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 as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1" and "2" have both been used to designate both the outer sleeve and sleeve seat. As shown in Fig. 1, the outer sleeve is “2” and the sleeve seat is “1”. Fig. 2 has been corrected, but this is a problem throughout the Drawings (see Figs. 3-5 and 7-10). The Examiner assumes that “1” is meant to designate the outer sleeve as this is consistent with the Specification.
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. 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 § 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 1-7 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.
The newly amended limitation to claim 1 uses the pronoun “it” where the use is unclear as to the exact part of the claimed device being referenced. Is the “it” the front end of the outer sleeve, just the sleeve, or some other feature. The Examiner assumes this is in reference to the front end, but pronouns often create ambiguity in claims, as is the case here. Appropriate correction is required.
Claim 1 also refers to “the bloody water”. While this is not a structural limitation of the claim, there is no antecedent basis for the term. Appropriate correction is required.
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 1-5 and 7 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Karasawa et al. (US 5,575,756).
Regarding Claim 1, Karasawa discloses:
A fluid-assisted minimally-invasive surgery visualization device (numerous embodiments read on the claims, the Examiner is focusing on Fig. 20 unless stated otherwise), comprising
an outer sleeve assembly (120 in Fig. 20),
an imaging module (endoscope 72 includes an imaging module with a cover glass 75 protecting the optics; shown in Fig. 8 and described in Col 11 Lines 6-11),
an imaging module support body (inserting section 72) and
a water delivery pipe (shown extending from 135 in Fig. 20; see Col 15 Lines 56-63);
wherein the outer sleeve assembly comprises
an outer sleeve (121 in Fig. 20) and
a sleeve seat (123 in Fig. 20),
a water supply cavity (124 in Fig. 20) in communication with a rear end of the outer sleeve is provided inside the sleeve seat, and the water supply cavity is further in communication with the water delivery pipe (see Fig. 20 showing the delivery pipe connected to the seat to deliver water to the proximal end of the assembly);
the imaging module is supported on the outer sleeve assembly by the imaging module support body (shown in Fig. 20 in that the distal end of 72 includes the imaging module and is held by the insertion portion), the imaging module is accommodated in the outer sleeve (shown in Fig. 20 with the module inserted into the outer sleeve 121), and one segment of clear water cavity is formed between a front end surface of the outer sleeve and a lens of the imaging module (space 126, see Fig. 20);
wherein when the front end of the outer sleeve approaches a tissue surface, the clear water inside it flushes away the bloody water to make the tissue surface clearly observable (functional limitation, Karasawa’s device includes a water feed means to clean debris and bloody water away from the lens to make the target clearly observable; see Col 16 Lines 5-6).
Regarding Claim 2, Karasawa further discloses wherein the outer sleeve and the sleeve seat are of integral structure or of split structure (see Fig. 20 showing the portions 121 and 123 being integral).
Regarding Claim 3, Karasawa further discloses wherein the imaging module support body is supported on the outer sleeve or on the sleeve seat (see Fig. 20 showing the support body 72 supported on the sleeve seat at the proximal end of the assembly).
Regarding Claim 4, Karasawa further discloses wherein the imaging module support body is a rod body (72 is a rod body in that it is a cylindrical rod-shaped element), or a support bracket, or a hard wire body, or a cooperative structure of rod body and support bracket.
Regarding Claim 5, Karasawa further discloses wherein the imaging module support body is a rod body (72 is a rod body in that it is a cylindrical rod-shaped element), a rear end of the rod body is supported on a rear part of the sleeve seat (see Fig. 20 showing at least a portion of 72 being supported on a portion of the seat 123 that is proximal to the distalmost end of the seat; the Examiner also notes that several embodiments disclose a configuration nearly identical to Applicant’s in this regard including the one in Fig. 1 and Fig. 58), a first through hole is disposed at a part of the sleeve seat located behind the water supply cavity (see Fig. 20 showing the insertion portion 72 extending through a proximal hole that is proximal to the water supply cavity), and the rod body is supported and mounted at the rear part of the sleeve seat by the first through hole (shown in Fig. 20).
Regarding Claim 7, Karasawa further discloses wherein a water supply hole (128) in communication with the water supply cavity is disposed on a wall of the sleeve seat (see Fig. 20); and the water supply hole is connected with the water delivery pipe (shown in Fig. 20 with the supply pipe connecting to 128).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Karasawa et al. (US 5,575756) in view of Miyamoto (US 2012/0046524).
Karasawa discloses the invention substantially as claimed as stated above, but does not explicitly disclose wherein all or part of the outer sleeve is a flexible pipe. Flexible overtubes are common and well-known in the art. Miyamoto discloses one such cleaning tube 9 (see Fig. 1A and Paragraph 0050 describing the flexible material) for attaching to an endoscope. Making the overtube flexible allows the tube to be attached to a flexible endoscope such that the two can advance tortuous body passages. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s sleeve to be flexible as taught by Miyamoto. Such a modification allows for the tube and an inserted scope to be flexible so that they can navigate tortuous body passages as is known in the art.
Response to Arguments
Applicant's arguments filed April 15, 2026, have been fully considered but they are not persuasive.
The Drawing objection is maintained. The Examiner mentioned Figs. 1 and 2, but this is a problem throughout the Drawings.
Applicant makes several points about how the current invention differs from the prior art. The Examiner notes that even assuming that these arguments are true, the claims do not overcome the prior art. The newly amended features do not further limit the structure. Karasawa’s device is designed to remove debris, including blood, from the front. Applicant’s arguments as to how this is done are not relevant because such features are not in the claims.
The Examiner also notes that looking at Applicant’s disclosure, in particular Figs. 1-2, the disclosed device is simply an overtube with a fluid port and space for inserting an endoscope. Structurally, this is pretty common in the art. There isn’t much there to distinguish over other sheath and endoscope combinations.
The application is not in condition for allowance at this time.
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 TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/Primary Examiner, Art Unit 3795
