DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This is a Final Office Action.
Election/Restrictions
Applicant's election, without traverse, of Group (I) in the reply filed on May 30, 2023 is acknowledged. Group (I), drawn to compounds in claims 47 and 48, pyrrolo[2,3-d]pyrimidines and pyrrolo[2,3-b]pyridines, and compositions thereof, embraced by claims 47, 48, 61 and 78 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species:
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and indicated claims 47, 61-64, 76 and 77 read on said species.
Claims 47 and 61 are pending and under examination.
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.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 9464088.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘088 patent, which is shown below on the left-side, is similar to the presently claimed compound on page 21, lines 21-22, see also bottom right structure. The only differences between the compounds are: a) the substitution of the fluorine atom on the pyridine ring, 5-fluoro versus Applicant’s 5-chloro; and b) 6-CF3 versus Applicant’s 2-CF3.
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a) MPEP 2144.09 states, “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)… and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). The replacement of a chlorine with fluorine atom is obvious since said atoms are halogens and are considered equivalent.
b) Since these compounds are positional isomers, the compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
The claims in the ‘088 are drawn to methods of inhibiting JAK activity and treating specific diseases, which is the same utility instantly disclosed.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9999619 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘619 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 2 in the ‘619 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘619 patent are drawn to methods of treating graft versus host disease, which is presently disclosed.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10695337 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘337 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 2 in the ‘337 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘337 patent are drawn to methods of treating a skin disorder, which is presently disclosed.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11285140 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘140 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 2 in the ‘140 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘140 patent are drawn to methods of treating graft versus host disease, which is presently disclosed.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 9655854 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘854 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 29 in the ‘854 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘854 patent are drawn to methods of treating psoriasis, rheumatoid arthritis, primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis, which is presently disclosed, with a sustained release dosage of 400 to 600 mg. The present application teaches the compositions may be a sustained release composition, see page 84, line 9 and the dosage is taught on page 84, lines 30-31.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5-11, 19-25 and 29-31 of U.S. Patent No. 10064866 in view of Lannutti et al. (Blood, 2009, 114(22), pp. 1-2, abstract 286). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘866 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. The claims in the ‘866 patent are drawn to methods of treating diffuse large B-cell lymphoma, which is presently disclosed, in combination with a PI3K inhibitor.
Lannutti et al. teaches PI3K inhibitors as treatments for B cell malignancies, see abstract. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. That is, generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11324749 in view of ClinicalTrials.gov, < https://clinicaltrials.gov/ct2/show/NCT00227591>, downloaded 5/15/2024) and further in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘749 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 3 in the ‘749 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘749 patent are drawn to methods of treating leukemia, lymphoma and multiple myeloma, which is presently disclosed. In the ‘749, claims are drawn to an additional therapeutic agent, i.e., chemotherapeutic agent, lenalidomide; and corticosteroid (predinisone). The combination of two known chemotherapeutic agents is obvious. It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Thus, combining them flows logically from having been individually taught in the prior art. Moreover, the ClinicalTrials reference provides motivation to combine lenalidomide and prednisone.
Claims 47 and 61 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11406640 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘640 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 19 in the ‘640 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘640 patent are drawn to methods of treating lung allograft dysfunction, a method of reducing the risk of bronchiolitis obliterans syndrome, a method of reducing the risk of lung re-transplantation, and a method of reducing the risk of hospitalization diagnosed with bronchiolitis obliterans syndrome or a lung transplantation. The present application teaches suppression of the immune and inflammatory pathways, see page 3.
Claims 47 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11992490 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘490 application patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 4 in the ‘490 application is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘490 application are drawn to a method of treating cutaneous lupus erythematous (CLE). The specification teaches treating lupus, see page 72.
Claims 47 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11918581 in view of Berge et al. (Journal of Pharmaceutical Sciences, 1977, 66(1), pp. 1-19) and Mannon, R. B. (American Journal of Transplantation, 2006, 6, pp. 867-875). Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘581 patent is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. Claim 2 in the ‘581 patent is drawn to an adipic acid salt, which Berge et al. teach adipate as a non-FDA approved commercially marketed salt, see page 3, Table II. The claims in the ‘581 patent are drawn to a method of treating graft versus host, restrictive allograft syndrome, and chronic lung allograft dysfunction. The specification teaches treating these conditions, see page 72.
Mannon teaches the use of a ROCK inhibitor to treat kidney allografts, where the fibrogenic cascade outlined may have similar applicability to other transplanted organs, see page 868, top left paragraph. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. That is, generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069.
PROVISIONAL REJECTIONS
Claims 47 and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 12-19 of copending Application No. 17556374 in view of Raza (Microscopy Research and Technique, 2000, 50, pp. 229-235).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the species in claim 1 of the ‘374 application is similar to the presently claimed compound on page 21, the penultimate species listed. See the NSDP rejection over U.S. 9464088, where the same compounds are cited and the same motivation rationale applies here. The claims in the ‘374 application are drawn to a method of treating myelodysplastic syndrome with a selective JAK 1 inhibitor. The specification teaches treating CMML, see page 74.
Claims 12-18 of the ‘374 teach an additional therapeutic agent, e.g., anti-TNF alpha agent. Raza teaches anti-TNF alpha agents treat myelodysplastic syndromes, see abstract. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. That is, generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached on Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624