to do so.), the apparatus comprising a cutting surface (as defined by elements 13) having a plurality of cutting edges (15) arranged in an incision pattern, wherein the cutting surface is configured to prepare the tissue graft by incising at least part of the tissue graft according to the incision pattern, said incision pattern being configured to achieve expansion of at least part of the prepared graft (as shown in fig. 3); wherein the incision pattern is confined to a limited area of the tissue graft, the limited area being defined by arrangement of the cutting edges on the cutting surface (i.e., according to the plan view of the cutting edges shown in fig. 6); wherein the incision pattern comprises a plurality of cutting edges arranged end to end in two or more columns (according to fig. 6); wherein the apparatus further comprises a bearing surface (16) configured to be arranged in opposition to the cutting surface, wherein in use, the tissue graft is arranged between the cutting surface and the bearing surface and the cutting surface incises the tissue graft when pressure is applied to one or both of the bearing surface and the cutting surface; wherein the bearing surface is a substantially convex surface; wherein the cutting surface is a substantially flat surface, wherein the cutting surface is provided on a die pad (10) with a handle portion (21 or 23) adapted to be gripped by a user to apply pressure to incise the tissue graft, and wherein the die pad (10) and the handle portion (21) are formed from a unitary piece of material; wherein the incision pattern is confined to a limited area of the tissue graft and wherein the limited area is defined by arrangement of the cutting edges on the cutting surface; wherein the limited area has an end portion with a predefined shape; wherein the predefined shape is rectangular; wherein the apparatus further comprises a mask member (combination of 17 and 18, as shown in fig. 5), the mask member having a solid area and one or more open areas that correspond to the limited area, wherein when the mask member is configured to be arranged between the cutting surface (16) and the tissue graft (G), wherein the solid area protects the tissue graft from the cutting edges; wherein the cutting surface is provided in a base plate (14, according to col. 2, lines 9-14) with the cutting edges directed upward to incise at least part of the tissue graft by downward movement of the tissue graft onto the cutting surface (if the tissue graft is oriented and moved towards the baseplate); and wherein the incision pattern comprise a plurality of cutting arranged end to end and in two or more columns.
With respect to claim 64, Hill et al. do not explicitly disclose, as claimed, lengths of the cutting edges, spacing between ends of neighboring cutting edges, or spacing between columns. Nevertheless, it would have been a matter of obvious design choice to configure the apparatus, so that a cutting-edge length, spacing between ends of neighboring cutting edges, or spacing between columns is as desired, since such modifications would have involved mere changes in sizes of components of the apparatus (e.g., blades and block). Changes in size are generally recognized as being within the level of ordinary skill in the art. In re Rose.
With respect to claim 65, Hill et al. disclose the invention substantially as claimed, but do not explicitly disclose that the apparatus is configured to prepare a tissue graft of approximately 10 to 60 mm in width and approximately 60 to 140 mm in length; and/or wherein the apparatus is configured to provide expansion ratio of up to 2:1 or 1.5:1. Nevertheless, Hill et al. teach, in col. 2, lines 56-62; that the tissue graft may be “any size” on the apparatus. Thus, it would have been a matter of obvious design choice to configure the apparatus, so that it can prepare a tissue graft having a size as desired, since such a modification would have involved mere changes in sizes of components of the apparatus. Changes in size are generally recognized as being within the level of ordinary skill in the art. In re Rose.
However, Hill et al. do not explicitly disclose that the cutting edges are configured to incise the fascia tissue in a longitudinal direction of connective fibers in the fascia tissue graft. Bleyer et al. teach, in figures 1 and 3 and col. 5, line 15 to col. 6, line 28; an apparatus with cutting edges (according to col. 6, lines 14-18) for preparing a tissue graft (10), wherein the cutting edges are configured to incise submucosa tissue or renal capsule tissue, which is tissue similar to fascia tissue. Bleyer et al. also teach that the incisions are in a longitudinal direction of the tissue graft. Whitson et al. teach, in col. 8, lines 36-45 and col. 9, lines 16-29; a perforated tissue graft of submucosal tissue, wherein connective (collagen) fibers of the tissue are oriented along the longitudinal axis of the tissue graft. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Bleyer et al. and Whitson et al., to modify the cutting edges of Hill et al., so that they are configured to incise the fascia tissue in a longitudinal direction of connective fibers in the fascia tissue graft. Such a modification would make for an expandable tissue graft that has pseudoisotropic properties, wherein such properties would allow construction of a tissue graft with predictable or desired mechanical strength, size, and porosity.
Claims 67 and 69-73 are rejected under 35 U.S.C. 103 as being unpatentable over LeVaughn et al. (2019/0091371) in view of Bleyer et al. (8,049,059), and further in view of Whitson et al. (5,755,791). LeVaughn et al. disclose the invention substantially as claimed. LeVaughn et al. disclose, at least in figure 5 and para. [0130] – [0132}; a kit for preparing a tissue graft from fascia tissue comprising fascia lata or rectus sheath fascia (Note: The introductory statement of intended use (“for preparing a tissue graft (G) from fascia tissue comprising fascia lata or rectus sheath fascis”) has been carefully considered but deemed not to impose any structural limitations on the claims patentably distinguishable over the device of LeVaughn et al.), which is capable of being used as claimed if one desires to do so.), the kit comprising: (a) a cutting surface (a roller—the cylindrical part shown in fig. 5) having a plurality of cutting edges arranged in an incision pattern, wherein the cutting surface is configured to prepare the graft by incising at least part of a tissue graft according to the incision pattern, wherein the incision pattern is confined to a limited area of the tissue graft, the limited area being defined by arrangement of the cutting edges on the cutting surface (i.e., the cutting edges bordering a cutting die); (b) a bearing surface (the flat rectangular part shown in fig. 5) configured to be arranged in opposition to the cutting surface; and (c) a housing (the parts surrounding and connected to the cylindrical part and the rectangular part, shown in fig. 5) containing the cutting surface and the bearing surface; wherein in use, the tissue graft is arranged between the cutting surface and the bearing surface and the cutting surface incises the tissue graft when pressure is applied to one or both of the bearing surface and the cutting surface; wherein the kit further comprises an apparatus for preparing the graft (the roller), the apparatus including at least the cutting surface; wherein the housing comprises a tray (the part below the flat rectangular part) with a base portion (the flat rectangular part) which provides a base plate; wherein the cutting surface is provided on a cutting tool (the roller) with a handle portion (the hand crank, shown at the left-hand side of fig. 5) adapted to be gripped by a user when in use, to apply pressure to incise the tissue graft, the tool being supplied in the kit; and wherein the cutting tool includes a roller (the cylindrical part), the roller providing the cutting surface; wherein the bearing surface comprises an alignment feature (the raised parts at the ends of the roller) for positioning the tissue graft before use of the cutting surface to prepare the tissue graft; and wherein the bearing surface is a substantially flat surface (at the flat rectangular part), and wherein the cutting surface is a substantially convex surface (at the roller).
However, LeVaughn et al. do not explicitly disclose that the cutting edges are configured to incise the fascia tissue in a longitudinal direction of connective fibers in the fascia tissue graft. Bleyer et al. teach, in figures 1 and 3 and col. 5, line 15 to col. 6, line 28; an apparatus with cutting edges (according to col. 6, lines 6-15) for preparing a tissue graft (10), wherein the cutting edges are configured to incise submucosa tissue or renal capsule tissue, which is tissue similar to fascia tissue. Bleyer et al. also teach that the incisions are in a longitudinal direction of the tissue graft. Whitson et al. teach, in col. 8, lines 36-45 and col. 9, lines 16-29; a perforated tissue graft of submucosal tissue, wherein connective (collagen) fibers of the tissue are oriented along the longitudinal axis of the tissue graft. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Bleyer et al. and Whitson et al., to modify the cutting edges of LeVaughn et al., so that they are configured to incise the fascia tissue in a longitudinal direction of connective fibers in the fascia tissue graft. Such a modification would make for an expandable tissue graft that has pseudoisotropic properties, wherein such properties would allow construction of a tissue graft with predictable or desired mechanical strength, size, and porosity.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over LeVaughn et al. (2019/0091371) in view of Bleyer et al. (8,049,059) and Whitson et al. (5,755,791), and further in view of Williams et al. (12,151,050). LeVaughn et al. in view of Bleyer et al. and Whitson et al. disclose the invention substantially as claimed, but do not explicitly disclose that the cutting edges are arranged on the cutting surface for preparation of the graft for use in one of: surgical treatment of pelvic organ prolapse by transvaginal repair, wherein the cutting edges are arranged to incise only a middle portion of the graft; surgical treatment of pelvic organ prolapse by sacral colpopexy, wherein the cutting edges are arranged to incise only an end portion of the graft; and surgical treatment of stress urinary incontinence by mid-urethral sling surgery, wherein the cutting edges are arranged to incise only a middle portion of the graft having a width less than 20 mm when harvested. Williams et al. teach, in col. 61, lines 30-38; col. 142, lines 1-10; and col. 143, lines 6-21; preparation of a perforated graft for pelvic organ prolapse or stress urinary incontinence. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Williams et al., to modify the cutting edges of LeVaughn et al. in view of Bleyer et al. and Whitson et al., so that a graft is prepared as desired. Such a modification would allow the graft to have a shape, strength, and porosity, as desired, for tissue reinforcement and/or repair.
Response to Amendment
Applicant’s arguments with respect to claims 54-61 and 64-73 have been considered but are moot in view of new grounds of rejection.
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.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771
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