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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-16, 25 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170304040 A1 (herein “Greenhalgh”).
Regarding Claim 1, Greenhalgh discloses an implant for repairing or reconstructing soft tissue (See [57] for explanation of implant for soft tissue repair), the implant comprising:
a substrate comprising a biotextile or a medical textile (See [63-65] explanation on biotextile or medical textile) having an upper surface and a lower surface (See Figs 11 and 12 for upper and lower surfaces); and
a nonuniform stitching pattern embroidered into the substrate (See [79] for contemplation of any stitching type or combination to form the pattern on the substrate, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example) that increases a strength of the implant relative to the substrate without changing a compliance of implant relative to the substrate (See [81] for using embroidered pattern on substrate to reinforce), wherein the nonuniform stitching pattern comprises one or more filaments ((See [79] for contemplation of any stitching type or combination to form the pattern on the substrate) stitched into curved lines forming a plurality of adjacent cells having non-parallel sides across the upper surface of the substrate (See Fig 2A-G for potential patterns that can be combined in any combination with cells like 2C).
Regarding Claim 2, Greenhalgh further discloses the implant of claim 1, wherein the one or more filaments stitched into curved lines has a radius of curvature that varies along the curved lines (See Fig 2G that has curves and straight lines with varying radii).
Regarding Claim 4, Greenhalgh further discloses the implant of claim 1, wherein the nonuniform stitching pattern is configured so that the one or more filaments intersect at corners of the plurality of adjacent cells at a shared intersection stitching point (Cell described as any closed shape, See [79] for contemplation of any stitching type or combination to form the pattern on the substrate, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example, See [84] for intersection of non-parallel sewn lines).
Regarding Claim 5, Greenhalgh further discloses the implant of claim 1, wherein the plurality of adjacent cells have a plurality of different shapes comprising two-sided, three-sided, four-sided, five-sided, and six-sided shapes (Cells described as any closed shape, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example, See [84] for intersection of non-parallel sewn lines, See Fig 9A-D for patterns of intersecting sewn fibers forming as different sided shapes).
Regarding Claim 6, Greenhalgh further discloses the implant of claim 1, wherein the plurality of adjacent cells form an irregular pattern across the upper surface of the substrate (See 2A-G for upper surface with pattern, See [80] for random patterns with Fig 2G as non-limiting example).
Regarding Claim 7, Greenhalgh further discloses the implant of claim 1, wherein the substrate comprises a plurality of layers of material (See Fig. 11-A-C for multiple layers).
Regarding Claim 8, Greenhalgh further discloses the implant of claim 7, wherein the nonuniform stitching pattern is stitched into two or more of the plurality of layers of materials (See [80] for stitching pattern for multiple layers).
Regarding Claim 9, Greenhalgh further discloses the implant of claim 1, wherein the substrate comprises a sheet of extracellular matrix material (ECM) (See [99] for layer of ECM and Fig 11A-C and 12A-C for stacked layer).
Regarding Claim 10, Greenhalgh further discloses the implant of claim 1, wherein the implant is configured as a graft for one or more of hernia repair and tissue reconstruction (See [57] for explanation of implant for soft tissue repair including hernia repair).
Regarding Claim 11, Greenhalgh further discloses The implant of claim 1, wherein the plurality of adjacent cells have a distribution of surface areas greater than 1 mm2( See [98] for sizes of cells).
Regarding Claim 12, Greenhalgh further discloses The implant of claim 1, wherein the plurality of adjacent cells have a distribution of areas between about 1 mm2 and 100 mm2( See [98] for sizes of cells).
Regarding Claim 13, Greenhalgh further discloses The implant of claim 1, wherein the plurality of adjacent cells have approximately the same area (See [32] for grid pattern which indicates the adjacency of the cells like Fig 2C and the relative size of each being in-between 10 and 35 mm indicating approximately similar areas).
Regarding Claim 14, Greenhalgh further discloses The implant of claim 1, further comprising a border stitch around a perimeter of the implant (See Fig 14B for stitch that lines the edge of the pattern indicating a border stitch).
Regarding Claim 15, Greenhalgh further discloses The implant of claim 1, wherein the one or more filaments comprises a biocompatible material (See [13, 72] for filament made from bioabsorbable materials including examples).
Regarding Claim 16, Greenhalgh further discloses The implant of claim 15, wherein the biocompatible material is resorbable (See [13, 72] for filament made from bioabsorbable materials including examples).
Regarding Claim 25, Greenhalgh further discloses A method of using an implant for repairing or reconstructing soft tissue (See [11, 23, 36, 57] for discussion of repairing soft tissue (specifically for hernia repair)), the method comprising:
surgically implanting the implant with a patient's body (See [11] for implanting graft inro patient undergoing hernia repair surgical procedure), wherein the implant includes a nonuniform stitching pattern embroidered into the substrate (See [79] for contemplation of any stitching type or combination to form the pattern on the substrate, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example) that increases a strength of the implant relative to the substrate without changing a compliance of implant relative to the substrate (See [81] for using embroidered pattern on substrate to reinforce), wherein the nonuniform stitching pattern comprises one or more filaments ((See [79] for contemplation of any stitching type or combination to form the pattern on the substrate) stitched into curved lines forming a plurality of adjacent cells having non-parallel sides across the upper surface of the substrate (See Fig 2A-G for potential patterns that can be combined in any combination with cells like 2C).
Regarding Claim 26, Greenhalgh further discloses The method of claim 25, wherein surgically implanting the implant comprises orienting the upper surface of the substrate nearer to a particular tissue type of the patient's body relative to a lower surface of the substrate that is opposite the upper surface (See [23] for orienting the implant with the upper surface which is the layer with adhesion barrier being proximal to the tissue (i.e. the upper surface near to the tissue and the lower surface away)).
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.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170304040 A1 (herein “Greenhalgh”).
Regarding Claim 3, Greenhalgh discloses the implant of claim 2, wherein the curved lines have a radius of curvature (See Fig 2G that has curves and straight lines with varying radii).
Greenhalgh does not explicitly disclose the radius of curvature and only offers the curved lines pattern as potential example, however “an absolute value of the radius of curvature is greater than 3 millimeters” is a value based on the ideal compliance of the implant determined by the size of the cells which a range in [98] is recited that encompasses the claimed radius. Courts have found that where general conditions of claims are disclosed in prior art, it is not inventive to discover workable ranges by routine experimentation (see MPEP § 2144.05 subsection II). Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the recited radius with implant disclosed by Greenhalgh in order to create an implant with the ideal and desired compliance, a routine optimization (see MPEP § 2144.05 subsection II) of the radius of the curvature of the stitches of the cells helps to accomplish this.
Claim(s) 17-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170304040 A1 (herein “Greenhalgh”) in view of US 20170020646 A1 (herein “Romano”).
Regarding Claim 17, Greenhalgh discloses an implant for repairing or reconstructing soft tissue (See [57] for explanation of implant for soft tissue repair), the implant comprising:
a substrate comprising a biotextile or a medical textile (See [63-65] explanation on biotextile or medical textile) having an upper surface and a lower surface (See Figs 11 and 12 for upper and lower surfaces); and
a nonuniform stitching pattern embroidered into the substrate (See [79] for contemplation of any stitching type or combination to form the pattern on the substrate, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example), wherein the nonuniform stitching pattern comprises one or more filaments (See [79] for contemplation of any stitching type or combination to form the pattern on the substrate) stitched into curved lines forming a plurality of adjacent cells having non-parallel sides across the upper surface of the substrate (See Fig 2A-G for potential patterns that can be combined in any combination with cells like 2C), wherein the one or more filaments stitched into curved lines has a radius of curvature that varies along the curved lines (See Fig 2G that has curves and straight lines with varying radii).
Greenhalgh does not teach that the compliance is the same in every direction, however Romano which also teaches about an implant for soft tissue repair discloses:
the implant has the same compliance in any direction in the plane of the substrate (See [55] for compliance control being isotropic [i.e. the same in all directions]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use isotropic compliance of Romano with the implant disclosed by Greenhalgh as courts have found it obvious to combine prior art elements according to known methods to yield predictable results (MPEP 2143).
Regarding Claim 18, Greenhalgh further discloses a method for forming an implant for repairing or reconstructing soft tissue (See [22] for method of making implant), the method comprising:
stitching one or more filaments into a substrate to form a nonuniform stitching pattern in the substrate, the substrate comprising a biotextile or a medical textile (See [22] for embroidering stitching pattern onto substrate, the substrate which is described as biotextile in [12]), where the nonuniform stitching pattern increases a strength of the implant relative to the substrate without changing a compliance of implant relative to the substrate (See [16] for attachment or pattern minimally changing compliance (i.e. few percent which in terms of relativity is negligent)), wherein the nonuniform stitching pattern comprises the one or more filaments stitched into curved lines forming a plurality of adjacent cells having non-parallel sides across an upper surface of the substrate (See Fig 2A-G for potential patterns that can be combined in any combination with cells like 2C).
Greenhalgh does not teach that the compliance is the same in every direction, however Romano which also teaches about an implant for soft tissue repair discloses:
the implant has the same compliance in any direction in the plane of the substrate (See [55] for compliance control being isotropic [i.e. the same in all directions]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use isotropic compliance of Romano with the implant disclosed by Greenhalgh as courts have found it obvious to combine prior art elements according to known methods to yield predictable results (MPEP 2143).
Regarding Claim 19, Greenhalgh does not teach that the compliance is the same in every direction, however Romano which also teaches about an implant for soft tissue repair discloses:
testing the compliance in one or more directions along the plane of the substrate to confirm that the implant has the same compliance in any direction in the plane of the substrate (See [29-30] for testing for substrate compliance).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the compliance testing of Romano with the implant manufacturing methods disclosed by Greenhalgh as courts have found it obvious to apply a known technique to a known method ready for improvement to yield predictable results (MPEP 2143).
Regarding Claim 20, Greenhalgh as modified by Romano discloses the method of claim 18, and Greenhalgh further comprising determining the nonuniform stitching pattern ([57] describes matching the compliance to the body for optimal results, [99] describes how the pattern alters the compliance, selecting the patters as describes in [79-80] would be based off of desired compliance of implant).
Regarding Claim 21, Greenhalgh as modified by Romano discloses the method of claim 18, and Greenhalgh wherein the substrate includes one or more layers of the biotextile or the medical textile (See [22] for embroidering stitching pattern onto substrate, the substrate which is described as biotextile in [12]), wherein stitching the one or more filaments into the substrate comprises stitching the one or more filaments into the one or more layers of the biotextile or the medical textile (See [22] for sewing one or more sheets together which includes one or two stitches that create patterns where the stitches are created by filaments that are further described in [13]).
Regarding Claim 22, Greenhalgh as modified by Romano discloses the method of claim 18, and Greenhalgh further teaches wherein stitching the one or more filaments into the substrate comprises stitching the one or more filaments so that the curved lines have radius of curvature that varies along the curved lines (See [13] for stitching of filaments, See Fig 2G that has curves and straight lines with varying radii).
Regarding Claim 23, Greenhalgh as modified by Romano discloses the method of claim 18, and Greenhalgh further teaches wherein stitching the one or more filaments into the substrate comprises stitching the one or more filaments in a lock-stitch configuration (See [21] for contemplation that stitch pattern may include lock-stitch pattern).
Regarding Claim 24, Greenhalgh as modified by Romano discloses the method of claim 18, and Greenhalgh further teaches wherein stitching the one or more filaments into the substrate comprises stitching one or more non-parallel lines, curved shapes, circles, ovals, irregular shapes, loops, dots, or any combination thereof into the substrate (See [79] for contemplation of ant stitching type or combination to form the pattern on the substrate, see [80] for contemplation of random patterns similar to Fig. 2G as a non-limiting example, See Fig 2A-G for potential patterns that can be combined in any combination with cells like 2C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lukas M Lehman whose telephone number is (571)272-5040. The examiner can normally be reached M-F 7:30-5.
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/L.M.L./ Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/ Primary Examiner, Art Unit 3700