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 .
Election/Restrictions
Applicant’s election without traverse of Species I, Figures 1-8, in the reply filed on 5/26/2026 is acknowledged.
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II-III, there being no allowable generic or linking claim. Although Claims 6-7 were recommended as drawn to Species I in the Restriction Requirement mailed 3/25/2026, claims 6-7 are properly classified under nonelected Species II. Claim 6 recites a plurality of slits and Claim 7 recites a cluster of intersecting slits, both of which are exclusive to Species II, Figures 9-21. Therefore, at this time, Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “48” has been used to designate both “a camera 48” and “a tip 48 of the tubing 36” in Fig. 1 and paragraph 0055 of Applicant’s 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 Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, “inner periphery” should read “the inner periphery”
Appropriate correction is required.
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 flaps" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the flaps” is being interpreted as “the plurality of flaps.”
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0187756 A1 to Maurice (“Maurice”) in view of U.S. Patent Appl. Publ. No. 2019/0350441 A1 to Saiga (“Saiga”).
Regarding claim 1, Maurice discloses a bifluidic valve (a gas/water valve 230; Fig. 3, paragraph 0049) for use in an endoscope (endoscopic system 100; Fig. 1, paragraph 0400), the bifluidic valve being configurable selectively to an insufflating configuration and an irrigating configuration (the gas/water valve 230 is primarily used to control gas delivery from the gas supply system to insufflate lumens within the GI tract and also to control fluid delivery from the water supply system for optical lens cleaning; paragraph 0050), the bifluidic valve comprising:
a valve housing with an inner surface at least partially defining a housing interior (receiving cylinder 250; Fig. 3, paragraph 0051), the valve housing at least partially defining a gas inlet and a gas outlet (the receiving cylinder has a gas inlet 252, and a gas outlet 254; Fig. 3, paragraph 0051);
a valve spool being elongate to define an axial direction (valve stem 240; Fig. 3, paragraph 0051), the valve spool extending into the housing interior (valve stem 240 extends into receiving cylinder 250; Fig. 3), the valve spool and the inner surface defining an annular gap therebetween (space between valve stem 240 and receiving cylinder 250; Fig. 2A-3); and
a valve seal extending across the annular gap in a radial direction between the valve spool and the inner surface (the gas/water valve 230 includes … a second sealing member 264 … disposed about a valve stem 24; Fig. 3, paragraph 0051), the valve seal is resiliently flexible between a deformed shape and a more relaxed shape, the valve seal being in the deformed shape when the bifluidic valve is in the insufflating configuration to connect the gas inlet in fluid communication with the gas outlet (when the vent 343 is digitally covered by a user’s finger U, the space between the receiving cylinder 250 and the valve stem 240 begins to pressurize, and the deformable second sealing member 264 on the valve stem 240 intentionally deforms, allowing the gas to be redirected through the primary radial passageway 244, past the deformable second sealing member 264 and out of the receiving cylinder 250 via the gas port 254 to the distal end of the flexible shaft; Fig. 2B, paragraph 0057), the valve seal being in the more relaxed shape when the bifluidic valve is in the irrigating configuration to block fluid communication between the gas inlet and the gas outlet (when the gas/water valve 230 is depressed, the gas is prevented from entering the receiving cylinder 250 and it is redirected to the water supply system … which begins to pressurize and force fluid (i.e. sterile water) to flow from the water supply system, through the endoscope umbilical to the water inlet port 256 of the gas/water valve 230, through the inner volume of the receiving cylinder 250 … to the water outlet port 258, and to the distal end of the flexible shaft; Fig. 2C, paragraph 0062).
However, Maurice does not explicitly disclose wherein the valve seal comprising a plurality of flaps that are resiliently flexible between a deformed shape and a more relaxed shape.
Saiga teaches a bifluidic valve (air/water supply button 9; Fig. 5, paragraph 0116) comprising a valve seal extending across the annular gap in a radial direction between the valve spool and the inner surface (the seal member 912 has … protrusion portions 9122; Fig. 5, paragraph 0114), the valve seal comprising a plurality of flaps (thin portions 9122d; Fig. 11, paragraph 0116) that are resiliently flexible between a deformed shape and a more relaxed shape (in the exposed portion 9122b, at least the thin portion 9122d is deformed by a change in an air pressure; Fig. 11, paragraph 0116), the plurality of flaps being in the deformed shape when the bifluidic valve is in the first configuration to connect the gas inlet in fluid communication with the gas outlet (in the case where the leak hole 9522 is closed by a finger, an air pressure in the first hole portion 9111 increases, and the check valve 9122 is deformed to the main body portion 911 side, and a space between the check valve 9122 and the first member 92 is opened; Fig. 42, paragraph 0162), the plurality of flaps being in the more relaxed shape when the bifluidic valve is in the irrigating configuration to block fluid communication between the gas inlet and the gas outlet (protrusion portion 9122 seals the gap in the relaxed configuration; Fig. 5, paragraph 0116).
Saiga is considered to be analogous to the claimed invention because it is in the same field of biofluidic valves for an endoscope. 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 bifluidic valve of Maurice to incorporate the teachings of Saiga by using a valve seal with a plurality of flaps. It would have been obvious to one of ordinary skill in the art at the time of the invention to replace the valve seal of Maurice with the valve seal of Saiga as it is merely the selection of functionally equivalent one-way valve seals recognized in the art and one of ordinary skill in the art would have a reasonable expectation of success in doing so.
Regarding claim 2, Maurice, as previously modified by Saiga, discloses the bifluidic valve according to claim 1. Maurice, as modified by Saiga, further discloses wherein the valve seal includes an inner periphery and an outer periphery (inner periphery and outer periphery as indicated in annotated Fig. 2A below; Fig. 2A), inner periphery is attached to the valve spool (the gas/water valve 230 includes … a second sealing member 264 … disposed about a valve stem 24; Fig. 3, paragraph 0051), the outer periphery is spaced apart from the inner surface when the plurality of flaps are in the deformed shape (the outer periphery of the second sealing member 264 is spaced apart from the inner surface of the receiving cylinder 250; Fig. 2B), and the outer periphery engages the inner surface when the flaps are in the more relaxed shape (the outer periphery of the second sealing member 264 engages with the inner surface of the receiving cylinder 250; Fig. 2A).
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Regarding claim 4, Maurice, as previously modified by Saiga, discloses the bifluidic valve according to claim 1. Maurice, as modified by Saiga, further discloses wherein the valve housing at least partially defines a liquid inlet and a liquid outlet (the receiving cylinder has … a water inlet 256, and a water outlet 258; Fig. 2A, paragraph 0051), the valve spool is movable in the axial direction relative to the valve housing between a home position and a depressed position (the gas/water valve 230 is configured to maintain any one of three functional configurations when disposed in the receiving cylinder 250 (i.e. open, covered, and depressed); Fig. 2A-2C; paragraph 0055), the valve spool in the depressed position configures the bifluidic valve to the irrigating configuration to establish fluid communication between the liquid inlet and the liquid outlet (when the gas/water valve 230 is depressed, the gas is prevented from entering the receiving cylinder 250 and it is redirected to the water supply system … which begins to pressurize and force fluid (i.e. sterile water) to flow from the water supply system, through the endoscope umbilical to the water inlet port 256 of the gas/water valve 230, through the inner volume of the receiving cylinder 250 … to the water outlet port 258, and to the distal end of the flexible shaft; Fig. 2C, paragraph 0062), the valve spool in the home position obstructs fluid communication between the liquid inlet and the liquid outlet (the fourth sealing member 268 is disposed and configured to prevent or allow water flow for lens cleaning based upon the configuration of the gas/water valve 230; Fig. 2A-2B, paragraph 0053), and the valve seal moves in the axial direction with the valve spool as the valve spool moves between the home position and the depressed position (the gas/water valve 230 can be transitioned to the third configuration when the gas/water valve 230 is depressed by the user’s fingers, as depicted by the arrows AA in Fig. 2C; Fig. 2C, paragraph 0062).
Regarding claim 5, Maurice, as previously modified by Saiga, discloses the bifluidic valve according to claims 1 and 4. Maurice, as modified by Saiga, further discloses wherein the valve spool at least partially defines a vent that can be selectively covered and uncovered manually (vent 242; Fig. 2A-2C, paragraph 0056), the vent when uncovered connects the gas inlet in fluid communication with atmosphere (when the gas/water valve 230 is in use, the first configuration allows gas to pass from the control unit, through the gas inlet port 252, into a central location within the receiving cylinder 250 between the second sealing member 264 and the third sealing member 266, into the primary radial passageway 244, through the primary axial passageway 243 and exits the gas/water valve 230 to the atmosphere through the vent 242 in the center of the gas/water valve 230; Fig. 2A, paragraph 0056), the vent when covered blocks fluid communication between the gas inlet and the atmosphere (the user can transition the gas/water valve 230 from the first configuration to the second configuration by obstructing the vent 242 in the center of the gas/water valve 230 such that gas cannot flow out to the atmosphere; Fig. 2B, paragraph 0057), and the bifluidic valve is configured in a vented configuration when the vent is uncovered while the valve spool is in the home position (Fig. 2A; paragraph 0056).
Allowable Subject Matter
Claim 3 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, Maurice, as previously modified by Saiga, discloses the bifluidic valve according to claim 1. Saiga teaches wherein the plurality of flaps are distributed in a circular pattern around the valve spool (Fig. 11). However, Maurice and Saiga fail, alone or in combination, do not explicitly disclose wherein each flap of the plurality of flaps includes an inlet edge and an outlet edge, the inlet edge of each flap overlies the outlet edge of an adjacent flap of the plurality of flaps, the inlet edge of each flap is exposed to the gas inlet, the outlet edge of each flap is exposed to the gas outlet, the plurality of flaps are in overlapping sliding contact with each other at the inlet and outlet edges to facilitate the plurality of flaps flexing between the deformed shape and the more relaxed shape.
U.S. Patent Appl. Publ. No. 2019/0232041 A1 to Spohn et al. teaches a valve seal (cylindrical flange members 240a, 240b; Fig. 28-29, paragraph 0139) comprising a plurality of flaps that are resiliently flexible between a deformed shape and a more relaxed shape (only resilient flaps 241 are illustrated, shown in the undeflected state, which deflect when subjected to fluid pressure above the deflection flow force threshold; Figs. 28-29).
Sophn fails to explicitly teach each flap of the plurality of flaps includes an inlet edge and an outlet edge, the inlet edge of each flap overlies the outlet edge of an adjacent flap of the plurality of flaps, the inlet edge of each flap is exposed to the gas inlet, the outlet edge of each flap is exposed to the gas outlet, the plurality of flaps are in overlapping sliding contact with each other at the inlet and outlet edges to facilitate the plurality of flaps flexing between the deformed shape and the more relaxed shape.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modify the above endoscope to have the above features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2020/0375434 A1 to Scutti et al. teaches an endoscope with a combined air/water valve in the abstract and following descriptive text.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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