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 .
Response to Amendment
This office action is responsive to an amendment filed on 10/13/2025. As directed by the amendment, claims 26, 28, 34-37, and 41-47 were amended, claims 1-25, 27, 29-33, and 38-40 were cancelled, and new claim 48 was added. Thus, claims 26, 28, 34-37, and 41-48 are presently pending in this application.
Claim Objections
Claims 26, 41 and 47 are objected to because of the following informalities:
In claim 26, line 16, the term “the atmosphere” is suggested to be changed to --an atmosphere-- in order to clarify the claim.
In claim 41, line 16, the term “the atmosphere” is suggested to be changed to --an atmosphere-- in order to clarify the claim.
In claim 47, line 15, the term “the atmosphere” is suggested to be changed to --an atmosphere-- in order to clarify the claim.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the limitations “a nebulizer module fluidically coupled to the first reservoir and the second reservoir, the nebulizer module configured to: receive a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol” (claim 26, lines 6-11, the term “module” is a generic placeholder and the function is “nebulizer” and “configured to: receive a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol”), “a dosage module configured to independently control delivery of the first liquid and the second liquid to the nebulizer module” (claim 26, lines 17-18, the term “module” is a generic place holder and the function is “configured to independently control delivery of the first liquid and the second liquid to the nebulizer module”), “the wearable device is configured to track the health indication associated with the user” (claim 34, lines 3-4, the term “device” is a generic placeholder and the function is “configured to track the health indication associated with the user”), “receiving, with the nebulizer module, a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir…transforming, by the nebulizer module, the received first liquid into an inhalant and the received second liquid into an aerosol” (claim 41, lines 4-10, the term “module” is a generic placeholder and the function is “nebulizer” and receiving a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir and transforming the received first liquid into an inhalant and the received second liquid into an aerosol), “independently controlling, by the dosage module, delivery of the first liquid and the second liquid to the nebulizer module” (claim 41, lines 17-18, the term “module” is a generic placeholder and the function is independently controlling delivery of the first liquid and the second liquid to the nebulizer module), “automatically adjusting, by a controller module, a set ratio between the first amount of the first liquid and the second amount of the second liquid” (claim 43, lines 2-3, the term “module” is a generic placeholder and the function is “controller” and “automatically adjusting…a set ration between the first amount of the first liquid and the second amount of the second liquid”), “the wearable device is worn by the user and is configured to track the health indication associated with the user” (claim 46, lines 3-4, the term “device” is a generic placeholder and the function is “configured to track the health indication associated with the user”), “a nebulizer module fluidically coupled to the first reservoir and the second reservoir, the nebulizer module configured to: receive a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol” (claim 47, lines 6-11, the term “module” is a generic placeholder and the function is “nebulizer” and “configured to: receive a first amount of a first liquid from the first reservoir and a second amount of a second liquid from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol”), and “a dosage module configured to independently control delivery of the first liquid and the second liquid to the nebulizer module” (claim 47, lines 17-18, the term “module” is a generic place holder and the function is “configured to independently control delivery of the first liquid and the second liquid to the nebulizer module”).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26, 28, 34-37, and 41-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 26, the limitation “output the inhalant and aerosol to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece” (lines 13-15) is not supported by the original disclosure and is therefore, new matter. The original disclosure fails to disclose that the nebulizer is configured to output the inhalant and aerosol to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece.
Regarding claim 41, the limitation “the inhalant and aerosol are output to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the first outlet” (lines 13-15) is not supported by the original disclosure and is therefore, new matter. The original disclosure fails to disclose that the inhalant and aerosol are output to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the first outlet.
Regarding claim 47, the limitation “output the inhalant and aerosol to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece” (lines 12-14) is not supported by the original disclosure is therefore, new matter. The original disclosure fails to disclose that the nebulizer module is configured to output the inhalant and aerosol to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece.
Regarding claim 48, the limitation “the first liquid is comprised of at least one psychoactive compound, the second liquid is comprised of at least one flavor compound and neither the first liquid nor the second liquid is comprised of a cannabinoid compound” (lines 1-4) is not supported by the original disclosure and is therefore, new matter. The original disclosure fail to disclose that the first liquid is comprised of at least one psychoactive compound, the second liquid is comprised of at least one flavor compound and neither the first liquid nor the second liquid is comprised of a cannabinoid compound.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 34-37 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 pre-AIA the applicant regards as the invention.
Regarding claim 34, the limitation “the health indication associated with the user” (lines 3-4) lacks proper antecedent basis.
Regarding claim 34, the limitation “the at least one health indication” (line 5) lacks proper antecedent basis. Furthermore, it is unclear if the at least one health indication is referring to “the health indication” in lines 3-4 of claim 34 or not.
Regarding claim 35, the limitation “the user device” (line 2) lacks proper antecedent basis.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 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.
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.
Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301).
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Regarding claim 26, Murray discloses a portable device (101m-2 in fig. 53, see paragraphs 1611-1612, see 101m-2 in fig. 52 for reference as to the portability of the device) for administering aerosol mixtures to a user (aerosol from 108m/111m and 250m, see fig. 53, paragraphs 1611-1614), the portable device comprising: a mouthpiece (109m, figs. 52-53, paragraph 1612) including a first outlet (108m, figs. 52-53 and paragraph 1605), a second outlet (outlet of 250m, paragraphs 1614-1619 and see the annotated-Murray fig. 53 above), a first reservoir (105m, figs. 52-53 and paragraphs 1604-1606) and a second holder (holder for holding liquid absorbed pad in 250m, see paragraphs 1611-1615) separate from the first reservoir, a nebulizer module (portion of the device comprises 250m and connected portion comprising 111m, see fig. 53) fluidically coupled to the first reservoir and the second holder (see paragraphs 1610-1624), the nebulizer module comprises a first liquid nebulizer device (111m) and second liquid nebulizer device (252m), the nebulizer module configured to receive a first amount of a first liquid from the first reservoir and transformed the received first liquid into an inhalant, aerosolize a second liquid from a second holder to transform the second liquid into an aerosol, the second liquid includes at least one flavor compound (see paragraphs 1611-1617, Murray discloses that 250m is a flavor delivery article which comprises flavor liquid, flavor liquid would include a flavor compound, see paragraphs 0025-0027 for reference), output the inhalant and aerosol to the first outlet and second outlet respectively (see paragraphs 1610-1624, the nebulizer module comprising 250m and 111m are configured to output the inhalant and the aerosol through the first outlet and the second outlet respectively), wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece; and introduce the aerosol into the atmosphere around the user (see fig. 53 and paragraphs 1610-1624, as shown, the second outlet would keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece); a dosage module configured to independently control delivery of the first liquid to the nebulizer module and control the nebulization of the second liquid (the dosage module is the controller, which independently control the delivery of the first liquid and second liquid, since the controller is configured to heat 111m, and by aerosolizing/vaporizing current liquid that are in direct contact with the heater 111m, more liquid would be delivered to 111m, furthermore, the controller is responsible for the nebulization of the second liquid, see paragraphs 1614-1624, alternatively, the dosage module can include the controller and 111m and 252m), but fails to disclose that the second nebulizer device comprising a second reservoir and the dosage module is configured to control delivery of the second liquid to the nebulization module.
However, Lee teaches a nebulizer device (see the vaporizer 200 in fig. 2A, paragraphs 0060-0061) for administering aerosol active ingredient mixtures to a user (see paragraphs 0004-0005 and paragraph 0060), the device comprising: a first reservoir (reservoir 205 comprising 227, see figs. 2A and 3, see paragraph 0061) and a second reservoir (reservoir 203 comprising 211, see figs. 2A and 3, paragraph 0061) separate from the first reservoir (see figs. 2A and 3); a nebulizer module (237, 235, 243, 239, 213, 221, 221, 223, 241, 249, see figs. 2A and 3, paragraphs 0060-0067) fluidically coupled to the first reservoir and the second reservoir (see figs. 2A and 3), the nebulizer comprises a second nebulizer device (203, 213, 241, 223, 221, 211, fig. 3), the nebulizer module configured to: receive a first amount of a first liquid (227 from reservoir 205) from the first reservoir and a second amount of a second liquid (211 from reservoir 203) from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol (see figs. 2A and 3, and paragraphs 0060-0067, the heater 235/237 and vibrator 213/241 are responsible for taking a dose and then converting it to an inhalant and an aerosol), wherein the second liquid includes a flavor compound (flavor compound of 211, see paragraph 0062 of Lee, Lee discloses that the vaporizable material 211 is a flavorant); and a dosage module (portion of 250/800 that comprises the algorithm/instruction to set dosage, figs. 2A-3, paragraphs 0065, 0069-0073, and 0085-0087) configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (see paragraphs 0065 and 0069-0072, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241).
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 second nebulizer device of Murray to be the second nebulizer device as taught by Lee for the purpose of providing an alternative nebulizer device that would provide the predictable result of allowing a liquid flavor to be nebulized (see paragraphs 0060-0062 of Lee).
The modified Murray fails to disclose that the first liquid includes a cannabinoid compound.
However, Cabigon teaches a therapeutic liquid comprising cannabinoid and THC (see fig. 3 and paragraphs 0030-0031 and 0034, see first tank comprising THC:CBD ratio of 15:1).
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 first liquid of the modified Murray to include a cannabinoid and THC as taught by Cabigon for the purpose of providing a therapeutic and recreational drug that would provide therapeutic effect to the user seeking the drug (see abstract and paragraphs 0030-0031 and 0034 of Cabigon).
The modified Murray discloses a first reservoir and a second reservoir and that the dosage module configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (after the modification with Lee, the nebulizer module is the portion of the device that comprise 111m of Murray and 213, 241, 223, 221 of Lee, the second liquid will be in a second reservoir 203 of Lee instead of on an absorbent pad, therefore, when the dosage module (controller of Murray) aerosolize the liquid adjacent to 213 of Lee, liquid adjacent to the liquid that is being aerosolized would be delivered to the 213 of Lee of the nebulizer module, see paragraphs 0062-0065 of Lee) and a nozzle including the second outlet (see paragraph 1611 and fig. 53 of Murray, Murray discloses that 250m comprising 252m and 254m are placed within a recess of the main body 102m, and can be flushed with the outer surface, therefore, there would be a portion that forms the opening that can be interpreted as the nozzle), however, if there is any doubt that the modified Murray discloses a nozzle including the second outlet.
However, Zhang teaches a nozzle comprising a second outlet for providing flavor aerosol to the user’s nose (see nozzle 415 and 416 comprising an outlet (opening at the exposed end of 416 that is closest to 400), figs. 9-10 and paragraph 0074 of the English translation) and to introduce the flavor aerosol into the atmosphere around the user (see figs. 9-10, the flavor exiting the nozzle is capable of being introduce into the atmosphere base on the configuration as shown).
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 second outlet of the modified Murray to have a nozzle comprising a second outlet as taught by Zhang for the purpose of providing an alternative outlet that would provide the predictable result of providing flavor compound to the nasal area of the user (see paragraph 0074 of Zhang).
Furthermore, if there is any doubt that the dosage module of the modified Murray can be considered as a dosage module that is configured to independently control delivery of the first liquid and the second liquid to the nebulizer module.
Hatamian discloses a dosage module having flow controller (pump 870, flow meter 865 and valve 860, paragraphs 0081-0084) configured to control delivery of a liquid to a nebulizer module (vaporizer 875, see 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 dosage module of the modified Murray to modify each of the first reservoir and second reservoir of the modified Murray to have the flow controller as taught by Hatamian for the purpose of providing an alternative means of controlling the dosage (see paragraphs 0081-0084 of Hatamian).
After the modification, each of the reservoirs would have a respective flow controllers, wherein both of the flow controllers of Hatamian can be considered as the dosage module.
Regarding claim 28, the modified Murray discloses the dosage module includes: a first flow controller coupled with the first reservoir and configured to control a flow of the first liquid from the first reservoir to the nebulizer module; and a second flow controller coupled with the second reservoir and configured to control a flow of the second liquid from the second reservoir to the nebulizer module (the dosage module is redefined to include portion of the nebulizer module, specifically, the first controller is the heater 111m of Murray and associated controller of Murray and the second flow controller is the vibrating mesh screen 213 of Lee and associated controller of Murray/Lee, since the heater 111m is configured to vaporize the liquid, which would control a flow of the first liquid from the first reservoir, while the vibrating mesh screen 213 of Lee is responsible for vibrating and nebulizing the liquid from the second reservoir, therefore would control a flow of the second liquid from the second reservoir, see paragraphs 0067-0069 and 0082 of Lee and see paragraphs 1615-1624 of Murray, alternatively, see the flow controller of pump 870, flow meter 865 and valve 860, fig. 8 of Hatamian).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301) as applied to claim 26 above, and further in view of Kim (KR 20210072525) and Edwards (2014/0243749).
Regarding claim 34, the modified Murray discloses providing a first amount and a second amount (the first amount is from the dose of inhalant formed by 111m of Murray and the second amount is the dose of aerosol formed by 250m modified to be 203/213 of Lee), but fails to disclose that the portable device is configured to be in communication with a wearable device worn by the user, wherein the wearable device is configured to track the health indication associated with the user, and the portable device is configured to receive the at least one health indication from the wearable device.
Kim teaches a nebulizer (see device 100, figs. 1-2, paragraph 0022) comprising a dosage module (controller 140) that automatically adjust a dosage in response to a health indication of the user (paragraph 0049, see pulse rate being used to control the amount of aerosol, see pulse sensor 135 in paragraphs 0037-0040).
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 dose module and the first amount and second amount of the modified Murray to be automatically controlled by a health indication of the user as taught by Kim for the purpose of providing comfort and safety to the user by allowing the device to intelligently modulate the dosage based on the user’s heart rate.
The modified Murray discloses that the portable device is configured to be in communication with a sensor, the sensor configured to track the health indication associated with the user and the portable nebulizer device is configured to receive the sensor (see pulse sensor 135 of Kim, paragraphs 0037-0040 of Kim), but fails to disclose that the sensor is a wearable device.
However, Edwards discloses a health indication sensor that is incorporated onto a wearable device, wherein the wearable device is a watch (see paragraph 0200).
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 sensor for measuring a pulse rate of the user of the modified Murray to be part of a wearable device as taught by Edwards for the purpose of providing an alternative means of capturing the user’s pulse.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777), Kim (KR 20210072525), Edwards (2014/0243749) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301) as applied to claim 34 above, and further in view of Hyde (2010/0163041) and Pauley (2021/0402110).
Regarding claim 35, the modified Murray discloses that the wearable device is a watch (see the modification with Edwards above), but fails to disclose a user device.
However, Hyde teaches a user device that is separate from a nebulizer device and is in communication with a nebulizer device, the user device comprising a processor and a memory storing instructions which, when executed by the processor, cause the user device to: receive a dosing scheme from the user of the user device (“a device”) and others, provide instructions to the nebulizer device (see paragraph 0137, Hyde discloses that the processor 156 of nebulizer device 100 (see paragraph 0108, fig. 1E and paragraph 0114) receives dosing instruction sets, and the dosing instruction set are from a laptop computer or a cell phone, which would have a processor and memory to store some form of instruction to allow the user device to receive the dosing scheme from the user and provide that instruction to the nebulizer device, Hyde further discloses that the dosing instruction set are defined by the user, see paragraph 0117, therefore, in order for the dosing instruction set to be sent from the laptop, the laptop must receive the instruction from the user one way or another, see paragraph 0140 and fig. 1E, as shown, the 164 interface receive a set of instruction that are defined by the user 166).
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 nebulizer device of the modified Murray to have the user device for receiving a dosing scheme that can send instructions to the nebulizer module of the modified Murray to adjust a dosing scheme of each of the first amount and the second amount of the modified Murray as taught by Hyde for the purpose of providing a smart and customizable inhaler system by allowing the user and others to provide a dosing scheme to the user of the system.
The modified Murray discloses a phone (see modification with Hyde), but fails to disclose that the watch is a smart watch and the phone is a smart phone.
However, Pauley teaches a smart phone (paragraph 0057).
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 cell phone of the modified Murray to be a smart phone as taught by Pauley for the purpose of providing an alternative multifunctional phone that would perform equally well and would allow the smart phone to be used as a user device as needed by Lee.
The modified Murray discloses that the phone is a smart phone, but fails to disclose that the watch is a smart watch.
However, Pauley teaches a smart watch (paragraph 0057).
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 watch of the modified Murray to be a smart watch as taught by Pauley for the purpose of providing an alternative multifunctional watch that would perform equally well and would allow the smart watch to be used as a wearable device as needed by Kim.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777), Kim (KR 20210072525), Edwards (2014/0243749) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301) as applied to claim 34 above, and further in view of Mayle (2017/0266397) and Lopez (2018/0289062).
Regarding claim 36, the modified Murray discloses that the at least one health indication includes a heat rate and in response to the heart rate reaching above a threshold, automatically adjusting an amount of the first liquid including the cannabinoid compound (see the modification with Kim, Kim discloses that the control unit extract and obtain heart rate, Kim further discloses in paragraph 0079 that high heart rate equate to high stress, and further discloses in paragraph 0083 that the control unit can adjust the power supply to adjust or maintain the stress level), but fails to disclose that when the heart rate reach above a threshold, automatically adjusting the amount of the first liquid including the cannabinoid compound.
However, Mayle teaches monitoring heart rate (pulse rate, paragraph 0066) and determines whether or not the user’s pulse rate decreased, and further discloses that dosage are adjusted in order to treat certain ailments, Mayle further discloses that if the dosage is deemed too overwhelming, that the dosage should be decreased (see paragraph 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 modify the device of the modified Murray to decrease the dosage of the first liquid including the cannabinoid compound if the user is overwhelm with the high dosage as taught by Mayle for the purpose of treating a particular ailment and to provide safety to the user by reducing the dosage when the user is overwhelm with the high dosage (see paragraph 0066 of Mayle).
Lopez discloses that an overwhelming amount of cannabinoid would increase heart rate (see paragraph 0194).
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 device of the modified Murray to lower the dosage of the first liquid of the modified Murray when heart rate is increased as taught by Lopez for the purpose of utilizing heart rate to determine if a dosage is too overwhelming, thereby providing safety to the user by reducing the dosage when the user’s heart rate is overwhelmingly high (see paragraph 0066 of Mayle and paragraph 0194 of Lopez).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777), Kim (KR 20210072525), Edwards (2014/0243749) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301) as applied to claim 34 above, and further in view of Mayle (2017/0266397) and Lopez (2018/0289062).
Regarding claim 37, the modified Murray discloses that the at least one health indication includes a heat rate (biometric indication) and in response to the heart rate reaching above a threshold, automatically adjusting the user-specific dosing scheme to adjust the dosage of the first liquid including the cannabinoid compound (see the modification with Kim, Kim discloses that the control unit extract and obtain heart rate, Kim further discloses in paragraph 0079 that high heart rate equate to high stress, and further discloses in paragraph 0083 that the control unit can adjust the power supply to adjust or maintain the stress level), but fails to disclose that when the heart rate reach above a threshold, automatically adjusting the amount of the first liquid including the cannabinoid compound.
However, Mayle teaches monitoring heart rate (pulse rate, see paragraph 0066) and determines whether or not the user’s pulse rate decreased, and further discloses that dosage are adjusted in order to treat certain ailments, Mayle further discloses that if the dosage is deemed too overwhelming, that the dosage should be decreased (see paragraph 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 modify the device of the modified Murray to decrease the dosage of the first liquid including the cannabinoid compound if the user is overwhelm with the high dosage as taught by Mayle for the purpose of treating a particular ailment and to provide safety to the user by reducing the dosage when the user is overwhelm with the high dosage (see paragraph 0066 of Mayle).
Lopez discloses that an overwhelming amount of cannabinoid would increase heart rate (see paragraph 0194).
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 device of the modified Murray to lower the dosage of the first liquid of the modified Murray when heart rate is increased as taught by Lopez for the purpose of utilizing heart rate to determine if a dosage is too overwhelming, thereby providing safety to the user by reducing the dosage when the user’s heart rate is overwhelmingly high (see paragraph 0066 of Mayle and paragraph 0194 of Lopez).
Claims 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777) and alternatively in view of Hatamian (2020/0061301).
Regarding claim 41, Murray discloses a method of administering aerosol compounds (aerosol compounds from 108m/111m and 250m, see fig. 53, paragraphs 1611-1614) to a user with a nebulizer device (101m-2 in fig. 53, see paragraphs 1611-1612, see 101m-2 in fig. 52 for reference as to the portability of the device) including a first outlet (108m, figs. 52-53 and paragraph 1605), a second outlet (outlet of 250m, paragraphs 1614-1619 and see the annotated-Murray fig. 53 above), a first reservoir (105m, figs. 52-53 and paragraphs 1604-1606), a second holder (holder for holding liquid absorbed pad in 250m, see paragraphs 1611-1615), a nebulizer module (portion of the device comprises 250m and connected portion comprising 111m, see fig. 53), and a dosage module (the dosage module is the controller for 111m and 250m or alternatively, the dosage module is the nebulizing device of each of 111m and 252m and the controller, which independently control the delivery of the first liquid and second liquid, since the controller is configured to heat 111m, and by aerosolizing/vaporizing current liquid that are in direct contact with the heater 111m, more liquid would be delivered to 111m, furthermore, the controller is responsible for the nebulization of the second liquid, see paragraphs 1607 and 1614-1624), the method comprising: receiving, with the nebulizer, a first amount of a first liquid from the first reservoir, wherein: the second holder is separate from the first reservoir (see fig. 53), the nebulizer module is fluidically coupled to the first reservoir and the second holder (see paragraphs 1610-1624), the nebulizer module comprises a first liquid nebulizer device (111m) and second liquid nebulizer device (252m), transforming, by the nebulizer module, the received first liquid into an inhalant and the second liquid into an aerosol, the second liquid includes at least one flavor compound (see paragraphs 1611-1617, Murray discloses that 250m is a flavor delivery article which comprises flavor liquid, flavor liquid would include a flavor compound, see paragraphs 0025-0027 for reference), the inhalant and aerosol are output to the first outlet and second outlet respectively (see paragraphs 1610-1624, the nebulizer module comprising 250m and 111m are configured to output the inhalant and the aerosol through the first outlet and the second outlet respectively), wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece; and the aerosol is introduced into the atmosphere around the user via the second outlet (see fig. 53 and paragraphs 1610-1624, as shown, the second outlet would keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece); independently controlling, by the dosage module, delivery of the first liquid to the nebulizer module and control the nebulization of the second liquid (the dosage module is the controller, which independently control the delivery of the first liquid and second liquid, since the controller is configured to heat 111m, and by aerosolizing/vaporizing current liquid that are in direct contact with the heater 111m, more liquid would be delivered to 111m, furthermore, the controller is responsible for the nebulization of the second liquid, see paragraphs 1614-1624), but fails to disclose that the second nebulizer device comprising a second reservoir in order to receive, with the nebulizer module a second amount of a second liquid from the second reservoir and independently controlling, by the dosage module, delivery of the second liquid to the nebulization module.
However, Lee teaches a nebulizer device (see the vaporizer 200 in fig. 2A, paragraphs 0060-0061) for administering aerosol active ingredient mixtures to a user (see paragraphs 0004-0005 and paragraph 0060), the device comprising: a first reservoir (reservoir 205 comprising 227, see figs. 2A and 3, see paragraph 0061) and a second reservoir (reservoir 203 comprising 211, see figs. 2A and 3, paragraph 0061) separate from the first reservoir (see figs. 2A and 3); a nebulizer module (237, 235, 243, 239, 213, 221, 221, 223, 241, 249, see figs. 2A and 3, paragraphs 0060-0067) fluidically coupled to the first reservoir and the second reservoir (see figs. 2A and 3), the nebulizer comprises a second nebulizer device (203, 213, 241, 223, 221, 211, fig. 3), the nebulizer module configured to: receive a first amount of a first liquid (227 from reservoir 205) from the first reservoir and a second amount of a second liquid (211 from reservoir 203) from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol (see figs. 2A and 3, and paragraphs 0060-0067, the heater 235/237 and vibrator 213/241 are responsible for taking a dose and then converting it to an inhalant and an aerosol), wherein the second liquid includes a flavor compound (flavor compound of 211, see paragraph 0062 of Lee, Lee discloses that the vaporizable material 211 is a flavorant); and a dosage module (portion of 250/800 that comprises the algorithm/instruction to set dosage, figs. 2A-3, paragraphs 0065, 0069-0073, and 0085-0087) configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (see paragraphs 0065 and 0069-0072, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241).
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 method and the second nebulizer device of Murray to be the second nebulizer device as taught by Lee for the purpose of providing an alternative nebulizer device that would provide the predictable result of allowing a liquid flavor to be nebulized (see paragraphs 0060-0062 of Lee).
The modified Murray discloses a first reservoir and a second reservoir and that the dosage module configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (after the modification with Lee, the nebulizer module is the portion of the device that comprise 111m of Murray and 213, 241, 223, 221 of Lee, the second liquid will be in a second reservoir 203 of Lee instead of on an absorbent pad, therefore, when the dosage module (controller of Murray) aerosolize the liquid adjacent to 213 of Lee, liquid adjacent to the liquid that is being aerosolized would be delivered to the 213 of Lee of the nebulizer module, see paragraphs 0062-0065 of Lee), but fails to disclose that the first liquid includes a cannabinoid compound.
However, Cabigon teaches a therapeutic liquid comprising cannabinoid and THC (see fig. 3 and paragraphs 0030-0031 and 0034, see first tank comprising THC:CBD ratio of 15:1).
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 first liquid of the modified Murray to include a cannabinoid and THC as taught by Cabigon for the purpose of providing a therapeutic and recreational drug that would provide therapeutic effect to the user seeking the drug (see abstract and paragraphs 0030-0031 and 0034 of Cabigon).
Furthermore, if there is any doubt that the dosage module of the modified Murray can be considered as a dosage module that is configured to independently control delivery of the first liquid and the second liquid to the nebulizer module.
Hatamian discloses a dosage module having flow controller (pump 870, flow meter 865 and valve 860, paragraphs 0081-0084) configured to control delivery of a liquid to a nebulizer module (vaporizer 875, see 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 dosage module of the modified Murray to modify each of the first reservoir and second reservoir of the modified Murray to have the flow controller as taught by Hatamian for the purpose of providing an alternative means of controlling the dosage (see paragraphs 0081-0084 of Hatamian).
After the modification, each of the reservoirs would have a respective flow controllers, wherein both of the flow controllers of Hatamian can be considered as the dosage module.
Regarding claim 42, the modified Murray discloses the dosage module includes: controlling, by a first flow controller coupled with the first reservoir, a flow of the first liquid from the first reservoir to the nebulizer module; and controlling, by a second flow controller coupled with the second reservoir, a flow of the second liquid from the second reservoir to the nebulizer module (the dosage module is redefined to include portion of the nebulizer module, specifically, the first controller is the heater 111m of Murray and associated controller of Murray and the second flow controller is the vibrating mesh screen 213 of Lee and associated controller of Murray/Lee, since the heater 111m is configured to vaporize the liquid, which would control a flow of the first liquid from the first reservoir, while the vibrating mesh screen 213 of Lee is responsible for vibrating and nebulizing the liquid from the second reservoir, therefore would control a flow of the second liquid from the second reservoir, see paragraphs 0067-0069 and 0082 of Lee and see paragraphs 1615-1624 of Murray, alternatively, see the flow controller of pump 870, flow meter 865 and valve 860, fig. 8 of Hatamian).
Regarding claim 43, the modified Murray discloses automatically adjusting, by a controller module, a set ratio between the first amount of the first liquid and the second amount of the second liquid in accordance with a user-specific dosing scheme, wherein the user-specific dosing scheme includes independently increasing or decreasing the first amount of the first liquid and/or the amount of the second liquid while the inhalant and the aerosol are independently output from the first outlet and the second outlet (fig. 53 and see paragraphs 1607 and 1615-1624 of Murray, controller module is the controller that is responsible for controlling 252m and 111m, when the controller control the dosage of the inhalant and the aerosol, there would be a set ratio between the first amount of the first liquid and the second amount of the second liquid and would be in accordance to a user-specific dosing scheme, which would have increase or decreasing the first amount and/or second amount). Furthermore, if there is any doubt that the modified Murray discloses the dosing scheme including the ratio between the first amount of the first liquid and the second amount of the second liquid (in the event that the applicant is trying to claim the ratio as a parameter that is being set within the dosing scheme).
Cabigon teaches a dosing scheme including a ratio as a parameter that is being set (see paragraphs 0007, 0020 and 0021-0022, ratio between two different ingredients are being a parameter that is being set).
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 dosing scheme of the modified Murray to include a ratio as a form of setting a dose of two different inhalant as taught by Cabigon for the purpose of providing an alternative way of setting a dose between two different materials being inhaled by the user. Furthermore, there appears to be no criticality between setting individual doses between two inhalants versus setting a ratio which then becomes instruction to set individual doses of two inhalants.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777) and alternatively in view of Hatamian (2020/0061301) as applied to claim 43 above, and further in view of Kim (KR 20210072525).
Regarding claim 45, the modified Murray fail to disclose automatically adjusting, by the controller module, the user-specific dosing scheme in response to at least one health indication associated with the user, and the ratio between the first amount of the first liquid and the second amount of the second liquid is adjusted according to the adjusted user-specific dosing scheme.
Kim teaches a nebulizer (see device 100, figs. 1-2, paragraph 0022) comprising a dosage module (controller 140) that automatically adjust a dosage in response to a health indication of the user (paragraph 0049, see pulse rate being used to control the amount of aerosol, see pulse sensor 135 in paragraphs 0037-0040).
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 dose module and the first amount and second amount of the modified Murray to be automatically controlled by a health indication of the user as taught by Kim for the purpose of providing comfort and safety to the user by allowing the device to intelligently modulate the dosage based on the user’s heart rate.
Claim 46 rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937), Cabigon (WO 2020/165777) and Kim (KR 20210072525) and alternatively in view of Hatamian (2020/0061301) as applied to claim 45 above, and further in view of Edwards (2014/0243749).
Regarding claim 46, the modified Murray discloses that the portable nebulizer device is configured to be in communication with a sensor, the sensor configured to track the health indication associated with the user and the portable nebulizer device is configured to receive the sensor (see pulse sensor 135 of Kim, paragraphs 0037-0040 of Kim), the method comprises, receiving, by the nebulizer device, the at least one health indication from the sensor (see paragraphs 0037-0040 of Kim), but fails to disclose that the sensor is a wearable device, the wearable device worn by the user is configured to track the health indication associated with the user, and the method further comprises, receiving, by the nebulizer device, the at least one health indication from the wearable device.
However, Edwards discloses a health indication sensor that is incorporated onto a wearable device, wherein the wearable device is a watch, the wearable device worn by the user is configured to track the health indication associated with the user (see paragraph 0200).
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 sensor for measuring a pulse rate of the user of the modified Murray to be part of a wearable device as taught by Edwards for the purpose of providing an alternative means of capturing the user’s pulse.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301).
Regarding claim 47, Murray discloses a portable device (101m-2 in fig. 53, see paragraphs 1611-1612, see 101m-2 in fig. 52 for reference as to the portability of the device) for administering aerosol mixtures to a user (aerosol from 108m/111m and 250m, see fig. 53, paragraphs 1611-1614), the portable device comprising: a mouthpiece (109m, figs. 52-53, paragraph 1612) including a first outlet (108m, figs. 52-53 and paragraph 1605), a second outlet (outlet of 250m, paragraphs 1614-1619 and see the annotated-Murray fig. 53 above), a first reservoir (105m, figs. 52-53 and paragraphs 1604-1606) and a second holder (holder for holding liquid absorbed pad in 250m, see paragraphs 1611-1615) separate from the first reservoir, a nebulizer module (portion of the device comprises 250m and connected portion comprising 111m, see fig. 53) fluidically coupled to the first reservoir and the second holder (see paragraphs 1610-1624), the nebulizer module comprises a first liquid nebulizer device (111m) and second liquid nebulizer device (252m), the nebulizer module configured to receive a first amount of a first liquid from the first reservoir and transformed the received first liquid into an inhalant, aerosolize a second liquid from a second holder to transform the second liquid into an aerosol, the second liquid includes at least one flavor compound (see paragraphs 1611-1617, Murray discloses that 250m is a flavor delivery article which comprises flavor liquid, flavor liquid would include a flavor compound), output the inhalant and aerosol to the first outlet and second outlet respectively (see paragraphs 1610-1624, the nebulizer module comprising 250m and 111m are configured to output the inhalant and the aerosol through the first outlet and the second outlet respectively), wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece; and introduce the aerosol into the atmosphere around the user (see fig. 53 and paragraphs 1610-1624, as shown, the second outlet would keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the mouthpiece); a dosage module configured to independently control delivery of the first liquid to the nebulizer module and control the nebulization of the second liquid (the dosage module is the controller, which independently control the delivery of the first liquid and second liquid, since the controller is configured to heat 111m, and by aerosolizing/vaporizing current liquid that are in direct contact with the heater 111m, more liquid would be delivered to 111m, furthermore, the controller is responsible for the nebulization of the second liquid, see paragraphs 1614-1624, alternatively, the dosage module can include the controller and 111m and 252m), but fails to disclose that the second nebulizer device comprising a second reservoir and the dosage module is configured to control delivery of the second liquid to the nebulization module.
However, Lee teaches a nebulizer device (see the vaporizer 200 in fig. 2A, paragraphs 0060-0061) for administering aerosol active ingredient mixtures to a user (see paragraphs 0004-0005 and paragraph 0060), the device comprising: a first reservoir (reservoir 205 comprising 227, see figs. 2A and 3, see paragraph 0061) and a second reservoir (reservoir 203 comprising 211, see figs. 2A and 3, paragraph 0061) separate from the first reservoir (see figs. 2A and 3); a nebulizer module (237, 235, 243, 239, 213, 221, 221, 223, 241, 249, see figs. 2A and 3, paragraphs 0060-0067) fluidically coupled to the first reservoir and the second reservoir (see figs. 2A and 3), the nebulizer comprises a second nebulizer device (203, 213, 241, 223, 221, 211, fig. 3), the nebulizer module configured to: receive a first amount of a first liquid (227 from reservoir 205) from the first reservoir and a second amount of a second liquid (211 from reservoir 203) from the second reservoir; transform the received first liquid into an inhalant and the received second liquid into an aerosol (see figs. 2A and 3, and paragraphs 0060-0067, the heater 235/237 and vibrator 213/241 are responsible for taking a dose and then converting it to an inhalant and an aerosol), wherein the second liquid includes a flavor compound (flavor compound of 211, see paragraph 0062 of Lee, Lee discloses that the vaporizable material 211 is a flavorant); and a dosage module (portion of 250/800 that comprises the algorithm/instruction to set dosage, figs. 2A-3, paragraphs 0065, 0069-0073, and 0085-0087) configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (see paragraphs 0065 and 0069-0072, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241).
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 second nebulizer device of Murray to be the second nebulizer device as taught by Lee for the purpose of providing an alternative nebulizer device that would provide the predictable result of allowing a liquid flavor to be nebulized (see paragraphs 0060-0062 of Lee).
The modified Murray discloses a first reservoir and a second reservoir and that the dosage module configured to independently control delivery of the first liquid and the second liquid to the nebulizer module (after the modification with Lee, the nebulizer module is the portion of the device that comprise 111m of Murray and 213, 241, 223, 221 of Lee, the second liquid will be in a second reservoir 203 of Lee instead of on an absorbent pad, therefore, when the dosage module (controller of Murray) aerosolize the liquid adjacent to 213 of Lee, liquid adjacent to the liquid that is being aerosolized would be delivered to the 213 of Lee of the nebulizer module, see paragraphs 0062-0065 of Lee) and a nozzle including the second outlet (see paragraph 1611 and fig. 53 of Murray, Murray discloses that 250m comprising 252m and 254m are placed within a recess of the main body 102m, and can be flushed with the outer surface, therefore, there would be a portion that forms the opening that can be interpreted as the nozzle), however, if there is any doubt that the modified Murray discloses a nozzle including the second outlet.
However, Zhang teaches a nozzle comprising a second outlet for providing flavor aerosol to the user’s nose (see nozzle 415 and 416 comprising an outlet (opening at the exposed end of 416 that is closest to 400), figs. 9-10 and paragraph 0074 of the English translation) and to introduce the flavor aerosol into the atmosphere around the user (see figs. 9-10, the flavor exiting the nozzle is capable of being introduce into the atmosphere base on the configuration as shown).
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 second outlet of the modified Murray to have a nozzle comprising a second outlet as taught by Zhang for the purpose of providing an alternative outlet that would provide the predictable result of providing flavor compound to the nasal area of the user (see paragraph 0074 of Zhang).
Furthermore, if there is any doubt that the dosage module of the modified Murray can be considered as a dosage module that is configured to independently control delivery of the first liquid and the second liquid to the nebulizer module.
Hatamian discloses a dosage module having flow controller (pump 870, flow meter 865 and valve 860, paragraphs 0081-0084) configured to control delivery of a liquid to a nebulizer module (vaporizer 875, see 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 dosage module of the modified Murray to modify each of the first reservoir and second reservoir of the modified Murray to have the flow controller as taught by Hatamian for the purpose of providing an alternative means of controlling the dosage (see paragraphs 0081-0084 of Hatamian).
After the modification, each of the reservoirs would have a respective flow controllers, wherein both of the flow controllers of Hatamian can be considered as the dosage module.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (2022/0022537) in view of Lee (WO 2021/202937) and alternatively in view of Zhang (WO 2023/044998) and Hatamian (2020/0061301) as applied to claim 47 above, and further in view of Rubin (2020/0107578).
Regarding claim 48, the modified Murray discloses that the second liquid includes at least one flavor compound (see paragraphs 1611-1617, Murray discloses that 250m is a flavor delivery article which comprises flavor liquid, flavor liquid would include a flavor compound, see paragraphs 0025-0027 for reference) and does not mention a cannabinoid (see paragraph 0037, the flavorant maybe include menthol, licorice, chocolate, fruit flavor, vanilla, spice and tobacco flavor), the first liquid is a psychoactive compound that comprises nicotine (see paragraph 0036) and does not mention a cannabinoid, but fails to specifically disclose that the first and second liquids do not comprise a cannabinoid compound.
However, Rubin teaches a liquid that does not comprise cannabinoid (see paragraphs 0105 and 0124).
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 first liquid and second liquid of the modified Murray to be free of cannabinoid as taught by Rubin for the purpose of providing a formulation that is desired by a user who is not in need of such substance or
for the purpose of reducing dependency of cannabinoid (see paragraphs 0105 and 0124 of Rubin).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (WO 2021/202937) in view of Cabigon (WO 2020/165777) and alternatively in view of Hatamian (2020/0061301).
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Regarding claim 41, Lee discloses a method for administering aerosol compounds to a user with a nebulizer device (see the vaporizer 200 in fig. 2A, paragraphs 0060-0061, due to the device having a mouthpiece 207 and a battery, see paragraph 0009, the device would be portable and when view in light of the device 100 shown in fig. 1) (see paragraphs 0004-0005 and paragraph 0060), the device comprising: a first outlet, a second outlet (see the annotated-Lee fig. 3 above), a first reservoir (reservoir 205 comprising 227, see figs. 2A and 3, see paragraph 0061) and a second reservoir (reservoir 203 comprising 211, see figs. 2A and 3, paragraph 0061); a nebulizer module (237, 235, 243, 239, 213, 221, 221, 223, 241, 249, see figs. 2A and 3, paragraphs 0060-0067), a dosage module (portion of 250/800 that comprises the algorithm/instruction to set dosage, figs. 2A-3, paragraphs 0065, 0069-0073, and 0085-0087), the method comprising: receiving, with the nebulizer module, a first amount of a first liquid (first liquid is 227, see figs. 2A and 3) from the first reservoir and a second amount of a second liquid (211, see figs. 2A and 3) from the second reservoir (see paragraphs 0022, 0037-0038, claims 3-4 of Lee, Lee discloses that the first and second reservoirs and the first and second aerosol generation mechanisms are a separable cartridge), wherein the second reservoir is separate from the first reservoir (see figs. 2A and 3), the nebulizer module is fluidically coupled to the first reservoir and the second reservoir (see figs. 2A and 3); transforming, by the nebulizer module, the received first liquid into an inhalant and the received second liquid into an aerosol that are provided to the user (see figs. 2A and 3, paragraphs 0060-0067), the second liquid includes a flavor compound (flavor compound of 211, see paragraph 0062 of Lee, Lee discloses that the vaporizable material 211 is a flavorant), the inhalant and aerosol are output to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the first outlet, and the aerosol is introduced into the atmosphere around the user via the second outlet (see the annotated-Lee fig. 3 above, as shown, inhalant and aerosol are output to the first outlet and second outlet, respectively, wherein the second outlet is configured to keep the aerosol from mixing with the inhalant at any point prior to the exit of the inhalant from the first outlet, furthermore, paragraphs 0069-0071 discloses that vaporization maybe be based on predefined periods can be every 10 seconds or every 5 seconds, therefore, if during those period, if the user puff and quickly disconnect from the mouthpiece 207, then the aerosol would be introduced into the atmosphere around the user via the second outlet, alternatively, the user can blow through the inlet and would cause aerosol to exit through the second outlet); independently controlling, by the dosage module, delivery of the first liquid and the second liquid to the nebulizer module (see paragraphs 0065 and 0069-0072, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241), but fails to disclose that the first liquid includes a cannabinoid compound.
However, Cabigon teaches a therapeutic liquid comprising cannabinoid and THC (see fig. 3 and paragraphs 0030-0031 and 0034, see first tank comprising THC:CBD ratio of 15:1).
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 first liquid of Lee to include a cannabinoid and THC as taught by Cabigon for the purpose of providing a therapeutic and recreational drug that would provide therapeutic effect to the user seeking the drug (see abstract and paragraphs 0030-0031 and 0034 of Cabigon).
Furthermore, if there is any doubt that the dosage module of the modified Lee can be considered as a dosage module having flow controllers.
Hatamian discloses a dosage module having flow controller (pump 870, flow meter 865 and valve 860, paragraphs 0081-0084).
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 dosage module of the modified Lee to modify each of the first reservoir and second reservoir of the modified Lee to have the flow controller as taught by Hatamian for the purpose of providing an alternative means of controlling the dosage (see paragraphs 0081-0084 of Hatamian).
After the modification, each of the reservoirs would have a respective flow controllers, wherein both of the flow controllers of Hatamian can be considered as the dosage module.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (WO 2021/202937) in view of Cabigon (WO 2020/165777) and alternatively in view of Hatamian (2020/0061301) as applied to claim 41 above, and alternatively in view of Cabigon (WO 2020/165777).
Regarding claim 43, the modified Lee discloses automatically adjusting, by a controller module (see paragraphs 0065 and 0069-0072, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241, since the two rate are independently controlled and varied, the ratio between the two would be set, wherein the controller is interpreted as the portion of 250/800 that takes information from the dosage module (portion of 250/800 that store dosage instruction), and send that to the nebulizer module), a set ratio between the first amount of the first liquid and the second amount of the second liquid in accordance with the user-specific dosing scheme, wherein the user-specific dosing scheme includes independently increasing or decreasing the first amount of the first liquid (see algorithm/instruction to set dosage in figs. 2A-3, paragraphs 0065, 0069-0073, and 0085-0087 of Lee, Lee discloses that the controller can change the rate of the aerosol coming from the vibrating screen 213 and the vaporization rate of the second vaporizable material 227 from the heating element 235, which would control the delivery of the first liquid 227 and the second liquid 211 to the heater and wick 237/235 and vibrating mesh 213/241, since the two rate are independently controlled and varied, the ratio between the two would be set, the dosage would be set by independently increasing or decreasing the first amount). Furthermore, if there is any doubt that the modified Lee discloses the dosing scheme including a set ratio between the first amount of the first liquid and the second amount of the second liquid (in the event that the applicant is trying to claim the ratio as a parameter that is being set within the dosing scheme).
Cabigon teaches a dosing scheme including a ratio as a parameter that is being set (see paragraphs 0007, 0020 and 0021-0022, ratio between two different ingredients are being a parameter that is being set).
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 dosing scheme of the modified Lee to include a ratio as a form of setting a dose of two different inhalant as taught by Cabigon for the purpose of providing an alternative way of setting a dose between two different materials being inhaled by the user. Furthermore, there appears to be no criticality between setting individual doses between two inhalants versus setting a ratio which then becomes instruction to set individual doses of two inhalants.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (WO 2021/202937) in view of Cabigon (WO 2020/165777) and alternatively in view of Hatamian (2020/0061301) and Cabigon (WO 2020/165777) as applied to claim 43 above, respectively, and further in view of Giroux (2007/0074722).
Regarding claim 44, the modified Lee discloses that the user-specific dosing scheme is predefined (see paragraph 0070 of Lee, Lee discloses that the predefined information include rate, and the rate is different for the liquid 211 vs the liquid 227, in order to have rate for the different material, furthermore, see paragraph 0009 of Lee, Lee discloses that the cartridge is separable and comprise the first reservoir and the second reservoir) and a cartridge that includes the first and the second liquids (see paragraphs 0037-0038, 0066 and 0068 of Lee), but fails to disclose that the user-specific dosing scheme is predefined based on information regarding at least one compound cartridge inserted into the nebulizer device.
However, Giroux teaches a nebulizer device (device 100, fig. 9) comprises a compound cartridge (cartridge that comprises nose piece and atomization chamber in fig. 11) having an RFID tag comprising a user-specific dosing scheme (information on RFID, see paragraphs 0030 and 0041) is predefined based on information regarding the compound cartridge inserted into the nebulizer device (see paragraph 0030, Giroux discloses a medicament cartridge comprises intelligent ID tag such as an RFID tag, and further discloses in paragraph 0041 that the medicament associated ID tag comprises adjusting operational parameters selected from the group consisting of atomization or nebulization rate).
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 of the modified Lee to have the RFID tag and be configured to have the user-specific dosing scheme being predefined based on information regarding the cartridge as taught by Giroux for the purpose of providing a smart cartridge and nebulizer device that increase safety and efficacy by allowing the nebulizer to select a specific dosage scheme based on the information regarding the cartridge.
Response to Arguments
The arguments to the newly added claim limitations in claims 26, 28, 34-37, and 41-48 has been addressed in the above rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Buchberger (10,701,969) is cited to show an inhaler comprising a portion configured to provide an inhalant to the nasal area.
Batista (2023/0354891) is cited to show a cartridge comprising a nasal airflow passage.
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/TU A VO/Primary Examiner, Art Unit 3785