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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “exit face of the aperture plate” being non-parallel and being parallel to the direction of airflow at the same time, as established by Claim 6, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. Currently, the abstract exceeds 150 words in length.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 2, 3, 6-9, 11, 12, and 16-21 are objected to because of the following informalities:
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 2, Line 9).
The phrase “fluid convertible to droplets” should be changed to –the fluid convertible to the droplets—for consistency (Claim 3, Line 2).
The phrase “the exit face” should be changed to – the exit side face—for consistency (Claim 6, Line 1).
The phrase “the exit face” should be changed to – the exit side face—for consistency (Claim 7, Line 1).
The phrase “the exit face” should be changed to – the exit side face—for consistency (Claim 8, Line 1).
The phrase “the exit face” should be changed to – the exit side face—for consistency (Claim 9, Line 1).
The phrase “fluid convertible to droplets” should be changed to –the fluid convertible to the droplets—for consistency (Claim 11, Line 2).
The phrase “fluid convertible to droplets” should be changed to –the fluid convertible to the droplets—for consistency (Claim 12, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 16, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 17, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 18, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 19, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 20, Line 2).
The phrase “direction of airflow” should be changed to –a direction of airflow—to correct the grammatical error (Claim 21, Line 2).
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 6 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 6 states “the exit face of the aperture plate is parallel to the direction of airflow” (Lines 1-2). This statement fails to comply with the written description requirement because there are no embodiments in the instant disclosure that can have the exit face of the aperture plate be non-parallel, as stated in Claim 2, and parallel to the direction of airflow at the same time. It appears the applicant was trying to say there are two embodiments involved, each with different orientations of the aperture plate. However, the instant disclosure only establishes two separate embodiments each having the different aperture plate configurations (Example: Figs 6 and 11A). There is nothing in the instant disclosure that show a single embodiment having both non-parallel and parallel configurations at the same time. Therefore, there is sufficient 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 exit face of the aperture plate is perpendicular to the direction of airflow.
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 2-21 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 2 states “the internal components” (Line 3). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say any components within the device are arranged in-line. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Additionally, the internal components are never identified. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as any components within the device are arranged in-line. Similar rejections are applied to Claim 10 (Line 3).
Claim 6 states “the exit face of the aperture plate is parallel to the direction of airflow” (Lines 1-2). This statement is indefinite because it contradicts the exit face of aperture plate being non-parallel to the direction of airflow as stated in Claim 2. It appears the applicant was trying to say there are multiple embodiments involved. However, the contradiction creates confusion regarding whether or not the exit face of the aperture plate is parallel to the direction of airflow. Therefore, whether or not the aperture plate is parallel to the direction of airflow cannot be determined. For examination purposes, the claim limitation will be interpreted as the exit face of the aperture plate is perpendicular to the direction of airflow.
Claim 11 states “a maximum capacity of ten doses or less” (Lines 1-2). This statement is indefinite because it is unclear how the maximum capacity can change to a smaller maximum capacity when Claim 10 already establishes the maximum capacity being ten doses. It appears the applicant was trying to say that the maximum capacity is capable of being changed. However, this creates confusion regarding the maximum capacity since the maximum capacity was already previously established as being ten doses. Changing the maximum capacity would be indefinite as it contradicts what was previously established. Therefore, the maximum capacity cannot be determined. For examination purposes, the claim limitation will be interpreted as the maximum capacity can be ten doses or can also be less doses.
Claims 3-5, 8, 9, and 12-21 are rejected for being dependent on rejected Claims 2 and 10.
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.
Claims 11, 14, 17, and 20 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.
Claim 11 states “a maximum capacity of ten doses or less” (Lines 1-2). This limitation fails to further limit the subject matter of the claim upon which it depends because it broadens Claim 10 in which the maximum capacity is not just ten doses, but also less doses.
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 § 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 2-21 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) and Edwards et al. (US 2013/0327327 A1).
Regarding Claim 2, Takei discloses a droplet delivery device (Apparatus of Figs 2-3) comprising: a housing (17 and 31, Figs 2-3) defining a linear internal airflow pathway (7, Fig 2) within the housing that terminates at a first end (end at 20, Fig 2) at an inhalation opening (20, Fig 2), wherein the internal components of the droplet delivery device are arranged in-line so that the housing extends linearly between the inhalation opening at the first end and a second opposite end of the droplet delivery device (7 and 20 are in-line in which 17 and 31 extend linearly between 20 and the opposite end from 20, Figs 2-3); an ejector mechanism (1, Fig 3) having a transducer configured to vibrate (method (piezo ink jet system) of ejecting a drug using oscillating pressure of an electromechanical transducer (piezoelectric element) which gives mechanical energy to the drug, paragraph 0059), wherein the ejector mechanism includes an exit side face (8, Fig 5) that is non-parallel to direction of airflow through the airflow pathway (8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5); and a removable fluid reservoir (2, Figs 3-6) in fluid communication with the ejector mechanism (drug tank 2 is pushed into the ejection head unit 1, the hollow needle 38 breaks through the fixed rubber stopper 36, and the ejection head unit 1 and drug tank 2 are communicated, paragraph 0070; 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).
Takei fails to disclose the ejector mechanism coupled directly or indirectly to an aperture plate, wherein the aperture plate includes an exit side face that is non-parallel to direction of airflow through the airflow pathway, wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the ejector mechanism coupled directly or indirectly to an aperture plate (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), wherein the aperture plate includes an exit side face that is non-parallel to direction of airflow through the airflow pathway (112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B) 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.
Takei-Fink combination teaches it is determined whether the liquid measure obtained by subtracting the full dosage, used for the past, from the first medical fluid amount is larger than maximum ejection amount in the following ejection (Takei: paragraph 0086) and 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 (Takei: paragraph 0063). Takei-Fink combination implies that there could be at least one dose contained in the drug tank.
Takei-Fink combination does not explicitly teach the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge amount for disposable cartridges.
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 size of the tank to hold ten doses or less, as taught by Edwards, since this is a known cartridge amount for disposable cartridges. Sizing the tank to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the tank according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs.
Regarding Claim 3, Takei-Fink-Edwards combination teaches the removable fluid reservoir has a maximum capacity of one dose of fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claim 4, Takei-Fink-Edwards combination teaches the fluid reservoir is disposable (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; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 5, Takei-Fink-Edwards combination teaches the fluid reservoir is disposable (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; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 6, Takei-Fink-Edwards combination teaches the exit face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 7, Takei-Fink-Edwards combination teaches the exit face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 8, Takei-Fink-Edwards combination teaches the exit face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 9, Takei-Fink-Edwards combination teaches the exit face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 10, Takei discloses a droplet delivery device (Apparatus of Figs 2-3) comprising: a housing (31, Fig 3) defining a linear internal airflow pathway (7, Figs 2-3) within the housing that terminates at a first end (end of 20, Figs 2-3) at an inhalation opening (20, Figs 2-3), wherein the internal components of the droplet delivery device are arranged in-line so that the housing extends linearly between the inhalation opening at the first end and a second opposite end of the droplet delivery device (7 and 20 are in-line in which 31 extends linearly between 20 and the opposite end from 20, Figs 2-3); an ejector mechanism (1, Fig 3) having a transducer configured to vibrate (method (piezo ink jet system) of ejecting a drug using oscillating pressure of an electromechanical transducer (piezoelectric element) which gives mechanical energy to the drug, paragraph 0059); and a removable fluid reservoir (2, Figs 3-6) in fluid communication with the ejector mechanism (drug tank 2 is pushed into the ejection head unit 1, the hollow needle 38 breaks through the fixed rubber stopper 36, and the ejection head unit 1 and drug tank 2 are communicated, paragraph 0070; 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), wherein the fluid reservoir externally couples and decouples to an external surface of the housing (2 externally couples and decouples with external surface of 31, Fig 3; 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). It is noted that Applicant has not specified which external surface of the housing is involved in the instant claim.
Takei fails to disclose the ejector mechanism coupled directly or indirectly to an aperture plate, wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the ejector mechanism coupled directly or indirectly to an aperture plate (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.
Takei-Fink combination teaches it is determined whether the liquid measure obtained by subtracting the full dosage, used for the past, from the first medical fluid amount is larger than maximum ejection amount in the following ejection (Takei: paragraph 0086) and 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 (Takei: paragraph 0063). Takei-Fink combination implies that there could be at least one dose contained in the drug tank.
Takei-Fink combination fails to explicitly teach the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge amount for disposable cartridges.
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 size of the tank to hold ten doses, as taught by Edwards, since this is a known cartridge amount for disposable cartridges. Sizing the tank to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the tank according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. It is noted that Applicant has not provided any details of criticality regarding the maximum capacity needing to be only ten doses since Applicant has described ten doses and other lesser doses in the instant disclosure as fulfilling the same purpose of a small volume drug ampoule (Specification: paragraph 0061).
Regarding Claim 11, Takei-Fink-Edwards combination teaches the removable fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172).
Regarding Claim 12, Takei-Fink-Edwards combination teaches the removable fluid reservoir has a maximum capacity of one dose of fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claim 13, Takei-Fink-Edwards combination teaches the fluid reservoir is disposable (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; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 14, Takei-Fink-Edwards combination teaches the fluid reservoir is disposable (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; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 15, Takei-Fink-Edwards combination teaches the fluid reservoir is disposable (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; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 16, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 17, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 18, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 19, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 20, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Regarding Claim 21, Takei-Fink-Edwards combination teaches an exit face of the aperture plate is non-parallel to direction of airflow through the airflow pathway (Takei: 8 of 1 is shown to be non-parallel or perpendicular to 7, Figs 2-3 and 5).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. US 11738158 B2, hereafter ‘158, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘158 discloses most of the claimed invention (Claims 1 and 14) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘158-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘158-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘158-Edwards combination teaches all of the claimed invention (‘158: Claims 1 and 14).
Regarding Claim 10, ‘158 discloses most of the claimed invention (Claims 1 and 14) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘158-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘158-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘158-Edwards combination teaches all of the claimed invention (‘158: Claims 1 and 14).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 11458267 B2, hereafter ‘267, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘267 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘267-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘267-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘267-Edwards combination teaches all of the claimed invention (‘267: Claim 2).
Regarding Claim 10, ‘267 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘267-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘267-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘267-Edwards combination teaches all of the claimed invention (‘267: Claim 2).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 12285559 B2, hereafter ‘559, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘559 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘559-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘559-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘559-Edwards combination teaches all of the claimed invention (‘559: Claim 2).
Regarding Claim 10, ‘559 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘559-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘559-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘559-Edwards combination teaches all of the claimed invention (‘559: Claim 2).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 11771852 B2, hereafter ‘852, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘852 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘852-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘852-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘852-Edwards combination teaches all of the claimed invention (‘852: Claim 2).
Regarding Claim 10, ‘852 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘852-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘852-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘852-Edwards combination teaches all of the claimed invention (‘852: Claim 2).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of U.S. Patent No. US 12642920 B2, hereafter ‘920, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘920 discloses most of the claimed invention (Claims 15-16) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘920-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘920-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘920-Edwards combination teaches all of the claimed invention (‘920: Claims 15-16).
Regarding Claim 10, ‘920 discloses most of the claimed invention (Claims 15-16) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘920-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘920-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘920-Edwards combination teaches all of the claimed invention (‘920: Claims 15-16).
Claims 2-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/219,329, hereafter ‘329, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘329 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘329-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘329-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘329-Edwards combination teaches all of the claimed invention (‘329: Claim 2).
Regarding Claim 10, ‘329 discloses most of the claimed invention (Claim 2) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘329-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘329-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘329-Edwards combination teaches all of the claimed invention (‘329: Claim 2).
Claims 2-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 19/191,443, hereafter ‘443, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘443 discloses most of the claimed invention (Claim 5) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘443-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘443-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘443-Edwards combination teaches all of the claimed invention (‘443: Claim 5).
Regarding Claim 10, ‘443 discloses most of the claimed invention (Claim 5) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘443-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘443-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘443-Edwards combination teaches all of the claimed invention (‘443: Claim 5).
Claims 2-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of copending Application No. 17/609,610, hereafter ‘610, in view of Edwards et al. (US 2013/0327327 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘610 discloses most of the claimed invention (Claims 9-10) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 reservoir to be removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claim 3, ‘610-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘610-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 6-9, ‘610-Edwards combination teaches all of the claimed invention (‘610: Claims 9-10).
Regarding Claim 10, ‘610 discloses most of the claimed invention (Claim 9-10) except for: a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 reservoir to be removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
Regarding Claims 11-12, ‘610-Edwards combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘610-Edwards combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘610-Edwards combination teaches all of the claimed invention (‘610: Claims 9-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US 20020129812 A1 discusses a nebulizer with single dose and multi-dose cartridges.
US 20150352301 A1 discusses self-puncturing liquid drug cartridges with a vibratable membrane.
US 6223744 B1 discusses a wearable aerosol delivery apparatus with a reservoir containing at least one dose.
US 20020056760 A1 discusses an inhaler that teaches reducing the size of the reservoir for single dose.
US 20010002592 A1 discusses an apparatus for nebulizing a liquid in which the tank can be a reuseable container or a single-dose cartridge.
US 20060054166 A1 discusses an inhalation nebulizer in which the liquid storage container can be provided a metered volume from a single dose or multi dose container.
US 3828773 A discusses a nebulizing apparatus that is suitable for controlled single or multiple dosage.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 pm.
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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