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 .
Priority
This application is a national stage application under 35 U.S. C. § 371 of International
Application No. PCT/IN2022/050166, filed 02/25/2022, which claims the priority benefit of
INDIA Application No. 202121008622, filed 03/01/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/29/2024 was filed in
compliance with the provisions of 3 7 CFR 1. 97. Accordingly, the information disclosure
statements are being considered by the examiner.
Election/Restrictions
Claims 26-31 are allowable. Claims 32-44, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions groups I , II and III, as set forth in the Office action mailed on 12/29/2025, is hereby withdrawn and claims 32-44 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of claims
Claims 26-44 are pending and currently under examination. Claims 1-25 have been cancelled by applicant without prejudice or disclaimer. New claims 26-44 have been added. New claims 32-44 withdrawn from examination by applicant in the reply dated 06/16/2026 to incorporate the restriction dated 12/29/2025 have been rejoined as disclosed above.
Applicant’s arguments, filed 06/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Specification
The use of the term Vyndamax, Vyndaqel, (pg. 2), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 29 is objected to because of the following informalities: sub bullets are missing from the 3 different claim limitations. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claims limitation “b)” uses a comma “,” at the end of the limitation which can be interpreted to mean applicant intended to add further limitations to “b)” and should be changed to a semi-colon --;-- for clarity of the record. Appropriate correction is required.
Claim 44 is objected to because of the following informalities: The preamble of claim 44 is missing the term “of” or “for” between “method” and “treating” in line 1 of the instant claim. 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.
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 39-43 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 39 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claim 39 as written contains 2 sentences wherein the 1st sentence ends with a period at the end of limitation d) and the second sentence “wherein the process is carried out without isolating a tafamidis salt from the tafamidis salt solution” appears afterwards. This rejection may be overcome by amending the claim language to one sentence form. Claims 40-43 are rejected for being dependent on claim 39 and therefore suffer from the same rejection.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Applicants compound of a crystalline Form C1 of 2-(3,5-Dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid commonly known as "Tafamidis" with a XRPD diffractogram with characteristics peaks at 5.48, 6.44, 7.51, 9.57, 11.80, 13.65, 18.51 and 20.53 ± 0.2° 2θ or with peaks at 16.24, 19.36, 23.68 and 27.55 ± 0.2° 2θ makes a contribution over the closest prior art of Matecic (WO2020232325Al). Matecic teaches crystalline forms of tafamidis (2-(3,5-dichlorophenyl)-l,3-benzoxazole-6-carboxylic acid) and methods of forming various crystal forms [00108]-[00133]. However, Matecic does not fairly teach or suggest to one of ordinary skill the specific 2θ angles disclosed by the applicant nor the methods of preparing the specific crystalline forms. Therefore, the disclosures of instant claims 26-28, 30-31, and 33-38 of the instant application are found free of the art as of the current record.
Conclusion
Claims 26-28, 30-31, and 33-38 are allowable, claims 29, 32, and 44 are objected to, and claims 39-43 are rejected.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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