DETAILED ACTION
Applicant’s arguments, filed 16 December 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Rejections - 35 USC § 112 (New)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “expected shelf life of about 6 months” in claims 1, 22, and 23 is a relative term which renders the claim indefinite. The terms “expected” and “about” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instant case, para. [00472] discusses the “about” in terms of “expected” shelf life, but it remains unclear to the Examiner what time period is encompassed by the term “about,” such that one of ordinary skill in the art would know when a shelf life infringes on the claimed invention. Moreover, “expected” is a descriptive term and thus it is unclear to the Examiner what period of shelf life is considered “expected,” such that one of ordinary skill in the art would know when a shelf life infringes on the claimed invention.
Claim Rejections - 35 USC § 103 (maintained)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Note: The text of rejections in this Office action are reiterated from previous Office actions.
Claims 1, 4-5, 7, 11-12, and 18-20 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), as evidenced by “Stomach acid test” (Mount Sinai, 2017) (hereinafter Mount Sinai) and “Chitosan films in food applications” (Melro et al., 12/22/2020) (hereinafter Melro).
Regarding claims 1, 4 and 5, Magdassi discloses biocompatible delivery systems comprising biocompatible polymeric beads having a two-phase core and shell (i.e. claimed first shell) structure for controlled or sustained release of bioactive molecules/compounds (abstract). The internal core compartment of each bead may comprise a water-in-oil emulsion comprising at least one bioactive compound (i.e. claimed first active ingredient), wherein the bioactive compound is either dispersed (for water-insoluble or poorly soluble compounds) or dissolved (for water-soluble compounds) in the discontinuous aqueous phase dispersed within the continuous oil phase of the emulsion. The internal core compartment is surrounded by a polymeric shell compartment comprising a biocompatible polymer ([0014]). The discontinuous aqueous phase may comprise Tween® 80 (i.e. claimed first polymer) and the continuous oil phase may comprise sunflower oil (i.e. claimed lipophilic carrier) (i.e. vegetable oil) and Span® 80 (i.e. claimed emulsifying agent having a HLB of 4.3) ([0073]). The term “bioactive compound” refers to any compound having therapeutic or cosmetic activity and may include proteins, peptides, hormones, drugs, vitamins, antioxidants, anti-inflammatory agents and the like ([0015]). Oral formulations may be readily prepared by combining the emulsion beads with pharmaceutically acceptable diluents or carriers as known in the art. Such carriers enable the delivery systems of the invention to be formulated as capsules, dragées, pills, tablets, gels, liquids, slurries, suspensions, syrups and the like, for oral ingestion by a patient ([0028]). The biocompatible polymeric beads deliver a stable, effective concentration of bioactive compounds for extended periods ranging from a few hours to a few months ([0011]). Instability would be evidenced by creaming, flocculation (reversible aggregation), and/or coalescence (irreversible aggregation) ([0008]).
Magdassi differs from the instant claim insofar as not explicitly disclosing wherein the continuous oil phase comprises a wax.
However, Muller discloses a dispersion having an oily phase, an aqueous phase, in the form of a water-in-oil emulsion, and at least one active ingredient (abstract). The oil phase can consist of oils, that means lipids being liquid at room temperature of 20°C. It is also possible to blend these oils with lipids being solid at room temperature of 20°C ([0069]). Examples for lipids being solid at room temperature include carnauba wax ([0071]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Magdassi discloses wherein the continuous oil phase comprises an oil, such as sunflower oil. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated carnauba wax into the continuous oil phase of Magdassi since blending carnauba wax with oils that are liquid at room temperature of 20°C (e.g. sunflower oil) is another known and effective way for forming oil phases of emulsions as taught by Muller.
Regarding claim 1 reciting for use in food or a beverage, this is merely a recitation of the intended use of the composition. As discussed above, the beads of Magdassi may be orally ingested; therefore, the composition of the prior art would be usable in food or a beverage, whether the prior art recognizes such use or not.
Regarding claim 1 reciting wherein “the dispersed phase comprises a stable particle dispersion of the one or more particles in the continuous phase, the stable particle dispersion being characterized by a zeta potential having a magnitude of at least about 30 millivolts, as measured by laser doppler electrophoresis, and wherein the one or more particles have an expected shelf life of about 6 months,” although Magdassi does not explicitly disclose, verbatim, a zeta potential as instantly claimed, Magdassi discloses polymeric beads delivering a stable, effective concentration of the bioactive compounds, i.e., the polymeric beads of Magdassi do not exhibit flocculation (reversible aggregation). As noted by para. [00243] of the instant Specification filed 09 February 2023, “Zeta potentials of approximately 30 mV or larger in either the positive or negative direction establish a stable particle dispersion, as charges of high magnitudes repel each other in solution; on the other hand, values below that threshold tend to aggregate and flocculate.” Accordingly, since the polymeric beads of Magdassi exhibit stability (as evidenced by its ability to deliver a stable therapeutic concentration of the bioactive compound), and do not flocculate/aggregate, one of ordinary skill in the art would reasonably conclude the polymeric beads of Magdassi to have a zeta potential of at least 30 millivolts as measured by laser doppler electrophoresis. Moreover, as noted by para. [00174] of the instant Specification, a particle dispersion includes a phase mixture composed of dispersed phases that may form particles while one or many phases within the phase mixture are called continuous phase that are continuously connected. Thus it would reasonably appear that the polymeric beads of Magdassi, having a core compartment comprising a dispersed phase and a continuous phase, surrounded by a polymeric shell, the polymeric shell comprising a biocompatible polymer, would meet the limitations of a stable particle dispersion as instantly claimed.
Finally, the claimed amount of “expected” shelf life, while interpreted as an intended use limitation, would also have been obvious to one of ordinary skill in the art since they overlap with the amounts of the prior art (i.e. delivering a stable, effective concentration of the bioactive compounds for extended periods including a few months). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 7, Magdassi further discloses wherein the beads serve as an entero-coating preventing the active substance from being released within the stomach, thus enhancing safety and extending the duration of action by preventing the active substance from being exposed to the acid pH within the stomach ([0028]). Therefore, since the active substance is not released within the stomach, the beads of Magdassi has a shell that retards the release of the active substance after consumption.
Regarding claim 11 reciting wherein a plurality of the beads is administered in one capsule as a single dose, this is merely a recitation of the intended use of the composition. As discussed above, the beads of Magdassi may be orally ingested; therefore, the composition of the prior art would be suitable to be administered in one capsule as a single dose, whether the prior art recognizes such use or not.
Regarding claim 12 reciting wherein a plurality of the beads is administered in a 1 to 2 ounces shot as a single dose, this is merely a recitation of the intended use of the composition. As discussed above, the beads of Magdassi may be orally ingested; therefore, the composition of the prior art would be suitable to be administered in a 1 to 2 ounces shot as a single dose, whether the prior art recognizes such use or not.
Regarding claim 18, as discussed above, Magdassi discloses wherein the shell comprises a biocompatible polymer. Magdassi further discloses wherein the biocompatible polymers include, inter alia, chitosan ([0025]).
As evidenced by Melro, chitosan is a cationic polysaccharide with the ability to form films. Chitosan is water-insoluble but can be dissolved in acidic solutions (p.1, abstract). Chitosan is insoluble in pure water and organic solvents, but can be solubilized in diluted acidic aqueous solutions, below pH 6.0. Above this range, chitosan is insoluble owing to deprotonated amines (p.2, ¶ 2).
Thus, since the polymeric shell of Magdassi comprises chitosan, and chitosan is water-insoluble and can only be solubilized in acidic aqueous solutions below pH 6.0, the polymeric shell of Magdassi comprises a material that does not break down in an aqueous solution with a pH above 6.
Regarding claim 19, Magdassi further discloses wherein the biocompatible polymeric beads may extend duration of action by preventing the bioactive compounds from being exposed to the acid pH within the stomach ([0028]).
As evidenced by Mount Sinai, the normal pH of the stomach fluid is acidic, ranging from about 1.5 to about 3.5 (values may vary slightly depending on the lab doing the test) (p.1, § Normal Results).
Therefore, since the beads prevent the active substance from being exposed to acid pH within the stomach, the shells of the beads do not break down in an acidic pH value such as 1.5-3.5.
Regarding claim 20, Magdassi further discloses wherein the bioactive compound may include vasodilators such as theophylline (i.e., claimed first active ingredient) ([0052]).
Response to Arguments
Applicant asserts independent claims 1, 22, and 23 now recite "the dispersed phase comprises a stable particle dispersion of the one or more particles in the continuous phase, the stable particle dispersion being characterized by a zeta potential having a magnitude of at least about 30 millivolts, as measured by laser doppler electrophoresis, and wherein the one or more particles have an expected shelf life of about 6 months." These features are not taught in the art of record, and for at least for this reason, the claims are allowable. Applicant further asserts Magdassi's "emulsion beads" are expressly built around a water-in-oil emulsion in the bead core (aqueous droplets dispersed in a continuous oil phase). Magdassi, para. 14. Magdassi explains in its Background that emulsions are "thermodynamically unstable" dispersed systems, and that instability during storage is evidenced by creaming, flocculation, and/or coalescence. Id, para. 8. That disclosure cuts against any suggestion that Magdassi is teaching (or motivating) formulation toward a stable particle dispersion characterized by a specific electrokinetic criterion such as that claimed. Magdassi's references to "stable" relate to delivery performance (a stable effective concentration over time), not physical/colloidal stability of the internal dispersed system as defined by zeta potential. Id. para. 32. A statement about maintaining a stable therapeutic concentration does not teach or suggest that the core contains a dispersion meeting a specific electrokinetic stability threshold. Indeed, Magdassi's emulsifiers include surfactants such as Cremophor and Tween-type materials, and it notes preferred "non-ionic polyoxyethylene" derivatives. Id. para. 55. Non-ionic surfactants commonly stabilize via steric/interfacial film effects rather than using a high-magnitude zeta potential. Thus, there is no reason to think that Magdassi's particles have, or are readily modified to have, the claimed properties.
The Examiner does not find the argument persuasive. Although Magdassi does not explicitly disclose, verbatim, a zeta potential as instantly claimed, Applicant agrees that Magdassi does explain in para. [0008] that instability of an emulsion is also evidenced by flocculation (reversible aggregation). Magdassi further discloses in para. [0009] wherein the polymeric beads fulfills the unmet need of systems that exhibit controlled release of bioactive compounds. Thus one of ordinary skill in the art would reasonably conclude the polymeric beads of Magdassi to be stable, i.e., no flocculation/aggregation. According to para. [00243] of the instant Specification filed 09 February 2023, “Zeta potentials of approximately 30 mV or larger in either the positive or negative direction establish a stable particle dispersion, as charges of high magnitudes repel each other in solution; on the other hand, values below that threshold tend to aggregate and flocculate.” Accordingly, since the biocompatible polymeric beads of Magdassi exhibit stability (as evidenced by its ability to deliver a stable therapeutic concentration of the bioactive compound as agreed by Applicant), and do not flocculate/aggregate, one of ordinary skill in the art would reasonably conclude the polymeric beads of Magdassi to have a zeta potential of at least 30 mV.
Moreover, regarding Applicant’s assertion that Magdassi's "emulsion beads" comprise a water-in-oil emulsion in the bead core (aqueous droplets dispersed in a continuous oil phase) thus does not teach, suggest or motivate toward a stable particle dispersion, the Examiner does not find the argument persuasive.
As discussed above, Magdassi’s polymeric beads exhibit stability. Furthermore, according to para. [0043] of the instant Specification, a particle may be made of droplets, including wherein “a droplet of aqueous solution may be covered by a layer of oil acting as the boundary wall.” Similarly, para. [00174] of the instant Specification notes wherein a particle dispersion includes a phase mixture composed of dispersed phases that may form particles while one or many phases within the phase mixture are called continuous phase that are continuously connected. Thus it would reasonably appear that the polymeric beads of Magdassi, having a core compartment comprising a dispersed phase and a continuous phase, which is surrounded by a polymeric shell, the polymeric shell comprising a biocompatible polymer, would meet the limitations of a stable particle dispersion as instantly claimed. As such, Applicant’s argument is unpersuasive.
Accordingly, Examiner disagrees that patentability has been demonstrated for the claims (in their current scope). The Examiner notes that as one way to overcome a prima facie case of obviousness, Applicant may demonstrate objective evidence showing results that would have been unexpected to one having ordinary skill in the art at the time of the invention, and also demonstrate that the instant claims are reasonably representative (i.e. commensurate in scope) with the results provided. See MPEP 716.02(d).
Claims 2 and 21 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2011/0091636 A1 (Elleman et al., 04/21/2011) (hereinafter Elleman).
The disclosures of Magdassi and Muller are discussed above.
Regarding claim 2, as discussed above, Magdassi discloses wherein the continuous oil phase may comprise Span® 80. Magdassi further disclose wherein Span® is an emulsifier ([0060]).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing wherein the continuous oil phase comprises ethyl methyl cellulose.
However, Elleman discloses water-in-oil emulsions comprising a fat phase (abstract). The fat phase may be mixed with an emulsifier ([0053]). Suitable emulsifiers include ethylmethylcellulose (i.e., claimed second polymer).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Magdassi discloses wherein the continuous oil phase may comprise an emulsifier. Accordingly, it would have been obvious to one of ordinary skill in the art to have included an emulsifier such as ethylmethylcellulose into the continuous oil phase since it is a known and effective emulsifier suitable for fat/oily phase of water-in-oil emulsions as taught by Elleman.
Regarding claim 21, as discussed above, Magdassi discloses wherein the discontinuous aqueous phase may comprise Tween® 80 (i.e., emulsifier).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing wherein the discontinuous aqueous phase comprises alginic acid.
However, Elleman further discloses wherein suitable emulsifiers include alginic acid and polysorbate 80 (TWEEN® 80) ([0203]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to have used alginic acid (i.e., claimed first polymer) as the emulsifier in the discontinuous aqueous phase since it is another known and effective emulsifier as taught by Elleman.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Elleman.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 5,332,595 A (Gaonkar, 07/26/1994).
Magdassi and Muller are discussed previously, and their collective teachings differ from those of instant claim 3 insofar as they do not specifically disclose wherein the second polymer in the continuous phase further includes ethyl cellulose.
Gaonkar discloses very stable W/O/W multiple emulsions having an ethylcellulose-containing oil phase, which emulsions exhibit improved stability at temperatures between 0° C and 10° C (abstract). Ethyl cellulose may be dissolved in the oil phase (col. 19, lines 55-56).
It would have been obvious to one of ordinary skill in the art to have included ethyl cellulose dissolved in the oil phase of Magdassi et al of the core compartment to provide improved stability at temperatures between 0° C and 10° C, as taught by Gaonkar.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Gaonkar.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 6 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2017/0079921 A1 (Krishnamurthy et al., 03/23/2017) (hereinafter Krishnamurthy).
The disclosures of Magdassi and Muller are discussed above. As discussed above, Magdassi discloses biocompatible polymeric delivery system comprising biocompatible polymeric beads for controlled or sustained release of bioactive molecules/compounds. Magdassi further discloses wherein variations in the volume of the polymeric matrix provide flexibility in the amount of the bioactive compound released per time period, and the total duration of compound release ([0045]).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing wherein at least 20% of the bioactive molecules/compounds are released within 60 minutes after consumption and at least 20% is not released within 4 hours after consumption.
However, Krishnamurthy discloses oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect (abstract). The controlled/modified release formulation may contain a wide variety of pharmaceutically active drugs ([0046]). The formulations may be used with any multiparticulate system, such as beads, in order to obtain a desired sustained-release of the therapeutically active agent. It is desired that the formulation be prepared such that an initial immediate release of drug provides an early onset of effect, which onset is analogous to an immediate release formulation, and that the formulation further provides a sustained release component which maintains therapeutically effective levels of the drug in the plasma for the desired amount of time, followed by a relatively rapid drop-off in blood plasma levels relative to typical sustained release formulations. The immediate release component preferably represents from about 30% to about 40% of the total dose and the controlled release component preferably represents from about 60% to about 70% of the total dose contained in the formulation ([0047]). The onset of action may occur from about 0.5 to about 4 hours after the oral dosage form is administered, and maintain effective plasma levels until about 8 to 12 hours after oral administration of the dose ([0048]).
Accordingly, since immediate release followed by sustained release is desirable in the art as taught by Krishnamurthy, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed release profiles using no more than routine experimentation based on when one desires for onset of effect to occur. As supported by MPEP § 2144.05(II)(A), “where 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.” One would have had a reasonable expectation of success since Magdassi discloses wherein the volume of the polymeric matrix provide flexibility in the amount of the bioactive compound released per time period, and the total duration of compound release.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Krishnamurthy.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 8 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2015/0190348 A1 (Haksar et al., 03/29/2007) (hereinafter Haksar).
The disclosures of Magdassi and Muller are discussed above.
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing a water-insoluble second shell substantially surrounding the first shell.
However, Haksar discloses a pharmaceutical or nutraceutical composition with a core, an inner coating layer, and an outercoating layer, wherein a pharmaceutical or a nutraceutical active ingredient is contained in the core, one or more salts of alginic acid is contained in the inner coating layer, and one or more water-insoluble polymers is contained in the outer coating layer (abstract). The coating layers have the function of controlling the release of the active ingredient. The coating layers have also the function of providing resistance of the release rates against the presence of ethanol or against the presence of calcium ions ([0040]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the beads of Magdassi to have the coating layers of Haksar motivated by the desire to not only control the release of the active ingredient, but to provide resistance of release rates against the presence of ethanol and calcium ions, which is desirable in the art as taught by Haksar.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Haksar.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claims 9-10 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2009/0186093 A1 (Liu et al., 07/23/2009) (hereinafter Liu).
Regarding claim 10, the disclosures of Magdassi and Muller are discussed above.
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing wherein the bead has an average diameter between 50-950 microns.
However, Liu discloses a core-shell particle comprising a core component and shell component ([0054]). The size of the core-shell particles may be adapted for a particular environment and/or for a particular application of interest. The amount of a shell component and/or a thickness of a shell component can be controlled and/or optimized with respect to various characteristics and features such as specific binding capacity, selectivity, persistence, robustness, etc. ([0139]). Generally, for example, the size of the core-shell particles may typically range from about 100 nm to about 5 mm ([0140]).
Magdassi discloses polymeric beads having a core-shell structure but does not specifically disclose a size. Accordingly, given the general guidance provided by Liu, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed diameter ranges (i.e., bead diameter between 50-950 microns), using no more than routine experimentation, to adapt for desired environments and/or applications as taught by Liu. As supported by MPEP § 2144.05(II)(A), “where 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.”
Regarding claim 9 reciting wherein the one or more particles have an average diameter of smaller than 250 nanometers, as discussed above, Liu discloses wherein beads may range from about 1000 nm to about 5 mm. Accordingly, since beads may be 100 nm, the discontinuous phase particles of the core of the bead having an average diameter of smaller than 250 nanometers would have been obvious.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Liu.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2015/0104545 A1 (Dardelle et al., 04/16/2015) (hereinafter Dardelle).
The disclosures of Magdassi and Muller are discussed previously, and their collective teachings differ from the instant claims insofar as not explicitly disclosing wherein a second active is contained in the shell.
Dardelle discloses a method of manufacturing core/shell capsules. These shell compositions provide unexpected benefits to the core/shell capsules, such as desired functional properties, including delivery ([0019]).
As discussed above, Magdassi discloses wherein the bead may comprise at least one bioactive compound/molecule. Accordingly, it would have been obvious to one of ordinary skill in the art to have included a second bioactive in the shell since this is a known and effective method of incorporating a second bioactive compound/molecule, as taught by Dardelle.
Regarding claim 17, as discussed previously, Magdassi discloses wherein the biocompatible polymeric beads may comprise at least one bioactive compound/molecule. Magdassi further discloses wherein the bioactive compounds may be a cosmetically effective agent or a therapeutic agent ([0032]). The therapeutic agent may include, inter alia, hormone and hormone antagonist ([0033]).
It would have been obvious to one of ordinary skill in the art that one active ingredient, e.g. hormone antagonist, would reduce the effect of a second active ingredient, e.g. hormone, on a body of a person consuming the polymeric beads.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Dardelle.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 14 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2010/0255087 A1 (Coulter, 10/07/2010).
The disclosures of Magdassi and Muller are discussed above. Magdassi further discloses wherein the bioactive compound may include antioxidants ([0054]).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing curcumin as an antioxidant.
However, Coulter discloses an oral composition comprising minicapsules comprising one or more therapeutic or prophylactic substances in a solid core (abstract). A solid outer shell layer may encapsulate the solid core ([0030]). The composition may further comprise excipients to reduce systemic side effects including antioxidants, such as curcumin ([0053]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Magdassi discloses wherein the bioactive compound may include antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have included an antioxidant such as curcumin since it is a known and effective antioxidant as taught by Coulter.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Coulter.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 15 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2018/0296493 A1 (Kaufman, 10/18/2018).
The disclosures of Magdassi and Muller are discussed above. Magdassi further discloses wherein the bioactive compound may include anti-inflammatory agents ([0054]).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing cannabidiol as an anti-inflammatory agent.
However, Kaufman discloses nanosphere compositional structure comprising encapsulated cannabinoids (claim 1). The term “cannabinoid” includes cannabidiol (CBD) ([0039]). Cannabinoids have anti-inflammatory actions ([0060]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Magdassi discloses wherein the bioactive compound may include anti-inflammatory agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the polymeric beads of Magdassi to include an anti-inflammatory agent such as cannabinoids including cannabidiol since it is a known cannabinoid having anti-inflammatory actions suitable as encapsulated actives (i.e., in a core) as taught by Kaufman.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Kaufman.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 16 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2019/0201350 A1 (White et al., 07/04/2019) (hereinafter White).
The disclosure of Magdassi and Muller are discussed above. As discussed above, Magdassi discloses wherein the bioactive compound refers to any compound having therapeutic or cosmetic activity and may include vitamins.
Magdassi and Muller differ from the instant claim insofar as not disclosing wherein the bioactive compound is nicotinamide.
However, White discloses an extended release fat-soluble active composition including an extended release bead multiparticulate comprising a fat-soluble active (abstract). The extended release fat-soluble active composition may be an oral dosage form. The extended release component may comprise a fat-soluble active formulated for sustained release, delayed release, or both, such that the extended release component provides a sustained and enhanced supply of a fat-soluble active, a latter burst of a fat-soluble active, or combinations thereof ([0014]). The fat-soluble active of the extended release component may comprise fat-soluble vitamins, the derivatives thereof, or cannabinoids ([0016]). The extended release lipid multiparticulates may comprise a performance enhancing component in addition to the fat-soluble active. The performance enhancing component may include a vitamin such as vitamin B3 (optionally in the form of nicotinamide) ([0049]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Magdassi disclose wherein the composition may comprise vitamins. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a vitamin such as vitamin B3, in the form of nicotinamide, since it is a known and effective vitamin to provide performance enhancing benefits in oral active-containing beads as taught by White.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and White.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 22 stands rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 2011/0091636 A1 (Elleman et al., 04/21/2011) (hereinafter Elleman) and US 2009/0186093 A1 (Liu et al., 07/23/2009) (hereinafter Liu).
The disclosure of Magdassi and Muller are discussed above. As discussed above, Magdassi discloses wherein the shell (i.e., first shell) comprises a biocompatible polymer. Magdassi further discloses wherein the biocompatible polymers include cellulose ([0025]).
Magdassi and Muller differ from the instant claim insofar as not explicitly disclosing wherein the discontinuous aqueous phase comprises alginic acid.
However, Elleman further discloses wherein suitable emulsifiers include alginic acid and polysorbate 80 (TWEEN® 80) ([0203]).
As discussed above, Magdassi discloses wherein the discontinuous aqueous phase may comprise Tween® 80 (i.e., emulsifier). Thus, it would have been prima facie obvious to one of ordinary skill in the art to have used alginic acid (i.e., claimed first polymer) as the emulsifier in the discontinuous aqueous phase since it is another known and effective emulsifier as taught by Elleman.
The combined teachings of Magdassi, Muller, and Elleman do not disclose wherein the bead has an average diameter between 50-950 microns.
However, Liu discloses a core-shell particle comprising a core component and shell component ([0054]). The size of the core-shell particles may be adapted for a particular environment and/or for a particular application of interest. The amount of a shell component and/or a thickness of a shell component can be controlled and/or optimized with respect to various characteristics and features such as specific binding capacity, selectivity, persistence, robustness, etc. ([0139]). Generally, for example, the size of the core-shell particles may typically range from about 100 nm to about 5 mm ([0140]).
Magdassi discloses polymeric beads having a core-shell structure but does not specifically disclose a size. Accordingly, given the general guidance provided by Liu, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed diameter ranges (i.e. bead diameter between 50-950 microns), using no more than routine experimentation, to adapt for desired environments and/or applications as taught by Liu. As supported by MPEP § 2144.05(II)(A), “where 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.”
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Elleman and Liu.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0208134 A1 (Magdassi et al., 09/22/2005) (hereinafter Magdassi) in view of US 2006/0188534 A1 (Muller, 08/24/2006), and further in view of US 5,332,595 A (Gaonkar, 07/26/1994) and US 2017/0079921 A1 (Krishnamurthy et al., 03/23/2017) (hereinafter Krishnamurthy).
The limitations of claim 23 have been addressed when addressing the limitations of claims 1, 3 and 6 as discussed above and previously. Accordingly, claim 23 is rejected based on the same reasons set forth above and previously in rejecting claims 1, 3 and 6.
Response to Arguments
Applicant does not present specific arguments with regards to Magdassi and Krishnamurthy.
Since the Examiner has discussed Magdassi above, this rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612