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 .
Current Status of 18/020,980
This Office Action is responsive to the amended claims and Applicant remarks of 04/08/2026. Claims 1 and 6-25 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2020/047196, filed 20 August 2020, which claims priority to U.S. Provisional Application No. 63/066,105, filed 14 August 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/08/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Double Patenting Rejections:
17/431,460: Applicants allege that there are insufficient reasons for the artisan to arrive at the instantly claimed tablet compositions comprising the specific compounds and organic acids of the claims. Applicants contend that ‘460’s compound of Formula (III) would need to be limited to specific variables and then combined with one of the specifically claimed organic acids to form a tablet composition. The claimed compounds are not expressly disclosed in the reference. The rejection is withdrawn.
Applicants further argue that the claimed table compositions exhibit unexpected results based on the alleged improved stability of the compositions comprising an organic acid, citing Example 2 of the instant application. This argument is not persuasive. Applicants have overstated the significance of the data because the reported stability tests fail to provide a direct comparison under the same conditions.
In the first stability test, the HCl salt of Compound 2 was evaluated at 50°C, 80°C, and 100°C, and purity was measured after 8 hours. No relative humidity was reported. In the second example, a physical mixture of the free base form of Compound 2 and fumaric acid was evaluated at 40°C and 75% relative humidity for two weeks and was then evaluated for purity. The two tests differ in the form of Compound 2 evaluated, the acid present, the tested temperatures, the humidity conditions, and the duration of exposure.
The test do not isolate the effect of using an organic acid instead of an inorganic acid and do not establish the alleged superior stability improvement. To support such an assertion, Applicant would need to provide a comparison where the HCl containing composition and the organic acid composition are evaluated under the same stability conditions. Accordingly, Applicants have failed to provide a reasonable showing of unexpected results.
17/764,329: Applicants allege that the amendments to the rejected claims to recited specific compounds and organic acids render them distinct from the ‘329 application. The claimed compounds are not expressly disclosed in the reference. The rejection is withdrawn.
U.S. Patent No. 12,086,788: Applicants allege that the amendments to the rejected claims to recited specific compounds and organic acids render them distinct from the ‘788 patent. The claimed compounds are not expressly disclosed in the reference. The rejection is withdrawn.
U.S. Patent No. 11,501,284: Applicants allege that the amendments to the rejected claims to recited specific compounds and organic acids render them distinct from the ‘284 patent. The claimed compounds are not expressly disclosed in the reference. The rejection is withdrawn.
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 7-10 and 18-25 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 term “about” in claims 7-10 and 18-25 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “about” is used to define the claimed numerical ranges that define components of the claimed compositions without a clear definition of the term. Accordingly, the claims fail to clearly define the metes and bounds of the claimed ranges, rendering the scope of the claims indeterminate to the artisan.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “wherein the weight ratio of the compound of Formula (I) to the fumaric acid is from about 1:5 to about 5:1”, and the claim also recites the same weight ratio “is from about 1:4 to about 4:1, from about 1:3 to about 3:1, from about 1:2 to about 2:1, from about 1:1.5 to about 1.5:1, about 1:1; about 1:1.1, about 1:1.2, about 1:1.25, about 1:1.3, about, 1:1.4, or about 1:1.5” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “wherein the compound of Formula (I) free base content in the tablet is from about 5 mg to about 500 mg”, and the claim also recites “from about 10 mg to about 250 mg, from about 20 mg to about 100 mg” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “wherein the fumaric acid content in the tablet composition is from about 5 wt.% to about 50 wt.%:, and the claim also recites “from about 5 wt.% to about 40 wt.%, from about 5 wt.% to about 30 wt.%, from about 10 wt.% to about 30 wt.%, from about 20 wt.% to about 25 wt.%, from about 5 wt.% to about 15 wt.%, or from about 10 wt.% to about 15 wt.%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Allowable Subject Matter
The closest prior art is U.S. Patent No. 12,637, 467, which is commonly owned by the Applicants of the instant application. ‘467 teaches compounds of Formulas (III) and (IV) with the following structures
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. The reference also teaches pharmaceutical compositions comprising these compounds (Claim 6). Page 39 of the ‘467 specification discloses that it is within the scope of the present application to convert the compounds of the present application into pharmaceutically acceptable salt with various organic and inorganic acids. A broad list of suitable organic acids are presented on page 39. A narrower aspect of the pharmaceutically acceptable salts is listed in the final paragraph of page 40 and includes acetate, fumarate, citrate, succinate, and tartrate which correspond to the claimed organic acids. Claim 6 of the ‘467 patent discloses pharmaceutical compositions comprising the compounds of Formula (III). The specification expressly teaches that, for oral administration, suitable oral formulations include tablets (pg. 42-43, first para). The reference therefore teaches tablets comprising the compounds of Formula (III).
While the ‘467 discloses tablet pharmaceutical compositions comprising similar compounds and the claimed organic acids, the reference fails to provide a teaching or suggestion that would guide the artisan to arrive at the specifically claimed compounds of instant claim 1. Without this guidance, the artisan would be unable to arrive at the instantly claimed compounds without undue experimentation. The claimed tablet compositions are therefore novel and non-obvious in view of the prior art of record.
Conclusion
Claims 1, 6, and 11-17 are allowed.
Claims 7-10 and 18-25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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