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 .
The examiner acknowledges receipt of request for extension of time, request for continued examination under 37 CFR 1.114, amendment, IDS and remarks filed 11/17/2025.
Claims 27 and 29 are amended.
Claims 27-30 are added and pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Priority
This application is a Continuation of 18/588,259 filed 02/27/2024, now pending, which is a Continuation of 17/805,956 filed 06/08/2022, now US12064434 B2, which is a Continuation of 17/003,771 filed 08/26/2020, now abandoned, which is a Continuation of 15/564,534 filed 10/05/2017, now US 10799506 B2, which is a 371 of PCT/IB2016/052136 filed 04/14/2016 and which claims benefit of 62/148,240 filed 04/16/2015.
Information Disclosure Statement
The IDS filed 11/17/2025 has been considered by the examiner.
Response to Arguments
35 U.S.C. 102 and CAPONIGRO et al. (WO 2014097125 A1): on pages 3, 4 and 5 of the remarks filed 11/17/2025, applicant argues that CAPONIGRO does not expressly teach aqueous moisture barrier and that the examiner failed to make prima facie case of anticipation, that the examiner has not met the burden to show that the characteristic is necessarily taught as required by MPEP because Ando does not say that all sugar coatings are aqueous moisture barriers and the examiner has not shown and Ando does not teach that all sugar coatings are aqueous moisture barriers.
Further applicant argues that “The Office Action on page 3 states "iv) Ando does not have to show that all sugar coatings are aqueous moisture barriers." As noted above, this is not true, as MPEP § 2112 makes it clear that the Examiner does have to show this, otherwise the
characteristic does not "necessarily flow" from the prior art. Further, The Office Action on pages 3-4 states "v) Ando was relied upon for teaching that sugar coated tablets are protected from moisture and applicant admits of this teaching in the remarks filed 04/28/2025." Applicant notes that Applicant stated in the response of 04/28/2025: "[T]he Ando reference thus does not show that all sugar coatings are necessarily aqueous moisture barriers, and in fact shows that there are
different kinds of sugar coatings which are not aqueous moisture barriers." Again, the Examiner is implying that for inherency it is enough to show that some sugar coatings are moisture barriers, but under MPEP § 2112 this is not sufficient. As a result, Applicant submits that Ando does not show that the sugar coating recited in Caponigro is an aqueous moisture barrier, and thus Caponigro does not anticipate claim 27 of the instant application.
Additionally, Claim 27, as presently amended, is directed to a coated tablet, "wherein the tablet is essentially free of cracking defects". This feature is not taught in the applied art either expressly or inherently, and for this reason also the amended claims are not anticipated by Caponigro.
For at least these reasons, Caponigro evidenced by Ando does not teach all elements of claim 27, and Applicants respectfully request withdrawal of the rejection
under 35 U.S.C. § 102.”
Response: Applicant’s argument is that all sugar coatings are not aqueous moisture barriers and that the examiner has not shown that all sugar coatings are aqueous moisture barrier. The examiner disagrees. i) While claim 27 requires aqueous moisture barrier, Claim 27 is limited to any aqueous moisture barrier and claim 27 is directed to a coated tablet comprising an aqueous moisture barrier coating, …, wherein the tablet is essentially free of cracking defects. The claim does identify or name a coating material that is an aqueous moisture barrier. The non-naming of compound that is an aqueous moisture barrier means any compound that is identified in the art as an aqueous moisture barrier including sugar coat. ii) Regarding the new limitation that the tablet is essentially free of cracking defects, the prior art CAPONIGRO does not say that its tablet has cracking defects, does not expressly or implicitly teach that its tablets have cracking defects. iii) Ando does not have to show that all sugar coatings are necessarily aqueous moisture barriers. iv) The examiner relied on Ando as an evidentiary reference teaching sugar coatings as aqueous moisture barrier. Applicant appears to say that some sugars are excluded from the teaching of Ando and the examiner does not find sugars excluded in Ando. v) The examiner agrees with applicant that the MPEP 2112 IV states that "[t]he fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic," and further states "[l]n relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." By applicant’s reasoning, and the examiner agrees that the feature of “an aqueous moisture barrier coating” for the coated tablet is a functional recitation for a compound that is not mentioned in the claim or is a characteristic of a compound not mentioned in the claim. Thus, a compound in a coating that inherently has that characteristic/function/property would inherently meet that limitation. The fact finder’s question is whether a sugar coat would inherently have the characteristic function/property. The answer is yes which is supported by the Ando reference. The basis for that finding was provided by the office action in the reference of Ando which teaches that sugar coat has the characteristic. Hence the rejection was proper. Any coating material that has the claimed functional characteristic would meet the limitation. In the instant case no specific compound is named as having that characteristic. Rejection over CAPONIGRO will be made below.
For 35 U.S.C. 102 and TRINIUS (EP 2 742 940 A1): Applicant argues that TRINIUS does not expressly describe aqueous moisture barrier coating and that the examiner is required to show that TRINIUS describes tablet with aqueous moisture barrier. Applicant further argues that MPEP directs that the examiner has the burden of showing that a characteristic is necessarily taught and that it is not sufficient that it may be present and it is not applicant’s initial burden to show that a characteristic is not taught. Applicant further requires that the examiner show that PVA based coatings have inherent characteristic of being aqueous moisture barrier. Furthermore, applicant argues that the instant specification/disclosure does not define all PVA coatings as aqueous moisture barrier (amb coating) coatings and that the teachings in the as filed disclosure for “aqueous moisture barrier coating is e.g., OPADRY amb II coating where the coating is PVA based” does not logically mean that all PVA based coatings are amb or all amb coatings are PVA based and that the disclosure shows that in certain embodiments, AMB coatings are PVA based but not that all PVA based coatings are aqueous moisture barrier. In furtherance of the above argument, applicant cites Rajabi, previously submitted by applicant on form 1449, as teaching that although PVA resists water transmission, PVA coating as a moisture barrier depends on a number of variables (page 325 of Rajabi). That TRINIUS does not teach that the tablet is essentially free of cracking defects as not required by amended claim 27.
Response: i) While TRINIUS does not expressly describe aqueous moisture barrier coating, it was clearly stated in the office action that PVA based coatings are aqueous moisture barrier using the as filed specification as a dictionary for what the functional recitation of “aqueous moisture barrier is. Thus, the requirement of MPEP 2112 IV is not violated because it was clearly described as to why PVA coating has the functional characteristic of aqueous moisture barrier. Claim 1 broadly claims aqueous moisture barrier coating. No specific aqueous moisture barrier is claimed. ii) The examiner cited the as filed specification as a dictionary for the functional limitation of “aqueous moisture barrier” and thus examiner showed that PVA based coatings have inherent characteristic of being aqueous moisture barrier. Rajabi does not remove TRINIUS as art. iii) ) Regarding the new limitation that the tablet is essentially free of cracking defects, the prior art TRINIUS does not say that its tablet has cracking defects, does not expressly or implicitly teach that its tablets have cracking defects.
Rejection over TRINIUS will be made below
For 35 U.S.C. 103 and CAPONIGRO et al. (WO 2014097125 A1) as evidenced by Ando et al.: Applicant disagrees with this rejection for the reasons presented under 35 USC 102 over CAPONIGRO that CAPONIGRO does not anticipate claim 27 because in particular, CAPONIGRO does not disclose a tablet with an aqueous moisture barrier coating. Applicant further argues that Example 5 of the as filed specification where tablets coated wit OPDARY that is not an aqueous moisture barriers (amb) coating showed cracking defects and those coated with OPADR amb II were essentially free of cracks. Applicant thus states that claims 28-30 are not obvious over CAPONIGRO.
Response: While Example 5 teaches that ribociclib tablet coated with OPADRY standard HPMC based coating shows cracking defects and ribociclib tablet coated with OPADRY amb II which is aqueous moisture barrier based on PVA coating showed no cracking defect, the claims are not directed to ribociclib tablet coated with OPADRY II coating material. Further, the response presented above to applicant’s arguments against CAPONIGRO for the rejection under 35 USC 102 is incorporated here. Therefore, applicant’s arguments are not persuasive. The rejection is being made below.
For 35 U.S.C. 103 over TRINIUS (EP 2 742 940 A1): Applicant states that it has been argued that TRINIUS does not anticipate claim 27 for not disclosing tablet coated with aqueous moisture barrier and that the same argument is applicable to the rejection under 35 USC 103 and claims 27-30 are not obvious over TRINIUS.
Response: The same response provided for the argument over CAPONIGRO is applicable here. The response presented against the argument over rejection under 35 USC 102 is incorporated here. TRINIUS does teach that its tablets have cracking defects. Therefore, TRINIUS renders claims 28-30 and the rejection is being made below.
For obviousness type double patenting rejections: Applicant is requesting that the rejections be held in abeyance.
Response: The rejections will be maintained until the rejections are overcome.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 27 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by CAPONIGRO et al. (WO 2014097125 A1) as evidenced by Ando et al. “Evaluation of a novel sugar coating method for moisture protective tablets” in International Journal if Pharmaceutics, Vol. 336, pp 319-328 (2007).
Claims 27 and 29 are amended to recite that the tablets are essentially free of crack. The prior art CAPONIGRO does not teach that its tablet have cracking defects. The rejection presented below is the same as that presented in the final office action mailed 08/07/2025. The absence of cracking defects in the tablet will also be addressed.
CAPONIGRO teaches a formulation comprising cyclin dependent kinase inhibitor (CDK
inhibitor) compound A described as 7-Cyclopentyl-2-(5-piperazin-l-ylpyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and pharmaceutically acceptable salt having the structure below:
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which is a ribociclib (see the whole document with emphasis on pages 2 and 3 and claims 1-3); succinate sat is preferred (see the whole document with emphasis on pages 5 and 6 and claim 3). The formulation is in the form of a sugar coated tablet with the active agent (A) or ribociclib present at from about 1% to about 60% (4th full paragraph of page 9). The formulation contains disintegrant (1st full paragraph of page 10) namely cross-linked polymers such as cross-linked polyvinyl pyrrolidone or crospovidone (POLYPLASDONE) or croscarmellose (3rd full paragraph).
For Claim 27, CAPONIGRO does not say that the sugar coat is an aqueous moisture barrier. However, it is known in the art that sugar coated tablets are protected from moisture as evidenced by Ando (see at least the title, abstract, introduction of Ando). CAPONIGRO does not teach that its tablet is cracked or have cracking defects so that the limitation of the tablet being essentially free of cracking defects is met.
Therefore, CAPONIGRO as evidenced by Ando teaches all the elements of claim 27.
Claim(s) 27 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by TRINIUS (EP 2 742 940 A1) for reasons of record and reiterated herein below.
Claims 27 and 29 are amended to recite that the tablets are essentially free of crack. The prior art TRINIUS does not teach that its tablet have cracking defects. The rejection presented below is the same as that presented in the final office action mailed 08/07/2025. The absence of cracking defects in the tablet will also be addressed.
TRINIUS discloses film coated tablet (see the whole document with emphasis on
paragraphs [0100], [0107], [0109]) and in paragraph [0108], polyvinyl alcohol (PVA) is named as a coating material (see also claims 37, 39). The coated tablet has a core (see the whole
document, Example 9.2 on page 17). In one aspect, the active agent is drug2 described in
Formula A below which is ribociclib or pharmaceutically acceptable salt thereof such as the
succinate salt, and the formulation is used to treat hyperproliferative disease (paragraphs [0024], [0025], pages 24 and 25):
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The unit dosage forms have therapeutically effective amount of the drug and the amount
is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and at least 90% (see at least paragraphs
[0065]-[0066]). In paragraph [0069], it is contemplated that the amount of the active agent be
not more than 90%. PVA coat is a PVA based coating and meets the limitation of aqueous moisture barrier coating because using the as filed specification as a dictionary shows that aqueous moisture barrier coating is PVA based coating. The coated tablet of TRINIUS contains disintegrants such as crosslinked polyvinyl pyrrolidone (crospovidone), sodium starch glycolate, crosslinked sodium carboxymethyl cellulose (croscarmellose sodium) (paragraph [0135]).
Thus the PVA coated tablet having active agent represented by Formula A or its pharmaceutically acceptable salt in the core of the tablet anticipates coated tablet of claims 27.
TRINIUS does not teach that its tablet is cracked or have cracking defects so that the limitation of the tablet being essentially free of cracking defects is met.
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(s) 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over CAPONIGRO et al. (WO 2014097125 A1) as evidenced by Ando et al. “Evaluation of a novel sugar coating method for moisture protective tablets” in International Journal if Pharmaceutics, Vol. 336, pp 319-328 (2007) for reasons of record and reiterated herein below.
Claim 28 depends on claim 27.
CAPONIGRO as evidenced by Ando has been described above to anticipate claim 27.
For claim 28, the therapeutic agent is present in CAPOLIGRO at from about 1% to about 60% (4th full paragraph of page 9) as described above. While CAPONIGRO teaches amounts of from about 1% to about 60% therapeutic agent (A), CAPONIGRO differs from claim 28 in that in claim 28, the therapeutic agent is present in at least 40%. However, the disclosed range of 1-60% overlaps the claimed range of at least 40%.
It has been settled in 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) that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In the instant case, the disclosed range of about 1 to about 60% allows for a range of about 40%.
For claims 29 and 30, CAPONIGRO does not specifically state that the coated tablet has 254.4 mg active agent (A) or ribociclib succinate and that the active agent (A) or ribociclib succinate is present in at least 40%. However, the disclosed range of 1-60% overlaps the claimed range of at least 40%.
It has been settled in 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) that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In the instant case, the disclosed range of about 1 to about 60% allows for a range of about 40%. Further, the artisan guided by the teachings of CAPONIGRO would be able to reasonably ascertain amount of agent (A) ribociclib succinate in the coated tablet that would be effective to treat tumors and hematological malignancies rendering claim 29 prima facie obvious.
CAPONIGRO does not teach that its tablet is cracked or have cracking defects so that the limitation of the tablet being essentially free of cracking defects is met.
Therefore, CAPONIGRO as evidenced by Ando renders claims 28-30 prima facie obvious.
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRINIUS (EP 2 742 940 A1) for reasons of record and reiterated herein below.
Claim 28 depends on claim 27.
For claim 28, the therapeutic agent is present in TRINIUS therapeutically effective amount of the drug and the amount is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and at least 90% (see at least paragraphs [0065]-[0066]) as described above. Drug2a which is ribociclib is combined with drug3a or 3b (see at least line 1 of page 50). Thus while TRINIUS teaches amounts of from about at least 40%, 50%, 60%. 70%, 80% and 90% of therapeutic agent (A) or drug2a in combination with drug3, TRINIUS differs from claim 28 in that in TRINIUS, the therapeutic drug2a agent (ribociclib) is present in those amounts in combination with another drug 3. However, the disclosed ranges, least 40%, 50%, 60%. 70%, 80% and 90% overlaps the claimed range of at least 40%. It has been settled in 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) that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In the instant case, the disclosed range of about least 40%, 50%, 60%. 70%, 80% and 90% allows for a range of about 40%.
For claims 29 and 30, TRINIUS does not specifically state that the coated tablet has 254.4 mg active agent (A) or ribociclib succinate and that the active agent (A) or ribociclib succinate is present in at least 40%. Further, for claim 29, the artisan guided by the teachings of CAPONIGRO would be able to reasonably ascertain amount of agent (A) ribociclib succinate in the coated tablet that would be effective to treat tumors and hematological malignancies
It has been settled in 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) that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. However, the disclosed range of least 40%, 50%, 60%. 70%, 80% and 90% overlaps the claimed range of at least 40%.
TRINIUS does not teach that its tablet is cracked or have cracking defects so that the limitation of the tablet being essentially free of cracking defects is met.
Therefore, TRINIUS renders claims 28-30 prima facie obvious.
Suggestion: It is suggested that the claims be amended to recite OPADRY amb II, coated material, PVA based, as the aqueous moisture barrier (see example 5 cited by the applicant in the remarks filed 11/17/2025.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Claims 27-30 remain rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-14; and1-6 of U.S. Patent Nos. 10799506 B2 and 12064434 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued the issued coated tablets having polyvinyl alcohol based moisture barrier coating teach all the elements of the examined claims. The comprising language is open. Patent claims of US 10799506 B2 and 12064434 B2 do not teach that their tablets have cracking defects.
Claims 27-30 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, 3-4, 9-13, 15-21 and 23-26 of co-pending Application No. 18/588259 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach all the elements of the examined claims. The comprising language is open. The co-pending claims do not teach the presence of cracking defects.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613