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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-2, 4-6, 9-16, and 23-31 in the reply filed on Dec. 19, 2025 is acknowledged.
Claim Rejections - 35 USC § 112 v
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 13 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.
Claim 13 recites “upon implanting into a patient” in line 3. The claim is not clear as it does not state what is being implanted into the patient. The Examiner notes the claim was considered for examination purposes as reciting “upon implanting the mesh into a patient.”
Claim Rejections - 35 USC § 102
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, 4-6, 10-12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Odermatt et al. (US 2012/0330093 A1) (“Odermatt”).
With respect to claim 1, Odermatt discloses a mesh (abstr., 0015, 0088, 0127), comprising a first layer – element 22 - having a first plurality of channel openings, a second layer – element 24 - having a second plurality of channel openings (0125), and a structure comprising stitched structs – element 23 - and disposed between the first layer and the second layer forming a volume therebetween, the volume comprising channels and internal passageways – the structure is formed by loop knitting (0048, 0137, 0139, 0221, 0222, Figs. 2a-2f), wherein the structure is attached to the first layer and the second layer by knitting (0106-0108, 0139), wherein the first layer has a first density (0094), and a first stitch pattern (0141), and the second layer has a second density (0094), and a second stitch pattern (0141), wherein the first density and the second density are substantially the same (0094), and/or the first stitch pattern and the second stitch pattern are substantially the same (0094).
Regarding claim 2, Odermatt discloses a mesh of claim 1, wherein the mesh is a surgical mesh (0102, 0103), for supporting soft tissue (0028, 0071), wherein the mesh is configured to be surgically implanted during tissue support and repair (0103-0105).
As to claim 4, Odermatt teaches the mesh of claim 1, wherein the first density and the second density are different (0094, 0141).
With respect to claim 5, Odermatt teaches the mesh of claim 1, wherein both the first layer and the second layer are knit layers (0125).
Regarding claim 6, Odermatt teaches the mesh of claim 1, wherein the structure comprises a form sheet having a wave shape (Figs. 2a-2f).
As to claim 10, Odermatt teaches the mesh of claim 1, wherein the first layer, the second layer and the structure comprise polycaprolactone, trimethylene carbonate or copolymers thereof (0119, 0121).
With respect to claim 11, Odermatt teaches the mesh of claim 1, wherein the structure, when viewed as a cross-section of the mesh, forms a “V” shape (Figs. 2a-2f).
Regarding claim 12, Odermatt teaches the mesh of claim 1, wherein at least one of the first plurality of channel openings and the second plurality of channel openings defines a diamond shaped structure and/or a honeycomb shaped structure (0141).
Regarding claim 14, Odermatt teaches the mesh of claim 1, wherein the mesh comprises a regenerative agent and a therapeutic agent (0101).
Claim(s) 24-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Odermatt et al. (US 2012/0330093 A1) (“Odermatt”).
With respect to claim 24, Odermatt discloses a mesh (abstr., 0015, 0088, 0127), comprising a form sheet having a wave shape – element 23, the form sheet extending along a plane, threads integrated with the form sheet (0107, 0108), and a first layer – element 22 – attached to peaks of the wave shape of the form sheet (Figs. 2a-2f), wherein the wave shape of the form sheet defines a volume extending along the plane, the volume comprising channels and internal passageways – the form sheet is formed by loop knitting (0048, 0137, 0221, 0222, Figs. 2a-2f), the first layer has a first plurality of channel openings (0125), and wherein the first layer and the form sheet comprise polycaprolactone, trimethylene carbonate or copolymers thereof (0119, 0121).
Regarding claim 25, Odermatt teaches the mesh of claim 24, wherein the first layer is present – element 22 (Figs. 2a-2f).
As to claim 26, Odermatt teaches the mesh of claim 24, wherein the first layer is a knit layer (0125).
With respect to claim 27, Odermatt teaches the mesh of claim 25, further comprising a second layer – element 24 - having a second plurality of channel openings (0125).
Regarding claim 28, Odermatt teaches the mesh of claim 27, wherein the second layer is a knit layer (0125).
As to claim 29, Odermatt teaches the mesh of claim 27, wherein both the first layer and the second layer are knit layers (0125).
With respect to claim 30, Odermatt teaches the mesh of claim 24, wherein the threads are present (0107, 0108).
Regarding claim 31, Odermatt teaches the mesh of claim 24. Odermatt teaches a method comprising implanting the mesh into a patient (0102).
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.
Claim(s) 9, 13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odermatt.
Regarding claim 9, Odermatt teaches the mesh of claim 1. The claim does not provide further structural limitations. The recitation “the mesh is completely absorbable within 18 months in a patient’s body” has been interpreted as a recitation of intended use. Since Odermatt discloses the mesh having all the elements of the mesh of claim 1, it would be obvious to one of ordinary skill in the art that the mesh of Odermatt is capable to perform as intended.
With respect to claim 13, Odermatt teaches the mesh of claim 1. Odermatt discloses the first plurality of channel openings, the second plurality of channel openings forming a macroporous structure (0083-0087), wherein the pores have a diameter of from 100 to 10000 micrometers (0086), the channels and the internal passageways correspondingly forming a macroporous structure (Figs. 2a-2f), thus, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the structure of Odermatt would permit infiltration of fluids upon implanting the mesh into a patient.
Regarding claim 15, Odermatt teaches the mesh of claim 1. The reference is silent with respect to specifically a ball burst strength of at least 50 N, however, since Odermatt discloses all the elements of the mesh of claim 15, it would be obvious to one of ordinary skill in the art that the mesh of Odermatt is capable to perform as intended.
Regarding claim 16, Odermatt teaches the mesh of claim 1. Odermatt teaches the mesh wherein the first plurality of channel openings, the second plurality of channel openings have a diameter of from about 500 to about 5000 µm (0086). The range of the diameter overlaps the range recited in claim 16; overlapping ranges have been held to establish prima facie obviousness (MPEP 2144.05).
Information Disclosure Statement
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNA PLESZCZYNSKA whose telephone number is (571)270-1617. The examiner can normally be reached M-F ~ 11:30-8.
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/Joanna Pleszczynska/
Primary Examiner, Art Unit 1783