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 Claims
Claims 135-154 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement 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 135-156 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-12, 15, 17 and 19-24 of U.S. Patent No. 11,434,247 B1 (hereafter referred to as “Bookser”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Bookser claim the same compounds that are required for the method of treatment of the instant claims, and because Bookser’s claim 19 claims a method that anticipates instant claim 135.
Instant claim 135 is drawn to a method of enhancing memory in a subject with a cognitive disorder, comprising administering to the subject an effective amount of a compound or pharmaceutically acceptable salt thereof, selected from the group consisting of:
• 6-methyl-4-[(l-methylcyclopropyl)amino]-N-(1H-pyrrol-2-ylmethyl)furo[2,3-d]pyrimidine-5-carboxamide (hereafter referred to as “compound 98”)1;
• N-[(2-fluorophenyl)methyl]-6-methyl-4-[(l-methylcyclopropyl)amino]furo[2,3-d]pyrimidine-5-carboxamide (hereafter referred to as “compound 218”)2;
• 6-methyl-N-[(5-methyl-1,3-oxazol-2-yl)methyl]-4-[(1-methylcyclopropyl)amino]furo[2,3-d]pyrimidine-5-carboxamide (hereafter referred to as “compound 448”)3;
• N-[(6-methoxypyrimidin-4-yl)methyl]-6-methyl-4-[(l-methylcyclopropyl)amino]furo[2,3-d]pyrimidine-5-carboxamide (hereafter referred to as “compound 666”)4.
Instant claims 136-139 further limit claim 135, each to a specific compound or a pharmaceutically acceptable salt thereof to be administered, the compound for each of claims 136, 137, 138 and 139 being compound 98, 218, 448 or 666, respectively.
Instant claims 140, 142, 144 and 146 further limit claims 136-139, respectively, to wherein the cognitive disorder is Parkinson’s disease.
Instant claims 141, 143, 145 and 147 further limit claims 140, 142, 144 and 146, respectively, to wherein the cognitive disorder is Parkinson’s disease with mild cognitive impairment (PD-MCI).
Instant claim 148 is drawn to a method of treating a dyskinetic disorder associated with Parkinson’s disease, comprising administering to a subject in need thereof an effective amount of a compound, or pharmaceutically acceptable salt thereof, selected from the group consisting of compounds 98, 218, 448 and 666.
Instant claims 149-151 further limit claim 148, each to a specific compound or a pharmaceutically acceptable salt thereof to be administered, the compound for each of claims 149, 150, and 151 being compound 218, 448 or 666, respectively.
Instant claims 152-154 further limit claims 149-151, respectively, to wherein the dyskinetic disorder is levodopa.
Bookser’s claim 1 claims a genus of furopyrimidinecarboxamide compounds that encompasses instant compounds 98, 218, 448 and 666.
Bookser’s claims 2-5, 12 and 15 further limit claim 1, each to a narrower genus of compounds that continues to encompass instant compounds 98, 218, 448 and 666.
Bookser’s claim 8 further limits claim 1 to a narrower genus of compounds that continues to encompass instant compound 218.
Bookser’s claim 9 further limits claim 1 to a narrower genus of compounds that continues to encompass instant compounds 98, 448 and 666.
Bookser’s claim 10 further limits claim 1 to a narrower genus of compounds that continues to encompass instant compound 666.
Bookser’s claim 11 further limits claim 1 to a narrower genus of compounds that continues to encompass instant compounds 98 and 448.
Bookser’s claim 17 claims a Markush group of specific compounds that includes, by name, compounds 98 (Col. 402, lines 49-50), 218 (Col. 403, lines 48-50), 448 (Col. 405, lines 10-12) and 666 (Col. 409, lines 50-52).
Bookser’s claim 19 claims a method of enhancing memory in a subject in need thereof, comprising administering to the subject an effective amount of a compound of claim 1.
Bookser’s claim 20 further limits claim 17 to a smaller Markush group that continues to includes compounds 98 and 218.
Bookser’s claim 21 further limits claim 17 to a smaller Markush group that continues to includes compound 448.
Bookser’s claim 22 further limits claim 17 to a smaller Markush group that continues to includes compound 666.
Bookser’s claim 23 further limits claim 21 to the specific compound 448.
Bookser’s claim 24 further limits claim 22 to the specific compound 666.
Claims 135-147 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,006,325 B2 (hereafter referred to as “Dart Neuroscience”. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Dart Neuroscience anticipate the instant claims.
The limitations of claims 135-147 are discussed in the rejection above and hereby incorporated into the instant rejection.
Dart Neuroscience’s claim 1 is drawn to a pharmaceutical composition comprising a compound selected from a Markush group that includes compounds 98 and 218. Claim 2 further limits claim 1 to wherein the compound is compound 98.
Dart Neuroscience’s claim 3 is drawn to a pharmaceutical composition comprising a compound selected from a Markush group that includes compound 448. Claim 4 further limits claim 3 to wherein the compound is compound 448.
Dart Neuroscience’s claim 5 is drawn to a pharmaceutical composition comprising a compound selected from a Markush group that includes compound 666. Claim 6 further limits claim 5 to wherein the compound is compound 666.
Dart Neuroscience’s claim 7 further limits claim 2 to a method of enhancing memory in a subject with a cognitive disorder, comprising administering a composition according to claim 2. Claim 8 further limits claim 7 to wherein the cognitive disorder is Parkinson’s disease. Claim 13 further limits claim 8 to wherein the disorder is Parkinson’s disease with mild cognitive impairment (PD-MCI).
Dart Neuroscience’s claim 9 further limits claim 4 to a method of enhancing memory in a subject with a cognitive disorder, comprising administering a composition according to claim 4. Claim 10 further limits claim 9 to wherein the cognitive disorder is Parkinson’s disease. Claim 14 further limits claim 10 to wherein the disorder is Parkinson’s disease with mild cognitive impairment (PD-MCI).
Dart Neuroscience’s claim 11 further limits claim 6 to a method of enhancing memory in a subject with a cognitive disorder, comprising administering a composition according to claim 6. Claim 12 further limits claim 11 to wherein the cognitive disorder is Parkinson’s disease. Claim 16 further limits claim 12 to wherein the cognitive disorder is Parkinson’s disease with mild cognitive impairment (PD-MCI).
Dart Neuroscience’s claim 15 further limits claim 5 to a method of enhancing memory in a subject with a cognitive disorder, comprising administering a composition according to claim 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 This compound is designated “Example 98” in the instant Specification – see page 178, lines 9-10.
2 This compound is designated “Example 218” in the instant Specification – see page 217, lines 14-15.
3 This compound is designated “Example 448” in the instant Specification – see page 293, lines 13-14.
4 This compound is designated “Example 666” in the instant Specification – see page 362, lines 14-15.
Prosecution Insights