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 .
According to paper filed on Feb. 9, 2026, the applicants have elected group II and furthermore, have elected species I for further prosecution.
Claims 1-20 are pending in the application. Claims 1-9 and 16-20 are withdrawn from further consideration as being directed to non-elected subject matter.
Claim Rejections - 35 USC § 112
4. 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 10-15 are 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 treating brain diseases, does not reasonably provide enablement for preventing brain diseases. 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. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
It is well known in the art that there are multiple mechanisms involved in the etiology of any disease condition including every known brain disease. According to Schmitt (CNS Drugs), there are currently six different categories of drugs in the clinical trial for treating Alzheimer disease, each category having different mechanism of action (see table 1 on page 829). There is no teaching or guidance present either in the specification or prior art references provided showing any other mechanism involved besides inhibiting cholinesterase (for cholinesterase inhibitors) or oxidative stress (for antioxidants). There are no working examples present showing complete (100%) inhibition of various parameters such as infarct volume by combination of cholinesterase inhibitor and an antioxidant (see figure 16). Actually, there was modest increases in expression levels of motor neuron markers by combination of cholinesterase inhibitor and an antioxidant (see figures 9-11). Therefore, in absence of such teachings, guidance, prior art, absence of working examples and unpredictability, the instant compounds will have therapeutic utility for treating but not preventing brain diseases.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10-14 10-14 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Ieni (WO 2004/034963 A2).
Ieni discloses methods and compositions using cholinesterase inhibitors. The method of treating Alzheimer disease and vascular dementia by combination of cholinesterase inhibitors (including donepezil) and antioxidants disclosed in claims 12 and 15 by Ieni anticipates the instant claims when brain disease is either Alzheimer or vascular dementia in the instant claims.
Claim(s) 10-15 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by John (WO 2017/004436 A2).
John discloses Pharmaceuticals in combination for treating neurodegenerative diseases. The method of treating Alzheimer disease and dementia by combination of cholinesterase inhibitors (including donepezil) and antioxidants (including NAC, tocopherol) disclosed in claims 1-10, 12, 51-52, 60 and 71 (specifically claims 52 and 71) by John anticipates the instant claims when brain disease is either Alzheimer or dementia in the instant claims.
Claim(s) 10-11 and 13-15 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Shea (U.S. Patent 8,597,640 B2).
Shea discloses combination of pharmaceuticals for treating neurological disorders. The method of treating Alzheimer disease by combination of cholinesterase inhibitors and antioxidants disclosed in claims 1-15 by Shea anticipates the instant claims when brain disease is Alzheimer’s disease in the instant claims.
Claim(s) 10-11 and 13-15 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Schmitt (CNS Drugs).
Schmitt discloses combination therapy in Alzheimer’s disease. The method of treating Alzheimer disease by combination of cholinesterase inhibitors and alpha linoic acid (an antioxidant) and Donepezil (a cholinesterase inhibitor) and tocopherol (vitamin E, an antioxidant) disclosed in table II (see pages 835-836) by Schmitt anticipates the instant claims when brain disease is Alzheimer’s disease in the instant claims.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621