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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 December 2025 has been entered. Claim 14 is currently amended. Claims 14-28, 30, and 33-35 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-28, 30, and 33-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In amended claim 14, it is unclear whether the plurality of separate and distinct receiving regions is different from the inflow region coupled to a distal end of the extension tube, which renders the scope of the claim unclear. Additionally, it is unclear whether the plurality of receiving regions each connect to a respective inflow region, or if a single inflow region connects to the plurality of receiving regions. For examination purposes, the claim will be read as wherein the plurality of separate and distinct receiving regions connect to a single inflow region via the extension tube. Dependent claims 15-28, 30, and 35 are necessarily rejected as depending on a rejected base claim.
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.
Claims 14-17, 21-28, 30, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry et al. (US PGPub No. 2019/0358387), hereinafter Elbadry, in view of Sauder (US PGPub No. 2018/0235523).
Regarding claim 14, Elbadry teaches a vascular access assembly, comprising:
an extension tube having a proximal end and a distal end (Figs. 1A-1B: tubing set T);
a catheter having a proximal end and a distal end (Fig. 1B: in-dwelling patient catheter 12), the distal end configured to be positioned in a blood vessel of a patient (par. 0003: “The system may be used, for example, with in-dwelling catheters for […] central venous line catheters, and the like”);
a junction (Figs. 1B-2: patient monitoring device 00) couplable to at least one distinct fluid source (par. 0108: “the patient may connect the opposite tube fitting from the patient monitoring device to the tubing line from the prescribed therapy (e.g., the dialysis tubing port for peritoneal dialysis patients, the intravenous drug tubing port for patients with PICC lines treating infection, etc.)”) and having an inflow region coupled to a distal end of the extension tube (Fig. 2: first connector 13; par. 0180: “A first connector (13) configured to connect to one or more of an infused and drained dialysate containers”) and an outflow region coupled to a proximal end of the catheter (Fig. 2: second connector 14; par. 0180: “a second connector (14) configured to connect to the in-dwelling catheter”),
the junction configured to be positioned such that a first portion of the junction is extracorporeal and a second portion of the junction is intracorporeal (Fig. 13: connector 53 and in-dwelling catheter connector 14; par. 0121: “the patient monitoring device (00) connected via a connector (53) to the in-dwelling catheter connector (14);” examiner interprets the in-dwelling catheter connector 14 and the coupled portion of the in-dwelling catheter as an intracorporeal portion of the junction, and the rest of the device as an extracorporeal portion of the junction),
wherein the junction is configured to fluidly couple the extension tube and the catheter (Fig. 2: connectors 13 and 14 fluidly coupled via fluid conduit 15);
a sensor configured to obtain measurements (Fig. 2: sensors 1-11, 24, 25);
and at least one controller configured to be communicatively coupled to the sensor (Fig. 2: processor 16; par. 0180: “The processor (16) includes the hardware and the firmware that, with the support of program memory and random access memory (17) controls the network of sensors, receives the sensor data, processes the sensor data, stores the processed data in the memory module (19), communicates with a transmitter (e.g., via Bluetooth, Wi-Fi) or directly (e.g. via LTE cellular) to the database server system (not shown) via the wireless communication module (18), and manages the local power supply (21)”),
wherein the at least one controller is further configured to obtain the measurements via the sensor while the catheter is positioned within the blood vessel; and determine at least one physiological parameter based on the measurements (par. 0125: “a durable component may include at least one sensor and a processor to measure patient fluid and detect patient infection”).
Elbadry does not explicitly teach wherein the junction is couplable to the fluid source through a plurality of separate and distinct receiving regions. However, in an analogous art, Sauder teaches a vascular access assembly with a junction couplable to two distinct fluid sources (Fig. 11: IV fluids 106A, 106B in reservoirs 105A, 105B) through a plurality of extracorporeal separate and distinct receiving regions (Fig. 11: distinct regions from IV pumps 110A, 110B combining at coupling 372; par. 0089: “Output of the IV fluids 106A, 106B from the pumps 110A, 110B can be combined at coupling 372, fed together into the primary infusion tube 116, which is plugged into the base 118 at one end of the umbilical 120 running from the console 104 to the sensor housing 122”).
To provide the vascular access assembly of Elbadry with a junction couplable to more than one fluid source through a plurality of separate and distinct receiving regions, as suggested by Sauder, would have been obvious to one skilled in the art for the following reasons:
Elbadry discloses a prior art vascular access assembly upon which the claimed invention (having a plurality of separate and distinct receiving regions for coupling to multiple fluid sources) can be seen as an “improvement” (Elbadry only provides one receiving region for coupling to a single fluid source). Sauder teaches a prior art vascular access assembly using a known technique that is applicable to the assembly of Elbadry, namely, the technique of providing a coupling for multiple fluid lines to connect to a singular intravenous site. Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that applying the known technique taught by Sauder to the vascular access assembly of Elbadry would have yielded predictable results and resulted in an improved system, namely, a system that can receive multiple IV fluids at a singular intravenous site.
Regarding claim 15, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the sensor is disposed at an interior region of the junction (Figs. 2-3: sensors 1, 43, 11, 23 inside patient monitoring device 00).
Regarding claims 16 and 22, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the sensor is disposed at an exterior region of the junction and wherein at least a portion of the sensor is exposed at an exterior surface of the junction such that, when the junction is positioned against a patient's skin, the sensor is in contact with the patient's skin (par. 0180: “A skin color sensor (24) and/or a skin surface temperature sensor (25) may be located such that the sensors are exposed to or in positioned against the skin surface, next to an in-dwelling catheter exit site”).
Regarding claims 17 and 23, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the sensor comprises a plurality of sensors, including a first sensor at an exterior region of the junction (Fig. 2: sensors 24 and 25 positioned against skin surface; see also par. 0180) and a second sensor at an interior region of the junction (Fig. 3: sensors 1, 43, 11, 23 inside patient monitoring device 00).
Regarding claim 21, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the junction is a portion of a central venous catheter, a midline catheter, a peripherally-inserted central catheter, a peripheral intravenous line, or an arterial line catheter (par. 0003: “The system may be used, for example, with in-dwelling catheters for peritoneal dialysis in end stage renal disease (ESRD) patients, urinary catheters, hydrocephalus shunts, ascites drainage catheters, insulin pumps in diabetic patients, feeding tubes, central venous line catheters, and the like”).
Regarding claim 24, the combination teaches the device of claim 23 as described previously. Elbadry further teaches wherein each of the plurality of sensors have a portion that is exposed at an exterior surface of the junction such that, when the junction is positioned against a patient's skin, each of the sensors is in contact with the patient's skin (par. 0180: “A skin color sensor (24) and/or a skin surface temperature sensor (25) may be located such that the sensors are exposed to or in positioned against the skin surface, next to an in-dwelling catheter exit site”).
Regarding claim 25, the combination teaches the device of claim 23 as described previously. Elbadry further teaches wherein at least one of the sensors is disposed at an exterior surface of the junction (Fig. 2: sensors 24 and 25 positioned against skin surface; see also par. 0180) and at least one of the sensors is disposed at an interior region of the junction (Fig. 3: sensors 1, 43, 11, 23 inside patient monitoring device 00).
Regarding claim 26, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the junction is a unitary body (Fig. 3 and par. 0181: “the enclosure may be heat-welded or glued together”) formed of a heat molded material (par. 0211: “The enclosure parts may be manufactured (e.g., injection molded, machined, 3-D printed) from flexible materials such as silicone, thermoplastic polyurethane (TPU), and the like”).
Regarding claim 27, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the junction includes a first sensor adjacent the inflow region (Fig. 2: flow sensor 1 adjacent first connector 13) and a second sensor adjacent the outflow region (Fig. 2: creatinine sensor 11 adjacent second connector 14).
Regarding claim 28, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the junction includes an opening at the inflow region configured to receive a portion of a tubular shaft therethrough (Fig. 3: connector 13; par. 0181: “Tubing connectors (e.g., standard Luer connectors) may include one connection port (13) connected to the dialysate solution and one connection port (14) connected to the in-dwelling catheter”).
Regarding claim 30, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the inflow region includes a receiving region, wherein the receiving region is configured to permanently or detachably receive a portion of a tubular shaft therein (Fig. 3: connector 13; par. 0181: “Tubing connectors (e.g., standard Luer connectors) may include one connection port (13) connected to the dialysate solution and one connection port (14) connected to the in-dwelling catheter”) but does not explicitly teach wherein the receiving region is surrounded by a body of the junction. However, in the same embodiment, Elbadry teaches a receiving region for receiving a portion of a tubular shaft therein that is surrounded by a body of the junction (Fig. 3: connector 14; par. 0181: “The connection port for the catheter (14) may be contained within the enclosure (26)”). It would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inflow region of Elbadry to have a receiving region surrounded by a body of the junction, as taught for the outflow region of Elbadry, since applicant has not disclosed that surrounded the receiving region with the junction solves any stated problem or is for any particular purpose, and it appears that the invention would perform equally as well with a connection port contained within the enclosure as a connection port external to the enclosure.
Regarding claims 33-34, the combination teaches the device of claim 14 as described previously. Elbadry further teaches wherein the at least one controller is configured to compare the at least one physiological parameter to a predetermined threshold, and wherein the at least one controller is configured to provide an indication of the patient's health based on the comparison (par. 0365-0366: “A high temperature exceeding 105° F. and a four standard deviation drop in pH value would warrant an extreme severity alert. […] the server and/or device processor may be configured to determine critical emergency scenarios of the patient's condition and triggers additional action. In one example for a patient with a urinary catheter, the temperature sensors measure the skin surface temperature at 110° F. and the accelerometers detect minimal patient movement over a 24 hour period. In addition to sending high-severity alerts to the provider, the system triggers a call to emergency personnel”).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry in view of Sauder and further in view of Dent et al. (US PGPub No. 2008/0051764), hereinafter Dent.
Elbadry in view of Sauder teaches the device of claim 14 as described previously. Elbadry further teaches flow sensors to measure the inflow through the extension tube and outflow through the catheter (par. 0007: “The flow sensor may be used to measure the fill volume (FV) of infused dialysate solution infused through the catheter and/or the drain volume (DV) of waste dialysate solution exiting the catheter to determine the FV/DV ratio”) but is silent with respect to the specific placement of the sensors and does not explicitly teach wherein the sensor is disposed within a lumen of the extension tube, within a lumen of the catheter, or within a wall of the catheter. However, in a related biomonitoring art, Dent teaches a vascular access assembly (par. 0022: “a flexible conduit may be positionable in the vasculature or a cavity of a human body”) wherein various monitoring sensors are disposed within lumens or within walls of a tube or catheter (par. 0024: “one or more sensors may be positionable in a flexible conduit […] Sensors may be bonded, glued, and/or otherwise affixed to a flexible conduit. Sensors may be implanted on a flexible conduit. In an embodiment, sensors may not be coupled to a flexible conduit. Sensors may be positionable in an opening in a flexible conduit”). In light of Dent’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the assembly of Elbadry by placing the sensor within a lumen of the extension tube or catheter or implanted within a wall of the catheter, as taught by Dent, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Elbadry in view of Sauder and further in view of Reghabi et al. (US PGPub No. 2005/0065556), hereinafter Reghabi.
Elbadry in view of Sauder teaches the device of claim 33 as described previously. Elbadry further teaches wherein, based on the comparison, the controller is configured to provide an indication of a health condition of a patient (par. 0365-0366: “A high temperature exceeding 105° F. and a four standard deviation drop in pH value would warrant an extreme severity alert. […] the server and/or device processor may be configured to determine critical emergency scenarios of the patient's condition and triggers additional action. In one example for a patient with a urinary catheter, the temperature sensors measure the skin surface temperature at 110° F. and the accelerometers detect minimal patient movement over a 24 hour period. In addition to sending high-severity alerts to the provider, the system triggers a call to emergency personnel”) but does not explicitly teach wherein the health condition is at least one of sepsis, pulmonary embolism, metastatic spinal cord compression, anemia, dehydration/volume depletion, vomiting, pneumonia, congestive heart failure, kidney failure, volume overload, performance status, arrythmia, neutropenic fever, acute myocardial infarction, pain, opioid toxicity, hyperglycemic/diabetic ketoacidosis, hypoglycemia, hyperkalemia, hypercalcemia, hyponatremia, one or more brain metastases, superior vena cava syndrome, gastrointestinal hemorrhage, immunotherapy-induced or radiation pneumonitis, immunotherapy-induced colitis, diarrhea, cerebrovascular accident, stroke, pathological fracture, hemoptysis, hematemesis, medication-induced QT prolongation, heart block, tumor lysis syndrome, sickle cell anemia crisis, gastroparesis/cyclic vomiting syndrome, hemophilia, cystic fibrosis, chronic pain, and seizure.
However, in a related biomonitoring art, Reghabi teaches using a sensor inserted into the vasculature to detect the health condition of sepsis (par. 0060: “a variety of parameters may be monitored in connection with sepsis or septic shock using the implantable, multi-parameter sensor. According to embodiments of the present invention, lactate levels, blood oxygen saturation, base deficit and pH, for example, may be monitored in connection with sepsis or septic shock in a patient. Also, these parameters may be continuously monitored”), which allows blood chemistry levels to be regulated and the incidence of sepsis decreased (par. 0005: “sepsis, a toxic condition resulting from the spread of bacteria or their products from a focus of infection, can lead to global tissue hypoxia, multiple organ failures, cardiovascular collapse and eventual death. Increased blood lactate concentrations and decreased mixed venous oxygen saturation are classic indicators of the early phases of septic shock. By monitoring these parameters, blood chemistry levels can be regulated and the incidence of sepsis decreased”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the assembly of Elbadry by indicating the health condition of sepsis, as taught by Reghabi, in order to regulate blood chemistry levels and decrease the incidence of sepsis, as taught by Reghabi.
Response to Arguments
Applicant’s arguments, filed 02 December 2025, with respect to the rejection(s) of claim 14 under 35 U.S.C. 102(a)(2) have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of Sauder. As described previously, Sauder teaches a junction couplable to multiple fluid sources through a plurality of separate and distinct receiving regions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794