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 11/20/2023 has been entered: Claims 1-20 remain pending in the present application. Claims 1, 7, 9, 12, 16, and 18-20 are currently amended. Claims 1-20 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.
Claims 1-15 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 1 recites the limitation "the urethra" in line 3. There is insufficient antecedent basis for this limitation in the claim. In an effort to promote compact prosecution, this limitation is interpreted as -- a urethra--.
Claims 2-15 are rejected via their dependency on claim 1.
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, 5-13, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otto (US 2007/0225668 A1).
Regarding claim 1, Otto discloses a fluid collection system (Fig. 9; Abstract) comprising:
a fluid collection device (system 10) including an external catheter (cup 18);
a fluid collection container (reservoir 26) configured to receive fluid from the fluid collection device (¶s 53-54);
a pump in fluid communication with the fluid collection device (¶s 52-58 describe how the pump is used to draw fluid into the collection device and the fluid container; Figs. 12-14 shows pump assembly 44); and
a control system (Fig. 32) including at least one sensor (¶ 52 describes one or more sensors) configured to monitor at least one of a status of the fluid collection system (¶s 52-54 describe the sensors indicating a number of properties; ¶ 74 explicitly describes a fullness sensor), and a controller operatively coupled to the at least one sensor (Fig. 32 shows control circuit 150) and configured to communicate at least one status of the fluid collection system to a control panel (control panel 30).
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 18-19, 42, and 51-52 describe how the cup 18 is intended to collect urine from a user while avoiding urine skin contact; ¶ 61 indicates positioning the receptacle 16 against a user).
Regarding claim 5, Otto further discloses a battery operatively coupled to the pump (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).
Regarding claim 6, Otto further discloses the control system is configured to control the pump (Fig. 32 shows how controller logic is used to operate the pump; ¶s 53-56 describe how the control system controls the pump, such as via control panel 30).
Regarding claim 7, Otto further discloses the pump is disposed in a housing configured to couple to the fluid collection container (Fig. 13 shows an expanded view where pump 44 is disposed in enclosure 12, along with bag 26).
Regarding claim 8, Otto further discloses the control panel is located on the housing (Figs. 1, 11, and 13 show how control panel 30 is located on the housing).
Regarding claim 9, Otto further discloses the control panel comprises at least one status indicator (Fig. 11 shows status indicators 32; ¶ 56).
Regarding claim 10, Otto further discloses the status indicator includes an indicator light (¶ 56 describes the status indicators 32 including lights).
Regarding claim 11, Otto further discloses the status indicator includes an audible indication (¶ 74 indicates the inclusion of audiovisual alarms).
Regarding claim 12, Otto further discloses the control panel includes a user input to the control system (¶s 20 and 53-56 describe how the control panel can be used to control the pump).
Regarding claim 13, Otto further discloses a display configured to display the at least one status of the fluid collection system (status indicators 32; ¶ 56).
Regarding claim 15, Otto 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 (¶ 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).
Regarding claim 16, Otto further discloses 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 18-19, 42, and 51-52 describe how the cup 18 is intended to collect urine from a user seated adjacent to the urine collection system; ¶ 61 indicates positioning the receptacle 16 against a user);
receiving fluid discharged from the user in the fluid collection device (¶s 18-19, 42, and 51-53);
receiving fluid discharged from the fluid collection device in the fluid collection container (¶s 53-54 describe use of reservoir 26);
determining, with at least one sensor, at least a status of the fluid collection system (¶s 52-54 describe the sensors indicating a number of properties; ¶ 74 explicitly describes a fullness sensor); and
transmitting, from a control system, to a control panel the 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).
Regarding claim 17, Otto further discloses using a pump (pump 44, best seen in Fig. 13) to pull a vacuum on a tube (tubing 28) in fluid communication with the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container ((¶s 18-19, 42, and 51-56 describe the use of the pump to draw fluid into collection container 26).
Regarding claim 18, Otto further 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, Otto further discloses wherein transmitting from a control system, to a control panel the at least one status of the fluid collection system includes transmitting to a control panel located on a housing for the pump (Fig. 32 shows how controller logic is used to operate the pump; ¶s 53-56 describe how the control system controls the pump, such as via control panel 30; Figs. 1, 11, and 13 show how control panel 30 is located on the housing).
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).
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, Otto further teaches having a fluid level sensor (¶ 74 describes a reservoir fullness sensor), but 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.
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 fluid level sensor of Otto with the sensor arrangement 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 Otto, as applied to claim 1 above, and further in view of Friedrich (US 2013/0324954 A1).
Regarding claim 4, Otto does not explicitly teach at least one sensor including a power consumption sensor operatively coupled to the pump.
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 Otto 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Otto, as applied to claim 1 above, and further in view of Peake et al (US 2009/0199857 A1).
Regarding claim 14, Otto further teaches monitoring when a maximum or threshold run-time of the pump is exceeded (¶ 56), but does not explicitly teach a programmable timer configured to indicate when a component of the fluid collection system requires replacement.
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 Otto 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 cup 18 should be replaced/cleaned, or to replace filters within the system, pump motors, etc.).
Conclusion
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.
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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