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 .
Election/Restrictions
Applicant’s election without traverse of Invention 1, in the reply filed on 12/03/2025 is acknowledged.
Applicant’s cancellation of claims 3, 13-17, and 19, amendment of claims 1-2, 4, 11, 18, and 20, and addition of claims 21-27 in the response filed 12/03/2025 is acknowledged.
No claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/03/2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-2, 4-12, 18, and 20-27 are currently under examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the
“a component comprising a wall having an outer layer and an inner layer” (Claim 1),
“wherein the hydrophobic bond is configured to form a space between the unit and the hydrophobic layer such that the space is configured to allow passage of the one or more VOCs to the olfactory receptor present on the unit.” (Claim 4),
“wherein the component comprises a slit comprising a microslit” (Claim 11),
“a transistor to generate the electrophysiological signal; wherein the transistor comprises a gate electrode and a gate insulating film” (Claim 21),
“wherein the handheld device comprises a pump and a regulator configured to maintain a flow rate of air inside the component” (Claim 26),
“a monitor to display the electrophysiological signal on detection of the one or more VOCs by the olfactory receptor in an quantitative and an qualitative manner.” (Claim 27)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because the drawings do not show every feature of the invention specified in the claims and Fig. 1, Fig. 2, and Fig. 3 are blurry.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2, 4-12, 18, and 20-27 are objected to because of the following informalities:
In Claim 1, “in the response of the captured one” (line 6-7), should read -in response to the capture of one-,
In Claim 2, “wherein capture” (line 1), should read -wherein the capture-,
In Claim 21, “further comprises” (line 1), should read -further comprising-,
In Claim 22, “in the response of the captured one” (line 2), should read -in response to the capture of one-,
In claim 27, “an quantitative and an qualitative manner” (line 3), should read - a quantitative and qualitative manner-
Claims 2, 4-12, 18, and 20-27 are dependent on claim 1, and as such are also objected to.
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:
Claim 20: The claim limitation “the device comprises a deep learning algorithm configured to detect one or more VOCs” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “algorithm” coupled with functional language “configured to detect one or more VOCs” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “algorithm”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“The term 'deep learning algorithm' or 'a deep learning algorithm' herein refers to an algorithm that dynamically run data through one or several layers of networks such as decision- making networks that are pre-trained to serve a task. Data could be passed through one or more layers of the networks to processes the data. In an embodiment, network could be a neural network or an artificial neural network.” or equivalents thereof, as described in Par. 64 of the disclosure filed on 10/18/2024, which lacks sufficient detail within the applicants specification, and it will be interpreted as any generic algorithm capable of the indicated function.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 recites “the device comprises a deep learning algorithm configured to detect one or more VOCs”, which lacks sufficient detail within the applicant’s specification in regards to the structure of the deep learning algorithm that performs the indicated function of detecting one or more VOCs. The applicant’s specification does state “The term 'deep learning algorithm' or 'a deep learning algorithm' herein refers to an algorithm that dynamically run data through one or several layers of networks such as decision- making networks that are pre-trained to serve a task. Data could be passed through one or more layers of the networks to processes the data. In an embodiment, network could be a neural network or an artificial neural network.” (Par. 64 of applicant’s specification) and “machine learning algorithms such as deep learning may be used following analysis of VOCs. Machine learning refers to computer algorithms that improve in their accuracy of identifying and classifying data. Deep learning is a type of machine learning designed to mimic the human brain, as it continues to improve accuracy with massive data sets such as types of oral microbes.” (Par. 82 of applicant’s spec.). However, the applicant has not provided sufficient detail in regards to the specific weights, biases, or layers used for the deep learning algorithm itself. As such, the claim is rejected.
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 1-2, 4-12, 18, and 20-27 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 1 recites the limitation “A device comprising a component comprising a wall having an outer layer and an inner layer, wherein the inner layer comprises a hydrophobic layer, and a unit having at least one lipid layer surrounding a region comprising an aqueous environment”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what is comprised by “a component”. For example, the limitation “a component comprising a wall having an outer layer and an inner layer, wherein the inner layer comprises a hydrophobic layer” indicates a component that has a wall having both an inner layer and an outer layer. However, it is unclear whether the component further includes “a unit having at least one lipid layer surrounding a region comprising an aqueous environment”, or if the unit is meant to simply be part of the device due to the limitation stating “a component comprising a wall having an outer layer and an inner layer…”, with no comma present between the outer layer and inner layer. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the unit being present in the device.
Claim 1 recites the limitation “wherein the device is configured to detect one or more VOCs”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what VOCs are being detected. The claim also recites “wherein the lipid layer comprises an olfactory receptor configured to capture one or more volatile organic compounds (VOCs) to release an ionized molecule in the response of the captured one or more of the VOCs”, indicating the capture of one or more VOCs to release an ionized molecule. Are these the same VOCs that the device is configured to detect? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, these will be interpreted as any VOCs.
Claim 1 recites the limitation “wherein the inner layer comprises a hydrophobic layer” and “wherein the unit and the inner layer of the wall interact via a hydrophobic bond”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what type of layer is considered to be “hydrophobic”. The applicant’s specification does state “the term 'hydrophobic bond' herein refers to an attraction between water-hating molecules. The attraction between water-hating molecules could bring change in physical phenomena, for example: hydrophobic regions of proteins aggregate to form globules. In some embodiment, hydrophobic forces may assist in formation of a channel, etc. In an embodiment, interior region of the wall of the device is coated with a hydrophobic material. The hydrophobic material could generate hydrophobic force due to interaction of the wall and the lipid layer of the unit.” (Par. 54 of applicant’s spec.). However, this merely further describes the hydrophobic bond rather than the material used for the layer itself. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any layer capable of the indicated function.
The term “about” in claim 5 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far above or below “about one part per million to about one part per billion” the sensitivity of the device is. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any sensitivity amount in the in the millions up to the billions.
The term “about” in claim 6 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far above or below “about one part per billion” the sensitivity of the device is. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any sensitivity amount in the billions.
Claim 7 recites the limitation “wherein one or more VOCs comprise molecules released from a microbiome of a user using the device” This is a “use” claim that is indefinite, as the applicant fails to effectively define the metes and bounds of the claim. The applicant merely recites the use, without providing further detail as to how the use is practiced, and as such the claim indefinite. For examination purposes, this will be interpreted as any type of use that results in the release of the indicated VOCs.
Claim 27 recites the limitation “a monitor to display the electrophysiological signal on detection of the one or more VOCs by the olfactory receptor in an quantitative and an qualitative manner”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the manner in which the signal is displayed. What does it mean for the signal to be displayed in a quantitative and qualitative manner? What specifically is being displayed on the monitor? Is this a graph? The applicant’s specification makes no further clarification regarding the manner in which a signal is displayed in both a quantitative and qualitative manner. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as displaying a signal in any manner.
Claim 20 limitation “the device comprises a deep learning algorithm configured to detect one or more VOCs” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The applicant’s specification does state “The term 'deep learning algorithm' or 'a deep learning algorithm' herein refers to an algorithm that dynamically run data through one or several layers of networks such as decision- making networks that are pre-trained to serve a task. Data could be passed through one or more layers of the networks to processes the data. In an embodiment, network could be a neural network or an artificial neural network.” (Par. 64 of applicant’s specification) and “machine learning algorithms such as deep learning may be used following analysis of VOCs. Machine learning refers to computer algorithms that improve in their accuracy of identifying and classifying data. Deep learning is a type of machine learning designed to mimic the human brain, as it continues to improve accuracy with massive data sets such as types of oral microbes.” (Par. 82 of applicant’s spec.). However, the applicant has not provided sufficient detail in regards to the specific weights, biases, or layers used for the deep learning algorithm itself. As such, the applicant has failed to effectively define the metes and bounds of the claim as it is unclear as to the actual structure of the deep learning algorithm. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For examination purposes, this will be interpreted as any generic algorithm capable of the indicated function.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2, 4-12, 18, and 20-27 are dependent on claim 1, and as such are also rejected.
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 7-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because single "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. Therefore, the claim is rejected as it does not fall under a statutory category of 35 U.S.C. 101.
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 claims are generally directed towards a detection device. The device comprises an outer layer, inner layer that comprises a hydrophobic layer, and a unit comprising a lipid layer surrounding an aqueous environment. The lipid layer further comprises an olfactory receptor configured to one or more volatile organic compounds to release an ionized molecule to detect one or more volatile organic compounds.
Claim(s) 1-2, 4, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada (US Pub. No. 20220326204) hereinafter Yamada.
Regarding claim 1, Yamada discloses A device (Fig. 1) comprising a component comprising a wall (Fig. 1A,1b (Substrate – 10)) having an outer layer and an inner layer (Fig. 1B (outer layer considered to be the area outside of wells 16 and 14)) (Fig. 1B (inner layer considered to be the area inside of wells 16 and 14)), wherein the inner layer comprises a hydrophobic layer (Par. 38, “At least the surface of each gas flow path 20 is hydrophobic. The hydrophobicity of the surface prevents the gas flow paths 20 from being blocked with liquid even when the well 14 is filled with a droplet, and enables to maintain spaces through which a gas can flow. The hydrophobicity can be easily imparted by performing a hydrophobic treatment on the gas flow paths 20. The hydrophobic treatment can be performed, for example, by coating a fluorine coating agent.”), and a unit having at least one lipid layer surrounding a region comprising an aqueous environment (Par. 37 (droplets in wells)) (Par. 42, “In operation, a lipid bilayer(s) is/are formed in the through hole(s) 18 in the partition wall 12 by the well-known droplet contact method. The method of forming a lipid bilayer is well known, and is also disclosed in Patent Literature 1. When a receptor protein or the like that should be reconstituted in the lipid bilayer(s) is added to a liquid to be filled into one of the wells, the protein is naturally reconstituted (retained) in the lipid bilayer(s). Examples of the protein include: various types of receptor proteins; peptide proteins such as α-hemolysin, gramicidin and alamethicin; various types of ion channels; and ABC transporter proteins; but not limited thereto.”) (Par. 54, “To each of the second wells, 5 μL of a mixture of lipid DOPC (1,2-dioleoyl-sn-glycero-3-phosphocholine)…” “…In this manner, lipid bilayers were formed in the through holes 18 in each partition wall 12.”) (Par. 48, “the present invention will now be specifically described with reference to Examples”),
wherein the lipid layer comprises a receptor configured to capture one or more volatile organic compounds (VOCs) to release an ionized molecule in the response of the captured one or more of the VOCs (Par. 3, “volatile organic compounds (target substances)”) (Par. 42, “In operation, a lipid bilayer(s) is/are formed in the through hole(s) 18 in the partition wall 12 by the well-known droplet contact method. The method of forming a lipid bilayer is well known, and is also disclosed in Patent Literature 1. When a receptor protein or the like that should be reconstituted in the lipid bilayer(s) is added to a liquid to be filled into one of the wells, the protein is naturally reconstituted (retained) in the lipid bilayer(s). Examples of the protein include: various types of receptor proteins; peptide proteins such as α-hemolysin, gramicidin and alamethicin; various types of ion channels; and ABC transporter proteins; but not limited thereto.”) (Par. 43, “After the formation of the lipid bilayer(s), a sample gas containing a target substance is introduced from the gas introduction path 22. The sample gas can be introduced into the gas introduction path 22, using a pump, a syringe or the like. This causes the sample gas to flow through each gas flow path 20, and to be discharged from the gas discharge path 24. At this time, the target substance in the sample gas flowing through each gas flow path 20 diffuses into the droplet filled in the well 14. By measuring the current flowing…”)(Par. 44, “As will be specifically described in the Examples below…” “… it is also possible to continuously measure the changes over time in the concentration of the target substance in the sample gas.”),
wherein the unit and the inner layer of the wall interact via a hydrophobic bond layer (Par. 38, “At least the surface of each gas flow path 20 is hydrophobic. The hydrophobicity of the surface prevents the gas flow paths 20 from being blocked with liquid even when the well 14 is filled with a droplet, and enables to maintain spaces through which a gas can flow. The hydrophobicity can be easily imparted by performing a hydrophobic treatment on the gas flow paths 20. The hydrophobic treatment can be performed, for example, by coating a fluorine coating agent.”), and wherein the device is configured to detect one or more VOCs (Par. 44, “As will be specifically described in the Examples below…” “… it is also possible to continuously measure the changes over time in the concentration of the target substance in the sample gas.”) (Fig. 1) (Par. 43, 47 (target substance)) (Par. 3 (Volatile organic compound)).
Yamada fails to explicitly disclose wherein the lipid layer comprises a receptor configured to capture one or more volatile organic compounds (VOCs) to release an ionized molecule in the response of the captured one or more of the VOCs (Examiner's Note: Yamada fails to explicitly disclose wherein the receptor is an olfactory receptor).
However, Yamada does teach in an example wherein the lipid layer comprises an olfactory receptor configured to capture one or more volatile organic compounds (VOCs) to release an ionized molecule in the response of the captured one or more of the VOCs (Par. 65, “Nitrogen gas was injected at a flow rate of 0.5 L/min, from the gas introduction hole 28 of the device produced in Example 1. To each of the second wells, 5 μL of the same lipid solution as that used in Example 2 was added dropwise, and 23 μL of a solution obtained by mixing liposomes containing olfactory receptor protein with the same Buffer 1 as that used in Example 2 was further added dropwise. To each of the first wells, 28 μL of Buffer 1 was added dropwise. In this manner, lipid bilayers were formed in the through holes 18 in each partition wall 12, and the olfactory receptor protein was reconstituted in the lipid bilayers.”) (Par. 66, “an electrical measurement was started, while introducing 5 ppm octenol gas continuously generated by a gas generator, from the gas introduction hole 28. The octenol gas was switched to nitrogen gas at the time point 7 minutes after the start of the measurement, switched back to the octenol gas again at the time point of 25 minutes, and further switched again to the nitrogen gas at the time point of 50 minutes. Current signals indicating the opened state and closed state of olfactory receptor channels were obtained, and the opening rate (opened state/(opened state+closed state)) was estimated at each of the time points.”) (Par. 62, “When octenol is captured by the olfactory receptor protein, a current flows between the wells and is detected as a current signal. ”) (Par. 43,47 (target substance detection)) (Par. 3 (Volatile organic compound)) (Par. 42 (receptors)) (Par. 48, “The present invention will now be specifically described with reference to Examples”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with an example of Yamada to include wherein the lipid layer comprises a receptor configured to capture one or more volatile organic compounds (VOCs) to release an ionized molecule in the response of the captured one or more of the VOCs through the combination of examples as differing receptor types are known (Yamada (Par. 42)) and it would have yielded the same or similar result of determining a target substance concentration.
Regarding claim 2, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Yamada does teach in an example wherein capture of one or more VOCs is configured to produce an electrophysiological signal (Par. 66, “Current signals indicating the opened state and closed state of olfactory receptor channels were obtained, and the opening rate (opened state/(opened state+closed state)) was estimated at each of the time points.”)(Par. 62, “When octenol is captured by the olfactory receptor protein, a current flows between the wells and is detected as a current signal.”) (Par. 47 (target substance detection)) (Par. 3 (Volatile organic compound)) (Par. 42 (receptors)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with an example of Yamada to include wherein capture of one or more VOCs is configured to produce an electrophysiological signal through the combination of references as it would have yielded the same or similar result of determining a target substance concentration.
Regarding claim 4, modified Yama further discloses wherein the hydrophobic bond is configured to form a space between the unit and the hydrophobic layer such that the space is configured to allow passage of the one or more VOCs to the receptor present on the unit (Par. 38, “At least the surface of each gas flow path 20 is hydrophobic. The hydrophobicity of the surface prevents the gas flow paths 20 from being blocked with liquid even when the well 14 is filled with a droplet, and enables to maintain spaces through which a gas can flow. The hydrophobicity can be easily imparted by performing a hydrophobic treatment on the gas flow paths 20. The hydrophobic treatment can be performed, for example, by coating a fluorine coating agent.”) (Par. 37).
Modified Yamada fails to explicitly disclose the olfactory receptor.
However, Yamada does teach in an example the olfactory receptor (Par. 65, “Nitrogen gas was injected at a flow rate of 0.5 L/min, from the gas introduction hole 28 of the device produced in Example 1. To each of the second wells, 5 μL of the same lipid solution as that used in Example 2 was added dropwise, and 23 μL of a solution obtained by mixing liposomes containing olfactory receptor protein with the same Buffer 1 as that used in Example 2 was further added dropwise. To each of the first wells, 28 μL of Buffer 1 was added dropwise. In this manner, lipid bilayers were formed in the through holes 18 in each partition wall 12, and the olfactory receptor protein was reconstituted in the lipid bilayers.”) (Par. 62, “When octenol is captured by the olfactory receptor protein, a current flows between the wells and is detected as a current signal. ”) (Par. 47 (target substance detection)) (Par. 3 (Volatile organic compound)) (Par. 42 (receptors)) (Par. 48, “The present invention will now be specifically described with reference to Examples”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with an example of Yamada to include an olfactory receptor for the reasoning as indicated in claim 1 above.
Regarding claim 10, modified Yamada further discloses wherein the lipid layer comprises a lipid bilayer (Par. 37 (droplets in wells)) (Par. 42, “In operation, a lipid bilayer(s) is/are formed in the through hole(s) 18 in the partition wall 12 by the well-known droplet contact method. The method of forming a lipid bilayer is well known, and is also disclosed in Patent Literature 1....”) (Par. 54, “To each of the second wells, 5 μL of a mixture of lipid DOPC (1,2-dioleoyl-sn-glycero-3-phosphocholine)…” “…In this manner, lipid bilayers were formed in the through holes 18 in each partition wall 12.”) (Par. 48, “the present invention will now be specifically described with reference to Examples”).
Regarding claim 11, modified Yamada further discloses wherein the component comprises a slit comprising a microslit (Par. 38, “At least the surface of each gas flow path 20 is hydrophobic. The hydrophobicity of the surface prevents the gas flow paths 20 from being blocked with liquid even when the well 14 is filled with a droplet, and enables to maintain spaces through which a gas can flow. The hydrophobicity can be easily imparted by performing a hydrophobic treatment on the gas flow paths 20. The hydrophobic treatment can be performed, for example, by coating a fluorine coating agent.”) (Par. 37, Fig. 1b (well -14 with gas flow path – 20)).
Claim(s) 5, 6, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada as applied to claim 4 and 1 above, and further in view of Li (US Pub. No. US 20250090104) hereinafter Li.
Yamada teaches the device of claim 4 above.
Regarding claim 5, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Li teaches wherein the device is configured to detect one or more VOCs with a sensitivity within a range of about one part per million to about one part per billion (Par. 92, “It is important to determine all VOCs concentration level changes within ppb level to pptv level or even at lower level of detection at ppm level using sensors that could be used to associate with blood glucose mmol/L level, Hba1c level and inflammatory response for prediabetes due to hyperglycemia”) (Par. 100, 104 (VOC measurement at different levels)).
Yamada and Li are considered to be analogous art to the claimed invention as they are involved with analyte measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Li to include wherein the device is configured to detect one or more VOCs with a sensitivity within a range of about one part per million to about one part per billion through the combination of references as differing sensitivities are known in the art (Li (Par. 92)) and it would have yielded the predictable result of assessing patient health (Li (Par. 92)) and because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a primary facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 6, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Li further teaches wherein the sensitivity is about one part per billion (Par. 92, “It is important to determine all VOCs concentration level changes within ppb level to pptv level or even at lower level of detection at ppm level using sensors that could be used to associate with blood glucose mmol/L level, Hba1c level and inflammatory response for prediabetes due to hyperglycemia”) (Par. 100, 104 (VOC measurement at different levels)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Li with that of Li to include wherein the sensitivity is about one part per billion for the reasoning as indicated in claim 5 above.
Yamada teaches the device of claim 1 above.
Regarding claim 18, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Li teaches wherein the VOCs comprises at least one of (S)-2-hydroxypropanoic acid, heptylhydroperoxide, 2,3-dihydroxypropanal, nonanoyl chloride, dodecanal, (Z)-2-nonenal, 4,5-dimethyl, -3(2H)-isoxazolone, (Z)-2-decenal, trichloro acid 3-tridecyl ester, levoglucosan, 4-(dimethylamino)-3-methyl-2-butanone, 4-methyl-1-butene-l, 1-pentanoic acid ester, diethylphthalic acid, l-chloro-8-heptadecene, pentadecanoic acid, 1,2-benzenedicarboxylic acid butyldecyl ester, nonanal, 1-butanol, 3-hydroxy-2-butanone, hexanol , 2-pentanone, tetrahydrofuran, 2-methylpyrazine, (E)-2-nonenal (Par. 100, “breath emitted VOCs such as p-cymene, 1-butanol, 1-pentanol are found to be strongly associated with IL-6 or interleukin families and more prominently tumor necrosis factor α (TNF-α) due to systemic inflammation are considered to be independent predictors of the future development of diabetes. This will be the level 1 factors (refer to Table 8) for the VOCs novelty for use to detect onset of diabetes. Subjects with no hyperglycemia, on the other hand, are found to have about 0.02 ppb to about 0.6 ppb P-cymene, about 0.5 ppb to about 5 ppb 1-butanol and/or about 0.1 ppb to about 2.1 ppb 1-pentanol in their breath”) (Par. 18 (hyperglycemia prediction)) (Par. 92 (VOCs in breath)) (Table 1,2).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Li to include wherein the VOCs comprises at least one of (S)-2-hydroxypropanoic acid, heptylhydroperoxide, 2,3-dihydroxypropanal, nonanoyl chloride, dodecanal, (Z)-2-nonenal, 4,5-dimethyl, -3(2H)-isoxazolone, (Z)-2-decenal, trichloro acid 3-tridecyl ester, levoglucosan, 4-(dimethylamino)-3-methyl-2-butanone, 4-methyl-1-butene-l, 1-pentanoic acid ester, diethylphthalic acid, l-chloro-8-heptadecene, pentadecanoic acid, 1,2-benzenedicarboxylic acid butyldecyl ester, nonanal, 1-butanol, 3-hydroxy-2-butanone, hexanol, 2-pentanone, tetrahydrofuran, 2-methylpyrazine, (E)-2-nonenal through the combination of references as differing analyte measurements and health conditions are known in the art (Li (Par. 100)(Table 1,2)) and it would have yielded the predictable result of assessing the diabetic condition of the user (Li (Par. 92, 100)).
Claim(s) 7-8, 20, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada as applied to claim 4, 1, and 11 above, and further in view of Reddy (US Pub. No. 20200029858) hereinafter Reddy.
Yamada teaches the device of claim 4 above.
Regarding claim 7, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy teaches wherein one or more VOCs comprise molecules released from a microbiome of a user using the device (Par. 49, “As used herein, the term “substance” can include any VOC…” “…Other substances may include respiration components produced by certain bacteria within a subject's mouth, stomach, and/or intestinal tract. In addition, substances can include other bodily fluids and secretions from a subject including, but not limited to, serum, urine, feces, sweat, vaginal discharge, saliva, and sperm.”) (Par. 57, 59 (sensor module detecting VOC)) (Par. 43, 60 (health conditions)).
Yamada and Reddy are considered to be analogous art to the claimed invention as they are involved with analyte measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Reddy to include wherein one or more VOCs comprise molecules released from a microbiome of a user using the device through the substitution of analytes measured as differing analytes are known in the art (Reddy (Par. 49)) and it would have yielded the predictable result of assessing the health of the user through exhaled breath (Reddy (Par. 60)).
Regarding claim 8, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy further teaches wherein the microbiome comprises gut microbe and/or oral microbiome (Par. 49, “As used herein, the term “substance” can include any VOC…” “…Other substances may include respiration components produced by certain bacteria within a subject's mouth, stomach, and/or intestinal tract. In addition, substances can include other bodily fluids and secretions from a subject including, but not limited to, serum, urine, feces, sweat, vaginal discharge, saliva, and sperm.”) (Par. 57, 59 (sensor module detecting VOC)) (Par. 43, 60 (health conditions)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Reddy with that of Reddy to include wherein the microbiome comprises gut microbe and/or oral microbiome for the reasoning as indicated in claim 7 above.
Yamada teaches the device of claim 1 above.
Regarding claim 20, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy teaches the device comprises a deep learning algorithm configured to detect one or more VOCs (Par. 101, 102 (machine learning algorithm to detect substance)) (Par. 104 (mathematical processing)) (Par. 42 (machine learning to detect VOC)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Reddy to include the device comprises a deep learning algorithm configured to detect one or more VOCs through the combination of references as differing analysis techniques are known (Reddy (Par. 101,102,42)) and it would have yielded the predictable result of improving the detection accuracy.
Yamada teaches the device of claim 11 above.
Regarding claim 25, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy teaches wherein the device is a handheld device (Par. 48 (handheld device))
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Reddy to include wherein the device is a handheld device through the combination of references as it would have yielded the predictable result of improving the mobility of the device.
Regarding claim 27, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Yamada does disclose A system comprising the device of claim 1 (as indicated in claim 1 above), and the olfactory receptor (as indicated in claim 1 above).
However, Reddy teaches a monitor to display the electrophysiological signal on detection of the one or more VOCs by the receptor in an quantitative and an qualitative manner (Par. 20, “…generating an electronic signal associated with a concentration or amount of the one or more VOCs; and outputting, via a display device, an indication of a health condition or disease associated with the concentration or amount of the one or more VOCs.”) (Par. 114, Fig. 7, (output to display device based on detection of the one or more VOCs)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Reddy to include a monitor to display the electrophysiological signal on detection of the one or more VOCs by the olfactory receptor of Yamada in an quantitative and an qualitative manner through the combination of references as it would have yielded the predictable result of directly providing the user with the results.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Reddy as applied to claim 7 above, and further in view of Burch (US Pub. No. 20040006257) hereinafter Burch.
Yamada and Reddy teach the device of claim 7 above.
Regarding claim 9, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy does teaches wherein the microbiome includes bacteria (Par. 49, “As used herein, the term “substance” can include any VOC…” “…Other substances may include respiration components produced by certain bacteria within a subject's mouth, stomach, and/or intestinal tract. In addition, substances can include other bodily fluids and secretions from a subject including, but not limited to, serum, urine, feces, sweat, vaginal discharge, saliva, and sperm.”) (Par. 57, 59 (sensor module detecting VOC)) (Par. 43, 60 (health conditions)).
Burch teaches measurement wherein the microbiome includes Actinobacteria and/or Prevotella (Par. 66, “Using the methods and apparatus of the present invention it is also possible to detect the off-gases associated with bacteria associated with oral maladies including, but not limited to, Prevotella intermedia; Fusobacterium nucleatum; Porphyromonas gingivalis; Porphyromonas endodontalis; Prevotella loescheii…”) (Par. 63, “Alternatively, the disease is diagnosed by identifying marker gases from a particular microorganism or pathogen. In general, certain volatile marker gas(es) characterize the detection or diagnosis of a disease state or medical condition. The marker gases can be off-gases of microorganisms, such as virus, fungus, and a bacterium”) (Par. 60 (assessment of diseases)) (Par. 20 (marker gasses)).
Yamada, Reddy, and Burch are considered to be analogous art to the claimed invention as they are involved with analyte measurements
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Reddy with that of Reddy and Burch to explicitly include wherein the microbiome of Reddy includes Actinobacteria and/or Prevotella through the combination of references as differing analyte measurements are known in the art (Reddy (Par. 49)) (Burch (Par. 63,66)) and it would have yielded the same or similar result of assessing the health of the user through monitoring specific markers (Burch (Par. 63)) (Reddy (Par. 60)).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Reddy as applied to claim 7 above, and further in view of Li (US Pub. No. US 20250090104) hereinafter Li.
Yamada and Reddy teach the device of claim 7 above.
Regarding claim 12, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Reddy does teaches wherein the device is configured to detect diabetes (Par. 49, “As used herein, the term “substance” can include any VOC…” “…Other substances may include respiration components produced by certain bacteria within a subject's mouth, stomach, and/or intestinal tract. In addition, substances can include other bodily fluids and secretions from a subject including, but not limited to, serum, urine, feces, sweat, vaginal discharge, saliva, and sperm.”) (Par. 57, 59 (sensor module detecting VOC)) (Par. 43, 60 (diabetic health condition)).
Li teaches wherein the device is configured to detect onset of a diabetes (Par. 100, “breath emitted VOCs such as p-cymene, 1-butanol, 1-pentanol are found to be strongly associated with IL-6 or interleukin families and more prominently tumor necrosis factor α (TNF-α) due to systemic inflammation are considered to be independent predictors of the future development of diabetes. This will be the level 1 factors (refer to Table 8) for the VOCs novelty for use to detect onset of diabetes. Subjects with no hyperglycemia, on the other hand, are found to have about 0.02 ppb to about 0.6 ppb P-cymene, about 0.5 ppb to about 5 ppb 1-butanol and/or about 0.1 ppb to about 2.1 ppb 1-pentanol in their breath”) (Par. 18 (hyperglycemia prediction)) (Par. 92 (VOCs in breath)).
Yamada, Reddy, and Li are considered to be analogous art to the claimed invention as they are involved with analyte measurements
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Reddy with that of Reddy and Li to explicitly include wherein the device is configured to detect onset of a diabetes through the combination of references as differing analyte measurements and health conditions are known in the art (Reddy (Par. 43, 49)) (Li (Par. 100)) and it would have yielded the predictable result of assessing the diabetic condition of the user (Li (Par. 92, 100)) (Reddy (Par. 43, 60)).
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada as applied to claim 1 above, and further in view of Ando (US Pub. No. 20190227044) hereinafter Ando.
Yamada teaches the device of claim 1 above.
Regarding claim 21, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Ando teaches further comprises a transistor to generate the electrophysiological signal (Par. 7, “A first insulating film is formed on a gate electrode of the transistor, and an electrolytic aqueous solution is disposed on the first insulating film. Then, the sensor cell is disposed in the electrolytic aqueous solution, and a proton is adsorbed onto the first insulating film. When the olfactory receptor recognizes the odor molecule, positive ions in the electrolytic aqueous solution flow from an ion channel of the olfactory receptor into the sensor cell. As a result, the proton is dissociated from the first insulating film into the electrolytic aqueous solution, and the potential of the gate electrode is changed.”) (Par 25 (transistor)) (Claim 1) (Claim 7, “wherein a potential change of the gate electrode which is caused when the olfactory receptor recognizes the odor molecule is differentiated with time to measure a concentration of the odor molecule.”); wherein the transistor comprises a gate electrode and a gate insulating film (Par. 7, “A first insulating film is formed on a gate electrode of the transistor, and an electrolytic aqueous solution is disposed on the first insulating film. Then, the sensor cell is disposed in the electrolytic aqueous solution, and a proton is adsorbed onto the first insulating film. When the olfactory receptor recognizes the odor molecule, positive ions in the electrolytic aqueous solution flow from an ion channel of the olfactory receptor into the sensor cell. As a result, the proton is dissociated from the first insulating film into the electrolytic aqueous solution, and the potential of the gate electrode is changed.”) (Par 25 (transistor, gate electrode, insulating film)) (Claim 1).
Yamada and Ando are considered to be analogous art to the claimed invention as they are involved with analyte measurements
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada with that of Ando to explicitly include further comprises a transistor to generate the electrophysiological signal; wherein the transistor comprises a gate electrode and a gate insulating film through the combination of references as differing sensing structures are known (Ando (Par. 3)) and it would have yielded the same or similar result of monitoring analyte concentrations (Ando (Par. 96) (Claim 8)).
Regarding claim 22, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Ando further teaches wherein an inflow of the ionized molecule into the transistor in the response of the captured one or more of the VOCs by the olfactory receptor is configured to change the potential of the gate electrode (Ando (Par. 7, “A first insulating film is formed on a gate electrode of the transistor, and an electrolytic aqueous solution is disposed on the first insulating film. Then, the sensor cell is disposed in the electrolytic aqueous solution, and a proton is adsorbed onto the first insulating film. When the olfactory receptor recognizes the odor molecule, positive ions in the electrolytic aqueous solution flow from an ion channel of the olfactory receptor into the sensor cell. As a result, the proton is dissociated from the first insulating film into the electrolytic aqueous solution, and the potential of the gate electrode is changed.”) (Par 25 (transistor)) (Claim 1) (Claim 7, “wherein a potential change of the gate electrode which is caused when the olfactory receptor recognizes the odor molecule is differentiated with time to measure a concentration of the odor molecule.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Ando with that of Ando to explicitly include wherein an inflow of the ionized molecule into the transistor in the response of the captured one or more of the VOCs by the olfactory receptor is configured to change the potential of the gate electrode for the reasoning as indicated in claim 21 above.
Regarding claim 23, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Yamada does teach in an example wherein the device is configured to measure concentration of the one or more of the VOCs captured by the olfactory receptor (Yamada (Par. 66, “Current signals indicating the opened state and closed state of olfactory receptor channels were obtained, and the opening rate (opened state/(opened state+closed state)) was estimated at each of the time points.” (concentration)) (Par. 62, “When octenol is captured by the olfactory receptor protein, a current flows between the wells and is detected as a current signal.”) (Par. 43, 47 (target substance detection)) (Par. 3 (Volatile organic compound)) (Par. 42 (receptors))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Ando with an example of Yamada to include wherein the device is configured to measure concentration of the one or more of the VOCs captured by the olfactory receptor through the combination of references as it would have yielded the same or similar result of determining a target substance concentration.
Regarding claim 24, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Ando further teaches wherein the change in the potential of the gate electrode is configured to measure concentration of the one or more of the VOCs captured by the olfactory receptor (Ando (Par. 7, “A first insulating film is formed on a gate electrode of the transistor, and an electrolytic aqueous solution is disposed on the first insulating film. Then, the sensor cell is disposed in the electrolytic aqueous solution, and a proton is adsorbed onto the first insulating film. When the olfactory receptor recognizes the odor molecule, positive ions in the electrolytic aqueous solution flow from an ion channel of the olfactory receptor into the sensor cell. As a result, the proton is dissociated from the first insulating film into the electrolytic aqueous solution, and the potential of the gate electrode is changed.”) (Par 25 (transistor)) (Claim 1) (Claim 7, “wherein a potential change of the gate electrode which is caused when the olfactory receptor recognizes the odor molecule is differentiated with time to measure a concentration of the odor molecule.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Ando with that of Ando to explicitly include wherein the change in the potential of the gate electrode is configured to measure concentration of the one or more of the VOCs captured by the olfactory receptor for the reasoning as indicated in claim 21 above.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Reddy as applied to claim 25, and further in view of Ahmad (US Pub. No. 20170119280) hereinafter Ahmad.
Yamada and Reddy teach the device of claim 25 above.
Regarding claim 26, modified Yamada fails to explicitly disclose the limitations of the claim.
However, Ahmad teaches wherein the handheld device comprises a pump and a regulator configured to maintain a flow rate of air inside the component (Par. 374, “FIG. 23 and FIG. 24 present examples of apparatuses that can measure the production rate of acetone in the human body, as measured through breath. The devices in both figures are the same except for the positioning and components of the sensor element (items 206, 210, and 212 in both figures)…” “…Components (206, 210, and 212) comprise a gas sampling line, whereby a pump (212) removes gas from the mixing chamber (204) and pushes it through a flow measurement element (206) and a sensor element (210). A separate gas sampling line, with its own motive force (pump), is desirable to divorce sensor gas sampling from user breath input. In certain sensor configurations, particularly packed bed columns, a significant restriction to breathing is imposed by the sensor element. It is desirable to maintain breathing resistance as low as possible for user comfort, and thus a separate sample line allows the breath collection to be designed for optimal user interface, completely independent of sensor requirements which include, in general, known and steady flow rates and constant gas line pressures.”) (Par. 375, “a flow restrictor and differential pressure transducer (206) is placed upstream of the sensor element and the sampling pump.”).
Yamada, Reddy, and Ahmad are considered to be analogous art to the claimed invention as they are involved with analyte measurements
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamada and Reddy with that of Ahmad to explicitly include wherein the handheld device comprises a pump and a regulator configured to maintain a flow rate of air inside the component through the combination of references as it would have yielded the predictable result of maintaining a proper flow rate for sample collection (Ahmad (Par. 374)).
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791