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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 10, 21, 23-24, 26, 33 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Mead et al. in view of Shaabani et al.
Mead et al. teaches oral administration of S[+] apomorphine for treating ALS in mice (p. 444-446; Supplementary Table 3
PNG
media_image1.png
488
630
media_image1.png
Greyscale
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.
Mead et al. does not teach wherein the half-life is at least about 2 hours after oral administration to a mammal or wherein the at least one pharmaceutically acceptable excipient is sodium carboxymethyl cellulose.
Shaabani et al. teaches CMC as capable of “controlled drug release” (abstract) and “CMC is most commonly used” (p. 21). Routine use of CMC in oral dosage forms is described at pp. 24-27. It is clear that CMC-Na is a routinely used excipient in oral dosage forms with predictable effects on pharmacokinetic parameters. Accordingly, given that Mead et al. teaches oral dosing of S-apomorphine, it would have been obvious to incorporate CMC-Na into an oral dosage form and an increased half-life as claimed would naturally flow from the teachings of the prior art. Furthermore, said increase would have been expected because it is known in controlled drug release systems and 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. With respect to claims 1, 10, 21, 26 and 46, the values lie within those taught by Mead et al. The pharmacokinetic parameters recited in instant claims 23-24 and 33 not explicitly taught by the prior art would necessarily flow from the teachings of the prior art. 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 in view of Shaabani et al.
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 issued claims do not teach wherein the half-life is at least about 2 hours after oral administration to a mammal or wherein the at least one pharmaceutically acceptable excipient is sodium carboxymethyl cellulose.
Shaabani et al. teaches CMC as capable of “controlled drug release” (abstract) and “CMC is most commonly used” (p. 21). Routine use of CMC in oral dosage forms is described at pp. 24-27. It is clear that CMC-Na is a routinely used excipient in oral dosage forms with predictable effects on pharmacokinetic parameters. Accordingly, given that the issued claims teach oral dosing of S-apomorphine, it would have been obvious to incorporate CMC-Na into an oral dosage form and an increased half-life as claimed would naturally flow from the teachings of the prior art. Furthermore, said increase would have been expected because it is known in controlled drug release systems and 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. The pharmacokinetic parameters recited not explicitly taught by the prior art would necessarily flow from the teachings of the prior art. Furthermore, there is nothing to suggest that the instantly claimed parameters are critical. 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 85-103 of copending Application No. 17/286,797 (reference application) in view of Shaabani et al.
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 copending claims do not teach wherein the half-life is at least about 2 hours after oral administration to a mammal or wherein the at least one pharmaceutically acceptable excipient is sodium carboxymethyl cellulose.
Shaabani et al. teaches CMC as capable of “controlled drug release” (abstract) and “CMC is most commonly used” (p. 21). Routine use of CMC in oral dosage forms is described at pp. 24-27. It is clear that CMC-Na is a routinely used excipient in oral dosage forms with predictable effects on pharmacokinetic parameters. Accordingly, given that the copending claims teach oral dosing of S-apomorphine, it would have been obvious to incorporate CMC-Na into an oral dosage form and an increased half-life as claimed would naturally flow from the teachings of the prior art. Furthermore, said increase would have been expected because it is known in controlled drug release systems and 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. The pharmacokinetic parameters recited not explicitly taught by the prior art would necessarily flow from the teachings of the prior art. Furthermore, there is nothing to suggest that the instantly claimed parameters are critical.
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, 4, 8, 11-13, 16, 19-21 and 24 of copending Application No. 17/633,143 (reference application) in view of Shaabani et al.
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.
The copending claims do not teach wherein the half-life is at least about 2 hours after oral administration to a mammal or wherein the at least one pharmaceutically acceptable excipient is sodium carboxymethyl cellulose.
Shaabani et al. teaches CMC as capable of “controlled drug release” (abstract) and “CMC is most commonly used” (p. 21). Routine use of CMC in dosage forms is described at pp. 24-27. It is clear that CMC-Na is a routinely used excipient in dosage forms with predictable effects on pharmacokinetic parameters. Accordingly, given that the copending claims are drawn to dosage forms of S-apomorphine, it would have been obvious to incorporate CMC-Na into a dosage form and an increased half-life as claimed would naturally flow from the teachings of the prior art. Furthermore, said increase would have been expected because it is known in controlled drug release systems and 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. The pharmacokinetic parameters recited not explicitly taught by the prior art would necessarily flow from the teachings of the prior art. Furthermore, there is nothing to suggest that the instantly claimed parameters are critical. 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see pp. 5-6, filed 12/23/2026, with respect to the rejection under 35 U.S.C. 102 have been fully considered and are persuasive. Amendments moot the rejection. The rejection of 11/24/2025 has been withdrawn.
Applicant's arguments filed 12/23/2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding half-life are not persuasive as they would naturally flow from the teachings of the prior art. The inclusion of CMC-Na in an oral dosage form is obvious. See modified rejection under 35 U.S.C. 103 supra. With respect to the assertion that Mead teaches away from oral-dosing, oral PK parameters are taught and that various PK data are only taught for non-oral dosing cannot be considered to teach away from oral dosing when oral dosing is clearly taught. With respect to the double patenting rejections, modified rejections are presented supra.
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.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights