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 .
Response to Amendment
The amendment filed 5/11/2026 has been entered: Claims 1-16, and 18-21 remain pending in the present application. Claims 1 and 16 are currently amended and claim 21 is new. Claims 1-16, and 18-21 are examined on the merits.
Applicant’s amendments have been acknowledged, and overcome each and every 112(b) rejection previously set forth in the non-final office action mailed 2/11/2026. All previous 112(b) rejections have been withdrawn. However, a new 112(b) rejection is made as set forth below.
Response to Arguments
Applicant’s claim amendments with respect to at least independent claim(s) 1 and 16 have necessitated a new grounds of rejection. Applicant’s arguments have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Birbara is newly presented as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention, as well as the newly amended limitations.
Giezendanner, Otto, and Peake remain in the present rejection as teaching references for disclosing and/or rendering obvious the remaining limitations of the claims.
Applicant’s arguments regarding the dependent claims are similarly moot as claims 1 and 16 remain rejected as set forth below.
Information Disclosure Statement
The references cited by applicants in the information disclosure statement filed on 5/11/2026 has been made of record.
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 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.
Claims 1-16, and 18-21 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.
The newly claimed term “generally rigid” in independent claims 1 and 16 is a relative term which renders the claims indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In an effort to promote compact prosecution, the term “generally rigid” is interpreted as being rigid to support a partial vacuum. Appropriate correction is required.
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, 6-9, 12-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birbara et al. (US 2012/0066825 A1).
Regarding claim 1, Birbara discloses a fluid collection system (Fig. 2; Abstract) comprising:
a fluid collection device (collection device 110) including an external catheter (receptacle 124);
a fluid collection container (reservoir 130) that is generally rigid (¶ 26 indicates the reservoir is rigid) and has an interior region and a port in fluid communication with the interior region (¶s 26-27 describes fitting connectors 148 and how the reservoir received fluid in an interior volume), wherein the fluid collection canister is configured to receive fluid from the fluid collection device through the port (¶s 23-29);
a pump in fluid communication with the fluid collection device (Figs. 1-3 shows pump 142) and is configured to pull at least a partial vacuum on the interior region of the fluid collection container effective to pull at least a partial vacuum on the port and to draw the fluid from the fluid collection device and into the fluid collection container through the port (¶s 6, 23-28, and 40-45 describe how the pump is used to draw fluid into the collection device and the fluid container); and
a control system (control board 188) including at least one sensor (¶s 43-49 describes the sensors 190 and 192) configured to monitor at least one of a status of the fluid collection system (¶s 43-49 describe the sensors monitoring the presence of urine), and a controller operatively coupled to the at least one sensor (¶s 38-39 and 45-49 describe how the sensors are used with the control board to automatically control the pump operation) and configured to communicate at least one status of the fluid collection system to a control panel (control panel 186, which communicates the ON/OFF status of the device as in ¶ 40; ¶s 57-59 also describe alarms).
Further, the limitations of the external catheter being “configured to be positioned adjacent to a urethra to collect fluid discharge from a user” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the foam layer of Hartwell and Otto has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. a user would be capable of positioning a urethra adjacent to the external catheter to collect fluid discharge from a user; ¶s 10 and 23-26 describe how the receptacle 124 is intended to collect urine from a user).
Regarding claim 6, Birbara further discloses the control system is configured to control the pump (¶s 45-49 describe how the control board is used to control the pump).
Regarding claim 7, Birbara further discloses the pump is disposed in a housing configured to couple to the fluid collection container (Figs. 2-3 and 8a-8b show pump 142 disposed within housing 112 and coupled to the collection reservoir 130 via conduit 144).
Regarding claim 8, Birbara further discloses the control panel is located on the housing (Figs. 1-2 show control panel 186 being in top cover 119 of housing 112 ).
Regarding claim 9, Birbara further discloses the control panel comprises at least one status indicator (¶ 4 describes ON/OFF indication).
Regarding claim 12, Birbara further discloses the control panel includes a user input to the control system (¶s 38-42 describe various inputs including manual/automatic operation switch and ON/OFF switch).
Regarding claim 13, Birbara further discloses the control system including an alarm (¶ 57).
Regarding claim 15, Birbara further discloses the control system is configured to provide the status of the fluid collection system in real-time is communicated by the control panel (the ON/OFF status of the fluid collection system would be reflected in real-time by the ON/OFF switch as described in ¶ 40).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Otto, as applied to claim 1 above, and further in view of Giezendanner et al. (US 2017/0128638 A1).
Regarding claims 2-3, Birbara further discloses that the at least one sensor includes a fluid level sensor (sensor 190); and the control system is configured to start the pump when the fluid level sensor reaches a predetermined limit and stops the pump when the urine level is below a predetermined threshold (¶s 45-49 describes how the sensor activates the pump when urine is detected, i.e. the fluid level sensor reaches a predetermined limit, and then the pump is deactivated by the absence of fluid, i.e. when the urine level is below a predetermined threshold; ¶ 57 also discloses a fluid level measuring apparatus 153).
Birbara does not explicitly disclose (claim 2) the fluid level sensor being disposed adjacent to the fluid collection container or (claim 3) the fluid level sensor is a capacitive sensor configured to detect a property related to the volume or mass of the fluid in the fluid collection container.
However, Giezendanner teaches a medical suction pump in fluid system (Figs. 1-2 and 7-9; Abstract), thus being in the same field of endeavor, comprising a fluid level sensor disposed adjacent to a fluid collection container (¶s 54 and 69 describe filling level sensors 30 and 31 disposed over a measurement area of the receiving container 2), and said fluid level sensor being a capacitive sensor configured to detect a property related to the volume of the fluid in the fluid collection container (¶s 15, 53-54, and 67-69 specifically describe a capacitive filling sensor use to detect the filled volume of fluid in the collection container).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Birbara to comprise the capacitive sensor of Giezendanner. Doing so with thus comprise (claim 2) the fluid level sensor being disposed adjacent to the fluid collection container or (claim 3) the fluid level sensor is a capacitive sensor configured to detect a property related to the volume or mass of the fluid in the fluid collection container. Doing so would be advantageous in detecting a filling level of the fluid container with precise measurement capabilities (¶ 67 of Giezendanner).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Birbara, as applied to claim 1 above, and further in view of Friedrich (US 2013/0324954 A1).
Regarding claim 4, Birbara does not explicitly teach at least one sensor including a power consumption sensor operatively coupled to the pump.
However, Friedrich teaches a general medical suction device (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a power consumption sensor operatively coupled to the pump (¶ 25 describes current sensors which detect the current consumption of the motor which drives the pump).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Birbara to comprise a power consumption sensor operatively coupled to the pump, as taught by Friedrich. Doing so would be advantageous in monitoring adherence of the pump to a predetermined pump operation (¶ 25 of Friedrich).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Birbara, as applied to claim 1 above, and further in view of Otto (US 2007/0225668 A1).
Regarding claim 5, Birbara further discloses a battery operatively coupled to the pump (battery pack 180).
Birbara does not explicitly teach where the control system is configured to communicate a battery status to the control panel
However, Otto teaches a fluid collection system (Fig. 9; Abstract) comprising a fluid collection device (system 10), thus being in the same field of endeavor, which also comprises a battery (Fig. 32 illustrates how the control circuit 150 operatively coupled to the battery and power systems to the pump) where the control system is configured to communicate a battery status to the control panel (Fig. 11 shows how the control panel has a battery indicator; ¶s 56 and 74-75 further describes the battery status system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control panel and control board of Birbara to communicate a battery status to the control panel, as taught by Otto. Doing so would be advantageous in notifying a user when the battery is low (¶ 74 of Otto).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Birbara, as applied to claim 9 above, and further in view of Otto.
Regarding claim 10, Birbara does not explicitly teach the status indicator includes at least one of a digital display or an indicator light.
However, Otto teaches a fluid collection system (Fig. 9; Abstract) comprising a fluid collection device (system 10), thus being in the same field of endeavor, which also comprises a status indicator including an indicator light (¶ 56 describes the status indicators 32 including lights).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control panel and control board of Birbara to comprise a status indicator including an indicator light, as taught by Otto. Doing so would be advantageous in conveying additional information to a user (¶ 56 of Otto).
Regarding claim 11, Birbara does not explicitly teach the status indicator includes an audible indication.
However, Otto teaches a fluid collection system (Fig. 9; Abstract) comprising a fluid collection device (system 10), thus being in the same field of endeavor, as well as a status indicator including an audible indication (¶ 74 indicates the inclusion of audiovisual alarms).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control panel and control board of Birbara to comprise a status indicator including an indicator light, as taught by Otto. Doing so would be advantageous in conveying additional information to a user (¶ 56 of Otto).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Birbara, as applied to claim 1 above, and further in view of Peake et al (US 2009/0199857 A1).
Regarding claim 14, Birbara further teaches monitoring when a maximum or threshold run-time of the pump is exceeded (¶s 47 and 49), but does not explicitly teach a programmable timer configured to indicate when a component of the fluid collection system requires replacement.
However, in addressing the same problem as applicant, the problem being the maintenance and replacement of parts of a medical device, Peake teaches a replacement indication system for medical devices (Figs. 5-6 and 22; Abstract) which uses a digital programmable timer to provide reminders for when parts of the medical system should be replaced (¶ 112).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Birbara to comprise the programmable timer configured to indicate when a component of the system requires replacement, as taught by Peake. Doing so would be advantageous in alerting and reminding a user when parts of the device should be serviced (¶ 112 of Peake; e.g. to remind a user when receptacle 124 should be replaced/cleaned, or to replace filters within the system, pump motors, etc.).
Claims 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Birbara in view of Otto.
Regarding claim 16, Birbara teaches a method of using a fluid collection system (Fig. 9; Abstract), the method comprising:
placing a fluid collection device including an external catheter at least proximate to a urethra of a user (¶s 10 and 23-26 describe how the receptacle 124 is intended to collect urine from a user);
receiving fluid discharged from the user in the fluid collection device (¶s 6, 23-28, and 40-45);
pulling, with a pump (pump 142), an at least partial vacuum on an interior region of a fluid collection container that is generally rigid (¶ 26 indicates the reservoir is rigid) to pull at least a partial vacuum on a port of the fluid collection container in fluid communication with the fluid collection device to draw the fluid discharged from the user into the fluid collection container through the port (¶s 6, 23-28, and 40-45 describe how the pump is used to draw fluid into the collection device and the fluid container),
receiving fluid discharged from the fluid collection device in the fluid collection container (¶s 6, 23-28, and 40-45);
determining, with at least one sensor, at least a status of the fluid collection system (¶s 38-39 and 45-49 describe how the sensors are used with the control board to automatically control the pump operation).
Birbara does not explicitly teach transmitting, from a control system, to a control panel the at least one status of the fluid collection system.
However, Otto teaches a fluid collection system (Fig. 9; Abstract) comprising a fluid collection device (system 10), thus being in the same field of endeavor, comprising a sensor (¶s 52 and 54), as well as transmitting, from a control system, to a control panel at least one status of the fluid collection system (¶s 52-56 and 74 describe how status panel 30 is used to display a status of the system as transmitted by a control system 150).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Birbara to comprise transmitting, from a control system, to a control panel the at least one status of the fluid collection system, as taught by Otto. Doing so would be advantageous to convey additional information to a user (¶ 56 of Otto).
Regarding claim 18, Birbara further teaches wherein determining with at least one sensor at least one status of the fluid collection system includes detecting at least a volume of fluid within the fluid collection device (¶s 57-60 describe fluid level sensor 177).
Otto also teaches discloses wherein determining with at least one sensor at least one status of the fluid collection system includes detecting at least a volume of fluid within the fluid collection device (¶ 74 describes a reservoir fullness sensor used to detect a volume of fluid within the fluid collection device).
Regarding claim 19, Birbara teaches the control panel located on the housing for the pump (control panel 186 on top cover 119, part of housing 112).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Birbara to comprise transmitting, from a control system, to a control panel the at least one status of the fluid collection system, as taught by Otto. Doing so would thus comprise transmitting to a control panel located on a housing for the pump. Doing so would be advantageous to convey additional information to a user (¶ 56 of Otto).
Regarding claim 20, Otto further discloses providing, with the control system, the at least one status of the fluid collection system in real-time is communicated by the control panel (¶ 56 describes the reservoir labeled indicator light would indicate that a predefined threshold level of fullness is met or not me, thus indicating in real-time the status of the container; ¶ 56 also describes various other sensors and alerts that wound indicate a current/real-time status of the fluid collection system, such as the battery status or the pump being in auto/manual modes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Birbara to comprise providing at least one status of the fluid collection system in real-time as taught by Otto. Doing so would be advantageous to convey additional information to a user (¶ 56 of Otto).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Birbara and Otto, as applied to claim 16 above, and further in view of Giezendanner.
Regarding claim 21, Birbara further discloses the at least one sensor includes a fluid level sensor (sensor 190); and starting, with the control system, the pump when the fluid level sensor reaches a predetermined limit and stopping, with the control system, the pump when the urine level is below a predetermined threshold (¶s 45-49 describes how the sensor activates the pump when urine is detected, i.e. the fluid level sensor reaches a predetermined limit, and then the pump is deactivated by the absence of fluid, i.e. when the urine level is below a predetermined threshold; ¶ 57 also discloses a fluid level measuring apparatus 153).
Birbara does not explicitly disclose he fluid level sensor being disposed adjacent to the fluid collection container.
However, Giezendanner teaches a medical suction pump in fluid system (Figs. 1-2 and 7-9; Abstract), thus being in the same field of endeavor, comprising a fluid level sensor disposed adjacent to a fluid collection container (¶s 54 and 69 describe filling level sensors 30 and 31 disposed over a measurement area of the receiving container 2), and said fluid level sensor being a capacitive sensor configured to detect a property related to the volume of the fluid in the fluid collection container (¶s 15, 53-54, and 67-69 specifically describe a capacitive filling sensor use to detect the filled volume of fluid in the collection container).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Birbara to comprise the capacitive sensor of Giezendanner. Doing so with thus comprise the fluid level sensor being disposed adjacent to the fluid collection container. Doing so would be advantageous in detecting a filling level of the fluid container with precise measurement capabilities (¶ 67 of Giezendanner).
Conclusion
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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 E 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.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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