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 .
Priority
Priority claimed date provisional patent application (PRO) 63/590,791 is acknowledge.
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.
Claim 1 recites the limitation "An Internet of Things (loT) based emergency medical event management system for identifying one or more emergency medical events and providing rescue medication during the one or more emergency medical events of one or more individuals, the non-invasive based emergency medical event management system comprising…" in the non-invasive based emergency medical event management system. There is insufficient antecedent basis for this limitation in the claim. Claim 1 “an Internet of Things (IoT) based emergency medical event management system” and then says “the non-invasive based emergency medical event management system comprising:”. so it’s not clear if the system they are claiming is the same one they are defining by all the limitations.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Rejection Under 35 U.S.C. § 101
Claims 1-18 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories Analysis
The claims are directed to statutory subject matter, encompassing the following statutory categories:
Process (Claims 7-12): The language reciting "collecting, ... obtaining, ... processing, ... analyzing, ... and providing" defines a series of acts or steps, aligning with the definition of a process in MPEP § 2106.03.
Machine (Claims 1-6): The language reciting "one or more non-invasive devices, ... one or more communication devices, ... and one or more IoT-enabled drug delivery devices" describes a concrete thing consisting of parts, aligning with the definition of a machine in MPEP § 2106.03.
Manufacture (Claims 13-18): The language reciting "A non-transitory computer-readable storage medium" describes a tangible article given a new form through artificial efforts, aligning with the definition of a manufacture in MPEP § 2106.03.
Having confirmed the claims are directed to statutory subject matter, the analysis proceeds to Step 2A.
Step 2A, Prong One: Judicial Exception Analysis
The claims are directed to a judicial exception because they recite the abstract idea of collecting medical data, mentally analyzing it to diagnose an emergency, and organizing a corresponding medical treatment. Under their Broadest Reasonable Interpretation (BRI), the claims automate the long-standing medical practice of observing a patient's symptoms, diagnosing the severity of their condition, and administering a corresponding treatment.
Independent Claim
13. A non-transitory computer-readable storage medium having instructions stored therein that when executed by one or more hardware processors, cause the one or more hardware processors to execute operations of:
collecting at least one of: one or more biological samples and one or more biomarkers, from the one or more individuals;
obtaining data associated with at least one of: the one or more biological samples and the one or more biomarkers, at one or more non-invasive devices, from the one or more sensors;
processing the data associated with at least one of: the one or more biological samples and the one or more biomarkers, to detect severity of the one or more emergency medical events, using one or more processors of the one or more non-invasive devices;
obtaining information associated with the severity of the one or more emergency medical events, at one or more communication devices, from the one or more non-invasive devices;
analyzing the information associated with the severity of the one or more emergency medical events, using the one or more communication devices;
obtaining the analyzed information associated with the severity of the one or more emergency medical events, at one or more loT-enabled drug delivery devices, from the one or more communication devices; and
providing a corresponding rescue medication based on the severity of the one or more emergency medical events using one or more drug delivery mechanisms of the one or more IoT- enabled drug delivery devices.
Note: The bolded portions represent additional elements evaluated in Prong Two and Step 2B. The non-bolded portions represent the abstract idea. Publication #20250125029 was used for applicant language reference.
Claim Abstract Idea Classification & Rationale
Under their Broadest Reasonable Interpretation (MPEP § 2111), the independent claims 1, 7, and 13 recite a process of collecting patient biomarker data, analyzing it to determine the severity of a medical emergency, and acting on that determination by providing medication. This process aligns with the following abstract idea categories:
Mental Process (MPEP § 2106.04(a)(2)(III)): The claims recite a diagnostic method, which is a quintessential mental process performed by medical professionals. The claims recite the cognitive steps of obtaining data, processing it to "detect severity," and analyzing that information to decide on a corresponding action. The specification details this cognitive process, explaining that the processors are configured to "compare the measured concentration of biological compounds, with one or more pre-determined threshold values" and then "detect the severity of the one or more emergency medical events based on determination of the one or more ranges" (Spec., para. [0049]). This comparison and determination are a foundational aspect of human diagnostic reasoning.
Certain Method of Organizing Human Activity (MPEP § 2106.04(a)(2)(II)): The claims recite managing a medical response by coordinating the collection of patient data with the delivery of care. The claims recite the interactive steps of a patient being monitored, data being routed to an analysis stage, and a therapeutic device being activated. The specification outlines this management workflow, stating that after analysis, the system is configured to "trigger one or more signals to activate the one or more IoT-enabled drug delivery devices...for providing the corresponding rescue medication" (Spec., para. [0053]). This sequence of monitoring, analyzing, and triggering a therapeutic action is a method of Managing Personal Behavior or Relationships (specifically, managing a person's medical state).
Manual Replication Scenario (Human Equivalence)
The abstract nature of the claims is reinforced because the entire process is analogous to fundamental human activities, as illustrated by a parent caring for a sick child:
Collect Data: A parent uses a thermometer to collect a biomarker (the child's temperature).
Process Data to Determine Severity (Mental Process): The parent reads the thermometer (e.g., "103°F"). They mentally process this information, comparing it to their knowledge of normal body temperature, and determine the child has a severe fever.
Analyze and Decide on Action (Managing Personal Behavior): The parent analyzes the situation (the child's discomfort, the time of day) and decides on a course of action: to administer medicine. This workflow is a direct example of managing a person's well-being.
Provide Corresponding Medication: The parent selects the appropriate fever-reducing medication from a cabinet, measures the correct dose based on the child's age, and gives it to the child. This completes the human-managed process from diagnosis to treatment.
Dependent Claims Analysis
The dependent claims 2-6, 8-12, and 14-18 are also directed to an abstract idea as they add only further mental steps or specify a particular, technological environment for the abstract idea of the independent claims.
Claims 2, 8, and 14: These claims, under BRI, recite "comparing the measured concentration of biological compounds, with one or more pre-determined threshold values" to detect severity. This is a specific instance of the Mental Process of diagnosis, directly mirroring how a doctor compares patient test results to standard medical reference ranges.
Claims 4, 10, and 16: These claims recite "generating one or more scores indicating a level of confidence." This describes the Mental Process of quantifying a judgment or diagnosis, a common cognitive step in medical evaluation.
Claims 5, 11, and 17: These claims recite "analyzing the severity...based on the generated one or more scores" and "triggering one or more signals." This is a further recitation of the Mental Process of making a decision based on analyzed data.
Claims 3, 6, 9, 12, 15, and 18: These claims do not recite a separate abstract idea but inherit the abstract idea from their parent claims. They merely specify the particular types of sensors (e.g., CGM, EEG), biological markers (e.g., VOCs), or analysis techniques used as the source of data for the underlying abstract mental process. As stated in MPEP § 2106.04(d), limitations that amount to "a mere instruction to implement an abstract idea on a computer, or apply the abstract idea in a particular technological environment" do not render a claim eligible. These claims simply apply the abstract diagnostic method in the specific context of known medical sensing technologies.
The additional elements recited in the claims are generic components configured to perform the abstract mental and organizational steps, which will be further evaluated in the following analysis.
Step 2A, Prong Two: Integration into a Practical Application
The claims fail to integrate the abstract idea into a practical application because the additional elements, individually and in combination, merely provide a generic technological environment for performing the abstract diagnostic and care management method.
Evaluation of Independent Claims 1, 7, and 13 Additional Elements
Group 1: Generic Hardware (Claims 1, 7, 13): The recitation of “one or more non-invasive devices,” “one or more sensors,” “one or more processors,” “one or more communication devices,” and “one or more IoT-enabled drug delivery devices” fails to integrate the abstract idea.
(MPEP § 2106.05(f)) - Mere Instructions: Under their Broadest Reasonable Interpretation (MPEP § 2111), the claims simply instruct the use of generic hardware to perform the abstract idea. For instance, the limitation "one or more processors configured to...process the data...to detect severity" is a mere instruction to apply the abstract mental step of diagnosis on a computing device.
(MPEP § 2106.05(a)) - No Tech Improvement: The claim elements, interpreted broadly, do not improve the functioning of the underlying technology. The recitation of "one or more sensors configured to collect...biomarkers" and "one or more IoT-enabled drug delivery devices" does not specify any improvement to sensor or drug delivery technology but rather uses them as generic tools in their usual capacity.
(MPEP § 2106.05(g)) - Insignificant Activity: The claims bookend the abstract analysis with insignificant pre- and post-solution activities. The step of "collecting...one or more biological samples" is pre-activity data gathering, while "providing a corresponding rescue medication" is a post-solution activity action taken after the crucial abstract determination has been made.
(MPEP § 2106.05(h)) - Linking to Environment: The claim language "An Internet of Things (IoT) based...system" and the recitation of IoT-enabled devices merely links the abstract idea to a particular technological environment. This is an insufficient field-of-use limitation that does not amount to a practical application.
Group 2: Generic Storage Medium (Claim 13): The recitation of a "non-transitory computer-readable storage medium" also fails to integrate the abstract idea.
(MPEP § 2106.05(f)) - Mere Instructions: The language "A non-transitory computer-readable storage medium having instructions stored therein that when executed...cause the...processors to execute operations of..." is a classic example of merely claiming the abstract process as code on a generic medium. Under BRI, this limitation adds no more than an instruction to store the abstract idea.
(MPEP § 2106.05(a)) - No Tech Improvement: The "non-transitory computer-readable storage medium" itself is not improved. The claim is not directed to a more efficient or effective memory device, but simply uses a medium for its basic purpose of storing data, which is not a technical improvement.
(MPEP § 2106.05(g)) - Insignificant Activity: The act of storing instructions on the medium is an insignificant pre-solution activity. The substance of the invention lies in the abstract logic of the "operations," not the routine act of saving them to a storage device beforehand.
(MPEP § 2106.05(h)) - Linking to Environment: This element nominally links the abstract idea to a computer environment by reciting a storage medium, but it does not integrate the idea in any meaningful way beyond stating that the abstract process can be implemented on a generic computer system.
Combination Analysis: When viewed as a whole, the combination of these elements does not integrate the abstract idea. The claim describes a generic arrangement of hardware (sensors, processors, communication links, dispensers) and software storage performing an abstract analysis, which does not transform the abstract idea into a patent-eligible practical application.
Dependent Claims Analysis
The dependent claims add only minor limitations that fail to provide the necessary integration.
Claims 2, 4, 5, 8, 10, 11, 14, 16, 17: These claims do not add new physical elements. They merely recite more specific steps of the abstract mental process (e.g., "comparing...with...threshold values," "generating one or more scores"). These limitations further define the abstract idea itself rather than integrating it into a practical application.
Claims 3, 6, 9, 12, 15, 18: These claims add specific, sensor types ("a continuous glucose monitoring (CGM) sensor") and biomarkers ("volatile organic compounds"). This is a mere field-of-use limitation (h) that fails to integrate the abstract idea because it simply names well-known tools to carry out the data collection step.
Conclusion: Because the claims are directed to an abstract idea without integrating it into a practical application, the analysis proceeds to Step 2B.
Step 2B: Inventive Concept Analysis
The claims lack an inventive concept because the additional elements, individually and in combination, do not amount to significantly more than the judicial exception itself.
Evaluation of Independent Claims 1, 7, and 13 Additional Elements
Group 1: Generic Hardware (Claims 1, 7, 13):
(MPEP § 2106.05(f)) - Mere Instructions: The claim recites generic hardware to perform the abstract steps. The specification describes these components in purely functional terms, stating that "the one or more sensors 202 are configured to collect" (Spec., para. [0044]), "the one or more processors 204 are...configured to process the data" (Spec., para. [0047]), and the "IoT-enabled drug delivery devices 102 are configured to... provide a corresponding rescue medication" (Spec., para. [0041]), without detailing any specific, unconventional structure or operation that would amount to more than simply implementing the idea.
(MPEP § 2106.05(a)) - No Tech Improvement: The claims do not improve computer or medical device functionality. The specification describes standard, off-the-shelf technology, noting communication devices may be "a mobile device, a smartphone, a personal digital assistant (PDA), a tablet computer, a phablet computer, a wearable computing device, a laptop, a desktop, a server, and the like" (Spec., para. [0040]), and the delivery mechanism can be any type, including "an injection-based mechanism, a pump-based mechanism, a transdermal patch-based mechanism" (Spec., para. [0054] as it relates to dual modes). Further, the general computing environment is described as a "standalone, client or server computer system" (Spec., para. [0034]), confirming no improvement to the technology itself is taught.
Group 2: Generic Storage Medium (Claim 13):
(MPEP § 2106.05(d)) - Well-Understood, Routine, Conventional: Reciting a "non-transitory computer-readable storage medium" is a routine drafting convention and adds no inventive concept. The specification describes it in boilerplate terms as "any apparatus that can comprise, store, communicate, propagate, or transport the program" and lists well-known examples such as "a semiconductor or solid-state memory, magnetic tape, a removable computer diskette, a random-access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk" (Spec., paras. [0070], [0071]), confirming its absolute high-level.
(MPEP § 2106.05(a)) - No Tech Improvement: The medium does not improve the computer's function; it merely stores instructions. The generic description and list of existing technologies in the specification at paragraph [0071] fail to teach any improvement to storage medium technology itself, instead confirming it is a generic component.
(MPEP § 2106.05(g)) - Insignificant Activity: The act of storing data is a routine, insignificant activity that precedes the execution of the abstract idea. The specification provides no details to suggest this element is anything more than a generic data repository, referring to it only as a "medium...[that] can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system" (Spec., para. [0071]) without further inventive detail.
(MPEP § 2106.05(h)) - Linking to Environment: This element provides a nominal link to a "computer" environment but does not contribute an inventive concept. It is a generic recitation used to place the abstract idea in a technological context without adding any inventive substance, as evidenced by the boilerplate description of a "representative hardware environment" in paragraph [0073].
Viewed as a whole, the combination of these additional elements amounts to no more than a generic IoT system applied to the abstract idea of medical diagnosis.
Dependent Claims Analysis
Group 1 (Claims 2, 8, 14): These claims add the data processing step of "compare the measured concentration of biological compounds, with one or more pre-determined threshold values" (Spec., para. [0014]). This is a basic a data analysis technique, as confirmed by the detailed description in paragraph [0049].
Group 2 (Claims 3, 9, 15): These claims name specific types of well-known medical sensors. This is a mere field-of-use limitation
The dependent claims, even when considered with the independent claims, do not supply an inventive concept. They simply narrow the abstract idea to a particular medical context (e.g., using an EEG).
Because the claims are directed to an abstract idea without reciting any additional elements that, individually or in combination, amount to significantly more than the abstract idea itself, the claims are ineligible for patent protection. Therefore, Claims 1-18 are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 7-11, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017087888A1-Levine.
Prior art Levine teaches Claim 1.
An Internet of Things (IoT) based emergency medical event management system for identifying one or more emergency medical events and providing rescue medication during the one or more emergency medical events of one or more individuals, the non-invasive based emergency medical event management system comprising: (Levine, par. 0083, 0107)
Levine describes an integrated system that performs exactly these functions. It uses sensors to detect an emergency and automatically provides medication, with the capability to notify external services.
one or more non-invasive devices, wherein the one or more non-invasive devices comprise: (Levine, par. 0076-0077)
The prior art explicitly describes a "non-invasive, wearable device" for monitoring physiological signals like chest wall movement.
one or more sensors configured to collect at least one of: one or more biological samples and one or more biomarkers, from the one or more individuals;
The prior art discloses using non-invasive sensors to gather "physiologic signals" (biomarkers). (Levine, par. 0009, 0076-0077)
one or more processors configured to: obtain data associated with at least one of: the one or more biological samples and the one or more biomarkers, from the one or more sensors; (Levine, par. 0009-0010, 0091-0093)
and process the data associated with at least one of: the one or more biological samples and the one or more biomarkers, to detect severity of the one or more emergency medical events; (Levine, par. 0009-0010, 0076-0080, 0086, 0091-0093, 0107)
The prior art describes a "controller" that performs the functions of the claimed "processor." This controller receives biological signals from wearable sensors and processes them using a specific algorithm to calculate an "Airway Obstruction Severity Score," which directly corresponds to detecting the severity of an emergency medical event like an asthma attack or anaphylaxis.
one or more communication devices communicatively connected to the one or more non-invasive devices, wherein the one or more communication devices are configured to: (Leveni, par. 0079, claim 6
The prior art explicitly describes an architecture where a wearable sensor communicates with an external device, such as a smartphone or smartwatch. This external device serves as the communication device.
obtain information associated with the severity of the one or more emergency medical events, from the one or more non-invasive devices; (Leveni, par. 0080)
The prior art describes the non-invasive device calculating an Airway Obstruction Severity (AOS) score. It explicitly states that if this score exceeds a certain threshold, an "alert" is sent to the mobile device. This alert is the "information associated with the severity."
and analyze the information associated with the severity of the one or more emergency medical events; (Leveni, par. 0107, 0079, 0086)
and one or more IoT-enabled drug delivery devices are communicatively connected to the one or more communication devices, wherein the one or more IoT-enabled drug delivery devices are configured to: (Leveni, par. 0010, 0107)
The prior art explicitly describes a "wearable injector" that is "communicatively coupled" to a controller. The system's integration with a smartphone to notify external parties like 911 confirms the "IoT-enabled" nature of the drug delivery device.
obtain the analyzed information associated with the severity of the one or more emergency medical events, from the one or more communication devices; (Leveni, par. 0010, 0086)
The prior art teaches that after the controller determine presence of anaphylaxis symptoms (the analysis), it automatically causes the needle to move (the injector obtaining the information). It also links the injection directly to a severity "threshold" being exceeded.
and provide a corresponding rescue medication based on the severity of the one or more emergency medical events using one or more drug delivery mechanisms. (Leveni, par. 0010, 0158-0159)
The prior art repeatedly describes the automatic injection of epinephrine as the system's response to detecting a severe event.
Prior art Levine teaches Claim 2.
The IoT-based emergency medical event management system of claim 1, wherein in processing the data associated with at least one of: the one or more biological samples and the one or more biomarkers, to detect the severity of the one or more emergency medical events, the one or more processors of the one or more non-invasive devices are configured to:
obtain the data associated with at least one of: the one or more biological samples and the one or more biomarkers, from the one or more sensors of the one or more non-invasive devices, wherein the data associated with at least one of: the one or more biological samples and the one or more biomarkers, comprise concentration of biological compounds measured from the data associated with at least one of: the one or more biological samples and the one or more biomarkers; (Leveni, par. 0100 – 0101, 0133)
The prior art explicitly describes a "biosensor" as a component of the overall system, which is designed to measure the "levels" of specific biological compounds that are key indicators of an allergic reaction. This directly corresponds to the claimed function of measuring the "concentration of biological compounds."
compare the measured concentration of biological compounds, with one or more pre-determined threshold values, wherein the one or more pre-determined threshold values comprise one or more ranges indicating the severity of the one or more emergency medical events; (Leveni, par. 0100-0103, 0086)
The prior art teaches that the system's logic is based on comparing measured values to thresholds to determine a course of action. Specifically for biological compounds, the prior art states that a "high level or a rapid rise in histamine" is used to identify an allergic reaction and trigger the auto-injector. Therefore it is comparing the measured histamine concentration against a high level (pre-determined threshold) that defines what level is considered "high" and indicative of a severe event.
and detect the severity of the one or more emergency medical events based on determination of one or more ranges, upon comparison of the measured concentration of biological compounds, with the one or more pre-determined threshold values. (Leveni, par. 0010, 0100-0103, 0086)
The prior art teaches this exact function. The controller is configured to use the measurement of biological compounds to make a specific determination about the presence and severity of an emergency medical event. When the system finds that histamine levels have crossed a threshold into a "high" range, it concludes that this is a "measure of early anaphylaxis," thereby detecting the severity of the event.
Prior art Levine teaches Claim 3.
The IoT-based emergency medical event management system of claim 1, wherein the one or more sensors comprise at least one of:
a continuous glucose monitoring (CGM) sensor configured to detect glucose level in blood;
a breath sensor configured to detect at least one of: ethane, pentane, and relevant volatile organic compounds (VOC) corresponding to myocardial infarction;
a wearable electroencephalogram (EEG) sensor configured to detect one or more electrical activities of a brain;
an oxygen saturation sensor configured to detect blood oxygen level;
an electrocardiogram sensor (ECG) configured to detect one or more electrical activities of a heart; and. (Leveni par. 0143, 0097, 0149)
The prior art explicitly and repeatedly discloses the use of an electrocardiogram (ECG) sensor as a primary input for its detection algorithm. The system is described as using ECG signals to extract clinical features for determining the severity of a medical event like anaphylaxis or asthma.
one or more wearable glasses configured to monitor eye movements indicating at least one of: seizure and one or more neurological issues
Prior art Levine teaches Claim 4.
The IoT-based emergency medical event management system of claim 1, wherein the one or more processors of the one or more non-invasive devices are configured to:
generate one or more scores indicating a level of confidence for detecting the severity of the one or more emergency medical events; (Leveni, par. 0097-0098, 0009-0010)
The prior art explicitly teaches that its detection algorithm is configured to assess the "likelihood" or "probability" of a medical event. Paragraph [0098] states that the algorithm "considers different features from the input signals to assess the likelihood of an imminent anaphylactic attack." This "likelihood" is a score indicating the confidence in the detection. Paragraph [0009] similarly describes the controller's function as determining the "probability of future occurrence," which is another form of a confidence score.
and transmit information associated with the generated one or more scores indicating the level of confidence for detecting the severity of the one or more emergency medical events, to the one or more communication devices. (Leveni, par. 0098, 0080)
A processor calculates a likelihood score for an event, such as an anaphylactic attack. If the score exceeds a set threshold, it sends an alert to a mobile device. The alert serves as the information associated with the likelihood score.
Prior art Levine teaches Claim 5.
The IoT-based emergency medical event management system of claim 4, wherein the one or more communication devices are configured to:
obtain the information associated with the generated one or more scores indicating the level of confidence for detecting the severity of the one or more emergency medical events, from the one or more non-invasive devices; (Leveni, par. 0080, 0098)
The prior art describes a system where the processor's algorithm assesses the "likelihood" of an event. When this assessment crosses a critical point (a "threshold"), an "alert" is sent to a "mobile device." This transmitted alert is the "information associated with" the confidence score.
analyze the severity of the one or more emergency medical events based on the generated one or more scores indicating the level of confidence; (Leveni, par. 0080, 0098)
The prior art discloses that the main processor, which performs the analysis, can be housed within the smartphone (the communication device). Also, it describes the smartphone taking actions (like notifying 911) that are contingent upon the severity information it receives, An analysis or decision-making step to initiate those actions.
and trigger one or more signals to activate the one or more IoT-enabled drug delivery devices for providing the corresponding rescue medication based on the severity of the one or more emergency medical events. (Leveni, par. 0080, 0090-0093, 0098, 0009-0010, 0100-0103)
The prior art explicitly describes this trigger function. The controller, upon determining that an injection is based on its analysis of the biological signals, is configured to "trigger actuation" of the injector or "automatically cause" the injection to occur.
Note: Claims 7-11, and 13-17 are rejected with the same analysis above for being very similar to claims 1-5.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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.
Claim(s) 6, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017087888A1-Levine and US20210015399A1 - Gouma.
Prior art Levine teaches Claim 6.
The IoT-based emergency medical event management system of claim 2, wherein the biological compounds measured from at least one of: the one or more biological samples and the one or more biomarkers, comprise one or more
wherein the one or more volatile organic compounds are identified in at least one of:
Leveni explain claim 2 as explained before, however biological or biomarkers are not describing as volatile organic compounds using gas sensors with chemical analysis techniques. However, Levine describe in par. 0101-0102 an electrochemical histamine biosensor that it is a chemical analysis technique.
Gouma describes how analyzing a subject's breath gas, which contains volatile organic compounds (VOCs) and biomarkers, can be used for disease diagnosis and health status monitoring. (Gouma, par. 0002-0006)
Gouma also describe breath gas sensing system that monitors changes in exhaled nitric oxide (NO) and isoprene, which are biomarkers used to evaluate physiological changes and hypoxia-related episodes (emergency condition) in subjects like fighter pilots and people at high altitudes. Par. 0007-0009
It is obvious to combine before the filling date because, Levine and Gouma share a system comprising a sensor that are non-invasive to detect a chemical biomarker in a biological sample to detect emergency condition. Levine, par. 0013, 0088, 0100-0102,0124, 0177-0181, Gouma, 0002-0009
A Person Having Ordinary Skill in the Art (PHOSITA) would have been motivated to combine the teachings of Gouma and Levine by the clear market and design incentive to apply a known, successful biosensor technology to a different, but analogous, diagnostic problem with a reasonable expectation of success. For example, detect hypoxia-related episode an emergency condition. (Gouma, par. 0007)
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684