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 .
Status of the Claims
Claims 1-15 are pending and currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received and placed in the file.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 11/01/2024 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
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 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a dosage form comprising a core comprising at least one biologically active ingredient, an intermediate coating layer onto or above the core, the ICL comprising: at least one polymer; at least one alkaline agent; at least one release acceleration agent; and an enteric coating layer onto or above the intermediate coating layer, the ECL comprising: at least one polymer, does not reasonably provide enablement for wherein the dosage form provides at least 80% drug release at pH value 5 within 60 min and wherein the dosage form provides at least 80% drug release at pH value of 3 within 60 min.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims,
as discussed below:
The breadth of the claims/(B) The nature of the invention:
The claims are directed towards a dosage form comprising a core comprising at least one biologically active ingredient, an intermediate coating layer onto or above the core, the ICL comprising: at least one polymer; at least one alkaline agent; at least one release acceleration agent; and an enteric coating layer onto or above the intermediate coating layer, the ECL comprising: at least one polymer. The claims require an enteric coating layer, but then further add the limitations of drug release at pH value 5 and 3 within 60 min.
(C) The state of the prior art/(E) The level of predictability in the art:
It is known in the art that enteric coating layers release medication when the environmental pH rises above 5.5. Mohylyuk teaches in accordance with the chemical composition of investigated commercial enteric-coated delayed-release pellets, HPMC-P and methacrylic acid copolymer were used as enteric polymers (Table VII). These polymers are intended to deliver the drug into the duodenum and to dissolve at a pH of 5.5 and higher. In this study, all investigated commercial enteric-coated pellets had completely disintegrated at pH 5.5 (discussion section, third paragraph). LFA tablet presses teach The purpose of the enteric coating on tablets is to: protect the stomach against the negative/irritant effects of the tablet’s formulation; protect the active ingredient of the tablet against stomach acids by preventing it from dissolving in low pH fluids; and release the active ingredient in a specific location, which usually is in the lower area of the stomach or intestine, i.e., when the pH is 5.5 or higher (enteric-coated tablets section). Maderuelo et al. teaches the enteric coating is an outer coating that can be used in oral pharmaceutical dosage forms, and is usually made up of synthetic polymers or natural products. The enteric coating prevents the delivery of a drug in the stomach but permits release of the drug in the small intestine. To achieve this, a polymer insoluble at acid pH but soluble at intestinal pH is used. When the drug reaches the upper small intestine, the coating dissolves al lowing drug release (Enteric coating and its function section, first and second paragraph). Lastly, Yamamura teaches Distribution of pH in the gastrointestinal tract. In the stomach, strong bactericidal action is necessary, and gastric juices have a fairly strong acidity at pH 1.0–2.0 (upper right). The pH of the intestinal lumen increases on average to 6.1 in the duodenum, 7.1 in the middle small intestine, and 7.5 in the distal small intestine (right middle). Thereafter, the pH temporarily reduces to approximately 6.0 near the cecum at the entrance of the large intestine and increases toward the rectum and becomes around 7.0 near the exit of the large intestine (lower right) (Figure 1). With regards to the predictability in the art, one of ordinary skill in the art would understand that enteric coatings do not release in low pHs, therefore it seems fairly predictable that an enteric coatings would not dissolve to release the drug in a pH of 3 or 5.
Finally, MPEP 2164.03 indicates that the physiological art in general is unpredictable. “A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.”
(D) The level of one of ordinary skill: One having ordinary skill in the art would be an individual possessing an advanced degree in medicine, biomedicine, or pharmaceutical sciences.
(F) The amount of direction provided by the inventor/(G) The existence of working examples:
The specification discloses that dissolution testing in acid stage medias as well as and in in buffer stage medias with pHs ranging from 1.2 to 5 within examples 1-9, wherein in some examples no drug release was detected in pHs below 5.0, whereas in some examples drug was released in pHs below 5.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In view of the foregoing analysis, the examiner concludes that the quantity of experimentation required to practice the full scope of the invention, as claimed, would be undue.
In conclusion, therefore, the composition as instantly claimed comprising an enteric coating, but further releasing a drug at a pH of 3 and 5 seems to be an inoperative composition based on the teachings of the prior arts wherein enteric coatings release at a pH 5.5 or higher. However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In reCook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971). See MPEP 2164.08(b).
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 1-15 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 1 recites “ b) an intermediate coating layer (ICL) onto or above the core, the ICL comprising: i) at least one polymer; ii) at least one alkaline agent; iii) at least one release acceleration agent selected from the group consisting of iron oxide, aluminum oxide, titanium dioxide, dimethyl sulfoxide, zinc oxide, sucrose, maltose, lactose, dextrates, glucose, fructose, dyes, and any mixture thereof;” in lines 5-9. This language is indefinite because it is not clear if the intermediate coating layer requires all 3 of the one polymer, one alkaline agent and one acceleration agent or is it just any one of the components in the intermediate layer.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation an alkali or an earth alkali metal salt, and the claim also recites selected from the group consisting of calcium oxide, calcium carbonate, magnesium carbonate, magnesium oxide, sodium carbonate, sodium bicarbonate and sodium hydroxide or any combination thereof; or magnesium oxide or magnesium carbonate which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 1-11 and 13, are rejected under 35 U.S.C. 103 as being unpatentable over Loevgren et al. (EP0244380B1, Published 01/07/1993) in view of Wu (CN1985822A, Published 06/27/2007).
Applicant’s Invention
The claims are drawn to a dosage form, comprising; a) a core comprising at least one biologically active ingredient, b) an intermediate coating layer (ICL) onto or above the core, the ICL comprising; i) at least one polymer; ii) at least one alkaline agent; iii) at least one release acceleration agent selected from the group consisting of iron oxide, aluminum oxide, titanium dioxide, dimethyl sulfoxide, zinc oxide, sucrose, maltose, lactose, dextrates, glucose, fructose, dyes, and any mixture thereof; wherein the at least one release acceleration agent is present in 0.1 to 20 wt.-% based on the weight of the at least one polymer; and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, the ECL comprising; i) at least one polymer.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-2, an 4-5, Loevgren teaches the object of the present invention is thus an enteric coated dosage form of acid labile compounds (paragraph [0019]), wherein cores containing the acid labile compound (i.e., active ingredient) mixed with alkaline compounds or an alkaline salt of the acid labile compound optionally mixed with an alkaline compound are coated with two or more layers (paragraph [0019]). Loevgren also teaches the alkaline reacting cores containing an acid labile compound must be separated from the enteric coating polymer(s) containing free carboxyl groups, which otherwise causes degradation/discolouration of the acid labile compound during the coating process or during storage. The subcoating layer, (the separating layer) (i.e., intermediate layer), also serves as a pH-buffering zone in which hydrogen ions diffusing from the outside in towards the alkaline core can react with hydroxyl ions diffusing from the alkaline core towards the surface of the coated particles (paragraph [0025]). Loevgren further teaches the separating layer(s) can be applied to the cores - pellets or tablets, wherein the material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications (paragraph [0027]). Loevgren continues to teach the pH-buffering properties of the separating layer can be further strengthened by introducing in the layer substances chosen from a group of compounds usually used in antacid formulations such as, for instance, magnesium oxide, hydroxide or carbonate, aluminum or calcium hydroxide, carbonate (i.e., alkaline agents) (paragraph [0025]). Loevgren also teaches ordinary plasticizers, pigments, titanium dioxide (i.e., acceleration agent), talc and other additives may also be included into the separating layer (paragraph [0028]). Loevgren further teaches the enteric coating layer is applied on to the sub-coated cores conventional coating techniques such as using solutions of polymers (paragraph [0029]).
Regarding claim 3, Loevgren teaches the object of the present invention is to provide an oral, pharmaceutical preparation (paragraph [0017]).
Regarding claims 6 and 10, Loevgren teaches the material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, for instance sugar, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropyl methylcellulose (paragraph [0027]).
Regarding claim 7, Loevgren teaches as enteric coating polymers can be used co-polymerized methacrylic acid/methacrylic acid methyl esters (i.e., methacrylic acid and methyl methacrylate copolymer) such as, for instance, compounds known under the trade name EudragitR L12,5 or EudragitR L100 (paragraph [0027]).
Regarding claim 8, Loevgren teaches The enteric coating can also be applied using water-based polymer dispersions such as EudragitR L 100-55 (Röhm Pharma) (i.e., 50% methacrylic acid and 50% ethyl acrylate) (paragraph [0030]).
Regarding claim 9, Loevgren teaches As enteric coating polymers can be used, for example, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate (i.e., anionic cellulose) (paragraph [0029]).
Regarding claim 11, Loevgren teaches the core material is in the form of small beads or tablets containing the active ingredient together with an alkaline reacting compound or an alkaline salt of the active ingredient optionally together with an alkaline reacting compound (i.e., distributed in a matrix structure), wherein the core comprises hydroxypropyl cellulose, talc, lactose, Mg(OH)2 mixed together in example 3 (paragraph [0052]).
Regrading claim 13, Loevgren teaches the polymer solution (III) (i.e., intermediate layer) was sprayed onto the uncoated pellets in a fluidized bed apparatus. The spray guns were placed above the fluidized bed (i.e., spray coating) (paragraph [0041]). Loevgren also teaches the polymer solution (IV) (i.e., enteric coating) was sprayed on the subcoated pellets in a fluidized bed apparatus with spray guns placed above the bed (i.e., spray coating) (paragraph [0043]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Loevgren does not teach wherein the at least one release acceleration agent is present in 0.1 to 20 wt% based on the weight of the at least one polymer. However this deficiency is cured by Wu.
Wu teaches the pellet core of the omeprazole enteric-coated pellet preparation contains a compound selected from omeprazole or a single enantiomer. The alkali salt of the body is used as an active component and a pharmaceutical excipient, and an intermediate isolation coating layer and an enteric coating protection layer are coated on the core material (abstract). Wu also teaches the intermediate layer is a barrier coating layer, and is made of a light-shielding agent (such as titanium dioxide (i.e., acceleration agent)) And HPMC or / and PEG composition, wherein the content of the sunscreen (i.e., light-shielding agent) is 1% to 3% (Summary of the invention, second paragraph).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have the acceleration agent present in 0.1 to 20 wt% based on the weight of the at least one polymer of Loevgren’s dosage form. Loevgren teaches the subcoating layer, (the separating layer) (i.e., intermediate layer), also serves as a pH-buffering zone in which hydrogen ions diffusing from the outside in towards the alkaline core can react with hydroxyl ions diffusing from the alkaline core towards the surface of the coated particles (paragraph [0025]). Loevgren also teaches titanium dioxide (i.e., acceleration agent) and other additives may also be included into the separating layer (paragraph [0028]). The material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, hydroxypropyl methylcellulose (paragraph [0027]). One would have understood in view of Wu that the intermediate layer is a barrier coating layer, and is made of a light-shielding agent (such as titanium dioxide (i.e., acceleration agent)) And HPMC or / and PEG composition, wherein the content of the sunscreen (i.e., light-shielding agent) is 1% to 3% (Summary of the invention, second paragraph). It would have been obvious to have the acceleration agent present in 0.1 to 20 wt% based on the weight of the at least one polymer of Loevgren’s dosage form because Loevgren teaches an intermediate layer that is made from hydroxypropyl methylcellulose which can comprise titanium dioxide (i.e., acceleration agent) and Wu teaches an intermediate layer which comprises a light-shielding agent such as titanium dioxide and HPMC, wherein the titanium dioxide can be in an amount of 1% to 3% (Summary of the invention, second paragraph).
Claims 1-13, are rejected under 35 U.S.C. 103 as being unpatentable over Mcguffy et al. (US20170119680A1, Published 05/04/2017) in view of Loevgren et al. (EP0244380B1, Published 01/07/1993).
Applicant’s Invention
The claims are drawn to a dosage form, comprising; a) a core comprising at least one biologically active ingredient, b) an intermediate coating layer (ICL) onto or above the core, the ICL comprising; i) at least one polymer; ii) at least one alkaline agent; iii) at least one release acceleration agent selected from the group consisting of iron oxide, aluminum oxide, titanium dioxide, dimethyl sulfoxide, zinc oxide, sucrose, maltose, lactose, dextrates, glucose, fructose, dyes, and any mixture thereof; wherein the at least one release acceleration agent is present in 0.1 to 20 wt.-% based on the weight of the at least one polymer; and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, the ECL comprising; i) at least one polymer.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1-3, and 5-6, Mcguffy teaches the present invention advances the state of the art by developing oral solid dosage forms that achieve extended release of pharmaceutically active ingredients (paragraph [0036]). Mcguffy also teaches according to a first embodiment of the invention, an extended release oral solid dosage form comprises: (a) a fill material, said fill material comprising a liquid or semi-solid fill material containing at least one pharmaceutically active ingredient; (b) a capsule, said capsule a hard-shell capsule, containing the fill material; and (c) a coating surrounding the capsule, said coating comprising (1) a water-insoluble polymer and (2) a pore former (i.e., intermediate coating layer)(paragraph [0036]). Mcguffy continues to teach in a preferred embodiment, the pore formers of the coating of the present invention are water-soluble, pH-independent materials. Suitable pore formers include, without limitation, sucrose, dextrates, maltose, fructose, lactose (i.e., acceleration agent) (paragraph [0041]). Mcguffy further teaches similarly, an optional top-coat may be applied on the surface of the extended release coating on the capsules in order to reduce capsule sensitivity to higher ambient moisture level and/or temperature and to reduce/prevent agglomeration such as hydroxypropylmethylcellulose (i.e., polymer (paragraph [0045]).
Regarding claims 7 and 8, Mcguffy teaches in a preferred embodiment, the water-insoluble polymers of the coating of the present invention are pharmaceutically acceptable polymeric materials which include ethyl acrylate and methyl methacrylate copolymer (e.g., Eudragit NE30D) (paragraph [0040]).
Regarding claim 9, Mcguffy teaches suitable water-insoluble polymers of the coating (i.e., intermediate layer) include, without limitation, ethyl cellulose (e.g., Ethocel, Aquacoat ECD, Surelease®) (paragraph [0040]).
Regrading claim 10, Mcguffy teaches suitable water-insoluble polymers of the coating (i.e., intermediate layer) include, without limitation, polyvinyl acetate, ethyl cellulose (e.g., Ethocel, Aquacoat ECD, Surelease®) (paragraph [0040]). Mcguffy also teaches exemplary top-coats (i.e., enteric coating) include hydroxypropyl methyl cellulose, and polyvinyl alcohol (paragraph [0045]).
Regarding claim 11, Mcguffy teaches release can be achieved in hard-shell capsules (e.g., gelatin- and hypromellose-based) with liquid or semi-solid, preferably immediate-release, fills (paragraph [0036]). Mcguffy also teaches preparing a fill material, said fill material comprising a liquid or semi-solid fill material containing at least one pharmaceutically active ingredient, wherein fill material may be prepared in a closed stainless steel vessel capable of mixing under vacuum or in a suitably sized non-reactive vessel (i.e., distributed in a matrix structure) (paragraph [0047]).
Regarding claim 12, Mcguffy teaches (a) preparing a fill material, said fill material comprising a liquid or semi-solid fill material containing at least one pharmaceutically active ingredient; (b) encapsulating the fill material of step (a) with a capsule, said capsule comprising a hard-shell capsule; (c) applying a coating onto the surface of the capsule, said coating comprising (1) a water-insoluble polymer and (2) a pore former (i.e., core is the hard-shell capsule) (paragraph [0046]).
Regarding claim 13, Mcguffy teaches the coating can be applied by any conventional means. For example, the coating can be applied by spraying the coating solution/suspension onto the surface of the capsules in a perforated coating pan, semi-perforated coating pan, non-perforated coating pan, sugar coating pan, fluid bed coater/dryer, or any other piece of equipment suitable for film coating (paragraph [0050]), wherein the process of the invention may further comprise the steps of applying a top-coat after applying the coating (paragraph [0051]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Mcguffy does not teach the alkaline agent in the intermediate layer selected from the group consisting of calcium oxide, calcium carbonate, magnesium carbonate, magnesium oxide, sodium carbonate, sodium bicarbonate and sodium hydroxide (instant claims 1 and 4). However this deficiency is cured by Loevgren et al.
Loevgren teaches the object of the present invention is thus an enteric coated dosage form of acid labile compounds (paragraph [0019]), wherein the alkaline reacting cores containing an acid labile compound must be separated from the enteric coating polymer(s) containing free carboxyl groups, which otherwise causes degradation/discolouration of the acid labile compound during the coating process or during storage. The subcoating layer, (the separating layer) (i.e., intermediate layer), also serves as a pH-buffering zone in which hydrogen ions diffusing from the outside in towards the alkaline core can react with hydroxyl ions diffusing from the alkaline core towards the surface of the coated particles (paragraph [0025]). Loevgren further teaches the separating layer(s) can be applied to the cores - pellets or tablets, wherein the material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications (paragraph [0027]). Loevgren continues to teach the pH-buffering properties of the separating layer can be further strengthened by introducing in the layer substances chosen from a group of compounds usually used in antacid formulations such as, for instance, magnesium oxide, hydroxide or carbonate, aluminum or calcium hydroxide, carbonate (i.e., alkaline agents) (paragraph [0025]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have an alkaline agent in the intermediate layer selected from the group consisting of calcium oxide, calcium carbonate, magnesium carbonate, magnesium oxide, sodium carbonate, sodium bicarbonate and sodium hydroxide in Mcguffy’s oral solid dosage forms. Mcguffy teaches according to a first embodiment of the invention, an extended release oral solid dosage form comprises: (a) a fill material, said fill material comprising a liquid or semi-solid fill material containing at least one pharmaceutically active ingredient; (b) a capsule, said capsule a hard-shell capsule, containing the fill material; and (c) a coating surrounding the capsule, said coating comprising (1) a water-insoluble polymer and (2) a pore former (i.e., intermediate coating layer)(paragraph [0036]). The artisan of ordinary skill would have been motivated to add an alkaline agent in the intermediate layer of Mcguffy’s oral solid dosage form because Loevgren teaches the pH-buffering properties of the separating layer (i.e., intermediate layer) can be further strengthened by introducing in the layer substances chosen from a group of compounds usually used in antacid formulations such as, for instance, magnesium oxide, hydroxide or carbonate, aluminum or calcium hydroxide, carbonate (i.e., alkaline agents) (paragraph [0025]). The skilled artisan would have had reasonable expectation of success because Mcguffy teaches the coating compositions of the present invention function to provide extended or zero-order release of a pharmaceutically active ingredient by forming a barrier around the capsules and allowing the fill materials and pharmaceutically active ingredient to escape through small openings (i.e., pores) in the water-insoluble polymer created by the pore former (paragraph [0027]), suitable pore formers include, without limitation, hypromellose (HPMC), hydroxypropyl cellulose, povidone (polyvinylpyrrolidone), polyvinyl alcohol (paragraph [0041]), and Loevgren teaches the material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, for instance sugar, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropyl methylcellulose (paragraph [0027]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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