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 .
Priority
This application is a 371 of PCT/EP2020/066311 filed 06/12/2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on Application No. DENMARK PA 201900718, filed on 06/13/2019, Application No. DENMARK PA 201901451, filed on 12/10/2019 and Application No. DENMARK PA 201901196, filed on 10/10/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1, 3-6, 9, 11-14 and 16-20 are pending. Claims 1 and 9 are amended. Claims 18-20 are new. Claims 14, 16 and 17 are withdrawn.
Claims 1, 3-6, 9, 11-13 and 18-20 (claim set filed 03/04/2026) are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 03/04/2026 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
The previous claim 1 objection has been withdrawn necessitated by amendment of claim 1.
The previous claim 7 rejection under 35 U.S.C. 112(b) has been withdrawn necessitated by cancellation of claim 7.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites: “102 CFU/g biomass”. The specification recites the same steps a, b and c as claim 18 and has “102 CFU/g biomass” (p. 21, line 11-16). Applicant is suggested to use superscript if that was the intention of the Applicant. Appropriate correction is required.
Maintained/Modified Rejections
The following rejections are maintained and/or modified taking into consideration amendment
to claims filed on 03/04/2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US 20200108105 A1) as evidenced by Fasina (Fasina et al. LWT – Food Science and Technology, 2008,41, 1501-1505).
Guriev teaches a microcapsule containing live probiotic organism in a solid matrix for topical treatment for improving skin and mucous membrane: “A microcapsule for a topical treatment for improving skin and mucus membranes condition includes a matrix material in a solid state, in which a live probiotic microorganism is encapsulated…” (Abstract). Guriev discloses that the matrix material comprises animal and vegetable oils, fats and waxes, including plant waxes (paragraph 0030). Plant wax is one of the organogelators, viscosity increasing agents, in instant application. Guriev describes that matrix material can be selected as a mixture of the recited substances (paragraph 0031). Guriev mentions that the composition can have the form of aqueous or anhydrous gel (paragraph 0068). Guriev teaches that microcapsules can have size of 100 μm or less and contain lyophilized microorganisms: “… microcapsules have a size of 100-2000 μm and are prepared by spraying the molten matrix material into the fluidized bed of the lyophilisate of microorganisms.” (paragraph 0037) and “… the microcapsules have a size of 20-1000 μm and are prepared by cooling the sprayed suspension of microorganisms in the matrix material.” (paragraph 0039). Guriev discloses advantages of developed formulation: “efficient delivery of viable microorganisms to the skin and mucous membranes” (paragraph 0024), improved usability and stability (paragraphs 0025 and 0026).
The specification defines “embedding” as: “By "embedding" or "mixing" or "dispersing" or "enrobing" or "coating" it is meant that the probiotic microorganism is dispersed within and fully enveloped by the oil gel. By "enveloped" it is meant to enclose or enfold completely within the oil.” (p. 5, lines 1-4). Guriev teaches microcapsules to have suspension of microorganisms in the matrix material (paragraph 0036) and describes preparation of suspension by stirring lyophilizate of microorganisms in the matrix until homogeneous suspension is formed (paragraph 0089). That is similar to the description in the specification and indicates that microorganism in Guriev teaching is embedded in the matrix material which can be the mixture of matrix materials including vegetable oil and plant waxes as described above.
Thus, Guriev teaches preparation of a composition comprising oil, viscosity increasing agent, wax, and viable lyophilized microorganism. Although the components of composition in Guriev teaching can be the same as components of instant composition, one would not immediately envisage combination of oils and organogelators, waxes, and therefore the rejection is made under obviousness.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look at the guidance provided by Guriev and use his composition of probiotics encapsulated in oil gel. One would have been motivated to do so since Guriev described composition with increased usability and stability which can be used for treatment of skin and mucous membranes . A skilled artisan would have reasonably expected success in the preparation of probiotics in oil gel composition following the description of the prior art.
It would have been obvious to one of ordinary skill in the art that microorganism in Guriev teaching is embedded in the matrix material. One would have been motivated to expect that with reasonable success since Guriev teaches stirring the lyophilized bacterial powder in the composition material to reach the homogeneous suspension that correspond to specification definition of “embedded” as probiotic microorganism to be mixed or dispersed within the oil gel. Thus, Guriev teaching makes claim 1 obvious.
Regarding claims 3, 4 and 6, Guriev teaches the oil component to be a vegetable oil: “… lipids: animal and vegetable oils and fats, fully hydrogenated or partially hydrogenated vegetable and animal oils and fats” (paragraph 0030). The vegetable oils have low melting point below 15 degrees Celsius as evidenced by Fasina (p. 1503, Table 2). For instance, peak melting temperature for corn oil is -22.26° Cand for soybean oil - -17.26° C (p. 1503, Table 2). Thus, Guriev teaching as evidenced by Fasina renders claims 3, 4 and 6 obvious.
Regarding claim 5, Guriev teaches that the microcapsules contain matrix material in a solid state (Abstract) melting above 25° C when it comes in contact with skin: “…the claimed microcapsules consist of a matrix in which microorganisms are encapsulated wherein the matrix material has the property of melting or softening at a temperature selected from the range of 25-43° C….” (paragraph 0027). Guriev discloses that the developed formulation provides controlled release of microorganisms: “… capable of effectively and controlled releasing upon contact with the skin and mucous membranes of human or warm-blooded animal.” (paragraph 0023). Thus, Guriev teaching renders claim 5 obvious.
Regarding claim 9, Guriev teaches microcapsules to contain lyophilized microorganisms (paragraph 0037) and microorganism to be selected from different bacteria including Lactobacillus species (paragraph 0063). Guriev provides example of preparation of microcapsules from lyophilized Lactobacillus species (Example 5, paragraph 0112). Thus, Guriev teaching renders claim 9 obvious.
Regarding claims 11-13, Guriev teaches that microcapsule can be used for topical treatment of skin and mucous membranes (Abstract) at different conditions and disorders: “ to normalize the microflora, homeostasis and barrier function 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).” (paragraph 0002). Guriev discloses that microcapsules can be applied to mucous membrane on different body parts: “The microcapsules provided herein and compositions containing said microcapsules can be applied to the skin (on any area of the body skin) or to the mucous membranes (oral, nasal cavity, eyes, genitals)…” (paragraph 0074). Furthermore, claims 11-13 recite intended use. Note the recitation of intended use is given weight to the extent that it imparts a structural limitation and the prior art needs to be capable of performing the intended use. See MPEP 2111.02, section II. Thus, Guriev teaching renders claims 11-13 obvious.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US 20200108105 A1) as applied to claim 1 above, and further in view of Blake (Blake et al. J. Am.Oil Chem. Soc., 2014, 91, 885-903) as evidenced by Hazan (Hazan et al. BMC Microbiol., 2012, 12, 259, 1-7).
The teaching of Guriev has been set forth above.
Regarding claims 18 and 19, as described above for claim 1, Guriev teaches microcapsules containing suspension of microorganisms in the matrix material which can be mixture of matrix materials including vegetable oil and plant waxes (paragraphs 0030, 0031, 0036) and describes preparation of suspension by stirring lyophilizate of microorganisms in the matrix until homogeneous suspension is formed (paragraph 0089). That indicates that microorganism in Guriev teaching is embedded in the matrix material. Guriev provides examples of microcapsules formulated as gel and containing viable Lactobacillus microorganisms in the amount of from 8.8 x 106 U/g on 0 days (Table 2) where units (U) are not specified. CFU is the gold standard method for counting viable bacteria as evidenced by Hazan (p. 1, left column). Therefore it would have been obvious to one of ordinary skill in the art that the amount of bacteria in Guriev teaching can correspond to 8.8 x 106 CFU/g since both are measuring viable bacteria. Thus, the amount of microorganisms in Guriev teaching reads on claim 18 limitation of 102 CFU/g ( or 102 CFU/g considering Objection to claim 18 above).
However, Guriev does not explicitly teach immobilizing the lyophilized biomass in a three-dimensional network formed by the organogelator.
Blake teaches plant wax network and waxes oil binding capacity (Abstract). Blake discloses that plant waxes are organogelators that can successfully gel liquid oil. Blake describes the gelation as: “The gelation mechanism is attributed to the arrangement of n-alkanes or wax esters into small microcrystalline platelets, which, upon aggregation, form a complex three-dimensional network that easily entraps liquid oil.” (p. 886, right column, 2nd paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that stirring of the lyophilized microorganisms with the matrix materials including organogelator, plant waxes, in Guriev teaching will result in immobilizing lyophilized biomass in a three-dimensional network formed by the organogelator. One would have been motivated to expect that with reasonable success since Blake teaches plant wax to have three-dimensional network that can entrap liquid oil and hence can entrap the lyophilized microorganisms when stirred to a homogeneous suspension as described by Guriev. Thus, Guriev and Blake teachings as evidenced by Hazan render claims 18 and 19 obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US 20200108105 A1), and further in view of Mody (WO 2017223150 A1 on record in IDS).
The teaching of Guriev has been set forth above.
Guriev does not teach preparation of the oil gel composition according to steps recited in claim 20.
Mody teaches stable suspension of probiotic powder in an oil and wax combination (paragraph 0009). The composition contains at least one edible oil, including vegetable oils, such as sunflower oil, corn oil or rice bran oil (paragraphs 0010, 0014); at least one edible wax including plant waxes such as carnauba wax or candelilla wax (paragraph 0015) and a probiotic powder including lactic acid bacteria species (paragraph 0016). Mody discloses that the suspension is made by heating the edible oil in a vessel to above the melting point of the edible wax, adding edible wax and agitating the mixture until the oil and wax mixture is homogenous and shows no visible striations; then cooling mixture to below 30°C and adding probiotic powder and agitating the mixture until the probiotic powder is well suspended (paragraph 0027). Mody mentions that probiotics are freeze-dried which is lyophilized (paragraph 0103). Mody provides more detailed instruction in the Examples for the preparation of the composition, containing various oils and waxes and of characterization of the resulting composition stability (Examples 1-3, paragraphs 0102-0105).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that add method of preparation of the oil gel by heating the oil and wax to completely dissolve the wax followed by cooling to below 30°C prior to adding and mixing the lyophilized probiotics as taught by Mody to the method of preparation of microcapsules with the gel composition based on Guriev teaching. One would have been motivated to do that because Mody method results in complete melting of organogelator leading to homogenous suspension of oil, wax and probiotics and Mody provides detailed instructions for the preparation of suspension and evaluates properties of suspensions made of various oil components . A skilled artisan would have reasonably expected success in that combination since Mody and Guriev teach the same components of the composition, i.e. vegetable oils, plant waxes and lactic acid bacteria probiotics. Thus, Guriev and Mody teachings render claim 20 obvious.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
Applicant argues (addressing p. of the Remarks) that: “Guriev does not teach or suggest a composition wherein at least one viable microorganism is embedded in a mixture of an oil and an organogelator. The encapsulation provided by the present invention is structurally and mechanically distinct from the disclosure of Guriev (and Fasina).”. Applicant further argues that Guriev discloses a layer-by-layer encapsulation technique and the claimed invention is drawn to a continuous polymer-oil matrix rather than a layered shell. Applicant states that the three-dimensional construction provides benefits of improved microorganism viability and enhances evenness of spreading the composition on skin or mucous membranes and these benefits are absent in cited references. These arguments are not persuasive because:
Guriev teaches the same structure, i.e. the composition composed of the claimed
components, i.e. oils (including vegetable oils), organogelators (including plant wax) and lyophilized microorganisms (including Lactobacillus). Even though Guriev does not explicitly describe mixing oils and organogelators, Guriev teaches their mixtures (paragraphs 0030, 0031, 0037, 0063).
Guriev teaches the same form of the composition, aqueous or anhydrous gel (paragraph
0068). Although Guriev discloses gel layering method (Table 2, sample 3), it is one of different methods of composition preparation and composition can be formulated as gel (Table 2, samples 1 and 2). Guriev describes preparation of the composition by stirring of probiotic powder into the matrix materials until homogeneous suspension is formed (paragraph 0089) providing microorganisms embedded in the oil gel as described above based on specification definition of “embedded” as probiotic microorganism to be mixed or dispersed within the oil gel.
Guriev discloses the same intended use of the composition, i.e. for topical treatment of
skin and mucous membranes at different conditions and disorders (paragraph 0002). Additionally, Guriev teaches compositions with increased usability and stability and no abrasive effect (paragraphs 0023-0026) providing motivation to one of ordinary skill in the art to use his composition of probiotics encapsulated in the oil gel for treatment of skin and mucous membranes. Thus, Guriev composition is not structurally and functionally different from the claimed composition unless shown on the contrary.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., improvement of microorganism viability and enhancement of evenness of spreading the composition on skin or mucous membranes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Besides, although the specification provides working examples showing that lyophilized cells are more stable in the gels than non-lyophilized cells (Table 1) and maintained viability longer (p. 25, lines 31-33), the specification does not demonstrate the effect of spreading the composition on skin or mucous membranes. Additionally, Guriev demonstrated that probiotic cells retain viability in the composition of his invention and reported absence of abrasive effect when applied on the skin (Table 2).
New claims 18-20 are addressed as described in the rejection above.
Thus, the 35 U.S.C. 103 rejection is maintained and modified necessitates by amendment of claims.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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