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(s) filed on 11/14/2023, 02/28/2024, 11/21/2024, and 02/02/2026 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-8, in the reply filed on 04/22/2026 is acknowledged. Claim 9-13 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/22/2026.
As such, claims 1-8 are being examined in the current application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The term “first reference value” of claims 2, 4, 10, and 12-13 invoke 112(f). The specification cites “A dimension or unit of the first reference value may be set according to a type of a physical quantity (a pressure, a flow rate, or a flow velocity) to be detected by the air flow sensor 14 (see [0171])” and “The first reference value may be used as a value for determining whether a user starts inhalation by using the powder inhalation device 1. The first reference value may be set as a value for detecting the user's inhalation intention (see [0172]).” For examination purposes, as best understood, the first reference value is a type of physical quantity (a pressure, a flow rate, or a flow velocity) detected by an air flow sensor.
The term “second reference value” of claims 3, 5 and 11 invoke 112(f). The specification cites “…the controller 20 may determine a second reference value for operating the powder diffuser 15 based on the maximum value of the physical quantity of the air flow in the air flow passage 13 (see [0163])” and further discusses the second reference value to be proportional to maximum value of the physical quantity of the pressure, flow rate and/or the flow velocity and therefore the second reference value may be determined to be proportional to the user’s inhalation ability as seen in [0183]-[0192] and [0254]. For examination purposes, as best understood, the second reference value is either proportional to a maximum value of the pressure, flow rate and/or the flow velocity or proportional to the user’s inhalation ability.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stangl (US 20030164169 A1).
Regarding claim 1, Stangl teaches a powder inhalation device (Stangl teaches an inhalation device with medicament 6 in the form of powder as seen in Figs. 1-3C and [0024]) comprising:
a storage tank (storage container 8, see Fig. 1) configured to store a medium in a powder form (storage container 8 stores medicament 6 in the form of powder that is then placed on membrane 5 as seen in Figs. 1 and 3A-3C and see [0024]);
a powder loading unit (membrane 5, see Fig. 1) configured to receive the medium from the storage tank (storage container 8 stores medicament 6 in the form of powder that is then placed on membrane 5 as seen in Figs. 1-3C and see [0024]);
an air flow passage through which an air flow comprising a mixture of air and the medium transferred to the powder loading unit flows (there is an air flow passage in which an airflow comprising a mixture of ambient air from inhalation valve 3 and medicament 6 flows through mixing chamber 2 and out through mouthpiece 9 as seen in Figs. 3A-3C and [0027] and [0030]);
an air flow sensor (sensor 100, see Fig. 1) configured to detect a change in the air flow of the air flow passage (sensor 100 detects the respiratory flow rate and emits a signal to a control means 101 to indicate the end of exhalation and the beginning of inhalation as seen in [0029], therefore detecting a change in the respiratory flow rate);
a powder diffuser (oscillator 1, see Fig. 1) configured to diffuse the medium transferred to the powder loading unit toward the air flow passage (“If the oscillator 1 is activated, the membrane 5 starts to oscillate. The oscillation of the membrane 5 is transferred, as shown in FIG. 2B, to the medicament in the form of a powder which is at least partially deagglomerated and disperses as a particle cloud 6a above the membrane 5 in the mixing chamber 2.” See [0025] and Figs. 2A-2C); and
a controller (control means 101, see Fig. 1) configured to receive a signal from the air flow sensor, and operate the powder diffuser based on the change in the air flow of the air flow passage (sensor 100 detects the respiratory flow rate and emits a signal to a control means 101 to activate the oscillator 1 if a respiratory flow rate is detected to indicate the end of exhalation and the beginning of inhalation as seen in [0029]).
Regarding claim 6, Stangl teaches the device of claim 1, and further teaches wherein the powder loading unit comprises a vibration plate (membrane 5, see Fig. 1) configured to vibrate the medium, and the powder diffuser comprises a vibration device (oscillator 1, see Fig. 1) configured to diffuse the medium transferred to the powder loading unit toward the air flow passage by vibrating the vibration plate (“If the oscillator 1 is activated, the membrane 5 starts to oscillate. The oscillation of the membrane 5 is transferred, as shown in FIG. 2B, to the medicament in the form of a powder which is at least partially deagglomerated and disperses as a particle cloud 6a above the membrane 5 in the mixing chamber 2.” See [0025] and Figs. 2A-2C).
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stangl (US 20030164169 A1) in view of Abrams (JP 2008132362 A; machine translated 7/10/2026).
Regarding claim 2, Stangl teaches the device of claim 1, and further teaches wherein
the air flow sensor is further configured to detect a physical quantity of at least one of a pressure, a flow rate, and a flow velocity of the air flow of the air flow passage (sensor 100 detects the respiratory flow rate of the air flow as seen in Fig. 1 and [0029])
and further teaches sensor 100 detects the respiratory flow rate and emits a signal to a control means 101 to indicate the end of exhalation and the beginning of inhalation as seen in [0029]
but does not teach the controller is further configured to, when a detection value of the physical quantity detected by the air flow sensor is equal to or greater than a first reference value, obtain a maximum value of the physical quantity of the air flow of the air flow passage based on the signal of the air flow sensor.
However, Gumaste teaches the controller (inspiratory volume processor 238 and high frequency vibrator controller 244, see Fig. 14) is further configured to, when a detection value of the physical quantity detected by the air flow sensor (air flow detection device 208, see Fig. 12 and [0052]-[0054]) is equal to or greater than a first reference value, obtain a maximum value of the physical quantity of the air flow of the air flow passage based on the signal of the air flow sensor (Gumaste teaches microphone 208 sending a signal 248 that is responsive to the detected airflow 210 and the signal 248 is used to control various components of the inhaler 202 as seen in [0052]-[0055]. Gumaste further teaches inhalation volume processor 238 to calculate the peak of the inhalation flow 210 from the signals 248 by the patient as seen in [0056]. Therefore, when an airflow is detected at a value by the microphone 208, inhalation volume processor 238 calculates the peak inhalation of the air flow due to the signal 248 from microphone 208).
Stangl teaches control means 101 to activate oscillator 1 if the respiratory flow rate detected by the sensor 100 indicates the end of exhalation and beginning of inhalation as seen in [0029]. As such, there is a value or threshold that will indicate the end of exhalation and beginning of inhalation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Stangl to include the controller to use the signal values to calculate the peak of the inhalation flow as taught by Gumaste to have the processor activate the vibrator right before peak inhalation for optimal inhalation absorption of the drug (see [0056]).
Regarding claim 3, Stangl in view of Gumaste teaches the device of claim 2, and further teaches wherein the controller is further configured to:
determine a second reference value for operating the powder diffuser, based on the maximum value of the physical quantity of the air flow of the air flow passage (Gumaste teaches the inhalation volume processor 238 calculating the peak of the inhalation flow 210 based on signals 248 by the patient and using the information to adjust threshold signals from the high frequency vibrator threshold generating member 242 as seen in [0056]. Stangl in view of Gumaste will have oscillator 1 (taught by Stangl) to have the threshold based on the peak of the inhalation flow as taught by Gumaste), and
operate the powder diffuser when the detection value of the air flow detected by the signal of the air flow sensor is equal to or greater than the second reference value, and
stop an operation of the powder diffuser when the detection value of the air flow detected by the signal of the air flow sensor is less than the second reference value (Gumaste teaches processor 238 operating the vibrator at the timing right before the peak inhalation by the user as seen in [0056]. The detected signal 248 from microphone 208 is equal to or greater than the threshold for the high frequency vibrator threshold generating member 242 and activates the vibrator as seen in [0052]-[0056]. Furthermore, when the peak inhalation is complete and the signal 248 is less than the threshold, the vibrator will stop. Stangl in view of Gumaste will have processor 238 of Gumaste operate oscillator 1 of Stangl to oscillate right before peak inhalation when the detected signal from sensor 101 is equal to or greater than the threshold based on the peak. Similarly, after the peak inhalation is completed, and the signal is less than the threshold, oscillator 1 will stop).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stangl (US 20030164169 A1) in view of Denyer (US 20060243277 A1).
Regarding claim 4, Stangl teaches the device of claim 1, and further teaches wherein
the air flow sensor is further configured to detect a physical quantity of at least one of a pressure, a flow rate, and a flow velocity of the air flow in the air flow passage (sensor 100 detects the respiratory flow rate of the air flow as seen in Fig. 1 and [0029])
and further teaches sensor 100 detects the respiratory flow rate and emits a signal to a control means 101 to indicate the end of exhalation and the beginning of inhalation as seen in [0029]
but does not teach the controller is further configured to measure an inhalation maintenance time for which a detection value of the physical quantity detected by the signal of the air flow sensor is maintained at or above a first reference value.
However, Denyer teaches the controller (processor 20, see Fig. 4) is further configured to measure an inhalation maintenance time for which a detection value of the physical quantity detected by the signal of the air flow sensor (airflow detector 18, see Fig. 4 and [0038]) is maintained at or above a first reference value (Denyer teaches processor 20 to read the airflow detector 18 to check whether or not inhalation has started as seen in Fig. 6 and [0046]. Denyer further teaches measuring a patient’s breathing including the inhalation based on the detection from airflow detector 18 as seen in Fig. 7 and [0036], [0040] and [0049]-[0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Stangl to include the processor to measure inhalation time based on detection as taught by Denyer to have the device adapt to a person’s breathing pattern to have reduction in treatment times (see [0061]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stangl (US 20030164169 A1) in view of Denyer (US 20060243277 A1), as applied to claim 4 above, and further in view of Davidson (US 20170119981 A1) and Abrams (US 6026809 A).
Regarding claim 5, Stangl discloses operating the powder diffuser when the detection value of the air flow is detected by the signal of the air flow sensor (Stangl teaches control means 101 to activate oscillator 1 if the respiratory flow rate detected by the sensor 100 indicates the end of exhalation and beginning of inhalation as seen in [0029]. As such, Stangl teaches operating oscillator 1 in response to a detected airflow value). Stangl in view of Denyer is silent to the controller further configured to: determine a second reference value for operating the powder diffuser, based on the inhalation maintenance time, operate the powder diffuser when the detection value of the air flow detected by the signal of the air flow sensor is equal to or greater than the second reference value, and stop an operation of the powder diffuser when the detection value is less than the second reference value.
Davidson teaches determining a reference value for operating an inhaler device, based on the inhalation maintenance time (Davidson teaches inhalation is detected when the measured inhalation flow rate is above a predefined threshold and the threshold is equal to the value that is to be maintained for a targets flow pattern as seen in [0135]. Davidson further teaches an increased flow rate based on a user’s inhalation time as seen in [0162]. As such, Davidson teaches determining a threshold for inhalation control based on inhalation-related timing considerations and adjusting inhalation flow parameters based on the user’s inhalation time. Accordingly, Davidson teaches selecting or determining a reference value for inhalation operation based on inhalation duration or maintenance time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the operation of the powder diffuser, as taught by Stangl in view of Denyer, to include the second reference value based on the inhalation maintenance time, as taught by Davidson to determine a second reference value for operating the powder diffuser, based on the inhalation maintenance time, operate the powder diffuser when the detection value of the air flow detected by the signal of the air flow sensor is equal to or greater than the second reference value as Davidson teaches using inhalation timing to set or adjust a threshold for inhalation control for the purpose of adjusting parameters based on the user’s inhalation ability (see Davidson [0162]). Therefore, modified Stangl teaches operating oscillator 1 of Stangl to measure an inhalation maintenance time (as taught by Denyer) and to determine parameters such as flow rate (taken as second reference value) based on inhalation time as taught by Davidson.
Stangl in view of Denyer and Davidson fails to disclose stopping an operation of the powder diffuser when the detection value is less than the second reference value.
However, Abrams teaches stopping an operation of the powder diffuser when the detection value is less than the reference value (“The vibrator in this second embodiment may comprise a piezoelectric vibrator. Additionally, the controller of this second embodiment may control the vibrator by automatically actuating the vibrator when the at least one detected characteristic of the gas stream has a magnitude that exceeds a minimum threshold value therefor indicative of inhalation by the user, and by automatically deactivating the vibrator when the magnitude of the at least one detected characteristic is less then the minimum threshold.” See Col. 4, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Stangl to stop an operation of the powder diffuser when the detection value is less than the reference value as taught by Abrams to have the powder diffuser be deactivated when the user is not optimally inhaling above the detection value to avoid unnecessary operation and conserve power.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stangl (US 20030164169 A1) in view of Hodson (US 5469843 A).
Regarding claim 7, Stangl teaches the device of claim 1, but does not teach wherein the powder diffuser comprises an impact device configured to diffuse the medium transferred to the powder loading unit toward the air flow passage by applying physical impact to the powder loading unit.
However, Hodson teaches wherein the powder diffuser (impaction mechanism 28 and hammer 30, see Fig. 1) comprises an impact device (hammer 30, see Fig. 1) configured to diffuse the medium transferred to the powder loading unit (elongate carrier 14, see Fig .1) toward the air flow passage by applying physical impact to the powder loading unit (Hodson teaches area 24 of elongate carrier 14 struck by hammer 30 which is driven by a spring to assist the release of medicament 26 into the developing airstream as seen in Fig. 1 and Col. 5, lines 10-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Stangl to replace the powder diffuser with the impaction mechanism and hammer as taught by Hodson as an alternative mechanism to aid in dispensing medicament into the airflow.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stangl (US 20030164169 A1) in view of Morrison (US 20170209655 A1).
Regarding claim 8, Stangl teaches the device of claim 1, but does not teach wherein the powder diffuser comprises a blower configured to diffuse the medium transferred to the powder loading unit toward the air flow passage by generating a flow of air.
However, Morrison teaches wherein the powder diffuser (synthetic jet blower 510 and piezo 511, see Fig. 5) comprises a blower (synthetic jet blower 510, see Fig. 5 and [0081]) configured to diffuse the medium transferred to the powder loading unit (membrane or diaphragm 513, see Fig. 5) toward the air flow passage by generating a flow of air (Morrison teaches using both piezo 511 and synthetic jet blower 510 to de-agglomerate dry powder medicament in an inhaler and to direct airflow out through outlet 514 as seen in [0045]-[0046] and [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Stangl to include a blower as taught by Morrison as a known additional de-agglomerating structure for a dry powder inhaler (see [0045]-[0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Suzuki (US 20180007960 A1) teaches a flavored inhaler with start and end threshold values.
Morrison (US 20170274162 A1) teaches a dry powder inhaler with a breath detection system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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