IP protection

 

1 Please provide a short description of the state-of-the-art and/or current trends in the field? How does the result fit into it?
Medical examination diagnosis of the respiratory system is almost a standard procedure for every patient doing a check up as well as for everyone that faces a lung or breath related problem. Breath sounds have long been important indicators of respiratory health and disease. Acoustical monitoring of respiratory sounds has been used by researchers for various diagnostic purposes. A few decades ago, physicians relied on their hearing to detect any symptomatic signs in respiratory sounds of their patients. However, with the aid of computer technology and digital signal processing techniques in recent years, breath sound analysis has drawn much attention because of its diagnostic capabilities. Computerized respiratory sound analysis can quantify changes in lung sounds, make permanent records of the measurements made and produce graphical representations that help with the diagnosis and treatment of patients suffering from lung diseases. Digital signal processing techniques have been widely used to derive characteristics features of the lung sounds for both diagnostic and assessment of treatment purposes.

One issue of interest for both physicians and researchers in this field is to find features which best describe the relationship between the respiratory flow and the lung sounds of patients compared to that of healthy individuals. Since lung sounds have relatively low frequency and low intensity, it is crucial to remove the noise and other interfering sounds (i.e., heart sounds) from the lung sounds prior to any diagnostic analysis. Adventitious lung sounds that are of diagnostic value include crackles, wheezes, rhonchi, and stridor.

  • Crankles are small clicking, bubbling, or rattling sounds in the lung. They are believed to occur when air opens closed air spaces.
  • Wheezes are high-pitched sounds produced by narrowed airways. They can be heard when a person breathes out (exhales).
  • Rhonchi are sounds that resemble snoring. They occur when air is blocked or becomes rough through the large airways.
  • Stridor is a wheeze-like sound heard when a person breathes. Usually it is due to a blockage of airflow in the windpipe (trachea) or in the back of the throat.

Out of these sounds, the R&D developer [Π1] concentrated on the automated detection and analysis of wheezes. Wheezes are related to underlying pathologies of the respiratory system (such as asthma and COPD) and the percentage of the respiratory sound recordings which are covered by wheezes is strongly related to the severity of the underlying pathology.

 

2 What is the problem/need/knowledge gap that the research result is responding to?  How was it addressed before?
The main problem that the R&D result is trying to face is the correct diagnosis of pathologies of the respiratory system by using modern computer technology.

The human body communicates information regarding its condition through the sounds it produces. Today the examination of respiratory system sounds is carried out through chest auscultation. The history of chest auscultation by unaided ears goes back to almost 2000 years ago. The discovery and use of respiratory lung sounds as indicators of health and disease began with Laënnec, who formalized the relationship between human pulmonary diseases and respiratory auscultation in 1819. From his work the stethoscope was developed in 1921. Stethoscope enabled physicians to listen to respiratory sounds of their patients and detect any symptomatic signs. However, the use of stethoscope has certain disadvantages. The conclusions of hearing are subjective’ and depend from the experience of the doctor. Even the same doctor can be led to different conclusions with repetition of hearing. Important role at the hearing plays also the noise of environment. Moreover, the possibility to record and store the sounds at the hearing so as to able to reproduce them in the future is not provided and, finally, chest auscultation is a qualitative and not a quantitative method of diagnosis. However, new electronic stethoscopes have recently reached the market, and these offer both better hearing as well as the ability to record sounds.

For the diagnosis and the follow-up of the course of respiratory system diseases a variety of respiratory tests is used. Between these, spirometrisis constitutes the most useful and easy respiratory test that is used widely for diagnosis of obstructive diseases, like asthma and COPD. The spirometer is a device that records the volume of air that is inhaled and exhaled. The results of this test depend considerably on the degree of effort of the patient examined. The guides given to the patient play an important role in the examination and it is essential they are given rightly.

Modern technology has provided physicians with new diagnostic solutions. Breath sound analysis using digital signal processing techniques is the most important among these. Computerized respiratory sound analysis can quantify changes in lung sounds, make permanent records of the measurements made and produce graphical representations that help with the diagnosis and treatment of patients suffering from lung diseases. The R&D developer concentrated on the automated detection and analysis of wheezes, high-pitched sounds produced by narrowed airways which are related to underlying pathologies of the respiratory system, such as asthma and COPD.

 

3 What is the potential for further research?
There is strong potential for further research. The R&D result concentrated on breath sounds related with two main diseases, asthma and COPD. However further R&D can be made in order to examine other sound categories (as crankles, rhonchi, stridor) and other respiratory system related diseases as bronchitis, emphysema, pneumonia and lung cancer. The number of patients suffering from these diseases has increased drastically in the last decades and the development of such a product would have multiple advantages and strong sales potential.

Furthermore, further research can be made in order to examine the differences in the sounds in different age and gender groups (kids-adults-elderly, men-women).

 

4 What is the proposed method of IPR-protection? (patent, license, trademark etc.)
The R&D result can be secured with a national and international patent.

 

5 What are the steps that need to be taken in order to secure the IPR-protection? What is the cost of IPR-protection?
Greek procedures and costs

According to Law 1733/1987 the institution competent to grant Patents in Greece, is the Industrial Property Organization (OBI -http://www.obi.gr). The applicant submits the patent specification (Description, Claims, Abstract, Drawings) to OBI, who, in a period of approximately 8 months, sends to the applicant the Search Report. The applicant may submit observations on the Search Report, within three months from its’ issuing. If the observations are accepted, the Examiner transforms the Search Report. In any case, the Examiner issues the Final Search Report, according to which, the Patent is granted or not. If the Patent is to be granted, the applicant is informed about paying the editing and granting Fees.

A patent is granted within 18 months from the date of the submission of the application. All the patent information remains secret for a period of 18 months, even if the patent finally is not granted to the applicant. The patent is valid for 20 years from the date of the submission of the application (priority date), without any extension of the protection period.

The patent is valid for a period of twenty (20) years, provided the applicant/owner of the patent, pays the yearly protection fees in due time. OBI does not inform the owner about the expiration of the time limits. It is the applicant’s responsibility to pay in due time. Payment of the yearly protection fees may be accepted within 6 months from the expiration, with a 50% penalty fees. Publication of the abstract is made on the official OBI Newsletters.

 

Greek National Costs

National Patent

According to the official site of the Industrial Property Organization (OBI- http://www.obi.gr) the cost for a national Patent, to be filled, granted and protected for 20 years, is as follows (2010 costs):

Filling Fees       50,00€

Additional Filling Fees for each claim exceeding ten 30,00€ per claim

Search Report Fees       800,00 + 300,00 = 1100€

Granting Fees   150,00€

Fees for register the transfer, licensing, or rights amendments, company name amendment, change of proprietor/owner        200,00€

Annual protection fees    

Year of protection                                          Cost         

1st 0
2nd 0
3rd                   20
4th 50
5th 80
6th      90
7th   100
8th 115
9th 140
10th 190
11th  240
12th  300
13th  400
14th  500
15th  600
16th  700
17th  800
18th  900
19th 1000
20th 1100

 There are also legal fees of the Attorney who will prepare the patent specification (i.e. Description, Claims, Abstract). These can be estimated at around 1000€.

European Patent Procedures

According to the Munich Convention of October 5th, 1973, it is possible to obtain, with a single application, a protection title in each of contracting States. The application consists of:

- request for a grant

- description of invention

- claims and drawings

- abstract and technical information.

The request must be filed in the official European Patent Office request for grant form (form 1001), which can be obtained free of charge from the EPO or any patent office of the contracting states. The applications may be sent directly by post or submitted online or via electronic data media using software issued by the EPO. The procedure includes different steps that can be clustered in two basic phases. A third stage comes into play when opposition is received, and provides for the appeal proceedings. The main steps are:

Phase one is to apply for the grant of European Patent according to the European Patent Convention (EPC) (form 1001 and annexes related to description, claims, summary and the design) and pay the fees due. The second phase is carried out by the Examining Division on the applicant’s request as described above. The EPO examines whether the application and the invention, to which it relates, meets the requirements of the Convention considering the search report. It specifically means, the invention has to undergo the scrutiny of patentability requirements. The examination is done with respect to the entire application and the final decision is also made with respect to its entirety. The Examining Division communicates to the applicant if the patent is granted or is refused, withdrawn, or deemed to be withdrawn. The applicant then has to approve the text of patent proposed by the examining division, provide a translation of claims into the other EPO official language not used and pay the grant fee. The grant becomes effective on mention in the European Patent Bulletin. The patent proprietor also receives a certificate for the European patent, with the specification annexed.

International Patent Procedures

An application for the grant of a patent is international when it is filed under and with reference to the Patent Cooperation Treaty (PCT). It is administered by the International Bureau of the World Intellectual Property Organization (WIPO).

In order to obtain the protection for an invention in a wider number of countries, the applicant can fill in an international patent application according to the Patent Cooperation Treaty (PCT) or the Agreement of Cooperation for Licences. This is an agreement managed from the WIPO agreed between 117 countries with the aim to offer one procedure to obtain a license in a greater number of countries. The PCT has the same effect as a series of individually applications to each country. The PCT does not eliminate the necessity to continue the procedure of release in each country, but it facilitates the procedure because the application will face the international phase after 30 months.

Costs for European and International patent fee

There are associated costs for any international application, not least translation costs. The applicant must choose wisely the countries to which he will apply for grant of a patent because as wider is the number of countries the applicant choose, more expensive will be the patent fees. The EPO web site provides a section on their schedule of fees, costs and prices.

According to the Greek Patent Office the cost of an International patent is around 2.900 euros.

 

6 What is you overall assessment of the scientific maturity of the research result?
The R&D result is not scientifically complete. However if further development is undertaken, in can become a truly successful medical diagnostic device/software.

 [Π1]tsekarisma

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