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
The Amendments filed on Oct. 17, 2025 has been received and entered.
Claims 1-21 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of the species fish oil, waxy and non-waxy oil, about 8-15% by weight d-alpha-tocopherol polyethylene glycol succinate (TPGS) in the reply filed on March 12, 2025 is acknowledged.
Response to Amendment
Claim Rejections - 35 USC § 103
Claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bromley (US 20160081975 A1). This is not a new rejection but with slight modification.
Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020], in an amount of from between 40% to 90%, by weight of the composition, or is 40%-55%, 40%-70%, 40%-85%, 50%-65%, 50%-70%, 50%-75%, 50%-85%, 60%-70%, 60%-80%, 60%-90%, 70%-85%, 70%-90%, or 80%-90%, inclusive, by weight of the concentrate [0022], the pre-gel concentrate contains a non-aqueous solvent, for example, benzyl alcohol, d-limonene, or a mixture thereof, in an amount between 7% and 16%, inclusive, by weight of the concentrate; a polyethylene glycol (PEG)-derivative of vitamin E, for example, D-α-tocopheryl polyethylene glycol succinate (TPGS) (an emulsifier), or a water-soluble vitamin E derivative mixture that is a high dimer PEG derivative of vitamin E mixture that is a high dimer TPGS mixture, in an amount between 25% and 35%, inclusive, by weight of the concentrate; and a non-polar ingredient in an amount between 53% and 66%, inclusive, by weight of the concentrate [0025], waxy compositions are of relatively low viscosity a little above their liquefying point. Exemplary of waxes that have waxy consistencies are natural waxes, including waxes of vegetal origin, such as beeswax [0163], the pre-gel concentrates provided herein further contain a non-polar ingredient, other than the PEG derivative of vitamin E, non-essential fatty acids, phospholipids. [0020] (which are non-waxy lipids). Emulsions refers to a colloidal dispersion of two immiscible liquids such as an oil and water, which can be used to disperse non-polar compounds in a dispersed phase [0144]. Soft gel capsule allows for sufficient bioavailability of the pharmaceuticals, nutraceuticals and/or dietary supplements contained within are desired. Encapsulation of a composition permits accurate delivery of a specified dose of non-polar ingredients in a bioavailable, easily consumed mode [0007].
However, Bromley does not teach the amounts, an average diameter of about 15-20 micron.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising the amounts of the active agent combination for the following reasons. The reference does teach the composition for making a soft gel. Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020], in an amount of from between 40% to 90%, by weight of the composition, or is 40%-55%, 40%-70%, 40%-85%, 50%-65%, 50%-70%, 50%-75%, 50%-85%, 60%-70%, 60%-80%, 60%-90%, 70%-85%, 70%-90%, or 80%-90%, inclusive, by weight of the concentrate [0022], the pre-gel concentrate contains a non-aqueous solvent, for example, benzyl alcohol, d-limonene, or a mixture thereof, in an amount between 7% and 16%, inclusive, by weight of the concentrate; a polyethylene glycol (PEG)-derivative of vitamin E, for example, D-α-tocopheryl polyethylene glycol succinate (TPGS) (an emulsifier), or a water-soluble vitamin E derivative mixture that is a high dimer PEG derivative of vitamin E mixture that is a high dimer TPGS mixture, in an amount between 25% and 35%, inclusive, by weight of the concentrate; and a non-polar ingredient in an amount between 53% and 66%, inclusive, by weight of the concentrate [0025]. Thus, it would have been obvious to make a composition containing lipids, TPGS, way and non-waxy oils for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include water in a soft gel composition because Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020]. One would have been motivated to make use water for the expected benefit of creating emulsified phases for dispersing nonpolar ingredients in a soft gel composition. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include an average diameter of about 15-20 micron because Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020]. The soft gel capsule allows for sufficient bioavailability of the pharmaceuticals, nutraceuticals and/or dietary supplements contained within are desired. Encapsulation of a composition permits accurate delivery of a specified dose of non-polar ingredients in a bioavailable, easily consumed mode [0007]. One would have been motivated to make use a soft gel with a specific diameter for the expected benefit of delivering compositions in a soft gel composition for oral consumption. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Response to Arguments
Applicant argues that Bromley does not teach at least 3-9% water and teaches away from semisolid composition.
In response to Applicant’s argument, Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020], the pre-gel concentrate contains a non-aqueous solvent, for example, benzyl alcohol, d-limonene, or a mixture thereof, in an amount between 7% and 16%, inclusive, by weight of the concentrate; a polyethylene glycol (PEG)-derivative of vitamin E, for example, D-α-tocopheryl polyethylene glycol succinate (TPGS) (an emulsifier), or a water-soluble vitamin E derivative mixture that is a high dimer PEG derivative of vitamin E mixture that is a high dimer TPGS mixture, in an amount between 25% and 35%, inclusive, by weight of the concentrate; and a non-polar ingredient in an amount between 53% and 66%, inclusive, by weight of the concentrate [0025] as an emulsion in a soft gel composition. Emulsion would require water. The amount of water would be determined by the concentration of the nonpolar ingredients. One of ordinary skill in the art would know how much to adjust for the emulsion to be formed in a dispersed solution for filling a soft gel.
Applicant argues that the diameter of the waxes are not inherent.
In response to Applicant’s argument, Bromley teaches a soft gel formulation for encapsulation comprising non-polar ingredients fish oil, coconut oil [0020]. The soft gel capsule allows for sufficient bioavailability of the pharmaceuticals, nutraceuticals and/or dietary supplements contained within are desired. Encapsulation of a composition permits accurate delivery of a specified dose of non-polar ingredients in a bioavailable, easily consumed mode [0007]. One would determine a diameter for soft gel that can be easily swallowed and disperse its contents for efficient absorbability in the body.
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.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655