DETAILED ACTION
Status of Application
Receipt of the claims filed 9/27/2024 are acknowledged.
Claims 1-30 are included in the prosecution.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 18 are objected to because of the following informalities:
Claim 18, line 2, recites “53 to 73 DE of the corn syrup” which should read as “of the 53 to 73 DE corn syrup”.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-21 and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona.
Regarding claims 1-21 and 24-29, Shah is drawn to controlled-release melatonin compositions and related methods. In one embodiment, a controlled-release medicament composition comprises 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 (abstract).
Shah discloses a controlled-release medicament composition comprising melatonin dispersed in a controlled melatonin release portion that comprises a polymer matrix. The polymer matrix is adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment. Additionally, the polymer matrix is adapted to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment, as is found in various regions of a mammalian G.I. tract, for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment [0012].
Shah discloses a controlled-release medicament composition comprising melatonin dispersed in a hydrogel matrix having sufficient acidic moieties therein to maintain an acidic environment local to the melatonin when the melatonin is in a gastrointestinal tract of a patient. This ensures that the composition releases melatonin into the plasma following administration to a human patient according to the endogenous melatonin profile [0013].
Shah discloses the controlled-release layer is a combination of one or more polymers. The polymers can be selected from any number of pharmaceutically acceptable polymers such as alginates [0050].
Shah discloses embodiments of a medicament composition may comprise substances for the preparation of a final dosage form. Examples of these substances include one or more excipients, diluents, colorants, flavorings, coating agents (glazing), sweetening agent [0043].
Shah discloses melatonin medicament compositions can be made in many different ways. These include wet granulation processes, such as aqueous granulation processes, or dry granulation processes, where dry powder based blending process is followed by direct compression, or with an intermediate roller compaction step or a combination thereof [0076].
Shah discloses a method for making a melatonin medicament composition comprises dry blending the active ingredient with at least one polymer suitable for forming the controlled-release layer and conventional processing aids plus optional fillers. Optional fillers include but are in no way limited to dry starches. The dry blend can then be formed into a typical dosage form for oral administration. In a preferred embodiment, at least one of the polymers forms a hydrogel [0077].
Shah discloses a method of wet granulation comprising steps of mixing and spraying water [0119].
Shah does not disclose wherein alginate is calcium alginate.
However, Cardona is drawn to a composite microparticle for oral delivery of an active agent to a subject. The microparticles are general in the form of self-sustaining bodies comprising a crosslinked polymer matrix and a plurality of emulsion droplets distributed throughout. The active agent is encapsulated in the emulsion droplets. A plurality of delivery enhancing moieties are presented on the exterior surface of said self-sustaining body and/or on the emulsion droplets. The microparticle is resistant to enteric degradation and will localize in the gastrointestinal tract of the subject without crossing the intestinal mucosa into the intestinal bloodstream (abstract).
Cardona discloses the polymer matrix comprises (consists essentially or even consists of) swellable and/or biodegradable polymers such as calcium alginate. In preferred embodiments, calcium alginate (obtained for example by reaction of sodium alginate as the polymer precursor with a calcium salt such as CaCl2)) is the primary constituent of the crosslinked polymer matrix. In the configuration contemplated herein, it forms multiple cross-linked helix-helix aggregates resulting in superior encapsulation strength [0052].
Cardona discloses the polymer matrix is initially made using sodium alginate as the polymer base building block which is then converted to a more stable calcium form through ionic exchange. For example, upon contacting sodium alginate aggregates with an aqueous solution of calcium chloride or calcium acetate, for example, the sodium of the alginate aggregates is replaced by calcium [0053].
Cardona discloses the encapsulated active agent may be melatonin. The active agent may be encapsulated in various suitable forms, including solid forms, liquid forms, and the like. It will also be appreciated that one or more additional active agents could also be included in the particle, distributed throughout the polymer matrix (in addition to the active agent(s) in the emulsion droplet) [0066].
Cardona discloses the emulsion droplets are dispersed in a carrier matrix, in lieu of the self-sustaining polymer particles. That is, instead of using the polymer matrix particles described above, the emulsion droplets can be delivered via another type of vehicle or carrier. Exemplary carrier matrices include various types of gel or liquid carrier compositions, such as hydrogels [0081].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition as previously disclosed by Shah, wherein the alginate is calcium alginate, as previously disclosed by Cardona, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah and Cardona are in the field of hydrogels comprising melatonin, and Cardona discloses the polymer matrix comprises swellable and/or biodegradable polymers such as calcium alginate. In preferred embodiments, calcium alginate is the primary constituent of the crosslinked polymer matrix. In the configuration contemplated herein, it forms multiple cross-linked helix-helix aggregates resulting in superior encapsulation strength [0052]. One of ordinary skill in the art would have had a reasonable expectation of success in making composition, as disclosed by Shah in view of Cardona, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona as applied to claims 1-21 and 24-29 above and further in view of Shah et al. (US 20160243038 A1) hereinafter Shah1.
Regarding claims 22-23, Shah does not explicitly disclose the presence of L-theanine.
However, Shah1 discloses the melatonin composition may include at least one sedative ingredient in combination with melatonin. Such sedative ingredients may include a skeletal muscle relaxer, and/or a GABA modulator such as a GABA receptor agonist. Examples of sedative ingredients include, but are not limited to L-theanine [0037]. Shah1 discloses an effective amount of L-theanine may be 25-250 mg, 50-200 mg, or about 100 mg may be used [0066]. Shah1 discloses a therapeutically effective amount of melatonin may be 1-1,000 mg/day, [0065].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition as previously disclosed by Shah in view of Cardona, to comprise L-theanine, as previously disclosed by Shah1, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah, Cardona and Shah1 are in the field of hydrogels comprising melatonin, and Shah1 discloses further presence of L-theanine [0037]. One of ordinary skill in the art would have had a reasonable expectation of success in making formulation, as disclosed by Shah in view of Cardona and Shah1, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
Claims 30 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona as applied to claims 1-21 and 24-29 above and further in view of Daniel et al. (US 20220287355 A1) hereinafter Daniel.
Regarding claim 30, Shah discloses melatonin medicament compositions can be made in many different ways. These include wet granulation processes, such as aqueous granulation processes, or dry granulation processes, where dry powder based blending process is followed by direct compression, or with an intermediate roller compaction step or a combination thereof [0076].
Shah discloses a method for making a melatonin medicament composition comprises dry blending the active ingredient with at least one polymer suitable for forming the controlled-release layer and conventional processing aids plus optional fillers. Optional fillers include but are in no way limited to dry starches. The dry blend can then be formed into a typical dosage form for oral administration. In a preferred embodiment, at least one of the polymers forms a hydrogel [0077].
Shah in view of Cardona do not explicitly disclose wherein the process of preparation comprises a step of using a mold.
However, Daniel discloses the oral product is in chewable form. For the preparation of the oral product in chewable form, generally, the mixture is combined with water, binder, sweeteners including one or more sugars, sugar alcohols, or combinations thereof, flavor, and an acid at elevated temperature. The resulting composition is then deposited into molds for storage at ambient temperature, during which time the composition cools and solidifies, forming the oral product [0221].
Daniel discloses the active ingredient comprises or further comprises a pharmaceutical ingredient. The pharmaceutical ingredient can be any known agent adapted for therapeutic, prophylactic, or diagnostic use. These can include, for example, melatonin. The pharmaceutical ingredient is typically at a concentration of from about 0.001% w/w to about 10% by weight based on the total weight of the oral product. [0120-0121].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as previously disclosed by Shah in view of Cardona, to comprise a mold, as previously disclosed by Daniel, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah, Cardona, and Daniel are in the field of oral compositions comprising melatonin, and Daniel discloses preparation of the oral product in chewable form, generally, the mixture is combined with water, binder, sweeteners including one or more sugars, sugar alcohols, or combinations thereof, flavor, and an acid at elevated temperature. The resulting composition is then deposited into molds for storage at ambient temperature, during which time the composition cools and solidifies, forming the oral product [0221]. One of ordinary skill in the art would have had a reasonable expectation of success in making formulation, as disclosed by Shah in view of Cardona and Daniel, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
DETAILED ACTION
Status of Application
Receipt of the claims filed 2/6/2024 are acknowledged.
Claims 31-37 are cancelled.
Claims 1-30 are included in the prosecution.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 18-19 are objected to because of the following informalities:
Claim 18, line 2, recites “53 to 73 DE of the corn syrup” which should read as “of the 53 to 73 DE corn syrup”.
Claim 19, line 1, recites “according to any one of claim 7” which should read as “according to claim 7”.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-21 and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona.
Regarding claims 1-21 and 24-29, Shah is drawn to controlled-release melatonin compositions and related methods. In one embodiment, a controlled-release medicament composition comprises 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 (abstract).
Shah discloses a controlled-release medicament composition comprising melatonin dispersed in a controlled melatonin release portion that comprises a polymer matrix. The polymer matrix is adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment. Additionally, the polymer matrix is adapted to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment, as is found in various regions of a mammalian G.I. tract, for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment [0012].
Shah discloses a controlled-release medicament composition comprising melatonin dispersed in a hydrogel matrix having sufficient acidic moieties therein to maintain an acidic environment local to the melatonin when the melatonin is in a gastrointestinal tract of a patient. This ensures that the composition releases melatonin into the plasma following administration to a human patient according to the endogenous melatonin profile [0013].
Shah discloses the controlled-release layer is a combination of one or more polymers. The polymers can be selected from any number of pharmaceutically acceptable polymers such as alginates [0050].
Shah discloses embodiments of a medicament composition may comprise substances for the preparation of a final dosage form. Examples of these substances include one or more excipients, diluents, colorants, flavorings, coating agents (glazing), sweetening agent [0043].
Shah discloses melatonin medicament compositions can be made in many different ways. These include wet granulation processes, such as aqueous granulation processes, or dry granulation processes, where dry powder based blending process is followed by direct compression, or with an intermediate roller compaction step or a combination thereof [0076].
Shah discloses a method for making a melatonin medicament composition comprises dry blending the active ingredient with at least one polymer suitable for forming the controlled-release layer and conventional processing aids plus optional fillers. Optional fillers include but are in no way limited to dry starches. The dry blend can then be formed into a typical dosage form for oral administration. In a preferred embodiment, at least one of the polymers forms a hydrogel [0077].
Shah discloses a method of wet granulation comprising steps of mixing and spraying water [0119].
Shah does not disclose wherein alginate is calcium alginate.
However, Cardona is drawn to a composite microparticle for oral delivery of an active agent to a subject. The microparticles are general in the form of self-sustaining bodies comprising a crosslinked polymer matrix and a plurality of emulsion droplets distributed throughout. The active agent is encapsulated in the emulsion droplets. A plurality of delivery enhancing moieties are presented on the exterior surface of said self-sustaining body and/or on the emulsion droplets. The microparticle is resistant to enteric degradation and will localize in the gastrointestinal tract of the subject without crossing the intestinal mucosa into the intestinal bloodstream (abstract).
Cardona discloses the polymer matrix comprises (consists essentially or even consists of) swellable and/or biodegradable polymers such as calcium alginate. In preferred embodiments, calcium alginate (obtained for example by reaction of sodium alginate as the polymer precursor with a calcium salt such as CaCl2)) is the primary constituent of the crosslinked polymer matrix. In the configuration contemplated herein, it forms multiple cross-linked helix-helix aggregates resulting in superior encapsulation strength [0052].
Cardona discloses the polymer matrix is initially made using sodium alginate as the polymer base building block which is then converted to a more stable calcium form through ionic exchange. For example, upon contacting sodium alginate aggregates with an aqueous solution of calcium chloride or calcium acetate, for example, the sodium of the alginate aggregates is replaced by calcium [0053].
Cardona discloses the encapsulated active agent may be melatonin. The active agent may be encapsulated in various suitable forms, including solid forms, liquid forms, and the like. It will also be appreciated that one or more additional active agents could also be included in the particle, distributed throughout the polymer matrix (in addition to the active agent(s) in the emulsion droplet) [0066].
Cardona discloses the emulsion droplets are dispersed in a carrier matrix, in lieu of the self-sustaining polymer particles. That is, instead of using the polymer matrix particles described above, the emulsion droplets can be delivered via another type of vehicle or carrier. Exemplary carrier matrices include various types of gel or liquid carrier compositions, such as hydrogels [0081].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition as previously disclosed by Shah, wherein the alginate is calcium alginate, as previously disclosed by Cardona, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah and Cardona are in the field of hydrogels comprising melatonin, and Cardona discloses the polymer matrix comprises swellable and/or biodegradable polymers such as calcium alginate. In preferred embodiments, calcium alginate is the primary constituent of the crosslinked polymer matrix. In the configuration contemplated herein, it forms multiple cross-linked helix-helix aggregates resulting in superior encapsulation strength [0052]. One of ordinary skill in the art would have had a reasonable expectation of success in making composition, as disclosed by Shah in view of Cardona, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona as applied to claims 1-21 and 24-29 above and further in view of Shah et al. (US 20160243038 A1) hereinafter Shah1.
Regarding claims 22-23, Shah does not explicitly disclose the presence of L-theanine.
However, Shah1 discloses the melatonin composition may include at least one sedative ingredient in combination with melatonin. Such sedative ingredients may include a skeletal muscle relaxer, and/or a GABA modulator such as a GABA receptor agonist. Examples of sedative ingredients include, but are not limited to L-theanine [0037]. Shah1 discloses an effective amount of L-theanine may be 25-250 mg, 50-200 mg, or about 100 mg may be used [0066]. Shah1 discloses a therapeutically effective amount of melatonin may be 1-1,000 mg/day, [0065].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition as previously disclosed by Shah in view of Cardona, to comprise L-theanine, as previously disclosed by Shah1, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah, Cardona and Shah1 are in the field of hydrogels comprising melatonin, and Shah1 discloses further presence of L-theanine [0037]. One of ordinary skill in the art would have had a reasonable expectation of success in making formulation, as disclosed by Shah in view of Cardona and Shah1, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
Claims 30 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20120195968 A1) hereinafter Shah in view of Cardona et al. (US 20190247312 A1) hereinafter Cardona as applied to claims 1-21 and 24-29 above and further in view of Daniel et al. (US 20220287355 A1) hereinafter Daniel.
Regarding claim 30, Shah discloses melatonin medicament compositions can be made in many different ways. These include wet granulation processes, such as aqueous granulation processes, or dry granulation processes, where dry powder based blending process is followed by direct compression, or with an intermediate roller compaction step or a combination thereof [0076].
Shah discloses a method for making a melatonin medicament composition comprises dry blending the active ingredient with at least one polymer suitable for forming the controlled-release layer and conventional processing aids plus optional fillers. Optional fillers include but are in no way limited to dry starches. The dry blend can then be formed into a typical dosage form for oral administration. In a preferred embodiment, at least one of the polymers forms a hydrogel [0077].
Shah in view of Cardona do not explicitly disclose wherein the process of preparation comprises a step of using a mold.
However, Daniel discloses the oral product is in chewable form. For the preparation of the oral product in chewable form, generally, the mixture is combined with water, binder, sweeteners including one or more sugars, sugar alcohols, or combinations thereof, flavor, and an acid at elevated temperature. The resulting composition is then deposited into molds for storage at ambient temperature, during which time the composition cools and solidifies, forming the oral product [0221].
Daniel discloses the active ingredient comprises or further comprises a pharmaceutical ingredient. The pharmaceutical ingredient can be any known agent adapted for therapeutic, prophylactic, or diagnostic use. These can include, for example, melatonin. The pharmaceutical ingredient is typically at a concentration of from about 0.001% w/w to about 10% by weight based on the total weight of the oral product. [0120-0121].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as previously disclosed by Shah in view of Cardona, to comprise a mold, as previously disclosed by Daniel, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Shah, Cardona, and Daniel are in the field of oral compositions comprising melatonin, and Daniel discloses preparation of the oral product in chewable form, generally, the mixture is combined with water, binder, sweeteners including one or more sugars, sugar alcohols, or combinations thereof, flavor, and an acid at elevated temperature. The resulting composition is then deposited into molds for storage at ambient temperature, during which time the composition cools and solidifies, forming the oral product [0221]. One of ordinary skill in the art would have had a reasonable expectation of success in making formulation, as disclosed by Shah in view of Cardona and Daniel, by applying a known technique to a known product ready for improvement to yield predictable results, see MPEP 2141.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See
MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) -
706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR
1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to
www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent 12,233,048 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose melatonin encapsulated within a calcium alginate hydrogel, wherein the composition is held within a gel, wherein the gel is formed using starch as a gelling agent, and wherein the weight ratio of the melatonin to the calcium alginate hydrogel is from 5:95 to 15:85, the dosage form further comprising additional melatonin which is not encapsulated within the calcium alginate hydrogel..
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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