DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 08/07/24.
The examiner acknowledges the amendments to the claims and specification.
Claims 1-3 and 5 are pending in this application.
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 Objections
Claim 1, line 9 is objected to because of the following informalities: it reads “transverse orientation” and should rather read as --the transverse position-- to be consistent with the previous recitation in line 6. Appropriate correction is required.
Claim 1, line 9 is further objected to because of the following informalities: it reads “it is fixed by the guillotine”, wherein for clarity should read as --the needle is fixed by the guillotine--.
Claim 1, line 10 is objected to because of the following informalities: it reads “characterized in that” and it is suggested to instead read as --wherein--. Appropriate correction is required.
Claim 3, line 2 is objected to because of the following informalities: it reads “wherein it is also provided with” and should instead read as --wherein the device is also provided with--. Appropriate correction is required.
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.
Claim 3 is 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.
In claim 3 there is an inconsistency with the language of claim 1 (upon which claim 3 depends), wherein a “suture needle” is only functionally recited (“two facing blades intended to house a suture needle”) in claim 1, lines 3-4. However, lines 2-3 of claim 3 appear to positively recite the suture needle as an element of the invention, along with a thread (“wherein it [the device] is also provided with a thread, associated with the suture needle”). As such it is unclear whether Applicant intends the claims to positively recite the suture needle. For examination purposes, claim 3 will be considered as positively reciting the suture needle, wherein a thread is associated with the suture needle.
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:
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gorski et al., hereinafter “Gorski” (U.S. Pub. No. 2017/0071597) in view of Yoon (U.S. Patent No. 6,224,614).
Regarding claim 1, Gorski discloses a thread suturing flexible device 10 (Figures 4-6) capable of endoscopic use (see abstract) comprising a proximal end and a distal end, wherein the distal end is provided with a clamp (jaw assembly 100) formed by two facing blades (jaws 110, 160) intended to house a suture needle (such as needle 200) in a position parallel to a main axis of the device (see position of suture needle 200 in Figures 2, 4, 17 in a low profile stowed position; [0006]) wherein the proximal end is provided with control mechanisms (within handle assembly 300 including trigger mechanism 350; Figures 41-45, [0105]) for the opening and closing of said clamp (see jaw assembly 100 opening and closing in Figures 46-51 by closure mechanism 340) and changing of orientation of the needle to a transverse position (see position of suture needle 200 in Figures 4-6, 14-20 moved via latching mechanism; [0089]) and passing of said needle from one blade to another of the clamp (see position of suture needle 200 going from one jaw in Figure 46 to the other jaw in Figure 51 via toggle mechanism; [0110]), wherein each blade is provided with a guillotine (first shim 360 and second shim 370; Figures 18-22, [0113]-[0118], [0120]-[0121]) adapted to slide on the blade (a distal portion of each of the first and second shims 360, 370 slidably contacts an inner part or shim channel of a respective jaw/blade, and therefore are “adapted to slide on the blade” to hold needle 200; see for example shim 360 partially advanced within shim channel 141 in Figures 21-22) and a corresponding blade hole (shim channel) so that when the needle changes its orientation to the transverse position, it is fixed by the guillotine and the corresponding hole (first shim 360 and second shim 370 are slidable within the respective jaws/blades within shim channels to retain the needle 200 in position).
However, Gorski does not disclose the guillotines being provided with a cutting edge.
In the same field of art, namely thread suturing flexible devices, Yoon teaches in Figures 3A-3B, 9-14 a suture needle clamp with two facing blades (needle driver 40 and needle catcher 50) having guillotines (abutment surfaces 71, 71’) adapted to slide on the blade (abutment surfaces are able to be moved axially and slidably contact an inner part of a respective blade, and therefore are “adapted to slide on the blade” to hold a needle N; col. 5, lines 5-25), wherein the guillotines are provided with a cutting edge (col. 9, lines 7-10; cutting elements are defined on the abutment surfaces which can be used to cut suture material S).
It would have been obvious to one of ordinary skill before the effective filing date to modify the guillotines of Gorskin with a cutting edge, as taught by Yoon, in order to allow a surgeon to cut suture material and permit withdrawal of the device and suture needle (Id.).
Regarding claim 2, Gorski as modified teaches the claimed invention, as discussed above, including a first metal cable (drive rod 342 for opening and closing the jaws, which can be made of metal; Gorski, Figure 44, [0108], [0111], [0128]) adapted to open and close the clamp (Id.), and second metal cables (elongate proximal portions of shims 360, 370 in Figures 52-63) to move a corresponding guillotine on its blade (Gorski further teaches that various actuation cables and shims within the device may be made of metal; Id.).
However, Gorski does not teach a first sliding tab attached to the first metal cable, and corresponding sliding tabs attached to the second metal cables.
Yoon further teaches in Figures 3A-3B corresponding sliding tabs 47, 47’ (col. 6, lines 30-38) in order to actuate respective guillotines (abutment surfaces 71, 71’ are axially movable by cables or holding members 45, 45’ of needle driver 40 and needle catcher 50).
It would have been obvious to one of ordinary skill before the effective filing date to modify Gorski with respective sliding tabs, as taught by Yoon, in order for a user to easily actuate axially movable cables that control the guillotines, as well as to actuate the clamp, since doing so would be substitution of one known user actuation element for another, which would yield predictable results, namely allowing a user to selective actuate movement of the clamp and the guillotines. See MPEP 2143.
Regarding claim 3, Gorski as modified teaches the device is also provided with a thread 220 (Figures 4-6; Gorski) associated with the suture needle 200 for changing the orientation of the needle (thread 220 is capable of being manipulated such that the needle orientation changes).
Regarding claim 5, Gorski as modified teaches the claimed invention, as discussed above, except for each blade is provided with a stop at its distal end.
In Figures 3A-3B Yoon further teaches each blade (needle driver 40 and needle catcher 50) has a stop (abutment surfaces 72, 72’) at its distal end.
It would have been obvious to one of ordinary skill before the effective filing date to modify each blade of Gorski as modified with a respective stop, as taught by Yoon, in order to securely hold the suture needle between the guillotines 71, 71’ and the stops 72, 72’ (Yoon; col. 8, lines 1-2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771