DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/01/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 07/01/2026, is acknowledged. Amendments to the specification have been entered.
Claims 1-2, 8-17, 20-23 are pending in this action. Claim 7 has been cancelled. Claims 3-6, 18-19, 24-25 have been cancelled previously. Claims 1-2, 8-17, 20-23 have been amended. Claims 1-2, 8-17, 20-23 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a 371 of PCT/MX2020/050034, filed September 29, 2020.
Claim Objections
Claims 1, 22, 23 are objected to because of the following informalities:
Claim 1 comprises the typographic error “micronized fenofibrate, or its micronized salt” that needs to be corrected to “micronized fenofibrate or its micronized salt”.
Claim 1 comprises the typographic errors “d10”, “the d50“, “the d90” that need to be corrected to “a d10”, “a d50“, ‘a d90” or clarified.
As stated previously, claim 22 comprises the typographic error “incorporating the atorvastatin” that needs to be corrected to “incorporating atorvastatin”.
Claim 23 comprises the typographic error “iron oxide in weight gain” that needs to be corrected to “iron oxide” or clarified.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-2, 8-17, 20-23 are 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the limitation “a pharmaceutically acceptable amount of at least one of binders, diluents, disintegrants, pH modulators, surfactants, lubricants, solvents, and coatings, or mixtures thereof” that is not reasonably clear. First, it is unclear if said limitation disclose compositions comprising a mixture of one or more binders in combination with other recited functional agents, OR a mixture comprising at least one of recited functional agents? Second, it is noted that claim 1 discloses compositions in a solid form of tablet. To this point, it is noted that “surfactant” is a chemical compound that decreases the surface tension or interfacial tension between two liquids, a liquid and a gas, or a liquid and a solid (see Wikipedia), i.e., between different phases. Therefore, it is unclear what is understood as a surfactant in the claimed solid compositions. Therefore, the metes and bounds of the claim are not reasonably clear, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to the limitations “pH modulators”, “solvents”, as well as to claims 12, 13, 17. Clarification is required.
Newly amended claim 1 recites the limitation “particle diameter of less than 30 µm”, and further recites the numerical limitations for d10, d50 and d90. In the present case, it is unclear to which particles diameters said limitation, i.e., “less than 30 µm”, refers. Furthermore, it is noted that terms d10, d50, d90 are not clearly defined in the instant specification, because it is not clearly stated what “% of the particles” (i.e., by volume, by mass, by number) is used to characterize said characteristics of the diameter distribution (i.e., d10, d50, d90). Clarification is required.
Newly amended claim 1 further discloses “compositions”, wherein several elements are characterized by their assumed function (e.g., binders, diluents, disintegrants, etc.) and not by the structure essential for said compositions. This claim is unclear and indefinite, because the function of a particular compound may change and/or depend on conditions. In specification the applicant provides a support to this point stating that some starch derivatives (e.g., pregelatinized starch, corn starch) can be used as diluents and as disintegrants (Para. 0059). Therefore, given that the scope of the claims is not limited by claim language that does not limit a claim to a particular structure (MPEP 2111.04), one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
Claims 2, 8-11, 14-16, 20-22 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-2, 8-17, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over García-Salgado López, WO 2014/195900A2 (cited in IDS, machine translation, hereinafter referred to as García-Salgado López), in view of Ryde et al., US 2003/0224058 A1 (hereinafter referred to as Ryde), and Shenoy et al., US 2009/0162442 A1 (hereinafter referred to as Shenoy).
García-Salgado López teaches solid oral pharmaceutical compositions/tablets that may include: (i) 10-80 mg of atorvastatin or its calcium salt, and (ii) 67-400 mg of fenofibrate that can be micronized, and further provides the examples of compositions comprising 20 mg or 20.7 mg of atorvastatin calcium salt and 160 mg of fenofibrate (Claims 1, 3, 6, 23, 25; Detailed Description of the Invention; Examples 3, 4 as applied to claims 1, 2).
García-Salgado López teaches that said compositions may include one or more excipients selected from diluents, binders, disintegrants, surfactants, lubricants, co-solvents, coating, etc. (Claims 7, 33; Detailed Description of the Invention as applied to claim 1). To this point, García-Salgado López teaches that said compositions may include: (i) 5-40 wt% of poloxamer, e.g., Poloxamer 188 (Claim 1; Detailed Description of the Invention; Examples as applied to claim 8); (ii) 5-50 wt% of lactose monohydrate (Claim 16; Detailed Description of the Invention as applied to claim 9); (iii) 1-5 wt% of sodium starch glycolate (Claim 12; Detailed Description of the Invention as applied to claim 11); (iv) 0.5-2 wt% of sodium lauryl sulfate (Claims 11, 13, 17 ; Detailed Description of the Invention; Examples as applied to claim 13); and (v) 0.25-5 wt% of magnesium stearate (Claim 11; Detailed Description of the Invention; Examples as applied to claim 14). García-Salgado López also teaches that said compositions/tablets may contain 2.5- 6 wt% of a coating that gives protection from humidity, light, etc. and said coatings may include polyvinyl alcohol, titanium dioxide, Opadry, and other constituents (Claim 42; Page 25).
García-Salgado López does not teach micronized fenofibrate having a particle size of less than 30 µm (claim 1), and also does not teach compositions comprising magnesium aluminum silicate (claim 10), magnesium oxide (claim 12), or a moisture barrier coating Opadry AMB (claim 16).
Ryde teaches solid dosage forms/compositions/tablets comprising fenofibrate particles having an effective average particle size of less than 2 µm (Para. 0013, 0014, 0140) that can used in combination with atorvastatin (Para. 0066-0068). Ryde teaches that said compositions/tablets may include: (i) a combination of surface stabilizers such as sodium lauryl sulfate, poloxamers such as Pluronic F-68 (that is the different name for Poloxamer 188; see Wikipedia) and magnesium aluminum silicate (Para. 0081-0083); (ii) lactose monohydrate/filling agent (Para. 0105); (iii) sodium starch glycolate/disintegrant (Para. 0110); (iv) magnesium stearate/lubricant (Para. 0106); and (v) can be coated with Opadry AMB composition present in an amount of 3.8-4.5 wt% (Para. 0196-0198).
Shenoy teaches compositions/tablets comprising fibrate/fenofibrate and statin/atorvastatin as active compounds (Title; Abstract; Para. 0060, 0064), wherein said compositions/tablets also include: (i) sodium lauryl sulfate/stabilizer (Para. 0063); (ii) magnesium aluminum silicate, magnesium oxide, sodium starch glycolate, lactose as absorbent carriers (Claim 15; Para. 0059, 0065, 0066, 0069, 0070); (iii) poloxamer, e.g., poloxamer 188, magnesium stearate as carriers or lubricants (Para. 0068, 0070, 0096, 0104, 0105). Shenoy also teaches controlling average particle diameter of active compounds to be less than 10 microns (Para. 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control fenofibrate particles size and/or use/try additional functional agents and/or a coating as taught by Ryde and Shenoy preparing composition as taught by García-Salgado López. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used for improving bioavailability of fenofibrate that is insoluble in water, as well as the efficiency and stability of compositions comprising a combination of fibrate/fenofibrate and statin/atorvastatin. Claims 20-23 are rejected as been dependent on rejected base claim.
Response to Arguments
Applicant's arguments, filed 07/01/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant's arguments that García-Salgado López teaches the use of a co-solvent in preparation of disclosed compositions, it is noted that newly amended claim 1 discloses compositions in a solid state/tablet, wherein said compositions may include “solvents” (i.e., plural). Further, it is noted that the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). To this point, it is noted that the Patent Office is not equipped to manufacture products by the myriad number of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the applicants.
In response to applicant‘s argument that preferred embodiments and examples shown by Shenoy correspond to liquid multiphase formulations, it is noted that “A reference is not limited to working examples.” In re Fracalossi 215 USPQ 569 (CCPA 1982). “A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill might reasonably infer from the teachings. In re Opprecht 12 USPQ 2d 1235, 1236 (Fed. Cir. 1989); In re Bode 193 USPQ 12 (CCPA 1976); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Bozek 163 USPQ 545, 549 (CCPA 1969); In re Preda 159 USPQ 342 (CCPA 1968); In re Van Mater 144 USPQ 421 (CCPA 1965); In re Jacoby 135 USPQ 317 (CCPA 1962); In re LeGrice 133 USPQ 365 (CCPA 1962). “Nonpreferred embodiments can be indicative of obviousness.” Merck & Co. v. Biocraft Laboratories Inc. 10 USPQ 2d 1843 (Fed. Cir. 1989); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Kohler 177 USPQ 399 (CCPA 1973); In re Mills 176 USPQ 196 (CCPA 1972); In re Bozek 163 USPQ 545 (CCPA 1969); In re Meinhardt 157 USPQ 270 (CCPA 1968); In re Boe 148 USPQ 507 (CCPA 1976); In re Nehrenberg 126 USPQ 383. In the present case, the examiner maintains the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control fenofibrate particles size and/or use/try additional functional agents and/or a coating as taught by Ryde and Shenoy preparing composition as taught by García-Salgado López, because the cited prior art teaches that said approach can be used for improving bioavailability of fenofibrate that is insoluble in water, as well as the efficiency and stability of compositions comprising a combination of fibrate/fenofibrate and statin/atorvastatin.
Applicant is advised to clarify the claim language/scope, the structures of the constituents to be included into the claimed compositions/products as well as method steps to make said compositions/products, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in conditions for allowance.
Conclusion
No claim is allowed at this time.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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