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 11/25/2025. As directed by the amendment, claims 14, 62, and 63 were amended, claims 3, 8-12, 25, 27-28, 33-47, and 52-54 were cancelled and new claims 64-66 were added. Thus, claims 1-2, 4-7, 13-24, 26, 29-32, 48-51, and 55-66 are presently pending in this application.
Claim Objections
Claim 63 is objected to because of the following informalities:
In claim 63, line 6, the term “the first and/or second active substance” is suggested to be changed to --the first active substance and/or second active substance-- 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.
Presently, no limitation(s) is/are being interpreted under 112(f).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-7, 13-19, 22, 48-51 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis (2018/0154103).
Regarding claim 1, Davis discloses a method for providing, during a single inhalation of an aerosol (see paragraphs 0147-0148, Davis discloses that based on the defined THC and CBD ratio, there would be a corresponding heating profiles and that THC is evaporated at 157° C, and that CBD is evaporated at 160-180° C, therefore, when CBD is being evaporated, THC would be evaporated as well, and would provide both the first and second active substances simultaneously into aerosol formed by the inhaler, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC) formed by a single vaporization chamber (see fig. 3C and paragraphs 0105-0117, Davis discloses that the spring holder 8 and enclosure fitting 10 allows the puck to be placed and as shown, the puck is to be placed between 8 and 9, therefore, as shown, the vaporization chamber would be the chamber where puck is located and within stem piece 13, which is a single chamber) of an inhaler (inhaler is the device that is used with the tablet shown in figs. 2A-2D, see fig. 3C (paragraphs 0103-0117), also see fig. 1B and 1A), a first active substance from a source material and a second active substance from the source material (see compressed vaporizer tablet/cartridge in figs. 2A-2D is the source material, paragraph 0089, furthermore, Davis discloses in paragraphs 0044 and 0045 that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, THC being the first substance and CBD being the second substance, Davis further discloses heating profiles in paragraphs 0147-0148, therefore, when the substances is heated at 160-180° C, there would be both CBD and THC being provided to the user in a single inhalation), the source material being comprised in a single holder placeable in a vaporization chamber (see paragraphs 0215-0229 and figs. 14A-17, the single holder being the carousel and the vaporization chamber is the chamber for heating the tablet and the chamber the carousel is placed within, alternatively, the single holder is the disc cartridge, see fig. 14A), the method comprising: providing the single holder (carousel or disc cartridge, see paragraphs 0215-0229)(see paragraphs 0044 and 0045, Davis discloses that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, furthermore, paragraph 0101 stated that the cartridge having RFID tags, the product information may include product blend THC to CBD ratio, see the single holder being the carousel, paragraphs 0215-0229); defining at least one desired ratio in the formed aerosol of an amount of the first and second active substance to be delivered to a user from said single holder placeable in said single vaporization chamber (see paragraph 0101, RFID tags include information that include product blend, THC to CBD ratio, dosing amounts, and optimum vaporization temperature, further discloses in paragraph 0147 that depending on the THC to CBD ratio, the microcontroller may be programmed to utilize a particular metered air flow, heating profile, furthermore, the ratio would be a desired ratio in the formed aerosol, since the output aerosol would be based off of the ratio being set by the inhaler); setting operation parameters in accordance with the desired ratio, the operation parameters including one or more of (a) a heating profile of the source material and (b) an airflow provide through the source material; and operating the inhaler according to the operation parameters to deliver to the user the first and second substances together during the single inhalation, the first and second active substances released from said source material at the defined desired ratio (see paragraphs 0044, 0045, 0101 and 0146-0148, Davis discloses that the cartridge comprises RFID device containing THC to CBD ratio and that based on the ratio information, the microcontroller may be programmed to utilize particular metered air flow, heating profile, and further stated that for example, THC evaporates at 157° C and CBD evaporates between about 160° C and 180° C, therefore, whichever the ratio that is being defined by the system when a particular heating profile is chosen based on the ratio information off of the RFID would be the defined ratio, furthermore, Davis further discloses in paragraph 0269 that the microprocessor is adapted to control the airflow over a period of time based on a desired dosage of selected therapeutic compounds desired to be delivered for inhalation, furthermore, when the heating profile is set at 160-180° C, the THC would be evaporated as well in order to provide the first and second substances in 1 single inhalation, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC, see full disclosure).
Regarding claim 2, Davis discloses that the defining includes defining an amount of at least the first substance to be deliver during the single inhalation (see paragraphs 0101 and 0147-0148 and Davis discloses THC to CBD ratio, in order to define a ratio and to also use the ratio to provide a heating profile, there would be an amount being defined in order to know how much to provide to the user).
Regarding claim 4, Davis discloses that a change in operation parameters changes an efficiency of at least one of a vaporization of at least one of the first active substance and the second active substance (relatively, when a heating profile (temperature) is changed, efficiency of the vaporization of the first active substance or the second substance is changed, since if the temperature is set at 157° C, THC would be evaporated but not CBD).
Regarding claim 6, Davis discloses that the source material is a botanical material (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
Regarding claim 7, Davis discloses that the first substance is CBD and the second substance is a cannabinoid different than the first substance (see paragraph 0044, Davis discloses CBD and THC, therefore, it can be defined such that the first active substance can be CBD and the second active substance is THC, THC is a cannabinoid that is different from CBD).
Regarding claim 13, Davis discloses that the heating profile is set to release the first active substance and the second active substance simultaneously into said aerosol formed by said single vaporization chamber of the inhaler (see paragraphs 0147-0148, Davis discloses that based on the defined THC and CBD ratio, there would be a corresponding heating profiles and that THC is evaporated at 157° C, and that CBD is evaporated at 160-180° C, therefore, when CBD is being evaporated, THC would be evaporated as well, and would provide both the first and second active substances simultaneously into aerosol formed by the inhaler, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC).
Regarding claim 14, Davis discloses an inhaler (inhaler is the device that is used with the tablet shown in figs. 2A-2D, see fig. 3C (paragraphs 0103-0117), also see fig. 1B and 1A) for delivering an aerosol (see paragraphs 0147-0148, Davis discloses that based on the defined THC and CBD ratio, there would be a corresponding heating profiles and that THC is evaporated at 157° C, and that CBD is evaporated at 160-180° C, therefore, when CBD is being evaporated, THC would be evaporated as well, and would provide both the first and second active substances simultaneously into aerosol formed by the inhaler, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC) formed by a single vaporization chamber (see fig. 3C and paragraphs 0105-0117, Davis discloses that the spring holder 8 and enclosure fitting 10 allows the puck to be placed and as shown, the puck is to be placed between 8 and 9, therefore, as shown, the vaporization chamber would be the chamber where puck is located and within stem piece 13, which is a single chamber) of the inhaler, said aerosol comprises at least two active substances released from a source material to an inhaling user (see compressed vaporizer tablet/cartridge in figs. 2A-2D, paragraph 0089, furthermore, Davis discloses in paragraphs 0044 and 0045 that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, THC being the first substance and CBD being the second substance, Davis further discloses heating profiles in paragraphs 0147-0148, therefore, when the substances is heated at 160-180° C, there would be both CBD and THC being provided to the user in a single inhalation see compressed vaporizer tablet/cartridge in figs. 2A-2D via the aerosol, paragraph 0089, furthermore, Davis discloses in paragraphs 0044 and 0045 that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, THC being the first substance and CBD being the second substance, Davis further discloses heating profiles in paragraphs 0147-0148, therefore, when the substances is heated at 160-180° C, there would be both CBD and THC being provided to the user in a single inhalation), said source material comprising a mixture of the at least two active substances (see paragraphs 0044 and 0045, Davis discloses that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, furthermore, paragraph 0101 stated that the cartridge having RFID tags, the product information may include product blend THC to CBD ratio), said source material being comprised in a single holder, placeable in a vaporization chamber (see paragraphs 0215-0229 and figs. 14A-17, the single holder being the carousel and the vaporization chamber is the chamber for heating the tablet and the chamber the carousel is placed within, alternatively, the single holder is the disc cartridge, see fig. 14A); defining a ratio of an amount of the first and second active substance to be delivered to a user (see paragraph 0101, RFID tags include information that include product blend, THC to CBD ratio, dosing amounts, and optimum vaporization temperature, further discloses in paragraph 0147 that depending on the THC to CBD ratio, the microcontroller may be programmed to utilize a particular metered air flow, heating profile), the inhaler comprising: a controller pre-programmed with and/or in communication with a storage (see memory in paragraph 0074) including a plurality of operation profiles (see paragraphs 0044 and 0045, Davis discloses that plant source materials may contain hundreds of constituent parts and further discloses that bioactive compounds includes THC and CBD, furthermore, paragraph 0101 stated that the cartridge having RFID tags, the product information may include product blend THC to CBD ratio, wherein the plurality of operation profiles are the airflow and/or heating profiles for the different ratios); defining a ratio of an amount of the first and second active substance to be delivered to a user (see paragraph 0101, RFID tags include information that include product blend, THC to CBD ratio, dosing amounts, and optimum vaporization temperature, further discloses in paragraph 0147 that depending on the THC to CBD ratio, the microcontroller may be programmed to utilize a particular metered air flow, heating profile); and at least one of: at least one conductor (heater, see paragraphs 0147-0148 and see “heater” in figs. 1A, 1B and see fig. 3C and paragraphs 0105-0109, the heat sink 7 transfer heat from the internally mounted plug style electric heater to the fins, and air is pumped through the heat sink) configured to supply sufficient energy for heating the source material when the source material is received within the single vaporization chamber of the inhaler (see paragraphs 0105-0118); an airflow system comprising at least one conduit (see air pump in paragraphs 0054, 0059, 0082-0083 and 0109, air pump would have conduit) for passing airflow through the source material and for delivering together the at least two active substances released from the source material to an inhaling user (paragraphs 0054, 0059, 0082-0083 and 0109), in a single inhalation; wherein each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances said aerosol (see paragraphs 0147-0148 and paragraphs 0139-0146 regarding different ratios, the ratio would be a desired ratio and the output of the substances would be substances of the aerosol, see full disclosure).
Regarding claim 15, Davis discloses that each of the operation profiles is associated with a different therapeutic or psychoactive or adverse effect the ratio is expected to have on the user (see the paragraphs 0147-0148 and 0139-0146, Davis discloses THC and CBD and different ratios, and since THC and CBD are active ingredients and is the same substances as disclosed by the applicant, a different ratio would provide different therapeutic or psychoactive or adverse effect, depending on the user).
Regarding claim 16, Davis discloses that the different effect includes a different magnitude of said therapeutic and/or said psychoactive or said adverse effect (see the paragraphs 0147-0148 and 0139-0146, Davis discloses THC and CBD and different ratios, and since THC and CBD are active ingredients and is the same substances as disclosed by the applicant, a different ratio would provide different therapeutic or psychoactive or adverse effect, which would provide a different effect including different magnitude of said therapeutic, psychoactive or adverse effect depending on the user).
Regarding claim 17, Davis discloses a user interface configured to receive feedback input from the user and to automatically select an operation profile of said plurality of operation profiles in response to the feedback input (the user interface is interpreted as the microcontroller (see fig. 1A and paragraph 0147) and the RFID reader, since the user would be the one providing the cartridge/tablet having the RFID code (see paragraph 0101), the microcontroller and the RFID reader would be a user interface that is configured to receive feedback input (RFID code on the cartridge) from the user and to automatically select an operation profile of said plurality of operation profiles in response to the feedback input, see paragraphs 0147-0148).
Regarding claim 18, Davis discloses the controller is configured (microcontroller in paragraph 0147 and fig. 1A) for setting two or more operation profiles from said plurality of operation profiles for use during a single inhalation, the two or more operation profiles selected according to amounts of the active substance to be released from the source material and delivered to the user (see paragraphs 0101 and 0147-0148, Davis discloses that based on the ratio of THC and CBD stored on the RFID, the microcontroller will control airflow and heating profiles for use during a single inhalation, the two or more operation profiles would be selected according to amounts the microcontroller and the designer of the device wants to release from the source material and delivered to the user (see dosage), the two or more operation profiles can be either air flow profile and heating profile or different heating profiles for different ratios).
Regarding claim 19, Davis discloses that the two or more operation profiles are configured to deliver the same amount of first active substance to the user (see paragraphs 0147-0148, when temperature is below 160° C (temperature set a particular operating profile) and the airflow is set at a particular profile, the THC (first substance) would be the same (see precise metered doses can then be consistently administered to the user in paragraph 0220), alternatively, when another cartridge of the same ratio and same information is being provided, the two or more operation profiles would be the same, and would provide the same amount of first active substance to the user, see paragraph 0055 for the tablet/cartridge being replaceable).
Regarding claim 22, Davis discloses that each of the plurality of operation profiles is configured to operate within a single inhalation (see paragraph 0147, Davis discloses that the operation profiles include airflow and heating profile and further discloses in paragraphs 0054, 0083, 0109 and 0220 that the use of air pump to provide air flow through the heater, therefore, the utilization of airflow + heating profiles are within a single inhalation since both are operated to move the vapors to the user).
Regarding claim 48, Davis discloses that the botanical material comprises a single strain of botanical material (see abstract and paragraph 0259, Davis discloses that the compressed tablet is formed from a plant source, therefore, would comprise a single strain of botanical material, it is noted that the claim is open ended, therefore, plant material has at least one single strain of botanical material).
Regarding claim 49, Davis discloses that the at least one ratio comprises a plurality of ratios (see paragraph 0101, RFID tags include information that include product blend, THC to CBD ratio, dosing amounts, and optimum vaporization temperature, further discloses in paragraph 0147 that depending on the THC to CBD ratio, the microcontroller may be programmed to utilize a particular metered air flow, heating profile, furthermore, paragraphs 0215-0229 discloses a plurality of tablets within a disc cartridge, therefore, within different period of time, there would be a plurality of ratios being defined, at least one per tablet, alternately see paragraph 0148, if the heating profile is set below 160°C but above 157°C, THC would evaporates as one ratio and the other ratio would be when the heating profile is changed when CBD needs to be evaporated).
Regarding claim 50, Davis discloses that the single holder is a chip (See figs. 14A-17 and paragraphs 0215-0229, the carousel is a chip, shape-wise).
Regarding claim 51, Davis discloses that the heating profile comprises heating for at least two different period of times so as to provide the desired ratio (see paragraphs 0007 and 0084 and 0147, Davis discloses heating profile can be utilized depending on THC to CBD ratio, which would comprise two different period of times, since period of times is broadly claimed, therefore, whatever period is utilized by the heating profile of Davis, can be broken up into two different period of times).
Regarding claim 62, Davis discloses that the source material comprises cannabis (see paragraph 0103), and where the second active substance is THC and the first active substance is CBD, wherein the second active substance is different form the first active substance (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Lord (2015/0245660).
Regarding claim 55, Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of Davis to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Lord (2015/0245660).
Regarding claim 56, Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of Davis to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Levin (2013/0298905).
Regarding claim 59, Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of Davis to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Levin (2013/0298905).
Regarding claim 60, Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of Davis to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 63 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103).
Regarding claim 63, Davis discloses a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Since Davis discloses in paragraph 0146 that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 63 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103) in view of Hearn (2017/0056368).
Regarding claim 63, Davis discloses a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of Davis to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claim 64 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103).
Regarding claim 64, Davis discloses an aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Since Davis discloses in paragraph 0146 that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 64 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103) in view of Hearn (2017/0056368).
Regarding claim 64, Davis discloses an aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of Davis to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claim 65 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103).
Regarding claim 65, Davis discloses an aerosol both of said at least two active substances are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Since Davis discloses in paragraph 0146 that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 65 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Davis (2018/0154103) or, in the alternative, under 35 U.S.C. 103 as obvious over Davis (2018/0154103) in view of Hearn (2017/0056368).
Regarding claim 65, Davis discloses an aerosol both of said at least two active substances are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
However, if there is any doubt that Davis discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of Davis to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claims 1-4, 6, 13 and 48-51 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982).
Regarding claim 1, Davidson discloses a method for providing, during a single inhalation (see paragraph 0144, Davidson discloses that the method includes providing a dose cartridge comprises drug substance material for deliver over no more than 1 inhalation) of an aerosol (see paragraph 0201, drug substance can be fluid/solution, therefore, when vaporized would have the form of an aerosol) formed by a single vaporization chamber (see fig. 12, as shown, the conduit 1222 and 1232 and 1215 forms a single vaporization chamber (see paragraph 0233 of Davidson)) of an inhaler (inhaler device in fig. 12 and paragraph 0231), a first active substance from a source material and a second active substance from said source material (one active substance is in the first cartridge 2300C and the second active substance is in the cartridge 2300D in fig. 12, the source material is the material that comprises the materials of cartridges within the carousel 1210), the source material being comprised in the single holder placeable in a vaporization chamber (the holder is the carousel 1210, which is placed within a vaporization chamber (defined as the chamber 1210 is within and also the chamber where 2300C and 2300D are being heated)), the method comprising: providing the single holder (see fig. 12 and paragraphs 0231-0232, as shown and disclosed, the single holder (carousel 1210) is being provided, Davidson discloses simultaneous administration of substances from a plurality of dose cartridge clamping chambers 1220 and 1230, furthermore, Davidson discloses in paragraphs 0038, 0132 and 0159 that the pallet comprises powder comprising the heat-vaporizing drug substance, for reference see figs. 5A-5B, which shows a cartridge 2300 comprising a pallet 2304, paragraphs 0146-0147 and 0163), a desired ratio (see paragraphs 0105 and 0231, Davidson discloses an inhaler for simultaneous administration of substances, see paragraph 0241, Davidson discloses that the dose cartridge is separately actuatable, optionally, wherein the two are heated at different times or simultaneously actuating the cartridges, therefore, for each instances, there is a ratio between the two substances) in the formed aerosol of an amount of the first and second active substances to be delivered to a user from said single holder placeable in said single vaporization chamber (see paragraphs 0231 and 0241, each cartridge comprises a heating profile, and by actuating both or one after the other, there would be a ratio of an amount of the first and second active substances to be delivered to a user); setting operation parameters in accordance with the desired ratio, the operation parameters including one or both of (a) a heating profile of the source material and (b) an airflow profile through the source material (since the inhaler provides simultaneous or sequential activation of the cartridges, there would be a ratio between the two substances, furthermore, the operation parameters would be based on the ratio since the heating profiles is based on what ratio is being defined by the inhaler, furthermore, Davidson discloses in paragraphs 0234 and 0242 that the airflow is controlled, since there is an associated ratio for the first and second active substances within the cartridges, there would be an airflow that is being set in response to the ratio), operating the inhaler according to the operation parameters to deliver to the user the first and second substances together during the single inhalation (see paragraph 0144 and 0231), the first and second active substances released from said source material at the desired ratio (see fig. 12 and paragraph 0231, furthermore, the ratio would be a desired ratio in the formed aerosol, since the heating profile would provide a particular ratio of the first substance and second substance, which can be viewed as the desired ratio), but fails to disclose that the step of defining the ratio of an amount of the first and second active substances to be delivered.
Atkins teaches a method for providing, during an inhalation from an inhaler, a controllable ratio between at least a first active substance and a second active substance, defining a desired ratio of an amount of the first and second active substances to be delivered to a user, setting operation parameters in accordance with the desired ratio, the operation parameters including at least one of a heating profile, operating the inhaler according to the operation parameters to deliver to the user, the at least first and second substances together (see figs. 10 and 11, a first substance is in side A and a second substance is in side B, controller is control circuitry 1012 (paragraph 0177) or 1122 (paragraph 0179), Atkins further discloses in paragraph 0173 that the ratio of the vapor constituents can be adjusted, therefore, there would be a plurality of operation profiles, each profile being each adjustment of the user, and each operation profile would include a ratio that was set, see paragraphs 0177-0179, furthermore, the ratio would be a desired ratio in the formed aerosol, since the output aerosol would be based off of the ratio being set by the inhaler).
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 method and inhaler of Davidson to have a controllable ratio between at least a first active substance and a second active substance, defining a desired ratio of an amount of the first and second active substances to be delivered to a user, setting operation parameters in accordance with the desired ratio, the operation parameters including at least one of a heating profile, operating the inhaler according to the operation parameters to deliver to the user, the at least first and second substances together as taught by Atkins for the purpose of providing user adjustability, by allowing the user and the inhaler to set different ratio of active substances, thereby, allowing the user to find a user suitable composition of active substances (see paragraphs 0173 and 0177-0179 of Atkins).
Regarding claim 2, the modified Davidson discloses that the defining includes defining an amount of at least the first substance to be delivered to the user during the single inhalation (see paragraph 0144 and 0231-0234 of Davidson, Davidson discloses simultaneously providing a first and second active substances from a first and second cartridges 2300C and 2300D, and that the dose cartridge is provided during a single inhalation (paragraph 0144), see the modification with Atkins, Atkins discloses in paragraphs 0173 and 0177-0179 that the ratio can be adjusted by the user and the value for each substance can be defined).
Regarding claim 4, the modified Davidson discloses that a change in operation parameters changes an efficiency of at least one of vaporization of a least one of the first active substance and the second active substance (see paragraphs 0173 and 0177-0179 of Atkins, Atkins discloses actively adjusting a ratio by the user, once the ratio is controllable by the user, and depending on the user, the ratio would create a change in the operation parameters such as the heating profile and how much to dispense, therefore the efficacy of at least one of: the first active substance and the second active substance would be change).
Regarding claim 6, the modified Davidson discloses that the source material includes a botanical material (see paragraphs 0025, 0111 and 0144 of Davidson, Davidson discloses that the material can be a botanical substance).
Regarding claim 13, the modified Davidson discloses that the heating profile is set to release the first active substance and the second active substance simultaneously into said aerosol formed by said single vaporization chamber of the inhaler (see paragraphs 0231-0234 of Davidson and fig. 12 of Davidson).
Regarding claim 48, the modified Davidson discloses that the botanical material comprises a single strain of botanical material (see abstract and paragraphs 0025, 0111 and 0127 of Davidson, Davidson discloses that the material comprises botanical substance, therefore, would comprise a single strain of botanical material, it is noted that the claim is open ended, therefore, plant material has at least one single strain of botanical material).
Regarding claim 49, the modified Davidson discloses that the at least one ratio comprises a plurality of ratios (see paragraphs 0105 and 0231, Davidson discloses an inhaler for simultaneous administration of substances, see paragraph 0241, Davidson discloses that the dose cartridge is separately actuatable, optionally, wherein the two are heated at different times or simultaneously actuating the cartridges, therefore, for each instances, there is a ratio between the two substances, see fig. 12, there are a plurality of cartridges within the carousel 1210 (holder of source material), therefore, within different period of time, there would be a plurality of ratios being defined, one ratio for 1 set of cartridges and another ratio for another set of cartridges).
Regarding claim 50, the modified Davidson discloses that the single holder is a chip (see the carousel 1210 in fig. 12 and paragraph 0232 with reference to the carousel 1010 and 1020 in fig. 10 and paragraph 0226, the carousel is in the shape of a chip).
Regarding claim 51, the modified Davidson discloses that the heating profile comprises heating for at least two different periods of time so as to provide the desired ratio (see paragraph 0227 of Davidson, Davidson disclosed that the applied heating profile are optionally identical or separate in order to release drug substance(s) at different times or releasing different drug substance compositions, alternatively, any period of time can be sectioned off to be two different period of times, since the claim does not claim how long is a period of time or each of the two periods of time).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Valadi (11,006,661).
Regarding claim 5, the modified Davidson fails to disclose that the second substance is a chemical derivative of the first substance.
However, Valadi teaches a substance including plurality of substances comprising a cannabinol and chemical derivative of the cannabinol (see claim 1 and col 2, lines 49-59, see “cannabinol and derivatives”).
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 substance of the modified Davidson to be a cannabinol and the second substance of the modified Davidson to be a chemical derivative as taught by Valadi for the purpose of providing a therapeutic substance that would provide a particular effect to the user (see col 2, lines 49-59 of Valadi).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Valadi (11,006,661).
Regarding claim 5, the modified Davidson fails to disclose that the second substance is a chemical derivative of the first substance.
However, Valadi teaches a substance including cannabinol and derivatives (see claim 1 and col 2, lines 49-59, see “cannabinol and derivatives”).
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 substance and second substance of the modified Davidson to be cannabinol and derivatives as taught by Valadi for the purpose of providing a therapeutic substance that would provide a particular effect to the user (see col 2, lines 49-59 of Valadi).
After the modification, the both the first and second substances would include cannabinol and derivatives, therefore, the cannabinol within the first cartridge can be interpreted as the first substance and the derivative within the second cartridge can be interpreted as the second substance.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Adelson (2017/0304567).
Regarding claim 7, the modified Davidson discloses that the first and second substances can include THC (see paragraph 0110 of Davidson), but fails to disclose that the second substance include a cannabinoid different than the first substance or a terpene.
However, Adelson teaches a substance comprising a cannabinoid comprising cannabidiol (CBD) (see paragraph 0068).
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 substance of the modified Davidson to have CBD as taught by Adelson for the purpose of providing a therapeutic drug combination that would provide a therapeutic effect to the user (see paragraph 0068 of Adelson).
It is noted that CBD is a cannabinoid that is different from THC.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Wand (2016/0309774).
Regarding claim 7, the modified Davidson discloses that the first and second substances can include THC (see paragraph 0110 of Davidson), but fails to disclose that the second substance include at least one of a cannabinoid different than the first substance or a terpene.
However, Wand teaches a substance comprising a substance comprising a cannabidiol (CBD) and terpene (see paragraph 0017).
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 substance of the modified Davidson to have CBD and terpene as taught by Wand for the purpose of providing a therapeutic drug combination that would provide a therapeutic effect to the user (see paragraph 0017 of Wand).
After the modification, the second substance can be interpreted as CBD or terpene.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Lord (2015/0245660).
Regarding claim 55, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of the modified Davidson to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Levin (2013/0298905).
Regarding claim 59, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of the modified Davidson to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Adelson (2017/0304567).
Regarding claim 62, the modified Davidson discloses that the source material is cannabis (paragraphs 0039 and 0111 of Davidson) and a second substance include THC (see paragraph 0110 of Davidson, the THC can be interpreted as the second substance), but fails to disclose that the second substance is different than the first substance.
However, Adelson teaches a substance comprising a cannabinoid comprising cannabidiol (CBD) (see paragraph 0068).
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 substance of the modified Davidson to have CBD as taught by Adelson for the purpose of providing a therapeutic drug combination that would provide a therapeutic effect to the user (see paragraph 0068 of Adelson).
It is noted that CBD is a cannabinoid that is different from THC. Therefore, after the modification, THC is the second active substance and the first active substance is CBD.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Davis (2018/0154103).
Regarding claim 63, the modified Davidson fails to disclose a desired ratio between a first active substance and a second active substance from a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present, and wherein the first and/or second active substance is selected from a CBD.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Since the modified Davidson discloses in paragraph 0146 of Davis that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Davis (2018/0154103) and Hearn (2017/0056368).
Regarding claim 63, the modified Davidson fails to disclose a desired ratio between a first active substance and a second active substance from a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present, and wherein the first and/or second active substance is selected from a CBD.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of the modified Davidson to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Davis (2018/0154103).
Regarding claim 64, the modified Davidson fails to disclose said aerosol both of said first active substance and said second active substance are present, and wherein the first and/or second active substance is selected from a CBD.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Since the modified Davidson discloses in paragraph 0146 of Davis that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 1 above, and further in view of Davis (2018/0154103) and Hearn (2017/0056368).
Regarding claim 64, the modified Davidson fails to disclose said aerosol both of said first active substance and said second active substance are present, and wherein the first and/or second active substance is selected from a CBD.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of the modified Davidson to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claims 14-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982).
Regarding claim 14, Davidson discloses an inhaler (inhaler device in fig. 12 and paragraph 0231) for delivering an aerosol (see paragraph 0201, drug substance can be fluid/solution, therefore, when vaporized would have the form of an aerosol) formed by a single vaporization chamber (see fig. 12, as shown, the conduit 1222 and 1232 and 1215 forms a single vaporization chamber (see paragraph 0233 of Davidson)) of an inhaler (inhaler device in fig. 12 and paragraph 0231), said aerosol comprises at least two active substances released from a source material to an inhaling user (one active substance is in the first cartridge 2300C and the second active substance is in the cartridge 2300D in fig. 12, the one distinct source material is the portion that comprises 1215, 1230 and 1220 and the cartridges 2300C and 2300D), said source material comprising a mixture of the at least two active substances (see fig. 12 and paragraphs 0231-0232, as shown, the first and second active substances are mixed in the source material since they exist in the same space to form a combination, alternately, when the substances are being released at the same time, the two substances would form a mixture, furthermore, Davidson discloses simultaneous administration of substances from a plurality of dose cartridge clamping chambers 1220 and 1230, furthermore, Davidson discloses in paragraphs 0038, 0132 and 0159 that the pallet comprises powder comprising the heat-vaporizing drug substance, for reference see figs. 5A-5B, which shows a cartridge 2300 comprising a pallet 2304, paragraphs 0146-0147 and 0163), the source material being comprised in a single holder placeable in a vaporization chamber (the holder is the carousel 1210, which is placed within a vaporization chamber (defined as the chamber 1210 is within and also the chamber where 2300C and 2300D are being heated)), the inhaler comprising: a controller pre-programmed with and/or in communication with a storage including a plurality of operation profiles (see paragraphs 0082 and 0215 for a controller/processor, and see paragraph 0227 for a plurality of operation profiles (“heating profiles”), since there are heating profiles for each cartridges being controlled by a microprocessor, there would have to be storage for storing instruction for the heating profiles, see paragraph 0083 for computer readable storage medium), an airflow system comprising at least one conduit for passing airflow through the source material and for delivering together the at least two active substances released from the source material to an inhaling user, in a single inhalation (see airflow system comprising conduit formed by the channels for accommodating 1222 and/or the extraction conduits 1222 and 1232 in fig. 12 and paragraphs 0231-0233 and 0235, alternatively, the airflow system can be interpreted as valve or aperture in paragraph 0234, see paragraph 0144 for single inhalation, the channels or the valve/aperture allow air to be passing through and allow air to be delivered to the user); wherein each of the plurality of operation profiles involves an associated desired ratio of amounts of different active substance in said aerosol (see paragraph 0227, Davidson discloses heating profiles are controlled separately, therefore, there would be an associated ratio with the heating profiles since one cartridge is being dispensed relative to the other, furthermore, Davidson discloses multiple heating profiles, furthermore, the ratio would be a desired ratio in the formed aerosol, since the heating profile would provide a particular ratio of the first substance and second substance, which can be viewed as the desired ratio), but fails to disclose that each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances.
However, Atkins teaches a controller programmed with a plurality of operation profiles, wherein each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances in said aerosol (see figs. 10 and 11, a first substance is in side A and a second substance is in side B, controller is control circuitry 1012 (paragraph 0177) or 1122 (paragraph 0179), Atkins further discloses in paragraph 0173 that the ratio of the vapor constituents can be adjusted, therefore, there would be a plurality of operation profiles, each profile being each adjustment of the user, and each operation profile would include a ratio that was set, see paragraphs 0177-0179).
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 inhaler and controller of Davidson to have a plurality of operation profiles and each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances as taught by Atkins for the purpose of providing user adjustability, by allowing the user and the inhaler to set different ratio of active substances, thereby, allowing the user to find a user suitable composition of active substances (see paragraphs 0173 and 0177-0179 of Atkins).
It is noted that due to the usage of the limitation “at least one of:” in claim 14, line 6, the limitation “at least one conductor configured to supply sufficient energy for heating the source material when the source material is received within the single vaporization chamber of the inhaler” is not required. However, if there is any doubt that the limitation is required or not required. The modified Davidson discloses at least one conductor configured to supply sufficient energy for heating the source material when the source material is received within the single vaporization chamber of the single vaporization chamber of the inhaler (see dose cartridge 2300 in fig. 5A comprising a heating element 2306, paragraph 0147, where the heating element 2306 can be considered as at least one conductor, or the power source that allows the heater to be heated is the conductor, furthermore, as shown in fig. 12, the source material is received within the single vaporization chamber of inhaler since the manufacturing of the device).
Regarding claim 15, the modified Davidson discloses that each of the operations profiles is associated with a different therapeutic effect the ratio is expected to have on the user (see paragraphs 0040 and 0111 of Davidson, Davidson discloses a plurality of different substance including cannabis, therefore, different ratio would have a different therapeutic effect, see paragraphs 0177-0179 of Atkins).
Regarding claim 16, the modified Davidson discloses that the different effect includes a different magnitude of said therapeutic effect (see paragraphs 0040 and 0111 of Davidson, Davidson discloses a plurality of different substance including cannabis, different ratio would have a different therapeutic effect, furthermore, different ratio would provide a different amount, therefore, the magnitude of the effect would be different, however, has similar effect, see paragraphs 0177-0179 of Atkins).
Regarding claim 17, the modified Davidson discloses a user interface configured to receive feedback input from the user and to automatically select an operation profile of said plurality of operation profiles in response to the feedback input (see user interface of Atkins, see paragraphs 0177-0179 of Atkins, each adjustment for a ratio would produce an operation profile after the modification).
Regarding claim 22, the modified Davidson discloses that each of the plurality of operation profiles is configured to be operated within a single inhalation (see the modification with Atkins, after the modification, user can modify and set a ratio (each adjustment being an operation profile, paragraphs 0177-0179 of Atkins), and since the user can inhale, each of the plurality of operation profile is configured to operate within a single inhalation, it is noted that the claim does not claim that each of the entire one of a plurality of operation profiles is configured to operate within a single inhalation, therefore, since a user can inhale in a single inhalation, each of the plurality of the operation profiles can be operate within a single inhalation, even if the applicant claims each of an entire one of the plurality of operation profiles, Davidson discloses in paragraph 0144 that a dose cartridge may comprise a drug substance material for deliver over no more than 1 inhalation).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14, and further in view of Fleming (2007/0240712).
Regarding claim 18, the modified Davidson discloses that the controller is configured for setting two or more operation profiles of the plurality of operation profiles for use during an inhalation session, wherein the two or more operation profiles are selected according to amounts of the active substances to be released from the source material and delivered to the user (see paragraph 00241 of Davidson, Davidson discloses that the activation of the cartridges are sequential in order to have a time offset, furthermore, Atkins discloses in paragraphs 0034 that the vaporization of each substance can be at or near the same time, therefore, after the modification, depending on the substance, once a ratio is set, within each ratio setting, there would be operation profiles, one operation profile can be when one substance is being vaporized and the other is not, and the second operational profile would be both are being vaporized at the same time, once the time where only one substance is being vaporized has elapsed, alternatively, the two or more operation profiles would be interpreted as a first operation profile having a first ratio set by the user and a second operation profile having a second ratio set by the user, see modification with Atkins in claim 14, in both instances, there would be an amounts of active substances to be released from the source material and delivered to the user), furthermore, the modified Davidson discloses that each cartridge comprises a drug substance material that is for deliver no more than 1 inhalation (Davidson discloses in paragraph 0144 that a dose cartridge may comprise a drug substance material for deliver over no more than 1 inhalation), but fails to disclose that the controller is configured for setting two or more operation profiles for use during a single inhalation.
However, Fleming teaches that the controller is configured for setting two or more operation profiles for use during a single inhalation (see paragraph 0064, Fleming discloses a variable dose of a drug is delivered by a patient by using at least one vibrator 690, and configured to sequentially activate multiple selected dose packs so as to result in the delivery of a specific dose of the drug in one inhalation).
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 two or more operation profiles of the modified Davidson to take place during a single inhalation as taught by Fleming for the purpose of providing a specific therapeutic substance at a particular dosage according a specific sequence, that would bring about a therapeutic effect to the user (see paragraph 0064 of Fleming).
Regarding claim 19, the modified Davidson discloses that the two or more operation profiles are configured to deliver the same amount of a first active substance to the user (see the modification with Fleming, after the modification, there would be a mode where the first active substance is delivered at a time that is offset from the second active substance within the same single inhalation, however, if the user leaves the setting unchanged for the particular drug being used, then the two or more operation profiles are configured to deliver the same amount of a first active substance for a second set of two or more operation profiles of a second set of first and second active substance for a second inhalation, alternatively, if a first of the two operation profiles is being interpreted as a first ratio set by the user and the second of the two operation profiles is being interpreted as a second ratio set by the user, since the user can manually set the ratio and the amount being released by each cartridge (see paragraphs 0177-0179 of Atkins), a user is able to adjust the interface such that the amount for the first active substance for the first and the second operations profiles to be the same).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Patton (2013/0269694).
Regarding claim 20, the modified Davidson fails to disclose that the storage is configured on a cellular phone application.
However, Patton teaches an inhaler (inhaler 100, fig. 1) comprising a controller pre-programmed with and/or in communication with a storage including operation profile; wherein the storage is configured on a cellular phone application (see 190B or 190A, see fig. 1, paragraph 0023, in order to store such instruction, there would be some form of application on the phone).
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 inhaler of the modified Davidson to have the storage being configured on a cellular phone application as taught by Patton for the purpose of providing a smart system that allows the use of a smart phone to control the inhaler thereby providing convenience to the user (see paragraph 0023 of Patton).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Goldstein (2018/0263288).
Regarding claim 21, the modified Davidson fails to disclose that the storage is cloud base.
However, Goldstein teaches a controller’s storage is cloud base (see paragraphs 0121 and 00149-0151).
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 inhaler of the modified Davidson to have the storage of the modified Davidson to be a part of the storage that is cloud based as taught by Goldstein for the purpose of providing a smart inhaler system that would enable remote control, information collection, and self-learning for the vaporizer (see paragraphs 0149-0151 of Goldstein).
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Lord (2015/0245660).
Regarding claim 56, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of the modified Davidson to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Levin (2013/0298905).
Regarding claim 60, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of the modified Davidson to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Davis (2018/0154103).
Regarding claim 65, the modified Davidson fails to disclose that said aerosol both of said at least two active substances are present.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Since the modified Davidson discloses in paragraph 0146 of Davis that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 above, and further in view of Davis (2018/0154103) and Hearn (2017/0056368).
Regarding claim 65, the modified Davidson fails to disclose that said aerosol both of said at least two active substances are present.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of the modified Davidson to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claims 23-24, 26, 29-30, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Gould (2018/0043115) and Atkins (2019/0124982).
Regarding claim 23, Davidson discloses a method for delivering to a user, via an inhaler (inhaler device in fig. 12 and paragraph 0231), an aerosol (see paragraph 0201, drug substance can be fluid/solution, therefore, when vaporized would have the form of an aerosol) formed by a single vaporization chamber (see fig. 12, as shown, the conduit 1222 and 1232 and 1215 forms a single vaporization chamber (see paragraph 0233 of Davidson)) of an inhaler (inhaler device in fig. 12 and paragraph 0231), said aerosol comprises a known ratio between a first substance and a second substance (see paragraphs 0231-0234, first substance is in first cartridge 2300C and second substance is in the second cartridge 2300D), the method comprising: a desired ratio of an amount in said aerosol of the first substance and the second substance (see paragraphs 0231 and 0241, each cartridge comprises a heating profile, and by actuating both or one after the other, there is a ratio of an amount of the first and second active substances to be delivered to a user), setting operation parameters in accordance with the desired ratio, the operation parameters including at least one of a heating-time profile and an airflow-time profile to be applied to a source material portion containing the second substance (since the inhaler provides simultaneous or sequential activation of the cartridges, there would be a ratio between the two substances, furthermore, the operation parameters would be based on the ratio since the heating profiles is based on what ratio is being defined by the inhaler, furthermore, Davidson discloses in paragraphs 0234 and 0242 that the airflow is controlled, since there is an associated ratio for the first and second active substances within the cartridges, there would be an airflow that is being set in response to the ratio, relatively), the source material being comprised in a single holder placeable in a vaporization chamber (the holder is the carousel 1210, which is placed within a vaporization chamber (defined as the chamber 1210 is within and also the chamber where 2300C and 2300D are being heated))(see fig. 12 and paragraphs 0231-0232); operating the inhaler according to the operation parameters to deliver to the user the first substance and the second substance at the defined ratio (see paragraphs 0144 and 0231-0234, see paragraph 0166, Davidson discloses heating profiles are controlled separated, therefore, there would be an associated ratio with the heating profiles since one substance is being heated relative to the other, furthermore, the ratio would be a desired ratio in the formed aerosol, since the heating profile would provide a particular ratio of the first substance and second substance, which can be viewed as the desired ratio), but fails to disclose that the first substance is a cannabinoid and the second substance is an acidic form of the cannabinoid.
However, Gould teaches a first substance including a cannabinoid that is THC and a second substance comprises an acidic form of that cannabinoid which is THCA (see paragraph 0029 and claim 14) (see paragraph 0029 and paragraphs 0027-29, see “dried herbs”, Gould discloses in paragraph 0032 the vaporization of concentrate such as cannabis).
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 substance and the second substance of the modified Davidson to have the THC and THCA, respectively, as taught by Gould for the purpose of providing a therapeutic drug combination that would provide a therapeutic effect to the user (see paragraph 0029 and claim 14 of Gould).
Furthermore, the modified Davidson fails to disclose the step of defining a desired ratio of an amount to be delivered of the at least one cannabinoid and the acidic form of the at least one cannabinoid.
Atkins teaches a method for providing, during an inhalation from an inhaler, a controllable desired ratio between at least a first active substance and a second active substance, defining a desired ratio of an amount in an aerosol of the first and second active substances to be delivered to a user, setting operation parameters in accordance with the desired ratio, the operation parameters including at least one of a heating profile, operating the inhaler according to the operation parameters to deliver to the user, the at least first and second substances together (see figs. 10 and 11, a first substance is in side A and a second substance is in side B, controller is control circuitry 1012 (paragraph 0177) or 1122 (paragraph 0179), Atkins further discloses in paragraph 0173 that the ratio of the vapor constituents can be adjusted, therefore, there would be a plurality of operation profiles, each profile being each adjustment of the user, and each operation profile would include a ratio that was set, see paragraphs 0177-0179).
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 method and inhaler of the modified Davidson to have a controllable desired ratio between at least a first active substance and a second active substance, defining a desired ratio of an amount in said aerosol of the first and second active substances to be delivered to a user, setting operation parameters in accordance with the ratio, the operation parameters including at least one of a heating profile, operating the inhaler according to the operation parameters to deliver to the user, the at least first and second substances together as taught by Atkins for the purpose of providing user adjustability, by allowing the user and the inhaler to set different ratio of active substances, thereby, allowing the user to find a user suitable composition of active substances (see paragraphs 0173 and 0177-0179 of Atkins).
Regarding claim 24, the modified Davidson discloses at least one cannabinoid is Δ9-THC and the acidic form of that cannabinoid is THCA (see the modification with Gould, paragraph 0029 and claim 14 of Gould).
Regarding claim 26, the modified Davidson discloses that the ratio is defined individually per the user, according to a therapeutic effect (see the modification with Atkins, see paragraph 0177-0179 of Atkins, Atkins discloses that the ratio is individually defined by the user via a user interface, and that would be according to a treatment plan of the user).
Regarding claim 29, the modified Davidson discloses that the operation parameters are selected so as to increase vaporization of the acidic form before decarboxylation (see paragraph 0110 of Davidson, Davidson discloses heating the substances to a vaporization temperature, since any form of heating would be from 0 (no heat) to an operational temperature, there would be a point where vaporization of the acidic form would take place before decarboxylation).
Regarding claim 30, the modified Davidson discloses that the parameters are set such that increasing a rate of airflow through the source material (first and second substances), while maintaining heating duration constant (see paragraphs 0144 and 0228 of Davidson, Davidson discloses that the user inhales, and that the airflow is estimated and controlled, therefore, when the user inhales, there would be an increasing in the rate of airflow through the source of material, furthermore, heating duration can be interpreted as the start and beginning of the heating of the substance that is being inhaled, which would be constant once set, see paragraphs 0110, 0166 and 0227 of Davidson, alternatively, the term “other heating duration…constant” can be interpreted as future heating durations of current cartridges or other cartridges at the time the user is inhaling), the modified Davidson discloses that a user can adjust the ratio by adjusting individual substances (see paragraphs 0177-0179 of Atkins), but fails to disclose increasing the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of the at least one cannabinoid.
However, the feature of choosing to increases the ratio by increasing acidic form (THCA) would be considered as an obvious treatment design choice, since it is based on the doctor and/or the user as to what amount of acidic form is suitable for the user’s therapeutic effect or the disease/disorder/discomfort being treated.
Furthermore, if there is any doubt that the feature of choosing to increase the ratio by increasing Acidic form (THCA) would be considered as an obvious treatment design choice, 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 method to increase the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid for the purpose of providing a ratio that would provide a specific therapeutic effect to the user, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
After the modification, in the instance where the user increases the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid, whenever the rate of airflow through the source material is increased, and the other heating duration being held constant, there would an increase in the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid relative the point where no substance were being heated or a point in time where the user did not increase the ratio.
Regarding claim 57, the modified Davidson discloses that said aerosol is formed in a single inhalation (see airflow system comprising the channels for accommodating 1222 and the extraction conduits 1222 and 1232 in fig. 12 and paragraphs 0231-0233 and 0235, alternatively, the airflow system can be interpreted as valve or aperture in paragraph 0234, see paragraph 0144 for single inhalation, the channels or the valve/aperture allow air to be passing through and allow air to be delivered to the user).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Gould (2018/0043115) and Atkins (2019/0124982) as applied to claim 23 above, and further in view of Manas (2019/0183185).
Regarding claim 31, the modified Davidson discloses that the parameters are set such that there is a raising of the heating temperatures (see paragraph 0110 of Davidson, Davidson discloses heating the substances/cartridges to a particular temperature to vaporize the active substances, therefore, there would be a step of raising the heating temperatures), the modified Davidson discloses that a user can adjust the ratio by adjusting individual substances (see paragraphs 0177-0179), but fails to disclose reducing the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of the at least one cannabinoid.
However, the feature of choosing to decreasing the ratio by decreasing the acidic form (THCA) would be considered as an obvious treatment design choice, since it is based on the doctor and/or the user as to what amount of acidic form is suitable for the user’s therapeutic effect or the disease/disorder/discomfort being treated.
Furthermore, if there is any doubt that the feature of choosing to reduce the ratio by increasing Acidic form (THCA) would be considered as an obvious treatment design choice, 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 method to reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid for the purpose of providing a ratio that would provide a specific therapeutic effect to the user, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
After the modification, in the instance where the user reduces the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid, whenever the inhaler is raising the heating temperature, this would reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid relative the point where no substance were being heated or a point in time where the user did not reduce the ratio and further discloses to control airflow between both substances in unison (paragraph 0242 of Davidson), but fails to disclose while maintaining the airflow constant.
However, Manas teaches inhaling by the user at a constant airflow (see paragraph 0093, see a vapor to be inhaled by the user at a preferably constant rate of nicotine flow).
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 method of the modified Davidson to inhale at a constant airflow as taught by Manas for the purpose of providing a method of inhaling a therapeutic vapor 9see paragraph 0093 of Manas).
After the modification, in the instance where the user reduces the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid, whenever the inhaler is raising the heating temperature, while maintaining airflow constant during inhalation, this would reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid relative the point where no substance were being heated or a point in time where the user did not reduce the ratio
Regarding claim 32, the modified Davidson discloses that the parameters are set such that there is a lengthening of the heating duration, (see paragraph 0110 of Davidson, Davidson discloses heating the substances/cartridges to a particular temperature to vaporize the active substances, therefore, relatively, there would be a step of lengthening the heating duration), the modified Davidson discloses that a user can adjust the ratio by adjusting individual substances (see paragraphs 0177-0179 of Atkins), but fails to disclose reducing the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid.
However, the feature of choosing to decreasing the ratio by decreasing the acidic form (THCA) would be considered as an obvious treatment design choice, since it is based on the doctor and/or the user as to what amount of acidic form is suitable for the user’s therapeutic effect or the disease/disorder/discomfort being treated.
Furthermore, if there is any doubt that the feature of choosing to reduce the ratio by increasing Acidic form (THCA) would be considered as an obvious treatment design choice, 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 method to reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid for the purpose of providing a ratio that would provide a specific therapeutic effect to the user, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
After the modification, in the instance where the user reduces the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid, whenever the inhaler is raising the heating temperature and lengthening the heating duration, this would reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid relative the point where no substance were being heated or a point where the user did not reduce the ratio, and further discloses to control airflow between both substances in unison (paragraph 0242 of Davidson), but fails to disclose while maintaining the airflow constant.
However, Manas teaches inhaling by the user at a constant airflow (see paragraph 0093, see a vapor to be inhaled by the user at a preferably constant rate of nicotine flow).
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 method of the modified Davidson to inhale at a constant airflow as taught by Manas for the purpose of providing a method of inhaling a therapeutic vapor 9see paragraph 0093 of Manas).
After the modification, in the instance where the user reduces the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid, whenever the inhaler is raising the heating temperature and lengthening the heating duration while maintaining the airflow constant during an inhalation by the user, this would reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of that cannabinoid relative the point where no substance were being heated or a point where the user did not reduce the ratio.
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Gould (2018/0043115) and Atkins (2019/0124982) as applied to claim 57 above, and further in view of Lord (2015/0245660).
Regarding claim 58, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of the modified Davidson to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Gould (2018/0043115) and Atkins (2019/0124982) as applied to claim 23 above, and further in view of Levin (2013/0298905).
Regarding claim 61, the modified Davidson discloses a heating time period and inhalation time (see paragraphs 0004-0023 of Davidson), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of the modified Davidson to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Gould (2018/0043115) and Atkins (2019/0124982) as applied to claim 23 above, and alternatively in view of Raichman (2018/0104214).
Regarding claim 66, the modified Davidson discloses that said aerosol both of said at least one cannabinoid and an acidic form of the at least one cannabinoid are present (see the modification with Gould above, the aerosol is being modified to have both THC and THCA).
However, if there is any doubt that the modified Davidson discloses that said aerosol both of said at least one cannabinoid and an acidic form of the at least one cannabinoid are present.
Raichman teaches an aerosol both of at least one cannabinoid and an acidic form of the at least one cannabinoid are present (see paragraphs 0074 and 0183, see dose of vapor may comprises THCA and THC).
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 aerosol of the modified Davidson to have the at least one cannabinoid and an acidic form of the at least one cannabinoid are present as taught by Raichman for the purpose of providing a particular therapeutic effect that is needed by the patient/user (see paragraphs 0074 and 0183 of Raichman).
Claims 14-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982).
Regarding claim 14, Davidson discloses an inhaler (inhaler device in paragraph 0004 and shown in figs. 6A-7B) for delivering aerosol (see paragraph 0201, drug substance can be fluid/solution, therefore, when vaporized would have the form of an aerosol) formed by a single vaporization chamber (the single vaporization chamber is the chamber where the substances are being vaporized, see figs. 6A-7B and paragraph 0166, furthermore, see figs. 7A-7B with reference to paragraph 0209, as shown, the clamping chamber is for heating the vaporized substance from dose cartridge 2300, therefore, the clamping chamber forms the single vaporization chamber) of an inhaler, said aerosol comprises at least two active substances released from a distinct source material (the entire cartridge in fig. 5C and surrounding structures 2312B and 2312 in fig. 7A) to an inhaling user (see fig. 5C, the entire cartridge assembly 2350 in fig. 5C is the distinct source material, see paragraph 0166), the inhaler comprising: a controller pre-programmed with and/or in communication with a storage including a plurality of operation profiles (see paragraphs 0082 and 0215 for a controller/processor, see paragraph 0166, Davidson discloses that the heating elements 2356 and 2356A can be operated separately and can have two different substances or a single substance operated in two sequential dosing sequences, therefore, each heating element would have an associated heating profile, since there are heating profiles being controlled by a microprocessor, there would have to be storage for storing instruction for the heating profiles, see paragraph 0083 for computer readable storage medium), and at least one conductor configured to supply sufficient energy for heating the source material when the source material is received within the single vaporization chamber of the inhaler (see dose cartridge 2350 in fig. 5C comprising a heating element 2356 and 2356A, paragraph 0147, where the heating element 2356 or 2356A can be considered as at least one conductor, or the entire cartridge can be considered as part of the at least one conductor); wherein the plurality of operation profiles involves an associated desired ratio of the two different active substance (see paragraph 0166, Davidson discloses heating profiles are controlled separated, therefore, there would be an associated ratio with the heating profiles since one substance is being heated relative to the other, furthermore, the ratio would be a desired ratio in the formed aerosol, since the heating profile would provide a particular ratio of the first substance and second substance, which can be viewed as the desired ratio), but fails to disclose that each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances in said aerosol.
However, Atkins teaches a controller programmed with a plurality of operation profiles, wherein each of the plurality of operation profiles is associated with a different ratio of amounts of the at least two active substances (see figs. 10 and 11, a first substance is in side A and a second substance is in side B, controller is control circuitry 1012 (paragraph 0177) or 1122 (paragraph 0179), Atkins further discloses in paragraph 0173 that the ratio of the vapor constituents can be adjusted, therefore, there would be a plurality of operation profiles, each profile being each adjustment of the user, and each operation profile would include a ratio that was set, see paragraphs 0177-0179).
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 inhaler and controller of Davidson to have a plurality of operation profiles and each of the plurality of operation profiles is associated with a different desired ratio of amounts of the at least two active substances as taught by Atkins for the purpose of providing user adjustability, by allowing the user and the inhaler to set different ratio of active substances, thereby, allowing the user to find a user suitable composition of active substances (see paragraphs 0173 and 0177-0179 of Atkins).
It is noted that due to the usage of the limitation “at least one of:” in claim 14, line 6, the limitation “an airflow system for passing airflow through the source material and for delivering together the at least two active substances released from the one distinct source material to an inhaling user, in a single inhalation” is not required. However, if there is any doubt that the limitation is not required. The modified Davidson discloses an airflow system for passing airflow through the source material and for delivering together the at least two active substances released from the one distinct source material to an inhaling user, in a single inhalation (see conduits 2312B and/or 2312 and paragraphs 0205 and 0212 of Davidson, see paragraph 0144 of Davidson for single inhalation, the inlet and outlet allow air to be passing through and allow air to be delivered to the user).
Regarding claim 15, the modified Davidson discloses that each of the operations profiles is associated with a different therapeutic effect the ratio is expected to have on the user (see paragraphs 0040 and 0111 of Davidson, Davidson discloses a plurality of different substance including cannabis, therefore, different ratio would have a different therapeutic effect, see paragraphs 0177-0179 of Atkins).
Regarding claim 16, the modified Davidson discloses that the different effect includes a different magnitude of a therapeutic effect (see paragraphs 0040 and 0111 of Davidson, Davidson discloses a plurality of different substance including cannabis, different ratio would have a different therapeutic effect, furthermore, different ratio would provide a different amount, therefore, the magnitude of the effect would be different, however, has similar effect, see paragraphs 0177-0179 of Atkins).
Regarding claim 17, the modified Davidson discloses a user interface configured to receive feedback input from the user and to automatically select an operation profile in response to the feedback input (see user interface of Atkins, see paragraphs 0177-0179 of Atkins).
Regarding claim 22, the modified Davidson discloses that each of the plurality of operation profiles is configured to be operated within a single inhalation (see the modification with Atkins, after the modification, user can modify and set a ratio (each adjustment being an operation profile, paragraphs 0177-0179 of Atkins), and since the user can inhale, each of the plurality of operation profile is configured to operate within a single inhalation, it is noted that the claim does not claim that each of the entire one of a plurality of operation profiles is configured to operate within a single inhalation, therefore, since a user can inhale in a single inhalation, each of the plurality of the operation profiles can be operate within a single inhalation, even if the applicant claims each of an entire one of the plurality of operation profiles, Davidson discloses in paragraph 0144 that a dose cartridge may comprise a drug substance material for deliver over no more than 1 inhalation).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14, and further in view of Fleming (2007/0240712).
Regarding claim 18, the modified Davidson discloses that the controller is configured for setting two or more operation profiles from said plurality of operation profiles for use during an inhalation session, wherein the two or more operation profiles are selected according to amounts of the active substances to be released from the source material and delivered to the user (see paragraph 0166 of Davidson, Davidson discloses that the activation of the heating element for the different substances are overlapped, furthermore, Atkins discloses in paragraphs 0034 that the vaporization of each substance can be at or near the same time, therefore, after the modification, depending on the substance, once a ratio is set, within each ratio setting, there would be operation profiles, one operation profile can be when one substance is being vaporized and the other is not, and the second operational profile would be both are being vaporized at the same time, once the time where only one substance is being vaporized has elapsed, alternatively, the two or more operation profiles would be interpreted as a first operation profile having a first ratio set by the user and a second operation profile having a second ratio set by the user, see modification with Atkins in claim 14, in both instances, there would be an amounts of active substances to be released), furthermore, the modified Davidson discloses that each cartridge comprises a drug substance material that is for deliver no more than 1 inhalation (Davidson discloses in paragraph 0144 that a dose cartridge may comprise a drug substance material for deliver over no more than 1 inhalation), but fails to specifically disclose that the controller is configured for setting two or more operation profiles for use during a single inhalation.
However, Fleming teaches that the controller is configured for setting two or more operation profiles for use during a single inhalation (see paragraph 0064, Fleming discloses a variable dose of a drug is delivered by a patient by using at least one vibrator 690, and configured to sequentially activate multiple selected dose packs so as to result in the delivery of a specific dose of the drug in one inhalation).
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 two or more operation profiles of the modified Davidson to take place during a single inhalation as taught by Fleming for the purpose of providing a specific therapeutic substance at a particular dosage according a specific sequence, that would bring about a therapeutic effect to the user (see paragraph 0064 of Fleming).
Regarding claim 19, the modified Davidson discloses that the two or more operation profiles are configured to deliver the same amount of a first active substance to the user (see the rejection to claim 18 directly above, after the modification with Fleming, there would be a mode where the first active substance is delivered at a time that is offset from the second active substance within the same single inhalation, however, if the user leaves the setting unchanged for the particular drug being used, then the two or more operation profiles are configured to deliver the same amount of a first active substance for a second set of two or more operation profiles of a second set of first and second active substance for a second inhalation, alternatively, if a first of the two operation profiles is being interpreted as a first ratio set by the user and the second of the two operation profiles is being interpreted as a second ratio set by the user, since the user can manually set the ratio and the amount being released by each cartridge (see paragraphs 0177-0179 of Atkins), a user is able to adjust the interface such that the amount for the first active substance for the first and the second operations profiles to be the same).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 directly above, and further in view of Patton (2013/0269694).
Regarding claim 20, the modified Davidson fails to disclose that the storage is configured on a cellular phone application.
However, Patton teaches an inhaler (inhaler 100, fig. 1) comprising a controller pre-programmed with and/or in communication with a storage including operation profile; wherein the storage is configured on a cellular phone application (see 190B or 190A, see fig. 1, paragraph 0023, in order to store such instruction, there would be some form of application on the phone).
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 inhaler of the modified Davidson to have the storage being configured on a cellular phone application as taught by Patton for the purpose of providing a smart system that allows the use of a smart phone to control the inhaler thereby providing convenience to the user (see paragraph 0023 of Patton).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 directly above, and further in view of Goldstein (2018/0263288).
Regarding claim 21, the modified Davidson fails to disclose that the storage is cloud base.
However, Goldstein teaches a controller’s storage is cloud base (see paragraphs 0121 and 00149-0151).
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 inhaler of the modified Davidson to have the storage of the modified Davidson to be a part of the storage that is cloud based as taught by Goldstein for the purpose of providing a smart inhaler system that would enable remote control, information collection, and self-learning for the vaporizer (see paragraphs 0149-0151 of Goldstein).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Valadi (11,006,661).
Regarding claim 5, Davis discloses that the substances include THC, CBD and cannabinol CBN (see paragraphs 0044), Davis fails to disclose that the second substance is a chemical derivative of the first substance.
However, Valadi teaches a substance including plurality of substances comprising a cannabinol and chemical derivative of the cannabinol (see claim 1 and col 2, lines 49-59, see “cannabinol and derivatives”).
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 substance of Davis to be a cannabinol and the second substance of Davis to be a chemical derivative as taught by Valadi for the purpose of providing a therapeutic substance that would provide a particular effect to the user (see col 2, lines 49-59 of Valadi).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Valadi (11,006,661).
Regarding claim 5, Davis discloses that the substances include THC, CBD and cannabinol CBN (see paragraphs 0044), Davis fails to disclose that the second substance is a chemical derivative of the first substance.
However, Valadi teaches a substance including cannabinol and derivatives (see claim 1 and col 2, lines 49-59, see “cannabinol and derivatives”).
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 substance and second substance of Davis to be cannabinol and derivatives as taught by Valadi for the purpose of providing a therapeutic substance that would provide a particular effect to the user (see col 2, lines 49-59 of Valadi).
After the modification, the both the first and second substances would include cannabinol and derivatives, therefore, the cannabinol within the first cartridge can be interpreted as the first substance and the derivative within the second cartridge can be interpreted as the second substance.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Patton (2013/0269694).
Regarding claim 20, Davis fails to disclose that the storage is configured on a cellular phone application.
However, Patton teaches an inhaler (inhaler 100, fig. 1) comprising a controller pre-programmed with and/or in communication with a storage including operation profile; wherein the storage is configured on a cellular phone application (see 190B or 190A, see fig. 1, paragraph 0023, in order to store such instruction, there would be some form of application on the phone).
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 inhaler of Davis to have the storage being configured on a cellular phone application as taught by Patton for the purpose of providing a smart system that allows the use of a smart phone to control the inhaler thereby providing convenience to the user (see paragraph 0023 of Patton).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Goldstein (2018/0263288).
Regarding claim 21, Davis fails to disclose that the storage is cloud base.
However, Goldstein teaches a controller’s storage is cloud base (see paragraphs 0121 and 00149-0151).
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 inhaler of Davis to have the storage of Davis to be a part of the storage that is cloud based as taught by Goldstein for the purpose of providing a smart inhaler system that would enable remote control, information collection, and self-learning for the vaporizer (see paragraphs 0149-0151 of Goldstein).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 directly above, and further in view of Davis (2018/0154103).
Regarding claim 65, the modified Davidson fails to disclose that said aerosol both of said at least two active substances are present.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Since the modified Davidson discloses in paragraph 0146 of Davis that the combination of both THC and CBD can be useful for treating cancer patients, the feature of choosing to have the aerosol with both THC and CBD being present is considered as an obvious treatment design choice, since the aerosol having both THC and CBD is dependent on the patient’s condition and needs and is based on the doctor’s determination of what combination of THC and CBD being present in the aerosol is appropriate for the patient in need of such treatment.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson (2017/0095624) in view of Atkins (2019/0124982) as applied to claim 14 directly above, and further in view of Davis (2018/0154103) and Hearn (2017/0056368).
Regarding claim 65, the modified Davidson fails to disclose that said aerosol both of said at least two active substances are present.
However, Davis teaches a desired ratio between a first active substance and a second active substance form a cannabis source material, wherein in said aerosol both of said first active substance and said second active substance are present (see paragraphs 0139-0145, Davis discloses CBD:THC ratios, including 4:1, a ratio of 4:1 if relative to the total of CBD+THC, therefore, both would be present, furthermore, see paragraphs 0044-0045, 0061, 0148, 0255, Davis discloses that the constituents include both THC and CBD that evaporates into aerosol at 160° C, and further discloses in paragraph 0255 that the temperature can be heated up into the ranged of 140-220° C, temperature above 160 to 220° C would vaporize both CBD and THC, therefore, the aerosol both of said first active substance and said second active substance are present, furthermore, paragraphs 0101-0104 disclose a THC to CBD ratios and further discloses in paragraph 0146 a combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone, therefore, the aerosol for a combination of CBD and THC would have both CBD and THC present), furthermore, the first active substance can be interpreted as the CBD, while the second active substance can be interpreted as the THC, which is different from the CBD (see paragraphs 0043-0044 and 0048-0049, Davis discloses that the loose plant source material contains THC and CBD and CBN, plant source material is a botanical material).
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 active substances of the modified Davidson to be the first and second active substances as taught by Davis for the purpose of providing a particular desired therapeutic effects.
However, if there is any doubt that the modified Davidson discloses said aerosol both of said first active substance and said second active substance are present.
Hearn teaches an aerosol both of CBD and THC (see paragraphs 0030 and 0139).
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 aerosol of the modified Davidson to have both CBD and THC as taught by Hearn to effectively treat neuropathic pain (see paragraphs 0030 and 0139 of Hearn).
Claims 23-24, 26, 29-30, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Gould (2018/0043115).
Regarding claim 23, Davis discloses a method for delivering to a user, via an inhaler (inhaler is the device that is used with the tablet shown in figs. 2A-2D, see fig. 3C (paragraphs 0103-0117), also see fig. 1B and 1A), an aerosol (see paragraphs 0147-0148, Davis discloses that based on the defined THC and CBD ratio, there would be a corresponding heating profiles and that THC is evaporated at 157° C, and that CBD is evaporated at 160-180° C, therefore, when CBD is being evaporated, THC would be evaporated as well, and would provide both the first and second active substances simultaneously into aerosol formed by the inhaler, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC) formed by a single vaporization chamber (see fig. 3C and paragraphs 0105-0117, Davis discloses that the spring holder 8 and enclosure fitting 10 allows the puck to be placed and as shown, the puck is to be placed between 8 and 9, therefore, as shown, the vaporization chamber would be the chamber where puck is located and within stem piece 13, which is a single chamber) of the inhaler, said aerosol comprises at least a first active substance and a second active substance (see paragraph 0044 and 0147, the first substance is the THC and the second substance is CBD), the method comprising: defining a desired ratio of an amount in said aerosol of the at least one first active substance and the second active substance (see paragraph 0101, RFID tags include information that include product blend, THC to CBD ratio, dosing amounts, and optimum vaporization temperature, further discloses in paragraph 0147 that depending on the THC to CBD ratio, the microcontroller may be programmed to utilize a particular metered air flow, heating profile, furthermore, the ratio would be a desired ratio in the formed aerosol, since the output aerosol would be based off of the ratio being set by the inhaler); setting operation parameters in accordance with the defined desired ratio, the operation parameters including one or both of (a) a heating-time profile and (b) an airflow-time profile to be applied to a source material containing at least the first active substance and the second active substance, said source material being comprised in a single holder, placeable in a vaporization chamber (see paragraphs 0215-0229 and figs. 14A-17, the single holder being the carousel and the vaporization chamber is the chamber for heating the tablet and the chamber the carousel is placed within) (tablet in figs. 2A-2d is the source material, which comprises a blend of different plant source material, this include compressing loose plant source material that has been processed into a compressible state, see paragraphs 0089 and 0138); operating the inhaler according to the operation parameters to deliver to the user the first active substance and the second active substance at the defined desired ratio (see paragraphs 0044, 0045, 0101 and 0146-0148, Davis discloses that the cartridge comprises RFID device containing THC to CBD ratio and that based on the ratio information, the microcontroller may be programmed to utilize particular metered air flow, heating profile, and further stated that for example, THC evaporates at 157° C and CBD evaporates between about 160° C and 180° C, therefore, whichever the ratio that is being defined by the system when a particular heating profile is chosen based on the ratio information off of the RFID would be the defined ratio, furthermore, Davis further discloses in paragraph 0269 that the microprocessor is adapted to control the airflow over a period of time based on a desired dosage of selected therapeutic compounds desired to be delivered for inhalation, furthermore, when the heating profile is set at 160-180° C, the THC would be evaporated as well in order to provide the first and second substances in 1 single inhalation, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC, see full disclosure), but fails to disclose that the first substance is a cannabinoid and the second substance is an acidic form of the cannabinoid.
However, Gould teaches a first substance including a cannabinoid that is THC and a second substance comprises an acidic form of that cannabinoid which is THCA (see paragraph 0029 and claim 14) (see paragraph 0029 and paragraphs 0027-29, see “dried herbs”, Gould discloses in paragraph 0032 the vaporization of concentrate such as cannabis).
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 substance and the second substance of Davis to have the THC and THCA, respectively, as taught by Gould for the purpose of providing a therapeutic drug combination that would provide a therapeutic effect to the user (see paragraph 0029 and claim 14 of Gould).
Regarding claim 24, the modified Davis discloses at least one cannabinoid is Δ9-THC and the acidic form of that cannabinoid is THCA (see the modification with Gould, paragraph 0029 and claim 14 of Gould).
Regarding claim 26, the modified Davis discloses that the ratio is defined individually per the user, according to a desired therapeutic effect (see paragraphs 0055 and 0184, Davis discloses that the ratio is defined via RFID information in paragraphs 0090 and 0101, and the cartridge is replaceable by the user, therefore, the ratio is defined individually per the user according to a desired therapeutic effect, since the user is what defines which cartridge to put in).
Regarding claim 29, the modified Davis discloses that the operation parameters are selected so as to increase vaporization of the acidic form before decarboxylation (see paragraphs 0147-148 discloses heating the substances to a vaporization temperature, since any form of heating would be from 0 (no heat) to an operational temperature, there would be a point where vaporization of the acidic form would take place before decarboxylation).
Regarding claim 30, the modified Davis discloses that the parameters are set such that increasing a rate of airflow through the source material, while maintaining heating duration constant, increases the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of said at least one cannabinoid (see paragraph 0255 and 0147, Davis discloses about providing airflow and heat, since the air pump is what is responsible for bringing the heat to the tablet to evaporate active substances, the increasing of the rate of airflow through the source material while maintaining heating duration constant (any heating duration is considered as constant, since duration is time based, so if the entire tablet takes 5 minutes of heating to be consumed, then 5 minute is the heating duration, and this would remain constant) would increases the ratio between the acidic form and the total as time goes on since at the beginning when the airflow and heat starting from 0 would not evaporate the acidic form).
Regarding claim 57, the modified Davis discloses that said aerosol is formed in a single inhalation (see paragraphs 0044, 0045, 0101 and 0146-0148, Davis discloses that the cartridge comprises RFID device containing THC to CBD ratio and that based on the ratio information, the microcontroller may be programmed to utilize particular metered air flow, heating profile, and further stated that for example, THC evaporates at 157° C and CBD evaporates between about 160° C and 180° C, therefore, whichever the ratio that is being defined by the system when a particular heating profile is chosen based on the ratio information off of the RFID would be the defined ratio, furthermore, Davis further discloses in paragraph 0269 that the microprocessor is adapted to control the airflow over a period of time based on a desired dosage of selected therapeutic compounds desired to be delivered for inhalation, furthermore, when the heating profile is set at 160-180° C, the THC would be evaporated as well in order to provide the first and second substances in 1 single inhalation).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Gould (2018/0043115) as applied to claim 23 above, and further in view of Raichman (2018/0104214).
Regarding claim 31, the modified Davis discloses that the parameters are set such that there is a raising of the heating temperatures (see paragraphs 0147, 0251 and 0255 of Davis, Davis discloses heating at a particular temperature to evaporate the substances, and further discloses the raising of the temperature) and maintaining air flow constant (see paragraph 0083, Davis discloses that the blower is set at 9 LPM), but fails to disclose reducing the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of the at least one cannabinoid.
However, Davis discloses in paragraph 0172 that the microprocessor of the present vaporizing apparatus can be set to provide a metered air flow and temperature profile which best achieves the desired vaporization or inhibition. Raichman teaches reducing the ratio between the acidic form and the total of the at least one cannabinoid and the acidic form of the at least one cannabinoid by raising the heating temperature (see paragraphs 0174 and 0178-0179, Raichman discloses that as the temperature is increased, the acidic form (THCA) is converted into additional THC).
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 raising of the temperature of the modified Davis to reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of the at least one cannabinoid as taught by Raichman for the purpose of providing a heating profile that would allow for the treatment of pain in human (see paragraphs 0178-0179 of Raichman).
Regarding claim 32, the modified Davis discloses that the parameters are set such that there is a lengthening of the heating duration (see paragraph 0251 of Davis, Davis discloses that it takes forty five seconds to reach operational temperature and that that is stable air temperature exiting the helical tubing in both low flow and high flow applications, therefore, there is a lengthening of the heating duration relative, while the air flow temperature is stable) while maintaining temperature constant, but fails to specifically disclose reducing the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of said at least one cannabinoid.
However, Davis discloses in paragraph 0172 that the microprocessor of the present vaporizing apparatus can be set to provide a metered air flow and temperature profile which best achieves the desired vaporization or inhibition. Raichman teaches reducing the ratio between the acidic form and the total of the at least one cannabinoid and the acidic form of the at least one cannabinoid by raising the heating temperature and lengthening the heating duration (see paragraphs 0174 and 0178-0179, Raichman discloses that as the temperature is increased, the acidic form (THCA) is converted into additional THC).
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 raising of the temperature and lengthening of the heating duration of the modified Davis to reduce the ratio between the acidic form and the total of: the at least one cannabinoid and the acidic form of the at least one cannabinoid as taught by Raichman for the purpose of providing a heating profile that would allow for the treatment of pain in human (see paragraphs 0178-0179 of Raichman).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Gould (2018/0043115) as applied to claim 57 above, and further in view of Lord (2015/0245660).
Regarding claim 58, the modified Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that a time period of the single inhalation is between 0.5-5 seconds.
However, Lord teaches a single inhalation having a time period being between 0.5-5 seconds (see paragraphs 0093-0095, Lord discloses that inhalation time typically last between 2 and 3 seconds).
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 heating time period and the inhalation time of the modified Davis to be 0.5-5 seconds as taught by Lord for the purpose of providing an inhalation time that is usable for the average user.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Gould (2018/0043115) as applied to claim 23 above, and further in view of Levin (2013/0298905).
Regarding claim 61, the modified Davis discloses a heating time period and inhalation time (Davis discloses a heater for heating for inhalation purposes, see paragraph 0084), but fails to disclose that said heating profile comprises a heating time period is between 0.5-3 seconds.
However, Levin teaches a heating profile comprises a heating time period is between 0.5-3 seconds (see paragraphs 0051 and 0059, see heating time of 3 seconds or less).
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 heating time period of the modified Davis to be between 0.5-3 seconds as taught by Levin for the purpose of providing a quick and effective heating time period (see paragraphs 0051 and 0059 of Levin).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (2018/0154103) in view of Gould (2018/0043115) as applied to claim 23 above, and alternatively in view of Raichman (2018/0104214).
Regarding claim 66, the modified Davis discloses that said aerosol both of said at least one cannabinoid and an acidic form of the at least one cannabinoid are present (see the modification with Gould above, the aerosol is being modified to have both THC and THCA).
However, if there is any doubt that the modified Davis discloses that said aerosol both of said at least one cannabinoid and an acidic form of the at least one cannabinoid are present.
Raichman teaches an aerosol both of at least one cannabinoid and an acidic form of the at least one cannabinoid are present (see paragraphs 0074 and 0183, see dose of vapor may comprises THCA and THC).
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 aerosol of the modified Davis to have the at least one cannabinoid and an acidic form of the at least one cannabinoid are present as taught by Raichman for the purpose of providing a particular therapeutic effect that is needed by the patient/user (see paragraphs 0074 and 0183 of Raichman).
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
The applicant on page 12, lines 1-14 of the remarks argues that Davis fails to teach a method or an inhaler which can provide two active substances during a single inhalation from a source material while controlling the ratio between the two active substances in an aerosol formed during the single inhalation. Thus, while Davis is aware of the different evaporation temperatures for THC and CBD and teaches how to evaporate THC and avoid evaporation of CBD “by controlling the temperature to be below 160°C but above 157°C, the vaporizer unit can promote or inhibit vaporization of various constituent compounds” (paragraph 0148), thus result with an aerosol which contains only THC and not CBD, Davis fails to teach or suggest how to deliver both THC and CBD during a single inhalation while controlling the ratio between THC and CBD in the aerosol. However, the argument is not persuasive because in paragraphs 0147-0148 of Davis, Davis discloses that based on the defined THC and CBD ratio, there would be a corresponding heating profiles and that THC is evaporated at 157° C, and that CBD is evaporated at 160-180° C, therefore, when CBD is being evaporated, THC would be evaporated as well, and would provide both the first and second active substances simultaneously into aerosol formed by the inhaler, furthermore, see paragraph 0104, Davis discloses ability to derive multiple THC to CBD ratios from only two strains will make the technology appealing, furthermore, see paragraphs 0139-0146, Davis discloses different combination of CBD and THC including psychoactive ratios and non-psychoactive ratios. Furthermore, paragraph 0146 specifically disclose combination of CBD and THC will likely have a greater anti-cancer effect or analgesic effect than CBD or THC alone. Paragraph 0145 discloses that a ratio of 1:1 THC and CBD is a psychoactive ratio that would be useful for treating neuropathic pain, clearly the inhalation has the ratio of THC to CBD. Furthermore, Davis discloses in paragraphs 0084 and 0255 that the heating element can heat air to 220° C and discloses in paragraph 0140 Charlotte’s web is a well-known example of a CBD dominant strain, used to treat children with severe epilepsy and Dravet syndrome, therefore, when the heater is set at a temperature for a desired CBD dominant ratio, there, will be both CBD and THC. Furthermore, paragraph 0046, Davis discloses “optimize the inhalation and efficacy of the therapeutic compounds”. In the abstract of Davis, Davis discloses that the vaporizer apparatus is adapted to recognize a type of compressed tablet placed into the holder, and to control an air flow and a heat source based on selected therapeutic compounds desired to be released from the recognized type of compressed tablet. Davis further discloses in paragraph 0012 that the microcontroller may vary the temperature profile over a set period of time in order to target specific therapeutic compounds or a blend of different therapeutic compounds selected to alleviate specific conditions or ailments and in combinations with paragraphs 0139-0172 and the rest of the disclosure clearly shows that a single inhalation would comprise multiple therapeutic compounds including THC and CBD. Paragraph 0148 merely shows an example that depending on the ratio of THC to CBD, the microcontroller may be programmed to evaporate THC but not CBD. The disclosure of paragraph 0148 and the entire disclosure of Davis does not state that for every single inhalation disclosed by Davis, only THC is being vaporized. Such interpretation does not align with the disclosure of Davis as whole as explained above. Therefore, the rejection still stands.
The arguments in page 15 of the remarks appears to attach the reference individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant on page 16, line 1 to page 18, line 10 of the remarks argues that the examiner has made a clear error in considering that “conduit 1222 and 1232 and 1215” of Davidson to “form a single vaporization chamber”. Applicant point that according to the Merriam Webster dictionary, “vaporization” is the action or process of vaporizing, which requires to “convert (as by the application of heat or by spraying) into vapor”. While Davidson describes vaporization of a drug substance by heating (paragraph 0144), e.g, using heating element 2306 (Para. 0164), the examiner has not shown how conduits 1222, 1232, and 1215 of Davidson can vaporize a drug substance and convert it to vapors. The examiner has failed to show how the following cited paragraphs 0105, 0231, 0138 describe a single vaporization chamber. However, the arguments is not persuasive because the conduits 1222 and 1232 and 1215 form a single vaporization chamber in that the chamber is where vaporization takes place and transported to the user. Furthermore, the applicant’s requirement that the conduits 1222, 1232, and 1215 of Davidson must be the structure that vaporize a drug substance and convert it to vapors is unreasonable. A heater being positioned within a chamber wherein the heater is configured to directly vaporize the material would make the chamber that the heater is positioned in a vaporization chamber. The conduits 1222, 1232 and 1215 formed a vaporization chamber because vapors are being formed and transported within the chamber. Furthermore, the cited paragraphs of 0105, 0231 and 0138 clearly shows that the cartridges carry drug substances that are being vaporized in the single inhalation chamber, by disclosing that the cartridges are being heated in order to vaporize the vapor/aerosol that is then being transported to the user, see fig. 12. Therefore, the rejection still stands.
The applicant on page 18, line 11 to page 19, line 8 of the remarks argues that with Atkins, and specifically figure 10 and paragraph 0177 which were cited by the examiner, applicants point that Atkins uses two separate compartments of the reservoir (side A 1005, and side B 1007), each is in fluid communication with its own heater coil (heater A 1001, and heater B 1003). With respect to figure 11 and paragraph 0179, applicants point that Atkins teaches “a multi chamber fluid reservoir with a single heater. The reservoir in this system is dual chamber. In this example, the fluid reservoir is separated into two compartments (side A 1118, side B 1119)”. Thus, in both examples, Atkins uses two separate compartments each with a different load of source material. However, Atkins fails to teach or suggest how to control the ratio between the evaporated active substances if the source material is placed in a single evaporation chamber. However, the argument is not persuasive because the single vaporization chamber is taught by Davidson. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For the remainder of the arguments that attack the references individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The arguments to the newly added claim limitations in claims 1-2, 4-7, 13-24, 26, 29-32, 48-51, and 55-66 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.
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/TU A VO/Primary Examiner, Art Unit 3785