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
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 1-6, 9-10, 12, 13, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie (US 20140350599).
Regarding claim 1, Torrie (fig. 1) discloses a system (8) comprising:
a first T-Anchor (16);
a second T-Anchor (18); and
a length of suture (10) between the first T-Anchor (16) and the second T-Anchor (18), wherein applying and releasing tension to the second T-Anchor allows for tissue compression or apposition (As seen in fig. 10-11) [0100-0101 and 0112]. As stated in the reference and demonstrated in fig. 10 and 11, tension is applied to the T-anchors (16 and 18) via a suture tail (30). Said tension compresses the sides of a tissue (22 and 24) together to repair a tear (12).
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Annotated Fig. 2A of the Torrie reference.
Regarding claim 2, Torrie discloses the system of Claim 1. Torrie further discloses wherein at least one T-Anchor (16) comprises blunt end (“Blunt end;” See annotated fig. 2A above). As the adjective “blunt” is not provided by the specification, the Merriam-Webster dictionary definition is used: “having an edge or point that is not sharp” (Blunt Definition & Meaning - Merriam-Webster). As the specified edge does not contain any feature that is sharp, it is considered a blunt end.
Regarding claim 3, Torrie discloses the system of Claim 1. Torrie further discloses wherein at least one T-Anchor (16) comprises beveled edge (“Beveled edge;” see annotated fig. 2A above). As the adjective “beveled” is not provided by the specification, the Merriam-Webster dictionary definition is used: “cut at an angle that is not a right angle” (Beveled Definition & Meaning - Merriam-Webster). As the specified edge is not a right angle, it is considered a beveled end.
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Annotated Fig. 5 of the Torrie reference.
Regarding claim 4, Torrie discloses the system of Claim 1. Torrie further discloses a connector (“Connector”, comprising needle 100 and sheath 200) between a delivery system (“Delivery System” comprising handle 180 and slider 190) and the second T-Anchor (18) (Fig. 3-4 and annotated fig. 5) [0105-0106], wherein the delivery system is configured to apply tension before release of the second T-Anchor [0111] (As seen in fig. 11).
Regarding claim 5, Torrie discloses the system of Claim 1. Torrie further discloses the second T-Anchor (18) has a suture tail (30) configured to reposition the second T-Anchor when tension is applied [0112] (Fig. 1 and 10-11). As shown in fig. 10-11, when tension is applied onto suture tail (30), the T-anchors (16 and 18) are repositioned towards the tissue surface (20) to close the tear (12 made up of sides 22 and 24). The tension applied to the suture tail (30) shortens the length of suture (10) between the anchors (16 and 18) and repositions them towards the surface of the tissue (20).
Regarding claim 6, Torrie discloses the system of Claim 1. Torrie further discloses wherein the second T-Anchor (18) has a suture tail (30) configured to lock the second T-Anchor (Via slip knot 28) when tension is released (Fig. 1 and 11) [0112]. As stated in the cited reference, the suture tail (30) forms a slip knot (28) that allows for the suture (10), and thus the connected T-anchors (16 and 18), to move in one direction (32) and prevents the sutures and anchors from moving in the opposite direction. It is also stated that after tension is applied, further manipulation of the suture (10) is not required to secure the anchors (16 and 18), which indicates the release of the tension locks the T-anchors in place.
Regarding claim 9, Torrie discloses the system of Claim 1. Torrie further discloses wherein at least one T-Anchor is bioresorbable [0136].
Regarding claim 10, Torrie discloses the system of Claim 1. Torrie further discloses wherein the suture is looped around the first T- Anchor (16) and the second T-Anchor (18) (As seen in fig. 1) [0101].
Regarding claim 12, Torrie (fig. 1) discloses a method comprising:
positioning a first T-Anchor (16);
positioning a second T-Anchor (18); and
applying and releasing tension to the second T-Anchor for tissue compression or apposition (As seen in fig. 10-11) [0100-0101 and 0112]. As stated in the reference and demonstrated in fig. 10 and 11, tension is applied to the T-anchors (16 and 18) via a suture tail (30). Said tension compresses the sides of a tissue (22 and 24) together to repair a tear (12)
Regarding claim 13, the method of claim 12 as taught by Torrie does not require tying knots (there are no knots required for the positioning and tensioning steps which are the only steps required by claim 12; also see at least fig. 12 of Torrie).
Regarding claim 17, applying and releasing tension to the second T-Anchor for tissue compression or apposition further comprises closing a wound (12; Figs. 10-11).
Regarding claim 18, Torrie (Fig. 16A and 17) discloses a system (1010) comprising:
a first element (1012);
a second element (1014); and
a length of suture (1016) between the first element (1012) and the second element (1014) wherein applying and releasing tension to at least one element allows for relative movement and/or rotation between the first element and the second element ([0139] states that pulling on free end of suture 1016 causes second element 1014 to rotate (Fig. 18A and B) and for the first element 1012 to move).
Regarding claim 19, Torrie discloses the system of Claim 18. Torrie further discloses wherein the relative movement and/or rotation between the first element and the second element is configured to enhance the initial anchoring of the system [0139].
Regarding claim 20, Torrie discloses the system of Claim 18. Torrie further discloses wherein at least one element (1012) comprises a beveled tip (Formed by 1022a and 1022b) [0124] (Fig. 16A).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Torrie (US 20140350599) in view of Bonutti (US 5522846).
Regarding claim 8, Torrie discloses the system of Claim 1. Torrie discloses a first T-anchor and a second T-anchor but does not disclose wherein the first T-Anchor and the second T-Anchor each have a suture tail to remove the first T-Anchor and the second T-Anchor.
In the same field of endeavor, namely an anchoring system to secure suture [Abstract], Bonutti discloses an anchor (10) with a suture tail (50 with ends 54 and 58) to remove the anchor (Fig. 11-16) [Col 6 lines 34-51].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the invention to modify the device of Torrie to include a suture to remove a T-anchor, as taught by Bonutti, for the advantage that the suture allows for the anchor to change from an anchoring orientation to a removal orientation, thus preventing trauma when removing the anchor and improve ease of use in removal [Col 6 lines 23-25 and lines 55-67 & col 7 lines 1-4].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Torrie (US 20140350599) in view of Fanton (US 20140288597).
Regarding claim 11, Torrie discloses the system of Claim 1. Torrie does not disclose a hinge. In the same field of endeavor, namely an anchoring system to secure suture [Abstract], Fanton discloses an anchor (110’) including a hinge (115) (Fig. 6A-6B) [0218]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Torrie to include a hinge, as taught by Fanton, for the advantage that the hinge allows for an anchor to be opened up to position a suture end within the opened anchor [0219] thus facilitating ease of suture loading in the anchor.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Torrie (US 20140350599).
Regarding claims 14 and 15, Torrie discloses the method of Claim 12. However, Torrie fails to make explicit whether the method is for permanent or temporary anchoring. Examiner here contends permanent and temporary anchoring are the only two possible anchoring options, and therefore define a finite number of solutions. Thus, Examiner takes the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have used the method of Torrie for either permanent or temporary anchoring as needed for any given procedure.
Regarding claim 16, Torrie discloses the method of Claim 12. However, Torrie fails to make explicit the method is used for mesh tacking in hernia repair. Examiner here contends tacking mesh to a hernia site to repair a hernia is a well known process, and thus takes the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have used the method of Torrie for tacking a hernia mesh to a site for hernia repair.
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 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie (US 20140350599) or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Torrie (US 20140350599) in view of Yeung (US 20140288600).
Regarding claim 7, Torrie discloses the system of Claim 1. Torrie further discloses wherein the first T-Anchor (16) has a suture tail (30) to reposition the first T-anchor [0112] (Fig. 1 and 10-11). As shown in fig. 10-11, when tension is applied onto suture tail (30), the T-anchors (16 and 18) are repositioned towards the tissue surface (20) to close the tear (12 made up of sides 22 and 24). The tension applied to the suture tail (30) shortens the length of suture (10) between the anchors (16 and 18) and repositions them towards the surface of the tissue (20).
In the alternative, if Torrie is interpreted as not explicitly disclosing wherein the first T-Anchor has a suture tail to reposition the first T-anchor:
In the same field of endeavor, namely an anchoring system to secure suture [Abstract and 0002], Yeung discloses wherein a first T-Anchor (144) has a suture tail (122) to reposition the first T-anchor [0116] (Fig. 27-29, with fig. 30-31 showing a second T-anchor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Torrie to include the first T-anchor having a suture tail to reposition the first T-anchor, as taught by Yeung, for the advantage that repositioning the anchor allows for a more secure positioning within the body, providing anchoring strength for repair [0110].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN J SEVERSON whose telephone number is (571)272-3142. The examiner can normally be reached Monday-Friday 6:00-2:00 central.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan J. Severson/Primary Examiner, Art Unit 3771