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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Regarding claim 32, Kamani’763 teach in Figure 1, an XRD pattern of ribociclib succinate form B of the prior art invention
PNG
media_image1.png
802
1005
media_image1.png
Greyscale
which is identical to the XRD instant claims XRD in Figure 2; thus Kamani’763 suggest that the prior art form B is the instant applications modification E. See column 3 lines 8 – 9. See claim 32 limitataion for a process of making riboclicib succinate crystalline form Modification E where the modification E exhibits an X-ray powder diffraction pattern substantially in accordnace with Figure 2
PNG
media_image2.png
600
1090
media_image2.png
Greyscale
. More specifically, Kamani’763 teach that the above XRD spectrum have characteristic peaks at 2θ 12.9o ±0.20o, 13.7o ±0.20o, 18.7o±0.20o , 19.9o ±0.20o, and 23.0o ±0.20o. See column 2 lines 54 – 58. Additionally, Kamani’763 teach that the purpose of preparing the crystalline form was to eliminate the health hazards associated with the use of excessive organic solvents in the conventional synthetic methods. See column 1 lines 40 – 42. Moreover, Kamani’763 teach that crystalline polymorphism in the active ingredient(s) of a pharmaceutical composition tends to compromise the storage stability, and hence efficacy, of the pharmaceutical composition. See column 1 lines 50 – 53. Likewise, Kamani’763 teach that the present invention can be prepared into any general dosage forms, including tablet, powder, capsule, suppository, suspension, liposome, and spray. See column 11 lines 24 – 26.
Furthermore, Kamani’763 teach a process of making Kamani’763 form B, that is examined modification E, where 7-cyclopentyl-N,N-dimethyl-2-{[ 5-(piperazin-1-yl)pyridin-2-yl]amino }-7H-pyrrolo [2,3-d]pyrimidine-6-carboxamide, that is ribociclib was added to an organic solvent which was heated to 80±5oC until completely dissolved to. See column 6 lines 45 – 47. See claim 32 limitation for a process of making riboclicib succinate crystalline form Modification E comprising the steps of: (b) providing a solution of free base of ribociclib in a second organic solvent at a third temperature ranging between about 60 °C and about 85 °C.
Next, Kamani’763 teach that to the solution of riboclicib slowly add a succinic acid-containing organic solvent into the solution, whose temperature is kept at 75±2°C. See column 6 lines 51 – 52. See claim 32 limitation for a process of making riboclicib succinate crystalline form Modification E comprising the steps of: (a) providing a solution of succinic acid in a first organic solvent at a second temperature ranging between about 70 °C and about 85 °C and (d) adding the solution of succinic acid to said crystallization vessel at a fourth temperature ranging between about 60 °C and about 85 °C.
Additionally, Kamani’763 teach that the solution is heated to 70±10° C. and stir for about 2 h, with or without crystal seeds before cooling the solution to 15±7° C. See column 6 lines 54 – 16. See claim 32 limitation for a process of making riboclicib succinate crystalline form Modification E comprising the steps of: (e) immediately after the addition in (d) is complete, adding seed crystals of pure Modification E to obtain a turbid mixture; (f) cooling the turbid mixture to a fifth temperature ranging between about 0 °C and about 20 °C to obtain Modification E.
Moreover, Kamani’763 teach that was subject to to suction filtration to obtain a filter cake, which is subsequently rinsed with an alcohol-based organic solvent and then dried at about 55±5° C to produce off-white solids, which are ribociclib succinate in crystalline form B. See column 6 lines 57 – 61. See claim 32 limitation for a process of making riboclicib succinate crystalline form Modification E comprising the steps of: (g) optionally separating Modification E from the mixture and optionally rinsing the filtered solid with an organic solvent; and (h) optionally drying Modification E obtained from step (g).
Regarding claim 32 limitation of step (c ) for a method where (c) transferring the solution of free base of ribociclib to a crystallization vessel and step (d) for a method where (d) adding the solution of succinic acid to said crystallization vessel at a fourth temperature ranging between about 60 °C and about 85 °C; while the prior art of Kamani’763 fails to explicitly teach step (c ) and (d) Kamani’763 does teach the core steps of combining the free base ribociclib solution and the succinic acid solution at 75± 2oC. Additionally, with regards to claim 32 limitation of step (e) where (e) immediately after the addition in (d) is complete, adding seed crystals of pure Modification E to obtain a turbid mixture; Kamani’763 does state that following the mixing the seed solution was added without stipulating a time where the solution is just stirring.
Given that there are two main ways to combine the free base ribociclib solution and the succinic acid solution which are either by adding the succinic acid solution to the free base ribociclib solution or by adding the free base ribociclib solution to the succinic acid solution it would have been prima facie obvious to one of ordinary skill in the art to pick either by adding the succinic acid solution to the free base ribociclib solution or by adding the free base ribociclib solution to the succinic acid solution. Additionally, the temperature taught by Kamani’763 of 75± 2oC and 80± 2oC fall within the temperature range of the instant application of about 60oC and about 85oC; a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)(MPEP 2144.05 (I)). Thus the prior art reference of Kamani’763 renders obvious the process of making of examined claim 32.
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.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6 of U.S. Patent No. US 12064434 B2 to Costa et. al. (Costa’434) in view of US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Costa’434 recite a coated tablet comprising ribociclib succinate and different components. See reference claim 1. Moreover, Costa’894 recite in subsequent dependent claims differing composition amounts for the tablet core. See reference claims 2 – 6.
However, Costa’434 fail to recite whether the ribociclib succinate is crystal form modification E made using the process of examined claim 32. See examined claim 32.
The teachings of Kimani’763 as they relate to the prior art rejection of examined claim 32 is given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the examined application to modify the invention of Costa’434 for a coated pharmacuitcal tablet comprising ribociclib succinate in view of Kimani’763, that is to use the crystal form modification E of ribociclib succinate prepared as recited above. One of ordinary skill in the art would have been motivated to make this modification to a maintain the storage stability, and efficacy, of the pharmaceutical composition. One of ordinary skill in the art would have had a reasonable expectation of success because the prior art established that the crystalline form can be prepared into any general dosage forms, including as a tablet.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4 of U.S. Patent No. US 12419894 B2 to Costa et. al. (Costa’894) in view of US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Costa’894 recite a coated tablet comprising ribociclib succinate and different components. See reference claims 1 and 3. Moreover, Costa’894 recite in subsequent dependent claims differing composition amounts for the tablet core. See reference claims 2 and 4.
However, Costa’894 fail to recite whether the ribociclib succinate is crystal form modification E made using the process of examined claim 32. See examined claim 32.
The teachings of Kimani’763 as they relate to the prior art rejection of examined claim 32 is given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the examined application to modify the invention of Costa’894 for a coated tablet comprising ribociclib succinate in view of Kimani’763, that is to use the crystal form modification E of ribociclib succinate prepared as recited above. One of ordinary skill in the art would have been motivated to make this modification to a maintain the storage stability, and efficacy, of the pharmaceutical composition. One of ordinary skill in the art would have had a reasonable expectation of success because the prior art established that the crystalline form can be prepared into any general dosage forms, including as a tablet.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of U.S. Patent No. US 10799506 B2 (Gururajan’506) in view of US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Gururajan’506 recite a coated pharmaceutical oral tablet comprising ribociclib succinate and different components. See reference claims 1 and 7. Moreover, Gururajan’506 recite in subsequent dependent claims differing composition amounts for the tablet core. See reference claims 2 – 6, and 8 – 14.
However, Gururajan’506 fail to recite whether the ribociclib succinate is crystal form modification E made using the process of examined claim 32. See examined claim 32.
The teachings of Kimani’763 as they relate to the prior art rejection of examined claim 32 is given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the examined application to modify the invention of Gururajan’506 for a coated pharmaceutical oral tablet comprising ribociclib succinate in view of Kimani’763, that is to use the crystal form modification E of ribociclib succinate prepared as recited above. One of ordinary skill in the art would have been motivated to make this modification to a maintain the storage stability, and efficacy, of the pharmaceutical composition. One of ordinary skill in the art would have had a reasonable expectation of success because the prior art established that the crystalline form can be prepared into any general dosage forms, including as a tablet.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12390468 B2 to Grandeury et. al. (Grandeury’468) in view of US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Granddeury’468 recite a process of making ribociclib succinate crystalline form Modification E comprising: providing a solution of about 0.1 mg/mL to about 1.0 mg/mL ribociclib monosuccinate in an organic solvent wherein the solution is substantively free of water and maintained at a first temperature ranging between about 50° C. and about 80° C. for a first period of time; mixing ribociclib succinate crystalline form Modification A with the solution to form a mixture at the first temperature; and removing the organic solvent from the mixture after maintaining the mixture at the first temperature for a second period of time to obtain Modification E; wherein modification E exhibits an X-ray powder diffraction pattern substantially in accordance with FIG. 2, that is
PNG
media_image3.png
498
756
media_image3.png
Greyscale
and modification A exhibits an X-ray powder diffraction pattern substantially in accordance with Fig. 1. See reference claim 1. See examined claim 32 limitataion for a process of making riboclicib succinate crystalline form Modification E where the modification E exhibits an X-ray powder diffraction pattern substantially in accordnace with Figure 2
PNG
media_image2.png
600
1090
media_image2.png
Greyscale
.
However, Granddeury’468 fail to recite the process of making modification E as recited as delineated in examined claim 32. See examined claim 32.
The teachings of Kimani’763 as they relate to the prior art rejection of examined claim 32 is given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the examined application to modify the invention of Granddeury’468 for process of making ribociclib succinate modification E in view of Kimani’763, that is to use the method as delineated above in the prior art rejection. One of ordinary skill in the art would have been motivated to make this modification as an alternative method for making ribociclib succinate modification E. One of ordinary skill in the art would have had a reasonable expectation of success because both process exhibit XRD diagrams that are substantially identical.
Claim 32 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 – 32 of copending Application No. 18/588259 to Costa et.al. (Costa’259) in view of US Patent No. US 10336763 to Kamani et. al. (Kimani’763; cited on the IDS dated June 2nd, 2025).
Coasta’259 recite a pharmaceutical oral tablet comprising ribociclib succinate where the tablet is made by a process comprising recited steps. See reference claim 27. Moreover, Coasta’259 recite in subsequent dependent claims differing composition amounts for the tablet core. See reference claims 26 – 31.
However, Coasta’259 fail to recite whether the ribociclib succinate is crystal form modification E made using the process of examined claim 32. See examined claim 32.
The teachings of Kimani’763 as they relate to the prior art rejection of examined claim 32 is given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the examined application to modify copending Coasta’259 for a tablet comprising ribociclib succinate in view of Kimani’763, that is to use the crystal form modification E of ribociclib succinate prepared as recited above. One of ordinary skill in the art would have been motivated to make this modification to a maintain the storage stability, and efficacy, of the pharmaceutical composition. One of ordinary skill in the art would have had a reasonable expectation of success because the prior art established that the crystalline form can be prepared into any general dosage forms, including as a tablet.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claim 32 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
Prosecution Insights