DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/29/26 has been entered.
Receipt is acknowledged of Amendments and Remarks filed on 05/29/26 and an IDS filed on 05/07/26. Claims 1, 7, 17, 24-26 and 33 have been amended, no new claims have been added and no claims have been canceled. Accordingly, claims 1, 7, 17 and 20-36 remain pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 24-26 are indefinite for reciting “6 months or more”, “1 year or more” and “5 years or more”. These limitations are one-sided ranges that are open to infinity, which the Specification does not support and are not possible.
NOTE: Claim 23, line 1, is missing the term “wherein” after -claim 17-.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7 and 24-36 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al (WO 2020234883) in view of Zamengo et al (The role of time and storage conditions on the composition of hashish and marijuana samples: a four-year study).
Davidson et al teach a method for generating a delivery regimen of at least one active substance to a user, comprising: receiving input including one or both of timed activities to be engaged by the user, timed preferred user experiences; and automatically generating a delivery regimen including at least one of delivery times and amounts of the at least one active substance, based on: (a) estimating at least one of a timing and magnitude of at least one effect expected to be induced by the at least one active substance on the user; and (b) estimating an impact of the at least one effect on the timed activities and/or the timed preferred user experiences (See abstract and claim 1).
Regarding claims 1, 7, 30-36, Davidson et al teach a method of pulmonary delivering to a subject at least a first pharmacologically active agent and a second pharmacologically active agent, at least one of which being in at least one plant material; the method is carried out by independently delivering the agents to the subject using a metered dose inhaler device that is configured to vaporize at least a first pre-determined vaporized amount of the first agent and at least a second pre-determined vaporized amount of the second agent upon controllably heating the plant material, wherein heating is effected such that the first pre-determined vaporized amount is delivered to the subject successively, concomitantly and/or at least partially overlapping with the delivery of the second pre-determined vaporized amount, and wherein each of the pre-determined vaporized amounts of each of the agents independently induces in the subject at least one pharmacokinetic effect and/or at least one pharmacodynamic effect (See Page 1, lines 14-24).
Further regarding claim 1, the said method of delivering includes inhalation and relates to actively controlling a user’s mood and or psychoactive state by planning a delivery of at least one active agent (See page 5, lines 11-21). It is also disclosed that the suggested action may have its own independent effect on the user and/or may have a synergistic or antagonistic effect with one or more other actions or substances, such as a synergistic effect with an active substance delivered by the delivery device. The active agent may be THC (See page 21, last two paragraphs).
Further regarding claims 1 and 33-36, Davidson et al disclose an embodiment wherein the active substances are released from different strains of a botanical, such as cannabis. A single delivery regimen may combine administering of different cannabinoids, different terpenoids, flavonoid substance and/or placebo. These may be delivered in the same dose, or, alternatively, in separate doses (See page 4, lines 19-28 and page 40, lines 1-8). It is also disclosed that the delivered substance is an active substance released from a source material by means of heating and/or airflow (See page 22, lines 22-23).
It is also disclosed that he delivery device is a metered-dose inhaler. Optionally, the inhaler comprises or is configured to receive or attach to a plurality of dose units, for example contained in a cartridge or magazine. In some embodiments, the dose units (and/or their content) are arranged and/or selected for use by the device according to the delivery regimen.
Furthermore, Davidson et al state that in a vaporizing metered dose inhaler, the dose may be extracted by application of heat and/or controlling the airflow (See page 30). Provided is a system for planned delivery of at least one active substance to a user, comprising: a user interface configured to receive as input at least one of timed activities to be engaged by the user, timed preferred user experiences; a processor programmed to generate a delivery regimen including at least one of delivery times and amounts of the at least one active substance. In some embodiments, the processor is programmed to generate the delivery regimen based on one or both of personal user data and population data, pertaining to pharmacokinetics and/or pharmacodynamics of the at least one active substance (See pages 5 and 9-10).
Regarding claims 1, 7 and 30-32, Davidson et al teach that a dose unit 206 houses the active substance or a source material from which the active substance is released. Delivery device 203 releases the at least one active substance from a material. In an example, the delivery device comprises a heating mechanism for heating a source material, e.g. cannabis, in order to release one or more substances by vaporization, such as D9- tetrahydrocannabinol (THC), cannabidiol (CBD), and/or other cannabinoids and/or terpenoids (See pages 28-29).
Regarding claim 7 and 30-32, it is disclosed that monitoring is carried out via one or more invasive or non-invasive sensors. Optionally, data collected by the sensors is indicative of pharmacodynamic effects. Optionally, data collected by the sensors comprises physiological feedback. Examples of sensors may include: a touch screen, a gyroscope, accelerometer, proximity sensor and/or gesture sensor, etc, for example, to detect visual tracking, saccade variance, eye vascular expansion, pupil dilation and/or pulsation; etc, (See page 31).
It is also disclosed that he delivery device is a metered-dose inhaler. Optionally, the inhaler comprises or is configured to receive or attach to a plurality of dose units, for example contained in a cartridge or magazine. In some embodiments, the dose units (and/or their content) are arranged and/or selected for use by the device according to the delivery regimen.
Davidson et al lack a disclosure regarding the storage condition of the source material or selecting a dose based on the storage condition. This would have been obvious to include in view of the teachings of the prior art including Zamengo et al.
Zamengo et al conduct a study that investigates the role of time and different real-life storage conditions on the composition of different varieties of cannabis products (hashish and marijuana).
Regarding the storage conditions of the source material, Zamengo et al disclose that in the said study, six high-potency cannabis products constituted by herbal and resin materials containing different initial concentrations of delta 9-Tetrahydrocannabinol (THC) were employed. Four representative samples were collected from each study material and were maintained for a prolonged time (four years) under different controlled storage conditions: (A) light (24 h) and room temperature (22 °C); (B) darkness (24 h) and room temperature; (C) darkness and refrigeration (4 °C); (D) darkness and freezing (−20 °C). The concentration of the three main cannabinoids, i.e. THC, Cannabinol (CBN, produced from the degradation of THC), and Cannabidiol (CBD), were measured by GC-FID around every 100 days along the four-year study.
Significant changes in the THC (degradation) and CBN (formation) content were detected under storage conditions A and B, and almost 100% of THC was degraded after four years. Data treatment indicated that the storage temperature and light exposure had two different effects on the conversion of THC to CBN: temperature changed only the speed, light changed both the speed and the stoichiometry of this conversion (See abstract).
Zamengo et al provide their results in Tables 1 and 2 and Fig. 1, reproduced below. The data show different source material, storage conditions including temperature, light exposure and storage duration. In Figure 1, they provide data regarding the storage conditions effecting the source material or released substances over time. That is the degradation process.
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Regarding claims 24-26 Zamenga et al state that the said study was conducted for 4 years.
Regarding claims 27-30 Zamenga et al state that the said conditions included exposure to light, temperature and storage duration. It is also stated that the product is controlled and studied during the 4-year period, i.e tracked through its life cycle.
Regarding claim 33, Zamengo et al, teach that the said study was conducted on delta 9-Tetrahydrocannabinol (THC), which is a well-known product of cannabis satvia.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Zamengo et al with that of Davidson et al to arrive at the instant invention. It would have been obvious to do so because Davidson et al teach compositions and method of delivering a substance to a user from a device that can volatilize or use air flow to release a substance from a source material and wherein the delivery is via inhalation and the device is programmed to generate the delivery regimen based on data and pertaining to pharmacokinetics and/or pharmacodynamics of the at least one active substance. It is disclosed that the said source material can comprise cannabis, THC and terpenes. Davidson et al do not expressly teach that the selection is based on the storage condition. However, Zamengo et al clearly teach that compositions comprising hashish (cannabis) degrade over time and this degermation is a product of or related to conditions including light and temperature as well as storage time. Thus, one of ordinary skill in the art would have been motivated to have incorporated the teachings of Zamengo et al with that of Davidson et al and make selecting a dose based on the storage condition an important step in the delivery of such substances to a subject since, especially as a medical treatment an effective dose is required to achieve the desired therapeutic outcome.
Thus, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Additionally, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claims 1, 7, 17, 20-36 are rejected under 35 U.S.C. 103 as being unpatentable over Alarcon (US 202000022416) in combination with Zamengo et al (The role of time and storage conditions on the composition of hashish and marijuana samples: a four-year study).
Alarcon teach a vaporizing article, comprising a vaporizer drive circuit; one or more memories configured to store a percentage of at least one constituent in an inhalation media, one or more compensation values for at least one compensation category for the at least one constituent, and instructions; and a control circuit comprising a processor coupled with the one or more memories configured to run the instructions, the instructions configured to cause the processor to: receive a dose target for a constituent; determine whether to perform compensation for an inhalation media dose in order to ensure the dose target is met; when compensation is to be performed, determine the properly compensated inhalation media dose based on an associated compensation value for the constituent; and control the vaporizer drive circuit so as to dispense a compensated dose of the inhalation media (See abstract).
Regarding claims 1, 7 and 17, Alarcon teaches a system, a method, and a device for delivering doses and electronically sharing dosing information of an inhalation media, and more particularly for electronic vaporizer products (See [0002] and [0137]).
It is disclosed that “When the user inhales, electrical current is provided to the vaporizer element 109 which causes it to heat up and vaporize the inhalation media present on the vaporizer element 109. The vapor combines with air to form an aerosol that is inhaled by the user. After repeated doses and inhalations, the inhalation media within the cartridge 200 can be entirely consumed. At this time, the user can replace the empty cartridge 200 with a new full cartridge” (See [0074]).
Regarding claims 1, 7, 17, 20-23 and 27-36, Alarcon teaches that it is known that THC degrades into CBN over time, depending on temperature and exposure to other conditions. Thus, the rate of conversion from a first constituent into a second constituent can be characterized and captured in an equation or compensation factor such that the dose of the second constituent can be compensated (See [0180]).
The dose compensation process can take additional input from any of an ambient temperature sensor, temperature sensor and data logger built into cartridge, oxygen sensor, moisture sensor, UV light sensor, radiation sensor or other environmental sensor. Using such environmental information, a more accurate compensation factor or rate constant, i.e., compensation value can be selected for use in the dose compensation calculation. In other words, compensation values for a plurality of compensation categories, e.g., temperature, oxygen level, moisture, UV light exposure, radiation exposure, etc., can be determined and stored for use in determining an inhalation media dose compensation (See [0181]).
Alarcon further discloses that certain constituents may increase over time, as CBN does due to THC degradation. In certain cases, where the user requests a dose of a first constituent, the amount of one or more other constituents calculated to be in the dose after application of the dose compensation process can exceed threshold values. A list of dose constituent threshold values can, therefore, also be stored in memory, memory IC, computing device or database. By way of example, a threshold can be related to constituent toxicity at a level identified through pharmacological studies. Dose compensation process can be configured to automatically calculate the amounts of other constituents present in the inhalation media dose, notify the user if such amounts exceed any thresholds (See [0182]). Alarcon teach a device that comprises cartridge, airflow, airflow pathway, control circuit, sensors, etc; (See [0080], [0113]-[0114], [0116], [0154], [0230]).
Alarcon teach that key constituents can include cannabinoids, nicotine, flavonoids, terpenes, terpenoids, drugs, medicines, active ingredients, preservatives, solvents, and carrier materials (See [0166]).
Alarcon also discloses that “For example, if a user wanted to consume a 5 mg dose of THC from an inhalation media that was originally 50% THC by mass, and the retrieved compensation factor based on the determined age was 1.5, then a total dose of 15 mg would be dispensed so that the user would receive the desired 5 mg of THC” (See [0177]).
Alarcon lacks a specific disclosure on the duration of time for stored source material. This is known as taught by Zamengo et al.
Teachings of Zamengo et al are delineated above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Zamengo et al with that of Alarcon to arrive at the instant invention. It would have been obvious to do so because Alarcon teach compositions and method of delivering a substance to a user from a delivery device that can volatilize and incorporate air flow to release a substance from a source material and wherein the delivery is via inhalation and the device is programmed to generate the delivery regimen based on data and pertaining to storage conditions including temperature, UV exposure, moisture, etc, of the at least one active substance. It is disclosed that the said source material can comprise cannabinoids such as THC and terpenes. While Alarcon teach sensors detecting the storage conditions of the source material to determine the dose, and disclose that the source material may degrade over time, there is no specific disclosure on the duration of storage. However, Zamengo et al clearly teach that compositions comprising hashish (cannabis) degrade over time and this degradation is a product of or related to conditions including light and temperature as well as storage time. Thus, one of ordinary skill in the art would have been motivated to have incorporated the teachings of Zamengo et al with that of Alarcon and make selecting a dose based on the storage conditions and storage time an important step in the delivery of such substances to a subject since, especially as a medical treatment an effective dose is required to achieve the desired therapeutic outcome.
Thus, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Additionally, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claims 1, 7, 17 and 20-36 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 20150223523) in view of Davidson et al (US 20180344954) and Zamengo et al (The role of time and storage conditions on the composition of hashish and marijuana samples: a four-year study).
McCullough teach a drug delivery system including a cylindrical structure and electrodes, wherein a dose of a drug can be disposed on each substrate portion and configured to volatilize into a gas in response to the resistive heating of the respective substrate portion (See abstract).
Regarding claims 1, 7 and 33-36, McCullough teaches a drug delivery product that allows for inhalation of at least one of THC and CBD without inhaling other undesirable components found in raw cannabis or created by burning the raw cannabis. The amount and purity of THC or CBD in the drug delivery product can be controlled for dosage. The drug delivery product can be formed using a separation and coating process that facilitates controlled deposition of THC or CBD onto a substrate to form the drug delivery product. The said method is directed to controlled volatilization of at least one of THC and CBD from preferably comminuted cannabis plant material and absorption, deposition, adsorption or otherwise condensing the volatilized THC or CBD or both on a substrate held at a temperature to assure capture of the volatilized THC, CBD or both (See [0007] and [0009]). The drug delivery cartridges can be used with various types of drug delivery devices to aid in inhalation of the THC or CBD (See [0041] and [0144]).
Regarding claims 17 and 20, McCullough teaches that an electrical power circuit can be connected to the conductive material to resistively heat the conductive material to a temperature sufficient to volatilize the drug on the coated substrate. In an example, the electrical power circuit can include an electrical control circuit and one or more feedback sensors to resistively heat the conductive material to a sufficient temperature and thereafter accurately maintain the temperature over a period of time. The drug delivery device can also control other parameters that impact the amount of drug(s) delivered to the user, including, for example, a temperature that the cartridge is heated to and the rate of airflow (See [0111]-[0112] and [0114]).
Regarding claims 17 and 20, McCullough teaches that the drug delivery device can control how much air passes through the drug delivery cartridge and how much air is delivered to the user. In an example, a valve device inserted into the air flow of the drug delivery device can be used to control the volume of air available to the user. For example, the valve device can be located in the mouthpiece of a drug delivery device to throttle the volume of air flowing through the mouthpiece. The said delivery device also comprises an electrical power circuit which can be connected to the conductive material to resistively heat the conductive material to a temperature sufficient to volatilize the drug on the coated substrate. The electrical power circuit can include an electrical control circuit and one or more feedback sensors to resistively heat the conductive material to a sufficient temperature and thereafter accurately maintain the temperature over a period of time (See [0110] and [0114]).
McCullough lacks an express disclosure on the device detecting the storage condition of the material, the cartridge comprising a logger or memory component, or tracking the lifecycle of the cartridge. These are known in the art as taught by Davidson et al ‘954 and Zamenga et al.
Davidson et al ’954 teach a dose unit including at least one isolated bioactive agent applied on a carrier material in thermal contact with an electrically heating element configured to vaporize a pre-determined amount of the agent for pulmonary delivery thereof, as well as devices for effecting vaporization and pulmonary delivery of the isolated agent, and methods for preparing the dose unit, controllably releasing the agent therefrom, methods for pulmonary delivery thereof (See abstract).
Regarding claims 17 and 20, Davidson et al disclose methods and devices for controlled delivery by inhalation of vaporizable substances. The device further comprises circuitry for controlling (controller) activation of the heating element (See [0361]).
Regarding claims 21-23, Davidson et al disclose that the data processor includes a volatile memory for storing instructions and/or data. The said device further comprises a sensor in fluid communication with the mouthpiece, the sensor adapted to estimate an air flow rate and send a signal to a controller, the controller adapted for vaporizing the pharmaceutically active agent according to the airflow rate. In some embodiments, the device further comprises a controller configured to synchronize the application of heat with the movement of a cartridge and/or with airflow rate effected by inhalation (See [0125] and [0359]-[0360]).
Regarding claims 17 and 30, Davidson et al state that the controller tracks which dosage is in which cartridge slot, and/or its status. Optionally, the controller automatically and/or upon command selects an appropriate dose unit, and advances it into position by as many steps as needed to make it available for pulling. Optionally, this selection allows out-of-order access to dose units in the carousel (See [0326]).
Teachings of Zamengo et al are delineated above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Davidson et al and Zamengo et al with that of McCullough to arrive at the instant invention. It would have been obvious to do so because McCullough and Davidson et al ‘954 references disclose delivery methods, delivery devices and compositions for delivering a pharmaceutically active agent including THC by vaporization or by air flow to a subject. McCullough teaches that the plant material, i.e. the source material can contain THC, CBD or both and wherein the device can be set to vaporize one or both compounds. Davidson et al teach a similar method and discloses a device and a cartridge comprising the source material wherein the device comprises sensory mechanisms to detect the pharmacokinetics and status of the material and wherein the source material can comprise cannabis, THC, etc. Zamengo et al clearly teach that compositions comprising hashish (cannabis) degrade over time and this degermation is a product of or related to conditions including light and temperature as well as storage time. Thus, one of ordinary skill in the art would have been motivated to have incorporated the teachings of Zamengo et al with that of McCullough and Davidson et al and make selecting a dose based on the storage condition being an important step in the delivery of such substances to a subject since, especially as a medical treatment an effective dose is required to achieve the desired therapeutic outcome.
Thus, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Additionally, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 17 and 20-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-13, 17-22, 32-33, 35, 37, 42 and 56 of copending Application No. 18/854,085 (not yet published) in view of McCullough (US 20150223523) and/or Davidson et al (WO 2020234883). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of McCullough and/or Davidson et al.
Specifically, the examined claims are drawn to a method of delivering via inhalation from a source material a pharmacologically-effective dose, comprising: selecting a type of dose to be delivered via an inhalation device, the dose being a pharmacologically-effective dose based on the dose, selecting at least one of a heating profile and an airflow profile to be applied to the source material; releasing from the source material one or more substances of an amount depending on the dose to be delivered, wherein said selecting based on the dose comprises selecting based on conditions in which the source material has been contained or stored over a time period. Examined claim 17 is directed to an inhaler for delivery of a dose. … the inhaler comprising: an airflow conduit for conducting airflow to a proximal opening of a mouthpiece; a holder configured to position the source material at a delivery position within the airflow conduit; and a circuitry programmed to apply heating and/or airflow profiles to the source material suitable for the delivery of the selected dose based on data regarding one or both of storage conditions and duration of said storage of the source material.
Reference claims are directed to an inhaler device for use with a source material cartridge, the source material cartridge comprising a logger on which data regarding conditions associated with storage of the cartridge is recorded, the inhaler device comprising: a heating assembly configured to heat the source material of the cartridge when the cartridge is received by the inhaler device; a reader positioned and configured to read the data regarding conditions associated with storage from the logger of the cartridge when the cartridge is received by the inhaler device; and a controller configured to: select a heating profile for the heating assembly according to the data | regarding conditions associated with storage which is read by the reader; and control the heating such that a predetermined amount of at least one substance is released from the source material. Claims are also directed to a method of delivering via inhalation at least one substance released from a source material, comprising: receiving at a controller the-data-at a controller regarding conditions associated with storage of the source material recorded over time; selecting, in accordance with the data, at least one of a heating profile and an airflow profile for the source material; and applying at least one of the heating profile and the airflow profile to release a predetermined amount of at least one substance from the source material.
The examined claims differ from the reference claims in that they contain more limitations of the compounds and less limitations related to the control and data collecting than the reference claims. However, as taught by Davidson et al and McCullough, the features of the delivery devices including the controls and collecting of data is known in the art and would have been obvious to include as there is high risk of overdose with substances including THC and CBD. That is the combination of Davidson et al and/or McCullough with the reference claims would have readily led one of ordinary skill in the art to the examined claims or vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 05/29/26 have been fully considered but they are not persuasive.
Applicant’s first argument regarding the references is that “While Zamengo describes the effect of extended storage (4 years at 22°C) of cannabis herbal and resin material on THC degradation, the Examiner has not shown if and where Davidson (883') describes or mentions storage conditions or time of storage of the source material as a parameter taken into consideration for selecting the airflow profile and/or heating profile for the inhaling device. The Examiner has not identified any disclosure in Davidson that even remotely suggests collecting storage- condition data, or using such data to dynamically control device parameters. Applicants point that the claimed invention is not merely considering a dose, but rather, actively controlling device operating parameters, and doing so based on historical storage conditions of the source material itself” (See Remarks, page 9).
The above argument is not persuasive. Firstly, it is noted that claim 1 is drawn to a method of delivering via inhalation from a source material a dose. The critical step in achieving the claimed method is the delivery of the source material. That is, the steps of selecting a dose and selecting it based on condition data do not materially affect the claimed delivery via inhalation. Secondly, Davidson et al clearly discloses selecting a dose (amount) based on the pharmacokinetics and pharmacodynamics of the active substance, therefore meeting “conditions data”, as stated in claim 1. Davidson et al also disclose vaporizing, i.e. heating the source material. Thus, meeting the profile selection limitation. It is also noted that heating profile still requires an airflow profile. Thus, it is not clear how one is selecting between the two profiles. Thirdly, Davidson et al clearly teaches the said critical method step. As stated above, Davidson et al teach a method of delivering a substance to a subject via inhalation, wherein the delivery device comprises a processor programmed to generate a delivery regimen including at least one of delivery times and amounts of the at least one active substance, and wherein, the delivery regimen is based on one or both of personal user data and population data, pertaining to pharmacokinetics and/or pharmacodynamics of the at least one active substance.
Zamengo et al teach that cannabinoids are source material that may degrade over time and lose potency or have a changed dosing characteristic. Thus, Davidson et al in combination with Zamengo et al would have naturally led one of ordinary skill in the art to the conclusion that a processor programmed to generate a delivery regimen including at least one of delivery times and amounts of the at least one active substance, would benefit from collecting data on the condition of the source material to accurately assign the dosing regimen.
Regarding the second rejection over McCullough in view of Davidson et al ‘954 and Zamengo, Applicant argues that “With respect to McCullough, the cited paragraphs relate only to heating and capture of volatilized compounds (Para. [0007] and [0009]), or general feedback sensors (Para. [0114]) but they are completely unrelated to degradation, storage effect or dose adjustment based on prior storage conditions. With respect to Davidson, the Examiner relies on Para. [0326] with respect to allegedly the "status" or an "out-of-order" dosage, however, the Examiner has not shown if and where Davidson mentions or relates to the status of the source material due to storage conditions. In addition, the Examiner relies on Para. [0125] and [0359]- [0360] for allegedly storing instructions and/or "data". However, the Examiner has not shown if and where Davidson mentions or relates to a "data" related to the status of the source material due to storage conditions” (See Remarks pages 11-12).
This argument is also not convincing. 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 rejection is based on the combination of references, which would have led one of ordinary skill in the art to the claimed invention. Specifically, McCullough and Davidson et al teach a delivery device that can volatize, incorporate airflow and deliver a dose of a cannabinoid such as THC to a subject in need thereof. Davidson et al teach that the said device may contain sensors and be programmed to deliver the desired dose. Zamengo et al teach that cannabinoids such as THC degrade over time and their potency is changed. Thus, one of ordinary skill in the art would have readily determined that the dose of the said THC in the delivery device of McCullough and Davidson et al should adjusted based on its potency at the time of delivery. It is also noted that the condition data on storge can be and in most cases is from previous data collected (see Instant claims 1 and 23). This is taught by Zamengo et al. Zamengo et al provide extensive teachings on the effect of different storage conditions such as temperature and light exposure on the degradation and effectiveness of THC over time. Therefore, the knowledge available to one of ordinary skill in the art as also disclosed by Zamengo et al that cannabinoids such as THC degrade over time, would have motivated one of ordinary skill in the art to program McCullough and Davidson et al’s delivery device to select the appropriate dose for delivery to the subject as safe and effective dose is required from any treatment composition.
Additionally, it is considered that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Since Zamengo et al shows and confirms that the dosage of THJC changes over time, such as in a 4 year test, one of ordinary skill in the art would have readily discovered that the dose should be determined at the time of delivery for it to be effective.
Regarding the provisional nonstatutory double patenting rejection of pending claims over claims of copending application No. 18/854,085 in view of McCullough and/or Davidson, Applicant made no argument and stated that “Applicants request to hold the rejection in abeyance until allowable subject matter is agreed upon” (See Remarks, page 12).
The request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Claims 1, 7, 17 and 20-36 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights