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 Response and the Request for Continued Examination, each filed May 19, 2026, are acknowledged.
Claims 12-13, 16-21 and 24 were pending. Claims 12 and 16-21 are being examined on the merits. Claims 13, 24 and new claim 25 are newly withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 19, 2026 has been entered.
Response to Arguments
Applicant’s arguments filed May 19, 2026 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The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the claims: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 24
Rejection of claims under 35 USC § 112(b), indefiniteness
The following rejections are MODIFIED in view of the instant claim amendments:
Rejection of claims under 35 USC § 101
Response to arguments regarding 35 USC § 101 rejections
The 35 USC § 101 rejections are modified in view of the instant claim amendments. However, to the extent that Applicant’s arguments relate the modified rejections, the Examiner notes the following:
Applicant argues that the rejections under 35 USC § 101 should be withdrawn because the claim 12 limitations of “analyzing” and “determining” refer to specific laboratory techniques and not abstract ideas (Remarks, p. 7).
The Examiner agrees in part and disagrees in part. Specifically, “determining/”analyzing” are so broad that it is unclear what steps they comprise. While they can be construed to comprise performing specific laboratory techniques, they can also be construed to comprise abstract ideas. This is discussed further below in the 35 USC § 112(b) rejection.
Applicant additionally argues that …
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Remarks, p. 7.
The Examiner disagrees. First, the elected species is determining/calculating the abundance ratio of Corynebacteriaceae to Staphylococcaceae ranging from 3.2:1 to 9:1, and thus the limitations relating to an abundance of at least 15% are non-elected and are not being examined. Second, Applicant has not explained why reciting a particular ratio would integrate a JE into a practical application, and it is not clear to the Examiner why this would be the case.
Election/Restrictions
Instantly amended claims 13 and 24, and newly submitted claim 25, are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The subject matter of claims 13, 24 and 25 have been amended/ do not require the species elected in the response to the Election of Species requirement mailed March 13, 2025. Specifically, regarding claim 13, the use of a culture-based detection method of culturing cells was not elected in the Response filed May 9, 2025. Further, claim 24 has been amended to remove all of the species elected in the May 9, 2025 Response, and new claim 25 does not recite any elected species either. Thus, all of claims 13 and 24-25 are directed to non-elected subject matter.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13 and 24-25 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 and 16-21 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 and 16-21 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 and 16-21 recite a judicial exception. Specifically, in claim 12 the steps of determining/calculating the abundance ratio of Corynebacteriaceae to Staphylococcaceae, and then determining/analyzing whether the abundance ratio falls within the reference range of 3.2:1 to 9:1, are abstract ideas.
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).
In this case, claims 12 and 16-21 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 and processing facial skin samples of various subjects, and measuring bacteria levels by detecting nucleic acids corresponding to the bacteria using various nucleic acid detection techniques (i.e., the elected species) were all performed routinely prior to the effective filing date of the claimed invention. Therefore, the additional elements in claims 12 and 16-21 are not non-routine or unconventional.
In view of the foregoing, claims 12 and 16-21 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 and 19-21 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.
Claim 12 recites the limitation “determining in a sample comprising facial skin
microbiome a Corynebacteriaceae to Staphylococcaceae abundance ratio ranging from 3.2:1 and 9:1”, the meaning of which is unclear. Specifically, “determining” is so broad that it is not clear whether the analysis step includes a physical measurement or not. For example, “determining … a … ratio …” could be construed to mean performing a calculation to generate a ratio or it could be construed to mean performing a physical measurement of the abundance of each of the recited bacteria. Similarly, the “from 3.2:1 and 9:1” could be construed to mean selecting, from a list of samples with various abundance ratios, those samples with ratios that fall within that reference level. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claims 19-21 depend from claim 12, and consequently incorporate the indefiniteness issues of claim 12.
Prior Art
The closest prior art to the elected species 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, 154, 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.
Thus, the elected species is free of the art.
Conclusion
Claims 12 and 16-21 are being examined, and are rejected. No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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.
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