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 2-21 are pending in the current application.
2. This application is a CON of 18/153,947 01/12/2023 PAT 12,134,606; 18/153,947 is a DIV of 17/672,086 02/15/2022 PAT 11,572,350; 17/672,086 is a CON of PCT/EP2021/084081 12/03/2021.
Obviousness type 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.
3. Claims 2-4, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,572,350. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims have all the claimed compounds in claim 2. Claim 2 patent claim only differs from claim 2 by the two compounds on col. 129 lines 62-67 and has the other 30 compounds in claim 2. Claim 3 contains these two compounds appear in instant claim 3 along with a subset of additional compounds of claim 2. These two compounds along with the E isomer are the subject of the additional ‘350 patent claims.
4. Claims 5-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,134,606. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 5-10 is drawn to treating viral hepatitis, which appears in the patent claim 1 list of diseases on line 37 col 110. According to the patent specification col. 6 line 5-51, “viral hepatitis (including hepatitis A, hepatitis B, hepatitis C, hepatitis D and hepatitis E);”. In a similar manner the cholestatic liver disease of claim 11 is listed in patent 2. The specific progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), biliary atresia, and non-alcoholic steatohepatitis (NASH) are listed in claims 3-6. The itchy patent is described in claim 7 while primary biliary cirrhosis (PBC) appears in claim 1. With regard tot claim 19, the specification col. 9 line 17-18 explains decreasing bile acids is a consequence of the treatments, “In some embodiments, the treatment of biliary atresia decreases the level of serum bile acids in the subject.” “In some embodiments, the treatment of NASH decreases the level of serum bile acids in the subject.” Col. 40 lines 43-44. This is also supported by the data on col. 102.
5. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,180,465 (cited on the IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because while being broader the claims of the ‘465 patent are drawn to the claimed compounds in the genus of claim 1 where R2 is F or H, R3 is alkylthio, R1 is C4 alkyl, R6 is H, R5 is carboxyl and R 4 is H. Each of these sub definitions is pointed to directly by the dependent claims 3-8 which essentially define the instantly claimed compounds. In addition, all of the instantly claimed species are listed in claims 9 and 18. Regarding the methods of claims 5-21, these methods are disclosed in the ‘465 patent specification at column 11 line 52 to column 12 line 46 as well as column 14 lines 44 ff. This disclosure in the specification makes the method obvious over the compound claims; 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 and as such the safe harbor provision of 35 U.S.C 121 does not apply to this relationship.
6. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,708,340 (cited on the IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because while being somewhat broader the claims of the ‘340 patent are drawn to the same methods with the same compounds. The genus of claim 1 where R2 is F or H, R3 is alkylthio, R1 is C4 alkyl, R6 is H, R5 is carboxyl and R 4 is H describes the claimed methods. Each of these sub definitions is pointed to directly by the dependent claims 10-16 which define the instantly claimed compounds. In addition, all of the instantly claimed species are listed in claim 17. One could not practice the claimed method without the instantly claimed compounds.
7. Claims 2-21 re rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. 12,202,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the patent claims are the same as the instant claims. Claims 1-10 are drawn to the species of claim 1-4 and the claims 12-17 are drawn to methods of treating hepatitis which is a listed liver diseases in claim 5-10. Moreover the method of the instant claims 12-121 is disclosed in the specification of the ‘809 patent and such a disclosure in the specification makes the additional method obvious over the compound claims 1-10; 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 patent and as such the safe harbor provision of 35 U.S.C 121 does not apply to this relationship.
8. Claims 2-21, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-36 of copending Application No. 18/974,438. Although the claims at issue are not identical, they are not patentably distinct from each other because while being broader the claims of the ‘438 patent application are drawn to the claimed compounds in the genus of claim 18-21 where R2 is F or H, R3 is alkylthio, R1 is alkyl, and R4 is H or F. This genus subsumes all the claimed species. The methods of 22-36 are the same and use the species of the instant claims 2-3 in claims 35-36.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
9. 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.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
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