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 the Claims
Claims 5 – 8 and 11 – 21 are pending.
Claims 5 – 7 are rejected.
Claim 21 is objected.
Claims 8 and 11 – 20 are withdrawn.
Response to Applicant’s Remarks
Applicant’s remarks filed on April 15, 2026 have been fully considered.
The objections to claims 5 – 7 and 21 are withdrawn in view of amendments to correct all the issues in the claims.
The objections to claims 11 – 12 and 14 are withdrawn in view of withdrawal of said claims.
The rejection under 35 U.S.C. §112(b) of claims 5 – 7 and 21 is withdrawn in view of amendments to recite proper antecedent basis in claim 5.
Regarding the rejection under 35 U.S.C. §112(b) of claims 6 – 7, Applicant amended to recite the limitation “the acid for step b)” in claim 6. The rejection is partially withdrawn because Applicant did not amend the claim or present any remarks with respect to the limitation “the cyclisation reaction”.
The rejection under 35 U.S.C. §112(b) of claims 11 – 14 is withdrawn in view of amendments to withdraw the claims from examination.
Regarding the rejection under 35 U.S.C. §102(a)(2) of claims 5 and 7, Applicant’s remarks have been considered and addressed below:
On page 18, 2nd – 4th paragraphs, Applicant state that Example 1 of Reddy et al. describes a synthetic process for preparing Tafamidis meglumine salt, but does not disclose the claimed solid form (Form-4) of Formula I. Further, Reddy et al. do not disclose the specific solid-state form (Form-4), its XRPD data, thermal data (DSC/TGA), polymorph designation in relation to claimed Form-4. Reddy et al. teach the process for the preparation of Tafamidis meglumine salt and not isolating Tafamidis Form-4. Applicant further note that the claimed process does not involve the azeotropic distillation and does not use toluene, the process is simple heating and isolation by adding suitable solvent. Applicant assert that Examiner relies on inherency because the reference does not provide any teaching or suggestion that Form-4 is inevitably formed or is the only possible outcome. Thus, inherency is not established.
In response to applicant's argument that Reddy et al. fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., specific solid-state form (Form-4), its XRPD data, thermal data (DSC/TGA), polymorph designation in relation to claimed Form-4) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, Applicant’s arguments rely on language solely recited in preamble recitations in the claim. When reading the preamble in the context of the entire claim, the recitation “for the preparation of Form-4 of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole of formula (I)” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. The claims also do not recite specific limitations such as XRPD data, thermal data (DSC/TGA), or polymorph designation in order to sufficiently identify, isolate or reproduce the claimed Form-4. Thus, Applicant’s arguments are not persuasive and the rejection is maintained.
Claim Objections
Claims 5, 7 and 21 are objected to because of the following informalities:
Claim 5:
Line 2 of the claim: The structure of the compound, 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole of formula (I), is blurry and not legible. In order to overcome the objection, Applicant may amend to increase the size and clarity of the structure of formula (I).
Line 11 of the claim: The limitation “… phosphoric acid, polyphosphoric acid, or a combination thereof” is grammatically incorrect because it does not recite proper conjunction “and” for the claimed group of alternatives in the combination. In order to overcome the objection, Applicant may amend the limitation as follows: “… phosphoric acid, and polyphosphoric acid, or a combination thereof”.
Line 15 of the claim: The limitation “… phosphoric acid, polyphosphoric acid, or a combination thereof” is grammatically incorrect because it does not recite proper conjunction “and” for the claimed group of alternatives in the combination. In order to overcome the objection, Applicant may amend the limitation as follows: “… phosphoric acid, and polyphosphoric acid, or a combination thereof”.
Claim 7:
Line 5 of the claim: The structure of the compound, 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole meglumine salt of Formula (IA), is blurry and not legible. In order to overcome the objection, Applicant may amend to increase the size and clarity of the structure of Formula (IA).
Claim 21 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.
Appropriate correction is required.
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.
Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 6 recites the limitation “the cyclisation reaction”. See, line 2 of the claim. However, claim 5 or 6 do not establish the basis of said limitations. It is unclear whether Applicant regards step b) of claim 5 as the cyclisation reaction, or if there is another interpretation for said limitation. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rathnakar Reddy et al. WO 2021/019448 A1 (effect. filed August 1, 2019).
With respect to claim 5, Rathnakar Reddy et al. teach a process of Example 1 for the preparation of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole, comprising adding methanesulfonic acid to a reaction mixture comprising a starting compound, 4-[(3,5-Dichlorobenzoyl)amino]-3-hydroxybenzoic acid (instant formula (V)). The reaction mixture is co-distilled with toluene (solvent in step c) in the instant claims) at 106 °C. The process further comprises adding isopropanol to the reaction mixture, heated, filtered, washed with isopropanol and dried to obtain the final product, Tafamidis meglumine (meglumine salt of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole). See, e.g., page 12, paragraphs 1-2).
With respect to claim 7, Rathnakar Reddy et al. also teach a process of Example 3 for converting Tafamidis (6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole in the instant claims) and isolating a solid form of potassium salt of Tafamidis. See, e.g., bridging paragraph between pages 12-13.
Thus, the prior art Rathnakar Reddy et al. WO 2021/019448 A1 anticipates the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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