DETAILED ACTION
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 .
Status of Claims
The amendments and arguments filed 16 June 2026 are acknowledged and have been fully considered. Claims 1-15 are currently pending. No claims are amended; no claims are cancelled; claims 6 and 14-15 are withdrawn; no claims are new.
Claims 1-5 and 7-13 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5, 7-9, and 11-13 are MAINTAINED rejected under 35 U.S.C. 103 as being unpatentable over Guriev (RU 2652277; of record, US 2020/0108105 used as English equivalent) in view of Milanovic et al. (J Serbian Chemical Society, 2001, Vol. 66, 435-441; of record), Drouillard et al. (WO 2018/144653; of record), and Mattson (US 2007/0160589; of record) as evidenced by Faergemand et al. (“Using emulsifiers to improve food texture”, 2003, Ch. 10) and PubChem (“Glycerin”; of record), and Spectrum (“Shea butter”).
Claim 1 is drawn to a microcapsule comprising a fat-based coating surrounding a composition providing an encapsulated composition, the encapsulated composition comprising a viable microorganism (more specifically Lactobacillus plantarum (Applicant’s elected species)), and a water content below 5% (w/w), wherein the encapsulated composition comprises a protective agent, wherein the fat-based coating is shea butter fat (Applicant’s elected species).
Claim 2 is drawn to the microcapsule of claim 1, wherein the protective agent is a cryoprotectant (more specifically glycerin (Applicant’s elected species)).
Claim 3 is drawn to the microcapsule of claim 1, wherein the protective agent is a polyhydroxy compound, and wherein the polyhydroxy compound is selected from maltose; lactose; trehalose; skim milk powder; dextran; dextrose; peptone; glutamate; polyethylene glycol; and a combination thereof.
Claim 8 is drawn to the microcapsule of claim 1, wherein the viable microorganism is dried.
Guriev teaches in Example 5 (Pars. [0112-0118]) the formation of microcapsules comprising a mixture of mono-, di-, and triglycerides encapsulating a lyophilizate of Lactobacillus acidophilus, Lactobacillus casei, and Lactobacillus plantarum (i.e., freeze-dried microorganisms), wherein the microcapsules contain live encapsulated microorganisms with a moisture content of 1.7%.
As disclosed in the instant specification at pg. 8 lines 26-28, a fat relates to a substance comprising primarily carbon and hydrogen and which is hydrophobic and soluble in organic solvents and insoluble in water. As evidenced by Faergemand et al. at section 10.2.1, monodiglycerides (i.e., the combination of mono- and di- glycerides) are oil soluble and only dispersible in water in the presence of co-emulsifiers (i.e., insoluble in water). As such, under the broadest reasonable interpretation, “fat-based coating” encompasses the mono-, di-, and triglyceride coating taught by Guriev.
As such, Guriev teaches a microcapsule comprising a fat-based coating (mono-, di-, and triglycerides) surrounding a composition providing an encapsulated composition, the encapsulated composition comprising a viable microorganism (Lactobacillus acidophilus, Lactobacillus casei, and Lactobacillus plantarum), and a water content below 5% (w/w), wherein the viable microorganism is dried (freeze-dried).
The microcapsule of Guriev differs from the instantly claimed microcapsule in the following way:
the microcapsule of Guriev does not comprise a protective agent; and
the microcapsule of Guriev does not comprise shea butter.
Yet, as to 1: Milanovic et al. teach the lyophilization of lactic acid bacteria (Abstract). Milanovic et al. further teach the use of cryoprotectants to “protect cells membranes against the effects of exposure to low temperature. A large number of different cryoprotectivants have been used for preparing bacterial suspensions before drying: saccharose, lactose, trehalose, glycerol, sodium glutamate, adonitol, peptone, dextran… These components generally improve the resistance of freezing.” (Pgs. 435-436).
As evidenced by PubChem, glycerol is another name for glycerin (Synonyms on pg. 1).
Drouillard et al. teach similar compositions of encapsulated freeze-dried microorganisms (Par. [0100]). Drouillard et al. further teach the use of a mono- and diglyceride coating (i.e., fat-based coating) to encapsulate a freeze-dried microorganism composition including the cryoprotectant sucrose, demonstrating that fat-based coatings are suitable to encapsulate freeze-dried microorganisms including a cryoprotectant.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the microcapsule of Guriev to include a cryoprotectant such as glycerin or lactose. It would have been obvious to combine the known encapsulated lyophilized bacteria of Guriev with the known cryoprotectant of Milanovic et al. to yield the predictable result of a microcapsule with a higher number of live bacteria after lyophilization, with a reasonable expectation of success.
And, as to 2: Guriev further teach the encapsulating material being selected from lipids including animal and vegetable oils and fats, fully hydrogenated or partially hydrogenated vegetable and animal oils and fats, saturated and unsaturated fatty acids, partially hydrogenated or fully hydrogenated fatty acids, fatty acid esters, saturated and unsaturated partially hydrogenated or fully hydrogenated monoglycerides, diglycerides and triglycerides, phospholipids, lecithins, partially hydrogenated or fully hydrogenated phospholipids and lecithins, lysolecithins and lysophosphatidylcholine (Par. [0030]), indicating that a large number of fats are suitable for forming the coating, additionally teaching the coating ensuring stability of the microorganisms during storage (Par. [0018]).
Mattson teaches similar encapsulated probiotic microorganisms to enable long-term stability (Par. [0017]). Mattson further teaches that shea butter is a suitable fat for encapsulating probiotic organisms (Par. [0021]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the microcapsule composition of Guriev to include shea butter. It would have been obvious to substitute one known fat suitable for encapsulating probiotic microorganisms for another to obtain the predictable result of a fat encapsulated microorganism, with a reasonable expectation of success.
Based on all of the foregoing, claims 1-3 and 8 are rejected as prima facie obvious.
Claim 5 is drawn to the microcapsule according to claim 1, wherein the fat-based coating has a melting temperature in the range of 25-37°C.
As evidenced by Spectrum, the melting range of shea butter is 28-38°C (Pg. 4), overlapping with the instantly claimed range.
As such, claim 5 is also rejected as prima facie obvious.
Claim 7 is drawn to the microcapsule of claim 1, wherein the fat-based coating is emulsified in a hydrophilic phase.
Claim 9 is drawn to a topical composition comprising the microcapsule of claim 1.
Guriev further teaches the microcapsule compositions in the form of emulsions (Par. [0068]), including a cosmetic cream (Par. [0167]) comprising water and glycerol monostearate (i.e., an emulsifier).
As such, claims 7 and 9 are also rejected as prima facie obvious.
Claim 11 is drawn to a composition comprising the microcapsule of claim 1 for use as a medicament.
Claim 12 is drawn to a composition comprising the microcapsule according to claim 1 for the treatment, alleviation, and/or prophylaxis of a skin disorder.
Claim 13 is drawn to the composition of claim 1 wherein the skin disorder is selected from aged skin and UV-irritated skin.
Claims 11-13 are intended use claims and do not impart any further structural limitations to the claims. Nevertheless, Guriev teaches in Example 14 (Pars. [0165-0166]) formulating the microcapsules of Example 5 in a gel that can be used as a vehicle for external pharmaceuticals. Guriev further teaches that the microcapsules can be used “in medicine and cosmetology as an external medicine and cosmetic for normalizing the microflora and functional state of the skin and mucous membranes during aging, damage by environmental factors (UV rays, wind, low temperatures, injuries) and pathological processes (Microbial infections, inflammatory and allergic diseases, metabolic disorders)” (Par. [0172]).
As such, claims 11-13 are also rejected as prima facie obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Guriev, Milanovic et al., Drouillard et al., and Mattson as applied to claims 1-3, 5, 7-9, and 11-13 above, and further in view of Keshtmand et al. (WO 2017/095897; of record).
The teachings of Guriev, Milanovic et al., and Drouillard et al. have been set forth above.
Claim 4 is drawn to the microcapsule of claim 1, wherein the encapsulated composition comprises below 1% (w/w) water.
Guriev, Milanovic et al., and Drouillard et al. do not teach the encapsulated composition comprising below 1% (w/w) water.
However, Keshtmand et al. teach similar freeze-dried compositions of viable microorganisms and cryoprotectants (Abstract). Keshtmand et al. further teach that live microorganisms are generally sensitive to moisture (Pg. 1 lines 12-26), indicating that the amount of water in the composition is directly correlated to the survival rate of the microorganisms.
And, as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the water content is clearly a result-effective variable, determining the survival rate of the encapsulated microorganisms. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal water content in order to best achieve the desired results.
As such, claim 4 is rejected as prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Guriev, Milanovic et al., Drouillard et al., and Mattson as applied to claims 1-3, 5, 7-9, and 11-13 above, and further in view of Cloud Nine Soap Co. (“How is lotion made?”; of record).
The teachings of Guriev, Milanovic et al., and Drouillard et al. have been set forth above.
Claim 10 is drawn to the topical composition according to claim 9, wherein the topical composition comprises 5-75% (w/w) water.
Guriev teaches in Example 15 (Par. [0167]) formulating the microcapsules into a cosmetic cream comprising water. Guriev is silent to the amount of water in the cream composition.
However, Cloud Nine Soap Co. teaches that the viscosity of a lotion or cream is determined by the percentage of water used in the recipe (Pg. 2).
As discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of water is clearly a result-effective variable, determining the viscosity of the composition. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of water in order to best achieve the desired results.
As such, claim 10 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 16 June 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 2 of the Remarks that the mono-, di-, and triglyceride coating of Guriev does not describe a fat-based coating, further arguing on pgs. 2-3 that Mattson does not teach encapsulation or suggest that shea butter can replace the coating in the microcapsules of Guriev.
This argument is not persuasive. As disclosed in the instant specification at pg. 8 lines 26-28, a fat relates to a substance comprising primarily carbon and hydrogen and which is hydrophobic and soluble in organic solvents and insoluble in water. As evidenced by ScienceDirect, monodiglycerides (i.e., the combination of mono- and di- glycerides) are oil soluble and only dispersible in water in the presence of co-emulsifiers (i.e., insoluble in water). As such, under the broadest reasonable interpretation, “fat-based coating” encompasses the mono-, di-, and triglyceride coating taught by Guriev.
Further, Mattson explicitly teaches that encapsulating probiotic culture in a fat-based coating enables long term stability (Par. [0017]), explicitly disclosing encapsulation. And as taught by Guriev at Par. [0030], a large number of fats are suitable for forming the coating for stabilizing the probiotics. As such, one of ordinary skill in the art would be motivated to substitute shea butter as the fat coating in the microparticles of Guriev with a reasonable expectation of success, as shea butter is taught to be suitable for a fat-based coating enabling long term stability and Guriev indicates a large number of fats are a suitable coating.
Applicant argues on pg. 4 of the Remarks that the improvement of the storage stability of the live microorganisms is an unexpected result.
This argument is not persuasive. Guriev teaches in Table 2 on pg. 9 a formulation comprising the microparticles of example 5 having a water content of 1.7% (Par. [0113]) providing microorganism stability over a period of time of up to 364 days. As such, one of ordinary skill in the art would expect that fat-based microparticles encapsulating microorganisms with a water content under 5% to provide improved storage stability.
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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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
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