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 1-15 have been presented for examination on the merits.
Claims 1, 10, 13, 14 and 15 are independent.
Claim Objections
Claims 1, 5, 10, 13-15 are objected to because of the following informalities:
In claims 1, 5, 10, 13 and 15, the compound name of bempedoic is capitalized. Common chemical names and compound names should not be capitalized.
In claim 5, “free of lubricant” should either be -free of a lubricant- or -free of lubricants-.
In claims 13-15, words “liquid” and “excipient” appear to contain two different fonts.
Appropriate correction is required.
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.
Claims 2, 5-6, 8, 11-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is indefinite for reciting “the composition as claimed in claim 1 that exhibits tablet composition”. It is not clear what is the meets and scope of “exhibits tablet composition”. The term “exhibit” generally means -display-. Thus, it is not clear if the composition is a table composition, or the composition is in the form of a tablet or displays as a tablet.
Claim 5 is indefinite because it depends on claim 3 which recites the presence of components including magnesium stearate. Claim 5 however recites wherein bempedoic acid is a dry blend free of lubricant. Since magnesium stearate is a lubricant, it is not clear how the dry blend is free of lubricant.
Claim 6 recites the limitation "one or more lubricants" in the composition of claim 3. There is insufficient antecedent basis for this limitation in the claim. Claim 3 recites magnesium stearate, which according to the Specification is one of the listed lubricants. The Specification states “Non limiting examples of lubricant are colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate; and a pharmaceutically acceptable excipient” (See [0012] of published Spec. and instant claim 7). Thus, claim 3 does not provide support for -one or more lubricants-.
Claim 6 recites the limitation "in external phase of granules” in the composition of claim 3. There is insufficient antecedent basis for this limitation in the claim. Claim 3 does not provide support for granules or an external phase.
Claim 8 recites the limitation "sodium starch glycolate” in the composition of claim 3. There is insufficient antecedent basis for this limitation in the claim. Claim 3 does not provide support for sodium starch glycolate, only starch.
In claim 11, the recitation of “the amount of bempedoic acid is between 80 mg and 250 mg” is indefinite because it is not recited or clear what the said amount is based on. That is, is it based on one granule, a dose of granules, or else.
Claim 12 recites the limitation "The dry granules" in claim 10. There is insufficient antecedent basis for this limitation in the claim. Claim 10 is directed to a pharmaceutical granulate and does not support a dry granulate.
In claim 12 the full term related to the abbreviation “LOD” has not been provided.
Furthermore, claim 12 is indefinite for reciting that the LOD is less than 2% without indicating the basis for the said percentage. For example, “by weight of the composition”.
Additionally, the term “is” appears to be missing from -dried granules less than 2%-.
Claim 13 recites the limitation "the granulation liquid" in step i). There is insufficient antecedent basis for this limitation in the claim. Claim 13 does not provide support for a granulation liquid prior to this recitation.
Claim 13 recites the limitation "the mixture" in step iii). There is insufficient antecedent basis for this limitation in the claim. Claim 13 does not provide support for a mixture prior to this recitation.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The term “immediate release” in claims 1 and 15 is an intended use limitation and not limiting the scope of the claimed composition or method.
Claim 3 states that the said composition comprises one or more of …… . Claim 8 which depends on claim 3, recites the concentration ranges of each of the said components. Given their broadest reasonable interpretation, only one of the said components is required by claim 8.
In claim 4, the term “free” does not have a definition in the Specification.
Applicant’s claims
Claim 1 is directed to an oral immediate release pharmaceutical composition comprising bempedoic acid.
Claims 13-15 are directed to a process for wet granulation, making a granulate or tablet.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Abdelnasser et al (US 20180338922).
Abdelnasser et al teach compositions comprising: bempedoic acid, methods of using and processes for making said compositions. Notably, the formulations herein provide pharmaceutical compositions having excellent stability and release properties (See abstract).
Regarding claims 1-2, Abdelnasser et al teach oral immediate release tablets comprising 180 mg bempedoic acid (See [0235]).
Regarding claims 3 and 7, Abdelnasser et al teach a pharmaceutical composition comprising: bempedoic acid admixed with a lubricant selected from the group consisting of: colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. The said composition further comprises one or more of hydroxypropyl cellulose (HPC-L), a saccharide, microcrystalline cellulose and a starch (See [0044]-[0045] and [0049]).
Regarding claims 3 and 4, Abdelnasser et al teach a pharmaceutical composition wherein the saccharide, is lactose monohydrate (See [0054]).
Regarding claim 5, Abdelnasser et al teach a composition comprising bempedoic acid and one or more excipients. When bempedoic acid is blended with celluloses, starch or saccharide, this embodies a composition free of lubricants (See [0048]-[0049]).
Regarding claim 6, Abdelnasser et al teach that wherein the composition is in the form of a tablet and further comprises a polyvinyl alcohol (PVA) based coating; and wherein the coating comprises: polyvinyl alcohol (PVA), glycerol monocaprylocaprate type 1, sodium lauryl sulfate, titanium dioxide and talc (See [0056] and claim 5).
Regarding claims 8-9, Abdelnasser et al teach a pharmaceutical composition wherein the amount of magnesium stearate is between 1 mg and 10 mg, the amount of hydroxypropyl cellulose (HPC-L) is between 5 mg and 25 mg, the amount of saccharide is between 50 mg and 100 mg, the amount of microcrystalline cellulose is between 25 mg and 100 mg and the amount of sodium starch glycolate is between 5 mg and 50 mg (See [0057]).
Regarding claims 10-11, Abdelnasser et al teach a granulated composition comprising 180 mg bempedoic acid; 3.5 mg colloidal silicon dioxide; 9.6 mg microcrystalline cellulose; and 12 mg hydroxypropyl cellulose (See claim 10).
Regarding claim 12, Abdelnasser et al teach that loss on drying of granules is controlled with a limit of not more than 2% (See Tables 22 and 34).
Regarding claim 14, Abdelnasser et al teach a process of making granules comprising co-sifting and dry blending the granule materials, wet granulation of the material by adding a fluid, drying and milling and sizing the granules (See Table 31).
Claims 1-3 and 5-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lalwani et al (WO 2019161307).
Lalwani et al teach pharmaceutical formulation comprising the components: (i) 50-70% bempedoic acid, (ii) a filler, (iii) a diluent or solubilizer, and (iv) a binder, wherein the formulation is formulated for the sustained release of bempedoic acid (See abstract and claim 1). The said formulations may be immediate release formulation (See [0031]).
Regarding claims 1, 3, 7 and 9, Lalwani et al teach the composition wherein the filler is selected from a group consisting of microcrystalline cellulose, sodium carboxymethylcellulose, and diluent or solubilizer is selected from a group consisting of sodium lauryl sulfate and sodium starch glycolate (See [0004] and claims 1-3). Excipients can be added to satisfy certain pharmaceutical functions such as diluents (fillers), binders, granulating agents, disintegrants, and lubricants (See [0117]).
Regarding claim 2, Lalwani et al teach that the said formulations are formulated as oral tablets (See [0009], [0015], [0047], [0084] and [0120]).
Regarding claim 5, Lalwani et al teach oral tablet composition that may comprise excipients other than lubricants.
Regarding claims 8-11, Lalwani et al teach a composition wherein the filler component is, e.g., microcrystalline cellulose, and is present in the amount of 5-50% w/w, or the binder component is about 0.1-1.5% w/w. The said formulation may comprise from 50-70% w/w bempedoic acid, 30%-45% w/w filler component, 1-5% w/w diluent or solubilizer component, and 0.1-1.5% w/w binder component. The formulations may comprise, e.g., 40, 80, 100, 180, or 220 mg of bempedoic acid (See [0006] and claims 18-20).
Regarding claim 12, Lalwani et al teach that the wet spheres comprising ETC-1002 are then dried until their moisture content, as measured in terms of loss on drying (LOD), is <2% (See [00298]).
Regarding claims 6 and 13-15, Lalwani et al teach the processes to make solid dosage form include a generic process such as manufacturing by the wet granulation technique. For example, bempedoic acid and polymer(s) are blended using a solvent, such as methanol, as the granulation fluid. The remaining excipients are dissolved in a portion of granulation fluid and this mixture is wet blended slowly added to the bempedoic acid with continual mixing in the blender. Granulating fluid is added until a wet blend is produced, which wet mass blend is then forced through a predetermined screen onto oven trays. The blend is dried. The dried granules are then sieved. Then a lubricant such as magnesium stearate is granulated into the mixture and then put into milling jars and milled. Following that, the composition is then co-pressed and perhaps coated with a further excipient (See [00185]). Suitable solvents suitable for manufacturing the dosage form components comprise aqueous or inert organic solvents that do not adversely harm the materials used in the system. The solvents include, aqueous buffer solvents, methanol, ethanol, water, aqueous solvents, etc, (See [0190]).
Claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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