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 without traverse of Group I, Claims 1-6, 9-11, 13-14, 16, and 18 in the reply filed on 05/04/2026 is acknowledged. Claims 19-20, 22-23, 26, 28-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Status of Claims
Claim(s) 1-6, 9-11, 13-14, 16, 18-20, 22-23, 26, 28-29 is/are pending in the application.
Claim(s) 19-20, 22-23, 26, 28-29 is/are withdrawn from further consideration
Claim(s) 1-6, 9-11, 13-14, 16, and 18 is/are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/09/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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.
Claim(s) 4 is/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.
Claim 4 recites the limitation “the at least one sensor comprises a sensor array” which is indefinite. According to ¶0087 and Fig. 4 of Applicant’s publication, a sensor array 145 comprises multiple sensors. Thus, the limitation is indefinite because it is inconsistent with the specification. The limitation has been examined below as if it read -- a sensor array comprises the at least one sensor [[comprises a sensor array]] --.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 10, and 18 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Braga (US PGPUB 20190001030).
Regarding claim 1, Braga discloses a system for detecting a value of a parameter of a canister (a canister assembly 240: Abstract, ¶0075-0076, 0079, and 0104; Figs. 2-3 and 10-11), the system comprising:
a therapy unit (a control unit 246: ¶0076, 0083, and Fig. 10) comprising:
at least one wall having an interior surface (opposite to a bottom side of the control unit 246) and an exterior surface (a bottom side of the control unit 246: ¶0102); and
a controller (a processor 1310: ¶0083 and Fig. 10);
a canister (a collection canister 242: ¶0076, 0086; Figs. 2 and 10) comprising:
a canister body (a chamber 260/1335: ¶0086, 0105; Figs. 10-11); and
a lid configured to be coupled to the canister body to form a sealed interior (a canister top 1336: ¶0102, 0105, and Fig. 11), the lid further configured to be coupled to the exterior surface of the at least one wall of the therapy unit (the lid is coupled to the exterior surface of the at least one wall of the therapy unit via ports 1374 and 1396: ¶0102 and Fig. 10); and
at least one sensor configured to be communicatively coupled to the controller (a sensor 1320: ¶0104 and Fig. 10) and to generate a signal indicative of a parameter associated with the canister (¶0043 and 0107), the controller being configured to receive the signal from the at least one sensor and to determine a value of the parameter (¶0104 and 0107).
Regarding claim 2, Braga further discloses the parameter is an amount of fluid in the sealed interior of the canister (¶0104).
Regarding claim 3, Braga further discloses the system further comprises a user interface configured to be communicatively coupled to the controller and to output the value of the parameter associated with the canister (¶0083 and 0103).
Regarding claim 4, Braga further discloses a sensor array comprises the at least one sensor (the system of Braga is capable having multiple sensors formed a sensor array: ¶0096, 0118; Figs. 11 and 18).
Regarding claim 5, Braga further discloses the at least one sensor is coupled to the interior surface of the at least one wall (the sensor 1320 is coupled to the interior surface of the at least one wall via line 1321: ¶0104 and Fig. 10) and a probe of the at least one sensor is directed towards the exterior surface of the at least one wall (a first portion 1322/1324 of electrodes/probes 1325A-B of the sensor 1320 is directed towards the exterior surface of the at least one wall).
Regarding claim 6, Braga further discloses the at least one wall of the therapy unit comprises at least one cavity (Fig. 10), the at least one sensor disposed proximate to the at least one cavity (Fig. 10); the lid comprises at least one cavity (Fig. 11); and the at least one cavity of the lid is configured to align with the at least one cavity of the at least one wall of the therapy unit (Fig. 10).
Regarding claim 10, Braga further discloses the at least one sensor is integrated into at least one of the lid and the canister body of the canister (¶0104, 0106, and Fig. 11).
Regarding claim 18, Braga further discloses an airflow device (a pump 1360: ¶0077-0078 and Fig. 10), the airflow device configured to be actuated by the controller in response to the parameter associated with the canister (¶0080, 0083, and 0099).
Claim Rejections - 35 USC § 103
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 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 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.
Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Braga (US PGPUB 20190001030) in view of Sage (US PGPUB 20060181695).
Regarding claim 9, Braga does not disclose the at least one sensor comprises a non-contact fluid sensor.
In an analogous art for being directed to solve the same problem, having a non-contact fluid sensor to measure at least one characteristic of the flow of the liquid, Sage discloses a device for delivering liquid via a flow channel and the device comprising a memory having a stored value indicative of a flow characteristic of the flow channel coupled to the flow channel and a flow sensor that measures at least one characteristic of the flow of the liquid through the channel (¶0011). Sage further discloses the flow sensor made in a non-contact fashion, wherein the components of the sensor are physically isolated from the fluid flow (¶0012).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Braga in view of Sage by having the at least one sensor made of a non-contact fluid sensor, motivated by the desires to eliminate the risk of contamination or cross-contamination and reduce the need for cleaning or replacement since there is no direct contact.
Claim(s) 11 is/are rejected under 35 U.S.C 103 as being unpatentable over Braga (US PGPUB 20190001030) in view of Culbert (US PGPUB 20190381223).
Regarding claim 11, Braga further discloses the at least one sensor is coupled to the interior surface of the at least one wall (the sensor 1320 is coupled to the interior surface of the at least one wall via line 1321: ¶0104 and Fig. 10) and a probe of the at least one sensor is directed towards the exterior surface of the at least one wall (a first portion 1322/1324 of electrodes/probes 1325A-B of the sensor 1320 is directed towards the exterior surface of the at least one wall).
Braga further discloses the lid of the canister comprises a first connector (a suction port 1374: ¶0099 and Figs. 10-11) configured to align with a second connector on the at least one wall of the therapy unit (Fig. 10) and the parameter comprises an amount of fluid in the at least one protrusion of the lid of the canister (¶0077, 0080, and 0102-0103).
Braga does not disclose a first connector is at least one protrusion and a second connector on the at least one wall of the therapy unit is at least one recess.
In an analogous art for being directed to solve the same problem, providing connection between two elements, Culbert discloses a system for aspiration comprising an aspiration catheter and a peristaltic pump (Abstract). Culbert further discloses connecting a first connector 1016 to a second connector 1012 for connecting an aspiration console with an aspiration lumen of the aspiration catheter (¶0176). Culbert also discloses the first connector 1016 is a protrusion (a male luer: ¶0176 and Fig. 13) and the second connector 1012 is a recess (a female luer: ¶0176 and Fig. 13).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Braga in view of Culbert by having the first connector to be at least one protrusion and the second connector to be at least one recess, in order to connect 2 elements, as suggested in ¶0176 of Culbert.
Claim(s) 13 is/are rejected under 35 U.S.C 103 as being unpatentable over Braga (US PGPUB 20190001030) in view of Taniguchi (US PGPUB 20160168529).
Regarding claim 13, Braga does not disclose the at least one sensor is an air bubble fluid sensor.
In an analogous art for being directed to solve the same problem, detecting a liquid level of liquid in a container, Taniguchi discloses a method for producing a cell concentrate using a cell suspension treatment system including a storage container of a cell suspension (Abstract). Taniguchi further discloses a detecting unit comprising an air bubble sensor (¶0110-0111) for the benefit of detecting a liquid level of storage liquid in the storage container (¶0111).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Braga in view of Taniguchi by having/using an air bubble fluid sensor as the at least one sensor, in order to detect a liquid level of liquid in the canister, as suggested in ¶0111 of Taniguchi.
Claim(s) 14 is/are rejected under 35 U.S.C 103 as being unpatentable over Braga (US PGPUB 20190001030) in view of Callaghan (US PGPUB 20140243790).
Regarding claim 14, Braga does not disclose the at least one sensor is an optical sensor and the parameter is a color of fluid in the sealed interior of the canister.
In an analogous art for being directed to solve the same problem, detecting color of fluid in a container/chamber/tubing, Callaghan discloses an apparatus 408 for accessing and/or isolating the lymphatic system of a patient (¶0107 and Figs. 10A-B). Callaghan further discloses the apparatus comprising an optical sensor provided at an inlet of a container (¶0134) for the benefit of detecting a color of fluid in the container (¶0134).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Braga in view of Callaghan by having/using an optical sensor as the at least one sensor, in order to detect a color of liquid in the canister, as suggested in ¶0134 of Callaghan. Thus, the parameter of the system of Braga in view of Callaghan is a color of fluid in the sealed interior of the canister.
Claim(s) 16 is/are rejected under 35 U.S.C 103 as being unpatentable over Braga (US PGPUB 20190001030) in view of Guirguis (US PGPUB 20180228945).
Regarding claim 16, Braga does not disclose an orientation detector configured to generate a signal indicative of an orientation of the canister, the orientation detector configured to be communicatively coupled to the controller, wherein the controller is further configured to receive the signal from the orientation detector to determine the value of the parameter associated with the canister.
In the same field of endeavor, an apparatus for fluid level detection in canister, Guirguis discloses a system comprising a therapy unit (a hub 42: ¶0039 and Fig. 2) and a canister (cartridge 40: ¶0039 and Fig. 3). Guirguis further discloses an orientation detector configured to generate a signal indicative of an orientation of the canister (an inertial motion sensor 516 to determine the orientation of the canister: ¶0053 and Fig. 5) and the orientation detector configured to be communicatively coupled to the controller (Fig. 5), wherein the controller is further configured to receive the signal from the orientation detector to determine the value of the parameter associated with the canister (¶0056).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Braga in view of Guirguis by incorporating an orientation detector/sensor, in order to determine the orientation of the canister, as suggested in ¶0053 of Guirguis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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