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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, species 1 (Figs. 1A-1C) and Subspecies a (Fig. 6A), claims 1-9 and 18-19 in the reply filed on 11/21/2025 is acknowledged. Claims 8-17 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species (claims 8-9 are directed to a non-elected embodiment of Figs. 2A or 3A), there being no allowable generic or linking claim. Thus, claims 1-7 and 18-19 are presently pending in this application.
Claim Rejections - 35 USC § 112
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.
Claim 6 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 6 recites the limitation "the tissue-facing surface” and “the second surface”. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7 and 18-19 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Bates (2011/0152897).
Regarding claim 1, Bates discloses a method of soft tissue repair (abstract), comprising:
introducing a self-deploying tissue augmentation patch 30 (Fig. 1) to a surgical repair site (claim 21 discloses a method of delivering a patch ; par. 0021 discloses a self-expanding patch), the patch being introduced in a pre-deployment state (as shown in Figs. 2-3 where the patch is in a rolled configuration) and the self-deploying patch having a flexible resilient member 32 (Fig. 1) that is configured to assist in the deployment of the self-deploying patch from the pre-deployment state to the post-deployment state after introducing the self-deploying tissue augmentation patch to the surgical site (par. 0021 discloses the self-deploying resilient member and par. 0026 discloses the resilient member 32 allows the rolled sheet graft 31 to take a planar form after deployment at the implantation site), initiating at least a deployment operation of the self-deploying tissue augmentation patch (Fig. 3 and pars. 0029-0030 disclose using pushing member 60 to push the patch outside the delivery lumen to allow the resilient element 32 to self-deploy), the deployment operation moving the self-deploying tissue augmentation patch from the pre- deployment to the post-deployment state (par. 0030 and Fig. 1 disclose the patch takes a planar form in post-deployment state); and coupling the self-deploying tissue augmentation patch in the post-deployment state to tissue in the surgical repair site (par. 0030 discloses anchoring the patch to the body), wherein the tissue augmentation patch in the post-deployment state defines a first length, a first width, and a first thickness (planar configuration of patch 30; Fig. 1 and par. 0030), wherein the tissue augmentation patch in the pre-deployment state defines a second length, a second width, and a second thickness (rolled patch configuration; Figs. 2-3), at least one of the second length or second width being smaller than the respective first length or first width (the pre-deployment or rolled configuration has a width that is smaller than the planar width; Figs. 1-2), and the second thickness being greater than the first thickness (the thickness of the rolled patch is greater than the thickness of the planar patch, Figs. 1-2), wherein, in the pre-deployment state, at least a portion of the tissue augmentation patch is overlapping with a different portion of the tissue augmentation patch (the rolled configuration has the patch overlapping with portions of itself; Fig. 2), and wherein, during at least a final portion of the movement from the pre-deployment state towards the post-deployment state, the flexible resilient member urges the movement of the tissue augmentation patch towards the post-deployment state (pars. 0021 and 0030 disclose a self-deploying resilient member 32 which unrolls to present the patch body 31 in a planar form).
Regarding claim 2, Bates discloses wherein, in the pre-deployment state, at least a portion of the flexible resilient member 32 is overlapping with a different portion of the flexible resilient member (Fig. 2 discloses the resilient member 32 is overlapping with portions of itself).
Regarding claims 3-4, Bates discloses the flexible resilient member comprises a wire and wherein the wire defines a shape memory that preferentially biases the wire to move the tissue augmentation patch towards the post-deployment shape (par. 0009 discloses the resilient member is made of Nitinol wire and par. 0021 discloses a self-deploying resilient member where the shape memory characteristics of Nitinol would allow for preferential biasing to post-deployment shape).
Regarding claim 7, Bates discloses wherein at least a portion of the flexible resilient
member 32 is embedded in the tissue augmentation patch (par. 0026 discloses the patch comprising a sleeve area that is formed around the resilient member 32 which embeds the resilient member in the patch).
Regarding claims 18-19, Bates discloses wherein the tissue augmentation patch comprises at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, or fascia and wherein the tissue augmentation patch comprises collagen (pars. 0038 and 0039 disclose the patch is made of collagenous material).
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.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bates (2011/0152897) in view of Duchon et al. (2002/0010457).
As best understood, Bates discloses the claimed invention of claim 1 including a flexible resilient member; except for wherein the flexible resilient member defines a first rounded closed curve in the post-deployment state and two or more second rounded closed curves in the pre-deployment state, the first curve having a maximum chord greater than a maximum chord of either of the two or more second rounded closed curves and wherein the movement from the pre-deployment state towards the post-deployment state comprises a twisting movement and a folding movement of the tissue augmentation patch such that, in the pre-deployment state at least a portion of the tissue-facing surface is opposing a portion of the second surface. However, Duchon teaches a similar hernia repair device 60 (pars. 0088, 0125 and Figs. 13A-13C) comprising a flexible resilient member 80 (Fig. 13B) defining a first rounded closed curve in the post-deployment state (par. 0125 and as shown in Fig. 13B, post insertion expanded shape of the resilient member 80 having a first rounded closed curve) and two or more second rounded closed curves in the pre-deployment state (par. 0125 and as shown in Fig. 13C, the wires 80/82 are twisted to form two smaller rounded closed curves prior to insertion) , the first curve having a maximum chord greater than a maximum chord of either of the two or more second rounded closed curves (as shown in Figs. 13B-13C) and wherein the movement from the pre-deployment state towards the post-deployment state comprises a twisting movement and a folding movement of the tissue augmentation patch such that, in the pre-deployment state at least a portion of the tissue-facing surface is opposing a portion of the second surface (par. 0125 and Fig. 13C disclose the twisting of the resilient member 80 which allows for the folding of the member where the surfaces of the wires facing the tissue would get twisted and face an opposing surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Bates to include the flexible resilient member defines a first rounded closed curve in the post-deployment state and two or more second rounded closed curves in the pre-deployment state, the first curve having a maximum chord greater than a maximum chord of either of the two or more second rounded closed curves and wherein the movement from the pre-deployment state towards the post-deployment state comprises a twisting movement and a folding movement of the tissue augmentation patch such that, in the pre-deployment state at least a portion of the tissue-facing surface is opposing a portion of the second surface, as taught and suggested by Duchon, for facilitating the insertion and delivery of the resilient member in the delivery cannula and at the implantation site (par. 0125 of Duchon).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774