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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 August 2025 has been entered.
Status of Claims
The amendments and arguments filed 12 August 2025 are acknowledged and have been fully considered. Claims 1-15 are currently pending. Claims 1 and are amended; no claims are cancelled; claims 6 and 14-15 are withdrawn; no claims are new.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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular the rejection of claims under 35 U.S.C. 112b is withdrawn in view of Applicant’s amendment to claim 7. 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 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 Merriam-Webster (“Fat”) 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; poly ethylene 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%.
And as evidenced by Merriam-Webster, fats are compounds of carbon, hydrogen, and oxygen that are glycerides of fatty acids (Definition 2b), 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]).
Mattson teaches similar encapsulated probiotic microorganisms (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 12 August 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 2 of the remarks that Guriev and Drouillard et al. do not teach a fat-based coating.
This argument is not persuasive. As evidenced by Merriam-Webster, fats are “various compounds of carbon, hydrogen, and oxygen that are glycerides of fatty acids”, encompassing mono-, di-, and triglycerides. As such, under the broadest reasonable interpretation of “fat-based coating”, both Guriev and Drouillard et al. teach fat-based coatings.
Applicant argues on pg. 3 of the remarks that it is not obvious to an ordinary artisan to reduce the water content from 8.7% as described in Guriev to less than 5% as claimed.
This argument is not persuasive. Guriev teach in Example 5 (Pars. [0112-0118]) a fat-based encapsulation of lactic acid bacteria having a water content of about 1.7%, overlapping with the instantly claimed range. As such, there is no need for a motivation to decrease the water content of Guriev to be less than 5%, as Guriev explicitly teaches a microcapsule with a fat-based coating surrounding a viable microorganism, further having a water content of 1.7%.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611