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 .
Allowable Subject Matter
Claims 19 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose wherein the plurality of perforations for at least one of the plurality of grip segments are arranged in a hexagonal pattern.
The prior art fails to teach or disclose wherein the at least two grip segments have elliptical shaped configurations, and wherein the at least two grip segments are positioned with a long-side of the grip segment approximately parallel to a portion of a periphery of the layer of repair fabric.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 7, 8, 10, 13-16, 18, 20-23, 25-27, 41, and 89 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2019/0117363 to Felix et al. in view of U.S. Patent Pub. No. 2002/0077661 to Saadat.
As to Claim 1, Felix discloses an implantable prosthesis (20, Fig. 1, [0049]). The prosthesis comprises a layer (34) of biologically compatible repair fabric [0070], and a plurality of grip segments (26) integrated with the layer of repair fabric [0070], each of the plurality of grip segments (26) includes a plurality of grips (e.g. 24 within grip region 26. [0064]).
As to Claim 2, Felix discloses an implantable prosthesis wherein the plurality of grip segments (26) includes a plurality of microtextured grip segments [0068].
As to Claim 4, Felix discloses an implantable prosthesis wherein the plurality of grip segments (26) includes three or more grip segments integrated with the layer of repair fabric (three grip segments seen in Fig. 1, [0065]).
As to Claim 7, Felix discloses an implantable prosthesis wherein the plurality of grip segments (26) are arranged on the layer of repair fabric (34) to maintain a center portion of the repair fabric free of grip segments (seen in Fig. 1, [0066]).
As to Claim 8, Felix discloses an implantable prosthesis wherein the layer of repair fabric (34) has a preformed three-dimensional configuration with an apex which is free of grip segments [0100].
As to Claim 10, Felix discloses an implantable prosthesis wherein the plurality of grip segments occupy approximately 20% to approximately 30% of a surface of the layer of repair fabric [0100].
As to Claim 20, Felix discloses an implantable prosthesis wherein the plurality of grips are arranged in a hexagonal pattern on at least one of the grip segments (hexagon within grips 24, Fig. 1).
As to Claim 21, Felix discloses an implantable prosthesis wherein the layer of repair fabric has a preformed three-dimensional configuration with an apex and a rounded ridge extending from the apex to an outer periphery of the layer of repair fabric (Fig. 1, [0100], a portion of at least one of the plurality of grip segments extending across the rounded ridge (region 26 extending towards apex of 25, Fig. 1).
As to Claim 23, Felix discloses an implantable prosthesis wherein at least two grip segments (26) are arranged on the layer of repair fabric (34) entirely on one side of the rounded ridge (seen in Fig. 1).
As to Claim 25, Felix discloses an implantable prosthesis wherein at least one grip segment (26) is arranged on the layer of repair fabric (34) closer to a periphery of the grip segment than to the rounded ridge (seen in Fig. 1).
As to Claim 26, Felix discloses an implantable prosthesis wherein the plurality of grip segments includes six or more grip segments integrated with the layer of repair fabric (Fig. 24, [0104]).
As to Claim 27, Felix discloses an implantable prosthesis (20, Fig. 1, [0049]). The prosthesis comprises a layer (34) of biologically compatible repair fabric [0070], and a plurality of microtextured grip segments (26, [0068]) integrated with the layer of repair fabric [0070], each of the plurality of grip segments (26) includes a plurality of grips (e.g. 24 within grip region 26. [0064]).
As to Claim 41, Felix discloses a method of fabricating an implantable prosthesis [0012]. The method comprises providing a layer of biologically compatible repair fabric (34), and attaching a plurality of grip segments (26) to a surface of the layer of repair fabric [0012], wherein each of the plurality of grip segments (26) includes a plurality of grips (e.g. 24 within grip region 26. [0064]).
As to Claim 89, Felix discloses an implantable prosthesis wherein each of the plurality of grips (Fig. 18) includes a first pillar (30) and a plurality of second pillars (70) extending from a surface of the first pillar (seen in Fig. 18).
As to Claims 1, 2, 4, 7, 8, 10, 13-16, 18, 20-23, 25-27, 41, and 89, Felix discloses the claimed invention except for each of the plurality of grip segments plurality of perforations extending therethrough, wherein the plurality of perforations for at least one of the plurality of grip segments are arranged in a two-dimensional pattern with equal spacing, wherein the plurality of perforations for at least one of the plurality of grip segments are arranged in at least three distinct regions on the grip segment, wherein each region includes a group of perforations, wherein a distance between regions is greater than a distance between adjacent perforations in a region., wherein perforations of each group have uniform spacing within each region, wherein the plurality of perforations for at least one of the plurality of grip segments are arranged in an array which extends in a direction along a length of the grip segment, wherein each of the plurality of grip segments includes a substrate with opposing first and second surfaces, at least one of the plurality of grip segments including a plurality of grips on each of the first and second surfaces, the plurality of grips on the first surface facing away from the layer of repair fabric and the plurality of grips on the second surface facing toward the layer of repair fabric.
Saadat discloses an implantable prosthesis (20, [0021]) and method of fabricating [0069] including a grip segment (Fig. 1) having a plurality of perforations (26) extending therethrough, wherein the plurality of perforations (26, [0048]) for at least one of the plurality of microtextured grip segments (21 including grips 22) are arranged in a two-dimensional pattern with equal spacing (seen in Fig. 1). The plurality of perforations (26) for at least one of the plurality of grip segments are arranged in at least three distinct regions on the grip segment (distinct regions having perforations 26 seen in Fig. 1). Each region includes a group of perforations groupings of perforations 26, [0048]). A distance between regions is greater than a distance between adjacent perforations in a region (determined by groupings of perforations, [0048)]. Perforations of each group have uniform spacing within each region (determined by groupings of perforations, [0048)]. The plurality of perforations (26) for at least one of the plurality of grip segments are arranged in an array which extends in a direction along a length of the grip segment (seen in Fig. 1). Each of the plurality of grip segments (Fig. 1) includes a substrate (21) with opposing first (23) and second (24) surfaces (Fig. 1, [0044]), at least one of the plurality of grip segments including a plurality of grips (22) on each of the first and second surfaces [0044], the plurality of grips on the first surface facing away from the layer of repair fabric and the plurality of grips on the second surface facing toward the layer of repair fabric (Fig. 1, [0044]) in order to allow for the tissue edges and body fluids to contact one another across the substrate, thereby accelerating the healing process [0048].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify implantable prosthesis of Felix with the perforation modification of Saadat in order to allow for the tissue edges and body fluids to contact one another across the substrate, thereby accelerating the healing process.
Claims 5, 6, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2019/0117363 to Felix et al. in view of U.S. Patent Pub. No. 2002/0077661 to Saadat in view of U.S. Patent Pub. No. 2013/0158572 to Meneghin et al.
As to Claims 5 and 6, Felix discloses an implantable prosthesis wherein the grip regions (26) can have varying shapes (e.g. semi-annular or triangular periphery [0103]).
As to Claims 5, 6, 9, 11, and 12, Felix and Saadat disclose the claimed invention except for wherein at least one of the plurality of grip segments has an L-shaped configuration, wherein at least one of the plurality of grip segments has an elliptical shaped configuration, wherein the plurality of perforations on at least one of the plurality of grip segments occupy approximately 6% to approximately 20% of the grip segment, wherein each of the plurality of perforations has a diameter of approximately 0.100 inches to approximately 0.110 inches, wherein the plurality of perforations are spaced apart at a center distance of approximately 0.25 inches to approximately 0.30 inches.
Meneghin discloses an implantable prosthesis (2) having grip portions (4), wherein at least one of the plurality of grip segments has an L-shaped configuration (various shapes described in [0078]), wherein at least one of the plurality of grip segments has an elliptical shaped configuration (various shapes described in [0078]). The plurality of perforations on at least one of the plurality of grip segments occupy approximately 6% to approximately 20% of the grip segment [0048]. Each of the plurality of perforations has a diameter of approximately 0.100 inches to approximately 0.110 inches [0043], wherein the plurality of perforations are spaced apart at a center distance of approximately 0.25 inches to approximately 0.30 inches [0043, 0057, 0075] in order to allow the surgeon to select a region particularly suited for a target region of the patient [0078].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify implantable prosthesis of Felix and Saadat with the grip portion shape modification of Meneghin in order to allow the surgeon to select a region particularly suited for a target region of the patient.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
