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 .
Priority
This application is a CON of 17881390 filed 08/04/2022 (ABN).
17881390 has PRO of 63229189 filed 08/04/2021.
17881390 is also a CIP of 17328548 filed 05/24/2021 (PAT 11559485).
17328548 is a CON of PCT/US2021/030154 filed 04/30/2021.
PCT/US2021/030154 has PRO of 63122751 filed 12/08/2020, PRO of 63067064 filed 08/18/2020, and PRO of 63018213 filed 04/30/2020.
However, the subject matter of “the package insert further indicates to the user a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” as recited in independent claims 31, 38, and 45 is not present in any of the prior applications of 17881390, 17328548 PCT/US2021/030154, PRO of 63229189, PRO of 63122751, PRO of 63067064, and PRO of 63018213. Furthermore, the subject matters of dependent claims 36, 43, and 50 are also not present in any of the prior applications of 17881390, 17328548 PCT/US2021/030154, PRO of 63229189, PRO of 63122751, PRO of 63067064, and PRO of 63018213. Thus, claims 31-51 will not receive priority filing date benefits of the prior applications of 17881390, 17328548 PCT/US2021/030154, PRO of 63229189, PRO of 63122751, PRO of 63067064, and PRO of 63018213.
Accordingly, claims 31-51 are afforded the effective filing date of 09/26/2024 (actual filing date).
Information Disclosure Statement
The information disclosure statements (IDS) submitted 09/26/2024 (2) have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to preliminary papers filed 09/26/2024 in which claims 1-30 were canceled; and claims 31-51 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 31-51 are pending in this instant application, and examined herein on the merits for patentability.
Claim Objections
Claim 36 is objected to because of the following informalities: it appears that the recitation of “the orally disintegrating tablet comprises 10 to 100 mg nilotinib” in claim 36 may have been a typographical oversight because claim 31 already recites this limitation and subsequently following said recitation in claim 36 is the limitation of “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation.” Appropriate correction is required.
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 31, 38, and 45 introduce new matter as the claims recite the limitation: “the package insert further indicates to the user a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation.” There is no support in the specification for this limitation.
Claims 36, 43 and 50 introduce new matter as the claims recite the limitation: “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation.” There is no support in the specification for this limitation.
After a thorough review of the disclosure from the specification including the examples, as well as, the original claims, there appeared to be no support for the above limitations of claims 31, 36, 38, 43, 45, and 50.
While paragraphs [0016], [0377]-[0389] and [0475]-[0480] disclosed about package insert, and how “the package insert informs the user of the proper use of the pharmaceutical composition” (paragraph [0016]) and how “the package insert informs a user of the kit that the administered dosage comprises a total of 20 to 160 mg nilotinib” (paragraph [0389]), there is no support in said paragraphs for limitation of “the package insert further indicates to the user a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” as recited in claims 31, 38, and 45, as well as, no support in said paragraphs for limitation of “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation” as recited in claims 36, 43 and 50.
MPEP §2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments.
Claims 32-35, 37, 39-42, 44, 46-49 and 51 are also rejected, as they dependent directly or indirectly from claim 31, 38, and 45, thereby also containing the conflicting new matter limitation.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 31, 36, 38, 43, 45, and 50 at the time of filing of the instant application.
Claim Rejections - 35 USC § 102
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) 31-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wertz et al (US 2021/0353534 A1).
Regarding claims 31, 38 and 45, Wertz teaches a kit comprising a pharmaceutical composition and a package insert; wherein the pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion; wherein the amorphous solid dispersion comprises nilotinib and one or more polymers; wherein the orally disintegrating tablet comprises 10 mg to 100 mg nilotinib; wherein the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket- rack apparatus with disks in a medium of distilled water; wherein the package insert informs the user that the pharmaceutical composition can be administered with food or without food (Abstract; [0011]-[0015] and [0017]-[0442]). Wertz teaches the package insert does not include a warning that the pharmaceutical composition should not be administered with food ([0015] and [0357]).
While Wertz does not expressly mentioned “the package insert further indicates to the user a dosage that is at least 50% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation” as recited in claims 31, 38 and 45, it is noted that the every structural limitations of the kit comprising the pharmaceutical composition of claims 31, 38 and 45 have been taught Wertz supra, and thus, the claimed “the package insert further indicates to the user a dosage that is at least 50% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation” is an instruction from package insert (printed matter) that is not functionally related to the product. It is noted that [w]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Regarding claims 32, 39, and 46, Wertz teaches the disintegration time is 30 seconds or less ([0385]; claim 45).
Regarding claims 33, 40, and 47, Wertz teaches when the orally disintegrating tablet is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes ([0215]-[0219] and [0386]-[0389]).
Regarding claims 34, 41, and 48, Wertz teaches that in the dissolution testing at least 25% of the nilotinib is released into the dissolution medium within 30 minutes ([0215]-[0219] and [0386]-[0389]).
Regarding claims 35, 42, and 49, Wertz teaches the orally disintegrating tablet is free from flavorants ([0178] and [0406]).
Regarding claims 36, 43, and 50, As discussed above, Wertz teaches the orally disintegrating tablet comprises 10 mg to 100 mg nilotinib. With respect to the claimed limitation of “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation,” it is noted that said limitation is a printed matter. As discussed above, every structural limitations of the kit comprising the pharmaceutical composition of claims 31, 38 and 45 have been taught Wertz supra, and thus, the claimed “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation” is an instruction from package insert (printed matter) that is not functionally related to the product. It is noted that [w]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Regarding claims 37, 44, and 51, Wertz teaches the orally disintegrating tablet comprises 15 to 75 mg nilotinib ([0157], [0408]; claim 47).
As a result, the aforementioned teachings from Wertz are anticipatory to claims 31-51 of the instant invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 31-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain (WO 2020/172120 A1) in view of Djordjevic et al (US 2016/0120809 A1).
Regarding claims 31, 38, and 45, Jain teaches a pharmaceutical composition in the form of a tablet comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib and a pharmaceutically acceptable carrier including hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), and disintegrants ([0015]-[0016], [0026], [0028], [0033]-[0035], [0059]-[0061], [0088]-[0093], [0095], [0098], [0100], [0108], [0113]-[0114], [0127], [0138]-[0134], [0167]; Example, 1 Table 2; Example 7, Tables 9 and 10). Jain teaches the pharmaceutical composition in the form of a tablet includes 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]). Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Jain teaches the pharmaceutical composition is included in a kit with instructions for oral administration of the composition, wherein the instructions indicate that the composition can be administered to a human subject without regard to food ([0040]-[0041] and [0153]; claim 19). It is noted that while Jain does not indicate that the instructions (package insert) informs the user that the pharmaceutical composition can be administered with food and that instructions (package insert) further indicates to the user a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation, as in claims 31, 38, and 45, said instructions or package inserts are printed matter that is not functionally related to the product. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III). It is further noted that Jain teaches that the pharmaceutical composition has reduced strength/dose as compared to the dose of reference formulation, wherein the composition eliminates or reduces the food effect, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib (i.e., TASIGNA®) (Jain: [0018]). Given that Jain also contemplates a kit comprising the pharmaceutical composition and instructions, it would have been reasonably obvious that the instruction provided by the kit would indicate to the human subject “a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” because as discussed above, Jain teaches that the pharmaceutical composition has reduced strength/dose as compared to the dose of reference formulation, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib.
While Jain does not teach the claimed disintegration time, it would have been reasonably obvious that such claimed properties of “the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water” would have been implicit in the substantially identical in structure or composition of Jain, as the tablet of Jain contains an amorphous solid dispersion of nilotinib and hydroxypropyl methyl cellulose acetate succinate, thereby meeting the claimed the amorphous solid dispersion comprises nilotinib and one or more polymers. Furthermore, Djordjevic provides a reasonable predictability and expectation, as Djordjevic established that the use of ionic polymer such as hydroxypropyl methyl cellulose acetate succinate (HPMC-AS) to produce amorphous solid dispersion of poorly water soluble drugs (especially those drugs in BCS classes II and IV – nilotinib is a BCS class IV drug) provides fast disintegration property when compressed into tablets, as well as, enhanced dissolution/bioavailability (Djordjevic: Abstract; [0018], [0025]-[0026], [0029], [0034], [0040], [0042], [0046]-[0048], [0051]-[0052], [0058], [0063], [0073], [0082]; Examples 2 and 3). Djordjevic further indicated that tablet containing hydroxypropyl methyl cellulose acetate succinate (HPMC-AS) disintegrate in water rather quickly (i.e., in less than 30 seconds), and dissolution profile of a composition containing a solid drug dispersion with a poorly water soluble ionic polymer exhibits rapid drug release (Djordjevic: [0029], [0051]-[0052] and [0095]-[0096]). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 32, 39, and 46, Djordjevic established that tablet containing hydroxypropyl methyl cellulose acetate succinate (HPMC-AS) disintegrate in water rather quickly (i.e., in less than 30 seconds). Thus, the pharmaceutical composition of Jain containing nilotinib and hydroxypropyl methyl cellulose acetate succinate being substantially the same in structure as the claimed pharmaceutical composition would implicitly exhibit a disintegration time of 30 seconds or less. It is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 33, 40, and 47, it is noted that the limitation of “wherein when the orally disintegrating is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes,” as recited in claims 43, 50 and 57 is a conditional clause/limitation which merely describe how the orally disintegrating tablet are used and “when” they used is conditional and does not need to be performed. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPFIJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, nonlimiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Since the orally disintegrating tablet of Jain is substantially the same as the orally disintegrating tablet of the claimed invention, it is presumed that “when” the orally disintegrating tablet of Jain is put in the same condition of “subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1,” the substantially the same orally disintegrating tablet of the prior art would be expected to behave in the same manner of “at least 10% of the nilotinib is released into the dissolution medium within 30 minutes” as claimed because Djordjevic indicated that the orally disintegrating tablet comprising amorphous solid dispersion of poorly water soluble drug and a polymer such as hydroxypropyl methylcellulose acetate succinate enhanced dissolution and bioavailability of the drug (Djordjevic: [0017]-[0018], [0029] and [0033]-[0034]); and Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claims 34, 41, and 48, as discussed above, the limitation of “wherein when the orally disintegrating is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes,” as recited in claims 43, 50, and 57 is a conditional clause/limitation which merely describe how the orally disintegrating tablet are used and “when” they used is conditional and does not need to be performed. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPFIJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, nonlimiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Since the orally disintegrating tablet of Jain is substantially the same as the orally disintegrating tablet of the claimed invention, it is presumed that “when” the orally disintegrating tablet of Jain is put in the same condition of “subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1,” the substantially the same orally disintegrating tablet of the prior art would be expected to behave in the same manner of “at least 25% of the nilotinib is released into the dissolution medium within 30 minutes” as recited in claims 44, 51, and 58 because Djordjevic indicated that the orally disintegrating tablet comprising amorphous solid dispersion of poorly water soluble drug and a polymer such as hydroxypropyl methylcellulose acetate succinate enhanced dissolution and bioavailability of the drug (Djordjevic: [0017]-[0018], [0029] and [0033]-[0034]); and Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claims 35, 42, and 49, the pharmaceutical composition of Jain does not contain flavors (Jain: [0036], [0039]; Examples 7, Tables 9 and 10), thereby is free from flavorant.
Regarding claims 36, 43, and 50, as discussed above, Jain teaches the pharmaceutical composition in the form of a tablet includes 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]). With respect to the claimed limitation of “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation,” it is noted that said limitation is a printed matter that is not functionally related to the product. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III). It is further noted that Jain teaches that the pharmaceutical composition has reduced strength/dose as compared to the dose of reference formulation, wherein the composition eliminates or reduces the food effect, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib (i.e., TASIGNA®) (Jain: [0018]). Given that Jain also contemplates a kit comprising the pharmaceutical composition and instructions, it would have been reasonably obvious that the instruction provided by the kit would indicate to the human subject “a dosage that is at least 60% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” because as discussed above, Jain teaches that the pharmaceutical composition has reduced strength/dose as compared to the dose of reference formulation, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib, which is a range that includes or overlaps the claimed “at least 60%.”
Regarding claims 37, 44, and 51, Jain teaches the pharmaceutical composition in the form of a tablet includes 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 31-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shu et al (US 2016/0038496 A1) in view of Jain (WO 2020/172120 A1) and Center For Drug Evaluation and Research (“Guidance for Industry - Orally Disintegrating Tablets.” Retrieved online on 13 July 2023. Published date: December 2008; hereafter as “CDER”).
Regarding claims 31, 38 and 45, Shu teaches a pharmaceutical composition comprising an amorphous solid dispersion containing a protein kinase inhibitor dispersed in a polymer matrix of hydroxypropylmethyl cellulose acetate succinate (HPMCAS) ([0003], [0006]-[0068], [0183], [0396] and [0402]). Shu teaches the pharmaceutical composition is in the form of an orally disintegrating tablet ([0396]). Shu teaches the pharmaceutical composition is included in a kit containing instructions for use to administer the pharmaceutical composition ([0281], [0489]-[0491]).
However, Shu does not teach the nilotinib of claims 31, 38 and 45.
Regarding the nilotinib of claims 31, 38 and 45, Jain teaches a pharmaceutical composition in the form of a tablet comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib (a protein kinase inhibitor) and a pharmaceutically acceptable carrier including hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), and disintegrants ([0015]-[0016], [0026], [0028], [0033]-[0035], [0059]-[0061], [0088]-[0093], [0095], [0098], [0100], [0108], [0113]-[0114], [0127], [0138]-[0134], [0167]; Example, 1 Table 2; Example 7, Tables 9 and 10). Jain teaches the pharmaceutical composition in the form of a tablet includes 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]). Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Jain teaches the pharmaceutical composition is included in a kit with instructions for oral administration of the composition, wherein the instructions indicate that the composition can be administered to a human subject without regard to food ([0040]-[0041] and [0153]; claim 19).
It would have been obvious to one of ordinary skill in the art to incorporate nilotinib as the protein kinase inhibitor in the amorphous solid dispersion of Shu, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Shu and Jain are commonly drawn to pharmaceutical compositions in the form of tablet comprising amorphous solid dispersion containing a protein kinase inhibitor dispersed in a polymer matrix of hydroxypropylmethyl cellulose acetate succinate (HPMCAS) with improved pharmacokinetic properties (Shu: [0014], [0062] and [0143]; Jain: Abstract, [0013], [0023], [0071], [0076]). Thus, an ordinary artisan would have looked to incorporating nilotinib as the protein kinase inhibitor in the amorphous solid dispersion of Shu, as it would have been a simply substitution of one known protein kinase inhibitor for another to achieve predictable results a pharmaceutical composition containing an amorphous solid dispersion containing nilotinib and hydroxypropylmethyl cellulose acetate succinate (HPMCAS) with improved pharmacokinetic properties, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to routinely optimize the dosage amount of nilotinib included in in the amorphous solid dispersion of Shu to a dosage amount of 10 mg to 100 mg, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because as discussed above, Jain provided the guidance to do so by teaching that the dosage amount of nilotinib in a pharmaceutical composition (amorphous solid dispersion) can be 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib, as this dosage amount is the unit dosage amounts suitable in tablet formulation ([0155] and [0166]).
It is noted that while Shu in view of Jain does not indicate that the instructions (package insert) informs the user that the pharmaceutical composition can be administered with food and that instructions (package insert) further indicates to the user a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation, as in claims 31, 38, and 45, said instructions or package inserts are printed matter that is not functionally related to the product. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III). It is further noted that Jain teaches that the pharmaceutical composition containing an amorphous solid dispersion of nilotinib has reduced strength/dose as compared to the dose of reference formulation, wherein the composition eliminates or reduces the food effect, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib (i.e., TASIGNA®) (Jain: [0018]).Given that Shu in view of Jain also contemplates a kit comprising the pharmaceutical composition and instructions, it would have been reasonably obvious that the instruction provided by the kit would indicate to the human subject “a dosage that is at least 50% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” because as discussed above, Jain that the pharmaceutical composition containing an amorphous solid dispersion of nilotinib has reduced strength/dose as compared to the dose of reference formulation, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib.
While Shu in view of Jain do not teach the claimed disintegration time, it would have been reasonably obvious that such claimed properties of “the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water” would have been implicit in the substantially identical in structure or composition of Shu in view of Jain, as the tablet of Shu in view of Jain contains an amorphous solid dispersion of nilotinib and hydroxypropyl methyl cellulose acetate succinate, thereby meeting the claimed the amorphous solid dispersion comprises nilotinib and one or more polymers. Furthermore, CDER provides a reasonable predictability and expectation, as CDER established that orally disintegrating tablet taught in Shu by industry standard should be considered solid preparations that disintegrate rapidly in the oral cavity with an in-vitro disintegration time of approximately 30 seconds or less when based on USP disintegration test method (CDER: pages 2-3). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 32, 39, and 46, it would have been reasonably obvious that such claimed properties of “the orally disintegrating tablet is characterized by a disintegration time of 30 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water” would have been implicit in the substantially identical in structure or composition of Shu in view of Jain, as the tablet of Shu in view of Jain contains an amorphous solid dispersion of nilotinib and hydroxypropyl methyl cellulose acetate succinate, thereby meeting the claimed the amorphous solid dispersion comprises nilotinib and one or more polymers. Furthermore, CDER provides a reasonable predictability and expectation, as CDER established orally disintegrating tablet taught in Shu by industry standard should be considered solid preparations that disintegrate rapidly in the oral cavity with an in-vitro disintegration time of approximately 30 seconds or less when based on USP disintegration test method (CDER: [0040]-[0041] and [0153]; claim 19). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 33, 40, and 47, it is noted that the limitation of “wherein when the orally disintegrating is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes,” as recited in claims 43, 50 and 57 is a conditional clause/limitation which merely describe how the orally disintegrating tablet are used and “when” they used is conditional and does not need to be performed. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPFIJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, nonlimiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Since the orally disintegrating tablet of Shu in view Jain is substantially the same as the orally disintegrating tablet of the claimed invention, it is presumed that “when” the orally disintegrating tablet of Shu in view of Jain is put in the same condition of “subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1,” the substantially the same orally disintegrating tablet of the prior art would be expected to behave in the same manner of “at least 10% of the nilotinib is released into the dissolution medium within 30 minutes” as claimed because Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claims 34, 41, and 48, as discussed above, the limitation of “wherein when the orally disintegrating is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes,” as recited in claims 43, 50, and 57 is a conditional clause/limitation which merely describe how the orally disintegrating tablet are used and “when” they used is conditional and does not need to be performed. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPFIJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, nonlimiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Since the orally disintegrating tablet of Shu in view of Jain is substantially the same as the orally disintegrating tablet of the claimed invention, it is presumed that “when” the orally disintegrating tablet of Shu in view of Jain is put in the same condition of “subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1,” the substantially the same orally disintegrating tablet of the prior art would be expected to behave in the same manner of “at least 25% of the nilotinib is released into the dissolution medium within 30 minutes” as recited in claims 44, 51, and 58 because Jain teaches the pharmaceutical composition is an immediate-release formulation that rapidly release the majority of the therapeutic compound, particularly useful conditions for immediate-release are release of at least or equal to about 80% of the therapeutic compound within thirty minutes after oral ingestion ([0125] and [0139]). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claims 35, 42, and 49, the pharmaceutical compositions of Shu and Jain do not contain flavors (Shu: Examples 5-8; Jain: [0036], [0039]; Examples 7, Tables 9 and 10), thereby is free from flavorant.
Regarding claims 36, 43, and 50, as discussed above, Jain provided the guidance for the pharmaceutical composition of Shu in the form of a tablet to include 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]). With respect to the claimed limitation of “the package insert indicates to the user a dosage that is at least 60% less as compared to a labeled dosage of a conventional immediate-release crystalline nilotinib formulation,” it is noted that said limitation is a printed matter that is not functionally related to the product. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III). It is further noted that Jain teaches that the pharmaceutical composition containing an amorphous solid dispersion of nilotinib has reduced strength/dose as compared to the dose of reference formulation, wherein the composition eliminates or reduces the food effect, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib (i.e., TASIGNA®) (Jain: [0018]).Given that Shu in view of Jain also contemplates a kit comprising the pharmaceutical composition and instructions, it would have been reasonably obvious that the instruction provided by the kit would indicate to the human subject “a dosage that is at least 60% less as compared to labeled dosage of a conventional immediate-release crystalline nilotinib formulation” because as discussed above, Jain that the pharmaceutical composition containing an amorphous solid dispersion of nilotinib has reduced strength/dose as compared to the dose of reference formulation, wherein the dose of nilotinib administered to a human subject is reduced by at least 50% in comparison to a reference formulation which is current marketed formulation of nilotinib, which is a range that includes or overlaps the claimed “at least 60%.”
Regarding claims 37, 44, and 51, as discussed above, Jain provided the guidance for the pharmaceutical composition of Shu in the form of a tablet to include 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 75 mg or 100 mg of nilotinib ([0166]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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 31-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11559485 in view of Jain (WO 2020/172120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in Patent ‘485 significantly overlap with the subject matter of the instant claims i.e., pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion; wherein the amorphous solid dispersion comprises 10 to 100 mg nilotinib and one or more polymers; wherein the orally disintegrating tablet is characterized by a disintegration time of 40 seconds or less, as determined according to USP <701> Disintegration, using a basket-rack apparatus with disks in a medium of distilled water, and wherein when the orally disintegrating is subjected to dissolution testing according to USP <711> Dissolution using Apparatus 2 at 100 rpm and a dissolution medium consisting of 20 mM citrate buffer at pH 3.1, at least 10% of the nilotinib is released into the dissolution medium within 30 minutes.
It is noted the pharmaceutical composition in the claims of Patent ‘485 is species, and the pharmaceutical composition in the claims of the instant application is a genus. Thus, nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. As such, the species or sub-genus claimed in the conflicting patent ‘485 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
While the pharmaceutical composition of the instant claims is included in a kit containing a package insert, one of ordinary skill in the art would have been motivated to include the pharmaceutical composition of the Patent ‘485 in a kit in order to package and ship the formulation as well as to provide instructions for a consumer/provider on how to utilize the product in view of the guidance from Jain ([0040]-[0041] and [0153]; claim 19). Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11559485 in view of Jain.
Claims 31-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11389450 in view of Jain (WO 2020/172120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘450 significantly overlap with the subject matter of instant claims. While the claims in Patent ‘450 being a method of use, the pharmaceutical composition used in the method of Patent ‘450 is substantially the same as the pharmaceutical composition in the instant claims, i.e. pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib free base and one or more polymers, wherein the dosage amount of nilotinib substantially overlaps.
It is noted the pharmaceutical composition used in the claims of Patent ‘450 is species, and the pharmaceutical composition in the claims of the instant application is a genus. Thus, nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. As such, the species or sub-genus claimed in the conflicting Patent ‘450 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
While the pharmaceutical composition of the instant claims is included in a kit containing a package insert, one of ordinary skill in the art would have been motivated to include the pharmaceutical composition used in the Patent ‘450 in a kit in order to package and ship the formulation as well as to provide instructions for a consumer/provider on how to utilize the product in view of the guidance from Jain ([0040]-[0041] and [0153]; claim 19). Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11389450 in view of Jain.
Claims 31-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-24 of U.S. Patent No. 12029740 in view of Jain (WO 2020/172120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in Patent ‘740 significantly overlap with the subject matter of the instant claims i.e., pharmaceutical composition is in the form of an orally disintegrating tablet that comprises an amorphous solid dispersion; wherein the amorphous solid dispersion comprises 10 to 100 mg nilotinib and one or more polymers.
It is noted the pharmaceutical composition in the claims of Patent ‘740 is species, and the pharmaceutical composition in the claims of the instant application is a genus. Thus, nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. As such, the species or sub-genus claimed in the conflicting patent ‘740 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
While the pharmaceutical composition of the instant claims is included in a kit containing a package insert, one of ordinary skill in the art would have been motivated to include the pharmaceutical composition of the Patent ‘740 in a kit in order to package and ship the formulation as well as to provide instructions for a consumer/provider on how to utilize the product in view of the guidance from Jain ([0040]-[0041] and [0153]; claim 19). Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 12029740 in view of Jain.
Claims 31-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12016861 in view of Jain (WO 2020/172120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘861 significantly overlap with the subject matter of instant claims. While the claims in Patent ‘861 being a method of use, the pharmaceutical composition used in the method of Patent ‘861 is substantially the same as the pharmaceutical composition in the instant claims, i.e. pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib free base and one or more polymers, wherein the dosage amount of nilotinib substantially overlaps.
It is noted the pharmaceutical composition used in the claims of Patent ‘861is species, and the pharmaceutical composition in the claims of the instant application is a genus. Thus, nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. As such, the species or sub-genus claimed in the conflicting Patent ‘861 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
While the pharmaceutical composition of the instant claims is included in a kit containing a package insert, one of ordinary skill in the art would have been motivated to include the pharmaceutical composition used in the Patent ‘861 in a kit in order to package and ship the formulation as well as to provide instructions for a consumer/provider on how to utilize the product in view of the guidance from Jain ([0040]-[0041] and [0153]; claim 19). Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 12016861 in view of Jain.
Claims 31-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11998548 in view of Jain (WO 2020/172120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘548 significantly overlap with the subject matter of instant claims. While the claims in Patent ‘548 being a method of use, the pharmaceutical composition used in the method of Patent ‘548 is substantially the same as the pharmaceutical composition in the instant claims, i.e. pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib free base and one or more polymers, wherein the dosage amount of nilotinib substantially overlaps.
It is noted the pharmaceutical composition used in the claims of Patent ‘548 is species, and the pharmaceutical composition in the claims of the instant application is a genus. Thus, nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. As such, the species or sub-genus claimed in the conflicting Patent ‘548 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
While the pharmaceutical composition of the instant claims is included in a kit containing a package insert, one of ordinary skill in the art would have been motivated to include the pharmaceutical composition used in the Patent ‘548 in a kit in order to package and ship the formulation as well as to provide instructions for a consumer/provider on how to utilize the product in view of the guidance from Jain ([0040]-[0041] and [0153]; claim 19). Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP §2112.01 (III).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11998548 in view of Jain.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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