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 Application
This Office Action is in response to applicant’s arguments filed on 5/28/26. Claims 1-18, 21, 23-27, 29-32, 36-37 have been cancelled. Claims 19-20, 22, 28, 33-35, 38 are pending. Claims 19, 28, 33-35 have been amended. Claims 19-20, 22, 28, 33-35, 38 are examined herein.
Applicant’s amendments have rendered the 112 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with regard to the remaining rejections have been fully considered but found not persuasive, therefore maintained for reasons of record and repeated below for Applicant’s convenience.
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.
Claims 19-20, 22, 28, 33-35, 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,512,656. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating JNCL by orally administering miglustat and trehalose.
Claims 19-20, 22, 28, 33-35, 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,083,741. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating JNCL by orally administering miglustat and trehalose.
Response to Arguments
Applicant argues that the referenced claims do not recite the efficacy of oral miglustat alone and without trehalose.
This is not persuasive because the instant claims do not specifically preclude the administration with trehalose.
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 19-20, 22, 28, 33-35, 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sardiello et al. (WO 2017/185010, of record).
Sardiello et al. teach a method of treating lysosomal storage disorder and disorders characterized by lysosomal dysfunction by administering a composition comprising the protein kinase B inhibitor, trehalose, with the trehalase inhibitor, miglustat (abstract and claims 1-7). The term lysosomal storage disorder and disorders characterized by lysosomal dysfunction includes JNCL, juvenile Batten, or CLN3 disease (paragraph 000122). Trehalose can be administered parenterally at a dose of between 0.1 to 1 g/kg and completed within less than 120 minutes (paragraph 0008), wherein the dosage range may be less than 0.54 g/kg/day (paragraph 000139) and the dosage time administered within less than 90 minutes (paragraph 000141). The frequency of dosing can be once a week (paragraph 000145). Miglustat can be administered at a dose of 100, 200, 300, 400 or 500 mg (paragraph 00080). The frequency of dosing may be once, twice, three times or more per day (paragraph 000145). Oral, parenteral, and intravenous administration is taught, for example in a capsule, along with a pharmaceutically acceptable carrier (paragraphs 000102-000103). Figure 30 shows the effect of the active agents on neuronal cell death in Batten mice, specifically preventing neuronal cell death (paragraph 000157 and Example 4). Neuroinflammation is taught to be mitigated (paragraphs 000188 and 000201). Microglial activation is also taught (paragraphs 00035 and 000188).
It is noted that the limitation regarding “reducing ganglioside accumulation” is considered a mechanism of action that will necessarily occur in vivo since the same claimed active agents are being administered to the same claimed patient population.
Response to Arguments
Applicant argues that Sardiello et al. does not teach that miglustat is specifically orally administered.
This is not persuasive because the Sardiello et al. clearly teach, in general, that oral administration, for example in a capsule (paragraphs 000102-000103). Therefore, one of ordinary skill in the art could have readily envisioned orally administering miglustat from the teachings of Sardiello et al.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam 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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/Yong S. Chong/Primary Examiner, Art Unit 1623
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