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 .
Response to Amendment
In response to amendments, filed December 2, 2025, claims 4, 13, and 16-18 have been amended. No additional claims have been cancelled. No claims have been added. Claims 1-2, 4, 6-10, 12-13, and 15-18 are pending.
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed February 25, 2026, with respect to the claim objections have been fully considered and are persuasive in view of the amendments. The claim objections have been withdrawn.
Applicant’s arguments with respect to the prior art claims have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Hershey (US 20210204919 A1) and Takata (US 20180340866 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
The explicit disclosure of evaluating the “peel strength” per the present application (when peeling off the tape and release paper) is not required to meet the claim limitations. Absent persuasive evidence to the contrary, the tape and method applied as prior art (Hershey/Takata) have the same structure as the claimed invention -- base material with adhesive per Hershey [0038, 0040], rubber adhesive per Takata [0052] (also discloses cotton base material with natural rubber adhesive not claimed in present invention but referred to in arguments pertaining to unexpected results), and therefore, inherently perform with the same results under the same conditions with respect to the adhesive and peel strengths claimed. Hershey’s [0040] “In some embodiments, the water-soluble adhesive comprises a water-soluble polymeric adhesive. … In some embodiments, the adhesive layer does not comprise a rubber adhesive” means other embodiments may comprise a rubber adhesive, not that embodiments cannot comprise a rubber adhesive. None of the cited references teach away from the use of a rubber adhesive in specifying an inability to use a rubber adhesive.
Regarding applicants argument pertaining to the unexpected results shown in Table 1 of the present invention’s specification are not persuasive because applicant’s arguments are not commensurate in scope with the claim language, as the claim language does not require the specifics of the Example 1 -- use of cotton cloth as the base material and use of natural rubber as the adhesive layer – that yielded the unexpected results. Furthermore, Takata [0052] does disclose a cotton cloth base material with natural rubber adhesive.
Claim Rejections - 35 USC § 112
Claims 1-2, 8-10, 12-13, and 15-18 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.
In claims 1, 9, and 18, it appears applicant is aiming to claim the test methods, however, the testing steps are conditional (“when”) rather than positively recited. The scope of the claim is unclear. For purposes of examination, the test methods are not required. If the intent is to claim the described test methods of the adhesive tape, then the steps must be positively recited in a separate claim, as the specification does not disclose a method of actively testing an adhesive tape as part of the process of collecting a skin indigenous microorganism or evaluating a physical condition. By virtue of dependency, claims 2, 8, 10, 12-13, and 15-17 are also rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 4 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hershey (US 20210204919 A1).
Regarding claim 4, Hershey teaches a method of evaluating a physical condition of a subject (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”), the method comprising the step of:
determining a value of an abundance proportion of a skin indigenous microorganism on a skin surface of the subject among a skin microbial flora collected from the skin surface or a parameter based on the abundance proportion (Hershey: [0065] “microbial species diversity and abundance of microbes can be evaluated based on the microbial nucleic acids extracted from the first set of the biological materials;” [0073] “analysis from each set of the biological materials can be combined to determine a biological material profile of a target skin site from which the biological materials are collected”),
a correlation criterion of the abundance proportion or parameter with the physical condition being pre-established (Hershey: [0073] “reference biological material profile [e.g., a biological material profile obtained from subjects without the skin disease or disorder]”),
and then comparing the value with the correlation criterion (Hershey: [0073] “a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile (e.g., a biological material profile obtained from subjects without the skin disease or disorder)”),
wherein determining the value of the abundance proportion of the skin indigenous microorganism or the parameter is carried out based on a result of a genome analysis of DNA according to the method of claim 1 (Hershey: [0065] “microbial DNA may be extracted from the first set of the biological materials and analyzed by shotgun metagenomic sequencing. Shotgun metagenomic sequencing allows comprehensive sampling of all genes in all microorganisms present in a given sample. Thus, microbial species diversity and abundance of microbes can be evaluated based on the microbial nucleic acids extracted from the first set of the biological materials.”).
Regarding claim 6, Hershey teaches a method of presenting information to a subject (Hershey: [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”), the method comprising the steps of:
evaluating a physical condition of the subject by the method according to claim 4 (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”),
and presenting, when the physical condition is evaluated to be outside a target condition (Hershey: [0073] “a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile”), information registered in a data base, including an ingredient capable of directing the value of the abundance proportion or the parameter toward a numerical range of the abundance proportion or parameter obtained based on the correlation criterion when the physical condition is within the target condition (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen;” [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development. The methods described herein can also be used to identify clinically relevant biomarkers of disease—to aid diagnosis, disease severity, predict natural history, or to help select the best treatment strategy”).
Regarding claim 7, Hershey teaches a method of presenting information to a subject (Hershey: [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”), the method comprising the steps of:
evaluating a physical condition of the subject by the method of claim 4 (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”);
presenting, when the physical condition is evaluated to be outside a target condition, information registered in a data base, including an ingredient capable of directing the value of the abundance proportion or the parameter toward a numerical range of the abundance proportion or parameter obtained based on the correlation criterion when the physical condition is within the target condition (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen… a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile;” [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development.”),
re-evaluating the physical condition of the subject by the method of claim 4 after consumption of the ingredient, and updating the information based on the extent of improvement in the physical condition after the re-evaluation (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen;” [0109] “aid diagnosis and guide selection of the most optimal treatment;” [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”).
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.
Claim(s) 1-2, 8-10, 12-13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey (US 20210204919 A1) in view of Takata (US 20180340866 A1).
Regarding claim 1, Hershey teaches a method of collecting a skin indigenous microorganism on a skin surface ([0035] “methods for collecting biological materials from the skin of a subject;” [0057] “Cells may comprise microbial cells (e.g., but not limited to bacteria, fungus, yeasts, and/or viruses) from the skin surface of the subjects and/or host skin cells (e.g., keratinocytes and other skin cells) of the subject.” Fig. 5), the method comprising the steps of:
providing an adhesive tape ([0038] “adhesive tapes”), the adhesive tape comprising: a base material; and an adhesive layer provided on at least a portion of a surface of the base material, wherein the adhesive layer contains an adhesive ([0038] “Adhesive tapes in each set (e.g., first set, second set, and/or third set) used for collecting skin samples in any of the methods described herein are water-soluble adhesive tapes comprising a water-soluble adhesive attached to a solid substrate, which may also be water soluble.” [0040] “In some embodiments, the water-soluble adhesive layer comprises a water-soluble acrylic polymer (e.g., but not limited to acrylic acid polymer or acrylic acid ester/acrylic acid copolymer). In some embodiments, the water-soluble adhesive comprises a pressure-sensitive polymeric adhesive. In some embodiments, the adhesive layer does not comprise a rubber adhesive.” [0041] “The water-soluble adhesive layer is attached to a solid substrate, e.g., a solid support”).
While one could conclude that some embodiment of Hershey includes a rubber adhesive based on “In some embodiments, the adhesive layer does not comprise a rubber adhesive” (Hershey [0040]), to provide positive recitation of this feature, Takata is introduced, teaching a stratum corneum collecting device for collecting the stratum corneum of skin and detecting a specific component from the stratum corneum of the skin.
Takata discloses providing an adhesive tape, the adhesive tape comprising: a base material; and an adhesive layer provided on at least a portion of a surface of the base material, wherein the adhesive layer contains an adhesive and the adhesive contains a rubber adhesive ([0052] “The adhesive layer 16 is formed by … attaching a substrate in the form of a sheet, which is coated an adhesive agent, to the outer peripheral surface of the columnar portion 15. Specific examples of the adhesive agent include natural rubber, synthetic rubbers such as polyisobutylene rubber, polybutadiene rubber, silicone rubber, polyisoprene rubber and styrene-isoprene-styrene block copolymer rubber; and synthetic resins such as polypropylene resin, polystyrene resin, and polyacrylic acid ester copolymer resin. Rosin, hydrogenated rosin, and esters thereof, polyterpene resin, petroleum resin, etc. may also be employed as a tackifier. Specific examples of the substrate include paper; staple fiber; cotton; cloth; nonwoven cloth; films made of various resins such as polyester resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride; aluminum foil, etc. These substrates may be employed singly or in combination. However, the adhesive agent, the tackifier, and the substrate are not limited to these examples.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and tape of Hershey to include a rubber adhesive as disclosed in Takata to collect stratum corneum from the skin of a subject (Takata [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of the adhesive taught by Hersey with a natural rubber adhesive like taught by Takata in order to yield predictable results because the substitution of one adhesive for another does not change the principle of operation and yields a reasonable expectation of results in being used for the same purpose of collecting samples from the skin. Additionally, it has been held to be within the general skill of a worker in the art to select a known art recognized material on the basis of its suitability for the intended use. See MPEP 2144.07.
The combination of Hershey/Takata further discloses extracting DNA contained in the skin indigenous microorganisms by allowing the adhesive layer, to which the skin indigenous microorganisms have been adhered, to make contact with a liquid (Hershey: [0054] “the collected adhesive tapes are stored in a reagent that maintains the stability and integrity of the biological materials to be analyzed and dissolves the water-soluble adhesive material of the adhesive tapes to release the adhered biological materials.”); and performing a genome analysis of extracted DNA (Hershey: [0065] “In some embodiments, microbial nucleic acids may be extracted from the first set of the biological materials, e.g., for identification of microbial cells. In some embodiments, the microbial nucleic acids may amplified by any methods known in the art, e.g., by polymerase chain reaction, before they are detected and/or analyzed. In some embodiments, microbial DNA may be extracted from the first set of the biological materials and analyzed by shotgun metagenomic sequencing.” [0068] “Nucleic acids from the biological materials may be analyzed by any methods known in the art.”).
The combination of Hershey/Takata is silent on the test methods for adhesive strength and peel strength in accordance with JIS Z 0237 -- the adhesive tape has an adhesive strength of 10.0 N or more when a 12 mm-wide test piece thereof is pressure-bonded to a Bakelite plate by one reciprocation of a 2 kg roller and then measured for adhesive strength at a pulling speed of 300 mm/min and a pulling angle of 90° according to JIS Z 0237: 2009, and the adhesive tape has a peel strength of 0.25 N or more when a 12 mm-wide test piece thereof is measured using a silicone-treated fine paper sheet as a release sheet and measured for peel strength at a pulling speed of 300 mm/min and a pulling angle of 1800 according to JIS Z 0237: 2009. However, under BRI the claim language does not require the testing steps, as the structures inherently meet the properties of the adhesive tape when tested under the described testing conditions. The structures of the 2k roller, Bakelite plate, and release sheet are contingent on performing of the testing steps, and under BRI, as the testing steps are not positively recited method steps in the method of collecting samples from the skin, the steps of testing the properties of the adhesive tape are not required. Therefore, the structures of the roller, plate, and release sheet are not required in the method of collecting samples from skin.
Regarding claim 2, the combination of Hershey/Takata discloses the method for collecting skin indigenous microorganisms according to claim 1, wherein the adhesive tape is configured to collect skin indigenous microorganisms (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components thereof from a target skin site. Cells may comprise living cells and/or dead cells (including fragments thereof). Cells may comprise microbial cells (e.g., but not limited to bacteria, fungus, yeasts, and/or viruses) from the skin surface of the subjects and/or host skin cells (e.g., keratinocytes and other skin cells) of the subject.”).
Regarding claim 8, the combination of Hershey/Takata discloses a method of screening for a substance capable of improving or preventing a physical condition (Hershey: [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”), the method comprising the step of: selecting a candidate substance based on how the candidate substance changes a value of an abundance proportion of a skin indigenous microorganism on a skin surface or a parameter based on the abundance proportion, a correlation criterion of the abundance proportion or parameter with the physical condition being pre-established (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen … a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile”),
wherein the determining the value of the abundance proportion of the skin indigenous microorganism or the parameter is carried out based on a result of genome analysis of DNA according to claim 1 (Hershey: [0065] “microbial DNA may be extracted from the first set of the biological materials and analyzed by shotgun metagenomic sequencing. Shotgun metagenomic sequencing allows comprehensive sampling of all genes in all microorganisms present in a given sample. Thus, microbial species diversity and abundance of microbes can be evaluated based on the microbial nucleic acids extracted from the first set of the biological materials.”).
Regarding claim 9, Hershey teaches a method for collecting skin metabolites on a skin surface ([0035] “methods for collecting biological materials from the skin of a subject;” [0057] “Cells may comprise microbial cells (e.g., but not limited to bacteria, fungus, yeasts, and/or viruses) from the skin surface of the subjects and/or host skin cells (e.g., keratinocytes and other skin cells) of the subject.” Fig. 5), the method comprising the steps of:
providing an adhesive tape ([0038] “adhesive tapes”), the adhesive tape comprising: a base material; and an adhesive layer provided on at least a portion of a surface of the base material, wherein the adhesive layer contains an adhesive ([0038] “Adhesive tapes in each set (e.g., first set, second set, and/or third set) used for collecting skin samples in any of the methods described herein are water-soluble adhesive tapes comprising a water-soluble adhesive attached to a solid substrate, which may also be water soluble.” [0040] “In some embodiments, the water-soluble adhesive layer comprises a water-soluble acrylic polymer (e.g., but not limited to acrylic acid polymer or acrylic acid ester/acrylic acid copolymer). In some embodiments, the water-soluble adhesive comprises a pressure-sensitive polymeric adhesive. In some embodiments, the adhesive layer does not comprise a rubber adhesive.” [0041] “The water-soluble adhesive layer is attached to a solid substrate, e.g., a solid support”).
While one could conclude that some embodiment of Hershey includes a rubber adhesive based on “In some embodiments, the adhesive layer does not comprise a rubber adhesive” (Hershey [0040]), to provide positive recitation of this feature, Takata is introduced.
Takata discloses providing an adhesive tape, the adhesive tape comprising: a base material; and an adhesive layer provided on at least a portion of a surface of the base material, wherein the adhesive layer contains an adhesive and the adhesive contains a rubber adhesive ([0052] “The adhesive layer 16 is formed by … attaching a substrate in the form of a sheet, which is coated an adhesive agent, to the outer peripheral surface of the columnar portion 15. Specific examples of the adhesive agent include natural rubber, synthetic rubbers such as polyisobutylene rubber, polybutadiene rubber, silicone rubber, polyisoprene rubber and styrene-isoprene-styrene block copolymer rubber; and synthetic resins such as polypropylene resin, polystyrene resin, and polyacrylic acid ester copolymer resin. Rosin, hydrogenated rosin, and esters thereof, polyterpene resin, petroleum resin, etc. may also be employed as a tackifier. Specific examples of the substrate include paper; staple fiber; cotton; cloth; nonwoven cloth; films made of various resins such as polyester resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride; aluminum foil, etc. These substrates may be employed singly or in combination. However, the adhesive agent, the tackifier, and the substrate are not limited to these examples.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and tape of Hershey to include a rubber adhesive as disclosed in Takata to collect stratum corneum from the skin of a subject (Takata [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of the adhesive taught by Hersey with a natural rubber adhesive like taught by Takata in order to yield predictable results because the substitution of one adhesive for another does not change the principle of operation and yields a reasonable expectation of results in being used for the same purpose of collecting samples from the skin. Additionally, it has been held to be within the general skill of a worker in the art to select a known art recognized material on the basis of its suitability for the intended use. See MPEP 2144.07.
The combination of Hershey/Takata further discloses extracting the skin metabolites by allowing the adhesive layer, on which the skin metabolites adhered, to make contact with a liquid (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components;” [0058] “Cellular components are materials derived from cells, including, … metabolites;” [0054] “the collected adhesive tapes are stored in a reagent that maintains the stability and integrity of the biological materials to be analyzed and dissolves the water-soluble adhesive material of the adhesive tapes to release the adhered biological materials.”).
The combination of Hershey/Takata is silent on the test methods for adhesive strength and peel strength in accordance with JIS Z 0237 -- the adhesive tape has an adhesive strength of 10.0 N or more when a 12 mm-wide test piece thereof is pressure-bonded to a Bakelite plate by one reciprocation of a 2 kg roller and then measured for adhesive strength at a pulling speed of 300 mm/min and a pulling angle of 90° according to JIS Z 0237: 2009, and the adhesive tape has a peel strength of 0.25 N or more when a 12 mm-wide test piece thereof is measured using a silicone-treated fine paper sheet as a release sheet and measured for peel strength at a pulling speed of 300 mm/min and a pulling angle of 1800 according to JIS Z 0237: 2009. However, under BRI the claim language does not require the testing steps, as the structures inherently meet the properties of the adhesive tape when tested under the described testing conditions. The structures of the 2k roller, Bakelite plate, and release sheet are contingent on performing of the testing steps, and under BRI, as the testing steps are not positively recited method steps in the method of collecting samples from the skin, the steps of testing the properties of the adhesive tape are not required. Therefore, the structures of the roller, plate, and release sheet are not required in the method of collecting samples from skin.
Regarding claim 10, the combination of Hershey/Takata discloses the method for collecting skin metabolites according to claim 9, wherein the adhesive tape is configured to collect skin metabolites (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components;” [0058] “Cellular components are materials derived from cells, including, … metabolites”).
Regarding claim 12, the combination of Hershey/Takata discloses the method for collecting skin metabolites according to claim 9, wherein the skin metabolite is a soluble protein (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components;” [0058] “Cellular components are materials derived from cells, including, e.g., but not limited to nucleic acids, polypeptides, lipids, carbohydrates, small molecules, and combinations of any of these. … Polypeptides are polymers of amino acid residues, including, e.g., proteins and peptides. Examples of polypeptides include, but are not limited to growth factors, enzymes, metabolites”).
Regarding claim 13, the combination of Hershey/Takata discloses a method of evaluating a physical condition of a subject (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”), the method comprising the step of:
determining a value of an abundance proportion of a skin metabolite on a skin surface of the subject among skin metabolites collected from the skin surface or a parameter based on the abundance proportion (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components;” [0058] “Cellular components are materials derived from cells, including, …metabolites” [0073] “analysis from each set of the biological materials can be combined to determine a biological material profile of a target skin site from which the biological materials are collected”),
a correlation criterion of the abundance proportion or parameter with the physical condition being pre-established (Hershey: [0073] “reference biological material profile [e.g., a biological material profile obtained from subjects without the skin disease or disorder]”),
and then comparing the value with the correlation criterion (Hershey: [0073] “a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile [e.g., a biological material profile obtained from subjects without the skin disease or disorder]”),
wherein the skin metabolites collected from the skin surface of the subject are skin metabolites obtained according to the method of claim 9 (Hershey: [0102] “the methods described herein can be used to simultaneously collect microbial analytes, e.g., bacteria, protein, and metabolites, from a skin surface, and host analytes [e.g., proteins, DNA, RNA, and metabolites]”).
Regarding claim 15, the combination of Hershey/Takata discloses a method of presenting information to a subject (Hershey: [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”), the method comprising the steps of:
evaluating a physical condition of the subject by the method according to claim 13 (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”),
and presenting, when the physical condition is evaluated to be outside a target condition (Hershey: [0073] “a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile”), information registered in a data base, including an ingredient capable of directing the value of the abundance proportion or the parameter toward a numerical range of the abundance proportion or parameter obtained based on the correlation criterion when the physical condition is within the target condition (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen”; [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development. The methods described herein can also be used to identify clinically relevant biomarkers of disease—to aid diagnosis, disease severity, predict natural history, or to help select the best treatment strategy”).
Regarding claim 16, the combination of Hershey/Takata discloses a method of presenting information to a subject (Hershey: [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”), the method comprising the steps of:
evaluating a physical condition of the subject by a method of evaluating a physical condition of a subject (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”),
and presenting, when the physical condition is evaluated to be outside a target condition, information registered in a data base, including an ingredient capable of directing the value of the abundance proportion or the parameter toward a numerical range of the abundance proportion or parameter obtained based on the correlation criterion when the physical condition is within the target condition (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen… a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile;” [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development. The methods described herein can also be used to identify clinically relevant biomarkers of disease—to aid diagnosis, disease severity, predict natural history, or to help select the best treatment strategy”),
and the method further comprising the steps of: re-evaluating the physical condition of the subject by the method of evaluating a physical condition of a subject after consumption of the ingredient (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen”), and updating the information based on the extent of improvement in the physical condition after the re-evaluation (Hershey: [0109] “aid diagnosis and guide selection of the most optimal treatment;” [0116] “methods described herein can be used to better understand the molecular underpinnings of the disease or identify new targets for therapeutic intervention and drug development”),
wherein the method of evaluating a physical condition of a subject (Hershey: [0073] “a skin condition of a subject from which the biological materials are collected can be assessed accordingly”) comprising the step of:
determining a value of an abundance proportion of a skin metabolite on a skin surface of the subject among skin metabolites collected from the skin surface or a parameter based on the abundance proportion (Hershey: [0057] “Biological materials collected from a target skin site may comprise cells and/or cellular components;” [0058] “Cellular components are materials derived from cells, including, …metabolites” [0073] “analysis from each set of the biological materials can be combined to determine a biological material profile of a target skin site from which the biological materials are collected”),
a correlation criterion of the abundance proportion or parameter with the physical condition being pre-established (Hershey: [0073] “reference biological material profile [e.g., a biological material profile obtained from subjects without the skin disease or disorder]”),
and then comparing the value with the correlation criterion (Hershey: [0073] “a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile [e.g., a biological material profile obtained from subjects without the skin disease or disorder]”),
wherein the skin metabolites collected from the skin surface of the subject are skin metabolites obtained according to the method of claim 9 (Hershey: [0102] “the methods described herein can be used to simultaneously collect microbial analytes, e.g., bacteria, protein, and metabolites, from a skin surface, and host analytes [e.g., proteins, DNA, RNA, and metabolites]”).
Regarding claim 17, the combination of Hershey/Takata discloses a method of screening for a substance capable of improving or preventing a physical condition (Hershey [0109] guide selection of the most optimal treatment), the method comprising the step of:
selecting a candidate substance based on how the candidate substance changes a value of an abundance proportion of a skin metabolite on a skin surface or a parameter based on the abundance proportion, a correlation criterion of the abundance proportion or parameter with the physical condition being pre-established (Hershey: [0073] “the skin condition can be assessed before and after a treatment to monitor therapy efficacy and/or to determine appropriate treatment regimen … a subject can be diagnosed for a skin disease or disorder based on the determined biological material profile, as compared to a reference biological material profile”),
wherein the skin metabolites collected from the skin surface of the subject are skin metabolites obtained according to the method of claim 9 (Hershey: [0102] “the methods described herein can be used to simultaneously collect microbial analytes, e.g., bacteria, protein, and metabolites, from a skin surface, and host analytes [e.g., proteins, DNA, RNA, and metabolites]”).
Regarding claim 18, Hershey discloses a method of measurement of total DNA content of a skin indigenous microorganism on a skin surface of a subject (Hershey: [0019] “process for collecting biological materials from skin for microbiome, DNA, and RNA analyses”), the method comprising the step of:
preparing a DNA solution by extracting DNA from skin indigenous microorganisms collected from the skin surface by using an adhesive tape for collecting skin indigenous microorganisms (Hershey: [0039] “A water-soluble adhesive is dissolvable in water and/or in an aqueous buffer solution;” [0054] “the collected adhesive tapes are stored in a reagent that maintains the stability and integrity of the biological materials to be analyzed and dissolves the water-soluble adhesive material of the adhesive tapes to release the adhered biological materials.”),
measuring the total DNA content of the skin indigenous microorganism contained in the DNA solution (Hershey: [0065] “In some embodiments, microbial nucleic acids may be extracted from the first set of the biological materials, e.g., for identification of microbial cells. In some embodiments, the microbial nucleic acids may amplified by any methods known in the art, e.g., by polymerase chain reaction, before they are detected and/or analyzed. In some embodiments, microbial DNA may be extracted from the first set of the biological materials and analyzed by shotgun metagenomic sequencing.” [0068] “Nucleic acids from the biological materials may be analyzed by any methods known in the art.”);
providing an adhesive tape ([0038] “adhesive tapes”), the adhesive tape comprising: a base material; and an adhesive layer provided on at least a portion of a surface of the base material, wherein the adhesive layer contains an adhesive, and the adhesive contains a rubber adhesive ([0038] “Adhesive tapes in each set (e.g., first set, second set, and/or third set) used for collecting skin samples in any of the methods described herein are water-soluble adhesive tapes comprising a water-soluble adhesive attached to a solid substrate, which may also be water soluble.” [0040] “In some embodiments, the water-soluble adhesive layer comprises a water-soluble acrylic polymer (e.g., but not limited to acrylic acid polymer or acrylic acid ester/acrylic acid copolymer). In some embodiments, the water-soluble adhesive comprises a pressure-sensitive polymeric adhesive. In some embodiments, the adhesive layer does not comprise a rubber adhesive.” [0041] “The water-soluble adhesive layer is attached to a solid substrate, e.g., a solid support”).
The combination of Hershey/Takata is silent on the test methods for adhesive strength and peel strength in accordance with JIS Z 0237 -- the adhesive tape has an adhesive strength of 10.0 N or more when a 12 mm-wide test piece thereof is pressure-bonded to a Bakelite plate by one reciprocation of a 2 kg roller and then measured for adhesive strength at a pulling speed of 300 mm/min and a pulling angle of 90° according to JIS Z 0237: 2009, and the adhesive tape has a peel strength of 0.25 N or more when a 12 mm-wide test piece thereof is measured using a silicone-treated fine paper sheet as a release sheet and measured for peel strength at a pulling speed of 300 mm/min and a pulling angle of 1800 according to JIS Z 0237: 2009. However, under BRI the claim language does not require the testing steps, as the structures inherently meet the properties of the adhesive tape when tested under the described testing conditions. The structures of the 2k roller, Bakelite plate, and release sheet are contingent on performing of the testing steps, and under BRI, as the testing steps are not positively recited method steps in the method of collecting samples from the skin, the steps of testing the properties of the adhesive tape are not required. Therefore, the structures of the roller, plate, and release sheet are not required in the method of collecting samples from skin.
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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