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 .
Claim Objections
Claims 1, 4, 7, 13, 18, and 19 are objected to because of the following informalities:
The phrase “the actuator” should be changed to –the piezoelectric actuator—for consistency (Claim 1, Line 15).
The phrase “a” should be changed to –an—to correct the grammatical error (Claim 4, Line 1).
The phrase “position” should be changed to –positioned—to correct the grammatical error (Claim 7, Line 2).
The phrase “ejected droplets” should be changed to –the droplets— for consistency (Claim 13, Line 2).
The phrase “an additional pressure sensor” should be changed to –a pressure sensor—since this is the first time a pressure sensor is mentioned (Claim 18, Lines 2-3).
The phrase “a piezoelectric” should be changed to –the piezoelectric—for consistency (Claim 19, Line 4).
The phrase “a respirable range” should be changed to –the respirable range—for consistency (Claim 19, Lines 8-9).
The phrase “a subject” should be changed to –the subject—for consistency (Claim 19, Line 9).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 states “an exit side of the aperture plate provides a plane that is perpendicular to the direction of airflow through the airflow channel” and “droplets are ejected in parallel to the direction of airflow such that the droplets are directed through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing” (Lines 2-6). This statement fails to comply with the written description requirement because the device is never described in such a way that the perpendicular aperture plate is capable of having the droplets ejected in parallel to the direction of airflow and having the droplets to then change trajectory by 90 degrees. It appears the applicant was trying to claim the embodiment in which the aperture plane is parallel to the airflow and is capable of ejecting the droplets into the airflow perpendicularly to have a 90 degree change of trajectory. However, the instant disclosure does not have support for this particular kind of device in which the aperture plate is perpendicular and is capable of producing droplets that go in a 90 degree change of trajectory. The instant specification only describes an aperture plate parallel to the airflow that produces droplets that go in a 90 degree change of trajectory (Specification: paragraphs 0013, 0066, and 0087). The instant drawings show the aperture plate being parallel to the airflow which would produce the 90 degree change (Drawings: Fig 3C). The aperture plate that is perpendicular to the airflow would only have the droplets going parallel due to the structure of the housing (Drawings: Fig 6). Therefore, there is reasonable doubt that Applicant was in possession of the claimed invention at the time of filing. For examination purposes, the claim limitation will be interpreted as the aperture plate is parallel to the direction of airflow and that the droplets are ejected perpendicularly to the direction of airflow as reflected by the original Claim 3 in the Claim set filed July 7, 2023. It is noted that the preliminary amendment filed February 26, 2024 did not carry over the original claim limitations of Claim 3 in the Claim set filed July 7, 2023 which created this discrepancy.
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.
Claim 3 is 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 3 states “an exit side of the aperture plate provides a plane that is perpendicular to the direction of airflow through the airflow channel” and “droplets are ejected in parallel to the direction of airflow such that the droplets are directed through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing” (Lines 2-6). This statement is indefinite because it is unclear how parallel droplets in an airflow can suddenly have a 90 degree change of trajectory. It appears the applicant was trying to claim the embodiment in which the aperture plane is parallel to the airflow and is capable of ejecting the droplets into the airflow perpendicularly to have a 90 degree change of trajectory. However, the claim limitation creates confusion into which direction the droplets are going as the embodiments disclosed in the instant application do not mention droplets in the airflow that are capable of going both in parallel and in a 90 degree change of trajectory. Additionally, it is unclear how an aperture plate perpendicular to the airflow can produce a 90 degree change of trajectory when the droplets released would only be going in parallel to the airflow. Therefore, the direction of the droplets cannot be determined. For examination purposes, the claim limitation will be interpreted as the aperture plate is parallel to the direction of airflow and that the droplets are ejected perpendicularly to the direction of airflow as reflected by the original Claim 3 in the Claim set filed July 7, 2023. It is noted that the preliminary amendment filed February 26, 2024 did not carry over the original claim limitations of Claim 3 in the Claim set filed July 7, 2023 which created this discrepancy.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-11, and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Takei et al. (US 2010/0282254 A1) in view of Fink et al. (US 2018/0021530 A1).
Regarding Claim 1, Takei discloses an electronically actuated in-line droplet delivery device (Apparatus of Fig 2) comprising: a housing (housing of apparatus of Fig 2) configured in a substantially in-line orientation (the housing of apparatus of Fig 2 is in line in relation to 7, Figs 2-3; 7 is inside of the housing, Figs 2-3) including a linear airflow channel (7, Fig 2; 7 is straight and linear, Fig 2); a mouthpiece (20, Fig 2) positioned at an airflow exit (exit end of 7, Fig 2) of the linear airflow channel; an ampoule (2, Figs 3-4) including a reservoir (reservoir of 2 or 33, Figs 3-4); an electronically actuated ejector mechanism (1, Figs 3-4) in fluid communication with the reservoir (1 is connected to 2, Figs 3-4) and configured to generate droplets (1 is made of 1a from which drug is ejected, paragraph 0048); the ejector mechanism comprising a piezoelectric actuator (electromechanical transducer which gives mechanical energy to a drug, paragraph 0059) and the piezoelectric actuator coupled to a power source (29, Fig 8; electric power supplied from battery 29, paragraph 0067) and operable to oscillate at a frequency to thereby generate the droplets (ejecting a drug using oscillating pressure of an electromechanical transducer, paragraph 0059; oscillation would inherently have a frequency); and one or more electrical contacts (9a and/or 9, Fig 4) coupled to the ampoule (9 is connected to 1 which is connected to 2, Fig 4) and to the power source configured to complete an electrical circuit that powers the actuator (113 detects drug cartridge is mounted in the body and is connected to control unit 4, 110 for giving drive signal is connected through electrical connection surface 9a to ejection head unit 1, 110 designed to execute necessary spraying by itself with control data and activation signal from 4, paragraph 0083; when not mounted display no cartridge is performed, paragraph 0086; Fig 10 shows if the drug cartridge does not exist, the device goes to power down and does not function).
Takei does not explicitly disclose an aperture plate, the aperture plate having a plurality of openings formed through its thickness; oscillate the aperture plate at a frequency.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including an aperture plate, the aperture plate having a plurality of openings formed through its thickness; oscillate the aperture plate at a frequency (vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024; mesh are known to have a plurality of openings) since this is a well-known form of ejecting mechanism with an electromechanical transducer for delivering a drug.
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 electromechanical transducer to have an aperture plate or vibrating mesh, as taught by Fink, since this is a well-known form of ejecting mechanism with an electromechanical transducer for delivering a drug.
Regarding Claim 3, Takei-Fink combination teaches the housing and ejector mechanism are oriented such that an exit side of the aperture plate provides a plane that is parallel to the direction of airflow through the airflow channel (Takei: the ejection head 8 is shown to be in parallel to the airflow channel 7, Figs 2-6) and the droplets are ejected perpendicular to the direction of airflow such that the droplets are directed through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing (Takei: due to the orientation of 8, the droplets would enter 7 perpendicularly and would change trajectory by 90 degrees to exit 7, Figs 2-6).
Regarding Claim 4, the current Takei-Fink combination fails to teach an air inlet flow element is positioned within the mouthpiece.
However, Fink further teaches an air inlet flow element is positioned within the mouthpiece (mouthpiece end 110 of conduit 102, paragraph 0041; restrictor plates may be positioned within conduit 102, paragraph 0045; 110 is part of 102) to provide an increase in pressure differential varying according to inspiratory flow rate which ensures a relatively constant flow rate and to provide a relatively laminar flow downstream of the restrictor plate (paragraphs 0025 and 0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place an air inlet flow element or restrictor plate inside of the mouthpiece and modify the size of the airflow channel to be longer to accommodate for the restrictor plate, as taught by Fink, to provide an increase in pressure differential varying according to inspiratory flow rate which ensures a relatively constant flow rate and to provide a relatively laminar flow downstream of the restrictor plate (Fink: paragraphs 0025 and 0046). This would provide further control and stability of the flow rate going through the airflow channel of the device.
Regarding Claim 5, Takei-Fink combination teaches the air inlet flow element is positioned behind the exit side of the aperture plate along the direction of airflow (Fink: 400 is positioned behind 406, Figs 4-7; 400 is disposed between 404 and 406, paragraph 0048).
Regarding Claim 6, Takei-Fink combination teaches the air inlet flow element is positioned in-line along the direction of airflow (Fink: 400 is positioned in-line of direction of airflow within 402, Figs 4-7).
Regarding Claim 7, the current Takei-Fink combination fails to teach an air inlet flow element positioned within the airflow channel and having one or more openings formed therethrough and configured to increase or decrease internal pressure resistance within the droplet delivery device during use.
However, Fink further teaches an air inlet flow element positioned within the airflow channel (mouthpiece end 110 of conduit 102, paragraph 0041; restrictor plates may be positioned within conduit 102, paragraph 0045; 110 is part of 102) and having one or more openings formed therethrough (302a, Fig 3A; plurality of apertures, paragraph 0046) and configured to increase internal pressure resistance within the droplet delivery device during use (air passing through apertures forms a relatively laminar flow, paragraph 0046; 300a provides increase in pressure differential, pressure differential exists between conduit and outside of conduit, paragraph 0046; as airflow reaches restrictor plate, pressure differential is increased and a relatively laminar flow is created, paragraph 0049; the presence of the restrictor plate along with the apertures is configured to increase an internal pressure resistance which is the same as an increase in a pressure differential) to provide an increase in pressure differential varying according to inspiratory flow rate which ensures a relatively constant flow rate and to provide a relatively laminar flow downstream of the restrictor plate (paragraphs 0025 and 0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place an air inlet flow element or restrictor plate inside of the mouthpiece and modify the size of the airflow channel to be longer to accommodate for the restrictor plate, as taught by Fink, to provide an increase in pressure differential varying according to inspiratory flow rate which ensures a relatively constant flow rate and to provide a relatively laminar flow downstream of the restrictor plate (Fink: paragraphs 0025 and 0046). This would provide further control and stability of the flow rate going through the airflow channel of the device.
Regarding Claim 8, Takei-Fink combination teaches the air inlet flow element comprises an array of one or more openings (Fink: 302a has multiple openings and is considered an array, Fig 3A).
Regarding Claim 9, Takei-Fink combination teaches the air inlet flow element comprises one or more baffles (Fink: restrictor plate that has a plurality of apertures, restrictor array may include multiple restrictor plates in series, paragraph 0025; a baffle is considered a plate).
Regarding Claim 10, Takei-Fink combination teaches the one or more baffles comprise one or more airflow openings (Fink: restrictor plate that has a plurality of apertures, restrictor array may include multiple restrictor plates in series, paragraph 0025; 302a, Fig 3A; plurality of apertures, paragraph 0046).
Regarding Claim 11, Takei-Fink combination teaches the aperture plate comprises a domed shape (Fink: vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024).
Regarding Claim 14, Takei-Fink combination teaches the mouthpiece is removably coupled with the device (Takei: 20 and 7 are sectioned, inlet 20 is thrown away every inhalation, or it is washed after inhalation and is re-used, paragraph 0063).
Regarding Claim 15, Takei-Fink combination teaches the reservoir is removably coupled with the housing (Takei: ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation, paragraph 0063; in order to make a user easily mount an inhalation apparatus body, before the drug tank 2 is connected to the ejection head unit 1, it is suitable for these to construct the drug cartridge 10 as one body, paragraph 0071; a cartridge detection sensor 113 which detects that the drug cartridge into which the ejection head unit 1 and drug tank 2 are sectioned is mounted in the inhalation apparatus body, paragraph 0083).
Regarding Claim 16, Takei-Fink combination teaches the reservoir is coupled to the ejector mechanism to form a combination reservoir/ejector mechanism module (Takei: 10, Fig 6), and the combination reservoir/ejector mechanism module is removably coupled with the housing (Takei: ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation, paragraph 0063; in order to make a user easily mount an inhalation apparatus body, before the drug tank 2 is connected to the ejection head unit 1, it is suitable for these to construct the drug cartridge 10 as one body, paragraph 0071; a cartridge detection sensor 113 which detects that the drug cartridge into which the ejection head unit 1 and drug tank 2 are sectioned is mounted in the inhalation apparatus body, paragraph 0083).
Regarding Claim 17, Takei-Fink combination teaches menu switching, down, and up buttons (Takei: paragraph 0062). The current Takei-Fink combination fails to teach a wireless communication module.
However, Fink further teaches a wireless communication module (input device 902, Fig 9; input may be manually entered by user or provided via wireless interface, paragraph 0051; a wireless communication module must exist within the input device to receive inputs wirelessly) since this is a known way to receive inputs into the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a wireless communication module in connection to a wireless interface, as taught by Fink, since this is a known way to receive inputs into the device. This provides further possibilities and ways for the device to be controlled.
Regarding Claim 18, Takei-Fink combination teaches the device further comprises one or more sensors selected from a pressure sensor (Takei: pressure sensor 43, paragraph 0084).
Regarding Claim 19, the current Takei-Fink combination teaches a method for delivering a therapeutic agent as an ejected stream of droplets in a respirable range to the pulmonary system of a subject for the treatment of a pulmonary disease, disorder or condition (Takei: device can be used for an inhalation apparatus for making user inhale a drug, paragraph 0001), the method comprising: (a) generating an ejected stream of droplets via a piezoelectric actuated droplet delivery device of claim 1 (See Rejection of Claim 1 above). The current Takei-Fink combination also teaches in order to absorb efficiently medical fluid, which is ejected, in lungs, it is important that a droplet diameter is extremely as minute as several microns (Takei: paragraph 0003). The current Takei-Fink combination fails to teach wherein at least about 50% of the ejected stream of droplets have an average ejected droplet diameter of less than about 6 microns; and (b) delivering the ejected stream of droplets to the pulmonary system of the subject such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of a subject during use to thereby treat the pulmonary disease, disorder or condition.
However, Fink further teaches wherein at least about 50% of the ejected stream of droplets have an average ejected droplet diameter of less than about 6 microns (mesh can produce respirable particles in the 3.5-5 micron diameter range, paragraph 0058; mean mass aerodynamic diameter ranging from 3.0-4.5 micron, paragraph 0065; majority of droplets are shown to be less than 6 microns); and (b) delivering the ejected stream of droplets to the pulmonary system of the subject such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of a subject during use (mesh can produce respirable particles in the 3.5-5 micron diameter range, paragraph 0058; mean mass aerodynamic diameter ranging from 3.0-4.5 micron, paragraph 0065; 3.5-5 micron diameter particles are known to be within the respirable range) to thereby treat the pulmonary disease, disorder or condition (aerosolization systems provide effective delivery for a variety of medicaments, deliver medicaments directly to user’s respiratory system, enabling faster treatment of various medical conditions, paragraph 0002; ensuring proper delivery of an aerosolized medication to a user’s respiratory system, Abstract; aerosolization systems delivering medicaments to a user’s respiratory system are known to be used to treat pulmonary diseases, disorders, or conditions) since these are known ranges for droplet diameters specifically for treatment of pulmonary diseases.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device produce droplets with an average ejected droplet diameter of less than about 6 microns, as taught by Fink, since these are known ranges for droplet diameters specifically for treatment of pulmonary diseases. Takei already teaches there is an importance to have droplet diameters in the microns to treat lung diseases. Fink merely further supports Takei’s statement by showing the well-known ranges of droplet diameters involved in treating lung diseases.
Regarding Claim 20, Takei-Fink combination teaches wherein the pulmonary disease, disorder or condition is selected from asthma (Fink: aerosolization systems provide effective delivery for a variety of medicaments, such as insulin and asthma medications, paragraph 0002; asthma is a well-known pulmonary condition treated by these devices).
Regarding Claim 21, Takei-Fink combination teaches the therapeutic agent is an asthma medication (Fink: aerosolization systems provide effective delivery for a variety of medicaments, such as insulin and asthma medications, paragraph 0002).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Takei et al. (US 2010/0282254 A1) and Fink et al. (US 2018/0021530 A1) as applied to Claim 1, and in further view of Fink et al. (US 2005/0217666 A1), hereafter 2nd Fink.
Regarding Claim 12, Takei-Fink combination teaches the claimed invention of Claim 1. Takei-Fink combination fails to teach the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene 53WO 2019/071008PCT/US2018/054417 (UHMWPE), nickel, nickel-cobalt, nickel-palladium, pallaidium, platinum, metal alloys thereof, and combinations thereof.
However, 2nd Fink, of the same field of endeavor, teaches a method of treating a patient with pulmonary disease (Abstract) including the aperture plate is composed of a material selected from the group consisting of nickel-palladium, palladium, metal alloys thereof, and combinations thereof (aerosolization element may be constructed from a variety of materials, comprising metals, palladium is believed to be of particular usefulness, palladium alloys such as PdNi, paragraph 0082) since these are well-known materials particularly useful for aerosolizing liquids (paragraph 0082).
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 aperture plate to be made of palladium, as taught by 2nd Fink, since these are well-known materials particularly useful for aerosolizing liquids (2nd Fink: paragraph 0082).
Regarding Claim 13, Takei-Fink combination teaches the claimed invention of Claim 1. Takei-Fink combination fails to teach one or more of the plurality of 5openings have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters.
However, 2nd Fink, of the same field of endeavor, teaches a method of treating a patient with pulmonary disease (Abstract) including one or more of the plurality of 5openings have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters (varying particle size distribution of nebulized mist by varying aperture exit diameter, paragraph 0032; vibratory element 86 may be replaced with a respective assembly that has apertures of a different size, such as different exit diameter, to produce a mist having a different aerosol particle size, paragraph 0085) to control the particle size distribution within the nebulized mist (paragraph 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the diameters of the openings, as taught by 2nd Fink, to control the particle size distribution within the nebulized mist (2nd Fink: paragraph 0032). This would be a simple modification to do as a way to optimize the particle size distribution for different patients and for different kinds of medicament to ensure the desired or most effective treatment.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Takei et al. (US 2010/0282254 A1) and Fink et al. (US 2018/0021530 A1) as applied to Claim 20, and in further view of Zaffaroni et al. (US 2010/0181387 A1).
Regarding Claim 22, Takei-Fink combination teaches the claimed invention of Claim 20. Takei-Fink combination fails to teach the therapeutic agent is selected from albuterol sulfate, ipratropium bromide, tobramycin, fluticasone propionate, fluticasone furoate, tiotropium, glycopyrrolate, olodaterol, salmeterol, umeclidinium, and combinations thereof.
However, Zaffaroni, of the same field of endeavor, teaches a device, method and system for producing a condensation aerosol (Abstract) including the therapeutic agent is selected from ipratropium bromide (a listed respiratory agent, paragraph 0322), tobramycin (listed anti-infective agent, paragraph 0290; listed cystic fibrosis management drug, paragraph 0302), and fluticasone propionate (listed heat stable drug, paragraph 0225; a listed respiratory agent, paragraph 0322) since these are known drugs with various therapeutic benefits used in vaporization for maximizing alveolar delivery and rapidly delivering drugs to target organs (paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these listed therapeutic agents in the device, as taught by Zaffaroni, since these are known drugs with various therapeutic benefits used in vaporization for maximizing alveolar delivery and rapidly delivering drugs to target organs (Zaffaroni: paragraph 0059).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Takei et al. (US 2010/0282254 A1) and Fink et al. (US 2018/0021530 A1) as applied to Claim 19, and in further view of Noolandi et al. (US 2002/0077369 A1).
Regarding Claim 23, Takei-Fink combination teaches the claimed invention of Claim 19. Takei-Fink combination fails to teach the ejected stream of droplets is delivered over a period of time less than about 2 seconds.
However, Noolandi, of the same field of endeavor, teaches an improved method and apparatus for delivering medication to the lungs (Abstract) including the ejected stream of droplets is delivered over a 10period of time less than about 2 seconds (it may be desirable to maximize ejection of droplets during a very short time interval to take advantage of optimal air speed, thus typically all ejectors will fire for a fraction of second, paragraph 0034) since it is well-known and typical for ejectors to fire for a fraction of second to take advantage of optimal air speed (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 eject the stream of droplets over a period of time less than 2 seconds, as taught by Noolandi, since it is well-known and typical for ejectors to fire for a fraction of second to take advantage of optimal air speed (Noolandi: paragraph 0034). Delivering the droplets over a very small period of time avoids the optimal air speed from changing drastically over a longer period of time and ensures that the droplets are delivered at the best timeframe throughout inhalation.
Claims 1, 2, 11, 14, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mironov et al. (US 2017/0231277 A1) in view of Fink et al. (US 2018/0021530 A1).
Regarding Claim 1, Mironov discloses an electronically actuated in-line droplet delivery device (apparatus of Fig 1) comprising: a housing (housing of apparatus of Fig 1) configured in a substantially in-line orientation (housing of apparatus of Fig 1 is in-line with the channel through 120, Fig 1) including a linear airflow channel (channel through 120, Fig 1); a mouthpiece (120, Fig 1) positioned at an airflow exit (124, Fig 1) of the linear airflow channel; an ampoule (200, Fig 1) including a reservoir (201, Fig 1); an electronically actuated ejector mechanism (302, Fig 2) in fluid communication with the reservoir and configured to generate droplets (302 is an aerosol-generating element, paragraph 0177); and one or more electrical contacts (electrodes 304 and 305, Fig 2) coupled to the ampoule (cartridges shown in FIGS. 2 to 12 comprise liquid storage portions and electrode arrangements, paragraph 0175) and to the power source configured to complete an electrical circuit that powers the actuator (electrical contacts (not shown) extend through the housing, from the outer surface to the inner surface of each of the plates, when the cartridge 300 is received in a cavity of a main unit, the contacts of the cartridge 300 abut complimentary contacts in the cavity of the main unit to electrically connect the sensor 303 to a power supply and a control system of the main unit, paragraph 0178; control system may be configured to measure the electrical quantity between the first electrode and the second electrode, enable the control system to control operation of the aerosol-generator before the aerosol-generator is operated, may substantially prevent and/or reduce damage to the aerosol-generator from atomization of an unsuitable liquid aerosol-forming substrate, paragraph 0056; the aerosol generating system does not operate unless the control system senses suitable electrodes on the cartridge; control system would not allow the device to operate if the cartridge is not present). Mironov also discloses the aerosol-generator may be configured to atomize received aerosol-forming substrate using ultrasonic vibrations and may comprise an ultrasonic transducer and one or more vibratable elements (paragraph 0112).
Mironov does not explicitly disclose the ejector mechanism comprising a piezoelectric actuator and the piezoelectric actuator coupled to a power source and operable to oscillate at a frequency to thereby generate the droplets; an aperture plate, the aperture plate having a plurality of openings formed through its thickness; oscillate the aperture plate at a frequency.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the ejector mechanism comprising a piezoelectric actuator and the piezoelectric actuator coupled to a power source (112 and piezoelectric element, Fig 1B and paragraph 0024) and operable to oscillate at a frequency to thereby generate the droplets (typically vibratable mesh will be vibrated at a frequency in range from 50kHz to about 150 kHz, paragraph 0024); an aperture plate, the aperture plate having a plurality of openings formed through its thickness; oscillate the aperture plate at a frequency (vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024; mesh are known to have a plurality of openings) since this is a well-known form of ejecting mechanism for delivery of an aerosol.
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 aerosol generating element to be an ultrasonic transducer with an aperture plate or vibrating mesh, as taught by Fink, since this is a well-known form of ejecting mechanism for delivery of an aerosol.
Regarding Claim 2, Mironov-Fink combination teaches the housing and ejector mechanism are oriented such that an exit side of the aperture plate provides a plane that is perpendicular to the direction of airflow through the airflow channel and the droplets are ejected in parallel to the direction of airflow (Mironov: the aerosol-generator may be configured to atomize received aerosol-forming substrate using ultrasonic vibrations and may comprise an ultrasonic transducer and one or more vibratable elements, paragraph 0112; Mironov-Fink combination would obviously have the aperture plate be perpendicular to the airflow of the mouthpiece so that the droplets are released directly towards the outlet 124 of Mironov).
Regarding Claim 11, Mironov-Fink combination teaches the aperture plate comprises a domed shape (Fink: vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024).
Regarding Claim 14, Mironov-Fink combination teaches the mouthpiece is removably coupled with the device (Mironov: mouthpiece portion connected by a hinged connection but any kind of connection may be used, such as a snap fitting or a screw fitting, paragraph 0168; mouthpiece is a separate component and thus is removable from the device).
Regarding Claim 15, Mironov-Fink combination teaches the reservoir is removably coupled with the housing (Mironov: cartridge 200 is disposable, paragraph 0166; 101 defines a cavity 112 into which 200 is received, paragraph 0167).
Regarding Claim 17, Mironov-Fink combination teaches the aerosol-generating system may comprise an input, such as a switch or button (Mironov: paragraph 0133).
The current Mironov-Fink combination fails to teach a wireless communication module.
However, Fink further teaches a wireless communication module (input device 902, Fig 9; input may be manually entered by user or provided via wireless interface, paragraph 0051; a wireless communication module must exist within the input device to receive inputs wirelessly) since this is a known way to receive inputs into the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a wireless communication module in connection to a wireless interface, as taught by Fink, since this is a known way to receive inputs into the device. This provides further possibilities and ways for the device to be controlled.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mironov et al. (US 2017/0231277 A1) and Fink et al. (US 2018/0021530 A1) as applied to Claim 1, and in further view of Fink et al. (US 2005/0217666 A1), hereafter 2nd Fink.
Regarding Claim 12, Mironov-Fink combination teaches the claimed invention of Claim 1. Mironov-Fink combination fails to teach the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene 53WO 2019/071008PCT/US2018/054417 (UHMWPE), nickel, nickel-cobalt, nickel-palladium, pallaidium, platinum, metal alloys thereof, and combinations thereof.
However, 2nd Fink, of the same field of endeavor, teaches a method of treating a patient with pulmonary disease (Abstract) including the aperture plate is composed of a material selected from the group consisting of nickel-palladium, palladium, metal alloys thereof, and combinations thereof (aerosolization element may be constructed from a variety of materials, comprising metals, palladium is believed to be of particular usefulness, palladium alloys such as PdNi, paragraph 0082) since these are well-known materials particularly useful for aerosolizing liquids (paragraph 0082).
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 aperture plate to be made of palladium, as taught by 2nd Fink, since these are well-known materials particularly useful for aerosolizing liquids (2nd Fink: paragraph 0082).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mironov et al. (US 2017/0231277 A1) and Fink et al. (US 2018/0021530 A1) as applied to Claim 1, and in further view of Alelov (US 2012/0048266 A1).
Regarding Claim 18, Mironov-Fink combination teaches the claimed invention of Claim 1. Mironov-Fink combination fails to teach the device further comprises one or more sensors selected from an infra-red transmitter, a photodetector, a pressure sensor, and combinations thereof.
However, Alelov, of the same field of endeavor, teaches a smoke inhalation device (paragraph 0002) including the device further comprises one or more sensors selected from a pressure sensor (sensors 240 can be, for example, a flow sensor, a thermocouple or pressure sensor to detect the air stream passing through the device, paragraph 0029) to detect the air stream passing through the device (paragraph 0029).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a pressure sensor, as taught by Alelov, to detect the air stream passing through the device (Alelov: paragraph 0029). This addition would be used by the controller to check the operation of the device and whether or not the device is in use.
Conclusion
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
