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, IDS and remarks filed 06/01/2026.
Claims 27-30 are pending.
No claim is amended.
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.
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 06/01/2026, applicant argues that the examiner relies on sugar coating being inherently “aqueous moisture barrier coating” and that MPEP 2112 requires that inherent feature be necessarily present, not merely probably or possibly present; that MPEP 2112 and MPEP 2112.01 specifically states that “the mere fact that a certain thing may result from a given set of circumstance is not sufficient … the feature must inevitably and necessarily be present.” That neither CAPONIGRO nor Ando establishes that all sugar coatings or even the unspecified sugar coating of CAPONIGRO necessarily functions as an aqueous moisture barrier coatings. That at best, the cited references show that sugar coatings can be moisture protective under certain conditions and that under MPEP 2112, this is legally not sufficient because the mere 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” citing MPEP 2112,
That on the contrary,
“. Caponigro merely lists "sugar coated tablets" among possible dosage forms
without characterizing moisture barrier properties.
• Ando demonstrates that moisture protection depends on specific structural and
process conditions (e.g., amorphous sucrose crystallization via OSDRC; see Abstract), not on sugar coating per se.” That Ando’s moisture protective result is tied to a specific novel method of manufacturing sugar coated tablets using one step dry-coated tablets and amorphous sucrose crystallization to achieve moisture protection, construction/process (OSDRC + amorphous sucrose crystallization), not to sugar coating generally. That Ando distinguishes conventional sugar coating by teaching that in general, sugar coated tablets are manufactured using a sugar solution/suspension and thus require water proofing and sealing layer to prevent water from entering the core. That the office’s aqueous moisture barrier mapped to sugar coating is undermined by Ando’s teaching that dry coating avoids aqueous solutions (citing pages 319, 320, 328 of Ando).
Furthermore, applicant argues that the examiner’s position of inherency reduces inherency to improper possibilities. That CAPONIGRO does not expressly or inherently teach that its tablet is “essentially free of cracking defects.” For anticipatory rejection, MPEP 2131 requires that each and every element set forth in the claim be found expressly or inherently described in a single prior art reference; that under MPEP 2112, inherency requires necessity and not silence because silence is not a disclosure.
Response: Applicant’s arguments on pages 3, 4 and 5 of the remarks filed 06/01/2026 is that all sugar coatings are not aqueous moisture barriers; that Ando’s moisture protection is due to the process of dry coating with sugar; that neither CAPONIGRO nor Ando establishes that all sugar coatings or even the unspecified sugar coating of CAPONIGRO necessarily functions as an aqueous moisture barrier coatings; and that inherency requires necessity and not silence. The examiner disagrees. i) Claim 27 is directed to a coated tablet comprising an aqueous moisture barrier coating, …, wherein the tablet is essentially free of cracking defects. Claim 27 requires aqueous moisture barrier coating. Claim 27 is therefore limited to any coating that would function as aqueous moisture barrier. Claim 27 does not list or name or recognize or identify a specific coating that is aqueous moisture barrier coating. Therefore, any compound/composition identified in the art as an aqueous moisture barrier including would meet the limitation and a sugar coat is known/identified/taught in the art as aqueous moisture barrier. CAPONIGRO teaches sugar coated tablet comprising ribociclib as an active agent and ribociclib is present at from about 1% to about 60% (4th full paragraph of page 9). It is evidenced in the prior art, Ando, that sugar coating is moisture barrier. Applicant’s argument that Ando’s moisture protective result is tied to a specific novel method of manufacturing sugar coated tablets using one step dry-coated tablets and amorphous sucrose crystallization to achieve moisture protection such that the sugar coating in in CAPONIGRO cannot be a moisture barrier is not persuasive because the claim 27 is not directed to process of manufacturing aqueous moisture barrier and CAPONIGRO and/or Ando do not have to teach that all sugar coatings are aqueous moisture barrier. Ando is an evidentiary reference teaching sugar coat as aqueous moisture barrier. “Aqueous moisture barrier” is an inherent characteristic/property of the coating” and it is evident from Ando that sugar coating is aqueous moisture barrier. MPEP 2112.01, cited by applicant in the arguments, in section I, teaches that “where the claimed and prior art products are identical or substantially identical in structure or composition, … a prima facie case of either anticipated of obvious has been established.” Citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430 (CCPA 1977). In the instant case, CAPONIGRO teaches sugar coated tablet and sugar coating is known in the art (Ando) to have the characteristic/property/function of aqueous moisture barrier. Claim 27 claims the coating as functional property/characteristic. No specific coating material/compound is claimed. While applicant appears to require the office to show why it is legally sufficient to use Ando as an evidentiary reference teaching that sugar coating is an aqueous moisture barrier, applicant provides no evidence or arguments that sugar coatings cannot be moisture protective. In fact, applicant admits, in the last two lines of page 3 of the remarks filed 06/01/2026, that the cited references show that sugar can be moisture protective under certain conditions. Also in MPEP 2112 (cited by applicant), section 1I, states that “the fact that a characteristic is a necessary feature or result of a prior art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.” Ando is an evidentiary reference. Ando’s teaching that dry coating avoids aqueous solutions does not undermine sugar coating being aqueous moisture barrier because Ando teaches sugar coated tablet is protected from moisture.
ii) Regarding applicant’s reference to MPEP 2131, the examiner notes that using Ando as evidentiary reference to show characteristic that sugar coating is moisture protective is permitted under 2131.01 (C). The examiner agrees with applicant that CAPONIGRO does not expressly teach that its tablet is “essentially free of cracking defects” or that the tablet has cracks. However, the coated tablet of CAPONIGRO is inherently essentially free of cracks in light of the silence of CAPONIGRO. 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 is being maintained below. The coated tablet of CAPONIGRO is essentially free of cracks because CAPONIGRO does not say that its coated tablet is cracked.
For 35 U.S.C. 102 and TRINIUS (EP 2 742 940 A1): Applicant argues that TRINIUS does not anticipate claim 27: A. Applicant argues that the office action improperly relied of the specification as a Dictionary citing MPEP 2111. The specification indicates that certain AMB coatings may be PVA based but does not define all PVA based coating as AMB coatings; that the office action relies on TRINIUS’s disclosure of PVA as a coating material and applicant disagrees that PVA coating is an aqueous moisture barrier because the as filed specification does not define all PNA based coatings as moisture barrier.
B) Applicant also argues that the examiner failed to show that PVA based coatings necessarily function as moisture barriers and that no such showing has been made and that under MPEP 2112, it is insufficient that a property may be present, it must be inevitable.
C) Applicant argues that the examiner improperly treats silence as disclosure and just like CAPONIGRO, TRINIUS does not teach that its coated tablet is essentially free of cracks.
Response: A) 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. Applicant has not claimed PVA based coatings that aqueous moisture barrier that would distinguish from the PVA based coatings in TRINIUS. B) 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. Using the specification as a dictionary does not violate MPEP 2112. MPEP 2112 section 1I, states that “the fact that a characteristic is a necessary feature or result of a prior art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”
C) TRINIUS does not say that its tablet has cracking defects such that it is proper that TRINIUS does not teach its coated tablet is cracked and hence the coated tablet is essentially free of cracking defects.
Therefore, the rejection over TRINIUS will is being maintained below.
For 35 U.S.C. 103 and CAPONIGRO et al. (WO 2014097125 A1) as evidenced by Ando et al.: i) Applicant argues that there is no teaching/suggestion/motivation to arrive at the claimed invention because CAPONIGRO broadly mentions sugar coated tablets; that Ando does not teach routine substitution of coatings on high-load ribociclib succinate tablet cores to solve cracking and that Ando emphasizes that conventional sugar coating uses aqueous solutions requiring a sealing layer to prevent water ingress (at page 319) underscoring that sugar coating is not straightforwardly equated to an aqueous moisture barrier coating of the kind claimed. ii) "Essentially free of cracking defects" is a meaningful performance limitation not suggested in the art and that Example 5 of applicant’s disclosure identifies a specific and non-intuitive technical issue (cracking) and a solution via barrier coatings and that neither the problem nor the solution is taught or suggested by CAPONIGRO. iii) Applicant argues that the office action suggests that at least 40% lies between the disclosed range of about 1-60%, but that the claimed high loading ribociclib succinate cores plus and aqueous moisture barrier coating achieving tablets “essentially free of cracking defects” is not taught or suggested and the office action does not articulate a reason an artisan would have selected an aqueous moisture barrier coating for cracking mitigation.
Response: The examiner respectfully disagrees. i) Claim 27 is described as being anticipated by CAPOIGRO as evidenced by Ando in that CAPONIGRO teaches sugar coated tablet comprising ribociclib with sugar coating meeting the limitation of aqueous moisture barrier, which is evidenced by the teaching of Ando. Ando was not relied upon for process of coating a tablet and that claims are not directed to process of coating tablet. Ando was not relied upon for suggesting substitution but that sugar coating functionally aqueous moisture coating. ii) Applicant has cited Example 5 of the as filed specification. However, 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 coated tablet of CAPONIGRO is essentially free of cracks because CAPONIGRO does not say that its coated tablet is cracked. iii) The examiner agrees that at least 40% is encompassed within the disclosed range of about 1-60%. The 1-60% allows for at least 40% rendering the claimed range of at least 40% of claim 28 prima facie obvious. The claims are not directed to crack mitigation.
For 35 U.S.C. 103 over TRINIUS (EP 2 742 940 A1): i) Applicant argues that TRINIUS does not teach moisture barrier functionality, or cracking mitigation; that the office action does not identify where TRINIUS teaches that coating is a moisture barrier or that the tablet yields tablets essentially free of cracking defects; TRINIUS does not give any indication that cracking defects would be expected; that the examiner cannot just assume that silence in the prior art about cracking would be expected and does not suggest a solution for this issue; ii) Claims 29-30 include specific dose of 254.4 mg.
Response: i) The claims are not directed to cracking mitigation; TRINIUS teaches PVA based coating that is an aqueous moisture barrier according the as filed specification; the examiner agrees that TRINIUS does not teach that the PVA based coating is functionally moisture barrier, but the as filed specification recognizes PVA based coating as aqueous moisture barrier. ii) 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 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
Therefore, the rejection under 35 USC over TRINIUS is being maintained 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.
The claims have not been amended. Thus the rejection is reiterated herein below because the claims have not been amended.
Maintained Rejections
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 remain 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) 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 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:
PNG
media_image1.png
293
392
media_image1.png
Greyscale
which is a ribociclib (see the whole document with emphasis on pages 2 and 3 and claims 1-3); succinate salt 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 say 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):
PNG
media_image2.png
226
291
media_image2.png
Greyscale
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 specific disclosed aqueous moisture barrier material (see example 5 cited by the applicant in the remarks filed 06/01/2026).
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.
New Rejection
Necessitated by IDS
06/01/2026
Claims 27-30 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12419894 B2 (cited by applicant on form 1449) in view of TRINIUS (EP 2 742 940 A1) and further in view of VERDECIA REYES et al. (US 20140275042 A1). Claims 1-4 of US 12419894 B2 teach the examined claims. The issued tablet is coated. The issued claims do not teach aqueous moisture barrier. However, TRINIUS teaches that ribociclib tablet coated with PVA based coating (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). Therefore, taking the teachings of TRINIUS and the issued claims, the artisan would be motivated to coat the issued tablet PVA based coat with the expectation of predictably effecting immediate release. PVA is an immediate release material (see paragraph [0069]) and it is aqueous moisture barrier material using the as filed specification as a dictionary.
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.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 06/01/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached on 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights