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 .
This application is made special under Track I, granted January 27, 2026.
Election/Restrictions
Applicant's election with traverse of Group III (e.g. claims 21-30) in the reply filed on June 26, 2026 is acknowledged. The traversal is on the ground(s) that Group III necessarily encompasses Groups I and II, because:
any mixture of hydroxypropyl-β-cyclodextrins substituted with six to eleven and thirteen to fourteen hydroxypropyl groups as required in Group III would necessarily encompass the mixtures of hydroxypropyl-β-cyclodextrins substituted with eight to eleven and thirteen to fourteen hydroxypropyl groups required in Group I; and hydroxypropyl-β-cyclodextrins substituted with seven to eleven and thirteen to fourteen hydroxypropyl groups required in Group II. This is not found persuasive because Groups I, II and III are distinct products with materially different design each from the other as discussed in the restriction/election mailed April 28, 2026.
The Examiner also notes Applicant’s argument does not address said distinctions written within said restriction/election and thus the requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 26, 2026.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 01/13/2026 and 04/29/2026 have been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set filed December 16, 2025 has been entered.
Claims 1-20 are withdrawn from further consideration as being drawn to a nonelected invention as discussed above.
Thus, claims 21-30 are examined on the merits herein.
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.
Claims 21 and 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pitha et al. (Published March 1986, International Journal of Pharmaceutics, Vol. 29, Issue 1, pp. 73-82, IDS filed 01/13/2026).
Regarding claims 21 and 25-28, Pitha teaches the preparation and characterization of hydroxypropyl-β-cyclodextrin, see pg. 73, title.
Pitha teaches Fig. 1 depicted as,
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454
656
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, see pg. 76, Fig. 1.
The Examiner notes the mass spectrum of Fig. 1 teaches a composition comprising an isomerically purified hydroxypropyl-β-cyclodextrin prepared by Procedure C as the acetone-insoluble fraction, and where it was further noted an absence of any starting material was present within the product (e.g. no more than 10 ppb of propylene glycol, required in claim 26; and no more than 1 ppm of propylene oxide, required in claim 27), see pg. 76, Fig. 1.
The Examiner also notes Fig. 1 shows the counts channel of said spectrum showing said fraction comprising β-cyclodextrins substituted with 3-14 hydroxypropyl groups and an average degree of substitution of 8.02, e.g. the mixture required in claim 21.
The Examiner further notes Fig. 1 shows the fraction not comprising any unsubstituted β-cyclodextrin or β-cyclodextrin substituted with one hydroxypropyl group as required in claim 25.
Finally, the Examiner reasonably interprets the product of Pitha comprises 0 ppm chloride as required in claim 28 in view of the teachings of procedure C of Pitha, used to create the product of Fig. 1, as procedure C does not comprise a reactant containing chloride ions and uses distilled water within the procedure, see pg. 75, left column, procedure C, paragraph 1.
Accordingly, in view of the combined teachings as discussed above, Pitha anticipates the composition recited in claims 21 and 25-28.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(I) Claims 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 11-13, 26, and 30 of U.S. Patent No. 11,958,917 B2 (Applicant: Beren Therapeutics P.B.C., IDS filed 01/13/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising mixtures of isomerically-purified hydroxypropyl-β-cyclodextrin molecules.
Reference claim 1 recites a composition comprising a mixture of isomerically purified hydroxypropyl-β-cyclodextrin molecules, comprising β-cyclodextrin substituted with eight-fourteen hydroxypropyl groups; wherein the composition comprises less than 1% β-cyclodextrin substituted with seven hydroxypropyl groups; and wherein the composition comprises no more than 1 ppm propylene oxide.
Reference claim 2 recites the composition comprises less than 1% β-cyclodextrin substituted with one-six hydroxypropyl groups.
Reference claim 12 recites about 15% to about 21% of the hydroxypropyl substitutions in the hydroxypropyl-β-cyclodextrin molecules are located at the 3-O position.
Reference claim 13 recites about 79% to about 85% of the hydroxypropyl substitutions in the hydroxypropyl-β-cyclodextrin molecules are located at the 2-O position.
Accordingly, in view of the combined recitations within reference claims 12-13, the Examiner reasonably interprets that 0-6% of the hydroxypropyl substitutions in the hydroxypropyl-β-cyclodextrin molecules are located at the 6-O position as required in instant claim 30.
Reference claim 26 corresponds to instant claim 26.
Reference claim 30 corresponds to instant claim 28.
Reference claim 11 recites wherein the average degree of substitution of the mixture of isomerically purified hydroxypropyl-β-cyclodextrin is about 9 to about 10.
Although, ‘917 does not explicitly state said mixture (a) comprises less than 0.05% unsubstituted β-cyclodextrin, required in claim 25, line 1-2; and (b) has an average degree of substitution of about 7.5 to about 8.5 as required within instant claim 21, last line of the claim.
With respect to limitation (a), the Examiner notes reference claim 2 recites the composition comprises less than 1% β-cyclodextrin substituted with one-six hydroxypropyl groups. Therefore, in view of this recitation the Examiner reasonably interprets the composition comprises less than 1% unsubstituted β-cyclodextrin.
With respect to limitation (b), the ‘917 specification defines “about” as used within the disclosure to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint (see Col. 28, line 65- Col. 29, line 2).
Therefore, the Examiner reasonably interprets the composition as recited in reference claim 1 encompasses an average degree of substitution of about 8.5 as required in instant claim 21.
Accordingly, the Examiner notes the recitation of the reference claims as discussed above make obvious instant claims 21-30.
(II) Claims 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14, and 17-18 of U.S. Patent No. 12,215,174 B2 (Applicant: Beren Therapeutics P.B.C., IDS filed 01/13/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising mixtures of isomerically-purified hydroxypropyl-β-cyclodextrin molecules.
Reference claim 1 recites a composition comprising a mixture of isomerically-purified hydroxypropyl-β-cyclodextrin molecules comprising of β-cyclodextrin substituted with seven hydroxypropyl groups; and less than 1% of β-cyclodextrin substituted with five hydroxypropyl groups; and wherein the mixture has an average degree of substitution of 6.02-7.98.
Reference claim 2 recites the mixture comprises less than 1% β-cyclodextrin substituted with four hydroxypropyl groups.
Reference claim 3 recites the mixture comprises less than 1% β-cyclodextrin substituted with three hydroxypropyl groups.
Reference claim 4 recites the mixture comprises less than 0.05% unsubstituted β-cyclodextrin and less than 0.05% with one hydroxypropyl group.
Reference claims 5-11 recite the mixture comprises less than 1% β-cyclodextrin substituted with eight-fourteen hydroxypropyl groups respectively.
Reference claim 14 corresponds to instant claim 26.
Reference claim 17 corresponds to instant claim 27.
Reference claim 18 corresponds to instant claim 28.
Although, ‘174 does not explicitly recite the composition comprises β-cyclodextrin substituted with six hydroxypropyl groups as recited in instant claim 21, line 3. However, the Examiner notes reference claim 1 recites the mixture comprises β-cyclodextrin substituted with seven hydroxypropyl groups; and less than 1% of β-cyclodextrin substituted with five hydroxypropyl groups.
Accordingly, when said mixture includes an amount between 0-1% of β-cyclodextrin substituted with five hydroxypropyl groups as well as β-cyclodextrin substituted with seven hydroxypropyl groups as referenced above; the Examiner reasonably interprets said mixture also comprises β-cyclodextrin substituted with six hydroxypropyl groups as required by instant claim 21.
Accordingly, the Examiner notes the recitation of the reference claims as discussed above make obvious instant claims 21-28.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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