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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recited “wherein the film coating comprises: 33-37% hydroxypropylcellulose, 30-36%hydroxypropylmethylcellulose, 25-30% titanium dioxide and 2-5% iron oxides”. First, there is no conjunction word “and/or” in between the three components here in claim 5, therefore, it is not quite clear if all three components are required. Second, it is noted that claim 5 depends from claim 1, in which claim 1 did not recite iron oxide.
Claim 12 recited the limitation “wherein said tablet composition comprises 10-30% w/w of one or more diluents, 0-7% w/w of one or more binders, 2-15% w/w of one or more disintegrants, 0.25-1.0% w/w of one or more glidants and 0.25-2.0% w/w of one or more lubricants, all relative to the total tablet weight.” It is noted that claim 1 did not recite anyone of these components recited herein in claim 12. Could the phrase read: “wherein said tablet composition further comprises”?
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, 2, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. US 2019/0224204 A1, in view of Shi et al. CN 109053738 A.
Claims 3-5, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. US 2019/0224204 A1, in view of Shi et al. CN 109053738 A and Turkyilmaz et al. WO 2020055359 A2.
These rejections have been withdrawn in view of the Amendment filed 11/28/2025.
Claims 1, 3-6 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nogueiras et al. WO 2020127912 A1, in view of Shi et al. CN 109053738 A and Turkyilmaz et al. WO 2020055359 A2.
Nogueiras teaches a tablet composition comprising ibrutinib and one or more pharmaceutically acceptable excipients, characterized in that ibrutinib is form C, having characteristic peaks in the X-ray powder diffraction pattern at the following 2 theta (±0.2) angles: 6.9º, 18.2º, 19.2º, 19.6º and 23.0º, measured using a Cu Kα radiation; and ibrutinib form C is present in an amount from 60 to 80% w/w relative to the total weight of the tablet; and the tablet composition is free of surfactant. See Abstract and pages 2-4. The tablet compositions according to the present invention comprise, besides ibrutinib form C, one or more pharmaceutically acceptable excipients. The excipients to be used in accordance with the present invention are well-known and are those excipients which are conventionally used by the person skilled in the art. The pharmaceutically acceptable excipients are chosen from one or more diluents, binders, disintegrants, glidants or lubricants. The pharmaceutical composition according to the present invention comprises preferably 10-30% w/w of one or more diluents, 0-7% w/w of one or more binders, 2-15% w/w of one or more disintegrants, 0.25-1.0% w/w of one or more glidants and 0.25-2.0% w/w of one or more lubricants, all relative to the total tablet weight. The diluent to be used in accordance with the present invention may be any diluent known to a person of ordinary skill in the art. Particularly, the diluent to be used in accordance with the present invention is an inorganic diluent, polysaccharide, mono- or disaccharide or sugar alcohol. Lactose and microcrystalline cellulose are particularly preferred diluents. In one embodiment of the present invention, the diluent is added as intragranular component. In another embodiment, the diluent is added partially to the intragranular phase and partially to the extragranular phase. See page 6 and Examples. The tablets may be optionally further coated by a film-coat. The coating serves generally for cosmetic purposes. The coating material typically has no influence on the release rate, except of an inherent short initial delay in dissolution due to the time necessary to dissolve the coat. The coating may be selected from amongst one or more of those suitable coating materials known in the art. The coating may be performed by applying one or more film forming polymers, with or without other pharmaceutically inert excipients, as a solution/suspension. Coating is done using any conventional coating technique known in the art, such as spray coating in a conventional coating pan or fluidized bed processor; or dip coating. See page 8. Film coating comprises HPMC and iron oxide is found in the Examples.
Nogueiras does not expressly teach film coating comprising the claimed combine cellulosic polymers.
However, the claimed coating components are known in the art. See the teaching in the Turkyilmaz reference. Page 6 discloses a suitable film coating composition comprising ingredients such as hydroxypropylmethyl cellulose (hypromellose), hydroxypropyl cellulose, polyvinyl alcohol (PVA), polyethylene glycol (PEG), talc, polyvinyl alcohol-polyethylene glycol copolymers (Kollicoat IR), ethylcellulose dispersions (Surelease), polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate copolymer (PVP-VA) and all kinds of Opadry?, pigments, dyes, titanium dioxide, iron oxides or polymethylmetacrylate copolymers (Eudragit) or mixtures thereof.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at to, by routine experimentation select a film composition that comprises cellulose mixture similar to that of the present invention in view of the teaching of Turkyilmaz. This is because Nogueiras teaches the desirability to coat ibrutinib with a film coating composition that does not comprise a plasticizer, this is because Nogueiras teaches a tablet coated with a film coating composition similar to that of Tukyilmaz, and this is because Turkyilmaz teaches combination of cellulose polymers in a film coating composition is known in the art.
Response to Arguments
Applicant’s arguments filed 11/28/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615