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 .
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, 9, and 16 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Pollock et al (WIPO Application Publication WO2022/140443, hereinafter “Pollock”). Regarding claim 1, Pollock teaches a container and tube set arranged and configured to couple to an endoscope for use in an endoscopic procedure, the container and tube set comprising:
a first container (figure 14b element 1437-2) configured to contain a fluid
the first container having a port (figure 14b circled below) in fluid communication with a bottom portion thereof
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a first water supply tube including a first end (figure 14b circled above), a second end (figure 14b pointed at to by arrow above), and a first lumen (figure 14b space inside 1445c) extending therethrough, wherein the first lumen is in fluid communication with the first container (first lumen is connected without blockage to the first container) and the second end of the first water supply tube is positioned external to the first container (second end is not within element 1437-2 shown above)
a branched connector (figure 14b circled below) positioned in line with the first water supply tube between the first and second ends thereof, the branched connector including a first fluid inlet, a first fluid outlet, and a second fluid outlet, a portion of the first lumen of the first water supply tube extending between the first fluid inlet and the first fluid outlet (1445c extends between the first fluid inlet and outlet)
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a second container (figure element 1437-1) configured to contain a fluid, the second container having a second fluid inlet (figure 14b labeled above) in selective fluid communication with the second fluid outlet of the branched connector (second fluid inlet and second fluid outlet have no structures blocking fluid transfer between them)
a second water supply tube including a first end, a second end, and a second lumen extending therethrough (figure 14b all labelled below, with second lumen being the space within element 1433), wherein the second lumen is in selective fluid communication with the bottom portion of the second container and the second end of the second water supply tube is positioned external to the second container (second end is connected to the first container, outside of the second container)
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a flow control valve (figure 14b element 1499b labelled above) in fluid communication with the second water supply tube, the flow control valve configured to obstruct flow through the second water supply tube when water pressure at the flow control valve is below a threshold pressure (paragraph 133 details check valve and flow obstruction).
Regarding claim 9, Pollack teaches a container and tube set arranged and configured to couple to an endoscope for use in an endoscopic procedure, the container and tube set comprising:
a first container (figure 14b element 1437-2) configured to contain a fluid
the first container having a port (figure 14b circled below) in fluid communication with a bottom portion thereof
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a first water supply tube including a first end (figure 14b circled above), a second end (figure 14b pointed at to by arrow above), and a first lumen (figure 14b space inside 1445c) extending therethrough, wherein the first lumen is in fluid communication with the first container (first lumen is connected without blockage to the first container) and the second end of the first water supply tube is positioned external to the first container (second end is not within element 1437-2 shown above)
a branched connector (figure 14b circled below) positioned in line with the first water supply tube between the first and second ends thereof, the branched connector including a first fluid inlet, a first fluid outlet, and a second fluid outlet, a portion of the first lumen of the first water supply tube extending between the first fluid inlet and the first fluid outlet (1445c extends between the first fluid inlet and outlet)
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a second container (figure element 1437-1) configured to contain a fluid, the second container having a second fluid inlet (figure 14b labeled above) in selective fluid communication with the second fluid outlet of the branched connector (second fluid inlet and second fluid outlet have no structures blocking fluid transfer between them)
a second water supply tube including a first end, a second end, and a second lumen extending therethrough (figure 14b all labelled below, with second lumen being the space within element 1433), wherein the second lumen is in selective fluid communication with the bottom portion of the second container and the second end of the second water supply tube is positioned external to the second container (second end is connected to the first container, outside of the second container)
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a first gas supply tube including a first end, a second end, and a third lumen extending therethrough (figure 14b all labelled below, with third lumen being the cavity within element 1440c), wherein the third lumen is in operative fluid communication with the second container and the second end of the first gas supply tube is positioned external to the second container
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and a flow control valve (figure 14b element 1499b above) in fluid communication with the second water supply tube and the first gas supply tube (the flow control valve 1499b and gas supply tube have no fluid blocking structures between them), the flow control valve configured to obstruct flow through the second water supply tube when water pressure at the flow control valve is below a threshold pressure
Regarding claim 16, Pollack teaches a container and tube set arranged and configured to couple to an endoscope for use in an endoscopic procedure, the container and tube set comprising:
a first container (figure 14b element 1437-2) configured to contain a fluid
the first container having a port (figure 14b circled below) in fluid communication with a bottom portion thereof
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a first water supply tube including a first end (figure 14b circled above), a second end (figure 14b pointed at to by arrow above), and a first lumen (figure 14b space inside 1445c) extending therethrough, wherein the first lumen is in fluid communication with the first container (first lumen is connected without blockage to the first container) and the second end of the first water supply tube is positioned external to the first container (second end is not within element 1437-2 shown above)
a branched connector (figure 14b circled below) positioned in line with the first water supply tube between the first and second ends thereof, the branched connector including a first fluid inlet, a first fluid outlet, and a second fluid outlet, a portion of the first lumen of the first water supply tube extending between the first fluid inlet and the first fluid outlet (1445c extends between the first fluid inlet and outlet)
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a second container (figure element 1437-1) configured to contain a fluid, the second container having a second fluid inlet (figure 14b labeled above) in selective fluid communication with the second fluid outlet of the branched connector (second fluid inlet and second fluid outlet have no structures blocking fluid transfer between them)
a second water supply tube including a first end, a second end, and a second lumen extending therethrough (figure 14b all labelled below, with second lumen being the space within element 1433), wherein the second lumen is in selective fluid communication with the bottom portion of the second container and the second end of the second water supply tube is positioned external to the second container (second end is connected to the first container, outside of the second container)
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a flow control valve (figure 14b element 1499b labelled above) in fluid communication with the second water supply tube, the flow control valve configured to obstruct flow through the second water supply tube when water pressure at the flow control valve is below a threshold pressure (paragraph 133 details check valve and flow obstruction).
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.
Claims 2-4, 10, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pollack in view of Reddy et al (U.S Patent Application Publication 2019/0091434, hereinafter “Reddy”). The disclosure of Reddy is directed towards respirators. This art is considered analogous to the containers and tubing of the claimed invention due to respirators also dealing with pressure differentials affecting fluid flow between spaces. Regarding claim 2, while Pollack teaches the limitations of claim 1, it fails to teach a container and tube set wherein the flow control valve comprises a cross slit disk within a valve housing. Reddy teaches a container and tube set wherein the flow control valve comprises a cross slit disk (paragraph 82 “valve with a cross-slit”) within a valve housing. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the cross slit valve of Reddy in order to allow for a higher rate of flow through the valve, as cross slits offer high volume and flow capacity as well as self-sealing capability when the required pressure differential is not reached. These advantages allow for a wider range of output fluid pressures to be incorporated into the endoscopic procedure, allowing for pressure adjustments to perform the intended therapy without injuring the patient.
Regarding claim 3, Pollack fails to teach a container and tube set wherein the cross slit disk is made of a flexible material, the valve housing is made of a rigid material, and the flexible material has a greater elasticity than the rigid material. Reddy teaches a container and tube set wherein the cross slit disk is made of a flexible material (paragraph 84 valve can be made up of an elastomer), the valve housing is made of a rigid material (paragraph 82 valve housing is made up of a “rigid wall”), and the flexible material has a greater elasticity than the rigid material (elastomers are flexible, while rigid materials are not). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of pollack to have an elastic cross slit disk and a rigid housing in order to create a properly functioning valve. If the cross slit disk was not made up of a flexible material, flow would be mostly or entirely blocked due to the flaps of the slit not being movable in relation to the pressure buildup of the fluid. The rigid housing allows the flaps to be anchored in a stable position, keeping the valve from being bent or twisted by the fluid flow and being rendered less useful or useless.
Regarding claim 4, Pollack fails to teach a container and tube set wherein the cross slit disk is made of thermoplastic or silicone. Reddy teaches a container and tube set wherein the cross slit disk is made of thermoplastic or silicone (paragraph 84 “valve may be concave and/or made of a silicone material”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack to use silicone in the construction of the cross slit disk in order to “facilitate self-reverting” of the valve as stated in paragraph 84.
Regarding claim 10, Pollack teaches the limitations of claim 9, but fails to teach a container and tube set wherein the flow control valve comprises a water channel that is obstructed when the valve is closed and a gas channel that is not obstructed when the valve is closed. Reddy teaches teach a container and tube set wherein the flow control valve comprises a water channel that is obstructed when the valve is closed and a gas channel that is not obstructed when the valve is closed (paragraph 136 “fluid filter for blocking water and allowing the flow of gas”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the capability to obstruct water but allow gas through when closed in order to protect the gas supply line from moisture that may enhance the possibility of growth of harmful bacteria, protecting the patient from contracting illnesses during an endoscopic procedure.
Regarding claim 11, Pollack teaches the limitations of claim 9, Reddy teaches the limitations of claim 10, and Pollack further teaches a container and tube set wherein the water channel and the gas channel are coaxial, the gas channel exterior to the water channel (figure 14b gas channel 1440c contains water channel 1445c, and both are coaxial).
Regarding claim 12, Pollack fails to teach a container and tube set wherein the flow control valve comprises a cross slit disk within a valve housing. Reddy teaches a container and tube set wherein the flow control valve comprises a cross slit disk (paragraph 82 “valve with a cross-slit”) within a valve housing. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the cross slit valve of Reddy in order to allow for a higher rate of flow through the valve, as cross slits offer high volume and flow capacity as well as self-sealing capability when the required pressure differential is not reached. These advantages allow for a wider range of output fluid pressures to be incorporated into the endoscopic procedure, allowing for pressure adjustments to perform the intended therapy without injuring the patient.
Regarding claim 13, Pollack fails to teach a container and tube set wherein the cross slit disk is made of a flexible material, the valve housing is made of a rigid material, and the flexible material has a greater elasticity than the rigid material. Reddy teaches a container and tube set wherein the cross slit disk is made of a flexible material (paragraph 84 valve can be made up of an elastomer), the valve housing is made of a rigid material (paragraph 82 valve housing is made up of a “rigid wall”), and the flexible material has a greater elasticity than the rigid material (elastomers are flexible, while rigid materials are not). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of pollack to have an elastic cross slit disk and a rigid housing in order to create a properly functioning valve. If the cross slit disk was not made up of a flexible material, flow would be mostly or entirely blocked due to the flaps of the slit not being movable in relation to the pressure buildup of the fluid. The rigid housing allows the flaps to be anchored in a stable position, keeping the valve from being bent or twisted by the fluid flow and being rendered less useful or useless.
Regarding claim 17, Pollack teaches the limitations of claim 16, and teaches an endoscopic surgical device wherein the container and tube set further comprises a first gas supply tube (figure 14b element 1440c) including a first end (figure 14b labelled below), a second end (figure 14 labelled below), and a third lumen extending therethrough (figure 14b the space within the gas supply tube), the third lumen in operative fluid communication with the second container and the second end of the first gas supply tube positioned external to the second container wherein the flow control valve is in fluid communication with the first gas supply tube (figure 14b the flow control valve 1499b and gas supply tube have no fluid blocking structures between them).
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Pollack fails to teach a flow control valve comprising a water channel that is obstructed when the valve is closed and a gas channel that is not obstructed when the valve is closed. Reddy teaches a flow control valve comprising a water channel that is obstructed when the valve is closed and a gas channel that is not obstructed when the valve is closed (paragraph 136 “fluid filter for blocking water and allowing the flow of gas”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the capability to obstruct water but allow gas through when closed in order to protect the gas supply line from moisture that may enhance the possibility of growth of harmful bacteria, protecting the patient from contracting illnesses during an endoscopic procedure.
Regarding claim 18, Pollack fails to teach an endoscopic surgical device wherein the flow control valve comprises a cross slit disk within a valve housing; and wherein the cross slit disk is made of a flexible material (paragraph 84 valve can be made up of an elastomer), the valve housing is made of a rigid material (paragraph 82 valve housing is made up of a “rigid wall”), and the flexible material has a greater elasticity than the rigid material (elastomers are flexible, while rigid materials are not). Reddy teaches a flow control valve comprising a cross slit disk within a valve housing; and wherein the cross slit disk is made of a flexible material (paragraph 84 valve can be made up of an elastomer), the valve housing is made of a rigid material (paragraph 82 valve housing is made up of a “rigid wall”), and the flexible material has a greater elasticity than the rigid material (elastomers are flexible, while rigid materials are not). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of pollack to have an elastic cross slit disk and a rigid housing in order to create a properly functioning valve. If the cross slit disk was not made up of a flexible material, flow would be mostly or entirely blocked due to the flaps of the slit not being movable in relation to the pressure buildup of the fluid. The rigid housing allows the flaps to be anchored in a stable position, keeping the valve from being bent or twisted by the fluid flow.
Regarding claim 19, Pollack fails to teach an endoscopic surgical device wherein the cross slit disk is made of thermoplastic or silicone. Reddy teaches a cross slit disk made of thermoplastic or silicone (paragraph 84 “valve may be concave and/or made of a silicone material”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack to use silicone in the construction of the cross slit disk in order to “facilitate self-reverting” of the valve as stated in paragraph 84.
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pollack and Reddy in view of Lurvey et al (U.S. Patent Application Publication 2008/0021381, hereinafter “Lurvey”). Regarding claim 5, while Pollack and Reddy combined teach the limitations of claims 1 and 3, they fail to teach a container and tube set wherein the valve housing is made of metal or rigid polymer. Lurvey teaches a container and tube set wherein the valve housing is made of metal or rigid polymer (paragraph 72 rigid or semi-rigid plastic housing). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the container and tube sets of Pollack and Reddy with a rigid polymer valve housing in order to create a properly functioning valve. The rigid polymer housing allows the valve flaps to be anchored in a stable position, keeping the valve from being bent or twisted by the fluid flow and being rendered less useful or useless.
Regarding claim 20, while Pollack and Reddy combined teach the limitations of claims 16 and 18, they fail to teach an endoscopic surgical device wherein the valve housing is made of metal or a rigid polymer. Lurvey teaches an endoscopic surgical device wherein the valve housing is made of metal or a rigid polymer (paragraph 72 rigid or semi-rigid plastic housing). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the container and tube sets of Pollack and Reddy with a rigid polymer valve housing in order to create a properly functioning valve. The rigid polymer housing allows the valve flaps to be anchored in a stable position, keeping the valve from being bent or twisted by the fluid flow and being rendered less useful or useless.
Claims 6-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pollack in view of Kurihara et al (U.S. Patent Application Publication 2021/0023496, hereinafter “Kurihara”). Regarding claim 6, while Pollack teaches the elements of claim 1, it fails to teach a container and tube set wherein the flow control valve comprises a conical housing in direct contact with the second container. Kurihara teaches a container and tube set wherein the flow control valve comprises a conical housing (figure 4b conical valve housing circled below) in direct contact with the second container (figure 4b “second chamber” element 74c). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the conical valve housing in direct contact with the second container in order to create a one way flow of gas across the valve, allowing gas to enter when needed for the endoscopic operation, but not flow back into the device (as detailed in paragraph 61) when it’s needed within the patient.
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Regarding claim 7, Pollack fails to teach a container and tube set wherein the flow control valve comprises a tubular nose corresponding to the inner diameter of the second water supply tube. Kurihara teaches a container and tube set wherein the flow control valve comprises a tubular nose (figure 4b tubular nose pointed to with an arrow above) corresponding to the inner diameter of the second water supply tube (figure 4b tubular nose corresponds to flow path element 77 as pointed to with the arrow above). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the valve and supply tube configuration of Kurihara in order to reduce the time required for the valve to open when fluid enters the supply tube. When the tubular nose is in contact with an inner diameter of the supply tube, the valve is forced open immediately as the tube fills, allowing fluid to reach the treatment area within the patient quickly, speeding up an operation and also allowing for fluid to be administered right when it is needed during an operation without delay.
Regarding claim 8, Pollack fails to teach a container and tube set wherein the flow control valve is an integral component of the second container. Kurihara teaches a container and tube set wherein the flow control valve is an integral component of the second container (figure 4b above see conical valve makes up one wall of the second container 74c). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the valve and supply tube configuration of Kurihara in order to reduce the time taken for fluid to reach the second container when entering through the valve. With the valve being an integral component of the second container, there is less distance to travel from supply tube to container, allowing fluid to reach the treatment area within the patient quickly, speeding up an operation and also allowing for fluid to be administered right when it is needed during an operation without delay.
Regarding claim 14, Pollack teaches the limitations of claim 9, but fails to teach a container and tube set wherein the flow control valve comprises a conical housing in direct contact with the second container. Kurihara teaches a container and tube set wherein the flow control valve comprises a conical housing (figure 4b conical valve housing circled below) in direct contact with the second container (figure 4b “second chamber” element 74c). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the conical valve housing in direct contact with the second container in order to create a one way flow of gas across the valve, allowing gas to enter when needed for the endoscopic operation, but not flow back into the device (as detailed in paragraph 61) when it’s needed within the patient.
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Regarding claim 15, Pollack fails to teach a container and tube set wherein the flow control valve comprises a tubular nose corresponding to the inner diameter of the second water supply tube. Kurihara teaches a container and tube set wherein the flow control valve comprises a tubular nose (figure 4b tubular nose pointed to with an arrow above) corresponding to the inner diameter of the second water supply tube (figure 4b tubular nose corresponds to flow path element 77 as pointed to with the arrow above). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the flow control valve of Pollack with the valve and supply tube configuration of Kurihara in order to reduce the time required for the valve to open when fluid enters the supply tube. When the tubular nose is in contact with an inner diameter of the supply tube, the valve is forced open immediately as the tube fills, allowing fluid to reach the treatment area within the patient quickly, speeding up an operation and also allowing for fluid to be administered right when it is needed during an operation without delay.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM Monday-Friday.
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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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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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