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 § 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 2 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.
Claim 2 recites the limitation "the second lateral direction" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 2 is dependent off of claim 1, where neither claim 1 nor claim 2 previously recites “a second lateral direction”. Claim 1 does recite directions with respect to “a longer side direction”, “ a first short side direction”, and “a second short side direction”. It is unclear if “the second lateral direction” is “the second short side direction” or if the “lateral” basis of the direction is supposed to be include to include “a lateral second direction”. Since the direction trying to be claimed is unclear, the claim is considered to be indefinite.
Claim Rejections - 35 USC § 102
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.
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, 2, 6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2014/0296880 to Heneveld in view of U.S. Patent Publication 2008/0249543 to Kaladelfos and U.S. Patent Publication 2016/0302789 to Hirotsuka.
As to claim 1, Heneveld discloses a device capable of being a ligation device (paragraph 48) comprising:
a columnar main body (10);
a first jaw portion (30) connected to one end of the main body in a longer side direction (figure 1a);
a second jaw portion (40) connected to the one end of the main body in the longer side direction such that the second jaw portion is movable between a holding position (figure 1b) where the first jaw portion and the second jaw portion hold a ligation object therebetween and a separated position (figure 1a) where the second jaw portion is separated from the first jaw portion;
a thread feed rod (70) including a thread engagement portion (80) at a distal end of the thread feed rod, the thread engagement portion being configured to engage with a thread (71, figure 4a) to be used for ligation of the ligation object, the thread feed rod being accommodated in the first jaw portion (figure 2b), the thread feed rod being movable between a retracted position (figure 2b) where the thread engagement portion is located inside the first jaw portion and a protruding position (figure 6a) where the thread engagement portion protrudes from the first jaw position when the second jaw portion is located at the holding position (figure 6a,b); and
a thread pulling member (72) disposed inside the main body (paragraph 56, the means to actuate the pawl will be inside the main body), the thread pulling member including a thread hook portion (43, the aperture of the pawl can read on a thread hook portion since it can hook/snag/capture the suture) at a distal end of the thread pulling member, the thread hook portion being configured to catch the thread engaged with the thread engagement portion (paragraph 56, figure 6a-d),
wherein the second jaw portion has:
a hook passage hole (figure 6a where the proximal portion of 42 extends) extending along the long side direction, the hook passage hole through which the thread hook portion is insertable (figure 6a-d); and
a thread feed rod passage hole (90, figure 2b paragraph 52 ) through which the thread feed rod is insertable along a first short side direction, the first short side direction being a direction from the first jaw portion toward the second jaw portion and intersecting the long side direction (figure 2b, paragraph 6a-d,
wherein the hook passage hole and the thread feed rod passage hole partially intersect each other (figure 6a-d), and
wherein when the thread hook portion is located closer to a distal end of the second jaw portion in the long side direction than an intersecting position of the hook passage hole and the thread feed rod passage hole and the thread feed rod is located at the protruding position (figure 6a,b), the thread engagement portion of the thread feed rod is located downstream of the hook passage hole in the first short side direction (figure 6a,b), and is disposed at a position where the thread engagement portion overlaps the hook passage hole in a second short side direction intersecting the long side direction and the first short side direction (figure 6a,b).
If it would not be known that that thread pulling member of Heneveld would be disposed inside the main body, Kaladelfos teaches a similar device (suturing device, abstract) having a thread pulling member disposed inside the main body (figure 5, 8 paragraph 50) for the purpose of being able to actuate a similar thread pulling member. Kaladelfos teaches that thread pulling member can be disposed in the main body as it extends to the rear end of the device in order to allow the user to pull/actuated the member. Heneveld does disclose that the thread pulling member will be pulled in order to contract and contain the suture. This similar pulling actuation can be based on the rod 136 that is disposed in the main body. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the thread pulling member be disposed in the main body in order to manually actuate and pull the thread pulling member.
If it would not be known that Heneveld would be able to read on the thread hook portion, Hirotsuka teaches a similar device (suture manipulating device, abstract) having a thread pulling member comprising a hook portion in order to use a known shaped device to pull a thread (paragraph 120). Hirotsuka teaches multiple of different shaped devices which can engage and pull an end portion of a suture. The thread pulling member of Heneveld can use a similar device which can read on a hook in order to help secure and pull the thread. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the thread pulling member of Heneveld include a thread hook portion in order to use a similarly shaped device to hold and pull the thread portion as desired.
As to claim 2, with the device of Heneveld, Kaladelfos, and Hirotsuka above, Heneveld discloses wherein the thread feed rod has a recessed groove (the posts 76 can define a groove extending between the posts, figure 5a,b) at a position upstream of the thread engagement portion in the first short side direction (figure 5c) and overlapping the thread engagement portion in the second lateral direction (figure 5a-c, the “groove” can extend in a direction that is lateral to the distal face), and wherein when the thread feed rod is at the protruding position, the recessed groove is located at a position where the recessed groove overlaps the hook passage hole in the first short side direction (figure 6b).
As to claim 6, with the device of Heneveld, Kaladelfos, and Hirotsuka above, Heneveld discloses the thread engagement portion of the thread feed rod is a groove (the posts 76 can define a groove extending between the posts, figure 5a,b) extending along the long side direction.
Claims 1, 6, 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,336,229 to Noda in view of U.S. Patent 3,842,840 to Schweizer, U.S. Patent Publication 2009/0012538 to Saliman, or U.S. Patent Publication 2011/0118760 to Gregoire.
As to claim 1, Noda discloses a ligation device (col. 2 ll. 59-61) comprising:
a columnar main body (202);
a first jaw portion (216) connected to one end of the main body in a longer side direction (figure 9);
a second jaw portion (end of 204) connected to the one end of the main body in the longer side direction such that the second jaw portion is movable between a holding position (figure 12) where the first jaw portion and the second jaw portion hold a ligation object therebetween and a separated position (figure 10) where the second jaw portion is separated from the first jaw portion (the claim does not state that the second jaw portion is hingably coupled to the main body but just the jaw can be movable between positions, the device is movable between the holding position and the separated position, so the second jaw portion, which is a part of the device can be movable between the positions);
a thread feed rod (224) including a thread engagement portion (col. 10 ll. 62-64, how the suture engages the snap or the like) at a distal end of the thread feed rod, the thread engagement portion being configured to engage with a thread (218) to be used for ligation of the ligation object (col. 10 ll. 56-64), the thread feed rod being accommodated in the first jaw portion (figure 11-13), the thread feed rod being movable between a retracted position (figure 11) where the thread engagement portion is located inside the first jaw portion and a protruding position (figure 12) where the thread engagement portion protrudes from the first jaw position when the second jaw portion is located at the holding position (figure 12); and
a thread pulling member (240) disposed inside the main body, the thread pulling member including a thread hook portion (col. 11 ll. 27-28, the capture rod can have the hook) at a distal end of the thread pulling member, the thread hook portion being configured to catch the thread engaged with the thread engagement portion (figure 12, col. 11 ll. 27-29),
wherein the second jaw portion has:
a hook passage hole (241) extending along the long side direction, the hook passage hole through which the thread hook portion is insertable; and
a thread feed rod passage hole (227) through which the thread feed rod is insertable along a first short side direction, the first short side direction being a direction from the first jaw portion toward the second jaw portion and intersecting the long side direction (figure 9-12),
wherein the hook passage hole and the thread feed rod passage hole partially intersect each other (figure 9-12), and
wherein when the thread hook portion is located closer to a distal end of the second jaw portion in the long side direction than an intersecting position of the hook passage hole and the thread feed rod passage hole and the thread feed rod is located at the protruding position (figure 12), the thread engagement portion of the thread feed rod is located downstream of the hook passage hole in the first short side direction (figure 9-12), and is disposed at a position where the thread engagement portion overlaps the hook passage hole in a second short side direction intersecting the long side direction and the first short side direction (figure 9-12), but is silent about the thread engagement portion is at a distal end of the thread feed rod. Noda does disclose different mechanisms for passing the suture (col. 11 ll. 27-35).
Schweizer teaches a similar device (suturing device, abstract) having a thread engagement portion (63, figure 4,6) is at a distal end of the thread feed rod (62) for the purpose of grasping a length of suture to pass it to opposite jaws (col. 2 ll. 56-68). Saliman also teaches a similar device (suturing device, abstract) having a thread engagement portion (1703, figure 17a,b or 1821, figure 18d,e) is at a distal end of the thread feed rod (1701;1817) for the purpose of providing variations of a device that can shuttle a suture (paragraph 133, 135). Gregoire further teaches a similar device (suturing device, abstract) having a thread engagement portion (116, figure 4b,) is at a distal end of the thread feed rod (110) for the purpose of assisting in capturing and passing a suture (paragraph 24, 26). Schweizer, Saliman and Gregoire all teach different mechanisms that have a thread engagement portion on a distal end of a thread feed rod which can pass a suture. Noda does disclose that other suture passing mechanisms can be used. Substituting the thread feed rod of Schweizer/Saliman/Gregoire can provide an additional structure which can help pass the suture into the thread pulling member. It would have been obvious to one of ordinary skill in the art before the effective filing date to have a thread feed including a thread engagement portion at a distal end of the thread feed in the device Noda in order for assisting in capturing and passing the thread to the thread pulling member.
As to claim 6, with the device of Noda and Schweizer/Saliman/Gregoire above, Saliman teaches the thread engagement portion of the thread feed rod is a groove (figure 17a) extending along the long side direction.
As to claim 9, with the device of Noda and Schweizer/Saliman/Gregoire above, Schweizer further teaches a thread storage portion (52) in which the thread is stored in a first jaw portion (26, figure 1-3) for the purpose of efficiently supplying the thread (col. 2 ll. 50-56). Using the cartridge/bobbin allows the device to organize the thread so it won’t get tangled. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a thread storage portion in which the thread is stored in the first jaw portion of Noda as modified by Schweizer/Saliman/Gregoire in order for efficiently supplying the thread.
Claim 3, 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,336,229 to Noda in view of U.S. Patent 3,842,840 to Schweizer, U.S. Patent Publication 2009/0012538 to Saliman, or U.S. Patent Publication 2011/0118760 to Gregoire as applied to claims 1, 6, 9 above, and further in view of U.S. Patent Publication 2012/0123448 to Flom.
As to claim 3, Noda as modified by Schweizer/Saliman/Gregoire discloses the device above but is silent about the thread pulling member includes a tubular body having a notch constituting the thread hook portion and the thread hook holding member.
Flom teaches a similar device (suturing device, abstract) comprising wherein the thread pulling member includes a tubular body (10) having a notch (35) constituting the thread hook portion; and a thread hook holding member (60) slidable into the tubular body and catches and holds the thread between the thread hook holding member and the notch (paragraph 89, figure 10) for the purpose of securely clamping on the suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the thread pulling member of Noda as modified by Schweizer/Saliman/Gregoire comprise a tubular body having a notch constituting the thread hook portion; and a thread hook holding member slidable into the tubular body and catches and holds the thread between the thread hook holding member and the notch in order to securely clamp on the thread.
As to claim 14, Noda as modified by Schweizer/Saliman/Gregoire discloses the device above but is silent about a second thread pulling member configured to move between a first position in which the second thread pulling member extends parallel to the thread pulling member and a second position where the second thread pulling member is coaxial with the thread pulling member. the thread pulling member includes a tubular body having a notch constituting the thread hook portion and the thread hook holding member.
Flom teaches a similar device (suturing device, abstract) comprising a second thread pulling member (60) configured to move between a first position (figure 8) in which the second thread pulling member extends parallel to the thread pulling member (10) and a second position (figure 10) where the second thread pulling member is coaxial with the thread pulling member for the purpose of securely clamping on the suture (paragraph 89). It would have been obvious to one of ordinary skill in the art before the effective filing date to use a second thread pulling member in the device of Noda as modified by Schweizer/Saliman/Gregoire in order to securely clamp on the thread.
Claim 7, 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0296880 to Heneveld in view of U.S. Patent Publication 2008/0249543 to Kaladelfos and U.S. Patent Publication 2016/0302789 to Hirotsuka as applied to claims 1, 2, 6 above, and further in view of U.S. Patent Publication 2022/0304674 to Litke.
As to claim 7, Heneveld as modified by Kaladelfos and Hirotsuka discloses the device above but is silent about a first cutter configured to cut the thread is fixed to the second jaw portion.
Litke teaches a similar device (suturing device) having a first cutter (1071, figure 2, paragraph 42,43, 46) configured to cut the thread fixed to a device for the purpose of trimming excess material. The blade 1071 is seen to be positioned on top of the device but can be positioned anywhere and in any orientation. The top of the device of Heneveld is second jaw. Further, the blade 1071 is positioned just proximal to where the suture needle is located and the rest of the tubular body of the device. The blade 1071 would be to fixed to the second jaw, between the thread feed rod passage hole (closer to the distal end) and the main body (proximal end) which can allow easier access to trim the excess suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to have a first cutter configured to cut the thread fixed to the second jaw portion of Heneveld as modified by Kaladelfos and Hirotsuka, disposed between the thread feed rod passage hole and the main body in the long side direction in order to trim excess thread material.
As to claim 8, Heneveld as modified by Kaladelfos, Hirotsuka, and Litke discloses the first cutter is fixed to the second jaw portion (as taught by Litke), and the thread feed rod is movable from a first protruding position (figure 6a-d of Heneveld) where the thread feed rod protrudes from the thread feed rod passage hole to cause the thread pulling member to catch and hold the thread to a second protruding position (figure 6a-d of Heneveld) at which the thread engagement portion of the thread feed rod protrudes further from the first protruding position in the first short side direction when the second jaw portion is at the holding position.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0296880 to Heneveld in view of U.S. Patent Publication 2008/0249543 to Kaladelfos and U.S. Patent Publication 2016/0302789 to Hirotsuka as applied to claims 1, 2, 6 above, and further in view of U.S. Patent 3,842,840 to Schweizer.
As to claim 9, Heneveld as modified by Kaladelfos and Hirotsuka discloses the device above but is silent about the first jaw portion has a thread storage portion in which the thread is stored.
Schweizer teaches a similar device (suturing device, abstract) having a thread storage portion (52) in which the thread is stored in a first jaw portion (26, figure 1-3) for the purpose of efficiently supplying the thread (col. 2 ll. 50-56). Using the cartridge/bobbin allows the device to organize the thread so it won’t get tangled. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a thread storage portion in which the thread is stored in the first jaw portion of Heneveld as modified by Kaladelfos and Hirotsuka in order for efficiently supplying the thread.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0296880 to Heneveld in view of U.S. Patent Publication 2008/0249543 to Kaladelfos and U.S. Patent Publication 2016/0302789 to Hirotsuka as applied to claims 1, 2, 6 above, and further in view of U.S. Patent Publication 2015/0342599 to Kostrzewski.
As to claim 15, Heneveld as modified by Kaladelfos and Hirotsuka discloses the device above including the second jaw portion is coupled to the main body at a proximal end of the second jaw portion via a first pin (39, paragraph 60) so as to be openable and closable with respect to the first jaw portion, and the first pin extends parallel to the second short side direction (figure 8a-c), but is silent about a coupling member that couples the first jaw and the second jaw to the main body, where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin extending parallel to the first short side direction.
Kostrzewski teaches a similar device (suturing device, abstract) comprising a coupling member (50 that couples a first jaw and a second jaw (34,36) to the main body (20), where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin (54) extending parallel to the first short side direction for the purpose of articulating the distal end of the device to achieve the desired orientation of the device (paragraph 87). It would have been obvious to one of ordinary skill in the art before the effective filing date to use a coupling member that couples the first jaw and the second jaw of Heneveld as modified by Kaladelfos and Hirotsuka to the main body, where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin extending parallel to the first short side direction in order for articulating the distal end of the device to achieve the desired orientation of the device.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,336,229 to Noda in view of U.S. Patent 3,842,840 to Schweizer, U.S. Patent Publication 2009/0012538 to Saliman, or U.S. Patent Publication 2011/0118760 to Gregoire as applied to claims 1, 6, 9 above, and further in view of U.S. Patent Publication 2015/0342599 to Kostrzewski.
As to claim 15, Noda as modified by Schweizer/Saliman/Gregoire discloses the device above including the second jaw portion is coupled to the main body at a proximal end of the second jaw portion via a first pin (234, figure 11, 12) so as to be openable and closable with respect to the first jaw portion, and the first pin extends parallel to the second short side direction (figure 11, 12), but is silent about a coupling member that couples the first jaw and the second jaw to the main body, where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin extending parallel to the first short side direction.
Kostrzewski teaches a similar device (suturing device, abstract) comprising a coupling member (50 that couples a first jaw and a second jaw (34,36) to the main body (20), where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin (54) extending parallel to the first short side direction for the purpose of articulating the distal end of the device to achieve the desired orientation of the device (paragraph 87). It would have been obvious to one of ordinary skill in the art before the effective filing date to use a coupling member that couples the first jaw and the second jaw of Noda as modified by Schweizer/Saliman/Gregoire to the main body, where the coupling member is rotatably connected to an end portion of the columnar main body via a second pin extending parallel to the first short side direction in order for articulating the distal end of the device to achieve the desired orientation of the device.
Allowable Subject Matter
Claims 4, 5, 10-13 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Of note: A call was made to the applicant for an examiner’s amendment to place the application in condition for allowance (incorporating subject matter of claim 10 into claim 1) but an agreement was not reached.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,234,443 to Phan, U.S. Patent 5,792,151 to Heck, U.S. Patent 9,220,497 to Lanois, U.S. Patent Publication 2009/0105751 to Zentgraf, U.S. Patent Publication 2008/0177285 to Brock, U.S. Patent Publication 2011/0066165 to Skinlo, U.S. Patent Publication 2014/0276981 to Hendricksen, U.S. Patent Publication 2019/0321030 to Fanton, U.S. Patent Publication 2019/0336124 to Pisarnwongs, and U.S. Patent Publication 2019/0336125 to Nadim all discloses similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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
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