Prosecution Insights
Last updated: April 19, 2026
Application No. 17/518,151

MICROBIOME AND METOBOLOME CLUSTERS TO EVALUATE SKIN HEALTH

Final Rejection §101§102§103§112
Filed
Nov 03, 2021
Examiner
FONSECA LOPEZ, FRANCINI ALVARENGA
Art Unit
1685
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Johnson & Johnson Consumer Inc.
OA Round
2 (Final)
20%
Grant Probability
At Risk
3-4
OA Rounds
4y 9m
To Grant
95%
With Interview

Examiner Intelligence

Grants only 20% of cases
20%
Career Allow Rate
3 granted / 15 resolved
-40.0% vs TC avg
Strong +75% interview lift
Without
With
+75.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 9m
Avg Prosecution
58 currently pending
Career history
73
Total Applications
across all art units

Statute-Specific Performance

§101
27.2%
-12.8% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
9.8%
-30.2% vs TC avg
§112
23.8%
-16.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 15 resolved cases

Office Action

§101 §102 §103 §112
DETAILED ACTION Notice of 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 . 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 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. Applicant's response, filed 12/03/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. Herein, "the previous Office action" refers to the Non-Final Rejection of 06/03/2025. Withdrawal of rejections In view of the claim amendments and the Remarks from 12/03/2025, the following rejections are withdrawn: claim 5 under 35 U.S.C. § 112(b); claims 1-5 under 35 U.S.C. § 101; claim 1 under 35 U.S.C. § 102 over Ammons; claim 4 under 35 U.S.C. § 103 over Ammons and Willenborg; and claim 5 under 35 U.S.C. § 103 over Ammons and Schmid. The following rejections and/or objections are either maintained or newly applied for claims 1 and 5. They constitute the complete set applied to the instant application. Status of the Claims Claims 1-5 are pending. Claim 5 is objected to. Claims 1-5 are rejected. Priority This application claims priority from US Application No. 63/110,445 (11/06/2020) as reflected in the filing receipt mailed on Feb. 01, 2022. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1 and 5 is 11/06/2020. Information Disclosure Statement The information disclosure statement (IDS) submitted on 09/10/2025 was considered. Specification Objections The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code – pg. 13 footnote. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Drawings Color photographs and color drawings in Fig. 1-2 and 4-8 (filed 01/27/2022) are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). Claim objections Claims 1 and 5 are objected to because of the following informalities. Appropriate correction is required. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate. Claim 1 recites improper/inconsistent use of commas vs. semi-colons. As it appears in the claims, there's a comma before the first "wherein" clause and a semi-colon before the second. Also, the semi-colon before the "and" before "assessing" is improper. When listing elements the claims should read "X and Y" not "X; and Y." To overcome this objection, the claims may be amended to read "…said skin and …", "… microbiome clusters; …" and "… basic environment and wherein … ." Same issue repeats in claim 5. In claim 5, colons should begin lists in which list elements are separated by newlines, here "the method comprising" should be followed by a colon. Each "wherein" clause should be recited in a new line. Response to drawings remarks The Remarks of 12/03/25 have been fully considered but are not yet persuasive for the reasons below: Applicant asserts in pg. 3 para. 2: "The Examiner has asserted that the present application file contains at least one drawing executed in color and that copies of the present application will be provided by the Office upon filing of the proper request and the payment of the necessary fee. In response, Applicant respectfully asserts that the Replacement Drawings filed on January 24, 2022, in the subject application are not executed in color, and therefore a petition is not required. Reconsideration is respectfully requested." The issue regarding the drawings originates from the most recent version of drawings filed on 1/27/2022. The drawings objection is maintained due to issues regarding Fig. 1-2 and 4-8 which are displayed in color on the most recent version of drawings in this instant application. To overcome this objection, the examiner may file replacement drawings (as the one set filed on 01/24/22) in which the colored drawings are removed. MPEP 6.27 III pertains. Claim Rejections - 35 USC § 112 35 USC § 112(a) The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. Claims 1 and 5 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 1 and 5 recite “wherein an abundance of Cutibacterium sp. in said microbiome is an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment." However, Cutibacterium species are known in the art to maintain low skin pH by releasing free fatty acids, which speaks to a more acidic environment. Therefore, the claim recites the opposite of what is known in the art as discussed in the Wands factors analysis below. In re Wands (8 USPQ2d 1400 (CAFC 1988)) considered the issue of enablement in molecular biology. The following eight factors were to be taken into account: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims. In considering these factors for the instant claims: a) In order to practice the claimed invention, one of skill in the art must be able to assess the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. For the reasons below, one would not be able to practice the claimed limitation and the amount of experimentation necessary would be unviable. b) and c) The instant specification at pg. 21 para. 2 indicates the “association between Cutibacterium, Actinomyces and Bergeyella in individuals with ceramide- and lipid-rich, relatively drier and basic skin surface." As such, the instant specification discloses the opposite of what is known in the art, therefore associating Cutibacterium sp. to a basic environment. d) The nature of the invention is drawn to assessing the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment (claim 2). e) and g) The prior art discusses how Cutibacterium species maintains a more acidic environment: Lee et al (J. Clin. Med.8(7):987 (2019)) discloses how Cutibacterium acnes maintain a low skin pH by releasing free fatty acids (pg. 6 para. 3) (i.e. hence, acidic). Based on these teachings, it is clear that the claim recites the opposite of what is known in the art which indicated that Cutibacterium species maintains a more acidic environment. As such, one would not be able to practice the claimed limitation and assess the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. f) The relative skill of those in assay testing is high. h) The claims encompass assessing the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. Claims 1 and 5 recite “wherein an abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment." However, Staphylococcus species are known in the art to be more stable in a basic environment and; therefore, the claim recites the opposite of what is known in the art as discussed in the Wands factors analysis below. In re Wands (8 USPQ2d 1400 (CAFC 1988)) considered the issue of enablement in molecular biology. The following eight factors were to be taken into account: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims. In considering these factors for the instant claims: a) In order to practice the claimed invention, one of skill in the art must be able to assess the abundance of Staphylococcus sp. in said microbiome as an indication of a lysine- and sugar-rich, more hydrated and acidic environment. For the reasons below, one would not be able to practice the claimed limitation and the amount of experimentation necessary would be unviable. b) and c) The instant specification at pg. 21 para. 2 indicates the “association of multiple commensals such as Corynebacterium, Lactobacillus, Clostridium, Escherichia, Pseudomonas and Staphylococcus in individuals with a lysine- and sugar-rich, relatively moistened and more acidic skin surface." As such, the instant specification discloses the opposite of what is known in the art, therefore associating Staphylococcus sp. to an acidic environment. d) The nature of the invention is drawn to assessing the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment. e) and g) The prior art discusses how Staphylococcus species favors a more basic environment: Rippke et. al. (Am. J. Clin. Dermatol. 5:217–223 (2004)) discloses how Staphylococcus showed large deviations from its normal geometry at pH 5 compared with pH 8, with probable effects on its catalytic activity, while adhesion of Staphylococcus to human cells increased with increasing pH values (pg. 4 col. 2 para. 3) (i.e. basic environment). Based on these teachings, it is clear that the claim recites the opposite of what is known in the art which indicated that Staphylococcus species favors a more basic environment. As such, one would not be able to practice the claimed limitation and assess the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment. f)The relative skill of those in assay testing is high. h) The claims encompass assessing the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment. Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 112(a) The Remarks of 12/03/25 have been fully considered but are not yet persuasive for the reasons below: Applicant asserts from pg. 3 para. 4 to pg. 4 para. 1: Using the samples from individuals in the cohort…skin environment of infants was analyzed. The results from this analysis are shown … Cutibacteria … association with a dryer environment ……Cutibacteria have a positive Pearson's correlation with pH, indicating an association with a more basic environment. In contrast, Staphylococci have a positive correlation with SSH indicating an association with a more hydrated environment - and a negative correlation with pH – indicating an association with a more acidic environment … The teachings from the prior art are opposite to the subject matter claimed in this instant application. Cutibacteria here is being claimed as a bacteria typically associated with dry and basic environments, while the prior art associates this bacteria to a low skin pH – thus, acidic environments (Lee et al J. Clin. Med.8(7):987 (2019)). Furthermore, Staphylococci here is being claimed as a bacteria typically associated with more hydrated and acidic environments, while the prior art associates this bacteria as favoring areas of higher pH thus, basic environments (Rippke et. al. (Am. J. Clin. Dermatol. 5:217–223 (2004)). One of ordinary skill would not be able to practice the claimed limitation because the recited types of bacteria are not typical of the environments being claimed. Applicant remarks point to evidence based on what was found in their experiments, but the experimental results still oppose the evidence in the field.. It may help to further traverse this rejection to cite evidence in the art that supports the claimed scientific assertions. Claim Rejections - 35 USC § 112(b) 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. Claims 1 and 5 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. The following issues cause the respective claims to be rejected under 112(b) as indefinite: 1. Claims 1 and 5 are indefinite because they lack a conjunction between the recited "wherein" clauses. It is unclear whether one or both wherein clauses are required. This rejection may be overcome by amending the claims to recite "and" or "or" between the "wherein" clauses. 2. In claim 1, the following recitations lack antecedent basis. The recited "said skin" does not have antecedent since the "skin" in the preceding "skin health" is an adjective modifying "health." Same issue occurs in claim 5. Above issue repeats for "the make-up;" which also occurs in claim 5. In the first "wherein" clause, "said microbiome" lacks antecedent basis. Same issue occurs in claim 5. 3. Claim 5 is indefinite regarding its relationship to claim 1. Separate from the related rejection below of claim 5 under 112(d), it also generally is not clear how the steps and elements of claim 5 relate to claim 1, from which claim 5 depends. For example, it is not clear how to interpret the recited "A method of claim 1..." Also, elements instantiated in claim 5 repeat elements instantiated in claim 1 without reciting a clear relationship. The recited "to deduce... skin barrier function" is interpreted as intended use. The remaining recitations after "to deduce … " are the same as in claim 1. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 5 is rejected under 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend. MPEP 608.01(n).III pertains. The claim 5 preamble is not clearly limiting, and it is not clear that the rest of the claim differs in scope from claim 1. The recited "to deduce... skin barrier function" is interpreted as intended use, not further limiting. MPEP 2111.02 pertains. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1 and 5 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). 101 background MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials. Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)? Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))? Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))? Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)? Analysis of instant claims Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)? The instant claims are directed to a method (claims 1 and 5), which falls within one of the categories of statutory subject matter. [Step 1: claims 1 and 5 - Yes]. Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))? With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as: • mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations) (MPEP 2106.04(a)(2)(I)); • certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or • mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)). Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include: • "observing microbiome and metabolome clusters on a surface area of said skin" (claim 1); • “assessing said skin health based on the make-up of said microbiome and metabolome clusters” (claim 1); • “deduce treatment benefits on skin traits” (claim 5). Under the BRI, the recited limitations are mental processes because the human mind is capable of evaluate data representing microbiome and metabolome information from a skin sample; “assess” said skin health given a list that describes “the make-up of said microbiome and metabolome clusters” and “deduce” treatment benefits including but not limited to skin moisturization and skin barrier function by visual inspection. Since the claims do not specify any manner in which this “assessing” step is performed, all the limitations are interpreted under the broad reasonable interpretation. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: claims 1 and 5 - Yes]. Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))? The claims do not recite any additional elements and therefore cannot integrate the abstract idea into a practical application. [Step 2A Prong Two: claims 1 and 5 - No] Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)? The claims do not recite any additional elements and therefore do not have any additional elements that can provide an inventive concept. [Step 2B: claims 1 and 5 - No] Conclusion: Instant claims are directed to non-statutory subject matter For these reasons, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Regarding instant claims 1 and 5, the claimed invention does not constitute significantly more than the abstract idea, so the instant claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter. Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 101 The Remarks of 12/03/25 have been fully considered but are not yet persuasive for the reasons below: It appears that pg. 14 para. 3 represents the only Applicant remarks specific to 101 and the instant claims (emphasis added): Plots 1 and 2 demonstrate that an abundance of Cutibacteria or Staphylococci on the surface of infant skin allows the skilled person to determine the metabolomic profile ….provides an improved method for determining the health of infant skin. It appears that these remarks address Step 2A, Prong Two – 1st consideration regarding improvement over the previous state of a technology field (MPEP §§ 2106.04(d)(1) and 2106.05(a)). It is not yet clear what is the particularly asserted improvement, "improved method for determining the health of infant skin" being too broad. As examples, it would help to narrow "better" to particular aspects. As described in detail above, one would not be able to practice the claimed limitation and assess the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment or assess the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. Thus, there is no relationship between the claimed bacteria and the asserted improvement within the scope of the claim. Claim Rejections - 35 USC § 102 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)(l) 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ammons (“Biochemical Association of Metabolic Profile and Microbiome in Chronic Pressure Ulcer Wounds” PLoS ONE 10(5): e0126735 (2015)) as cited on the attached Form PTO-892. Claim 1 recites “method of evaluating infant skin health, comprising: observing microbiome clusters on a surface area of said skin; and assessing said skin health based on the make-up of said microbiome clusters, wherein an abundance of Cutibacterium sp. in said microbiome is an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment; wherein an abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment." Ammons teaches the correlation between the bacterial microbiome and metabolome in chronic pressure ulcer wounds (reading on “evaluating skin health”); quantifying the association between (reading on “assessing) the relative abundance of bacterial genera and metabolite concentration (reading on “metabolome”) in chronic pressure ulcer wounds (Fig. 15) and identifying significantly contributing variables to the clustering of metabolite profiles (pg. 10 para. 1). As described in detail in the 122(a) Claim Rejection above, one would not be able to practice the claimed limitation and assess the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment or assess the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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. Claim 5 is rejected under 35 U.S.C. 103(a) as being unpatentable over Ammons as applied to claim 1 above under 35 USC § 102 Claim Rejection above and further in view of Schmid-Wendtner (“The pH of the Skin Surface and Its Impact on the Barrier Function” Skin pharmacology and physiology 19.6:296-302 (2006)), as cited on the attached Form PTO-892. Claim 5 recites “to deduce treatment benefits on skin traits, including but not limited to skin moisturization and skin barrier function, the method comprising observing microbiome clusters on a surface area of said skin; and assessing said skin health based on the make-up of said microbiome clusters, wherein an abundance of Cutibacterium sp. in said microbiome is an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment; wherein an abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment" Ammons does not explicitly teach the recited limitations above. However, Schmid teaches that bacteria can grow over a wide pH range (pg. 300 col. 2 para. 1); wherein the use of skin cleansing agents with a pH of about 5.5 for the prevention and treatment of skin diseases (pg. 296 col. 2 para. 1) for the maintenance of skin moisture and skin barrier function (pg. 299 col. 2 para. 2-3). As described in detail in the 122(a) Claim Rejection above, one would not be able to practice the claimed limitation and assess the abundance of Staphylococcus sp. in said microbiome is an indication of a lysine- and sugar-rich, more hydrated and acidic environment or assess the abundance of Cutibacterium sp. in said microbiome as an indication of a ceramide- and lipid-rich, relatively dryer and more basic environment. Rationale for Combining (MPEP §2142-2143) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings by Schmid to the teachings by Ammons to understand the skin pH relevance for the integrity of the barrier function (pg. 301 col. 2 para. 1 Schmid) and skin moisture (pg. 296 col. 1 para. 1 Schmid). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating skin processes. Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 102/103 The Remarks of 12/03/25 have been fully considered but are not yet persuasive. Applicant's remarks summarize the amendments and have been addressed by revision to the rejection. No other substantive arguments have been identified. Conclusion No claims are allowed. 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 FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET. 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, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /F.F.L./Examiner, Art Unit 1685 /G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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Prosecution Timeline

Nov 03, 2021
Application Filed
May 30, 2025
Non-Final Rejection — §101, §102, §103
Dec 03, 2025
Response Filed
Jan 16, 2026
Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
20%
Grant Probability
95%
With Interview (+75.0%)
4y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 15 resolved cases by this examiner. Grant probability derived from career allow rate.

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