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 .
Applicant’s response filed 6/4/2026 have been entered.
Claims 1-50 are pending.
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.
Claim(s) 1-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO99/08670 (‘670), from IDS filed 1/14/2026, and US 2010/0267676 (‘676) in view of US 9, 993,449 (‘449).
‘670 teaches the use of GABA analog as useful in treating IBD, ulcerative colitis, Crohn’s disease and preventing GI damage (see claims 1 and 11). ‘670 teaches one of the GABA analogs as gabapentin (a GABA agonist) (see claim 3).
‘676 teaches the use of GABA derivative for treating neuropathies such as celiac disease (see [0491]). ‘676 teaches gabapentin as one of the suitable appropriate GABAB ligand (see [0516]).
The references do not expressly teach the herein claimed compound, in the dosage herein claimed, in the method o treating the herein claimed diseases.
‘449 teaches the herein claimed compound, in an effective amount, as a GABA aminotransferase inhibitor (see co1. 5-6). ‘449 teaches “Gabaergic drugs are those that improve secretion or transmission of GABA. These drugs as a family have been used to treat a wide variety of nervous system disorders including fibromyalgia, neuropathy, migraines related to epilepsy, restless leg syndrome, and post traumatic distress disorder. Gabaergic drugs include GABAA and GABAB receptor ligands, GABA reuptake inhibitors, GABA aminotransferase inhibitors, GABA analogs, or molecules containing GABA itself.” (See Col. 1, lines 30-38).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ CPP-115 in the method of treating IBD and other recited GI inflammatory conditions.
One of ordinary skill in the art would have been motivated to employ CPP-115 in the method of treating IBD and other recited GI inflammatory conditions. It is known that GABA agonist such as gabapentin as useful in treating the herein claimed disorders. CPP-115 is an inhibitor of the enzymes that metabolizes GABA, which in turns enhancing the GABA presence and signaling, similar to administering a GABA agonist. Since the administration of GABA agonist can treat the herein claimed disorders, either by treating the pain associated with it or the disease itself, it would be reasonably expected to treat the herein claimed disorders by enhancing GABA via using CPP-115 to inactivate GABA aminotransferase.
As for the dosage employed in the method, the optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As the GABA aminotransferase inhibition/inactivating potency of CPP-115 is known, and the GABA activity related to the treatment of the herein claimed disorders, adjusting the amount of CPP-115 to maximize the therapeutic effects and minimize the side effect would be reasonably expected to be successful.
No claims are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-50 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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