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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 04, 2026 has been entered.
Response to Amendment
The Amendment filed May 04, 2026 has been entered. Claims 1, 3, 5-6, 10-14, 16, 18-24 and 26 remain pending in the application.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-6, 10-14, 16 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Coppede et al. (US 2018/0279930 A1) (“Coppede”) in view of Dervisevic, M., Dervisevic, E. & Şenel, M. Recent progress in nanomaterial-based electrochemical and optical sensors for hypoxanthine and xanthine. A review. Microchim Acta 186, 749 (2019) (“Dervisevic”) in view of Holmberg et al. (WO 2020/037334 A1) (“Holmberg”).
Regarding claim 1, Coppede discloses A device for detecting metabolites (Abstract and entire document and see at least [0027], “Embodiments of the invention disclosed herein are directed to articles of clothing that allow for monitoring of different analytes (e.g., electrolytes and molecules) in human sweat during fitness activity, while training, or simply in everyday life.”), the device comprising a carbon-based sensor, wherein the carbon-based sensor comprises pyrolytic carbon (FIG. 2 and [0040], “The system could be made of a three electrode structure, one reference electrode of Ag/AgCl as a wire inside the textile, a working electrode and a counter electrode. Common working electrodes can consist of materials ranging from inert metals such as gold, silver or platinum, to inert carbon such as glassy carbon or pyrolytic carbon.”).
Coppede fails to explicitly disclose detecting hypoxanthine as the metabolite
the pyrolytic carbon as Stress Activated Pyrolytic Carbon (SAPC).
However, in the same field of endeavor, Dervisevic teaches detecting hypoxanthine as the metabolite (Abstract, page 748-749 intro, sensing hypoxanthine with carbon-based sensors)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede to include hypoxanthine as a metabolite as taught by Dervisevic to study the significance in clinical and food science (Abstract).
Coppede as modified fails to explicitly disclose the pyrolytic carbon as Stress Activated Pyrolytic Carbon (SAPC).
However, reasonably pertinent to the problem faced, Holmberg teaches the pyrolytic carbon as Stress Activated Pyrolytic Carbon (SAPC).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to substitute one known element, the pyrolytic carbon as disclosed by Coppede for the SAPC as taught by Holmberg to obtain predictable results and different manufacturing and desirable physical properties ([1002]).
Regarding claim 3, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the carbon-based sensor is capable of detecting the hypoxanthine ([0040], “The textile gradient structure device allows absorption and control of the flux of sweat, and the integrated electrodes allow voltammetry measurements. In this way, it is possible to measure different analytes using a textile wearable potentiometric and voltammetric device, such as the measurements of the concentration of a specific ion. In particular, using ion selective membranes, such the one described in the paragraphs below, on the Counter electrode, for example made of textile fiber functionalized with conducting polymer (PEDOT:PSS) and successively covered with the ion selective membrane, it is possible to detect single ions in the sweat (Na.sup.+, K.sup.+, Ca.sup.2+, Mg.sup.2+, etc.).”).
Regarding claim 5, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the hypoxanthine is detected continuously ([0005], “Thus, embodiments of the presently disclosed textile allow the effective control of the sweat analyzed, monitoring of sweat during time, and correlation of the results of the analysis with the physiological state of the wearer over time.” [0027 – 0028], “In order to provide a sensor that is able to monitor electrolytes and other molecules in sweat in real time, the sweat sample must be controlled in quantity, position, and timing in such a way as to perform significant measurements.” And [0031] [ 0038] discussing monitoring and detecting in real-time, continuously).
Regarding claim 6, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the hypoxanthine is detected in real-time ([0005], “Thus, embodiments of the presently disclosed textile allow the effective control of the sweat analyzed, monitoring of sweat during time, and correlation of the results of the analysis with the physiological state of the wearer over time.” [0027 – 0028], “In order to provide a sensor that is able to monitor electrolytes and other molecules in sweat in real time, the sweat sample must be controlled in quantity, position, and timing in such a way as to perform significant measurements.” And [0031] [ 0038] discussing monitoring and detecting in real-time, continuously).
Regarding claim 10, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the device detects the hypoxanthine in a bodily fluid (Abstract and entire document and see at least [0027], “Embodiments of the invention disclosed herein are directed to articles of clothing that allow for monitoring of different analytes (e.g., electrolytes and molecules) in human sweat during fitness activity, while training, or simply in everyday life.”).
Regarding claim 11, Coppede as modified discloses The device according to claim 10, Coppede further discloses wherein the bodily fluid is sweat (Abstract and entire document and see at least [0027], “Embodiments of the invention disclosed herein are directed to articles of clothing that allow for monitoring of different analytes (e.g., electrolytes and molecules) in human sweat during fitness activity, while training, or simply in everyday life.”).
Regarding claim 12, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the hypoxanthine is analysed continuously ([0005], “Thus, embodiments of the presently disclosed textile allow the effective control of the sweat analyzed, monitoring of sweat during time, and correlation of the results of the analysis with the physiological state of the wearer over time.” [0027 – 0028], “In order to provide a sensor that is able to monitor electrolytes and other molecules in sweat in real time, the sweat sample must be controlled in quantity, position, and timing in such a way as to perform significant measurements.” And [0031] [ 0038] discussing monitoring and detecting in real-time, continuously).
Regarding claim 13, Coppede as modified discloses The device according to claim 1, Coppede further discloses wherein the hypoxanthine is analysed in real-time ([0005], “Thus, embodiments of the presently disclosed textile allow the effective control of the sweat analyzed, monitoring of sweat during time, and correlation of the results of the analysis with the physiological state of the wearer over time.” [0027 – 0028], “In order to provide a sensor that is able to monitor electrolytes and other molecules in sweat in real time, the sweat sample must be controlled in quantity, position, and timing in such a way as to perform significant measurements.” And [0031] [ 0038] discussing monitoring and detecting in real-time, continuously).
Regarding claim 14, Coppede as modified discloses The device according to claim 1, Coppede further discloses for use in assisting athletic performance, fitness, and general health (Abstract and entire document and see at least [0027], “Embodiments of the invention disclosed herein are directed to articles of clothing that allow for monitoring of different analytes (e.g., electrolytes and molecules) in human sweat during fitness activity, while training, or simply in everyday life.”).
Regarding claim 16, Coppede discloses A method for detecting hypoxanthine in sweat, the method comprising the steps of: a. providing a device, b. contacting the device with a bodily fluid, and c. determining the presence of the hypoxanthine, wherein the device comprises a carbon-based material including Stress Activated Pyrolytic Carbon (SAPC) (The same rejections as applied to claim 1 apply to the method claim as the device of claim 1 is provided and contacts the skin as discussed in the rejection above.).
Regarding claim 22, Coppede as modified discloses A wearable comprising the device according to claim 1 (Abstract and entire document and see at least [0004] wearable).
Regarding claim 23, Coppede as modified discloses The device of claim 1, Coppede as modifeid further discloses wherein the carbon based sensor further includes a material selected from the group consisting of carbon nanofibers (CNFs), carbon nanotubes (CNTs), and mixtures thereof (Holmberg Abstract, background and entire document).
Regarding claim 24, Coppede as modified discloses The device of claim 1, Coppede further discloses wherein the carbon-based sensor comprises an electrode assembly including a counter electrode, a reference electrode, and a working electrode comprising the SAPC (FIG. 1-2 and [0040], “The system could be made of a three electrode structure, one reference electrode of Ag/AgCl as a wire inside the textile, a working electrode and a counter electrode. Common working electrodes can consist of materials ranging from inert metals such as gold, silver or platinum, to inert carbon such as glassy carbon or pyrolytic carbon. Counter electrode could be a textile wire with conducting polymer (PEDOT:PSS) or a textile wire functionalized with specific materials that could react with different elecrolytes in the sweat. Voltammetry measurement can be performed by measuring the change in potential between counter and working electrode and also by measuring with respect to reference electrode, the result of which is proportional to the specific ion concentration.”).
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Coppede in view of Dervisevic in further view of Holmberg in further view of Gao et al. (US 2022/0110588 A1) (“Gao”).
Regarding claim 18, Coppede as modified discloses An assay using the device according to claim 1, Coppede as modified fails to disclose wherein an alteration in the levels of the hypoxanthine in a bodily fluid is an indication of abnormal metabolic activity.
However, in the same field of endeavor, Gao teaches wherein an alteration in the levels of the hypoxanthine in a bodily fluid is an indication of abnormal metabolic activity ([0106] assays and [0109] discussing changes in metabolite levels for indication of health status such as metabolic activity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to include wherein an alteration in the levels of the hypoxanthine in a bodily fluid is an indication of abnormal metabolic activity as taught by Gao to monitor health accurately ([0090], “As described herein, biosensor 100 allows for a fully-integrated platform with enhanced wearability and sensing accuracy. In embodiments, biosensor 100 may be ultrathin, transparent, and may use minimal power consumption.”).
Regarding claim 19, Coppede as modified discloses The assay according to claim 18, Coppede as modified fails to disclose wherein the alteration in the levels is relative to a base level of the hypoxanthine.
However, in the same field of endeavor, Gao teaches wherein the alteration in the levels is relative to a base level of the hypoxanthine ([0106] assays and [0109] discussing changes in metabolite levels for indication of health status such as metabolic activity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to include wherein the alteration in the levels is relative to a base level of the hypoxanthine as taught by Gao to monitor health accurately ([0090], “As described herein, biosensor 100 allows for a fully-integrated platform with enhanced wearability and sensing accuracy. In embodiments, biosensor 100 may be ultrathin, transparent, and may use minimal power consumption.”).
Regarding claim 20, Coppede as modified discloses The assay according to claim 19, Coppede as modified fails to disclose wherein when the alteration is an increase above the base level, a symptom, health, psychological or neurological condition is indicated.
However, in the same field of endeavor, Gao teaches wherein when the alteration is an increase above the base level, a symptom, health, psychological or neurological condition is indicated ([0106] assays and [0109] discussing changes in metabolite levels for indication of health status such as metabolic activity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to include wherein when the alteration is an increase above the base level, a symptom, health, psychological or neurological condition is indicated as taught by Gao to monitor health accurately ([0090], “As described herein, biosensor 100 allows for a fully-integrated platform with enhanced wearability and sensing accuracy. In embodiments, biosensor 100 may be ultrathin, transparent, and may use minimal power consumption.”).
Regarding claim 21, Coppede as modified discloses The assay according to claim 18, Coppede as modified fails to disclose wherein when the alteration is an increase above the base level, a tumour or cancer condition is indicated.
However, in the same field of endeavor, Gao teaches wherein when the alteration is an increase above the base level, a tumour or cancer condition is indicated ([0133] discussing metabolites and cancer detection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to include wherein when the alteration is an increase above the base level, a tumour or cancer condition is indicated as taught by Gao to monitor health accurately ([0090], “As described herein, biosensor 100 allows for a fully-integrated platform with enhanced wearability and sensing accuracy. In embodiments, biosensor 100 may be ultrathin, transparent, and may use minimal power consumption.”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Coppede in view of Dervisevic in further view of Holmberg in further view of Heikenfeld et al. (US 2018/0153451 A1) (“Heikenfeld”).
Regarding claim 26, Coppede as modified discloses The method of claim 16, Coppede as modified fails to disclose further comprising calibrating the device to compensate for pH variations in the bodily fluid.
However, in the same field of endeavor, Heikenfeld teaches further comprising calibrating the device to compensate for pH variations in the bodily fluid ([0010], pH calibration, see also [0011 – 0012] and [0045 – 0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Coppede as modified to include as taught by Heikenfeld to calibrate based on the environment ([0010]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 5-6, 10-14, 16, 18-24 and 26 have been considered but are moot because the new ground of rejection does not solely rely on any reference solely applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH A TOMBERS/Examiner, Art Unit 3791
Prosecution Insights