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 . Claims 1, 3, 11, 15, 17-19, 22, 24, 26-27, 29 and 31-38 are pending in this application.
Election/Restrictions
Applicant’s election of Group I (Claims 1, 3, 11, 17, 19 and 32-38) in the reply filed on 01/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Since the conditions for rejoinder are met, Groups II and III (Claims 15 and 18) are hereby rejoined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for most of the treatment of most of the diseases recited in claim 18, does not reasonably provide enablement for the treatment acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and prevention of the all diseases recited in claim 18. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
(1). Breadth of Claims: Claim 18 is directed to a method of treating acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions.
a. Scope of use - The scope of use that applicants intend to claim may well be very broad.
It has been recited in claim 18, a method of treating neurological disorders in general. There is no such an agent, which can treat neurological disorders generally. That is because neurological disorders are extremely varied in origin and nature of effect. The origin and the nature of many neurological disorders such as Huntington’s disease, Pick’s disease, Frontotemporal dementia, Cerebro-Oculo-Facio-Skeletal (COFS) syndrome (cranofacial and skeletal abnormalities), Motor neuron disease (muscle weakness), Corticobasal ganglionic degeneration, Creutzfeldt-Jacob disease (fatal disease), Dementia with Lewy bodies, and Progressive supranuclear palsy Dementia are different one from the other. Many neurodegenerative disorders are untreatable to this day.
The symptoms and nature of these diseases are also different one from the other. It can be shown that many of these neurodegenerative disorders have different origin and nature of effect. Some neurological disorders are hereditary (Charcot-Marie-Tooth disease). Many neurodegenerative disorders vary in how they affect the body and its functions. Diseases such as Cerebral palsy, and Parkinson’s disease affect the movement of the patient. Diseases such as Alzheimer’s disease affect the memory of the patient.
Cognitive disorders - are disorders in a brain that prevents someone from thinking well, from solving problems, or from storing information. Three main types of cognitive disorders are: Delirium, Dementia, and Amnesia.
Dementia is a label for a cluster of symptoms involving deterioration in behaviors such as memory, language, and reasoning. The deterioration results from a disease process in the brain. The disease progresses from mild through severe stages and interferes with the ability to function independently in everyday life. Dementias are fatal medical diseases that have major psychosocial consequences.
Dementia is classified as cortical or subcortical depending on the area of brain affected.
Cortical dementia causes problems in memory, thinking, and language. Alzheimer's Disease is a disorder that causes cortical dementia. The cognitive problems, depending on their nature, are called aphasia, apraxia, amnesia, and agnosia. These problems may include difficulty finding words, difficulty comprehending written or spoken material, and even mutism. Speech, which is the machinery for sound, is usually normal; however, it is the language component that breaks down. The memory problem is often an inability to learn new information.
Insight into the condition is usually absent and a person's mood is unconcerned or uninhibited. The motor system is normal, at least in the early stages.
Subcortical dementia affects parts of the brain below the cortex and is characterized by slowing, difficulty in retrieving information from memory, and altered mood. Parkinson's disease and multiple sclerosis are examples of a condition that can result in a subcortical dementia. Language ability is usually normal, although speech is dysfunctional and the motor system may result in stooped or extended posture, increased muscle tone, and tremors. Memory problems are due to a difficulty in retrieving information that is in fact learned. The person's mood may be either apathetic or depressed, and insight into the condition is usually present.
Delirium is a condition of severe confusion and rapid changes in brain function, usually the result of treatable physical or mental illness.
Acute confusional states are usually the result of a physical or mental illness and are usually temporary and reversible. Delirium involves a rapid alternation between mental states (for example, from lethargy to agitation and back to lethargy), with attention disruption, disorganized thinking, disorientation, changes in sensation and perception, and other symptoms. Disorders that cause delirium are numerous and varied. They may include conditions that deprive the brain of oxygen or other substances. Delirium may be caused by diseases of body systems other than the brain, by poisons, by fluid/electrolyte or acid/base disturbances, and by other serious, acute conditions.
Mental retardation is also a cognitive disorder that is described as below-average general intellectual function with associated deficits in adaptive behavior that occurs before age 18. Causes of mental retardation are numerous, but a specific reason for mental retardation is determined in only 25% of the cases. Failure to adapt normally and grow intellectually may become apparent early in life or, in the case of mild retardation, not become recognizable until school age or later. An assessment of age-appropriate adaptive behaviors can be made by the use of developmental screening tests. The failure to achieve developmental milestones is suggestive of mental retardation. A family may suspect mental retardation if motor skills, language skills, and self-help skills do not seem to be developing in a child or are developing at a far slower rate than the child's peers. The degree of impairment from mental retardation has a wide range from profoundly impaired to mild or borderline retardation. Less emphasis is now placed on degree of retardation and more on the amount of intervention and care required for daily life.
Causes of mental retardation can be roughly broken down into several categories:
unexplained (This category is the largest and a catchall for undiagnosed incidences of mental retardation.)
trauma (prenatal and postnatal)
infectious (congenital and postnatal)
chromosomal abnormalities
genetic abnormalities and inherited metabolic disorders
metabolic
nutritional
environmental
As shown above, since the origin and nature of mental retardation is different one
from the other, it is impossible to treat mental retardation in general.
Autism - is a cognitive disorder as discussed above that has no effective pharmacological treatment to this day.
Amnesia - is loss of memory; it is retrograde if memories before a fixed event are lost, and anterograde if memories after a fixed event are lost. An individual may have both kinds of amnesia.
Amnesias, as the name indicates, are characterized by memory losses without sufficient cognitive deficits to indicate a diagnosis of delirium or dementia, and can be subcategorized into those: Caused by medical conditions, caused by substance abuse, etc.
As shown above, since the origin and nature of cognitive disorders is different one
from the other, it is impossible to treat cognitive disorders in general.
The treatment of drug addiction is recited in claim 18. The notion that a compound could be effective against chemical dependencies or drug addiction in general is absolutely contrary to our current understanding of how chemical dependencies operate. There is not, and probably never will be, a pharmacological treatment for “drug addiction” generally. That is because “drug addiction” is not a single disease or cluster of related disorders, but in fact, a collection with relatively little in common. Addiction to barbiturates, alcohol, cocaine, opiates, amphetamines, benzodiazepines, nicotine, etc. all involve different parts of the CNS system; different receptors in the body. For example, cocaine binds at the dopamine reuptake transmitter. Heroin addiction, for example, arises from binding at the opiate receptors, cigarette addiction arises from some interaction at the nicotinic acid receptors, many tranquilizers involve the benzodiazepine receptor, alcohol involves yet another system, etc. All attempts to find a pharmaceutical to treat chemical addictions generally have thus failed.
Applicants claim the treatment of sleep disorders in general, but the nature of sleep disorders vary one from the other. Sleep disorders are any disorders that are related to sleeping. Sleep problem can affect a person's physical health, daily activities, and mental health. Sleep disorders are medical conditions that can potentially be serious. Common sleep disorders include:
Sleep apnea - People with sleep apnea stop breathing for a very short time many times during the night. Its main symptoms are loud snoring and feeling sleepy during the day. People with this disorder don't get enough restful sleep at night, making it hard for them to function during the day. Sleep apnea can lead to high blood pressure, heart failure, heart attack, and stroke.
Narcolepsy - When a person has narcolepsy, brain messages about when to sleep and when to be awake get mixed up. This can make a person fall asleep when they don't want to, often without any warning like feeling drowsy. If not controlled with medication, this disorder can cause serious problems in a person's personal, social, and work life. It can also limit a person's activities, such as driving a car, work, and exercising. This disorder may run in families.
Restless legs syndrome - A person with this disorder can have unpleasant feelings or sensations in the legs, mostly in the calves or lower legs. In some cases, the arms may also be affected. These feelings are often described as creeping, crawling, tingling, pulling, or painful. This disorder can be hard to diagnose and is sometimes mistaken for nervousness, insomnia stress, or arthritis. It seems to affect women more often than men.
Insomnia - People with insomnia have trouble falling asleep or staying asleep during the night. They can wake up often during the night and have difficulty getting back to sleep, or they can wake up too early in the morning. Sleep does not feel satisfying when a person has insomnia. A person can feel sleepy, tired, and irritable during the day and have trouble focusing on tasks.
Sleep disorders also cover such as snoring. Since sleep disorders are extremely broad in nature and vary in nature as shown above, the enablement rejection is proper.
It has been recited in claim 18, a method of treating a method of eating disorders. Eating disorders are complex mental health conditions that involve extreme behaviors related to food and body image. The most common type include anorexia nervosa, bulimia nervosa, binge eating, and avoidant/restrictive food intake disorder (ARIFID).
Anorexia nervosa is an eating disorder characterized by weight loss (or lack of appropriate weight gain in growing children); difficulties maintaining an appropriate body weight for height, age, and stature; and, in many individuals, distorted body image. People with anorexia generally restrict the number of calories and the types of food they eat. Some people with the disorder also exercise compulsively, purge via vomiting and laxatives, and/or binge eat.
Bulimia nervosa is a serious, potentially life-threatening eating disorder characterized by a cycle of bingeing and compensatory behaviors such as self-induced vomiting designed to undo or compensate for the effects of binge eating.
Binge eating disorder (BED) is a severe, life-threatening, and treatable eating disorder characterized by recurrent episodes of eating large quantities of food (often very quickly and to the point of discomfort); a feeling of a loss of control during the binge; experiencing shame, distress or guilt afterwards; and not regularly using unhealthy compensatory measures (e.g., purging) to counter the binge eating.
Avoidant Restrictive Food Intake Disorder (ARFID) is a new diagnosis in the DSM-5, and was previously referred to as “Selective Eating Disorder.” ARFID is similar to anorexia in that both disorders involve limitations in the amount and/or types of food consumed, but unlike anorexia, ARFID does not involve any distress about body shape or size, or fears of fatness.
As shown above, the disorders of neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions are very broad in nature and the disorders vary one from the other. The burden is on applicants, to show that their compounds can treat the disorders that are listed above.
b. Scope of Compounds - The scope of the compounds is also broad. It is apparent that hundreds of combinations of compounds can be created from the definitions, owing especially to broad scope of R1, Xa, and Xb.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance for the treatment of acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to these difluoromethyl-pyridin-2-yl-triazoles are in use for the treatment of acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions.
(4). Working Examples: There is a biological Examples and data for in vitro inhibition of binding HEK cells expressing the human GABA receptor at pages 93-105, but there is no way to convert this data into specific useful knowledge, especially in view of the difficult nature of some of these disorders.
(5). Nature of the Invention and Predictability: The invention is directed to treating acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(6). The Relative Skill of Those in the Art: The relative skill is extremely very low. To this day, there is no magic bullet that can treat acute/chronic neurological disorders, eating disorders, sleep disorders, cognitive disorders and drug addictions in general.
(7). The Quantity of Experimentation Necessary: Immense, because of points (1), (2) and (6).
Note that it is difficult to treat many of the disorders claims herein as shown above. Instant claim 18 embraces not only for the treatment but the prevention, which is not remotely enabled. It is presumed in the prevention of the diseases/or disorders claimed herein there is a way of identifying those people who may develop e.g. anxiety, depression etc. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the disorders claimed herein. To this day the only means available is the treatment of patients suffering from e.g. anxiety, depression, pain, etc. and not the prevention of a healthy patient from getting the claimed diseases in the first place.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Allowable Subject Matter
Claims 1, 3, 11, 15, 17, 19 and 32-38 are allowed.
Information Disclosure Statement
6. Applicant’s Information Disclosure Statement, filed on 06/17/2025 and 05/02/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624