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 .
Claims 1-4, 6, 7, 10, 13-15, 17, 18, 22, 24, 25, 27-29, 31, 33, 35, 37, 39, 42, 44, 53, 56, 68 and 84 are pending in this application.
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.
Claims 22, 24 and 37 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The scope of the method claims is not adequately enabled solely based on melatonin receptor activity provided in the specification.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims, which embrace substituted N-{2-[(-[(3-bromophenyl)-{(4-fluorophenyl)amino]ethyl)acetamide compounds.
HOW TO USE: Claims 22, 24 and 37 are to a method for managing or treating a disease, disorder or condition associated with melatonin receptor activity. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. The scope of claims 22, 24 and 37 includes diseases and/or conditions not even known at this time, which may be associated with melatonin receptor activity. While the treatment of insomnia has been linked with melatonin receptor activity the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced. It is difficult to treat many of the disorders claimed herein.
The scope of "neuropsychiatric disorder", “metabolic disorder” and “addiction” cannot be deemed enabled. The terms "neuropsychiatric disorder", “metabolic disorder” and “addiction” covers a broad array of different disorders that have different modes of action and different origins. The term "neuropsychiatric disorder" covers such diverse disorders as depression, bipolar disorder, mania, schizophrenia, attention deficit/hyperactivity disorder, autism spectrum disorder, Alzheimer's Disease; Parkinson's Disease; multiple sclerosis, generalized anxiety disorder, panic disorder, post-traumatic stress disorder, obsessive-compulsive disorder, post stroke depression, head injury sequelae, epilepsy, migraines, insomnia, eating disorder, Huntington’s disorder, dementia, delirium, chronic weariness disorder, cognitive debilitation disorder, Tourette condition, borderline personality disorder, progeria, seizures, palsies, etc. These exhibit a very broad range of effects and origins. For example, some give progressive dementia without other prominent neurological signs, such as Alzheimer's disease, whereas other dementias have such signs, such as Diffuse Lewy Body Disease. Some give muscular wasting without sensory changes, e.g., ALS, and some do have the sensory changes such as Werdnig-Hoffmann. Some are abnormalities of posture, movement or speech, such as Striatonigral degeneration, and other are progressive ataxias, such as OPCA. Some are linked to tau mutations, such as Alzheimer's disease and FTDP-17, and other such as Parkinson's clearly do not. Some affect only vision such as retinitis pigmentosa. Even within those that fall into the same category of effects, there are often striking differences. For example, Alzheimer's disease and Pick's disease both give progressive dementia without other prominent neurological signs. But the characteristic Alzheimer's neurofibrillary tangles are not seen in Pick's Disease, which has straight fibrils, as opposed to the paired helical filaments of Alzheimer's disease. Pick's Disease gives lobal atrophy, not seen in Alzheimer's disease. There are differences in origins, even with what little is known. Thus, among progressive dementias, CJD is definitely caused by an infectious agent; so far as can be determined, this is not so for Huntington's disease. Even among the hereditary disorders, the origins are different. Thus, FTDP-17 comes from chromosome 17, Huntington's disease from 4, and the neurodegenerative disorder that people with Down's syndrome develop later in life is presumably connected in some way to 21.
Metabolism is the chemical process your body uses to transform the food you eat into the fuel that keeps you alive. A metabolic disorder occurs when the metabolism process fails and causes the body to have either too much or too little of the essential substances need to stay healthy. The term “metabolic disorder” covers such diverse disorders as Sickle cell anemia, cystic fibrosis, Maple syrup urine disease, Gaucher’s disease, Hemochromatosis, Hurler syndrome, Niemann-Pick disease, Tay-Sachs disease, Fabry disease, Krabbe disease, Galactosemia, Glycogen storage disease, Mitochondrial disorders, Friedreich ataxia, Peroxisomal disorders, Zellweger syndrome, Adrenoleukodystropy, Wilson’s disease, Organic acidemias, Urea cycle disorders, Lesch-Nyhan syndrome, Prader-Willi syndrome, Tangier disease, Glucose galactose malabsorption, Menkes syndrome, Pancreatic cancer, Porphyria, Refsum disease, Obesity, Hyperthyroidism, Hypothyroidism, Diabetes, Galactosemia, Dyslipidemia, Hiplipidemia, Phenylketonuria, etc.
The scope of “addiction disorder” cannot be deemed enabled. The notion that a compound could be effective against chemical dependencies in general is 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 re-uptake site. Heroin addiction, for example, arises from binding at the opiate receptors, cigarette addiction 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.
The great majority of these have no treatment at all, and of those that do, none or virtually none have been treated with such inhibitors as are disclosed here. The great diversity of diseases falling within the "neuropsychiatric disorder" and “metabolic disorder” categories means that it is contrary to medical understanding that any agent (let alone a genus of trillions of compounds) could be generally effective against such diseases. The intractability of these disorders is clear evidence that the skill level in this art is low relative to the difficulty of the task. Further, what little success there has been does not point in this direction. Thus, what very few treatments that the massive research effort on Alzheimer's disease has produced are means of providing Acetylcholinesterase inhibition, unrelated to the mechanism of action in this case.
No screening protocol(s) are ever described. Thus, no evidence of in vitro effectiveness is seen in the specification for one of the instantly claimed substituted diazepine compounds. In general, pharmacological activity is a very unpredictable area. In cases involving physiological activity "the scope of the enablement obviously varies inversely with the degree of unpredictability of the factors involved." In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970). Since this case involves unpredictable in-vivo physiological activities, the scope of the enablement given in the disclosure presented here was found to be low.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
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.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
As stated in the MPEP, 2164.08 ''[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). AII that is necessary is that one skilled in the art be able to practice the claimed invention, given the Ievel of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination.''
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 1-4, 7, 10, 13, 15, 17, 18, 22, 24, 25, 27-29, 31, 33, 35, 37, 39, 42, 44, 53, 56, 68 and 84 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 following reasons apply:
Claims 1, 10 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R4 and R5 together with the carbon and the nitrogen atom to which they are attached form a cyclopentyl group, however, the ring contains a nitrogen atom and thus is unable to form a cyclopentyl group.
Claim 17 is vague and indefinite in that it is not known what is meant by the pharmaceutically acceptable salts of the salts of the 3rd, 4th, 5th, 6th, 7th and 8th species.
Claim 18 is vague and indefinite in that it is not known what is meant by the pharmaceutically acceptable salts of the salts of the species.
Claim Objections
Claims 1, 17, 18, 22, 24, 25, 27-29, 31, 33, 35, 37, 39, 42, 44, 53, 56, 68 and 84 are objected to because of the following informalities:
Claim 1 contains the bullet point “A-is”;
Claim 17, in the 6th species there is a close parenthesis but not a corresponding open parenthesis; and
Claim 17, in the 8th species there is an open parenthesis but not a corresponding close parenthesis.
Appropriate correction is required.
Claims 6 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624