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 .
Status of the Claims
Claims 1-23 are pending and under current examination. New claims 22 and 23 have been added.
Response to Arguments
Applicant’s arguments filed 10/27/2025 (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 asserts that the cited references do not render obvious the claims under examination (page 6 of Remarks) and concludes (page 7 of Remarks) that one would not have arrived at the claimed invention from combining the cited references, for specific reasons addressed below.
Applicant argues that Lanzalaco does not cure Baum’s deficiency and does not teach hyposeborrheic skin or any effects on sebaceous production of P. Acnes. In reply, this 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 or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Moreover, teaching of alternative embodiments does not constitute a teaching away. Here, it is maintained that Baum teaches topical application in a method of use by topical skin application and that Lanzalaco teaches that P. acnes produces short chain fatty acids including propionic acid in skin hydrating methods of treatment. It is noted that dry skin is neither argued to be the same as or mutually exclusive with hyposeborrheic skin; 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.
Applicant argues that Manissier mentions hyposeborrheic disorder but is concerned with a type of lipid different than those of the instant invention (i.e., glycerides and not short chain fatty acids). In reply, Applicant’s argument is not persuasive in view of Baum’s example for instance a method of treating a scalp condition including application of a formulation including butyric acid (see Table 2 and [0107] in particular). In reply, Applicant’s position is noted but is not persuasive in view of the references considered as a whole for what they reasonably would have suggested with Manissier 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.
Applicant argued that one would not have used short chain fatty acids for preventing and/or treating hyposeborrheic dry skin because Baum’s formulation is for the treatment of dandruff, which Applicant concludes is for the opposite effect as instantly claimed. In reply, this argument is not persuasive because it is based on Baum alone where the rejection of references is based on a combination of references.
Applicant argues that Baum’s active agents do not include the claimed short chain fatty acids and would not have led to selection of the claimed short chain fatty acids with 3 to 8 carbons from all possibilities in Baum; Applicant points to case law and MPEP 2144.08 noting that the Examiner must consider the size of the genus. In reply, Lanzalaco provides rationale for selecting a short chain producing component for treating dry skin and/or hyposeborrheic skin disorders.
Further regarding claim 21, Applicant argues that KR100539965B1 includes P. Acnes ATCC6919 as a test agent for a different purpose than in the instant claims and concludes that one would not have used it in a cosmetic method based on KR100539965B1’s teaching. In reply, Applicant’s argument is noted but the prior art may do what the inventor has done but for a different purpose and render obvious the claimed invention. KR100539965B1 provides rationale for including P. acnes ATCC 6919 culture topically in methods of treating dry skin.
Applicant asserts in the paragraph bridging pages 8 and 9 of Remarks that the claim recitations related to treating hyposeborrheic dry skin and/or hyposeborrheic aged skin patentable distinguish the claims over the cited art and on page 9 particularly cites case law decisions in alleged support of his position; particularly noted is the conclusion that claim preambles and uses may provide patentable distinction in certain circumstances. Applicant cites continuing on page 10 case law requiring motivation and predictability to conclude obviousness. In reply, Applicant’s argument is noted, however the cited art does teach methods of treating hyposeborrheic dry skin in particular, as detailed in the rejection below where it is maintained that a reasonable expectation of success provides reasonable predictability for the rationale of record.
Applicant argues that ATCC 6919 in the instant application is not a trademarked name. In reply, Applicant’s argument is persuasive, and the rejection is withdrawn. The examiner thanks Applicant for the explanation.
Regarding the rejection of claims 1-21 on the ground of non-statutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/010,739, Applicant argues that the instant application should issue and the double patenting rejection based on the later filed applications should be withdrawn and cites MPEP 804.IB1 in support of his position and argues that a terminal disclaimer need not be filed. In reply, Applicant’s argument is noted but is not persuasive at this time since the provisional nonstatutory double patenting rejection is not the only rejection remaining in the application. Applicant’s position will be re-considered in due course, if applicable.
Maintained Rejections and New Rejections of New Claims 22 and 23
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 1-20, 22, and 23 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).
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 from 3 to 8 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. 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 in the new ground of rejection necessitated by amendment.
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].
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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 acids and the use of 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].
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 do 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 skilled artisan to have discovered the optimum or workable ranges of the short chain fatty acid.
Regarding claim 1, Baum teaches the use of 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.
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 2, Baum teaches the use of a cosmetic composition for the process for preventing condition of the scalp [0002].
Regarding claim 3, Baum teaches a propanoic and butyric acid which is a straight and saturated aliphatic chain [0014].
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 skilled 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 1-5.
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 13, Baum teaches consisting of applying short fatty acid including propanoic and butyric acid [0014].
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 16, 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 19, 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 22 and 23, 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 1-20, 22, and 23 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.
Maintained Grounds of Rejection and New Rejections of New Claims 22 and 23
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of copending Application No. 18/010,739 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The instant application is drawn to a method of treating dry skin using a composition containing a short chain fatty acid.
The conflicting claims are drawn to a cosmetic composition containing a short chain fatty acid containing 3 to 8 carbon atoms and teaches a method of application. The instant claims differ from the copending claims on account of the process of producing the product encompassed in the instant method of use claims. There does not appear to be a patentable distinction between the products produced by alternate processes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed at this time.
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 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