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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/6/2026, 4/16/2026, 11/12/2025, 8/22/2025 and 12/9/2024 was considered by the examiner.
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.
Claims 1-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muraoka et al. (EP 3053578) in view of Ikeda et al. (US 2012/0237602).
Muraoka is directed to composition for providing cancer therapy using azabicyclo compounds of the following generic structure:
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(see Formula 1, pages 3 and 4) wherein X1 is N, X2 is N, X3 and X4 are CH, Y1, Y3 and Y4 are CH and Y2 is CR4 where R4 can be an C1-C6 alkyl (encompasses ethyl, C2), R3 is a COR5 wherein R5 is an unsubstituted amino group, R2 is C1-C6 alkyl group (encompasses isopropyl) and R1 is a substituted 1H-imidazol-1-yl group (see page 9, lines 20-45). A preferred azabicyclo compound of Muraoka’s composition is 3-ethyl-4-{3-isopropyl-4-(4-(1-methyl-1H-pyrazol-4-yl)-1H-imidazol-1-yl)-1H-pyrazolo[3,4-b]pyridin-1-yl}benzamide (which is identical to the structure/formula claimed: 3-ethyl-4-(4-(4-(1-methylpyrazol-4-yl)imidazol-1-yl)-3-propan-2-ylpyrazolo(3,4-b)pyridin-1-yl)benzamide which has the following chemical structure:
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).
Muraoka’s composition may be formulated as an oral composition such as a tablet or coated tablet (see page 19; see instant claims 9 and 10) and may be used in method of treating a tumor (see instant claims 16-21).
Muraoka fails to teach their coated tablet as comprising crystalline cellulose and having a disintegration time of less than 360 seconds.
Ikeda is directed to press-coated orally disintegrating tablets for delivering a granulated drug, e,g, chemotherapeutic drugs (see [0090]), wherein the tablet comprises a disintegrant, such as microcrystalline cellulose, e.g. PH-302, PH-102, in an amount of 20 (see abstract, [0020] and claim 13; see instant claims 1, 3, 15 and 18), such that the tablet exhibits a total disintegration time of preferably less than 60 seconds (see [0040]). The dosage forms may comprise about 15% of active therapeutic agent (see Tables 9 and 11; math not shown). Although the instantly claimed range of active is not overlapping with that described by the reference, values that are close are considered obvious. See MPEP 2144.05(I) and (II). The granulated therapeutic has a particle size of 165 microns (see [0145]; see instant claim 7).
The microcrystalline cellulose is to have a bulk density of 0.1-0.5 g/cm3 (see [[0061]; see instant claims 2 and 17). Table 1-1 teaches that the microcrystalline cellulose comprises about 37% by mass the tablet formulation (86g/230g) (see instant claims 3, 4 and 19).
Ikeda teaches that their final coated tablet is a solid product that has a dimension of 5-16 mm (see [0102]; see instant claims 9-11 and 24-27).
Regarding instant claims 5 and 20, the comparison of disintegration times between the uncoated and coated tablet is not discussed by the references. However, given that the coating is understood to be a barrier between the tablet core and the dissolution medium, it would reasonably be expected that doing away with it would reduce the time to disintegration. As the coated tablet of Ikeda already overlaps with the properties of the presently claimed coated tablet, it would therefore be expected that the theoretical uncoated tablet would also share the claimed property of disintegrating more quickly.
Regarding instant claim 6, this is a product-by-process claim as it sets forth how the composition is made (‘wet granulation’) rather than provide a structure feature/limitation to the composition. See MPEP 2113. However, it is noted that Ikeda contemplates wet granulation process for preparing their composition (fluidized bed granulation) (see [0085]); see instant claims 6, 13, 14 and 22).
Thus, it would have been obvious to modify Muraoka’s tablet formulation to have the composition of Ikeda with a reasonable expectation for success as Ikeda’s formulation is rapidly disintegrating which enables for smaller tablet dimensions and minimization of additives which negatively impact the dosage form (see [0002]). See MPEP 2143(I)(A) which states that is obvious to combine prior art elements according to known method to yield predictable results.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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