Patent 9,730,911

Daniel Kramer
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Introduction

Historical Significance of Cannabis

The cannabis plant has a rich history spanning back thousands of years with the earliest written
reference to cannabis showing up in a Chinese pharmacopeia in 1500 BC. During the inception
of the American colonies, cannabis had an important role in an unsuspecting form; hemp, which
is derived from the fibers of the cannabis plant and used to create products from rope to cloth,
was an important American export. In fact, Virginia passed a law requiring hemp to be grown on
every farm in the colony in 1619. As the growth of the cotton plant surpassed the need for hemp,
cannabis transitioned from being used for material purposes to that of medicine and recreation.
Marijuana usage, a mixture of dried leaves, stems, and seeds that is smoked in a fashion akin to
tobacco, began to rise in the states. Marijuana is frequently smoked for medicinal or recreational
purposes; the mixture is known to alleviate the symptoms of chronic illness or chemotherapy
treatment, as well as create a “high” euphoric feeling for those who smoke recreationally. [1]

Marijuana being classified as a Class I drug, indicating no medicinal benefit, is relatively new.
Until the early 20th century, smoking pot was not taboo. However, Prohibition-esque puritanism,
as well as the prevalent use of marijuana from Mexican refugees after the Mexican-American
war, eventually caused marijuana to become criminalized and outlawed in 1937 with the
Marijuana Tax Act. Recently, public and government views of marijuana and cannabis based
products are being reconsidered; today, eleven states allow for recreational marijuana use and 33
states allow for medical use. [1]

Science Background of Cannabis

Due to its largely illicit nature until recently, cannabis science is relatively foreign to most
Americans. The following list of definitions and explanations is meant to provide background
and reference for subsequent analyses. [2]

Definitions [3] [4]

● Cannabis: a genus of flowering plant that encompases three different species, cannabis
sativa, cannabis indica, and cannabis ruderalis. In the context of this patent, cannabis
refers to any combination of these species
● Cannabinoids: Naturally occurring compounds from the cannabis plant that produce
different medical effects in the body. There have been over 85 cannabinoids isolated from
the plant. Medical cannabis is based around formulations of specific cannabinoids to cure
a set of symptoms
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● Endocannabinoid System (ECS): A neuromodulatory system in the brain that plays a

role in the central and peripheral nervous system. The ECS contains relevant receptors
and enzymes that break down cannabinoids, and modulating ECS activity has been found
to hold therapeutic promise
● CB1 receptor: An ECS receptor that psychoactive molecules have an affinity to bind to.
THC tends to bind to the CB1 receptor
● CB2 receptor: An ECS receptor that non- psychoactive molecules have an affinity to
bind to. CBD tends to bind to the CB2 receptor
● Tetrahydrocannabinol (THC): The primary psychoactive component of the cannabis
plant. THC serves to act as a pain reliever and anti-inflammatory, as well as stimulate
neurogenesis
● Cannabidiol (CBD): A non-psychoactive, primary cannabinoid that is attributed to
antidepressant, anti-inflammatory, anti-anxiety, and neuroprotective effects. Combined
with THC, CDB lessens the psychoactive and memory-loss effects from THC.
● Cannabinol (CBN): The primary product of THC degradation that increases with
exposure to light and air. CBN is only mildly psychoactive and has an affinity to the CB2
receptor.
● Cannabichromene (CBC): A non-psychoactive cannabinoid that is common in many
tropical strains of cannabis
● Terpenes: A diverse group of hydrocarbons found in the essential oils of plants. They are
linked to the fragrance of that plant
● Flavonoid: A large group of biologically active water plant compounds that have been
found to have therapeutic properties
● Cannabis Concentrates: Mixed extracts from the cannabis plant that contain
concentrated amounts of select cannabinoids.
● Decarboxylation: A chemical reaction that removes a carboxyl group (a carbon atom
double bonded to an oxygen atom) from a molecule. In the context of cannabis, this
converts acid forms of cannabinoids to usable, decarboxylated forms in the body.
Decarboxylation can be achieved via smoking, vaporizing, or cooking. Cannabinoids
with the designation “a” after their abbreviation have been decarboxylated.
● Winterizing: A process to remove unwanted waxes and lipids (which cause poor taste,
throat irritation and can alter chemical composition) of cannabis concentrate. WInterizing
consists of dissolving a mixture of the cannabis product and non-polar substance into a
polar substance at sub-zero temperatures, thereby separating waxes and lipids for easy
filtration.

Cannabis interacting with the brain

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As mentioned in the historical significance section, cannabis has been smoked for centuries due
to its several healing properties and effects. Smoking (or heating and ingesting cannabis by other
means) causes cannabinoids and/or terpenes to become decarboxylated and able to be used by
the body. These cannabinoids and terpenes are able to easily cross the blood-brain barrier and
interact with the ECS in the brain. Once these molecules attach to their preferred ECS receptors,
they produce a multitude of positive health effects, ranging from anti-anxiety to anti-
inflammatory effects. The most controversial of these effects is the psychoactive “high” that is
attributed to smoking marijuana with large amounts of THC content. [5]

The science behind both the safety and addictiveness of marijuana/THC is still relatively
inconclusive, yet seems to lean in favor of cannabis. For example, a National institute on Drug
Abuse (NIDA) study in 1994 found that only approximately 9% of daily marijuana users become
dependent. For comparison, a NIDA study in 2018 found that roughly 30% of patients
prescribed opioids, a common chronic pain reliever, abused them. Another study by the NIDA in
2014 was frank stating that they found no causation between marijuana usage and cancer,
specifically lung cancer, and increased occurrence of mental illness. However, research on how
marijuana affects adolescents’ brains in particular is still a hotbed of research as cannabis is still
scheduled as a Class 1 Drug. [6]
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Patent Summary

The following section provides a summary of patent US 9,730, 911 as well as touching upon file
history. [7] All references and mentions of the patent are taken from the actual patent document
provided by the USPTO. [8] [8]

File History

As described by the Requirement for Restriction/Election document within the file history, the
rationale behind this patent is “each invention...is directed to or involves the use or making of
compounds which are recognized in the art as being distinct from one another because of their
diverse chemical structure, their different chemical properties, modes of action, different effects
and reactive conditions. Additionally, the level of skill in the art is not such that one invention
would be obvious over either of the other inventions.”

Additionally, within the file history, it is found that US Patent ‘911 eliminated twenty-one of its
original claims from their patent application before having the patent approved by the PTO. It
can be understood that these claims were removed as the subject matter is “drawn to natural
phenomenon, or law of nature.” This means that the PTO believed that the patent’s original
claims one through twenty and fifty-two can be considered non-statutory subject matter as the
term, “an extract,” can be considered to be found in nature or occuring from natural processes.

Preliminary information

This invention is covered by a United States utility patent, US 9,730, 911, and was granted on
August 15, 2017. The inventor’s cited are Tony Verzura and Earnie Blackmon, who both hail
from Denver, Colorado. Both the applicant and the assignee of this patent is United Cannabis
Corp (UCANN). UCANN is a publicly traded biotechnology company that focuses on treating
chronic conditions and diseases with cannabinoids, which are compounds from cannabis or
marijuana plants. Particularly, the company promotes the refinement of genetics to create new
medical strains of cannabis. UCANN carries their own line of medicinal products, as well as
providing consulting services for prospective medical or recreational dispensaries. United
Cannabis Corp was founded in California where medical cannabis became permissible in 1999,
and soon followed to Colorado in 2009, where its current operations are headquartered. [9]

Summary and Field of the Invention

As best summarized by the patent itself, “This invention relates to the extraction of
pharmaceutically active components from plant materials, and more particularly to a botanical
drug substance (BDS) comprising of cannabinoids obtained by extraction from cannabis.” As
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alluded to in the introduction of this paper, there is a burgeoning market of cannabis-based

medicine to treat chronic illness and this invention falls within such field. Commercially, this
extract and specified formulations are used in UCANN’s Prana Bio Nutrient Medicinal Product
line.

In essence, this invention can be broken down into five points; (1) A cannabis extract comprising
a mixture of at least 95% cannabinoids, and at least 1 terpene/flavonoid, (2) formulations
containing the extracts according to the invention, (3) a method for preparing the cannabis-rich
extract from (4) a method for preparing cannabis juice and lastly, (5) a method in the form of
treatment/dosing schedule to treat specific ailments. The following sections will describe each
point in more detail.

Cannabis Extract

The invention provides a cannabis extract that is comprised of a mixture of at least 95% total
cannabinoids, and at least one terpene/flavonoid. The extract is an oil-based, whole plant product
that contains both active and inactive cannabinoids. Specifically, the extract must contain both
CBDa and THCa, and at least two cannabinoids selected from CBNa, CBCa, THC, CBN, and
CBC. The purpose of these cannabinoids formulated into an extract becomes apparent within the
detailed description of the patent, as described, “These various cannabinoid compounds are
designed to selectively affect various cannabinoid receptors in the nervous system, immune
system, and other tissues...provide an extract with specific physiological properties that are
mediated through separate pathways and receptors, which provide numerous benefits and
advantages.”

Formulations of the extract

The invention covers formulations of the extract in liquid, sublingual, and oral form. According
to the patent, liquid dosage forms may be administered via pump-action or aerosol sprays,
tablets, pastilles, gels, capsules, suppositories, powders, etc. and vaporizers. Orally, the extracts
may be delivered in dosage forms that provide 5mg, 10mg, 20mg, or 50mg of total cannabinoids
per dose. Sublingually, the formulation optionally will comprise a stevia sweetener in addition to
the extracts and be delivered in .5mg, 1mg, or 2mg drops.

The preferred formulation is liquid and infused with a Medium Chain Triglyceride (MCT). MCT
are suitable for human consumption and are a combination of fatty acids that are commonly
found in coconut and kern oils. Mixing the invention’s formulation with MCT would allow for a
bio-safe product that could be used as an ingredient in an edible supplement.

Method of Preparing the Cannabis Extracts

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This invention includes a method to prepare a cannabis extract. This method comprises of
extracting cannabinoids from the fresh or live plant material to produce the first extract, and then
winterizing and purging this said extract. The extract may also be decarboxylated prior to the
extraction step.

Method of Preparing the Cannabis Juice

This invention also provides a method for preparing cannabis juice via first blanching fresh
cannabis leaves in cold water and then juicing the leaves in a cold press or masticating juicer.
This juice is then filtered and optionally freeze dried. Compared to manufactured extracts, raw
cannabis juice retains cannabinoid acids that are broken down after traditional heating
procedures. Thus, cannabis juice is able to provide unique healing benefits related to chronic
pain, neuropathy, and IBS.

Treatment and Drug Dosing Schedules

Accordingly, this invention also includes specific treatment schedules to cure specific ailments.
The invention specifies treatment protocols for cancer/tumor management, anxiety/PTSD, and
opiate dependency. Each schedule is laid out in detail and includes when, how much, and what
formulation of the extract should be taken.

Preferred Embodiments

The inventors of this utility patent specified their preferred embodiments of the invention
through detailed examples of: preparation and storage of cannabis, extraction of active
cannabinoids, extraction of inactive cannabinoids, extraction using NEOBEE 895 MCT, flower
and hash rosin extraction, preparation of raw cannabinoids, formulation of cannabis extracts,
exemplary stacking protocol for cancer/tumor treatment and management, exemplary protocol
for anxiety/PTSD, exemplary protocol for chronic pain, and exemplary protocol for opiate
dependency. A summary of these preferred embodiments are as follows.

Preparation & Storage of Cannabis

The mother plant should originate from a single seed source with specific starting ratios of
cannabinoids (90% cannabinoid and/or phytocannabinoid concentrated form). Fresh plant
material should be harvested from new plants grown from cuttings of the mother plant. Fresh
harvested material should be stored in a frozen state immediately: flash freeze for 10 minutes at a
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temperature between 10 and -50 degrees fahrenheit and store in vacuum seal bags for at least 36
hours.

Extraction of Inactive Cannabinoids

While still in the frozen state, gently spread and break apart the cannabis flowers on curing
screens into small pieces less than 0.7 inches to be air dried out. Place the material in a stainless
steel cylinder inside a closed loop hydrocarbon extraction machine. Run liquid hydrocarbon
through the product at 45 pounds of pressure for 45 minutes at -20 degrees fahrenheit. Winterize
the material by applying a secondary gas (filtered cold ethanol wash) or by storing the extract
solution at -20 to -75 degrees fahrenheit before filtering through activated charcoal. Finally,
purge the extract under an Across International Digital Vacuum Drying Oven with a solvent
rated recovery pump for about 48 hours. Remove the final product and store it in amber glass
containers without light exposure at temperatures below 40 degrees fahrenheit.

Extraction of Active Cannabinoids

This embodiment is very similar to that for the inactive cannabinoids. However, in order to
extract the active cannabinoids, there is an added step. Once the flowers are air dried, put the
plant material in a sterile containment oven at 221 degrees fahrenheit for 15 minutes and then
284 degrees fahrenheit for 45 minutes. This decarboxylates the phytocannabinoids and makes
them active upon extraction. From here, continue on with the winterization process from the
previous embodiment and end with storing in an amber glass storage container without light
exposure.

Extraction Using NEOBEE 895 MCT

Starting ratios of cannabinoids should be 1:1, 2:1, 3:1, 4:1, 8:1, 18:1, 20:1, 30:1, 50:1, or 70:1.
For cannabis flowers, make sure they are dried out to below 3% moisture content and broken
apart or milled into ~2 mm pieces. Combine cannabis flowers, flower rosin, hash rosin, hashish,
or kif with NEOBEE 895 MCT. Determine the ratio of cannabis to MCT based on starting
material, test results, ratio’s, and desired mg per ml outcome. Heat the MCT Oil and starting
cannabis material in a brewer, double broiler, or on a heat plate at 106 degrees fahrenheit for a
minimum of 3 hours. This will extract and infuse the desired cannabinoids into the MCT oil. In
order to separate the cannabis content from the oil at this point strain it through a 15 micron
stainless steel filter or silk screen. Press the soaked cannabis content to remove all remaining oil,
filter it, and add it back to the concentrated infused THCa or CBDa NEOBEE 895 MCT mixture.
This will be considered inactive until the infused cannabis and NEOBEE 895 MCT oil are heated
at 221 degrees fahrenheit for 15 minutes and 284 degrees fahrenheit for 45-120 minutes. Another
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way to infuse active content into the MCT oil is by combining decarboxylated cannabis flowers,
flower rosin, hashish, kif, THC, or CBN with NEOBEE 895 MCT and heating it at 106 degrees
fahrenheit for at least 3 hours. This is the process used for all milligram to milliliter and specific
ratio dosages for capsules, topical, transdermal, sublinguals, etc.

Flower & Hash Rosin Extraction

Cure the cannabis flowers until moisture is below 10% and then place them into a stainless steel
or nylon silk screen with the desired micron rating. Place sheets of non-stick parchment paper 2x
wider than the straining screens below them to collect the extracted cannabinoid oils and resin.
Depending on the desired outcome, use a mechanical heat plate press of minimum pressure 2500
psi between 100 and 300 degrees fahrenheit for a range of 4 seconds to 3 minutes. This
mechanically separates the cannabinoids and terpenes present in the raw cannabis flowers with
concentrations of THCa, THC, CBDa, CBD, CBGa, CBG, CBN, and CBL. Combine this
mechanically separated cannabis with NEOBEE 895 MCT to make desired formulations,
concentration, and ratios for the various delivery methods.

Preparation of Raw Cannabinoids

High content CBD plants are best for juicing because they contain more CBDa than non-CBD
producing strains. Here is the process for preparation:
1) During vegetation and not the flowering cycle, remove only the fresh cannabis leaves
2) Blanch the leaves in cold water to clean them
3) Juice the leaves in a cold press juicer or commercial masticating juice
4) Filter the juice through a stainless steel filter to remove particulates
5) Pour the juice immediately into 1 oz containers or 10 oz containers and freeze-dry it at -
50 degrees fahrenheit
6) This freeze-dried cannabis juice can be infused into food or put into capsules or packets

Formulation of Cannabis Extracts

Use any of the previously explained methods to produce 1 gram of cannabis oil. Mix it with a
minimum 95% total cannabinoid concentration per 40 ml of NEOBEE 895 for approximately 24
hours at under 90 and above 70 degrees fahrenheit in zero light. Mix the resultant infusion with
NEOBEE 895 to produce 5mg, 10mg, 20mg, and 50 mg total cannabinoids capsules. For
sublingual formulations, combine 0.5 g or 350 mg of the resultant infusion with 9 ml of
NEOBEE 895 and 1 ml of natural sweeteners and flavor additives.

Exemplary Stacking Protocol for Cancer/Tumor Treatment and Management.

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This preferred embodiment outlines a 7 week treatment plan with dosages specified for morning,
afternoon, dinner, and bedtime that change with each week. The plan starts with 70 mg of
cannabinoids absorbed daily and ends with 500 mg daily. Each day the methods of treatment
include both raw and capsule form type.

Exemplary Protocol for Anxiety/PTSD

This preferred embodiment outlines general daily dosage guidelines for those feeling anxiety or
experiencing symptoms of PTSD. There are recommendations for morning, afternoon, after
dinner, and bedtime ranging from 2mg to 10mg in CBD and CBN capsule and sublingual forms.

Exemplary Protocol for Chronic Pain

This preferred embodiment outlines general daily dosage guidelines for morning, afternoon,
dinner, and bedtime. These dosages also range from 2 to 10 mg and contain CBD, THC, and
CBN in capsule and sublingual forms.

Exemplary Protocol for Opiate Dependency

This preferred embodiment outlines a 16 week program for weaning off opiates by slowly
increasing cannabinoid intake in place of opiates and then decreasing the cannabinoid intake as
well. Every two weeks the dosage changes starting at 81 mg daily, peaking at 154mg daily, and
ending at 51 mg daily. Each day, the user takes raw cannabinoids in the morning and CBD
capsules throughout the day in the afternoon and at dinner and bedtime.

Other Embodiments

The authors of this patent made sure to clarify that these embodiments do not limit the scope of
the invention and only serve to illustrate it. Other advantages, modifications, and aspects are
within the scope of the claims below.

Claims

The inventors of this utility patent listed thirty-six claims within their patent. The following list
summarizes these claims in relation to the invention.
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1. This independent claim is with regards to the liquid cannabinoid formulation, specifying
that at least 95% of the total cannabinoids must be tetrahydrocannabinolic acid (THCa).
2. This dependent claim is with regards to the formulation of claim one, specifying it must
also comprise at least one terpene/flavonoid.
3. Claim three further specifies claim two, stating the “terpene/flavonoid is d-limonene
linalool, 1,8-cineole (eucalyptol), .alpha.-pinene, terpineol-4-ol, p-cymene,
borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.-myrcene, .beta.- caryophyllene,
cannflavin A, apigenin, quercetin or pulegone”.
4. Claim four is dependent on claim two, specifying the formulation must have no more
than 4% terpene total.
5. Claim five is independent and states the liquid cannabinoid formulation of the total
cannabinoids must contain at least 95% tetrahydrocannabinol (THC).
6. Claim six is dependent on claim five, adding that the liquid formulation must also contain
one terpene/flavonoid.
7. Claim seven also is dependent on claim five, specifying the formulation contains no more
than 4% terpene.
8. Claim eight is dependent on claim six, specifying the terpene/flavonoid is “d-limonene
linalool, 1,8-cineole (eucalyptol), .alpha.-pinene, terpineol-4-ol, p-cymene,
borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.-myrcene, .beta.- caryophyllene,
cannflavin A, apigenin, quercetin or pulegone”
9. This claim specifies claims one through five, stating the formulation contains no more
than 4% terpene and such terpene contains myrcene, caryophyllene and limonene.
10. The tenth claim is independent and states the liquid cannabinoid formulation in which
95% of the total cannabinoids is cannabidiol (CBD).
11. Claim eleven is dependent on claim ten, stating the formulation contains less than 1%
THC.
12. Claim twelve also is dependent on claim ten, stating the formulation contains at least one
terpene/flavonoid.
13. This claim also specifies claim ten, stating the total formulation contains no more than
4% terpene.
14. Claim fourteen further specifies claim twelve, stating the terpene/flavonoid is “d-
limonene linalool, 1,8-cineole (eucalyptol), .alpha.-pinene, terpineol-4-ol, p-cymene,
borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.- myrcene, .beta.-caryophyllene,
cannflavin A, apigenin, quercetin or pulegone”
15. Claim fifteen specifies claim ten, stating the total liquid formulation contains no more
than 4% terpene and such terpene contains myrcene, caryophyllene, and limonene.
16. This claim is independent and states that out of the total cannabinoids, at least 95% of the
liquid cannabinoid formulation is THCa and cannabidiolic acid (CBDa).
17. Claim seventeen is dependent on claim sixteen, stating the liquid formulation contains at
least one terpene/flavonoid.
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18. Claim eighteen is dependent on claim sixteen, stating the total formulation contains no
more than 4% terpene.
19. Claim nineteen further specifies claim seventeen, stating the terpene/flavonoid is “ d-
limonene linalool, 1,8-cineole (eucalyptol), .alpha.-pinene, terpineol-4-ol, p-cymene,
borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.- myrcene, .beta.-caryophyllene,
cannflavin A, apigenin, quercetin or pulegone”
20. The twentieth claim is independent and states that out of the total cannabinoids, at least
95% of the liquid cannabinoid formulation is THC and CBD.
21. Claim twenty-one further specifies claim twenty, stating the formulation contains at least
one terpene/flavonoid
22. The twenty-second claim also is dependent on claim twenty, stating the formulation
contains no more than 4% terpene.
23. The twenty-third claim further specifies the formulation of claim 21, stating the
terpene/flavonoid is “d-limonene linalool, 1,8-cineole (eucalyptol), .alpha.-pinene,
terpineol-4-ol, p-cymene, borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.-
myrcene, .beta.-caryophyllene, cannflavin A, apigenin, quercetin or pulegone”
24. Claim twenty-four is dependent on claims sixteen through twenty, stating the total
formulations contain no more than 4% terpene and such terpenes contain myrcene,
limonene, pinene, and caryophyllene.
25. Independent claim twenty-five states that out of the total cannabinoids, at least 95% are
CBD, cannabinol (CBN) and THC.
26. Dependent claim twenty-six further specifies claim twenty-five, stating the formulation
contains less than 9% THC.
27. Claim twenty-seven is dependent on claim twenty-five, stating that at least one
terpene/flavonoid is contained within the formulation.
28. Claim twenty-eight also further specifies claim twenty-five, stating the formulation
contains no more than 4% terpene.
29. Claim twenty-nine is dependent on claim twenty-seven, stating the terpene/flavonoid is
“d-limonene linalool, 1,8-cineole (eucalyptol), .alpha.-pinene, terpineol-4-ol, p-cymene,
borneol, .DELTA.-3-carene, .beta.-sitosterol, .beta.- myrcene, .beta.-caryophyllene,
cannflavin A, apigenin, quercetin or pulegone”
30. Claim thirty further specifies claim twenty-five, stating the formulation has no more than
4% terpene and such terpene contains myrcene, pinene and caryophyllene.
31. Independent claim thirty-one states that in the creation of any one of these preceding
claims, the liquid formulation is infused “in a medium chain triglyceride (MCT).”
32. Claim thirty-two further is dependent on claim thirty-one, stating the MCT is NEOBEE
895.
33. Claim thirty-three further specifies claims one, five, ten, sixteen, twenty or twenty-five,
stating the creation of oral, sublingual, buccal or topical use.
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34. Claim thirty-four is dependent on thirty-three, stating the sublingual formation also
contains a sweetener.
35. Claim thirty-five further specifies claim 34, stating the specific sweetener used in
sublingual formulations is stevia extract.
36. Claim thirty-six further specifies claim thirty-four, stating the formulation contains lemon
oil, orange oil, or both.

Prior Art

Six instances of U.S. Patent documents were cited for ‘911. The following summaries describe
each

1) Wallace: 6,949,582 B1: September 2005 [10]

US Patent Number 6949582 is a method patent with regards to relieving analgesia and reducing
inflammation using a topical cannabinoid mixture. This mixture contained several cannabinoids,
including THC and CBD, as well as terpenoids and flavonoids. However, only 2.5% of the total
volume by weight is attributed to cannabinoids. Specifically, this liniment was engineered to be
absorbed by the skin and interact with cannabinoid receptors to produce its stated therapeutic
effects.

2) Murry et al: 2003/0050334: March 2003 [11]

US Patent Number 2003/0050334 is a utility patent application publication that deals with
processes for supercritical fluid extraction of cannabinoids or other components of medicinal
value from a cannabis plant. The results from this extraction yields different strengths and
varieties of extracted compounds or mixtures of compounds.

3) Murty et al: 2011/0092583: April 2011 [12]

US Patent Number 2011/0092583 is a utility patent application publication that outlines an oral
drug that utilizes THC to suppress hepatic first pass metabolism. It targets chylomicron and
lipoprotein delivery to improve dissolution, stability, and bioavailability of drug compounds of
dronabinol or other cannabinoids. Cannabinoid compounds are dissolved in an oily medium with
a surfactant which promotes self-emulsification. Dosage forms can also include antioxidants, co-
solvents, metabolic inhibitors, viscosity modifying agents, efflux inhibitors, and amphiphilic
solutes to induce semi-solid formation for targeted release rates.

4) Newland: 2012/0264818: October 2012 [13]

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US Patent Number 2012/0264818 is a utility patent application publication for topical

compositions with cannabis extracts. These compositions specifically utilize heat treatment of
mature, dried, powdered cannabis sativa flower and bud leaves in carriers. They mean to treat
pain and MRSA infections through various methods. The patent application outlines methods of
making the topical composition as well as patches, bandages, coverings, and strips containing the
topical composition.

5) Parolaro: 2013/0059018 : March 2013 [14]

US Patent Number 2013/0059018 is a utility patent application publication with regards to an

invention stating that phytocannabinoids can be used by themselves or in a botanical drug
substance (BDS,) to treat patients with cancer. Specifically, the patent states that doses of
phytocannabinoids can be used to treat individuals suffering from cancer by administering a
therapeutically effective amount of phytocannabinoids as well as an amount of non-
phytocannabinoids to these patients. The phytocannabinoids portion of the compound contains
50% of the plant’s extract with the exception that the main ingredient is not tetrahydrocannabinol
(THC) or cannabidiol (CBD.) Furthermore, the non-phytocannabinoid is said to contain 15% of
the plant’s extract and also contains a “monoterpene fraction comprising a principle monoterpene
which is selected from myrcenes or pinenes and a sesquiterpene fraction comprising a principle
sesquiterpene which is selected from caryophyllenes or humulenes to the patient.”

6) Wurzer: 2014/0271940 : September 2014 [15]

US Patent Number 2014/0271940 is a utility patent application publication with regards to

extracting concentrates from cannabis plants, specifically capturing terpene concentrates and/or
concentrates for the use of vaping, infusion into edible matter, within electronic inhalation dives
as well as in nutraceuticals.
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Design Challenge and Patent Analysis

Design Challenges

Throughout the past decade, the use of opioids has been the preferred method of treatment for
pain and a variety of other symptoms. According to the CDC, more than 191 million opioid
prescriptions were dispensed to American patients in 2017- this is more than half the US
population. Opioids are a category of narcotic pain killers that are immensely addicting and have
side effects that can interfere with one’s daily life including limiting one’s ability to think
critically, operate heavy machinery and other cognitive abilities. Additionally, opioids are very
hard to stop taking as unpleasant withdrawal symptoms occur including vomiting, nausea, pain,
insomnia and difficulties regulating one’s body temperature. With this, it can be understood that
patients need a fast-acting drug to treat symptoms that opioids are usually prescribed to treat but
without the possibility of addiction and additional unpleasant ailments. The “White Space” these
inventors choose to address relates to a new category of drugs which effectively treat the same
symptoms opioids treat, but with limited short and long term adverse symptoms, improving
patients' lives. The cannabis formulations cited in the patent transform naturally occurring
elements to create a new, helpful, and effective medicinal product. [16]

New

This patent can be considered new as it depicts unique formulations for creating cannabis
extracts in liquid, sublingual, and oral form. Specifically, the patent presents a novel recipe
including a preset amount of cannabinoids, terpenes and flavonoids, in order to produce the
extracts in their preferred embodiment- thus producing favorable medicinal effects. Although,
there may be other cannabis concentrates in the market, due to the citations, this invention can be
considered new as it is the first BDS cannabis patent of its type.

Useful

For decades, many of the ailments and addictions outlined in the preferred embodiments were
previously treated via synthetic and potentially addictive substances. In light of the opiate
epidemic, costing thousands of American lives, this method for extracting cannabinoids and the
treatment protocols outlined provides a much safer and natural remedy as per the existing
science.

Non-obviousness
 15

There have been multiple indications that ‘911’s invention indeed meets the criterion for non-
obviousness. Most notably, the Prana Bio Nutrient Medicinal Product line has met a long felt but
unsolved need and has been licensed, signifying industry acceptance. Firstly, the unsolved need
can be evidenced by the invention’s prior art, where there is only one published patent cited and
the rest are mere patent applications. This suggests that while the basis of the invention might
have already been conceptualized in the market, Prana Bio Nutrient Products addresses the
unmet need. Additionally, according to a press recent press release, United Cannabis partnered
with Releaf Global Pty Ltd. to distribute its Prana Bio Nutrient Medicinals and other cannabis-
centric products throughout Australia and other territories. This highlights that Prana products
are unique and non-obvious as they are accepted by a global market. [17]
 16

Litigation [9] [18] [19]

Perhaps what is notable about the ‘911 patent isn’t the invention itself, but the litigation
surrounding it. In July of 2018, United Cannabis Corp. (UCANN) filed suit against Pure Hemp
Collective, another medical marijuana company based in Colorado, for infringement on its ‘911
patent. As of April 25th of this year, it was decided that this case will proceed toward a jury trial.
This is significant; it is the first infringement case being litigated related to cannabis in the US.

Specifically, UCANN is claiming infringement of claims 10, 12, 20-22, 25, 27, 28, 32, and 33 of
the ‘911 patent. Referencing the claim numbers in the patent analysis section of the paper, these
claims deal with the concentrated liquid CBD formulations and the MCT formulations. Pure
Hemp argues that the claims and patent itself is invalid; they assert that the formulations are
natural phenomena and UCANN’s formulations are common knowledge within the medical
cannabis field. However, a few days prior to the announcement that the trial would proceed, the
presiding judge threw out much of Pure Hemp’s counterarguments, stating that:

Pure Hemp has failed to establish beyond genuine dispute that a liquefied version of
cannabinoids and related chemicals at the concentrations specified in the 911 Patent is
anything like a natural phenomenon. It may be true, as Pure Hemp insists, that
cannabinoids in nature can take the form of a resin; that a resin can be highly viscous;
that a highly viscous substance may at times be considered a liquid; and therefore it is
logically possible that cannabinoids in nature might appear in a form that could, in some
sense, be deemed a "liquid." . . . Even accepting as much, the 911 Patent specifies
threshold concentrations of cannabinoids and related chemicals. Pure Hemp nowhere
claims that these precise concentrations, or anything close to them, occur in liquid form
in nature. Accordingly, UCANN's claims are not restatements of "the handiwork of
nature. [20]

This is a clear and strong assertion that indeed the invention of ‘911 is of patentable nature under
Alice. [21] However, the debate to whether patent ‘911 is “new, useful, and non-obvious”, and
thus can be infringed upon, remains in the jury’s hands in the preceding summer months.

Implications of Litigation

This landmark case has tremendous implications for cannabis in the future. If ‘911 is upheld and
UCANN receives an injunction against Pure Hemp and reaps damages from patent infringement,
it could stand to substantially increase the value and competitive edge of both recreational and
medical cannabis industries. Additionally, UCANN’s success in this case could encourage states
to legalize recreational marijuana, as cannabis products and companies will be shown to have the
ability to uphold IP rights. This provides further economic incentives and safety nets to
 17

encourage prospective cannabis business and innovation, additionally spurring states to legalize
cannabis as a potential revenue stream from them. [17]
 18

References

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[16] “Prescription Opioids | Drug Overdose | CDC Injury Center,” 31-Aug-2018. [Online].
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[17] “United Cannabis Partners with Releaf Global to Enter Australian Market.” [Online].
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172000654.html. [Accessed: 08-Jun-2019].
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[18] “Colorado Cannabis Patent Lawsuit Will Be Worth Watching,” Cannabis Business Times.
[Online]. Available: https://www.cannabisbusinesstimes.com/article/ucann-pure-hemp-
patent-lawsuit-cannabis/. [Accessed: 08-Jun-2019].
[19] “Bess&Besheba Archives,” PureHempCollective.com. .
[20] “Only The Law Is Hazy For CBD Patent Eligible Under Section 101 | Blogs |
PharmaPatents | Foley & Lardner LLP.” [Online]. Available:
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under-section-101. [Accessed: 08-Jun-2019].
[21] “Cannabis Patent Litigation Update: The 911 Patent Passes the (Alice) Test!,” Canna Law
BlogTM, 08-May-2019. [Online]. Available: https://www.cannalawblog.com/cannabis-patent-
litigation-update-the-911-patent-passes-the-alice-test/. [Accessed: 11-Jun-2019].