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. Status of Claims Claims 1-6, 23, 39-41, 62, 95-96, 110-115, and 119 are pending. Priority Instant application 18/021,238 , filed 02/14/2023 claims priority as follows: Information Disclosure Statement All references from IDS(s) received 02/14/2023 have been considered unless marked with a strikethrough. Election/Restrictions Applicant's election with traverse of Group I, claims 1-6, in the reply filed on 12/01/2025 is acknowledged. The traversal is on the ground(s) that Group I and Group III are linked so as to form a single general inventive concept. Particularly, applicant alleges that Group I and Group III are linked by the general inventive concept of specific, well-characterized crystalline polymorphic forms of erdafitinib formate , which applicant argues represent a patentable contribution over the art. This is not found persuasive because Group I and Group III are only linked by their recitation of erdafitinib formate , which is not necessarily a crystalline or specific polymorphic form. As set forth in the rejection of claim 1 under 102 below, erdafitinib formate does not represent a contribution over the prior art. Therefore, the technical feature linking Group I and Group III (erdafitinib formate ) does not represent a special technical feature. The requirement is still deemed proper and is therefore made FINAL. Claims 23, 39-41, 62, 95-96, 110-115, and 119 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/01/2025. Claim Objections Applicant is advised that should claim 3 or 5 be found allowable, claim 4 or 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 3 recites “ The Erdafitinib formate according to Claim 2 , designated Form B ”. Please note that the term “ F orm B ” is being interpreted in light of the Specification as referring to a crystal form of erdafitinib which necessarily comprises all of the characteristics disclosed for solid F orm B in the specification, including, but not limited to the XRPD pattern of Fig. 2. The person having ordinary skill recognizes that a single solid form of a compound ( e.g. , Form B) is a unique substance with characteristics that are necessarily present in that substance. The as-filed specification discloses in Example 2 the “Preparation of Form B of Erdafitinib Formate ” (page 32). The obtained substance designated “Form B” was analyzed by XRPD and the pattern is shown in Figure 2. Therefore, while claim 3 recites only four characteristic XRPD peaks, “ F orm B ” recited by claim 3 is considered to necessarily comprise the additional characteristic features recited in claim 4 . Therefore, claim 4 is a substantial duplicate of claim 3 . The same rationale applies to claim 6, which fails to further limit claim 5, which designates Form D. See also the rejection under 112(d) further below. In the interest of compact prosecution , the objection would be withdrawn if the phrase “designated Form B” was removed from claim 3; and if the phrase “designated Form D” was removed from claim 5. Claim Rejections - 35 USC § 112 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 s 4 and 6 are 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 3 recites “ The Erdafitinib formate according to Claim 2 , designated Form B ”. Please note that the term “ F orm B ” is being interpreted in light of the Specification as referring to a crystal form of erdafitinib which necessarily comprises all of the characteristics disclosed for solid F orm B in the specification, including, but not limited to the XRPD pattern of Fig. 2. The person having ordinary skill recognizes that a single solid form of a compound ( e.g. , Form B) is a unique substance with characteristics that are necessarily present in that substance. The as-filed specification discloses in Example 2 the “Preparation of Form B of Erdafitinib Formate ” (page 32). The obtained substance designated “Form B” was analyzed by XRPD and the pattern is shown in Figure 2. Therefore, while claim 3 recites only four characteristic XRPD peaks, the recitation of “ F orm B ” in claim 3 is considered to necessarily require the additional characteristic features recited in claim 4 . Therefore, claim 4 fails to further limit claim 3 . The same rationale applies to claim 6 , which fails to further limit claim 5, which designates Form D. 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. In the interest of compact prosecution , the rejection would be withdrawn if the phrase “designated Form B” was removed from claim 3; and if the phrase “designated Form D” was removed from claim 5. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Elawady et al. ( Microchemical Journal , vol. 154, May 2020, p. 104555 ) as evidenced by Domotor et al. ( European Journal of Pharmaceutical Sciences , vol. 192, Jan. 2024, p. 106651 ) . Elawady discloses erdafitinib formate . In particular, Elawady discloses the separation of erdafitinib (“ERD”) and antipyrine using an acetonitrile/ammonium formate /formic acid solution at pH 3.2 (page 2, “Chromatographic and mass spectrometric conditions”). Domotor is relied upon as evidence that erdafitinib has a pK a (HL + ) of 9.10 (page 3, Table 1). Therefore, a solution of erdafitinib in a n acetonitrile/ formic acid/ammonium formate solution at pH 3.2 would contain erdafitinib formate . Accordingly, claim 1 is anticipated by Elawady . 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Oruganti et al. ( WO 2020208592 A1 ; cited in IDS ) in view of Black et al. ( Journal of Pharmaceutical Sciences , vol. 96, no. 5, May 2007, pp. 1053–68 ). Oruganti discloses a process for the preparation of erdafitinib, its purification and amorphous solid dispersion (title, abstract). In particular, Oruganti discloses (page 4, “seventh embodiment”) a process using acid addition salts of erdafitinib formed with organic acids for the purification of erdafitinib, comprising: reacting crude erdafitinib with an organic acid in a suitable solvent to provide acid addition salt of Erdafitinib; and converting acid addition salt of Erdafitinib obtained from step a) to Erdafitinib by conventional methods. Oruganti states that the inventors observed that an impurity (“impurity A”) was not reduced in significant content when using hydrochloride salt of erdafitinib (page 16, 2 nd para. from bottom). However, the impurity A was “reduced significantly when acid addition salt of erdafitinib formed with organic acids was used for the purification process” (page 16, 2 nd para. from bottom). Oruganti contemplates that erdafitinib acid addition salts may be formed with a “ wide variety of organic acids ” (page 17, 5 th para.). Oruganti does not disclose using formic acid. However, a person having ordinary skill would have recognized formic acid as an “organic acid” contemplated by Oruganti . For example, see Black et al. which is drawn to the screening of pharmaceutical salts and identifies 25 anions which give a distribution of charge and stereochemistry across the range of acidic counter-ions “used regularly in the pharmaceutical industry” (page 1054, right side, “Molecular considerations”; and Table 1). Note that formic acid is listed in table 1 amongst the carboxylic acids acetic, benzoic, salicylic, and trichloroacetic. Finding of prima facie obviousness The Supreme Court in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143. Examples of rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Applying KSR example rationale (B) and/or (G), it would have been prima facie obvious to prepare the formate salt of erdafitinib (which is an organic acid addition salt) in order to purify erdatifinib as taught by Oruganti . A person having ordinary skill would have reasonably predicted that the formate salt of erdafitinib could have been used to purify erdafitinib in view of Oruganti’s teaching that impurity A was “reduced significantly when acid addition salt of erdafitinib formed with organic acids was used for the purification process”. The acid addition of salts of Erdafitinib formed with organic acids have an advantage over acid addition of salts of Erdafitinib formed with inorganic acid like hydrochloric acid. Further, in view of Black’s teaching that formic acid is used regularly in the pharmaceutical industry, a person having ordinary skill would have been motivated to select formic acid as an “organic acid” for Oruganti’s process. Therefore, claim 1 is obvious over Oruganti in view of Black. With respect to claim 2, Oruganti teaches that the precipitated salt of erdafitinib formed with organic acid may be isolated and dried by common techniques known in the literature (page 18, lines 2-3). Crystallinity is an advantage of salt forms of pharmaceuticals (see e.g. Black, “salts may offer advantages over the corresponding free acid or base in terms of physical properties such as…crystallinity). Crystallization is a common purification technique available to the person of ordinary skill in the art of organic synthesis. See page 10, wherein Oruganti states “the erdafitinib obtained may be optionally further purified by recrystallization or by slurrying it in a suitable solvent or by column chromatography or any other suitable technique”. Applying KSR example rationale (G), it would have therefore been prima facie obvious to purify the erdafitinib formate salt by crystallization to obtain crystalline erdafitinib formate in view of Oruganti’s teaching that the precipitated salt of erdafitinib formed with organic acid may be isolated and dried by common techniques known in the literature. Therefore, claim 2 is obvious over Oruganti in view of Black. Allowable Subject Matter Claims 3 and 5 are 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. Conclusion Claims 1, 2, 4, and 6 are rejected. Claims 3 and 5 are objected to. Claims 23, 39-41, 62, 95-96, 110-115, and 119 are withdrawn . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kyle Nottingham whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0640 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F from 10:00 am - 6:00 pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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