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 Status
Claims 6-13 are pending. Claims 6-11 are allowed. Claims 12-13 are rejected.
Priority
Applicant cannot rely upon the certified copy of the foreign priority applications because translations of said applications have not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The earliest priority date for the purpose of examination is January 18th, 2023.
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 12-13 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 12 recites a method of preparing drugs of dopamine D1/D5 receptor agonists, comprising “using the crystalline form according to claim 6.” However, it is unclear how the crystalline form is used in the method of preparing as the claim does not explicitly describe any active steps.
Likewise, claim 13 recites a method of preparing drugs for treating Parkinson’s disease, comprising “using the crystalline form according to claim 6” and fails to include any active steps.
Allowable Subject Matter
Claims 6-11 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is WO 2023/102087 by Przeczkova et al. cited in the IDS filed 10/11/2024. The prior art teaches solid state forms of (-)-Tavapadon including crystalline forms 1, 3 and 5 and crystalline form R1 which is a racemic mixture. Crystalline form 1 of the prior art is characterized as follows (paragraph [0043]):
an X-ray powder diffraction pattern having peaks at 8.5, 11.7, 14.9, 15.7 and 18.5 degrees 2-theta ± 0.2 degrees 2-theta, and also having any one, two, three, four or five additional peaks selected from 9.3, 16.9, 20.0, 24.5 and 25.0 degrees 2-theta ± 0.2 degrees 2-theta.
The peaks at 14.9 and 16.9 degrees 2-theta ± 0.2 degrees 2-theta overlap with the 15.1 and 17.0 degrees 2-theta ± 0.2 degrees 2-theta required by the instant crystalline form; however, crystalline form 1 of the prior art does not possess a peak at 7.8 degrees 2-theta ± 0.2 degrees 2-theta.
Regarding crystalline form 3, the prior art reports (paragraph [0051]):
Crystalline Form 3 of Tavapadon may be further characterized by an X-ray powder diffraction pattern having peaks at 8.1, 8.6, 13.1, 14.1 and 15.8 degrees 2-theta± 0.2 degrees 2-theta, and also having any one, two, three, four or five additional peaks selected from 16.3, 18.6, 20.5, 21.6 and 22.5 degrees 2-theta ± 0.2 degrees 2-theta.
The peak at 8.1 degrees 2-theta ± 0.2 degrees 2-theta overlaps with the 7.8 degrees 2-theta ± 0.2 degrees 2-theta required by the instant crystalline form; however, crystalline form 1 of the prior art does not possess at peaks at 15.1 and 17.0 degrees 2-theta ± 0.2 degrees 2-theta.
Crystalline form 5 of the prior art is characterized by “an X-ray powder diffraction pattern having peaks at 8.5, 13.4, 16.4, 20.9 and 22.5 degrees 2-theta ± 0.2 degrees 2-theta, and also having any one, two, three, four or five additional peaks selected from 7.7, 14.0, 14.8, 21.8 and 23.1 degrees 2-theta ± 0.2 degrees 2-theta” (paragraph [0058]). The secondary peaks at 7.7 and 14.8 degrees 2-theta ± 0.2 degrees 2-theta overlap with the peaks at 7.8 and 15.1 degrees 2-theta ± 0.2 degrees 2-theta required by the instant claims. Crystalline form 5 does not possess a peak at 17.0 degrees 2-theta ± 0.2 degrees 2-theta.
Crystalline form R1 of (±)-Tavapadon possesses “an X-ray powder diffraction pattern having peaks at 8.5, 11.8, 15.0, 18.5 and 20.1 degrees 2-theta ± 0.2 degrees 2-theta, and also having any one, two, three, four or five additional peaks selected from 9.4, 15.8, 17.5, 20.8 and 23.6 degrees 2-theta ± 0.2 degrees 2-theta” (paragraph [0071]). The peak at 15.0 degrees 2-theta ± 0.2 degrees 2-theta overlaps with the peaks at 15.1 degrees 2-theta ± 0.2 degrees 2-theta required by the instant claims. Crystalline form 5 does not possess a peak at 17.0 degrees 2-theta ± 0.2 degrees 2-theta. However, crystalline form R1 of the prior art does not possess at peaks at 7.8 and 17.0 degrees 2-theta ± 0.2 degrees 2-theta.
Przeczkova et al. provide no motivation or guidance for modifying the method of preparing the crystals in a manner that would produce crystalline forms of (-)-Tavapadon with each of the peaks at 7.8, 15.1, and 17.0 degrees 2-theta ± 0.2 degrees 2-theta with a reasonable expectation of success. For this reason, the prior art neither anticipates nor renders obvious the instant claims.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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