DETAILED ACTION
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 Application
The Amendment and Response filed October 28, 2025 is acknowledged.
Claims 12-23 were pending. Claims 12-13, 16-21 and new claim 24 are being examined on the merits. Claims 14-15 and 22-23 are canceled.
Response to Arguments
Applicant’s arguments filed October 28, 2025 have been fully considered.
The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the claims:
Objection to claim 12
Rejection of claims 12-23 under 35 USC § 112(b), indefiniteness, in part
Rejection of claims 18 and 22-23 under 35 USC § 112(d)
The following rejections are MODIFIED in view of the instant claim amendments:
Rejection of claims 12-23 under 35 USC § 101
Rejection of claims 12-23 under 35 USC § 112(b), indefiniteness, in part
Response to arguments regarding 35 USC § 101 rejections
Applicant argues that the rejections under 35 USC § 101 should be withdrawn because the treatment steps of both independent claims 12 and 24 “amount to significantly more than the judicial exception because the specification teaches that modifying the skin microbiome (not just identifying it) treats or prevents metabolic syndrome, and the claimed combination of facial skin microbiome analysis with specific therapeutic interventions … represents an unconventional approach that transforms the body’s microbiome to achieve a therapeutic result” (Remarks, pp. 6-7).
The Examiner disagrees. Applicant does not cite any portion of the specification in support of the assertion that “the specification teaches that modifying the skin microbiome (not just identifying it) treats or prevents metabolic syndrome”, nor can the Examiner find any support in the specification for such a statement. Para. 95 of the specification teaches that the method may be used to alter or modify the skin microbiome, but does not teach or suggest that modifying the skin microbiome will result in “treat[ing] or prevent[ing] metabolic syndrome”. The Examiner is additionally unaware of any art that teaches such a causal relationship between modifying the skin microbiome and treating or preventing metabolic syndrome. Thus, as noted below in the rejection, the treatment does not have more than a nominal or insignificant relationship to the judicial exception. Further, claims 12 and 24 do not require “modifying the skin microbiome (not just identifying it) [to] treat or prevent metabolic syndrome”. Rather, the claims require (i) modifying the skin microbiome (claim 12) or administering composition(s) capable of doing so (claim 24) and (ii) treating or preventing metabolic syndrome, but do not require a cause-and-effect relationship between the steps. That is, the claims require that both (i) and (ii) occur, but do not require that performing (i) results in (ii) happening. Rather, the claims, at least, encompass embodiments wherein administering the composition results in treating metabolic syndrome (perhaps, hyperglycemia), which then subsequently results in a change in the skin microbiome (perhaps, the hyperglycemia is mitigated and in response the skin microbiome reverts to a microbiome consistent with an individual with normal blood glucose levels).
Applicant additionally argues that the claimed method integrates the judicial exception into a practical application because the bacterial ratio determination of Corynebacteriaceae to Staphylococcaceae ranging from 3.2:1 to 9:1 in facial skin is unconventional and provides a non-routine diagnostic marker of metabolic syndrome (Remarks, p. 7).
The Examiner disagrees. As noted below in the rejection, the step of determining the abundance ratio of Corynebacteriaceae to Staphylococcaceae, and using that to determine that the subject is at increased risk of developing metabolic syndrome or an associated condition, are abstract ideas. In addition, the correlation between the Corynebacteriaceae to Staphylococcaceae abundance ratio ranging from 3.2:1 to 9:1 and the subject being at increased risk of developing metabolic syndrome or an associated condition is a law of nature. Thus, these limitations are the judicial exceptions (JEs). The JEs themselves cannot integrate the claim into a practical application. MPEP 2106.04(d)(II) states that an evaluation of integration into a practical application involves identifying if there are any additional elements recited in the claim beyond the JEs, and, if so, do those additional elements individually or in combination integrate the JEs into a practical application.
These arguments are not persuasive. The rejections are modified in view of the instant claim amendments.
Response to arguments regarding indefiniteness rejections
The indefiniteness rejections of claims 14-15 are withdrawn as the claims have been canceled. The rejection of claim 18 based on the term “insulin-resistance related” is withdrawn in view of the instant claim amendments.
The indefiniteness rejections of claim 12 and its dependent claims based on the term “a condition associated therewith” is maintained. While one instance of the limitation has been removed from claim 12 and the limitation has been entirely removed from claims 17-18, the limitation still appears twice in claim 12. The term also appears in new claim 24. Consequently, the rejection is maintained as to claim 12 and its dependent claims, and newly applied to claim 24.
Claim Objections
Claim 24 is objected to because of the following informalities:
Claim 24 includes a bulleted list that includes periods (“a. …; and b. …”). Each claim must
end with a period, and periods may be used abbreviations, but periods may not be used elsewhere in the claims. MPEP 608.01(m). The bulleted list should be reformatted as, e.g., “a) …; and b) …”, or something equivalent.
Appropriate correction is required.
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 12-13, 16-21 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Eligibility is considered in light of MPEP 2106 III, which incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 17, 2019 (84 Fed. Reg. 50) and clarified in the October 2019 Update.
As can be seen in the MPEP 2106 III Figure, eligibility analysis requires one to address the following questions: (i) Step 1 – Is the claim directed to one of the four statutory categories (i.e., process, machine, manufacture or composition of matter); (ii) Step 2A – Is the claim directed to a judicial exception (i.e., a natural phenomenon, law of nature or abstract idea); and (iii) Step 2B – does the claim recite additional elements that amount to significantly more than the judicial exception. In addition, as can be seen in the MPEP 2106.04 II Figure, Step 2A is a two-prong inquiry, with Prong One asking whether the claims recite a judicial exception (i.e., an abstract idea, natural phenomenon or law of nature) and Prong Two asking whether the claims recite additional elements that integrate the judicial exception into a practical application.
In this case, as to Step 1, claims 12-13, 16-21 and 24 are directed to one of the four statutory categories since they are drawn to a process.
The analysis cannot be streamlined, so the claims are considered with respect to Step 2A.
With respect to Prong One of Step 2A, claims 12-13, 16-21 and 24 recite a judicial exception. Specifically, in claims 12 and 24, the step of determining the abundance ratio of Corynebacteriaceae to Staphylococcaceae, and using that determine that the subject is at increased risk of developing a metabolic syndrome or an associated condition, are abstract ideas. In addition, in claims 12 and 24, the correlation between the Corynebacteriaceae to Staphylococcaceae abundance ratio ranging from 3.2:1 to 9:1 and the subject being at increased risk of developing a metabolic syndrome or an associated condition is a law of nature.
With respect to Prong Two of Step 2A, the claims do not recite additional elements that integrate the judicial exceptions into a practical application for the following reason. In particular, the claims do not recite additional elements that integrate the judicial exceptions into a practical application because most of the elements in the claims other than the judicial exceptions (i.e., obtaining biological samples, measuring nucleic acid levels, performing clinical tests on individuals for input for an equation, determining the levels of biomarkers in a sample) constitute insignificant extra-solution activity as described in the 2019 PEG and MPEP 2106.05(g).
Further, in claim 12, the step of topically administering to the facial skin of a subject determined as being at an increased risk a therapeutically effective amount of an agent selected from a probiotic, a prebiotic, an anti-inflammatory drug, a topical solution, or any combination thereof, optionally in conjunction with the dietary modification steps of claims 13 and 16, are also insufficient to integrate the exception into a practical application. That is, while administering a particular treatment can integrate the exception into a practical application, to do so the treatment must have more than a nominal or insignificant relationship to the judicial exception. See MPEP 2106.04(d)(2)(b), which also provides an example of a treatment step reciting “treating a patient with a blood glucose level over 250 mg/dl with aspirin” which is insufficient to integrate the judicial exception into a practical application because aspirin is not known in the art as a treatment for ketoacidosis or diabetes. Similarly, here is it not clear the recited treatments are understood in the art to treat or prevent metabolic syndrome or an associated condition. The instant specification suggests that at least some of the treatments are intended to modify the skin microbiome itself (para. 92), and instant claim 12 has been amended to require that, as well. However, it is also not clear that modifying the skin microbiome is known in the art as treating or preventing metabolic syndrome or an associated condition.
Claim 24 similarly recites the step of topically administering to a subject determined as being at an increased risk a therapeutically effective amount of an agent selected from a probiotic selected from Staphylococcus epidermis and Staphylococcus hominis, and a prebiotic which promotes the growth of Staphylococcaceae and inhibits the growth of Corynebacteriaceae. Claim 24 is analyzed with reasoning corresponding to that of claim 12. That is, it is not clear that modifying the skin microbiome is known in the art as treating or preventing metabolic syndrome or an associated condition, and thus this step does not integrate the judicial exception into a practical application.
In this case, claims 12-13, 16-21 and 24 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only routine and conventional elements are recited in combination with the judicial exceptions. As evidenced by Cutcliffe and Kwaszewska (cited below in conjunction with the discussion of prior art), obtaining facial skin samples of various subjects (claims 19-21) and measuring bacteria levels by detecting nucleic acids corresponding to the bacteria using a nucleic acid detection technique (i.e., the elected species), and performing various treatment steps were all performed routinely prior to the effective filing date of the claimed invention. Further, claims 17 and 18 do not have additional elements, as they further define the treatment/prevention step outcomes (claim 17) or the metabolic syndrome or associated condition (claim 18). Therefore, the additional elements in claims 12-13, 16-21 and 24 are not non-routine or unconventional.
In view of the foregoing, claims 12-13, 16-21 and 24 are rejected under 35 U.S.C. 101 as being drawn to a judicial exception without significantly more.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-13, 16-21 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Indefiniteness rejections
Claim 12 recites the limitation “metabolic syndrome or a condition associated therewith” (once in the last line of step (a) and once in the penultimate line of the claim), the meaning of which is unclear. Specifically, the term “associated” has no fixed meaning in the art as to metabolic syndrome, and thus it is not clear just how “associated” a disease has to be to satisfy the recited limitation of being “associated” with metabolic syndrome. For instance, is diabetes “associated []with” metabolic syndrome? What about pancreatitis? or stroke? The specification provides a list of conditions “associated” with metabolic syndrome (para. 18), but indicates that this list is merely an embodiment of these conditions. Thus, in claim 12, it is not clear if the list of conditions associated with metabolic syndrome is intended to be limited to those recited in the specification (para. 18), or if it is intended to encompass additional “associated conditions”. Claim 24 also recites the same limitation (once in the last 2 lines of step (a)), and is rejected with the same reasoning. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claims 13 and 16-21 depend directly or indirectly from claim 12, and consequently
incorporate the indefiniteness issues of claim 12.
Prior Art
The closest prior art is Cutcliffe1 (US Patent App. Pub. No. 2016/0271189) and Kwaszewska2 (Cohabitation relationships of corynebacteria and staphylococci on human skin, Folia microbiologica, 59(6): 495-502, 2014).
Cutcliffe is directed to methods for microbiome-related treatment of health conditions
and disease. More specifically, Cutcliffe teaches a method for determining a predisposition to develop metabolic or associated condition in a subject (paras. 52, 109), comprising determining bacterial diversity in a facial skin sample of a variety of subjects (paras. 78, 132-133, 145, 370), and comparing that to a control (para. 133), using nucleic acid detection techniques (paras. 150-151, 154, 167, 394). Cutcliffe also teaches administering to the subject a prebiotic agent or a probiotic agent (paras. 4), or modifying the diet of the subject (para. 334), and treating or preventing a condition associated with metabolic syndrome (paras. 52, 357). Cutcliffe also teaches determining the diversity and abundance of microorganisms, and teaches that skin can be colonized by both Staphylococcus and Corynebacterium (para. 89), but does not teach any particular ratio of the two types of bacteria.
Kwaszewska is directed to the microbiome of healthy human skin. Kwaszewska also teaches that that facial skin can be colonized by both Staphylococcus and Corynebacterium and teaches that Staphylococcus dominates on healthy human skin (abstract).
However, neither Cutcliffe nor Kwaszewska, whether considered alone or in combination, teach the recited Corynebacteriaceae to Staphylococcaceae abundance ratio ranging from 3.2:1 to 9:1, nor would there appear to be any reason for the ordinary artisan to arrive at this ratio through routine optimization.
Conclusion
Claims 12-13, 16-21 and 24 are being examined, and are rejected. Claim 24 is objected to. 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 CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Cutcliffe was cited in the Information Disclosure Statement submitted November 18, 2022.
2 Kwaszewska was cited in the Information Disclosure Statement submitted November 18, 2022.