DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11, 13, 15-16, 24, 28-30 and 33-44 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The applicant was not in possession of the limitation where “the pressure sensor [is] spaced from surfaces of the balloon”. The claimed limitation is not found in either the written description or represented in a figure.
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.
Claim(s) 11, 13, 15, 24, 28-30, 33-37, 39, 40, 43 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130066166 A1 to Burnett et al. (hereinafter, Burnett) in view of US 5275169 A to Afromowitz et al. (hereinafter, Afromowitz).
Regarding Claim 11, Burnett discloses a multi-lumen catheter for monitoring intra-abdominal pressure, the catheter comprising inter alia:
an elongated body (Foley catheter proximal section 14, middle portion 13 and distal portion 12) configured and dimensioned for insertion into a bladder of a patient ([0087] “FIGS. 6A-6D show various views and details of a sensing Foley catheter, per an embodiment of the sensing Foley catheter system. FIG. 6A schematically arranges the sensing Foley catheter into a proximal section 14 that remains external to the body when in use, a portion 13 that resides in the urethra, and a distal portion 12 that resides in the bladder, when placed into a human subject.”),
the catheter having a first lumen (luminal opening 23), a second lumen (luminal opening 24), a third lumen (luminal opening 25),
a first balloon at a distal portion (pressure balloon 38) and a second balloon (retention balloon 36) proximal of the first balloon (see FIG. 6D),
the first lumen communicating with the first balloon for inflation of the first balloon via insertion of an inflation fluid ([0104] “Released gas passes … through a first solenoid-controlled fill valve to enter the catheter line, ultimately filling the balloon that comprises the pressure-sensing interface” e.g., to pressure ballon 38) ([0103] “a pressure tuning circuit that regulates the balloon volume and pressure will inflate the balloon”),
the second lumen communicating with the bladder to remove fluid from the bladder ([0083] “A urine drainage lumen 23 has a distal opening 41 that resides in the bladder portion 12 of the catheter, and has an opening at the proximal end 14 of the catheter… conveys the urine to a collecting receptacle”), and
the third lumen communicating with the second balloon to inflate the second balloon to stabilize the catheter ([0083] “an air or fluid 24 that communicates with a bladder retention balloon 36”),
a pressure sensor ([0019] “a pressure sensor that includes a pressure interface and a transducer, the sensor not including a pressure-transmitting column. These embodiments typically have a pressure sensing mechanism or transducer proximate the pressure interface. Such pressure sensors may include, by way of example, any of a piezoelectric electric mechanism, an optical sensing mechanism, a microelectricalmechanical (MEMS) mechanism, or an acoustic wave sensing mechanism.”),
wherein 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 by pressure exerted by a wall of the bladder which compresses the inflation fluid within the balloon to provide pressure readings based on pressure within the balloon ([0084] “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”) ([0101] “ Pressure impinging on the external face of balloon (facing the internal aspect of the bladder) is subject to change according to the physiology of the patient. Pressure on the internal face of the balloon (which is in fluid communication with the fluid column)”) ([0093] “a pressure signal generated in response to changes in pressure within the bladder”) ([0095] “considerations related to optimizing the pressure around the pressure interface of the device are informed by Boyle's ideal gas law”) ([0099] “Deflation or compression of a type 2 balloon occurs by way of generally inwardly directed wrinkling and infolding.”),
wherein average pressure is computed ([0091] “Larger excursions generally relate to heavier breathing, or in the setting of an upward drift in the baseline, a higher peritoneal pressure.”) ([0093] “the totality of the electrical signal profile, a surrogate for the pressure profile within the peritoneal cavity, into component profiles”) (e.g., extracting a baseline pressure from oscillation respirator/cardiac signals is an averaging operation) and the catheter is connectable to a display to display pressure readings ([0073] “a data collection and processing apparatus in the form a bedside console 80”) ([0074] “The bedside console may record and display output/input data.”).
Burnett discloses the claimed invention except for expressly disclosing where the pressure sensor is positioned within the first balloon, the pressure sensor spaced from surfaces of the balloon. However, Afromowitz teaches a catheters for determining physiological characteristics of body lumens (col. 1, lines 8-13) and further teaches a fluid filled balloon 42 that has a pressure sensor 43 within the balloon 42 (col. 6, line 63 to col. 7, line 18). Looking to FIG. 2C, several of the surfaces of the balloon as spaced from the pressure sensor. 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 to be located within a spaced from surfaces of a balloon as set forth in Afromowitz, as Afromowitz teaches that it is important that accurate pressure results be taken at the balloon, and the pressure readings not taken at the balloon can result in back pressure (when at the proximal end) and can be influenced by several variables such as catheter wall compliance, wall movement, wall pressure (when at distal end) (col. 7, lines 19-31). Therefore, providing the sensor of Burnett within the balloon, as motivated to do so by Afromowitz, would have allowed for accurate pressure measurements.
Regarding Claim 13, Burnett teaches catheter of claim 11, further comprising a temperature sensor positioned within the catheter spaced axially from the sensor for measuring pressure ([0083] “Analyte sensors or temperature sensors 50 may be disposed on the catheter, either on the urethral portion 10 or the bladder-residing portion 12 of the catheter.”)
Regarding Claim 15, Burnett teaches catheter of claim 11, wherein a side opening in the second lumen is between the first and second balloons ([0083] “A urine drainage lumen 23 has a distal opening 41 that resides in the bladder portion 12 of the catheter, and has an opening at the proximal end 14 of the catheter.”).
Regarding Claim 16, Burnett teaches the catheter of claim I1, wherein bladder pressure is measured continuously while the first balloon is inflated ([0103] “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 the pressure readings ([0074] “The bedside console may record and display output/input data.”), and the pressure sensor provides continuous pressure measurements throughout its duration of insertion without requiring infusion of water into the bladder (Burnett’s balloon embodiment sensing bladder pressure through a sealed pressure-sensing balloon, therefore, infusion is not required).
Regarding Claim 24, Burnett teaches the catheter of claim 11, wherein the second lumen is independent of the first and third lumens (luminal openings 23, 24 and 25 are all separate).
Regarding Claim 28, Burnett teaches the catheter of claim 11, wherein the first balloon is only partially filled to increase compliancy and remains partially filled during all pressure measurements such that the balloon is not entirely filled during all pressure measuring ([0099] “in a state of partial inflation, the balloon, as a whole, is highly supple and conformable, broadly taking the shape as may be dictated by a confining space.”) ([0094] “the disclosed technology provides an automatic priming method that maintains the balloon in an inflated state, but with a minimal pressure differential.”).
Regarding Claim 29, Burnett teaches the catheter of claim 11, wherein an indicator indicates if measured pressure exceeds a threshold value ([0105] “A short burst of peaks and valleys in bladder pressure activity can serve as a proxy … a healthcare provided may be notified”).
Regarding Claim 30, Burnett teaches the catheter of claim 11, wherein pressure is measured without requiring infusion of water into the bladder (Burnett’s balloon embodiment sensing bladder pressure through a sealed pressure-sensing balloon, therefore, infusion is not required).
Regarding Claim 33, Burnett teaches the catheter of claim 13, wherein bladder pressure is measured continuously ([0103] “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 the pressure readings ([0074] “The bedside console may record and display output/input data.”), and the pressure sensor provides continuous pressure measurements throughout its duration of insertion without requiring infusion of waterinto the bladder (Burnett’s balloon embodiment sensing bladder pressure through a sealed pressure-sensing balloon, therefore, infusion is not required).
Regarding Claim 34, Burnett teaches the catheter of claim 11, further comprising a temperature sensor positioned within the catheter axially spaced from the pressure sensor ([0083] “Analyte sensors or temperature sensors 50 may be disposed on the catheter, either on the urethral portion 10 or the bladder-residing portion 12 of the catheter.”).
Regarding Claim 35, Burnett teaches the catheter of claim 11, further comprising an oxygen sensor positioned within the catheter axially spaced from the pressure sensor ([0088] “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.”).
Regarding Claim 36, Burnett teaches the catheter of claim 11, wherein transmission wires connected to the pressure sensor extend externally to the first lumen.
Regarding Claim 37, Burnett teaches the catheter of claim 16, where the first balloon is only partially filled to increased compliancy and remains partially filled during all pressure measurements such that the balloon is not entirely filled during all pressure measuring ([0099] “in a state of partial inflation, the balloon, as a whole, is highly supple and conformable, broadly taking the shape as may be dictated by a confining space.”) ([0094] “the disclosed technology provides an automatic priming method that maintains the balloon in an inflated state, but with a minimal pressure differential.”).
Regarding Claim 39, Burnett teaches the catheter of claim 11, wherein transmission wires connected to the pressure sensor are positioned within the first lumen ([0084] “such column may share a lumen that also serves as a sensing conduit such as lumen 25.”) (see [0083] leads in lumen 25, e.g., sensing lumen and lead lumen are the same lumen).
Regarding Claim 40, Burnett teaches the catheter of claim 36, wherein the transmission wires are positioned in a fourth lumen independent of the first lumen (see [0083] leads in lumen 25, with [0084] “dedicated lumen” for the fluid column as the first lumen).
Regarding Claim 43, Burnett teaches the catheter of claim 11, wherein the second balloon is a different configuration than the first balloon (see FIG. 6D).
Regarding Claim 44, Burnett teaches the catheter of claim 43, where the second balloon has a height greater than a height of the first balloon (see FIG. 6D).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of Afromowitz as applied to claim 11 above, and further in view of US 20170136209 A1 to Burnett et al. (hereinafter, ‘209).
Burnett in view of Afromowitz teach the claimed invention except for expressly disclosing where the second lumen is larger than the first and third lumens. However, ‘209 teaches a second lumen of a body pressure sensor catheter is larger than the first lumen for the purpose of providing little degradation in signal (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.
Claim(s) 41 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of Afromowitz as applied to claim 11 above, and further in view of US 6248083 B1 to Smith et al. (hereinafter, Smith).
Burnett in view of Afromowitz 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 Afromowitz, which is located within the first balloon, to include the temperature sensors of Smith as Smith 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
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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