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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-13, and 15-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1 and 12, the limitation “a first grasping member including: a rotation member supported by a first rotation shaft; a second grasping member…wherein the first grasping member and the second grasping member are connected by a second rotation shaft” is not mentioned in the specification and is considered new matter. While several different embodiments are disclosed, the specification fails to describe a first and second rotation shaft.
The specification refers to:
First Embodiment: an open-close rotation shaft 23 ([0028]);
Modification Example 2: the rotation shaft 35 ([0074]);
Modification Example 3: a rotation shaft 39 ([0076]);
However, while the specification describes different rotation shafts in different embodiments, the specification fails to provide support for a single embodiment using both a first and second rotation shaft simultaneously.
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(s) 1-2 and 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi et al. (US 2019/0167267; hereinafter Kobayashi).
Kobayashi shows a stapler (Fig. 7, [0054]-[0058]), comprising: a grasping portion including: a first grasping member (24a) including: a rotation member supported by a first rotation shaft (rotation member 11; [0054], [0058]); a wire fixed to the rotation member (pushing wire 13; [0022]-[0023]); and a pusher located between a staple and the rotation member (driving member 30; [0057]), and a second grasping member (24b) including a recess configured to receive the staple, wherein the first grasping member and the second grasping member are connected by a second rotation shaft (fixed pulley 28; [0054]-[0058]), wherein the rotation member pushes the pusher in a direction intersecting with a longitudinal direction when the rotation member rotates by the wire, and wherein the pusher pushes the staple in the direction when the rotation member pushes the pusher (rotation of pulley 12 acts to move driving member 30, so as to linearly push slider 27, causing pusher 4 to be pushed by the inclined surface of the slider to cause the staples to be pushed out toward the upper jaw, and the pieces of tissue are joined by the staples, [0059]).
Kobayashi also shows a suturing mechanism (Fig. 7, [0054]-[0058]), comprising: a grasping portion including a first grasping member (24a) and a second grasping member (24b) that are connected by a rotation shaft to be openable and closeable ([0054], [0058]); a staple extraction portion (4) provided in the first grasping member; and a staple reception portion (10) provided in the second grasping member, wherein when the grasping portion is in a closed state, the staple extraction portion and the staple reception portion are opposite to each other (Fig. 7 illustrates open state of jaws, where when the jaws are in a closed state the portions are opposite to each other), and the staple extraction portion comprises: a rotation member (11) configured to extract the accommodated staple toward the opposite staple reception portion by a rotation operation ([0059]); and a straight-moving member (27) configured to interlock with the rotation operation of the rotation member and straightly move for extracting the staple toward the staple reception portion (rotation of pulley 12 acts to move driving member 30, so as to linearly push slider 27, causing pusher 4 to be pushed by the inclined surface of the slider to cause the staples to be pushed out toward the upper jaw, and the pieces of tissue are joined by the staples, [0059]).
Kobayashi also shows wherein the rotation member includes a contact portion being in contact with the straight-moving member to move the straight-moving member tougher with the rotation operation (driving member 30, [0059]); further includes a power transmission member configured to rotate the rotation member (pushing wire 13, [0057]); wherein the power transmission member is a wire that is wound around the rotation member, and the rotation member is rotated by pulling the wire (push wire 13, [0057]); wherein a rotation axis of the rotation member is substantially parallel to the rotation axis of the grasping member (pulley 12, [0059]; Fig. 7); wherein the rotation member is a pulley (pulley 12, [0059]).
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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (US 2019/0167267; hereinafter Kobayashi) in view of Rockrohr (US 2016/0303743; hereinafter Rockrohr).
Kobayashi shows the invention substantially as described in the 102 rejection above.
Kobayashi fails to show wherein the rotation member is a link mechanism; wherein the rotation member is a cam mechanism.
Rockrohr discloses jaw assemblies for robotic surgical systems. Rockrohr teaches wherein the rotation member is a link mechanism ([0146]); wherein the rotation member is a cam mechanism ([0146]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Kobayashi to additionally or in substitute utilize link or cam mechanisms as taught by Rockrohr, as a as it would be within the level of one of ordinary skill in the art, without undue experimentation, to employ different known mechanical mechanisms for delivering the staple into the patient’s tissue, including the particular benefits of known cam or link type mechanisms for mechanically controlling an end of a surgical device.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (US 2019/0167267; hereinafter Kobayashi) in view of Marczyk et al. (US 2017/0020524; hereinafter Marczyk).
Kobayashi shows the invention substantially as described in the 102 rejection above.
Kobayashi fails to show wherein the straight-moving member includes a planar portion in contact with the contact portion, and the contact portion includes a curved surface portion in contact with the planar portion; wherein the planar portion is an inclination surface being inclined with respect to a direction orthogonal to a movement direction of the straight-moving member, and the contact portion is configured to press the straight-moving member with respect to a wall surface of a staple accommodation portion accommodating the straight-moving member while moving the straight-moving member in the movement direction.
Marczyk discloses an endoscopic stapler. Marczyk teaches wherein the straight-moving member includes a planar portion in contact with the contact portion, and the contact portion includes a curved surface portion in contact with the planar portion ([0084]); wherein the planar portion is an inclination surface being inclined with respect to a direction orthogonal to a movement direction of the straight-moving member, and the contact portion is configured to press the straight-moving member with respect to a wall surface of a staple accommodation portion accommodating the straight-moving member while moving the straight-moving member in the movement direction ([0084]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Kobayashi to modify the straight moving member and corresponding pushing element, so that the straight moving member has a curved surface taught by Marczyk, as it would be within the level of one of ordinary skill in the art, without undue experimentation, to employ different known mechanical mechanisms for delivering the staple into the patient’s tissue. Furthermore, Marczyk teaches that the curved surface allows for rotation of the pusher about a pivot member ([0084]), to efficiently rotatably deliver the staple in the desired direction and to achieve the desired surgical stapler facilitating the use of a small diameter tool assembly including staples capable of suturing thicker tissues ([0069]).
Claim(s) 11-13 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (US 2019/0167267; hereinafter Kobayashi) in view of Cropper et al. (US 2008/0296344; hereinafter Cropper).
Kobayashi shows the invention substantially as described in the 102 rejection above.
Kobayashi fails to show a flexible endoscope; and a suturing mechanism configured to attach a distal-end portion of the flexible endoscope. Also, wherein the grasping portion is attached to a cap that is attachable to a distal-end portion of a flexible endoscope.
Cropper discloses a surgical instrument for fastening tissue with a staple. Cropper teaches a flexible endoscope ([0026]-[0028]); and a suturing mechanism configured to attach a distal-end portion of the flexible endoscope ([0027]). Also, wherein the grasping portion is attached to a cap that is attachable to a distal-end portion of a flexible endoscope ([0026], [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Kobayashi to utilize an endoscope and a cap for attaching the suturing mechanism to the endoscope as taught by Cropper, as Cropper teaches that the endoscope and cap attachment allows for visual confirmation of staple placement ([0030]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (US 2019/0167267; hereinafter Kobayashi) in view of Cropper et al. (US 2008/0296344; hereinafter Cropper) as applied to claim 13 above, and further in view of Marczyk et al. (US 2017/0020524; hereinafter Marczyk).
Kobayashi shows the invention substantially as described in the 102 rejection above.
Kobayashi fails to show wherein the straight-moving member includes a planar portion in contact with the contact portion, and the contact portion includes a curved surface portion in contact with the planar portion; wherein the planar portion is an inclination surface being inclined with respect to a direction orthogonal to a movement direction of the straight-moving member, and the contact portion is configured to press the straight-moving member with respect to a wall surface of a staple accommodation portion accommodating the straight-moving member while moving the straight-moving member in the movement direction.
Marczyk discloses an endoscopic stapler. Marczyk teaches wherein the straight-moving member includes a planar portion in contact with the contact portion, and the contact portion includes a curved surface portion in contact with the planar portion ([0084]); wherein the planar portion is an inclination surface being inclined with respect to a direction orthogonal to a movement direction of the straight-moving member, and the contact portion is configured to press the straight-moving member with respect to a wall surface of a staple accommodation portion accommodating the straight-moving member while moving the straight-moving member in the movement direction ([0084]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Kobayashi and Cropper to modify the straight moving member and corresponding pushing element, so that the straight moving member has a curved surface taught by Marczyk, as it would be within the level of one of ordinary skill in the art, without undue experimentation, to employ different known mechanical mechanisms for delivering the staple into the patient’s tissue. Furthermore, Marczyk teaches that the curved surface allows for rotation of the pusher about a pivot member ([0084]), to efficiently rotatably deliver the staple in the desired direction and to achieve the desired surgical stapler facilitating the use of a small diameter tool assembly including staples capable of suturing thicker tissues ([0069]).
Response to Arguments
Applicant's arguments filed 9/25/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments that Kobayashi fails to teach a second rotation shaft, examiner respectfully disagrees. Kobayashi teaches the first grasping member and the second grasping member are connected by a second rotation shaft (fixed pulley 28; [0054]-[0058]).
Conclusion
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797