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 .
Notice of Amendment
The Amendment filed 6/5/2026 has been entered. Claims 1-15, 18-20 are pending in the application with claims 1, 13, 14, 18, 20 amended, claims 7-9 withdrawn, claims 16, 17 cancelled.
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 20 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 20 recites the limitation "the first portion" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6, 10, 13-15, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saiga et al. (US Patent Application Publication No. 2021/0076910, hereinafter Saiga).
In regard to claim 1, Saiga discloses a medical device (10, Fig. 7), comprising:
a suction valve set (10, Figs. 11,16,19) including a working channel valve (102,103,105) configured to be inserted into a working channel of valve well (8) and control flow through the working channel (61) of a valve well, a balloon channel (65) of the valve well, and an atmospheric channel (via channel extending through body (105) shown in Figs. 7,9), the working channel valve (102,103,105) comprising a valve body (105) with a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, and one or more channels comprising the atmospheric channel extending through the valve body between an opening in the proximal end of the valve body (the proximal end of the valve body (105) defines an open end) and a first port in the outer surface of the valve body (via gap along an outer surface of the valve body (105) between adjacent legs of the valve body, wherein suction is applied to the leak hole (1021a) from the suction channel (68) through the valve body, Figs. 7,9); and
a valve interface mechanism (104) operable to move the working channel valve between a first state (Fig. 7), a second state (Fig. 12), and a third state (Fig. 14), the first state comprising the working channel valve configured to place a suction channel (68) of the valve well in fluid communication with the atmospheric channel (Fig. 7), the second state comprising the working channel valve configured to place the suction channel in fluid communication with the working channel (Fig. 12), and the third state comprising the working channel valve configured to place the suction channel in fluid communication with the balloon channel (Fig. 14).
In regard to claim 2, Saiga teaches the valve interface mechanism, in the first state, configured to position a first portion of the one or more channels in fluid communication with the atmospheric channel and a second portion of the one or more channels in fluid communication with the suction channel (Fig. 7).
In regard to claim 3, Saiga teaches the valve interface mechanism, in the second state, configured to position a first portion of the one or more channels in fluid communication with the suction channel and a second portion of the one or more channels in fluid communication with the working channel (Fig. 12).
In regard to claim 4, Saiga teaches the valve interface mechanism, in the second state, configured to position the outer surface of the valve body to block flow through the atmospheric channel (Fig. 12).
In regard to claim 5, Saiga teaches the valve interface mechanism, in the third state, configured to position the outer surface of the valve body to block flow through the working channel (Fig. 14).
In regard to claim 6, Saiga teaches the valve interface mechanism, in the second state, configured to position the outer surface of the valve body to block flow through the atmospheric channel (Fig. 12).
In regard to claim 10, Saiga teaches wherein the valve interface mechanism, in the first state, is configured to position the outer surface of the valve body to block flow through the working channel (Fig. 7).
In regard to claim 13, Saiga teaches wherein the working channel valve comprises a second port extending through the outer surface and to a bottom of the working channel valve (via a different gap formed between legs of the valve body that opens to both the top and bottom of the valve body, Figs. 7,9).
In regard to claim 14, Saiga wherein the first port is spaced from the bottom of the working channel valve (Fig. 9).
In regard to claim 15, Saiga wherein the first port diametrically opposes the second port (Fig. 9 wherein the ports are circumferentially spaced apart).
In regard to claim 18, Saiga discloses a valve assembly (10, Fig. 7), comprising:
a valve well (8, Fig. 7) comprising a working channel (61), a balloon channel (65), and a suction channel (68);
a suction valve set (10, Figs. 11,16,19) including a working channel valve (102,103,105) configured to be inserted into a working channel of valve well (8) and control flow through the working channel (61) of a valve well, a balloon channel (65) of the valve well, and an atmospheric channel (via channel extending through body (105) shown in Figs. 7,9), the working channel valve (102,103,105) comprising a valve body (105) with a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, and one or more channels comprising the atmospheric channel extending through the valve body between an opening in the proximal end of the valve body (the proximal end of the valve body (105) defines an open end) and a first port in the outer surface of the valve body (via gap along an outer surface of the valve body (105) between adjacent legs of the valve body, wherein suction is applied to the leak hole (1021a) from the suction channel (68) through the valve body, Figs. 7,9); and
a valve interface mechanism (104) operable to move the working channel valve between a first state (Fig. 7), a second state (Fig. 12), and a third state (Fig. 14), the first state comprising the working channel valve configured to place a suction channel (68) of the valve well in fluid communication with the atmospheric channel (Fig. 7), the second state comprising the working channel valve configured to place the suction channel in fluid communication with the working channel (Fig. 12), and the third state comprising the working channel valve configured to place the suction channel in fluid communication with the balloon channel (Fig. 14).
In regard to claim 20, Saiga teaches wherein the working channel valve comprises: a second port extending through the outer surface and to a bottom of the working channel valve (via a different gap formed between legs of the valve body that opens to both the top and bottom of the valve body, Figs. 7,9), and the first portion is spaced from the bottom of the working channel valve (Fig. 9).
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:
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 11, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Saiga et al. (US Patent Application Publication No. 2021/0076910, hereinafter Saiga) in view of Ouchi et al. (US Patent No. 4,325,362, hereinafter Ouchi).
In regard to claims 11, 12 and 19, Saiga fails to teach wherein the working channel valve is configured to be rotated to transition between the first state, the second state, and the third state, wherein the valve interface mechanism is configured to translate a linear input acting on the working channel valve into rotation of the working channel valve to transition the working channel valve between the first state, the second state, and the third state.
Ouchi teaches an analogous endoscope valve (20, Figs. 6-11) configured to transition between four configurations (Figs. 7-10) allowing for different flow states of the valve. Ouchi further teaches that transitioning between the four configurations of the valve is accomplished through rotation of adjusting member (280) thereby aligning outlets (27a-27c) with grooves (290a-290d), Figs. 7-10. Ouchi further teaches a piston (30) that engages with grooves (221a-221d) which are positioned to be associated with the outlets (27a-27c) and grooves (290a-290d) providing tactile feedback between each of the four configurations of the valve (Fig. 6).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the suction valve of Saiga to transition between flow states of the valve via rotation as taught by Ouchi as a matter of design choice for transitioning between different flow states of the valve while further providing the user with tactile feedback when the transition between each flow state has been achieved.
Response to Arguments
Applicant’s arguments with respect to claims 1-6, 10-15, 18-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Comments
In order to advance prosecution, the examiner suggests amending Claims 1 and 18 to include the features of Claims 13 and 20 and further defining the function of the second port.
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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 July 18, 2026
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