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 group I in the reply filed on 01/26/2026 is acknowledged. Claims 31-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/29/2023 and 02/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-57 are pending with claims 1-30 being examined, claims 31-57 are deemed withdrawn.
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 element and the housing must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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
Claim 1-30 are objected to because of the following informalities:
Claims 1-30 lack the appropriate claim identifier (Original), (Currently amended, (Previously presented), (Withdrawn), (Canceled) (See MPEP 2234).
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.
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.
Claim limitation “element configured to passivate (the electrode)” in claim 1 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “element” coupled with functional language “passivate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “element” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 1 has/have been interpreted to cover “a membrane” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., para [0089] “As illustrated in FIG. 3, a membrane 336 can allow continuous solute passivation”).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 4, 6, 7, 14, 15, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claims 2, 3, 4, 14, 15, and 17 recite “the element”. There is lack of antecedent basis for this limitation in the claim since claim 1 previously recites “at least one element”. The limitations will be interpreted as “the at least one element” for consistency and clarity.
Dependent claims 6 and 7 are rejected as being dependent on claims 2 and 3.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-5, 8-9, 15, 18-21, 25-26 and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record).
Regarding claim 1, Lin teaches a device for detecting the presence of, or measuring the concentration of, at least one analyte (Lin; [0023]) in a sample fluid (Lin; [0024] “sample or bodily fluid”), the device comprising:
at least one electrode (Lin; fig. 18. 608, 609);
a sensor fluid in communication with the at least one electrode (Lin; fig. 18. 608 and sample solution), the sensor fluid including a plurality of aptamers (Lin; fig. 18 freely diffusing aptamers in the sensor fluid (Lin; [0053] “the graphene surface can be functionalized with aptamers”, and “the target analyte can compete and capture some of the free aptamers”); and
at least one element configured to passivate the at least one electrode by continuous solute passivation (Lin; fig. 18. 605).
Regarding claim 2, Lin teaches the device of claim 1 (see above), wherein the element includes a membrane (Lin; [0033] “The graphene can be a graphene sheet”) that is impermeable to at least one passivating solute adjacent to the at least one electrode (Lin; [0313] “polymerized functionalization of the graphene”, and [0052] “analytes selectively captured by aptamers immobilized on the graphene sensor”).
Regarding claim 3, Lin teaches the device of claim 1 (see above), wherein the element includes a membrane that is permeable to at least one passivating solute adjacent to the at least one electrode (Lin; [0033] “the graphene nanosensor can be coated with a glucose-permeable hydrogel”).
Regarding claim 4, Lin teaches the device of claim 1 (see above), wherein the element includes one or more solutes of a plurality of solutes endogenous to a sample fluid (Lin; [0493] “the sensor is immersed in a glucose solution”, and [0583] “exposing the graphene channel to insulin solutions without biochemical functionalization”).
Regarding claim 5, Lin teaches the device of claim 4 (see above), wherein the sample fluid is one of blood or interstitial fluid (Lin; [0030]).
Regarding claim 8, Lin teaches the device of claim 1 (see above), further comprising at least one reservoir fluid (Lin; [0299] “buffer solution was introduced into the graphene surface”).
Regarding claim 9, Lin teaches the device of claim 8 (see above), wherein the reservoir fluid contains the at least one element (Lin; [0299] “buffer solution was introduced into the graphene surface (element)”).
Regarding claim 15, Lin teaches the device of claim 1 (see above), further comprising a housing having one or more interior chambers (Lin; fig. 3A illustrates what appears to be a housing, and [0049] “enrichment and sensing chamber”) containing the at least one electrode (Lin; [0050] “the sensing chamber can include a graphene nanosensor”), sensor fluid (Lin; [0053] “a sample can be introduced into the enrichment chamber”), and element configured to passivate the at least one electrode; and wherein the housing is at least a portion of an in-dwelling device (Lin; fig. 3a and [0290 “implanted sensor”).
Regarding claim 18, Lin teaches the device of claim 1 (see above), wherein the at least one element configured to passivate the electrode is located in a passivating layer adjacent to the electrode (Lin; [0039]).
Regarding claim 19, Lin teaches the device of claim 1 (see above), wherein the at least one element comprises an exogenous molecule (Lin; [0044] “low molecular-weight molecules can be a bodily fluid”).
Regarding claim 20, Lin teaches the device of claim 1 (see above), wherein the at least one element comprises an endogenous solute from the sample fluid (Lin; [0034] “the first analyte can be glucose”).
Regarding claim 21, Lin teaches the device of claim 20 (see above), wherein the endogenous solute is configured to leave the electrode and be replaced by another molecule (Lin; [0272] “aptamers on the surface of the nanosensor can be replaced with other receptors”).
Regarding claim 25, Lin teaches the device of claim 1 (see above), further comprising a reservoir fluid in fluid communication with the sensor fluid (Lin; [0299] “buffer solution was introduced onto the graphene surface”).
Regarding claim 26, Lin teaches the device of claim 25 (see above), wherein the reservoir fluid includes albumin, peptides (Lin; [0054] “the aptamer can be a peptide”), or non-natural chemical solutes with single or multiple thiol binding sites, and is configured to continuously introduce the albumin, peptides, or non-natural chemical solutes to the electrode (Lin; [0054] “the aptamer can be functionalized to the surface of the graphene”, and [0111]).
Regarding claim 28, Lin teaches the device of claim 26 (see above), wherein the reservoir fluid is configured to accept waste from the sensor fluid (Lin; [0455] “the chamber was thoroughly rinsed with a buffer solution, after the waste outlet was closed…”).
Regarding claim 29, Lin teaches the device of claim 1 (see above), wherein the plurality of aptamers further comprising one or more anchor aptamers immobilized via a linkage to a hydrogel (Lin; [0046] “the graphene sensor can be functionalized with an aptameter that binds (anchors) the target analyte”, [0028] “the nanosensor can be coated with a biocompatible glucose-permeable hydrogel”, [0038] the hydrogel being responsive to an analyte”).
Regarding claim 30, Lin teaches the device of claim 10 (see above), wherein the membrane has a selective permeability based on size, charge, or at least one other property of the at least one element (Lin; [0052] “analytes can be selectively captured by the aptamers immobilized on the graphene sensor”, and [0284] “aptamer can selectively bind to a target molecule, which selectively binds to insulin molecules”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-17 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record).
Regarding claim 16, Lin teaches the device of claim 15 (see above), further comprising one or more microneedles in fluid communication with the one or more interior chambers.
Lin teaches the device including chambers (see above) wherein the device is implanted (see above) and glucose is diffused between the implanted and the patient tissue (Lin; [0332]).
It would have been obvious to include one or more microneedles in fluid communication with the one or more interior chambers in order to obtain the glucose sample.
Regarding claim 17, Lin teaches the device of claim 1 (see above) further comprising a housing having one or more interior chambers (Lin; fig. 3A illustrates what appears to be a housing, and [0049] “enrichment and sensing chambers”) containing the at least one electrode (Lin; [0050] “the sensing chamber can include a graphene nanosensor”), sensor fluid (Lin; [0053] “a sample can be introduced into the enrichment chamber”), and element configured to passivate the at least one electrode (Lin; [0202] “nanosensor can be constructed on a substrate, the substrate can be fabricated on a flexible film and the nanosensor device”);
and wherein the housing is adapted to be implanted into a subject (Lin; fig. 3A-B, and [0290] “testing the device in mice via subcutaneous implantation”).
Regarding claim 24, Lin teaches the device of claim 10 (see above), wherein the membrane is permeable to the analyte and wherein the membrane is positioned to retain the at least one element within at least 500 pm of the electrode.
Lin teaches a membrane and an element (see above).
Lin does not explicitly teach the membrane is permeable to the analyte and wherein the membrane is positioned to retain the at least one element within at least 500 pm of the electrode.
It would have been obvious to position the membrane to retain the at least one element within at least 500 pm of the electrode in order to provide space to retain the analyte and filter impurities.
Claims 10 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record) in view of Heikenfield (US 20200319214 A1; hereinafter “Heikenfield ‘214”).
Regarding claim 10, Lin teaches the device of claim 1 (see above), wherein the membrane is permeable to analyte in a sample fluid (Lin; [0028]).
Lin fails to teach the one or more aptamers of the plurality of aptamers each include a redox tag; and wherein the device further includes at least one membrane in communication with the sensor fluid and adapted to be in communication with a sample fluid, and is impermeable to each aptamer of the plurality of aptamers.
However, Heikenfield ‘214 teaches the analogous art of analyte detection (Heikenfield ‘214; [0015]) that includes aptamer sensors (Heikenfield ‘214; Title) wherein the aptamer sensor includes a redox tag (Heikenfield ‘214; [0023] “sensor 120 may include a redox tag”); and wherein the device further includes at least one membrane in communication with the sensor fluid and adapted to be in communication with a sample fluid (Heikenfield ‘214; [0031]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s aptamers wherein the one or more aptamers of the plurality of aptamers each include a redox tag; and wherein the device further includes at least one membrane in communication with the sensor fluid and adapted to be in communication with a sample fluid as taught by Heikenfield ‘214 because Heikenfield ‘214 teaches analyte detection (Heikenfield ‘214; [0015]) that includes aptamer sensors (Heikenfield ‘214; Title) wherein the aptamer sensor includes a redox tag (Heikenfield ‘214; [0023] “sensor 120 may include a redox tag”); and wherein the device further includes at least one membrane in communication with the sensor fluid and adapted to be in communication with a sample fluid (Heikenfield ‘214; [0031]).
The modification allows to filter the sample and remove impurities.
Lin fails to teach the membrane is impermeable to each aptamer of the plurality of aptamers
However, Heikenfield ‘311 teaches the analogous art of biofluid sensors (Heikenfield ‘311) that includes a membrane (Heikenfield ‘311) wherein the membrane is impermeable to each aptamer of the plurality of aptamers (Heikenfield ‘311; [0076]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s membrane to be impermeable to each aptamer of the plurality of aptamers as taught by Heikenfield ‘311 because Heikenfield ‘311 teaches of biofluid sensors (Heikenfield ‘311) that includes a membrane (Heikenfield ‘311) wherein the membrane is impermeable to each aptamer of the plurality of aptamers (Heikenfield ‘311; [0076]).
The modification allows the solvent to dissolve the analyte to create a solution (Heikenfield ‘311; [0076]).
Regarding claim 23, Lin teaches the device of claim 10 (see above), wherein the membrane is configured to allow only solutes from the sample fluid to permeate therethrough, and wherein the solutes from the sample fluid include the analyte (Lin; [0199] the hydrogel can be permeable to the target analyte”, and [0028] “the graphene nanosensor can be coated with a hydrogel).
Regarding claim 24, Lin teaches the device of claim 10 (see above), wherein the membrane is permeable to the analyte and wherein the membrane is positioned to retain the at least one element within at least 500 pm of the electrode.
Lin teaches a membrane and an element (see above).
Lin does not explicitly teach the membrane is permeable to the analyte and wherein the membrane is positioned to retain the at least one element within at least 500 pm of the electrode.
It would have been obvious to position the membrane to retain the at least one element within at least 500 pm of the electrode in order to provide space to retain the analyte and filter impurities.
Claims 11, 22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record) in view of Heikenfield et al. (US 20190142311 A1; hereinafter “Heikenfield ‘311”).
Regarding claim 11, Lin teaches the device of claim 1 (see above) to include a plurality of aptamers (see above).
Lin fails to teach wherein the plurality of aptamers comprise a plurality of signaling aptamers, and a plurality of anchor aptamers.
However, Heikenfield ‘311 teaches the analogous art of biofluid sensors (Heikenfield ‘311; Title) that includes a plurality of aptamers (Heikenfield ‘311; [0072] “the sensor could be an electrochemical aptamer, and the binding solute could be an aptamer that is suspended in solution”) wherein the plurality of signaling aptamers (Heikenfield ‘311; fig. 9A. 920, 922, and [0042]), and a plurality of anchor aptamers (Heikenfield ‘311; [0071] specific binding materials includes beads that bind to the solutes”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s plurality of aptamers to include a plurality of signaling aptamers, and a plurality of anchor aptamers as taught by Heikenfield ‘311 because Heikenfield ‘311 teaches biofluid sensors (Heikenfield ‘311; Title) that includes a plurality of aptamers (Heikenfield ‘311; [0072] “the sensor could be an electrochemical aptamer, and the binding solute could be an aptamer that is suspended in solution”) wherein the plurality of signaling aptamers (Heikenfield ‘311; fig. 9A. 920, 922, and [0042]), and a plurality of anchor aptamers (Heikenfield ‘311; [0071] specific binding materials includes beads that bind to the solutes”).
The modification allows to sense and detect the analyte.
Regarding claim 22, Lin teaches the device of claim 10 (see above) to include a membrane (see above).
Lin fails to teach wherein the membrane has a molecular weight cutoff of chosen from at least one of less than 300 Da, less than 1000 Da, less than 3 kDa, less than 10 kDa, less than 30 kDa, less than 100 kDa, and less than 300 kDa.
However, Heikenfield ‘311 teaches the analogous art of analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s membrane to have a molecular weight cutoff of <1000Da as taught by Heikenfield ‘311 because Heikenfield ‘311 teaches analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
The modification allows to remove cortisol from sweat (Heikenfield ‘311; [0096]).
Regarding claim 27, Lin teaches the device of claim 26 (see above), wherein the reservoir fluid is configured to supply the at least one element to the sensor fluid (Lin; [0057], [0064]).
Lin fails to teach wherein the membrane has a molecular weight cutoff of chosen from at least one of less than at least one element.
However, Heikenfield ‘311 teaches the analogous art of analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s membrane to have a molecular weight cutoff of <1000Da as taught by Heikenfield ‘311 because Heikenfield ‘311 teaches analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
The modification allows to remove cortisol from sweat (Heikenfield ‘311; [0096]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record) in view of Heikenfield et al. (US 20190142311 A1; hereinafter “Heikenfield ‘311”) further in view of Vallee et al. (US 20210310057 A1 in place of WO 2019232618 A1; hereinafter “Vallee”).
Regarding claim 12, Lin teaches the device of claim 11 (see above) to include a plurality of redox tags (see above).
Lin fails to teach each redox tag of the plurality of redox tags is bound to a signaling aptamer of the plurality of signaling aptamers.
However, Valle teaches the analogous art of molecular detection (Vallee; Title) to include aptamers (Vallee; fig. 8A-B “quinine, antibody”) wherein each redox tag of the plurality of redox tags is bound to a signaling aptamer of the plurality of signaling aptamers (Vallee; fig. 8A-B, and [0017]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s plurality of redox tags to be bound to a signaling aptamer of the plurality of signaling aptamers as taught by Vallee because Valle teaches molecular detection (Vallee; Title) to include aptamers (Vallee; fig. 8A-B “quinine, antibody”), wherein each redox tag of the plurality of redox tags is bound to a signaling aptamer of the plurality of signaling aptamers (Vallee; fig. 8A-B, and [0017]).
The modification allows to target binding induced changes.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record) in view of Heikenfield (US 20200319214 A1; hereinafter “Heikenfield ‘214”), further in view of Heikenfield et al. (US 20190142311 A1; hereinafter “Heikenfield ‘311”).
Regarding claim 13, Lin teaches the device of claim 10 (see above) to include a membrane (see above).
Lin fails to teach wherein the membrane has a molecular weight cutoff of <1000Da.
However, Heikenfield ‘311 teaches the analogous art of analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s membrane to have a molecular weight cutoff of <1000Da as taught by Heikenfield ‘311 because Heikenfield ‘311 teaches analyte detection (Heikenfield ‘311; [0015]) that includes a membrane (Heikenfield ‘311; [0096] “nanofiltration membrane”) wherein the membrane has a molecular weight cutoff of <1000Da (Heikenfield ‘311; [0096] “nanofiltration membrane. For example a 100-200 (Da) filter”).
The modification allows to remove cortisol from sweat (Heikenfield ‘311; [0096]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20200196925 A1; hereinafter “Lin” previous of record) in view of Heikenfield et al. (US 20180353748 A1; hereinafter “Heikenfield ‘748”).
Regarding claim 14, Lin teaches the device claim 1 (see above) to include at least one electrode, sensor fluid and element (see above).
Lin fails to teach a housing having one or more interior chambers containing the at least one electrode, sensor fluid, and element configured to passivate the at least one electrode; and wherein the housing is adapted to be placed outside of the body and the stratum- corneum of the skin of a subject.
However, Heikenfield ‘748 teaches the analogous art of a device for detecting an analyte (Heikenfield ‘748; [0079] “sensor to measure sweat estrogen”) that includes a housing (Heikenfield ‘748; Abstract “a device placed on the skin”, and [0105] “the invention may include a housing”) the housing having one or more interior chambers (Heikenfield ‘748; fig. 6. 14) containing the at least one electrode (Heikenfield ‘748; fig. 6. 650), sensor fluid (Heikenfield ‘748. Fig. 6 (arrows), and element configured to passivate the at least one electrode (Heikenfield ‘748; fig. 6. 687 and [0102] “material 687 prevents biofluid from fouling sensors”); and wherein the housing is adapted to be placed outside of the body and the stratum- corneum of the skin of a subject (Heikenfield ‘748; Abstract).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s at least one electrode, sensor fluid and element to be located in the interior of the housing as taught by Heikenfield ‘748 because Heikenfield ‘748 teaches a device for detecting an analyte (Heikenfield ‘748; [0079] “sensor to measure sweat estrogen”) that includes a housing (Heikenfield ‘748; Abstract “a device placed on the skin”, and [0105] “the invention may include a housing”) the housing having one or more interior chambers (Heikenfield ‘748; fig. 6. 14) containing the at least one electrode (Heikenfield ‘748; fig. 6. 650), sensor fluid (Heikenfield ‘748. Fig. 6 (arrows)), and element configured to passivate the at least one electrode (Heikenfield ‘748; fig. 6. 687 and [0102] “material 687 prevents biofluid from fouling sensors”); and wherein the housing is adapted to be placed outside of the body and the stratum- corneum of the skin of a subject (Heikenfield ‘748; Abstract).
The modification allows to have the structures from being exposed to the subjects skin.
Conclusion
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798