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 .
Response to Arguments
Applicant argues in the response filed 10/15/2025 that the claim amendments would overcome the 102 rejections with respect to Schreurs, Gamache, and Terril. The rejections have been withdrawn. New rejections with respect to Soltz and Leung have been made below.
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.
Claims 1, 3-5, 9, 10, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2009/0020584 to Soltz.
As to claim 1, Soltz discloses a device capable of being a connective tissue repair device (paragraph 9) comprising a central hub member (40) formed with an aperture (50) and first and second anchoring (74, 76) members that extend from opposing sides of said central hub member (figure 8), wherein said first and second anchoring members each have a depth (figure 8) that extends between a sharp edge (82/84, paragraph 51, the tips penetrate tissue, and are seemed to sharp as seen in figure 9, compared to the opposite end of the staple) which is sharp for pushing into tissue (paragraph 51,52) and a dull edge (72), and the dull edges of the first and second anchoring member are coupled to a cover plate (98, via contact with 100) which has a perimeter that extends beyond perimeters of both of the first and second anchoring members (figure 8,9).
As to claim 3, Soltz discloses the first and second anchoring members are mirror images of each other about a latitudinal axis of the connective tissue repair device (figure 9).
As to claim 4, Soltz discloses the first and second anchoring members are arcuate (figure 9).
As to claim 5, Soltz discloses the first and second anchoring members are partial circles or ellipses (figure 9, after the tips of the anchoring members are formed as seen in figure 9, they approach partial circles).
As to claim 9, Soltz discloses the cover plate is a stop to prevent the first and second anchoring members from sinking into tissue beyond said depths (figure 9). The cover plate increases the surface area of the staple at the proximal end which can act as a stop to prevent the staple from entering “further” into the tissue beyond the depth.
As to claim 10, Soltz discloses the cover plate is formed with one or more mounting holes (112, 116).
Claims 1-4, 6, 8, 9, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2017/0333039 to Leung.
As to claim 1, Leung discloses a device capable of being a connective tissue repair device (paragraph 5, the device of 400, figure 15a) comprising a central hub member (the central section of 400, see annotated figure below) formed with an aperture (with the similar opening 190 of 120 of figure 1 as applied to figure 15a, see annotated figure below) and first and second anchoring (see annotated figure below) members that extend from opposing sides of said central hub member (figure 15b), wherein said first and second anchoring members each have a depth (figure 15b) that extends between a sharp edge (tips of the microstructures can be sharp and penetrate skin, paragraph 285, 286) which is sharp for pushing into tissue (paragraph 285, 286) and a dull edge (the opposite side of the array, figure 15b), and the dull edges of the first and second anchoring member are coupled to a cover plate (410) which has a perimeter that extends beyond perimeters of both of the first and second anchoring members (figure 15a). Of note, other embodiments of the microstructure arrays, for instance figure 41b, 43a, can read on the claims of record, since they comprise a similar central hub with an aperture, first and second anchoring members with a depth between a sharp edge and a dull edge, where the dull edge are coupled to cover plate with a perimeter extending beyond the perimeter of the anchoring members.
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As to claim 2, Leung discloses the first and second anchoring members are mirror images of each other about a longitudinal axis of the connective tissue repair device (figure 15a, 41b, 43a).
As to claim 3, Leung discloses the first and second anchoring members are mirror images of each other about a latitudinal axis of the connective tissue repair device (figure 15a, 41b, 43a).
As to claim 4, Leung discloses the first and second anchoring members are arcuate (paragraph 258, 269). The arrays have a curvature which can read on being arcuate.
As to claim 6, Leung discloses the hub member comprises sharp edges adjacent said sharp edges of the first and second anchoring members (see annotated figure above). The sharp edges of the hub are next to / adjacent the sharp edges of the anchoring member.
As to claim 8, Leung discloses the first and second anchoring members are formed with one or more apertures (see annotated figure above, as well as the embodiment of the figures 41b, 43a ).
As to claim 9, Leung discloses the cover plate is a stop to prevent the first and second anchoring members from sinking into tissue beyond said depths (figure 15a). The cover plate increases the surface area of the staple at the proximal end which can act as a stop to prevent the staple from entering “further” into the tissue beyond the depth.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2017/0333039 to Leung in view of U.S. Patent Publication 2012/0078371 to Gamache.
As to claim 7, Leung discloses the device above but is silent about the sharp edges of the hub member and the sharp edges of the first and second anchoring member form one continuous sharp edge. Leung disclose discloses the microarray can be any type, dimension, geometry (paragraph 254-255).
Gamache teaches a similar device (tissue fixation) having sharp edges of the hub member and sharp edges of first and second anchoring members form one continuous sharp edge (figure 7a, paragraph 68, 73). The continuous sharp edge allows for the “cross bar” or central hub to penetrate tissue which helps to secure the device to tissue. Having a continuous sharp edge in the device of Leung will help to assist the device in penetrating tissue and securing the device to tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date for the device of Leung have a sharp edge of the anchoring members and a sharp edge of the central hub comprise a continuous sharp edge in order for helping to secure the device to tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2002/0022861 to Jacobs, U.S. Patent Publication 2008/0082124 to Hess, and U.S. Patent Publication 2012/0130374 to Bouduban all disclose similar devices capable of disclosing, rendering obvious, or providing evidence on the claims of record.
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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771