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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ningbo Hitcm Medical Devices Co Ltd. (Chinese Patent Publication CN113288019A, hereinafter “Ningbo”). Regarding claim 1, Ningbo teaches an access assembly for receiving an endoscope, comprising:
a tubular body (figure 5 element 414), configured to extend along a longitudinal axis of the access assembly and to receive the endoscope
a proximal seal member (figure 5 element 422), configured to be connected to a proximal end of the tubular body in a sealed manner
a distal seal member (figure 5 element 450), configured to be connected to a distal end of the tubular body in a sealed manner, wherein an inner wall of the tubular body, a distal surface of the proximal seal member, and a proximal surface of the distal seal member collectively define a cavity of the access assembly (figure 5 proximal and distal seals close off a cavity in the tubular body)
one or more fluid supply passages (figure 8 element 432), each comprising a fluid input port (figure 8 element 430) for receiving a fluid from a fluid source, a fluid discharge port for discharging the fluid received from the fluid source into the cavity (figure 8 element 434), and a fluid pipeline (figure 8 element 432) for fluidly communicating the fluid input port with the fluid discharge port
and one or more fluid control components (figure 7 sealing flaps 452), arranged at a position corresponding to a respective fluid discharge port (sealing flaps are on part of the distal seal member)
wherein when a distal end of the endoscope extends distally from the cavity through the distal seal member, (figure 8 see endoscope 212 extending distally from distal seal member 450) fluid discharge port is clamped between a respective fluid control component (figure 8 flaps 452 pointed at with arrows below) and a side wall of the endoscope (figure 8 element 212) so that the fluid discharge port is blocked (sealing flaps pressed against the side wall of the endoscope blocks fluid flow through the distal port)
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when the distal end of the endoscope is retracted proximally into the cavity through the distal seal member (figure 9 see endoscope 212 retracted into the access assembly), the fluid discharge port is released from a clamping between the respective fluid control component and the side wall of the endoscope so that the fluid discharge port is restored to be unblocked (figure 9 see distal seal 450 is unblocked to allow fluid discharge from patient body into access assembly)
Regarding claim 2, Ningbo teaches an access assembly wherein the one or more fluid control components comprise one or more protrusions each arranged on the inner wall of the tubular body, at an axial and circumferential position corresponding to the respective fluid discharge port (figure 8 sealing flaps pointed to arrows above).
Regarding claim 3, Ningbo teaches an access assembly wherein the one or more protrusions comprise at least one annular protrusion circumferentially arranged on the inner wall of the tubular body, at an axial position corresponding to the fluid discharge port (figure 7 see sealing flaps 452 are arranged circumferentially around the discharge port).
Regarding claim 4, Ningbo teaches an access assembly wherein the one or more fluid control components comprise one or more protrusions arranged on an outer surface of the respective fluid discharge port (figure 10 see protrusion on an outer surface circled below of fluid discharge port 434 that creates the fluid jetting angle LG2).
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Regarding claim 5, Ningbo teaches an access assembly wherein any two or more selected from the group consisted of the one or more fluid control components, the one or more fluid discharge ports, and the distal seal member are integrally formed from a flexible material (both the proximal and distal seal member are made of elastic materials, and both seal members are fluid control components as they prevent/allow fluid flow into the access assembly).
Regarding claim 6, Ningbo teaches an access assembly wherein the flexible material is a medical grade silicone (paragraph 8 of section “Detailed Ways” states “the vacuum sealing member 450 is formed of an elastic material that meets medical grade requirements, such as silica gel, silicone rubber, and the like”).
Regarding claim 7, Ningbo teaches an access assembly further comprising a vacuum suction member for sucking the fluid from the cavity (figure 1 vacuum source 330).
Regarding claim 8, Ningbo teaches an access assembly wherein the fluid discharge port is configured to be directed to a proximal direction along the longitudinal axis of the access assembly (the fluid discharge port at the distal end of the access assembly allows for fluid discharge proximally into the access assembly originating from the patient’s body).
Regarding claim 9, Ningbo teaches a method of using an access assembly for receiving an endoscope, comprising:
providing the access assembly and inserting the endoscope through the access assembly (figure 1 endoscope 212 inserted into access assembly body 412)
connecting the fluid supply passage to a respective fluid source (figure 1 fluid source 310)
retracting the distal end of the endoscope proximally into the cavity through the distal seal member so that the fluid discharge port is restored to be unblocked to clean the distal end of the endoscope with the fluid (shown in figure 10 with endoscope 212 retracted and in the fluid discharge angle of port 434)
Regarding claim 10, Ningbo teaches a method further comprising extending the distal end of the endoscope distally from the cavity through the distal seal member so that the fluid discharge port is blocked to stop discharging the fluid into the cavity (figure 8 see endoscope 212 extended through access assembly and flaps of seal 450 pressed between the endoscope and assembly walls, sealing the discharge port).
Regarding claim 11, Ningbo teaches a method wherein the connecting the fluid supply passage to a respective fluid source comprises: connecting a plurality of fluid supply passages (figure 1 elements 432 or 412) to a plurality of respective fluid sources (figure 1 element 310 or the patient body cavity) which respectively provide one selected from the group consisted of a liquid, a gas, and a gas-liquid mixture (fluid source 310 provides a liquid for cleaning the endoscope, and the patient’s body supplies gas into the lumen 412).
Regarding claim 12, Ningbo teaches an access assembly wherein any two or more selected from the group consisted of the one or more fluid control components, the one or more fluid discharge ports, and the distal seal member are integrally formed from a flexible material (both the proximal and distal seal member are made of elastic materials, and both seal members are fluid control components as they prevent/allow fluid flow into the access assembly).
Regarding claim 13, Ningbo teaches an access assembly wherein any two or more selected from the group consisted of the one or more fluid control components, the one or more fluid discharge ports, and the distal seal member are integrally formed from a flexible material (both the proximal and distal seal member are made of elastic materials, and both seal members are fluid control components as they prevent/allow fluid flow into the access assembly).
Regarding claim 14, Ningbo teaches an access assembly wherein any two or more selected from the group consisted of the one or more fluid control components, the one or more fluid discharge ports, and the distal seal member are integrally formed from a flexible material (both the proximal and distal seal member are made of elastic materials, and both seal members are fluid control components as they prevent/allow fluid flow into the access assembly).
Regarding claim 15, Ningbo teaches an access assembly wherein the flexible material is a medical grade silicone (paragraph 8 of section “Detailed Ways” states “the vacuum sealing member 450 is formed of an elastic material that meets medical grade requirements, such as silica gel, silicone rubber, and the like”).
Regarding claim 16, Ningbo teaches an access assembly wherein the flexible material is a medical grade silicone (paragraph 8 of section “Detailed Ways” states “the vacuum sealing member 450 is formed of an elastic material that meets medical grade requirements, such as silica gel, silicone rubber, and the like”).
Regarding claim 17, Ningbo teaches an access assembly wherein the flexible material is a medical grade silicone (paragraph 8 of section “Detailed Ways” states “the vacuum sealing member 450 is formed of an elastic material that meets medical grade requirements, such as silica gel, silicone rubber, and the like”).
Conclusion
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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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