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 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 1-51 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 1 recites “a drainage tube having a drainage lumen in fluid communication with a second end of the catheter” but it is unclear if the limitation “in fluid communication with a second end of the catheter” is meant to convey that the drainage tube is in communication with the “catheter lumen” of line 4, the “pressure lumen” of line 9, or both of these lumens. For the purposes of this examination, the drainage tube is interpreted as being coupled to the catheter lumen and not the pressure lumen.
Claim 1 recites “a controller in communication with the fluid reservoir” but it is unclear what relationship this limitation is meant to convey. It is unclear how a controller in meant to “communicate” with a fluid reservoir. For the purposes of this examination, the limitation will be interpreted as the controller being physically attached to the fluid reservoir through any means.
Claim 1 recites “a mean arterial pressure (MAP) received by the controller” but it is unclear where the MAP is received from. It is unclear if the MAP is being generated by the system through some measurement modality or is being received from an outside source. It is unclear what element of the system would be responsible for generating such a value For the purposes of this examination, the limitation will be interpreted as the MAP being determined by the system.
Claims 2-27 are rejected by virtue of their dependence on claim 1.
Claim 3 recites “wherein the controller is further configured to determine a fluid volume collected within the fluid reservoir” but it is unclear how the controller performs such a determination. In particular, it would seem that some element of the system must make a measurement in order for the controller to determine the fluid volume. It is unclear what element of the system makes such a measurement and what the measurement entails. For the purposes of this examination, the limitation will be interpreted as any type of measurement modality which can be used to extrapolate a fluid volume. This rejection is further applied to claim 30.
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.
Claims 19 and 20 recite “the pressure transducer is coupled to sense the arterial pressure in parallel / series” but it is unclear what this limitation is meant to convey. It is unclear what other element is being compared to the pressure transducer to determine if it is in series or in parallel. For the purposes of this examination, the limitation will be interpreted as being in series or parallel with other pressure measurements. This rejection is further applied to claims 45 and 46.
Claim 21 recites “a splitter in communication with the controller” but it is unclear how this element relates to the rest of the claimed system. In particular, the splitter is being interpreted as described in the above presented claim interpretation section as including valves and stopcocks but it is unclear what relationship, if any, is present between the claimed splitter and the claimed lumens and reservoir of claim 1. For the purposes of claim 1, the limitation is interpreted as being in fluid communication with at least one of the lumens or reservoirs of claim 1.
Claim 22 recites “a display in simultaneous communication with the splitter” but it is unclear what this limitation is meant to convey. It is unclear what sort of connection constitutes “simultaneous communication” between a valve and a display. For the purposes of this examination, the limitation is interpreted as a controller in communication with both the splitter and a display.
Claims 23 and 26 recites “the controller is further configured to measure a urinary output from the patient on a continuous basis / at a predetermined frequency” but it is unclear how the controllers carry out such a measurement. It is unclear what element of the system measures urinary output and how the controller calculates urinary output values therefrom. For the purposes of this examination, the limitation will be interpreted as any means of measuring fluid flow or volume and the controller 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.)
Claim 28 recites “receiving a mean arterial pressure (MAP) by the controller” but it is unclear from where such a measurement is received. For the purposes of this examination, the limitation will be interpreted as being calculated by the controller using the pressure signals collected from the pressure sensing membrane.
Claims 29-51 are rejected by virtue of their dependency on claim 28.
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.
Claims 1-7, 18-22, 27-33, 44-46, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 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 the fluid reservoir and 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).
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); and
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).
Regarding claims 2 and 29, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 discloses the system of claim 1 and the method of claim 28 respectively Burnett further discloses the system and method wherein the controller is further configured determine a fluid volume collected within the fluid reservoir (Paragraphs 0140-0144: the volume of urine collected in the reservoir may be measured using several modalities; Paragraph 0202: urine volume measurement device connected to the reservoir.).
Regarding claim 4, Burnett discloses the system of claim 1. Burnett further discloses 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 5 and 31, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses the system and method further comprising a display in communication with the controller for displaying the APP (Paragraphs 0313 and 0327: the system may include various input/output devices; the system may determine the APP which may be displayed).
Regarding claims 6-7 and 32-33, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 18 and 44, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 claims 19-20 and 45-46, Burnett discloses the system of claim 18 and the method of claim 44 respectively. Burnett further discloses 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).
Regarding claim 21, Burnett discloses the system of claim 1. Burnett further discloses 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 discloses the system of claim 21. Burnett further discloses the system further comprising a display in simultaneous communication with the splitter (Paragraphs 0313 and 0392: the controller is in communication with the splitter and the display and thus the splitter and display are in simultaneous communication.).
Regarding claims 27 and 51, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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).
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 8-17, 23-26, 34-43, and 47-50 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 claims 8 and 34, Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 discloses the system and method of claim 9 and 35 respectively. Burnett further discloses 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 23, 26, 47, and 50 Burnett discloses the system of claim 1 and the method of claim 28 respectively. Burnett further discloses 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 (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 discloses the system of claim 23 and the method of claim 47 respectively. Burnett further discloses 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).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791