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 for extension of time request for continued examination under 37 CFR 1.114, amendment, remarks and IDS filed 12/10/2025.
Claims 1 and 27 are amended.
Claims 1, 4, 9-13, 15, 17-19, 23-27 are 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/10/2025 has been entered.
Priority
This application is 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 12/10/2025 has been considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Rejections under 35 USC 102: Applicant argues that the recitation that the tablet is essentially free of cracking defects overcomes the rejections under 35 USC 102 over Caponigro and Trinius.
Response: The examiner disagrees. First, applicant’s specification states that when the tablet is coated with OPADRY amb II, the tablets show improved appearances and are essentially free of cracking defects (see page 5, lines 10 and 11 from the bottom of the page). Essentially free does not mean free. The claims have not recited the specific coating that applicant’s original disclosure accords would render the tablets essentially free of cracking defects. Secondly, Caponigro and Trinius do not teach that their tablets have cracks or cracking defects.
Rejections under 35 USC 103: Applicant argues that amending claims 1 and 27 to recite the tablet is essentially free of cracking defects overcomes the rejections under 35 USC 103 over Caponigro and Trinius.
Response: The examiner disagrees. First, applicant’s specification states that when the tablet is coated with OPADRY amb II, the tablets show improved appearances and are essentially free of cracking defects (see page 5, lines 10 and 11 from the bottom of the page). Essentially free does not mean free. The claims have not recited the specific coating that applicant’s original disclosure accords would render the tablets essentially free of cracking defects. Secondly, Caponigro and Trinius do not teach that their tablets have cracks. Or cracking defects.
Double Patenting Rejections: Applicant requests the rejections be held abeyance until claims are found allowable.
Response: The rejection will be reiterated below because the rejections are not overcome.
Rejections are maintained below with minor modification to address the amendment.
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.
Claim(s) 1 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAPONIGRO et al., (WO 2014097125 A1) for reason of record with minor modification to address the amendment.
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 having the structure below:
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and which is ribociclib of the claims (see the whole document with emphasis on pages 2 and 3 and claims 1 and 4-9). The preferred salt is succinate salt (see the whole document with emphasis on pages 5 and 6 and claim 3). The formulation is administered orally in the form of sugar-coated tablets or capsules (see the whole document with emphasis on page 9). The therapeutic agent is present in the formulation at from about 0.1% to about 99% and preferably from about 1% to about 60% (page 9, 4th full paragraph).
Claims 1 and 27 are directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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.
Thus, the teachings of CAPONIGRO anticipates claims 1 and 27.
Claim(s) 1, 15 and 27 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by TRINIUS (EP 2 742 940 Al) for reason of record with minor modification to address the amendment.
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%. In the case of Formula A, Formula A is used in combination with formula
B1 or B2 (page 25).
Thus, the PVA coated tablet having active agent represented by Formula A or its
pharmaceutically acceptable salt in the core of the tablet anticipates the tablet of claims 1 and 15.
Claims 1 and 27 are directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
TRINIUS does not say that its tablet has cracking defects, does not expressly or implicitly teach that its tablets have cracking defects so that the limitation of the tablet being essentially free of cracking defects is met.
Thus, TRINIUS teaches all the elements of claims 1, 15 and 27.
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.
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.
Claim(s) 1, 4 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over CAPONIGRO et al., (WO 2014097125 A1) for reasons of record and reiterated herein below.
CAPONIGRO has been described above as teaching the formulation of claim 1. For
claims 4, and 9-13, various %amounts of the ribociclib in the tablet formulation are recited.
CAPONIGRO does not teach the exact ranges recited in these claims. However, CAPONIGRO teaches that the therapeutic agent, compound A or 7-Cyclopentyl-2-(5-piperazin-l-ylpyridin-2-
ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide or ribociclib is present
at from about 0.1 % to about 99.9%, preferably from about 1% to about 60% (page 9, 4th full
paragraph). These disclosed amounts of from about 0.1 % to about 99.9 % and from about 1% to
about 60% overlaps and encompasses the claimed ranges of at least 32% to about 65%.
Specifically, the disclosed ranges allow for the claimed ranges and the specific amounts and the
difference is in the %amounts of the active agent, in this case, ribociclib in the claims and in the
prior art CAPONIGRO. Since the disclosed ranges encompass or overlap the recited ranges in
claims 4 and 9-13, it flows that the artisan would be motivated to optimize the formulation of
CAPONIGRO with respect to amounts of ribociclib disclosed in CAPONIGRO that would
produce the expected results from the active agent ribociclib that is disclosed in CAPONIGRO to
be effective for treating cancers such as those listed in the last full paragraph of page 4 of
CAPONIGRO. Thus, CAPONIGRO has disclosed the general conditions of the claims and
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,
456, 105 USPQ 233,235 (CCPA 1955).
Therefore, it is prima facie obvious to optimize the formulation of CAPONIGRO with respect to amounts of the active agent, ribociclib, that would be effective for treating cancers such as those listed in the last full paragraph of page 4 of CAPONIGRO.
Further, with respect to the ribociclib being in the core of the tablet, one embodiment of
the tablet of CAPONIGRO is a sugar-coated tablet (4th full paragraph of page 9) and generally a coated tablet has a core; and with the case of sugar-coating, it flows that the active agent is in the core and protected by the sugar coating from objectionable taste.
Claim 1 is directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
CAPONIGRO does not teach that its tablet has cracking defects.
Therefore, CAPONIGRO renders claims 4 and 9-13 prima facie obvious.
Claims 1, 4, 9-13, 17-19 and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRINIUS (EP 2 742 940 Al) for reasons of record and reiterated herein below.
TRINIUS has been described above as anticipating claims 1 and 14. TRINIUS teaches
that the active agent is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and at least 90%
(see at least paragraphs [0065]-[0066]) but not more than 90% (paragraph [0069]). Thus, the active agent is present from at least 10% to about 90%.
TRINIUS does not teach the exact ranges recited in claims 4, 9-13, 17-19 and 23-26.
These disclosed amounts of from at least 10% to about 90 % but not more than 90%
overlaps and encompasses the claimed ranges of at least 32% to about 60%. Specifically, the
disclosed ranges allow for the claimed ranges and the specific amounts and the difference is in
the %amounts of the active agent, in this case, ribociclib in the claims and in the prior art
TRINIUS. Since the disclosed ranges encompass or overlap the recited ranges in claims 4, 9-13
and 17-26, it flows that the artisan would be motivated to optimize the formulation of TRINIUS
with respect to amounts of ribociclib disclosed in TRINIUS that would produce the expected
results from the active agent ribociclib that is disclosed in TRINIUS to be effective for treating hyperproliferative disease (paragraphs [0024], [0025] , pages 24 and 25).
Thus, TRINIUS has disclosed the general conditions of the claims and "[W]here the
general conditions of a claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955).
Therefore, it is prima facie obvious to optimize the formulation of TRINIUS with respect
to amounts of the active agent, ribociclib, that would be effective for treating hyperproliferative disease guided by the disclosed ranges of the active agent.
Claim 1 is directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
TRINIUS does not teach that its tablet has cracking defects.
Claims 4, 9-13, 17-19 and 23-26 are rendered prima facie obvious by the teachings of TRINIUS.
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 1, 4, 9-13, 15-19 and 23-26 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-14; 1-6; and 1-4 of U.S. Patent Nos. 10799506 B2 and 12064434 B2 and 12419894 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued coated oral tablets of the issued claims teach all the elements of the coated oral tablet of the examined claims (see claims 15-17). The comprising language of the examined claims is open to coated oral tablets. The issued claims do not say that the tablets have cracking defects
Claims 1 and 27 are directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claims 1, 4, 9-13, 15-19 and 23-26 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 27-30 of co-pending Application No. 18977210 (reference application) respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending coated oral tablets of the co-pending claims teach all the elements of the coated oral tablet of the examined claims (see claims 15-17). The comprising language of the examined claims is open to coated oral tablets. The co-pending claims do not say that the tablets have cracking defects.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 27 are directed to pharmaceutical oral tablet comprising ribociclib succinate. The process steps make the same product of pharmaceutical oral tablet comprising ribociclib succinate. The product of the prior art is the same as the claimed product, pharmaceutical oral tablet comprising ribociclib succinate. There is nothing in the recited steps that provide product that is different from the claimed product. Applicant has not pointed to section of the specification that teaches that the recited process produces pharmaceutical oral tablet comprising ribociclib succinate that is difference form the pharmaceutical oral tablet comprising ribociclib succinate of the prior art.
PRODUCT-BY-PROCESS claims are not limited to manipulations of the recited steps, only the structure implied by the steps. In the instant case, the structure implied by the steps is a pharmaceutical oral tablet comprising ribociclib succinate, which is the same structure in the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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
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).
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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.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613