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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9, 2026 has been entered.
Response to Amendment
Applicant is thanked for their January 9, 2026 response to the Office Action filed October 17, 2025. The amendment has been entered and, accordingly, claims 1, 4-7, 10-11, and 13 have been amended. Claims 1-16 are currently pending in this application.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2016059682 by Nakayasu et al (hereinafter “Nakayasu”).
Regarding claim 13, Nakaya discloses a method for providing protective air flow in a clean room (Abstract) wherein the clean room comprises a clean area subject to contamination (area near center of clean room 100 which includes treatment table 28) comprising steps of:
having a normal patient mode (normal patient mode, being a first setting for the air flows, is necessarily present in the adjustable system, which has multiple settings, or modes, corresponding to different adjustment settings of the airflow control plates 61-64);
in the normal patient mode, diffusing first air flows, each having a first air flow volume A l/s (Fig 5 D51 and D55) from each of a from a first supply air diffuser and a second supply air diffuser (Fig 5 sub-blowing units 50A and 50B), arranged within a ceiling of the clean room and on opposite sides of the clean area (Fig 5), each first air flow being directed along the ceiling and towards the clean area and towards each other (Fig 5; paragraph [0035]) so that the first air flows are arranged to collide inside the clean area so that a combined air flow is directed towards the floor of the clean area and the clean area is flushed with the combined air flow (paragraph [0036]), wherein in the normal patient mode a second air flow volume B is 0 l/s so that no second air flows are diffused towards the perimeter of the room (corresponding to the setting in which air flow control plate 62 closes outlet 52n; paragraph [0043]);
initiating an isolation mode, (isolation mode, being a second, additional setting, is necessarily present in the adjustable system, which has multiple settings, or modes); and
in the isolation mode, diffusing second air flows, each having a second air flow volume B l/s, from the first supply air diffuser and the second supply air diffuser, each being directed along the ceiling of the clean room and towards the perimeter of the clean room and in an opposite direction to the first air flow from the same supply air diffuser (Fig 5 D53 and D57), wherein in the isolation mode the second air flow volume B is more than 0 l/s and wherein the first air flows continue to be diffused in the isolation mode (corresponding to a setting in which airflow control plates 61 and 62 are set such that both outlets 52M and 52n are open, as in Figs 5-6).
Regarding claim 16, Nakayasu further teaches that the ratio of the first air flow volume A and the second air flow volume B can be adjusted between 100:0 and 0:100 (Fig 3 and Fig 6 and paragraph [0031], each of first air flow volume D51 and second air flow volume D53 would be adjusted by moving 61 and 62 as shown in Fig 3; A ratio of 100:0 is achieved when 61 closes the opening while 62 is open and a ratio of 0:100 can be achieved when 62 closes the opening while 61 is open and any ratio in between in achievable with other positions of 61 and 62).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nakayasu in view of US 2016/0209065 by Hagström (hereinafter “Hagström ‘065”) .
Regarding claim 1, Nakayasu teaches a protective air supply system for controlling air supply flows in a clean room (Abstract), wherein the clean room comprises a clean area subject to contamination (area near center of clean room 100 which includes treatment table 28), comprising:
- a first air supply diffuser and a second air supply diffuser, arranged to be installed within a ceiling of the clean room on opposite sides of the clean area and spaced from side walls of the clean room (Fig 2 sub-blowing units 50A and 50B) so that each of the first and second air supply diffusers is configured to diffuse:
-- a first air flow, having a first air flow volume A l/s, directed along the ceiling of the clean room and towards the clean area, and towards the other first air flow from the other air supply diffuser (Fig 5 D51 and D55; paragraph [0035]), and
-- a second air flow, having a second air flow volume B l/s, directed along the ceiling of the clean room and towards a perimeter of the clean room and in opposite direction than the first air flow (Fig 5 D53 and D 57; paragraph [0038]).
Nakayasu also teaches that teaches that the first air flow volume and the second air flow volume may be adjusted along with their ratio (Fig 6; paragraph [0031], flow rate volume A adjusted by airflow control plate 61, while flow rate volume B is adjusted by air flow control plate 62) and that the system can initiate between a normal patient mode and an isolation mode, wherein, in the normal patient mode, each air supply diffuser is arranged to diffuse the first air flow and the second air flow volume B is 0 l/s so that no second air flow is diffused towards the perimeter of the clean room (paragraph [0043], by rotating airflow control plates 61/ 62, airflow may be configured to flow out of one of the openings, particularly opening 52m only), and, in the isolation mode, each air supply diffuser is arranged to diffuse the first air flow directed towards the clean area of the clean room and the second air flow directed towards the perimeter of the clean room wherein the second air flow volume B is more than 0 l/s (Fig 5).
But Nakayasu is silent with regards to a controller configured to control these air flow volumes and the resulting modes.
However, Hagström ‘065 teaches a controller used for controlling a ventilation system of a clean room (Fig 1 apparatus 300 controls ventilation devices 11 and 12 of clean room 10; paragraph [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the protective air supply system of Nakayasu by including a controller configured to adjust the air flow volumes and their ratios, initiating between the different modes or settings. Nakayasu teaches all of the components to be controlled, particularly the air flow control plates 61/62, but is silent as to the manner of their control. It would be obvious to control these devices from a controller in order to allow for automatic control or to allow users, such as medical staff, to control the ventilation settings through a controller from an easily accessible location, such as a user interface near the patient, as taught by Hagström ‘065.
Regarding claim 2, Nakayasu/Hagström ‘065 teaches the protective air supply system according to claim 1. Nakayasu teaches that the total air flow volume can be adjusted by the air conditioner (paragraph [0034]). But Nakayasu/Hagström ‘065 does not explicitly teach that a combined air flow volume A+B is adjustable from 70 l/s to 200 l/s.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the combined air flow volume A+B adjustable in the range of 70 l/s to 200 l/s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu teaches the general conditions of an adjustable combined air flow volume and the desire for providing the air flow needed for comfort of the patient and medical staff. It is observed that the combined air flow volume is a result effective variable because an increased air supply volume would result in an increase in the overall turnover rate of air in the room and thus an increase in cleanliness, as well as an increased air velocity, which would increase the entrapment of contaminants. Alternatively, a decrease in air supply volume would require less energy usage. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the combined volume adjustable in the range of 70 l/s to 200 l/s, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 3, Nakayasu further teaches that that the ratio of the first air flow volume A and the second air flow volume B can be adjusted between 100:0 and 0:100 (Fig 3 and Fig 6 and paragraph [0031], each of first air flow volume D51 and second air flow volume D53 would be adjusted by moving 61 and 62 as shown in Fig 3; A ratio of 100:0 is achieved when 61 closes the opening while 62 is open and a ratio of 0:100 can be achieved when 62 closes the opening while 61 is open and any ratio in between in achievable with other positions of 61 and 62; also see paragraph [0043], airflow may be configured to blow out of one of 52m/52n).
Regarding claim 4, Nakayasu, as modified with the controller taught by Hagström ‘065, teaches the protective air supply system of claim 1. See details in parent claim 1 rejection above, including the motivation for a person of ordinary skill to modify. Nakayasu teaches that the system can be adjusted to create a more comfortable space for the medical staff and the patient (paragraph [0043]), and teaches adjusting between the isolation mode and the normal patient mode (based on the settings of the airflow control plates 61/62; paragraph [0043]). Hagström ‘065 further teaches that the controller is configured to adjust the ventilation settings based on operational requirements of the room (Hagström ‘065, paragraph [0033], adjusts ventilation settings based on a level of criticality of the operation, Fig 3, or the system may be set to an economy mode when an operation is not being performed, paragraph [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention, having modified the protective air supply system of Nakayasu with the controller taught by Hagström ‘065, to configure the controller to switch between the isolation mode and the normal patient mode based on operational requirements of the clean room, thus providing for the use of different settings, or modes, depending on the usage of the room and the operational requirements.
Regarding claim 6, Nakayasu/ Hagström ‘065 does not explicitly disclose that in the isolation mode the first air flow volume A and the second air flow volume B ratio is 1:1.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the ratio of the first air flow volume A and the second air flow volume B to be 1:1, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu discloses an adjustable first air volume A and second air flow volume B. It is observed that the ratio of the first air volume A and the second air flow volume B is a result effective variable because as increased second air flow would result in more airflow into the corners of the room to achieve greater overall cleanliness (Nakayasu paragraph [0042]), as well as more airflow against the backs of medical staff to increase their thermal comfort (Nakayasu paragraph [0040]). An increased first air flow, on the other hand, would result in more airflow towards the patient in the clean area, providing a clean and comfortable environment for the patient (Nakayasu paragraph [0037]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the ratio of the first air flow volume and the second air flow volume 1:1 in an isolation mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 7, Nakayasu/ Hagström ‘065 does not explicitly teach that in the isolation mode the first air flow volume A is the same as in the normal patient mode and the second air flow volume B is increased.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the first air flow volume A the same as in the normal patient mode and to increase the air flow volume B, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu discloses the general conditions. It is observed that the ratio of the first air volume A and the second air flow volume B is a result effective variable because as increased second air flow would result in more airflow into the corners of the room to achieve greater overall cleanliness (Nakayasu paragraph [0042]), as well as more airflow against the backs of medical staff to increase their thermal comfort (Nakayasu paragraph [0040]). An increased first air flow, on the other hand, would result in more airflow towards the patient in the clean area, providing a clean and comfortable environment for the patient (Nakayasu paragraph [0037]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the first air flow volume A the same in the normal patient mode and the isolation mode, while increasing second air flow volume B in the isolation mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 8, Nakayasu/ Hagström ‘065 does not explicitly teach that in the normal patient mode a combined air flow volume A+B is 70 l/s.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the combined air flow volume of A+B 70 l/s in the normal patient mode since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu shows the general conditions of a first air flow volume and a second air flow volume B and a combined airflow volume which is adjusted by the air conditioner (Nakayasu paragraph [0034]). Hagström ‘065 further teaches that the air supply volume of a room effects the level of cleanliness of the room (Hagström ‘065 paragraph [0024]), with different levels of cleanliness needed for different operations (Hagström ‘065 paragraph [0033]), and an energy-saving mode when high levels of cleanliness are not needed (Hagström ‘065 paragraph [0038]). It is observed that the combined air flow volume is a result effective variable because an increased air supply volume would result in an increase in the overall turnover rate of air in the room and thus an increase in cleanliness, while a decrease in air supply volume would require less energy usage. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the combined air flow volume of A+B 70 l/s in the normal patient mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 9, Nakayasu/ Hagström ‘065 does not explicitly teach that in the isolation mode a combined air flow volume A+B is 200 l/s.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the combined air flow volume of A+B 200 l/s in the isolation mode since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu shows the general conditions of a first air flow volume and a second air flow volume B and a combined airflow volume which is adjusted by the air conditioner (Nakayasu paragraph [0034]). Hagström ‘065 further teaches that the air supply volume of a room effects the level of cleanliness of the room (Hagström ‘065 paragraph [0024]), with different levels of cleanliness needed for different operations (Hagström ‘065 paragraph [0033]), and an energy-saving mode when high levels of cleanliness are not needed (Hagström ‘065 paragraph [0038]). It is observed that the combined air flow volume is a result effective variable because an increased air supply volume would result in an increase in the overall turnover rate of air in the room and thus an increase in cleanliness, while a decrease in air supply volume would require less energy usage. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the combined air flow volume of A+B 70 l/s in the normal patient mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 10, Nakayasu further discloses that each of the first and second air supply diffusers is provided with multiple nozzles (Fig 3 sub-units have openings/nozzles 52n and 52m on either side of flow path forming member 51), and wherein at least some of the multiple nozzles are closable (Fig 3 airflow control plates 61 and 62 can close nozzles).
Regarding claim 11, Nakayasu further teaches that in the isolation mode, the multiple nozzles are open and in the normal patient mode some of the multiple nozzles are closed (isolation mode uses both airflows D51 and D53, as shown in Fig 6, with both nozzles 52m/52n open; normal patient mode uses only airflow D51, so nozzle 52n is closed).
Regarding claim 12, Nakayasu further teaches that the first and second air supply diffusers comprise separate chambers for the air to be diffused as the first air flow and the second air flow (Fig 3 flow path forming member 51 divides diffuser 50A/B into chambers 52m and 52n).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nakayasu.
Regarding claim 14, Nakayasu discloses the protective air supply system according to claim 13 (see details in claim 13 rejection above).
Nakayasu does not explicitly disclose that the method further comprises supplying air volume A+B of 70 l/s in the normal patient mode.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the combined air flow volume of A+B 70 l/s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu shows the general conditions and it is observed that the combined ratio of air flow volume is a result effective variable because an increased air supply volume would result in an increase in the overall turnover rate of air in the room and an increased air velocity in the target clean area, while a decrease in air supply volume would require less energy usage. It would have been obvious to one of ordinary skill in the art at the time the invention was made to supply a combined air flow volume A+B of 70 l/s in the normal patient mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 15, Nakayasu discloses the protective air supply system according to claim 14. See details in parent claim 14 rejection above, including the motivation for a person of ordinary skill to modify.
Nakayasu does not explicitly disclose that the method further comprises increasing the supply air volume A+B to 200 l/s when the isolation mode is initiated.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to make the combined air flow volume of A+B 200l/s since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). In the instant case, Nakayasu shows the general conditions and it is observed that the combined ratio of air flow volume is a result effective variable because an increased air supply volume would result in an increase in the overall turnover rate of air in the room, while a decrease in air supply volume would require less energy usage. It would have been obvious to one of ordinary skill in the art at the time the invention was made to supply a combined air flow volume A+B of 200 l/s in the isolation mode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record teaches or suggests a protective air supply system for controlling air supply flows in a clean room with all of the limitations of claim 5, particularly the limitation that “the controller is further configured to adjust a supply air temperature to be 3-5֯ C lower than a room air temperature, and wherein the supply air temperature is lowered only when the isolation mode is initiated.”
The closest prior art of record is the following:
Nakayasu/Hagström ‘065 teaches the protective air supply system according to claim 1, as discussed above. Nakayasu further teaches that the air supply temperature to the system may be controlled by the air conditioner (paragraph [0026]). Nakayasu also teaches that the second air flows are particularly advantageous in maintaining the thermal comfort of the medical staff (paragraph [0040]). But Nakayasu does not teach that a supply air temperature is adjusted to be 3-5֯ C lower than a room air temperature or that the supply air temperature is lowered only when the isolation mode is initiated.
JP ‘2012239633 by Gondo et al teaches a protective air supply system for controlling air supply flows in a clean room (paragraph [0007]) having a first air flow directed towards a patient (Fig 2 central blown air 21 directed towards patient 4) and a second air flow directed towards medical staff that surround the patient (Fig 2 peripheral blown air 23 directed towards operator 9). Gondo teaches that it is advantageous for the air blowing on the patient to be set to the room temperature, while the air blowing on the medical staff is set to approximately 5 ֯C lower than a room air temperature to maintain a thermal environment appropriate for both the surgeon and the patient (paragraph [0022]). But Gondo does not teach that the protective air supply system has different modes of operation or that the air supply temperature is lowered only when an isolation mode is initiated.
Since none of the other prior art of record teaches a protective air supply system for controlling air supply flows in a clean room having both a normal patient mode and an isolation mode, as claimed, where the air supply temperature is lowered only when the isolation mode is initiated, these limitations, when combined with every other limitation of the claim, distinguish the claim from the prior art.
Response to Arguments
Applicant’s arguments with respect to claim 5, as amended, have been fully considered and are persuasive. The rejection of claim 5 has been withdrawn.
Applicant's arguments regarding independent claims 1 and 13, as well as dependent claims 8-9 have been fully considered, insofar as they apply to the references and reasoning still being relied upon, but they are not persuasive.
Applicant argues on page 9-10 that Nakayasu fails to teach the claimed mode-specific operation with second air flow volume B equal to 0 l/s in normal patient mode, stating that “Nakayasu’s system provides continuous variability in air-flow parameters, not distinct operational modes where specific air flow are categorically present or absent based on the selected mode.” Examiner respectfully disagrees. The system taught by Nakayasu does teach a system with continuous variability in air-flow parameters, including a state where either airflow volume A or B may be 0 l/s. The claimed modes of operation can be interpreted as being states or settings within the selections of available parameters. Similar reasoning can also be applied to claim 13.
Regarding claims 8-9, Applicant argues on pages 11-12 that it would not have been obvious to make the combined air flow volume A + B to be 70 l/s in the normal patient mode, as claimed in claim 8, or to be 200 l/s in the isolation mode, as claimed in claim 9. Examiner respectfully disagrees. Examiner notes that the rejection of this Office Action now relies on Nakayasu (modified by Hagström ‘065) rather than the previous Hagström to teach the general conditions of the claim, but the specific volumes of the combined air flow are still believed to be unpatentable as the routine optimization of a result-effective variable (MPEP 2144.05). Nakayasu teaches that the system can adjust the combined flow rate (paragraph [0026] and [0034]), in addition to adjusting the ratio of the flow through each of 52m and 52n (by adjusting air flow control plates 61/62; paragraph [0031]), indicating that adjusting said combined flow rate may indeed be necessary or desirable. Applicant has argued that “even if combined volumetric flow rate were recognized as result-effective, the Office has not established that the specific values of 70 l/s and 200 l/s represent mere optimization rather than critical values.” Applicant may rebut the argument by showing that the specific values are critical. However, Applicant’s disclosure provides no evidence of criticality. Paragraph [0046] – [0049] of Applicant’s specification discloses a desire to adjust the air flow volume for thermal comfort of the patient in the normal patient mode and an additional air flow in the isolation mode. Applicant’s disclosure does not disclose any reason why the specific air flow volumes of 70 l/s and 200 l/s are critical to the operation of the system.
Conclusion
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/AMY E CARTER/Examiner, Art Unit 3762
/Allen R. B. Schult/Primary Examiner, Art Unit 3762