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 Office action is responsive to Applicant’s amendment and remarks, filed 08 Dec 2025, in which claim 9 is amended to change the scope and breadth of the claim, and claims 13-16 are canceled.
This application is the national stage entry of PCT/IB2021/058935, filed 29 Sep 2021; and claims benefit as a CON of 17/039,483, filed 30 Sep 2020, issued as PAT 11,446,325.
Claims 9-12 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 08 Dec 2025, with respect that claims 9-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as not being enabling for the full scope of the claim has been fully considered and is persuasive, as claims 13-16 are canceled, and amended claim 9 does not specifically recite prevention of a lysosomal neurodegenerative disease.
This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 08 Dec 2025, with respect that claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over McKew et al. (US 2015/0216895, published 06 Aug 2015, of record) in view of Kennedy et al. (US 2018/0371110, published 27 Dec 2018, provided by Applicant in IDS filed 29 March 2023) and Matencio et al. (International Journal of Pharmaceutics, 2020, 584, article 119440, 4 pages, Available online 16 May 2020, of record) has been fully considered and is persuasive, as amended claim 9 does not specifically recite prevention of a lysosomal neurodegenerative disease, and Applicant’s remarks are persuasive that the teachings of the prior art would not have led one of ordinary skill in the art to combine McKew et al. in view of Kennedy et al. and Matencio et al. in a manner that arrives at the method of the claimed invention with a reasonable expectation of success.
Further, Palanca et al. (Int. J. Med. Sci., 2013, 10(10), p1278-1285, cited in PTO-892) teaches clinically relevant sugammadex (SUG) concentrations cause apoptotic/necrosis neuron death in primary cultures. Studies on the underlying mechanism revealed that sugammadex-induced activation of mitochondria-dependent apoptosis associates with depletion of neuronal cholesterol levels (page 1278, abstract). While SUG exhibits a very low transfer across the blood-brain barrier (BBB), different neurodegenerative conditions imply moderate or severe alterations of the BBB integrity. Under these clinical conditions, SUG may cross the BBB in specific areas, leading to potential SUG-induced neuronal toxicity (page 1279, left column, paragraph 2). However, cholesterol accumulation may be a double edge sword since, as other reports suggest, excessive accumulation of cholesterol in mitochondria may be a key step in promoting e.g. Alzheimer disease progression (page 1284, right column, paragraph 2). The potential association of SUG-induced alteration in cholesterol homeostasis with oxidative stress and apoptosis activation represents new research windows that deserve further studies (page 1284, right column, paragraph 3).
Upon reconsideration of all factors, the teachings of McKew et al. in view of Kennedy et al. and Matencio et al. and further in view of Palanca et al. suggest an invitation for further studies or research, and does not suggest that one of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable or predictable expectation of success to modify the method of McKew et al. with the teachings of Kennedy et al., Matencio et al., and Palanca et al. to arrive at the claimed method.
This rejection has been withdrawn.
Applicant’s remarks, filed 08 Dec 2025, with respect that claims 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,446,325 has been fully considered and is persuasive, as Applicant’s remarks are persuasive that the original patent is surrendered and ceases to exist because the reissue application has issued as a reissue patent.
This rejection has been withdrawn.
The following are modified grounds of rejection necessitated by Applicant’s amendment, filed 08 Dec 2025, in which claim 9 is amended to change the scope and breadth of the claim, and claims 13-16 are canceled.
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.
Amended Claims 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. RE50534.
RE50534 is a reissue of U.S. Patent No. 11,446,325.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-4 of the patent recite a method for the treatment of Niemann Pick disease, which comprises administering an effective amount of a S-(carboxyalkyl)thio-cyclodextrin or a pharmaceutically applicable salt thereof to a patient in need thereof. Reference claims 2-4 recite limitations of the cyclodextrin administered, meeting limitations of claims 10-12, respectively. Niemann Pick disease is known to be a lysosomal neurodegenerative disease as evidenced by McKew et al. (US 2015/0216895, published 06 Aug 2015, of record) as detailed in the previous Office action. The invention of reference claims 1-4 is fully encompassed within the scope of claims 10-12, and renders claims 10-12 unpatentable under an anticipation-type analysis.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 08 Dec 2025, have been fully considered and not found to be persuasive.
Applicant notes the change in scope of the amended claims. However, reference claims 1-4 are drawn to treatment of Niemann Pick disease, a lysosomal neurodegenerative disease, comprising administering an effective amount of the same compounds, meeting all limitations of the claimed invention as amended. Therefore the reference claims 1-4 render the amended claims 9-12 unpatentable.
As no terminal disclaimer is recorded, it is proper to maintain this modified rejection.
Conclusion
No claim is currently in condition for allowance.
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.
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/JONATHAN S LAU/Primary Examiner, Art Unit 1693