Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The office acknowledges Applicants’ filing of the claims dated 7/23/2024. Claims 1-15 are pending and are examined based on the merits herein.
Application Priority
This application filed 07/23/2024 is a Con of 18062911, filed 12/07/2022, is a Continuation of 17029151, filed 09/23/2020, now US 11524935, 17029151 is a Continuation of 16225893, filed 12/19/2018, 16225893 is a Continuation of 15605278 , filed 05/25/2017, now US 10202335, 15605278 is a Continuation of 14495532 , filed 09/24/2014, now US 9663455, 14495532 is a Continuation of 13508147, filed 06/13/2012, now US 8895609, 13508147 is a National Stage entry of PCT/KR2010/007698, International Filing Date: 11/03/2010, PCT/KR2010/007698 Claims Priority from Provisional Application 61258780, filed 11/06/2009.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,895,609 (‘609).
The instant claim 1 is directed to:
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The dependent claims are limited to specific enantiomers, extent of enantiomers in the mixture, specific stereoisomers of compound of formula I, and an additional ADHD agent in the method.
‘609 reference claims are to:
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The dependent claims 2-13 are limited to specific enantiomers, extent of enantiomers in the mixture, specific stereoisomers of compound of formula I.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the reference claims use a compound of formula I (e.g. wherein R, R1 and R2 are H and x=1) in a method of treating attention deficit hyperactivity disorder (ADHD). Further the elected compound O-carbamoyl phenyl alaninol ((R)-(beta-amino-benzenepropyl) carbamate) has been claimed to treat ADHD. Thus instant claim 1 is obvious over the reference claim 1. The instant claims 2-14 directed to the use of different enantiomers and specific stereoisomer of the elected compound in treating ADHD are addressed by the reference claims 2-13.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. 9,663,455 (‘455).
The instant claims as discussed above.
‘455 reference claims are to a method of diminishing symptoms associated with ADHD or treating ADHD administering a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof, to a mammal in need of treatment:
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The method claim 14 of the reference patent is to a method of treating ADHD with the compounds of formula I. The dependent claims 2-13, 15-26 are limited to specific enantiomers, extent of enantiomers in the mixture, specific stereoisomers of compound of formula I.
The instant claim 1 would have been obvious over the reference claims because the patent claims compounds of formula I for use in diminishing symptoms of ADHD or treating ADHD. Further the compound O-carbamoyl phenyl alaninol ((R)-(beta-amino-benzenepropyl) carbamate) is one of the compounds of formula I of the reference claims (claims 5, 8 18, 21). The instant claims 2-14 directed to the use of different enantiomers and specific stereoisomer of O-carbamoyl phenyl alaninol in treating ADHD are addressed by the reference claims 2-13, 15-26.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. 10,202,335 (‘335).
The instant claims as above.
‘335 reference claim 1 is directed to:
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The dependent claims 2-10 are limited to specific enantiomers, extent of enantiomers in the mixture, specific stereoisomers of compound of formula I.
The instant claim 1 would have been obvious over the reference claims because they teach compounds of formula I for treating ADHD. Further the reference claims teach the compound O-carbamoyl phenyl alaninol ((R)-(beta-amino-benzenepropyl carbamate) to treat ADHD. The instant claims 2-14 directed to the use of different enantiomers and specific stereoisomer of O-carbamoyl phenyl alaninol in treating ADHD are addressed by the reference claims 2-10.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. 11,524,935 (‘935).
The instant claims as above.
‘935 reference claims are directed to:
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The dependent claims are limited to specific compounds (R=H, X=1; or R, R1, R2=H, X=1) (claims 2-3) and to specific enantiomers, extent of enantiomers in the mixture, extent of enantiomers in the mixture, specific stereoisomers of compound of formula I.
The instant claim 1 would have been obvious over the reference claims because they teach compounds of formula I in treating ADHD. Further taught is O-carbamoyl phenyl alaninol ((R)-(beta-amino-benzenepropyl carbamate) to treat ADHD. The instant claims 2-14 directed to the use of different enantiomers and specific stereoisomer of the elected compound in treating ADHD are addressed by the reference claims 2-16.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-12, 22-36 of US 10829443 (‘443) or claims 1-8 of US 11560354 (‘354) or claims 1-6 of US 12384743 (‘743).
The instant method claims as above.
‘443 reference claims are directed to a composition comprising (R)-2-amino-3-phenylpropyl carbamate hydrochloride and for treating attention deficit/hyperactivity disorder by administering the composition to the subject. The composition dosage forms include tablet, capsule.
‘354 reference claims are directed to a composition comprising (R)-2-amino-3-phenylpropyl carbamate hydrochloride and for treating attention deficit/hyperactivity disorder by administering the composition to the subject. The composition dosage forms include tablet, capsule.
‘743 reference claims are directed to crystalline (R)-2-amino-3-phenylpropyl carbamate hydrochloride having an X-ray powder diffraction pattern as shown in FIG. 1 Form A, its HCl salt and its use in treating ADHD.
The instantly claimed method would have been obvious over the reference claims because they teach the composition comprising (R)-2-amino-3-phenylpropyl carbamate hydrochloride (the salt) in a method of treating ADHD. As to the therapeutically effective amount limitation, it is noted that the reference method claim teaches treating ADHD. Thus the amount administered in the method is therapeutically effective. As to the pharmaceutically acceptable carrier, the reference claims teach a composition that comprises the active agent and a carrier in a dosage form, e.g. tablet. Thus claim 1 would have been obvious over the reference claims. As to claims 2-14, it is noted that the reference claims teaches using the enantiomer (R)-2-amino-3-phenylpropyl carbamate hydrochloride in ADHD treatment. Hence a skilled artisan would have found it obvious to use specific enantiomers, extent of enantiomers in the mixture, extent of enantiomers in the mixture, specific stereoisomers of compound as it is routine in the art to use other enantiomers and in specific ratios in expectation of achieving similar or better therapeutic effects.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,895,609 (‘609) or claims 1-26 of U.S. 9,663,455 (‘455) or claims 1-10 of U.S. 10,202,335 (‘335) or claims 1-16 of U.S. 11,524,935 (‘935) or claims 8-12, 22-36 of US 10829443 (‘443) or claims 1-8 of US 11560354 (‘354) or claims 1-6 of US 12384743 (‘743) in view of Spencer et al. (J Clin Psychiatry, 2004, 65, p 22-26).
The instant claim 15 requires one other therapeutic agent in the same composition in the method of treating ADHD.
The reference patent(s) do not teach the additional agent for ADHD treatment. ‘
Spencer disclose pharmacological treatments aimed towards the treatment of ADHD in adolescents and adults that include methylphenidate, desipramine, monoamine oxidase inhibitors etc. (See Abstract, p 23-25).
A person skilled in the art would have found it obvious to add additional therapeutic agent for e.g. methylphenidate in the ADHD treatment as a combination therapy to attain additive or synergistic benefits. A person skilled in the art would have found it obvious to add additional therapeutic agent in the same composition is to administer the agents effectively, for better patient compliance. One of ordinary skill in the art would have found it obvious to incorporate the active agents herein in a single combination pharmaceutical composition because combining the agents herein each of which is known to be useful to treat ADHD individually into a single composition useful for the very same purpose is prima facie obvious. See In re Kerkhoven 205 USPQ 1069. Thus claim 15 would have been obvious over the reference claims and Spencer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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