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 .
Information Disclosure Statement
The information disclosure statement filed 01/09/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein concerning the Non-Patent Literature titled “First Office Action issued in related Chinese Application No. 202080100922.3” has not been considered.
Response to Amendment
This Office Action is in response to the amendment filed on 02/02/2026. Claims 1, 4-5, 7-9, 11-12, 15-16, and 18-20 are amended. Claims 2-3, 10, and 13-14 are canceled. Claims 6 and 17 are as previously presented. As such, claims 1, 4-9, 11-12, and 15-20 are pending in the instant application.
The amendment to the drawings filed on 02/02/2026 has been considered and is entered.
The amendment to the specification filed on 02/02/2026 has been considered and is entered.
All objections and rejections pursuant of 35 U.S.C. 112(b) have been withdrawn in light of the amendments.
Claim Objections
Claims 8-9 and 11 are objected to because of the following informalities:
Claim 8, lines 7-8: “the target oxygen concentration” should read “a target oxygen concentration” to establish antecedent basis.
Claim 9, lines 3-4: “a target oxygen concentration” should read “the target oxygen concentration” for consistency and clarity.
Claim 11, line 3: “the first flow rate-electric current curve” should read “a first flow rate-electric current curve” to establish antecedent basis.
Claim 11, line 4: “the second flow rate-electric current curve” should read “a second flow rate-electric current curve” to establish antecedent basis.
Appropriate correction is required.
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, 4-9, 11-12, and 15-20 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 limitations “when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, a flow rate-electric current curve of the first gas flow rate controller becomes nonlinear” in lines 15-17, and “when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, a flow rate- electric current curve of the second gas flow rate controller becomes nonlinear” in lines 17-19. The scope of the flow rate-electric current curve becoming nonlinear is unclear. On page 8 of the Remarks (filed 02/02/2026), Applicant points to paragraphs [0099] and [0114] of the specification for support of the limitation recited above. However, paragraph’s [0099] and [0114] of Applicant’s specification does not provide further information to clarify the scope of the flow rate-electric current curve becoming nonlinear when the gas flow rate control values fall within a designated range of the respective flow rate controllers. For the purpose of examination, the above limitation recited in claim 1 (lines 15-19) will be interpreted as – when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, the first gas flow rate controller controls the flow rate of the first gas to be zero – and – when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, the second gas flow rate controller controls the flow rate of the second gas to be zero – based on paragraphs [0099] and [0114] of Applicant’s specification.
Claim 11 recites the limitation "the first flow rate-electric current curve" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is referencing the flow rate-electric current curve of the first gas flow rate controller recited in claim 1 (lines 16-17), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation of claim 11 will be interpreted as – the flow rate-electric current curve of the first gas flow rate controller – as recited in claim 1 (lines 16-17).
Claim 11 recites the limitation "the second flow rate-electric current curve" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is referencing the flow rate-electric current curve of the second gas flow rate controller recited in claim 1 (lines 18-19), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation of claim 11 will be interpreted as – the flow rate-electric current curve of the second gas flow rate controller – as recited in claim 1 (lines 18-19).
Claim 12 recites the limitations “when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, a flow rate-electric current curve of the first gas flow rate controller becomes nonlinear in lines 17-19, and ““when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, a flow rate- electric current curve of the second gas flow rate controller becomes nonlinear” in lines 19-21. The scope of the flow rate-electric current curve becoming nonlinear is unclear. On page 8 of the Remarks (filed 02/02/2026), Applicant points to paragraphs [0099] and [0114] of the specification for support of the limitation recited above. However, paragraph’s [0099] and [0114] of Applicant’s specification does not provide further information to clarify the scope of the flow rate-electric current curve becoming nonlinear when the gas flow rate control values fall within a designated range of the respective flow rate controllers. For the purpose of examination, the above limitation recited in claim 12 (lines 17-21) will be interpreted as – when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, the first gas flow rate controller controls the flow rate of the first gas to be zero – and – when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, the second gas flow rate controller controls the flow rate of the second gas to be zero – based on paragraphs [0099] and [0114] of Applicant’s specification.
Claim 20 recites the limitation "the first flow rate-electric current curve" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is referencing the flow rate-electric current curve of the first gas flow rate controller recited in claim 12 (lines 18-19), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation of claim 20 will be interpreted as – the flow rate-electric current curve of the first gas flow rate controller – as recited in claim 12 (lines 18-19).
Claim 20 recites the limitation "the second flow rate-electric current curve" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is referencing the flow rate-electric current curve of the second gas flow rate controller recited in claim 12 (lines 20-21), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation of claim 20 will be interpreted as – the flow rate-electric current curve of the second gas flow rate controller – as recited in claim 12 (lines 20-21).
Claims 4-9 and 15-19 are rejected due to their dependency on a rejected claim.
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 1, 4, 7-9, 12, 15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Stenzler (US 20060207594 A1).
Regarding claim 1, Stenzler discloses a ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) applied to a high-frequency ventilation system (device 2; Fig. 1), wherein the high-frequency ventilation system (device 2; Fig. 1) comprises a gas source interface (20, 24; Fig. 1), an inspiratory branch (8; Fig. 1), a ventilation control device (36; Fig. 1), and a high-frequency pressure reduction module (10; Fig. 1), wherein the inspiratory branch (8; Fig. 1) comprises a first gas branch (gas flow branch of 20, see Annotated Fig. 1 below), a second gas branch (34; Fig. 1), a mixing branch (8 after the connection point of 34 and gas flow branch of 20, see Annotated Fig. 1 below), a first gas flow rate controller (30; Fig. 1) that generates a first high-frequency pulse flow rate ([0067], lines 3-6; [0067], lines 7-10) and is arranged at the first gas branch (Fig. 1), and a second gas flow rate controller (32; Fig. 1) that generates a second high-frequency pulse flow rate ([0069], lines 3-6; [0069], lines 6-10) and is arranged at the second gas branch (Fig. 1), wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) comprises:
determining a first gas flow rate control value of the first gas flow rate controller (30 control value for oxygen-containing gas according to desired inspiration flow profile and preset oxygen concentration, see [0031], [0037], second to last sentence of [0063], and [0094]) and a second gas flow rate control value of the second gas flow rate controller (32 control value for NO-containing gas according to desired inspiration flow profile and preset oxygen concentration, see [0031], [0037], second to last sentence of [0063], and [0094]) according to a target output flow rate and an oxygen concentration setting value ([0031], [0037], [0067], [0094], [0096]); and
determining whether the first gas flow rate control value falls within a first designated range of the first gas flow rate controller (30 and CPU 36 determine if flow rate of oxygen-containing gas falls within desired inspiration flow profile and if oxygen concentration of oxygen-containing gas falls within preset oxygen concentration, see [0031], [0037], [0067], [0094], [0096]) and determining whether the second gas flow rate control value falls within a second designated range of the second gas flow rate controller (32 and CPU 36 determine if flow rate of NO-containing gas falls within desired inspiration flow profile and if oxygen concentration of NO-containing gas falls within preset oxygen concentration, see [0031], [0037], [0067], [0094], [0096]), wherein: when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, the first gas flow rate controller controls the flow rate of the first gas to be zero ([0067][0083]; Figs. 3A-3B; Examiner’s Note: see 112b rejection of claim 1 above for interpretation of claim limitation); when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, the second gas flow rate controller controls the flow rate of the second gas to be zero ([0073]; [0079], lines 1-5; [0084]; Figs. 3A-3B; Examiner’s Note: see 112b rejection of claim 1 above for interpretation of claim limitation).
Stenzler fails to explicitly disclose wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) comprises:
maintaining the first gas flow rate controller turned on when it is determined that the first gas flow rate control value falls within the first designated range; and
maintaining the second gas flow rate controller turned on when it is determined that the second gas flow rate control value falls within the second designated range.
However, it would have been readily understood by one of ordinary skill in the art that prior to the effective filing date of the claimed invention, that the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) is capable of maintaining the first gas flow rate controller (30; Fig. 1) turned on if at least the concentration value of oxygen-containing gas (20; [0094]) is within the set-point oxygen concentration, and maintaining a second gas flow rate controller (32; Fig. 1) turned on if at least the concentration value of NO-containing gas (22; [0094]) is within the set-point NO concentration as Stenzler does disclose the CPU (36; Fig. 1) is capable of opening and/or closing the first control valve (30; Fig. 1) and the second control valve (32; Fig. 1) when a gas concentration falls outside of a set-point gas concentration ([0095]-[0096]).
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Regarding claim 4, Stenzler as modified teaches the invention as set forth in claim 1, wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
controlling the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10); and
controlling the first gas flow rate controller (30; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10).
Stenzler fails to explicitly disclose controlling the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10) when the first gas flow rate control value falls into the designated range and the second gas flow rate control value falls outside the second designated range; and controlling the first gas flow rate controller (30; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10), if the first gas flow rate control value falls outside the first designated range and the second gas flow rate control value falls into the second designated range.
However, Stenzler does disclose maintaining the first gas flow rate controller turned on, if the first gas flow rate control value falls into the first designated range (see claim 1 above) and adjusting the flow rate of the second gas (22) if the second gas flow rate control value falls outside of the second designated range ([0095], 2-7); and maintaining the second gas flow rate controller turned on, if the second gas flow rate control value falls into the second designated range (see claim 1 above) and adjusting the flow rate of the first gas (20) if the firs gas flow rate control value falls outside of the first designated range ([0096]). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the control method of Stenzler such that the control method explicitly teaches controlling the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10), if the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls outside the second designated range ([0094]; claim 1 above; [0095], lines 2-7, where if the concentration value of NO falls outside of the set-point concentration, the second control valve 32 is controlled; [0069], lines 3-10, where when the second control valve 32 is controlled, a high-frequency oscillation is generated); and controlling the first gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10), if the first gas flow rate control value falls outside the first designated range and the second gas flow rate control value falls into the second designated range ([0094]; claim 1 above; [0096], where if the concentrating of oxygen falls outside of the concentration value of oxygen-containing gas, the flow rate of the oxygen-containing gas 20 is adjusted; [0067], lines 3-10, where when the first control valve 30 is controlled, a high-frequency oscillation is generated) for successful ventilation of a patient.
Regarding claim 7, Stenzler as modified teaches the invention as set forth in claim 1, wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
controlling the first gas flow rate controller (30; Fig. 1) and the second gas flow rate controller (32; Fig. 1) to generate respective high-frequency pulse flow rates ([0067], lines 3-10; [0069], lines 3-10) when the first gas flow rate control value falls outside the first designated range ([0096], where if the concentrating of oxygen falls outside of the concentration value of oxygen-containing gas, the flow rate of the oxygen-containing gas 20 is adjusted; [0067], lines 3-10, where when the first control valve 30 is controlled, a high-frequency oscillation is generated) and the second gas flow rate control value falls outside the second designated range ([0095], lines 2-7, where if the concentration value of NO falls outside of the set-point concentration, the second control valve 32 is controlled; [0069], lines 3-10, where when the second control valve 32 is controlled, a high-frequency oscillation is generated).
Regarding claim 8, Stenzler as modified teaches the invention as set forth in claim 1, wherein the inspiratory branch (8; Fig. 1) is further provided with an oxygen concentration detector (46; Fig. 1; [0094], lines 5-9), which is configured to detect an oxygen concentration of an output gas of the inspiratory branch ([0094], lines 2-6);
wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
adjusting the first gas flow rate controller and the second gas flow rate controller according to the oxygen concentration of the output gas of the inspiratory branch and a target oxygen concentration ([0096], where the flow rate of the oxygen-containing gas is adjusted via the first control valve 30, see [0067], lines 3-10; [0069], lines 3-10, where the flow rate of NO is adjusted via the second control valve 32) when the oxygen concentration of the output gas of the inspiratory branch is detected by the oxygen concentration detector fails to reach the target oxygen concentration ([0096]).
Regarding claim 9, Stenzler as modified teaches the invention as set forth in claim 8, wherein adjusting the first gas flow rate controller and the second gas flow rate controller according to the oxygen concentration of the output gas of the inspiratory branch and a target oxygen concentration ([0096], where the flow rate of the oxygen-containing gas is adjusted via the first control valve 30, see [0067], lines 3-10; [0069], lines 3-10, where the flow rate of NO is adjusted via the second control valve 32), comprises:
adjusting the first gas flow rate controller and the second gas flow rate controller according to the oxygen concentration of the output gas of the inspiratory branch and the target oxygen concentration ([0096], where the flow rate of the oxygen-containing gas is adjusted via the first control valve 30, see [0067], lines 3-10; [0069], lines 3-10, where the flow rate of NO is adjusted via the second control valve 32), based on a preset adjustment rule ([0096], lines 2-3, where the set-point oxygen concentration is a preset range of oxygen concentration values for use as determination factors in the adjustment method of the first control valve 30 and the second control valve 32).
Regarding claim 12, Stenzler discloses a high-frequency ventilation system (device 2; Fig. 1) comprising:
a gas source interface (20, 24; Fig. 1);
an inspiratory branch (8; Fig. 1);
a ventilation control device (36; Fig. 1); and
a high-frequency pressure reduction module (10; Fig. 1),
wherein the inspiratory branch (8; Fig. 1) comprises: a first gas branch (gas flow branch of 20, see Annotated Fig. 1 below), a second gas branch (34; Fig. 1), a mixing branch (8 after the connection point of 34 and gas flow branch of 20, see Annotated Fig. 1 below), a first gas flow rate controller (30; Fig. 1) which generates a first high-frequency pulse flow rate ([0067], lines 3-6; [0067], lines 7-10) and is arranged at the first gas branch (Fig. 1), and a second gas flow rate controller (32; Fig. 1) which generates a second high-frequency pulse flow rate ([0069], lines 3-6; [0069], lines 6-10) and is arranged at the second gas branch (Fig. 1), wherein the ventilation control device (36; Fig. 1) is configured to:
determine a first gas flow rate control value of the first gas flow rate controller (30 control value for oxygen-containing gas according to desired inspiration flow profile and preset oxygen concentration, see [0031], [0037], second to last sentence of [0063], and [0094]) and a second gas flow rate control value of the second gas flow rate controller (32 control value for NO-containing gas according to desired inspiration flow profile and preset oxygen concentration, see [0031], [0037], second to last sentence of [0063], and [0094]) according to a target output flow rate and an oxygen concentration setting value ([0031], [0037], [0067], [0094], [0096]); and
determine whether the first gas flow rate control value falls within a first designated range of the first gas flow rate controller (30 and CPU 36 determine if flow rate of oxygen-containing gas falls within desired inspiration flow profile and if oxygen concentration of oxygen-containing gas falls within preset oxygen concentration, see [0031], [0037], [0067], [0094], [0096]) and determining whether the second gas flow rate control value falls within a second designated range of the second gas flow rate controller (32 and CPU 36 determine if flow rate of NO-containing gas falls within desired inspiration flow profile and if oxygen concentration of NO-containing gas falls within preset oxygen concentration, see [0031], [0037], [0067], [0094], [0096]), wherein: when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, the first gas flow rate controller controls the flow rate of the first gas to be zero ([0067][0083]; Figs. 3A-3B; Examiner’s Note: see 112b rejection of claim 1 above for interpretation of claim limitation); when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, the second gas flow rate controller controls the flow rate of the second gas to be zero ([0073]; [0079], lines 1-5; [0084]; Figs. 3A-3B; Examiner’s Note: see 112b rejection of claim 1 above for interpretation of claim limitation).
Stenzler fails to explicitly disclose wherein the ventilation control device (36; Fig. 1) is configured to:
maintain the first gas flow rate controller turned on when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller; and
maintain the second gas flow rate controller turned on when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller.
However, it would have been readily understood by one of ordinary skill in the art that prior to the effective filing date of the claimed invention, that the ventilation control device (36; Fig. 1) is capable of maintaining the first gas flow rate controller (30; Fig. 1) turned on if at least the concentration value of oxygen-containing gas (20; [0094]) is within the set-point oxygen concentration, and maintaining a second gas flow rate controller (32; Fig. 1) turned on if at least the concentration value of NO-containing gas (22; [0094]) is within the set-point NO concentration as Stenzler does disclose the CPU (36; Fig. 1) is capable of opening and/or closing the first control valve (30; Fig. 1) and the second control valve (32; Fig. 1) when a gas concentration falls outside of a set-point gas concentration ([0095]-[0096]).
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Regarding claim 15, Stenzler as modified teaches the invention as set forth in claim 12, wherein the ventilation control device (36; Fig. 1) is further configured to:
control the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10); and
control the first gas flow rate controller (30; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10).
Stenzler fails to explicitly disclose controlling the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10) when the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls outside the second designated range; and controlling the first gas flow rate controller (30; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10) when the first gas flow rate control value falls outside the first designated range and the second gas flow rate control value falls into the second designated range.
However, Stenzler does disclose maintaining the first gas flow rate controller turned on, if the first gas flow rate control value falls into the first designated range (see claim 12 above) and adjusting the flow rate of the second gas (22) if the second gas flow rate control value falls outside of the second designated range ([0095], 2-7); and maintaining the second gas flow rate controller turned on, if the second gas flow rate control value falls into the second designated range (see claim 12 above) and adjusting the flow rate of the first gas (20) if the firs gas flow rate control value falls outside of the first designated range ([0096]). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the ventilation control device (36; Fig. 1) of Stenzler such that the ventilation control device (36; Fig. 1) is explicitly configured to: control the second gas flow rate controller (32; Fig. 1) to generate high-frequency oscillation ([0069], lines 3-10) when the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls outside the second designated range ([0094]; claim 12 above; [0095], lines 2-7, where if the concentration value of NO falls outside of the set-point concentration, the second control valve 32 is controlled; [0069], lines 3-10, where when the second control valve 32 is controlled, a high-frequency oscillation is generated); and control the first gas flow rate controller (30; Fig. 1) to generate high-frequency oscillation ([0067], lines 3-10) when the first gas flow rate control value falls outside the first designated range and the second gas flow rate control value falls into the second designated range ([0094]; claim 12 above; [0096], where if the concentrating of oxygen falls outside of the concentration value of oxygen-containing gas, the flow rate of the oxygen-containing gas 20 is adjusted; [0067], lines 3-10, where when the first control valve 30 is controlled, a high-frequency oscillation is generated) for successful ventilation of a patient.
Regarding claim 18, Stenzler as modified teaches the invention as set forth in claim 12, wherein the ventilation control device is further configured to:
control the first gas flow rate controller (30; Fig. 1) and the second gas flow rate controller (32; Fig. 1) to generate respective high-frequency pulse flow rates ([0067], lines 3-10; [0069], lines 3-10) when the first gas flow rate control value falls outside the first designated range ([0096], where if the concentrating of oxygen falls outside of the concentration value of oxygen-containing gas, the flow rate of the oxygen-containing gas 20 is adjusted; [0067], lines 3-10, where when the first control valve 30 is controlled, a high-frequency oscillation is generated) and the second gas flow rate control value falls outside the second designated range ([0095], lines 2-7, where if the concentration value of NO falls outside of the set-point concentration, the second control valve 32 is controlled; [0069], lines 3-10, where when the second control valve 32 is controlled, a high-frequency oscillation is generated).
Regarding claim 19, Stenzler as modified teaches the invention as set forth in claim 12, wherein the inspiratory branch (8; Fig. 1) is further provided with an oxygen concentration detector (46; Fig. 1; [0094], lines 5-9), which is configured to detect an oxygen concentration of an output gas of the inspiratory branch ([0094], lines 2-6);
wherein the ventilation control device (36; Fig. 1) is further configured to:
adjust the first gas flow rate controller and the second gas flow rate controller based on a preset adjustment rule, according to the oxygen concentration of the output gas of the inspiratory branch and a target oxygen concentration ([0096], where the flow rate of the oxygen-containing gas is adjusted via the first control valve 30, see [0067], lines 3-10, and where the set-point oxygen concentration is a preset range of oxygen concentration values for use as determination factors in the adjustment method of the first control valve 30 and the second control valve 32; [0069], lines 3-10, where the flow rate of NO is adjusted via the second control valve 32) when the oxygen concentration of the output gas of the inspiratory branch which is detected by the oxygen concentration detector fails to reach the target oxygen concentration ([0096]).
Claims 5-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Stenzler as applied to claims 1 and 12 above, and further in view of Sugiura (JP 2001/120660 A).
Regarding claim 5, Stenzler as modified teaches the invention as set forth in claim 1, but fails to explicitly disclose wherein the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
controlling the high-frequency pressure reduction module (10; Fig. 1) to generate high-frequency oscillation when the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls into the second designated range.
However, Sugiura teaches a ventilation adjustment method with an oscillating air pressure urging unit (50; Fig. 5) including a blower (52; Fig. 5) and flow rate regulating valve (607; Fig. 5) to generate a high-frequency oscillation ([0042], see provided translation), where the blower (52; Fig. 5) and the flow rate regulating valve (607; Fig. 5) are controlled according to preset operating conditions ([0062]-[0063]; [0065], see provided translation). Sugiura further teaches when gas flow concentrations are within a preset concentration value ([0065]-[0066], see provided translation), the exhaled air flows through an endotracheal tube (81) toward an exhaust path (70) to be discharged to the atmosphere ([0068], see provided translation), where a blower (52) is used to encourage the exhaled gas to move out of the endotracheal tube even if inhaled air is still being supplied to the lungs ([0068], see provided translation). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the high-frequency pressure reduction module of Stenzler with the oscillating air pressure urging unit of Sugiura such that the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
controlling the high-frequency pressure reduction module (Sugiura: 50; Fig. 5) to generate high-frequency oscillation (Sugiura: [0042], see provided translation) when the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls into the second designated range (Sugiura: [0065]-[0066], see provided translation; [0068], see provided translation) to ensure the exhaled gas is discharged from a patient interface, even if inhaled air is still being supplied to the lungs (Sugiura: [0068], see provided translation).
Regarding claim 6, Stenzler as modified teaches the invention as set forth in claim 5, wherein the high-frequency pressure reduction module (Sugiura: 50; Fig. 5) comprises a high-frequency valve (Sugiura: 607; Fig. 5) and a turbine (Sugiura: 52; Fig. 5);
wherein controlling the high-frequency pressure reduction module to generate high-frequency oscillation (see claim 5 above), comprises:
controlling the high-frequency valve and the turbine to generate the high-frequency oscillation according to a preset high-frequency oscillation frequency ([0062]-[0063]; [0065], see provided translation).
Regarding claim 16, Stenzler as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein the ventilation control device (36; Fig. 1) is further configured to:
control the high-frequency pressure reduction module to generate high-frequency oscillation when the first gas flow rate control value falls into the first dead designated and the second gas flow rate control value falls into the second designated range.
However, Sugiura teaches a ventilation controller to control and adjust an oscillating air pressure urging unit (50; Fig. 5) including a blower (52; Fig. 5) and flow rate regulating valve (607; Fig. 5) to generate a high-frequency oscillation ([0042], see provided translation), where the blower (52; Fig. 5) and the flow rate regulating valve (607; Fig. 5) are controlled according to preset operating conditions ([0062]-[0063]; [0065], see provided translation). Sugiura further teaches when gas flow concentrations are within a preset concentration value ([0065]-[0066], see provided translation), the exhaled air flows through an endotracheal tube (81) toward an exhaust path (70) to be discharged to the atmosphere ([0068], see provided translation), where a blower (52) is used to encourage the exhaled gas to move out of the endotracheal tube even if inhaled air is still being supplied to the lungs ([0068], see provided translation). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify replace the high-frequency pressure reduction module of Stenzler with the oscillating air pressure urging unit of Sugiura such that the ventilation control device (36; Fig. 1) is further configured to:
control the high-frequency pressure reduction module (Sugiura: 50; Fig. 5) to generate high-frequency oscillation (Sugiura: [0042], see provided translation) when the first gas flow rate control value falls into the first designated range and the second gas flow rate control value falls into the second designated range (Sugiura: [0065]-[0066], see provided translation; [0068], see provided translation) to ensure the exhaled gas is discharged from a patient interface, even if inhaled air is still being supplied to the lungs (Sugiura: [0068], see provided translation).
Regarding claim 17, Stenzler as modified teaches the invention as set forth in claim 16, wherein the high-frequency pressure reduction module comprises a high-frequency valve and a turbine module (Sugiura: 50; Fig. 5) comprises a high-frequency valve (Sugiura: 607; Fig. 5) and a turbine (Sugiura: 52; Fig. 5);
the ventilation control device (36; Fig. 1) is further configured to:
control the high-frequency valve and the turbine to generate the high-frequency oscillation according to a preset high-frequency oscillation frequency ([0062]-[0063]; [0065], see provided translation).
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stenzler as applied to claims 1 and 12 above, and further in view of Jin (CN 102266630 A) in view of Cewers (US 2008/0092891 A1).
Regarding claim 11, Stenzler as modified teaches the invention as set forth in claim 1, but is silent to the ventilation adjustment method further comprises: obtaining the first flow rate-electric current curve of the first gas flow rate controller and the second flow rate-electric current curve of the second gas flow rate controller.
However, Jin teaches a ventilation system with two proportional valves, where the opening degree of the two proportional valves affects oxygen concentration of an output gas ([0004], see provided translation). Jin further teaches when one or both of the proportional valves is not capable of providing the required flow rate, a control method of the proportional valves based at least on oxygen concentration will adjust the opening degree of the proportional valves such that the desired flow rate may be achieved ([0004], see provided translation). Jin also teaches a method for controlling a ventilator, where the relationship between the opening degree and the flow rate of the proportional valves is acquired ([0009], see provided translation), wherein the opening degree of the proportional valve is adjusted if an oxygen concentration value is not within a preset oxygen concentration value ([0009], see provided translation). Additionally, Jin teaches the opening degree and flow rate of the air proportional valves can be graphed ([0032], see provided translation; Fig. 2).
Jin does not explicitly teach a relationship between the flow rate and electric current of the proportional valves.
However, Cewers teaches the amount a proportional valve is open is determined by the current flowing through an electromagnet ([0005], lines 5-12, where an electromagnet is a component of a proportional valve). Hence, it would be obvious to one of ordinary skill in the art to obtain a flow rate-electric current curve of a gas flow rate controller when provided the data for the flow rate and the opening degree of the gas flow rate controller (Jin: [0032], see provided translation; Fig. 2; Cewers: [0005], lines 5-12, where an electromagnet is a component of a proportional valve). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Stenzler with Jin and Cewers such that the ventilation adjustment method (adjustment method of device 2, where device 2 can be used for ventilation; [0094]-[0097]) further comprises:
obtaining the first flow rate-electric current curve of the first gas flow rate controller (obtain flow rate electric-current curve of the first gas flow rate controller 30 with data of first gas flow rates and opening degree of first gas flow rate controller 30, see [0032] of provided translation of Jin and [0005], lines 5-12 of Cewers, where an electromagnet is a component of a proportional valve) and the flow rate-electric current curve of the second gas flow rate controller (obtain flow rate electric-current curve of the second gas flow rate controller 32 with data of second gas flow rates and opening degree of second gas flow rate controller 32, see [0032] of provided translation of Jin and [0005], lines 5-12 of Cewers, where an electromagnet is a component of a proportional valve).
Regarding claim 20, Stenzler as modified teaches the invention as set forth in claim 12, wherein the ventilation control device is further configured to:
obtain a flow rate-electric current curve of the first gas flow rate controller (obtain flow rate electric-current curve of the first gas flow rate controller 30 with data of first gas flow rates and opening degree of first gas flow rate controller 30, see [0032] of provided translation of Jin and [0005], lines 5-12 of Cewers, where an electromagnet is a component of a proportional valve) and a flow rate-electric current curve of the second gas flow rate controller (obtain flow rate electric-current curve of the second gas flow rate controller 32 with data of second gas flow rates and opening degree of second gas flow rate controller 32, see [0032] of provided translation of Jin and [0005], lines 5-12 of Cewers, where an electromagnet is a component of a proportional valve).
Response to Arguments
On page 10 of the Remarks filed on 02/02/2026, Applicant argues Stenzler fails to disclose determining gas flow rate control values of gas flow controllers, as recited amended independent claim 1. However, Stenzler does disclose a first gas flow controller (30) and a second gas flow rate controller (32), where the first gas flow controller (30) controls a flow rate of oxygen-containing gas according to a received signal from CPU (36) that is based on a desired inspiration flow profile ([0031] and [0037]). Similarly, the second gas flow rate controller (32) taught by Stenzler controls a flow rate of NO-containing gas to determine a flow rate according to a received signal from CPU (36) that is based on a desired inspiration flow profile ([0031] and [0037]). Stenzler further teaches the oxygen-containing gas has a preset oxygen concentration (second to last sentence of [0063]). Hence, the first gas flow controller (30) and the second gas flow rate controller (32) has a first gas flow rate control value and a second gas flow rate control value, respectively, that are determined according to a desired inspiration flow profile and a preset oxygen concentration (Stenzler [0031], [0037], [0067], [0094], [0096]).
Therefore, Applicant's arguments with respect to Stenzler failing to disclose determining gas flow rate control values of gas flow controllers, as recited amended independent claim 1, are not persuasive.
On page 11 of the Remarks, Applicant argues Stenzler fails to disclose determining whether the gas flow rate control values fall within designated ranges as recited in amended claim 1. However, Stenzler does disclose determining if gas flow rate control values (oxygen-containing gas flow rate, NO-containing gas flow rate, and oxygen concentration, see Stenzler [0031], [0037], [0063]) fall within designated ranges (desired inspiration flow profile and preset oxygen concentration, see Stenzler [0031], [0037], [0067], [0094], [0096]; see rejection of amended claim 1 under 103 above).
Therefore, Applicant's arguments with respect to Stenzler failing to disclose determining whether the gas flow rate control values fall within designated ranges, as recited amended independent claim 1, are not persuasive.
On pages 11-12 of the Remarks, Applicant argues Stenzler, Jin, and Cewers fail to disclose a flow rate-electric current curve, and that the flow rate-electric current curve becomes nonlinear when the gas flow rate control values fall within their designated ranges of the respective gas flow rate controller, as recited in amended claim 1. Applicant’s arguments with respect to claim 1, as amended, have been considered but are moot because the amendment of “…when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, a flow rate-electric current curve of the first gas flow rate controller becomes nonlinear; when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, a flow rate- electric current curve of the second gas flow rate controller becomes nonlinear…” (amended claim 1, lines 15-19) necessitates new grounds of rejection. While Applicant provided specification paragraphs [0099] and [0114] to support the amendment of claim 1, the scope of the amendment (e.g., the flow rate controllers become nonlinear with the flow rate control values fall within respective designated ranges of the flow rate controllers) is unclear (see 112b rejection of claims 1 and 12 above). As such, the above limitations will be interpreted as – when the first gas flow rate control value falls within the first designated range of the first gas flow rate controller, the first gas flow rate controller controls the flow rate of the first gas to be zero – and – when the second gas flow rate control value falls within the second designated range of the second gas flow rate controller, the second gas flow rate controller controls the flow rate of the second gas to be zero – based on paragraphs [0099] and [0114] of Applicant’s specification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Burgess & Huang (US 20190240432 A1): Regarding a gases flow rate sensing system with a graph depicting a relationship between an output voltage and a flow rate.
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.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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