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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/2/2026 has been entered.
Status of the Claims
Claims 3, 13, 16, 19, 22, and 23 have been canceled. Claims 24 and 25 have been newly added. Accordingly, claims 1, 2, 4-12, 14, 15, 17, 18, 20, 21, 24, and 25 are pending and under current examination.
Withdrawn Rejections
The following rejections are withdrawn in view of Applicant’s amendments to the claims: all rejections of claims 3, 13, 16, 19, 22, and 23 are withdrawn in view of Applicant’s cancelation of these claims; the rejections of claims 1-20, 22, and 23 under 35 U.S.C. 103 as being unpatentable over Baum in view of Lanzalaco and Manissier is withdrawn in view of Applicant’s amendments to the claims; subsequently, the rejection of claim 21 further in view of KR100539965B1 is withdrawn; the rejection of claims 1-23 on the ground of nonstatutory double patenting as being unpatentable over claims in formerly copending Application No. 18010739 is withdrawn in view of Applicant’s abandonment of the copending application.
Response to Arguments
Applicant’s arguments filed 7/2/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows. Applicant notes support for the claim amendments; support is found in the specification as filed.
Applicant argues that Baum includes lactic acid which the amended claim language excludes and that Baum does not teach the particular claimed short chain fatty acid or the intended use claimed and that the secondary references do not cure this deficiency. In reply, with regard to claims 1, 2, 4-12, 14, 15, 17, 18, 20, and 21, it is noted that these claims do not exclude the specified alpha- or beta- hydroxy acid from the total claim but rather exclude that component from being the at least one short chain fatty acid comprising a straight and saturated aliphatic chain from 3 to 5 carbon atoms. Applicant appears to be arguing a limitation not claimed.
Applicant argues that the rationale applied for applying Lanzalaco is not what Applicant considers ‘the relevant question” but that Lanzalaco should be considered as to whether or not it provides basis for narrowing Baum’s disclosure to the claimed short chain fatty acid with a reasonable expectation of success for achieving Applicant’s claimed purpose or effect. In reply, Applicant’s argument is not persuasive because the reason or motivation to modify the reference may suggest what the inventor has done but for a different purpose. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.
Applicant argues on pages 7-9 that Lanzalaco does not direct “the skilled artisan” to select the newly claimed short chain fatty acids. In reply, the rejections have been withdrawn and newly presented modified as necessitated by amendment.
Applicant argues on page 9 that Manissier does not cure the deficiency of Baum and Lanzalaco. In reply, the functional language and/or language pertaining to the effects of performing the claimed method steps with the encompassed composition is addressed below as necessitated by amendment. Otherwise, it is maintained that performing the method steps as claimed using compositions as claimed in a method and encompassed composition as taught in the cited art reasonably would have produced the claimed effect or function since a method’s results are inseparable from performing its steps.
On page 11, Applicant argues that the Office has not established that the newly claimed functional effect is necessarily and inevitably present and points to Table 2 in support of his position that not every short chain acid necessarily promotes holocrine secretion; Applicant concludes that the examiner should not rely on inherency for the claim limitation pertaining to stimulation of sebogenesis and holocrine secretion as newly claimed. In reply, the new claim language is addressed below as necessitated by amendment. Nevertheless, Applicant’s argument is not persuasive because it is not logical since performing method steps as claimed and as taught by the prior art are considered inseparable from the effects of those steps. Moreover, it is noted that the cited art is in the same field of endeavor as the instant application thereby strengthening the examiner’s position.
Applicant’s citations to case law as on pages 10 and 12-16 are noted. In reply, Applicant’s arguments have been considered, and previously issued rejections are withdrawn and newly presented as modified in order to address the claim language as amended.
Regarding the secondary reference, which is KR 100539965, on pages 14 and 15 of Remarks, Applicant argues that this teaching does not teach the claimed method and is in contradiction with Lanzalaco since KR ‘965 teaches a culture medium and not a topical application. In reply, it is maintained that Lanzalaco teaches that P. acnes produces short chain fatty acids including propionic acid in skin hydrating methods of treatment, and Manissier is provided for providing rationale for treating dry skin with a moisturizing agent where dry skin may be the consequence of or associated with sebum production deficiency which causes hyposeborrheic dry skin.
Modified Rejections Necessitated by Amendments of 7/2/2026
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-12, 14, 15, 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Baum (US 20170143621 A) in view of Lanzalaco (US 20150202136 A1) and Manissier (FR2885491A1, translation enclosed previously). No new reference cited.
The instant claims are drawn to a method comprising applying to the skin of the face and/or body at least one short chain fatty acid comprising a straight and saturated aliphatic chain having a straight and saturated aliphatic chain from 3 to 5 carbon atoms, salts thereof, esters thereof and mixtures thereof; claim 1 further specifies the intended method is for preventing or treating hyposeborrheic dry skin and/or hyposeborrheic aged skin. The short chain fatty acid is not an alpha-hydroxy acid or a beta-hydroxy acid as newly recited in claim 1, and as also newly recited in claim 1, the applying step is claimed to stimulate sebocyte sebogenesis and promotes holocrine secretion by sebocytes.
Consistent with prior claim interpretation, the intended use of the claimed method of use is not interpreted to further limit over the stepwise application of the specified chemical compound, however assuming arguendo that the intended use breathes further light into the claim, rationale for specifically treating the type of dry skin which is hyposeborrheic dry skin is supplied below.
Baum teaches a method of applying lotion to the skin to treat dry skin [0055] and applying a composition consisting of applying short fatty acid including propanoic and butyric acid [0014] in an amount of about 0.1 to about 5% of the composition [0057] and the use of palmitic acid [0043]. It is noted that the at least one short chain fatty acid which is propanionic and butyric acid is not an alpha-hydroxy or beta-hydroxy acid or a salt or ester thereof as newly recited for instance in claim 1.
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It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the teachings of Baum to have created a method of treating skin with a short chain fatty acid which may be butyric acid, a straight-chain and saturated alkyl fatty acid . One would have been motivated to do so (limitations of claims 1, 2, and 4) to provide metabolome benefit in a topical formulation (see [0056] and [0067] and palmitic acid to aid on the treatment of skin disorders [0041] and serve as skin hydrating agent [0085]) based on Baum’s Example 2 demonstrating butyric acid in an embodiment of his invention.
Regarding claim 1, Baum teaches a method of treating dry skin (dandruff) by applying a composition [0010] & [0012] consisting of applying short fatty acid including propanoic and butyric acid [0014]. Baum teaches the treatment of dry skin [0055]. Furthermore, something which is old (e.g. the composition of Baum) does not become patentable upon the discovery of a new property (that the composition is able to treat or prevent dry skin), and this need not have been discovered at the time of filing. See MPEP 2112(I & II). Further regarding the particular dry skin condition which involves dry skin which is hyposeborrheic and/or hyposeborrheic aged skin, Baum’s general teaching of a stepwise method of treating dry skin has been addressed above, and Lanzalaco and Manissier cure Baum’s deficiency by teaching motivation for treating hyposeborrheic and dry skin rather than the more general dry skin of Baum. Moreover, regarding the particular intended use claim language recited in the preamble wherein the claimed method is “for preventing and/or treating hyposeborrheic dry skin and/or hyposeborrheic aged skin”, performing the steps with the components outlined above is considered at least to meet the condition of prevention since a process and its results are inseparable.
Lanzalaco teaches a method of improving skin feel and elasticity and moisturization [Claim 2] by the application of bacterial cell lysates, including those of P. acnes that produces short chain fatty acid including propionic acid [0044]. Manissier provides motivation for using fatty acids having a chain length overlapping with the instantly claimed chain length particularly in methods for preventing and/or treating dryness of keratinous substances and particularly to treat disorders associated with dry skin and/or hyposeborrheic skin (see Description paragraph 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to utilize Baum’s formulations and general methods of topical application wherein Baum’s formulations are as prepared by Lanzalaco, and one would have been motivated to do so particularly for the particular skin treatment methods of treating dry and/or hyposeborrheic skin as suggested by Manissier, with a reasonable expectation of success.
Further regarding claim 5, Baum does not teach the use of P. acnes. Lanzalaco teaches a method of improving skin feel and elasticity and moisturization [Claim 2] by the application of bacterial cell lysates and probiotic derived substances [0104]. Lanzalaco further teaches that P. acnes that produces short chain fatty acids including propionic acid [0044].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the teachings of Baum to have created a method of treating skin with a short chain fatty acids as well as palmitic acid. One would have been motivated to add short chain fatty acids to act as skin hydrating agent [0085] and palmitic acid to aid on the treatment of skin disorders [0041] and serve as skin hydrating agent [0085] for the treatment of dry skin as taught by Baum (see [0005] and for the treatment of persistent skin conditions including those conditions causing recurring skin rashes, dryness or itching as taught by Lanzalaco (see [0134]) and in particular skin dryness associated with hyposeborrheic skin as taught to be similarly treatable in Manissier’s disclosure (see translation abstract and description paragraph 1). Manissier teaches that dry skin may be the consequence and /or be associated with sebum production deficiency which causes hyposeborrrheic dry skin as observed during skin aging (see page 3 of translation, second and fifth paragraph). Manissier generally teaches short chain fatty acids in methods of treating dry skin (page 3 of translation which specifies fatty acids having a carbon chain between 6 and 12 carbons, a range overlapping with the instantly claimed fatty acid carbon chain length) to be useful to this end (see page 3, middle of the page “compounds consisting of fatty acids whose hydrocarbon chain comprises from 6 to 12 carbon atoms…have proven effective for the treatment of dry and/or weakened keratin materials”).
Accordingly, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the teachings of Baum and Lanzalaco to have created a method of treating skin with a short chain fatty acids from a cell lysate. One would have been motivated to add short chain fatty acids to including propionic acid [0044] as they are known to maintain a healthy skin pH and barrier properties [0044] and further to use fatty acids of similar and overlapping chain length as taught by Manissier in a method of treating dry hyposeborrheic as taught by Manissier. In other words, it would have been obvious to use Baum’s short chain fatty acid components produced in a manner as generally taught by Lanzalaco in a method of treating dry hyposeborrheic skin in particular as suggested by Manissier, with a reasonable expectation of success based on Baum, Lanzalaco, and Manissier’s suggestions outlined above.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the teachings of Baum and Lanzalaco, to create a method using P. Acnes. The artisan would have been motivated to have substituted the P. Acnes of Lanzalaco in place of the microbes of Baum for predictable production of propionic acid with a reasonable expectation of success. The simple substitution of one known element (bacteria of Baum) in place of another (bacteria of Lanzalaco) in order to achieve predicable results (production of propionic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Regarding claim 1 as amended, Baum teaches a propanoic and butyric acid which is a straight and saturated aliphatic chain [0014].
Regarding claim 2, Baum teaches the use of a cosmetic composition for the process for preventing condition of the scalp [0002].
Regarding claim 4, Baum teaches the use of propanoic and butyric acid [0014].
Regarding claim 5, Baum teaches a method of extracting cell lysate components [0011]&[0044]. Lanzalaco teaches the use of P. acnes that produces short chain fatty acid including propionic acid [0044].
Further regarding claim 6, it would have been obvious to achieve the desired range of the short chain fatty acid. A prima facie case of obviousness exists where the claimed ranges or amounts overlap with the prior art. See MPEP 2144.05(I). In this case, the general conditions of a short chain fatty acid produced by a bacterium in a cosmetic composition are found in the art and the amount of cell extract overlaps those with the claimed ranges. As such, it would not have been inventive for the artisan to have discovered the optimum or workable ranges of the short chain fatty acid. Regarding claim 6, Baum teaches that the cell lysate is about 0.1 to about 5% of the composition [0057]. The specific range can be achieved by routine optimization. See MPEP 2144.05(I).
Regarding claim 7, these limitations have been addressed above in regard to claims 1, 2, 4, and 5.
Regarding claim 8, Baum teaches the method of culturing microorganisms [0044], separating the culture from the supernatant by centrifugation [0044] and recovering the supernatant [0044]. Lanzalaco teaches the use of P. acnes that produces short chain fatty acid including propionic acid [0044].
Regarding claim 9, Baum teaches the method of culturing microorganisms [0044], separating the culture from the supernatant by centrifugation [0044] and recovering the supernatant [0044] and the use of palmitic acid [0043]. Lanzalaco teaches the use of P. acnes that produces short chain fatty acid including propionic acid [0044].
Regarding claim 10, Baum teaches that the composition is drawn to feeling of discomforts and rough to the touch [0019]. See teachings above regarding hyposeborrheic dry skin in particular.
Regarding claims 11 and 12, something which is old (e.g. the composition of Baum) does not become patentable upon the discovery of a new property (that the composition is able to treat hyposeborrheic dry skin), and this need not have been discovered at the time of filing. See MPEP 2112(I & II). Nevertheless, see limitations addressed above which further provide teachings for the particular method of treating the particular condition encompassed in the claims.
Regarding claim 14, Baum teaches consisting of applying short fatty acid including propanoic and butyric acid [0014].
Regarding claim 15, Lanzalaco teaches the use of P. acnes that produces short chain fatty acids including propionic acid [0044].
Regarding claim 17, Lanzalaco teaches the use of P. acnes that produces short chain fatty acid including propionic acid [0044].
Regarding claim 18, Baum teaches that the composition consists of about 0.1 to about 5% of cell lysate [0057]. The specific range can be achieved by routine optimization. See MPEP 2144.05(I).
Regarding claim 20, Baum teaches that the composition consists of about 0.1 to about 5% of cell lysate [0057]. The specific range can be achieved by routine optimization. See MPEP 2144.05(I).
Regarding claims 1, 7, 11, and 12 as amended, the aforementioned method reasonably would have been expected to have the effects instantly claimed since a product and its properties are inseparable and since a product and its properties of use would likewise be inseparable from their effects.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Baum (US 20170143621 A) in view of Lanzalaco (US 20150202136 A1) and Manissier (FR2885491A1, translation enclosed) as applied to claims 1, 2, 4-12, 14, 15, 17, 18, and 20 above, and further in view of KR100539965B1.
The teachings of Baum, Lanzalaco, and Manissier have been delineated above. None of these specifies a process of preparing a product as encompassed in the instant method of use claims such that the at least one microorganism of the species P. acnes, which is addressed above, is in particular P. acnes ATCC 6919.
KR100539965B1 cures this deficiency. KR100539965B1 teaches a method of treating dry skin such for prevention and alleviation of atopic dermatitis or dry dermatitis (see first two paragraphs of abstract, in particular) among other conditions where moisturization of the skin can be beneficial. Similar to Baum, KR100539965B1 encompasses fatty acid components for treating the skin (see “Background”, paragraph 2). KR100539965B1 teaches that atopic dermatitis includes non-allergic aspects including sebum secretion and dry skin problems (see “Background” section, paragraph 5). KR100539965B1 further demonstrates an embodiment in which P. acnes ATCC 6919 pre-cultured bacteria is applied topically (see Experimental Example 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add or substitute culture from P. acnes ATCC 6919 bacteria as taught in KR100539965B1’s Experimental Example 1 to be applied topically in the topical treatment methods of Baum, Lanzalaco, and Manissier, with a reasonable expectation of success. One would have been motivated to do so since KR100539965B1 teaches this particular bacterial culture to be applicable against specific skin problems associated with undesirable dermatitis where KR100539965B1 further discloses dry dermatitis and sebum secretion problems to be similarly treatable.
New Grounds of Rejection Necessitated by Addition of New Claims
Claims 1, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over JPS6143101A (“Yuzo”, newly cited).
The instant claims are drawn to a cosmetic method comprising applying to the skin of the face and/or body at least one specified short chain fatty acid component wherein the claimed process has the claimed functional effect and, further in claims 24 and 25 does not include alpha or beta hydroxy acids as further detailed in the claims.
Yuzo teaches a cosmetic product and method of application having superior antiseborrheic action by application topically (see abstract, in particular). Yuzo’s formulations include organic acids which include straight chain fatty acids such as propionic acid, butyric acid, and valeric acid, among others (see paragraph of translation starting “Examples of organic acids include straight…”). Yuzo’s formulations do not require additional inclusion of any alpha- hydroxy or beta-hydroxy acid or a salt or ester thereof, nor do they propose any combined organic acid components thereby meeting limitations in claim 24 and a lactic acid component as in claim 25.
Because Yuzo does not teach an embodiment selecting propionic acid in particular, this rejection is made using obviousness rationale. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention as filed to use propionic acid as an organic acid taught by Yuzo in Yuzo’s methods of antiseborrheic cosmetic application, with a reasonable expectation of success. See Yuzu Claim 1 and fourth paragraph in particular (“The present inventors have conducted various studies on improving the effects of antiseborrheic agents…”). One would have been motivated to use propionic acid or an equivalent single organic acid in combination with a carbonate as taught by Yuzo, with a reasonable expectation of success in view of Yuzo’s teaching that these may be desirably be combined (i.e., for pH adjustment) to achieve good water solubility properties and cosmetic antiseborrheic effects.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
