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 .
Receipt is acknowledged of Amendments and Remarks filed on 01/19/26. Claims 1, 7 and 17 have been amended, new claims 20-36 have been added and claims 2-6, 8-16 and 18-19 have been canceled. Accordingly, claims 1, 7, 17 and 20-36 are 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Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn.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 Objections
Claim 33 is objected to because of the following informalities: the terms/names Cannabis is capitalized. Chemical or generic names should not be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 7, 17 and 20-36 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 is indefinite fore reciting “selecting a type of dose…”. This renders the claim indefinite because it is not clear what types of doses are available to select from since the claim recites a pharmacologically effective dose.
Claim 17 is indefinite for reciting “… at least one substance from a source material to a user by inhalation from the source material…”. It is not clear why the “source material” is repeated twice in a sentence. For example, are the delivered substance from the source material and the inhalation from the source material different?
Claim 17 recites the limitation "of the selected dose" in line 9. There is insufficient antecedent basis for this limitation in the claim. Claim 17 does not recite “selecting a dose” preceding to this recitation and as such does not support the limitation.
Claims 24-26 are indefinite for reciting “at least 6 months”, “at least 1 year” and “longer than 5 years”. These limitations are one-sided ranges that are open to infinity, which the Specification does not support and not possible.
Other claims are rejected for depending on rejected base claims 1 and 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, 24-29 and 33-36 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 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 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 with respect to claim(s) 1-19 have been considered but are moot because Applicant’s amendments to the claims have necessitated modified grounds of rejections. Applicant’s arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicant’s only argument regarding the references, Davidson et al and McCullough is that they do not teach considering the storage conditions and or duration of storage of the source material. This is moot since the newly added reference Zamengo et al clearly renders this limitation obvious.
Claims 1, 7, 17 and 20-36 are rejected.
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.
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