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 .
Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive. Applicant argues that Erbey does not disclose the amended limitations of an external sensor excluding a urine sensor. Erbey describes in ¶[0433] non-invasive sensors 724 that are fully capable of being external and in contact with the skin and do not explicitly include a urine sensor as set forth in the rejection below. Thus the rejection for claim 1 over Erbey is maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 13-25, 30-33, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erbey (US 20170348507).
Regarding Claim 1, Erbey discloses a system for removing fluid from a urinary tract (Fig 1, 19 ¶[0364] urine collection assembly 100), comprising: at least one sensor configured to detect signal(s) representative of bioelectrical impedance and communicate signal(s) representative of the impedance (Fig 1, 19 ¶[0413-0414] sensors 724. Sensors may comprise conductance sensors. Information obtained from the sensors 724 can be transmitted to a central data collection module or processor and used, for example, to control operation of an external device, such as the pump 710), wherein the at least one sensor is configured to detect signal(s) representative of bioelectrical impedance and comprises an external sensor configure to be positioned in contact with skin, wherein the at least one external sensor excludes a urine sensor (¶[0433] non-invasive sensors 724 envisioned by Erbey are fully capable of being external and in contact with the skin and do not explicitly include a urine sensor); and a controller (Fig 19 ¶[0425] controller 714) configured to: receive and process the signal(s) from the at least one external sensor to determine if the impedance is above, below, or at a predetermined value; and provide a control signal, determined at least in part from the signal(s) representative of the impedance received from the at least one external sensor, to a negative pressure source to apply negative pressure to a urinary catheter when the impedance is below the predetermined value and to cease applying negative pressure when the impedance is at or above the predetermined value (Fig 24 ¶[0442-0444] The sensor may be used to measure information representative of blood protein, oxygen, creatinine, and/or hematocrit levels. Measured blood parameter values may be measured continuously or periodically and compared to various threshold or clinically acceptable values. Negative pressure may continue to be applied to the patient's kidney or ureter until a measured parameter value falls within a clinically acceptable range. Once a measured values fails within the threshold or clinically acceptable range, as shown at box 916, application of negative pressure may cease).
Regarding Claim 8, Erbey discloses that the at least one sensor configured to detect signal(s) representative of bioelectrical impedance comprises an external sensor configured to be positioned in contact with skin (¶[0433] patient monitoring sensors 724 include external sensors).
Regarding Claim 13, Erbey discloses that the negative pressure source comprises a pump configured to apply the negative pressure to the urinary catheter (Figs 1, 19 ¶[0408][0410] pump 710 induces negative pressure to the ureters/kidneys), the pump comprising at least one fluid port in fluid communication with a drainage lumen of the urinary catheter (Figs 1, 17B, 19 ¶[0409-0410] pump 710 may fluidly communicate with catheters 112, 114, 116 via outflow port 158).
Regarding Claim 14, Erbey discloses that at least a portion of the pump is configured to be positioned external to the urinary tract (Fig 19, pump 710 is externally positioned).
Regarding Claim 15, Erbey discloses that at least a portion of the pump is configured to be implanted in the urinary tract (¶[0437] at least a portion of the pump assembly can be positioned within the patient's urinary tract).
Regarding Claim 16, Erbey discloses that the pump comprises at least one of a rotary pump, a rotodynamic pump, or a positive displacement pump (¶[0436] Pump 710 may be a piston pump, diaphragm aspiration pump).
Regarding Claim 17, Erbey discloses that the pump is configured to provide negative pressure ranging from about 5 mmHg to about 150 mmHg to the drainage lumen of the urinary catheter, as measured at the at least one fluid port of the pump (¶[0436][0439]).
Regarding Claim 18, Erbey discloses that the pump is configured to produce negative pressure in the urinary catheter sufficient for establishing a pressure gradient across a glomerulus of a kidney (¶[0410] Pump 710 induces negative pressure in the kidneys, thus establishing a pressure gradient).
Regarding Claim 19, Erbey discloses that the controller is an external controller positioned outside of a body, the external controller being electrically coupled to the pump to provide the control signal and, optionally, power to the pump (Fig 19 ¶[0426-0427] controller 714 may be a separate electronic device in communication with the pump 710).
Regarding Claim 20, Erbey discloses that the controller is a pump controller disposed on a printed circuit board within a housing of the pump (¶[0426] controller 714 may be included in the pump 710).
Regarding Claim 21, Erbey discloses a remote computer device in wired or wireless communication with the controller, the remote computer device being configured to provide instructions to the controller for operating the negative pressure source and to receive information from the controller about at least one of the negative pressure source and/or about the impedance (Fig 19 ¶[0429-0431] feedback device 720 may be a computer that sends and receives data for operating the system, including the pump 710).
Regarding Claim 22, Erbey discloses the urinary catheter (Fig 1 ¶[0365] ureteral catheters 112, 114, and bladder catheter 116).
Regarding Claim 23, Erbey discloses that the urinary catheter comprises a ureteral catheter (Fig 1, ureteral catheters 112, 114) comprising a distal portion comprising a retention portion (Fig 1 ¶[0369] retention portion 130) and a proximal portion comprising a drainage lumen (Fig 1 ¶[0366] tube 122 of ureteral catheters 112 and 114 comprise drainage lumens 124).
Regarding Claim 24, Erbey discloses that the retention portion of the ureteral catheter comprises an outer periphery or protective surface area which prevents mucosal tissue from a kidney, renal pelvis, and/or uretero-renal pelvis junction from occluding one or more protected drainage holes, ports, or perforations of the catheter upon application of negative pressure through the ureteral catheter (Fig 3B ¶[0378] retention portion 130 includes drainage ports 132 on only the radially inward side of the retention structure with which prevents occlusion of the drainage ports 132 upon application of negative pressure).
Regarding Claim 25, Erbey discloses that the retention portion comprises a coil, and wherein the one or more protected drainage holes, ports, or perforations extend through a radially inwardly facing portion of a sidewall of the coil (Fig 3B ¶[0378] retention portion 130 comprises coils 184 with drainage ports 132 located only on the radially inward facing portion of the coil).
Regarding Claim 30, Erbey discloses that the controller is further configured to: as the negative pressure source is applying negative pressure to the urinary catheter, periodically compare the impedance to the predetermined value for impedance; and provide additional control signals to the negative pressure source to increase a magnitude of the negative pressure applied by the negative pressure source to the urinary catheter when the impedance is less than the predetermined value (¶[0435][0438-0439]).
Regarding Claim 31, Erbey discloses that the controller is configured to provide additional control signals to the negative pressure source to cause the negative pressure source to continue providing the increased magnitude of negative pressure to the urinary catheter until the thoracic impedance decreases below the predetermined value (¶[0435][0438-0439]).
Regarding Claim 32, Erbey discloses that the periodic comparison between the impedance and the predetermined value occurs at least one of every hour, every four hours, every eight hours, or every twenty four hours (¶[0438]).
Regarding Claim 33, Erbey discloses at least one fluid sensor connected to the urinary catheter or the negative pressure source configured to measure at least one of flow rate of fluid passing through the urinary catheter, total fluid volume of fluid passing through the urinary catheter, and/or an analyte concentration of fluid passing through the urinary catheter, wherein the control signal is determined based, at least in part, on measurements by the at least one fluid sensor (¶[0413-0414] sensors 174 may be flow sensors or analyte sensors which communicate with a processor to control operation of the pump).
Regarding Claim 35, Erbey discloses that the system is configured to remove fluid from a patient (Fig 1, 19 ¶[0391] bladder catheter 116 comprises an interior of which defines a drainage lumen 140 configured to conduct urine from the bladder 10 to an external urine collection container 712).
Regarding Claim 36, Erbey discloses that the patient is an animal (¶[0414][0453][0501] Humans are mentioned as patients, and the system is further tested on farm animals).
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.
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 9-11 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Erbey (US 20170348507) in view of Tran (US 20210106281 A1).
Regarding Claim 9, Erbey does not explicitly disclose that the external sensor is configured to measure total body impedance.
However, Tran teaches a medical monitoring system, thus from the same field of endeavor, wherein the external sensor is configured to measure total body impedance (¶[0117-0118] Circular flat electrodes as well as band type electrodes can be used. In one embodiment, the electrodes are in direct contact with the skin surface. An electrical current, injected at a single frequency, is used to measure whole body impedance) to detect acute dehydration, pulmonary edema, or hyperhydration (¶[0118]).
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 Erbey so that the external sensor is configured to measure total body impedance, as taught by Tran to detect acute dehydration, pulmonary edema, or hyperhydration (as motivated by Tran ¶[0118]).
Regarding Claims 10 and 11, Erbey does not explicitly disclose whether the at least one sensor configured to detect signal(s) representative of bioelectrical impedance comprises a first electrode configured to be positioned on an extremity and a second electrode configured to be positioned on another extremity wherein the first electrode is configured to be positioned on one of a shoulder, arm, wrist, palm, or finger, and the second electrode is configured to be positioned on one of a thigh, knee, leg, ankle, or foot.
However, Tran teaches a medical monitoring system, thus from the same field of endeavor, wherein the at least one sensor configured to detect signal(s) representative of bioelectrical impedance comprises a first electrode configured to be positioned on an extremity and a second electrode configured to be positioned on another extremity, wherein the first electrode is configured to be positioned on one of a shoulder, arm, wrist, palm, or finger, and the second electrode is configured to be positioned on one of a thigh, knee, leg, ankle, or foot (¶[0148] the sensors are mounted on the animal for detecting the body's electrical signals emanating from muscles (EMG and EOG) and brain (EEG) and cardiovascular system (ECG). Tran envisions leg sensors and finger sensors) to detect the body’s electrical signals emanating from muscles, brain, and cardiovascular system (¶[0148]).
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 Erbey so that the at least one sensor configured to detect signal(s) representative of bioelectrical impedance comprises a first electrode configured to be positioned on an extremity and a second electrode configured to be positioned on another extremity, wherein the first electrode is configured to be positioned on one of a shoulder, arm, wrist, palm, or finger, and the second electrode is configured to be positioned on one of a thigh, knee, leg, ankle, or foot, as taught by Tran to detect the body’s electrical signals emanating from muscles, brain, and cardiovascular system (as motivated by Tran ¶[0148]).
Regarding Claim 37, Erbey is silent whether the patient is a dog.
However, Tran teaches a medical monitoring system, thus from the same field of endeavor, wherein the patient is a dog (Fig 1B ¶[0031-0032]) to use processed data to determine animal health status for timely treatment to save the animal (¶[0007]).
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 Erbey so that the patient is a dog, as taught by Tran to use processed data to determine animal health status for timely treatment to save the animal (as motivated by Tran ¶[0007]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Erbey (US 20170348507 A1) in view of Min (US 20080091114 A1).
Regarding Claim 12, Erbey does not explicitly disclose that the signal(s) representative of bioelectrical impedance are representative of pulmonary edema, and wherein as pulmonary edema increases, the bioelectrical impedance decreases.
However, Min teaches techniques for correlating thoracic impedance with physiological status, thus from the same field of endeavor, wherein the signal(s) representative of bioelectrical impedance are representative of pulmonary edema, and wherein as pulmonary edema increases, the bioelectrical impedance decreases (¶[0003] For instance, pulmonary edema (e.g., increased fluid levels in the lungs) produces decreased thoracic impedance values for electrical signals passing through the pulmonary tissues) because correlating physiological status with thoracic impedance measurements would allow more accurate detection of pulmonary fluid levels (¶[0003]).
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 Erbey so that the signal(s) representative of bioelectrical impedance are representative of pulmonary edema, and wherein as pulmonary edema increases, the bioelectrical impedance decreases, as taught by Min because correlating physiological status with thoracic impedance measurements would allow more accurate detection of pulmonary fluid levels (as motivated by Min ¶[0003]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Erbey (US 20170348507 A1) in view of Dove (US 20230263442 A1).
Regarding Claim 34, Erbey is silent regarding at least one pressure sensor positioned on a distal end portion of the urinary catheter configured to measure pressure at a kidney, renal pelvis, ureter, or bladder, wherein the control signal is determined based, at least in part, on measurements by the at least one pressure sensor.
However, Dove teaches a urinary catheter comprising pressure sensors, thus from the same field of endeavor, including at least one pressure sensor positioned on a distal end portion of the urinary catheter configured to measure pressure at a kidney, renal pelvis, ureter, or bladder, wherein the control signal is determined based, at least in part, on measurements by the at least one pressure sensor (Fig 1 ¶[0038] pressure sensor 21 at end 17b of catheter 10 is configured to generate a signal indicative of an amount of suction force applied to the bladder, and control circuitry of external device 24 (or another device) may be configured to control operation of pump 23 based on the signal from the pressure sensor) to help ensure that pumping only occurs when urine is present in the bladder to minimize impacts to the bladder tissue (¶[0038]).
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 Erbey to include at least one pressure sensor positioned on a distal end portion of the urinary catheter configured to measure pressure at a kidney, renal pelvis, ureter, or bladder, wherein the control signal is determined based, at least in part, on measurements by the at least one pressure sensor, as taught by Dove to help ensure that pumping only occurs when urine is present in the bladder to minimize impacts to the bladder tissue (as motivated by Dove ¶[0038]).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/ Supervisory Patent Examiner, Art Unit 3781
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