DETAILED ACTION
This Office Action is in response to the filing of the application on 11/30/2022. Since the initial filing, no claims have been amended, added, or cancelled. Thus, claims 1-18 are pending in the application.
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 because Figs. 7, 9, 10, 11, and 12 show an exploded view, which should be embraced by a bracket to show the structural relationship between the components as required by 37 CFR 1.84(h)(1).
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.
Claim Objections
Claims 5 and 17 are objected to because of the following informalities:
Claims 5 and 17 recite the language “light source” in line 3. Examiner suggests changing to read --the light source-- in order to correct a grammatical issue.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 5, 11, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “and associated electronics” in lines 10-11. However, it is unclear what structures are being referred to by the term “associated electronics.” The limitation is too broad such that it is unclear what the limit of “associated electronics” for operation of the piezoelectric oscillator are (e.g. could include wires, a wirelessly connected cell-phone/ computer, a charging cable/ outlet and the entire power grid that connects to the outlet, and so on). As such, the claimed limitation is indefinite because its metes and bounds can’t be determined.
Claim 5 recites the term “can operate” in line 14. It is unclear whether or not the limitation which follows is being positively claimed, or is optional.
Claim 11 recites the term “can operate” in line 18. It is unclear whether or not the limitation which follows is being positively claimed, or is optional.
Claim 17 recites the term “can operate” in line 14. It is unclear whether or not the limitation which follows is being positively claimed, or is optional.
Any remaining claims are rejected for being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins, JR. et al. (US Pub. 2010/0222752; hereinafter “Collins”).
Regarding claim 1, Collins discloses a portable nebulizing device (see fluid atomizing device of Figs. 28-29) that integrates medication delivery with a reservoir to avoid cross-contamination (see [0234] and Fig. 32 where a medule containing the medicament is removable and replaceable, which allows the system avoid cross-contamination by replacing between patients), the portable nebulizing device comprising: a replaceable cartridge ([0234] and Figs. 32 and 35, the replaceable medule 2024 (the assembly of Fig. 35)) that connects to a reusable controller (see [0207] and Fig. 32 where microprocessor 2020 controls the system, and remains in place during replacement of the medule, see also [0202] where the controller remains in the system during replacement of the cartridge); the replaceable cartridge including a reservoir (see Fig. 35 where the shown replaceable medule has a reservoir 2006), the reservoir prefilled with medication (see [0233]-[0234] where the medule is pre-filled with the medicament); the replaceable cartridge including a piezoelectric oscillator (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213]), the piezoelectric oscillator acting to nebulize the medication (see [0222]), forming a mist for inhalation (see [0222] where the oscillation of the mesh plate creates a mist; see also [0233] where the system can be adapted for respiratory medicaments to be inhaled); the reusable controller including a battery and associated electronics for operation of the piezoelectric oscillator (see Fig. 32 where battery 2022 connects to microprocessor 2020, and any other electronics to operate the system; see also [0207]); whereby a user selects a replaceable cartridge (see [0234] where a replaceable medule is selected by the user), connects it to the reusable controller (see [0234] and Fig. 32 where the replaceable medule is connected to the housing of the device including handle portion 2004 with includes the microprocessor 2020), and uses the reusable controller to operate the piezoelectric oscillator (see [0207] and [0222]), causing the piezoelectric oscillator to dispense medication as a mist (see [0222]).
Regarding claim 2, Collins discloses the replaceable cartridge further comprising: a wick (see Fig. 35 wick 2046); the wick placed within the reservoir (see Fig. 35 where wick 2046 is within reservoir 2006); the wick carrying medication from the reservoir to the piezoelectric oscillator (see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056), where the medication is nebulized (see [0222] where the oscillation of the mesh plate creates a mist); whereby the wick ensures a consistent flow of medication to the piezoelectric oscillator (see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056 that is not affected by orientation and remains consistent within a range of 2.6 to 3.2 microliters per second).
Regarding claim 3, Collins discloses wherein: the wick is supported by a wick sleeve (see Figs. 35 and 54 where the wick 2046 can be enclosed by plug 2036, which can run along the length of the wick as seen in [0208] and Fig. 54 (as Fig. 49b does not exist)); the wick sleeve including channels that allow liquid from within the reservoir to be pass through the wick to the piezoelectric oscillator (see [0208] where the plug 2036 that encloses the wick 2046 can have cutouts in the plug that allow the fluid to contact the wick, and thus reach the mesh plate).
Regarding claim 7, Collins discloses a portable nebulizer for administering medication (see fluid atomizing device of Figs. 28-29), the portable nebulizer comprising: a replaceable cartridge ([0234] and Figs. 32 and 35, the replaceable medule 2024 (the assembly of Fig. 35)); a reservoir within the replaceable cartridge(see Fig. 35 where the shown replaceable medule has a reservoir 2006); a piezoelectric oscillator within the replaceable cartridge (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213]); the piezoelectric oscillator causing nebulization of liquid medication from within the reservoir (see [0222]), resulting in a mist that is discharged (see [0222] where the oscillation of the mesh plate creates a mist); the piezoelectric oscillator integrated into the replaceable cartridge (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213] where it is part of the medule), such that when the replaceable cartridge is replaced, the piezoelectric oscillator is also replaced (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213] where it is part of the replaceable medule); whereby replacing the piezoelectric oscillator when the replaceable cartridge is switched avoids cross-contamination of different liquid medications (see [0234] and Fig. 32 where a medule containing the medicament is removable and replaceable, which allows the system avoid cross-contamination by replacing between patients).
Regarding claim 8, Collins discloses the replaceable cartridge further comprising: a wick (see Fig. 35 wick 2046); the wick placed within the reservoir (see Fig. 35 where wick 2046 is within reservoir 2006); the wick carrying medication from the reservoir to the piezoelectric oscillator (see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056), where the medication is nebulized (see [0222] where the oscillation of the mesh plate creates a mist); whereby the wick ensures a consistent flow of medication to the piezoelectric oscillator (see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056 that is not affected by orientation and remains consistent within a range of 2.6 to 3.2 microliters per second).
Regarding claim 9, Collins discloses wherein: the wick is supported by a wick sleeve (see Figs. 35 and 54 where the wick 2046 can be enclosed by plug 2036, which can run along the length of the wick as seen in [0208] and Fig. 54 (as Fig. 49b does not exist)); the wick sleeve including channels that allow liquid from within the reservoir to be drawn into the wick to the piezoelectric oscillator (see [0208] where the plug 2036 that encloses the wick 2046 can have cutouts in the plug that allow the fluid to contact the wick, and thus reach the mesh plate).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Fornarelli (US Pub. 2017/0027230).
Regarding claim 13, Collins discloses a portable device for administering medication via nebulization (see fluid atomizing device of Figs. 28-29), the portable device including: a controller section (see [0207] and Fig. 32 where handle 2004 contains microprocessor 2020 which controls the system); a battery within the controller section (see Fig. 32 where battery 2022 is within the handle 2004); a cartridge ([0234] and Figs. 32 and 35, the replaceable medule 2024 (the assembly of Fig. 35)); the cartridge affixed to the controller section (see Fig. 32 where handle 2004 connects to and is integral with head 2002, such that the handle is affixed to the medule 2024 (Fig. 35)); a reservoir within the cartridge (see Fig. 35 where the shown replaceable medule has a reservoir 2006); a piezoelectric oscillator permanently affixed to the cartridge (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213]), whereby the piezoelectric oscillator is disposed of with the cartridge when the reservoir has been emptied of medication (see Fig. 35 where the replaceable medule shown has mesh plate 2056, which acts as a piezoelectric oscillator; see [0213], and thus is disposed of with the medule as seen in [0234]); whereby the cartridge is replaced, avoiding cross-contamination and thus ensuring accurate dosing (see [0234] and Fig. 32 where a medule containing the medicament is removable and replaceable, which allows the system avoid cross-contamination by replacing between patients).
Collins lacks a detailed description of whereby the piezoelectric oscillator is disposed of with the cartridge and controller when the reservoir has been emptied of medication; whereby the controller and cartridge are replaced simultaneously, avoiding cross-contamination and thus ensuring accurate dosing. However, it is noted that it is up to the user of the device to decide the disposability of the device. Hence, a user of the Collins device could choose to dispose of the entire device, or sections of the device, at any point, and replace them as needed. Thus, disposing of the Collins device and replacing it with a new device is considered to both 1) dispose of the cartridge and controller, and 2) replace the controller and cartridge. In the alternative that Collins does not have this feature, then it is taught by Fornarelli.
However, Fornarelli teaches a similar handheld vaporization device, where the entire device is disposable (see disposable assembly 10 in Fig. 1).
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 Collins device to be disposable as taught by Fornarelli, as it would keep the liquid securely contained without outside environmental influence (Fornarelli; see [0005]) while also ensuring that the device is not shared among users eliminating cross-contamination. It is understood that the device of Claim 13 only has two claimed segments, 1) a controller section and 2) a cartridge, which are both being simultaneously replaced. Thus, replacing the entire device with a new device also replaced both the controller and cartridge simultaneously.
Regarding claim 14, the modified Collins device has the cartridge further comprising: a wick (Collins; see Fig. 35 wick 2046); the wick placed within the reservoir (Collins; see Fig. 35 where wick 2046 is within reservoir 2006); the wick carrying medication from the reservoir to the piezoelectric oscillator (Collins; see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056), where the medication is nebulized (Collins; see [0222] where the oscillation of the mesh plate creates a mist); whereby the wick ensures a consistent flow of medication to the piezoelectric oscillator (Collins; see [0209] where the wick 2046 regulates fluid delivery to mesh plate 2056 that is not affected by orientation and remains consistent within a range of 2.6 to 3.2 microliters per second).
Regarding claim 15, the modified Collins device has wherein: the wick is supported by a wick sleeve (Collins; see Figs. 35 and 54 where the wick 2046 can be enclosed by plug 2036, which can run along the length of the wick as seen in [0208] and Fig. 54 (as Fig. 49b does not exist)); the wick sleeve including channels that allow liquid from within the reservoir to be drawn into the wick to the piezoelectric oscillator (Collins; see [0208] where the plug 2036 that encloses the wick 2046 can have cutouts in the plug that allow the fluid to contact the wick, and thus reach the mesh plate).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Collins as applied to claims 3 and 9 above, respectively, and further in view of Modlin et al. (US Pub. 2010/0224697).
Regarding claim 4, Collins discloses the wick within the wick sleeve.
Collins lacks a detailed description of the spring compressing the wick within the wick sleeve; the spring maintaining pressure of the wick against the piezoelectric oscillator; whereby the spring ensures consistent contact between the wick and the piezoelectric oscillator to ensure consistent delivery of medication.
However, Modlin teaches a device for dispensing particles via an ultrasonic transducer, where a spring (see Fig. 11 wick support housing spring 225) compresses a wick (see Fig. 11 wick 221) within a wick sleeve (see Fig. 11 wick support housing 223); the spring maintaining pressure of the wick against the oscillator (see [0064] (namely the page 11 portion) and Fig. 11 where wick 221 is forced into a bias state against a permeable vibrating surface 213A by use of the wick support hosing spring 225); whereby the spring ensures consistent contact between the wick and the oscillator to ensure consistent delivery of fluid (see [0064] (namely the page 11 portion) and Fig. 11 where the wick is maintained against the at a constant pressure of a few psi to maintain the bias and hold wick 221 in contact with permeable vibrating surface 213A for delivery of the fluid).
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 wick and wick sleeve of Collins to have a biasing spring as taught by Modlin, as it would hold the wick in contact with the piezoelectric oscillator, ensuring a constant and smooth flow of fluid to the oscillator without interruption.
Regarding claim 10, Collins discloses the wick within the wick sleeve.
Collins lacks a detailed description of the spring compressing the wick within the wick sleeve; the spring maintaining pressure of the wick against the piezoelectric oscillator; whereby the spring ensures consistent contact between the wick and the piezoelectric oscillator to ensure consistent delivery of medication.
However, Modlin teaches a device for dispensing particles via an ultrasonic transducer, where a spring (see Fig. 11 wick support housing spring 225) compresses a wick (see Fig. 11 wick 221) within a wick sleeve (see Fig. 11 wick support housing 223); the spring maintaining pressure of the wick against the oscillator (see [0064] (namely the page 11 portion) and Fig. 11 where wick 221 is forced into a bias state against a permeable vibrating surface 213A by use of the wick support hosing spring 225); whereby the spring ensures consistent contact between the wick and the oscillator to ensure consistent delivery of fluid (see [0064] (namely the page 11 portion) and Fig. 11 where the wick is maintained against the at a constant pressure of a few psi to maintain the bias and hold wick 221 in contact with permeable vibrating surface 213A for delivery of the fluid).
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 wick and wick sleeve of Collins to have a biasing spring as taught by Modlin, as it would hold the wick in contact with the piezoelectric oscillator, ensuring a constant and smooth flow of fluid to the oscillator without interruption.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Fornarelli as applied to claim 15 above, and further in view of Modlin.
Regarding claim 10, the modified Collins device has the wick within the wick sleeve.
The modified Collins device lacks a detailed description of the spring compressing the wick within the wick sleeve; the spring maintaining pressure of the wick against the piezoelectric oscillator; whereby the spring ensures consistent contact between the wick and the piezoelectric oscillator to ensure consistent delivery of medication.
However, Modlin teaches a device for dispensing particles via an ultrasonic transducer, where a spring (see Fig. 11 wick support housing spring 225) compresses a wick (see Fig. 11 wick 221) within a wick sleeve (see Fig. 11 wick support housing 223); the spring maintaining pressure of the wick against the oscillator (see [0064] (namely the page 11 portion) and Fig. 11 where wick 221 is forced into a bias state against a permeable vibrating surface 213A by use of the wick support hosing spring 225); whereby the spring ensures consistent contact between the wick and the oscillator to ensure consistent delivery of fluid (see [0064] (namely the page 11 portion) and Fig. 11 where the wick is maintained against the at a constant pressure of a few psi to maintain the bias and hold wick 221 in contact with permeable vibrating surface 213A for delivery of the fluid).
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 wick and wick sleeve of the modified Collins device to have a biasing spring as taught by Modlin, as it would hold the wick in contact with the piezoelectric oscillator, ensuring a constant and smooth flow of fluid to the oscillator without interruption.
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Collins as applied to claims 1 and 7 above, respectively, and further in view of another embodiment of Collins in view of Bache et al. (US Pub. 2019/0200675).
Regarding claim 5, Collins discloses the reusable controller and the piezoelectric oscillator.
The Collins embodiment lacks a detailed description of a light source: the light source having one or more states, including an on state where light is emitted, and an off state where light is not emitted; the light source operated by the reusable controller; the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir ; whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed.
However, a further embodiment of Collins teaches a similar embodiment of an atomizing device, where there is a light source (see [0185] indicator 1920 which can be a blinking light) the light source having one or more states (see [0185] where indicator 1920 has at least two states, being a state before activation, and the activation state), including an on state where light is emitted, and an off state where light is not emitted (see [0185] where indicator 1920 has at least two states, being a state before activation (off state), and the activation state (on state)); the light source operated by the reusable controller (see [0185] where the system controller 190 operates and includes the indicator 1920); the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir (see [0185] where the indicator 1920 is used to indicate an end to the current dispensation of medicament); whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed (see [0185] where the indicator light 1920 controlled by the system controller 190 is used to indicate that a dosage has been dispensed, which is an appropriate amount of medicament).
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 atomization device of Collins to include an indicator light for indicating a dosage completion as further taught by Collins (see [0185]), as it would provide a visual alert to the user that the dispensing of the medicament is finished, and the device can be moved away from the orifice (see [0185]).
The modified Collins device lacks a detailed description of wherein the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir.
However, Bache teaches a electric vaporization system, where the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir (see [0097] where the cartridge 20 can communicate to the processor 502 regarding what type of pre-vapor formulation is within the cartridge).
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 cartridge and controller of the modified Collins device to communicate the type of medication from the cartridge to the controller as taught by Bache, as it would allow for the controller to change the operational parameters based on the type of drug attached to the system, as well as change the fluid level sensor to adjust based on the drug composition (Bache; see [0097]-[0100], and where Collins has a fluid level sensor, as seen at Fig. 3 low level sensor 1250).
Regarding claim 11, Collins discloses the reusable controller connecting to the replaceable cartridge to create an operable portable nebulizer (a reusable controller (see [0207] and Fig. 32 where microprocessor 2020 controls the system, and remains in place during replacement of the medule, see also [0202] where the controller remains in the system during replacement of the cartridge and connects to the cartridge) and the piezoelectric oscillator.
The Collins embodiment lacks a detailed description of a light source: the light source having one or more states, including an on state where light is emitted, and an off state where light is not emitted; the light source operated by the reusable controller; the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir ; whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed.
However, a further embodiment of Collins teaches a similar embodiment of an atomizing device, where there is a light source (see [0185] indicator 1920 which can be a blinking light) the light source having one or more states (see [0185] where indicator 1920 has at least two states, being a state before activation, and the activation state), including an on state where light is emitted, and an off state where light is not emitted (see [0185] where indicator 1920 has at least two states, being a state before activation (off state), and the activation state (on state)); the light source operated by the reusable controller (see [0185] where the system controller 190 operates and includes the indicator 1920); the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir (see [0185] where the indicator 1920 is used to indicate an end to the current dispensation of medicament); whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed (see [0185] where the indicator light 1920 controlled by the system controller 190 is used to indicate that a dosage has been dispensed, which is an appropriate amount of medicament).
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 atomization device of Collins to include an indicator light for indicating a dosage completion as further taught by Collins (see [0185]), as it would provide a visual alert to the user that the dispensing of the medicament is finished, and the device can be moved away from the orifice (see [0185]).
The modified Collins device lacks a detailed description of wherein the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir.
However, Bache teaches a electric vaporization system, where the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir (see [0097] where the cartridge 20 can communicate to the processor 502 regarding what type of pre-vapor formulation is within the cartridge).
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 cartridge and controller of the modified Collins device to communicate the type of medication from the cartridge to the controller as taught by Bache, as it would allow for the controller to change the operational parameters based on the type of drug attached to the system, as well as change the fluid level sensor to adjust based on the drug composition (Bache; see [0097]-[0100], and where Collins has a fluid level sensor, as seen at Fig. 3 low level sensor 1250).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Fornarelli as applied to claim 13 above, and further in view of another embodiment of Collins in view of Bache.
Regarding claim 17, the modified Collins device has the reusable controller and the piezoelectric oscillator.
The modified Collins device lacks a detailed description of a light source: the light source having one or more states, including an on state where light is emitted, and an off state where light is not emitted; the light source operated by the reusable controller; the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir ; whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed.
However, a further embodiment of Collins teaches a similar embodiment of an atomizing device, where there is a light source (see [0185] indicator 1920 which can be a blinking light) the light source having one or more states (see [0185] where indicator 1920 has at least two states, being a state before activation, and the activation state), including an on state where light is emitted, and an off state where light is not emitted (see [0185] where indicator 1920 has at least two states, being a state before activation (off state), and the activation state (on state)); the light source operated by the reusable controller (see [0185] where the system controller 190 operates and includes the indicator 1920); the reusable controller changing between the one or more states of the light source to indicate the piezoelectric oscillator has dispensed one dose of the medication held within the reservoir (see [0185] where the indicator 1920 is used to indicate an end to the current dispensation of medicament); whereby the reusable controller can operate the light source to indicate when an appropriate dosage of medication has been dispensed (see [0185] where the indicator light 1920 controlled by the system controller 190 is used to indicate that a dosage has been dispensed, which is an appropriate amount of medicament).
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 atomization device of the modified Collins device to include an indicator light for indicating a dosage completion as further taught by Collins (see [0185]), as it would provide a visual alert to the user that the dispensing of the medicament is finished, and the device can be moved away from the orifice (see [0185]).
The modified Collins device lacks a detailed description of wherein the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir.
However, Bache teaches a electric vaporization system, where the replaceable cartridge communicates to the reusable controller a type of medication held within the reservoir (see [0097] where the cartridge 20 can communicate to the processor 502 regarding what type of pre-vapor formulation is within the cartridge).
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 cartridge and controller of the modified Collins device to communicate the type of medication from the cartridge to the controller as taught by Bache, as it would allow for the controller to change the operational parameters based on the type of drug attached to the system, as well as change the fluid level sensor to adjust based on the drug composition (Bache; see [0097]-[0100], and where Collins has a fluid level sensor, as seen at Fig. 3 low level sensor 1250).
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Collins as applied to claims 1 and 7 above, respectively, and further in view of Rubsamen et al. (US Pat. 5,507,277).
Regarding claim 6, Collins discloses a fluid within the reservoir (see Fig. 35 fluid 2008 within reservoir 2006); a medication within the fluid (see [0205] where the fluid 2008 contains the drug being administered); the medication having a set concentration (where a pre-filled medule has some set concentration that does not change; see also [0221] where the medule container can indicate the concentration of the medication within the fluid); whereby dispensing a certain volume of fluid results in dispensation of a known quantity of medication (see [0225] where the fluid is discharged at a known range of values between 2 and 10 microliters, and for .5 to 5 seconds, for a known volume of dispersion, and thus a known quantity of medication is given based on the known and labeled concentration).
Collins lacks a detailed description of the fluid being water-based with the medication within the fluid.
However, Rubsamen teaches a device for delivering a medicament to a patient, where the medicament can be in an aqueous form where the drug is dissolved in water before aerosolized (see Col. 14 lines 65-67).
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 medicament delivered by the Collins device to be an aqueous solution with the drug dissolved in water as taught by Rubsamen, as it would be a simple substitution of one type of fluid medicament for another, with the benefit of being able to be used with drugs which are water-soluble.
Regarding claim 12, Collins discloses a fluid within the reservoir (see Fig. 35 fluid 2008 within reservoir 2006); a medication within the fluid (see [0205] where the fluid 2008 contains the drug being administered); the medication having a set concentration (where a pre-filled medule has some set concentration that does not change; see also [0221] where the medule container can indicate the concentration of the medication within the fluid); whereby dispensing a certain volume of fluid results in dispensation of a known quantity of medication (see [0225] where the fluid is discharged at a known range of values between 2 and 10 microliters, and for .5 to 5 seconds, for a known volume of dispersion, and thus a known quantity of medication is given based on the known and labeled concentration).
Collins lacks a detailed description of the fluid being water-based with the medication within the fluid.
However, Rubsamen teaches a device for delivering a medicament to a patient, where the medicament can be in an aqueous form where the drug is dissolved in water before aerosolized (see Col. 14 lines 65-67).
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 medicament delivered by the Collins device to be an aqueous solution with the drug dissolved in water as taught by Rubsamen, as it would be a simple substitution of one type of fluid medicament for another, with the benefit of being able to be used with drugs which are water-soluble.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Fornarelli as applied to claims 13 above, and further in view of Rubsamen.
Regarding claim 18, the modified Collins device has a fluid within the reservoir (Collins; see Fig. 35 fluid 2008 within reservoir 2006); a medication within the fluid (Collins; see [0205] where the fluid 2008 contains the drug being administered); the medication having a set concentration (Collins; where a pre-filled medule has some set concentration that does not change; see also [0221] where the medule container can indicate the concentration of the medication within the fluid); whereby dispensing a certain volume of fluid results in dispensation of a known quantity of medication (Collins; see [0225] where the fluid is discharged at a known range of values between 2 and 10 microliters, and for .5 to 5 seconds, for a known volume of dispersion, and thus a known quantity of medication is given based on the known and labeled concentration).
The modified Collins device lacks a detailed description of the fluid being water-based with the medication within the fluid.
However, Rubsamen teaches a device for delivering a medicament to a patient, where the medicament can be in an aqueous form where the drug is dissolved in water before aerosolized (see Col. 14 lines 65-67).
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 medicament delivered by the modified Collins device to be an aqueous solution with the drug dissolved in water as taught by Rubsamen, as it would be a simple substitution of one type of fluid medicament for another, with the benefit of being able to be used with drugs which are water-soluble.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Flayler (US Pub. 2016/0286860) and Wu (US Pat. 9,427,026) are cited to show similar portable nebulizing devices with a controller and a battery.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785