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 .
Claim Rejections - 35 USC § 112
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 – 5 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.
Claim 1 recites the limitation “The compound” in line 1; however, since claim 1 is the independent claim and since this is the 1st mention of “the compound” the claim does not have antecedent basis. There is insufficient antecedent basis for this limitation in the claim. Moreover, claims 2 – 5 are included in the rejection since the claims dependent from claim 1 but do not address the deficiency.
Discussion of the Prior art
The closet prior art of Ye et. al. ((2019), Orphan Receptor GPR88 as an Emerging Neurotherapeutic Target, ACS Chem Neurosci, 10, 190 – 200) teach that G protein-coupled receptors (GPCRs), also known as seven-transmembrane domain receptors, are the largest group of signaling proteins in the human genome, with at least 800 members. See page 190 column 1 paragraph 1. Moreover, Ye et. al. teach GPCRs mediate a myriad of important physiological and pathological processes ranging from blood pressure regulation, allergic response, renal function, hormonal disorders, psychiatric disorders, and neurodegenerative diseases to the progression of human cancers. See page 190 column 1 paragraph 1. Furthermore, Ye et. al. teach that the large number of druggable GPCRs includes GPR88, a class A rhodopsin family orphan receptor, that is curiously expressed almost exclusively in the striatum of the brain in rodents, primates, and humans. See page 190 column 2 paragraph 2.
Additionally, Ye et.al. teach that GPR88 plays an important role in the regulation of various brain and behavioral functions, including cognition, mood, movement control, and cue-based reward learning, and is emerging as a promising drug target for the treatment of basal ganglia associated disorders. See page 190 column 2 paragraph 2 and page 191 column 1 paragraph 1. Moreover, Ye et.al. teach that several studies relevant to Parkinsons’s disease (PD) and Huntington’s disease (HD) have suggested changes in GPR88 expression, and notably Gpr88 KO mice have altered motor functions. See page 192 column 1 paragraph 4. See claim 4 limitations for a method of treating a psychiatric or neurological condition associated with impulse control deficits, addiction, speech delay, learning disabilities, depression, psychosis, bipolar disorder and/or emotional valence in a patient. See claim 5 limitations for a method where the selected psychiatric or neurological condition is Huntington’s disease and/or Parkinsons’s disease. In particular, Ye et. al. teach compound 3 of structure
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with an EC50 value of 3.5 nM in a cAMP HTRF assay. See page 193 Figure 3 and page 194 column 2 Table 1.
However, Ye et. al. fails to teach a compound of structure
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. See claim 1 limitation. The structure of compound 3 of Ye et.al., that is
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, and the compound of claim 1, differ structurally by the compound of claim 1 having an N-(2-difluoromethoxy)ethyl and a pyrimidine substituent groups in combination with the bicyclic methyl-1H-indazol-7-yl core. Moreover, as demonstrated in the examined specification the introduction of these substituent groups in combination with the bicyclic core lead to an improvement in cAMP activity in an A BRET hGPR88 receptor Assay from 228 nM to 47 nM. See examined specification page 8 lines 1 – 10 and Table 1. Thus, prior art compound 3 fails to anticipate or render obvious the compound of claim 1. Therefore, claims 1 – 3 are free of the prior art. Furthermore, claims 4 – 5 which depend on the compound of claim 1 which is free of the prior art; is also free of the prior art.
Conclusion
Claims 1 – 5 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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