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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/26 has been entered.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-8, 10-12, 31-33 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Wei et al (CN 11571724 A hereafter Wei) in view of Yoo et al (WO 2021/263132 A1 hereafter Yoo) and Hou et al (WO 2023/209062 A1 hereafter Hou).
Wei discloses a formulation that reduced nitrosamine impurities no more than 2 ppm in formulation comprising CDK inhibitors like ribociclib (abstract, claim 1). The CDK inhibitors can be present in salt form such as succinic salt (claim 7). The reference provides oral tablet for mass production, 130,000 tablets, comprising excipients such as microcrystalline cellulose and silica (Example 1). The resulting tablets have a nitrosamine concentration of 0.88 ppm at initial production and 0.88 ppm measured at 60oC after 5 hours in storage conditions [Table 1].
While the reference discloses the formulation of tablets with a dry process and a coating with water as a solvent, there is no recitation of the specific water activity of the formulation upon manufacture. Water activity is a know factor in storage stability as can be seen in the Yoo, along with storage and packaging conditions useful for protecting tablet formulations. These elements can be found in the prior art including Yoo.
Yoo discloses a solid table formulation comprising a variety of active agents including ribociclib [0002, 0183]. The tablets comprise excipients like cellulose polymers, crospovidone and microcrystalline cellulose [0024, 0030, 0148]. The solid tablet can be packaged into blister packs [0023, 0045, 0175]. The dosage form can be formed individually or in sealed containers [0187-0189]. The components are in powder form and are vacuumed and dried to a moisture level of up to 3%or up to 0.03 water activity [0287]. It would have been obvious to include these elements with the formulation of Wei as they solve the same problem and comprise similar components.
While the combination of Wei and Yoo discloses a pharmaceutical product comprising a ribociclib and common excipients. The combination is however silent to the shelf stability of the formulation, however the shelf stability of a solid table comprising common excipients is well known in the art as seen in the Hou patent.
Hou discloses a pharmaceutical dosage form comprising tablets or capsules [Example 8]. The solid dosages comprise excipients like lactose, microcrystalline cellulose [pg 10, claims]. The active agents comprise ribociclib [pg 13]. The solid dosage forms are shelf stable for up to 6 months at 40°C [Example 8]. These solid dosage forms comprise the same components as the combination and solve the same problem. As such the combination would have similar shelf stability as Hou establishes the features of solid ribociclib formulation comprising common excipients.
With these aspects in mind it would have been obvious to combined the prior art with an expected result of a stable pharmaceutical product. It would have been obvious to combine the formulations of Wei into blister packs as seen in Yoo as they comprise similar components. It would have been obvious that these solid tablets would be shelf stable as seen in the Hou patent as they comprise the same components. One of ordinary skill in the art would have been motivated combine the prior art disclosures in order to produce a stable solid pharmaceutical dosage.
Response to Arguments
Applicant’s arguments, see Remarks, filed 4/1/26, with respect to the rejection(s) of claim(s) 1, 3-8, 10-12, 31-33, 36 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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