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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 November 2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 19 November 2025, with respect to the rejection(s) of claim(s) 1-38 under 35 USC 103 have been fully considered and are persuasive. Specifically, the claim language specifies the vent being at the distal end which overcame the previous art of record. However, a new grounds of rejection is made in view of Stubber (US 2013/0102980).
Claims 1-38 are examined on the merits.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 8-21, and 23-37 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2013/0030262) in view of Skovlund (US 6503208) further in view of Stubber (US 2013/0102980).
Regarding claim 1, Burnett discloses a catheter (10, figure 6A, [0082]) having a length and an expandable retention member (36, figure 6A, [0087]) located near the distal end of the catheter, the catheter defining a drainage lumen (23, figure 6B, [0087]) at least partially through the catheter such that the distal end of the lumen terminates at a drainage opening (41, figure 5B, [0083]) near the distal end of the catheter (figure 5B), a drainage tube (63, figure 3, [0073]) and receptacle (61, figure 3, [0074]) which includes a fluid volume measuring system (80, figure 3, [0077]) and configured to fluidically coupled to the drainage lumen such that the tube is communication with the drainage opening ([0073-0074]), wherein urine is received in the drainage opening and through the drainage lumen ([0087]).
Burnett does not disclose a venting mechanism having a one way valve which is in communication with the drainage tube, configured to vent air near a distal end of the drainage tube and a pump in communication with the drainage tube and which is configured to form a negative pressure exerted on the fluid in the drainage tube such that the one way valve is urged to open by application of negative pressure directly upon the one way valve and a flow of the fluid through the drainage tube is unobstructed and a flow of fluid through the drainage tube is unobstructed.
Skovlund discloses a reservoir with catheter relatively pertinent to problem posed by Applicant of providing negative pressure and removing material from the patient. Skovlund teaches a venting mechanism (70 and 72, figure 7) having a one way valve (70, the air is allowed in and not out, col 5, lines 3-12) which is in communication with the drainage tube (56). Skovlund vent would be a short distance from the distal end of the drainage tube. A pump (58, col 5, lines 1-2) in communication with the drainage tube and which is configured to form a negative pressure exerted on the fluid in the drainage tube such that the one way valve is urged to open by application of negative pressure directly upon the one way valve (col 5, lines 3-12) and a flow of the fluid through the drainage tube is unobstructed and a flow of fluid through the drainage tube is unobstructed (col 5, lines 3-12, lines 55-60, the action of the valve still allows free flow through the drainage tube).
Skovlund provides the negative pressure regulator to prevent excess negative pressure be applied to the patient (col 5, lines 55-60). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burnett with valve and pump of Skovlund in order to prevent excess negative pressure be applied to the patient.
Burnett and Skovlund do not teach the vent being at the distal end of the drainage tube or at a proximal end of the catheter.
Stubber discloses a drainage device relatively pertinent to problem posed by Applicant of apply pressure for drainage comprising a catheter (66) attached to drainage tube (71) with a vent mechanism (40, figure 5, [0040]), the vent being at the distal end of the drainage tube or at a proximal end of the catheter (figure 5).
Stubber provides a vent mechanism in order to control drainage and pressure ([0046]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with the vent location of the Stubber device since it has been held that shifting position of an element (this case a vent) would not have modified the operation of the device. Here shifting the position of the Skovlund vent to the location of the Stubber device would not hinder the operation of the vent. The vent would still provide control over drainage to the system.
Regarding claim 2, Burnett further discloses the catheter is a Foley catheter ([0082]).
Regarding claim 3, Burnett further discloses an adapter (figure 6B, entire figure is adapter) is configured for attachment to a proximal end of the catheter and a port (catheter opening before the catheter branches in figure 6B) is fluidically coupled to the adapter ([0087]).
Regarding claim 4 and 5, Burnett further discloses the port is fluidically coupled to the drainage lumen ([0087]).
Regarding claim 6, Burnett further discloses the catheter is a Foley catheter ([0082]). Foley catheters are configured to be inserted into the urethra with a portion of the catheter remaining outside of the body (figure 6A).
Regarding claim 8, Burnett further discloses a pressure measuring mechanism (38, figure 6A, [0084]) located near the distal end of the catheter, wherein the pressure sensing mechanism produces a signal response to changes in pressure exerted on the unit ([0084-0086]).
Regarding claim 9, Burnett further disclose a mechanical or fiber optic pressure sensor ([0083]).
Regarding claim 10, Burnett discloses a pressure sensing balloon (38, [0084], figure 5A).
Regarding claim 11, Burnett discloses a pressure sensing balloon (38, [0084], figure 5A). The data is then used to capture and calculate the respiratory rate, cardiac rate through forces surrounding the balloon sensor.
Regarding claim 12 and 13, Burnett further discloses wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 1 Hz, it can be processed to yield a relative pulmonary tidal volume profile ([0009]) and wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 5 Hz, it can be processed to yield physiologic pressure profiles selected from a group consisting of cardiac output, relative cardiac output, and absolute cardiac stroke volume ([0009]).
Regarding claim 14-15, Burnett discloses an analyte sensor used to detect pH ([0015]).
Regarding claim 16, Burnett discloses an electrical activity sensor ([0016]).
Regarding claim 17, Burnett discloses a light source and sensor ([0017]) to measure light emitted from the light source.
Regarding claim 18, Burnett discloses positioning a catheter (10, figure 6A, [0082]) having a length and an expandable retention member (36, figure 6A, [0087]) located near the distal end of the catheter, the catheter defining a drainage lumen (23, figure 6B, [0087]) at least partially through the catheter such that the distal end of the lumen terminates at a drainage opening (41, figure 5B, [0083]) near the distal end of the catheter (figure 5B), receiving a fluid from the body lumen through the drainage opening and into the drainage lumen ([0083]), receiving the fluid through a drainage tube (63, figure 3, [0073]) and receptacle (61, figure 3, [0074]) which includes a fluid volume measuring system (80, figure 3, [0077]), and positioned outside the body lumen, wherein urine is received in the drainage opening and through the drainage lumen ([0087]).
Burnett does not disclose venting air through a venting mechanism having a one way valve which is in communication with the drainage tube and such that the one way valve is configured to vent air into the drainage tube, near a distal end of the drainage tube and applying negative pressure to fluid in the drainage tube via a pump in communication with the drainage tube such that the one way valve is urged to open by application of negative pressure directly upon the one way valve and a flow of fluid through the tube is unobstructed.
Skovlund discloses a reservoir with catheter relatively pertinent to problem posed by Applicant of providing negative pressure and removing material from the patient. Skovlund teaches a venting mechanism (70 and 72, figure 7) having a one way valve (70, the air is allowed in and not out, col 5, lines 3-12) which is in communication with the drainage tube (56) and a pump (58, col 5, lines 1-2) in communication with the drainage tube and which is configured to form a negative pressure exerted on the fluid in the drainage tube such that the one way valve is urged to open by application of negative pressure directly upon the one way valve (col 5, lines 3-12) and a flow of the fluid through the drainage tube is unobstructed and a flow of fluid through the drainage tube is unobstructed (col 5, lines 3-12, lines 55-60, the action of the valve still allows free flow through the drainage tube). Skovlund vent would be a short distance from the distal end of the drainage tube.
Skovlund provides the negative pressure regulator to prevent excess negative pressure be applied to the patient (col 5, lines 55-60). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burnett with valve and pump of Skovlund in order to prevent excess negative pressure be applied to the patient.
Burnett and Skovlund do not teach the vent being at the distal end of the drainage tube or at a proximal end of the catheter.
Stubber discloses a drainage device relatively pertinent to problem posed by Applicant of apply pressure for drainage comprising a catheter (66) attached to drainage tube (71) with a vent mechanism (40, figure 5, [0040]), the vent being at the distal end of the drainage tube or at a proximal end of the catheter (figure 5).
Stubber provides a vent mechanism in order to control drainage and pressure ([0046]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with the vent location of the Stubber device since it has been held that shifting position of an element (this case a vent) would not have modified the operation of the device. Here shifting the position of the Skovlund vent to the location of the Stubber device would not hinder the operation of the vent. The vent would still provide control over drainage to the system.
Regarding claim 19, Burnett further discloses the catheter is a Foley catheter ([0082]).
Regarding claim 20 and 21, Burnett further discloses an adapter (figure 6B, entire figure is adapter) is configured for attachment to a proximal end of the catheter and a port (catheter opening before the catheter branches in figure 6B) is fluidically coupled to the adapter ([0087]).
Regarding claim 23, Burnett further discloses detecting a change in pressure upon a pressure measuring mechanism (38, figure 6A, [0084]) indicative of the pressure within a bladder ([0084-0086]).
Regarding claim 24, Burnett discloses a pressure sensing balloon (38, [0084], figure 5A).
Regarding claim 25, Burnett discloses a pressure sensing balloon (38, [0084], figure 5A). The data is then used to capture and calculate the respiratory rate, cardiac rate through forces surrounding the balloon sensor ([0084].
Regarding claim 26-27, Burnett further discloses wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 1 Hz, it can be processed to yield a relative pulmonary tidal volume profile ([0009]) and wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 5 Hz, it can be processed to yield physiologic pressure profiles selected from a group consisting of cardiac output, relative cardiac output, and absolute cardiac stroke volume ([0009]).
Regarding claim 28-29, Burnett discloses an analyte sensor used to detect pH ([0015]).
Regarding claims 30-31, Burnett and Skovlund do not disclose the inner diameter of the drainage tube is less than or equal to about .25 inches (claim 30) and more specifically 0.125 inches (claim 31).
However, it would have been obvious to one having ordinary skill in the art at the effective filling date to select an optimal sized diameter for the purpose of having desired draining rate. The diameter of the drainage tube is a result effective parameter. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Burnette discloses the catheter is a Foley catheter ([0082]) that drains fluid from the body meaning the diameter can be optimize for the purpose of draining fluid at a desired flow rate; therefore, the diameter of the tube has a direct effect in the procedure to drain fluid, thus being a result effective variable.
Regarding claim 32-33, Burnett discloses a controller in communication with the system ([0031]) with having a memory ([0030] to store data) that can detect intra-abdominal pressure from the data from the sensor ([0106]).
Regarding claim 34, Burnett further discloses the analyte sensor is used to detect bacteria ([0038]).
Regarding claim 35, Burnett discloses a controller in communication with the system ([0031]) that can detect intra-abdominal pressure from the data from the sensor ([0106]).
Regarding claim 36, Burnett discloses a light source and sensor ([0017]) to measure light emitted from the light source.
Regarding claim 37, Burnett further discloses the analyte sensor is used to detect bacteria ([0038]).
Claims 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of Skovlund further in view of Stubber further in view of Goedje (US 2012/0041334).
Regarding claims 7 and 22, Burnett and Skovlund do not disclose periodically stopping fluid flow through the drainage lumen.
Goedje discloses a urinary catheter in the same field of endeavor as the Applicant. Goedje further teaches the proximal end of the drainage lumen attached to the drainage tube is configured to be periodically obstructed (figure 3c, showing obstruction of the flow through 22b, [0026]).
Goedje includes a valve in order to sample urine out of the system ([0026]). It would have been obvious to a person of ordinary skill in the art at the time of the effective filling date of the invention to modify Burnett with the valve of Goedje in order to sample urine from the system as desired.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view Skovlund further in view of Stubber further in view of Woodruff (US 8192368).
Regarding claim 38, Burnett and Skovlund do not teach a retention balloon positioned along the catheter and in proximity to the pressure sensing mechanism. “In proximity” is interpreted as near.
Woodruff discloses a pressure sensing catheter in the same field of endeavor as the Applicant. Woodruff teaches a second balloon (1140, figure 11, col 10, lines 61-65) positioned along the catheter and in proximity to the pressure sensing mechanisms (figure 11, balloon near the electronics).
Woodruff utilizes multiple balloons to sense pressure at different locations (col 3, lines 10-22). It would have been obvious to a person of ordinary skill in the art at the time of the effective filling date of the invention to modify Burnett and Skovlund with the balloons of Woodruff in order to sense pressure at multiple locations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached on M-F 9am-5pm.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/Primary Examiner, Art Unit 3781