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/EP2020/064124 filed 05/20/2020. 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 DK PA201900601, filed on 05/20/2019 and DK PA202000124, filed on 01/31/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1-9 and 11-19 are pending. Claims 1, 3, 8, 11 and 12 were amended. Claim 10 is cancelled. Claims 14, 15, 18 and 19 were withdrawn.
Claims 1-9, 11-13, 16 and 17 (claim set filed 02/26/2026) are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 02/26/2026 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.
A previously applied objection to claim 11 has been withdrawn necessitated by Applicant's amendment of claim 11.
The previous claim 17 rejection under 35 U.S.C. 112(a) has been withdrawn necessitated by submission of Declaration of Denis Boulard Global Head of IP & Legal R&I, L'Oreal SA (Applicant) that the strains are deposited and are available under the Budapest treaty.
The previous claims 3 and 8 rejection under 35 U.S.C. 112(b) have been withdrawn necessitated by amendment of claims 3 and 8.
The previous claim 10 rejection under 35 U.S.C. 112(d) has been withdrawn necessitated by cancellation of claim 10.
The previous claims 1, 2, 4-7, 9-11, 16 and 17 rejection under 35 U.S.C. 101 has been withdrawn necessitated by amendment of claim 1 and Applicant’s arguments which are persuasive. Applicant argues that: “Claim 1 has been amended to change the word "or" to "and" in claim 1 … thereby indicating that the viable strain in encapsulated, microencapsulated, spray-dried and/or lyophilized form is mandatory”. These arguments are persuasive regarding viable strain in the composition, but not regarding strain metabolites. However, claim 1 amendment requiring the composition to “comprise a pH in the range of 6.5 or below” alters the structure of judicial exception and integrates the judicial exception into practical application. Therefore, 35 U.S.C. 101 has been withdrawn.
The previous claims 1-6, 8-11, 13 and 16 rejection under 35 U.S.C. 102(a)(1)(a)(2) as anticipated by Mogna (US 20190015463 A1) has been withdrawn necessitated by Applicant’s amendment of claim 1 by including limitation for the composition to comprise a pH in the range of 6.5 or below not covered by prior art of Mogna.
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 1-9, 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna (US 20190015463 A1) in view of Lang (US 9585922 B2).
Regarding claim 1, Mogna teaches a composition comprising mixture of selected lactic bacteria strains to use in treatment of infections caused by pathogenic bacteria belonging to the species Propionibacterium acnes. (Abstract). Propionibacterium acnes is a former name for Cutibacterium acnes (Specification, p.1, line 16) and is used interchangeably. Mogna describes inhibition of P. acnes growth by multiple Lactobacillus strains and selection of the strains with highest activity: “Said inhibition activity is due to the ability of the strain Lactobacillus salivarius LS03 … to producing bacteriocins very active against the pathogen P. acnes.” (paragraph 0084). Mogna discloses that the composition can be used for prevention or treatment of dermatitis in general and different dermatological conditions including acne (Abstract). Mogna mentions that the composition is formulated in a pharmaceutical form (paragraph 0063) and can comprise suitable excipients (paragraph 0062). Mogna teaches that the selected bacterial strains can be viable or dead, in the form of lysed cells or metabolites (paragraph 0024).
Mogna does not teach the pH of the composition.
Lang teaches co-aggregation of lactic bacteria with pathogenic bacteria: “… microorganism belonging to the order of lactic acid bacteria or an analog, fragment, derivative, mutant or combination thereof, wherein the microorganism or analog, fragment, derivative, mutant or combination therefore can coaggregate with at least one pathogenic microorganism wherein the pathogenic microorganism is selected from the group comprising Staphylococcus aureus or Pseudomonas aeruginosa.” (column 4, lines 1-8). Lang discloses that coaggregation can inhibit bacterial growth or kill them or prevent the formation of biofilm (column 4, lines 12-14). Lang teaches that selected lactic acid bacteria coaggregate specifically with certain pathogenic bacteria and do not coaggregate with non-pathogenic bacteria: “… coaggregates specifically with the pathogenic bacteria Staphylococcus aureus and/or Pseudomonas aeruginosa. … In contrast with those, the preferred lactic acid bacteria do not exhibit any binding or coaggregation of commensal skin bacteria or other pathogenic microorganisms that populate the skin flora.” (column 7, lines 64-66, column 8, lines 3-6, Figure 7 and 8).
Lang teaches that composition of lactic acid bacteria can be in a medium with pH of 3‐8: “… it is preferable if the capability of the lactic acid bacteria according to the invention for specific binding to the pathogenic microorganisms persists even at a pH between approx. 3 and 8. That means that the lactic acid bacteria may be in a medium having a pH of 3 to 8 and still have their ability to bind Staphylococcus aureus and/or Pseudomonas aeruginosa” (column 15, lines 20‐26) that reads on the instant range of pH 6.5 or below.
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use guidance of Lang and maintain pH in Mogna’s composition in the range of 3-8. One would have been motivated to do so since optimal pH provides viability and activity of Lactobacillus strains that is necessary for efficient inhibition of pathogenic P. acnes and because Lang teaches that pH range for selected lactic acid bacteria to specifically coaggregate and inhibit bacterial growth of certain pathogenic versus commensal bacteria. A skilled artisan would have reasonably expected success in using Lang’s guidance because Mogna teaches composition of Lactobacillus strains inhibiting growth of P. acnes and Lang describes technique for selection of Lactobacillus strains inhibiting pathogenic strains associated with skin infections.
Second, claim 1 is interpreted as directed to a composition comprising one or more bacterial strains and a pharmaceutically or a cosmetically acceptable vehicle or excipient wherein the bacterial strains are provided in the recited forms and the composition has pH of 6.5 or below. The limitations of bacterial strains to exhibit stronger inhibition and 10% stronger inhibition of pathogenic C. acnes strains relative to the non-pathogenic C. acnes strains is interpreted as functional properties of the structure, i.e. composition. Since the instant specification appears to teach one or more bacterial strains that are naturally occurring strains and may be selected from Lactobacillus, Mogna teaches Lactobacillus strains used to treat infection against C. acnes and Lang teaches the instant pH for the composition, the same functional properties are necessarily present in composition based on Mogna and Lang teachings. MPEP 2112.01: “Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Thus, combination of Mogna and Lang teachings renders claim 1 obvious.
Claims 2-5 and 8 are directed to further limitations of functional properties of the composition of one or more bacterial strains inhibiting C. acnes. Therefore, the composition of Mogna and Lang teachings will necessarily provide co-aggregation inhibition, co-aggregation scored by a visual scale and formed within 1 hour and having particle size above 0.1 mm, 40% stronger inhibition of pathogenic C. acnes strains and strains of RT5 ribotype. Since the composition based on Mogna and Lang teachings is the same as instant composition as described above, Lactobacillus strains in Mogna teaching can perform the same functions as the instant strains. Thus, Mogna and Lang teachings render claims 2-5 and 8 obvious.
Regarding claims 6 and 16, Mogna teaches different Lactobacillus species in the composition inhibiting growth of P. acnes, including Lactobacillus salivarius, Lactobacillus delbrueckii ssp. Delbrueckii and Lactobacillus reuteri (paragraphs 0035‐0037). Thus, Mogna and Lang teachings render claims 6 and 16 obvious.
Regarding claim 9 and 13, Mogna teaches that the composition of selected lactic bacteria strains can be for topical use and in a pharmaceutical form as medicament: “The composition of the present invention comprising said mixture of selected strains of lactic bacteria is formulated in a pharmaceutical form for oral use (novel food, supplement product or medical device or pharmaceutical composition) in the form of powder, … tablet, capsule, pill or lozenge; or for topical use (composition for medical device or pharmaceutical composition) in the form of cream, ointment, … to be used as for skin applications, or for transdermal use also in the form of band aid.” (paragraph 0063). Thus, Mogna and Lang teachings render claims 9 and 13 obvious.
Regarding claim 11, Mogna teaches the concentration of bacterial strains: “In said mixtures, said at least a strain of bacteria, or the combination of said strains of Lactobacilli/Bifidobacteria of the present invention, is in a total amount comprised from 1×106 to 1×1012 CFU/g of mixture…” (paragraph 0060). That concentration is within a range of instant concentration and hence Mogna and Lang teachings render claim 11 obvious.
Regarding claim 7, Lang teaches preferable Lactobacillus bacteria for inhibition of pathogenic microorganisms including Lactobacillus plantarum (column 4, line 56).
Regarding claim 12, as described above for claim 1, Lang teaches that composition of lactic acid bacteria can be in a medium with pH of 3‐8 and maintain their ability to bind pathogenic strains (column 15, lines 20‐26) and that reads on the instant range of pH 5.5 or below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow guidance from Lang teaching and add Lactobacillus plantarum as lactic acid bacteria to the composition of Mogna teaching and maintain pH of the composition in the range of 3-8. One would have been motivated to do that with reasonably expected success since Lang teaches specific inhibition of pathogenic versus commensal strains with the preferred Lactobacillus and that the composition of Lactobacillus maintains inhibition of pathogenic bacteria at pH 3-8. Thus, combination of Mogna and Lang teachings render claims 7 and 12 obvious.
Claim 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna (US 20190015463 A1) in view of Lang (US 9585922 B2) as applied to claims 1 and 6 above, and further in view of Lebeer (Lebeer et al. BioRxiv, 2018, 1‐28).
Teachings of Mogna and Lang have been set forth above.
Mogna and Lang do not teach selection of Lactobacillus plantarum strain LB356R.
Regarding claims 7 and 17, Lebeer teaches selection of Lactobacillus strains for inhibition of acne‐related microorganisms (Abstract). Lebeer teaches a topical composition comprising live Lactobacillus plantarum: “… the present invention provides a topical skin composition comprising one or more live Lactobacillus species; wherein at least one of said Lactobacillus species is L. plantarum…” (p. 3, lines 2- 4). Lebeer discloses that Lactobacillus strains selected for the composition can compete with pathogenic bacteria causing different skin conditions, including acne, and that one of these bacteria is P. acnes: “The present invention is based on the discovery of specific Lactobacillus strains that can compete with growth of Propionibacterium acnes, … that are linked with skin conditions like acne vulgaris, dandruff, tinea pedis or other fungal skin infections.” (p. 5, lines 3-6). Lebeer discloses that specific strains of C. acnes are involved in skin inflammation (p. 3, lines 49‐51).
One of the Lactobacillus strains selected by Lebeer is Lactobacillus plantarum WCFS1 (p. 5, line 116). Lebeer describes that L. plantarum WCFS1 was among strains showing highest inhibition of C. acnes: “… all Lactobacillus strains tested inhibited the growth of C. acnes ATCC6919 and S. aureus ATCC29213, but L. pentosus KCA1 (vaginal origin) and L. plantarum WCFS1 (saliva origin) were among the bacteria tested able to exert the highest inhibition (p. 6, lines 127‐129 and Figure 2b). The selected Lactobacillus strains including L. plantarum WCFS1 were used for preparation of cream formulation application of which to acne patients reduced the relative abundance of pathogenic C. acnes and Staphylococcus (p. 8, lines 191‐193) and improved acne symptoms (p. 8, lines 195‐197).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Lactobacillus plantarum strain from Lebeer teaching to composition of lactic acid bacteria inhibiting growth of pathogenic P. acnes based on Mogna and Lang teachings. One would have been motivated to do so since Lebeer described that L. plantarum strain WCFS1 exerted high inhibition of pathogenic P. acnes and treatment of acne patients with formulation comprising strain WCFS1 reduced the amount of P. acne on the skin and improved acne symptoms. A skilled artisan would have reasonably expected success in the modification because Mogna and Lebeer described Lactobacillus strains inhibiting P. acnes and Lang and Lebeer teach Lactobacillus plantarum strains to inhibit pathogenic bacteria found on the skin.
Lactobacillus plantarum LB356R strain of instant application is a natural isolated strain and not genetically engineered strain as described in the Specification. LB356R strain was selected by screening of lactic bacteria from natural sources: ““Samples from different origins, such as homemade sauerkraut, kimchi and healthy human donor samples (vaginal, oral, anal, skin) were collected for isolation of at least 995 lactic acid bacteria.” (Specification p. 30, lines 24‐26). Although the prior art of Lebeer does not specifically teach the Lactobacillus plantarum LB356R strain, however, the prior art teaches natural isolated Lactobacillus plantarum strain having the same properties of treating pathogenic P. acnes associated with acne. Thus, it appears that the strain of the prior art can be either the same or an obvious variant of the strain in instant application. Thus, Mogna, Lang and Lebeer teachings render claim 17 obvious.
Response to Arguments
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding 35 U.S.C. 102 rejection in view of Mogna are moot, because the 35 U.S.C. 102 is withdrawn.
Applicant argues (addressing p. 3-4 of the Remarks) that Lang uses different bacterial strains than Mogna and the targeted pathogenic strains are different. Applicant further argues that: “Lang explicitly states that the preferred lactic acid bacteria do not exhibit any binding or coaggregation of other pathogenic microorganisms that populate the skin flora (e.g., pathogenic C. acnes strains), there is no reasonable expectation of success applying the teaching of Lang to Mogna.”. These arguments are not persuasive because:
First, although Mogna and Lang describe different pathogenic strains and different
Lactobacillus species, both Mogna and Lang teach strains belonging to the same genus, Lactobacillus, and are directed to the same purpose of inhibition of pathogenic bacterial strains of the skin by Lactobacillus strains providing motivation to combine these teachings and apply pH range from Lang teaching to the composition of Mogna’s teaching.
Second, Lang describes that the lactic bacteria of his invention inhibit pathogenic and not non-pathogenic (commensal) strains found on the skin: “It was completely surprising that the preferred lactic acid do not cause any coaggregation or binding of the commensal skin bacteria or microorganisms such as Corynebacterium jeikeium, Micrococcus luteus, Propionibacterium acnes or in particular Staphylococcus epidermidis.” (column 7, lines 49-54). P. acnes in Lang citation is included among non-pathogenic strains. P. acnes species are known to contain pathogenic and non-pathogenic strains as evidenced by Fitz-Gibbon (Fitz‐Gibbon et al. J. Invest. Dermatol., 2013, 133, 2152‐2160) teaching populations of P. acnes strains with different structure and pathogenicity identified in acne patients and healthy individuals (Abstract, p. 2153, right column, last paragraph). Although Lang describes, as cited by Applicant, that lactic bacteria of his invention do not bind or coaggregate with commensal and other pathogenic microorganisms of the skin flora (column 8, lines 4-6), Lang does not specifically mentions P. acnes among pathogenic strains not inhibited by lactic bacteria. However, since the pH range disclosed by Lang allows lactic bacteria to distinguish between pathogenic and non-pathogenic bacteria species, one of ordinary skill in the art would reasonably expect that Mogna’s composition of lactic bacteria strains selected for treatment of infections caused by pathogenic P. acnes will exhibit stronger inhibition of pathogenic versus non-pathogenic P. acnes strains at the pH range of Lang teaching.
In response to Applicant arguments (addressing p. 4 of the Remarks) that Lang discloses a tested pH value of 7.4 to obtain coaggregation and that there is no teaching or suggestion in Lang to modify Mogna composition to have pH 6.5 or below in order to improve the coaggregation of pathogenic C. acnes strains, these arguments are not persuasive because:
As described in the previous office action, although Lang describes pH 7.4 in working examples, Lang mentions that the preferable pH range is from 3 to 8 (column 15, lines 20-23). Lang discloses that the specific binding to the pathogenic microorganisms persists at pH from 3 to 8. Land describes that the fact that the preferred lactic acid bacteria exhibit their capacity to co-aggregate with pathogenic bacteria in a broad range of pH is especially advantageous since the pH of the skin may vary depending on cosmetic products or different regions of the body and the preferred lactic acid bacteria can be used universally in different areas of the body (column 15, lines 24- 37).
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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