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 .
DETAILED ACTION
This Office Action is responsive to the Response to Election/Restriction filed 06/16/2026.
The Preliminary Amendment filed 06/20/2024, amended claims 1-15 and added claims 16-19.
Claims 1-19 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/16/2026, is acknowledged.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-10 and 16-19 are examined on the merits herein.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 depends from claim 1, wherein claim 1 recites “wherein the composition is free of any additional preservatives,” in reference to potassium sorbate. However, claim 6 recites twelve species or class of compounds of “additional preservative” that the composition is free of. As such, the composition of claim 1 is free of any preservative and the composition of claim 6 is only free of the preservatives recited in its Markush group. As such, claim 6 fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nutridyn (published 09/21/2019, PTO-892).
Nutridyn teaches a liquid melatonin composition comprising melatonin, water, glycerin, xylitol, natural flavors, potassium sorbate, and citric acid.
Nutridyn teaches that a half of a dropper (0.5mL) of the composition can be administered or mixed with 8 ounces of water, wherein 1mg of melatonin is administered in the half dropper.
When the half dropper is administered with 8ounces of water, which is 236.588mL of water, the aqueous phase of the liquid melatonin composition of Nutridyn meets the limitation of “the aqueous phase comprises at least about 85% w/v water.” Since the amounts of the “Other Ingredients,” i.e., water, glycerin, xylitol, natural flavors, potassium sorbate, and citric acid is not known, the %w/v of the water in the 0.5mL half dropper or the 60mL bottle is not known.
Regarding claim 3, Nutridyn does not teach additional active ingredients.
Regarding claim 5, glycerin is glycerol.
Regarding claim 6, Nutridyn does not teach additional preservatives.
Regarding claim 7, Nutridyn does not teach alcohols other than glycerol.
Regarding claim 8, Nutridyn is free of thickening agents.
Regarding claim 10, Nutridyn is a medicament.
Claim Rejections - 35 USC § 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.
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.
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 1-3, 5-8, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over
Nutridyn (published 09/21/2019, PTO-892) in view of Anderson (Melatonin, Drugs.com, published 03/04/2021, PTO-892)
Nutridyn is applied to claims 1, 3, 5-8, and 10 as discussed above and incorporated herein.
Nutridyn differs from that of instant claims 2 and 16 in that it does not teach the instantly claimed concentration of melatonin.
Nutridyn explicitly teaches the administration of 1mg melatonin in 0.5mL, though the %w/v water is not known, Nutridyn teaches the administration of 1mg of melatonin in 0.5mL(half dropper) plus 8 ounces of water, which is 236.588mL. Nutridyn further teaches that the dosage amount can be varied “as directed by your healthcare practitioner.”
As such, Nutridyn teaches a concentration of melatonin ranging from 0.004mg/mL to 2mg/mL.
Anderson teaches melatonin as an effective treatment for jet lag and that it can aid sleep during times when you would not normally be awake. Anderson teaches effective starting doses as 0.3 to 0.5mg and up to 3-5mg (pgs. 3-4, “Melatonin Dosage”).
Anderson further teaches taking 0.1-0.5mg for insomnia, 1.8 to 3mg for daytime sleep for shift work sleep disorders, 0.5-1mg for delayed sleep phase disorders, and 0.5mg for non-24-hour sleep wake disorder (pgs. 4-5).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the concentration of melatonin in Nutridyn, to arrive at instant claims 2 and 16. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Nutridyn exemplifies administration of 2mg/ml melatonin and teaches a range of 0.004-2mg/ml melatonin administration, and 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),
- Nutridyn further teaches that the dosage amount can be varied “as directed by your healthcare practitioner,”
-Anderson teaches that it is known in the art to modify the amount of melatonin administered, and specifically teaches administering 0.1-3mg for different disorders/conditions, and
- "[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," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a concentration of melatonin that is effective to be administered as a sleep aide.
The optimization of known amounts/concentrations for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 1, 3-8, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over
Nutridyn (published 09/21/2019, PTO-892) in view of Europa (Note for Guidance on Excipients, Antioxidants, and Antimicrobial Preservatives in the Dossier for Application for Marketing Authorisation of a Medicinal Product, published 2003, PTO-892)
Nutridyn is applied to claims 1, 3, 5-8, and 10 as discussed above and incorporated herein.
Nutridyn differs from that of instant claims 4 and 17 in that it does not teach the concentration of potassium sorbate.
Europea teaches that when using an antimicrobial preservative, the concentration used must be justified in terms of efficacy and safety, such that the minimum concentration of preservative is used which gives the required level of efficacy (pg. 2).
Europea teaches that antimicrobial preservatives are used to prevent or inhibit the growth of micro-organisms which could present a risk of infection or degradation of the medicinal product. Europea teaches that the level of efficacy will vary according to the chemical structure of the preservative, its concentration, the physical and chemical characteristics of the medicinal product, such as its pH, the type and level of initial microbial contamination, the design of the pack, and the temperature at which the product is stored (pgs. 8-9, Antimicrobial Preservatives).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the concentration of the potassium sorbate in Nutridyn, to arrive at instant claims 4 and 17. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Nutridyn exemplifies administration of its composition in 0.5ml and 237ml amounts,
-Europea teaches that in pharmaceuticals the minimal concentration of preservative is used to give the required level of efficacy,
-Europea teaches that the level of efficacy will vary according to the chemical structure of the preservatives, their concentration, the physical and chemical characteristics of the medicinal product, the design of the pack, and the temperature at which the product is stored, and
- "[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," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a melatonin formulation that is optimized for efficacy and safety.
Claims 1, 3, 5-10, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nutridyn (published 09/21/2019, PTO-892) in view of Bokser (Stability of Pharmaceutical Products, published 2013, PTO-892)
Nutridyn is applied to claims 1, 3, 5-8, and 10 as discussed above and incorporated herein.
Nutridyn differs from that of instant claims 9 and 18-19 in that it does not explicitly teach that the composition is stable upon storage at room temperature for at least 12, 18 or 24 months.
Bokser teaches that most drug products are stored at controlled room temperature and are labeled as such (pg. 38). Bokser teaches that solutions should remain clear over a relatively wide temperature range such as 4° to 47°C (pg. 41), and teaches that most products require at least 24 month shelf life to be commercially viable (pg. 45).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of Nutridyn to be stable upon storage at room temperature for at least 12, 18, or 24, months, to arrive at instant claims 9, 18, and 19. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because Bokser teaches that most drug products are stored at room temperature and that most products require at least a 24 month shelf life.
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a drug product that is stable at room temperature for at least 24 months.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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