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 . Claims included in the prosecution are claims 1, 4, 14 and 21-23.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/10/2026 has been entered.
Applicants' arguments, filed 02/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a)
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 22 and 23 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.
This is a new matter rejection.
Claim 22 recites discrete solid particles. The claim fails to comply with the written description requirement since such limitation is not disclosed in the specification. At best, the specification discloses on page 18, line 16 wherein micronized fenofibrate are particles, but nowhere does it disclose wherein the particles are discrete solid particles.
Claim 23 recites wherein the composition is bioequivalent to a co-administration of a rosuvastatin immediate-release tablet and a fenofibrate immediate-release tablet, as determined by 90% confidence intervals for Cmax and AUC failing within 80-125% for both rosuvastatin and fenofibrate. The claim fails to comply with the written description requirement since the specification does not disclose wherein the claimed invention is bioequivalent to any co-administration of a rosuvastatin immediate-release tablet and fenofibrate immediate-release tablet. According to page 46, lines 5-9 of the specification, the composition is specifically bioequivalent to the concomitant administration of a 160 mg fenofibrate immediate-release tablet and a 20 mg rosuvastatin immediate-release tablet.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites wherein the rosuvastatin layer further comprises rosuvastatin calcium. The claim is indefinite since it is unclear if rosuvastatin calcium is in addition to the pharmaceutically acceptable salt of rosuvastatin recited in claim 1 or if rosuvastatin calcium is the pharmaceutically acceptable salt of rosuvastatin recited in claim 1.
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.
1. Claims 1, 4, 14, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al. (US 2008/0131503, Jun. 5, 2008) (IDS reference) (hereinafter Holm) in view of Grenier et al. (US 2005/0095297, May 5, 2005) (hereinafter Grenier), Kocevar et al. (WO 2014/009436, Jan. 16, 2014) (hereinafter Kocevar), and Kayser et al. (US 2008/0096900, Apr. 24, 2008) (hereinafter Kayser).
Holm discloses a pharmaceutical composition for oral administration comprising a fixed dose combination of a first solid pharmaceutical composition containing fenofibrate as the active substance and a second solid pharmaceutical composition containing an HMG-CoA reductase inhibitor such as a stain as the active substance, wherein the first and the second pharmaceutical compositions are present in separate entities in a single solid dosage form. For example, a multilayer tablet or two-layer tablet (abstract). The HMG-CoA reductase inhibitor may be rosuvastatin or a pharmaceutically acceptable salt thereof (¶ [0029]). The first and second pharmaceutical compositions are present in at least two separate layers (¶ [0026]). The first composition may comprise micronized crystalline fenofibrate (claim 28). The active substance(s) may be released relatively fast in order to obtain an enhanced on-set of action (¶ [0078]). The solid dosage form comprises from about 100 to about 170 mg of fenofibrate, such as 160 mg, and from about 5 to about 80 mg of statin, such as 20 mg (¶ [0073]). In one embodiment, about 70% w/w/ or more of the fibrate and/or the statin is released from the composition within about 20 min or 15 min when tested in an in vitro dissolution test (¶ [0085]). The composition may contain one or more pharmaceutically acceptable excipients (¶ [0033]). Suitable excipients include lactose as a filler, diluent and/or binder (¶ [0042]), microcrystalline cellulose as a filler, diluent and/or binder (¶ [0042]), croscarmellose sodium as a disintegrant (¶ [0044]), and crospovidone as a disintegrant (¶ [0044]). The lactose may be lactose monohydrate (¶ [0087]). The composition may also comprise one or more surfactants for improving solubility characteristics of the active substance (¶ [0049]). It is within the skills of the average practitioner to select a suitable vehicle being pharmaceutical acceptable, capable of dispersing or fully or at least partly dissolving the active substance using general knowledge and routine experimentation (¶ [0054]).
Holm differs from the instant claims insofar as not teaching wherein the micronized fenofibrate has D(v,50) of more than 0.04 µm and less than or equal to 20 µm.
However, Grenier discloses a pharmaceutical formulation comprising nanoparticles of a fibrate (abstract). The D50 particle size of fenofibrate is in the range 350-750 nm (0.35-0.75 µm) (¶ [0028]). The particle size is a volume average particle size (¶ [0027]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the fenofibrate of Holm to have a D50 particle size in the range of 350-750 nm (0.35-0.75 µm), wherein the particle size is a volume average particle size, since Holm does not disclose a particle size for the fenofibrate and this is a known and effective particle for fenofibrate used in pharmaceutical compositions as taught by Grenier.
The combined teachings of Holm and Grenier do not teach wherein a width of the particle size distribution expressed as span is from 1.2 to 3
However, Kocevar discloses a nanosuspension comprising abiraterone acetate in the form of particles having a particle size in the range of less than 5000 to 10 nm. It is preferred that the span, i.e. the width of the particle size distribution, is narrow. A narrow span results in better reproducibility of results from batch to batch. The span is from 30 to 0.01 (page 6/40).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the span of fenofibrate to be 30 to 0.01 since this range results in better reproducibility of results from batch to batch as taught by Kocevar.
The combined teachings of Holm, Grenier, and Kocevar do not teach wherein the composition comprises sodium lauryl sulfate, lactose anhydrous, and rosuvastatin calcium.
However, Kayser discloses a pharmaceutical composition (abstract). To aid dissolution of the compound of the composition into an aqueous environment a surfactant might be added as a wetting agent. Suitable surfactants include sodium lauryl sulfate (¶ [0198]). One may dilute the compound of the composition with diluents such as anhydrous lactose (¶ [0193]). Medicaments such as rosuvastatin calcium may be added to the composition (¶ [0260]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Holm discloses wherein the composition comprises one or more surfactants for improving solubility characteristics of the active substance. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium lauryl sulfate into the composition of Holm since it is a known and effective surfactant for aiding in dissolution as taught by Kayser.
Holm discloses wherein the composition comprises lactose as a diluent. Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated lactose anhydrous into the composition of Holm since it is a known and effective lactose for diluting as taught by Kayser.
Holm discloses wherein the composition comprises a pharmaceutically acceptable salt of rosuvastatin. Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated rosuvastatin calcium into the composition of Holm since it is a known and effective pharmaceutical salt of rosuvastatin as taught by Kayser.
Regarding instant claim 1 reciting wherein the fenofibrate layer comprises lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, crospovidone, and sodium lauryl sulfate, and the rosuvastatin layer comprises lactose anhydrous, microcrystalline cellulose, and crospovidone, Holm discloses wherein it is within the skills of the average practitioner to select a suitable vehicle being pharmaceutical acceptable, capable of dispersing or fully or at least partly dissolving the active substance using general knowledge and routine experimentation. Therefore, one of ordinary skill in the art would have arrived at the claimed combination of excipients in each layer through routine experimentation based on the excipients required for dispersing and/or dissolving the active substance in each layer.
Regarding instant claim 4 reciting that the fenofibrate is not in the form of a solid solution or solid dispersion, Holm discloses in ¶ [0056] wherein it is preferable that the form of the active substance be a solid solution or solid dispersion. Because this is merely a preferred embodiment, it would have been obvious to one of ordinary skill in the art that such form is not required. This is further evident from claim 29 of Holm, which is a dependent claim that recites wherein the first composition comprises a solid solution of fenofibrate. Since this limitation is in a dependent claim, it would have been obvious to one of ordinary skill in the art that Holm does not require the form of fenofibrate to be a solid solution. Therefore, since Holm does not disclose wherein fenofibrate is required to be in the form of a solid solution or solid dispersion, it would have been obvious to one of ordinary skill in the art that the fenofibrate does not need to be in such form.
Regarding instant claim 23, since the composition of Holm is substantially structurally the same as the claimed invention, comprises substantially the same rosuvastatin and fenofibrate as the claimed invention, comprises substantially the same amount of rosuvastatin and fenofibrate as the claimed invention, and immediately releases rosuvastatin and fenofibrate like the claimed invention, the composition of Holm is necessarily bioequivalent to a co-administration of a rosuvastatin immediate-release tablet and a fenofibrate immediate-release tablet like the claimed invention.
2. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Holm et al. (US 2008/0131503, Jun. 5, 2008) (IDS reference) (hereinafter Holm) in view of Grenier et al. (US 2005/0095297, May 5, 2005) (hereinafter Grenier), Kocevar et al. (WO 2014/009436, Jan. 16, 2014) (hereinafter Kocevar), Kayser et al. (US 2008/0096900, Apr. 24, 2008) (hereinafter Kayser), and further in view of Lerner et al. (WO 2007/075171 A1, Jul. 5, 2007) (hereinafter Lerner).
The teachings of Holm, Grenier, Kocevar, and Kayser are discussed above. Holm, Grenier, Kocevar, and Kayser do not teach wherein the micronized fenofibrate is present as discrete solid particles.
However, Lerner discloses a pharmaceutical composition of fenofibrate and a dosage form containing it (abstract). The fenofibrate can be present as discrete molecules or it can be present in aggregates (¶ [00018]).
Holm does not disclose the form of the micronized fenofibrate. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the micronized fenofibrate as discrete particles since this is a known and effective form of fenofibrate for pharmaceutical compositions as taught by Lerner.
Response to Arguments
Applicant argues that Holm neither discloses nor indicates the example to support the combination of fenofibrate with rosuvastatin.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to working examples. As such, Applicant’s argument is unpersuasive.
Applicant argues that it has been found that the activity of rosuvastatin in inhibiting HMG-COA reductase has been studied in the purified human catalytic domain and it was shown that rosuvastatin was more potent than other available statins with at least 50% inhibitory concentration.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided a copy of the NPL disclosing this. Therefore, the Examiner cannot verify whether Applicant’s statement is factual. Additionally, Applicant has provided the Kumar NPL reference in the 04/18/2025 IDS which discloses rosuvastatin in combination with fenofibrate. As such, using rosuvastatin with fenofibrate would have been obvious and Applicant’s argument is unpersuasive.
Applicant argues that Holm does not disclose or exemplify a composition comprising fenofibrate and rosuvastatin, and the content of fenofibrate granules exemplified in Holm differs from that of fenofibrate granules of independent claim 1.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, a prior art reference is evaluated for all that it reasonably suggests and is not limited to working examples. As such, Applicant’s argument is unpersuasive.
Applicant argues that Holm provides no guidance or motivation to select the specific claimed PSD ranges and span control in the range of 1.2 to 3 critical to performance of a multilayer fenofibrate and rosuvastatin composition.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art Is required to teach each and every claim limitation. As discussed in the rejection, Grenier and Kovevar teach the claimed PSD ranges and span control, respectively. Applicant has not addressed why the claimed PSD ranges and span control would not have been obvious from the teachings of Grenier and Kovevar. Also, Applicant has not shown wherein the claimed PSD ranges and span control are critical/unexpected. As such, Applicant’s argument is unpersuasive.
Applicant argues that Holm’s general disclosure of HMG-CoA reductase inhibitors’ does not direct a POSITA to select rosuvastatin in particular, nor to formulate it with fenofibrate in a multilayer, immediate-release tablet.
The Examiner does not find Applicant’s argument to be persuasive. Holm specifically discloses in paragraph [0029] wherein the HMG-CoA reductase may be rosuvastatin. Therefore, Holm does direct a POSITA to select rosuvastatin. Although there are multiple HMG-CoA reductases to select from, selecting from a finite number of identified, predictable solutions, with a reasonable expectation of success supports a conclusion of obvious. See MPEP 2143(I). As such, Applicant’s argument is unpersuasive.
Applicant argues that Grenier’s formulations are fundamentally different from independent claim 1.
The Examiner does not find Applicant’s argument to be persuasive. The rejection states wherein the composition of Holm is being modified, not the composition of Grenier. Greiner was used to provide motivation to formulate the fenofibrate of Holm to have a D50 particle size in the range of 350-750 nm (0.35-0.75 µm), wherein the particle size is a volume average particle size. Applicant has not addressed why this motivation would not have been obvious. As such, the rejection is maintained and Applicant’s argument is unpersuasive.
Applicant argues that Grenier does not teach or suggest that the same particle size range is optimal or even suitable when fenofibrate is in a separate layer of a multilayer dosage form with a statin, nor does Grenier discuss span or any PSD width parameter.
The Examiner does not find Applicant’s argument to be persuasive. It is not clear why having fenofibrate in a separate layer would affect what particle sizes are suitable. Also, it is not necessary for Greiner to discuss span since no one reference is required to teach each and every claim limitation. As discussed in the rejection, Kocevar teaches that limitation. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no teaching in Holm that any particular PSD or span is critical, nor any suggestion in Grenier that the D50 range taught there is particularly advantageous in a multilayer fixed-dose statin/fibrate tablet.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Kocevar teaches the claimed span. Furthermore, Applicant has not shown wherein the claimed particle size is advantageous. Therefore, it is not necessary for the prior art to teach wherein the claimed particle size is advantageous. As such, Applicant’s argument is unpersuasive.
Applicant argues that in Grenier, nanoparticles and nano-suspensions comprise fenofibrate, and vitamin E TPGS as a stabilizer. Independent claim 1 does not contain vitamin E TPGS to prepare multilayer immediate release formulation.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, the rejection states wherein the composition of Holm is being modified, not the composition of Grenier. As such, Applicant’s argument is unpersuasive.
Applicant argues that the claimed invention of independent claim 1 is not related to nanoparticles.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, the rejection states wherein the composition of Holm is being modified, not the composition of Grenier. As such, Applicant’s argument is unpersuasive.
Applicant argues that Kocevar does not disclose immediate-release bilayer tablets.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Holm teaches an immediate-release bilayer tablet. As such, Applicant’s argument is unpersuasive.
Applicant argues that Kocevar’s disclosed span range of 0.01 to 30 is extraordinarily broad and does not specifically teach or suggest of independent claim 1 narrow span of 1.2 to 3 as critical.
The Examiner does not find Applicant’s argument to be persuasive. In cases involving overlapping ranges, even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Therefore, the claimed range is still obvious since Kocevar teaches an overlapping range. Additionally, Applicant’s has not shown wherein the claimed range is critical. As such, Applicant’s argument is unpersuasive.
Applicant argues that Kocevar is non-analogous art.
The Examiner does not find Applicant’s argument to be persuasive. A reference is analogous to the claimed invention if the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem). See MPEP 2141.01(a). Kocevar is analogous art to the claimed invention because both the claimed invention and Kocevar are in the pharmaceutical field. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no motivation for a person of ordinary skill in the art to select the specific span of 1.2 to 3 for micronized fenofibrate based on a reference discussing abiraterone nano-suspensions having a span range this is orders of magnitude wider.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the span of fenofibrate to be 30 to 0.01 since this range results in better reproducibility of results from batch to batch as taught by Kocevar. Kocevar does not disclose wherein the span is specific to abiraterone acetate and Applicant has not shown wherein span is dependent on the drug. As such, Applicant’s argument is unpersuasive.
Applicant argues that the selection of a tight span of 1.2 to 3 recited in independent claim 1 is critical for the dissolution consistency of the micronized fenofibrate in the multilayer composition claimed by independent claim 1.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided objective evidence to support their allegation. Therefore, Applicant’s argument is merely speculative. Also, 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 MPEP 2144(IV). Therefore, the prior art does not need to teach the same reason for the claimed span as Applicant. As such, Applicant’s argument is unpersuasive.
Applicant argues that independent claim 1 does not merely recite generic excipients, it recites a specific pattern of excipient and carriers, separated by layer, in a particular fixed-dose composition. The claimed composition places the moisture-containing excipient in the fenofibrate layer. The claimed composition places the moisture-free excipient in the rosuvastatin layer to enhance stability.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown with objective evidence wherein the specific pattern of excipients is critical. Therefore, Applicant’s argument is merely speculative and unpersuasive. Also, 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 MPEP 2144(IV). Thus, it is not necessary for the art to disclose the specific pattern for the same reason as Applicant. As discussed in the rejection, Holm discloses wherein it is within the skills of the average practitioner to select a suitable vehicle being pharmaceutical acceptable, capable of dispersing or fully or at least partly dissolving the active substance using general knowledge and routine experimentation. Therefore, one of ordinary skill in the art would have arrived at the claimed combination of excipients in each layer through routine experimentation based on the excipients required for dispersing and/or dissolving the active substance in each layer. As such, Applicant’s argument is unpersuasive.
Applicant argues that Holm affirmatively directs the skilled person toward formulations in which fenofibrate is at least partially dissolved or molecularly dispersed in a carrier matrix.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments. Also, as discussed in the rejection, Holm discloses in ¶ [0056] wherein it is preferable that the form of the active substance be a solid solution or solid dispersion. Because this is merely a preferred embodiment, it would have been obvious to one of ordinary skill in the art that such form is not required. This is further evident from claim 29 of Holm, which is a dependent claim that recites wherein the first composition comprises a solid solution of fenofibrate. Since this limitation is in a dependent claim, it would have been obvious to one of ordinary skill in the art that Holm does not require the form of fenofibrate to be a solid solution. Therefore, since Holm does not disclose wherein fenofibrate is required to be in the form of a solid solution or solid dispersion, it would have been obvious to one of ordinary skill in the art that the fenofibrate does not need to be in such form. As such, Applicant’s argument is unpersuasive.
Regarding the status of foreign counterpart applications, the Examiner is not obligated to allow an application just because a foreign patent agency has allowed a similar application. The patent laws of each country vary. The claims in the current application do not appear to be nonobvious and allowable as shown in the rejection above. None of the arguments Applicant presented are persuasive. Therefore, no claims are allowed.
Conclusion
Claims 1, 4, 14 and 21-23 are rejected.
Claim 20 has been withdrawn.
No claims are allowed.
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/TRACY LIU/ Primary Examiner, Art Unit 1614