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 .
Status of Claims
Claims 1-17 are pending in the application.
Claims 1-17 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/24/2024, 11/18/2024, 04/02/2025, 07/18/2025, 10/31/2025, and 02/05/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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 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 1-7 and 9-12 are rejected under 35 U.S.C 103 as being unpatentable over Burnett (US PGPUB 20170136209) in view of Zani (US PGPUB 20170202698).
Regarding claim 1, Burnett discloses a catheterization system (drainage assembly: Abstract and Fig. 10A), comprising:
a catheter (a sensing Foley catheter 1000: ¶0137 and Fig. 10A) coupled to a drainage bag by tubing (fluid collection bag 1020: ¶0137 and Fig. 10A).
Burnett further discloses an indicator configured to detect and measure an attribute (an indicator 1112/1114/1155/1156/1158/1162: ¶0146, 0153, 0155, and Figs. 10A-B), but does not disclose the indicator selected from the group consisting of a location indicator, a duration indicator, an elevation indicator, a tamper indicator, a dependent loop indicator, a floor contact indicator, a patient securement indicator, and combinations thereof.
In the same field of endeavor, catheterization system, Zani discloses catheterization and urine drainage bag system 100 comprising a drainage bag 102 having at least one indicator element 104 (¶0023 and Fig. 1A). Zani further discloses a duration indicator (an indicator element provides a date of insertion of a catheter operably connected to the drainage bag: ¶0019 and Fig. 1A) for the benefit of providing information indicating that the one or more patient care protocols were performed (¶0018-0019).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system Burnett in view of Zani by incorporating a location indicator, in order to provide information indicating that the one or more patient care protocols were performed, as suggested in ¶0018-0019 of Zani.
Burnett further discloses data collected by the system configured to integrate with Electronic Health Records (EHRs) or Electronic Medical Records (EMRs) configured to record and display information (¶0147 and 0310); the system of Burnett/Zani is capable of transmitting information relating to the attribute to Electronic Health Records (EHRs) or Electronic Medical Records (EMRs).
Regarding claim 2, Burnett further discloses the attribute relates to the use of the catheterization system (¶0146, 0153, 0155, and Figs. 10A-B), and wherein the indicator includes a sensor configured to measure the attribute (the indicator 1156 and a temperature sensor configured to measure core body temperature: ¶0114, 0153, and Fig. 10B).
Regarding claim 3, Burnett further discloses the indicator is communicatively coupled with a network (¶0312).
Regarding claim 4, Burnett further discloses the attribute is selected from the group consisting of a geographical location, a measure of catheter dwell time, an elevation of the drainage bag relative to a bladder of a patient, a fault in the electrical or fluid communication between the catheter, tubing, and drainage bag, a dependent loop in the tubing, a contact between a portion of the catheter system and a floor surface, a detachment of a portion of the catheter system from the patient, and combinations thereof (error LED/indicator 1112 is an indicator if any error has occurred within the system: ¶0146 and Fig. 10A; thus, Burnett implicitly discloses the attribute being a fault in the electrical or fluid communication between the catheter, tubing, and drainage bag).
Regarding claim 5, Burnett further discloses the indicator is coupled to the drainage bag (¶0137 and Fig. 10A).
Regarding claim 6, Burnett further discloses the catheter includes a sensor disposed adjacent a distal end of the catheter (a pressure sensor is disposed near a distal end of the catheter: ¶0386).
Regarding claim 7, Burnett further discloses the catheter (1000) further includes: a catheter body (a catheter body 102: Fig. 1);
a balloon disposed adjacent to the distal end of the catheter (a balloon 104/108 disposed adjacent to the distal end of the catheter: Fig. 1);
a drainage lumen extending from the distal end to a proximal end of the catheter (a urine drainage lumen: ¶0110 and Fig. 1);
an inflation lumen extending from the balloon to the proximal end of the catheter (a retention balloon inflation lumen of sensing Foley catheter 2902: ¶0202 and Fig. 29), wherein the sensor is communicatively coupled with the indicator (temperature indicator 1156 shows the patient's core body temperature as sensed by the temperature sensor in the sensing Foley catheter: ¶0153 and Fig. 10B; thus, the temperature sensor is communicatively coupled with the temperature indicator).
Regarding claim 9, Burnett further discloses the sensor and the indicator are communicatively coupled by way of a wire disposed in a wall of the catheter body (temperature communication wire 112 connects temperature sensor to a display, connector and/or controller: ¶0112 and 0153; Figs. 1 and 10B).
Regarding claim 10, Burnett implicitly discloses the sensor and the indicator are communicatively coupled by means of wireless communication (Burnett discloses the sensing Foley catheter system comprising a loop controller which receives one or more pieces of data relating to patient parameters, and uses this information to control one or more medical treatment device or devices and the loop controller is connected either by a wired or wireless connection: ¶0212 and Fig. 33; the loop controller encompasses the communicatively coupling of the sensor and the indicator; thus, Burnett implicitly discloses the sensor and the indicator are communicatively coupled by means of wireless communication).
Regarding claim 11, Burnett further discloses the sensor is designed to detect one or more of: an internal body temperature (¶0112), a presence of moisture, a pressure (¶0170), a three-dimensional spatial location, a velocity of the catheter, a force on the catheter, a distance of the catheter to an object, and a proximity of the catheter to an object.
Regarding claim 12, Burnett further discloses the indicator is designed to communicate with the sensor to indicate an attribute relating to at least a three-dimensional spatial location, a presence of moisture, an inflation of the balloon, a velocity of the catheter, a force on the catheter, a proximity of the catheter to an object, a distance of the catheter to an object, or an internal body temperature (¶0153).
Claim(s) 13-14 is/are rejected under 35 U.S.C 103 as being unpatentable over Burnett in view of Zani, as applied to claim 6 above, and further in view of Tobescu (US PGPUB 20150343173).
Regarding claims 13-14, Burnett/Zani does not disclose the sensor is designed to detect a start point of dwell time and an end point of dwell time and the duration indicator is designed to indicate the real time duration of use of the catheter; and the start point of dwell time includes when the distal end is disposed within a bladder, when the balloon has been inflated, or when urine has started to flow through the catheter.
In the same field of endeavor, catheter, Tobescu discloses a catheter 10 comprising a duration indicator (a security unit 2 monitors a length of stay of the catheter in a body: ¶0454; thus, a security unit reads on the claimed duration indicator) and a sensor (a sensing element: ¶0007, 0010, 0189, 0205, 0545; thus, the sensor is capable of indicating the real time duration of use of the catheter and Tobescu implicitly suggests that the start point of dwell time includes when the distal end is disposed within a bladder or when urine has started to flow through the catheter) for the benefit of monitoring a length of stay of the catheter and thus facilitating to prevent a too long stay of catheter (¶0454).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Burnett/Zani in view of Tobescu by incorporating a duration indicator and a duration sensor, in order to monitor a length of stay of the catheter and thus facilitate to prevent a too long stay of catheter, as suggested in ¶0454 of Tobescu. Thus, the sensor of Burnett/Zani in view of Tobescu is capable of detecting a start point of dwell time and an end point of dwell time and wherein the start point of dwell time includes when the distal end is disposed within a bladder or when urine has started to flow through the catheter.
Claim(s) 15-17 is/are rejected under 35 U.S.C 103 as being unpatentable over Burnett in view of Zani, as applied to claim 6 above, and further in view of Hunter (US PGPUB 20170196478).
Regarding claim 15, Burnett/Zani does not disclose the sensor is designed to detect the three-dimensional spatial location of the catheter and the indicator is the location indicator.
In the same field of endeavor, catheter, Hunter discloses a catheter comprising a sensor to detect three-dimensional spatial location of the catheter (a position sensor: ¶0080 and 0097; the position sensor is capable of detecting image of the catheter; thus, the position sensor reads on the claimed “sensor to detect three-dimensional spatial location of the catheter”) for the benefits of allowing imaging of the catheter, and detecting of changes and/or movement over time (¶0080 and 0097). Hunter further discloses the data collected by the sensor is stored in a location indicator (a receiving unit or a memory located within the catheter: ¶0026-0027; the receiving unit or the memory is capable of indicating three-dimensional spatial location of the catheter sensed by the sensor; thus, the receiving unit or the memory reads on the claimed location indicator) for the benefit of providing an analysis of the signal provided by the sensor (¶0026).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Burnett/Zani in view of Hunter by incorporating a three-dimensional spatial location sensor and a location indicator, in order to confirm anatomical location and conformation, accurately determine the movement of the catheter during physical examination, and provide an analysis of the signal provided by the sensor, as suggested in ¶0015, 0026, and 0071 of Hunter.
Regarding claim 16, Burnett/Zani does not disclose wherein the sensor is designed to detect the force on the catheter and the indicator is a patient securement indicator.
Hunter further discloses the catheter comprising a sensor for the benefit of detecting force and mechanical stresses on the catheter (¶0014 and 0082). Hunter further discloses the data collected by the sensor is stored in a receiving unit or a memory located within the catheter (¶0026-0027: the receiving unit or the memory located within the catheter is capable of indicating proper placement and forces on the catheter sensed by the sensor; thus, the receiving unit or the memory reads on the claimed patient securement indicator) for the benefit of providing an analysis of the signal provided by the sensor (¶0026).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Burnett/Zani in view of Hunter by incorporating a sensor and a patient securement indicator, in order to detect force and mechanical stresses on the catheter, and provide an analysis of the signal provided by the sensor, as suggested in ¶0014, 0026, and 0082 of Hunter.
Regarding claim 17, Burnett/Zani does not disclose the sensor is a pressure sensor designed to detect a presence of accumulations of static fluid and the indicator is a dependent loop indicator.
Hunter further discloses the catheter comprising a pressure sensor (¶0093, 0105, 0110, and 0120) for the benefits of measuring pressure and detecting obstruction in the catheter (¶0120). Hunter further discloses the data collected by the sensor is stored in a receiving unit or a memory located within the catheter (¶0026-0027: the receiving unit or the memory located within the catheter is capable of indicating flow irregularities within the catheter sensed by the sensor; thus, the receiving unit or the memory reads on the claimed dependent loop indicator) for the benefit of providing an analysis of the signal provided by the sensor (¶0026).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Burnett/Zani in view of Hunter by incorporating a pressure sensor and a dependent loop indicator, in order to measure pressure, detect obstruction in the catheter, and provide an analysis of the signal provided by the sensor, as suggested in ¶0026 and 0120 of Hunter.
Allowable Subject Matter
The reasons for indicating allowable subject matter are the same as those presented in the Notice of Allowance Office Action filed on 01/19/2024 of Application number 17/054493.
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record is Burnett (US PGPUB 20170136209) and Martin (US PGPUB 20120078235).
Burnett discloses a catheter comprising a catheter body and the sensor is commutatively coupled with the indicator. Burnett fails to disclose the indicator is disposed in an external wall of the catheter body adjacent to the proximal end opposite a branching arm of the catheter body through which the inflation lumen passes. Burnett teaches the indicator displayed on a screen 1110 of an analysis system 1002. Examiner did not find any teachings/motivations to modify the catheter of Burnett to rearrange the indicator of Burnett to be disposed in an external wall of the catheter body adjacent to the proximal end opposite a branching arm of the catheter body through which the inflation lumen passes.
Martin discloses a catheter comprising a catheter body having a proximal end and a distal end and a balloon disposed adjacent to the distal end (Fig. 1). Martin fails to disclose an indicator is disposed in an external wall of the catheter body adjacent to the proximal end opposite a branching arm of the catheter body through which the inflation lumen passes. Martin teaches an indicator 48 disposed in an internal wall of the catheter body adjacent to the proximal end opposite a branching arm of the catheter body through which the inflation lumen passes (Fig. 2B). Examiner did not find any teachings/motivations to modify the catheter of Martin to rearrange the indicator of Burnett to be disposed in an external wall of the catheter body adjacent to the proximal end opposite a branching arm of the catheter body through which the inflation lumen passes. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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, SARAH AL-HASHIMI can be reached at (571) 272-7159. 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.
/NHU Q. TRAN/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781