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, 4, 7 and 10 are objected to because of the following informalities:
Claim 1,line 3: “(108)” should be deleted;
Claim 1, line 9: a comma should be inserted after “pressure”;
Claim 1, line 12: a comma should be inserted after “pressure”;
Claim 4, line 1: “fixed” should be –fixed–;
Claim 7, line 5: a comma should be inserted after “pressure”;
Claim 7, line 8: a comma should be inserted after “pressure”;
Claim 10, line 1: “fixed” should be –fixed–.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pressure sensor in connection with the urine through an isolating film membrane of claims 6 and 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“Means of a member of a group consisting of a flow sensor, a volumetric pump and any combination thereof” in claims 11 and 16.
“Means of at least one member of a group consisting of: passively flowing urine from said bladder and actively pumping urine from said bladder” in claim 14.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-16 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 “the measured pressure” in lines 8 and 11. Claim 1, line 7 recites “pressure measurements”. It is unclear which of the plurality of “pressure measurements” of line 7 is being referred to by “the measured pressure” in lines 8 and 11. For the purposes of examination, the recitation in line 8 will be interpreted to be “a first one of the pressure measurements”, and the recitation in line 11 will be interpreted to be “a second one of the pressure measurements”. Claim 7 recites a similar feature, so it is rejected on similar grounds.
Claim 1, lines 16-17 recites “the pressure measurement”. Claim 1, line 7 recites “pressure measurements”. It is unclear which of the plurality of “pressure measurements” of line 7 is being referred to by “the pressure measurement” in lines 16-17. For the purposes of examination, the recitation of “the pressure measurement” will be interpreted to be “one of the pressure measurements”. Claim 7 recites similar limitations, so it is rejected on similar grounds.
Claim 1, line 17 recites “the transfer of the fixed volume”. Claim 1, line 9 recites “transfer a fixed volume”. Claim 1, line 12 recites “transfer another of said fixed volume”. It is unclear whether the recitation in line 17 refers to the transfer of line 9 or line 12. Claim 7 recites similar limitations, so it is rejected on similar grounds.
Claims 2-6 are rejected by virtue of their dependence from claim 1.
Claims 8-13 are rejected by virtue of their dependence from claim 7.
Claim 11 recites “said step of measuring said amount of urine”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be refer to the transferring of the fixed volumes of urine.
Claim 14 recites “repeating steps (a) to (e)” in line 12. However, the claim does not teach or suggest any steps (a) to (e). Therefore, it is unclear what steps are repeated. For the purposes of examination, the recitation will be interpreted to be “repeating a calculation of an instantaneous urine production rate”. Claims 15-16 are rejected by virtue of their dependence from claim 14.
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, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0110456 A1 (Cooper) in view of US 2017/0136209 A1 (Burnett), US 10,744,298 B1 (Bello) and US 2017/0100068 A1 (Kostov)
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 a predetermined pressure is reached (¶ [0060] discloses switching the pump off when certain pressure changes such as negative pressure is sensed by the pressure sensing component); 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 the measured pressure reached a predetermined first pressure operate said pump (b), upon receiving an indication that the measured pressure reached a predetermined second pressure, operate said pump, and (c) repeating steps (a) to (c) at least once.
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 the measured pressure 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). 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 the measured pressure 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 the measured pressure reached a predetermined second 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)); (d) repeating steps (a) to (c) at least once (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).
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).
Claims 2, 3, 8, 9, 11, and 12 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 2008/0103408 A1 (Denton)
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 and 9, 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 Examiner notes that, in light of the indefiniteness of “said step of measuring said amount of urine”, the recitation is being interpreted to be refer to the transferring of the fixed volumes of urine.
The above combination teaches or suggests the transferring of the fixed volumes of urine is performed 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).
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)
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.
Claims 6 and 13 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 8 above, and further in view of US 5,438,876 A (Lewis)
With regard to claims 6 and 13, the above combination is silent regarding whether the pressure sensor is in connection with the urine through an isolating film membrane.
In a system relevant to the problem of monitoring pressures of a fluid, Lewis teaches a pressure sensor is in connection with the urine through an isolating film membrane (Fig. 1 and Col. 4, line 64 to Col. 5, line 11 depict a pressure transducer 10 comprising a pressure-sensing element 12 in connection with an exterior through an isolating diaphragm 20). 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 pressure sensor of the above combination with a pressure sensor that it is in connection with the urine through an isolating film membrane as taught by Lewis. Because both pressure sensors are capable of monitoring a pressure (Col. 4, line 64 to Col. 5, line 11 of Lewis; ¶ [0037] of Cooper), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Burnett and Kostov
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 for a predetermined time period (¶ [0042] discloses valve 28 occluding the catheter until a pressure of the bladder is assessed); 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 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.
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)
Claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Burnett, and Kostov, as applied to claim 14 above, and further in view of Denton
With regards to claim 15, the above combination is silent regarding whether said predetermined 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 minimum predetermined pressure of the above combination to incorporate, based on the teachings of Denton, that it is 0 mmHg. The motivation would have been to ensure the pump operates within biologically safe pressures.
Conclusion
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