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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-9, in the reply filed on January 9, 2026, is acknowledged. The election with traverse is noted, but since all claims to Group II have been cancelled, the restriction is currently moot. Newly presented claims are directed towards Group 1. Currently claims 1-9 and 18-25 are pending in this application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 and 18-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elbadry et al. (US 2019/0358387).
Regarding claims 1 and 18, Elbadry discloses a modular inline device for monitoring fluid for a plurality of signals and the related method of using, the device comprising (e.g. Figure 68A-D):
one or more sensor modules comprising one or more sensor elements (e.g. fluid sensor 6822), a processing module (e.g. processor not shown but described in [0133], a flow channel element (e.g. fluid conduit 6830), and a power source (e.g. power source 6840);
wherein the one or more sensor modules are connectable to the processing module by a releasable connection mechanism (e.g. engagement feature 6828 as shown in Figure 68C and [0138], wherein the sensor module is removeable as disclosed in [0138]);
said flow channel element defining fluid communication between a fluid source and one or more sensor elements, the one or more sensor elements configured to measuring signal data related to one or more biomarkers and properties of the fluid (e.g. different sensors as disclosed in [0009]); and
said power source providing power to each of the one or more sensor modules and said processing module (e.g. power source 6840).
Regarding claims 2 and 19, Elbadry additionally discloses a computing module in communication with said one or more sensor modules by a communication module, wherein the computing module receives and processes the signal data measured in said one or more sensor modules (e.g. communication between database server 29 and data processor as shown in Figure 1A).
Regarding claim 3, Elbadry additionally discloses a flow channel element that comprises:
an inlet port attachable in fluid communication with a catheter (e.g. inlet port 6832),
the catheter for insertion in a body of a patient, for receiving biofluid from the body of the patient and flowing it over the one or more sensor elements (e.g. catheter 28 as shown in Figure 1A); and
an outlet port, in fluid communication with said inlet port and with a fluid reservoir (e.g. outlet 8634), for receiving said biofluid from said inlet port and flowing it into said fluid reservoir (e.g. reservoir located between the inlet and outlet port).
Regarding claims 4 and 21, Elbadry additionally discloses wherein the biofluid comprises one or more of: peritoneal fluid, peritoneal drainage fluid, pleural drainage fluid, gastric juice, fecal matter, bile fluid, urine, amniotic fluid, dialysate, sebum, blood, or cerebrospinal fluid (e.g. blood and dialysate as disclosed in [0012]).
Regarding claims 5 and 25, Elbadry additionally discloses wherein the one or more sensor elements comprise one or more of: pressure sensors and flow sensors configured to measure, flow and volume of the fluid in the flow channel element (e.g. pressure sensor as disclosed in [0009]).
Regarding claims 6 and 22, Elbadry additionally discloses wherein said one or more sensor modules comprise one or more biosensor elements, configured to detect the signal data relating to the one or more biomarkers in the fluid (e.g. pH sensor as disclosed in [0009]).
Regarding claims 7 and 23, Elbadry additionally discloses wherein the one or more biomarkers comprise one or more of: pH, lactate, electrolytes, impedance, conductivity, dissolved oxygen, dissolved C02, temperature, inflammatory markers, enzymes, bacterial proteins, RNA or lipids (e.g. pH sensor as disclosed in [0009]).
Regarding claim 8, Elbadry additionally discloses wherein each of the one or more sensor modules is physically connected to said processing module by one or more connection mechanisms (e.g. engagement feature 6828 as shown in Figure 68C and [0138], wherein the sensor module is removeable as disclosed in [0138]);
Regarding claim 9, Elbadry additionally discloses wherein each of the one or more sensor modules is wirelessly connected to said processing module by one or more wireless communication mechanisms (e.g. wireless communication as disclosed in [0008]).
Regarding claim 20, Elbadry additionally discloses using more than one sensor module (e.g. Abstract).
Regarding claim 24, Elbadry additionally discloses determining, via the processing module, a risk assessment associated with the patient based on detection and processing of the one or more biomarkers in the fluid (e.g. alert based on a high risk condition as taught in [0169]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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