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 .
DETAILED ACTION
Status of the Claims
Claims 1-4, 12-13, 20, 23-27, and 55-62 are pending and are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement filed on January 17th 2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Nonstatutory 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 1-4, 13, 23-27, and 55-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,145,899. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compounds within the instant compound genus, as well as the treatment/prevention of identical diseases and disorders.
The instant claims are directed towards a compound of Formula I:
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The reference patent teaches the following compound, which is within the genus of claims 1-2 and 13:
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Regarding clams 3 and 4, directed to the compound of claim 2, wherein R6 is either
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or
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the compound of the reference patent differs from these two compounds only in the chirality of the R6 group. However, each of the compounds of claim 3 and 4 represent 50% of the particular compound space occupied (i.e. the deuterium in the R6 location must be in either the right-hand or left-hand configuration). As such, the reference compound must necessarily be either in the form described by claim 3 or 4. Furthermore, as there are only two possible configurations, one of ordinary skill in the art would have found the selection of either one of the two configurations obvious to try. See MPEP §2143(I)(E).
Regarding claims 23-27, and 55-62, directed towards pharmaceutical compositions comprising the compounds, kits comprising the compounds, and methods of treating/preventing lysosomal storage disorders, migraines, vertigo, restless leg syndrome, and improving mobility and cognitive function, each of these further limitations is taught by the reference patent (reference patent, claims 3-20).
Subject Matter Free of the Art
Claims 12 and 20 are free of the art.
Claim 12 is directed towards the compound of Formula I:
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wherein any 3 of R3, R4, R5, or R6 are deuterium.
Claim 20 limits the compound of claim 1 to:
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As described below, the compound of Formula I, is only found in applicant’s own U.S. Patent No. 12,145,899, and the particular deuteration patterns would not be predictable from the art due to the compounds’ superior activity in treating lysosomal storage disorders.
However, U.S. Patent No. 12,145,899 teaches neither the case in which 3 of of R3, R4, R5, or R6 are deuterium, nor the particular deuterium substitution pattern of claim 20.
Claims 12 and 20 are 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.
Relevant Art
Deuterated forms of acetyl leucine have been demonstrated in the art before, such as in Oba (Oba et al., J. Org. Chem. 2001, 66, 17, 5919–5922):
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Applicant’s particular deuterated forms are not found in the art outside of the cited patent above. Additionally, Oba does not teach the treatment of lysosomal storage disorders.
Strupp (WO 2018/029658 A1 published on February 15th 2018) teaches the treatment of lysosomal storage disorders with acetyl leucine (Strupp, pg. 86, claim 3). While there may exist a case for obviousness for the treatment of lysosomal storage disorders with a general deuterated form of acetyl leucine, applicant’s deuterated forms have shown superior results that could not have been predicted from the art.
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(Figure 1)
The significant decrease in fluorescence activity for applicant’s deuterated form, in comparison to the non-deuterated N-acetyl-DL-leucine, as measured by a LysoTracker corresponds to a decrease in acidic compartment volume of the lysosome, and in essence, treatment of lysosomal storage disorders1. This is not predicted from the art and is a demonstration of results that one of ordinary skill in the art would not and could not predict.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
1For example, see te Vruchte et al: te Vruchte et al., Relative acidic compartment volume as a lysosomal storage disorder-associated biomarker. J Clin Invest. 2014 Mar;124(3):1320-8
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