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 .
Receipt of amendment and response dated 08/04/25 is acknowledged.
Claim 6 has been canceled.
Claims 1-5 and 7-11 are pending.
The following rejections of record have been maintained:
Claims 1-5 and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11344535 in view of WO 2016192680 to Triastek et al (Triastek), and Praveen Nasa (World Journal of pharmaceutical research. vol. 3:5, page 344-368).
The above patented (‘535 patent) claims are directed to a pharmaceutical composition comprising pemafibrate, a salt thereof or a solvate thereof, and further a pharmaceutically acceptable additive. The patented claims further recite a tablet, a capsule, a granule, a powder or a pill.
Patented claims do not recite methacrylic acid-based polymer and the instant claimed tight package.
Triastek teaches a stable oral solid pharmaceutical dosage form that includes a drug loaded on to a substrate and a controlled release agent (abstract). The composition includes tablets, capsules, gel-caps etc., [0003]. For the said substrate, Triastek teaches instant several polymeric materials including the instant claimed methacrylic acid-based polymers such as poly(butyl methacrylate-co(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) 1:2:1, poly(dimethylaminoethylmethacrylate-co-methacrylic esters), poly(ethyl acrylate-co-methyl methacrylate-co-trimethylammonioethyl methacrylate chloride), poly(methyl acrylate-comethyl methacrylate-co-methacrylic acid) 7:3:1, poly(methacrylic acid-co-methylmethacrylate) 1:2, poly(methacylic acid-co-ethyl acrylate) 1:1, poly(methacylic acidco-methyl methacrylate) 1:1 [0006, 0075], which meet instant claims 2-3 and 7-8. Further, Triastek teaches several methacrylic and methacrylate copolymers, including poly(methacrylic acid-co-methacrylate), and hence meet claims 9-11. Triastek teaches several active agents such as anti-hypertensive drugs, anti-hypertensive drugs [0009], including pemafibrate (p 25, l 25). Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ methacrylic acid-based polymers, such as those taught by Triastek, in the composition of the patented claims because Triastek teaches that acrylic acid-based polymers as a substrate for providing controlled release of drugs, including the claimed pemafibrate. One of an ordinary skill in the art would have expected that the substrate provides a modified or a controlled release of the pemafibrate.
Patented (‘535 patent) claims and further lacks the instant claimed tight package selected from a tight container.
In this regard, Praveen teaches pharmaceutical package to protect the product from harmful effects of environmental gases, moisture, microbes etc. Praveen teaches primary package is in direct contact with the pharmaceutical product and a secondary package surrounds the primary package, with tertiary package used for transportation (abstract). Praveen teaches that the container and closure material should be carefully selected which do not affect the therapeutic efficacy of the products and the package should provide stability to the pharmaceutical product (p 344).
Praveen teaches that the pharmaceutical packaging and materials should have sufficient mechanical strength, not react with contents stored in it, should not support mould growth etc (see 1-11 on p 345). Table 1 of the reference teaches bottles, container, wrapper, packs, etc., airtight containers to protect from environmental hazards, and are sealed so as to be able to be opened more than once and remain airtight after reclosure (p 347). Fig. 6 further shows strip package, blister package (p 349 & fig. 7) ((meets SP and STP package of instant claims).
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare pemafibrate pharmaceutical formulations of the patented claims (‘535 patent) by employing methacrylic acid based polymers (taught by Triastek) and further store the composition in an airtight packages such as bottles, blister packages etc., because Triastek teaches methacrylic copolymers provide controlled release of pemafibrate, and Praveen further suggests storing pharmaceutical compositions, including tablets, in different types of packages such as stability, airtight container for stability over long time and protect the pharmaceutical composition from environmental conditions, and maintain the quality of the composition. A skilled artisan would have expected a stable pemafibrate composition that also provides a controlled release.
Claims 1-5 and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over ANY ONE of claims 1-21 of U.S. Patent No. 11298340 OR claims 1-10 of U.S. Patent No.11419855 OR claims 1-8 of U.S. Patent No 11730719, each in view of WO 2016192680 to Triastek et al (Triastek).
The above patented claims (11298340) are directed to a pemafibrate, a salt or solvate thereof, the composition in the form of a solid such as a tablet, capsule, powder or a pill. The composition is stored in a tight package such as a bottle package, pillow package etc.
US 855 patent claims recite a pemafibrate, a salt or solvate thereof and a cellulose, wherein the composition is stored in an airtight package. The composition is in a solid form and stored in a tight package such as a bottle package, pillow package etc.
US patent 719 claims recite a pemafibrate, a salt or solvate thereof, wherein the composition is stored in an airtight package. The composition is in a solid form and stored in a tight package such as a bottle package, pillow package etc.
Above sets of patented claims recite the same airtight packaging such as that claimed and hence it is inherent that the packaging of the patented claims provides the instant claimed protection.
The above patented claim sets do not recite the instant claimed methacrylic acid-based polymer. The teachings of Triastek are discussed above and incorporated herewith. Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ methacrylic acid-based polymers, such as those taught by Triastek, in the composition of the patented claim sets of ‘240, ‘719, ‘855 and ‘340 patents because Triastek teaches that acrylic acid-based polymers as a substrate for providing controlled release of drugs, such as pemafibrate. A skilled artisan would have expected a stable pemafibrate composition that also provides a controlled release.
Claims 1-5 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/418129 in view of WO 2016192680 to Triastek et al (Triastek).
Copending claims of Application No. 17/418129 are directed to a pemafibrate, a salt or solvate thereof, the composition in the form of a solid such as a tablet, capsule, powder or a pill. The composition is stored in a tight package such as a bottle package, pillow package etc. The above claims recite the same airtight packaging such as that claimed and hence it is inherent that the packaging of the claims provides instant claimed protection.
Further, the above claims do not recite the instant claimed a methacrylic acid-based polymer. The teachings of Triastek are discussed above and incorporated herewith. Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ methacrylic acid-based polymers, in the above claimed pemafibrate composition because Triastek teaches that acrylic acid-based polymers as a substrate for providing controlled release of drugs, such as pemafibrate. A skilled artisan would have expected a stable pemafibrate composition that also provides a controlled release.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/418518 in view of WO 2016192680 to Triastek et al (Triastek) and Praveen Nasa (World Journal of pharmaceutical research. vol. 3:5, page 344-368).
The above copending claims are directed to a pharmaceutical composition comprising pemafibrate and a methacrylic based polymer. The composition is in the form a tablet, capsule, pill etc. Co-pending claims do not recite methacrylic based polymers and airtight package of instant claims.
The teachings of Triastek and Praveen discussed above have been incorporated herewith. Triastek teaches a stable oral solid pharmaceutical dosage form that includes a drug loaded on to a substrate and a controlled release agent (abstract). The composition includes tablets, capsules, gel-caps etc., [0003]. For the said substrate, Triastek teaches instant several polymeric materials including the instant claimed methacrylic acid-based polymers.
It would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the composition of the copending claims comprising pemafibrate and methacrylic polymer, and further package the pharmaceutical composition of the copending claims in an airtight package because Triastek teaches that pharmaceutical compositions comprising methacrylic acid copolymers acts as a controlled release agent for pemafibrate can be prepared as tablets or capsules, and additionally, Praveen suggests airtight packaging materials such as bottles, strip packages etc., for providing stability of pharmaceutical products such as tablets, capsules etc., over a long period. Thus, one of an ordinary skill in the art would have expected that an airtight packaging of the claimed composition provides effective stability of pemafibrate from heat, moisture and other environmental influences.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 8426455 to Takizawa et al (Takizawa) in view of WO 2016192680 to Triastek et al (Triastek), and Praveen Nasa (World Journal of pharmaceutical research. vol. 3:5, page 344-368).
The previous rejection has inadvertently excluded claims 9-11.
Takizawa teaches a therapeutic agent for treating dyslipidemia and its excellent effects in lowering cholesterol and triglyceride level in blood plasma, wherein the agent is represented by formula I (abstract, col. 4, l 1-35). In particular, Takizawa teaches the same compound (R)-2-[3-[[N-(benzoxazol-2-yl)-N-3-(4-methoxyphenoxy)propyl]aminomethyl)phenoxy]butyric acid or a salt thereof (col. 4, l 41-45), which is the same as the instant pemafibrate (according to [0002] of the instant specification]. The composition is in the form of tablets, capsules, powders, granules etc (col.9, l 60-col. 10, l 7). The composition is in a solid form and includes a suitable pharmaceutical excipient such as binders, glidants, disintegrants etc (col. 10, l 8-27).
Takizawa does not teach the instant claimed methacrylic acid-based polymer and an airtight packaging.
The teachings of WO 2016192680 to Triastek et al (Triastek), and Praveen, discussed above, have been relied upon. Triastek teaches a stable oral solid pharmaceutical dosage form that includes a drug loaded on to a substrate and a controlled release agent (abstract). The composition includes tablets, capsules, gel-caps etc., [0003]. For the said substrate, Triastek teaches instant several polymeric materials including the instant claimed methacrylic acid-based polymers.
Praveen teaches that the pharmaceutical packaging and materials should have sufficient mechanical strength, not react with contents stored in it, should not support mould growth etc (see 1-11 on p 345). Table 1 of the reference teaches bottles, container, wrapper, packs, etc., airtight containers to protect from environmental hazards, and are sealed so as to be able to be opened more than once and remain airtight after reclosure (p 347). Fig. 6 further shows strip package, blister package (p 349 & fig. 7) ((meets SP and STP package of instant claims).
It would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the solid pharmaceutical composition of Takizawa, in the form of a tablet, powder, granule or capsule, and modify the composition to include a methacrylic acid-based copolymer and further prepare an airtight packaging of the said tablets, capsule, granule or powder so as to arrive at the instant claims. One of an ordinary skill in the art would have been motivated to do so because Triastek teaches including a methacrylic acid-based polymer as a controlled release polymer in oral, solid drug delivery compositions including pemafibrate, and Praveen teaches airtight packages such as airtight bottle, strip packages, blister packages etc., as primary packaging materials for the tablets, capsules and granules of Takizawa, to in order to maintain stability for a long time and also prevent reacting with external moisture, temperature and other environmental conditions. Hence, one of an ordinary skill in the art would have expected that the resulting composition provides both a controlled release of pemafibrate (with the methacrylic acid-based polymers) and a stable composition of pemafibrate, owing to a coating of methacrylic acid-based polymers of Triastek and a storage of the composition in an airtight packaging.
Response to Arguments
Applicant's arguments filed 8/4/25 have been fully considered but they are not persuasive.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 8426455 to Takizawa et al (Takizawa) in view of WO 2016192680 to Triastek et al (Triastek), and Praveen Nasa (World Journal of pharmaceutical research. vol. 3:5, page 344-368).
Applicants argue that Takizawa does not solve the problem of instability of pemafibrate in the presence of methacrylic acid-based polymer, a conventional drug excipient, Triastek lists numerous materials including methacrylic-based polymers but fail to recognize that the combination of pemafibrate and methacrylic-acid based polymer combination is unstable. It is argued that the instability could not be predicted from the properties of either pemafibrate or methacrylic acid polymers. Applicants further refer to Table 1 of the instant application to show that the combination, only when stored in tight package shows stability. It is argued that Praveen reference teaches the instant packages but does not recognize that packaging taught therein do not solve the stability problem when pemafibrate is in contact with methacrylic-based polymers. Applicants argue that the present claims have a limitation that the combination be storage stable, directed to solving an unrecognized problem with pemafibrate composition stability.
Applicants’ arguments are not found persuasive because instant claims are directed to a product but not directed to a method of imparting stability to a combination. Further, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). Further, the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). In the instant case, one of an ordinary skill in the art would have recognized from the teachings of Praveen that tight packages such as STP are conventionally used in packing in pharmaceutical composition such as strip packages, airtight bottles etc. and it is not necessary that the motivation to combine the teachings of the prior art need not be the same as that of Applicants. One of an ordinary skill in the art would have expected that the modification of the teachings of Takizawa et al (Takizawa) with that of WO 2016192680 to Triastek et al (Triastek), and Praveen would result in a stable and controlled release composition of pemafibrate because the strip packages and other airtight packages such as bottles would prevent the composition from exposing to various environmental conditions such as moisture, humidity, heat etc., and thus provide stability, as suggested by Praveen. One of an ordinary skill in the art would have expected the argued unexpected stability (Table 1) of a composition comprising pemafibrate (Takizawa et al) and methacrylic-based polymer (Triastek et al) by packing in an airtight packaging suggested by Praveen. One of an ordinary skill in the art would have expected because Praveen clearly teaches that the general packing materials of pharmaceutical products should not support mold growth, must provide stability and provide protection from environmental hazards, and further suggests instant claimed airtight packages.
Applicants argue that the Double patenting rejections of over ‘535 patent claims do not recognize that methacrylic acid polymers cause pemafibrate to be unstable. It is argued that the only term in the patent claims is pemafibrate. However, as explained above, the motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.”); In re Beattie, 91A F.2d 1309, 1312 (Fed. Cir. 1992). Furthermore, the present rejection depends on an additional reference, Praveen Nasa, which as explained above teaches packaging of pharmaceutical dosage forms such as tablets, capsules etc., employing airtight packaging.
With respect to the double patenting rejections over the claims of 11298340, 11419855, 11406621 and 11730719 patents, Applicants argue that the examiner failed to compare the claim limitations of the present claims with those of the patent references to show that there is any improper extension of the patent term. It is argued that Triastek does not recognize the problem of product instability when a methacrylic acid polymer is present in the composition nor its solution, and the present claims have been amended to require the packaging to impart stability to the composition.
The present rejection does not include an obvious double patenting rejection over the claims of US 11406621 in view of Triastek because, as pointed out by Applicants, the patented claims only recite pemafibrate composition and do not contain a tight package. Applicants’ arguments are not found persuasive with respect to 11298340, 11419855and 11730719 patents because page 5 (above) clearly describes the claimed subject matter of the cited patents (see pages 6-7 of the Office action dated 4/8/25). Further, the rejection clearly states that the patented claims lack methacrylic acid-based polymers and therefore rely on the teachings of Triastek. With respect to the argument that Triastek fails to recognize the instability of a combination of methacrylic based polymer and pemafibrate, the argument is not persuasive because the motivation to include methacrylic acid based polymer need not be the same as that of the instant application and one of an ordinary skill in the art would have been motivated to include a methacrylic acid based polymer in a pemafibrate composition in each of the above patented claim sets so as to provide controlled release of pemafibrate, as suggested by Triastek reference.
Applicants argue that the examiner ignored the differences between the claims of copending application 17/418129 because the alkylcellulose of the copending claims is a different species and that there is no reason to combine both alkyl cellulose and methacrylic based polymers. Applicants’ arguments are not found persuasive because the present claims include a “comprising” term that allows both alkyl cellulose and methacrylic-acid based polymers and further one of an ordinary skill in the art would have been motivated to include methacrylic-acid based polymers in the copending claims with an expectation to provide controlled release of pemafibrate. The rejection does not state substituting alkyl cellulose with methacrylic-acid based polymers and hence the argument that examiner does not provide a motivation for substitution of alkyl cellulose with methacrylic-acid based polymers is not found persuasive.
Applicants have not provided any arguments regarding the double patenting rejection over the pending claims of 17/418518.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAKSHMI S CHANNAVAJJALA/ Primary Examiner, Art Unit 1611