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 of Group II in the reply filed on 11/11/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 10, 17, 28-29, and 33 are objected to because of the following informalities: Claim 10 recites “the input and out of said circuit” in line 8, but instead should be -- an input and output of said electronic circuit--. Any recitations of a “circuit” thereafter should recite --electronic circuit--. Claim 10 recites “said sensing module” in lines 13-14, but instead should be --nanosensing module--. Claim 10 recites “a first device” in line “w),” but instead should be --the first device--. Claim 17 should be amended to omit one of the “second report” in line 2. Claims 28-29 recite “said device” in line 1, but instead should be --said first device--. Claim 33 recites “wherein graphene of said graphene based sensing device comprises a graphene selected from the group consisting of” in lines 1-2, but instead should be --wherein graphene of said graphene based sensing device is selected from the group consisting of--, Appropriate correction is required.
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.
Claims 10, 13 and 18-19 are 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 10 recites “a nanosensing element comprising a substrate supporting an electronic circuit comprising . . . a graphene . . . a microprocessor . . . a communicator . . . a connection to at least one power source” in lines 6-7, but is indefinite on multiple grounds. What is the comprising for each element correlated to, the nanosensing element, the substrate, the electronic circuit? As best understood by the specification, the nanosensing element comprises the graphene and will be interpreted as such(¶[0062]). The microprocessor appears to be part of the overall device, not solely to the any of the above elements (¶[0015]). The communicator is not referenced in the specification, but appears to be any one of a microprocessor or microcontroller (¶[0015,0055]). The device generally comprises the power source, not specific to the above elements (¶[0062]). For examination purposes, the limitation is interpreted to be taught be the prior art when the above components are disclosed as part of the overall device. Further clarification required.
Claim 13 recites “wherein said communication device apply an artificial intelligence engine,” but lacks detail in the specification. There is no support in the specification that all communication devices are capable of applying an artificial intelligence engine. It appears that only the central processor is capable of performing such application (¶[0007]). Since the claims fail to recite “the central processor” the specification lacks details for the step to be performed by any of the components listed in the independent claim or in claim 13. Moreover, the same issue regarding the AI engine apply for this claim.
Claim 18 recites “wherein said second report processes data combined from session reports in the same time period” in the first two lines, but lacks detail in the specification. There is no detail on the process of how the data between session reports in the same time period are combined. Further clarification required.
Claim 19 recites “wherein said second report compares session reports” in the first two lines, but lacks detail in the specification. There is no detail on the process of how the data between session reports are compared. Further clarification required.
Claim 30 recites “transmits data using the patient’s skin to a central station” in line 2, but fails to provide details on how that step is performed. It is undefined as to how the patients skin is used to transmit data. The specification merely recites that data is streamed through the patient’s skin, which is not the same as purposefully using the skin to perform the transmission (¶[0001]). Further clarification required.
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 10-33 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 10 recites “an activity station to produce biometric data” in line “y),” but lacks detail in the specification. “An activity station” is not recited once in the specification and is unclear as to what component performs the function or if it is a user of the device. “Biometric data” is recited once and the relationship with the “activity station” is unclear (¶[0006]). As such, the subject matter is not reasonably described in the specification and the inventor’s possession of the claimed invention is in question.
Claim 10 recites, in the last 2 lines, “a first device or an auxiliary device in use or,” but is indefinite and lacks proper antecedent basis. The limitation is unfinished and “a . . . an” should be --the . . . the--.
Claim 11 recites “wherein at least one of said device” in line 1, but is indefinite. What “at least of said device” is being referenced, the first device, the auxiliary device, the sensing device? As best understood by the specification, the device can be the first device and will be interpreted as such for examination (¶[0045]). Further clarification required.
Claim 12 recites “said at least one hand grip” in line 2, but lacks proper antecedent basis. Claim 11 does not mention “one hand grip” therefore, “said” is improperly used to refer to “a hand grip.” Amendment required to clarify the intended limitation.
Claim 14 recites “said communication devices” in line 1, but is indefinite. Which communication device are performed such function, all of them, one of them, some of them? Further clarification required.
Claim 16 recites “a database” in line 2, but is indefinite. Is it the same database in claim 1 or a different database? For examination purposes it will be interpreted as either. Further clarification required.
Claim 16 recites “said reported biometric data . . . y) with said reported biometric data” in line 2, but is indefinite. Is the reported biometric data the processed biometric data that forms a session report or the produced biometric data as recited in claim 1? Further clarification required.
Claim 16 recites “said second report to a data received . . . a person controlling . . . a device . . . a database” in lines 5-8, but is indefinite. Are the elements that same as in claim 10 or different? For examination, they will be interpreted as the same. As such, proper antecedent basis is required.
Claim 21 recites “unsubstantiated” in line 2, but is indefinite because it is unclear how that pertains to the limitation. Further clarification required.
Claim 27 recites “the method of claim 16” in the preamble, but is indefinite because claim 16 does not require stressful situations. It appears that claim 27 depends on claim 26 and will be interpreted as such. Amendment required.
Claim 31 recites “transmitting to a forward base, hospital, specialist, or trauma center,” but is indefinite. What is being transmitted, the data, the light from the sensors, or something else? For examination purposes, it will be interpreted that information regarding the use’s data is transmitted. Clarification required.
The term “essentially” in claim 33 is a relative term which renders the claim indefinite. The term “essentially” 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. The specification lacks defining the term “essentially” and therefore unclear the degree of flatness, e.g. %, +/-, etc.
Claims not recited are rejected by virtue of claim dependency.
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 10, 14-18, 21-23, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Putkaradze et al (US 20220146415), hereinafter Putkaradze, and further in view of Daniels (US 20210321903).
Regarding claim 10, Putkaradze teaches a method comprising: providing an individual with a first device (¶[0063,0091], sensor is placed near and/or on subject),
a sensor component comprising nanosensing module sensitive to volatile organic compounds (VOCs) (¶[0029,0064,0122], sensor can sense VOC’s, e.g., ethanol, as well as a VOC auxiliary sensor within the device);
wherein said nanosensing module comprises: a nanosensing element comprising a substrate supporting an electronic circuit comprising a graphene based sensing device connecting the input and output of said circuit (¶[0061], surface layer/substrate of the sensor/electronic system is composed of graphene nanotubes).
Putkaradze fails to teach wherein the circuit is functionalized with a biomolecule species.
Daniels teaches a device for detecting biomarkers formed of carbon nanotubes by functionalized the device with the carbon nanotubes (¶[0002,0339]). The carbon nanotubes are functionalized with short sing-stranded nucleic acid sequences to aid in binding with the target molecule (¶[0340]). As such, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze, such that the circuit is functionalized with a biomolecule species, as taught by Daniels, to aid in binding the target molecule to the sensor and allow for measurement of the target molecule (¶[0339]). Moreover, Putkaradze acknowledges that there are other suitable materials for enhancing sensor sensitivity, but fails to provide details, and Daniels teaches that it can be done with biomolecule species (¶[0061] of Putkaradze).
It follows, Putkaradze-Daniels teach a microprocessor for receiving, processing and transmitting said data; a communicator for accessing said processed data and communicating said processed data to a receiver (¶[0010,0055-57,0119-120] of Putkaradze); and
a connection to at least one power source that when activated energizes said sensing module (¶[0056], power supply 110 of Putkaradze) said first device further comprising: a fixture containing said nanosensing element comprised in said sensing module (fig. 15A-B and ¶[0118] of Putkaradze, inner shell 1505 is configured to house the sensor),
activating said first device at an activity station to produce biometric data (¶[0046] of Putkaradze, the device is configured to turn on and continuously measure, therefore has an activity station to produce biometric data);
processing said biometric data through an artificial intelligence (Al) engine to form a session report; transmitting said report to a data receiver selected from the group consisting of: said individual, a person controlling, managing, or advising said individual, a first device or an auxiliary device in use or planned for use by said individual, and a database. a first device or an auxiliary device in use or (¶[0010,0136-143] of Putkaradze, the device comprises a machine learning model to determine the characteristics of the subject, thereby producing a session report for a plurality of subjects, e.g., elderly, athletes, coaches, informing them and others of session conditions, e.g., health, via transmission of report).
Regarding claim 14, Putkaradze teaches wherein z) is repeated to a plurality of individuals and wherein said communicating devices accessing changed real, time date recommend a second teammate or captain to front the team (¶[0139], “In these embodiments, the olfactory sensor device may be in communication with a notification system (e.g., an alarm, a display, a paging system) configured to notify an athlete, trainer, or coach of each athlete's fatigue or injury status. . . . to optimally time substitutions, adjust strategy, or adjust training regimen in real time.” Each team player is notified in real time to recommend a substitution of any one player).
Regarding claim 15, Putkaradze teaches wherein said Al engine processes data relating to at least season (¶[0136-137], “wearable devices according to the present disclosure may be used to identify odorants useful for monitoring athlete performance, injury status, overall health, and/or conditioning level during off-season training, in-season training, or during competition. Such information could be further used to optimize the composition or make-up of athletics teams for an entire season, for a single game, or during particular stretches of individual games/matches. For instance, such information could be valuable in optimizing timing of player substitutions, offensive/defensive player matchups, or depth charts for particular games/matches.”).
Regarding claim 16, Putkaradze teaches accessing in a database said reported biometric data associated with said individual; u) combining said biometric data from said repeated y) with said reported biometric data associated with said individual (¶[0136], “Olfactory sensor devices according to the present disclosure may be used to evaluate the physical condition or status of an athlete by continuously monitoring the performance, vital signs, overall physical well-being, and/or conditioning level of the athlete” indicating that a plurality of parameters associated with the biometrics of the user are combined to evaluate the physical condition or status of an athlete);
t) processing said combined data through an Al engine to form a second report; and s) reporting said second report to a data receiver selected from the group consisting of: said individual, a person controlling, managing, or advising said individual (¶[0136-139], the reports are continuously generated, e.g., first, second, third, based on changing physical condition to determine when substitutions are required and sent to coaches and teammates).
Regarding claim 17, Putkaradze teaches wherein at least two session reports are processed to form said second report (¶[0136-139], multiple session reports generated “of each athlete's fatigue or injury status” comprise the second report (recommendation) to “optimally time substitutions, adjust strategy, or adjust training regimen in real time” ).
Regarding claim 18, Putkaradze teaches wherein said second report processes data combined from session reports in the same time period selected from the group consisting of: a preselected number of days (P[0136-139], session report are continuously generated and processed, therefore combined, during a season, game, etc., to determine the athletes current status, changing status, and prior status).
Regarding claim 21, Putkaradze teaches wherein the sensor system further comprises temperature, motion, and humidity sensors (¶[0122]).
Regarding claims 22-23, Putkaradze teaches wherein said module is sensitive to at least one VOC from the alcohol group (¶[0029,0109], methanol, ethanol, etc.).
Regarding claim 29, Putkaradze teaches wherein the device is disposed on at least the chest (¶[0139]).
Regarding claim 30, Putkaradze teaches wherein at least one second device (¶[0063], multiple sensors in parallel and/or auxiliary device 128), wherein the second device transmits data using the patient’s skin to a central station (fig. 1 and [0055,0139], data is transmitted by the multiple sensors (second, third, etc.) by emitting light into the user and obtaining the data reflected by skin (and other organs) to a central location (116, the controller, data analyzer)).
Regarding claim 31, Putkaradze teaches wherein said central station is on said individual’s chest or torso (¶[0139], “olfactory sensor devices may be worn on the athletes skin (arm, leg, shoulder, chest, back, etc.)”).
Regarding claim 32, Putkaradze teaches transmitting to a hospital and/or specialist (¶[0143]).
Claims 11-13 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Putkaradze in view of Daniels, as applied to claim 10, and further in view of Fiware (Cycle routes and air quality monitoring with REAL citizen’s engagement 2020).
Regarding claim 11, Putkaradze-Daniels fail to teach wherein at least one of said device is installed as a hand grip on an exercise machine. It is noted however, the device of Putkaradze is used during exercise but fails to mention the particular equipment (¶[0136-139] of Putkaradze).
Fiware discloses a bike with a handle, wherein on the handle a sensor is disposed to detect VOCs (pages 4, 6, and 10).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that wherein said device is installed as a hand grip on an exercise machine, as taught by Fiware, as it would merely be combining prior art elements (VOC sensors) according to known methods (place on handles of an exercise machine) to yield predictable results.
Regarding claim 12, Putkaradze-Daniels-Fiware teach wherein said exercise machine comprises a bicycle (page 10 of Fiware) and said at least one hand grip comprises at least one communication port, said at least one communication port capable of communicating with at least one device of at least one teammate or captain (¶[0123,0139] of Putkaradze, the wireless communication port communicates with teammate and coach, e.g., captain).
Regarding claim 13, Putkaradze teaches wherein said communicating devices apply an artificial intelligence engine to recommend one teammate or captain to front the team (¶[0139], “device may be in communication with a notification system (e.g., an alarm, a display, a paging system) configured to notify an athlete, trainer, or coach of each athlete's fatigue or injury status” and “when the olfactory sensor device determines one or more characteristics (e.g., identity, concentration) of one or more odorants indicating fatigue or injury, the olfactory sensor device communicates a message (e.g., alarm, text message, phone call, message on a remote display) to an athlete, coach, or trainer to optimally time substitutions, adjust strategy, or adjust training regimen in real time”(emphasis added). That is the device communication to at least one teammate to substitute a player, e.g. take one player out and therefore one to the front).
Regarding claim 24, Putkaradze-Daniels fail to teach wherein said wherein said individual operates equipment selected from the group consisting of: triangle bars, treadmills, resistance machines, cuff weights, dumbbells, horizontal and/or vertical bars, resistance grips, balance balls cyclers, and rope pulls.
Fiware teaches individuals can ride a bike, comprising horizontal handle bars, where the VOC sensor is located, to measure the VOC chemicals.
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that wherein said device is installed as a hand grip on an exercise machine, as taught by Fiware, as it would merely be combining prior art elements (VOC sensors) according to known methods (place on handles of an exercise machine) to yield predictable results.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Putkaradze in view of Daniels, as applied to claim 10, and further in view of Peterson et al. (US 20200124588), hereinafter Peterson.
Regarding claim 19 Putkaradze-Daniels fail to teach wherein said second report compares session reports from at least a first and a second session.
Peterson teaches a method and device for monitoring a subject brain health by measuring volatile organic compounds (abstract). The method further comprises measuring the VOC chemicals before and after an injury to compare the values and determine the severity of the injury and choice of treatment (¶[0054-55]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that the second report compares session reports from at least a first and a second session, as taught by Peterson, to aid in determining the severity of an injury and the choice of treatment to follow.
Regarding claim 20, Peterson teaches wherein the individual suffers an injury between first sessions and second session (¶[0055], “the later testing can be performed after the subject has experienced a blow to the head”).
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Putkaradze in view of Daniels, as applied to claim 10, and further in view of Thors et al. (US 20220007972), hereinafter Thors.
Regarding claim 25, Putkaradze-Daniels fail to teach wherein said providing comprises securing to said individual using a fixture selected from the group consisting of: hook and pile like fasteners, tie straps, magnets, adhesives, and elastics.
Thors teaches a non-invasive monitoring method and device to detect VOCs (abstract). The monitoring device configured to be worn on the user wrist via wristband, adhesives, etc. (¶[0081]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Putkaradze-Daniels, such that the monitoring device is secured to the individual via an adhesive, as taught by Thors, because Daniels requires attaching the device to the individual, but fails to provide details, and Thors teaches that it can be accomplished via an adhesive.
Regarding claim 26, Putkaradze-Daniels fail to teach wherein said AI is trained with VOC readings correlated with individuals stressful situations.
Thors teaches “ the physiological status is hypoglycemia and the VOC is acetone, methyl nitrate, pentyl nitrate (for example, 2-pentyl nitrate), ethanol, methanol, propanol, methane, propane, ethyl benzene, isoprene, O-xylene, M/P-xylene, formaldehyde, acetaldehyde or combinations of the foregoing,” “oxidative stress is associated with hypoglycemia, levels of these compounds may reflect changes in oxidative status indicative of hypoglycemia, ” “[n]eural networks, cluster analysis, and other artificial intelligence systems may be coupled with the wearable device of the present disclosure,” “train the sensor system . . . refine what is within an acceptable range for a physiological status or outside of an acceptable range for a physiological status, and/or to provide further analysis of a result (i.e., the presence, amount or concentration of an analyte),” and “[b]y using multiple networks, each network is trained for a specific VOC.” (¶[0056,0058,0078-80]). That is, Thors teaches correlating hypoglycemia to a VOC, where hypoglycemia is representative of oxidative stress (individuals stressful situation).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that said AI is trained with VOC readings correlated with individuals stressful situations, as taught by Thors, because Putkaradze requires evaluating the physical condition of an athlete based on vital signs, and Thors teaches it can be evaluated based on the correlation of VOCs with oxidative stress. The combination is merely combining prior art elements (correlation of VOCs with oxidative stress) to known methods (to obtain physical status of individual) to yield predictable results.
Regarding claim 27, Thors teaches wherein stress in said stressful situations is from the group consisting of low blood sugar (¶[0055-58]).
Regarding claim 28, Putkaradze-Daniels fail to teach wherein said device is incorporated within an accessory selected from the group consisting of: a helmet, a scarf, a headband, an earplug, an armband, a wristband, an ankle band, a knee band, a chest band, a waist band, a pair or shorts, a shirt, a fingerlet, a glove, a ring, a bracelet, a shoe insert, a vest, and a jacket.
Thors teaches wherein the wearable device is incorporating into a wristband (¶[0081]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that the device is incorporated into a wristband, as taught by Thors, because Putkaradze requires attaching the device to an individual but fails to provide details, and Thor teaches it can be accomplished via a wristband.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Putkaradze in view of Daniels, as applied to claim 10, and further in view of Haick (US 20190271685).
Regarding claim 33, Putkaradze-Daniels fail to teach wherein graphene of said graphene based sensing device comprises a graphene selected from the group consisting of: essentially flat graphene - including crumpled graphene, and single walled carbon nanotubes.
Haick teaches a system, device, and method for monitoring the health of a user based on measuring the VOCs (abstract). The device comprising a sensor single walled carbon nanotubes coated with an organic coating to detect VOCs. As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Putkaradze-Daniels, such that the graphene is single walled nanotubes, as taught by Haick, because Putkaradze requires graphene nanotubes to measure VOCs, but fails to provide details, and Haick teaches the graphene can be formed as a single walled carbon nanotubes for measurement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kam teaches a sensor apparatus based on chemically functionalized graphene as the sensing materials. US 20210239639
Daunert teaches diagnosing a condition in an individual by analyzing the individual's breath are provided. US 20210228104
Reddy teaches biomarkers for systems, methods, and devices for detecting and identifying certain substances, such as chemicals, volatile organic compounds (VOCs). US 20200337594
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791