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 .
Disposition of Claims
Claims 1-15, 17-19, and 21-22 are pending.
Claims 10-14 are withdrawn.
Claims 15 and 17-19 are allowed.
Claims 16 and 20 are cancelled.
Election/Restrictions
Claim 15 is allowable. The restriction requirement between species AI and AII, as set forth in the Office action mailed on 10/27/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 10/27/2025 is partially withdrawn. Claim 19, directed to nonelected Species AII, is no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 10-14, directed to nonelected Species AII and nonelected Species BII-BIII, remain withdrawn from consideration because they do not require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment
The amendment filed on 4/13/2026 has been entered. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112b rejection previously set forth in the Non-Final Office Action mailed 1/14/2026.
Response to Arguments
Applicant’s arguments, see pages 9-11, filed 4/13/2026, with respect to the rejection under 35 USC § 102 of Claim 1, have been fully considered and are not persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims; however, a new ground of rejection is not necessitated.
The applicant argues that the amended claims overcome the current grounds of rejection. The applicant’s argument is on the grounds that Parker fails to disclose “wherein when the valve is in the first configuration … the valve fluidly isolates the first inlet and the second fluid outlet.” Examiner respectfully disagrees. Parker discloses operating the valve system in a first configuration in which air is directed along a first flow path to the first air outlet into the second air conduit 43 to generate pressure in the air space 42 of the reservoir 24 (paragraph 0052). Parker further discloses subsequently operating the valve system in a second configuration to establish a second flow path to the third air conduit 45 to a manifold connection 46 to the second fluid outlet to fluid conduits 51 (paragraph 0053). A person of ordinary skill in the art would understand that, during the first configuration, the second flow path must be prevented because otherwise the disclosed pressure-generation operation could not occur. Accordingly, the valve system, specifically second air outlet valve 44, prevents fluid communication between the first inlet into air inlet valve 37 to the second fluid outlet to fluid conduits 51 during the first configuration and therefore fluidly isolates the first inlet and the second outlet as claimed.
Please see section 35 U.S.C. § 102 below for further explanation
Applicant’s arguments, see page 11, 4/13/2026, with respect to the rejection under 35 USC § 102 of Claim 15 as anticipated by Parker have been fully considered and are persuasive.
The rejection under 35 USC § 102 of Claim 15 has been withdrawn.
Claim Objections
Claim 21 is objected to because of the following informalities:
In claim 21, line 1, “a container and tube set” should read “a container and a tube set”. This suggested modification would help prevent clarity issues arising from a lack of antecedent basis.
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.
Claims 21-22 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.
Claim 21 recites the limitation "the first air outlet" in line 15. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the first air outlet” is being interpreted as “the first gas outlet.”
Claim 22 is rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
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.
(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.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2013/0205720 A1 to Parker et al. (“Parker”).
Regarding claim 1, Parker discloses a container and tube set arranged and configured to couple to an endoscope for use in an endoscopic procedure (a reservoir pump 26 is associated with the reservoir 24 and is adapted to enable delivery of the disinfectant fluid 25 to connectors 31-34, each adapted for connection to a specific internal channel of the endoscope 10; Fig. 2, paragraph 0045), the container and tube set comprising:
a container configured to contain a fluid (a reservoir 24 is provided which, when the conditioning station 20 is in use, will contain a disinfectant fluid 25 comprising an aqueous solution of hydrogen peroxide, optionally having colloidal silver suspended therein; Fig. 2, paragraph 0045), the container having a bottom portion and a top portion (the reservoir 24 can be divided into a top and a bottom portion; Fig. 2);
a water supply tube including a first end, a second end, and a first lumen extending therethrough, wherein the first lumen is in selective fluid communication with the bottom portion of the container and the second end of the water supply tube is positioned external to the container (a first fluid conduit 47 also connects the reservoir 24 to the manifold 46, and as can be seen in Fig. 2, has an open end 48 submerged in the disinfectant fluid 25; Fig. 2, paragraph 0047);
a gas supply tube including a first end, a second end, and a second lumen extending therethrough, wherein the second lumen is in operative fluid communication with the top portion of the container and the second end of the gas supply tube is positioned external to the container (a first air outlet valve 41 of the valve system 38 is connected to an air space 42 at the top of the reservoir 24, via a second air conduit 43; Fig. 2, paragraph 0047);
a manifold (manifold 46 and valve system 38); Fig. 2) including a first inlet (first inlet into air inlet valve 37 of valve system 28; Fig. 2) for receiving air (a first conduit 36 connects the reservoir pump 26 to an air inlet valve 37 of a three-way valve system; Fig. 2, paragraph 0047), a second inlet (second inlet into manifold 46 from first fluid conduit 47; Fig. 2) for receiving fluid from the container (a first fluid conduit 47 also connects the reservoir 24 to the manifold 46, and as can be seen in Fig. 2, has an open end 48 submerged in the disinfectant fluid 25; Fig. 2, paragraph 0047), a first air outlet (first outlet of first air outlet valve 41 of the valve system 38; Fig. 2, paragraph 0052), and a second fluid outlet (second fluid outlet of manifold 46 into fluid conduits 51; further fluid conduits 51 from the manifold to fluid valves 52 associated with each of the connectors 31-14; Fig. 2, paragraph 0047), wherein the first air outlet is fluidly coupled to the second end of the gas supply tube (a first air outlet valve 41 of the valve system 38 is connected to an air space 42 at the top of the reservoir 24, via a second air conduit 43; Fig. 2, paragraph 0047) and the second inlet is fluidly coupled to the second end of the water supply tube (a first fluid conduit 47 also connects the reservoir 24 to the manifold 46, and as can be seen in Fig. 2, has an open end 48 submerged in the disinfectant fluid 25; Fig. 2, paragraph 0047); and
a valve positioned within the manifold, the valve movable between a first configuration and a second configuration to control an air flow path (3-way valve system 38; Fig. 2, paragraphs 0052-0053),
wherein when the valve is in the first configuration, the first inlet is in fluid communication with the first air outlet, and the second inlet is in fluid communication the second fluid outlet (the microprocessor 59 then controls operation of the reservoir pump 26, the inlet 37, and first outlet 41 of the three-way valve system 38, so as to force air into the air space 42 at the top of the reservoir 24. This pressurizes the air space 42, thus causing the disinfectant fluid 25 to flow through the manifold connection 46 to the fluid valves 52 associated with each of the channel connectors 31-34; Fig. 2, paragraph 0052), and the valve fluidly isolates the first inlet and the second fluid outlet (second outlet valve 44 is not operated during the first configuration; Fig. 2, paragraph 0052-0053); and
wherein when the valve is in the second configuration, the first inlet is in fluid communication with the second fluid outlet (the microprocessor 59 then operates the reservoir pump 26 again, this time in combination with the inlet 37 and second outlet 44 of the three-way valve system 38, so as to force air through the manifold connection 46 to the fluid valves 52; Fig. 2, paragraph 0053).
Regarding claim 2, Parker discloses the container and tube set according to claim 1. Parker further discloses wherein when the valve is in the first configuration, air is configured to flow from the first inlet to the first air outlet and into the container and fluid is configured to flow from the container into the second inlet and to the second fluid outlet (the microprocessor 59 then controls operation of the reservoir pump 26, the inlet 37, and first outlet 41 of the three-way valve system 38, so as to force air into the air space 42 at the top of the reservoir 24. This pressurizes the air space 42, thus causing the disinfectant fluid 25 to flow through the manifold connection 46 to the fluid valves 52 associated with each of the channel connectors 31-34; Fig. 2, paragraph 0052).
Regarding claim 3, Parker discloses the container and tube set according to claim 1. Parker further discloses wherein when the valve is in the second configuration air is configured to flow from the first inlet to the second fluid outlet (the microprocessor 59 then operates the reservoir pump 26 again, this time in combination with the inlet 37 and second outlet 44 of the three-way valve system 38, so as to force air through the manifold connection 46 to the fluid valves 52; Fig. 2, paragraph 0053).
Regarding claim 4, Parker discloses the container and tube set according to claim 1. Parker further discloses wherein the second fluid outlet is configured to be in fluid communication with one or more fluid channels of an endoscope (a reservoir pump 26 is associated with the reservoir 24 and is adapted to enable delivery of the disinfectant fluid 25 to the connectors 31-34, each adapted for connection to a specific internal channel of the endoscope 10; Fig. 2, paragraph 0045-0046).
Allowable Subject Matter
Claims 5-9 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 5, Parker discloses the container and tube set according to claim 1. However, Parker does not explicitly disclose further comprising a connecting channel extending between the gas supply tube and the water supply tube.
U.S. Patent Appl. Publ. No. 2005/0245789 A1 to Smith et al. teaches an endoscopic system with a manifold that comprises gas and air channels (a manifold 140 that directs air, water, and/or vacuum to the various tubes or lumens within the endoscope; Fig. 3G, paragraph 0098). However, Smith does not explicitly disclose further comprising a connecting channel extending between the gas supply tube and the water supply tube.
Regarding claim 7, Parker discloses the container and tube set according to claim 1. However, Parker does not explicitly disclose wherein the valve comprises a rotating disc.
U.S. Patent Appl. Publ. No. 2007/0270714 A1 to Cushner et al. teaches a manifold with a valve comprising a rotating disc (the valve device 410 may comprise a rotatable disc or other barrier defining a single aperture 411 that may be selectively aligned with one or more of the plurality of collection devices 100 arranged in a substantially circular pattern within the cylindrical manifold device 400; Fig. 4, paragraph 0046). Cushner does not teach a rotating disc valve that fluidly isolates a first inlet and a second fluid outlet. Therefore, one of ordinary skill in the art would not combine the teachings of Parker and Cushner to add a rotating disc valve into the valve system of Parker.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modified the above container and tube set to have the above features.
Claims 15 and 17-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 15, Examiner’s reasons for allowance of Claim 16, the subject matter which has been incorporate into Claim 15, are described in Para. 19 of the Non-Final Rejection, mailed 1/14/2026, and therefore not reproduced herein for the sake of brevity.
Claims 21-22 would be allowable if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 21, Parker discloses a manifold for a container and tube set configured to couple to an endoscope for use in an endoscopic procedure (manifold 46 and valve system 38); Fig. 2), the tube set comprising a gas supply tube and a water supply tube, the manifold comprising:
a first inlet (first inlet into air inlet valve 37 of valve system 28; Fig. 2) for receiving gas (a first conduit 36 connects the reservoir pump 26 to an air inlet valve 37 of a three-way valve system; Fig. 2, paragraph 0047);
a second inlet (second inlet into manifold 46; Fig. 2) for receiving fluid from the container (a first fluid conduit 47 also connects the reservoir 24 to the manifold 46, and as can be seen in Fig. 2, has an open end 48 submerged in the disinfectant fluid 25; Fig. 2, paragraph 0047);
a first gas outlet (first outlet of first air outlet valve 41 of the valve system 38; Fig. 2, paragraph 0052) configured to fluidly couple with the gas supply tube in fluid communication with a top portion of the container (a first air outlet valve 41 of the valve system 38 is connected to an air space 42 at the top of the reservoir 24, via a second air conduit 43; Fig. 2, paragraph 0047);
a second fluid outlet (second fluid outlet of manifold 46 into fluid conduits 51; Fig. 2) configured to fluidly couple with the water supply tube in fluid communication with a bottom portion of the container (a first fluid conduit 47 also connects the reservoir 24 to the manifold 46, and as can be seen in Fig. 2, has an open end 48 submerged in the disinfectant fluid 25; Fig. 2, paragraph 0047);
a first lumen extending between the first inlet and the first gas outlet (path between first inlet valve 37 and first outlet valve 41; Fig. 2);
a second lumen extending between the second inlet and the second fluid outlet (fluid flows between second inlet of manifold 46 to second fluid outlet of manifold 46 into fluid conduit 51; Fig. 2);
a valve, the valve movable between a first configuration and a second configuration to control an air flow path (3-way valve system 38; Fig. 2, paragraphs 0052-0053),
wherein when the valve is in the first configuration, the first air outlet is fluidly coupled to the first inlet (the microprocessor 59 then controls operation of the reservoir pump 26, the inlet 37, and first outlet 41 of the three-way valve system 38, so as to force air into the air space 42 at the top of the reservoir 24. This pressurizes the air space 42, thus causing the disinfectant fluid 25 to flow through the manifold connection 46 to the fluid valves 52 associated with each of the channel connectors 31-34; Fig. 2, paragraph 0052) and the second fluid outlet is fluidly coupled to the second inlet (second outlet valve 44 is not operated during the first configuration; Fig. 2, paragraph 0052-0053), and when the valve is in the second configuration, the second fluid outlet is fluidly coupled to the first inlet (the microprocessor 59 then operates the reservoir pump 26 again, this time in combination with the inlet 37 and second outlet 44 of the three-way valve system 38, so as to force air through the manifold connection 46 to the fluid valves 52; Fig. 2, paragraph 0053).
However, Parker does not explicitly disclose a connecting channel extending between the first lumen and the second lumen.
U.S. Patent Appl. Publ. No. 2005/0245789 A1 to Smith et al. teaches an endoscopic system with a manifold that comprises gas and air channels (a manifold 140 that directs air, water, and/or vacuum to the various tubes or lumens within the endoscope; Fig. 3G, paragraph 0098). However, Smith does not explicitly disclose further comprising a connecting channel extending between the first lumen and the second lumen.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modified the above container and tube set to have the above features.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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