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
The amendments have overcome the previously presented 35 USC 112b rejection of claims 3, 13, and 14. Applicant's arguments with respect to the 35 USC prior art rejections of claims 3, 13, and 14 over Leiboff ‘636, which incorporates by reference Leiboff ‘635, in view of Sauer have been fully considered but they are not found persuasive. Sauer is relied upon to teach the claimed cylindrical shape having a distance between the first and second end of the cylindrical body portion being greater than a diameter of the bore of the cylindrical body portion as presented below. Applicant asserts that Leiboff ‘636/’635 teaches away from such a modification since Leiboff ‘636/’635 discloses that the diameter of the fastener is substantially larger than the width of the fastener to make it more difficult for the tacking device to be withdrawn in the direction of the foot (14). The examiner respectfully disagrees as this passage appears only to teach away from making the diameter of the fastener smaller such that the surface of the fastener abutting the wide end of the barb (18; fig. 20) would be decreased. Modifying the fastener of Leiboff ‘636/’635 in view of Sauer as discussed below to have an elongated, crimpable cylindrical body portion with a length greater than the diameter of the bore extending through the body portion of the fastener (see figs. 11, 11a of Sauer) need not involve any change to the diameter of the fastener. Rather, the length may be changed. Applicant also asserts that Leiboff ‘636/’635 teaches away from changing the shape of the fastener to the cylindrical shape taught by Sauer because it would make the fastener unable to sit on the surface of the skin or be buried subcutaneously. However, applicant does not provide any evidence for this assertion and the examiner maintains that there is nothing about the shape taught by Sauer that would prevent it from sitting on the surface of skin (noting that the cylindrical shape taught by Sauer has an enlarged flat surface at its end that can sit against tissue or skin; see figs. 7-9 of Sauer), or that would prevent it from being buried subcutaneously.
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.
Claim(s) 3, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leiboff (US 2005/0049636) in view of Sauer (US 5,520,702). It is noted that Leiboff incorporates by reference Application 10/636,841, which corresponds to US 2005/0049635.
Leiboff ‘636 discloses a surgical snare assembly comprising a surgical fastener (20; see [0049] of ‘636, which incorporates by reference the fastener 20 of ‘635; see figs. 19-23 of ‘635) having an entrance and an exit (either ends of opening through 20), a first suture engaging loop (16), first and second handles (14 and 15, respectively, noting the term “handle” is broadly construed as an element or part by which something can be grasped by hand) configured such that movement of the first handle a first distance away from the suture fastener causes the first suture engaging loop to move through the suture fastener from the exit to the entrance and movement of the second handle a second distance away from the suture fastener causes the first suture engaging loop to move through the suture fastener from the entrance to the exit (noting fastener is located along the filament between the two handles). A first length of wire extends from a first portion of the first suture engaging loop and a second portion of the first handle, and a second length of wire extends from a second portion of the first suture engaging loop and a first portion of the second handle. It is noted that the term “wire” is being given its broadest reasonable interpretation of an elongated, thin filament, and is not considered to denote any particular material composition.
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The second length of wire is removably secured to the second portion of the first suture engaging loop (see figs. 5 to fig. 6; [0051] – “the needle is then disengaged or cut-off from filament 12”, noting figures 5 to 6 illustrate the second length of wire along with 2nd handle 15 has been removed from the second portion of the first suture engaging loop).
The suture fastener (20) of Leiboff has a cylindrical body portion having a cylindrical bore therethrough (fig. 19 of ‘635). However, Leiboff does not expressly disclose that a distance between the first and second ends of the body portion is greater than a diameter of the bore, and that all or a portion of the cylindrical body portion is configured to be deformed by a surgical crimping device as required by claim 3.
Sauer discloses another suture fastener, wherein the suture fastener (100; figs. 8-9) is an elongated suture fastener comprising a cylindrical body portion that extends along a fastener axis from a first end to a second end, wherein a cylindrical bore extends through the body portion from the first end to the second end such that the first end of the body portion defines an entrance of the suture fastener and the second end of the body portion defines an exit of the suture fastener, wherein a distance between the first end and the second end of the body portion is greater than a diameter of the bore (as understood in view of at least fig. 11 and 11A), wherein all or a portion of the body portion is configured to be deformed by a surgical crimping device (fig. 8-9). It would have been obvious to one of ordinary skill in the art to have modified the suture fastener (20) of Leiboff to have an elongated, crimpable cylindrical body portion having a cylindrical bore, a distance between the first end and the second end of the body portion being greater than the diameter of the bore, as taught by Sauer in order to further enhance securement of the suture relative to the fastener by providing a cylindrical body portion elongated in the lengthwise direction that can be permanently deformed about suture passing through the bore once a desired position is achieved.
Regarding claim 14, as taught by Sauer, the suture fastener (100 of Sauer) further comprises an annular flange disposed about an outer circumference of the body portion at the first or the second end of the body portion (see figs. 8, 9, 11 of Sauer), which helps distribute force over a greater area of tissue as known by one of ordinary skill in the art. Thus, it would have been obvious to include such a flange on the fastener of Leiboff in view of Sauer so that it too may have the associated advantage.
Regarding claim 13, claim 3 includes that the first and second handles “are configured such that…” (see lines 10-16) and thereafter describes movement of the handles which moves the loop through the suture fastener. It is understood that the portion of suture being disposed through the suture fastener (claim 13) after the movement of the first handle (recited as functional in claim 3) is not being positively recited as part of, or in combination with, the surgical snare assembly. Rather, the suture being disposed through the suture fastener is a continuation of the “configured such that” language in claim 3, and drawn to an intended use of the surgical snare assembly. Because a suture can be loaded into the loop of the prior art of Leiboff and thereafter the loop can be moved (via movement of the first handle as claimed) through the suture fastener such that the suture is disposed through the suture fastener from the exit to the entrance, it meets this recitation of intended use.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 1/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771