DETAILED ACTION
Applicant' s arguments, filed 06/18/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/06/2023, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 6-30, and 32-51 are the current claims hereby under examination.
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 Interpretation
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0099624 A1.
Claims 21-22 recites the limitation “splitter” Applicant defines this limitation is paragraphs 0504-0505 of the specification. The term “splitter is interpreted in accordance with Applicant’s definition as being “valves, stopcocks, and/or other fluid directing mechanisms to manually and/or automatically direct fluid flow”.
Claim Rejections - 35 USC § 112(b)
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 18, 24-25, 28-30, and 32-51 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 18 recites “a pressure transducer in communication with the controller, wherein the pressure transducer is configured to sense arterial pressure used to determine the MAP” but it is unclear if this pressure transducer is the same as, related to, or different from “a pressure sensor” of claim 1. Additionally, it is unclear what relationship, if any, is present between the “pressure transducer” and the catheter system and/or the patient. The pressure transducer is recite as being in communication with the controller but such a relationship is insufficient to carry out the recite function of measuring arterial pressure. For the purposes of this examination, the pressure transducer will be interpreted as the same element as the pressure sensor of claim 1. This rejection is further applied to claim 44.
configured to calculate a urinary output therefrom. This rejection is further applied to claims 47 and 50.
Claims 24 and 25 recite “the controller is further configured to display a measurement of the urinary output” but it is unclear how the controller itself carries out the recited function of displaying values. For the purposes of this examination, the limitation will be interpreted as a display controlled by the controller to display the urinary output values. This rejection is further applied to claims 48-49.
Claim 28 recites “receiving via a controller an intra-abdominal pressure (IAP) signal from the pressure sensing membrane” but it is unclear if the membrane itself provides the pressure signal or if a sensor in communication with the membrane provides the pressure signals. For the purposes of this examination, the limitation will be interpreted as the controller receiving pressure signals from a pressure sensor in fluid communication with the pressure sensing membrane. (Examiner’s note, this limitation is being interpreted similar to claim 1 which aligns with paragraph 0123 of Applicant’s specification. If Applicant asserts that such an interpretation is incorrect and that the membrane itself provides the pressure signals then new grounds of rejection under 35 USC 112a may be necessitated.)
Claims 29-30 and 32-51 are rejected by virtue of their dependency on claim 28.
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.
Claims 1-4, 6-18, 21-30, 32-44, and 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett US Patent Application Publication Number US 2017/0136209 A1 hereinafter Burnett.
Regarding claim 1, Burnett discloses a drainage system for monitoring health of a patient (Abstract; Paragraphs 0199, 0200, and 0307: a sensing Foley catheter for monitoring health), comprising:
an elongate catheter having a first end configured for insertion within a body lumen (Paragraphs 0201 and 0260: the catheter may be placed in the patient’s bladder or urethra; Fig. 50: the end with the opening and balloons is considered the “first end” which is inserted), the catheter having at least one opening near or at the first end in fluid communication with a catheter lumen defined therethrough (Paragraphs 0202 and 0256; Fig. 50 references 5004: the sensing catheter with an opening for urine flow. Fig. 50 illustrates that the opening is near the first end for insertion);
a drainage tube having a drainage lumen in fluid communication with a second end of the elongate catheter (Paragraph 0256, 0266, and 0293: Figs. 50 and 55: opening 5004 is in fluid communication with port 5012 to allow urine to flow out of the bladder, lumen 5504 serves as a drainage lumen; Paragraph 0202: the urine lumen and urine output tube);
a fluid reservoir which is in fluid communication with the drainage lumen (Paragraph 0299: the urine collection device; Paragraph 0202: the urine reservoir);
a pressure sensing membrane disposed on the catheter, the pressure sensing membrane being in communication with a pressure lumen defined through the catheter (Paragraphs 0202 and 0256: pressure sensing balloon and associated lumen);
a pressure sensor coupled to the pressure lumen and configured to receive an intra-abdominal pressure (IAP) signal from the pressure sensing membrane via the pressure lumen (Paragraphs 0200, 0202, and 0372: the pressure sensor may measure pressure including IAP through the pressure measuring lumen); and
a controller in communication with a fluid reservoir sensor which is in communication with the fluid reservoir (Paragraphs 0140-0144: the volume of urine collected in the reservoir may be measured using several modalities, the sensor determines the volume of urine in the cassette and the controller uses that information to determine when the cassette should be emptied; Paragraph 0202: urine volume measurement device connected to the reservoir) and the controller in further communication with the pressure sensor, wherein the controller is configured to determine an abdominal perfusion pressure (APP) based on the IAP and a mean arterial pressure (MAP) received by the controller (Paragraphs 0273 and 0327: the controller may determine APP from IAP and MAP; Paragraph 0205: the catheter may measure a variety of parameters including IAP).
a display in communication with the controller for displaying the APP, wherein the controller is further configured to display the APP or MAP graphically over time (Paragraph 0155: the display of absolute values and trends of any pertinent parameter; Paragraphs 0313: the system may include various input/output devices including a display; Paragraph 0327: the system may determine the APP and MAP These paragraphs are considered sufficient to teach the display of graphical trends of APP and/or MAP over time because, while the display of such parameters is not explicitly recited, Burnett does disclose determining these parameters which indicates that they are relevant and Burnett further explicitly teaches the display of any pertinent parameters including historical values of the pertinent parameters. Thus, Burnett is considered to teach the graphical display of APP and/or MAP and their historical trends, or graphically over time)
Regarding claim 28, Burnett discloses a method for monitoring health of a patient (Abstract; Paragraphs 0199, 0200, and 0307: a sensing Foley catheter for monitoring health), comprising:
receiving a fluid from a body lumen via a catheter lumen defined through an elongate catheter having a pressure sensing membrane disposed on or near a first end inserted within the body lumen (Paragraphs 0201-0202, 0256, 0296, and 0372: the pressure sensing balloon inserted into the patient) and where the catheter has at least one opening near or at the first end in fluid communication with the catheter lumen (Paragraphs 0202, 0230, 0256, 0266, and 0293: Figs. 50 and 55: opening 5004 is in fluid communication with port 5012 to allow urine to flow out of the bladder, lumen 5504 serves as a drainage lumen; Paragraph 0202: the urine lumen and urine output tube);
collecting the fluid within a fluid reservoir in fluid communication with a drainage lumen (Paragraph 0299: the urine collection device; Paragraph 0202: the urine reservoir) defined through a drainage tube, where the drainage lumen is in fluid communication with a second end of the catheter (Paragraphs 0202, 0256, 0266, 0293, and 0299: Figs. 50 and 55: opening 5004 is in fluid communication with port 5012 to allow urine to flow out of the bladder, lumen 5504 serves as a drainage lumen;);
receiving via a controller an intra-abdominal pressure (IAP) signal from the pressure sensing membrane (Paragraphs 0200, 0202, 0230 and 0372: the pressure sensor may measure pressure including IAP through the pressure measuring lumen);
further receiving a mean arterial pressure (MAP) by the controller (Paragraphs 0273 and 0327: mean arterial pressure is utilized in calculations and thus must be received; Paragraph 0429-0430: MAP may be calculated using the pressure sensing balloon);
determining via the controller an abdominal perfusion pressure (APP) based on the IAP and the MAP (Paragraphs 0273 and 0327: the controller may determine APP from IAP and MAP; Paragraph 0205: the catheter may measure a variety of parameters including IAP), and
displaying the APP or MAP graphically over time via a monitor in communication with the controller (Paragraph 0155: the display of absolute values and trends of any pertinent parameter; Paragraphs 0313: the system may include various input/output devices including a display; Paragraph 0327: the system may determine the APP and MAP These paragraphs are considered sufficient to teach the display of graphical trends of APP and/or MAP over time because, while the display of such parameters is not explicitly recited, Burnett does disclose determining these parameters which indicates that they are relevant and Burnett further explicitly teaches the display of any pertinent parameters including historical values of the pertinent parameters. Thus, Burnett is considered to teach the graphical display of APP and/or MAP and their historical trends, or graphically over time)
Regarding claims 2 and 29, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method wherein the controller is further configured to determine the APP based on a difference between the MAP and the IAP (Paragraph 0327: the controller may determine the APP by finding the difference between MAP and IAP) .
Regarding claims 3 and 30, Burnett teaches the system of claim 1 and the method of claim 28 respectively Burnett further teaches the system and method wherein the controller is further configured to determine a fluid volume collected within the fluid reservoir based on a measurement received from the fluid reservoir sensor (Paragraphs 0140-0144: the volume of urine collected in the reservoir may be measured using several modalities. The controller determines when to empty the reservoir based on the sensed volume; Paragraph 0202: urine volume measurement device connected to the reservoir.).
Regarding claim 4, Burnett teaches the system of claim 1. Burnett further teaches the system further comprising a drainage valve located at an entry point where the drainage lumen connects to the fluid reservoir (Paragraphs 0148 and 0299: the outflow tubing is connected to the reservoir using one-way valves to prevent urine from exiting the reservoir once collected).
Regarding claims 6-7 and 32-33, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method further comprising a pump in communication with the controller and in fluid communication with the drainage tube (Paragraphs 0204-0205, 0209 and 0336: the fluid flow may be controlled by a pump in communication with a controller); and wherein the controller is further configured to actuate the pump to apply a negative pressure for clearing an airlock from the drainage tube (Paragraphs 0140, 0167, 0337 and 0343: the pump is used as the airlock clearing mechanism by applying a negative pressure; the pump is controlled by a controller).
Regarding claims 8 and 34, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method wherein the controller is configured to determine the APP in real-time (Paragraphs 0133, 0392, and 0426: the various pressure readings may be made using adjustable sampling frequencies including in real-time; Paragraphs 0273 and 0327: the APP is determined. These recitations are considered to at least suggest that the APP may be determined in real-time since the requisite parameters to calculate it may be determined in real-time).
Regarding claims 9 and 35, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method wherein the controller is configured to determine the APP at a predetermined frequency (Paragraphs 0133, 0392, 0426: the various pressure readings may be made using adjustable sampling frequencies; Paragraphs 0273 and 0327: the APP is determined. These recitations are considered to at least suggest that the APP may be determined at a predetermined frequency since the requisite parameters to calculate it may be determined at pre-determined frequencies).
Regarding claims 10-17 and 36-43, Burnett teaches the system and method of claim 9 and 35 respectively. Burnett further teaches the system and method wherein the controller is configured to determine the APP at various frequencies.
Burnett teaches that physiological measurements may be taken at predetermined frequencies (Paragraphs 0133, 0392, 0426), such recitations in combination with the teachings of determining APP (Paragraphs 0273 and 0327) are considered to at least suggest that APP may be determined at a predetermined frequency as described in the rejection of claims 9 and 35 above.
The particular frequency at which APP is determined is considered a matter of routine optimization and experimentation which depends on the available measurement sampling rates and particular patient needs. The specification does not set forth a surprising technical effect or benefit achieved by any particular APP determination frequency.
As such, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have configured the system of Burnett to measure APP periodically at any given frequency because the particular frequency at which APP is measured is considered to be a matter of routine optimization and experimentation of the sampling and/or calculation frequency to optimize the system for a particular patient or use case and does not produce a surprising technical effect.
Regarding claims 18 and 44, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method further comprising a pressure transducer in communication with the controller, wherein the pressure transducer is configured to sense arterial pressure used to determine the MAP (Paragraphs 0204-0206, 0273, 0319, 0372, and 0429-0430: the pressure transducer may measure mean arterial pressure).
Regarding claim 21, Burnett teaches the system of claim 1. Burnett further teaches the system further comprising a splitter in communication with the controller (Paragraphs 0208 and 0392: various valves, stopcocks, and/or solenoids may be in communication with the controller).
Regarding claim 22, Burnett teaches the system of claim 21. Burnett further teaches the system wherein the controller is in simultaneous communication with the splitter and a display (Paragraphs 0313 and 0392: the controller is in communication with the splitter and the display).
Regarding claims 23, 26, 47, and 50 Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method wherein the controller is further configured to measure a urinary output from the patient on a continuous basis or at a predetermined frequency based upon the fluid reservoir sensor which is in communication with the fluid reservoir (Paragraphs 0140-0144: the volume of urine collected in the reservoir may be measured using several modalities, the sensor determines the volume of urine in the cassette and the controller uses that information to determine when the cassette should be emptied; Paragraph 0202: urine volume measurement device connected to the reservoir; Paragraphs 0140, 0205, 0276, 0313, 0396 and 0403: urinary output may be measured continuously in real-time. Additionally the recitations of paragraph 0396 drawn towards the urinary output measurements being accurate to within a plurality of timeframes is considered to at least suggest the urinary output measurement being taken periodically in the given timeframes).
Regarding claims 24-25 and 48-49, Burnett teaches the system of claim 23 and the method of claim 47 respectively. Burnett further teaches the system and method wherein the controller is further configured to display a measurement of the urinary output on a continuous basis or at a predetermined frequency (Paragraphs 0140, 0205, 0276, 0396 and 0403: urinary output may be measured in real-time and/or at a predetermined frequency; the recitations of paragraph 0396 drawn towards the urinary output measurements being accurate to within a plurality of timeframes is considered to at least suggest the urinary output measurement being taken periodically in the given timeframes; Paragraphs 0145 and 0313 teaches an output device; These recitation are considered sufficient to at least suggest that the urinary output may be displayed in real-time or at a predetermined frequency).
Regarding claims 27 and 51, Burnett teaches the system of claim 1 and the method of claim 28 respectively. Burnett further teaches the system and method wherein the pressure sensing membrane comprises an expandable balloon disposed on the catheter (Paragraphs 0201-0202, 0296, and 0372: the pressure sensing balloon inserted into the patient).
Claims 19-20 and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett US Patent Application Publication Number US 2017/0136209 A1 hereinafter Burnett in view of Denton US Patent Application Publication Number US 20080103408 A1 hereinafter Denton.
Regarding claims 19-20 and 45-46, Burnett teaches the system of claim 18 and the method of claim 44 respectively. Burnett further teaches the system and method wherein the pressure transducer is coupled to sense the arterial pressure in parallel or in series (Paragraphs 0204-0206, 0273, 0319, 0372, and 0429-0430: the pressure transducer may measure mean arterial pressure; Paragraph 0319 recites that measurements may be performed in parallel or in series; Paragraph 0296: the blood pressure balloon and pressure transducer may be integrated with, or separate from the fluid retention and/or pressure sensing balloon;).
Burnett fails to explicitly recite the arterial pressure being sensed in parallel or in series with a second pressure transducer.
Denton teaches a device structured to generate an input signal to a monitor to visually indicate a value for one or more physiological state variables measured by one or more transducers. The device may be a Foley catheter (Abstract; Paragraph 0026). Thus, Denton falls within the same field of endeavor as Applicant’s invention.
Denton teaches the use of a secondary pressure transducer in an arterial line to receive arterial line pressure (Paragraphs 0045-0046)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the second pressure transducer for sensing arterial pressure as taught by Denton into the system and method of Burnett because Burnett teaches that parameters such as blood pressure may be received from elsewhere to be used by the system (Burnett Paragraph 0274) and receiving the arterial pressure from an arterial line sensor as taught by Denton in series and/or in parallel with the arterial pressure calculated by Burnett (Paragraph 0429) may improve the accuracy of arterial pressure sensing which could improve patient outcome and further result in more accurate calculations of parameters that rely on arterial pressure such as Abdominal perfusion pressure.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
In particular, Applicant’s arguments with respect to the prior art do not particularly point out elements of the amended claim are not taught by Burnett. Applicant’s arguments are considered moot in light of the new grounds of rejection presented above for the amended limitations.
In regards to Applicant’s arguments tot eh rejections presented under 35 USC 112, Applicant’s amendments and arguments are considered sufficient to overcome some of the previously presented rejections but not all of them.
In particular, Applicant argues that the “pressure transducer” of claim 18 is clearly a distinct element from the pressure sensor of claim 1 due to their different terms.
This argument is not found to be persuasive because one of ordinary skill in the art would recognize that “pressure transducer” is synonymous with “pressure sensor” and Applicant’s own specification uses the terms interchangeably to refer to the same element in paragraphs 0248, 0386, and 0388 which are each drawn towards an embodiment where the inserted balloon and associated pressure lumen are used to measure MAP using the “pressure transducer” in the controller (0248), or the “pressure sensor” in communication with the pressure lumen and balloon (0386 and 0388). Applicant’s specification does not provide a structural or functional distinction between a pressure sensor and a pressure transducer. Applicant points to paragraphs 0504-0505 referring to the embodiments of Figs. 68-71 where the pressure transducer records arterial pressure through an arterial line and is thus separate from the pressure sensor in communication with the pressure lumen but this argument is not found to be persuasive because Applicant’s claims are not distinctly direct towards such an embodiment. Applicant’s claim language does not exclude the embodiments of Figs. 26-29 which include a pressure sensor/transducer connected to the pressure lumen which also measures MAP as described in paragraphs 0386-0388. Thus, It is unclear if the pressure transducer of claim 18 is the same element as the pressure sensor of claim 1 since these terms are considered synonymous in the art and the specification does not clearly distinguish a pressure transducer from a pressure sensor. The terms are used interchangeably in the specification.
Applicant further argues that the rejections drawn towards 24-25, 28, and 48-49 are invalid because the interpretation set forth in the office action shows they are clear.
This argument is not found to be persuasive. The interpretation set forth in the office action is the Examiner’s understanding of what was intended by the claim language but such an interpretation being set forth does not indicate that the claim language clearly and distinctly describes the invention. In particular, the controller is still considered incapable of displaying data as set forth in claims 24-25 and 48-49 and the pressure sensing membrane of claim 28 is still considered incapable of providing pressure signals itself.
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 MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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