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 .
FINAL DETAILED ACTION
1. Applicant’s response filed on March 2, 2026 is acknowledged. Claims 32-34 and 39-43 have been canceled. Claims 44-47 have been added. Claims 31, 35-38 and 44-47 are currently pending and under examination. Please note that claim 35 has been amended but does not present its tracked marks. Even the amendment introduced on January 15, 2026, which was not entered, did not demonstrate the amendment to introduce the wherein clause in line 7. Appropriate action is required.
Objections Withdrawn
2. In view of Applicant’s amendments, the objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code is withdrawn.
3. In view of Applicant’s amendments, the objection to the disclosure because there is no Brief Description for the figures is withdrawn.
4. In view of Applicant’s amendments, the objections to claims 32-33, 35, 38 and 43 because of informalities is withdrawn.
Rejections Withdrawn
5. In view of Applicant’s amendments, the rejection of claim 36 for lacking insufficient antecedent basis is withdrawn.
6. In view of Applicant’s amendments, the rejection of claim 36 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
7. In view of Applicant’s amendments, the rejection of claims 32 and 39 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn.
8. In view of Applicant’s amendments, the rejection of claims 33-34 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5 and 6 of copending Application No. 18/013,627 (reference application US 2023/0240309 A1) is withdrawn.
9. In view of Applicant’s amendments, the rejection of claim(s) 33 and 42 under 35 U.S.C. 102(a)(1) as being anticipated by Taiyo, JP4388644B2; Published: 12/24/09 (Google translation provided) is withdrawn.
10. In view of Applicant’s amendments, the rejection of claim(s) 34 and 43 under 35 U.S.C. 102(a)(1) as being anticipated by Park, WO 2020/080736 A1; Published: 04/23/20 is withdrawn.
11. In view of Applicant’s amendments, the rejection of claim(s) 43 under 35 U.S.C. 102(a)(1) as being anticipated by Cortes-Zavaleta et al., International Journal of Food Microbiology, 2014; 173: 30-35 is withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. The rejection of claims 31, 35-38 and newly added claims 44-47 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained for the reasons set forth in the previous office action. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 31 is drawn to a composition for improvement of a skin condition comprising a supernatant produced from fermentation of a lactic acid bacteria wherein the supernatant comprises at least 3 metabolites produced by the lactic acid bacteria during fermentation wherein the at least 3 metabolites are selected from bacteriocins, lactic acid, acetic acid, succinic acid, azelaic acid, salicylic acid, indole-3-lactic acid, indole-3-acetic acid, 2-hydroxyisocaproic acid, 2-hydroxybuturic acid, N-acetyl tryptophan, glycolic acid, N-acetylglutamine, and N-acetylaspartic acid, and wherein at least one of the at least 3 metabolites include succinic acid, 2-Hydroxyisocaproic acid, azelaic acid, and/or salicylic acid, wherein the skin condition is selected from acne, rosacea, eczema, atopic dermatitis, psoriasis, photodamage, aging, striae, and scars.
Dependent claim 38 is drawn to a cosmetic product comprising the composition according to claim 31 for the treatment or prevention of a skin condition, wherein the skin condition is selected from: acne, rosacea, eczema, atopic dermatitis, psoriasis, photodamage, aging, striae, and scars.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus of skin conditions and metabolites or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession of the claimed invention. In the instant case, to fulfill the written description requirement, a representative number of conditions and the metabolites necessary to be administered that are capable of preventing the skin conditions as claimed need to be described.
A representative number of species means that the species that are adequately described are representative of the entire genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed genus.
The claimed invention is broad and the specification does not support or fully describe the breadth of the invention as claimed. Cleveland Clinic teaches that to treat and prevent skin conditions, a multi-pronged approach is necessary, focusing on hygiene, skincare, and lifestyle adjustments. General prevention includes practicing good hygiene, like frequent handwashing, and promptly cleaning and covering any cuts or scrapes. Specific treatments vary depending on the condition, but may include topical or oral medications, light therapy, or even surgical interventions for skin cancer. Preventive measures also involve sun protection, moisturizing, and avoiding known irritants.
Moreover, it is taught that common types of skin diseases include acne, alopecia, eczema, psoriasis, Raynaud’s phenomenon, rosacea, skin cancer and vitiligo. Many rare skin disease are genetic and can include actinic prurigo, argyria, chromhidrosis, epidermolysis bullosa, harlequin ichthyosis, lamellar ichthyosis, and lipoidica (see Cleveland clinic, https://my.clevelandclinic.org/health/diseases/21573-skin-diseases; 6/10/21).
The specification does not provide support for the breadth of the claim especially in light of the teachings of the state of the art. There are no specific examples of a composition comprising the specific combinations of metabolites capable of preventing acne, rosacea, eczema, atopic dermatitis, psoriasis, photodamage, aging, striae, and scars. The specification only specifically describes an evaluation test on acne skin using a supernatant from Lactobacillus plantarum LB356R. There is no clear structure as to what is within said supernatant. There are a plethora of skin conditions as well as a plethora of options encompassed by “3 or more metabolites”, however the specification does not provide adequate support as to which specific set of metabolites are efficient to prevent the skin condition as claimed.
As it pertains to the prevention of conditions, to be a prophylactic composition, in this case a composition comprising all the variations as broadly claimed between claims 31-36 and 43, to be administered must induce a protective immune response demonstrated by challenge experiments in an acceptable animal model. The specification does not provide substantive evidence that the broadly claimed composition is capable of inducing protective immunity against all conditions encompassed therein. This demonstration is required for the skilled artisan to be able to use the claimed composition for their intended potential purpose of prevention. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed composition, i.e. would not be able to accurately predict if protective immunity has been induced. It is clear the specification does not adequately describe the compositions correlating to the function as claimed. Moreover, aside from the one showing, there are no examples geared towards the invention as claimed. This is extremely important and is done by adequately providing the means and effectiveness of the claimed composition as it pertains to the genus of skin conditions and inflammatory or infectious diseases, so much so that a skilled artisan could readily be aware of it without undue burden and could administer said composition for its intended use as claimed with some modicum of success.
As it pertains to the state of the prior art, Cleveland Clinic teaches Many skin diseases respond well to treatment. Depending on the condition, a dermatologist or other healthcare provider may recommend antibiotics, antihistamines, laser skin resurfacing, medicated creams, ointments or gels, moisturizers, oral medications, steroid pills, creams or injections as well as surgical procedures. One may also reduce symptoms of skin conditions by making lifestyle changes: avoid or limit certain foods, such as sugar or dairy, if your healthcare provider suggests it; manage stress; practice good hygiene, including proper skin care; and avoid excessive alcohol use and smoking.
Applicant must claim their invention by what their specification has supported and provides efficacy for. Which compositions correlate to the functions as claimed?
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Written description requirement must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the "written description" inquiry, whatever is now claimed. The Guidelines further state, "[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of the genus of diseases, disorders and conditions as related to inflammation and obesity as claimed, the skilled artisan could not immediately recognize or distinguish members of the claimed genus. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description of a particular derivative is not deemed representative of the genus of immunogenic compositions to which the claims refer and hence do not meet the written description requirements.
Applicant arguments are centered around necessary amendments made to claim 31. Applicant, however, has not addressed the preventative language recited in claim 38. Even with amending the claims in terms of metabolites and skin conditions, the specification does not describe any instance of prevention of any skin conditions or those as now claimed. Further, there are no specific examples of a composition comprising any specific combinations of metabolites capable of treating or preventing acne, rosacea, eczema, atopic dermatitis, psoriasis, photodamage, aging, striae, and scars. The specification only specifically describes an evaluation test on acne skin using a supernatant from Lactobacillus plantarum LB356R. Perhaps Applicant should consider crafting the claims to encompass acne skin using a supernatant from Lactobacillus plantarum LB356R and/or provide evidence which supports their stated position. The rejection is maintained for the reasons set forth in the previous office action.
Conclusion
13. No claim is allowed.
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baek, WO 2020/081868 A1, which discloses a composition for improvement of a skin condition comprising at least 3 metabolites as recited. Baek does not teach a supernatant produced from fermentation of a lactic acid bacteria wherein the supernatant comprises produced by the lactic acid bacteria during fermentation wherein the at least 3 metabolites are selected from bacteriocins, lactic acid, acetic acid, succinic acid, azelaic acid, salicylic acid, indole-3-lactic acid, indole-3-acetic acid, 2-hydroxyisocaproic acid, 2-hydroxybuturic acid, N-acetyl tryptophan, glycolic acid, N-acetylglutamine, and N-acetylaspartic acid.
15. 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 case, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 August 26, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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