DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/4/2026 has been entered.
Response to Arguments
The Applicant argues that O’Beirne teaches measuring ballon diameter by sensing strain in the material, which is “quite different” from the pressure sensor of Claim 11. However, the Applicant has not pointed and distinctly argued how the claim language used to describe the pressure sensor is “quite different” from the measurement of balloon diameter by sensing strain in O’Berine. O’Berine simply admits that there is a known relationship between pressure measurements and balloon diameter. Utilizing an optical strain sensor to measure the deformation of a balloon in response to external pressure is simple substitution of one known pressure sensor element for another to achieve the same measurement goal. The fact that O’Berine uses pressure measurements to provide balloon diameter measurements does not change the fact that O’Berine still uses sensors positioned within balloons to measure pressure.
The Applicant argues that O’Beirne teaches that pressure measurements and balloon diameter measurements are different and that pressure measurements are “less accurate”. The Examiner disagrees and respectfully submits that the relative accuracy of a sensor does not negate its structural capacity, tied with motivational reasons for combination, to perform a pressure measurement task. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the column-type pressure sensor arrangement of Burnett with the intra-balloon pressure sensor arrangement of O’Beirne as O’Beirne teaches that such arrangement would have been immune to electromagnetic interference, would have matched well with polymer materials, and would have allowed for a low profile and could have been incorporated into a catheter without significantly increasing the profile of the device (O’Beirne paragraph [0021]). Furthermore, the Applicant’s arguments are not commensurate in scope with the claimed invention because the claimed invention merely states “wherein average pressure is computed”, and does not claim that balloon diameter cannot be measured as well, nor does it state that the average pressure is specifically used to account for balloon pinching without skewing results.
The Applicant argues that O’Brerine is directed to angioplasty and stent procedures to achieve proper inflated diameter. The Examiner notes that a reference is not limitation to its primary intended use but is available for all that it teaches. O’Beirne teaches a structure that entails placing sensors inside balloons to specifically monitoring balloon deformation. This teaching is directly applicable to the balloon-based pressure monitoring catheter of Burnett.
The Applicant argues that O’Breine is concerned with measurements during inflation and not measurements after inflation. The Examiner disagrees and respectfully submits that the Examiner relied on the primary reference of Burnett to disclose this limitation. ([0189] The control feedback loop between the optimally tuned pressure (manifesting as balloon pressure and volume) and the sensed physiologic pressure profile iterates continuously and or as needed to ensure high fidelity measurement of the physiologic data.) ([0426] A sharp increase in pressure or an increase above a certain threshold may indicate that the patient is sitting up, moving, coughing etc.) ([0189] …the pressure tuning controller may add or subtract minute amounts of air in a routinized or programmed sequence of steps until the amplitude of the sensed wave is greatest.). Substituting the Burnett sensor for the O’Berine sensor would result in a device that measures pressure “after inflation”.
The Applicant argues that rejections cannot be based on conclusionary statements, and Burnett does not disclose placement of a sensor within a balloon or measuring via deformation of that balloon. The Examiner disagrees and respectfully submits that the previous and instant Office Action cite Burnett as disclosing measuring pressure via the deformation of a balloon. The modification is a substitution of Burnett’s “fluid column” sensor for O’Breine’s “intra-balloon” sensor, motivated by the need for a lower profile. Therefore, the Examiner’s combination is not based on a conclusionary statements, but with explicit structural modifications and motivation.
The Applicant argues that the modification of Burnett in view of O’Breine would change Burnett’s principle of operation from pressure measurement to diameter measurement, rending it unsatisfactory for its intended purpose. The Examiner disagrees and respectfully submits that such modification would render the principle of operation to remain the same: monitoring physiological pressure of a body cavity via the physical deformation of a balloon. O’Beirne’s sensor is a structural means of measuring that deformation, using a different sensors to measure the same physical phenomenon (deformation) does not change the “principle operation” or the “intended purpose” of the device as a whole.
The rejections, even in light of the claim amendments, are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11, 13, 15, 16, 24, 26, 28-30, 33-39 and 41-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170136209 A1 to Burnett et al. (hereinafter, Burnett) in view of US 20120271339 A1 to O’Beirne et al. (hereinafter, O’Beirne).
Regarding Claim 11, Burnett discloses a multi-lumen catheter for monitoring intra-abdominal pressure (sensing Foley catheter system 1000, [0135-0156], Fig. 10A), the catheter comprising inter alia:
an elongated body (Foley catheter 102) configured and dimensioned for insertion into a bladder of a patient ([0005]), the catheter having a first lumen (pressure lumen 1010), a second lumen (urine lumen 1012), a third lumen (retention balloon port 118), a first balloon (inflatable pressure-sensing balloon 108) at a distal portion and a second balloon (bladder retention balloon 104) proximal of the first balloon (FIG. 1), the first lumen communicating with the first balloon ([0139] Pressure lumen 1010 is in fluid communication with pressure sensing balloon 108), the second lumen communicating with the bladder to remove fluid from the bladder ([0139] Urine lumen 1012 is in fluid communication with opening or openings 106 and urine reservoir or cassette 1022), and the third lumen communicating with the second balloon to inflate the second balloon to stabilize the catheter ([0110] Various internal lumens traverse the length of the catheter, such as an air or fluid lumen that communicates with a bladder retention balloon 104 and a retention balloon port 118).
Burnett further discloses a pressure sensor, where pressure is measured within the bladder in response to deformation of the first balloon in response to pressure exerted on an outer wall of the first balloon ([0111] An inflatable pressure-sensing balloon 108 (or a pressure sensing membrane arranged across an opening) may be positioned at or near the distal end of the catheter. Embodiments of a pressure-sensing balloon or pressure sensing membrane may be understood as comprising a pressure interface having a distal-facing surface exposed to pressure from within the bladder, and a proximal-facing surface exposed to a proximal fluid column.) ([0017] …a controller … programmed to … determine an intra-abdominal pressure … based in part upon changes in pressure within the balloon…), explicitly mentions that pressure can be measured after inflation of the first balloon ([0189] The control feedback loop between the optimally tuned pressure (manifesting as balloon pressure and volume) and the sensed physiologic pressure profile iterates continuously and or as needed to ensure high fidelity measurement of the physiologic data.) ([0426] A sharp increase in pressure or an increase above a certain threshold may indicate that the patient is sitting up, moving, coughing etc.) ([0189] …the pressure tuning controller may add or subtract minute amounts of air in a routinized or programmed sequence of steps until the amplitude of the sensed wave is greatest.), and mentions where an average pressure is computed ([0189] …upon insertion of the catheter, a pressure tuning circuit that regulates the balloon volume and pressure may inflate the balloon until it detects a physiologic-sourced pressure rate.) (Examiner note: A pressure rate implies “average pressure as rate is defined as change over time, and to determine a stable rate from oscillating pressure signals, a controller must provide an average of pressure values across a specific time window. Therefore, rate of pressure change does include an average, because average pressure change quantifies the change in pressure over a given time interval.).
Burnett discloses the claimed invention except for expressly disclosing where the pressure sensor is positioned within the first balloon, rather than the classic pressure column measurement as set forth in Burnett. However, O’Beirne teaches determining a balloon diameter of a balloon attached to a catheter for in vivo using an optical strain guard or sensor during inflation and closely monitoring (O’Beirne paragraphs [0008] and [0021]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the column-type pressure sensor arrangement of Burnett with the intra-balloon pressure sensor arrangement of O’Beirne as O’Beirne teaches that such arrangement would have been immune to electromagnetic interference, would have matched well with polymer materials, and would have allowed for a low profile and could have been incorporated into a catheter without significantly increasing the profile of the device (O’Beirne paragraph [0021]). Furthermore, a skilled artisan would have recognized that, in light of the motivation above, that such modification would have been a simple substitution of one type of one known element for measuring balloon pressure for another known element for measuring balloon pressure.
Regarding Claim 13, Burnett as modified teaches the catheter of claim 11, further comprising a temperature sensor positioned within the catheter spaced axially from the sensor for measuring pressure (O’Beirne [0112] In some embodiments, a temperature sensor may exist at or near the distal end of the catheter. Temperature port 110 may include temperature communication wire 112 which connects the temperature sensor to a display, connector and/or controller).
Regarding Claim 15, Burnett in view of O’Beirne teach discloses the catheter of claim 11, wherein a side opening (O’Beirne opening 106) in the second lumen is between the first and second balloons (Burnett: opening 106 can be seen between the first and second balloons in Fig. 10A).
Regarding Claim 16, Burnett in view of O’Beirne teach the catheter of claim 11, wherein bladder pressure is measured continuously while the first balloon is inflated (Burnett [0189] … upon insertion of the catheter, a pressure tuning circuit that regulates the balloon volume and pressure may inflate the balloon until it detects a physiologic-sourced pressure rate. Upon sensing that rate, the pressure tuning controller may add or subtract minute amounts of air in a routinized or programmed sequence of steps until the amplitude of the sensed wave is greatest. The control feedback loop between the optimally tuned pressure (manifesting as balloon pressure and volume) and the sensed physiologic pressure profile iterates continuously …) and communicates with an external monitor to visually display pressure readings (Burnett [0189] … automatic pressure tuning may be performed in the apparent background while the physiologic data is being transmitted and displayed …), and a pressure sensor provides continuous pressure measurements throughout its duration of insertion without requiring infusion of water into the bladder ([Examiner notes that the pressure sensor is capable of providing continuous pressure measurements through a duration of insertion, as there is no discussion of insertion with water into the bladder, rather, just general insertion, see Burnett [0109, 0126, 0188, 0189, etc.]).
Regarding Claim 24, Burnett in view of O’Beirne teaches the catheter of claim 11, wherein the second lumen is independent of the first and third lumens (Examiner notes pressure lumen 1010, urine lumen 1012, and retention balloon port 118 of Burnett are all described as specific, “independent” lumens).
Regarding Claim 26, Burnett in view of O’Beirne teach the catheter of claim 11, further comprising a pressure sensor connectable to the catheter (Burnett [0017] … controller which is configured to connect to the reservoir and is programmed to control a pressure within the first lumen), wherein connection of the pressure sensor automatically advances air into the first balloon to expand the first balloon and wherein connection of a hub to advance air into the first balloon provides a closed air system of the first lumen and first balloon (Burnett [0118, 0121-0123]).
Regarding Claim 28, Burnett in view of O’Beirne teach the catheter of claim 11, wherein connection of a hub to advance air into the first balloon only partially fills the first balloon to increase compliancy (Burnett [0122] … expansion of the balloon from a minimal volume …) (Examiner notes that the limitation “to increase compliancy” is purely functional, and the first balloon is fully capable of being only partially filled from it's minimal inflation step to maximum inflation step).
Regarding Claim 29, Burnett in view of O’Beirne discloses the catheter of claim 11, wherein an indicator indicates if measured pressure exceeds a threshold value ( Burnett paragraph [0426] A sharp increase in pressure or an increase above a certain threshold may indicate that the patient is sitting up, moving, coughing etc.).
Regarding Claim 30, Burnett in view of O’Beirne teach the catheter of claim 11, wherein pressure is measured without requiring infusion of water into the bladder (Examiner notes that the pressure sensor is capable of providing continuous pressure measurements through a duration of insertion, as there is no discussion of insertion with water into the bladder, rather, just general insertion, see Burnett [0109, 0126, 0188, 0189, etc.]).
Regarding Claim 33, Burnett in view of O’Beirne teach the catheter of claim 32, wherein bladder pressure is measured continuously while the first balloon is inflated (O’Beirne [0189] … upon insertion of the catheter, a pressure tuning circuit that regulates the balloon volume and pressure may inflate the balloon until it detects a physiologic-sourced pressure rate. Upon sensing that rate, the pressure tuning controller may add or subtract minute amounts of air in a routinized or programmed sequence of steps until the amplitude of the sensed wave is greatest. The control feedback loop between the optimally tuned pressure (manifesting as balloon pressure and volume) and the sensed physiologic pressure profile iterates continuously …) and communicates with an external monitor to visually display pressure readings (O’Beirne [0189] … automatic pressure tuning may be performed in the apparent background while the physiologic data is being transmitted and displayed …), and a pressure sensor provides continuous pressure measurements throughout its duration of insertion without requiring infusion of water into the bladder ([Examiner notes that the pressure sensor is capable of providing continuous pressure measurements through a duration of insertion, as there is no discussion of insertion with water into the bladder, rather, just general insertion, see O’Beirne [0109, 0126, 0188, 0189, etc.]).
Regarding Claim 34, Burnett in view of O’Beirne teach the catheter of claim 32, further comprising a temperature sensor positioned within the catheter axially spaced from the pressure sensor (O’Beirne [0112] In some embodiments, a temperature sensor may exist at or near the distal end of the catheter. Temperature port 110 may include temperature communication wire 112 which connects the temperature sensor to a display, connector and/or controller).
Regarding Claim 35, Burnett in view of O’Beirne teach the catheter of claim 32, further comprising an oxygen sensor positioned within the catheter axially spaced from the pressure sensor (O’Beirne [0305] Pulse oximetry elements allow for a determination of blood oxygen concentration or saturation, and may be disposed anywhere along the urethral length of the catheter. In some embodiments, the sensor or sensors are disposed within the tubing of the device to ensure approximation to the urethral mucosa).
Regarding Claim 36, Burnett in view of O’Beirne teach the catheter of claim 32, wherein transmission wires connected to the pressure sensor extend externally to the first lumen (O’Beirne [0110] Electrical or optical fiber leads may be disposed in a lumen that allows communication of sensing signals between distally disposed sensors and the proximal portion of the catheter, and then further communication to a data processing apparatus or controller).
Regarding Claim 37 Burnett in view of O’Beirne teach the catheter of claim 32, wherein the first balloon is only partially filled to increase compliancy (O’Beirne [0122] … expansion of the balloon from a minimal volume …) (Examiner notes that the limitation “to increase compliancy” is purely functional, and the first balloon is fully capable of being only partially filled from it's minimal inflation step to maximum inflation step).
Regarding Claim 38, Burnett in view of O’Beirne teach the catheter of claim 32, wherein the second lumen (O’Beirne urine lumen 1012 – O’Beirne [0160] Urine drainage lumens preferably have an inner diameter less than about 0.25 inches …) is larger than the first (pressure lumen 1010 – [0124] Embodiments of the sensing Foley catheter include a device utilizing a very small pressure lumen for air transmission. Pressure readings using inner lumen diameters of 3 mm, 1 mm, and 0.5 mm have been measured. Little degradation of the signal was seen when the air lumen diameter was decreased from 3 mm to 1 mm and 0.5 mm). While Burnett does not expressly disclose that the second lumen is also larger than the third lumen, one having an ordinary skill in the art at the time the invention was filed would have found it obvious to provide such dimensions, as the only difference between the prior art and the claimed invention is a recitation of a relative dimension of the claimed device, and a device having the claimed dimensions would not have performed differently or had any particular stated advantage over the prior art. Therefore the claimed define is not patentable distinct from the prior art device.
Regarding Claim 39 Burnett in view of O’Beirne teach the catheter of claim 32, wherein transmission wires connected to the pressure sensor are positioned within the first lumen (O’Beirne [0110] Electrical or optical fiber leads may be disposed in a lumen that allows communication of sensing signals between distally disposed sensors and the proximal portion of the catheter, and then further communication to a data processing apparatus or controller).
Regarding Claim 40, Burnett in view of O’Beirne teach the catheter of claim 36, wherein the transmission wires are positioned in a fourth lumen independent of the first lumen (O’Beirne [0113] Note that although FIG. 1 shows the proximal end of the catheter comprising multiple separate ports, some or all of the ports may be integrated into a single port, or integrated into a urine drainage line which travels to a urine drainage system and/or controller. Other lumens and/or ports may also exist; [0110] Electrical or optical fiber leads may be disposed in a lumen that allows communication of sensing signals between distally disposed sensors and the proximal portion of the catheter, and then further communication to a data processing apparatus or controller).
Regarding Claim 42, Burnett in view of O’Beirne teach the catheter of claim 11, where the temperature sensor is part of the pressure sensors.
Regarding Claims 43 and 44, Burnett in view of O’Beirne teach the catheter of claim 11, where the second balloon is a different configuration than the first balloon, where the second balloon has a height greater than a height of the first balloon (Burnett discloses independent lumens that allow the sensing and retention balloons to be inflated to different volumes and shapes to fit their specific anatomical locations. Adjusting the heigh or diameter of these balloons to accommodate varying lumen sizes means that Burnett is capable of providing the first and second balloon with different heights).
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.
Claim(s) 41 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of O’Beirne, in view of US 6248083 B1 to Smith et al. (hereinafter, Smith).
Burnett in view of O’Beirne disclose the claimed invention except for expressly disclosing where the temperature sensor is part of the pressure sensor, where the temperature sensor is located within the first balloon. However, Smith teaches a device for measure pressure within the body (col. 2, lines 10-14) which is in combination with a temperature sensor (col. 3, lines 47-55). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pressure sensor of Burnett in view of O’Beirne, which is located within the first balloon, to include the temperature sensors of O’Beirne, as O’Beirne teaches this would have provided a less bulky device (col. 1, lines 26-27) and further states that there is always some kind of calibration needed, and the combination pressure/temperature sensor would have allowed for such calibration (col. 1, lines 28-37).
Conclusion
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791