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.
Claims 14-17 are 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.
Regarding claim 12, “projecting the treatment target within a field of view showing the endoscope” is indefinite because it is unclear how this limitation is to be interpreted. How is the treatment target projected? Is the endoscope shown within the field of view? For examination purposes, “projecting the treatment target within a field of view showing the endoscope” is being interpreted to mean “moving the treatment target within a field of view surrounding the endoscope”.
Regarding claim 14, “until it rides on the first guide portion” is indefinite because it is unclear what “it” refers to. For examination purposes, “until it rides on the first guide portion” is being interpreted to mean “until the treatment tool rides on the first guide portion”.
Regarding claims 13 and 15-16, claims 13 and 15-16 are rejected because they depend from rejected claim 12.
Regarding claim 17, “the staple is ejected from the stapling head a plurality of times” is indefinite because it is unclear how the staple can be ejected more than one time if, while the staple is ejected, the staple is bent by coming in contact with pockets of the staple receiving portion (see for example Para. 0075 of Applicant’s specification). It is unclear how the staple can be ejected a plurality of times if the staple is bent and penetrates the tissue.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al (US 2020/0275925), hereinafter Smith.
Regarding claim 12, Smith discloses a suturing method comprising:
an insertion step (Para. 0042, 0051-0052) of inserting a medical stapler (Fig. 1, item 100) (Fig 2, item 200) and an endoscope (Fig. 2, item 250) into the body (Para. 0042, 0051-0052);
a grasping step (Para. 0042, 0051-0052) of grasping a treatment target (Para. 0052) inside the body with a treatment tool (Fig. 2, item 252, 254);
a retracting step (Para. 0042, 0051-0052) of retracting the treatment tool relative to the medical stapler (Para. 0042, 0051-0052) to draw in the treatment target to an endoscope side (Para. 0042, 0051-0052);
an observation step (Para. 0042, 0051-0052) of projecting the treatment target within a field of view (Para. 0042, 0051-0052) showing the endoscope (Para. 0042, 0051-0052); and
a suturing step (Para. 0042, 0051-0052) of ejecting a staple (Para. 0042, 0051-0052) from a stapling head (Fig. 2, item 201, 220, 222) of the medical stapler to suture a circumference of the treatment target (Para. 0042, 0051-0052).
Regarding claim 13, Smith discloses the suturing method according to claim 12, further comprising a first advancing step (Para. 0042, 0051-0052) of advancing the treatment tool with respect to the medical stapler (Para. 0042, 0051-0052) by causing the treatment tool to protrude from the endoscope (Para. 0042, 0051-0052).
Allowable Subject Matter
Claims 14-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 1-11 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the prior art of record fails to disclose, teach, or fairly suggest a medical stapler comprising: a stapling head including a staple ejection portion, the stapling head having a length in one direction; an anvil openably and closably coupled to the stapling head by a rotation shaft, the anvil having a length in one direction; a staple receiving portion provided in the anvil, the staple receiving portion being provided at a position facing the staple ejection portion when the stapling head and the anvil are in a closed state; and a first guide portion configured to be displaced to a protruding orientation or a retracted orientation, wherein in the protruding orientation, the first guide portion protrudes in a direction in which the anvil opens with respect to the stapling head when the anvil is in a closed state with respect to the stapling head, in the retracted orientation, the first guide portion does not protrude in the direction in which the anvil opens with respect to the stapling head when the anvil is in an open state with respect to the stapling head, and in the protruding orientation, the first guide portion is capable of lifting a treatment tool.
The prior art of record that comes closest to teaching these limitations is Smith et al (US 2020/0275925). Smith teaches a medical stapler comprising: a stapling head including a staple ejection portion, the stapling head having a length in one direction; an anvil openably and closably coupled to the stapling head by a rotation shaft, the anvil having a length in one direction; a staple receiving portion provided in the anvil, the staple receiving portion being provided at a position facing the staple ejection portion when the stapling head and the anvil are in a closed state; and a first guide portion configured to be displaced to a protruding orientation or a retracted orientation. However, Smith fails to teach wherein in the protruding orientation, the first guide portion protrudes in a direction in which the anvil opens with respect to the stapling head when the anvil is in a closed state with respect to the stapling head, in the retracted orientation, the first guide portion does not protrude in the direction in which the anvil opens with respect to the stapling head when the anvil is in an open state with respect to the stapling head, and in the protruding orientation, the first guide portion is capable of lifting a treatment tool. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Regarding claims 2-11, claims 2-11 are allowed because they depend from allowed claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERONICA MARTIN whose telephone number is (571)272-3541. The examiner can normally be reached Monday-Thursday 8:00-6:00.
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731