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
Acknowledgement is made to Applicant’s response filed 01/12/2026.
Claims 1-15 are pending.
Claims 9, and 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Claims 1-8, 10 and 14-15 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
carnauba wax and stearic acid for the at least one non-swelling release control agent,
mannitol (a diluent) for the excipient
optionally a polymeric non-swelling release control agent, specifically polyvinyl acetate.
Upon further search and examination the species election over the at least one non-swelling release control agent is broadened to include beeswax, paraffin wax, cetyl alcohol, stearic acid, phosphatidylcholine. The species election over a polymeric non-swelling release control agent is broadened to include cellulose, cellulose acetate, cellulose acetate phthalate, cellulose acetate butyrate, polyvinyl alcohol, polyvinyl chloride, polyvinyl acetate, polyvinylpyrrolidone, and ethyl cellulose. As well as excipients to include binders, glidants, lubricants.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/27/2023 and 02/19/2026 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-4 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1).
Barberich discloses compositions comprising melatonin (see entire document, for instance, abstract). Barberich discloses the total daily dose range is from about 1 mg to about 900 mg ([0021]). Barberich teaches suitable hydrophobic materials which may be used in accordance with the present invention include digestible, long chain (C.sub.8-C.sub.50, especially C.sub.12-C.sub.40), substituted or unsubstituted hydrocarbons, such as fatty acids, fatty alcohols, glyceryl esters of fatty acids, mineral and vegetable oils and natural and synthetic waxes ([0415]). The oral dosage form may contain up to 60% (by weight) of at least one digestible, long chain hydrocarbon ([0415]). Suitable waxes include, for example, beeswax, and carnauba wax ([0414]). Barberich discloses the phrase "pharmaceutically-acceptable carrier" as used herein means a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent ([0424]). Barberich teaches some examples of materials which can serve as pharmaceutically-acceptable carriers include mannitol ([0424]). Barberich teaches sustained release matrices can also be prepared via melt-granulation or melt-extrusion techniques ([0506]). Generally, melt-granulation techniques involve melting a normally solid hydrophobic material, e.g. a wax, and incorporating a powdered drug therein ([0506]). Barberich discloses cellulose acetate phthalate (CAP), polyvinylpyrrolidone, celluloses ([0484]).
Barberich, exemplifies a range is from about 1 mg to about 900 mg of melatonin rather than the instantly claimed 1 to 70% of melatonin. It would have been obvious to one of ordinary skill in the art to optimize the milligram of the melatonin. One would have been motivated to do so in order to arrive at a composition that it best suited for applying the ointment to the patient. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
Claims 1-4 and 14-15 are rejected under Barberich. Barberich does not teach within a single embodiment in order to anticipate but renders obvious the instant claims. As such it would be obvious at the time the invention was filed to rearrange the components of Barberich and obtain a composition as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, amount of polymeric non-swelling release controlling agent), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Barberich, to include an example amount of polymeric non-swelling release controlling agent, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Barberich, as cited above, and would yield predictable results.
Claim(s) 1-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) as applied to claims 1-4 and 14-15 above, and further in view of PILGAONKAR et al (US 20170128379 A1).
Barberich discloses compositions comprising melatonin (see entire document, for instance, abstract). Barberich teaches melt-granulation. Barberich discloses cellulose acetate phthalate (CAP), polyvinylpyrrolidone, celluloses (polymeric non-swelling release controlling agent) ([0484]). Barberich discloses the phrase "pharmaceutically-acceptable carrier" as used herein means a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent ([0424]). However, it a does not expressly disclose including amounts of polymeric non-swelling release controlling agent and excipient. PILGAONKAR et al remedy this deficiency.
PILGAONKAR teaches modified release pharmaceutical formulations offer many advantages over conventional immediate release formulations such as modified blood levels, desired therapeutic effect for long period of time, attenuation of adverse effects, reduced side effects, reduction in the number of daily doses, improved patient convenience and compliance, etc. PILGAONKAR discloses the amount of active agent in the composition can vary from about 0.01 weight % to about 85 weight %, based on the total weight of the composition ([0014]). PILGAONKAR teaches active agents include sedatives ([0011]- [0014]). PILGAONKAR discloses excipient include stabilizers in a concentration of about 0.001% to 20% by weight of the composition ([0016]). PILGAONKAR teaches melt granulation ([0024]). PILGAONKAR discloses the terms “release modifier” or “release rate modifier” have been used interchangeably for the purpose of the present invention and refer to a substance or a combination of substances ([0028]). Suitable polymeric water-insoluble release modifiers include polyvinyl acetate, polyvinyl chloride, ethyl cellulose, cellulose acetate, cellulose acetate phthalate, cellulose acetate butyrate ([0028]). PILGAONKAR teaches the bead matrix may be coated with at least one release modifier to a weight gain of about 1% to about 75% ([0030]). PILGAONKAR discloses paraffin waxes, synthetic waxes, spermaceti wax, carnauba wax, beeswax, candelilla wax, paraffin wax ([0021]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Barberich with the composition of PILGAONKAR et al. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
Claim(s) 1-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) as applied to claims 1-4 and 14-15 above, and further in view of KAWAGUCHI et al (US 20210369654 A1; also available as WO2020080394A1).
Barberich discloses compositions comprising melatonin (see entire document, for instance, abstract). Barberich teaches melt-granulation. Barberich discloses cellulose acetate phthalate (CAP), polyvinylpyrrolidone, celluloses (polymeric non-swelling release controlling agent) ([0484]). Barberich discloses the phrase "pharmaceutically-acceptable carrier" as used herein means a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent ([0424]). However, it a does not expressly disclose including amounts of polymeric non-swelling release controlling agent and excipient. KAWAGUCHI et al remedy this deficiency.
KAWAGUCHI relates to an agent for improving quality of sleep (see entire document, for instance, abstract). KAWAGUCHI discloses excipients ([0125]- [0127]). KAWAGUCHI teaches the content of the excipient in the tablet provided by the present invention may be in a range of 1 to 95% by weight, preferably in a range of 1 to 80% by weight, more preferably in a range of 3 to 80% by weight, and still more preferably in a range of 3 to 20% by weight relative to the tablet ([0128]). KAWAGUCHI disclose polyvinyl alcohol in a range of 0.1 to 30% by weight, preferably in a range of 0.1 to 10% by weight ([0129]- [0130]). KAWAGUCHI teaches the dosage form of the formulation granules ([0123]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Barberich with the composition of KAWAGUCHI et al. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
Claim(s) 1-4, 10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) as applied to claims 1-4 and 14-15 above, and further in view of LAUDON et al (US 20190060277 A1).
Barberich discloses compositions comprising melatonin (see entire document, for instance, abstract). Barberich teaches melt-granulation. Barberich discloses cellulose acetate phthalate (CAP), polyvinylpyrrolidone, celluloses (polymeric non-swelling release controlling agent) ([0484]). Barberich discloses the phrase "pharmaceutically-acceptable carrier" as used herein means a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent ([0424]). However, it a does not expressly disclose drug release. LAUDON et al remedy this deficiency.
LAUDON discloses melatonin mini-tablet formulations having precise pharmacologic and pharmacokinetic properties ([0007]). LAUDON teaches granulation ([0029]). LAUDON teaches the mini-tablets will release about greater than 70% of the active pharmaceutical ingredient within 6 hours of oral administration ([0019]). LAUDON discloses diluents, lubricants, binders, glidants, anti-adherents, and excipient ([0024]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Barberich with the composition of LAUDON et al. One would have been motivated to do so as LAUDON teaches a need in the art for improved drug delivery systems for use in patient populations having an inability to swallow tablets and capsules. There would be a reasonable expectation of success since Barberich and LAUDON are both drawn to compositions for melatonin.
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611