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
1. Claims 12-20 are pending in the current application.
2. This application is a CON of 18/145,315 12/22/2022 ABN; 18/145,315 is a CON of 17/108,066 12/01/2020 PAT 11578087; 17/108,066 is a CON of 16/580,676 09/24/2019 PAT 10882872; 16/580,676 is a CON of 15/590,159 05/09/2017 PAT 10562921 15/590,159 has PRO 62/335,565 05/12/2016.
Claim Objections
3. Claim 12 is objected to because of the following informalities: Claim 12 does not end in a period. Appropriate correction is required.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
4. Claims 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 13-14, 17-19, 22 of U.S. Patent No. 10,562,921. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of claims 12-14 is listed as the first compound in claims 14 and 18 and 3rd compound in claim 13, in racemic form, and the last compound in claim 18 as the single isomer, and the compound in claim 17 and 22. The structure VII-c in claim 10 is the small genus encompassing this compound. At least for the species claim, 12, the only distinction over the patent claim 17 is the pharmaceutical salt language. The ‘921 patent does not have a composition claim per se, however it would be obvious to formulate the compound in a composition for delivery of the drug. Claims 18-19, 22 have the same Chagas disease treatments as instant claims 15-20.
5. Claims 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 13 of U.S. Patent No. 10,882,872. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of claims 12-14 are listed as the last compound in claim 1 and 6, and the compound in claim 5, and 13. The only distinction over the patent claim 5 is the pharmaceutical salt language. The ‘872 patent does not have a composition claim per se, however it would be obvious to formulate the compound in a composition for delivery of the drug. Claims 6-8, 13 have the same Chagas disease treatments, t. cruzi, as instant claims 15-20.
6. Claims 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-11 of U.S. Patent No. 11,578,087. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of claims 12-14 are listed a in claims 10 and 11. The structure VII-c in claim 7 is the small genus encompassing this compound. The ‘087 patent does not have a composition claim per se, however it would be obvious to formulate the compound in a composition for delivery of the drug. With regard to the method claims 15-20, they are disclosed in the specification of the ‘087 patent, see col. 33 lines 4 ff. Such a disclosure in the specification makes the method obvious over the compound claim 80; see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). As per MPEP 804 II. (B) (2) (a): “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” In Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003), the earlier patent claimed a compound and the written description disclosed the utility of that compound. The later patent claimed nothing more than the earlier patent’s disclosed utility as a method of using the compound. Thus, the court found that the claims of the later patent and the claims of the earlier patent were not patentably distinct. The instant application is not related to the application as a divisional as such the safe harbor provision of 35 U.S.C 121 does not apply to this relationship.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. 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 for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/DAVID K O'DELL/Primary Examiner, Art Unit 1621
Prosecution Insights