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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a container and tube set, in the reply filed on 12/19/2025 is acknowledged.
Applicant’s election without traverse of Species AI: Figures 6A-B in the reply filed on 12/19/2025 is acknowledged.
Applicant’s election without traverse of Species BI: Figures 8A-B in the reply filed on 12/19/2025 is acknowledged.
Claims 10-14 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group I, nonelected Species AII, and nonelected Species BII-BVII, there being no allowable generic or linking claim.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “680” has been used to designate both the fluid reservoir and the cap in Fig. 8B.
The drawings are objected to under 37 CFR 1.84(t). The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in 37 CFR 1.84(g).
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
Claims 1-3 and 15 are objected to because of the following informalities:
In claim 1, lines 19-20, “the second inlet is in fluid communication the second fluid outlet” should read ““the second inlet is in fluid communication with the second fluid outlet”
In claim 2, lines 1-2, “when the valve is in the first configuration air is configured” should read “when the valve is in the first configuration, air is configured”
In claim 3, lines 1-2, “when the valve is in the second configuration air is configured” should read “when the valve is in the second configuration, air is configured”
In claim 15, line 23, “in fluid communication the third lumen” should read “in fluid communication with the third lumen”
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 15-19 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 15 recite the limitation "the gas supply tube" in line 12. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the gas supply tube” is being interpreted as “the first gas supply tube.”
Claim 15 recite the limitation "the water pickup tube" in line 23. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the water pickup tube” is being interpreted as “the water supply tube.”
Claims 16-19 are 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.
Claims 1-4 and 15 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 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 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 41; Fig. 2, paragraph 0052), and a second fluid outlet (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
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).
Regarding claim 15, 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 manifold (manifold 46 and valve system 38); Fig. 2);
a lens wash supply tube including a first end coupled to the manifold, a second end, and a first lumen extending therethrough (further fluid conduits 51 then lead from the manifold to fluid valves 52 associated with each of the connectors 31-34; Fig. 2, paragraph 0047), wherein the first lumen is in fluid communication with the manifold and the second end of the lens wash supply tube is configured for connection to an endoscopic system (a water channel connector 32 for connection to the water channel of the endoscope 10; Fig. 2, paragraph 0046);
a first gas supply tube including a first end coupled to the manifold, a second end, and a second lumen extending therethrough, wherein the second lumen is in fluid communication with the manifold and the second end of the gas supply tube is configured for connection to an endoscopic system (a first air conduit 36 connects the reservoir pump 26 to an air inlet valve 37 of a three-way valve system 38; Fig. 2, paragraph 0047);
a water supply tube including a first end, a second end coupled to the manifold, and a third lumen extending therethrough, wherein the third lumen is in fluid communication with the manifold and with the 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 second gas supply tube including a first end, a second coupled to the manifold, and a fourth lumen extending therethrough, wherein the fourth lumen is in fluid communication with the manifold and with the 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; Fig. 2, paragraph 0047); and
a valve positioned within the manifold, the valve movable between a first configuration and a second configuration (3-way valve system 38; Fig. 2, paragraphs 0052-0053);
wherein when the valve is in the first configuration, the first lumen of the lens wash supply tube is in fluid communication the third lumen of the water supply tube, and the second lumen of the first gas supply tube is in fluid communication with the fourth lumen of the second gas supply tube (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
wherein when the valve is in the second configuration, the first lumen of the lens wash supply tube is in fluid communication with the second lumen of the first gas supply tube (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).
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.
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.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of U.S. Patent Appl. Publ. No. 2007/0270714 A1 to Cushner et al. (“Cushner”).
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.
Cushner 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 is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with a manifold comprising a valve. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the valve of Parker with the rotating disc valve of Cushner, because the substitution of art recognized equivalents as shown by Cushner is within the level of ordinary skill in the art. In addition, the substitution of one valve for another is likely to be obvious when it does no more than yield predictable results.
Regarding claim 18, Parker discloses the container and tube set according to claim 15. However, Parker does not explicitly disclose wherein the valve comprises a rotating disc.
Cushner 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).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted valve of Parker with the rotating disc valve of Cushner, because the substitution of art recognized equivalents as shown by Cushner is within the level of ordinary skill in the art. In addition, the substitution of one valve for another is likely to be obvious when it does no more than yield predictable results.
Allowable Subject Matter
Claims 5-6, 8-9, and 16-17 are 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 8, Parker, as modified by Cushner, discloses the container and tube set according to claims 1 and 7. However, neither Parker nor Cushner discloses wherein in the first configuration, the rotating disc is configured to fluidly isolate the gas supply tube and the water supply tube.
Regarding claim 9, Parker, as modified by Cushner, discloses the container and tube set according to claims 1 and 7. However, neither Parker nor Cushner discloses wherein in the second configuration, the rotating disc is configured to block a flow of gas from the gas supply tube to the container and to block a flow of fluid from the container
Regarding claim 16, Parker discloses the container and tube set according to claim 15. 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 teach further comprising a connecting channel extending between the gas supply tube and the water supply tube.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2013/0098400 A1 to Nguyen et al. teaches an endoscopic system with a manifold configured to allow sterilant and then air into the endoscope channels as described in Fig. 5 and the corresponding 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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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