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 .
Response to Amendment
The amendment filed 13 April 2026 has been entered. Claim 14 is currently amended. Claims 14-28, 30, and 33-35 are pending in the application. Applicant’s amendments to the claims have overcome the rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 12 January 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 19, 21-28, 30, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande (US PGPub No. 2012/0302848) in view of Elbadry et al. (US PGPub No. 2019/0358387), hereinafter Elbadry.
Regarding claim 14, Deshpande teaches a vascular access assembly comprising:
an extension tube having a proximal end and a distal end (Fig. 1: extension tubes 34 and 36);
a catheter having a proximal end and a distal end, the distal end configured to be positioned in a blood vessel of a patient (Fig. 1: catheter 11 with distal end 30);
a junction having a unitary body couplable to at least one distinct fluid source through a plurality of separate and distinct receiving regions (Figs. 1-3: catheter 11 with extension tubes 34 and 36), wherein the junction includes:
at least two inflow regions, each inflow region being couplable to a respective fluid source (Fig. 3: connectors 40 of extension tubes 34, 36);
at least two distinct receiving regions, each receiving region coupled to a respective inflow region, wherein each receiving region fluidly couples to a different connection region of the junction (Fig. 3: inner lumens of extension tubes 34, 36);
at least two connection regions, each connection region fluidly coupling the respective receiving region to an outflow region, and the outflow region couplable to the proximal end of the catheter (Fig. 3: inner lumens of 34, 36 connected to catheter hub 32, coupled to the proximal end of catheter body 30);
the junction configured to be positioned to fluidly couple the extension tube and the catheter such that a first portion of the junction is extracorporeal and a second portion of the junction is intracorporeal, wherein the outflow region is coupled to the proximal end of the catheter at the intracorporeal second portion of the junction (see annotated Fig. 3);
PNG
media_image1.png
430
714
media_image1.png
Greyscale
Annotated Figure 3
and a sensor configured to obtain measurements (Fig. 3: sensor 12; par. 0027: “the sensory wire 14 is of a length to position the sensor 12 externally of the catheter 11 to facilitate blood flow across or over the sensor 12;” par. 0028: “The sensor 12 may be a conductivity, optical, or electrochemical sensor. In addition, the sensor 12 may be used to identify analytes including glucose, sodium, potassium, urea, hematocrit, oxygen saturation or other parameters relevant to patient health”).
Deshpande does not teach at least one controller configured to be communicatively coupled to the sensor, 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.
However, in an analogous art, Elbadry teaches a patient monitoring device for a vascular access assembly, comprising a sensor 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”), 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 teaches that a patient monitoring device with a controller as disclosed allows for remote monitoring of hemodialysis patients and detection of common complications (pars. 0429-430: “As hemodialysis administration includes the full circulation of the bloodstream into and out of the human body, the full range of the aforementioned sensing technology for peritoneal dialysis monitoring is applicable to remote monitoring of hemodialysis patients […] Furthermore, common complications can be detected through sensors”). 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 device of Deshpande by providing a controller as disclosed by Elbadry, in order to allow for remote monitoring of hemodialysis patients and detection of common complications, as taught by Elbadry.
Regarding claims 15 and 19, the combination teaches the device of claim 14 as described previously. Deshpande further teaches wherein the sensor is disposed at an interior region of the junction or within a lumen of the catheter (par. 0027: “in catheters configured to allow blood flow within the forward ends of the catheter lumens, the sensory wire 14 can be of a length to position the sensor 12 within the catheter lumen adjacent the forward end of the catheter lumen”).
Regarding claims 16-17, 22-25, and 27, the combination teaches the device of claim 14 as described previously. Elbadry further teaches a variety of sensor configurations, including: 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”), 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), and a second sensor at an interior region of the junction (Fig. 3: sensors 1, 43, 11, 23 inside patient monitoring device 00); or 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). Elbadry teaches that additional sensors allow the monitoring device to detect an infection state based on various parameters (e.g., par. 0018: “measuring a color of a patient skin using an image sensor, wherein the detected infection state is based at least in part on the color measurement”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined invention by providing additional sensors as disclosed by Elbadry, in order to detect an infection state, as taught by Elbadry.
Regarding claim 21, the combination teaches the device of claim 14 as described previously. Deshpande 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. 0006: “Catheters suitable for performing hemodialysis include single, dual lumen and triple lumen catheters. Prior to use, the catheter is placed within the body of a patient in a known manner and remains in place for extended periods of time;” examiner notes that hemodialysis catheters are typically central venous catheters).
Regarding claim 26, the combination teaches the device of claim 14 as described previously. Deshpande further teaches wherein the junction is a unitary body (Figs. 1 and 3: unitary body of catheter 11), but is silent with respect to material and does not explicitly teach wherein the unitary body is formed of a heat molded material. However, Elbadry teaches heat molded materials as known in the art for vascular access assemblies (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”), and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a heat molded material for the junction of the combined reference, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claims 28 and 30, the combination teaches the device of claim 14 as described previously. Deshpande further teaches wherein the junction includes an opening at the inflow region configured to receive a portion of a tubular shaft therethrough, wherein the inflow region includes a receiving region surrounded by a body of the junction, wherein the receiving region is configured to permanently or detachably receive a portion of a tubular shaft therein (Fig. 3: luer connectors 40; par. 0031: “luer connectors 40 facilitate connection of extension tubes 34 and 36 to a dialysis machine”).
Regarding claims 33-35, 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”), or wherein, based on the comparison, the controller is configured to provide an indication of a health condition of a patient, the health condition being 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 (par. 0431: “Anemia, a low concentration of red blood cells in the blood, can be observed through optical sensors that can quantify the optical signal of hemoglobin, which has a unique optical signature and signal peaks around about 410 nm and about 550 nm”). Examiner notes that as the limitations of claim 35 are recited in the alternative, the claim is considered to be met when only one of the limitations is met.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande in view of Elbadry and further in view of Dent et al. (US PGPub No. 2008/0051764), hereinafter Dent.
Deshpande in view of Elbadry 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 the combined reference 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.
Response to Arguments
Applicant’s arguments, filed 13 April 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Deshpande. As previously described, Deshpande teaches a vascular access assembly comprising a junction having a unitary body with the claimed features for inflow and outflow, such that a first portion of the junction is extracorporeal and a second portion of the junction is intracorporeal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gooch et al. (US PGPub No. 2022/0361821) teaches a vascular access assembly comprising a junction with a unitary body having at least a pair of hub lumens and extension legs.
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 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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
