The NON-final rejection mailed on September 23, 2025 is herewith WITHDRAWN.
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 filed on 10/09/2020 is a 371 of PCT/EP2019/059350 filed on 04/11/2019 and Foreign Priority to EP 18382250.1 filed on 04/12/2018.
DETAILED ACTION
Applicant’s response filed on September 23, 2025 to the Final rejection mailed on April 10, 2025 is acknowledged.
The claims corresponding to the elected subject matter are 1,2,5, 23, and 29-32 are herein acted on the merits.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the rejection of claims 1,2,5, 23-26, and 28 under 35 U.S.C. 103(a) as being unpatentable over Murad (US20030091666) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
Applicant’s arguments over the rejection of claims 1,2,5, 23-26, and 28 under 35 U.S.C. 103(a) as being unpatentable over Ueda (JP2004035454)is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
Applicant’s arguments over the rejection of claims 1,2,5 23, and 28 under 35 U.S.C. 103(a) as being unpatentable over Sturley et al. (WO2006023654) in view of Matsuda et al. (Study of the Anti-Photoaging Effect of Noni (Morinda citrifolia). Melanoma - From Early Detection to Treatment. Published 1/30/13) and Smith (US 20030100480 A1) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
Applicant’s arguments over the rejection of claims 1,2,5, 23-26, and 28 under 35 U.S.C. 103(a) as being unpatentable over Sturley et al. (WO2006023654) in view of Ueda (JP2004035454) and Smith (US 20030100480 A1) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.Applicant’s arguments over the rejection of claims 1,2,5, 23-26, and 28 under 35 U.S.C. 103(a) as being unpatentable over Sturley et al. (WO2006023654) in view of Ueda (JP2004035454) and Smith (US 20030100480 A1) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The rejections are as below:
Claim Objections
Claims 1, 30-32 objected to because of the following informalities: Applicant has interchanged between using the formal nomenclature and abbreviated microbial names. Examiner suggests Applicant use the formal nomenclature throughout.
Claim Rejections –
35 USC § 112 Notice of Pre-AlA or AIA Status
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.
Claims 1,2,5, 23, and 29-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of a skin disease resulting from microbial biofilm formation and/or from dysbiosis of skin microbiota, said disease selected from the group consisting of psoriasis, atopic dermatitis, acne, seborrheic dermatitis, dandruff, folliculitis, rosacea, contact dermatitis and combinations thereof, does not reasonably provide enablement for prevention of a skin disease resulting from microbial biofilm formation and/or from dysbiosis of skin microbiota, said disease selected from the group consisting of psoriasis, atopic dermatitis, acne, seborrheic dermatitis, dandruff, folliculitis, rosacea, contact dermatitis and combinations thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claims are drawn to of a method of treatment/and or prevention of a skin disease resulting from microbial biofilm formation and/or from dysbiosis of skin microbiota, said disease selected from the group consisting of psoriasis, atopic dermatitis, acne, seborrheic dermatitis, dandruff, folliculitis, rosacea, contact dermatitis and combinations thereof. The instant specification fails to provide information that would allow the skilled artisan to practice the prevention of skin diseases.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how
to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method of treatment/and or prevention of a skin disease resulting from microbial biofilm formation and/or from dysbiosis of skin microbiota, said disease selected from the group consisting of psoriasis, atopic dermatitis, acne, seborrheic dermatitis, dandruff, folliculitis, rosacea, contact dermatitis and combinations thereof. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant demonstrated the use of the compound in treating said skin diseases, nowhere in the specification did applicant demonstrate the prevention of the same. Further, the predictability of treating skin diseases is relatively low given that the various types of conditions have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. Thus, given that applicant has failed to demonstrate prevention of skin diseases utilizing the pharmaceutical composition, the examiner maintains that applicant has not enabled the breadth of the claims.
2 The breadth of the claims
The claims are thus very broad insofar as they recite the “prevention of a skin diseases resulting from microbial biofilm formation and/or from dysbiosis of skin microbiota, said disease selected from the group consisting of psoriasis, atopic dermatitis, acne, seborrheic dermatitis, dandruff, folliculitis, rosacea, contact dermatitis and combinations thereof. While such “treatment” might theoretically be possible for treating said skin diseases utilizing pharmaceutical composition claimed, as a practical matter it is nearly impossible to achieve prevention of skin diseases with the claimed pharmaceutical composition.
3. The amount of direction or quidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the claimed pharmaceutical composition in preventing skin diseases. No reasonably specific guidance is provided concerning useful therapeutic protocols for the claimed pharmaceutical composition , other than example 1. The latter is corroborated by the working example on page 19.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that every instantly claimed pharmaceutical composition could be predictably used for the prevent skin diseases as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected 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. Applicant has included topic and/or mucosal infections in the claims, but claims treatment of ‘skin’ diseases. There does not appear to be an overlap. Clarification is required.
Claim 30 is rejected 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. Applicant has included n after 10%. It appears applicant intended for the n to be “in”. Appropriate correction is required.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM PST.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622