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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 March 2026 has been entered.
Status of the Claims
Claims 1-5, 9, 11-13 are pending and subject to this Office Action. Claim 1 has been amended to include the limitations of claims 6, 8, and 10. Claim 7 has been canceled. Claims 12 and 13 have been added.
Response to Arguments
Applicant’s arguments, see pages 0, filed 06, with respect to the rejection(s) of claim(s) 1- under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of previously applied art and newly found art.
Claim 1 has been amended to add the limitations of claims 6, 8, and 10 and further add the limitations: after the liquid and gas are in dynamic equilibrium inside the first container.
Applicant argues, pages 7, that the Examiner's mapping is improper, as the source container cannot be equated with the aerosol-generating configuration recited in the claims.
The Examiner respectfully disagrees with this assessment. The limitations of independent claim one require:
a first container filled with a nicotine-containing solution and a propellant;
and a second container connected to the first container to be filled with the liquid of the first container,
a connection portion between the first container and the second container is opened
Sebastian teaches a cartridge that is designed to be filled with an aerosol precursor material containing nicotine and a propellant via source container(s) by way of a valve.[0051] The cartridge of Sebastian is considered to read on the first container and the source container is considered to read on the second container of the claims.
Applicant argues, page 8, that there is not teaching in Sebastian that corresponds to the limitation when the volume of the liquid in the first container is 15 vol% or less based on the internal volume of the first container, the repeated process of filling and depletion of the liquid is discontinued. Applicant goes on to argue that if the composition of the filling liquid differed at a later stage variations in the delivery could occur.
The Examiner notes that the claim language requires the filling be done when the liquid in the first container is 15% by volume or less. While Sebastian does not teach an explicit range where the refilling of the container would be needed, a person having ordinary skill would recognize that the first container would be required to be refilled when it was completely empty, which is also less than 15% by volume of the container.
Sebastian teaches that the cartridge can be refilled, the prior art does not explicitly teach that this process can be repeated multiple times with the same source container (first container). However, there is not structural difference between the prior art and the claimed invention and as such weight is not given to the limitation of how to refill the device as it does not distinguish the apparatus from the prior art structurally. The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim, and that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See MPEP §§ 2114 and 2173.05(g).
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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian, et al (US20170341850A1) and further in view of Rasouli, et al (US20110250324A1 from IDS dated 11/23/2022), Jang, et al (KR20200145152A, cited in IDS dated 11/23/2022) or in the alternative Geiger (US20090184131A1).
Regarding claim 1, Sebastian teaches an aerosol generating device and a device filling system designed to engage the filling system. (Abstract) The aerosol generating device contains a cartridge that has a reservoir that can be refilled. [0051] The device filling system is comprised of source containers that are designed to engage the aerosol delivery device to fill the delivery device with an aerosol precursor material. [0055] Sebastian teaches a source container and a cartridge with the reservoir, considered to read on the first and second containers respectively.
The aerosol precursor material in both the source container and subsequently the cartridge can contain a propellant [0008] and a nicotine content [0052] where the propellant is configured to expel the aerosol precursor. [0058] Sebastian teaches the cartridge is coupled to the source container by way of a valve assembly that comprises a one way valve. [0045]
Sebastian is silent as to the specifics of the aerosol precursor material and the phase of the propellant in the storage container or the cartridge reservoir.
Rasouli, directed to the design of hydrosol delivery devices, teaches one or more propellants in the storage canister may be a gas propellant, a compressed gas propellant, or a liquid propellant that forms a gas when expelled. [0021] As such, Rasouli teaches that the propellant can be in both the gas and liquid phase when in the storage container.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian by selecting a propellant that can be in both the liquid and gas phase in the storage (first) container as taught by Rasouli because both Sebastian and Rasouli are directed to propellant aerosol devices containing propellants, Rasouli teaches the propellant can also be a part of the formulation [0016] and can impact the sensory experience of the formulation [0012], and this involves using a known propellant to improve similar products in the same way.
Sebastian and Rasouli fail to teach that the internal space of the second container would have a mechanism that would be contracted or relaxed based on the amount of liquid in the container.
Jang, directed to the design of cartridges, teaches a cartridge that has a piston that is movable inside the container (second container) that is used to pressurize the liquid towards the outlet [0017] by reducing the volume of the space. When liquid is used to refill the second container the piston moves back to the bottom of the container. [0024]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by using a piston in the second container as taught by Jang because Sebastian, Rasouli and Jang are directed to aerosol delivery devices, Jang teaches this assures the liquid is moved towards the outlet plug [0070], and this involves combining prior art elements according to known methods to yield predictable results.
Alternatively, Geiger, directed to pressurized vessels with propellants, teaches that various forms of propellant for spraying substances are known. Geiger teaches that known an aerosol container where the storage camber contains a liquid substance to be sprayed and the propellant chamber contains a propellant composed of a gas phase and of a liquid phase. When the liquid is sprayed the volume of the storage chamber is decreased by means of the upward sliding of the piston. [0080]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by using a piston in the second container as taught by Geiger because Sebastian, Rasouli and Geiger are directed to aerosol delivery devices, Geiger teaches this configuration combined with a valve and a pressurized container allows a substance to be dispensed in a controlled manner [0062], and this involves combining prior art elements according to known methods to yield predictable results.
Additionally, Jang teaches the refilling of the cartridge is accomplished via a valve that is an electronic valve that allows the liquid to flow between the auxiliary container and the cartridge. The valve is operated by a signal from a controller [0077-0078] to allow for a certain amount of liquid composition to be transferred to the auxiliary container.[0083]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by using a valve for transferring a specific amount of a liquid composition to the cartridge as taught by Jang because Sebastian, Rasouli and Jang are directed to aerosol delivery devices, Jang teaches the valve is allows the liquid to flow between the cartridge and the auxiliary container until the valve is closed when the desired amount of liquid is contained in the auxiliary container [0078], and this involves combining prior art elements according to known methods to yield predictable results.
Sebastian teaches that the cartridge (second container) is coupled to the source container (first container) in order to refill the cartridge with an aerosol precursor composition solution contained in the source container. ([0045]; [0051]) Sebastian discloses that the mouth end cap can also define the fill channel [0045] thus the user would not be able to use the mouth end of the cartridge if the source container (first container) was not separated from the cartridge containing the reservoir (second container).
Sebastian teaches that the cartridge (second container) which is filled by the source container (first container) can be received in an aerosol delivery device control body. The device is used to generate an inhalable substance. ([0034-0035]) Once the cartridge is empty the cartridge can be refilled using the source container. [0040]
Sebastian teaches that the cartridge can be separated from the aerosol generating device (aerosol generator) and refilled using the device filling system (first container).
Sebastian teaches that the cartridge can be refilled, the prior art does not explicitly teach that this process can be repeated multiple times with the same source container (first container). However, there is not structural difference between the prior art and the claimed invention and as such weight is not given to the limitation of how to refill the device as it does not distinguish the apparatus from the prior art structurally. The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim, and that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See MPEP §§ 2114 and 2173.05(g).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian, et al (US20170341850A1) and Rasouli, et al (US20110250324A1 from IDS dated 11/23/2022) as applied to claim 1 above, and further in view of Bosch, et al (US20090181100A1, from IDS dated 11/14/2024).
Regarding claim 2, neither Sebastian nor Rasouli teach the use of a specific propellant or the vapor pressure of the propellant that would be used.
Bosch, directed to propellant based aerosol formulations, teaches the that the system is pressurized using a propellant, such as a CFC or HFA. [0146] Bosch discloses the boiling point temperature and pressures of various propellants. The examples include HFA-134a (tetrafluoroethane) which has pressure at/below 100 psig, and temperatures at/below 25° C. [0154]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by selecting a propellant as taught by Bosch because both Sebastian, Rasouli and Bosch are directed to aerosol formulations. Bosch teaches the vapor pressure of commonly used propellants known in the art and this merely involves substitution of one know propellant for another.
Claims 3-5, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian, et al (US20170341850A1) and Rasouli, et al (US20110250324A1 from IDS dated 11/23/2022) as applied to claim 1 above, and further in view of Hearn, et al (US20110315152A1, from IDS dated 11/23/2022).
Regarding claim 3, Sebastian and Rasouli are silent with respect to the amount of the nicotine containing solution that is used to fill the first container.
Hearn, directed to the design of aerosol delivery devices, teaches that the propellant level in a storage container in an aerosol generating device being between 60% and 99% of the total formulation of the solution. [0021] This would require the remaining 1% to 40% would be the nicotine containing solution. This range, as taught by Hearn, overlaps the range of the instant claim, and therefore the instant claim is prima facie obvious. See MPEPE 2144.05.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by having the nicotine containing solution in the amounts as taught by Hearn because Sebastian, Rasouli and Hearn are directed to aerosol delivery devices, Hearn teaches provides a nicotine amount akin to a tobacco cigarette [0022], and this involves substituting the use of a known solution composition to improve a similar device in the same way.
Regarding claim 4, Hearn teaches the refill container has a space in the refill container that is not filled by the nicotine formulation, i.e. ullage, of 20% [0021]; thus having a fill volume of the nicotine formulation of 80%. This value, as taught by Hearn, overlaps the nicotine-containing solution and the liquid propellant in the first container being 85% by volume or less based on internal volume and is therefore considered prima facie obvious. See MPEP 2144.05
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by allowing for a portion of the container to not me filled by the solution as taught by Hearn because Sebastian, Rasouli and Hearn are directed to aerosol delivery devices, Hearn teaches this fill volume is sufficient to provide the desired number of refills for the system, and this involves the use of known technique to improve similar devices in the same way.
Regarding claim 5, Hearn teaches that 0.1-10% of the solution is nicotine and the ratio is based on the weight of the propellant. [0015]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by using the nicotine ratio in the solution as taught by Hearn because Sebastian, Rasouli and Hearn are directed to aerosol delivery devices, Hearn teaches this provides a uniform dose of nicotine being released as the propellant is vaporized [0015], and this involves the use of known technique to improve similar devices in the same way.
Regarding claim 9, Hearn teaches that the reservoir (first container) provides up to 30 inhalations before being depleted and needing a refill. [0016] The claimed range of 1 to 15 puffs (inhalations) overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by having a number of inhalations in the first container as taught by Hearn because Sebastian, Rasouli and Hearn are directed to aerosol delivery devices, Hearn teaches this provides the same capacity for dose delivery as a conventional 20 pack of tobacco [0022] which involve using a known technique to improve similar products in the same way
Regarding claim 11, Hern teaches that the reservoir (first container) can provide 20 refills to a simulated cigarette device. [0020]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian and Rasouli by to provide the number of refills as taught by Hearn because both Sebastian, Rasouli and Hearn are directed to aerosol delivery devices, Hearn teaches the number of doses simulates the number of cigarettes in a pack of traditional cigarettes. [0022]
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian, et al (US20170341850A1), Rasouli, et al (US20110250324A1 from IDS dated 11/23/2022), and Greiger (US20090184131A1) as applied to claim 1 above, and further in view of Nadler (US20180117267A1).
Regarding claim 12, Sebastian and Rasouli are silent with respect to the storage container being expandable or collapsable.
Greiger teaches that the pressure vessel can comprise an inner bag in the aerosol container for dispensing the liquid substance. The inner bag will unfold, or expand, when the bag is filled with the substance to be inhaled. [0070] The vessel has a chamber below the inner bag that holds the substance; the chamber below the inner bag contains the propellant and is used to collapse the inner bag when the substance is used. [0071-0072]. However, Greiger teaches the propellant would be in a chamber below the bag holding the substance to be inhaled and not that the propellant would be mixed in with the liquid substance that is to be dispensed.
Nadler, directed to the design of inhalation devices, teaches the liquid reservoir that is pressurized by a propellant [0025]. The liquid reservoir can be an unventilated system in which the liquid storage has a modifiable volume using a trailing piston or by using a bag container. ([0027], Fig 2) A person having ordinary skill would understand that the use of a liquid reservoir that has a variable volume and a bag container would require the liquid storage reservoir to expand when filled and collapse as the reservoir contents, both liquid and propellant, are expelled.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian, Rasouli, and Greiger by using a liquid reservoir that has a variable volume as taught by Nadler because Sebastian, Rasouli, Greiger, and Nadler are directed to aerosol delivery devices, Nadler teaches the use of a variable volume, unventilated system leads to a constant liquid pressure and thus to a constant nebulization result. [0026] which involve using a known technique to improve similar products in the same way
Regarding claim 13, Greiger, as modified by Nadler, teaches that an expandable and collapsable bag can be used for the storage container that is used to provide the liquid to the spray head. ([0077], Fig 1)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIRGINIA R BIEGER whose telephone number is (703)756-1014. The examiner can normally be reached M-Th: 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phillip Louie can be reached at (571)270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.R.B./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755