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
Claims 11-25 were withdrawn (now cancelled) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 November 2025.
Claims 1-10 are examined on the merits.
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 10 is 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 10 recites “the information can be read by that different automated body fluid drain control system” which renders the claim indefinite. It is unclear whether the information is read or not is being positively recited by the claim. Further, the reference to “that different automated body fluid drain” appears to be referring to the same element does not refer to it as “the” or “said”. In an effort to compact prosecution, the claim is interpreted as -- the information configured to be read by said different automated body fluid drain control system--.
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.
Claims 1, 3-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnett (US 2019/0321588).
Regarding Claim 1, Burnett discloses a system for fluid drain control (1000; Fig 1, 10A-C; para [0137]), the system comprising a drain controller (1018; Fig 10A; para [0137]) and a plurality of drain cassettes (1022 ... cassettes; Fig 10A-C; para [0137], [0422]); wherein the plurality of drain cassettes (1022 ... cassettes; Fig 10A-C; para [0137], [0422]) are single-use drain cassettes (disposable; para [0137]), and where the plurality of single-use drain cassettes comprise at least two planes (as shown in Fig 10A).
Regarding Claim 3, Burnett discloses the system of claim 1, wherein the system further comprises a proximal valve (valve 1136; para [0138]) in fluidic contact with a body fluid (urine; para [0138]) that requires drainage and a distal valve (outflow valve 1146; Fig 10A; para [0148]) in fluidic contact with a drainage collection bag (drainage bag; para [0148]) that will collect the fluid (urine; para [0138]); and wherein each of the proximal valve and the distal valve are in fluidic contact with the other (Fig 10A; para [0148], the valves contact fluid and are thus in contact to each other through fluid); and wherein each of the proximal valve and the distal valve is capable of at least two of the following positions: open to drain, closed, and partially open or variably open (open to drain, closed; para [0137], [0148]).
Regarding Claim 4, Burnett discloses the system of claim 3, wherein the system further comprises a sampling port (1004; Fig 10A; para [0138]) that is in fluidic contact with the proximal valve (valve; para[0138]), and wherein the sampling port is either an open luer or a closed luer access point, including but not limited to needle-less access valves, a pre-pierced port, or other means of fluidic access (luer-lock; para [0364]).
Regarding Claim 5, Burnett discloses the system of claim 4, wherein the system further comprises a collection chamber (chamber of cassette 1022; Fig 10A; para [0137]) suitable for visual inspection (ultrasonic measurements; para [0140]) of the body fluid (urine; para [0138]).
Regarding Claim 6, Burnett discloses the system of claim 5, wherein the system further comprises a fluid sensor port (pressure lumen 1010 ... with pressure sensing balloon 108; para [0139]) that measures an amount (volume; para [0140]) of body fluid drained (urine; para [0138]).
Regarding Claim 7, Burnett discloses the system of claim 6, wherein the system further comprises a spectral analysis port (ultrasound transducer interface 1130; para [0140]) suitable for a spectrophotometry or other analytic sensor (ultrasonic measurements; para [0140]) to analyze the body fluid (urine; para [0138]) prior to entry of the body fluid (urine; para [0138]) into the collection chamber (chamber of cassette 1022; Fig 10A; para [0137]).
Regarding Claim 8, Burnett discloses the system of claim 7, wherein the system further comprises a pressure transducer (pressure sensing balloon 108; para [0139]) in fluidic contact with the body fluid (urine; para [0138]) prior to the proximal valve (valve; para [0138]).
Regarding Claim 9, Burnett discloses the system of claim 8, wherein the system further comprises a machine-readable identification component (cassette pressure interface 1150; Fig 10A; para [0140]) that identifies at least one item from the following list: a cassette manufacturer, a date of manufacturing, an expiration date of the consumable, a set of drainage modes supported by the cassette, an identification of the cassette, a proper disposal information of the cassette, a presence of various single-use cassette features, including: a known length of the proximal fluidic circuit, a known length of the distal fluidic circuit, a type of sampling port present, if alarm light indicators are present, a collection chamber size, and a type of analysis supported (urine volume measurements; para [0140]).
Regarding claim 10, Burnett further discloses wherein the system further comprises a machine-writable identification mechanism ([0145], RDIF adapter) that enables the system to write utilization and programming information into the cassette such that, if removed from the system and placed in a different automated body fluid drain control system, the information configured to be read by that different automated body fluid drain control system ([0145]), data specific to the patient can be recognized).
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 (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 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett in view of Anand (US 2018/0104459).
Regarding Claim 2, Burnett discloses the system of claim 1, but does not disclose wherein the single-use drain cassette further comprises an elastomeric or silicone membrane compressed between at least two of the two planes.
Anand discloses a valve cartridge relatively pertinent to problem posed by Applicant that controls the flow through a drainage device. Anand teaches a cartridge (214, figure 2C-2D, [0104]). That has an elastomeric membrane (316, figure 3B, [0119], umbrella valves deform to open/close) compressed between at least two planes of the housing of the cartridge (outside surfaces of the cartridge).
Anand provides more accurate control of flow of material through use of the valves ([0119]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burnett by adding and/or replacing the valve as taught by Anand in order to more accurately control flow through the cartridge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/ Primary Examiner, Art Unit 3781