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 .
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 4, 5, 7, 8, 11-23 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 4 in lines 13-14 recites “the at least one characteristic of the sweat”; there is insufficient antecedent basis for this limitation in the claim. Further, line 15 recites “at least one characteristic of the sweat”, such that it is additionally unclear if this is the same characteristic or a different characteristic. For the purposes of examination the claim will be treated as though referring to only one characteristic; clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recites only the sensor element comprising a reagent, while claim 4 defines a narrower “colorimetric reagent”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4, 5, 7-23 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2021/0000395) in view of Mohammed (US 2008/0254441).
Regarding claims 4 and 14, Rogers discloses a device comprising:
a) a substrate configured to be removably attached to a subject's skin (paragraph [0028], [0373]-[0374]; element 20), wherein the substrate has at least one inlet in fluid communication with at least the subject's skin and wherein the at least one inlet is configured to receive and transfer a sweat aliquot (element 50; paragraph [0091]);
b) at least one sweat collector element configured to receive the sweat aliquot from the at least one inlet of the substrate (element 40); and
c) at least one sensor element having a proximal end and a distal end, a first length, L, along a longitudinal axis of the device, measured between the proximal end and the distal end of the at least one sensor element, wherein the at least one sensor element is in fluid communication with the at least one sweat collector element; and wherein the at least one sensor element comprises a colorimetric reagent configured to change appearance upon reaction with at least one characteristic of the sweat to quantitatively detect at least one characteristic of the sweat (element 80; paragraphs [0008], [0028], [0415], [0447]);
wherein the device is configured to indicate a presence of the at least one characteristic of the sweat (paragraph [0008]).
Rogers does not disclose the system further comprising at least one ready indicator element that is in fluid communication with the at least one sweat collector element through at least one fluidic path having a proximal end and a distal end and having a second length, L2, as measured between the proximal and distal ends along the longitudinal axis of the device,
wherein the second length is greater than the first length (L2>L1), and wherein the at least one ready indicator element is configured to change appearance when contacted by the sweat aliquot to indicate that the device is ready for reading; Mohammed teaches a device comprising a substrate with an inlet configured to receive and transfer a fluid aliquot to a collector element (paragraph 0091]), a sensor element having proximal and distal ends and a first length between the ends, where the sensor element is in fluid communication with the collector element and configured to quantitatively detect at least one characteristic of the fluid (element 204), and a ready indicator element (element 202) in fluid communication with the sweat collector via a fluidic path having a proximal end and a distal end and a length between the ends, where the length of the ready indicator element is longer/greater than the length of the sensor element (see figure 3; paragraph [0098]); wherein the at least one ready indicator element is configured to change appearance when contacted by the sweat aliquot to indicate that the device is ready for reading (paragraph [0098], “thus the test result is ready for read”). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Rogers and included a ready indicator element also connected to the collector element, the ready indicator being of a longer length than the sensor element, in order to indicate that sufficient fluid has been collected to produce an observable result (paragraph [0098]).
Regarding claim 5, Rogers further discloses that the at least one sweat collector element has a predetermined shape and a predetermined contact area (figure 1), and wherein the at least one inlet has a shape and a contact area that is the same or different as the predetermined shape and predetermined contact area of the at least one sweat collector element (the objects are inherently either the same or different as it is not possible to be both).
Regarding claim 7, Mohammed does not explicitly teach that a portion of the at least one collector element extends into the proximal end of the at least one fluidic path; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have extended a portion of the collector element into the fluidic path, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the fluid connection between elements as taught by Mohammed. Moreover, it appears that any fluid connection that avoids loss, whether abutting or overlapping, would perform equally well to allow transfer of fluid to the ready indicator element. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rogers as modified by Mohammed with a portion of the collector element extending into the fluidic path of the ready indicator element, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Rogers and Mohammed.
Regarding claim 8, Mohammed further teaches that the at least one ready indicator element has a predetermined shape having a predetermined area and is positioned substantially parallel to the at least one collector element (figure 3); Mohammed does not explicitly teach that the distal end of the at least one fluidic path extends into a portion of the at least one ready indicator element. However, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have extended a portion of the fluidic path into the ready indicator element since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the fluid connection between elements as taught by Mohammed. Moreover, it appears that any fluid connection that avoids loss, whether abutting or overlapping, would perform equally well to allow transfer of fluid to the ready indicator element. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rogers as modified by Mohammed with a portion of the fluidic path extending into the ready indicator element, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Rogers and Mohammed, and with the ready indicator having a “predetermined” shape positioned substantially parallel to the collector element, as also taught by Mohammed, in order to minimize space required for the device.
Regarding claim 11, Mohammed further discloses that the at least one fluidic path is configured to transfer a first portion of the collected aliquot from the at least one collector element to at least one ready indicator element (paragraph [0098]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Rogers as modified by Mohammed with the fluidic path configured to transfer a first potion of the collected fluid to the indictor, as further taught by Mohammed, in order to allow the indicator to function.
Regarding claim 12, Mohammed further teaches a dye configured to dissolve in the portion of the fluid aliquot and displayed as part of the ready indicator element (paragraph [0098]), but does not specify the dye being in at least a portion of the at least one fluidic path and configured to be transferred to the ready indicator element. However, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have loaded the dye into the fluidic path for transfer to the ready indicator, since Applicant has not disclosed use of this configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the dye used for indication in Mohammed. Moreover, it appears that locating the dye at any point between fluidic path and ready indicator, would perform equally well to respond to the fluid and provide the desired indication. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Rogers and Mohammed with a dye in the fluidic path configured respond to the portion of fluid and to be transferred to the ready indicator element, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Rogers and Mohammed.
Regarding claim 13, Mohammed further teaches that the at least one sensor element is coupled to the at least one collector element such that it is positioned “above” the at least one fluidic path or wherein the at least one sensor element is coupled to the at least one collector element, such that it is positioned parallel to the at least one fluidic path (figures 2, 3; paragraph [0098]; the Examiner notes that “above” is a relative term entirely dependent upon a viewer’s orientation in the absence of any point of reference). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Rogers and Mohammed, with the sensor element coupled to the collector element “above” and/or parallel to the fluidic path, as further taught by Mohamed, in order to not interfere with operation.
Regarding claim 15, Rogers further discloses that the reagent is a colorimetric reagent configured to change an original color of the reagent upon reaction with the at least one characteristic of the sweat, and wherein the colorimetric reagent is present in an effective composition to determine a dynamic range of a concentration of the at least one characteristic of the sweat (paragraph [0447]).
Regarding claim 16, Rogers further discloses that the colorimetric reagent comprises silver chloroanilate, cobalt chloride, glucose oxidase, peroxidase, potassium iodide, lactate dehydrogenase, diaphorase, formazan dyes, 2,4,6-tris(2-pyridiyl)-s-triazine (TPTZ) complexed with mercury ion, silver ion, or iron ion, a 2,2-'bicinchoninic acid, a, 10- phenanthroline, a universal pH indicator, silver dichromate, a compound of fluorescein and silver nitrate, or any combination thereof (paragraph [0028]).
Regarding claim 17, Rogers further discloses that the reagent is impregnated within the at least one sensor element from a solution, a suspension, or formed in-situ by reaction with the at least one characteristic of the sweat, or by a printing method (paragraph [0447].
Regarding claim 18, Rogers further discloses that the at least one sweat collector element comprises a porous material configured to directionally adsorb and transfer the sweat aliquot (paragraph [0084]).
Regarding claim 19, Rogers further discloses that the at least one sweat collector element comprises a paper, a polymer, a textile, a foam, or any configuration thereof (paragraph [0084]).
Regarding claim 20, Rogers further discloses that the at least one characteristic of the sweat comprises an amount of cations, anions, pH, temperature, volume, an amount of biomarkers, or a combination thereof (paragraph [0447]).
Regarding claim 21, Rogers further discloses that the at least one characteristic of the sweat is:
a) the amount of cations selected from sodium, potassium, calcium, magnesium, aluminum, iron, or a combination thereof, or
b) the amount of anions selected from chlorides, lactates, or a combination thereof; and/or
c) wherein the biomarkers comprise glucose, cholesterol, uric acid, urea, ascorbic acid, lactate, electrolytes, proinflammatory cytokines, hormones, tuberculosis- specific proteins, Parkinson-specific proteins, schizophrenia-specific proteins, cancer-specific metabolic markers, cystic fibrosis specific markers, drug-specific markers, alcohol, or any combination thereof (paragraphs [0415]-[0418])
Regarding claim 22, Rogers further discloses that the at least one characteristic of the sweat is present in an amount from about 0.10 mM to about 500 mM (paraph [0418]).
Regarding claim 23, Rogers further disclose that the device further comprises an additional sensor element configured to sense a biological response different from one characteristic of the sweat and wherein the biological response comprises a heart rate, blood pressure, skin temperature, sweat rate, blood oxygen saturation, or any combination thereof (paragraph [0340]).
Response to Arguments
Applicant's arguments filed 6 March 2026 have been fully considered but they are not persuasive.
Applicant argues that Rogers, as modified by Mohammed, does not disclose “the specific configuration of a colorimetric quantitative sensor element working together with the particular ready indicator element now claimed”; it is unclear what claim limitation involves these elements “working together” in any manner, as they are recited as two separate elements which happen to be in the same device.
Applicant further argues that Mohammed’s indicator does not “provide a visual signal to the user that the device has reached an appropriate state of reading the quantitative result from the colorimetric sensor element, rather than merely indicating that some minimum fluid volume has reached an indicator region”. It should be noted that the claims merely recite that the indicator “is configured to change appearance when contacted by the sweat aliquot to indicate that the device is ready for reading”. It is entirely unclear what other “appropriate state of reading the quantitative result” Applicant’s remarks refer to, as this is not reflected in the claims. Mohammed clearly teaches that the indicator element 202 is configured to “change appearance” (its color) “when contacted by the sweat aliquot” (paragraph [0098], “they get in contact with a sample”) “to indicate that the device is ready for reading” (paragraph [0098], “thus the test result is ready for read”). In the absence of any specific limitation or re-definition of “ready for reading” that would render it different in any way than Mohammed’s clear teaching of the indicator being used to indicate the device being “ready for reading”, Applicant’s argument is entirely unpersuasive.
Regarding the dependent claims, Applicant generally argues that “certain structural and geometric arrangements” would have been more than “a mere matter of design choice” without specifically identifying any of these limitations or pointing to any part of the disclosure that would support this general allegation of “specific structural choices”. The mere allegation of specificity of unidentified elements is not persuasive, and these “several dependent claims” remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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