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 .
Status of Claims
Claims 1-5, 8-21 are pending and examined on the merits.
Information Disclosure Statement
The references cited by applicants in the information disclosure statements filed from 9/8/2023 to 5/19/2025 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR 1.97 and 1.98 does not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
Claim Objections
Claim 1 is objected to because of the following informalities:
Re Claim 1, “a senor” in the third clause should be “a sensor”.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
In [0042] of the current Specification, see e.g., page 11 of Specification filed on 9/8/2023 or [0042] of corresponding US Publication No. 2024/0156633, “system integrity sensor 136” should be “system integrity sensor 138.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3-5 & 10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for several sensors disposed at various locations within the fluid collection system, does not reasonably provide enablement for a sensor disposed within the exterior housing and the interior portion, wherein comprising a flow meter coupled to the tube and configured to detect if the fluid collection device is decoupled. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Re Claim 3, the claim recites “wherein the sensor further includes a flow meter coupled to the tube…” However, Claim 1, from which Claim 3 depends, requires that the sensor be disposed between the exterior housing and the interior portion and therefore it is not reasonable that the same sensor is also coupled to the tube. Additionally, the current Specification discloses system integrity sensor (138) being disposed in the tube (104) that is outside of the exterior housing (see Fig. 2C), further suggesting that there are multiple separate sensors rather than one single sensor inside the fluid collection container that performs all the claimed functions. Examiner interprets “a sensor” in Claim 1 to mean “at least one sensor” and subsequently carries this interpretation for all claims that depend from Claim 1. Claim 3 would then read “wherein the at least one sensor further includes a flow meter…”
Claims 4-5 are rejected for being dependent from Claim 3.
Claim 10 is rejected for the same reason as Claim 3. Examiner interprets Claim 10 to read “wherein the at least one sensor further includes a sensor configured to detect when the fluid collection device is decoupled…”
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 1-2, 9, 11-12, 15, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (US 2011/0265889).
Re Claim 1, Tanaka discloses a fluid collection system (automatic urine collecting system S, Fig. 1), comprising:
a fluid collection device (urine receiver R, e.g., [0051]) configured to collect fluid discharged from a user;
a fluid collection container (main tank part 2, Fig. 3) configured to receive the fluid from the fluid collection device ([0051]), wherein the fluid collection container includes a rigid exterior housing (housing part 42) and an interior portion (main tank 20) configured to contain the fluid;
at least one sensor (urine sensor S3, [0046] “urine sensor S3 includes a main-tank infrared sensor S31, a main-tank liquid level sensor S32, and a sub-tank infrared sensor S33”) configured to sense at least one of a property or status of the fluid collection system, wherein the at least one sensor is disposed between the exterior housing and the interior portion ([0079] “The main-tank infrared sensor S31, control substrate 423, and battery are housed in the tank housing part 42”) and the at least one sensor is configured to activate when the interior portion contains a predetermined volume of fluid ([0065]); and
a controller ([0088] “operation panel part 47 includes the operation panel 47a, a panel base 47b, and the control substrate 423”) operatively coupled to the at least one sensor, the controller configured to communicate at least one of the property or the status of the fluid collection system to a computing device ([0048]).
Re Claim 2, Tanaka discloses claim 1 and further discloses that the system comprising:
a tube (tube T) in fluid communication with the fluid collection device; and
a pump (suction pump 53) in fluid communication with the fluid collection device and the fluid collection container, wherein the pump is configured to pull an at least partial vacuum to draw the fluid from the fluid collection device through the tube into the fluid collection container.
Re Claim 9, Tanaka discloses claim 1, wherein the interior portion is generally rigid (“tank” implies a rigid container) and the at least one sensor includes at least one of a pressure sensor, a capacitive sensor, or an optical sensor (“main-tank infrared sensor S31”).
Re Claim 11, Tanaka discloses claim 2, and further disclosing a battery (55) operably coupled to the pump, wherein the controller is configured to communicate a battery status ([0048]).
Re Claim 12, Tanaka discloses claim 1, and further discloses wherein the controller is configured to operate the pump according to an input from the at least one sensor ([0046]).
Re Claim 15, Tanaka discloses claim 1, and further discloses wherein the computing device includes a programmable timer, an alert or alarm, or a display ([0048], where a personal computer necessarily has a display) configured to display the at least one of the property or the status of the fluid collection system.
Re Claim 17, Tanaka discloses a method of using a fluid collection system, the method comprising:
placing a fluid collection device (urine receiver R, Fig. 1, [0051]) at least proximate to a urethra of a user;
receiving fluid discharged from the user in a fluid collection device;
receiving fluid discharged from the fluid collection device in a fluid collection container (main tank part 2, which includes tank 20) wherein the fluid collection container includes a rigid exterior housing (“tank” implies it is rigid) and an interior portion configured to contain the fluid;
detecting, with a sensor (main tank sensor S3), at least one of a property or status of the fluid collection system, wherein the sensor is disposed between the exterior housing and the interior portion ([0079]) and the sensor is configured to activate when the interior portion contains a predetermined volume of fluid ([0065]); and
transmitting, from a controller coupled to the sensor, to a computing device the at least one of the property or the status of the fluid collection system ([0088], [0048]).
Re Claim 18, Tanaka discloses claim 17, and further discloses using a pump (53) to pull a vacuum on a tube (tube T) in fluid communication with the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container.
Re Claim 19, Tanaka discloses claim 17, and further discloses wherein detecting with a sensor at least one of a property or status of the fluid collection system further includes detecting at least one of a volume of fluid within the fluid collection device ([0065]), a flow property of the fluid passing through a tube, a pump status, or a battery status.
Claim Rejections - 35 USC § 103
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.
Claims 3, 13-14, 16, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Keelen (US 2022/0296406).
Re Claim 3, Tanaka discloses claim 1, but does not disclose wherein the at least one sensor further includes a flow meter coupled to the tube, the flow meter being configured to detect a vacuum status or measure a volumetric flow rate of the fluid. Keelen discloses a medical fluid collection system (see Abstract) utilizing suction to remove fluid from a patient via a tube (flexible tube 106), wherein the system comprises a flow meter coupled to the tube ([0062] “the flow meter 130 can be positioned at any suitable location along the flexible tube 106”) to measure volumetric flow rate of fluid that flows into a collection ([0062] “the flow meter 130 is configured to calculate the flow rate by determining the number of milliliters of fluid per second (or other suitable volume per time period) that flows into the collection reservoir 116”). It would have been obvious to one skilled in the art at the time of filing to modify with Keelen for the benefit of being able to accurately track how much fluid has been collected.
Re Claims 13-14, Tanaka discloses claim 1, but does not explicitly disclose wherein the computing device includes a module attached to an arm of a wheelchair or a smartphone and wherein the computing device is wirelessly coupled to the controller. Keelen discloses a medical fluid collection system (see Abstract) utilizing suction to remove fluid from a patient, wherein the system comprises a computing device including a module attached to a smartphone ([0066]) and wherein the computing device also communicates wirelessly with a controller/processor of the system ([0066]). It would have been obvious to one skilled in the art to modify Tanaka with the wireless computing device of Keelen such that it would be easy to perform complex computing and/or store large amounts of information remotely from the system.
Re Claim 16, Tanaka discloses claim 1, but does not explicitly disclose wherein the computing device is configured to provide the at least one of the property of the fluid collection system or the fluid collection system status in real-time as communicated by the controller. Keelen discloses a medical fluid collection system (see Abstract) utilizing suction to remove fluid from a patient, wherein the system comprises a computing device that has a display (e.g., [0010]) configured to display information about the patient or a fluid collection device that receives fluid from the patient (e.g., [0010]). It would have been obvious to one skilled in the art to modify Tanaka with the display of Keelen such that a caretaker, in particular one located remote from the patient, has a way to easily track the patient’s status/condition.
Re Claims 20-21, the claims are rejectable for the same reasons as explained for Claims 13 & 16, respectively.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka and Keelen as applied to claim 3 above, and further in view of Wakabayashi (US 2002/0058915).
Re Claim 4, Tanaka and Keelen combine to disclose claim 3, but they fail to disclose wherein the flow meter includes an in-line ball style sight flow indicator disposed within the tube, wherein a ball float is visible when the vacuum is drawn and not visible when the vacuum is absent. Wakabayashi discloses a medical drainage system comprising a flow meter (306, Figs. 7A-7E) that comprises a floating ball that would be visible through a window (Fig. 3) when vacuum is present. It would have been obvious to one skilled in the art at the time of filing to modify Tanaka and Keelen with the specific type of flow meter taught by Wakabayashi since the selection of a known structure suitable for an intended purpose establishes a prima facie case of obviousness (MPEP 2144.07).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka and Keelen as applied to claim 3 above, and further in view of Muller (US 2003/0110868).
Re Claim 5, Tanaka and Keelen combine to disclose claim 3, but they fail to disclose wherein the flow meter includes a spring and piston flow indicator disposed within the tube, wherein a calibrated spring holds the piston such that the piston is visible when the vacuum is drawn and not visible when the vacuum is absent. Muller discloses a flow meter comprising a spring (3’) and a piston (9, 9’). It would have been obvious to one skilled in the art at the time of filing to modify Tanaka and Keelen with the specific type of flow meter taught by Muller since the selection of a known structure suitable for an intended purpose establishes a prima facie case of obviousness (MPEP 2144.07).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Otto (US 2007/0225666).
Re Claim 8, Tanaka discloses claim 1 but does not teach wherein the interior portion is expandable and the at least one sensor is configured to activate when the interior portion expands to a predetermined volume. Otto discloses a medical suction system (Fig. 13) for removing fluid from a patient, wherein the system comprises an expandable interior portion (26) within an exterior housing (enclosure 12) and a sensor (sensor flap 62) is configured to activate when the interior portion expands to a predetermined volume ([0057]). It would have been obvious to one skilled in the art to adapt Otto’s volume sensor and expandable interior portion as the simple substitution of a known structure with another to obtain predictable results establishes a prima facie case of obviousness (MPEP 2143).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Askem et al. (US 2019/0358372).
Re Claim 10, Tanaka claim 1, but does not teach wherein the at least one sensor includes a sensor configured to detect when the fluid collection device is decoupled from the fluid collection container. Askem discloses a system for suctioning fluid away from a patient’s body, wherein the system comprises a connector switch that can be a sensor ([0126] “The connector switches contemplated herein … can include sensors and the like.”) detects whether a fluid collection device (“dressing”) is coupled to a fluid collection container (“canister”, [0126] “The connector switch can be further configured … to detect whether a canister or a dressing is attached to the connector port 203.”). It would have been obvious to one skilled in the art at the time of filing to modify Tanaka with a sensor taught by Askem to improve the safety and operation of the suction system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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, Rebecca Eisenberg can be reached at 571-270-5879. 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.
/SUSAN S SU/ Primary Examiner, Art Unit 3781
23 May 2026
Prosecution Insights