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 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.
Claims 26-35, 37, and 52-65 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US20170136209A1; hereinafter known as “Burnett”; previously cited) in view of Arne et al. (US8419638B2; hereinafter known as “Arne”; previously cited) in view of Millen (US6129709A; hereinafter known as “Millen”).
Regarding claim 26, 52, and 64 Burnett teaches a mobile monitoring device comprising an inline flow sensing device (See Burnett abstract [0114] [0125][0312], mobile device and a catheter system with various sensors) comprising:
an attachment point for attaching the inline flow sensing device to a user (See Burnett [0144], bed hooks 1116 attach to controller and bed);
an engageable sensor assembly (See Burnett [0110], sensor on catheter) comprising:
a fluid channel configured for passing a fluid from a body of the user (See Burnett [0292], catheter with a lumen which is an air channel incorporating a sensor),
at least one biosensor embedded in the fluid channel configured for testing the fluid while flowing through the fluid channel (See Burnett [0292], catheter with a lumen which is an air channel incorporating a sensor);
an input in fluid communication with the fluid channel, and attachable to a first existing catheter inserted in the body of the user, the first existing catheters configured for receiving the fluid from the body of the user and sending the fluid through the fluid channel across the at least one biosensor (See Burnett [0145], pressure port 1026 and 1024 connects to the bladder pressure line 1010 and 1008 which measure bladder pressure and temperature and are capable of testing other signals [0114]);
an output port (See Burnett [0140], 1132 outflows) and attachable to a second existing
catheter (See Burnett Figure 10A outflow tubing 1140 which is attached to the urine drainage
tube 1001); and,
a communication interface connected to the at least one biosensor and configured for transmitting bio signal data from the at least one biosensor (See [0313-0317], communication interfaces that transmit data);
a fluid reservoir (See Burnett Figure 10A 1020) in fluid communication with the output port (See Burnett Figure 10A output port 1132) via the second existing catheter (See Burnett Figure 10A outflow tubing 1140 which is attached to the urine drainage tube 1001);
a monitor configured to communicate with communication interface including a microcontroller configured for analyzing the bio signal data of the fluid from the body of the user (See [0313-0317], communication interfaces that transmit data, [0145]).
Burnett is silent to fluid channel configured for continuously testing the fluid and an output port in fluid communication with the fluid channel.
Arne teaches implantable devices for evaluating body-associated fluid transport structures (See Arne abstract) and further teaches a fluid channel configured for continuously testing the fluid (See Arne Claim 8) and an output port in fluid communication with the fluid channel (See Arne Claim 8 the lumen has a distal end which return blood).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Burnett with a fluid channel configured to continuously test the fluid and that has an output port in fluid communication with the fluid channel to retrieve data collected to determine medical treatment protocols (See Arne Col. 1 lines 36-45).
Burnett in view of Arne is silent to an attachment point for attaching the inline flow sensing device to a user.
Millen teaches an adjustable support system for wound drainage (See abstract), and further teaches an attachment point for attaching the device to a user (See Figure 2 part 150, Col 3 lines 42-51 a fastener that be clips, pins or hook-loops also see col. 3 lines 65-67 and col. 4 lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Burnett in view of Arne with an attachment point for attaching the device to a user as taught by Millen to modify Burnett’s device to provide the patient with stability and support with hook loop straps when a draining device is used (See Millen Col. 1 lines 1-15).
Regarding claim 27, Burnett teaches the fluid reservoir comprises one of a bulb, a balloon, a bag or a pump (See Burnett [0137], fluid collection bag 1020).
Regarding claim 28, Burnett teaches the microcontroller is configured to determine a condition of the user based at least in part on the biosignal data (See Burnett [0021-0022], urine specific parameters measurements indicate fluid overload or other conditions).
Regarding claim 29, Burnett teaches one of the at least one biosensor is configured to detect impedance or conductivity of the fluid (See Burnett [0154][0115][0182], measured parameters include conductance, biosensors to determine urine pH).
Regarding claim 30, Burnett teaches one of the at least one biosensor is configured to detect a pH level of the fluid (See Burnett [0115][0182], biosensors to determine urine pH).
Regarding claim 31, Burnett teaches one of the at least one biosensor is configured to measure at least one of lactate, amylase, urea or creatinine concentrations in the fluid (See Burnett [0182]).
Regarding claim 32, Burnett teaches one of the at least one biosensor is configured to determine flow rate of the fluid (See Burnett [0020][0182], urine output rate).
Burnett is silent to continuously determining a flow rate.
Arne teaches continuously determining a flow rate (See Arne Claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Burnett with a fluid channel configured to continuously test the fluid to retrieve data collected to determine medical treatment protocols (See Arne Col. 1 lines 36-45).
Regarding claim 33, Burnett teaches one of the at least one biosensor is configured to detect transmission of a light through the fluid (See Burnett Figure 21 and 22 and [0179-0180], use of light spectroscopy).
Regarding claim 34, Burnett teaches one of the at least one biosensor is configured to detect a color of the fluid based at least in part on a wavelength of the light (See Burnett figure 21 and 22 use of light spectroscopy [0048-0049], [0183]).
Regarding claim 35, Burnett teaches one of the at least one biosensor is configured to measure a temperature of the fluid (See Burnett [0153], temperature sensor).
Regarding claim 37, Burnett teaches comprising one or more additional biosensor embedded in the first existing catheter, second existing catheter, or the fluid reservoir (See Burnett [0114], catheter is equipped with biosensors).
Regarding claim 53, Burnett teaches determining, via the microcontroller, a condition of the user based at least in part on the biosignal data (See Burnett [0021-0022][0016-0024]; determine impact to patient based on measurement parameters); predicting, via the microcontroller, a future occurrence of a complication based at least in part on the condition of the user; and receiving a profile of the user (See Burnett [0021-0022][0115][0309], urine specific parameters measurements indicate fluid overload or other conditions, prediction), the profile of the user including at least one of: a type of a surgical procedure performed on the user, date and time of the surgical procedure, location of the surgical procedure, the user's age, height, weight, medical history, condition or illness, current or past medication, current factors related to a user, or inline flow sensing device details, wherein determining the condition of the user or predicting the future occurrence of the complication is predicted based at least in part on the profile of the user.
Regarding claim 54, Burnett teaches updating the profile of the user based at least in part on the biosignal data (See Burnett [0155]).
Regarding claim 55, Burnett teaches receiving flow data from one of the at least one biosensor; and determining, based at least in part on the flow data, a rate of flow of the fluid (See Burnett [0155]).
Regarding claim 56, Burnett teaches determining a rate of change in the rate of flow of the fluid over time and a rate of change in biosignal data over time (See Burnett [0020][0182]).
Regarding claim 57, Burnett teaches the biosignal data is received in near real-time (See Burnett [0182]).
Regarding claim 58, Burnett teaches determining light data associated with transmission of a light through the fluid from one of the at least one biosensor (See Burnett Figure 21 and 22 [0048][0049], use of light spectroscopy biosensors are paired with light sources [0179-0180]).
Regarding claim 59, Burnett teaches determining a color of the fluid based at least in part on a wavelength of the light (See Burnett Figure 21 and 22 [0048-0049]).
Regarding claim 60, Burnett teaches determining temperature data of the fluid from one of the at least one biosensor (See Burnett [0153], temperature sensor).
Regarding claim 61, Burnett teaches modulating the biosignal data based at least in part on temperature data, flow data, light data, pH data flow rate, impedance data, or conductivity data (See Burnett [0112][0153][0154], analyte temperature sensors).
Regarding claim 62, Burnett teaches determining a risk factor of the user based on a cross-correlation with a trend of bio-signal biosignal data from other users (See Burnett [0154-0155], assigning risk using index and trends overtime).
Regarding claim 63, Burnett teaches the condition of the user is based at least in part on determining whether the biosignal data is within bounds of a threshold (See Burnett [0012][0022], measurements can be increasing or decreasing).
Regarding claim 65, Burnett teaches one of the at least one biosensor comprises an electrode (See Burnett [0114]) but is silent to an electrode pair disposed sequentially along a length of the fluid channel. Arne teaches an electrode pair disposed sequentially along a length of the fluid channel (See Figure 4A and 4B see 430).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Burnett with an electrode pair disposed sequentially along a length of the fluid channel as taught by Arne to determine whether flow has increased or is absent in the transport structure of interest (See Arne Col. 10 lines 1-10 and col. 13 lines 30-46).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of Arne in view of Millen, as applied in claim 26 further in view Neale et al. (US20100331644A1; hereinafter known as “Neale”).
Regarding claim 66, Burnett teaches one of the at least one biosensor comprises an electrode (See Burnett [0114]) but is silent to electrodes each connected to a terminal via a lead. Arne teaches electrodes connected to a terminal via lead (See Arne Figure 4A and 4B see 430).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Burnett with an electrode connected to a terminal lead as taught by Arne to transmit data such as fluid transport structure data to an external unit (See Arne Col. 13 lines 30-46).
Burnett in view of Arne is silent to a working electrode, a reference electrode, and a counter electrode.
Neale teaches a catheter with sensors (See Neale [0179]), and further teaches a working electrode, a reference electrode, and a counter electrode (See Neale [0179][0194]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Burnett as modified with Arne and Millen with a working electrode, a reference electrode, and a counter electrode to further analyze the liquid which passes through the catheter (See Neale [0194][0197]).
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive.
At the onset the Examiner notes the discrepancy may be in the construction of “existing catheter” as the Examiner is merely interpreting this as a component that is separately usable with the sensing system. It appears the Applicant means to claim that the system works with an existing catheter system that is already being used and/or attached to the body. If this is correct then there may be issues with this configuration within a system/apparatus claim since it requires a clear method step of attaching and may not receive full patentable weight. Clarification is requested.
Regarding the argument that Burnett does not teach a sensor within the engageable sensor assembly, Burnett appears to teach that the sensors may be on or with the catheter or “a fluid lumen that is capable of transmitting…” which could reasonably be construed as the tubes of Burnett which would be part of the engageable sensor assembly rather than the catheter itself. Further the Applicant argues that Burnett does not teach two existing catheters. The Examiner notes that the catheters are not positively recited in claim 26 but also the broadest reasonable interpretation of a catheter could be a tube for removing fluid. It is unclear whether or not the two catheters each separately enter the body at different origin points or if they’re just separate tubes. Further, the argument towards the output port teachings of Burnett not being commensurate with the claim is traversed, as all is required is an output port in fluid communication with the fluid channel and attachable to a second existing catheter. There are multiple tubes that attach to the pinch valve(s) exit points and could be reasonably construed as a catheter and/or be attached to further catheters.
Regarding the argument to the Arne reference, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, Applicant says that Arne only has the means to attach via a catheter, which is how the instant application attaches directly to a patient. Clarification on the issues regarding the Burnett in view of Arne are requested. In response to applicant's argument that Arne is for returning bodily fluids and Burnett is only receiving bodily fluids, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The Arne reference provides a teaching for continuous testing which could be implemented in Burnett.
Regarding the arguments regarding inline vs. implantable devices and the details of the attachment point, the Examiner stresses that these details do not appear to readily or clearly recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes that some additional specificity or positively recitations of the catheters and there relationship to the patient/system would overcome the Burnett reference.
Regarding the combination of Burnett in view of Arne in view of Millen, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Millen broadly teaches moving the attachment point which is all that is required by the claim. The Applicant may want to clarify how the attachment is performed to overcome this position.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
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ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791
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