DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 § 112
2. 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.
3. Claim 19 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 19 recites the limitation "the pump system" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
4. 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.
5. Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2009/0062610 A1) in view of Sung (KR 20080101413 A – English translation).
Regarding claim 1, Williams discloses A medical device reprocessor system (see figure 2) comprising: a medical device (endoscope 200); a port (ends of distribution lines 30) that is in fluid communication with a portion of the medical device; a first fluid source (detergent container 86 housing a detergent or water supply 50) having a first fluid; a second fluid source (disinfectant container 92 containing a disinfectant) having a second fluid; a pump system (plurality of pumps 32, 38, 70, 72, 88, 94, 100, 110), wherein the pump system is in fluid communication with the first and second fluid sources and the port (as shown in figure 2); and a control module (28) operable to execute a control algorithm to sequentially deliver the first and second fluids to the port and terminate delivery of the first and second fluids at first and second predetermined time thresholds (see para [0025]-[0038]).
The limitations of this claim “operable to execute a control algorithm” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Williams and the control module is capable of being operable as claimed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Williams (see MPEP §2114).
NOTE: this is a recitation of intended use, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the microcontroller is cable of being programmed to operate as claimed as it has a programmable logic controller (PLC) (see para [0024]).
However, Williams does not appear to explicitly disclose wherein the control module is configured to repeat the sequential delivery of the first and second fluids for at least a predetermined number of cycles.
Sung discloses an automatic endoscope cleaner wherein the endoscope is first injected with a wash liquid and then injected with a disinfectant solution, and further teaches it is common to repeat the process 2-3 times (see English translation).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Williams to include a controller configured to repeat sequential delivery of a wash flid and a disinfectant solution, as taught by Sung, in order to ensure that the endoscope is sufficiently sterilized.
Regarding claim 2, Williams disclose a chamber (14a) that receives an endoscope (200) (see para [0026]).
Regarding claim 3, Williams discloses wherein the first and second fluids each comprise either a detergent, water, pressurized air, or a disinfectant (see para [0031]-[0033] - disinfectant 92, detergent solution 86, air from air pump 38, water from water source 50).
Regarding claim 4, Williams discloses wherein at least one of the first or second fluid sources is a chamber (see figure 2 – disinfectant 92 is held in a chamber and detergent 86 is held in a bottle which is a chamber).
Regarding claim 5, the limitations of this claim are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Williams and the control module is capable of being operable as claimed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Williams (see MPEP §2114).
NOTE: this is a recitation of intended use, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the microcontroller is cable of being programmed to operate as claimed as it has a programmable logic controller (PLC) (see para [0024]).
Regarding claim 6, Williams discloses a pressure testing feature configured to pressure test the medical device (catheter) to check for leaks (see para [0067] – Step 6. Pressurize the Endoscope Body and Measure the Leak Rate).
Regarding claim 7, the limitations of this claim are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Williams and the control module is capable of being operable as claimed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Williams (see MPEP §2114).
NOTE: this is a recitation of intended use, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the microcontroller is cable of being programmed to operate as claimed as it has a programmable logic controller (PLC) (see para [0024]).
Regarding claim 8, Williams disclose wherein the pump system (pumps 32) is in fluid communication with an alcohol (alcohol supply 134), wherein the control module (28) is operable to execute the control algorithm to deliver alcohol to the medical device (see para [0035]).
Regarding claim 9, Williams discloses a concentration measurement subsystem (concentration monitor subsystem 400) configured to determine a concentration of at least one of the first or second fluids within the chamber (see para [0057], [0087], and [0089] – concentration of disinfectant is measured during filling of chamber 14a).
Regarding claim 10, Williams disclose a filtering feature (filter 54) configured to filter microbes from at least one of the first or second fluids to the medical device (see para [0027] – filter 54 removes microbes from the water introduced from the water source 50 to the chamber 14a).
Regarding claim 11, Williams discloses a heating feature (inline heater 80) configured to heat at least one of the first or second fluids delivered to the medical device (see para [0030] and [0077]).
Regarding claim 12-14, Williams discloses a control module (controller 28) that is operable to execute the control algorithm to circulate a mixture of the first and second fluids in the chamber thereby exposing an outer surface of the medical device to the mixture, wherein the mixture is circulated for a third predetermined time threshold, and wherein the concentration of the mixture circulated in the chamber differs from the concentration of the mixture in the medical device. The limitations of claims 12-14 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Williams and the control module is capable of being operable as claimed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Williams (see MPEP §2114).
NOTE: this is a recitation of intended use, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the microcontroller is cable of being programmed as it has a programmable logic controller (PLC) (see para [0024]).
Regarding claim 15, Williams discloses a plurality of flow sensors, wherein each of the flow sensors is in fluid communication with at least one of the first or second fluids (see para [0036]-[0037] and [0078] – flow rates of detergent and disinfectant in the supply lines 30 are measured using channel pumps 32 and pressure sensors 42) .
Regarding claim 16, Williams discloses a plurality of valves (S1-S7) (see figure 2), wherein each of the valves is in fluid communication with at least one of the first or second fluids (valves S1-S7 are located along the fluid lines where water, disinfectant, and detergent pass thru – see para [0069] and [0090]).
Regarding claim 17, Williams discloses the pump system comprises a plurality of pumps (32), wherein each of the pumps (32) is in fluid communication with at least one of the first or second fluids (see figure 2; see para [0026]).
Regarding claims 18 and 19, Williams discloses multiple ports (ends of flush lines 30) each configured to couple the medical device (see para [0063] – flush lines 30 are attached to endoscope openings 226, 228, 228a, 230 and 232). The pump system (pumps 32) are configured to deliver the first and second fluids to the multiple ports coupled with the endoscope (200) (see para [0063], [0077], [0088]-[0089]).
Regarding claim 20, Williams discloses wherein at least one of the first or second fluids is received from an air supply system (36) separate from the system but configured to be in fluid communication with the system (see figure 2; para [0026]).
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E CONLEY whose telephone number is (571)272-8414. The examiner can normally be reached on M-F, 8:30am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN E CONLEY/Primary Examiner, Art Unit 1799
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