DETAILED ACTION
Claims 7-26 are pending and under consideration on the merits.
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 Rejections
The 112(d) rejection is withdrawn in view of the amendment.
The 112(b) rejection is withdrawn in view of the amendment, but a new rejection was necessitated by the amendment.
The 102 rejections are withdrawn in view of the amendment and replaced with 103 rejections over the same references.
The 103 rejections are maintained.
The double patenting rejection is revised in view of the amendment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/25 was filed prior to the mailing date of a Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Claim Rejections - 35 USC § 103
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 7-14, 18, and 22 are rejected under 35 U.S.C. 103 as unpatentable over Baum et al. (US Pat. Pub. 2019/0167565, published 6.6.2019; of record in IDS).
As to claims 7-14, 18, and 22, Baum discloses a method of treating dandruff or seborrheic dermatitis (i.e., disorders of the skin associated with the proliferation of yeasts of the Malassezia genus of claims 1 and claim 13)(paragraphs 2, 15, 55), the method comprising applying to the skin (paragraphs 12 and 15) a cosmetic composition comprising an effective amount of a conditioned culture medium comprising a probiotic or soluble metabolome component that is a short chain fatty acid such as propanoic acid (“propionic acid” of claims 7 and 8) or butyric acid (paragraphs 16-17). Examples 2-4 disclose specific embodiments wherein the metabolome component is butyric acid and is used in the amount of 0.1-1 wt%, which is within the range of claims 9 and 11.
Regarding claims 10 and 12, the composition may be in the of a shampoo, cream, lotion, gel, or paste (paragraph 58).
As to claims 18 and 22, the conditioned culture medium is obtained by culturing a microorganism, followed by separating and recovering a culture supernatant from the cells of the microorganism (paragraph 44).
Regarding claims 8 and 14, the Baum process will result in a reduction of Malassezia spp. Counts within the range of claims 7-8 and maintain the number of Cutibacterium acnes within the range recited by claims 7-8, and will maintain and/or restore at a normal level the ecoflora of the skin (claim 8) and prevent excessive colonization of the skin by the yeasts of the Malassezia genus and/or mediate growth of Cutibacterium acnes (claim 14) because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claims 7-14, 16-18, 20-22, and 23-26 are rejected under 35 U.S.C. 103 as unpatentable over Baum et al. (US Pat. Pub. 2019/0167565) as applied to claims 7-14, 18, and 22 above, and further in view of Lood (US Pat. Pub. 2022/0000762; filed 11.15.2019).
The teachings of Baum are relied upon as discussed above, but Baum does not further expressly disclose that the short chain fatty acid is obtained from Cutibacterium acnes ATCC 6919 as recited by claims 16-17,20-21, and 23-26, nor that the culture supernatant is stabilized via filtration as recited by claims 23 and 25.
Lood discloses that a composition comprising Cutibacterium Acnes ATCC 6919 is useful for treating pr preventing certain skin diseases such as dandruff or seborrheic dermatitis (paragraphs 1, 8-9, 88, 156), and that a supernatant comprising the Cutibacterium Acnes ATCC 6919 is obtained via centrifugation and concentrated via filtration (paragraphs 76 and 397).
As to claims 16-17, 20-21, and 23-26, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the method of treating dandruff or seborrheic dermatitis taught by Baum by selecting Cutibacterium Acnes ATCC 6919 as the source of the conditioned culture medium comprising the short chain fatty acid, instead of, or in addition to, the microorganisms disclosed by Baum, because Lood expressly teaches that Cutibacterium Acnes ATCC 6919 is useful for treating dandruff or seborrheic dermatitis, such that the skilled artisan reasonably would have expected it could be used as the source of the conditioned culture medium used in the Baum method. Such a modification is merely the substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claims 23 and 25, it further would have been prima facie obvious to obtain the Cutibacterium Acnes ATCC 6919 by a method comprising the step of filtrating a supernatant comprising the Cutibacterium Acnes ATCC 6919, because Lood expressly teaches that Cutibacterium Acnes ATCC 6919 for use in a dandruff-treating method should be obtained by a method comprising such a step.
Claims 15 and 19 are rejected under 35 U.S.C. 103 as unpatentable over Baum et al. (US Pat. Pub. 2019/0167565) as applied to claims 7-14, 18, and 22 above, and further in view of Lee et al. (US Pat. Pub. 2011/0070296).
The teachings of Baum are relied upon as discussed above, but Baum does not further expressly disclose that the propionic acid short chain fatty acid is in the form of its sodium salt sodium propionate as recited by claims 15 and 19.
Lee discloses topical compositions for treating a skin condition (Abstract), the composition comprising an antifungal agent such as propionic acid or sodium propionate (paragraph 97).
As to claims 15 and 19, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Baum by using sodium propionate instead of, or in addition to, propionic acid, because Lee teaches that both of these compounds are interchangeably useful as anti-fungal agent in topical compositions for the treatment of a skin condition, such that the skilled artisan reasonably would have expected that a sodium salt of the short chain fatty acids disclosed therein, such as sodium propionate, could be used as the anti-fungal agent in the Baum composition. Such a modification is merely the substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Response to Applicant’s Arguments
Applicant’s arguments will be addressed to the extent they may be relevant to the new grounds of rejection. Applicant argues that Baum does not disclose the performance thresholds recited by claims 7-8 as amended. Applicant argues that inherency requires that the claimed property necessarily and inevitably flow from the prior art disclosure. Applicant states that data demonstrates that selective performance depends on specific small chain fatty acids and conditions, for instance, 30mM sodium/propionate/sodium butyrate/ sodium valerate inhibit Malassezia while not affecting Cutbacterium acnes, whereas acetate at the same level shows no effect on Malassezia, such that the effect cannot be inherent to Baum’s disclosure.
In response, the 102 rejection over Baum, which relied on an inherency argument, has been withdrawn, and the new grounds of rejection is a 103 rejection over Baum. As stated in the new rejection, the Baum process will result in disclose the performance thresholds recited by claims 7-8 as amended because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise.
Additionally, while Applicant asserts that 30mM sodium/propionate/sodium butyrate/ sodium valerate was shown to inhibit Malassezia while not affecting Cutbacterium acnes, whereas acetate at the same level shows no effect on Malassezia, the rejection relies on Baum’s express teaching of an embodiment comprising propionic acid or butyric acid, and there is no evidence of record that the use of these fatty acids would not result in the functional characteristics of claims 7-8. In fact, both claims 7 and 8 expressly recite that the short chain fatty acid may be propionic acid or butyric acid.
Claims 7-26 are rejected under 35 U.S.C. 103 as unpatentable over Rice et al. (US Pat. Pub. 2022/0047475; filed 6.18.2019).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
As to claims 7-26, Rice discloses a method for treating hyposeborrheic dry or aged skin on the scalp comprising applying a composition comprising a conditioned culture medium comprising propionic, valeric acid, or butyric short chain fatty acids obtained from Propionibacterium acnes ATCC 6919 (“Cutibacterium acnes ATCC 6919” of claims 16-17, 20-21, and 23-26) in the amount of 0.01-5 wt% (claims 9 and 11), wherein the conditioned culture medium is obtained by culturing the microorganism, followed by separating and recovering a culture supernatant from the cells of the microorganism via centrifugation, and wherein the supernatant may be filtered (claims 18, 22, 23, 25)(see claims 1-20 of Rice and paragraphs 20, 45, 48, 50). The Rice process will result in a reduction of Malassezia spp. counts within the range of claims 7-8 and maintain the number of Cutibacterium acnes within the range recited by claims 7-8, and will prevent or treat desquamative skin disorders associated with the Malassezia genus (claim 7) such as dandruff (claim 13) and maintain and/or restore at a normal level the ecoflora of the skin and prevent excessive colonization of the skin by the yeasts of the Malassezia genus and/or mediate growth of Cutibacterium acnes (claims 8 and 14) because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Regarding claims 10 and 12, the composition may in the form of a gel (paragraph 97).
As to claims 15 and 19, the short chain fatty acids may be in the form of their sodium salts (paragraph 33).
Response to Applicant’s Arguments
Applicant’s arguments will be addressed to the extent they may be relevant to the new grounds of rejection. Applicant argues that Baum does not disclose the performance thresholds recited by claims 7-8 as amended. Applicant argues that inherency requires that the claimed property necessarily and inevitably flow from the prior art disclosure. Applicant states that data demonstrates that selective performance depends on specific small chain fatty acids and conditions, for instance, 30mM sodium/propionate/sodium butyrate/ sodium valerate inhibit Malassezia while not affecting Cutbacterium acnes, whereas acetate at the same level shows no effect on Malassezia, such that the effect cannot be inherent to Baum’s disclosure.
In response, the 102 rejection over Rice, which relied on an inherency argument, has been withdrawn, and the new grounds of rejection is a 103 rejection over Rice. As stated in the new rejection, the Rice process will result in disclose the performance thresholds recited by claims 7-8 as amended because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise.
Additionally, while Applicant asserts that 30mM sodium/propionate/sodium butyrate/ sodium valerate was shown to inhibit Malassezia while not affecting Cutbacterium acnes, whereas acetate at the same level shows no effect on Malassezia, the rejection relies on Baum’s express teaching that the short chain fatty acid may be propionic, valeric acid, or butyric, and there is no evidence of record that the use of these fatty acids would not result in the functional characteristics of claims 7-8. In fact, both claims 7 and 8 expressly recite that the short chain fatty acid may be propionic, valeric acid, or butyric acid.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 7-26 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of U.S. Pat. Appl. No. 17/415,790, and in view of Baum et al. (US Pat. Pub. 2019/0167565), Lood (US Pat. Pub. 2022/0000762) and/or Lee et al. (US Pat. Pub. 2011/0070296) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a method for treating hyposeborrheic dry or aged skin comprising applying a conditioned culture medium comprising propionic or butyric acid obtained from Propionibacterium acnes ATCC 6919 (“Cutibacterium acnes ATCC 6919”) in the amount of 0.01-5 wt%, wherein the conditioned culture medium is obtained by culturing a microorganism, followed by separating and recovering a culture supernatant from the cells of the microorganism).
The reference process will result in a reduction of Malassezia spp. Counts within the range of claims 7-8 and maintain the number of Cutibacterium acnes within the range recited by claims 7-8, prevent or treat desquamative skin disorders associated with the Malassezia genus and such as dandruff and maintain and/or restore at a normal level the ecoflora of the skin and prevent excessive colonization of the skin by the yeasts of the Malassezia genus and/or mediate growth of Cutibacterium acnes because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims.
Although the reference claims do not recite that the composition is in the form of a shampoo or that the short chain fatty acids are in the form of their sodium salts nor a step of obtaining the supernatant via centrifugation or stabilizing the culture supernatant via filtration, it would have been prima facie obvious to incorporate these limitations into the reference claims because Baum teaches that compositions comprising short chain fatty acids for the treatment of dandruff may be formulated as a shampoo and Lee teaches that propionic acid and its sodium salt are interchangeably useful as anti-fungal agent in topical compositions for the treatment of a skin condition, such that the skilled artisan reasonably would have expected that a sodium salt of the short chain fatty acids disclosed therein, such as sodium propionate, could be used as the active agent in the reference composition, and because Lood expressly teaches that Cutibacterium Acnes ATCC 6919 for use in a dandruff-treating method should be obtained by a method comprising a centrifugation and a filtration step.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant argues that the reference claims do not disclose the performance thresholds recited by claims 7-8 as amended.
In response, the reference process will result in the performance thresholds recited by claims 7-8 as amended because it comprises the same steps of administering to the same location of a subject a composition comprising the same ingredients in the same amounts recited by the claims.
Applicant argues that the reference claims are drawn to a method of treating dry or aged skin, while the present claims are methods to treat desquamative disorder of the skin.
In response, this is not persuasive because the reference method will result in the treatment of the same disorders recited by the present claims because it involves the same steps of administering the same composition recited by the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner., Art Unit 1600
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