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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 April 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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 16, 21-24, 27-28, 31-32, and 34 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.
Regarding Claim 16, it is unclear what further limitation is provided within this claim. This claim merely recites an obvious result of the elbow bend recited in Claim 15 (which Claim 16 is dependent on). Therefore, this limitation remains indefinite.
Regarding Claim 21, the limitation “the device” recited in lines 2 and 3 lacks proper antecedent basis. It is noted by the examiner that even if the applicant amends the claim to recite “the system”, this would leave the claim indefinite. It would be unclear which “system” is being referred given that the preamble of the claim recites “a urine salt monitoring system” as well as “a catheter system”. For this examination, the limitation is being interpreted to mean “secure the urine salt monitoring system”.
Additionally, the limitation “operable to mount to a urine collection” recited in the fourth line of the claim is indefinite. It is unclear how an object (a body portion) would mount to a liquid. This limitation should be recited in a way that provides a structure to the “urine collection” such as something similar to “operable to mount to a urine collection receptacle/device/container/something”.
Furthermore, the limitation “the urine” recited in the last line of the claim lacks proper antecedent basis. For this examination, this limitation is being interpreted to mean “urine”.
Regarding Claims 22-24, 27, and 28, the limitation “the system” recited in the preamble is indefinite. It is unclear which “system” is being referred given that the preamble of Claim 21 (which these claims are dependent on) recites “a urine salt monitoring system” as well as “a catheter system”. For this examination, the limitation is being interpreted to mean “the urine salt monitoring system”.
Regarding Claims 31 and 32, the limitation “the one or more sensors” lacks proper antecedent basis. For this examination, this limitation is being interpreted to mean “the two sensors”.
Regarding Claim 34, the limitation “the two sensors” lacks proper antecedent basis. For this examination, this limitation is being interpreted to mean “the one or more sensors”.
Claim Rejections - 35 USC § 102
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 9, 11-16, 21-24, and 27-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elbadry et. al.'387 (U.S. Patent Publication 20190358387).
Regarding Claim 9, Elbadry et. al.'387 discloses a urine salt monitoring device integrated with a catheter system, (Paragraph [0028] - the fluid conduit may be coupled to…a urinary catheter; Paragraph [0296] - salt content can be measured with an ionic conductivity sensor) the device comprising:
a clamp (301) connected to a catheter tube (34), the catheter tube (34) included in the catheter system (Paragraph [0218] - In some variations, a patient monitoring device may be clamped over a conventional tubing set and be configured to puncture a fluid conduit such that the patient monitoring device may be in direct contact with fluid within the fluid conduit…patient monitoring device (301) is clamped);
a body portion (26) mounted to a urine collection receptacle, the urine collection receptacle included in the catheter system (Paragraph [0104] - The various examples herein relate to systems used to collect, measure, analyze, transmit, and/or store patient data related to the infused and/or drained solutions into the human body via catheters for the monitoring of various therapies; Paragraph [0107] - In some variations, the patient monitoring device may be attached to a drain vessel (e.g., drain basin, toilet, sink, tub, waste bag, etc.) via a clip holder, hook, clamp, strap, adhesive, or other suitable mounting feature and/or device; Paragraph [0180] - housing or enclosure (26); Paragraph [0181] - The housing or enclosure (26) contains the patient monitoring device components; Paragraph [0182] - The housing or enclosure (26) contains at least a portion of the patient monitoring device components; Paragraph [0185] - In some variations, the patient monitoring device may be two or more separate components that can be attached to each other to provide full functionality. For example, a cartridge-based device may comprise a disposable cartridge configured to removably attach to a durable component interface (e.g., permanent enclosure/housing) of the patient monitoring device. The cartridge may comprise a set of fluid-contacting components (e.g., fluid conduit, fluid contact sensors); Paragraph [0197] - Alternately, after the fluid passes through the sensing channel, the sensing fluid channel may drain out directly to the waste receptacle; Paragraph [0217] - one or more portions of the fluid conduit (34) may comprise a sensor portion (302) and tubing connections (34); Paragraph [0317] - there may be a sterile collection container loaded at all times in the device for fluid sample collection that can be sent to a laboratory for analysis); and
a sensor housing (302) disposed in a cavity included in the body portion, the sensor housing (302) positioning one or more sensors configured to collect conductivity data describing salt content of urine collected by the catheter system (Paragraph [0104] - The various examples herein relate to systems used to collect, measure, analyze, transmit, and/or store patient data related to the infused and/or drained solutions into the human body via catheters for the monitoring of various therapies; Paragraph [0180] - housing or enclosure (26); Paragraph [0197] - Alternately, after the fluid passes through the sensing channel; Paragraph [0218] - The protruding sensors (304) may be further configured to penetrate the punch-out holes (303) when the patient monitoring device (301) is clamped over the sensor portion (302) of the fluid conduit (34) with a predetermined force, as shown in Figure 21C. In this manner, the set of sensors (304) of the patient monitoring device (301) may directly contact the fluid in the fluid conduit (34) while maintaining a fluidic seal; Paragraph [0219] - In some variations, two of the protruding sensors (304) may comprise electrodes configured to measure fluid conductivity…the set of protruding sensors (304) may include a set of protrusions configured to penetrate a wall of the sensor portion (302). For example, the set of protrusions may comprise a set of sharp needle-like ends. In some variations, the sensor portion (302) may be formed of rigid material such as PVC or nylon that may be easily punctured using a protrusion; Paragraph [0296] - salt content can be measured with an ionic conductivity sensor…because salt content in fluids affects conductivity),
the one or more sensors includes two or more electrodes operable to at least partially penetrate a same side of the catheter tube (34) to collect the conductivity data (Paragraph [0219] - In some variations, two of the protruding sensors (304) may comprise electrodes configured to measure fluid conductivity…the set of protruding sensors (304) may include a set of protrusions configured to penetrate a wall of the sensor portion (302). For example, the set of protrusions may comprise a set of sharp needle-like ends. In some variations, the sensor portion (302) may be formed of rigid material such as PVC or nylon that may be easily punctured using a protrusion).
Regarding Claims 21 and 29, the sections of Elbadry et. al.'387 cited above disclose an apparatus comprising the elements set forth in the claims. Additionally, Elbadry et. al.'387 discloses a computer processor configured to execute instructions to determine a conductivity value based on the sensor data and calculate a salt content of the urine based on the conductivity value (Paragraph [0296] - The amplitude of the received voltage (91) is measured by the microcontroller, and varies depending on the conductivity and presence of fluid in the fluid conduit. Because salt content in fluids affects conductivity, the dialysate salinity can be measured by the conductivity mechanism described).
Regarding Claim 11, Elbadry et. al.'387 discloses the system outlined in Claim 9 above as well as wherein the two or more electrodes are configured to contact urine as it flows through the catheter tube (34) (Paragraph [0218] - the set of sensors (304) of the patient monitoring device (301) may directly contact the fluid in the fluid conduit (34) while maintaining a fluidic seal).
Regarding Claim 12, Elbadry et. al.'387 discloses the system outlined in Claim 11 above as well as further comprising a cap placed over the sensor housing (302), the cap having a groove for disposing the catheter tube (34) and one or more openings within the groove (Paragraph [0217] - In particular, the patient monitoring device (301) may be configured to clamp over the sensor portion (302) to measure one or more properties of the fluid without direct fluid contact; see Annotated Figure 20A below).
PNG
media_image1.png
254
206
media_image1.png
Greyscale
Annotated Figure 20A
Regarding Claim 13, Elbadry et. al.'387 discloses the system outlined in Claim 12 above as well as wherein the two or more electrodes extend through the two or more openings formed into the groove to pierce the catheter tube (34) disposed inside the groove (Paragraph [0218] - The protruding sensors (304) may be further configured to penetrate the punch-out holes (303) when the patient monitoring device (301) is clamped over the sensor portion (302) of the fluid conduit (34) with a predetermined force, as shown in Figure 21C).
Regarding Claims 23-24, 28, and 30, the sections of Elbadry et. al.'387 cited above disclose an apparatus comprising the elements set forth in the claim. Furthermore, Elbadry et. al.’387 discloses guide channels that prevent sensors from being displaced when pressed against the catheter tube (Paragraph [0218] - the patient monitoring device (301) may include a set of protruding sensors (304) that may be configured to align with the punch-out holes (303). The protruding sensors (304) may be further configured to penetrate the punch-out holes (303) when the patient monitoring device (301) is clamped over the sensor portion 9302) of the fluid conduit (34) with a predetermined force).
Regarding Claim 14, Elbadry et. al.'387 discloses the system outlined in Claim 13 above as well as further comprising the clamp (301) configured to rotate over the groove to compress the catheter tube (34) against the two or more electrodes, the clamp (301) dimensioned to force the electrodes to pierce the catheter tube (34) when the clamp is secured over the groove (Paragraph [0218] - The protruding sensors (304) may be further configured to penetrate the punch-out holes (303) when the patient monitoring device (301) is clamped over the sensor portion 9302) of the fluid conduit (34) with a predetermined force, as shown in Figure 21C; Paragraph [0219] - In some variations, two of the protruding sensors (304) may comprise electrodes configured to measure fluid conductivity…the set of protruding sensors (304) may include a set of protrusions configured to penetrate a wall of the sensor portion (302). For example, the set of protrusions may comprise a set of sharp needle-like ends. In some variations, the sensor portion (302) may be formed of rigid material such as PVC or nylon that may be easily punctured using a protrusion).
Regarding Claims 22, 27, and 31-32, the sections of Elbadry et. al.'387 cited above disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 15, Elbadry et. al.'387 discloses the system outlined in Claim 9 above as well as comprising a connector for shaping the catheter tube into an elbow bend that forces a portion of the catheter tube extending over a top surface of the body portion to lay horizontally (Paragraph [0121] - the in-dwelling catheter connector (14); Paragraph [0183] - The two halves of the assembly (26a, 26b) may be removably coupled such as via snap fittings and/or an electrical connector. Different cartridges may comprise different configurations, such as different sensor packages. In some variations, a cartridge may comprise an enclosed housing such that fluid-contacting components are sterile until the cartridge is properly loaded into the durable component interface (e.g., first half (26a)); Paragraph [0184] - In each variation described in FIGS. 3, 4, and 5, one or more components of the patient monitoring device (e.g., battery, memory, sensors, fluid conduit) may be removable for ease of one or more of replacement, cleaning, data transfer, and charging; Paragraph [0185] - In some variations, the patient monitoring device may be two or more separate components that can be attached to each other to provide full functionality. For example, a cartridge-based device may comprise a disposable cartridge configured to removably attach to a durable component interface (e.g., permanent enclosure/housing) of the patient monitoring device. The cartridge may comprise a set of fluid-contacting components (e.g., fluid conduit, fluid contact sensors); see Annotated Figure 4 below).
PNG
media_image2.png
395
542
media_image2.png
Greyscale
Annotated Figure 4
Regarding Claim 16, Elbadry et. al.'387 discloses the system outlined in Claim 15 above as well as adjusting dwell time (Paragraph [0194] - a long fluid dwell time is desirable, the cross-sectional area of the measurement channel can be relatively small (e.g., about 100 to about 500 um diameters) to reduce the flow velocity via an increase in back pressure from the lumen reduction; Paragraph [0350] - the flow volume and dwell time can be used to normalize the data generated by conductivity, urea, glucose and/or other sensors for analyte concentration). Furthermore, by virtue of the catheter tube being shaped into an elbow bend, the dwell time of urine in a portion of the catheter tube disposed in the clamp is increased. Official notice is being taken that it is well known in the art that adding a bend (or kink) to a tube decreases the velocity of fluid flowing through the tube, thus increasing a dwell time of the fluid in the tube.
Regarding Claim 33, Elbadry et. al.'387 discloses the system outlined in Claim 9 above as well as wherein the two or more electrodes form two contacts along a flow of the urine through the catheter tube (34) to form a conductivity circuit with the flow of the urine (Paragraph [0219] - In some variations, two of the protruding sensors (304) may comprise electrodes configured to measure fluid conductivity).
Regarding Claim 34, Elbadry et. al.'387 discloses the system outlined in Claim 15 above. Official notice is being taken that it is well known in the art that adding a bend (or kink) to a tube decreases the velocity of a flow of fluid within the tube.
Response to Arguments
Applicant's arguments filed 20 April 2026 have been fully considered and they are not entirely persuasive.
Examiner has addressed rejections under 35 U.S.C. 112 in paragraph 4 above.
Without contesting the applicant’s argument pertaining to the instant application being inventive over the prior art of record, the examiner has cited additional prior art, as necessitated by amendments, that they believe directly teaches on each of the instant application’s amended claim limitations. More specifically, Claims 9, 11-16, 21-24, and 27-34 are rejected under 35 U.S.C. 102(a)(1) as necessitated by amendments, as discussed in Paragraph 5 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights