DETAILED ACTION
This action is in response to papers filed on 08/15/2025. Claims 1, 6-10, 13 and 16-17, 19, and 21-22 of S. Sugimoto et al., US 17/418,518 (June 25, 2021) are pending examination on the merit: claims 1, 10, 13, 16-17, 19 are amended, claims 2-5, 11-12, 14-15, 18, and 20 are canceled, and claims 21-22 are newly added. Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are rejected.
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
Acknowledgement is made of Applicant’s claim to benefit of this National Stage application PCT/JP2019/051389 filed on 12/27/2019.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/15/2025 has been entered.
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.
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over “Report on the deliberation results of Parmodia tablets 0.1 mg, Pharmaceutical Evaluation Division of Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare”, 2017, (“Parmodia Tablet Report 2017”), in view of Ceschel et al., (2001), Drug Delivery, 8:161–171; (“Ceschel”).
Regarding claims 1, 21 and 22, in the ‘Review Report’ section, dated May 17, 2017, of the Parmodia Tablet Report, a film-coated tablet, wherein each tablet contains 0.10 mg of Pemafibrate is disclosed:
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In the ‘Review Report (1)’ section, dated March 13, 2017, of the Parmodia Tablet Report, subsection 2.2 “Drug product” (p. 5), the following is disclosed about the composition of the drug product and formulation development:
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While the Parmodia Tablet Report 2017 discloses a pharmaceutical composition, in the form of a tablet, comprising pemafibrate, and also comprising typical pharmaceutically acceptable additives including alkylcellulose— present in the cited formulation as hydroxypropylcellulos—, Parmodia Tablet Report 2017 does not teach a pharmaceutical composition specifically comprising pemafibrate and an acrylic acid-based polymer.
However, to one of ordinary skill in the art, an acrylic acid-based polymer, such as the claimed (meth) acrylic polymer, or alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Nonetheless, as disclosed by Ceschel, Ceschel teaches the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, and the remaining two are both polyacrylic acid derivatives (Abstract).
Ceschel further discloses the tablets were tested using the parameters disclosed on p. 163 (“Technological Controls”), including uniformity of content, and uniformity of weight. According to Ceschel, “An overall comparison of results showed the tablets containing Carbopol 20% resulted to be the best formulation among those developed” (Abstract), particularly as it relates to drug absorption via the mucosal epithelium of the oral cavity “… which is especially useful if absorption after oral administration is incomplete or ineffective (e.g., with drugs undergoing strong first-pass effects after ingestion or which are digested on gastrointestinal transit) …” (p. 161). Table 1 of Ceschel teaches a range tested from 10 to 30 mass percent, overlapping Applicant’s claimed range, with 20% as the preferred as discussed above. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to substitute the alkylcellulose as disclosed by Parmodia Tablet Report 2017, for an acrylic acid-based polymer, such as carboxyvinyl polymer in view of Ceschel, and arrive at the claimed pharmaceutical composition comprising pemafibrate and an acrylic acid- based polymer. One would have been motivated to do so, with reasonable expectation of success, because these pharmaceutically active carriers are routine in the art and function, not only as excipients, binders, and sparingly water-soluble agents, but also to help with the uniformity of a formulation, as disclosed by Ceschel, improve uniformity of content. This therefore facilitates the development of a pharmaceutical formulation, according to claim 1, that is stable and efficient for its intended purpose. Claim 1 is therefore obvious over Parmodia Tablet Report 2017, in view of Ceschel.
Applicant has amended claim 1 to further recite mass percentages of free pemafibrate form with respect to total mass of the pharmaceutical composition and the (meth)acrylic acid-based polymer.
As discussed above, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. Parmodia Tablet Report 2017 teaches the method of claim 1, and further teaches the pharmaceutical composition comprising 0.1 mg of pemafibrate.
While the total weight of the composition is not expressly disclosed in Parmodia Tablet Report 2017, the total weight of a composition is routine, and can be optimized based on the desired effects by one of skill in the art, as long as the effective amount remains constant. The Parmodia Tablet Report 2017 teaches an effective amount to be 0.1 mg of pemafibrate.
Therefore, for a composition that is 100 mg in total weight, for example, that comprises 0.1 mg of pemafibrate would be equivalent to 0.1 mass % of pemafibrate. That is, “wherein the pemafibrate content is from about 0.1 … mass% as the free pemafibrate form of the total composition.”.
Consistent with this reasoning, and as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success based on desirability and form of administration including orally, buccally, etc., as disclosed by both prior arts. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Similarly in regard to the (meth)acrylic acid-based polymer, the same rationale is applied in view of Ceschel’s teachings. Furthermore, Applicant’s Specification does not disclose any criticality regarding the claimed range. Claim 1 is obvious over the prior arts.
Newly added claims 21-22 recite different concentrations of (A) and (B) per claim 1. Applicant’s Specification does not disclose any criticality regarding the claimed range, and as discussed above, it is considered routine to maintain active ingredient at the disclosed effective dose as taught by The Parmodia Tablet Report 2017, and adjust the composition concentration to reflect the effective amount. Consistent with this reasoning, and as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success based on desirability and form of administration including orally, buccally, etc., as disclosed by both prior arts. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Claims 21 and 22 are rejected as obvious, as is claim 1.
Regarding claim 6, and as disclosed and applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. As disclosed above, two of the three additives were polyacrylic acid derivatives (Abstract).
Regarding claim 7, and as disclosed and applied above to claim 6, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. As disclosed above, two of the three additives were polyacrylic acid derivatives (Abstract). Ceschel further teaches carboxyvinyl polymer, as an additive, to be the best of all three tablet formulations (Abstract).
Moreover, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Regarding claims 8-9, and as disclosed and applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. Parmodia Tablet Report 2017 teaches the compositions of claims 8-9, wherein the pharmaceutical composition is a solid preparation in the form of a tablet. Parmodia Tablet Report 2017 teaches the pharmaceutical composition, in the form of a tablet as disclosed and applied above to claim 1. Claims 8-9, as is claim 1, are also obvious.
Regarding claim 10, and as disclosed and applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. Parmodia Tablet Report 2017, in view of Ceschel teach the pharmaceutical composition of claim 10 comprising pemafibrate, a salt thereof or a solvate thereof, and an acrylic acid-based polymer as disclosed above.
While the prior art does not expressly disclose the method “… comprising the step of incorporating…” a (meth)acrylic acid-based polymer in a pharmaceutical composition comprising pemafibrate, a salt thereof or a solvate thereof, one of ordinary skill in the art would necessarily perform the claimed step in the course of preparing the obvious composition, for example, for commercial use; thus, meeting the claim limitation of improving content uniformity. Furthermore, Applicant’s Specification does not disclose any criticality regarding the claimed range. Claim 10 is therefore also obvious over Parmodia Tablet Report 2017, in view of Ceschel.
Regarding claim 13, and as applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. Similarly, while the total weight of the composition is not expressly disclosed in Parmodia Tablet Report 2017, the total weight of a composition is routine and can be optimized based on the desired effects by one of skill in the art. Moreover, as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Claim 13, as is claim 1, is also obvious.
Regarding claim 16, and as applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed. Ceschel teaches the composition of claim 12, and further discloses “wherein the (meth)acrylic acid-based polymer content is from about 0.001 to about 30 mass %.”.
Ceschel discloses a range in Table 1 on p. 162 wherein the acrylic acid-based polymer was present in the total formulation at 10%-30% mass percent. Moreover, as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Claim 16, as is claim 1, is also obvious.
Regarding claim 17, and as applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed.
Ceschel teaches the composition of claim 1, and further discloses “wherein the (meth)acrylic acid-based polymer content is from about 0.5 to about 5 mass%.”. Ceschel discloses a range in Table 1 on p. 162 wherein the acrylic acid-based polymer was present in the total formulation at 10%-30% mass percent. Moreover, as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Claim 17, as is claim 1, is also obvious.
Regarding claim 19, and as applied above to claim 1, Parmodia Tablet Report 2017, in view of Ceschel teachings are discussed.
While Parmodia Tablet Report 2017, in view of Ceschel teachings do not expressly disclose the limitations wherein the mass ratio of the (meth)acrylic acid-based polymer content to the pemafibrate content as the pemafirbate free form is: “… from 0.001 to 500 parts by mass…” as per claim 18, or “… from 1 to 25 parts by mass…”, optimizing the claimed range based on desirability of the composition is considered to be routine in the art. Moreover, as disclosed in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Claims 19, as is claim 1, is also obvious.
Applicant’s Arguments
Applicant argues that the references are directed to two different forms of administration, particularly oral and buccal administration and argues that buccal delivery and oral delivery are two different forms of administration. Applicant argues that no reasoning has been provided as to why one would change or optimize Ceschel’s buccal formulation into an oral formulation. Applicant argues that the motivation provided by the Examiner is not the motivation of the Applicant, and is thus essentially invalid for use as prior art.
On the contrary, Applicant argues that their invention combines pemafibrate in the presence of acrylic polymers which results in a more uniform composition— a problem that exist in formulating pemafibrate at low concentrations. Applicant argues that this motivation is not present in the prior arts cited. Applicant argues that no reasoning or suggestion has been provided as to why one of ordinary skill in the art would optimize the two components in the claimed ranges to achieve uniformity. Applicant argues that even if an “obvious to try” rationale is employed, there must be recognized need or market demand or a finite number of possible solutions. Applicant argues such an articulation is not present.
Examiner’s Response
Applicant’s arguments are acknowledged, but are not found to be persuasive in view of the rejection above. Moreover, Applicant does not provide any arguments supporting the assertion that the combination of references would render one of the references unsatisfactory for its intended purpose, and directs arguments primarily argues a single reference (i.e., “Ceschel”) as opposed to the combined teachings (i.e., the Parmodia Tablet Report 2017 in view of Ceschel).
Ceschel is the secondary reference. The primary reference teaches an oral formulation. The primary reference, in view of Ceschel teaches the claimed invention.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). MPEP § 2145.
As discussed above, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify an oral composition comprising pemafibrate and an alkylcellulose as disclosed by Parmodia Tablet Report 2017, and substitute one pharmaceutical excipient for another (i.e., for an acrylic acid-based polymer such as carboxyvinyl polymer), in view of Ceschel, and arrive at the claimed pharmaceutical composition comprising pemafibrate and a (methy)acrylic acid-based polymer such as carboxyvinyl polymer (see, instant claim 7). One would have been motivated to do so, with reasonable expectation of success, because Ceschel teaches that “An overall comparison of results showed the tablets containing Carbopol 20% (i.e., carboxyvinyl polymer or Carbopol 974P, an acrylic acid-base polymer) resulted in the best formulation among those developed for tablets, particularly as it relates to the enhanced drug absorption via the mucosal epithelium of the oral cavity. Drug absorption via the mucosal epithelium of the oral cavity is an established route of systemic drug delivery. Moreover, these pharmaceutically active carriers are routine in the art, and function not only as excipients, binders, and sparingly water-soluble agents, but also to help with the uniformity of a formulation, as disclosed by Ceschel. This facilitates the development of a pharmaceutical formulation, according to claim 1, that is stable and efficient for its intended purpose. Moreover, it should be noted that, "where 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." See MPEP § 2144.05. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955).
Regarding Applicant’s arguments about uniformity, Parmodia Tablet Report 2017, in view of Ceschel teach the pharmaceutical composition of instant claim 10 comprising pemafibrate, a salt thereof or a solvate thereof, and an acrylic acid-based polymer as disclosed above.
While the prior art does not expressly disclose the method “… comprising the step of incorporating…” a (meth)acrylic acid-based polymer in a pharmaceutical composition comprising pemafibrate, a salt thereof or a solvate thereof, one of ordinary skill in the art would necessarily perform the claimed step in the course of preparing the obvious composition, for example, for commercial use; thus, meeting the claim limitation of improving content uniformity. Claim 10 is therefore also obvious over Parmodia Tablet Report 2017, in view of Ceschel.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See 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), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In the instant case, one would be motivated to substitute one pharmaceutical excipient, (i.e., an alkylcellulose), for Carbopol 20% (i.e., carboxyvinyl polymer or Carbopol 974P, an acrylic acid-base polymer), because as disclosed by Ceschel, tablet formulations comprising Carbopol 20% resulted in the best formulation among those developed for tablets, particularly as it relates to the enhanced drug absorption via the mucosal epithelium of the oral cavity; thus, enhancing the drug’s performance. Ceschel teaches a range of 10-30 mass percent. In the absence of evidence demonstrating the criticality of the claimed range, a prima facie case of obviousness is established. According to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Moreover, "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.". In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See 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), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Furthermore, as discussed in MPEP 2144 (IV), the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
The rejections of claims 1, 6-10, 13 and 16-17, 19, and 21-22 as obvious over Parmodia Tablet Report 2017, in view of Ceschel is therefore maintained as final.
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 1, 6-10, 13 and 16-17, 19, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17418129 (‘129), in view of Ceschel et al., (2001), Drug Delivery, 8:161–171; (“Ceschel”).
The claims of ‘129 are directed to a pharmaceutical preparation comprising pemafibrate, a salt thereof or a solvate thereof; and an alkylcellulose species, formulated as a solid preparation and is in a package.
The main difference between the claimed invention and the claims of ‘129 is that the instant claims are directed to pemafibrate, a salt thereof or a solvate thereof; and an acrylic acid-based polymer as opposed to an alkylcellulose based polymer.
However, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Nonetheless, Ceschel teachings regarding the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, the two are both polyacrylic acid derivatives (Abstract) are disclosed and applied above to claim 1.
Therefore, the prima facie case of obviousness rational, as applied above to claim 1, is applied here. Moreover, the instant claims disclose the claimed formulation over a specified range. However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 7-11 of copending Application No. 17418091 (‘091).
Both the instant claims and the copending claims of ‘091 are directed to a pharmaceutical preparation comprising pemafibrate, a salt thereof or a solvate thereof; and an a (meth)acrylic acid-based polymer, formulated as a solid preparation.
The main difference between the claimed invention and the claims of ‘091 the ranges of the claimed formulation.
However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US11759456 (‘456).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘456 are directed to a pharmaceutical preparation comprising pemafibrate, a salt thereof or a solvate thereof; and an alkylcellulose species, formulated as a solid preparation.
The main difference between the claimed invention and the claims of ‘456 is that the instant claims are directed to pemafibrate, a salt thereof or a solvate thereof; and an acrylic acid-based polymer, as opposed to an alkylcellulose based polymer.
However, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Nonetheless, Ceschel teachings regarding the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, the two are both polyacrylic acid derivatives (Abstract) are disclosed and applied above to claim 1.
Therefore, the prima facie case of obviousness rational, as applied above to claim 1, is applied here. Moreover, the instant claims disclose the claimed formulation over a specified range. However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955).
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. US11406621 (‘621).
The claims of ‘621 are directed to a pharmaceutical preparation comprising pemafibrate, a salt or a solvate thereof; a lactose hydrate, and an alkylcellulose species, formulated as a solid preparation over a claimed mass range.
The main difference between the claimed invention and the claims of ‘621 is that the instant claims are directed to pemafibrate, a salt thereof or a solvate thereof; and an acrylic acid-based polymer as opposed to an alkylcellulose based polymer.
However, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Nonetheless, Ceschel teachings regarding the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, the two are both polyacrylic acid derivatives (Abstract) are disclosed and applied above to claim 1.
Therefore, the prima facie case of obviousness rational, as applied above to claim 1, is applied here. Moreover, the instant claims disclose the claimed formulation over a specified range and the presence of a lactose hydrate. However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955). Furthermore, the comprising language of the instant claims does not preclude the presence of a lactose hydrate.
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 16, and 19-24 of copending Application No. 18172855 (‘855), in view of Ceschel et al., (2001), Drug Delivery, 8:161–171; (“Ceschel”).
The claims of ‘855 are directed to a pharmaceutical preparation comprising pemafibrate, a salt thereof or a solvate thereof; and an alkylcellulose species, formulated as a solid preparation in a claimed amount.
The main difference between the claimed invention and the claims of ‘855 is that the instant claims are directed to pemafibrate, a salt thereof or a solvate thereof; and an acrylic acid-based polymer as opposed to an alkylcellulose based polymer. In addition to that, the claims of ‘855 include both lactose and magnesium stearate.
However, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents), along with both lactose and magnesium stearate.
Nonetheless, Ceschel teachings regarding the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, the two are both polyacrylic acid derivatives (Abstract) are disclosed and applied above to claim 1.
Therefore, the prima facie case of obviousness rational, as applied above to claim 1, is applied here. Moreover, the instant claims disclose the claimed formulation over a specified range. However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955). Furthermore, the comprising language of the instant claims does not preclude the presence of a lactose and magnesium stearate.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6-10, 13 and 16-17, 19, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US11419855 (‘855).
The claims of ‘855 are directed to a pharmaceutical preparation comprising pemafibrate, a salt or a solvate thereof; and an alkylcellulose species, formulated as a solid preparation and stored in a tight container.
The main difference between the claimed invention and the claims of ‘855 is that the instant claims are directed to pemafibrate, a salt thereof or a solvate thereof; and an acrylic acid-based polymer as opposed to an alkylcellulose based polymer.
However, to one of skill in the art, an acrylic acid-based polymer, including a (meth) acrylic polymer, and alkylcellulose are routine in the art of formulation as pharmaceutically acceptable carrier (for example, excipients, binders, and sparingly water-soluble agents).
Nonetheless, Ceschel teachings regarding the design of a pharmaceutical composition, in the form of three different tablets: the first comprising hydroxypropylmethyl cellulose, the second comprising carboxyvinyl polymer (Carbopol 974P), and the third tablet comprising polycarbophil; wherein the first polymer is a cellulose derivative, the two are both polyacrylic acid derivatives (Abstract) are disclosed and applied above to claim 1.
Therefore, the prima facie case of obviousness rational, as applied above to claim 1, is applied here. Moreover, the instant claims disclose the claimed formulation over a specified range. However, as disclosed above and in MPEP § 2144.05, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955).
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 September 22, 2025
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615