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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/29/2026 has been 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.
Any rejection not reiterated below are hereby withdrawn.
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) in view of Hassan et al. (CN 1688294 A) and Li et al. (WO 2005004900 A1). This is a new rejection.
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 of from about 3-9% water or polar solvent, an average diameter of about 15-20 micron.
Hassan et al. teaches a gel substance composition with water from about 8-4% (Claim 18).
Li et al. teaches a micronized form of the carrier agent, which is utilized in preparation of the solid oral dosage form of the present invention, is defined as a carrier agent which, when added to the present composition mixture of pharmacologically active agent and pharmaceutically inactive ingredients, has an average particle size of less than 40 micrometers. Desirably the carrier agent of the present invention has a micronized form which is defined as an average particle size of less than 20 microns (page 7, paragraph 4). The pharmaceutical compositions of the present invention may be provided as a capsule including a soft-gel capsule, tablet, caplet or other solid oral dosage form, all of which can be prepared by methods well known in the art (page 8, paragraph 2).
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, wax 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]. Hassan et al. teaches a gel substance composition with water from about 8-4% (Claim 18). 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.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make droplets having an average particle size of about 15-20 micron because Li et al. teaches a micronized form of the carrier agent, which is utilized in preparation of the solid oral dosage form of the present invention, is defined as a carrier agent which, when added to the present composition mixture of pharmacologically active agent and pharmaceutically inactive ingredients, has an average particle size of less than 40 micrometers. Desirably the carrier agent of the present invention has a micronized form which is defined as an average particle size of less than 20 microns (page 7, paragraph 4). The pharmaceutical compositions of the present invention may be provided as a capsule including a soft-gel capsule, tablet, caplet or other solid oral dosage form, all of which can be prepared by methods well known in the art (page 8, paragraph 2). One would have been motivated to make soft gel at less than 20 micron for the expected benefit of oral ingestion of soft gel compositons. 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 the references teaches away from the invention.
In response to Applicant’s argument, the references teach a soft gel composition ingredients. The claims are drawn toward a soft gel composition. There is no teaching away from the invention.
Applicant argues that Bromley does not teach at least 3-9% water and teaches away from semisolid composition.
In response to Applicant’s argument, Hassan et al. teaches a gel substance composition with water from about 8-4% (Claim 18). 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 references do not teach average of size of 15-20 micron.
In response to Applicant’s argument, Li et al. teaches a micronized form of the carrier agent, which is utilized in preparation of the solid oral dosage form of the present invention, is defined as a carrier agent which, when added to the present composition mixture of pharmacologically active agent and pharmaceutically inactive ingredients, has an average particle size of less than 40 micrometers. Desirably the carrier agent of the present invention has a micronized form which is defined as an average particle size of less than 20 microns (page 7, paragraph 4). The pharmaceutical compositions of the present invention may be provided as a capsule including a soft-gel capsule, tablet, caplet or other solid oral dosage form, all of which can be prepared by methods well known in the art (page 8, paragraph 2). Therefore, the oral composition for soft gel diameter administration is taught.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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