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 .
Drawings
The drawings are objected to because the line quality of the text in fig. 18A, fig. 18B and fig. 20A is not sufficiently dark and clear to allow satisfactory reproduction characteristics (see 37 CFR 1.84(l)). Additionally, Fig. 20A includes an arrow (left side of fig. 20A when viewing fig. 20A in intended orientation) that is not associated with a reference number and thus it is unclear what is being illustrated by the arrow. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 21-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akyuz et al. (US 2010/0241142) in view of Yoon (US 5,797,927). Regarding claims 21 and 30, Akyuz discloses a suture passer comprising: an elongate body (108; fig. 1) extending between a proximal handle end and a distal end; a first jaw and a second jaw at the distal end, the first (140) and second (144) jaws configured to cooperatively engage a target tissue; a tissue penetrator (250) that axially advances and retracts along the second jaw; and a suture (50) loaded within the second jaw (fig. 11a); wherein the second jaw includes a channel (164; fig. 4 and [0046]) that receives the tissue penetrator and also includes a slit (160; fig. 4), continuous with and extending from the channel, the slit terminating in an open distal end at an external surface of the second jaw (figs. 4, 5, 6a-c), and wherein the slit defines an opening width configured to allow a suture disposed along the slit to be removed upon application of tension on the suture. Further regarding claim 30, the channel (164) houses a suture (noting suture passes through area of channel 164 with suture alcove 158; fig. 11b) and the tissue penetrator, and wherein the slit is continuous with and extends from the channel (figs. 6a-6c); wherein the tissue penetrator is configured to axially slide and sequentially pass a first length of the suture through the target tissue and then a second length of the suture through the target tissue (see [0067] – suture passer may be used two times successively to pass each free end through tissue; see also figs. 11a-12d).
Akyuz fails to disclose that the opening width is further configured to hinder the suture from entering the slit as the tissue penetrator retracts or after the first length of suture is passed through tissue.
Yoon discloses another suture passer comprising first and second jaws (20, 18) and a tissue penetrator (80). Yoon discloses that the second jaw includes a slit (e.g., 128; figs. 5, 7-9) defining an opening configured to receive suture (fig. 5, 9). Yoon discloses that the slit has a width less than the diameter of the suture in order to prevent the suture from inadvertently falling out while permitting deliberate removal of the suture via the slit by application of a force so that suturing of anatomical tissue can be performed with tissue held between the jaws of the instrument (see abstract; figs. 6-9). It would have been obvious to one of ordinary skill in the art to have modified the slit of Akyuz to have an opening width less than the diameter of the suture as taught by Yoon in order to prevent the suture from inadvertently falling out of the slit while permitting deliberate removal of the suture by application of a force. With such a modification, the opening width of the slit of Akyuz in view of Yoon is configured to hinder suture from entering the slit as the tissue penetrator retracts, or reentering the channel (via the slit) after being passed through tissue in the same manner as the instant application since the opening width is smaller than the diameter of the suture and thus requires a deliberate application of force to move the suture through the narrow slot and into the channel.
Regarding claims 22 and 31, the slit (160) extends axially along a distal end of the second jaw (see fig. 4 of Akyuz).
Regarding claims 23 and 35, the slit extends axially and distally from a distal end of the channel (fig. 4 of Akyuz).
Regarding claim 24, the slit open distal end extends up to a distal facing external surface of the second jaw (fig. 4 of Akyuz).
Regarding claims 32 and 33, the slit as modified in view of Yoon is configured to allow the suture disposed along the slit to be removed upon application of tension as taught by Yoon (see abstract). The slit (160 of Akyuz) has an open distal end at an external surface of the second jaw for the suture disposed along the slit to exit as disclosed by Akyuz.
Regarding claims 25 and 34, as taught by Yoon, the slit open distal end defines an abrupt end, to hinder entrance of the suture into the slit. See figs. 5 and 7-9 of Yoon, wherein the slit is considered to have an abrupt end as there is no chamfered or flared entrance easing passage of the suture into the slit open distal end.
Regarding claim 26, the tissue penetrator is configured to sequentially release a first length of the suture and then engage a second length of the suture. It is noted that the limitation following “configured to” is a recitation of intended use. Since the tissue penetrator of Akyuz meets the structural limitations of the claim and is capable of carrying out this recitation of intended use (noting paragraph [0067] discloses that the suture passer may be employed two times successively to pass each free end of suture through a body tissue). The slit, as modified by Yoon to have an opening width less than the diameter of the suture, is configured to hinder the suture from entering the channel while the tissue penetrator moves to engage the second length of suture.
Regarding claim 27, the tissue penetrator is configured to sequentially pass and release a first length of the suture and then retract back into the second jaw to capture a second length of the suture (note: this is a functional limitation and the prior art must only be capable of performing the function in order to meet the limitation; a second length of suture may be loaded into alcove 158 of the second jaw and thereafter captured by the penetrator) and wherein the slit is configured to hinder the suture from entering the channel while the tissue penetrator retracts back (due to its width being smaller than the diameter of the suture as taught by Yoon; see figs. 5-9 of Yoon).
Regarding claims 28 and 37, the tissue penetrator defines a midline, and wherein the tissue penetrator has a suture loading slot (260; fig. 3b of Akyuz) on a first side of the midline and a distal-most point (258) that is laterally offset on a second side of the midline (see fig. 3b).
Regarding claims 29 and 38, the tissue penetrator has a sharp distal tip and wherein the second jaw channel includes a suture holding portion (158; fig. 4 of Akyuz) on a first side of a channel midline and a ramped cover (162/176) on an opposing side of the channel midline (see fig. 4, 6a, 6c), the ramped cover configured to cover the sharp distal tip and limit snagging of the suture with the sharp distal tip (when in position shown in fig. 6c of Akyuz for example).
Regarding claim 36, the tissue penetrator is configured to retract along the second jaw to capture the second length of the suture (e.g., second length can be loaded into suture alcove (158) and thereafter passed into slot 160 after it has been retracted to align with alcove 158; see position shown in fig. 6c) before passing the second length of suture through the target tissue and wherein the slit is configured to hinder the suture from entering the channel while the tissue penetrator is retracting due to the slit’s opening width being less than the diameter of the suture as taught by Yoon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,730,747 to Ek et al. discloses a suture passer comprising a jaw (314) having a channel (342) and a slit (340), wherein the slit has a width less than that of the channel (see figs. 8b, 8c).
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KSH 9/4/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771