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 .
This action is in response to papers filed October 14, 2025. The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1)/(a)/(2) as being anticipated by Gerber et al., (US 2018/0193546; hereinafter “Gerber”) referencing teaching reference to Powell et al., (WO 2023/249958; hereinafter “Powell”, which has been discussed below).
Note: The instant claims contain a large amount of functional language (ex: “fluid conduit is configured to receive a volume…”, “cartridge housing is configured for engagement”, etc.) However, functional/process language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. Therefore, if the prior art structure is capable of performing the function or intended use, then the prior art meets the limitation in the claims. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
Regarding claim 1, Gerber teaches a fluid sampling cartridge for capturing a fluid sample, the fluid sampling cartridge 201 comprising:
a fluid conduit having an interior conduit portion defined between a fluid conduit inlet 203 and a fluid conduit outlet 204, 205 of the fluid conduit, wherein the fluid conduit is configured to receive a volume of fluid at the fluid conduit inlet such that the fluid conduit defines a fluid flow path within the interior conduit portion 228 between the fluid conduit inlet and the fluid conduit outlet, wherein the fluid conduit defines a cavity extending through a fluid conduit sidewall in at least perpendicular direction relative to a central axis of the fluid conduit (see Fig. 2d para [0101] et seq.);
a capillary component (sensor card 209 including membrane ) having a first capillary end in fluid communication with the interior conduit portion 228 wherein the cavity receive at least a first portion of the capillary component, wherein the capillary component (sensing membranes 301) configured to receive at least a portion of the volume of fluid using capillary effect (Gerber clearly discloses that the sensing membrane (fiber) material inherently requires capillary action to absorb the fluid and expose the sensing areas 302-307), see para [0078] et seq., note that applicant’s specification discloses that a fiber material is an example of a capillary component that provides capillary effect or action on the fluid, see US 2024/0091761 para [0072],) and Gerber clearly teaches the use of membranes (i.e., fiber material inherently wick via capillary action any applied liquid along the fiber material and ultimately to the sensing regions 302, 302, 303, 304, 307 on the fiber);
a cartridge housing 203 defining an interior housing portion, wherein the cartridge housing is configured for engagement with the fluid conduit and the capillary component 209 such that at least a portion of the fluid conduit and at least a second portion of the capillary component are disposed within the interior housing portion (see para [0089] et seq.) Furthermore, Powell (WO 2023/249958 is direct to the same art of sensing peritoneal dialysis fluids, wherein Powell is used herein as a teaching reference) clear discloses membranes provide one or more microchannels 81, 81’ that may be a microfluidic channel made of cellulose, nylon, or another membrane material with capillary activity (capillary' force) that may draw up fluid (from drain tube), see para [0075] et seq.)
Regarding claim 2, Gerber discloses the cartridge housing is configured for selective arrangement in an installed position relative to a fluid sampling system, the installed position being defined by an arrangement of the capillary component relative to an imaging device (camera 206) of the fluid sampling system that enables the imaging device to capture imaging data associated with the fluid sample received within the capillary component (Gerber teaches in FIG. 2D, the fluid sensor apparatus 201 has a receiving slot 202 traversing a sampling chamber 228 along an axis. A removable sensor card 209 can be inserted into the receiving slot 202 as illustrated in FIGS. 2D and 2E to a specified depth of the fluid sensor apparatus 201. Indentations 230 on either side of the sampling chamber 228 at the depth of the fluid sensor apparatus 201 in FIG. 2D, can receive an edge of the sensor card 209, to seat or fasten the sensor card 209 in place. At a higher depth of the fluid sensor apparatus 201, a groove can be formed appurtenant to a sidewall of the sampling chamber 228 to receive a side edge of the sensor card 209. An edge of the sensor card 209 can be securely positioned in the sampling chamber 228 at a specified location or orientation with respect to a light source and/or photodetector, see para [0090] et seq.)
Regarding claim 3, Gerber discloses the cartridge housing comprises a conduit channel defined within the interior housing portion, the conduit channel being configured to receive at least a portion of the fluid conduit therein to secure the fluid conduit relative to the cartridge housing.
Regarding claim 4, Gerber teaches the cartridge housing comprises a capillary channel 202 defined within the interior housing portion, wherein a conduit channel is configured to receive at least the first portion of the capillary component therein to secure the capillary component relative to the cartridge housing (see para [0089] et seq.)
Regarding claim 6, Gerber discloses the cartridge housing defines one or more imaging orifices (clear windows) configured such that at least a portion of the capillary component is visible through the cartridge housing via the one or more imaging orifice (see para [0096] et seq.)
Regarding claim 7, Gerber discloses the one or more imaging orifice intersects at least a portion of a capillary channel defined by the cartridge housing, the conduit channel being configured to receive at least a portion of the capillary component therein to secure the capillary component relative to the cartridge housing (see para [0096] et seq.).
Regarding claim 8, Gerber discloses the one or more imaging orifice (clear windows) includes a first imaging orifice provided on a front surface of the conduit housing and a second imaging orifice provided on a rear surface of the conduit housing (see para [0098] et seq.)
Regarding claim 9, Gerber discloses the first imaging orifice is positioned at least substantially adjacent a front capillary surface of the capillary component disposed within the interior housing portion of the cartridge housing such that the front capillary surface is visible through the first imaging orifice, and wherein the second imaging orifice is positioned at least substantially adjacent a rear capillary surface of the capillary component such that the rear capillary surface is visible through the second imaging orifice (see para [0098] et seq.)
Regarding claim 10, Gerber discloses the cartridge housing is defined by a plurality of detachable components configured for selective attachment relative to one another to collectively define the cartridge housing (see para [0091] et seq.)
Regarding claim 11, Gerber discloses the cartridge housing comprises a front housing portion 1354 and a rear housing portion 1352 that are configured to be detachably fastened relative to one another to collectively define an exterior shell of the cartridge housing with the interior housing portion defined therein (see para [0374] et seq.)
Regarding claim 12, Gerber discloses the front housing portion defines a first conduit channel portion and the rear housing portion defines a second conduit channel portion, the first conduit channel portion and the second conduit channel portion collectively defining a conduit channel within the interior housing portion that is configured for receiving at least a portion of the fluid conduit (two part housing; see para [0374] et seq.)
Regarding claim 13, Gerber discloses the front housing portion defines a first capillary channel portion 203 and the rear housing portion defines a second capillary channel portion 228, the first capillary channel portion and the second capillary channel portion collectively defining a capillary channel within the interior housing portion that is configured for receiving at least a portion of the capillary component (see para [0090] et seq.)
Regarding claim 14, Gerber discloses the front housing portion defines a first imaging orifice and the rear housing portion defines a second imaging orifice, and wherein at least a portion of the capillary component defining a receiving area within which the capillary component captures the fluid sample is positioned in between the first imaging orifice and the second imaging orifice (see para [0096] et seq.)
Regarding claim 16, Gerber discloses the capillary component comprises a first opening 203 defined at a first capillary end and a second opening defined at a second capillary end 228, wherein the first opening defines a fluid inlet through which the capillary component receives the fluid sample (see para [0101] et seq.)
Regarding claim 17, Gerber discloses the capillary component is arranged relative to the fluid conduit such that the first opening of the capillary component is disposed within the interior conduit portion of the fluid conduit (see para [0089] et seq.)
Regarding claim 18, Gerber discloses the fluid sampling cartridge is configured for arrangement within fluid sampling system such that the fluid sample captured within the capillary component is disposed within a field of view of an imaging device [0096] et seq.)
Regarding claim 19, Gerber discloses the fluid sampling cartridge is configured to enable an imaging of the fluid sample captured within the capillary component by the imaging device at an instance during operation of the fluid sampling system in which the volume of fluid is flowing through the fluid conduit (see para [0096] et seq.)
Claims 1-4, 6-14, and 16-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Powell.
Note: The instant claims contain a large amount of functional language (ex: “fluid conduit is configured to receive a volume…”, “cartridge housing is configured for engagement”, etc.) However, functional/process language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. Therefore, if the prior art structure is capable of performing the function or intended use, then the prior art meets the limitation in the claims. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
Regarding claim 1, Powell teaches a fluid sampling cartridge for capturing a fluid sample, the fluid sampling cartridge comprising:
a fluid conduit (109) having an interior conduit portion defined between a fluid conduit inlet 120 and a fluid conduit outlet 34, wherein the fluid conduit is configured to receive a volume of fluid at the fluid conduit inlet such that the fluid conduit defines a fluid flow path within the interior conduit portion 228 between the fluid conduit inlet and the fluid conduit outlet, wherein the fluid conduit defines a cavity (and slot 98) extending through a fluid conduit side wall in an at least perpendicular direction relative to the central axis of the fluid conduit, (see Figs. 6-8 and para [0078] et seq.);
a capillary component having a first capillary end in fluid communication with the interior conduit portion and configured to receive at least a portion of the volume of fluid, the at least a portion of the volume of fluid received by the capillary component from the fluid conduit defining a fluid sample (see Figs. 6-8 and para [0078] et seq.); and
a cartridge housing 102 defining an interior housing portion, wherein the cartridge housing is configured for engagement with the fluid conduit and the capillary component 100 such that at least a portion of the fluid conduit and at least a portion of the capillary component are disposed within the interior housing portion (see Fig. 6-8 and para [0079] et al.)
Regarding claim 2, Powell discloses the cartridge housing is configured for selective arrangement in an installed position relative to a fluid sampling system, the installed position being defined by an arrangement of the capillary component relative to an imaging device (optical sensor) of the fluid sampling system that enables the imaging device to capture imaging data associated with the fluid sample received within the capillary component (see para [0067] et seq.)
Regarding claim 3, Powell discloses the cartridge housing comprises a conduit channel defined within the interior housing portion, the conduit channel being configured to receive at least a portion of the fluid conduit therein to secure the fluid conduit relative to the cartridge housing (see Figs. 6-8).
Regarding claim 4, Powell discloses the cartridge housing comprises a capillary channel defined within the interior housing portion, wherein a conduit channel being configured to receive at least a portion of the capillary component therein to secure the capillary component (see para [0075] et seq.)
Regarding claim 6, Powell discloses cartridge housing defines one or more imaging orifices configured such that at least a portion of the capillary component is visible through the cartridge housing via the one or more imaging orifice (see para [0126 et seq.)
Regarding claim 7, Powell discloses the one or more imaging orifice intersects at least a portion of a capillary channel defined by the cartridge housing, the conduit channel being configured to receive at least a portion of the capillary component therein to secure the capillary component relative to the cartridge housing (see para [0126] et seq.).
Regarding claim 8, Powell discloses the one or more imaging orifice (clear windows) includes a first imaging orifice provided on a front surface of the conduit housing and a second imaging orifice provided on a rear surface of the conduit housing (see para [0126] et seq.)
Regarding claim 9, Powell discloses the first imaging orifice is positioned at least substantially adjacent a front capillary surface of the capillary component disposed within the interior housing portion of the cartridge housing such that the front capillary surface is visible through the first imaging orifice, and wherein the second imaging orifice is positioned at least substantially adjacent a rear capillary surface of the capillary component such that the rear capillary surface is visible through the second imaging orifice (see para [0067] et seq.)
Regarding claim 10, Powell discloses the cartridge housing is defined by a plurality of detachable components configured for selective attachment relative to one another to collectively define the cartridge housing (see Fig. 6c and para [0078] et seq.)
Regarding claim 11, Powell discloses the cartridge housing comprises a front housing portion and a rear housing portion (parts of housing 102) that are configured to be detachably fastened relative to one another to collectively define an exterior shell of the cartridge housing with the interior housing portion defined therein (see para [0078] et seq.)
Regarding claim 12, Powell discloses the front housing portion defines a first conduit channel portion and the rear housing portion defines a second conduit channel portion, the first conduit channel portion and the second conduit channel portion collectively defining a conduit channel within the interior housing portion that is configured for receiving at least a portion of the fluid conduit (two part housing; see para [0078] et seq.)
Regarding claim 13, Powell discloses the front housing portion defines a first capillary channel portion 81 and the rear housing portion defines a second capillary channel portion, the first capillary channel portion and the second capillary channel portion collectively defining a capillary channel within the interior housing portion that is configured for receiving at least a portion of the capillary component (see para [0078] et seq.)
Regarding claim 14, Powell discloses the front housing portion defines a first imaging orifice and the rear housing portion defines a second imaging orifice, and wherein at least a portion of the capillary component defining a receiving area within which the capillary component captures the fluid sample is positioned in between the first imaging orifice and the second imaging orifice (see para [0096] et seq.)
Regarding claim 16, Powell discloses the capillary component comprises a first opening defined at a first capillary end 96b and a second opening defined at a second capillary end, wherein the first opening defines a fluid inlet through which the capillary component receives the fluid sample (see para [0079] et seq.)
Regarding claim 17, Powell discloses the capillary component is arranged relative to the fluid conduit such that the first opening of the capillary component is disposed within the interior conduit portion of the fluid conduit (see para [0089] et seq.)
Regarding claim 18, Powell discloses the fluid sampling cartridge is configured for arrangement within fluid sampling system such that the fluid sample captured within the capillary component is disposed within a field of view of an imaging device [0096] et seq.)
Regarding claim 19, Powell discloses the fluid sampling cartridge is configured to enable an imaging of the fluid sample captured within the capillary component by the imaging device at an instance during operation of the fluid sampling system in which the volume of fluid is flowing through the fluid conduit (see para [0096] et seq.)
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed October 14, 2025 have been fully considered but they are not persuasive. In response to the rejections of the claims over the Gerber, applicant argues that Gerber does not disclose a cavity extending through a fluid conduit sidewall in an at least perpendicular direction relative to a central of the fluid conduit, wherein the cavity receive at least a first portion of the capillary component, wherein the capillary component is configured to receive tat least portion of the volume of fluid using capillary effect .
The examiner respectfully disagrees. Gerber clear shows a conduit that receives the capillary component (i.e., membrane), see par a[0105] et seq. and Fig. 2D-E. With respect to applicant’s argument that the membrane is configured to receive at least a portion of the volume of fluid using a capillary effect, the examiner points to the membranes in Gerber are clearly fibers like applicant’s capillary portion. So it is expected that the membranes of Gerber will absorb liquid using capillary effect as it is an inherent property of fibrous membranes (see for example Powell). The examiner invites applicant to provide evidence, not arguments, that fibrous membranes such as those disclosed in Powell and Gerber, use some other means besides capillary action/absorption to wick fluids such that they reach the various sensor locations on the membrane. Thus, for the reasons delineated above, the claims are rejected over the prior art.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wang et al., (US 2023/0248890) teach a device for analyzing spent peritoneal dialysate from a peritoneal dialysis apparatus. The device comprises: a set of housings attachable to the peritoneal dialysis apparatus; a set of test components disposed in the housings, each test component and comprising one or more reagents for detecting one or more substances; and a set of fluidic conduits connected to the housings for communicating the dialysate from the peritoneal dialysis apparatus to the housings, wherein the test components are arranged for the reagents to react with the dialysate communicated to the housings and thereby detect the substances in the dialysate; and
Elbadry et al., (US 2019/0358387) teach a patient monitoring system may be used with catheters to monitor the infusion and drainage of any solution into the human body. The system may be used, for example, with in-dwelling catheters for peritoneal dialysis in end stage renal disease (ESRD) patients, urinary tract catheters, insulin pumps in diabetic patients, feeding tubes and central venous line catheters. The patient monitoring system includes one or more fluid pathways for infusing into and/or draining solutions out of the catheter, and one or more sensors to monitor the fluid. The patient monitoring system transmits the patient monitoring data to a database, allowing data storage, processing, and access through graphical user interfaces to patients and providers via device applications or browser-based web access portals
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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on Monday-Thursday 5:30am-3pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798