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 § 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 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: a step that would be considered a controlling step. As the claim is written the step of “controlling the irrigation procedure” is an incomplete step unless accompanied by the structure or part of the procedure being controlled, i.e. pumping, valve, flow rate, etc.
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 5,464,391 to DeVale (“DeVale”).
Regarding claim 14, DeVale discloses a method of controlling an irrigation procedure in an irrigation system (col.1, ll. 5-11), the method being performed by a processor (see sol. 3, ll. 39 stating, “[t]he control unit 20 includes,,,a controller 38…” and see col. 3, ll. 59-65 stating, “[t]he controller 38 preferably includes two microprocessors..”) of the irrigation system, a reservoir (18) of the irrigation system comprising an irrigation liquid (col. 3, ll. 5-8), the method comprising the steps of: initiating the irrigation procedure (see claim 21, “delivering fluid to the surgical site from an output of the cassette” and see col. 3, ll. 57-59 stating, “pump motor 39…is operated and controlled in speed by the controller 38.”); measuring one or more capacitive characteristics of a fluid in the tubing (col. 5, l. 67 through col. 6, l. 24); and controlling the irrigation procedure in accordance with the one or more capacitive characteristics of the fluid in the tubing (see col. 6, ll. 21-22 stating, “the output of the capacitors is also sent to control unit 20…” and at col. 6, ll. 26-32 stating, “the fluid detection information is conveyed to the medical personnel via a secondary display 110. The secondary display 110 is connected to the control unit 20…may be a blinking light or audible alarm”). It is noted that initiating an alarm is considered “controlling the irrigation procedure.”
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-9, 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2018/0078700 to Eliasson (“Eliasson”) in view of DeVale.
Regarding claims 1 and 14, Eliasson discloses an irrigation system (title and Fig. 3) configured to run an irrigation procedure for irrigation of the bowels of a user (see Field of Invention), the system comprising: a housing (1) comprising a reservoir (internal chamber of the housing) for containing an irrigation liquid (para. [0079]); a tubing (92 and 94) providing fluid communication between the reservoir and a catheter (2) for use with the irrigation system (see Fig. 3 and para. [0095]); a pump (4) for facilitating a flow of irrigation liquid from the reservoir, through the tubing, to the catheter (indirectly through pressurization of the reservoir); a control unit (3) comprising a processor (31) in communication with the pump (see Fig. 3 and para. [0093]); and a sensor (38) in communication with the processor (see Fig. 3 and para. [0097]) and configured to measure one or more characteristics of a fluid in the tubing (flow), wherein the processor is configured to control the irrigation procedure in accordance with the one or more characteristics of the fluid in the tubing (see para. [0097]).
Eliasson meets the claim limitations as described above but fails to specifically teach a capacitive sensor to measure one or more capacitive characteristics of a fluid in the tubing.
However, DeVale teaches, among other features, a reservoir (18) of the irrigation system comprising an irrigation liquid (col. 3, ll. 5-8), the method comprising the steps of: initiating the irrigation procedure (see claim 21, “delivering fluid to the surgical site from an output of the cassette” and see col. 3, ll. 57-59 stating, “pump motor 39…is operated and controlled in speed by the controller 38.”); measuring one or more capacitive characteristics of a fluid in the tubing (col. 5, l. 67 through col. 6, l. 24); and controlling the irrigation procedure in accordance with the one or more capacitive characteristics of the fluid in the tubing (see col. 6, ll. 21-22 stating, “the output of the capacitors is also sent to control unit 20…” and at col. 6, ll. 26-32 stating, “the fluid detection information is conveyed to the medical personnel via a secondary display 110. The secondary display 110 is connected to the control unit 20…may be a blinking light or audible alarm”).
However, at the time of filing, it would have been obvious to one skilled in the art to incorporate the fluid detection sensor (25) as taught by DeVale into the invention of Eliasson. The incorporation would have been made in order to indicate to the user when the fluid bag is empty. This incorporation would result in enhanced safety to the patient by providing more system information to the medical technician.
Regarding claim 2, Eliasson in view of DeVale teach the irrigation system according to claim 1 and Eliasson further discloses wherein the pump is an electrical air pump configured to pressurize the reservoir to facilitate the flow of irrigation liquid (para. [0023]).
Regarding claim 3, Eliasson in view of DeVale teach the irrigation system according to claim 1, and DeVale discloses wherein the capacitive sensor comprises a capacitive proximity sensor (see Fig. 11).
Regarding claim 4, Eliasson in view of DeVale teach the irrigation system according to claim 3, and DeVale discloses wherein the capacitive proximity sensor comprises a sensor plate (100,102) arranged adjacent to the tubing.
Regarding claim 5, Eliasson in view of DeVale teach the irrigation system according to claim 4, and DeVale discloses wherein the capacitive proximity sensor further comprises an electrically grounded ground plate (100,102) arranged adjacent to the tubing and opposite to the sensor plate to form a capacitor wherein the tubing is arranged between the sensor plate and the ground plate (see Fig. 11).
Regarding claim 6, Eliasson in view of DeVale teach the irrigation system according to claim 5, and DeVale discloses wherein the sensor plate and/or the ground plate are fitted according to an outer surface geometry of the tubing (see Fig. 11).
Regarding claim 7, Eliasson in view of DeVale teach the irrigation system according to claim 1, and DeVale discloses wherein the capacitive sensor comprises an auxiliary processor connected to the processor of the control unit. At the time of filing, it would have been obvious to incorporate the extra processor of DeVale into the invention of Eliasson in order to provide the capacitive sensor with the electronics needed to incorporate the sensor into the system of Eliasson.
Regarding claim 8, Eliasson in view of DeVale teach the irrigation system according to claim 7, and DeVale discloses wherein the auxiliary processor is configured to generate a binary output based on the one or more capacitive characteristics of the fluid in the tubing. See DeVale col. 3, ll. 5-23.
Regarding claim 9, Eliasson in view of DeVale teach the irrigation system according to claim 8, and DeVale discloses wherein the binary output comprises a first binary output indicative of liquid in the tubing and a second binary output indicative of gas in the tubing. See DeVale col. 3, ll. 5-23.
Regarding claim 11, Eliasson in view of DeVale teach the irrigation system according to claims 1, and DeVale discloses wherein the one or more capacitive characteristics are selected from one or more of (i) a capacitance as induced by a fluid, (ii) a permittivity of a fluid, (iii) a change of the capacitance as induced by a fluid, and (iv) a change of the permittivity. See DeVale col. 5, l. 67 through col. 6, l. 25.
Allowable Subject Matter
Claims 10 and 12-13 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.
Claim 15 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/ Primary Examiner, Art Unit 3993
