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 Claims
The amendments and arguments filed on 06/18/2026 are acknowledged and have been fully considered. Claims 1,3,6, and 14 have been amended. Claims 9, and 11-13 have been withdrawn. Claims 2 and 5 have been canceled. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1,3-4,6-8,10, and 14-15 will be examined on the merits herein.
Withdrawn Rejections
Rejection under 35 USC 112
Applicants’ amendment to claim 6 is persuasive in overcoming the previously raised indefiniteness rejection. Said rejection is withdrawn.
Rejections under 35 USC 102/103 and 103
Applicants’ amendment to claim 1 and 14 are persuasive in overcoming the previously raised prior art rejections based on Barberich alone. Said rejections are withdrawn.
New Grounds of Rejection — Necessitated by Amendment
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, 3-4,6-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) and PILGAONKAR et al (US 20170128379 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 teach in solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules, trouches and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers ([0434]). 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).”
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 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, 3-4,6-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) and KAWAGUCHI et al (US 20210369654 A1; also available as WO2020080394A1).
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 in solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules, trouches and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers ([0434]). 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).”
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 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, 3-4,6-8,10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barberich (US 20050164987 A1) and Shah et al (US 20120195968 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 teach in solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules, trouches and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers ([0434]). 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).”
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 does not expressly disclose drug release or amounts of polymeric non-swelling release controlling agent and excipient. Shah et al remedy this deficiency.
Shah discloses controlled-release melatonin compositions (see entire document, for instance, abstract). Shah teaches melatonin dispersed in a controlled melatonin release portion comprising a polymer matrix, the polymer matrix adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment and to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment (see entire document, for instance, abstract). Shah discloses a controlled-release medicament formulation comprising: approximately 0.5% to 1.5% w/w of melatonin; approximately 0.0% to 40.0% w/w of HPMC (an excipient per instant specification); and approximately 41.5% to 94.5% binder (see entire document, for instance, [0014]). Shah teaches binders include cellulose (a polymeric non-swelling release controlling agent per instant specification ([0077]). Shah discloses the dosage form releases approximately 50% of the melatonin within approximately 1-3 hours after being administered to a patient and release approximately 50-90% of the melatonin for approximately 3-9 hours after being administered to the patient ([0015]). Shah teaches stearic acid, mannitol, the controlled-release portion comprising the active ingredient further includes an enteric or pH-dependent coating such as cellulose acetate phthalates and other phthalates ([0077]- [0081]). Shah discloses the mixture is granulated and pressed into tablets ([0082]).
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 Shah et al. One would have been motivated to do so as Shah teaches a need in the art a controlled-release melatonin composition that can be delivered to the GI tract and will release a bioavailable amount of melatonin in the GI tract over the course of 6-8 hours. There would be a reasonable expectation of success since Barberich and Shah are both drawn to compositions for melatonin.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive. Applicant argue, “Barberich does not disclose or make obvious a melt granulated composition wherein the melatonin is embedded into the non-swelling release controlling agent comprising both a non- polymeric non-swelling controlling release agent and a polymeric non-swelling controlling release agent.” The Examiner respectfully disagrees. Barberich teach in solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules, trouches and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers ([0434]). Barberich teaches sustained release matrices can also be prepared via melt-granulation or melt-extrusion techniques ([0506]). The Examiner respectfully maintains the rejection and submits the instantly claimed invention is directed to a composition, and not the manner by which it is produced. As such the remarks are not considered persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham, can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
Prosecution Insights