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 § 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, 14 and 32 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 first density and a first stitch pattern (0094, 0141), a second layer – element 24 - having a second plurality of channel openings (0125), a second density and a second stitch pattern (0094, 0141), and a structure comprising stitched structs – element 23 – extending between the first layer and the second layer forming a volume therebetween, the stitched structs forming repeating cross-sectional support structures configured to maintain the volume – the first layer and the second layer are mutually spaced apart via the stitched structs (0106, 0221-0223), the spacer threads interpreted as corresponding to the stitched structs are monofilaments (0111). As the first and second layer are mutually spaced apart via the stitched struts, the structs maintain the volume, 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).
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), 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 repeating cross-sectional support structures formed by the stitched structs have 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).
As to claim 32, Odermatt teaches the mesh of claim 1. Odermatt discloses the first density and the second density being substantially identical (0094), and/or the first stitch pattern and the second stitch pattern being substantially identical (0094).
Claim Rejections 35 USC 102/103
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.
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) 24-31 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over 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 instant specification does not disclose specific materials of the form sheet, the form corresponding to elements 23 which are formed from filaments (0111), by loop knitting (0139) were interpreted as corresponding to the form sheet; the form sheet extending along a plane, threads integrated with the form sheet (0107, 0108, Figs. 2a-2f), 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, the first layer and the second layer are mutually spaced apart via the stitched structs (0106, 0221-0223), the spacer threads interpreted as corresponding to the form sheet are monofilaments (0048, 0111, 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).
Response to Arguments
Applicant’s arguments filed on May 22, 2026 have been fully considered.
The Applicant argued that the amended claim 1 requires architected stitched strut support structures having repeating cross-sectional geometries that maintain a volumetric architecture of the mesh, Odermatt not disclosing the presently claimed strut support architecture, the reference discussing formation of protruding retention structures. The Examiner notes claim 1 requires “the stitched struts forming repeating cross-sectional support structures configured to maintain the volume”, the volume present between the first layer and the second layer of the mesh.
The Examiner notes in Figs. 2a-2f the spacer threads are monofilaments (0111), the spacer threads interpreted as corresponding to the stitched structs, the stitched structs forming repeating cross-sectional support structures configured to maintain the volume – the first layer and the second layer are mutually spaced apart via the stitched structs (0106, 0221-0223). The first and second layers are mutually spaced apart via the stitched struts, the structs maintain the volume, the volume comprising channels and internal passageways – the structure is formed by loop knitting (0048, 0137, 0139, 0221, 0222, Figs. 2a-2f).
The Applicant reiterates that the claim language imposes an organized structural architecture on the stitched structs themselves, the structs forming “repeating cross-sectional support structures.” Odermatt discloses repeating cross-sectional support structures (0106, 0221, 0222, Figs. 2a-2f), the cross-sectional configuration having a “V” shape (Figs. 2a-2f).
The Applicant argued that claim 1 requires the support structures to maintain the volume comprising the channels and internal passageways, which is also lacking in Odermatt. The Examiner notes Odermatt discloses the first and second layer being mutually spaced apart via the stitched struts, thus, the structs maintain the volume, the volume comprising channels and internal passageways – the structure is formed by loop knitting (0048, 0137, 0139, 0221, 0222, Figs. 2a-2f).
The Applicant argued nothing in Odermatt describes the spacer threads as forming repeating cross-sectional support structures or “organized support geometries” recited in the amended claim 1. The Examiner notes the amended claim 1 does not recite “organized support geometries.” Cross-sectional support structures are disclosed in Odermatt, as discussed above with respect to claim 1.
Regarding Odermatt not disclosing support structures configured to maintain a volumetric scaffold architecture, claim 1 does not recite “a volumetric scaffold architecture.” Odermatt discloses that the first layer and the second layer are mutually spaced apart, thus, in the structure of Odermatt there exists a volume created between the first layer and the second layer.
The Examiner notes, the volumetric architecture, volumetric support structures, architected volumetric support structures, or architected support structures relied on by the Applicant are not limitations recited in claim 1.
Regarding claim 24, the Applicant argued Odermatt does not disclose a wave-shaped form sheet extending along a plane wherein the form sheet itself defines a wave geometry, “spacer threads” not being a “form sheet.” The Applicant argued in Odermatt the spacer geometry arises from knitted thread trajectories extending between opposed textile layer. The Examiner notes a “form sheet” is not defined in the instant specification based on the material used. A “wave shape” is defined in the instant specification as a curvature that has a triangular shape, among other shapes. The Applicant argued that a structure recited as being a “sheet” is materially different from the individual spacer yarns or the interlooped connecting threads of Odermatt. The Examiner notes since the “form sheet” is not defined in the specification, elements 23 of Odermatt formed from filaments and through loop knitting were interpreted as corresponding to the form sheet.
The Applicant argued Odermatt does not disclose a form-retaining wave architecture maintained through integrated reinforcement features recited in claim 24. The Examiner notes in Odermatt threads are integrated with the form sheet (0107, 0107, Figs. 2a-2f).
The Applicant argued Odermatt does not disclose an attachment of a layer to “peaks” of a wave-shaped form sheet because Odermatt does not disclose the form sheet in the first instance. The Examiner notes in Figs. 2a-2f Odermatt discloses an attachment of a layer to peaks of wave-shaped form sheet, the presence of the form sheet discussed above.
The Applicant discussed an embodiment of Odermatt wherein the spacer threads of the spacer fabric are severed and retention structures are formed. The Examiner notes that argument relates to an embodiment of Odermatt that does not negate the embodiment relied on by the Examiner in the rejection, as discussed above. The fact that Odermatt discusses medical products including protruding thread structures for self-retention with a tissue does not preclude the fact that Odermatt discloses a structure including the elements of the mesh of claim 24 even if the structure of Odermatt includes treads for self-retention (Figs. 2D and 2E).
The Applicant argued Odermatt does not disclose a structure analogous to a form sheet having a maintained wave shape that defines volumetric channels and internal passageways. The Examiner notes the structure of a mesh including a form sheet having a wave shape that defines channels and internal passageways is disclosed in Odermatt, as discussed above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Veronica Ewald can be reached at 571-272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joanna Pleszczynska/
Primary Examiner, Art Unit 1783
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