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 .
Claim Objections
Claims 1, 7, and 12 are objected to because of the following informality:
Claim 1, line 16: “repeating” should be replaced with –repeat–;
Claim 1, line 20: “a transfer” should be replaced with –one of the transfers–;
Claim 7, line 5: “said pump” should be replaced with –a pump–;
Claim 7, line 15: “a transfer” should be replaced with –one of the transfers–;
Claim 12, line 2: “a pump” should be replaced with –the pump–.
Appropriate correction is required.
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 1-5 and 7-12 are 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 1 recites “repeating steps (a) to (c) at least once until said predetermined second pressure indicates said bladder is substantially empty” in lines 16-17. The recitation suggests that the predetermined second pressure changes or varies until it indicates said bladder is substantially empty. However, the term “predetermined” indicates that the pressure is fixed, which conflicts with the aforementioned suggestion. Therefore, it is unclear whether the predetermined second pressure is fixed or varies. The specification does not provide clarification. Claim 7 recites a similar limitation, so it is rejected on similar grounds. For the purposes of examination, the recitation will be interpreted to be “repeat steps (a) to (c) at least once until one of the pressure measurements indicates said bladder is substantially empty”.
Claims 2-5 are rejected by virtue of their dependence from claim 1. Claims 8-12 are rejected by virtue of their dependence from claim 7.
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.
Claims 1, 5, 7, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0110456 A1 (Cooper) (previously cited) in view of US 2017/0136209 A1 (Burnett) (previously cited), US 10,744,298 B1 (Bello) (previously cited) and US 2017/0100068 A1 (Kostov) (previously cited)
With regards to claims 1 and 7, Cooper discloses a device and method for measuring a rate of production of urine in a patient (¶¶ [0030] [0031] discloses methods, systems, and devices monitoring bladder health, wherein bladder health includes monitoring in real-time the pressures, volumes, and compliance of urinary bladders, wherein data collected includes volume of expelled urine; Also see ¶ [0033]) comprising: a urine catheter connectable to a bladder (Figs. 1-3C and ¶ [0033] depict a urinary catheter); a pump connected between the urine catheter and a collection vessel or container (Figs. 1 and 4 and ¶¶ [0036], [0038] depict a pump 30 connected between the component 12 (which is coupled to a catheter) and a collection vessel or container); a pressure sensor (Fig. 1 and ¶ [0037] depict a pressure sensor component 18); and a processor (Fig. 1 and ¶¶ [0037], [0060] [0061] depict a CPU 40) configured to: (a) receive from the pressure sensor, in real-time, pressure measurements (¶¶ [0037], [0060] discloses the processor 40 receives data relating to the pressure readings); (b) upon receiving a measured pressure, operate said pump to transfer a fixed volume of urine (¶ [0060] depicts software 25 of processor 40 serving as an automated safety feature in the form of an automated switch that powers the pump on and off; ¶ [0047] discloses a driver switch 36 of pump 30 capable of being toggled on and off based on pressure readings; ¶¶ [0054], [0073] discloses the pump has a constant flow rate, which indicates that it transfers fluid at fixed volumes), and repeating the pressure measurements and operation of the pump (i.e., steps (a) to (b)) until the bladder is substantially empty (¶ [0060] discloses switching the pump off when certain pressure changes, such as negative pressure, are sensed by the pressure sensing component. The Examiner notes that the negative pressure is indicative of a substantially empty bladder. Additionally, the Examiner notes that, for the switch to turn the pump off based on the sensing component, the processor must constantly compare the pressure to the threshold pressure (a zero pressure) until the negative pressure is reached); and calculating a urine production rate (¶ [0054] discloses determining a volumetric flow rate (i.e., a urine production rate), amount of elapsed time, and total volume expelled).
Cooper is silent regarding whether the collection vessel or container is a urine bag.
In the same field of endeavor of monitoring draining of bodily fluids, Burnett teaches a collection vessel or container being a urine bag (¶¶ [0005]-[0006] depict urine flowing from a foley catheter to a drainage bag). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the collection vessel of Cooper with the urine bag of Burnett. Because both elements are capable of receiving discharged urine (¶¶ [0036], [0038] of Cooper; ¶¶ [0005]-[0006] of Burnett), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding (b) upon receiving an indication that one of the pressure measurements reached a predetermined first pressure operate said pump (c), upon receiving an indication that one of the pressure measurements reached a predetermined second pressure that is lower than said predetermined second pressure, operate said pump, and (d) repeating steps (a) to (c) at least once until the bladder is substantially empty.
In the same field of endeavor of monitoring draining of bodily fluids, Bello teaches measuring pressure of urine in a bladder, and, upon receiving an indication that one of the pressure measurements reaches a predetermined first pressure, draining the vessel until the vessel is empty (Col. 6, line 46 to Col. 7, line 5 teaches monitoring intra-bladder pressure in relation to either one or more threshold levels that indicate whether the bladder should be drained or multiple specific pressure levels correlating to multiple specific volume levels, and activating a pump such that patient may urinate normally (i.e., until the bladder is substantially empty)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the pump of Cooper to incorporate that it starts when a measured pressure reaches a predetermined first pressure as taught by Bello. The motivation would have been to improve the automation of the fluid draining.
The Examiner notes that the above combination of Cooper in view of Burnette teaches or suggests (b) upon receiving an indication that one of the pressure measurements reached a predetermined first pressure operate said pump to transfer a fixed volume of urine from said bladder into said urine bag (Beginning draining at a threshold pressure, according to Col. 6, line 46 to Col. 7, line 5 of Bello; Operating the pump to operate at a constant flow rate according to ¶¶ [0054], [0073] of Cooper); (c) upon receiving an indication that one of the pressure measurements reached a predetermined second pressure that is lower than said predetermined first pressure, operate said pump to transfer another of said fixed volume of urine from said bladder into said urine bag (Continuing operation of the pump of ¶¶ [0054], [0073] of Cooper through the defined pressure range (from the threshold pressure of Bello to the negative pressure of Cooper), and/or the continued operation of the pump of Cooper until the negative pressure is reached (¶ [0060] of Cooper) necessarily includes a comparison of the measured pressure to a value of zero–once that zero value is reached, the pump operates again until the negative pressure is determined); (d) repeating steps (a) to (c) at least once until said bladder is substantially empty (Continuing operation of the pump of ¶¶ [0054], [0073] of Cooper through the defined pressure range until a negative pressure is reached according to ¶ [0060] of Cooper, wherein the negative pressure is indicative of the bladder being substantially empty).
Although Cooper teaches calculating a urine production rate (¶ [0054] discloses determining a volumetric flow rate (i.e., a urine production rate), amount of elapsed time, and total volume expelled), the above combination is silent regarding (e) calculate an instantaneous urine production rate by dividing said fixed volume of urine by a time period, said time period being either a time from a start of the pressure measurement to a time of the transfer of the fixed volume or a time between two of the transfers of the fixed volume; and (f) generate an average urine production rate by averaging at least two values of said instantaneous urine production rate.
In a system relevant to the problem of monitoring a urine flow rate, Kostov teaches (e) calculating an instantaneous urine production rate by dividing said fixed volume of urine by a time period, said time period being either a time from a start of the pressure measurement to a time of the transfer of the fixed volume or a time between two of the transfers of the fixed volume (¶ [0024] discloses measuring a variable amount of time that is required for a fixed, pre-determined volume of fluid to accumulate allows for computation of the volume of fluid per unit time, i.e., the flow rate); and (f) generating an average urine production rate by averaging at least two values of said instantaneous urine production rate (¶ [0067] and Fig. 8 depict instantaneous flow rates and presenting data points as a rolling or moving average). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the urine production rate of Cooper to incorporate (e) calculating an instantaneous urine production rate by dividing said fixed volume of urine by a time period, said time period being either a time from a start of the pressure measurement to a time of the transfer of the fixed volume or a time between two of the transfers of the fixed volume; and (f) generating an average urine production rate by averaging at least two values of said instantaneous urine production rate as taught by Kostov. The motivation would have been to provide a more complete diagnostic analysis of the patient.
With regards to claim 5, the above combination teaches or suggests the pressure sensor is in direct fluid connection with the urine in an input port of the pump (Fig. 1 and ¶ [0037] of Cooper depicts the pressure sensor component 18 is positioned in and through the wall of the tube 14 and into the lumen 16).
With regards to claim 14, Cooper teaches method for measuring a rate of production of urine in a patient (¶¶ [0030] [0031] discloses methods, systems, and devices monitoring bladder health, wherein bladder health includes monitoring in real-time the pressures, volumes, and compliance of urinary bladders, wherein data collected includes volume of expelled urine; Also see ¶ [0033]) comprising steps of: inserting a catheter into said patient's bladder (Figs. 1-3C and ¶ [0033] depict a urinary catheter coupled to a bladder); occluding a lumen of said catheter (¶ [0042] discloses valve 28 occluding the catheter); emptying said bladder into collection vessel by means of at least one member of a group consisting of: passively flowing urine from said bladder and actively pumping urine from said bladder (Figs. 1 and 4 and ¶¶ [0036], [0038] depict a pump 30 connected between the component 12 (which is coupled to a catheter) and a collection vessel or container; ¶¶ [0057] [0044] discloses stopping the pump after urination has completed); measuring an amount of urine flowing through said lumen until a predetermined second pressure within said lumen is detected (¶ [0044] discloses detecting a flow rate until urination has completed; ¶ [0060] discloses the pump is turned off based when a negative pressure is sensed by the pressure sensing component ).
Cooper is silent regarding whether the collection vessel or container is a urine bag.
In the same field of endeavor of monitoring draining of bodily fluids, Burnett teaches a collection vessel or container being a urine bag (¶¶ [0005]-[0006] depict urine flowing from a foley catheter to a drainage bag). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the collection vessel of Cooper with the urine bag of Burnett. Because both elements are capable of receiving discharged urine (¶¶ [0036], [0038] of Cooper; ¶¶ [0005]-[0006] of Burnett), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding occluding a lumen of said catheter until a predetermined first pressure within said lumen is detected.
In the same field of endeavor of monitoring draining of bodily fluids, Bello teaches occluding a lumen of a catheter until a predetermined first pressure within said lumen is detected (Col. 6, line 61 to Col. 7, line 6 discloses that when pressure levels reach the pre-determined threshold, the system notifies the user when urine levels are high and manual activation of the pump initiates fluid release such that fluid is drawn through catheters and pumps, which indicates that a lumen of the catheter is occluded when the pump is not activated; Col. 6, lines 35-52 indicate the pressure transducer senses a pressure in the catheter). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the occlusion of the lumen of the catheter of the above combination such that it is occluded until a predetermined first pressure within said lumen is detected as taught by Bello. The motivation would have been to improve the automation of the fluid draining.
Although Cooper teaches calculating a urine production rate (¶ [0054] discloses determining a volumetric flow rate (i.e., a urine production rate), amount of elapsed time, and total volume expelled), the above combination is silent regarding calculating an instantaneous urine production rate by dividing said measured amount of urine by a time period, said time period being either a time from a first occlusion of said lumen or a time from a last emptying of said bladder; repeating a calculation of an instantaneous urine production rate; and generating an average urine production rate by averaging at least two values of said instantaneous urine production rate.
In a system relevant to the problem of monitoring a urine flow rate, Kostov teaches calculating an instantaneous urine production rate by dividing said measured amount of urine by a time period, said time period being either a time from a first occlusion of said lumen or a time from a last emptying of said bladder (¶ [0024] discloses measuring a variable amount of time that is required for a fixed, pre-determined volume of fluid to accumulate allows for computation of the volume of fluid per unit time, i.e., the flow rate in relation to a blocking mechanism or closure that allows for the volume to accumulate); repeating a calculation of an instantaneous urine production rate (¶ [0067] and Fig. 8 depict instantaneous flow rates and presenting data points as a rolling or moving average); generating an average urine production rate by averaging at least two values of said instantaneous urine production rate (¶ [0067] and Fig. 8 depict instantaneous flow rates and presenting data points as a rolling or moving average). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the urine production rate of Cooper to incorporate calculating an instantaneous urine production rate by dividing said measured amount of urine by a time period, said time period being either a time from a first occlusion of said lumen or a time from a last emptying of said bladder; repeating a calculation of an instantaneous urine production rate; and generating an average urine production rate by averaging at least two values of said instantaneous urine production rate as taught by Kostov. The motivation would have been to provide a more complete diagnostic analysis of the patient.
With regards to claim 16, the above combination teaches or suggests said step of measuring said amount of urine is performed by means of a member of a group consisting of a flow sensor, a volumetric pump and any combination thereof (¶ [0044] of Cooper discloses detecting a flow rate until urination has completed; ¶ [0051] of Cooper discloses the pump 30 is configured to detect the volumetric clow rate)
Claims 2, 3, 8, 9, 11, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Burnett, Bello, and Kostov, as applied to respective claims 1, 7, and 14 above, and further in view of US 2008/0103408 A1 (Denton) (previously cited)
With regards to claims 2 and 8, the above combination is silent regarding whether said predetermined first pressure is in a range from 3 mmHg to 70 mmHg.
In a system relevant to the problem of monitoring bladder pressure, Denton teaches intra-abdominal pressure is on the order of between 0-50 mmHg (¶ [0038]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure range over which the pump is operated of the above combination to incorporate, based on the teachings of Denton, a predetermined first pressure is in a range from 3 mmHg to 70 mmHg. The motivation would have been to ensure the pump operates within biologically safe pressures.
With regards to claims 3, 9, and 15 the above combination is silent regarding whether said predetermined second pressure is in a range from 0 mmHg to 5 mmHg.
In a system relevant to the problem of monitoring bladder pressure, Denton teaches intra-abdominal pressure is on the order of between 0-50 mmHg (¶ [0038]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure range over which the pump is operated of the above combination, based on the teachings of Denton, to incorporate a predetermined second pressure is in a range from 0 mmHg to 5 mmHg. The motivation would have been to ensure the pump operates within biologically safe pressures.
With regards to claim 11, the above combination teaches or suggests the fixed volume transferred in step (b) and/or step (c) is measured by means of a member of a group consisting of a flow sensor, a volumetric pump and any combination thereof (¶ [0054] of Cooper depict the pump maintaining a constant volumetric flow rate of the fluid).
With regards to claim 12, the above combination teaches or suggests the pressure sensor is in direct fluid connection with the urine in an input port of the pump (Fig. 1 and ¶ [0037] of Cooper depicts the pressure sensor component 18 is positioned in and through the wall of the tube 14 and into the lumen 16, which is in fluid connection with pump 3).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Burnett, Bello, and Kostov, as applied to respective claims 1 and 7 above, and further in view of US 5,730,149 A (Nakayama) (previously cited)
With regards to claims 4 and 10, the above combination is silent regarding whether said fix volume is in a range between 0.1 cc and 5 cc.
In a system relevant to the problem of pumping urine, Nakayama teaches that a stroke volume is about 2mL (Col. 18, lines 37-41). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination such that the fixed volume is in a range between 0.1 cc and 5 cc as taught by Nakayama. Because both the fixed volumes of Nakayama and Cooper are capable of being used for transporting urine (¶ [0054] of Cooper; Col. 18, lines 37-41 of Nakayama), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Response to Arguments
Claim Objections
There are new grounds of claim objections necessitated by the claim amendments filed 03/26/2026.
Drawing Objections
In view of the claim amendments filed 03/26/2026, the drawing objections were withdrawn.
Claim Rejections under 35 U.S.C. §112(b)
There are new grounds of claim rejections under 35 U.S.C. §112(b) necessitated by the claim amendments filed 03/26/2026.
Claim Rejections under 35 U.S.C. §103
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive.
On pages 9-11 of the response filed 03/26/2026, the Applicant provides arguments against Cooper and Bello individually and asserts that neither Cooper nor Bello teach operating a pump to transfer a fixed volume of urine upon reaching a predetermined second pressure that is lower than a predetermined first pressure or repeating the pressure measurement and pump operation until the second pressure indicates that the bladder is substantially empty.
First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As noted in the above rejection, the Examiner asserts that the combination of Cooper in view of Burnette teaches or suggests (b) upon receiving an indication that one of the pressure measurements reached a predetermined first pressure operate said pump to transfer a fixed volume of urine from said bladder into said urine bag (Beginning draining at a threshold pressure, according to Col. 6, line 46 to Col. 7, line 5 of Bello; Operating the pump to operate at a constant flow rate (which has corresponding fixed volumes) according to ¶¶ [0054], [0073] of Cooper); (c) upon receiving an indication that one of the pressure measurements reached a predetermined second pressure lower than said predetermined first pressure operate said pump to transfer another of said fixed volume of urine from said bladder into said urine bag (Continuing operation of the pump of ¶¶ [0054], [0073] of Cooper through the defined pressure range (from the threshold pressure of Bello to the negative pressure of Cooper) and/or the continued operation of the pump of Cooper until the negative pressure is reached (¶ [0060] of Cooper) necessarily includes a comparison of the measured pressure to a value of zero–once that zero value is reached, the pump operates again until the negative pressure is determined); (d) repeating steps (a) to (c) at least once until said bladder is substantially empty (Continuing operation of the pump of ¶¶ [0054], [0073] of Cooper through the defined pressure range until a negative pressure is reached according to ¶ [0060] of Cooper, wherein the negative pressure is indicative of the bladder being substantially empty).
Second, the Applicant appears to find support for these limitations in at least the last paragraph of page 17 of the specification, which indicates that “the pump is activated until the reported pressure in the bladder is lower than a second, lower threshold, lower horizontal dashed line 207, in a range of 0-15 mmHg”. The above combination of Cooper in view of Bello performs the same operation. The continued operation of the pump of Cooper until the negative pressure is reached (¶ [0060] of Cooper) necessarily includes a comparison of the measured pressure to a value of zero. Once that zero value is reached, the pump operates again until the negative pressure is determined. Therefore, the above combination of Cooper in view of Bello necessarily teaches or suggests the above limitations.
There are new grounds of rejections for claims 14-16 necessitated by the claim amendments filed 03/26/2026.
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 SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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