DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 103, 106, 109-110, 114, 116-117, and 119-121 are objected to because of the following informalities:
Claim 103 recites the limitation “the pump” in line 2. This limitation should be amended to recite “the pumping element” to maintain consistency in the claims.
Claim 106 recites the limitation “which pump”. This limitation should be amended to recite “which the pump”.
Claim 109 recites the limitation “the durable” in line 2. This limitation should be amended to recite “the durable system device” to maintain consistency in the claims.
Claim 110 recites the limitation “the durable system”. This limitation should be amended to recite “the durable system device” to maintain consistency in the claims.
Claim 114 recites the limitation “the material” in line 4. This limitation should be amended to recite “the compliant material” to maintain consistency in the claims.
Claim 114 recites the limitation “all of the nozzles of the array” in line 5. This limitation should be amended to recite “the nozzle array” to maintain consistency in the claims.
Claim 114 recites the limitation “wherein the sealing system can be moved to a second position when the user is inhaling through the airway”. This limitation should be amended to recite “configured to” language.
Claim 116 recites the limitation “the inhaler creates an aerosol into the inhalation airflow of the user”. This limitation should be amended to recite “configured to” language.
Claim 117 recites the limitation “a pressure sensor that detects a pressure drop in the airway when the user is inhaling”. This limitation should be amended to recite “configured to” language.
Claim 117 recites the limitation “the airway” in line 2. This limitation should be amended to recite “the inhalation airflow of the user” to maintain consistency in the claims.
Claim 119 recites the limitation “their inhalation rate”. This limitation should be amended to recite “the inhalation airflow rate” to maintain consistency in the claims.
Claim 119 recites the limitation “wherein the controller will restart aerosol generation if the user”. This limitation should be amended to recite “configured to” language.
Claim 120 recites the limitation “A durable system device”. The “A” should be lower case.
Claim 120 recites the limitation “the durable” in line 3. This limitation should be amended to recite “the durable system device” to maintain consistency in the claims.
Claim 120 recites the limitation “drawn out of it”. This limitation should be amended to recite “drawn out of the formulation chamber” to remove the use of the pronoun “it”.
Claim 120 recites the limitation “the cartridge” in line 8. This limitation should be amended to recite “the multidose cartridge” to maintain consistency in the claims.
Claim 121 recites the limitation “the cartridge” in lines 3 and 4. This limitation should be amended to recite “the multidose cartridge” to maintain consistency in the claims.
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 110-123 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 106 recites the limitation “a pump”. This limitation renders the claim indefinite because it is unclear if the pump recited in claim 106 is the same pumping element recited in claim 102 or a new pumping element. For the purpose of examination, Examiner will interpret this limitation as the same pumping element recited in claim 102.
Claim 110 recites the limitation “a pump”. This limitation renders the claim indefinite because it is unclear if the pump recited in claim 110 is the same pumping element recited in claim 102 or a new pumping element. For the purpose of examination, Examiner will interpret this limitation as the same pumping element recited in claim 102.
Claim 113 recites the limitation “the outlet” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an outlet”.
Claim 114 recites the limitation “the first position” in line 5. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a first position”.
Claim 114 recites the limitation “the user” in line 6. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a user”.
Claim 114 recites the limitation “the airway” in line 7. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an airway”.
Claim 114 recites the limitation “the airway” in line 7. This limitation renders the claim indefinite because it is unclear if Applicant is referring to an airway of the user, or an airway of the inhaler. For the purpose of examination, Examiner will interpret this limitation as an airway of the inhaler.
Claim 115 recites the limitation “the array of nozzle holes” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the nozzle array”.
Claim 116 recites the limitation “the inhalation airflow of the user” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an inhalation airflow of the user”.
Claim 116 recites the limitation “the average direction” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an average direction”.
Claim 116 recites the limitation “the array of holes” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the nozzle array”.
Claim 117 recites the limitation “the controller” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a controller”.
Claim 117 recites the limitation “the aerosolizer” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an aerosolizer”.
Claim 117 recites the limitation “the generation of aerosol” in line 4. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a generation of aerosol”.
Claim 118 recites the limitation “the lack” in line 1. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a lack”.
Claim 118 recites the limitation “the aerosolization” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the generation of aerosol”.
Claim 119 recites the limitation “the pressure threshold” in line 2. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the predetermined pressure drop”.
Claim 120 recites the limitation “the outlet” in line 7. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an outlet”.
Claim 121 recites the limitation “the drug contact surfaces” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a plurality of drug contact surfaces”.
Claim 122 recites the limitation “the aerosolizer” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an aerosolizer”.
Claim 122 recites the limitation “the amplitude” in line 3. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an amplitude”.
Claim 122 recites the limitation “the amount” in line 5. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an amount”.
Claim 122 recites the limitation “the user” in line 5. There is insufficient antecedent basis for the limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a user”.
Claims 111-112 and 123 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and thus, contain the same offending limitations.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 114-119 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubin (US 2019/0321570 A1).
In regards to claim 114, Rubin discloses an inhaler (10; see [0114]; see figure 1), comprising:
(i) a nozzle array (11; see [0114]; see figure 1; 11 is a round spout at the end of 15 for controlling the flow of 14 and thus, is considered a nozzle) which is formed in a substrate (substrate of 10; see figure 1); and
(ii) a sealing system (17 and 18; see [0116]; see figure 1) with a compliant material on one end (17 and 18 are valves and are thus, made from a compliant material which allows the valves to actuate);
wherein the material is in contact with the substrate (see figure 1) and blocks all or substantially all of the nozzles of the array when in the first position (closed position; 17 and 18 seal the internal environment of 10 when in a closed position and thus, block 11 from an external environment); and
further wherein the sealing system (17 and 18) can be moved to a second position (open position) when the user is inhaling through the airway (see [0116]).
In regards to claim 115, Rubin discloses the invention as discussed above.
Rubin further discloses further wherein the inhaler vibrates the substrate which contains the array of nozzle holes (see [0114]).
In regards to claim 116, Rubin discloses the invention as discussed above.
Rubin further discloses wherein the inhaler creates an aerosol into the inhalation airflow of the user (see [abstract], and further wherein the airflow flows in a direction which is substantially perpendicular to the average direction of aerosol generation from the array of holes (see figure 1 that the outlet 20 is perpendicular to 11).
In regards to claim 117, Rubin discloses the invention as discussed above.
Rubin further discloses further comprising a pressure sensor (airflow sensors; see [0122]) that detects a pressure drop in the airway when the user is inhaling (airflow sensors detect inhalation and thus, detect a pressure drop), whereupon when the controller (31; see [0122]; see figure 1) determines that a predetermined pressure drop has been exceeded, it actuates the aerosolizer and thus the generation of aerosol (31 can interpret the data to activate and aerosol generation; see [0122]).
In regards to claim 118, Rubin discloses the invention as discussed above.
Rubin further discloses wherein the controller senses the lack of sufficient inhalation airflow rate and stops the aerosolization (31 can interpret the data to regulate aerosol generation; see [0122]).
In regards to claim 119, Rubin discloses the invention as discussed above.
Rubin further discloses wherein the controller will restart aerosol generation if the user increases their inhalation rate and again exceeds the pressure threshold (31 monitors inhalation and activates aerosol generation during said inhalation; see [0122]) .
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentvelsen et al. (US 2013/0327322 A1) (hereinafter Bentvelsen) in view of Sexton et al. (US 2005/0166913 A1) (hereinafter Sexton).
In regards to claim 1, Bentvelsen discloses an aerosol generative device (20; see [0021]; see figure 4), comprising:
(i) a recirculation system (system seen in figure 4) comprising a first fluid passageway (2; see [0021]; see figure 4) that extends from a formulation chamber (1; see [0021]; see figure 4) to a pumping element (8; see [0021]; see figure 4);
(ii) a second fluid passageway (passageway between 3 and 8) that extends from the pumping element (8) to a pocket (3; see [0021]; see figure 4) directly behind an aerosolizer (5; see [0021]; see figure 4); and
(iii) a third fluid passageway (7; see [0021]; see figure 4) that extends from the pocket back to the first fluid passageway (7 extends from 3 and back to 2 through 1; see figure 4).
Bentvelsen does not disclose the aerosol generating device is an inhaler.
However, Sexton teaches an analogous aerosol generative device (10; see [0027]; see figure 2) which is an inhaler (see [0027]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol generating device as disclosed by Bentvelsen and to have formed the aerosol generating device as an inhaler as taught by Sexton in order to have provided an improved aerosol generating device that would add the known benefits of inhalers being smaller, and portable.
Claim(s) 103-106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentvelsen in view of Sexton as applied to claim 102 above, and further in view of Stedman et al. (US 2015/0352301 A1) (hereinafter Stedman).
In regards to claim 103, Bentvelsen as now modified by Sexton discloses the invention as discussed above.
Bentvelsen as now modified by Sexton does not disclose further comprising a filter placed between the pump and the pocket.
However, Stedman teaches an analogous aerosol generating device (40; see [0067]; see figure 3) comprising an analogous pump (20; see [0066]; see figure 3) and pocket (pocket defined by 58; see figure 2 and 3); further comprising a filter (16; see [0062]; see figure 6) placed between the pump and the pocket (see figure 3) for the purpose of filtering the medicament (see [0066]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol generating device as disclosed by Bentvelsen as now modified by Sexton and to have included the filter as taught by Stedman in order to have provided an improved aerosol generating device that would add the benefit of filtering the medicament prior to use (see [0066]) and therefore, ensuring the aerosolized medicament is free from potential contaminants prior to inhalation.
In regards to claim 104, Bentvelsen as now modified by Sexton and Stedman discloses the invention as discussed above.
Bentvelsen as now modified by Stedman further discloses wherein the filter has a pore size of about 0.1 µm to about 0.5 µm (see Stedman [0066]).
In regards to claim 105, Bentvelsen as now modified by Sexton and Stedman discloses the invention as discussed above.
Bentvelsen as now modified by Stedman further discloses wherein the pore size of the filter is chosen from about 0.1 µm, about 0.2 µm, and about 0.22 µm (see Stedman [0066]).
In regards to claim 105, Bentvelsen as now modified by Sexton and Stedman discloses the invention as discussed above.
Bentvelsen as now modified by Stedman further discloses further comprising a pump (8 of Bentvelsen) which pump is driven by a motor (8 uses 31 to create peristaltic like movements (see [0021]) and thus, inherently has a motor to drive 31 to create said movements), wherein whether the filter is intact can be determined by one or more of: an increase in motor speed, a decrease in current (the filter of Stedman creates an inhibiting force (see Stedman [0066]) therefore, a determination could be made by a user observing the system based on the current of the fluid that the filter is intact), an increase in voltage, and a shorter required pulse.
Claim(s) 107-108 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentvelsen in view of Sexton as applied to claim 102 above, and further in view of Century (US 2011/0223116 A1).
In regards to claim 107, Bentvelsen as now modified by Sexton discloses the invention as discussed above.
Bentvelsen as now modified by Sexton does not disclose further comprising a debubbler.
However, Century teaches an analogous aerosol generating device (see [abstract]) comprising an analogous formulation chamber (1101; see [0058]; see figure 11); further comprising a debubbler (1102 of 1101 may comprise a degasser (see [0059]) for the purpose of removing any bubbles or dissolved gasses (see [0059]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol generating device as disclosed by Bentvelsen as now modified by Sexton and to have included the debubbler as taught by Century in order to have provided an improved aerosol generating device that would add the benefit of adding a means for removing any bubbles or dissolved gasses (see [0059]).
In regards to claim 108, Bentvelsen as now modified by Sexton and Century discloses the invention as discussed above.
Bentvelsen as now modified by Century wherein the debubbler (degasser of Century) is a hydrophobic porous element (see Century [0059] that the degasser can be DEGASSEX.TM. Solvent Degasser which comprises a Teflon® membrane for removing the gas which is both hydrophobic and porous).
Claim(s) 109 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentvelsen in view of Sexton as applied to claim 102 above, and further in view of Voges (US 5,894,841 A).
In regards to claim 109, Bentvelsen as now modified by Sexton discloses the invention as discussed above.
Bentvelsen as now modified by Sexton does not disclose wherein the inhaler (10 of Sexton) is comprised of a durable system device (60 of Sexton; see Sexton [0035] and figure 2), and a multidose cartridge (32 of Sexton; see Sexton [0027] and figure 2; to form the aerosol generating device of Bentvelsen as an inhaler as taught by Sexton, the device of Bentvelsen would include the identified structures of Sexton).
Bentvelsen as now modified by Sexton does not disclose the multidose cartridge configured to be separably attached to the durable (system device). Sexton does disclose that 32 may be a container known in the art disclosed by U.S. Pat. No. 5,894,841 (Voges; see [0034]).
Voges teaches an analogous aerosol generating device (1; see [col 5 ln 50]; see figure 1) comprising an analogous durable system device (2 and 3; see [col 5 ln 50-55]; see figure 1) and multidose cartridge (10; see [col 5 ln 58]; see figure 2); the multidose cartridge (10) configured to be separably attached to the durable (system device) (see [col 6 ln 35-40]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the multidose cartridge as disclosed by Bentvelsen as now modified by Sexton and to have formed the multidose cartridge as being separable from the durable system device as taught by Voges in order to have provided an improved multidose cartridge that would add the benefit of being replaceable such that the empty cartridge can be replaced with a full cartridge as needed.
Claim(s) 110-113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentvelsen in view of Sexton and Voges as applied to claim 109 above, and further in view of Stalder et al. (US 2019/0321572 A1) (hereinafter Stalder).
In regards to claim 110, Bentvelsen as now modified by Sexton and Voges discloses the invention as discussed above.
Bentvelsen as now modified by Sexton further discloses further comprising a pump (8 of Bentvelsen), wherein the cartridge (32 of Sexton) contains components of a pump head (32 of Sexton is connected to 8 of Bentvelsen and thus, comprises a pump head (i.e. a connection to 8)), and the durable system (60 of Sexton) contains a pump motor (8 of Bentvelsen uses 31 to create peristaltic like movements (see [0021]) and thus, inherently has a motor to drive 31 to create said movements, said motor would be housed within 60 of Sexton when the device of Bentvelsen is utilized in the inhaler as taught by Sexton).
While 8 of Bentvelsen is described as a peristaltic pump which may comprise gear head, Bentvelsen as now modified by Sexton and Voges does not disclose the durable system contains a gear head.
However, Stalder teaches an analogous peristaltic pump (360; see [0067]; see figure 7) which comprises an analogous pump motor (see [0068]); further where the pump comprises a gear head (gear head which is inherently required to turn rotor 362; see [0067]) for the purpose of providing a flow of the aerosol forming substance into the supply conduit (see [0067]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump as disclosed by Bentvelsen as now modified by Sexton and Voges and to have included the gear head for turning the rotor mechanism of the pump as taught by Stalder in order to have provided an equivalent pump mechanism for providing a flow of the aerosol forming substance into the supply conduit (see [0067]).
In regards to claim 111, Bentvelsen as now modified by Sexton, Voges, and Stalder discloses the invention as discussed above.
Bentvelsen further discloses wherein the pump is a peristaltic pump (see [0021]).
In regards to claim 112, Bentvelsen as now modified by Sexton, Voges, and Stalder discloses the invention as discussed above.
Bentvelsen as now modified by Voges further discloses wherein the formulation chamber is flexible (see Voges [col 6 ln 31-40]).
Claim(s) 120-123 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sexton in view of Voges and Castro et al. (US 2002/0134376 A1) (hereinafter Castro).
In regards to claim 120, Sexton discloses an inhaler (10; see [0027]; see figure 2), comprising:
A durable system device (60; see [0035]; see figure 2), and a multidose cartridge (32; see [0034]; see figure 2) configured to be attached to the durable (see figure 2);
a formulation chamber containing a formulation comprising an active pharmaceutical ingredient (32 forms a chamber within 32 which comprises a pharmaceutical ingredient; see [0034]).
Sexton does not disclose the multidose cartridge configured to be separably attached to the durable (system device);
wherein the formulation chamber is flexible and collapses as formulation is drawn out of it; and
a valve placed close to the outlet of the formulation chamber, wherein the valve is opened upon connection of the cartridge to the durable system. Sexton does disclose that 32 may be a container known in the art disclosed by U.S. Pat. No. 5,894,841 (Voges; see [0034]).
Voges teaches an analogous aerosol generating device (1; see [col 5 ln 50]; see figure 1) comprising an analogous durable system device (2 and 3; see [col 5 ln 50-55]; see figure 1) and multidose cartridge (10; see [col 5 ln 58]; see figure 2); the multidose cartridge (10) configured to be separably attached to the durable (system device) (see [col 6 ln 35-40]); wherein the formulation chamber (10) is flexible and collapses as formulation is drawn out of it (see Voges [col 6 ln 31-40]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the multidose cartridge as disclosed by Sexton and to have formed the multidose cartridge as being separable from the durable system device, and formed from a flexible material which collapses as formulation is drawn out of it as taught by Voges in order to have provided an improved multidose cartridge that would add the benefit of being replaceable such that the empty cartridge can be replaced with a full cartridge as needed.
Sexton as now modified by Voges still does not disclose a valve placed close to the outlet of the formulation chamber, wherein the valve is opened upon connection of the cartridge to the durable system.
However, Castro teaches an analogous inhaler (10; see [0028]; see figure 1) comprising an analogous cartridge (12; see [0028]; see figure 1) and an analogous durable system device (16; see [0028]; see figure 1); further comprising a valve (14; see [0028]; see figure 1) placed close to the outlet of the formulation chamber (see figure 1), wherein the valve is opened upon connection of the cartridge to the durable system (14 is opened to the fill stage upon connection of 12 to 14 and actuation of 24; see [0042-0046]) for the purpose of providing a regulation of the volume of a medicinal formulation passing from a container to a metering chamber, which defines the maximum amount of the formulation that will be dispensed as the next dose (see [0004]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the durable system device as disclosed by Sexton as now modified by Voges and to have included the valve placed close to the outlet of the formulation chamber as taught by Castro in order to have provided an improved inhaler that would add the benefit of providing a regulation of the volume of a medicinal formulation passing from a container to a metering chamber, which defines the maximum amount of the formulation that will be dispensed as the next dose (see [0004]).
In regards to claim 121, Sexton as now modified by Voges and Castro discloses the invention as discussed above.
Sexton as now modified by Voges further discloses wherein one or more of a filter, a debubbler, flexible tubing (32 of Sexton as now modified by Voges is formed from a flexible tubing (see Voges [col 6 ln 35-40]), a rotor, an eccentric element or cam, a ring, and a support surface, are components of the cartridge; wherein the drug contact surfaces are contained wholly in the cartridge (32 of Sexton houses the drug and forms the only contact surfaces for the drug prior to aerolization).
In regards to claim 122, Sexton as now modified by Voges and Castro discloses the invention as discussed above.
Sexton further discloses wherein a computing system (40; see [0027]; see figure 1) controls an element chosen from a flow rate of one or more pumps, a state of one or more valves, a voltage supplied to the aerosolizer, the amplitude of oscillation of a component of the aerosolizer, a duration of pumping of one or more pumps, a duration of aerosolization of the aerosolizer (the inhaler control system 20, the medicament supply system 30, the medicament monitoring system 40, and in some instances the flow control system 50, are communicatively coupled to function together to control the release of the medicament (see [0028]) and thus, control a duration of aerosolization of the aerosolizer 34), such that the amount of nicotine, or other active ingredient, delivered to the user is consistently lowered over time.
In regards to claim 123, Sexton as now modified by Voges and Castro discloses the invention as discussed above.
Sexton further discloses wherein the element is a duration of aerosolization of an aerosolizer (the inhaler control system 20, the medicament supply system 30, the medicament monitoring system 40, and in some instances the flow control system 50, are communicatively coupled to function together to control the release of the medicament (see [0028]) and thus, control a duration of aerosolization of the aerosolizer 34).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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