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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/18/2023 and 07/01/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and oral administration in the reply filed on 07/01/2025 is acknowledged.
Claims 4, 7, 11, 18, 28-30, 40, 42, 44 and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/01/2025.
Claim Rejections - 35 USC §§ 102 or 103
Claims 1, 10, 21, 23-24, 26, 33 and 46 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Mead et al. (2013).
Mead et al. teaches oral administration of S[+] apomorphine for treating ALS in mice (p. 444-446; Supplementary Table 3
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The t1/2 is 0.78 hours, the Tmax is 0.25 hours, the Cmax is 168.24 ng/ml, the oral bioavailability is 13.46%, and the AUClast/Cmax ratio is 186.80/168.24 = 1.11. These values lie within the ranges of claims 1, 10, 21, 26 and 46, respectively. A skilled artisan would understand that the compound would necessarily be administered with a pharmaceutical excipient, i.e. in a liquid carrier or gelatin capsule. Alternatively, administration with an excipient is at once envisaged by a person of skill in the art. The pharmacokinetic parameters recited in instant claims 23-24 and 33 not explicitly taught by the prior art are considered inherent to the administration taught by Mead et al. Accordingly, claims 1, 10, 21, 23-24, 26, 33 and 46 are anticipated.
Assuming, arguendo, the prior art is interpreted not to anticipate the instantly claimed excipient and pharmacokinetic parameters for reasons supra, the claims would have still been obvious. It would have been prima facie obvious to a skilled artisan for an oral dosage form to include an excipient such as a liquid carrier (i.e. water or saline) or a gelatin capsule in order to deliver the API to the subject. Furthermore, even if it is argued that the pharmacokinetic parameters are not necessarily present, there is a reasonable expectation of success that the prior art composition would exhibit the claimed pharmacokinetic parameters. This is particularly true given that the various pharmacokinetic parameters which are recited by the prior art lie within the ranges claimed. Furthermore, PK parameters are optimization of PK properties is routine and such can be done via methods known to one of skill in the art, i.e., modification of dosage forms. Furthermore, there is nothing to suggest that the instantly claimed parameters are critical. Accordingly, claims 1, 10, 21, 23-24, 26, 33 and 46 are obvious.
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, 10, 21, 23-24, 26, 33 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,459,301. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 18 of the issued patent is drawn to a method of treating ALS with S-apomorphine and a pharmaceutical excipient. Claim 12 recites oral administration. The instant claims are at once envisaged in view of said teachings and the pharmacokinetic parameters are inherent and/or obvious. See rejection under 102/103 supra for rationale which applies in equal or greater force to the issued claims. The utility of the product claims is disclosed by the specification therefore rendering the instant claims obvious. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
Claims 1, 10, 21, 23-24, 26, 33 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75 and 85-91 of copending Application No. 17/286,797 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to treatment of neurodegenerative diseases with S-apomorphine. Claim 87 is directed to oral administration. Claim 88 is directed to a pharmaceutical composition comprising S-apomorphine and at least one pharmaceutically acceptable excipient. Claim 91 is directed to a human subject. The instant claims are at once envisaged in view of said teachings and the pharmacokinetic parameters are inherent and/or obvious. See rejection under 102/103 supra for rationale which applies in equal or greater force to the issued claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 10, 21, 23-24, 26, 33 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-4, 7-8, 11-13, 16-21 and 24-26 of copending Application No. 17/633,143 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a pharmaceutical composition comprising S-apomorphine and an excipient. Mead et al. (2013) teaches use of S-apomorphine in treating neurodegenerative disorders such as ALS. See rejection under 102/103 supra. It would have been obvious to administer the composition taught by the copending application for the purpose of treating neurodegenerative disorders such as ALS given that Mead et al. teaches the API for said purpose. The pharmacokinetic parameters are inherent and/or obvious as a result of the combination of references. See rejection under 102/103 supra for rationale which applies in equal or greater force to the issued claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 10, 21, 23-24, 26, 33 and 46 are rejected.
Claims 4, 7, 11, 18, 28-30, 40, 42, 44 and 48 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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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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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623