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. DETAILED ACTION Claims 1-21 are pending in the application. Claims 1- 7 and 9- 21 are rejected. Claim 8 is objected to. Priority This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/EP2022/066945 , filed June 22 nd , 2022 , which claims priority under 35 U.S.C. 119(a-d) to EP21181009.8 , filed June 22 nd , 2021 . Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. Information Disclosure Statement The Examiner has considered the Information Disclosure Statement(s) filed on February 16 th , 2026 and December 22 nd , 2023 . Claim Objections Claim 14 does not end in a period. Claim Rejections - 35 USC § 112(b) 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 appl icant regards as his invention. Claims 1- 7 and 9- 21 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. 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 1 recites the broad recitation “ at approximately (°2θ) at about 2θ”, and the claim also recites “±0.2 degrees” 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. Dependent claims 2- 7 and 9- 21 are rejected as indefinite for the same reason since they do not clarify the issue and where claims 2-6 and 13 recite analogous language using only “approximately” instead of both “approximately” and “about”. Claim 15 is rejected as indefinite for the same reason as discussed above since it recites both the term “about” and an explicit variation of ±2°C. The term “ essentially similar ” in claim s 7 and 11 is a relative term which renders the claim indefinite. The term “ essentially similar ” 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. While a person having ordinary skill in the can use XRPD patterns and 13C NMR spectra to identify materials, it is unclear how claims 7 and 11 are different from this normal practice that would appear to be embraced by claims 8 and 12, respectively . 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 16 recites the broad recitation “the range of from 2:1.2 to 2:0.8,” and the claim also recites “preferably is approximately 2:1” which is the narrower statement of the range/limitation, and claim 17 recites the broad recitation “the range from 1:0.8 to 1:1.2,” and the claim also recites “preferably is approximately 1:1” 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. Claim 14 is rejected because it refers to table 1 of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola , 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)” Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 recites that “the forms of urticaria include” certain subtypes; however, “include” is an open-ended transitional phrase. See MPEP 2111.03(I) . Accordingly, claim 20 is only reciting (1) subtypes already within the genus of the parent claim but not excluding others (resulting in a claim identical in scope to its parent claim) or (2) subtypes outside the genus of the parent claim (resulting in a claim broader in scope than its parent claim). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites that “subtypes include” a certain condition; however, “include” is an open-ended transitional phrase. See MPEP 2111.03(I) . Accordingly, claim 21 is only reciting (1) a condition already within the genus of the parent claim but not excluding others (resulting in a claim identical in scope to its parent claim) or (2) a condition outside the genus of the parent claim (resulting in a claim broader in scope than its parent claim). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Allowable Subject Matter Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art is U.S. Patent PGPub No. 2014/0315888 A1 by Ho et al. , which discloses salts of the same base compound, such as the following tartrate salt on page 90: . The prior art generally teaches that succinate salts can be prepared on page 7 (paragraph [0206]). The prior art, however, fails to teach or suggest methods that would yield a hemisuccinate monohydrate with a reasonable expectation success, let alone one that would necessarily having the propert y required by instant claim 1. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MATTHEW P COUGHLIN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1311 . 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Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW P COUGHLIN/ Primary Examiner, Art Unit 1626