DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to a preliminary amendment filed on 3/11/2026. As directed by the preliminary amendment, claims 1-34 were canceled, no claims were amended, and claims 35-68 were added. Thus, claims 35-68 are pending for this application.
Claim Warning
Applicant is advised that should claim 52 be found allowable, claim 53 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 35-39 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 35 recites the limitation "the air oscillations" in line 7. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 65 and 66 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claims 65 and 66 do not further limit claim 62, from which they depend, due to containing subject matter that has been previously claimed by upstream claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 35-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gutmark-Little (US 2020/0338288).
Regarding claim 35, Gutmark-Little discloses (Figs. 1-6) a device for the removal of mucus from airways, the device comprising:
a housing (casing of acoustic system 33) defining an air passage (passage shown in Fig. 1 through housing of system 33);
an air supply (air supply 24) communicatively coupled to the air passage of the housing (see Fig. 1), the air supply configured to provide air to the air passage of the housing (paragraph [0070]); and
an acoustic generator (speaker 58, paragraph [0073]) coupled to the housing, the acoustic generator configured to provide acoustic oscillations to the housing (paragraph [0073]);
wherein a combination of the air oscillations (via solenoid valve, paragraph [0071]) and the acoustic oscillations is configured to penetrate a mucus plug positioned in an airway of a patient within 10 seconds (penetration occurs within 10 seconds shown in Figs. 16A-16D (i.e. in Fig. 16A when speaker fraction % is 80%)).
Regarding claim 36, Gutmark-Little discloses an air oscillation device (solenoid valve 28) to provide air oscillations to the air passage of the housing (paragraphs [0071] and [0074]).
Regarding claim 37, Gutmark-Little discloses the air oscillation device comprises one of a flow pulsating element operably coupled to the air supply (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]).
Regarding claim 38, Gutmark-Little discloses a first configuration provides for penetrating a mucus plug positioned in the airway of the patient (i.e. 300bpm/300Hz, para [0093]-[0094]), the first configuration comprising a first air oscillation rate and a first acoustic oscillation rate (paragraphs [0093]-[0094]); and a second configuration provides for removing mucus from the airway of the patient (i.e. 400bpm/400Hz, paragraph [0095]) the second configuration comprising a second air oscillation rate and a second acoustic oscillation rate (paragraph [0095]).
Regarding claim 39, Gutmark-Little discloses the housing includes a nozzle (mouthpiece 62); and a combination of the air oscillations and the acoustic oscillations form a synthetic jet of air upon exiting the nozzle of the housing (paragraphs [0074] and [0077]).
Regarding claim 40, Gutmark-Little discloses (Figs. 1-6) a device for the removal of mucus from airways, the device comprising:
a housing (casing of acoustic system 33) defining an air passage (passage shown in Fig. 1 through housing of system 33);
an air supply assembly communicatively coupled to the air passage of the housing, the air supply assembly comprising an air supply (air supply 24) and a flow pulsating element (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]), and
an acoustic generator (speaker 58, paragraph [0073]) coupled to the housing, the acoustic generator configured to provide acoustic oscillations to the housing (paragraph [0073]);
wherein the device has a first configuration for penetrating a mucus plug positioned in the airway of the patient (i.e. 300bpm/300Hz, para [0093]-[0094]), the first configuration comprising a first air oscillation rate and a first acoustic oscillation rate (paragraphs [0093]-[0094]); and a second configuration for removing mucus from the airway of the patient (i.e. 400bpm/400Hz, paragraph [0095]) the second configuration comprising a second air oscillation rate and a second acoustic oscillation rate (paragraph [0095]).
Regarding claim 41, Gutmark-Little discloses wherein a combination of the air oscillations and the acoustic oscillations is configured to penetrate a mucus plug positioned in an airway of a patient within 10 seconds (penetration occurs within 10 seconds shown in Figs. 16A-16D (i.e. in Fig. 16A when speaker fraction % is 80%).
Regarding claim 42, Gutmark-Little discloses the housing includes a nozzle (mouthpiece 62); and a combination of the air oscillations and the acoustic oscillations form a synthetic jet of air upon exiting the nozzle of the housing (paragraphs [0074] and [0077]).
Regarding claim 43, Gutmark-Little discloses (Figs. 1-6) a device for the removal of mucus from airways, the device comprising:
a housing (casing of acoustic system 33) with a nozzle (mouthpiece 62), the housing defining an air passage (passage shown in Fig. 1 through housing of system 33);
an air supply assembly communicatively coupled to the air passage of the housing, the air supply assembly comprising an air supply (air supply 24) and a flow pulsating element (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]), and
an acoustic generator (speaker 58, paragraph [0073]) coupled to the housing, the acoustic generator configured to provide acoustic oscillations to the housing (paragraph [0073]);
wherein a combination of the air oscillations and the acoustic oscillations form a synthetic jet of air upon exiting the nozzle of the housing (paragraphs [0074] and [0077]).
Regarding claim 44, Gutmark-Little discloses wherein a combination of the air oscillations and the acoustic oscillations is configured to penetrate a mucus plug positioned in an airway of a patient within 10 seconds (penetration occurs within 10 seconds shown in Figs. 16A-16D (i.e. in Fig. 16A when speaker fraction % is 80%).
Regarding claim 45, Gutmark-Little discloses the device has a first configuration for penetrating a mucus plug positioned in the airway of the patient (i.e. 300bpm/300Hz, para [0093]-[0094]), the first configuration comprising a first air oscillation rate and a first acoustic oscillation rate (paragraphs [0093]-[0094]); and a second configuration for removing mucus from the airway of the patient (i.e. 400bpm/400Hz, paragraph [0095]) the second configuration comprising a second air oscillation rate and a second acoustic oscillation rate (paragraph [0095]).
Regarding claim 46, Gutmark-Little discloses (Figs. 1-6) a device for the removal of mucus from airways, the device comprising
a housing (casing of acoustic system 33) defining an air passage (passage shown in Fig. 1 through housing of system 33);
an air supply assembly communicatively coupled to the air passage of the housing, the air supply assembly comprising an air supply (air supply 24) and a flow pulsating element (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]), and
an acoustic generator (speaker 58, paragraph [0073]) coupled to the housing, the acoustic generator configured to provide acoustic oscillations to the housing (paragraph [0073]);
wherein the device has a first configuration for use in a patient with active lung operation (interpreted as intended use, device of Gutmark-Little capable of being used for patient with active lung operation and thus comprehends claim language), the first configuration comprising a first air oscillation rate and a first acoustic oscillation rate (i.e. 300bpm/300Hz, para [0093]-[0094]); and wherein the device has a second configuration for use in a patient without active lung operation (interpreted as intended use, device of Gutmark-Little capable of being used for patient with active lung operation and thus comprehends claim language), the second configuration comprising a second air oscillation rate and a second acoustic oscillation rate, the second air oscillation rate being higher than the first air oscillation rate (i.e. 400bpm/400Hz, paragraph [0095]).
Regarding claim 47, Gutmark-Little discloses wherein a combination of the air and the acoustic oscillations is configured to penetrate a mucus plug positioned in an airway of a patient within 10 seconds (penetration occurs within 10 seconds shown in Figs. 16A-16D (i.e. in Fig. 16A when speaker fraction % is 80%).
Regarding claim 48, Gutmark-Little discloses wherein: the housing includes a nozzle (mouthpiece 62); and a combination of the air oscillations and the acoustic oscillations form a synthetic jet of air upon exiting the nozzle of the housing (paragraphs [0074] and [0077]).; and
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 49 and 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355).
Regarding claim 49, Gutmark-Little discloses (Figs. 1-6) a device for treating airways, the device comprising:
a memory (memory 46);
a hand unit (comprising device body 12 and acoustic system 33, disclosed as being handheld in paragraph [0065]) comprising:
a housing (casing of acoustic system 33) containing an acoustic transducer (speaker 58, paragraph [0073]) configured to apply acoustic oscillations according to a predetermined pattern, a central duct (passage in Fig. 1 through housing of system 33), central duct (passageway 34) and an acoustic duct (pathway 60) in fluid communication with the central duct (paragraph [0074]) and a mouthpiece (mouthpiece 62) coupled to the housing (see Fig. 1).
Gutmark-Little does not disclose a base unit comprising a housing, the housing containing an air pump, a circuit board assembly, the hand unit operatively coupled to the base unit, and the central duct in fluid communication with the base unit.
However, Kolb teaches (Fig. 1-3) a therapeutic system comprising a base unit (base unit 20) comprising a housing (casing of base shown in Fig. 3), the housing containing an air pump, and a circuit board assembly (see paragraphs [0034]-[0035]), a hand unit (handpiece 30) operatively coupled to the base unit (paragraph [0034]), and a central duct (hose 24) in fluid communication with the base unit (via port 22 of base 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutmark-Little to include a base unit comprising a housing, the housing containing an air pump, a circuit board assembly, the hand unit operatively coupled to the base unit, and the central duct in fluid communication with the base unit, as taught by Kolb, for the purpose of reducing weight of handpiece by allocating heavy and larger components of system , i.e. air pump and circuit board, so that handpiece is more maneuverable by a user.
Regarding claims 52 and 53, modified Gutmark-Little discloses the housing of the hand unit further containing a flow pulsating element configured to alter the continuous airflow stream from the air pump according to a predetermined pattern (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]).
Claim(s) 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355), and further in view of Wright (US 2023/0121963).
Regarding claim 50, modified Gutmark-Little discloses a device having a base unit but does not disclose the base unit is configured to be mobile and worn by a patient.
However, Wright teaches (Figs. 4A-4B) a device having a base unit (comprising cooling and heating chambers 212,210) configured to be mobile and worn by a patient (disposed in a vest 402 and thus mobile and worn by patient, se paragraph [0048]-[0049] and Figs. 4A-4B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Gutmark-Little such that the base unit is configured to be mobile and worn by a patient, as taught by Wright, for the purpose of allowing a user to use the device on the go instead of only limiting use to a hospital setting (paragraphs [0048]-[0052] Wright).
Regarding claim 51, modified Gutmark-Little discloses a chest rack (hooks, paragraph [0049] Wright) configured to hold the hand unit in a stationary position to facilitate hands-free use of the device (paragraph [0049] Wright).
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355), and further in view of Greenblatt (US 10,953,169).
Regarding claim 54, modified Gutmark-Little discloses a device having a mouthpiece but does not disclose a nebulizer coupled to the mouthpiece of the device.
However, Greenblatt teaches (Fig. 3B) a pressure pulse therapy device comprising a mouthpiece (mouthpiece 61) and a nebulizer (nebulizer 71) couples to the mouthpiece (see Fig. 3B and Col. 5 lines 50-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Gutmark-Little such that a nebulizer is coupled to the mouthpiece of the device, as taught by Greenblatt, for the purpose of improving therapy of user by allowing for both pressure pulses and medicine to be delivered during treatment (Abstract Greenblatt).
Claim(s) 55-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355), and further in view of Birnkrant (US 2018/0043116).
Regarding claim 55, modified Gutmark-Little discloses the device includes a processor but does not disclose the device is configured for wireless communication.
However, Birnkrant teaches (Figs. 1-3) a device (device 100) configured for wireless communication (includes a wireless network device, paragraph [0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Gutmark-Little to be configured for wireless communication, as taught by Birnkrant, for the purpose of allowing for remote physicians to access and adjust operation of device without user having to visit physician in-person (paragraph [0080] Birnkrant).
Regarding claim 56, modified Gutmark-Little discloses a system comprising the device of claim 49 (see rejection of claim 49 above), but does not disclose the system further comprising: a first personal electronic application in communication with the device and in communication with a cloud-based server; and a second personal electronic application in communication with the cloud-based server.
However, Birnkrant teaches (Figs. 1-3) a system comprising a mucus mobilization device (device 110) and a first personal electronic application (therapist handheld device, paragraph [0061]) in communication with the device and in communication with a cloud-based server (paragraphs [0059] and [0061]); and a second personal electronic application (second mobile device, paragraphs [0060]-[0061]) in communication with the cloud-based server (paragraphs [0059] and [0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Gutmark-Little to be further comprise a first personal electronic application in communication with the device and in communication with a cloud-based server; and a second personal electronic application in communication with the cloud-based server., as taught by Birnkrant, for the purpose of allowing for remote physicians to access and adjust operation of device without user having to visit physician in-person (paragraphs [0061] and [0080] Birnkrant).
Regarding claim 57, modified Gutmark-Little discloses wherein the second personal electronic application is configured to control a variety of parameters of the device from a remote location via the cloud- based server and the first personal electronic application (paragraph [0061] Birnkrant).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355) and Ahmad (US 2014/0283834).
Regarding claim 58, Gutmark-Little discloses (Figs. 1-6) a method of treating airways, the method comprising the steps of:
providing a device comprising:
a memory (memory 46);
a hand unit (comprising device body 12 and acoustic system 33, disclosed as being handheld in paragraph [0065]) comprising:
a housing (casing of acoustic system 33) containing an acoustic transducer (speaker 58, paragraph [0073]) configured to apply acoustic oscillations according to a predetermined pattern, a central duct (passage in Fig. 1 through housing of system 33),
central duct (passageway 34) and an acoustic duct (pathway 60) in fluid communication with the central duct (paragraph [0074]) and
a mouthpiece (mouthpiece 62) coupled to the housing (see Fig. 1)
a flow pulsating element (solenoid valve 28 coupled to air supply 24, see Fig. 1 and paragraphs [0071] and [0074]) disposed in either the housing of the hand unit (see Fig. 1)
wherein the method includes operating the flow pulsating element to alter the continuous airflow stream according to a predetermined pattern (paragraph [0071]-[0072]); and
operating the acoustic transducer to generate acoustic soundwaves according to a predetermined pattern (paragraphs [0073]-[0074]).
Gutmark-Little does not disclose a base unit comprising a housing, the housing containing an air pump, a circuit board assembly, the hand unit operatively coupled to the base unit, and the central duct in fluid communication with the base unit, wherein operation of the device is controlled by a protocol stored on the circuit board assembly and the method includes inserting the mouthpiece into the mouth of a patient; operating the air pump to provide air flow to the patient via the central duct of the housing of the hand unit and the air flow duct of the mouthpiece.
However, Kolb teaches (Fig. 1-3) a therapeutic system comprising a base unit (base unit 20) comprising a housing (casing of base shown in Fig. 3), the housing containing an air pump, and a circuit board assembly (see paragraphs [0034]-[0035]), a hand unit (handpiece 30) operatively coupled to the base unit (paragraph [0034]), and a central duct (hose 24) in fluid communication with the base unit (via port 22 of base 20), wherein operation of the device is controlled by a protocol stored on the circuit board assembly (paragraphs [0034]-[0035]) and the method includes inserting the mouthpiece into the mouth of a patient (paragraph [0032]); operating the air pump to provide air flow to the patient via the central duct of the housing of the hand unit and the air flow duct of the mouthpiece (paragraph [0034]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutmark-Little to include a base unit comprising a housing, the housing containing an air pump, a circuit board assembly, the hand unit operatively coupled to the base unit, and the central duct in fluid communication with the base unit, wherein operation of the device is controlled by a protocol stored on the circuit board assembly and the method includes inserting the mouthpiece into the mouth of a patient; operating the air pump to provide air flow to the patient via the central duct of the housing of the hand unit and the air flow duct of the mouthpiece, as taught by Kolb, for the purpose of reducing weight of handpiece by allocating heavy and larger components of system, i.e. air pump and circuit board, so that handpiece is more maneuverable by a user.
Modified Gutmark-Little does not disclose sensing breathing cycles for inhalation and exhalation stages of a respiratory cycle of the patient during tidal breathing.
However, Ahmad teaches (Figs. 1-2) a respiratory treatment method comprising sensing breathing cycles for inhalation and exhalation stages of a respiratory cycle of the patient during tidal breathing (paragraph [0013]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Gutmark-Little to include step of sensing breathing cycles for inhalation and exhalation stages of a respiratory cycle of the patient during tidal breathing, as taught by Ahmad, for the purpose of determining the current breathing phase and predict breathing phases of a user so that treatment can be optimized (paragraph [0013] Ahmad).
Claim(s) 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355) and Ahmad (US 2014/0283834), and further in view of Greenblatt (US 10,953,169).
Regarding claim 59, modified Gutmark-Little discloses a device having a mouthpiece but does not disclose a nebulizer coupled to the mouthpiece of the device.
However, Greenblatt teaches (Fig. 3B) a pressure pulse therapy device comprising a mouthpiece (mouthpiece 61) and a nebulizer (nebulizer 71) couples to the mouthpiece (see Fig. 3B and Col. 5 lines 50-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Gutmark-Little such that a nebulizer is coupled to the mouthpiece of the device, as taught by Greenblatt, for the purpose of improving therapy of user by allowing for both pressure pulses and medicine to be delivered during treatment (Abstract Greenblatt).
Regarding claim 60, modified Gutmark-Little discloses the method further comprising the step of delivering medication to the patient via the nebulizer and the air flow duct (Col. 5 lines 50-58 Greenblatt).
Claim(s) 61-62 and 65-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355) and Ahmad (US 2014/0283834), and further in view of Birnkrant (US 2018/0043116).
Regarding claim 61, modified Gutmark-Little discloses a method of using device but does not disclose the method further comprising the step of using the device to store data related to at least one of patient adherence, patient progress protocol setting, and patient condition.
However, Birnkrant teaches (Figs. 1-3) method comprising the step of using the device to store data related to at least one of patient adherence, patient progress protocol setting, and patient condition (paragraphs [0080]-[0081]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Gutmark-Little to include the step of using the device to store data related to at least one of patient adherence, patient progress protocol setting, and patient condition, as taught by Birnkrant, for the purpose of improving patient therapeutic outcome by storing previous use settings so that patient condition can be improved over time based on treatment trends (paragraph [0080] Birnkrant).
Regarding claim 62, modified Gutmark-Little discloses the step of transmitting the stored data from the device to a cloud-based server (paragraphs [0059] and [0061] Birnkrant).
Regarding claim 65, modified Gutmark-Little discloses the method further comprising the step of using the device to store data related to at least one of patient adherence, patient progress protocol setting, and patient condition (see rejection of claim 61 above).
Regarding claim 66, modified Gutmark-Little discloses the method further comprising the step of transmitting the stored data from the device to a cloud-based server (see rejection of claim 62 above).
Regarding claim 67, modified Gutmark-Little discloses the method further comprising the step of downloading stored data from the cloud-based server to a remote application device (paragraph [0061] Birnkrant).
Regarding claim 68, modified Gutmark-Little discloses further comprising the step of adjusting the protocol of the device using the remote application device (paragraph [0061] Birnkrant).
Claim(s) 63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutmark-Little (US 2020/0338288) in view of Kolb (US 2023/0364355), Ahmad (US 2014/0283834), and Birnkrant (US 2018/0043116) and further in view of Greenblatt (US 10,953,169).
Regarding claim 63, modified Gutmark-Little discloses a device having a mouthpiece but does not disclose a nebulizer coupled to the mouthpiece of the device.
However, Greenblatt teaches (Fig. 3B) a pressure pulse therapy device comprising a mouthpiece (mouthpiece 61) and a nebulizer (nebulizer 71) couples to the mouthpiece (see Fig. 3B and Col. 5 lines 50-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Gutmark-Little such that a nebulizer is coupled to the mouthpiece of the device, as taught by Greenblatt, for the purpose of improving therapy of user by allowing for both pressure pulses and medicine to be delivered during treatment (Abstract Greenblatt).
Regarding claim 64, modified Gutmark-Little discloses the method further comprising the step of delivering medication to the patient via the nebulizer and the air flow duct (Col. 5 lines 50-58 Greenblatt).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Garde (US 2012/0199127) discloses a secretion removal system.
Faram (US 2011/0100360) discloses a lung therapy device having a handheld piece.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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