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 .
Amendment Entered
In response to the amendment filed on September 26th, 2025, amended claims 1-7 are entered. Claims 8-21 remain withdrawn, and Claims 1-7 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the abstract objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pg. 12 of the Reply, Applicant argues that the amended method cannot be performed in the human mind and therefore, does not recite a mental process. Examiner respectfully disagrees. Although the Applicant has amended to add a “learning unit”, “input unit”, “processing unit”, and “output unit”, the claimed “input unit” and “output unit” are categorized as data-gathering and data-outputting. Mere data-gathering and data-outputting is recognized by the court as insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g). Regarding the “learning unit” and “processing unit”, the claims simply recite mental processes performed on a computer control system. The “Federal Circuit has explained, ‘[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.’ Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015).” MPEP 2106.04(a)(2) III. Thus, the use of one or more “circuits” in the method claims and a processor and medium in the apparatus claim does not prevent identification of the abstract idea as a mental process. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps.
Furthermore, as noted below, the claims fall under the mathematical concepts group and/or the mental processes group. “A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
At Pgs. 12-13 of the Reply, Applicant argues that the amended claims recite additional elements that integrate the alleged judicial exception (which Applicant does not concede) into a practical application. Examiner respectfully disagrees. Once again, the Examiner would like to clarify that the step of “inputting” is determined to be part of extra-solution activity, in the form of data-gathering. Mere data-gathering is recognized by the court as insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g).
Furthermore, regarding the step of “determining…by the learning unit”, the claimed invention is merely using the computer as a tool to implement the process, particularly one that a clinician could complete if given the same data. The data is not being used for doing anything after the determination; therefore, the data is not practically applied. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III.
At Pgs. 13-14 of the Reply, Applicant argues that the claims as a whole add "significantly more" to the alleged judicial exception because they include a combination of elements that are not well-understood, not routine, and/or not conventional. Examiner respectfully disagrees. The claimed additional elements are: “computer”, “learning unit”, “input unit”, “processing unit”, and “output unit”. Given their broadest, reasonable interpretations, the additional elements are either generic computer components for performing generic computer functions or categorized as extra-solution activity, in the form of data-gathering. There is nothing special about these elements, as there are no limitations regarding specialized hardware for these structures. These claim limitations merely utilize machine learning as a means to calculate an otherwise abstract process, which is not significantly more.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1 recites “determine relationship” in line 6, but should read either “determine a relationship” or “determine relationships”
Claim 1 recites “the environmental factor information” in line 10, but should read “the at least one environmental factor information”
Claim 5 recites “smoking habit” in line 3, but should read “smoking habits”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“input unit” in Claim 1: [0053] of the Applicant’s Specification discloses wherein the input unit 12 includes an interface, wherein the interface may be connected to an operating unit such as a keyboard or mouse, a communication unit, and an external memory unit such as a CD-ROM, DVD-ROM, BD-ROM or memory stick
“learning unit” in Claims 1-4 and 6-7: [0012] of the Applicant’s Specification discloses wherein the learning unit 13 is in the information processing device 10, but the learning unit 13 may instead be in an external learning device 30 that is connected with the information processing device10 via a communication unit, forming the system 20 overall (Fig. 1B). The learning unit13 that includes the created learning model may also be relocated to another information processing device. The connection between the external learning device 30 and information processing device 10 may be a wired or wireless connection
“output unit” in Claims 3-4: [0054] of the Applicant’s Specification discloses wherein the output unit 15 includes an interface, wherein the output unit may be output means such as a display device with a liquid crystal display that directly displays the results of the learning system, or a printer, or it may be a communication unit for output to an external memory unit or output to a network
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-5 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 3 recites “determining the skin condition as information relating to the skin condition” in lines 3-4. It is unclear as to what this limitation entails as it is unclear what the “information” is referring to, and how exactly it is related to the determination. Clarification is requested.
Claim 3 recites the limitation "the transition" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “outputs the graph as the skin condition” in line 7. It is unclear as to whether this limitation is meant to be continued, or if the outputted graph is meant to represent the skin condition. Clarification is requested.
Claim 4 recites “a formula using age” in line 2. It is unclear as to whether this is referring to the previously referenced “formula using age” in line 3 of Claim 3, or a separate element.
Claim 4 recites “a graph” in line 4. It is unclear as to whether this is referring to the previously referenced “graph” in line 5 of Claim 3, or a separate element.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-7 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-7 recites a series of steps or acts for evaluating skin. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-7 recites at least one step or instruction for determining skin condition, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Specifically, Claim 1 recites:
A skin evaluating method executed by a computer comprising an input unit and a learning unit, comprising:
inputting single nucleotide polymorphism (SNP) information of a subject and environmental factor information via the input unit, into the learning unit; and
determining the subject's skin condition by the learning unit,
wherein the learning unit has been trained to determine relationship between skin conditions and information comprising individual SNP information and at least one environmental factor information selected from the group consisting of age, body height, body weight, body mass index (BMI), ultraviolet exposure information, and smoking information, and
wherein the SNP information of the subject and the environmental factor information are weighted for contribution to the skin condition, to determine the skin condition.
The claimed steps of weighting and determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. Accordingly, each of Claims 1-7 recites an abstract idea.
Further, dependent Claims 2-7 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 1 (and its respective dependent Claims 2-7) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1) either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “a computer comprising an input unit and a learning unit” as recited in independent Claim 1 and “processing unit” and “output unit” in dependent Claims 3-4, which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because the limitations amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and its respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by the computer. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and its respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and its respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-7 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons. These claims require the additional elements of: “a computer comprising an input unit and a learning unit” as recited in independent Claim 1 and “processing unit” and “output unit” in dependent Claims 3-4.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Accordingly, in light of Applicant’s specification, the claimed term “computer” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the method. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the invention because it describes additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-7 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 1-7 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-7 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-7 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-7 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-7 are not patent eligible and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Esposito (WO 2016/005793A1; cited by Applicant; previously cited) in view of Hosseini (U.S. Publication No. 2018/0260514; cited by Applicant).
Regarding Claim 1, Esposito discloses a skin evaluating method inputting single nucleotide polymorphism (SNP) information of a subject (a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (SNP); b) assigning a score to the result of each determination of step a); Page 2 Lines 5-7; Claim 1) and environmental factor information (c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c); Page 2 Lines 8-10; Claim 1), determining relationship between skin conditions and information comprising individual SNP information and at least one environmental factor information selected from the group consisting of age, body height, body weight, body mass index (BMI), ultraviolet exposure information and smoking information, and wherein the SNP information of the subject and the environmental factor information are weighted for contribution to the skin condition (e) assigning a total score to the individual, as determined from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; Page 2 Lines 11-13; Claim 1), to determine the skin condition (non-limiting examples of such defects are localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging, skin sagging; Page 2 Lines 20-21; wherein the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging; Claim 2).
Esposito fails to disclose wherein the method is executed by a computer comprising an input unit and a learning unit, comprising inputting information via the input unit, into the learning unit and determining the subject's skin condition by the learning unit, wherein the learning unit has been trained to determine relationship between skin conditions and information.
In a similar technical field, Hosseini teaches predicting skin age based on the analysis of skin flora and lifestyle data (Abstract), comprising a computer (An exemplary analysis system, according to various aspects of the present invention, may be implemented in conjunction with a computer system, for example a conventional computer system comprising a processor and a random access memory, such as a remotely-accessible application server, network server, personal computer or workstation; [0067]) comprising an input unit and a learning unit, comprising inputting information via the input unit (The computer system also suitably includes additional memory devices or information storage systems, such as a mass storage system and a user interface, for example a conventional monitor, keyboard and tracking device; [0067]), into the learning unit (The software required for receiving, processing, and analyzing biomarker information may be implemented in a single device or implemented in a plurality of devices; [0068]) and determining the subject's skin condition by the learning unit, wherein the learning unit has been trained to determine relationship between skin conditions and information (A machine-learning approach was used to generate computational models that predict donor age as a function of donor parameters (e.g. gender, ethnicity, hours of sleep, hours of sun exposure) and microbiome features (population structure, predicted metagenome). To this end, a statistics-based evolutional algorithm using symbolic regression was used to search the space of mathematical equations to find a model that best fits the data provided, varying both the form and parameters of possible models. Two models were generated. The first used only population structure data for microbiome features, the second incorporated predicted metagenomes and models metabolome in addition to population structure. All the microbiome features, lifestyle information and parameters were collected from human subjects; [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the learning unit teachings of Hosseini into the invention of Esposito in order to use a learning model that best fits the data provided, varying both the form and parameters of possible models, to best utilize all the information collected from human subjects, such as microbiome features, lifestyle information and parameters (Hosseini [0029]).
Regarding Claim 2, Esposito discloses wherein the individual SNP information and the at least one environmental factor information are used as variables, and weights are assigned to each of the variables with respect to each of the other variables (The "level of well-being" of a person is determined by combining a number of genetic and non-genetic indicators (scores), which represent: genetic data of each individual polymorphism; grouping of polymorphisms by areas (biological process/area of interest); determination of the weight of the polymorphisms of an area; determination of the weight in each area of the panel; assignation of history-taking questions to the areas of the defect of interest; determination of the weight of history-taking questions…the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging. The method of the invention was surprisingly found to afford cosmetic improvement and/or prevention of an aesthetic defect in an individual through an unique relationship of the presence of a SNP or a combination of SNPs to the administration of one or more biologically active substances; Page 5 Line 17 – Page 9 Line 12).
Esposito fails to specifically disclose wherein the learning unit comprises a learning model, wherein: the individual SNP information and the at least one environmental factor information are used as explanatory variables, measured values of the skin condition are used as objective variables, and the learning model is trained by multiple regression analysis to assign weights to each of the explanatory variables with respect to each of the objective variables.
In a similar technical field, Hosseini teaches predicting skin age based on the analysis of skin flora and lifestyle data (Abstract), wherein the learning unit comprises a learning model, wherein: the individual SNP information and the at least one environmental factor information are used as explanatory variables, measured values of the skin condition are used as objective variables, and the learning model is trained by multiple regression analysis (A machine-learning approach was used to generate computational models that predict donor age as a function of donor parameters (e.g. gender, ethnicity, hours of sleep, hours of sun exposure) and microbiome features (population structure, predicted metagenome). To this end, a statistics-based evolutional algorithm using symbolic regression was used to search the space of mathematical equations to find a model that best fits the data provided, varying both the form and parameters of possible models; [0029]) to assign weights to each of the explanatory variables with respect to each of the objective variables (Computational models were validated in one of two ways. The first validation method, the correlation between predicted and actual donor age was considered (FIG. 2). Here, the mixed model (Pearson Correlation Coefficient=0.81) outperformed the taxa-only model (Pearson Correlation Coefficient=0.72). While both predictions are strong, the mixed model has the advantage of not only being more accurate, but also the mixed model has the capacity to provide greater insight into the molecular mechanisms than link skin microbiome with skin age. In the second validation method, we predicted the effects of reduced sleep, increasing sun exposure, and use of antibiotics of skin “age” (FIG. 3). As expected, these parameters has a negative effect of predicted skin age. As predicted from computational model, every extra hour of lost sleep “ages” skin ˜0.98 years, every extra hour of sun “ages” skin ˜0.46 years, and the use of antibiotics “ages” skin ˜0.54 years…a Baysian Network (BN) model is generated for donor parameters and microbiome features to identify the potential causal links between them; [0031-0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the learning unit teachings of Hosseini into the invention of Esposito in order to use a model that best fits the data provided, varying both the form and parameters of possible models, to best utilize all the information collected from human subjects, such as microbiome features, lifestyle information and parameters (Hosseini [0029]).
Regarding Claim 3, Esposito discloses a formula using age as a variable, in addition to determining the skin condition as information relating to the skin condition (associated with questions about: Age; Page 11 Lines 10-11; Page 12 Lines 23-24; Page 15 Lines 3-6; Page 19 Lines 23-24; Page 20 Lines 8-10; Page 21 Lines 2-3; Page 21 Lines 15-16; Page 23 Lines 11-12; Page 24 Lines 4-5; Page 25 Lines 2-20).
Esposito fails to disclose wherein the computer further includes a processing unit and an output unit, and wherein the processing unit generates a graph showing the transition of the skin condition with respect to the age based on the formula and the output unit outputs the graph as the subject's skin condition.
In a similar technical field, Hosseini teaches predicting skin age based on the analysis of skin flora and lifestyle data (Abstract), wherein the computer further includes a processing unit (An exemplary analysis system, according to various aspects of the present invention, may be implemented in conjunction with a computer system, for example a conventional computer system comprising a processor and a random access memory, such as a remotely-accessible application server, network server, personal computer or workstation; [0067]) and an output unit (The computer system also suitably includes additional memory devices or information storage systems, such as a mass storage system and a user interface, for example a conventional monitor, keyboard and tracking device; [0067]), and wherein the processing unit generates a graph showing the transition of the skin condition with respect to the age based on the formula and the output unit outputs the graph as the subject's skin condition (FIG. 5 is a series of graphical representations generated using a random forest model built to predict biological age from skin microbiome alone (left panel) or from a combination of skin microbiome, plus metadata collected from individuals (right panel); [0019]; Accordingly, in one aspect, the invention proposes a model that can predict skin age from skin microbiome composition. The model has been built using a random forest approach that can take the microbiome composition as the only input (FIG. 5, left panel) with a R-squared value of 0.89. The model can be improved further by including other metadata including average hours of sun exposure, average hours of sleep, skin microbiome balance, skin microbiome diversity, and skin happiness. The new model which includes the microbiome composition and all above-mentioned metadata (FIG. 5, right panel) has an improved performance with a R-squared value of 0.93; [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the graph teachings of Hosseini into the invention of Esposito because the models demonstrate graphical representations generated to predict biological age from skin microbiome alone as well as a combination of skin microbiome, plus metadata collected from individuals, such as actual age (Hosseini [0019]).
Regarding Claim 4, Esposito discloses a formula using age (associated with questions about: Age; Page 11 Lines 10-11; Page 12 Lines 23-24; Page 15 Lines 3-6; Page 19 Lines 23-24; Page 20 Lines 8-10; Page 21 Lines 2-3; Page 21 Lines 15-16; Page 23 Lines 11-12; Page 24 Lines 4-5; Page 25 Lines 2-20) and behavioral factors (associated with questions about:…sun/protections; Page 22 Lines 2-5; associated with questions about…exposure to sun/sun lamps/use of protections: photoaging; Page 25 Lines 2-5; associated with questions about sun exposure; Page 19 Line 23 – Page 20 Line 3; associated with questions about…Smoke: venous-lymphatic stasis smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); Page 11 Lines 10-23; associated with questions about…Smoke: it increases inflammatory processes. Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); Page 13 Lines 14-23; associated with questions about…Smoke; Page 19 Lines 23-25; Page 21 Lines 2-4, 15-17; Page 22 Lines 2-3; associated with questions about…Smoke: due to the formation of oxidant molecules, it reduces collagen synthesis to 40%; Page 23 Lines 11-17; associated with questions about…Smoke: aging caused by external factors/lifestyle; Page 25 Lines 2-7) as variables, in addition to determining the skin condition as information relating to the skin condition (The "level of well-being" of a person is determined by combining a number of genetic and non-genetic indicators (scores), which represent: genetic data of each individual polymorphism; grouping of polymorphisms by areas (biological process/area of interest); determination of the weight of the polymorphisms of an area; determination of the weight in each area of the panel; assignation of history-taking questions to the areas of the defect of interest; determination of the weight of history-taking questions…the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging. The method of the invention was surprisingly found to afford cosmetic improvement and/or prevention of an aesthetic defect in an individual through an unique relationship of the presence of a SNP or a combination of SNPs to the administration of one or more biologically active substances; Page 5 Line 17 – Page 9 Line 12).
Esposito fails to disclose wherein the processing unit generates a graph showing the transition of the skin condition score with respect to the age, based on the formula using age and the behavioral factors as variables; and wherein the output unit issues an instruction to output the graph showing the transition of the skin condition with respect to the age as the subject's skin condition.
In a similar technical field, Hosseini teaches predicting skin age based on the analysis of skin flora and lifestyle data (Abstract), wherein the processing unit (An exemplary analysis system, according to various aspects of the present invention, may be implemented in conjunction with a computer system, for example a conventional computer system comprising a processor and a random access memory, such as a remotely-accessible application server, network server, personal computer or workstation; [0067]) generates a graph showing the transition of the skin condition score with respect to the age, based on the formula using age and the behavioral factors as variables (Figure 5); and wherein the output unit (The computer system also suitably includes additional memory devices or information storage systems, such as a mass storage system and a user interface, for example a conventional monitor, keyboard and tracking device; [0067]) issues an instruction to output the graph showing the transition of the skin condition with respect to the age as the subject's skin condition (FIG. 5 is a series of graphical representations generated using a random forest model built to predict biological age from skin microbiome alone (left panel) or from a combination of skin microbiome, plus metadata collected from individuals (right panel); [0019]; Accordingly, in one aspect, the invention proposes a model that can predict skin age from skin microbiome composition. The model has been built using a random forest approach that can take the microbiome composition as the only input (FIG. 5, left panel) with a R-squared value of 0.89. The model can be improved further by including other metadata including average hours of sun exposure, average hours of sleep, skin microbiome balance, skin microbiome diversity, and skin happiness. The new model which includes the microbiome composition and all above-mentioned metadata (FIG. 5, right panel) has an improved performance with a R-squared value of 0.93; [0035]).
Regarding Claim 5, Esposito discloses wherein the behavioral factors comprise ultraviolet protection measures (If the history of the patient is not completely positive, then the result suggests some changes to his/her lifestyle to improve his/her well-being…“lifestyle advice”…diet and lifestyle correction; Page 7 Line 22 – Page 9 Line 6; Table 1; - GPX: (glutathione peroxidase) is an enzymatic antioxidant…an optimal antioxidant barrier protects the skin from photoaging damages caused by UVA radiation, and can counteract free radical production and the resulting oxidative stress associated with environmental pollution, smoke, wrong diet; Page 24 Lines 19-23; associated with questions about:…sun/protections; Page 22 Lines 2-5; associated with questions about…exposure to sun/sun lamps/use of protections: photoaging; Page 25 Lines 2-5; associated with questions about sun exposure; Page 19 Line 23 – Page 20 Line 3) and smoking habit (associated with questions about…Smoke: venous-lymphatic stasis smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); Page 11 Lines 10-23; associated with questions about…Smoke: it increases inflammatory processes. Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); Page 13 Lines 14-23; associated with questions about…Smoke; Page 19 Lines 23-25; Page 21 Lines 2-4, 15-17; Page 22 Lines 2-3; associated with questions about…Smoke: due to the formation of oxidant molecules, it reduces collagen synthesis to 40%; Page 23 Lines 11-17; associated with questions about…Smoke: aging caused by external factors/lifestyle; Page 25 Lines 2-7).
Conclusion
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 CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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