DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 3/23/2026 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections- 35 USC § 103
4. 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gururajan et al. (US Patent 10799506) in view of Vachon et al. (WO 03092659).
Gururajan et al. (US Patent 10799506) (hereinafter Gururajan et al.) disclose ribociclib tablets for immediate release (abstract). The core contains excipients fillers, disintegrants and lubricants (col. 3, lines 22-55). In one embodiment the coating contains immediate release coating HPMC where PVA is not required (col. 3, line 55-56 and Fig. 3).
Gururajan et al. disclose fillers include microcrystalline cellulose and lactose, disintegrants include those such as sodium starch glycolate.
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have obvious to one of ordinary skill in the art before the effective filing date to have selected various combinations of the various disclosed ingredients in Gururajan et al. such as microcrystalline cellulose and lactose, disintegrants include those such as sodium starch glycolate to arrive at compositions yielding no more than one would expect from such an arrangement of the film forming composition.
Gururajan et al. does not disclose the coating comprises a combination of hydroxypropyl methyl HPMC and ethyl cellulose. Vachon et al. (WO 03092659) (hereinafter Vachon et al.) disclose coating materials that include HPMC, ethyl cellulose and combinations thereof at levels well known in tablet coatings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the coating be formed of HMPC and ethyl cellulose for the controlled release of the drug.
5. Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bhardwaj et al. (US Patent 9301957) in view of Liu et al. (US 20230172856) and Vachon et al. (WO 03092659).
. Bhardwaj et al. (US Patent 9301957) (hereinafter Bhardwaj et al.) disclose a solid dosage form comprising core and drug (nilotinib) and excipients and at least one polymer coating (abstract). The composition is a rapidly disintegrating tablet with a lag time as compared to an uncoated tablet (col. 1, lines 20-25). The composition comprises binding agents, lubricants, filling agents, suspending agents and excipients known in the art (col. 8, lines 50-65). The filling agent (diluent) is lactose monohydrate or microcrystalline cellulose col. 8, line 56 and col. 9, lines 20-30). The active ingredient may be 30-70 %, one or more excipient includes filler microcrystalline cellulose at 20-60 %, disintegrants (crosspovidone) can be from 2-14 %, glidants from 0.25-4 %, and lubricants from 0.25-2 % intra granular magnesium stearate and extra granular magnesium stearate from 0.7-3.5 % (col. 9, lines 20-35). The coating composition comprise one or more cellulose derivatives such as hydroxypropyl methyl cellulose and ethyl cellulose (col. 9, lines 47-49). The coating does not require PVA (see col. 9, lines 37-50 and Table 1).
Bhardwaj et al. disclose the drug as nilotinib but does not disclose Ribociclib.
Liu et al. (US 20230172856) (hereinafter Liu et al.) disclose treating cancer with formulations for immediate release that include chemotherapeutic agents and protein kinase inhibitors which are nilotinib or ribociclib (para 0142 and 0090). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the nilotinib in Bhardwaj et al. for the ribociclib as taught in Liu et al. One would have been motivated to do so because simple substitution of one known protein kinase inhibitor for another would obtain predictable results as both are art recognized protein kinase inhibitors for treatment of cancer which are useful in formulations for immediate release.
Bhardwaj et al. does not disclose the coating comprises a combination of hydroxypropyl methyl HPMC and ethyl cellulose. Vachon et al. (WO 03092659) (hereinafter Vachon et al.) disclose coating materials that include HPMC, ethyl cellulose and combinations thereof at levels well known in tablet coatings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the coating be formed of HMPC and ethyl cellulose for the controlled release of the drug.
RESONSE TO ARGUMENTS
6. Applicants arguments have been fully considered and are not persuasive for the reasons below.
Applicants argue that Gururajan discloses PVA coating having superior properties.
Applicants argue that the specific composition has surprisingly favorable and improved dissolution and solubility properties. The Declaration of Chowdary shows that the tablets of the invention provided more rapid drug release in comparison to the KISQALI® tablets. Tablets remained stable and impurities remained low.
Applicants argue that the structures of nilotinib and ribociclib contains different chemical groups.
In response, the Examiner respectfully submits that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious." Id. at 301, 213 USPQ at 536. Furthermore, "Obviousness does not require absolute predictability of success." Id. at 903, 7 USPQ2d at 1681.The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.
“Obviousness does not require absolute predictability of success.” Id. at 903, 7 USPQ2d at 1681. Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) (“To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’”); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) (“This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness.” (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that “the expectation of success need only be reasonable, not absolute”)).
Bhardwaj et al. disclose a rapidly disintegrating tablet with a lag time (i.e., immediate release). While Bhardwaj et al. disclose different classes of polymers that may be used to delay the initial release from the tablet, it is noted that these polymers disclosed are the same ones as claimed such as a coating of ethyl cellulose or HPMC. The instant claims recite a coating and to will delay the release of a drug. Applicants declaration is not commensurate in scope with the claims as specific ingredients in specific amounts where claim 1 recites no amounts of the coating. Furthermore the claims do not recite ingredients such as microcrystalline cellulose or croscarmellose sodium and there is no indication that other tablets would behave in the same manner that do not contain these ingredients in these amounts as recited in the Table on page 3 of the affidavit. As such, the claims are not commensurate in scope.
CONCLUSION
7. 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
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615