DETAILED ACTION
Status of claim rejections
The rejection of record under 35 USC 103 is maintained in view of Applicant’s arguments in the response filed 11/07/25.
The double patenting rejections of record are maintained in view of Applicant’s arguments in the response filed 11/07/25.
This Action is FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/07/2025 was filed after the mailing date of the Non-Final Office Action (05/09/2025). The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The examiner has interpreted the limitation of “the method increases the survival of one or more cells of the subject in response to oxidation and/or increases skin radiance and/or decreases wrinkles, fine lines, sagging skin, loss of elasticity of skin fibres, withered skin, thinned skin, alteration in skin pigmentation, and/or dullness of the skin” recited in claim 30 to be an intended result of the recited method of administering C. acnes (see MPEP 2111.04(I); see Non-Final Office Action 05/09/2025).
Maintained 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, 4, 7-12, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Allhorn et al (Nature Sci. Reports, 6(36412):1-16 (2016), prior art of record, hereinafter “Allhorn”) in view of Suzuki et al (US 2012/0141400, prior art of record, hereinafter “Suzuki”) as evidenced by Knodlseder et al (PLoS Pathog. 18(3):1-16 (2022), prior art of record, hereinafter “Knodlseder”).
Allhorn teaches strains of Propionibacterium acnes, which endogenously secrete radical oxygenase of Propionibacterium acnes (RoxP) (Abstract). As evidenced by the Specification, Cutibacterium acnes was formerly Propionibacterium acnes (Specification, see paragraph 0086, as published). Allhorn teaches RoxP is strongly secreted by, e.g., P. acnes strains of phylotypes IA, IB, II, and III (page 3, Expression of roxP). Allhorn further teaches that RoxP protects the bacterium from oxidative damage, enables its survival in an oxic environment, and assists in maintaining a healthy skin redox homeostasis (page 8, Discussion).
Allhorn teaches that RoxP has antioxidant properties (FIG. 4). More particularly, Allhorn teaches that “[i]n terms of activity, RoxP is on par with well-studied human antioxidants, including vitamin C, vitamin E and reduced gluthathione, as well as with the plasma protein α1-microglobulin shown to have radical scavenging activity. The antioxidant activity of RoxP might thus be beneficial for the bacterium as well as for the host, detoxifying free radicals on skin, suggesting a putative function of RoxP for maintaining the redox homeostasis on the skin” (page 8, Discussion).
Allhorn does not explicitly teach utilizing the P. acnes strains to reduce skin aging in a subject. However, it would have been prima facie obvious at the time of filing to utilize the P. acnes strains taught by Allhorn to reduce skin aging in a subject because Suzuki teaches that free radical oxidation is intimately involved in skin aging (see paragraph 0007). Suzuki further teaches that antioxidants exhibit ameliorative effects against skin aging, e.g., age spots, wrinkles, or sagging (see paragraphs 0009, 0032). Suzuki teaches antioxidant compositions to reduce skin aging in a subject can be formulated as, e.g., ointments, creams, lotions, etc. (see paragraph 0047).
As such, Suzuki provides a clear teaching, suggestion, and motivation to reduce skin aging in a subject by topical administration of compounds exhibiting antioxidant properties. One of ordinary skill in the art would have been motivated to combine the teachings of Allhorn and Suzuki with a reasonable expectation of success because, as discussed above, Allhorn teaches that RoxP advantageously exhibits an antioxidant capacity comparable to, e.g., vitamin C and vitamin E, and maintains redox homeostasis on the skin.
Regarding instant claim 7, Allhorn teaches that roxP is constitutively and strongly expressed in both exponential and stationary growth phases in different phylotypes of P. acnes, and that RoxP is the most abundantly secreted protein from P. acnes (FIG. 8; page 8, Discussion). As such, it would have been prima facie obvious at the time of filing to select the highest RoxP secreting strains taught by Allhorn, including types IA, IB, and/or III, and optimize the cell density, culture conditions, etc. to obtain a desired amount of RoxP secretion e.g., a least 1 μg RoxP per mL of medium when measured in stationary phase, to reduce skin aging with a reasonable expectation of success.
Regarding instant claims 8 and 10, Allhorn teaches P. acnes strain KPA171202 (type IB) (page 2). As evidenced by instant FIG. 8, KPA171202 inherently possess a -10 box with the sequence TGCTACACT. As evidenced by Knodlseder, strain KPA171202 is SLST type H2 (FIG. 1).
Regarding instant claim 11, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal amount of the C. acnes strains taught by Allhorn, e.g., at least 100 CFU per gram of composition, to reduce skin aging in a subject with a reasonable expectation of success. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 30, Allhorn and Suzuki, in combination, teach the required steps of administering the C. acnes composition as claimed. As such, anything beyond the recited steps is, absent evidence to the contrary, an intended result of practicing the claimed method. MPEP 2111.04(I) states that “wherein clauses limits a process claim only where the clause give meaning and purpose to the manipulative steps” (see, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) and that wherein clauses in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
On pg. 4-6 of the Remarks, Applicant argues the claims are drawn to a cosmetic method for reducing skin aging in a human subject by administering to the skin of the subject a cosmetically effective amount of a composition comprising a live C. acnes strain secreting RoxP. Applicant argues that paragraph 7 of the previously filed Declaration that the statement of Allhorn regarding, inter alia, detoxifying free radicals on the skin, refers to bacteria found naturally on the skin such that Allhorn does not teach a cosmetic method. Applicant argues that because Allhorn discusses hat P. acnes is commensal and opportunistic, one of ordinary skill would have thought the bacteria can have detrimental effects rather than suggesting a method of administering the bacteria to the skin of a subject. Applicant argues Suzuki does not remedy the deficiencies of Allhorn because Suzuki does not teach administering live C. acnes because Suzuki teaches using plant extracts as an active agent in external skin preparation. Applicant further urges that the examiner has not given a reason why, based on the combination of references, a PHOSITA would have modified the references to arrive at the claimed method and cites to paragraphs 24-27 of the Declaration to show the cosmetic overcomes critical limitations associated with topical antioxidants.
In response, the examiner disagrees. First, Allhorn explicitly teach strains of Propionibacterium acnes (i.e., C. acnes), which endogenously secrete radical oxygenase of Propionibacterium acnes (RoxP) (see Allhorn abstract), and “[t]he antioxidant activity of RoxP might thus be beneficial for the bacterium as well as for the host, detoxifying free radicals on skin, suggesting a putative function of RoxP for maintaining the redox homeostasis on the skin” (page 8, Discussion). Thus, Allhorn provides a teaching, suggestion, and motivation for the beneficial effects of P. acnes as it relates to antioxidant activity. Allhorn does not explicitly teach utilizing the P. acnes strains to reduce skin aging in a subject. But, Suzuki provides a clear teaching, suggestion, and motivation to reduce skin aging in a subject by topical administration of compounds exhibiting antioxidant properties. Suzuki teaches that free radical oxidation is intimately involved in skin aging (see paragraph 0007). Suzuki further teaches that antioxidants exhibit ameliorative effects against skin aging, e.g., age spots, wrinkles, or sagging (see paragraphs 0009, 0032). Indeed, the teachings of the combination of the references as a whole must be taken into consideration and balanced together.
Second, Applicant’s argument that the teachings of Allhorn would have led a PHOSITA to believe that the bacteria have detrimental effects directly contradicts the explicit teachings of the prior art. Allhorn specifically teaches that “[i]n terms of activity, RoxP (secreted by the bacteria) is on par with well-studied human antioxidants, including vitamin C, vitamin E and reduced glutathione, as well as with the plasma protein α1-microglobulin shown to have radical scavenging activity.” (page 8, Discussion). Thus, contrary to Applicant’s assertion, one of ordinary skill would have readily understood the benefits of using P. acnes rather than any negative effects associated with the bacteria being both commensal and opportunistic.
Third, with regard to Applicant’s arguments of “overcoming crucial limitations associated with topical antioxidants”, the Declaration recites that the composition caused a reduction in “overall photodamage, mottled pigmentation, radiance, and melanin variation” (see, e.g., Exhibit C) (i.e., signs of oxidative stress in the skin). Applicant has not provided any data that substantiates the argument that the composition provides any benefit that is inconsistent with the teaching, suggestion, and motivation provided by Allhorn and Suzuki. One of ordinary skill in the art would have readily recognized RoxP secreted by C. acnes to be capable of producing ameliorative affects against oxidative stress/free radical damage because the prior art teaches RoxP is capable of doing so. Thus, the rejections are maintained as set forth above.
Maintained 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, 4, 7-12, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 11-12, and 15 of U.S. Patent No. 11,541,081 in view of Allhorn and Suzuki.
The conflicting claims are drawn to a method for improving the appearance of skin and/or maintaining healthy skin in a human subject comprising administration of a composition, e.g., gel, cream, ointment, lotion, etc., comprising live Propionibacterium acnes (P. acnes) strains, e.g., SLST types D1, H1, H2, H3, K1, K2, K4, K6, K8, K9, and L1 (claims 1, 4, 6-7, 11-12, and 15).
While the conflicting claims teach improving the appearance of skin and/or maintaining healthy skin in a human subject, the conflicting claims do not explicitly teach preventing or reducing skin aging in a subject, as claimed. However, Allhorn teaches strains of Propionibacterium acnes, which endogenously secrete RoxP (Abstract). As evidenced by the Specification, Cutibacterium acnes was formerly Propionibacterium acnes (Specification, see paragraph 0086, as published). Allhorn teaches RoxP is strongly secreted by, e.g., P. acnes strains of phylotypes IA, IB, II and III (page 3, Expression of roxP). Allhorn further teaches that RoxP protects the bacterium from oxidative damage, enables its survival in an oxic environment, and possibly assists in maintaining a healthy skin redox homeostasis (page 8, Discussion).
Allhorn teaches that RoxP has antioxidant properties (FIG. 4). More particularly, Allhorn teaches that “[i]n terms of activity, RoxP is on par with well-studied human antioxidants, including vitamin C, vitamin E and reduced gluthathione, as well as with the plasma protein α1-microglobulin shown to have radical scavenging activity. The antioxidant activity of RoxP might thus be beneficial for the bacterium as well as for the host, detoxifying free radicals on skin, suggesting a putative function of RoxP for maintaining the redox homeostasis on the skin” (page 8, Discussion).
Moreover, Suzuki teaches that free radical oxidation is intimately involved in skin aging (¶ 0007). Suzuki further teaches that antioxidants ameliorate the effects of skin aging, e.g., age spots, wrinkles or sagging, caused by photooxidative stress (paragraphs 0009, 0032).
One of ordinary skill in the art would have been motivated to modify the conflicting claims in view of Allhorn and Suzuki in order to advantageously improve the appearance of skin and/or maintain healthy skin in a human subject by reducing skin aging caused by free radical oxidation with a reasonable expectation of success.
Regarding instant claim 7, Allhorn teaches that roxP is constitutively and strongly expressed in both exponential and stationary growth phases in different phylotypes of P. acnes, and that RoxP is the most abundantly secreted protein from P. acnes (FIG. 8; page 8, Discussion). As such, it would have been prima facie obvious at the time of filing to select the highest RoxP secreting strains taught by Allhorn, including types IA, IB, and/or III, and optimize the cell density, culture conditions, etc. to obtain a desired amount of RoxP secretion, e.g., a least 1 μg RoxP per mL of medium when measured in stationary phase, for use in the method taught by the conflicting, Allhorn, and Suzuki with a reasonable expectation of success.
Regarding instant claim 8, Allhorn teaches P. acnes strain KPA171202 (type IB) (page 2). As evidenced by instant FIG. 8, KPA171202 inherently possess a -10 box with the sequence TGCTACACT.
Regarding instant claim 11, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal amount of the C. acnes strains taught by conflicting claims and Allhorn, e.g., at least 100 CFU per gram of composition, to reduce skin aging in a subject according to the conflicting, Allhorn, and Suzuki with a reasonable expectation of success. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 30, the conflicting claims, Allhorn and Suzuki, in combination, teach the required steps of administering the C. acnes composition as claimed. As such, anything beyond the recited steps is, absent evidence to the contrary, an intended result of practicing the claimed method. MPEP 2111.04(I) states that “wherein clauses limits a process claim only where the clause give meaning and purpose to the manipulative steps” (see, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) and that wherein clauses in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Response to Arguments
On pg. 6 of the remarks, Applicant argues the double patenting rejections for much of the reasons as set forth above regarding Allhorn and Suzuki. Specifcally, Applicant argues one of ordinary skill would not have been motivated to contemplate using live C. acnes secreting RoxP to reduce skin aging nor have a reasonable expectation of success in doing so.
In response, the examiner disagrees. For the same reasons as set forth above, Allhorn and Suzuki render the claimed invention prima facie obvious. In combination with the conflicting claims, it is clear that the instant invention and copending claims are obvious variants of each other. Thus, the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 10364473 B2
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672