DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1-4, 6-13, and 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
Claims 1-4, 6-13, and 15-18 are within the four statutory categories. However, as will be shown below, claims 1-4, 6-13, and 15-18 are nonetheless unpatentable under 35 U.S.C. 101.
Claims 1, 8, and 13 are representative of the inventive concept and recite:
Claim 1
A method for ranking a cells of interest, the method comprising:
identifying cells of interest of a subject;
analyzing, via an OMICS sequencer, each portion of the cells to produce a multi-marker OMICS analysis;
determining a rank for each of the cells for one or more selected characteristics based on application of the multi-marker OMICS analysis to an expression model for the one or more selected characteristics;
and executing, via a computing device, a next action based on the rank for each of the cells, the next action including one or more of:
determination of a correlation between each analyzed cell and the one or more selected characteristic,
recommendation of use of a selected product or agent, design of a personalized mixture or product,
and prescription of a selected product.
Claim 8
An apparatus for ranking a cells of interest, the apparatus comprising:
an analysis circuitry configured to:
obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells exhibiting one or more characteristics;
and a ranking circuitry configured to:
determine a rank for each of the cells for the one or more characteristics based on application of the multi-marker OMICS analysis to an expression model for the one or more characteristics,
determine cell enrichment for each analyzed cells based on the rank for each of the cells, and determine a recommended use suggestion of a selected product based on history of use on the cells and based on the cell enrichment for each analyzed cells.
Claim 13
A computer program product for ranking a cells of interest, the computer program product comprising a non-transitory machine-readable storage medium storing software instructions that, when executed, cause an apparatus to:
obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells comprising one or more of cells subjected to an external stimuli or cells exhibiting one or more of a plurality of selected cell characteristics;
and determine a rank for each of the cells for one or more selected characteristics based on application of the multi-marker OMICS analysis to an expression model for the one or more selected characteristics; and determine a recommended use suggestion of a selected product based on history of use on the cells and based on the rank for each of the cells for the one or more selected characteristics.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the
highlighted components can practically be performed by the human mind (in this case, the process of
identifying, analyzing, determining, and designing) or using pen and paper. Other than reciting generic computer components/functions such as “apparatus”, “analysis circuitry”, “ranking circuitry”, “computer program product”, and “machine-readable storage medium storing software instructions”, nothing in the claims precludes the highlighted portions from practically being performed in the mind. For example, in claim 1, but for the method language, the claim encompasses the user identifying a subject of interest, analyzing and ranking the data in order to be able to determine the next steps. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components/functions, then it falls within
“Mental Processes” grouping of abstract ideas. The recitation of generic computer components/functions of recommending also covers behavioral or interactions between people (i.e. a computer and user interface), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions), hence the claim falls under “Certain Methods of Organizing Human Activity”.
Dependent claims 2-4, 6-7, 9-12, and 15-18 recite additional subject matter which further narrows or defines the abstract idea embodied in the claims.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the claims
recite the following additional limitations:
Claim 1 recites “OMICS sequencer”, “model”
Claim 8 recites “OMICS sequencer”, “model”, “apparatus”, “analysis circuitry”, “ranking circuitry”, and “obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells exhibiting one or more characteristics”
Claim 13 recites “OMICS sequencer”, “model”, “computer program product”, “machine-readable storage medium storing software instructions”, and “obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells comprising one or more of cells subjected to an external stimuli or cells exhibiting one or more of a plurality of selected cell characteristics”
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more limitations which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations of
Obtaining, attaching, inputting, and outputting data are recited as being performed by a
“model”, “apparatus”, “analysis circuitry”, “ranking circuitry”, “computer program product”, and “machine-readable storage medium storing software instructions”. These limitations
are recited at a high level of generality and amounts to no more than mere instructions to apply
the exception using a generic computer.
Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation of “OMICS sequencer”, “obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells exhibiting one or more characteristics”, and ““obtain a multi-marker OMICS analysis of a plurality of cells, each of the plurality of cells comprising one or more of cells subjected to an external stimuli or cells exhibiting one or more of a plurality of selected cell characteristics”.
Dependent claim 4 recites user interface and displaying
Dependent claim 11 recites user interface
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more limitations which:
Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation user interface and displaying.
Dependent claims 2-3, 6-7, 9-10, 12, and 15-18 do not include any additional elements beyond those already recited in claims 1, 8, and 13 and dependent claims 4 and 11, hence do not integrate the aforementioned abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improve the functioning of a computer or machine learning model or improves any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
Claims 1, 8, and 13 do not include additional elements that are sufficient to amount to significantly more
than the judicial exception. As discussed above with respect to discussion of integration of the abstract
idea into a practical application, the additional elements: A method in claim 1; amount to no more
than mere instructions to apply an exception to the abstract idea. Additionally, the additional
limitations, other than the abstract idea per se, amount to no more than limitations which amount to
elements that have been recognized as well-understood, routine, and conventional activity in particular
fields as demonstrated by the recitation of an additional element such as:
OMICS sequencer, which is a high-throughput machine used to analyze a complete set of molecules in a biological sample (Para 0185, Kengo(US 20190033293 A1) discloses: “The sequencing may employ a conventional sequencer based on the Sanger method and preferably employs a next-generation sequencer in consideration of analysis efficiency.”) in a manner that would be well-understood, routine, and conventional.
Obtaining data which is the process of a device or system acquiring information from another source (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)) in a manner that would be well-understood, routine, and conventional.
Display refers to an electronic device for a visual presentation of data (Para 0003, Audfray(US 20240420718 A1) discloses: “For example, conventional displays (e.g., 2D display screens) and audio systems (e.g., fixed speakers) may be unable to realize a virtual environment in ways that create a compelling, realistic, and immersive experience.”) in a manner that would be well-understood, routine, and conventional.
User interface which refers to the means by which the user and a computer system interact (Para 0005, Phillips(US 20230403242 A1) discloses: “One of the goals of the industry is to replace and/or supplement conventional user interfaces such as keyboards, displays, joysticks, handheld gaming controllers, etc. with new paradigms for human-machine communication and collaboration, thereby facilitate a major shift in user engagement in AR/VR-based gamespaces for providing a richer and more immersive player experience.”) in a manner that would be well-understood, routine, and conventional.
Dependent claims 2-3, 6-7, 9-10, 12, and 15-18 do not include any additional elements beyond those already recited in independent claims 1, 8, and 13. Therefore, they are not deemed to be significantly more than the abstract idea because, as stated above, the limitations of the aforementioned dependent claims amount to no more than generally linking the abstract idea to a particular technological environment or field of use, and/or do not recite and additional elements not already recited in independent claims 1, 8, and 13 hence do not amount to “significantly more” than the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the
combination of elements improves the functioning of a computer or improves any other technology,
and their collective function merely provide conventional computer implementation.
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.
Claims 1, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Stumpe(US20220261668A1) in view of Moon(US20110033842A1).
Claim 1
Stumpe discloses:
A method for ranking a cells of interest, the method comprising: (Para 0030 Moon discloses identifying cells of interest); analyzing, via an OMICS sequencer(Para 0139, Stumpe discloses calls from sequencing data, which can be considered analysis produced by an OMICS sequencer), each portion of the cells to produce a multi-marker OMICS analysis(Para 0005, Stumpe discloses biomarker identification from sequencing results from a tumor(cells)); determining a rank(Para 0194, Stumpe discloses ranking for potential biomarkers by identified by multi-omic data streams) for each of the cells for one or more selected characteristics(Para 0147, Stumpe discloses molecular data features) based on application of the multi-marker OMICS analysis to an expression model(Para 0149, Stumpe discloses applying machine learning models for inductive reasoning approaches and generating values for features) for the one or more selected characteristics; executing, via a computing device, determining a next action based on the rank for each of the cells(Figure 1, Stumpe discloses an actionable report as a product of AI filtering and ranking), the next action including one or more of: determination of a correlation between each analyzed cell and the one or more selected characteristic(Para 0005, Stumpe discloses correlation calculations), recommendation of use of a selected product or agent, design of a personalized mixture or product, and prescription of a selected product(Para 0141, Stumpe discloses recommender system for treatment).
Stumpe does not explicitly disclose:
identifying cells of interest of a subject
Moon discloses:
identifying cells of interest of a subject(Para 0030 Moon discloses identifying cells of interest)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add identifying cells of interest, as taught by Moon. One of ordinary skill would have been so motivated to provide a means to determine a method that allows for customized recommendations, but in this case, for a skin sampling kit which stores nucleic acids (Para 0028, Moon discloses: “However, the existing test methods are restricted in fundamentally and objectively evaluating all the individuals skins. Further, there is no scientifically standardized test method as yet. The most objective test method available now is one monitoring the change of microstructure of the skin following biopsy. However, this method is invasive, and the physiological, functional or biochemical changes cannot be monitored. Therefore, a new test method capable of accurately and objectively evaluating the human skin condition, thereby being of help in classifying the skin type, selecting personalized cosmetics or cosmeceuticals, and evaluating the effect after application thereof.”).
Claim 3
Stumpe discloses:
The method of claim 1, wherein the OMICS sequencer comprises one of a genomics sequencer(Para 0138, Stumpe discloses genomics sequencing, which is performed by a genomics sequencer), transcriptomics sequencer(Para 0138, Stumpe discloses transcriptomics sequencing, which is performed by a transcriptomics sequencer), proteomics sequencer, epigenomics sequencer, lipidomics sequencer, or metabolomics sequencer; wherein the multi-marker OMICS analysis comprises one of transcriptomics data(Para 0138, Stumpe discloses transcriptomics sequencing, which produces transcriptomics data), proteomics data, epigenomics data, genomics data(Para 0138, Stumpe discloses genomics sequencing, which produces genomic data), lipidomics data, or metabolomics data; wherein the cells of interest comprise one or more of skin cells, skin tissue, hair cells, scalp cells, scalp tissue, reconstructed tissue, or ex vivo skin; and wherein the one or more cells of interest are collected from one or more subjects of one or more different ages(Para 0155, Stumpe discloses date of birth), one or more difference races, one or more genders(Para 0155, Stumpe discloses gender).
Stumpe does not explicitly disclose:
proteomics data, epigenomics data, lipidomics data, or metabolomics data; wherein the cells of interest comprise one or more of skin cells, skin tissue, hair cells, scalp cells, scalp tissue, reconstructed tissue, or ex vivo skin
*Not all elements are required due to “one of” indication in claim
Moon discloses:
skin cells(Para 0041, Moon discloses skin cells)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add skin cells, as taught by Moon. One of ordinary skill would have been so motivated to provide a means identify sample types of interest to study the impact of stimuli, but in this case, for a skin sampling kit which stores nucleic acids (Para 0028, Moon discloses: “However, the existing test methods are restricted in fundamentally and objectively evaluating all the individuals skins. Further, there is no scientifically standardized test method as yet. The most objective test method available now is one monitoring the change of microstructure of the skin following biopsy. However, this method is invasive, and the physiological, functional or biochemical changes cannot be monitored. Therefore, a new test method capable of accurately and objectively evaluating the human skin condition, thereby being of help in classifying the skin type, selecting personalized cosmetics or cosmeceuticals, and evaluating the effect after application thereof.”).
Claim 6
Stumpe does not explicitly disclose:
The method of claim 1, wherein the one or more selected characteristics comprise one or more of differentiation, keratinization, immune response, angiogenesis, melanogenesis, autophagy/mitophagy, senescence, longevity, hair growth and health, microbiome, DNA repair, epigenetics, proteostasis, intercellular communication, scalp health, nutrient signaling, inflammation, wound healing response, oxidative stress response, proliferation, stem cell renewal, clonogenicity, or skin barrier health.
Moon discloses:
The method of claim 1, wherein the one or more selected characteristics comprise one or more of differentiation, keratinization, immune response(Para 0451, Moon discloses immunity), angiogenesis, melanogenesis(Para 0451, Moon discloses melanogenesis), autophagy/mitophagy, senescence, longevity, hair growth and health, microbiome, DNA repair, epigenetics, proteostasis, intercellular communication, scalp health, nutrient signaling, inflammation(Para 0451, Moon discloses inflammation), wound healing response, oxidative stress response, proliferation(Para 0451, Moon discloses proliferation), stem cell renewal, clonogenicity, or skin barrier health.
*Not all elements are required due to “one or more” indication in claim
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add immune response, inflammation, and proliferation, as taught by Moon. One of ordinary skill would have been so motivated to provide a means to specify what characteristics would be studied in order to be able to recommend proper treatment and product recommendations, but in this case, for a skin sampling kit which stores nucleic acids (Para 0028, Moon discloses: “However, the existing test methods are restricted in fundamentally and objectively evaluating all the individuals skins. Further, there is no scientifically standardized test method as yet. The most objective test method available now is one monitoring the change of microstructure of the skin following biopsy. However, this method is invasive, and the physiological, functional or biochemical changes cannot be monitored. Therefore, a new test method capable of accurately and objectively evaluating the human skin condition, thereby being of help in classifying the skin type, selecting personalized cosmetics or cosmeceuticals, and evaluating the effect after application thereof.”).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stumpe(US20220261668A1), Moon(US20110033842A1), Fores-Martos(Forés-Martos, J.; Forte, A.; García-Martínez, J.; Pérez-Ortín, J.E. A Trans-Omics Comparison Reveals Common Gene Expression Strategies in Four Model Organisms and Exposes Similarities and Differences between Them. Cells 2021, 10, 334.), and Kho(US20170208041A1).
Claim 2
Stumpe discloses:
(Para 0196, Stumpe discloses feature incidence) in the array of values;
Stumpe and Moon do not explicitly disclose:
Array of values
Average
score
Fores-Martos discloses:
array of values(Page 3, Fores-Martos discloses creation of array values)
average(Page 3, Fores-Martos discloses averaging results)
score(Page 5, Fores-Martos discloses a ranking z -score)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add array of values, average, and score, as taught by Fores-Martos. One of ordinary skill would have been so motivated to provide a means to normalize and calculate data to enable ranking, but in this case, t of various stimuli to cells to mimic actual stimuli experienced by the subject, which would better enable potential treatment recommendations, but in this case, for a trans-omics comparison used for common gene expression strategies(Page 1, Fores-Martos discloses: “The ultimate goal of gene expression regulation is on the protein level. However, because the amounts of mRNAs and proteins are controlled by their synthesis and degradation rates, the cellular amount of a given protein can be attained by following different strategies”).
Fores-Martos does not explicitly disclose: removing identifiers, re-assigning identifiers
Kho discloses:
removing identifiers(Figure 1, Kho discloses de-identification of data)
re-assigning the identifiers(Para 0011, Kho discloses adding identifiers)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add removing and reassigning identifiers, as taught by Kho. One of ordinary skill would have been so motivated to provide a means to anonymize data, to protect identity, but in this case, but in this case, t of various stimuli to cells to mimic actual stimuli experienced by the subject, which would better enable potential treatment recommendations, but in this case, for a system for enabling data deidentification and anonymous data linkage(Para 0002, Kho discloses: “Balancing patient privacy protections with efforts to advance data-driven medical and/or clinical research is an ongoing challenge for many healthcare organizations and the larger health care industry.”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stumpe(US20220261668A1), Moon(US20110033842A1), and Koller(US20210366577A1).
Claim 7
Stumpe and Moon do not explicitly disclose:
The method of claim 1, further comprising: prior to analysis of each portion of the cells, iteratively applying different stimuli to different portion of the cells; wherein the stimuli induces a pathological state for each different portion of cells; and wherein the stimuli comprises one or more of exposure to sunlight, exposure to ultraviolet light, exposure to environmental pollutants, exposure to chemicals, exposure to antibodies, exposure to vesicles, exposure to genetic stimuli, exposure to a selected temperature, exposure to a selected pressure, or a selected time.
Koller discloses:
The method of claim 1, further comprising: prior to analysis of each portion of the cells, iteratively applying different stimuli to different portion of the cells; wherein the stimuli induces a pathological state for each different portion of cells(Para 0014, Koller discloses providing an agent of environmental condition that the promotes the cell into a diseased state); and wherein the stimuli comprises one or more of exposure to sunlight, exposure to ultraviolet light, exposure to environmental pollutants, exposure to chemicals(Para 0015, Koller discloses chemical agents), exposure to antibodies, exposure to vesicles, exposure to genetic stimuli(Para 0015, Koller discloses gene editing agent), exposure to a selected temperature(Para 0015, Koller discloses temperature exposure), exposure to a selected pressure(Para 0015, Koller discloses pressure), or a selected time.
*Not all elements are required due to “one or more” indication in claim
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add stimuli, chemicals, genetic stimuli, temperature, and pressure, as taught by Koller. One of ordinary skill would have been so motivated to provide a means to test the impact of various stimuli to cells to mimic actual stimuli experienced by the subject, which would better enable potential treatment recommendations, but in this case, for predicting disease outcomes using machine learning models(Para 0002, Koller discloses: “The resources needed to identify and develop new therapeutics that would be effective for different patient populations remains difficult and expensive, thereby leaving many patients with significant unmet needs.”).
Claims 4, 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Stumpe(US20220261668A1), Moon(US20110033842A1), and Harley(US20210319907A1).
Claim 4
Stumpe discloses:
The method of claim 1, further comprising: in response to determination of the rank for each of the cells: (Para 0005, Stumpe discloses correlation calculations).
Stumpe and Moon do not explicitly disclose:
generating a user interface each of the cells based on ranking; and displaying data
Harley discloses:
generating a user interface(Para 0011, Harley discloses a user interface); displaying(Para 0191, Harley discloses displaying data) each of the cells based on ranking; and displaying data(Para 0191, Harley discloses displaying data)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add user interface and displaying data, as taught by Harley. One of ordinary skill would have been so motivated to provide a means to visualize data, but in this case, for a multi-omic search engine (Para 0006, Harley discloses: “Moreover, the data is usually inaccessible for interrogation at many levels of the bioinformatics pipeline. Data in the portals is often pre-filtered, not integrated, and usually not ranked. In addition, most portals do not host individual user data. The few that allow users to upload their own data typically do not provide means to integrate the user's data with the portal data, or to derive advanced cancer analytics and make this data accessible and ranked in terms of clinical actionability, pathogenicity, feature weight, or frequency.”)
Claim 8
Stumpe discloses:
An apparatus for ranking a cells of interest, the apparatus comprising: an analysis circuitry configured to: obtain a multi-marker OMICS analysis(Para 0139, Stumpe discloses calls from sequencing data, which can be considered analysis produced by an OMICS sequencer) of a plurality of cells(Para 0163, Stumpe discloses cells), each of the plurality of cells exhibiting one or more characteristics(Para 0147, Stumpe discloses molecular data features); and a ranking circuitry configured to: determine a rank(Para 0194, Stumpe discloses ranking for potential biomarkers by identified by multi-omic data streams) for each of the cells for the one or more selected characteristics based on application of the multi-marker OMICS analysis to an expression model(Para 0149, Stumpe discloses applying machine learning models for inductive reasoning approaches and generating values for features) for the one or more selected characteristics, and determine
Stumpe and Moon do not explicitly disclose:
cell enrichment
Harley discloses:
cell enrichment(Para 0135, Harley discloses pathway enrichment analysis)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add cell enrichment, as taught by Harley. One of ordinary skill would have been so motivated to provide a means to provide a recommendation that analyzes enrichment, but in this case, for a multi-omic search engine (Para 0006, Harley discloses: “Moreover, the data is usually inaccessible for interrogation at many levels of the bioinformatics pipeline. Data in the portals is often pre-filtered, not integrated, and usually not ranked. In addition, most portals do not host individual user data. The few that allow users to upload their own data typically do not provide means to integrate the user's data with the portal data, or to derive advanced cancer analytics and make this data accessible and ranked in terms of clinical actionability, pathogenicity, feature weight, or frequency.”)
Claim 9
Claim 9 recites similar limitations as claim 1. See claim 1 analysis.
Claim 10
Claim 10 recites similar limitations as claim 1. See claim 1 analysis.
Claim 11
Claim 11 recites similar limitations as claim 4. See claim 4 analysis
Claim 12
Claim 12 recites similar limitations as claim 5. See claim 5 analysis
Claim 13
Claim 13 recites similar limitations as claim 8. See claim 8 analysis
Claim 14
Claim 11 recites similar limitations as claim 5. See claim 5 analysis
Claim 15
Stumpe and Moon do not explicitly disclose:
The computer program product of claim 14, wherein the multi-marker OMICS analysis comprises one or more of a heatmap, a cell or sample by OMICS matrix, or a cell type distribution.
Harley discloses:
The computer program product of claim 14, wherein the multi-marker OMICS analysis comprises one or more of a heatmap(Para 0109, Harley discloses a heatmap), a cell or sample by OMICS matrix, or a cell type distribution.
*Not all elements are required due to “one or more” indication in claim
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to heatmap, as taught by Harley. One of ordinary skill would have been so motivated to provide a means to provide a means to view comprehensive data, but in this case, for a multi-omic search engine (Para 0006, Harley discloses: “Moreover, the data is usually inaccessible for interrogation at many levels of the bioinformatics pipeline. Data in the portals is often pre-filtered, not integrated, and usually not ranked. In addition, most portals do not host individual user data. The few that allow users to upload their own data typically do not provide means to integrate the user's data with the portal data, or to derive advanced cancer analytics and make this data accessible and ranked in terms of clinical actionability, pathogenicity, feature weight, or frequency.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stumpe(US20220261668A1), Moon(US20110033842A1), and Knoell(US20050240085A1).
Claim 16
Stumpe and Moon do not explicitly disclose:
The method of claim 1, wherein recommendation of use of a selected product or agent, design of a personalized mixture or product, and prescription of a selected product are further based on history of use of a product on the cells of interest.
Knoell discloses:
The method of claim 1, wherein recommendation of use of a selected product or agent, design of a personalized mixture or product, and prescription of a selected product are further based on history of use of a product on the cells of interest(Para 0051, Knoell discloses for a formulation such as a skin cream, prior cosmetic use may be considered as data).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the artificial intelligence engine of Stumpe to add recommendation of use of a selected product or agent, design of a personalized mixture or product, and prescription of a selected product are further based on history of use of a product on the cells of interest, as taught by Knoell. One of ordinary skill would have been so motivated to provide a means to provide an analytical means to provide customized recommendations, but in this case, for balanced care product customization(Para 0029, Knoell discloses: “methods exist by which intensive one-on-one treatment or consulting is available with a knowledgeable party. Such consultations however are limited by the lack of a repeatable process by which knowledge and information is gathered to continually improve the quality of the consultations or diagnosis.”).
Subject Matter Free of Prior Art
Claims 17 and 18 distinguish over prior art for the following reasons:
The primary reason for the indication of subject matter free of prior art is the
inclusion of the following limitations in the combination as recited and are not found
in the closest available prior art of record:
Claim 17:
“The apparatus of claim 8, wherein the ranking circuitry is further configured to design of a personalized mixture or product based on the rank for each of the cells”
Claim 18:
“The apparatus of claim 8, wherein the ranking circuitry is further configured to prescribe a selected product based on the rank for each of the cells.”
The closest available prior art of record as follows:
Moon(US20110033842A1) discloses a skin gene card for genetic testing used for personalized skincare, but does not fairly disclose or suggest the aforementioned configuration for the claimed invention.
Knoell(US20050240085A1) discloses balanced care product customization, but does not fairly disclose or suggest the aforementioned configuration for the claimed invention.
Berry(US20030216941A1) discloses a method for determining a customized cosmetic product, but does not fairly disclose or suggest the aforementioned configuration for the claimed invention.
Based on the evidence presented above, none of the closest available prior art of record fairly
discloses or suggests the claimed invention. For this reason, claims 17 and 18 would be found to be
subject matter free of prior art.
Response to Arguments
35 U.S.C. 101
Regarding the assertion that claims 1, 8, and 13 cannot be performed in the human mind (specifically referring to analyzing via OMICS sequencer).(Pages 6-7)
Applicant's arguments filed have been fully considered but they are not persuasive. The analyzing indicated in the claim as recited is very broad and non-specific, therefore can be considered abstract. The OMICS sequencer is added to the claim generally and would be considered insignificant extra-solution activity.
Regarding the assertion that the claims are a practical application and the features of the claims clearly improve the output of the OMICS sequencers and therefore transform the claims into patent-eligible subject matter (Pages 7-9).
Applicant's arguments filed have been fully considered but they are not persuasive. The claims aim to define the inputs and outputs of the sequencer and rely on generic computers and computer functions to perform functions that are considered abstract.
Regarding the assertion that the claims amount to significantly more than an abstract idea (Pages 9-11).
Applicant's arguments filed have been fully considered but they are not persuasive.
35 U.S.C. 102/103
Applicant’s arguments with respect to claim(s) 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.
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 SHERYL GOPAL PATEL whose telephone number is (703)756-1990. The examiner can normally be reached Monday - Friday 5:30am to 2:30pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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