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 .
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.
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.
Claims 9-10, 21, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren et. al.’453 (U.S. Patent Application 20140327453 – previously cited) in view of Adler et. al.’256 (WO Patent Application 2016103256 – previously cited), and further in view of Kurokawa'714 (JP Patent Application H02311714).
Regarding Claim 9, Lofgren et. al.’453 discloses a urine monitoring device integrated with a catheter system (Paragraph [0084] - a urine measuring device 100 for measuring of urine production of a patient carrying a urine catheter), comprising:
a body portion mounted to a urine collection receptacle, the urine collection receptacle included in a catheter system (Paragraph [0013] - The urine measurement system according to the invention is a closed system that comprises a tubing system connected to a patient's catheter, a measurement chamber and a collection bag. The tubing system leads the urine from the urine bladder to the measurement chamber; Paragraph [0084] - the device comprises a base station 105 provided with a cavern 138 for placing the burette 120 into, the side walls of the cavern 138 having left 139, right 137 and back 136 side walls, and being provided with two capacitance electrodes 140, 141 placed apart relative to each other, and capable of sensing a capacitance signal occurring between the two capacitance electrodes; Figure 1a);
a sensor housing disposed in a cavity of a body portion, a sensor housing disposing one or more sensors configured to collect sensor data describing one or more properties of urine collected by a catheter system (Paragraph [0084] - the burette 120 further comprises an inlet 122 and an outlet 130, 160 for the urine whose volume is to be measured. Further, the device comprises a base station 105 provided with a cavern 138 for placing the burette 120 into, the side walls of the cavern 138 having left 139, right 137 and back 136 side walls, and being provided with two capacitance electrodes 140, 141 placed apart relative to each other, and capable of sensing a capacitance signal occurring between the two capacitance electrodes; Paragraph [0014] - shows an example diagram of how capacitance values of the sensor electrode arrangement of FIG. 1g).
Lofgren et. al.’453 fails to disclose a clamp connected to a catheter tube, the catheter tube included in a catheter system. Adler et. al.’256 teaches a clamp connected to a catheter tube, the catheter tube included in a catheter system (Page 11 line 31 to Page 12 line 2 - an apparatus of the invention 100 is attached, for example by means of clamps that clamp onto the catheter 104 or tubing 108 at some location along the line from patient 102 to collection container 110). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 to include a clamp in order to secure a catheter tube from a user to a sensor in order to record data within the catheter tube (Page 12 lines 3-4 – be able to capture images of the urine stream within the catheter).
Lofgren et. al.’453 fails to disclose one or more sensors includes two or more electrodes operable to at least partially penetrate a side of the catheter tube. Kurokawa'714 teaches two or more electrodes that penetrate a wall of a tube to be in contact with a liquid inside of the tube (Page 2, 8 lines from the bottom to 5 lines from the bottom - A clamp (9a) is thrust, respectively, an electrode (3a) and (3b) are moved to an inner direction, and an electrode tip which is needlelike is pierced in a wall of tube from the outside, and changes into the state where penetrated a tube wall and it has exposed to an inside of tube). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 to include electrodes that can penetrate a wall of a tube in order to place the electrodes in direct contact with the fluid of interest without cutting the tube, as seen in Kurokawa’714 (Page 3 Lines 1-4 - A tube (1), an electrode (3a), and a seal of a between (3b) can be performed. As mentioned above, according to the electromagnetic flowmeter detector of present invention 1 example, it becomes possible to attach to an electromagnetic flowmeter detector as it is, without performing cutting a tube (1) which is flowing through fluid under test on the way).
The same rationale that applies to Claim 9 above, applies to Claims 21 and 29.
Regarding Claim 10, Lofgren et. al.’453 in view of Adler et. al.’256 discloses the device outline in Claim 9 above. Lofgren et. al.’453 further discloses two or more electrodes configured to measure conductivity of urine collected by a catheter system (Paragraph [0093] - two conductance electrodes 148 on the inside of the burette to come into contact with the urine and which conductance electrodes 148 are connected to contact plates 150 arranged on the outside of the burette 120).
Claims 11-14, 22-28, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren et. al.’453 (U.S. Patent Application 20140327453 – previously cited) in view of Adler et. al.’256 (WO Patent Application 2016103256 – previously cited), further in view of Kurokawa'714 (JP Patent Application H02311714) as applied to Claim 10 above, as evidenced by Blacklock et. al.’199 (GB Patent Application 2426199 – previously cited).
Regarding Claim 11, Lofgren et. al.’453 in view of Adler et. al.’256 and further in view of Kurokawa’714 discloses the device outlined in Claim 10 above. Lofgren et. al.’453 further discloses a conductivity sensor includes two or more electrodes (Paragraph [0052] - a measurement chamber to which urine from the patient is conveyed via a catheter to fill the measurement chamber, a set of electrodes, comprising at least two electrodes, connected to a processor, and arranged to sense the changing capacitance corresponding to changing levels of urine). However, Lofgren et. al.’453 in view of Adler et. al.’256 and further in view of Kurokawa’714 fails to disclose two or more electrodes configured to be inserted into a catheter tube to contact urine as it flows through a catheter tube. Kurokawa’714 teaches two or more electrodes configured to pierce a tube to contact fluid (Page 2, 8 lines from the bottom to 5 lines from the bottom - A clamp (9a) is thrust, respectively, an electrode (3a) and (3b) are moved to an inner direction, and an electrode tip which is needlelike is pierced in a wall of tube from the outside, and changes into the state where penetrated a tube wall and it has exposed to an inside of tube). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 to include electrodes that can penetrate a wall of a tube in order to place the electrodes in direct contact with the fluid of interest without cutting the tube as seen in Kurokawa’714 (Page 3 Lines 1-4 - A tube (1), an electrode (3a), and a seal of a between (3b) can be performed. As mentioned above, according to the electromagnetic flowmeter detector of present invention 1 example, it becomes possible to attach to an electromagnetic flowmeter detector as it is, without performing cutting a tube (1) which is flowing through fluid under test on the way). Further as evidenced by Blacklock et. al.’199 that teaches two or more electrodes configured to be inserted into a catheter tube to contact urine as it flows through a catheter tube (Page 5 Lines 18-20 - The catheter is designed such that in use the electrodes generate an electric field across the distal opening or distal opening. Urine passing through the distal opening or distal openings comes into contact with the electrodes; Page 6 Line 7 - the electrodes are made from metal). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the electrodes and measurement chamber of Lofgren et. al.’453 in view of Adler et. al.’256 and further in view of Kurokawa’714 to include electrodes inside a catheter tube as seen in Blacklock et. al.’199. This modification of including an electrode set-up similar to that in Blacklock et. al.’199 would enable the electrodes to interact directly with the urine inside of the catheter tube in order to sense the urine flowing through the system.
Regarding Claim 12, Lofgren et. al.’453 in view of Adler et. al.’256, further in view of Kurokawa’714 as evidenced by Blacklock et. al.’199 disclose the device outlined in Claim 11 above. Lofgren et. al.’453 further discloses a cap placed over a sensor housing, the cap having a groove for disposing a catheter tube and one or more openings within a groove (Paragraph [0089] - cavern 138, which also can be called "socket", of the base station 105 may be an open cavern, i.e., not completely surrounding the walls of the burette 120… the burette may be given a slightly tapering shape to provide a snug and consistent fit of the burette in the cavern). In the embodiment of Lofgren et. al.’453, the burette 120 acts as a cap for the socket which is part of the base station 105 that acts as a sensor housing.
Regarding Claim 13, Lofgren et. al.’453 in view of Adler et. al.’256, further in view of Kurokawa’714 as evidenced by Blacklock et. al.’199 disclose the device outlined in Claim 12 above. Lofgren et. al.’453 further discloses two or more electrodes extend through one or more openings formed into the grove to contact a catheter tube disposed inside a groove (Paragraph [0089] - the burette may be given a slightly tapering shape to provide a snug and consistent fit of the burette in the cavern. The snug and consistent fit assures good measuring conditions for particularly the capacitance electrodes; Figures 1c and 1d). Although Lofgren et. al.’453 doesn’t teach an electrode piercing a catheter, it is understood by one of ordinary skill in the art that a structure such as an electrode made of metal, as seen in Kurokawa’714 (**insert column and lines**) and Blacklock et. al.’199 (Page 6 Line 7), could puncture a wall of a catheter if enough pressure is applied. Furthermore, Kurokawa’714 teaches two or more electrodes configured to pierce a tube to contact fluid (Page 2, 8 lines from the bottom to 5 lines from the bottom - A clamp (9a) is thrust, respectively, an electrode (3a) and (3b) are moved to an inner direction, and an electrode tip which is needlelike is pierced in a wall of tube from the outside, and changes into the state where penetrated a tube wall and it has exposed to an inside of tube). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 in view of Adler et. al.’256 to include electrodes that can penetrate a wall of a tube in order to place the electrodes in direct contact with the fluid of interest without cutting the tube as seen in Kurokawa’714 (Page 3 Lines 1-4 - A tube (1), an electrode (3a), and a seal of a between (3b) can be performed. As mentioned above, according to the electromagnetic flowmeter detector of present invention 1 example, it becomes possible to attach to an electromagnetic flowmeter detector as it is, without performing cutting a tube (1) which is flowing through fluid under test on the way).
The same rationale that applies to Claim 13 above, applies to Claims 23-26, 28, and 30.
Regarding Claim 14, Lofgren et. al.’453 in view of Adler et. al.’256, further in view of Kurokawa’714 as evidenced by Blacklock et. al.’199 discloses the device outlined in Claim 13 above. Kurokawa’714 teaches a clamp configured to compress a tube in order for electrodes to pierce the tube and be contact with fluid inside of the tube (Page 2, 8 lines from the bottom to 5 lines from the bottom - A clamp (9a) is thrust, respectively, an electrode (3a) and (3b) are moved to an inner direction, and an electrode tip which is needlelike is pierced in a wall of tube from the outside, and changes into the state where penetrated a tube wall and it has exposed to an inside of tube). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 in view of Adler et. al.’256 to include electrodes that can penetrate a wall of a tube in order to place the electrodes in direct contact with the fluid of interest without cutting the tube as seen in Kurokawa’714 (Page 3 Lines 1-4 - A tube (1), an electrode (3a), and a seal of a between (3b) can be performed. As mentioned above, according to the electromagnetic flowmeter detector of present invention 1 example, it becomes possible to attach to an electromagnetic flowmeter detector as it is, without performing cutting a tube (1) which is flowing through fluid under test on the way). Furthermore, as evidenced by Adler et. al.’256, Adler et. al.’256 further teaches a clamp configured to compress a catheter tube against sensors (Page 11 line 31 to Page 12 line 4 - an apparatus of the invention 100 is attached, for example by means of clamps that clamp onto the catheter 104 or tubing 108 at some location along the line from patient 102 to collection container 110 in such a fashion as to be able to capture images of the urine stream within the catheter). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 in view of Kurokawa’714 as evidenced by Blacklock et. al.’199, to include a clamp as seen in Adler et. al.’256 in order to secure a catheter tube against electrodes in order to record data within the catheter tube.
The same rationale that applies to Claim 14 above, applies to Claims 22, 27, and 31-32.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren et. al.’453 (U.S. Patent Application 20140327453 – previously cited) in view of Adler et. al.’256 (WO Patent Application 2016103256 – previously cited), further in view of Kurokawa'714 (JP Patent Application H02311714) as applied to Claim 9 above, further in view of Ferguson et. al.’963 (WO Patent Application 2007018963 – previously cited).
Regarding Claim 15, Lofgren et. al.’453 in view of Adler et. al.’256 and further in view of Kurokawa’714 discloses the device outlined in Claim 9 above, but fails to disclose a top clip and a bottom clip for shaping the catheter tube into an elbow bend that forces a portion of the catheter tube extending over a top surface of the body portion to lay horizontally wherein the elbow bend increases dwell time of urine in a portion of the catheter tube disposed inside the clamp. Ferguson et. al.’963 teaches a clip for shaping a catheter tube into a bend that forces a portion of a catheter tube, wherein the bend increases dwell time of urine in a portion of the catheter tube (Paragraph [0018] - A clamp mechanism typically occludes the drain tube, preventing draining of urine through the drain tube of the catheter when the clamp mechanism is engaged. Thus, the clamp mechanism may control flow through the drain tube….a bending or kinking clamp mechanism that bends or kinks the drain tube). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Lofgren et. al.’453 in view of Adler et. al.’256 and further in view of Kurokawa’714 to include a clip that shapes a catheter tube as seen in Ferguson et. al.’963 in order to control dwelling time within the catheter tube.
While Ferguson et. al.’963 fails to provide details of a catheter tube being held in a horizontal configuration/orientation, it is noted that according to section 2144.04 IV. B. of the MPEP, the configuration of the catheter tube was a matter of choice. The catheter tube in Ferguson et. al.’963 is able to be bent and kinked. Therefore, the tube of Ferguson et. al.’963 could be bent or kinked in a horizontal position. In light of MPEP 2144.04 II. A., it would have been obvious to one of ordinary skill in the art to engineer the clip of Ferguson et. al.’963 to hold a catheter tube in a horizontal orientation across a top surface of a body portion in order to achieve a desired dwell time of the urine.
The same rationale that applies to Claim 15 above, applies to Claim 16.
Response to Arguments
Applicant's arguments filed 15 September 2025 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior drawing objections.
Applicant’s amendments have overcome the prior specification objections.
Applicant’s amendments have overcome the prior rejections under 35 U.S.C. 112(b).
Applicant’s amendments have overcome the prior rejections under 35 U.S.C. 101.
Claims 9-16 and 21-32 are rejected under 35 U.S.C. 103 with additional references cited as necessitated by amendments, as discussed in Paragraphs 3-5 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791