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 .
Applicant's election with traverse of Group I, claims 1-6 and 8 in the reply filed on 06/29/2026 is acknowledged. The traversal is on the ground(s) that undue burden to examine group II claims. his is not found persuasive because searching all the claims would require searching in numerous different classes and subclasses, as well as a different searching focus depending on whether the product or processes are being searched. Thus, the search would pose an undue burden on the Office.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/02/2024 was noted and 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 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)(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.
Claim(s) 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amini et al. (WO 2014/205088).
Amini discloses methods for analyzing the skin and subcutaneous tissue flora, e.g., the microbiome, and its associated metabolome, comparing the resulting profile of the skin and subcutaneous tissue flora and metabolome to a healthy profile, represented as a quantity and diversity of flora that falls within a range determined from a set of healthy skin types, and then customizing skin care and personal care products that will augment the flora residing on a test subject's skin and subcutaneous tissue and its associated metabolome or replicate a healthy flora profile on to that of a test subject (abstract). The method includes a) obtaining a sample comprising a plurality of microorganisms from the skin or subcutaneous tissue of the subject; b) analyzing and classifying the plurality of microorganisms of (a) to identify a microbiome of the subject; and c) comparing the microbiome of the subject to a reference microbiome representative of a microbiome of a subject having or at risk of the disease or disorder, wherein a similarity between the microbiome of the subject and the reference microbiome is indicative of the subject being at risk of, or having the disease or disorder, thereby diagnosing a disease or disorder in the subject. In embodiments the method further includes providing a personalized treatment regime to the subject. In some embodiments the method further includes formulating and administering a customized therapeutic formulation to the subject (0009). In embodiments, the method further includes clustering the results of (b) to identify individual cohorts of the plurality of samples. Such clustering effort will help to identify biological significant patterns which are characteristic of each cohort (0008). In one embodiment, discloses the development of customized skin care and personal care products for human and animal use that are based on the initial evaluation of the flora inhabiting the skin and subcutaneous tissue, analyzing the skin and subcutaneous tissue flora and its associated metabolome, comparing the resulting profile of the skin and subcutaneous tissue flora and metabolome to a healthy profile, represented as a quantity and diversity of flora that falls within a range determined from a set of healthy skin types, and then customizing skin care and personal care products that will augment the flora residing on a test subject's skin and subcutaneous tissue and its associated metabolome or replicate a healthy flora profile on to that of a test subject (0019). The exact composition of the skin care product blend may be determined after comparing the resulting profile of any individual's skin and subcutaneous tissue flora and metabolome to a healthy profile and then customizing skin care and personal care products that best shift the subject's skin and subcutaneous tissue flora and metabolome toward a healthy profile (0020). Based on the customized or personalized test results, a customized or personalized skin care or personal care blend may be formulated for that individual by blending a mixture of commensal and mutualistic microorganisms or their relevant metabolites that are depleted in that individual's flora or metabolome with or without the necessary substrates and nutrients that favor proliferation of commensal and mutualistic organisms (0032). The microbial composition of the affected cohort is distinct from the healthy profile. Microbial species which are associated with any given skin condition can be used as early diagnostic markers for individuals who have not developed a visual skin condition but may be prone to that. Examples of identified bacteria belong to any phylum, including Actinobacteria, Firmicutes, Proteobacteria, Bacteroidetes. It will typically include common species, such as Propionibacteria, Staphylococci, Corynebacteria, and Acenitobacteria species (0057). Skin condition, disease or disorder, including, but not limited to inflammation, rash, dermatitis, eczema, psoriasis, dandruff, acne, cellulitis, shingles, ringworm, and cancer, such as basal cell carcinoma, squamous cell carcinoma, and melanoma (0027). Additional disclosure includes that the invention contemplates generating a reference database containing a number of reference projected profiles created from skin samples of subjects with known states, such as normal or healthy skin, as well as various skin disease states. The individual’s profile may be compared with the reference database containing the reference profiles. If the profile of the subject matches best with the profile of a particular disease state in the database, the subject is diagnosed as having such disease state. Various computer systems and software can be utilized for implementing the analytical methods of this invention and are apparent to one of skill in the art.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Amini et al. (WO 2014/205088) in view of Apte et al. (US 2018/0122514).
Amini discloses methods for analyzing the skin and subcutaneous tissue flora, e.g., the microbiome, and its associated metabolome, comparing the resulting profile of the skin and subcutaneous tissue flora and metabolome to a healthy profile, represented as a quantity and diversity of flora that falls within a range determined from a set of healthy skin types, and then customizing skin care and personal care products that will augment the flora residing on a test subject's skin and subcutaneous tissue and its associated metabolome or replicate a healthy flora profile on to that of a test subject (abstract). The method includes a) obtaining a sample comprising a plurality of microorganisms from the skin or subcutaneous tissue of the subject; b) analyzing and classifying the plurality of microorganisms of (a) to identify a microbiome of the subject; and c) comparing the microbiome of the subject to a reference microbiome representative of a microbiome of a subject having or at risk of the disease or disorder, wherein a similarity between the microbiome of the subject and the reference microbiome is indicative of the subject being at risk of, or having the disease or disorder, thereby diagnosing a disease or disorder in the subject. In embodiments the method further includes providing a personalized treatment regime to the subject. In some embodiments the method further includes formulating and administering a customized therapeutic formulation to the subject (0009). In embodiments, the method further includes clustering the results of (b) to identify individual cohorts of the plurality of samples. Such clustering effort will help to identify biological significant patterns which are characteristic of each cohort (0008). In one embodiment, discloses the development of customized skin care and personal care products for human and animal use that are based on the initial evaluation of the flora inhabiting the skin and subcutaneous tissue, analyzing the skin and subcutaneous tissue flora and its associated metabolome, comparing the resulting profile of the skin and subcutaneous tissue flora and metabolome to a healthy profile, represented as a quantity and diversity of flora that falls within a range determined from a set of healthy skin types, and then customizing skin care and personal care products that will augment the flora residing on a test subject's skin and subcutaneous tissue and its associated metabolome or replicate a healthy flora profile on to that of a test subject (0019). The exact composition of the skin care product blend may be determined after comparing the resulting profile of any individual's skin and subcutaneous tissue flora and metabolome to a healthy profile and then customizing skin care and personal care products that best shift the subject's skin and subcutaneous tissue flora and metabolome toward a healthy profile (0020). Based on the customized or personalized test results, a customized or personalized skin care or personal care blend may be formulated for that individual by blending a mixture of commensal and mutualistic microorganisms or their relevant metabolites that are depleted in that individual's flora or metabolome with or without the necessary substrates and nutrients that favor proliferation of commensal and mutualistic organisms (0032). The microbial composition of the affected cohort is distinct from the healthy profile. Microbial species which are associated with any given skin condition can be used as early diagnostic markers for individuals who have not developed a visual skin condition but may be prone to that. Examples of identified bacteria belong to any phylum, including Actinobacteria, Firmicutes, Proteobacteria, Bacteroidetes. It will typically include common species, such as Propionibacteria, Staphylococci, Corynebacteria, and Acenitobacteria species (0057). Skin condition, disease or disorder, including, but not limited to inflammation, rash, dermatitis, eczema, psoriasis, dandruff, acne, cellulitis, rosacea, warts, seborrheic keratosis, actinic keratosis, tinea versicolor, viral exantham, shingles, ringworm, and cancer, such as basal cell carcinoma, squamous cell carcinoma, and melanoma (0027). Additional disclosure includes that the invention contemplates generating a reference database containing a number of reference projected profiles created from skin samples of subjects with known states, such as normal or healthy skin, as well as various skin disease states. The individual’s profile may be compared with the reference database containing the reference profiles. If the profile of the subject matches best with the profile of a particular disease state in the database, the subject is diagnosed as having such disease state. Various computer systems and software can be utilized for implementing the analytical methods of this invention and are apparent to one of skill in the art.
Amini fails to disclose identifying first and third individual microbiome network, second and fourth individual microbiome networks and comparing a difference of the microbiome networks.
Apte discloses a method for at least one of characterizing, diagnosing, and treating a cutaneous condition in at least a subject, the method comprising: receiving an aggregate set of biological samples from a population of subjects; generating at least one of a microbiome composition dataset and a microbiome functional diversity dataset for the population of subjects; generating a characterization of the cutaneous condition based upon features extracted from at least one of the microbiome composition dataset and the microbiome functional diversity dataset; based upon the characterization, generating a therapy model configured to correct the cutaneous condition; and at an output device associated with the subject, promoting a therapy to the subject based upon the characterization and the therapy model (abstract).
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In some variations, the first method 100 can further include: based upon the characterization, generating a therapy model configured to improve a state of cutaneous condition S150 (0015). In specific examples, method 100 can be used for characterization of and/or therapeutic intervention for one or more of: acne and dermatomyositis (0017). Thus, method 100 can be implemented for a population of subjects (e.g., including the subject, excluding the subject), wherein the population of subjects can include patients dissimilar to and/or similar to the subject (e.g., in health condition, in dietary needs, in demographic features, etc. (0020). Additionally, the characterization can be based upon features derived from a statistical analysis (e.g., an analysis of probability distributions) of similarities and/or differences between a first group of subjects exhibiting a target state (e.g., a health condition state) associated with the cutaneous condition, and a second group of subjects not exhibiting the target state (e.g., a “normal” state) associated with the cutaneous condition. In implementing this variation, one or more of a Kolmogorov-Smirnov (KS) test, a permutation test, a Cramér-von Mises test, and any other statistical test (e.g., t-test, Welch's t-test, z-test, chi-squared test, test associated with distributions, etc.) can be used (0072).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate steps of identifying first and third individual microbiome network, second and fourth individual microbiome networks and comparing a difference of the microbiome networks into Amini’s methods for analyzing the skin and subcutaneous tissue flora. The person of ordinary skill in the art would have been motivated to make those modifications because Apte teaches the characterization, generating a therapy model configured to correct the cutaneous condition, based upon features derived from a statistical analysis (e.g., an analysis of probability distributions) of similarities and/or differences between a first group of subjects exhibiting a target state (e.g., a health condition state) associated with the cutaneous condition, and a second group of subjects not exhibiting the target state (e.g., a “normal” state) associated with the cutaneous condition (0072). It would have been obvious to one of ordinary skill in the art to determining and comparing the difference of microbiome network in a subject, thereby diagnosing a disease or disorder and providing a personalized treatment regime to the subject and reasonably would have expected success because Apte teaches the outputs of the first method 100 can be used to generate diagnostics and/or provide therapeutic measures for an individual based upon an analysis of the individual's microbiome. As such, a second method 200 derived from at least one output of the first method 100 can include: receiving a biological sample from a subject S210; characterizing the subject with a form of cutaneous condition based upon processing a microbiome dataset derived from the biological sample S220; and promoting a therapy to the subject with the cutaneous condition based upon the characterization and the therapy model S230 (0136).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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/J.R.S/ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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