DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 11/06/23 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Objection to Specification
3. The use of several terms, which are each a trade name or a trademark used in commerce, has been noted in this application (e.g. BLIS Q24®; Tween®; Sigma®; Miglyol®; etc.). All trademarks, throughout the specification, should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever each appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Objection to Drawings
4. The drawings are objected to because of the presence of a Trademark (see BLIS Q24® in Figure 1) and/or for poor quality images preventing delineation of results (see Figure 3). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Election/Restrictions
5. Applicant's election, with traverse, of Group I, in the reply filed on 12/01/25, is acknowledged. The traversal is on the ground(s) that (A) the technical feature of “improving skin appearance through specifically formulated compositions” is not taught by the prior art (see Remarks, page 5) and (B) simultaneous search and examination would not introduce a significant prosecutorial burden (see Remarks, page 6).
This is not found persuasive because “improving skin appearance” is interpreted as an expression of an intended result based on the intended use of the product and the product per se (i.e. the only structural requirement of independent claim 1 is Micrococcus luteus Q24) is explicitly taught by the prior art (i.e. “specifically formulated compositions” is not the shared technical feature). Therefore, as set forth in the Restriction Requirement, Groups I - II lack unity of invention because even though the inventions of these groups require the shared technical feature of compositions comprising Micrococcus luteus Q24, this shared technical feature is not a special technical feature as it does not make a contribution over the prior art in view of, for example, Tagg et al. 2006 (WO 2006/104403A1; of record) which teaches compositions comprising Micrococcus luteus Q24 (see Examples 1-3; Table A). Accordingly, this argument is not persuasive because the shared technical feature is not a special technical feature according to PCT Rule 13.2, and thus, unity of invention is lacking.
With regards to the relative amount of burden on the Examiner, the Office disagrees because the inventions require different search strategies and raise different non-art issues under 35 U.S.C. 101, 112(a) and/or 112(b). Further, the Office notes a discussion of Unity of Invention under the Patent Cooperation Treaty Articles and Rules as it is applied as an International Searching Authority, International Preliminary Examining Authority, and in applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in MPEP Chapter 1800 (i.e. not MPEP 803 for independent and distinct) and 37 CFR 1.492 (i.e. not 37 CFR 1.16). Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claim Status
6. The amendment, filed 12/01/25, has been entered. Claims 1, 3-4, 6-7, 9, 14-15, 18, 27, 29-31, 33-34, and 36-39 are pending. Claims 2, 5, 8, 10-13, 16-17, 19-26, 28, 32, 35, and 40-49 are cancelled. Claim 1 is amended. Claims 34 and 36-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/01/25. Claims 1, 3-4, 6-7, 9, 14-15, 18, 27, 29-31, and 33 are under examination.
Claim Objections
7. Claim 33 is objected to because of the following informalities: improper use of an acronym/abbreviation. Acronyms and abbreviations must be spelled out and/or defined upon first use, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves); therefore, RH must be explained/defined. Further, there is a space missing between the % and the RH. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
9. Claims 1, 3-4, 6-7, 9, 14-15, 18, 27, 29-31, and 33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “improve” in claim 1 (see line 1) is a relative term which renders the claim indefinite. The term “improve” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, to what degree of improvement (and/or relative to what) is included vs. excluded in the scope of the claims? Thus, clarification is required to remove scope ambiguity.
With regards to claim 18, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired; See MPEP § 2173.05(c). In the present case, claim 18 recites the broad recitation “an antimicrobial”, and the claim also recites “an antibacterial agent” which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With regards to claim 29, the phrases “looks more radiant”; “looks healthier”; “feels more hydrated”; “feels softer”; “looks clearer”; and the term “reduced” (i.e. see several recitations in line 4) within claim 29 are each a relative term or phrase which renders the claim indefinite. These phrases and terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, to what degree (and/or compared to what and/or according to whom) does the skin need to “look” or “feel” in a particular manner and/or be “reduced” by what degree in order to be included vs. excluded from the scope of the claim. Accordingly, clarification is required to remove scope ambiguity.
Other dependent claims do not clarify the issue(s) identified above; therefore clarification is required to ascertain the metes and bounds of these claims.
Claim Rejections - 35 USC § 102
10. 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.
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
12. Claims 1, 3, 6, 9, 18, 29-31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tagg et al. 2006 (WO 2006/104403 A1; of record).
Tagg teaches methods comprising administering compositions (e.g. a non-aqueous composition) comprising cocoa and shea butters (i.e. each a viscosity modifier and an oil vehicle) and potassium alum (i.e. an antibacterial agent and an aluminum salt) and Micrococcus luteus Q24 including an explicit example of a concentration of 5 x 106 cfu/g (e.g. see page 2, lines 18-25; page 8, lines 10-32; and Example 2; meeting limitations found in instant claims 1, 3, 9, 18, and 30). Tagg teaches their compositions treat skin infections including impetigo, boils, carbuncles, folliculitis, and acne (e.g. improves the appearance of skin; reduces pathogenic impurities; see Table A on page 6 and Example 3, page 21, lines 15-17; meeting limitations found in instant claim 1 and 29). Tagg teaches compositions may be administered topically in either aqueous or non-aqueous forms (e.g. see page 3, lines 19-21; meeting limitations found in instant claims 1, 30, and 31). Tagg teaches compositions include surfactants (i.e. a dispersing agent; see page 8, line 29 to page 9, line 2; meeting limitations found in instant claim 6).
With regards to the limitation “…wherein the composition has a shelf-life of at least 6 months at 25°C at 60% RH” in claim 33; it is noted that the limitation does not add a positively recited step to the method per se and therefore has been interpreted as a functional property of the product used in the method; see MPEP 2112.01.
Accordingly, Tagg anticipates the invention as claimed.
Claim Rejections - 35 USC § 103
13. 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.
14. 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.
15. 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.
16. Claims 1, 3-4, 6-7, 9, 14-15, 18, 27, 29-31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Tagg et al. 2006 (WO 2006/104403 A1; of record) in view of Reindl et al. 2008 (WO 2008/064893).
The teachings of Tagg are outlined above.
With regards to the concentrations found in dependent claims 4, 7, and 27; MPEP 2144.05 states, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, the difference(s) between the invention and the prior art is the use of an additional probiotic bacteria found in dependent claims 14 and 15; and the selection of particular additional components including olive squalene and vitamin E (i.e. tocopherol) in dependent claim 27.
However, Reindl teaches methods for protecting skin via stabilizing the skin’s natural flora, including stabilizing the concentrations of Micrococcus luteus, which supports protection and prevention of the intrusion of pathogens (see page 1, last paragraph). Thus, Reindl teaches similar methods for improving the appearance of skin by increasing the growth of its resident flora, including that of Micrococcus luteus, comprising topical application of compositions comprising probiotics, including Lactobacillus spp. (e.g. see page 4, second paragraph; page 6, first paragraph; page 11, second paragraph; page 25, second paragraph; page 28, second paragraph; meeting limitations found in instant claims 14 and 15). Reindl teaches their compositions treat skin infections including impetigo and folliculitis (e.g. page 3, lines 9-15). Reindl teaches the compositions for cosmetic use advantageously contain natural oils such as olive oil as antioxidants, carriers, and/or emollients (e.g. page 47, second paragraph; page 53, first paragraph; page 59, first paragraph; and page 64, second paragraph; meeting limitations of using olive squalene and vitamin E, found in claim 27; see also Pertinent Art section below).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine methods for protecting skin comprising applying compositions of Micrococcus luteus Q24, as taught by Tagg, with similar methods for protecting skin comprising applying compositions of probiotics and natural oils, as taught by Reindl, in order to treat skin conditions such as impetigo and folliculitis, as taught by both Tagg and Reindl. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions. The person of ordinary skill in the art would have been motivated to make the modification because the use of probiotics and natural oils, including the use of Lactobacillus as a beneficial microbe together with the use of olive oil (i.e. a combination of olive squalene and tocopherol) as an antioxidant, carrier, and/or emollient, was recognized as useful for enhancing the growth of the skin’s resident flora, including promoting the growth of the target species Micrococcus luteus, as taught by Reindl. The person of ordinary skill in the art would have had a reasonable expectation of success because Tagg had already taught the use of compositions comprising Micrococcus luteus for treating skin infections such as impetigo and folliculitis, and Reindl had already taught the use of similar compositions for the same purpose wherein the use of the additional probiotic bacteria and the natural oils would promote the growth of the same Micrococcus luteus bacteria and treat the same skin infections of impetigo and folliculitis; therefore, the combination leads to expected results because each element performs the same function as it does individually.
Further, MPEP 2144.06 states that combining equivalents known for the same purpose is obvious: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In the instant case, both methods were for treating the same skin infections such as impetigo and folliculitis.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e. methods for treating skin infections comprising applying a composition of Micrococcus luteus Q24 and methods for treating skin infections comprising applying a composition of Lactobacillus spp. and olive oil to promote the growth of Micrococcus luteus) were known in the art. Thus combining these elements yields a method wherein each element merely performs the same function as it does separately so the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine these prior art elements according to a known method to yield predictable results.
Thus, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Pertinent Art
17. The following prior art, made of record and not relied upon, is considered pertinent to applicant’s disclosure, because it is the Office’s position that one of ordinary skill in the art would recognize that olive oil naturally and necessarily contains both olive squalene and vitamin E (a.k.a. tocopherol).
Amarowicz 2009 (Squalene: A natural antioxidant? Eur. J. Lipid Sci. Technol 111:411-412) teaches olive oil naturally and necessarily contains squalene and tocopherol (i.e. vitamin E; see first page, first paragraph); and is recognized for its stability and its antioxidant properties; and demonstrated a synergistic effect with tocopherol (see page 1, 3rd paragraph; and page 2, first paragraph); and demonstrated that during storage conditions squalene based compositions lost as little as 4% (see page 1, last paragraph)
Gopakumar 2012 (Therapeutic applications of squalene – a review; Fishery Technology 49:1-9) teaches olive oil naturally and necessarily contains squalene (i.e. olive squalene) at amounts between 0.1 and 0.7% (see Introduction).
Beltran et al. 2010 (Variability of vitamin E in virgin olive oil by agronomical and genetic factors; Journal of Food Composition and Analysis 23: 633-639) teaches vitamin E is the generic name for plant soluble lipid components including tocopherol and is found naturally in olive oil (see section 1; Table 1).
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
20. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/
Examiner, Art Unit 1645
January 13, 2026