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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claim 5 and claims depend therein) in the reply filed on 11/14/2025 is acknowledged.
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 5 and 22-35 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 5 recited the limitation “in amounts in the spray coated layer within 10% of the desired pharmaceutical amounts”. What is the “desired” pharmaceutical amount, and how will one determine that?
Claim 24 recited “a solvent system based on ethanol and water.” What is a “solvent system based on ethanol and water”?
Claim 29 recited “wherein the first coating of step (i) is also applied using spray coating step.” There is insufficient antecedent basis for this limitation in the claim. While claim 5 recited a first coating, there was no “first coating step” literally. Further on this subject, what is also applied as a coating step in claim 5 besides “spray coating” recited in claim 29?
Claims 22, 23, 30 and 32 recited limitations with respect to heating/curing the first coating. However, it is not quite clear if the steps of heating/curing and applying the coaing at temperature of 60°C or higher are the same. If so, then what about claim 30? Claim 30 recited that step (i) includes applying the coating at temperatures of up to maximally 55°C. If there are several methods to apply the first coating at different temperatures, then an election of species is required, and that is to elect temperature of 60°C or higher, or temperature of maximally 55°C. For examining purpose, the claims are interpreted to have temperature between 55°C-60°C.
Claim 31 recited “wherein the first coating around the core in step i) comprises ethylcellulose.” Is this ethyl cellulose the hydrophobic polymer or the hydrophilic substance of claim 5, or is it something else?
Claim 33 recited the limitation “Sildenafil or Buspirone” capitalized. This limitation is confused because both sildenafil and buspirone are not a trademark or trade name.
Claim 35 recited “the spray coated layer in at least 99% of the individual tablet in an amount thereof within 4% of the average amount of that compound in the batch.” It is not quite clear exactly what amount of testosterone is included in the coating.
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.
Claims 5 and 22-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bloemers et al. KR 20140048882 A.
Bloemers teaches a dual drug delivery device comprising a time controlled, immediate release drug delivery system for oral administration of a first active ingredient, and further comprising a second coating comprising a second active ingredient. See Abstract. Preferred time-controlled, immediate release drug delivery systems according to the invention comprise an immediate release formulation comprising a compressed core comprising one or more active ingredients enclosed by a coating, wherein release of the active ingredient from the core is preliminary. See Description of Embodiments. The first coating is preferably sprayed with a nozzle, for example on the core. To this end, the hydrophobic polymer and the water-soluble and / or water-insoluble hydrophilic material are suspended or dissolved in, for example, water or an organic solvent or a mixture thereof and sprayed onto the core until a predetermined average thickness of the first coating is obtained. Preferred organic solvents are alcohols, for example ethanol. The amount of the first coating is preferably about 0.5 to 30% (w / w), more preferably about 1 to 20% (w / w) of the total weight of the time controlled, immediate release drug delivery system. The hydrophobic coating polymer according to the present invention is preferably selected from water-insoluble coating materials such as cellulose derivatives and polymethacrylates produced by copolymerization of methacrylate monomers with hydrophobic groups, for example. Preferred polymethacrylate hydrophobic polymers are EUDRAGIT RL, EUDRAGIT RS, EUDRAGIT NE, and EUDRAGIT S. Preferred cellulose derivatives are selected from ethylcellulose and derivatives thereof. The most preferred hydrophobic polymer of the first coating of the drug delivery system according to the present invention comprises ethylcellulose. Ethylcellulose forms a mechanically weak hydrophobic film that breaks easily. The core comprises a drug in combination with a water-insoluble, gel-forming disintegrant which disintegrates upon contact with an aqueous medium. Formation of pores in the hydrophobic film, and the influx of water into the pores, causes rupture of the ethylcellulose coating. When the coating ruptures, the core disintegrates in minutes after the release of the drug. The preferred ethyl cellulose is Ethocel S. See Description of Embodiments. As is known to those skilled in the art, factors (process conditions) that may affect the uniformity of the inter-internal tablet of the first coating are, for example, fan speed, spray rate, spray pattern, nozzle type, viscosity, drying temperature, air Flow rate and coating time. If necessary, a heat-controlled curing step, for example a heat treatment at 60-80°C. for 1-3 hours, is applied to the first coating after coating, preferably after spraying of the first coating.
Most preferred examples are preferred combination therapies for the treatment of men or women, such as sexual dysfunction, desire disability, or erectile dysfunction. Preferably the combination treatment is treatment of disorders of libido. Preferably by using a combination of testosterone or a functional analog thereof and the first active ingredient, the testosterone or functional analog thereof has a peak plasma level of testosterone of about 2-6 hours, more preferably before the peak plasma level of the first active ingredient. Preferably 3-4 hours. The first active ingredient is preferably provided in a time controlled, immediate release drug delivery system according to the present invention. Sildenafil and buspirone are the preferred ingredients for the first active ingredient for the treatment of me or women sexual dysfunction.
The present invention also provides a dual drug delivery device comprising a time controlled immediate release drug delivery system according to the present invention wherein the first coating of the time controlled immediate release drug delivery system comprises a second active ingredient. Is surrounded by a second coating. The second active ingredient may or may not be similar to the first active ingredient. In one embodiment, the second active ingredient, for example a steroid such as testosterone, is provided sublingually by the dual drug delivery device according to the invention in the absence of the first active ingredient. In this embodiment, the core of the dual drug delivery device does not contain the active ingredient. The second coating comprising a steroid such as testosterone or a functional analog thereof preferably comprises a carrier selected from hydroxypropyl-β-cyclodextrin, poly-β-cyclodextrin, γ-cyclodextrin and polyvinylpyrrolidone. Preferred polyvinylpyrrolidone is a low molecular weight polyvinylpyrrolidone having a molecular weight of up to 80000. Suitable polyvinylpyrrolidone is preferably selected from K10, K15, K25, K30, and K50. Most preferred carrier is hydroxypropyl-β-cyclodextrin. The presence of testosterone, such as cyclodextrin, and poorly soluble steroids, such as carriers, provide fast and efficient delivery of testosterone to the mucosa rather than being rapidly absorbed into the circulation. The drug delivery device further comprising carriers, and excipients such as flavorant, sweetener and the like. See Description and Examples.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615