DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed April 29, 2026.
Claims 1, 2, 5-12, and 15-20 are pending.
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 .
Response to Amendments
Claims 1, 2, 5-12, and 15-20 are pending. Claim objections have been overcome.
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.
Claims 1, 2, 5-12, and 15-20 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1, 9, and 11:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent claims 1 falls within the statutory category of machine.
Independent claim 9 falls within the statutory category of method.
Independent claim 11 falls within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 9, and 11 (claim 1 being representative) claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in the independent claims (claim 1 being representative) is:
diagnostic assessments
receive one or more samples from a body of a patient, the sample(s) comprises one or more blood, tissue, saliva, urine or faeces;
determine one or more parameters based on information obtained from the one or more samples received
compare the determined one or more parameters with predefined parameters;
determine a health related information of the human body based on the comparison; and
determine a predictive analysis risk comorbidity alerts, and decision support for doctors based on the health related information;
perform real time diagnostic based on the received samples; and
transmit-send the health related information
This abstract idea is “certain methods of organizing human activity” as it is managing personal behavior and following rules and instructions to determine and send diagnosis information for a patient (MPEP § 2106.04(a)(2), subsection II)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1, 9, and 11 judicial exception is not integrated into a practical application.
In Claim 1 the additional elements are:
A computer system comprising one or more medical instrument sensors
a memory unit configured to store machine-readable instructions
a processor
a communication network
one or more user devices
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element (a) is recited as tools or equivalent to apply the abstract idea as “apply-it” to gather data
The additional element, (b), is recited as tools or equivalent to apply the abstract idea as “apply-it” to store data
The additional element (c) is executing the abstract idea and recited as tools or equivalent to apply the abstract idea as “apply-it” to analyze data
The additional element (d) is recited as tools or equivalent to apply the abstract idea as “apply-it” to communicate data
The additional element (e) is recited as tools or equivalent to apply the abstract idea as “apply-it” to communicate data
In Claim 9 there are no additional elements not already recited in independent claim 1 therefore purely treated as the abstract idea.
In Claim 11 the additional elements not already recited in the independent claim 1 are:
A portable medical device
an integrated touchscreen control panel
wireless communication module
a chemistry analyzer
a dry-strip reagent analyzer
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element (a) is executing the abstract idea and recited as tools or equivalent to apply the abstract idea as “apply-it” to gather, store, and analyze data
The additional element (b) and (c) are recited as tools or equivalent to apply the abstract idea as “apply-it” to output data
The additional element (d) and (e) are recited as tools or equivalent to apply the abstract idea as “apply-it” to process data
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims do not include additional elements sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea thus insufficient to provide “significantly more”. Therefore, the claim does not amount to significantly more and the claim is ineligible.
Dependent Claims 2, 5-8, 10, 12, and 15-20:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2, 5-8 fall within the statutory category of machine
The dependent claim 10 falls within the statutory category of method
The dependent claims 12, 15-20 fall within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2, 5-8, 10, 12, and 15-20 claimed invention is directed to an abstract idea without significantly more. The claims continue to limit the independent claims 1, 9, and 11 abstract idea by (1) further limiting the types of samples and data, and (2) further the rules and instructions to analyze data. Therefore, the dependent claims inherit the same abstract idea which is “certain methods of organizing human activity” as it is managing personal behavior and following rules and instructions to determine and send diagnosis information for a patient (MPEP § 2106.04(a)(2), subsection II)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2, 5-8, 10, 12, and 15-20 this judicial exception is not integrated into a practical application.
The dependent claims recite the additional elements below not already recited in the independent claims:
a group comprising spirometer, electrocardiography sensor, glucose ketone analyser, electronic blood pressure (BP) monitor, Lipid Profiler, creatinine monitor, HbA 1 C monitor, Hb monitor, urine analyser, cardiovascular analyser, thyroid, renal, liver function analyser, haemoglobin and white blood cell (WBC) analyser, cancer screening, communicable disease detector, cancer identifier, portable X-Ray, uric acid/UREA profiler, Thermometer, stethoscope, pulse oximeter, CBP analyser, mammogram.
a plurality of wheels and back strap
internet-enabled with an integrated 4G dongle
a laptop, a desktop PC, an AR/VR headset, a smartphone or a tablet, a patient database
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element (a) are recited as tools or equivalent to apply the abstract idea as “apply-it” to gather data
The additional element (b) are recited as tools or equivalent to apply the abstract idea as “apply-it” to move computer system
The additional element (c) are recited as tools or equivalent to apply the abstract idea as “apply-it” to communicate data
The additional element (d) are recited as tools or equivalent to apply the abstract idea as “apply-it” to communicate data
Accordingly, the dependent claims as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The dependent claims do not include additional elements sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea thus insufficient to provide “significantly more”. Therefore, the claim does not amount to significantly more and the claim is ineligible.
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.
Claims 1, 2, 5, 6, 7, 8, 9, and 10 are rejected to under 35 U.S.C. 103 as being unpatentable over Wang et. al (hereinafter Wang) (AU2013201509A1) in view of Lefkofsky (US20210118559A1)
As per claim 1, Wang teaches:
A system for diagnostic assessments, the system comprising: ([0009] discloses, “One aspect of the present invention is the design of a system capable of providing real time data transmission between a patient and medical practitioners to facilitate high throughput point-of-care testing in an ambulatory setting. The systems and methods provided herein simplify the laborious and expensive procedures of processing and analyzing the samples collected from a subject ( e.g., a patient) without the use of laboratory equipment or facility. The systems and methods are particularly useful for detection of an analyte from a small sample of bodily fluid to effect diagnosis, prognosis, treatment, and development of therapeutics.”)
one or more medical instrument having plurality of sensors, ([00112] discloses, “A reaction assembly preferably houses a detection assembly for detecting a signal produced by at least one assay on the fluidic device” and see [00114] discloses, “In some embodiments, the detection system may comprise non-optical detectors or sensors for detecting a particular parameter of a patient. Such sensors may include temperature, conductivity, potentiometric, and amperometric, for compounds that are oxidized or reduced, for example, 02, H202, and I2, or oxidizable/reducible organic compounds.”)
and configured to receive one or more samples from a body of a patient, the sample(s) comprises one or more blood, tissue, saliva, urine or faeces; ([0067] discloses, “Any bodily fluids suspected to contain an analyte of interest can be used in conjunction with the subject system or devices. Commonly employed bodily fluids include but are not limited to blood, serum, saliva, urine, gastric and digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluids derived from tumorous tissue, and cerebrospinal fluid. In a preferred embodiment, the bodily fluids are used directly for detecting the analytes present therein with the subject fluidic device without further processing.”)
a processor configured to determine one or more parameters based on information obtained from the one or more samples received by the one or more medical instruments; ([0073] discloses, “Once the assay is performed on the t1uidic device, a signal indicative of an analyte in the bodily fluid sample is generated and detected by a detection assembly. The detected signal may then be communicated to the communications assembly, where it can be transmitted to the external device for processing, including without limitation, calculation of the analyte concentration in the sample.” And see [00118] discloses, “In some embodiments the external device can be a computer system, server, or other electronic device capable of storing information or processing information. In some embodiments the external device includes one or more computer systems, servers, or other electronic devices capable of storing information or processing information.” / examiner interprets external device as a processor as someone of ordinary skill would understand as it is disclosed as a computer )
a memory unit operably connected to the processor and configured to store machine readable instructions, wherein the processor is configured by the machine-readable instructions to: ([00116] discloses, “In some embodiments the communication assembly can have a memory or storage device, for example localized RAM, in which the information collected can be stored. A storage device may be required if information cannot be transmitted at a given time due to, for example, a temporary inability to wirelessly connect to a network. The information can be associated with the fluidic device identifier in the storage device.” And see [00117] discloses, “In preferred embodiments an external device communicates with the communication assembly within the readers assembly” And see [00118] discloses, “In some embodiments the external device can be a computer system, server, or other electronic device capable of storing information or processing information. In some embodiments the external device includes one or more computer systems, servers, or other electronic devices capable of storing information or processing information.” And [0073] discloses, “The protocol to be run on the fluidic device may comprise instructions to the controller of the reader assembly to perform the protocol on the fluidic device, including but not limited to a particular assay to be run and a detection method to be performed.” / examiner interprets external device as a processor as someone of ordinary skill would understand as it is disclosed as a computer)
compare the determined one or more parameters with predefined parameters; ([00179] discloses, “comparing the detected values to a threshold value predetermined for said pharmacological parameter;” and see [00208] discloses, “The value(s) is compared with the parameter values estimated when the fluidic device was calibrated by the manufacturer. Signal results are then adjusted using the following equation: Signaladjusted = Signal*(Aractory calibration/ Ameasured within the assay) and the original calibration equation (Equation 1) is then used to calculate the analyte concentration.”)
determine a health related information of the human body based on the comparison; ([00179] discloses, “comparing the detected values to a threshold value predetermined for said pharmacological parameter;” and see [00208] discloses, “The value(s) is compared with the parameter values estimated when the fluidic device was calibrated by the manufacturer. Signal results are then adjusted using the following equation: Signaladjusted = Signal*(Aractory calibration/ Ameasured within the assay) and the original calibration equation (Equation 1) is then used to calculate the analyte concentration.” And see also [0073] / examiner notes the analyte concentration is health related information of a human body)
and determine a predictive analysis risk, …[…]…and decision support for doctors, based on the health related information; ([00173] discloses, “For example, if glucose were the analyte of interest, the concentration of glucose in a sample at a given time as well as the rate of change of the glucose concentration over a given period of time could be highly useful in predicting and avoiding, for example, hypoglycemic events.” And [00178] discloses, “The present invention therefore creates a business method which effectively performs at least part of the monitoring of a patient that is currently performed by medical personnel.”)
wherein the processor is configured to perform real time diagnostic based on the received samples; and ([0009] discloses, “One aspect of the present invention is the design of a system capable of providing realtime data transmission between a patient and medical practitioners to facilitate high throughput point-of-care testing in an ambulatory setting. The systems and methods provided herein simplify the laborious and expensive procedures of processing and analyzing the samples collected from a subject ( e.g., a patient) without the use of laboratory equipment or facility. The systems and methods are particularly useful for detection of an analyte from a small sample of bodily fluid to effect diagnosis, prognosis, treatment, and development of therapeutics.”)
and a communication interface configured to: transmit the health related information to one or more user devices over one or more networks. ([00115] discloses, “A communication assembly is preferably housed within the reader assembly and is capable of transmitting and receiving information wirelessly from an external device. Such wireless communication may be bluetooth or RTM technology. Various communication methods can be utilized, such as a dial-up wired connection with a modem, a direct link such as a Tl, ISDN, or cable line. In preferred embodiments a wireless connection is established using exemplary wireless networks such as cellular, satellite, or pager networks, GPRS, or a local data transport system such as Ethernet or token ring over a local area network. In some embodiments the information is encrypted before it is transmitted over a wireless network. In some embodiments the communication assembly may contain a wireless infrared communication component for sending and receiving information.” And see [00184] discloses, “The communication step to a third party can be performed wirelessly as described herein, and by transmitting the data to a third party's hand held device, the third party can be notified of the assay results virtually anytime and anywhere. Thus, in a time-sensitive scenario, a patient may be contacted immediately anywhere if urgent medical action may be required.”)
However, Wang does not explicitly teach:
…[…]…comorbidity alerts,…[…]…
However, Lefkofsky does teach:
…[…]…comorbidity alerts,…[…]… (see [0052] discloses, “For example , clinical information in the area of cancer may include demographics ( such as Year of Birth , Gender , Race / Ethnicity , Relevant Comorbidities , Smoking History ) , diagnosis ( Site ( Tissue of Origin ) , Initial Diagnosis Date , Initial Diagnosis , Histology ,”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s teachings as previously cited with Lefkofsky’s teachings as previously cited, the motivation being, Wang teaches exemplary analytes which may be indicative of certain diseases (see table 4) , therefore it would be obvious to one of ordinary skill that the operability of taking analyte data in Wang would improve by identifying any overlap in diseases for e.g. in table 4 to indicate any comorbidities as this is a choice of data analysis and the operation of Wang would not change.
As per claim 2, Wang teaches:
The system according to claim 1, wherein the one or more medical instruments include one or more instruments selected from: spirometer, electrocardiography sensor, glucose ketone analyser, electronic blood pressure (BP) monitor, Lipid Profiler, creatinine monitor, HbA 1 C monitor, Hb monitor, urine analyser, cardiovascular analyser, thyroid, renal, liver function analyser, haemoglobin and white blood cell (WBC) analyser, cancer screening, communicable disease detector, cancer identifier, portable X-Ray, uric acid/UREA profiler, Thermometer, stethoscope, pulse oximeter, CBP analyser, mammogram. ([0066] The subject system comprises a fluidic device having one or more of the following components: a sample collection unit, an assay assembly, a reader assembly, and a communication assembly. The sample collection unit typically allows a sample of bodily fluid collected from a subject to react with reactants contained within the assay assembly for generating a signal indicative of the presence of the analyte of interest. The reader assembly detects the signal, which is then transmitted via the communication assembly to an external device for further processing.” And see [0067] Any bodily fluids suspected to contain an analyte of interest can be used in conjunction with the subject system or devices. Commonly employed bodily fluids include but are not limited to blood, serum, saliva, urine, gastric and digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluids derived from tumorous tissue, and cerebrospinal fluid. In a preferred embodiment, the bodily fluids are used directly for detecting the analytes present therein with the subject fluidic device without further processing.” / examiner interprets the device which analyzes urine as a urine analyzer)
As per claim 5, Wang teaches:
The system according to claim 1, wherein the health related information is selected from a group comprising basic biometric data (including temperature), complete urine analysis, haemoglobin and white blood cell count, detailed cardiovascular function (electrocardiogram, heart rate), blood vitamin analysis, detailed diabetes blood glucose levels, renal function test, thyroid test, hypertension, liver function test, pulmonary function test, prostate function test, Cancer Markers, Tumour Markers, Infection Markers, comprises one or more of: like covid-19 antibody testing IgM, electrolyte measurement test, Malaria, Chikungunya, Typhoid, and HlNl- ([00150] In some embodiments markers according to the present invention are disease specific. Exemplary cancer markers include without limitation PSA (total prostate specific antigen), Creatinine, Prostatic acid phosphatase, PSA complexes, Prostrate-specific gene-1, CA 12-5, Carcinoembryonic Antigen (CEA), Alpha feto protein (AFP), hCG (Human chorionic gonadotropin), Inhibin, CAA Ovarian C1824, CA 27.29, CA 15-3, CAA Breast Cl 924, Her-2, Pancreatic, CA 19-9, Carcinoembryonic Antigen, CAA pancreatic, Neuron-specific enolase, Angiostatin DcR3 (Soluble decoy receptor 3), Endostatin, Ep-CAM (MK-1 ), Free lmmunoglobulin Light Chain Kappa, Free lmmunoglobulin Light Chain Lambda, Herstatin, Chromogranin A, Adrenomedullin, Integrin, Epidermal growth factor receptor, Epidermal growth factor receptor-Tyrosine kinase, Pro-adrenomedullin N-terminal 20 peptide, Vascular endothelial growth factor, Vascular endothelial growth factor receptor, Stem cell factor receptor, ckit/ KDR, KDR, and Midkine.”)
As per claim 6, Wang further teaches:
The system according to claim 1, wherein the communication interface comprises a wireless communications module configured for (i) local wireless communication and (ii) internet connectivity, comprising one or more of Wi-Fi, Bluetooth, or a cellular communications module selected from 3G, 4G, or 5G, and being internal to the portable medical device housing ([00115] discloses, “A communication assembly is preferably housed within the reader assembly and is capable of transmitting and receiving information wirelessly from an external device. Such wireless communication may be bluetooth or RTM technology. Various communication methods can be utilized, such as a dial-up wired connection with a modem, a direct link such as a Tl, ISDN, or cable line. In preferred embodiments a wireless connection is established using exemplary wireless networks such as cellular, satellite, or pager networks, GPRS, or a local data transport system such as Ethernet or token ring over a local area network. In some embodiments the information is encrypted before it is transmitted over a wireless network. In some embodiments the communication assembly may contain a wireless infrared communication component for sending and receiving information “ and see fig. 1)
As per claim 7, Wang does not teach:
The system according to claim 1, wherein the processor is further configured to: receive health information related to one or more patients for diagnostic assessments from doctors, hospitals or health organizations;
allow any patient of the one or more patients to view, share and maintain health data, preserving health records digitally and chronologically;
update information about any patient of the one or more patients thereby helping hospitals, medical stores and diagnostic centres ;
facilitate one or more information dialogs between patients, doctors, hospitals and all involved parties;
perform self-risk assessment tests for stress, and also examine risk to develop certain chronic diseases; and monitor prognosis and diagnosis of patients in real-time
However, Lefkofsky teaches:
The system according to claim 1, wherein the processor is further configured to: receive health information related to one or more patients for diagnostic assessments from doctors, hospitals or health organizations; ([0276] discloses, “In yet another example , analysis module 180i may request diagnostic results from subjects who also received diagnostic test results from the same laboratory and , if available , results for the same diagnostic tests from other laboratories to identify any bias that may be introduced introduced from that laboratory's specific processing of subject specimens.”)
allow any patient of the one or more patients to view, share and maintain health data, preserving health records digitally and chronologically; (e.g. [0302] discloses, “The status of each pathogen ( for example , whether it is detected in the patient specimen or not ) , may be included in a report delivered to the physician and / or patient .The report may be delivered to the physician and / or patient automatically upon completion of at least one assay ordered for the patient , or at another point in the assay and assay analysis workflow.” And see [0279] discloses, “Smart outputs may include adjustments to raw diagnostic testing results , evaluation thresholds , cohort reports or real time monitoring through software interface , or other such smart outputs which present a personalized diagnostic result for subject 102.” And see [0225] discloses, “the web portal may interface with one or more institution's EMR systems and retrieve results from a sub ject's records directly” and see [0183])
update information about any patient of the one or more patients thereby helping hospitals, medical stores and diagnostic centres ; (e.g. [0183] discloses, “A user , such as a health care provider or subject , is given remote access through the GUI to view , update , and analyze information about a subject's medical condition using the user's own local device ( e.g. , a personal computer or wireless handheld device ) . A user can interact with the system to instruct it to generate electronic records , update the electronic records , and perform other actions . The content server is configured to receive various information in different formats and it converts the information into the standardized format that is suitable for processing by mod ules operation on or in conjunction with the content server . Thus , information acquired from subjects ' electronic medi cal records ( EMR ) , unstructured text , genetic sequencing , imaging , and various other information can be converted into features that are used for training a plurality of machine learning models.”)
facilitate one or more information dialogs between patients, doctors, hospitals and all involved parties; ([0212] discloses, “The reports 870 can be provided to the user as part of a network - based subject management system that collects , converts and consolidates subject information from various physicians and health - care providers ( including labs ) into a standardized format , stores it in network - based storage devices , and generates messages comprising electronic reports once the reports are generated in accordance with embodiments of the present disclosure . In this way , a user ( e.g. , a physician , oncologist , or any other health care provider , or a subject , receives computer - generated predictions related to a likelihood of a subject's tumor metastasizing , a predicted location of the metastasis , and / or an associated timeline.”)
perform self-risk assessment tests for stress, and also examine risk to develop certain chronic diseases; and monitor prognosis and diagnosis of patients in real-time ([0009] discloses, “The raw test result may be a result from a medical test . Exemplary medical tests include, but are not limited to, tests to diagnose or predict the risk of a disease or other health condition , such as cancer , cardiovascular disease , diabetes and other endocrine diseases , skin disease , immune - mediated diseases , stroke , ratory disease , cirrhosis , high blood pressure , osteoporosis , mental illness , developmental disorders , digestive diseases , viruses , bacterial infections , fungus.” And see [0010] discloses, “Exemplary medical tests include , but are not limited to , a blood test , a biopsy test , an electrocardiography , an endoscopy , a pap test , a computed tomography , a bone marrow examination , a molecular test , a pulmonary function test , a physical examination , a lipid biopsy , a cardiac stress test , an esophageal motility test , a throat culture , an imaging scan or test , and so on .)” and see [0279] discloses, “Smart outputs may include adjustments to raw diagnostic testing results , evaluation thresholds , cohort reports or real time monitoring through software interface , or other such smart outputs which present a personalized diagnostic result for subject 102.” )
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s teachings as previously cited with Lefkofsky’s teachings as previously cited, the motivation being, Wang teaches working with doctors and referencing patient history as well as health records (e.g. [0017]) , therefore it would be obvious to one of ordinary skill that the operability of communication networks and patient data in Wang would improve by explicitly monitoring choice data and progress by patients and providers to decrease resources used and increase individualized patient care in real time.
As per claim 8, Wang does not explicitly teach:
The system according to claim 1, wherein the one or more user devices are selected from, a laptop, a desktop PC, an AR/VR headset, a smartphone or a tablet.
However, Lefkofsky teaches:
The system according to claim 1, wherein the one or more user devices are selected from, a laptop, a desktop PC, an AR/VR headset, a smartphone or a tablet. ([0258] discloses, “Mobile devices , such as cellular phones , laptop computers , tablets , and other mobile devices may install an application from the laboratory to implement methods and systems as described herein . A physician may utilize the application to begin an order , request specimen storage and mailing units , print mailing labels , track a subject's progress through the order processing pipeline , and review the reports order upon order fulfillment . Lab personnel may utilize the application to track an order that has been received , peri odically update the order status based upon fulfillment of certain conditions during order processing , and sign off on a completed report for release to ordering physician . The application may automatically supply notification to other lab personnel or the ordering physician of those condition fulfillments . Research participants may track a plurality of subjects who have registered with the research during execution of a clinical trial , including order fulfillment of laboratory results.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s teachings as previously cited with Lefkofsky’s teachings as previously cited, the motivation being, Wang teaches user device of a cell phone (e.g. [00121]) , therefore it would be obvious to one of ordinary skill to combine a cell phone with a smartphone in Lefkofsky is it is obvious a smartphone is a type of cell phone and the network communication of information in Wang would be the same hardware.
As per claims 9 and 10 they are method claims which repeats the same limitations of claims 1, 3, and 7 the corresponding system claim, as a series of process steps as opposed to a collection of elements. Since the teachings of Wang and Lefkofsky as well as motivations to combine discloses the structural elements that constitute the system of claims 1, 3, 7, and 8, it is respectfully submitted that they perform the underlying process steps, as well. As such, the limitations of claims 9 and 10 are rejected for the same reasons given above for claims 1, 3, and 7.
Claims 11, 12, 15, 16, 17, 18, 19, and 20 are rejected to under 35 U.S.C. 103 as being unpatentable over Wang et. al (hereinafter Wang) (AU2013201509A1) in view of McCombie et. al (hereinafter McCombie) (US11179105B2)
As per claim 11, Wang teaches:
A portable medical device for diagnostic assessments, the portable medical device comprises: ([0009] discloses, “One aspect of the present invention is the design of a system capable of providing real time data transmission between a patient and medical practitioners to facilitate high throughput point-of-care testing in an ambulatory setting. The systems and methods provided herein simplify the laborious and expensive procedures of processing and analyzing the samples collected from a subject ( e.g., a patient) without the use of laboratory equipment or facility. The systems and methods are particularly useful for detection of an analyte from a small sample of bodily fluid to effect diagnosis, prognosis, treatment, and development of therapeutics.”)
a plurality of medical instruments each medical instrument including one or more sensors, ([00188] discloses, “In some embodiments a patient may be provided with a plurality of fluidic devices to use to detect a variety of analytes.” And see [00112] discloses, “A reaction assembly preferably houses a detection assembly for detecting a signal produced by at least one assay on the fluidic device” and see [00114] discloses, “In some embodiments, the detection system may comprise non-optical detectors or sensors for detecting a particular parameter of a patient. Such sensors may include temperature, conductivity, potentiometric, and amperometric, for compounds that are oxidized or reduced, for example, 02, H202, and I2, or oxidizable/reducible organic compounds.”)
wherein each sensor of the one or more medical instruments is configured to receive one or more samples from body of a patient ([0067] discloses, “Any bodily fluids suspected to contain an analyte of interest can be used in conjunction with the subject system or devices. Commonly employed bodily fluids include but are not limited to blood, serum, saliva, urine, gastric and digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluids derived from tumorous tissue, and cerebrospinal fluid. In a preferred embodiment, the bodily fluids are used directly for detecting the analytes present therein with the subject fluidic device without further processing.”)
a processor configured to determine a plurality of parameters based on the information from the one or more samples received from the body of the patient; ([0073] discloses, “Once the assay is performed on the t1uidic device, a signal indicative of an analyte in the bodily fluid sample is generated and detected by a detection assembly. The detected signal may then be communicated to the communications assembly, where it can be transmitted to the external device for processing, including without limitation, calculation of the analyte concentration in the sample.” And see [00118] discloses, “In some embodiments the external device can be a computer system, server, or other electronic device capable of storing information or processing information. In some embodiments the external device includes one or more computer systems, servers, or other electronic devices capable of storing information or processing information.” / examiner interprets external device as a processor as someone of ordinary skill would understand as it is disclosed as a computer )
a memory unit operably connected to the processor and configured to store machine-readable instructions, the processor obtaining the machine-readable instructions from the memory unit, and being configured by the machine-readable instructions to compare the determined plurality of parameters with predefined parameters ([00116] discloses, “In some embodiments the communication assembly can have a memory or storage device, for example localized RAM, in which the information collected can be stored. A storage device may be required if information cannot be transmitted at a given time due to, for example, a temporary inability to wirelessly connect to a network. The information can be associated with the fluidic device identifier in the storage device.” And see [00117] discloses, “In preferred embodiments an external device communicates with the communication assembly within the readers assembly” And see [00118] discloses, “In some embodiments the external device can be a computer system, server, or other electronic device capable of storing information or processing information. In some embodiments the external device includes one or more computer systems, servers, or other electronic devices capable of storing information or processing information.” And [0073] discloses, “The protocol to be run on the fluidic device may comprise instructions to the controller of the reader assembly to perform the protocol on the fluidic device, including but not limited to a particular assay to be run and a detection method to be performed.” / examiner interprets external device as a processor as someone of ordinary skill would understand as it is disclosed as a computer) ([00179] discloses, “comparing the detected values to a threshold value predetermined for said pharmacological parameter;” and see [00208] discloses, “The value(s) is compared with the parameter values estimated when the fluidic device was calibrated by the manufacturer. Signal results are then adjusted using the following equation: Signaladjusted = Signal*(Aractory calibration/ Ameasured within the assay) and the original calibration equation (Equation 1) is then used to calculate the analyte concentration.”)
and determine health related information of the human body based on the comparison ([00179] discloses, “comparing the detected values to a threshold value predetermined for said pharmacological parameter;” and see [00208] discloses, “The value(s) is compared with the parameter values estimated when the fluidic device was calibrated by the manufacturer. Signal results are then adjusted using the following equation: Signaladjusted = Signal*(Aractory calibration/ Ameasured within the assay) and the original calibration equation (Equation 1) is then used to calculate the analyte concentration.” And see also [0073] / examiner notes the analyte concentration is health related information of a human body)
a communication interface configured to send the health related information to one or more user devices; wherein the portable medical device includes …[…]…and wireless communication module, ([00115] discloses, “A communication assembly is preferably housed within the reader assembly and is capable of transmitting and receiving information wirelessly from an external device. Such wireless communication may be bluetooth or RTM technology. Various communication methods can be utilized, such as a dial-up wired connection with a modem, a direct link such as a Tl, ISDN, or cable line. In preferred embodiments a wireless connection is established using exemplary wireless networks such as cellular, satellite, or pager networks, GPRS, or a local data transport system such as Ethernet or token ring over a local area network. In some embodiments the information is encrypted before it is transmitted over a wireless network. In some embodiments the communication assembly may contain a wireless infrared communication component for sending and receiving information “ and see fig. 1)
wherein the portable medical device is configured to perform real time diagnostic assessment based on the received samples received from the body of the patient, ([00122] discloses, “The subject apparatus and systems provide an effective means for high throughput and real-time detection of analytes present in a bodily fluid from a subject.”)
and wherein the portable medical device comprises a chemistry analyzer configured to receive whole blood, plasma, or serum to perform reagent-based testing, and a dry-strip reagent analyzer configured for blood or urine point-of-care testing. ([0080] In a preferred embodiment there is at least one reagent chamber. In some embodiments there may be two, three, four, five, six, or more, or any number of reagent chambers as are necessary to fulfill the purposes of the invention. A reagent chamber is preferably in fluid communication with at least one reaction site, and when the fluidic device is actuated as described herein, reagents contained in said reagent chambers are released into the fluidic channels within the fluidic device.” And see [0082] In some embodiments a reagent chamber contains approximately about 50μ1 to about 1ml of fluid. In some embodiments the chamber may contain about 100μ1 of fluid. The volume ofliquid in a reagent chamber may vary depending on the type of assay being run or the sample of bodily fluid provided. In some embodiments the reagents are initially stored dry and liquified upon initiation of the assay being run on the fluidic device.” And see [0067] and also see [0015])
However, Wang does not teach explicitly:
…[…]…an integrated touchscreen control panel…[…]…
However, McCombie does teach:
…[…]…an integrated touchscreen control panel…[…]…(Col. 5 lines 38-41 discloses, “A number of additional features may be incorporated into the electronics contained within the housing . By way of non - limiting example , the display may provide a touch screen interface for data entry to the processor”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s teachings as previously cited with McCombie’s teachings as previously cited, the motivation being, Wang teaches cellphones and communication modules as previously cited, therefore it would be obvious to one of ordinary skill that the operability of a cell phone is improved by addition of a smart control panel screen and would improve UX for patient care and would not render Wang inoperable.
As per claim 12, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 11 wherein the processor is further configured to generate clinical decision support information for healthcare professionals based on the determined health-related information. ([00173] discloses, “For example, if glucose were the analyte of interest, the concentration of glucose in a sample at a given time as well as the rate of change of the glucose concentration over a given period of time could be highly useful in predicting and avoiding, for example, hypoglycemic events.” And [00178] discloses, “The present invention therefore creates a business method which effectively performs at least part of the monitoring of a patient that is currently performed by medical personnel.”)
As per claim 15 it is a system claim which repeats the same limitations of claim 8 the corresponding method claim, as a collection of elements opposed to a series of process steps. Since the teachings of Wang and McCombie as well as motivations to combine discloses the process that constitute the system of claims 5, it is respectfully submitted that they recite the collection of elements, as well. As such, the limitations of claim 15 are rejected for the same reasons given above for claim 8.
As per claim 16, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 11 wherein determined health related information of the human body is determined within about 15 minutes. ([00122] discloses, “The subject apparatus and systems provide an effective means for high throughput and real-time detection of analytes present in a bodily fluid from a subject. / real time is interpreted by examiner as within this timeframe”)
As per claim 17, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 11 wherein the predictive analysis risk predictions include predictions of one or more of: diabetes; health comorbidities; cardiovascular disorders; stress related illness; kidney disease; respiratory disorders; liver disease; cancer. ([00173] discloses, “For example, if glucose were the analyte of interest, the concentration of glucose in a sample at a given time as well as the rate of change of the glucose concentration over a given period of time could be highly useful in predicting and avoiding, for example, hypoglycemic events.”)
As per claim 18, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 17 wherein the plurality of medical instruments includes one or more of the following integrated components: Pulmonary Function/Spirometer; ECG; Glucose Ketone Analyzer; Electronic BP Monitor; Lipid Profiler; Creatinine Monitor; HbA1 C Monitor; Hb Monitor; Urine Analyser; Cardiovascular Monitor; Thyroid, Renal, Liver Function monitor; Hemoglobin and WBC; Immuno Anaylser; Uric Acid/UREA Profiler. ([0066] The subject system comprises a fluidic device having one or more of the following components: a sample collection unit, an assay assembly, a reader assembly, and a communication assembly. The sample collection unit typically allows a sample of bodily fluid collected from a subject to react with reactants contained within the assay assembly for generating a signal indicative of the presence of the analyte of interest. The reader assembly detects the signal, which is then transmitted via the communication assembly to an external device for further processing.” And see [0067] Any bodily fluids suspected to contain an analyte of interest can be used in conjunction with the subject system or devices. Commonly employed bodily fluids include but are not limited to blood, serum, saliva, urine, gastric and digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluids derived from tumorous tissue, and cerebrospinal fluid. In a preferred embodiment, the bodily fluids are used directly for detecting the analytes present therein with the subject fluidic device without further processing.” / examiner interprets the device which analyzes urine as a urine analyzer)
As per claim 19, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 18 wherein the plurality of medical instruments includes one or more of the following external components: Cancer Detection; Communicable Disease Detection; Cancer Identifier; Portable X-Ray; Thermometer; Stethoscope; Pulse Oximeter; CBP Analyser. ([00150] In some embodiments markers according to the present invention are disease specific. Exemplary cancer markers include without limitation PSA (total prostate specific antigen), Creatinine, Prostatic acid phosphatase, PSA complexes, Prostrate-specific gene-1, CA 12-5, Carcinoembryonic Antigen (CEA), Alpha feto protein (AFP), hCG (Human chorionic gonadotropin), Inhibin, CAA Ovarian C1824, CA 27.29, CA 15-3, CAA Breast Cl 924, Her-2, Pancreatic, CA 19-9, Carcinoembryonic Antigen, CAA pancreatic, Neuron-specific enolase, Angiostatin DcR3 (Soluble decoy receptor 3), Endostatin, Ep-CAM (MK-1 ), Free lmmunoglobulin Light Chain Kappa, Free lmmunoglobulin Light Chain Lambda, Herstatin, Chromogranin A, Adrenomedullin, Integrin, Epidermal growth factor receptor, Epidermal growth factor receptor-Tyrosine kinase, Pro-adrenomedullin N-terminal 20 peptide, Vascular endothelial growth factor, Vascular endothelial growth factor receptor, Stem cell factor receptor, ckit/ KDR, KDR, and Midkine.”)
As per claim 20, Wang further teaches:
The portable medical device for diagnostic assessments according to claim 19 wherein the health related information comprises one or more of the following tests: Pulmonary Function Tests comprising one or more of: Obesity Parameters: BMI, BAI, SBMI , BFC, VFC, BA, BMR; Pulmonary Function Tests: FVC, MVV, SVC (Pre/Post); Other Parameters: SP02, Hb, Heart Rate; Liver Function Tests comprising one or more of: Obesity Parameters: BMI, BAI, SBMI BFC, VFC, BA, BMR; Liver Function Tests: Bilirubin, Urobilinogen; Kidney Function Tests comprising one or more of: Obesity Parameters: BMI, BAI, SBMI, BFC, VFC, BA, BMR; Kidney Function Tests: Creatinine, Uric Acid Renal; Other Parameters: Creatinine, Miro Albumin, Protein Urine Parameters: Micro Albumin, Protein, Creatinine; (Infection Diseases comprising one or more of: Screening of Infectious Diseases: dengue, cholera, H1N1, Typhoid, Ebola, Chikungunya and Malaria; Cardiovascular Tests comprising one or more of: Complete Cardiac Profile: ECG, Heart Rate, BP, hsCRP*, K+*; Obesity Parameters: BMI, BAI, SBMI, BFC, VFC, BA, BMR; Complete Diabetes Profile: FBS, GRBS, HbA1C; Complete Lipid Profile: TC, HDL, TG, LDL, TC/HDL, VLDL; Diabetic Function Tests comprising one or more of: Obesity Parameters: BMI, BAI, SBMI, BFC, VFC, BA, BMR; Complete Diabetes Profile: FBS, GRBS, HbA1C; Other Parameters: Creatinine, Uric Acid; Complete Lipid Profile: TC, HDL, TG, LDL, TC/HDL, VLDL; And Cancer Screening Tests comprising one or more of: Cancer Screening: quick, low interference and minimal pain; Breast, Cervical, Gastro intestinal, Colorectal, Oral, Prostate. ([00150] In some embodiments markers according to the present invention are disease specific. Exemplary cancer markers include without limitation PSA (total prostate specific antigen), Creatinine, Prostatic acid phosphatase, PSA complexes, Prostrate-specific gene-1, CA 12-5, Carcinoembryonic Antigen (CEA), Alpha feto protein (AFP), hCG (Human chorionic gonadotropin), Inhibin, CAA Ovarian C1824, CA 27.29, CA 15-3, CAA Breast Cl 924, Her-2, Pancreatic, CA 19-9, Carcinoembryonic Antigen, CAA pancreatic, Neuron-specific enolase, Angiostatin DcR3 (Soluble decoy receptor 3), Endostatin, Ep-CAM (MK-1 ), Free lmmunoglobulin Light Chain Kappa, Free lmmunoglobulin Light Chain Lambda, Herstatin, Chromogranin A, Adrenomedullin, Integrin, Epidermal growth factor receptor, Epidermal growth factor receptor-Tyrosine kinase, Pro-adrenomedullin N-terminal 20 peptide, Vascular endothelial growth factor, Vascular endothelial growth factor receptor, Stem cell factor receptor, ckit/ KDR, KDR, and Midkine.”)
Response to Arguments Regarding 35 U.S.C § 101 Rejection
Applicant’s arguments on pages 1-7 of remarks Claims 1 - 20 are rejected under 35 U.S.C. § 101 as not being directed to eligible subject matter based on the ground set out in detail below: In the Office Action, the Examiner has objected to independent claims 1, 9, and 11 as allegedly being directed to a mere abstract idea, law of nature, or natural phenomenon (Eligibility Step 2A-1). The dependent claims 2-8, 10, and 12-20 have also been objected to as they depend from the objected independent claims. Independent Claims 1, 9, and 11: In response to the objections raised in the sections, the applicant respectfully submits that, when considered as a whole, independent claims 1, 9, and 11 are directed to a portable medical diagnostic system and device, not to an abstract idea. These limitations define a machine-driven diagnostic workflow grounded in physical processes, including interaction with biological material and on-device biochemical analysis.
The claims are directed to a system or a portable medical device comprising one or more medical instruments having sensors configured to receive samples from a human body, and a processor configured to determine parameters based on the received samples. The Specification states that the sensors of medical instruments are configured to receive samples from the body of a person, the system determines parameters based on information from those samples. The claimed subject matter discloses that the physical acquisition of biological samples, and processing of data derived from those samples using medical instruments. These activities are not just human activity but rather a technical medical diagnostic assessment system. Therefore, the examiner it requested to withdraw the rejection.
Further, in the office action, the examiner has objected the independent claims and stated that "does the claim recite additional elements that integrate the judicial exception into a practical application"? (Eligibility Step 2A-2). In response to the objections raised in the section, the applicant respectfully submits that the claimed system addresses limitations of conventional diagnostic workflows, including: This represents a technical improvement to diagnostic systems, not mere automation. The claims are tied to a specific, non-generic medical device, comprising: " integrated diagnostic instruments " a chemistry analyser " sensors configured for biological sample acquisition " an integrated touchscreen control panel - a wireless communication module
This defines a self-contained diagnostic machine, not a generic computing environment. The claimed system performs: " acquisition of biological samples " chemical and physiological measurement " transformation of those samples into diagnostic outputs
The claims disclose a practical application. The specification discloses acquisition of biological samples using medical instruments, sensors receive samples including blood, tissue, saliva, urine, or faeces, the system using capillary blood and using specific medical instruments such as spirometer, electrocardiography sensor, glucose ketone analyser, blood pressure monitor, urine analyser and others. Using the above-mentioned instruments the computer system determines physiological parameters including temperature, blood pressure, glucose, protein, pH, bilirubin, heart rate, etc. After determining the parameters, results are produced in almost the real-time within about 15 minutes. The diagnostic system is an integrated system that physically interacts with the human body, acquires biological samples, and generates health-related outputs in real time. Therefore, the examiner it requested to withdraw the rejection.
Applicant draws the Examiner's attention to the August 4, 2025 Memorandum issued by Charles Kim, Deputy Commissioner for Patents, titled 'Reminders on evaluating subject matter eligibilitv of claims under 35 U.S.C. 101,' addressed to Technology Centers 2100, 2600, and 3600 (which includes Art Unit 3687). It emphasizes that a rejection under 35 U.S.C. § 101 should be made only where ineligibility is more likely than not, and emphasizes that claims must be assessed in their entirety, avoiding overgeneralization and improper classification as abstract ideas or mental processes, especially when the claimed invention demonstrates a technical advancement.
Also, in recent Ex Parte Desjardins (PTAB Sept. 26, 2025), decided by the Patent Trial and Appeal Board, holds that when an examiner rejects a patent claim under § 101 by saying the elements are "well-understood, routine, and conventional," the examiner must provide actual evidence to support that statement and cannot rely on mere conclusions or boilerplate language; consistent with Berkheimer v. HP Inc., the decision emphasizes that this issue involves a question of fact, so without proper factual support, such eligibility rejections are not sufficient.
Similarly, the independent claims and dependent clams thereon are objected by the examiner as "The independent claims do not include additional elements sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea thus insufficient to provide "significantly more". Therefore, the claim does not amount to significantly more and the claim is ineligible (Eligibility Step 2B).
Applicant respectfully submits that dependent claims 3-4 & 13-14 have been deleted from the claims and all the objection raised regarding those claims are moot now. In response to the objection raised in the section, the applicant respectfully disagrees and submits that the examiner hasn't provided any evidence that the claimed combination is well-understood, routine, or conventional and the claims requires, integration of heterogeneous diagnostic instruments, on-device chemical processing and real-time diagnostic execution within a portable device. The claims recite a specific combination of elements, and these elements, when considered as an ordered combination, define a complete diagnostic system. The Specification further discloses integration of multiple medical instruments in a single system, real-time processing of diagnostic information, and portability enabling use in remote locations. Thus, the claims amount to significantly more than an abstract idea, as they are directed to a specific, structured medical diagnostic device and method. The claimed invention is not centered on generic computing, but on medical instruments configured to receive biological samples and processing of physiological data derived from those samples, and the computing components operate in conjunction with specialized medical instruments and therefore do not merely implement an abstract idea on a generic computer. Therefore, the examiner it requested to withdraw the rejection. Berkheimer burden-shift statement The Berkheimer burden-shift statement, from Berkheimer v. HP Inc., refers to the principle that in patent eligibility analysis (especially under §101), whether something is "well- understood, routine, and conventional" is a question of fact, not just law; therefore, if a patent owner provides evidence that an element is not routine or conventional, the burden effectively shifts to the challenger (e.g., accused infringer) to prove otherwise with clear evidence, meaning courts cannot dismiss a patent as ineligible without properly considering factual disputes. Applicant respectfully submits that the claimed invention is not directed to a mere abstract idea, but to a specific portable device comprising tangible structural components configured to perform a defined technical function.
The claims 1-20 recite concrete elements and their interrelationships, thereby integrating any alleged abstract concept into a practical application. Further, the claimed invention provides significantly more than any alleged abstract idea, as it reflects a non-generic arrangement of components that achieves a technological improvement. Accordingly, the claims are directed to patent-eligible subject matter, and withdrawal of the § 101 rejection is respectfully requested.
Examiner appreciates applicant’s arguments but does not find them persuasive. MPEP 2106.04(a)(2) (II) states, “Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping.”
First examiner notes 35 U.S.C 101 is not an objection but rather a rejection on the record and must be overcome. In response to applicants first argument, examiner notes the claim is approached under broadest reasonable interpretation and examiner must take the substance of the positive recitation of the claim without reading the specification into the claims but in light of the specification. The examiner identifies the elements within the claims which are abstract and identifies the additional elements of the claim. The elements identified as abstract are reasonably interpreted to be a certain method of organizing human activity as a human could utilize devices to more efficiently gather and analyze data and this does not make it dispositive of being an abstract idea as stated in the MPEP as mere automation of executing something such as taking a blood or urine sample by simply applying a tool e.g. this case a medical instrument with sensors is not enough and any improvement recited is improvement to the abstract idea of managing personal behavior and following rules and instructions to determine and send diagnosis information for a patient (MPEP § 2106.04(a)(2), subsection II). The additional elements recited in the claim construction are mere data gathering steps and the diagnostic systems themselves are not recited as improved. The abstract idea cannot bring forth the practical application rather the additional elements must bring forth the practical application.
Further, examiner notes that each and every claim element was analyzed individually and as a whole and no overgeneralization was made to the claims in the rejection. There is no nexus between Ex Parte Desjardins and the recited claims as there is no improvement to machine learning claimed or other technical improvement to diagnostic systems themselves rather the claims recite additional elements which gather data such as sensors and portable medical instruments with chemical analyzers and do not bring forth a practical application and further do not draw back to a technical problem in the specification with diagnostic systems themselves but rather problems with the abstract idea as aforementioned thus also do not reflect a non-generic arrangement of components that achieves a technological improvement.
Further examiner notes that no assertion was made of "well-understood, routine, and conventional," elements within the rejection therefore no evidence was required as the additional elements are recited as “apply-it” level. Therefore the arguments associated with this are moot and if examiner was to make this assertion evidence would be provided as required.
Examiner maintains the 35 U.S.C § 101 rejection.
Response to Arguments Regarding 35 U.S.C § 102/103 Rejections
Applicant’s arguments on pages 7-17 of remarks have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner maintains the 35 U.S.C § 103 rejection.
Prior Art not cited but made of record
US20210005327A1 – Anwar et. al
The present disclosure relates to personalized health , spe cifically molecular based health management and digital consultation . In particular , the present disclosure is directed to methods and systems for assessing the health status of an individual based on correlations between multi - omics measures ( e.g. , genomics , metabolomics , exposomics and proteomics ) and diseases or health risks as disclosed in pub lished research data . The disclosure also relates to methods and systems for customized counseling to individuals regarding health status and actionable measures to improve their health status
Purpura (US6796473B2)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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