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 08/26/2025 that prior art Nakao and Starksen do not disclose the claim amendments with respect to the single wire axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening. The rejections have been withdrawn.
New rejections with respect to Starksen in view of Qadeer and Nakao in view of Qadeer as evidenced by Kobayashi and Yoon.
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.
Claims 1-3, 7-10, 13, 23 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2006/0241656 to Starksen in view of U.S. Patent Publication 2012/0209318 to Qadeer.
As to claim 1, Starksen discloses a surgical system capable for use in repairing a wound after an endoscopic procedure (paragraph 13-15), the surgical system comprising: a plurality of anchors (the anchors 526, as seen in figures 9a-c, 10a-f, paragraph 80-93 with the additional “improvement” including the “belt” as seen in the anchor 850, figure 16e, paragraph 110), each anchor of the plurality of anchors including: a main body (852, figure 16e), a head (“eyelet/loop”, paragraph 84, 88, for the slidable coupling of tether 534, as seen as the openings where tether 534 extends through) projecting proximal from the head and defining an opening (paragraph 84, figure 10f); and at least two tines (“sharp tips”, paragraph 88, or “intersecting semi-circles” paragraph 85, and/or tines of anchor 526 as seen in figure 10d of anchor 526, paragraph 88) projecting distally from the main body and configured to penetrate tissue, the at least two tines being fabricated from a shape memory material such that the at least two tines are resiliently biased toward a deployed configuration (paragraph 70, 71, figure 10f, 16e), in which the at least two tines project outwardly relative to the head and assume an arcuate shape (figure 10f, 16e); wherein the head and the at least two tines are monolithically formed from a single wire that passes through the main body (figure 10c, 16e, paragraph 70-72, the anchor is a single wire like element that extends through the “belt”), and a tether (534) fixed to at least one anchor of the plurality of anchors and passing through the opening of each anchor of the plurality of anchors (paragraph 80, 84) but is silent about the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening.
If it would not be known that the anchor 526 can be fabricated from a shape memory material similar to that as disclosed for anchor 210, paragraph 71, it would have been obvious to have anchor 526 be a shape memory material for the anchor to self deform as it is released. It would seem the anchor is a monolithic element that forms the anchor based on at least the figures and that the anchor 526 is a single piece. If it would not be known that the anchor is 526 is monolithically formed from singe piece of wire from the singe wire seen in the figures, it would have been obvious that the anchor be monolithic in order for ease of manufacturing the one piece “anchor”.
Qadeer teaches a similar device (clip device, abstract) having a single wire (10) being axially slidable relative to the main body (66, paragraph 66, 68, 69, 72 ) to allow selective adjustment of a length of the at least two tines (11,12) and a height of the opening (13) for the purpose of securing the legs in the deployed configuration as desired. The main body 852 of Starksen can be substituted for the body 66 which can allow the singe wire to move therethrough which can help position and secure the legs in the deployed position. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the main body of Qadeer as the main body in the system of Starksen which will allow the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening in order for securing the legs in the deployed configuration as desired.
As to claim 2, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines are configured to transition from a stowed configuration (paragraph 81, 82 figure 9c), in which the at least two tines are linear (paragraph 82, “straight/flat” will be able to held read on “linear”, to the deployed configuration).
As to claim 3, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines have a proximal facing surface having a concave shape and a distal facing surface having a convex shape (figure 10f).
As to claim 7, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines when in the deployed configuration extend in opposite directions from one another and perpendicular relative to a longitudinal axis defined by the main body (10f, 16d,e).
As to claim 8, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines each have a traumatic distal tip configured for penetrating tissue (paragraph 88, the distal tip will be a sharp enough to penetrate tissue).
As to claim 9, 23, Starksen discloses a surgical system capable for use in repairing a wound after an endoscopic procedure (paragraph 13-15), the surgical system comprising: a plurality of anchors (the anchors 526, as seen in figures 9a-c, 10a-f, paragraph 80-93 with the additional “improvement” including the “belt” as seen in the anchor 850, figure 16e, paragraph 110), each anchor of the plurality of anchors including: a main body (852, figure 16e), a head (“eyelet/loop”, paragraph 84, 88, for the slidable coupling of tether 534, as seen as the openings where tether 534 extends through) projecting from a proximal end portion of the main body and defining an elongate slot (paragraph 84, figure 10f); and at least two tines (“sharp tips”, paragraph 88, or “intersecting semi-circles” paragraph 85, and/or tines of anchor 526 as seen in figure 10d of anchor 526, paragraph 88) projecting from a distal end portion of the main body and configured to penetrate tissue, the at least two tines being fabricated from a shape memory material such that the at least two tines are resiliently biased from a stowed configuration (figure 9a, paragraph 80,81), in which the at least two tines are parallel with a longitudinal axis defined by the main body (figure 9c, paragraph 80,81, the flat, straight configuration will read on the ties being parallel with the longitudinal axis) toward a deployed configuration (figure 10f, 16e) in which the at least two tines project radially outward from the main body, wherein the head and the at least two tines are monolithically formed from a single wire that passes through the main body (figure 10c, 16e, paragraph 70-72, the anchor is a single wire like element that extends through the “belt”), but is silent about the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening.
If it would not be known that the anchor 526 can be fabricated from a shape memory material similar to that as disclosed for anchor 210, paragraph 71, it would have been obvious to have anchor 526 be a shape memory material for the anchor to self deform as it is released. It would seem the anchor is a monolithic element that forms the anchor based on at least the figures and that the anchor 526 is a single piece. If it would not be known that the anchor is 526 is monolithically formed from singe piece of wire from the singe wire seen in the figures, it would have been obvious that the anchor be monolithic in order for ease of manufacturing the one piece “anchor”.
Qadeer teaches a similar device (clip device, abstract) having a single wire (10) being axially slidable relative to the main body (66, paragraph 66, 68, 69, 72 ) to allow selective adjustment of a length of the at least two tines (11,12) and a height of the elongate slot (13) for the purpose of securing the legs in the deployed configuration as desired. The main body 852 of Starksen can be substituted for the body 66 which can allow the singe wire to move therethrough which can help position and secure the legs in the deployed position. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the main body of Qadeer as the main body in the system of Starksen which will allow the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the elongate slot in order for securing the legs in the deployed configuration as desired.
As to claim 10, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines have a proximal facing surface having a concave shape and a distal facing surface having a convex shape (figure 10f).
As to claim 13, with the device of Starksen and Qadeer above, Starksen discloses the at least two tines when in the deployed configuration extend in opposite directions from one another and perpendicular relative to a longitudinal axis defined by the main body (figure 10f, 16d,e).
Claims 1-3, 8-10, 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0234512 to Nakao in view of U.S. Patent Publication 2012/09318 to Qadeer, and as evidenced by U.S. Patent 2002/0128667 to Kobayashi and U.S. Patent 5,100,418 to Yoon.
As to claim 1, Nakao discloses a surgical system for use in repairing a wound after an endoscopic procedure (paragraph 16), the surgical system comprising: a plurality of anchors (anchor 60 in figure 14, used as the plurality of anchors 10 as seen in figure 1, paragraph 45), each anchor of the plurality of anchors including: a main body (54), a head (52) projecting proximally from the main body and defining an opening (figure 14); and at least two tines (16) projecting distally from the main body and configured to penetrate tissue, the at least two tines being fabricated from a shape memory material such that the at least two tines are resiliently biased toward a deployed configuration (paragraph 63, figure 1, 8), in which the at least two tines project outwardly relative to the head and assume an arcuate shape (figure 14); and a tether (11) fixed to at least one anchor of the plurality of anchors and passing through the opening of each anchor of the plurality of anchors (paragraph 63) but is silent about the head and the at two tines are monolithically formed from a single wire that passes through the main body, the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening.
Qadeer teaches a similar device (clip device, abstract) having an anchor comprising a head (13) and at least two tines (11, 12) monolithically formed from a single wire (110, paragraph 66) being axially slidable relative to a main body (66, paragraph 66, 68, 69, 72 ) to allow selective adjustment of a length of the at least two tines (11,12) and a height of the opening (13) for the purpose of securing the legs in the deployed configuration as desired. Nakao does disclose multiple different embodiments of anchors, where the embodiment figure 14 does seem to have a monolithic wire with two tines and a head passing through a main body cinch. The monolithic wire device that is axially slidable through the main body can be used in the system of Nakao to help close the incision. Having the opening and tines being adjustable can help attach the device to tissue and then secure the device in place. Yoon (figure 61) and Kobayashi (figure 1,11) can provide evidence that an adjustable anchor can be used in the system of Nakao with respect to have a serially loaded adjustable anchor in a lumen of a device. It would have been obvious to one of ordinary skill in the art before the effective filing date to use have the anchor of Nakao be at least two tines and an opening monolithically formed from a single wire as taught by Qadeer and use the main body of Qadeer as in the crimping mechanism of Nakao which will allow the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the opening in order for securing the legs in the deployed configuration as desired.
As to claim 2, with the device of Nakao and Qadeer above, Nakao discloses the at least two tines are configured to transition from a stowed configuration (figure 1, paragraph 63), in which the at least two tines are linear (figure 1, the tines are linear or at least linear compared to the splayed out configuration), to the deployed configuration. Qadeer also teaches the transition from the stowed linear configuration to the deployed configuration (figure 12-16).
As to claim 3, with the device of Nakao and Qadeer above, Nakao discloses the at least two tines have a proximal facing surface having a concave shape and a distal facing surface having a convex shape (figure 6). At least the proximal facing and distal facing part of the curved ends can read on the concave and convex shape. Qadeer also teaches concave/convex surfaces (figure 16).
As to claim 8, with the device of Nakao and Qadeer above, Nakao discloses the at least two tines each have a traumatic distal tip configured for penetrating tissue (ends of 36, figure 6, paragraph 63, will be a sharp enough to penetrate tissue).
As to claim 9, 23, Nakao discloses a surgical system for use in repairing a wound after an endoscopic procedure (paragraph 16), the surgical system comprising: a plurality of anchors (10, figure 1, paragraph 45), each anchor of the plurality of anchors including: a main body (34), a head (38) projecting from a proximal end portion of the main body and defining an elongate slot (figure 6); and at least two tines (16) projecting from a distal end portion of the main body (figure 6) and configured to penetrate tissue, the at least two tines being fabricated from a shape memory material such that the at least two tines are resiliently biased from a stowed configuration (figure 1, paragraph 63) in which at least two tines are parallel with a longitudinal axis defined by the main body (figure 1), toward a deployed configuration (paragraph 63, figure 1, 8), in which the at least two tines project radially outward from the main body (figure 6), but is silent about the head and the at two tines are monolithically formed from a single wire that passes through the main body, the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the elongate slot.
Qadeer teaches a similar device (clip device, abstract) having an anchor comprising a head (13) and at least two tines (11, 12) monolithically formed from a single wire (110, paragraph 66) being axially slidable relative to a main body (66, paragraph 66, 68, 69, 72 ) to allow selective adjustment of a length of the at least two tines (11,12) and a height of an elongate slot (13) for the purpose of securing the legs in the deployed configuration as desired. Nakao does disclose multiple different embodiments of anchors, where the embodiment figure 14 does seem to have a monolithic wire with two tines and an opening passing through a main body cinch. The monolithic wire device that is axially slidable through the main body can be used in the system of Nakao to help close the incision. Having the opening and tines being adjustable can help attach the device to tissue and then secure the device in place. Yoon (figure 61) and Kobayashi (figure 1,11) can provide evidence that an adjustable anchor can be used in the system of Nakao with respect to have a serially loaded adjustable anchor in a lumen of a device. It would have been obvious to one of ordinary skill in the art before the effective filing date to use have the anchor of Nakao be at least two tines and the head monolithically formed from a single wire as taught by Qadeer and use the main body of Qadeer as in the crimping mechanism of Nakao which will allow the single wire being axially slidable relative to the main body to allow selective adjustment of a length of the at least two tines and a height of the elongate slot in order for securing the legs in the deployed configuration as desired.
As to claim 10, with the device of Nakao and Qadeer above, Nakao discloses the at least two tines have a proximal facing surface having a concave shape and a distal facing surface having a convex shape (6). At least the proximal facing and distal facing part of the curved ends can read on the concave and convex shape.
As to claim 19, 21, 24, with the device of Nakao and Qadeer above, Nakao discloses an endoscopic tube (12) defining a channel (lumen of 12) and a distal end opening (distal opening as seen in figure 1a), wherein the plurality of anchors are slidable stowed within the channel prior to deployment from the distal end of opening (figure 1a), the plurality of anchors being configured for sequential deployment through the distal end opening with a distal-most anchor of the plurality of anchors being deployed first (figure 1a, paragraph 66). Nakao discloses the endoscopic tube which can stow the plurality of anchors and sequentially deploy them. Both Kobayashi (figure 1,11) and Yoon (figure 53) can provide further evidence that the tube with a channel can store a similar plurality of the anchors and sequentially deploy them through a distal opening.
As to claim 20, 22, 25, with the device of Nakao and Qadeer above, Nakao discloses the (a) tether fixed to the head of the distal-most anchor and passes through the opening of each anchor proximal to the distal-most anchor while the plurality of anchors are stowed within the channel (figure 1a,2), the tether being routed entirely within the channel while the plurality of anchors are stowed (figure 1a,2). Kobayashi (figure 1,11) can provide further evidence of the tether fixed to the distalmost anchor and through the opening of each anchor proximal to the distal-most anchor while the plurality of anchors are stowed within the channel, the tether being routed entirely within the channel while the plurality of anchors are stowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2002/0173805 to Matsuno and U.S. Patent Publication 2006/0259049 to Harada both disclose similar device capable of disclosing, rendering obvious, and/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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771