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Patent schematic for: Detecting substances using a wearable oral device

US20200229739-A1: “Detecting substances using a wearable oral device.”

Assignee: Canary Health Technologies Inc

Inventors: Reddy, Raj

IPC Codes: A61B 5/08; A61B 5/083; A61B 5/1486; A61B 5/087; A61B 5/00

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019795199, 22-Jan-2019

Wearable oral devices for detecting chemical substances to help detect diseases such as cancer and to help monitor the medication adherence behavior of a user. Three types of wearable device that are capable of non-invasively monitoring nanoparticle tracking code levels used to identify medications taken by patients are described: an instrumented mouthguard biosensor system; a miniature bonded sensor device that may be removably attached to a tooth of a user; and, a device with a flow path for exhaled gas or saliva. A transmitter coupled to the sensor is configured to transmit the detected chemical signals to a receiver such as a smartphone.

Represents the first patenting to have emerged in the name of Toronto, Canada-based Canary Health Technologies, of which the inventor is CEO and president. Raj Reddy is also the CEO and president of another Toronto-based company, nGageIT Digital Health Inc, and he can be seen to have previously described a sensor-based system for detecting volatile organic compounds in exhaled breath in US20200029858, that appeared to be in support of appears to be in support of nGageIT’s Airostotle™ Breath Diagnostics platform, that would now appear to be being commercialized by Canary Health Technologies for detecting cancers at earlier stages than leading liquid/blood based biopsy detection and/or screening technologies.

In June 2020, a COVID-19 breath test trial of Canary Health’s platform was set to begin in South Africa to see whether its 5-minute test could serve as a good temporary indicator of infection before a confirmatory PCR test. If successful, the rapid test would offer the advantages of being non-invasive, easy to use, and appropriate for use in settings other than hospitals. At that time the company was also reportedly discussing plans to conduct clinical trials of the device in the UK and the US.


WO2020148822-A1: “System, device, method, and program for alleviating symptoms experienced in association with treatment, including side effects of drug.”

Assignee: CureApp Inc

Inventors: Aijima, Masaki; Satake, Kohta

IPC Codes: G16H 70/40

Publication Date: 23-Jul-2020

Earliest Priority Details: WO2019JP1085, 16-Jan-2019

Smartphone-based system for alleviating symptoms experienced in association with treatment, including side effects of a drug. An algorithm analyzes and provides appropriate medical intervention based on each patient’s symptoms and circumstances taken from the patient's input data, daily progress, and physical condition. Within the invention’s claims, disclosure and examples there is an apparent focus on the system being used to address side effects associated with smoking cessation, and that information put into the system for analysis could include medical history information, prescription drug information, biological information, and patient activity. It is further claimed and described that part of the biological information being captured could be carbon monoxide levels present in the exhaled breath of patients that could be measured using a further external device.

For prior patenting in which one of the team (Satake) described a system and program for a patient attempting to quit smoking, see WO2018193592.

Dr Kohta Satake is the founder and CEO of Tokyo, Japan-headquartered CureApp, that also has a US subsidiary in Sunnyvale, California. The company is seeking to develop digital therapeutic solutions for a variety of conditions, including nicotine addiction, diabetes, and hypertension amongst others.

In May 2019, the company announced results from a phase 3 multicenter, randomized clinical trial comparative study that demonstrated that the CureApp nicotine-dependent treatment app to be clinically proved as a higher rate of sustained smoking cessation. The CureApp solution provides information and educational materials through applications that are easily placed on patient smartphones, as well as carbon monoxide monitors and doctors' web interfaces for tracking their progress. With this validation, CureApp's goal is to use this information for approval and inclusion in health care by Japanese regulators, as well as global expansion in several countries, including the US.


US20200230408-A1: “Systems and methods for treating patients with diseases associated with replicating pathogens.”

Assignee: electroCore Inc

Inventors: Errico, Joseph P.; Errico, Thomas; Simon, Bruce J.; Staats, Peter

IPC Codes: A61N 2/00; A61N 1/36; A61N 1/40; A61N 2/02; A61N 1/04

Publication Date: 23-Jul-2020

Earliest Priority Details: US2020838953, 02-Apr-2020

Systems and methods for treating an inflammatory or allergic response associated with a replicating pathogen, such as a virus in the coronaviridae family, with SARS-CoV-2 being referenced within the invention’s background and the treatment of respiratory distress in COVID-19 patients being discussed throughout. The methods include emitting an electrical impulse near a vagus nerve within the patient sufficient to inhibit or reduce an inflammatory or allergic response in the patient. It states that this therapy may include a feedback mechanism to provide potent anti-inflammatory benefits without the negative side effects of conventional immune suppression techniques and drugs, such as steroids and other nebulized drugs.

Comes one week after the publication of US20200222708, in which Joseph Errico (company co-founder) and Bruce Simon described the use of non-invasive nerve stimulation for immediate relief of acute symptoms associated with bronchial constriction such as asthma attacks, COPD exacerbations and/or anaphylactic reactions.

Ten days before the present invention’s publication, Basking Ridge, New Jersey-based electroCore announced that the US FDA had issued an Emergency Use Authorization (EUA) authorizing the use of its gammaCore Sapphire™ CV non-invasive vagus nerve stimulation (nVNS) at home or in a healthcare setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief.

gammaCore is currently FDA cleared in the US for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients.

Following the filing of the present patent application in April of this year, one may have expected it to have benefitted from the USPTO’s announcement in May 2020 concerning a new COVID-19 Prioritized Examination Pilot Program. By accelerating examination of COVID-19-related patent applications, without additional fees, it was hoped that it would permit such innovators to bring important and possibly life-saving treatments to market more quickly. However, this application’s quick turnaround and publication was actually down to it having been made special for advancement of examination upon providing evidence that one of the inventors, Bruce Simon, was 65 years of age, or more.


WO2020148768-A1: “Vascular-malformation implant system.”

Assignee: EndoStream Medical Ltd

Inventors: May, Alon; Mayer, Danel; Shezifi, Yuval

IPC Codes: A61B 17/12

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019793532, 17-Jan-2019

Minimally-invasive techniques for treating vascular malformations such as aneurysms, comprising a vascular implant system consisting of an implant and a delivery tool for delivering the implant to a site within a patient. The implant comprises an implant wire having a coil-wire portion.

Comes three weeks after the publication of WO2020136643, in which the same team of inventors described devices for treating vascular malformations.

Alon May is the founder of EndoStream Medical in Or Akiva, Israel that is developing what it describes as a patent-pending implant for the treatment of cerebral aneurysms. From the title of a clinical trial the company is currently recruiting for (ISRCTN96627183), it would appear the implant is to be commercialized as the Nautilus Endovascular Device. The study, that is to be run from The General Hospital of Fortaleza in Brazil, aims to evaluate the safety and effectiveness of the Nautilus device at treating brain aneurysms. The study had been expected to run until June 2021.


WO2020148757-A1: “System and method for selecting required parameters for predicting or detecting a medical condition of a patient.”

Assignee: GynIsUs Ltd

Inventors: Friedmann, Hila

IPC Codes: G16H 50/20; G16B 40/00

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019791914, 14-Jan-2019

Artificial intelligence (AI)-based system and method that uses algorithms to predict a medical precondition in a patient not yet showing any known or common symptoms, before the appearance of the medical condition based on electronic medical record (EMR). It is particularly claimed that precise early detection of disease may allow opportunities for early interventions that in turn will decrease morbidity. Other adverse outcomes should be trained under this model. The system and method is said to be able to predict gestational diabetes mellitus (GDM) or other pregnancy conditions (eg preeclampsia, preterm, postpartum hemorrhage, fetal heart disorder or fetal growth disorder) at preconception and early pregnancy in order to enable early intervention such as diet and life style modifications.

Follows the inventor’s and assignee’s first family of patenting, WO2018146682, in which they described a medical monitoring system.

Hila Friedmann is co-founder of Israeli start-up GynIsUs that also has offices in Santa Monica, California. Founded in 2015, the company has developed a solution for the detection and identification of preterm births and pathologies in the field of gynecology. It brings AI and precise medicine to women’s health from pregnancy to postpartum care. The company's AI platform (Safe Pregnancy AI - SPAI™) integrates data generated in real-time and on an ongoing basis. The company aggregates data from various sources (such as EMR, ultrasounds and wearable devices) to aid medical decision capabilities, based on patient-specific profiles. It is said to be able to deliver tailor-made solutions for natural and correct interpretation to enable physicians to make better and faster decisions.

With the outbreak of the COVID-19 pandemic, GynIsUs turned its expertise and technology to provide a solution that can support the medical centers. Through its Infectious Disease Monitor, that provides in-depth and precise epidemiological investigations to hospitals and medical centers, it can help slow the spread of COVID-19 in said hospitals and medical centers, and reduce the need for COVID-19 testing. It is also able to provide details on the severity of illness per patient and connect this to projections of their hospitalization time, and the number of beds available in ICU, so that they will be able to be prepared and minimize risk. The solution has been implemented in medical centers in New York, and the company is said to be is working on expanding its tool to other medical centers around the world.


US20200229741-A1: “System and method of evaluating and treating diabetes.”

Assignee: Hyder, Adnan Ali; Latif, Kashif

Inventors: Hyder, Adnan Ali; Latif, Kashif

IPC Codes: A61B 5/145; A61B 5/00; G16H 20/10; G16H 50/30

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019795763, 23-Jan-2019

Evidence-based protocols for wholistic evaluation and treatment of patients with diabetes, which include diagnosis, medical history assessment, nutrition and self-management, risk stratification, personalized medicine, behavioral health, continuous monitoring, episodes of care follow-up, and feedback into the population health.

The inventor Dr Kashif Latif has dedicated his life to the research and treatment of diabetes after his son was diagnosed with juvenile diabetes when he was just 11 months old. This led to him opening his AM Diabetes and Endocrinology Center in Bartlett, Tennessee, that is described as a comprehensive care facility for patients with diabetes and North America’s only specialized insulin pump center.

In August 2018, he gained some media attention after becoming the first doctor in North America’s mid-South to implant Senseonics’ Eversense® subcutaneous continuous glucose monitor under the skin of a diabetic patient that is then able to continually their monitor their blood glucose for 90 days. A transmitter is worn over the top of the sensor which reads the wearer's blood sugar levels through a chemical reaction, and then sends that information directly to a smart phone second by second.

Dr Latif’s prior patenting has related to a medical cannula that can enable a user to visually ascertain whether it has been bent or kinked during insertion or use, with it also being claimed that said cannula may be used to deliver an insulin solution to a patient. See US20190201636 that is assigned to a company called KLOSE Monitoring that is based at the same address as his AM Diabetes and Endocrinology Center in Bartlett, Tennessee - with the company’s name also bearing a close resemblance to the center’s telemedicine platform, Klosecare.


WO2020150662-A1: “Blood vessel constriction device.”

Assignee: Saranas Inc

Inventors: Bueche, Kenneth M.; Razavi, Mehdi; Syed, Zaffer

IPC Codes: A61B 5/00; A61N 1/05; A61M 25/06; A61B 5/053; A61B 5/02; A61B 5/0245; A61B 5/05

Publication Date: 23-Jul-2020 (also published as US20200229732-A1)

Earliest Priority Details: US2019793962, 18-Jan-2019

An impedance monitor and constriction device to detect a bleed and apply an electrical signal to electrodes around the area of the bleed to cause the blood vessel to constrict and thereby stop the bleed. Comes one week after the publication of WO2020146688 in which the inventors Bueche and Syed described a blood vessel access closure device with bioimpedance bleed monitoring capabilities.

Houston, Texas-based Saranas has developed what it calls the Early Bird® Bleed Monitoring System to detect and monitor bleeding complications associated with vascular access procedures by employing a plastic tube, or sheath, much like the ones commonly used for keeping arteries and blood vessels open during surgical procedures so that catheters and other devices can be inserted. The Saranas access sheath is fixed with sensors designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement, hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. When the sheath senses a change in the vessel’s electrical resistance, the device responds with audible and visual notifications to alert the clinical team of a potential bleed.

The inventor Zaffer Syed, who is president and CEO of Saranas, has described the company’s system as the canary in the coal mine for cardiologists, and the company’s name itself is derived from the Latin word for the Atlantic canary - Serinus canaria. Saranas was granted de novo classification by the US FDA for the Early Bird® in March 2019, and its commercial launch was announced in September 2019. Completion of the first US commercial case using the Early Bird® Bleed Monitoring System for real-time detection and monitoring of endovascular bleed complications was announced in November 2019.


WO2020150663-A1: “Adjustable flow glaucoma shunts and methods for making and using same.”

Assignee: Shifamed LLC

Inventors: Argento, Claudio; Backus, Andrew; Mixter, Colin

IPC Codes: A61L 31/14; A61F 9/007; A61M 27/00

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019794430, 18-Jan-2019

Adjustable flow glaucoma shunts comprising an adjustable fluid resistor, actuator, and/or actuation mechanism. The shunts may also include an adjustable opening pressure control mechanism. These mechanisms can be selectively adjusted or modulated to increase or decrease the outflow resistance and/or opening pressure of the shunt in response to changes in any (or any combination of) intraocular pressure (IOP), aqueous production rate, native aqueous outflow resistance, and/or native aqueous outflow rate. The shunts’ control elements are movable between the open position and the at least one resistance position in response to non-invasive energy, particularly laser energy. This allows a user to remotely actuate a flow control mechanism to selectively alter the flow of fluid through the shunt.

Follows WO2019018807 in which the same team of inventors described similar adjustable flow glaucoma shunts, and whose disclosure is said to be incorporated by reference in its entirety.

Founded in 2009 by serial entrepreneur Amr Salahieh, Campbell, California-headquartered Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products in the fields of cardiology and ophthalmology. The inventor Claudio Argento is the president and CEO of one of Shifamed’s newly formed portfolio companies, Myra Medical, that in October 2019 announced the raising of $3.2 million in a seed financing round. As evidenced from Argento’s patenting, Myra Medical was founded to produce surgical devices designed to enable maximum IOP reduction while reducing the risk of hypotony in patients with glaucoma. Proceeds from the seed round were to be earmarked for product development and pre-clinical programs.


US10716953-B1: “Wearable phototherapy apparatus.”

Assignee: Soletluna Holdings Inc

Inventors: Schmidt, David

IPC Codes: A61N 5/06; A44C 5/00

Publication Date: 21-Jul-2020

Earliest Priority Details: US2019438364, 11-Jun-2019

Wearable phototherapy apparatus that produces beneficial effects such as the activation of stem cells, improvement in strength, improvement in stamina, and pain relief via a non-transdermal container. The system may include an optional transdermal container coupled to the non-transdermal one that releases or increases copper peptide copper binding peptide glycyl-L-histidyl-Lysine (GHK-Cu) in a subject's body. The non-transdermal apparatus reflects or emits specific wavelengths of light to elevate levels of the copper binding peptide GHK-Cu in the body.

This patent was given prioritized examination, through the USPTO’s TrackOne Request process, meaning that it was not seen initially as a patent application, but has instead appeared publicly for the first time as this fully granted patent. TrackOne Requests can be viewed as an indicator of the assignee being particularly keen to see their invention protected as quickly as possible.

Whilst this may represent the first patent to have been published with Soletluna as an assignee, prior patenting from the inventor David Schmidt has been reassigned to Soletluna from a company of which he is founder and CEO, Lifewave Products; see eg US8734316-B2 (issued May 2014) in which he described a biomolecular wearable apparatus regulating thermomagnetic energy flow within human body for producing beneficial effects including an improvement in stamina and pain relief; and, US9532942-B2 (January 2017) describing a wearable that can produce a photobiomodulation effect to elevate glutathione levels and potentially help treat conditions such as pulmonary disease, degenerative brain conditions, viral infection, burn injuries, acute pancreatitis, immune dysfunction, or diabetes.

The addresses of the two companies in San Diego, California provided to the USPTO match one another, so could this Soletluna entity perhaps be a new IP holding company for Lifewave and its phototherapy patches that reflect particular wavelengths of light back onto a wearer’s skin in order to elicit certain health and wellness effects?

Areas of focus for the company’s patches include pain management, sleep improvement, and the proliferation of antioxidants. Within the patent’s disclosure we see the referencing of a study entitled, “Metabolic Implications of the LiveWave X39™ Patch” that explored the metabolic implications and physiologic results of wearing the LiveWave X39™ patch over a one week period. LifeWave says that, as here, its X39™ patch triggers an increase in the production of GHK-Cu that has been proven to activate stem cells in the body, and the company has received testimonials reporting how it has helped in areas such as wound healing, pain relief, improved energy levels, improvements in the quality and duration of sleep, and improved skin appearance.


WO2020148721-A1: “Systems, methods, and devices for three-dimensional imaging, measurement, and display of wounds and tissue specimens.”

Assignee: The University Health Network

Inventors: Dacosta, Ralph; Dunham, Danielle

IPC Codes: G01N 21/64; G16H 30/40; G01S 17/89; G06T 7/30; G06T 15/00; G01B 11/24; G01B 11/25; G06T 7/50

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019793837, 17-Jan-2019

Systems for co-registering imaging data to form three-dimensional superimposed images of a biological target such as a wound, bacterially infected tissue, a tumor, or a surgical bed. A three-dimensional map can be generated by projecting infrared radiation at a target area, receiving reflected infrared radiation, and measuring depth of the target area. The superimposed image can be used to track wound healing and to excise cancerous tissues such as breast tumors.

One of five applications published this week to name Dr Ralph DaCosta as an inventor - he being a Molecular Imaging Scientist at the Princess Margaret Cancer Centre and Techna Institute, University Health Network (UHN). Also see WO2020148722-A1 (Multi-modal system for visualization and analysis of surgical specimens), ‘148724-A1 (Devices, systems, and methods for tumor visualization and removal; assigned to SBI ALApharma Canada), ‘148725 (Modular endoscopic system for visualization of disease; to SBI ALApharma Canada), and ‘148726 (Modular system for multi-modal imaging and analysis; to MolecuLight Inc).

For prior patenting in which Dr DaCosta described systems for tumor visualization and removal, see WO2019148268 (assigned to UHN).

The UHN medical device spin-off MolecuLight was founded in 2012 by Dr DaCosta to commercialize a proprietary handheld real-time fluorescence imaging technology developed in his lab. Its first commercial product to be launched was the i:X™ imaging product, which is sold globally and aids clinicians in identifying infected wounds at the point-of-care.

In August 2019, MolecuLight announced that Germany’s photonamic GmbH had acquired its surgical oncology business, with the two having been collaborating for a number of years on a surgical oncology application combining MolecuLight’s intraoperative fluorescence imaging technology with photonamic’s imaging agent, 5-ALA. The agent is converted by tumor cells into a fluorescing molecule that can be detected by MolecuLight’s imaging device to provide surgeons and pathologists with real-time assessment of tumor removal. The acquisition resulted in a newly formed subsidiary of photonamic, SBI ALApharma Canada Inc, that can be seen to be the assignee on two of the applications from DaCosta this week, and that represent the first patenting to have been published in the new company’s name.


WO2020150224-A2: “Pulse oximetry using ambient light.”

Assignee: University of California

Inventors: Arias, Ana Claudia; Deckman, Igor Igal; Han, Donggeon; Khan, Yasser T.; Ting, Jonathan Kangyu

IPC Codes: A61B 5/024

Publication Date: 23-Jul-2020

Earliest Priority Details: US2019792112, 14-Jan-2019

Systems and methods for measuring pulse and blood oxygen saturation that may use ambient light as a light source and spectrally-selective sensors such as spectrally-selective organic photodiodes. In certain embodiments, flexible and/or stretchable electronics may be used. Also claimed is a heart rate measuring device that can conduct photoplethysmography (PPG) measurements. As the systems do not require and do not include a light source such as an LED, this reduces their complexity and their power consumption.

In 2014, the inventor Ana Claudia Arias, a Professor of Electrical Engineering and Computer Sciences, and a team of graduate students showed that printed organic LEDs could be used to create thin, flexible oximeters for fingertips or earlobes. Since then, they have worked to develop a way of measuring oxygenation in tissue using reflected light rather than transmitted light. Combining the two technologies let them create a new wearable sensor that can detect blood-oxygen levels anywhere on the body.

In November 2018, not too long before the filing of this application, it was reported how a new flexible sensor developed by engineers led by Professor Arias at the University of California, Berkeley, and that included another of the inventors, Yasser Khan (a graduate student in electrical engineering), could map blood-oxygen levels over large areas of skin, tissue and organs, potentially giving doctors a new way to monitor healing wounds in real time.

For prior patenting in which all the team bar Deckman described a flexible oximeter device for measuring pulse and blood oxygen saturation in tissue using reflectance spectroscopy, see WO2019226692. Prior to this, in WO2016015009, Professor Arias can be seen to have described reflectance-based pulse oximetry systems and methods.

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