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 § 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.
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.
Claims 5-8 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 5, discloses “the first width is wider than a width of the woven layer”. However, claim 1 discloses that “the first width” is the width of the first and second intermediate portions that belong to the flexible member and NOT to the two elongated layers. As understood by the Examiner, the flexible member includes the two elongated layers and the woven layer.
The Examiner believes that the Applicant’s representative is trying to say that the width of the two elongated layers is wider than the width of the woven layer. Correction or clarification is required.
Claim 7 recites the limitation "the first and second elongate layers" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1, talks about “two elongate layers” but does not mention “a first and second elongate layers”. Correction is required.
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.
Claims 1, 2, 4, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brunelle et al US Patent 10,.493,180 B2.
See figure below for Examiner’s interpretation.
Brunelle et al discloses an implantable tissue attachment device, comprising an elongate flexible member, wherein the flexible member comprises a woven layer and two collagen layers covering the woven layer. The flexible member includes a central portion, first and second intermediate portions extending from respective opposite first and second ends of the central portion, and a first end portion that extends from the first intermediate portion and a second end portion that extends from the second intermediate portion. Wherein the first and second intermediate portions establish a first width along a majority of their length, and wherein the first width is greater than a width of the central portion along at least a majority of the length of the first and second intermediate portions, wherein the first end portion transitions from the first intermediate portion and the width of the first end portion narrows along a portion the first end portion until reaching a minimum width at an outer tip of the first end portion, and wherein the second end portion transition from the second intermediate portion and the width of the second end portion narrows along a portion of the second end portion until reaching a minimum width at an outer tip of the second end portion.
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Regarding the woven and collagen layers, see col. 4, lines 59-67 and col. 2, lines 13-17.
Regarding claim 2, the end tips are shown in the figure above.
Regarding claim 4, see figure above showing that the portion to the right and to the left of the plane that extends to the middle of the central portion are a mirror-like configuration.
Regarding claims 16-18, the flexible member is capable of being used in a lateral or medial row fixation technique and being used with multiple knotless suture anchors.
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.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brunelle et al US Patent 10,.493,180 B2 in view of Qin et al US patent Pub. 2025/0281675A1.
Brunelle et al discloses the invention substantially as claimed. However, Brunelle et al does not disclose stitches all around the periphery of the implant.
Qin et al teaches an implant having three layers, the first layer made of polymeric material and two layers covering the polymeric material. A set of stitches passing along the length of the implant for the purpose of holding the layers in place and avoiding the delamination of the implant. See Figs. 12A-12B and Figs. 14A-15E.
It would have been obvious to one ordinary skill in the art to modify the Brunelle et al reference with the stitches of the Qin et al reference in order to hold the layers in place and avoid the delamination of the implant.
Regarding claim 19, Brunelle et al discloses the collagen-based layers can be made of cross-linked collagen bovine pericardium (see col. 8, lines 18-28 and col. 9, lines 4-27). However, Brunelle et al does not a partially cross-linked collagen.
It would have been obvious to one ordinary skill in the art to modify the cross-linked process of the Brunelle et al reference with a partial cross-linked process, since, it would have been obvious to one ordinary skill in the art to modify the Brunelle et al reference by using a partial cross-linked process in order to be capable of absorbing water and promote the growth an natural occurring tissue.
Allowable Subject Matter
Claims 3, 10-15 and 20-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 5-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/3/26
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