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
Applicant’s amendments filed on 04/09/2026 has been fully considered. Claims 1-12 are pending. Claims 1-3 and 6-8 are amended.
Response to Arguments
Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive.
Regarding the argument the prior art of Galbraith does not teach “an exhaust air port arranged to be positioned and to open in the main body of the blood purification apparatus”, the argument is unpersuasive. The mask 25 includes the tubing which is in the apparatus of Figures 5-5B (Paragraph 0053). The wording of the previous claim 1 did not require the exhaust air port to be directly located in the main body of the blood purification apparatus, only requiring it to be “positioned and to open in the main body”.
Regarding the argument that the prior art of Yuds does not teach the printed substrate of the claimed invention, the argument is not persuasive. The “printed substrate” of the claimed invention is described to be a structure that connects all of the electrical components with electrical power to operate the device, as described in Paragraph 0016 of the specification. The term “printed substrate” is interpreted to be a material/structure that is used to connect components together for electrical communication. The prior art of Yuds teaches a “system bus 250” in Paragraph 0026 and Figure 2, which is a material/structure that is used to connect components together for electrical communication, similar to the claimed invention. The applicant further discusses that the prior art of Yuds does not teach that the system bus does not connect intake air fan and the purification unit and being disposed in one of the intake air port and the exhaust air port. However, the claim limitation required “the purification unit disposed in one of the intake air port and the exhaust air port”, see lines 11-12 of claim 1, and not the printed substrate being located within the intake air port and the exhaust air port. Second, the printed substrate/system bus 250 of Yuds is used to within the machine to operate the device itself, thus the system bus is electronically connected to the intake air fan and the purification unit of Galbraith in view of Yuds for the controller of the device of Galbraith in view of Yuds to control the operation of the air purification of the device (see rejection of claim 1 below).
Though some of the same prior art references is re-used herein, amended claims 1 and 6 required a change in the grounds of rejection relying on the prior art combination as detailed below in the prior art rejection. The current amended claim limitations of claim 1 further narrows and changes the scope of the claim invention, more specifically requiring “an intake port positioned in a main body of the blood purification apparatus so that the intake air port is an opening in the main body” and “an exhaust air port positioned in the main body of the blood purification apparatus so that the exhaust air port is an opening in the main body”. The rejection of the amended independent claim 1 will further be addressed below.
Claim Objections
Claim 4 is objected to because of the following informalities:
Line 2 – “an intake air port” should read “the intake air port” and “an exhaust air port” should read “the intake air port”. Appropriate correction is required.
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, 7-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Galbraith et al. (Publication No. WO 2020/163596 A1) in view of Yuds et al. (Publication No. US 2020/0405934 A1).
For the purposes of examination, USPGPUB of Galbraith et al. (US 2022/0047791 A1) will be referenced in the rejection below.
Regarding claim 1, Galbraith teaches a blood purification apparatus (Abstract; Figure 3 and 5; Paragraph 0046 and 0054) including a blood purification unit that executes blood purification treatment by a blood pump (system 100’’ intakes blood into the CO2/oxygenator module 11 by blood pump 10 and purifies blood; Paragraph 0046; Figure 3), wherein the blood purification apparatus comprising:
an intake air port positioned in a main body of the blood purification apparatus so that the intake air port is an opening in the main body (gas inlet 40a’’ is an opening that is positioned in the housing 40’’ of the apparatus 100”; Paragraph 0076-0078; Figures 6-6B);
an exhaust air port positioned in the main body of the blood purification apparatus so that the exhaust air port is an opening in the main body (exhaust air port is an opening that is positioned in the housing 40” to connect the tubing of the mask 25” with the apparatus 100”; Figures 6-6B; Paragraph 0076-0078);
a purification unit that is disposed in one of the intake air port and the exhaust air port to purify flowing air passing therethrough (PSA module 13”; Figures 6-6B; Paragraph 0040 and 0078-0079);
an air purification unit that includes the purification unit, sucks external air by the intake air fan, and discharges the sucked external air from the exhaust air port after purification by the purification unit (ventilation module 38” that is comprised with the PSA module 13” to deliver purified air from the module 13” that takes air from gas inlet 40a” and discharges the air to the patient; Paragraph 0062; Figures 6-6B); and
a control unit that controls the blood purification unit, and the purification unit of the air purification unit (central processor 28 controls the apparatus 100” with the PSA module 13”, and the blood pump 10; Figures 6-6B; Paragraph 0057 and 0061-0062).
Galbraith does not teach an intake air fan disposed in the intake air port; a printed substrate to which the intake air fan and the purification unit disposed in one of the intake air port and the exhaust air port are connected so as to be able to drive together; wherein the control unit drives the intake air fan and the purification unit of the air purification unit in conjunction with running of the blood purification unit to flow air that is flowed from the intake air port to be out of the exhaust air port while purifying a space in which the printed substrate is disposed, and allows the air purification unit to purify air around a patient subjected to the purification of blood by the blood purification unit.
However, Yuds teaches an intake fan disposed in the intake air port (fan is in the intake portion of the air purification system 310 to pull in air from treatment area; Paragraph 0030); a printed substrate (system bus 250 connects electronic components to drive components together in the device; Paragraph 0026; Figure 2).
Galbraith and Yuds are considered to be analogous to the claimed invention because they are in the same field of blood/air filtration devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Galbraith to incorporate the teachings of Yuds and have the intake fan of Yuds in the intake air port of Galbraith and the printed substrate of Yuds electrically connecting the intake air fan and purification unit of Galbraith so that the processor of Galbraith controls both components. This allows for the fan to circulate the ambient air for filtration (Yuds; Paragraph 0030) and allow for all of the electrical components to be interconnected so that the processor can centrally control all components (Yuds; Figure 2; Paragraph 0026).
The combination of Galbraith in view of Yuds further teaches the printed substrate to which the intake air fan and the purification unit disposed in one of the intake air port and the exhaust air port are connected so as to be able to drive together (see combination above), the control unit that controls the intake air fan (see combination above; Galbraith; processor 28 in housing 40” runs intake air fan of Yuds, module 11, and air purification unit 38; Figure 3 and 6-6B; Paragraph 0042), wherein the control unit drives the intake air fan and the purification unit of the air purification unit in conjunction with running of the blood purification unit to flow air that is flowed from the intake air port to be out of the exhaust air port while purifying a space in which the printed substrate is disposed, and allows the air purification unit to purify air around a patient subjected to the purification of blood by the blood purification unit (processor 28 of Galbraith with the printed substrate of Yuds allows for the simultaneous operation of the intake air fan of Yuds and the purification unit 13 to transmit air from the intake air port to the exhaust port of Galbraith with the blood treatment 11 of Galbraith; Figure 3 and 6-6B; Paragraph 0042 and 0083).
Regarding claim 2, Galbraith in view of Yuds teaches the apparatus of claim 1. Galbraith further teaches wherein the air purification unit is arranged in a middle of a ventilation route that sucks and discharges the external air (module 13 with air purification unit 38, of Galbraith is in between the ventilation route that receives and discharges air through the device; Figure 6). The combination of Galbraith in view of Yuds does not teach a heating portion in the main body including the blood purification unit.
However, Yuds teaches a heating portion in the main body including the blood purification unit (air temperature device 330 that is an air heater in the main body of the dialysis machine 102; Figure 3; Paragraph 0031).
Galbraith and Yuds are considered to be analogous to the claimed invention because they are in the same field of blood/air filtration devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Galbraith in view of Yuds to incorporate the teachings of Yuds and have the air temperature device/heating portion of Yuds in the ventilation route of Galbraith in view of Yuds. This allows for the device to provide hotter air to the patient when the patient feels cold (Yuds; Paragraph 0031).
The combination of Galbraith in view of Yuds further teaches wherein the air purification unit is arranged in a middle of a ventilation route that sucks and discharges the external air so as to pass through a heating portion in the main body including the blood purification unit (see combination above).
Regarding claim 3, the combination of Galbraith in view of Yuds teaches the apparatus of claim 1. The combination of Galbraith in view of Yuds does not teach wherein the air purification unit is formed as a separate apparatus from an apparatus main body including the blood purification unit.
In addition, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have made the air purification unit of Galbraith in view of Yuds separable from the apparatus main body including the purification unit, since that it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961)(MPEP 2144.04 V.C.). The combination of Galbraith in view of Yuds further teaches the air purification unit is connected to the control unit with wire or wireless so as to be able to cooperate (Galbraith; processor 28 controls the oxygen that is delivered to exhaust 38’ towards the exhaust air port; Figure 6; Paragraph 0083).
Regarding claim 4, Galbraith in view of Yuds teaches the apparatus of claim 1. The combination of Galbraith in view of Yuds further teaches wherein out of an intake air port and an exhaust air port of the external air in the blood purification unit, at least the intake air port is disposed near a head of the patient (Galbraith, vent 40a” is nearby the head of the patient; Figure 6).
Regarding claim 5, Galbraith in view of Yuds teaches the apparatus of claim 4. The combination of Galbraith in view of Yuds further teaches wherein a member that changes an air flowing direction is disposed in one of or both the intake air port and the exhaust air port (Galbraith; outlet port 61 is disposed in the exhaust air port where the valves 61b-6c can change the air flow direction, either towards mask 25’ or to the CO2/oxygenator 11; Figure 7; Paragraph 0084).
Regarding claim 7, Galbraith in view of Yuds teaches the apparatus of claim 4. The combination of Galbraith in view of Yuds further teaches further comprising: an extending ventilation route (Galbraith; breathing tubing and mask 25” which extends the ventilation route between exhaust air port and vent 40a”; Figure 6-6B; Paragraph 0062-0063) that extends a ventilation route to outside of the main body, which is between the intake air port and the exhaust air port in the main body including the blood purification unit (ventilation route is between the gas inlet 40a” and the exhaust air port, the opening of the housing 40” that connects to the tubing of the mask 25” and the housing 40” having the blood pump 10; Figure 3 and 6-6B), the extending ventilation route is disposed in one of or both the intake air port and the exhaust air port (extending ventilation route of tubing and mask 25” is disposed in the exhaust air port, located at the opening in the housing 40”; Figures 6-6B).
Regarding claim 8, Galbraith in view of Yuds teaches the apparatus of claim 7. The combination of Galbraith in view of Yuds further teaches further comprising: a pathway member forming the extending ventilation route is created from a deformable material to be able to arbitrarily adjust an extending position of one of or both the intake air port and the exhaust air port (Galbraith; breathing tube is a pathway member that is made of deformable material and can adjust the extending position of the exhaust air port; Figure 6-6B).
Regarding claim 9, Galbraith in view of Yuds teaches the apparatus of claim 1. Galbraith teaches wherein the control unit is provided with a function to set a running schedule of the blood purification unit and drives the air purification unit in conjunction with the running schedule (operation time sensor 30 collects data regarding duration/schedule of system 100” operation and central processor 28 adjusts/drives system including unit 38 based on operational time; Figure 6-6B; Paragraph 0069).
Regarding claim 10, Galbraith in view of Yuds teaches the apparatus of claim 1. Galbraith further teaches further comprising: at least one or more of a light sensor that detects light, a human detection sensor that perceives a human, and a sound sensor that detects sound, wherein driving of the air purification unit is controlled based on a signal of the sensor (sensor 22 can be “a sensor that measures or senses CO.sub.2 or O.sub.2 in the gas flow via fluorescence or quenching, which uses a bifurcated optical fiber that has a light source sending and photo receiving unit on one end and is coated with a Ruthenium compound on the other end” – or a sensor that detects light changes from changing CO2 or O2 levels; Paragraph 0042).
Regarding claim 12, Galbraith in view of Yuds teaches the apparatus of claim 1. The combination of Galbraith in view of Yuds further teaches a blood purification management system to which a plurality of the blood purification apparatuses according to claim 1 that manages a running schedule (Galbraith; Paragraph 0069; see rejection of claim 1 above), wherein a control signal to drive the air purification unit is transmitted to one or more separate blood purification apparatuses disposed around the blood purification apparatus in which the blood purification unit runs (processor 28 which runs air purification unit and blood purification apparatus of Galbraith in view of Yuds based on operational time that there would be a control signal produced by processor 28 to adjust the purification of air and blood based on the operational time; Galbraith; Paragraph 0069).
Galbraith and Yuds are considered to be analogous to the claimed invention because they are in the same field of blood/air filtration devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Galbraith in view of Yuds to incorporate the teachings of Yuds and have the intake fan of Yuds in the intake air port of Galbraith and the printed substrate of Yuds connecting the intake air fan and purification unit of Galbraith, the processor of Galbraith providing the control signal to the air purification unit and the blood purification unit of Galbraith in view of Yuds. This allows for the fan to circulate the ambient air for filtration (Yuds; Paragraph 0030) and allow for all of the electrical components to be interconnected so that the processor can centrally control all components (Yuds; Figure 2; Paragraph 0026), wherein the control unit is able to automatically control the operational time of the air purification unit and blood purification apparatus based on sensor data received (Galbraith; Paragraph 0069).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith et al. (Publication No. WO 2020/163596 A1) in view of Yuds et al. (Publication No. US 2020/0405934 A1), as applied to claim 10 above, and further in view of Ahlmen et al. (Publication No. US 2017/0224234 A1).
Regarding claim 6, Galbraith in view of Yuds teaches the apparatus of claim 1. The combination of Galbraith in view of Yuds does not teach further comprising: a second intake air port and a second exhaust air port that are arranged in a front surface and a back surface of the main body including the blood purification unit or in two side surfaces of the main body.
However, Ahlmen teaches further comprising: a second intake air port (second gas inlet 29B adjacent to first gas inlet 29A; Paragraph 0112; Figure 2A-2B) and a second exhaust air port (second line 53 is adjacent to first line 33; Figures 2A-2B; Paragraph 0113-0114) that are arranged in a front surface and a back surface of the main body or in two side surfaces of the main body (second gas inlet 29B and second line 53 are located on the front and back surface of the main body of the device; Figures 2A-2B).
Galbraith in view of Yuds and Ahlmen are considered to be analogous to the claimed invention because they are in the same field of ventilation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Galbraith in view of Yuds to incorporate the teachings of Ahlmen and have second intake air port of Ahlmen on the front surface of the main body of Galbraith and the second exhaust air port with the pressure sensor of Ahlmen on the back surface of the main body of Galbraith. This allows for the device to have a first and second gas source for air delivery to the patient (Ahlmen; Paragraph 0112) and to have the second exhaust line for measuring air pressure from the patient (Ahlmen; Paragraph 0114).
The combination of Galbraith in view of Yuds and Ahlmen further teaches further comprising: the second intake air port and the second exhaust air port that are arranged in the front surface and the back surface of the main body including the blood purification unit or in two side surfaces of the main body (see combination above).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith et al. (Publication No. WO 2020/163596 A1) in view of Yuds et al. (Publication No. US 2020/0405934 A1), as applied to claim 10 above, and further in view of Hyde et al. (Publication No. US 2017/0196761 A1).
Regarding claim 11, Galbraith in view of Yuds teaches the apparatus of claim 10. Galbraith in view of Yuds does not teach a sound sensor, wherein suction capability of the air purification unit is controlled based on a magnitude of a sound signal detected by the sound sensor.
However, Hyde teaches a sound sensor (audio sensor; Paragraph 0308), wherein suction capability of the device is controlled based on a magnitude of a sound signal detected by the sound sensor (negative pressure level applied in the device is controlled based on the sound level collected by the audio sensor; Paragraph 0308).
Galbraith in view of Yuds and Hyde are considered to be analogous to the claimed invention because they are in the same field of pressure-based medical devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Galbraith in view of Yuds to incorporate the teachings of Hyde and have the audio sensor of Hyde be in the apparatus of Galbraith in view of Yads. This allows for the device to detect events of noise from the user and automatically modify or initiate the operation of the apparatus (Hyde; Paragraph 0308).
The combination of Galbraith in view of Yuds and Hyde further teaches wherein suction capability of the air purification unit is controlled based on a magnitude of a sound signal detected by the sound sensor (see the combination above).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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