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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24JUN2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 8, filed 20MAY2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Tokunaga in view of Peterson. While the previous functional language has been removed, the amended recitation that the proportional valve regulates vacuum levels independent from the flowrate is similarly considered functional. No specific structure is claimed which indicates that this result would not occur from a proportional valve being connected via a tee-fitting to the suction tube.
Claim Interpretation
Amended Claim 1 requires observation of the flowrate through the pump head. As claimed, the suction tube extends through the pump head, but no flow necessarily occurs within the pump head itself. As the flow passes through the suction tube and the suction tube is at least partially located within the pump head, the claim is interpreted to describe flow through the suction tube, said tube being located within the pump head.
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(s) 1-5, 11-13, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080023005 A1 (Tokunaga) in view of US 5354268 A (Peterson et al.).
Regarding Claims 1 and 2, Tokunaga teaches a portable suction pump (Fig. 1) for aspirating secretions from a patient's artificial airway, the portable suction pump comprising:
a peristaltic pump head (51) (Fig. 2);
a suction tube (15) extending from a patient through the peristaltic pump head (Figs. 1 and 2) that regulates flowrate of patient media, the suction tube having a tee-fitting conduit (connecting to 30 as seen in Fig. 1); and
a collection container (17A and 17B) having a plurality of ports for collecting patient media (17B having inlet and outlet ports as seen in Fig. 1).
Tokunaga further teaches the tee-fitting conduit (at 30, Fig. 1) extends to a vacuum sensor port (where 30 connects to 31) connecting to a vacuum sensor (31) in communication with a processor (18).
Tokunaga fails to teach the processor controlling a proportional valve employed to regulate the vacuum levels.
Peterson teaches a device (Fig. 17e) for control of vacuum and pressure, which is considered applicable to aspiration devices, wherein a processor (34) controls a proportional valve (770) regulates pressure levels (Col. 20: ll. 7-22) by connecting to atmosphere to increase or decrease pressure as desired.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the relief valve (33) of Tokunaga to incorporate the proportional valve of Peterson to regulate the vacuum levels (Peterson Col. 20: ll. 7-22), the use of proportional valves and associated circuitry being well known in the art (Peterson Col. 19: ll. 17-19).
The combined device is therefore considered to regulate vacuum levels independent from the flowrate as flowrate is dictated by the pump and actuation of the proportional valve would affect vacuum level.
“[T]hat regulates vacuum levels independent from the flowrate” is a statement of intended use that does not further limit the claimed invention. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 3, Tokunaga further teaches the tee-fitting conduit (at 30) connects to a second tee-fitting (at 33) where one conduit connects to the vacuum sensor (31, via 30).
As the proportional valve of claim 2 replaces (33), the combined device is considered to teach the other conduit connects to the proportional valve, the proportional valve having a first port and a second port (proportional valves necessarily having at least two ports for regulating the pressure, i.e., at least an inlet and outlet as seen in Fig. 1).
Tokunaga in view of Peterson fails to teach a wye-fitting.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second tee-fitting of Tokunaga with a wye-fitting as a simple substitution of one known fitting for another with a reasonable expectation of splitting a single line into two MPEP 2143 I.
Regarding Claim 4, Tokunaga further teaches the first port is opened to atmospheric air (valve 33 relieving to air) and the second port allows metered air to flow into the suction tube (between 33 and 52).
Regarding Claim 5, Tokunaga fails to teach processor control of the proportional valve.
Peterson further teaches use of processor (34) to operate the proportional valve (770) (Col. 20: ll. 7-22) when a predetermined pressure is reached (Col. 19: ll. 8-12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proportional valve of Tokunaga in view of Peterson with the processor control as taught by Peterson in order to increase control and allow for altering flow parameters.
By incorporating the processor control of Peterson with the device of claim 4, the combined device is considered to teach a vacuum level in the suction tube reaches a predetermined threshold, the processor instructs the proportional valve to open and allow air from the atmosphere to enter the suction tube to control the vacuum levels.
Regarding Claim 11, Tokunaga teaches a portable suction pump (Fig. 1) for aspirating secretions from a patient's artificial airway, the portable suction pump comprising:
a vacuum tube (15) extending from a patient through a peristaltic pump head (51) (Fig. 2), the suction tube having a tee-fitting conduit (connecting to 30 as seen in Fig. 1); and
the vacuum tube communicating with a vacuum sensor (31) via a tee-fitting conduit (where 30 connects to 31); a processor (18) for receiving vacuum sensor data from the vacuum sensor (connected in Fig. 1) [0078]; and
a collection container (17A and 17B) for collecting patient media (17).
Tokunaga fails to teach a proportional valve.
Peterson teaches a device (Fig. 17e) for control of vacuum and pressure, which is considered applicable to aspiration devices, wherein a proportional valve (770) regulates pressure levels (Col. 20: ll. 7-22) by connecting to atmosphere to increase or decrease pressure as desired.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the relief valve (33) of Tokunaga to incorporate the proportional valve of Peterson to regulate the vacuum levels (Peterson Col. 20: ll. 7-22), the use of proportional valves and associated circuitry being well known in the art (Peterson Col. 19: ll. 17-19).
The combined device is therefore considered to regulate vacuum levels independent from the flowrate as flowrate is dictated by the pump and actuation of the proportional valve would affect vacuum level.
“[T]hat regulates vacuum levels independent from the flowrate” is a statement of intended use that does not further limit the claimed invention. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 12, Tokunaga further teaches the tee-fitting conduit (at 30) connects to a second tee-fitting (at 33) where one conduit connects to the vacuum sensor (31, via 30).
As the proportional valve of claim 11 replaces (33), the combined device is considered to teach the other conduit connects to the proportional valve, the proportional valve having two ports (proportional valves necessarily having at least two ports for regulating the pressure, i.e., at least an inlet and outlet as seen in Fig. 1).
Tokunaga in view of Peterson fails to teach a wye-fitting.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second tee-fitting of Tokunaga with a wye-fitting as a simple substitution of one known fitting for another with a reasonable expectation of splitting a single line into two MPEP 2143 I.
Regarding Claim 13, Tokunaga further teaches the first port is opened to atmospheric air (valve 33 relieving to air) and the second port allows metered air to flow into the suction tube (between 33 and 52).
Regarding Claim 18, Tokunaga teaches a device which when used would constitute a method for aspirating secretions from a patient's artificial airway, the method comprising:
extending a vacuum tube (15) from a patient through a peristaltic pump head (16A);
enabling communication between the vacuum tube and a vacuum sensor (31) via a tee-fitting conduit (at 30);
receiving, via a processor (18), vacuum sensor data to determine if a valve needs to be activated to allow air into the vacuum tube to limit the vacuum levels [0078]; and
collecting patient media by a collection container (17A and 17B) [0064].
Tokunaga fails to teach a proportional valve.
Peterson teaches a device (Fig. 17e) for control of vacuum and pressure, which is considered applicable to aspiration devices, wherein a processor (34) controls a proportional valve (770) regulates pressure levels (Col. 20: ll. 7-22) by connecting to atmosphere to increase or decrease pressure as desired.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the relief valve (33) of Tokunaga to incorporate the proportional valve of Peterson to regulate the vacuum levels (Peterson Col. 20: ll. 7-22), the use of proportional valves and associated circuitry being well known in the art (Peterson Col. 19: ll. 17-19).
The combined device is therefore considered to regulate vacuum levels independent from the flowrate as flowrate is dictated by the pump and actuation of the proportional valve would affect vacuum level.
“[T]hat regulates vacuum levels independent from the flowrate” is a statement of intended use that does not further limit the claimed invention. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 19, Tokunaga further teaches the tee-fitting conduit (at 30) connects to a second tee-fitting (at 33) where one conduit connects to the vacuum sensor (31, via 30).
As the proportional valve of claim 11 replaces (33), the combined device is considered to teach the other conduit connects to the proportional valve.
Tokunaga in view of Peterson fails to teach a wye-fitting.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second tee-fitting of Tokunaga with a wye-fitting as a simple substitution of one known fitting for another with a reasonable expectation of splitting a single line into two MPEP 2143 I.
Regarding Claim 20, Tokunaga further teaches the first port is opened to atmospheric air (valve 33 relieving to air) and the second port allows metered air to flow into the suction tube (between 33 and 52).
As the combined device of claim 18 teaches a proportional valve, the combination is considered to teach the proportional valve having two ports (proportional valves necessarily having at least two ports for regulating the pressure, i.e., at least an inlet and outlet as seen in Fig. 1).
Claim(s) 6-9 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokunaga in view of Peterson and further in view of US 20090088710 A1 (Hoffman et al.), US 20210379312 A1 (Bernard et al.), and US 20110092958 A1 (Jacobs).
Regarding Claim 6, Tokunaga further teaches the inclusion of a ventilation valve to control pressure by exhausting to atmosphere [0007], but fails to teach the plurality of ports include a first port of the collection container for receiving the patient media, and second and third ports of the collection container for providing air vents to the atmosphere, the air vents incorporating viral filter.
Hoffman teaches a container (300) (Fig. 9) for collecting drainage of bodily fluids [Abstract] wherein the container comprises a plurality of ports including a first port (212) of the collection container for receiving the patient media [0049], and second (332) and third (340) ports of the collection container for providing air vents to the atmosphere [0071], the air vents incorporating antimicrobial filters (334 and 346) [0011 and 0071] to protect the atmosphere from the patient media.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga with the second and third vent ports of Tokunaga to maintain a closed system for suction [Tokunaga 0011].
“[T]o protect the atmosphere from the patient media” is a statement of intended use that does not further limit the claimed invention. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Tokunaga in view of Hoffman fails to explicitly teach viral filters.
Bernard teaches a ventilation system (1) wherein the pressure relief system includes viral filters [0016].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antimicrobial filters of Tokunaga in view of Hoffman with the viral filters of Bernard to provide caregiver protection [Bernard 0016].
Jacobs teaches a system for collecting fluids discharged from the body [Abstract] wherein the collection container (20) is full, a microprocessor (14) [0019] turns off the portable suction pump (12) [0022], and a pressure sensor within the canister [0033].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga in view of Hoffman and Bernard to incorporate the processor turning off the pump when the container is full as taught by Jacobs in order to prevent the container from overfilling [Jacobs 0022].
The combined device is considered to fulfill the limitation wherein the port provides pressure data to a pressure sensor that communicates with a microprocessor to turn off the peristaltic pump head when the collection container is full and a float valve closes.
Regarding Claim 7, Tokunaga in view of Hoffman and Bernard fails to teach the collection container is full, an internal liquid check valve closes and the second port closes.
Hoffman further teaches the use of a seal plug (232) to seal the second port (332) [0071].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of claim 6 to incorporate the seal plug of Hoffman in order to control fluid flow out of the container when fluid levels are too high [Hoffman 0071].
The combined device is considered to have a seal plug which is an internal valve which closes the second port.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal plug of the combined device with a check valve as a simple substitution of one known flow control device for another with a reasonable expectation of controlling fluid outflow in a closed system MPEP 2143 I.
Regarding Claim 8, Hoffman teaches the third port maintains its ability to regulate pressure even when the second port has been closed [0071]. The device of claim 6 is therefore considered to teach that the third port remains open when the collection container is full.
Regarding Claim 9, Tokunaga in view of Hoffman and Bernard fails to teach when the collection container is full, a processor turns off the portable suction pump.
Jacobs teaches a system for collecting fluids discharged from the body [Abstract] wherein the collection container (20) is full, a processor (14) turns off the portable suction pump (12) [0022].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga in view of Hoffman and Bernard to incorporate the processor turning off the pump when the container is full as taught by Jacobs in order to prevent the container from overfilling [Jacobs 0022].
Regarding Claim 14, Tokunaga in view of Peterson fails to teach the collection container has a plurality of ports including a first port of the collection container for receiving the patient media, and second and third ports of the collection container for providing air vents to the atmosphere, the air vents incorporating viral filters to protect the atmosphere from the patient media.
Hoffman teaches a container (300) (Fig. 9) for collecting drainage of bodily fluids [Abstract] wherein the container comprises a plurality of ports including a first port (212) of the collection container for receiving the patient media [0049], and second (332) and third (340) ports of the collection container for providing air vents to the atmosphere [0071], the air vents incorporating antimicrobial filters (334 and 346) [0011 and 0071] to protect the atmosphere from the patient media.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga with the second and third vent ports of Tokunaga to maintain a closed system for suction [Tokunaga 0011].
“[T]o protect the atmosphere from the patient media” is a statement of intended use that does not further limit the claimed invention. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Tokunaga in view of Hoffman fails to explicitly teach viral filters.
Bernard teaches a ventilation system (1) wherein the pressure relief system includes viral filters [0016].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antimicrobial filters of Tokunaga in view of Hoffman with the viral filters of Bernard to provide caregiver protection [Bernard 0016].
Jacobs teaches a system for collecting fluids discharged from the body [Abstract] wherein the collection container (20) is full, a microprocessor (14) [0019] turns off the portable suction pump (12) [0022], and a pressure sensor within the canister [0033].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga in view of Hoffman and Bernard to incorporate the processor turning off the pump when the container is full as taught by Jacobs in order to prevent the container from overfilling [Jacobs 0022].
The combined device is considered to fulfill the limitation wherein the port provides pressure data to a pressure sensor that communicates with a microprocessor to turn off the peristaltic pump head when the collection container is full and a float valve closes.
Regarding Claims 15 and 16, Tokunaga in view of Hoffman and Bernard fails to teach the collection container is full, an internal liquid check valve closes and the second port closes.
Hoffman further teaches the use of a seal plug (232) to seal the second port (332) [0071]; and the third port maintains its ability to regulate pressure even when the second port has been closed [0071]. The combined device is therefore considered to teach that the third port remains open when the collection container is full.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of claim 6 to incorporate the seal plug of Hoffman in order to control fluid flow out of the container when fluid levels are too high [Hoffman 0071].
The combined device is considered to have a seal plug which is an internal valve which closes the second port.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal plug of the combined device with a check valve as a simple substitution of one known flow control device for another with a reasonable expectation of controlling fluid outflow in a closed system MPEP 2143 I.
Regarding Claim 17, Tokunaga in view of Hoffman and Bernard fails to teach the collection container is full, a processor turns off the portable suction pump.
Jacobs teaches a system for collecting fluids discharged from the body [Abstract] wherein the collection container (20) is full, a processor (14) turns off the portable suction pump (12) [0022].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tokunaga in view of Hoffman and Bernard to incorporate the processor turning off the pump when the container is full as taught by Jacobs in order to prevent the container from overfilling [Jacobs 0022].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokunaga in view of US 20200397956 A1 (Luxon et al.).
Regarding Claim 10, Tokunaga teaches monitoring pressure [0035], but fails to teach the collection container has a first chamber and a second chamber, the first chamber collecting the patient media and the second chamber monitoring pressure within the collection container.
Luxon teaches an aspiration system (Fig. 1) wherein the collection container (128) has a first chamber (the main reservoir of container 128) and a second chamber (where pressure sensor meets controller 122), the first chamber collecting the patient [0069] media and the second chamber monitoring pressure within the collection container [0071].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container of Tokunaga with the two-chamber container of Luxon in order to measure pressure within the container [Luxon 0071].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200337900 A1 discloses the use of proportional valves connected to a tee-fitting for pressure regulation.
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/HANS KALIHER/ Examiner, Art Unit 3781
/CATHARINE L ANDERSON/ Primary Examiner, Art Unit 3781
