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 Patents
Source MDx® holds a broad-based, array of 26 issued patents in 22 countries and an additional 74 pending patent applications worldwide that cover technical aspects of RNA transcript-based measurement, concepts surrounding normal ranges in healthy human subjects, disease specific Precision Profiles™ and statistical methods generating multi-gene models that discriminate disease subjects from normal subjects. Source MDx®'s patent portfolio places the company in a highly differentiated position in the realm of molecular diagnostics, particularly as it relates to inflammation and immune related diseases and cancer. As such, Source MDx® continues to be at the forefront of researching and understanding the link between cancer and the immune response and how this link can be translated into whole blood RNA transcript-based diagnostic tests.
Core to Source MDx®'s intellectual property portfolio is a patent on the use of two or more RNA transcripts (target genes) amplified for use in a molecular diagnostic. Optimized RNA transcript-based measurement, with target genes designed to meet criteria of matched amplification efficiencies (concept of calibration) enables meaningful comparisons of gene expression responses in a variety of pre-clinical and clinical settings.
The value of the company's portfolio is enhanced by the inclusion of patent grants in 22 countries including leading industrial nations in North America, Europe and Asia. A brief summary of the patent portfolio includes ten groups of patents described below. The first three groups of patents are foundational molecular medicine patents that include issued patents in 22 countries, as well as pending international patents. The fourth group of patents focuses on cancer specific biomarker panels for seven types of cancer. The fifth group focuses on specific prostate cancer biomarker panels for early detection and predicting survival. The sixth group includes melanoma specific biomarker panels for predicting survival. The seventh grouping includes specific biomarker panels for five types of autoimmune diseases. The eighth group includes specific biomarker panels for infectious diseases including sepsis. The ninth group includes specific biomarker panels for other inflammatory diseases including eye disease. The tenth group includes all other patents.
The use of quantitative real-time PCR that has been optimized for precision and calibration in the measurement of RNA transcripts. This enables the detection of more subtle changes in gene expression that may be indicative of a disease state.
| Issued Patents |
| Patent Number | Country |
Issue/Grant Date |
Earliest Priority Date Date |
| 6,692,916 | U.S. | February 17, 2004 | June 28, 1999 |
| 784233 | Australia | June 22, 2006 | June 28, 1999 |
| 85924 | Singapore | June 30, 2006 | June 28, 1999 |
| *1198585 | Austria | June 13, 2007 | June 28, 1999 |
| *1198585 | Belgium | June 13, 2007 |
June 28, 1999 |
| *1198585 |
Cyprus |
June 13, 2007 |
June 28, 1999 |
| *1198585 | Denmark | June 13, 2007 |
June 28, 1999 |
| *1198585 |
Finland |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
France |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Germany |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Greece |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Ireland |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Italy |
June 13, 2007 |
June 28, 1999 |
| *1198585 | Luxembourg | June 13, 2007 |
June 28, 1999 |
| *1198585 |
Monaco |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Netherlands |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Portugal |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Spain |
June 13, 2007 |
June 28, 1999 |
| *1198585 |
Sweden |
June 13, 2007 |
June 28, 1999 |
| *1198585 | Switzerland | June 13, 2007 |
June 28, 1999 |
| *1198585 |
United Kingdom |
June 13, 2007 |
June 28, 1999 |
* European Patent No. 1198585 has been opposed by two parties. The Oppositions are currently under examination by the European Patent Office.
| Pending Patent Applications |
| Application Number | Country | Filing Date |
| 10/703143 | U.S. | November 3, 2003 |
| 10/701391 | U.S. | November 3, 2003 |
| 2378008 | Canada | June 28, 2000 |
| 147349 | Israel | June 28, 2000 |
| 2001-528624 | Japan | June 28, 2000 |
The concept of normal gene expression ranges in healthy human subjects and the use of a healthy normal human reference dataset for applying "treat-to-normal" strategies in the detection of disease and the evaluation of therapeutic response. Optimized RNA transcript-based measurement coupled with established normal reference ranges is the foundation of Source MDx®’s Precision Profile™ molecular diagnostic system. This brings RNA transcript-based measurement to the level of blood chemistries where measurements such as glucose levels are routinely compared to established normal ranges in order to facilitate medical decisions. Also claims the use of two or more genes in an RNA-based diagnostic using whole blood or any other biofluid or tissue sample to indicate an inflammatory or immune response. Such responses can signal the presence of disease, and in cancer, may further indicate the presence of tumors.
| Issued Patents |
| Patent Number |
Country |
Issue/Grant Date |
Earliest Priority Date Date |
| 6,960,439 | U.S. | November 1, 2005 |
June 28, 1999 |
Information technology and statistical methods regarding multi-gene algorithms that translate molecular data into actionable medical information regarding presence or progression of disease and response to therapy in individuals.
| Issued Patents |
| Patent Number |
Country |
Issue/Grant Date |
Earliest Priority Date Date |
| *6,964,850 |
U.S. |
November 15, 2005 |
November 9, 2001 |
| 227975 |
India |
January 27, 2009 |
November 9, 2001 |
* A Request for Ex Parte Re-Examination has been filed against U.S. Patent No. 6,964,850. The Re-examination is currently being reviewed by the United States Patent and Trademark Office.
| Pending Patent Applications |
| Application Number | Country | Filing Date |
| 11/158504 | U.S. | June 22, 2005 |
| 11/159376 | U.S. | June 22, 2005 |
| 2466502 | Canada | November 8, 2002 |
| 02826908.X | China | November 8, 2002 |
| 02792239.2 | Europe | November 8, 2002 |
| 2003-542649 | Japan | November 8, 2002 |
| 04-7007103 | Korea | November 8, 2002 |
Cancer specific biomarker panels (Precision Profiles™) including melanoma, colon, breast, prostate, cervical, ovarian and lung cancer.
| Pending Patent Applications |
| Indication | Application Number | Country | Filing Date |
| Melanoma |
Not yet assigned |
U.S. |
November 6, 2007 |
| Melanoma |
2007328427 |
Australia |
November 6, 2007 |
| Melanoma |
Not yet assigned |
Canada |
November 6, 2007 |
| Melanoma |
07870851.8 |
Europe |
November 6, 2007 |
| Lung |
12/514,686 |
U.S. |
November 6, 2007 |
| Lung |
2007322206 |
Australia |
November 6, 2007 |
| Lung |
Not yet assigned |
Canada |
November 6, 2007 |
| Lung |
07861766.9 |
Europe |
November 6, 2007 |
| Colon |
12/514775 |
U.S. |
November 6, 2007 |
| Colon |
2007322207 |
Australia |
November 6, 2007 |
| Colon |
Not yet assigned |
Canada |
November 6, 2007 |
| Colon |
07861767.7 |
Europe |
November 6, 2007 |
| Prostate |
PCT/US2007/023425 |
PCT |
November 6, 2007 |
| Ovarian |
PCT/US2007/023384 |
PCT |
November 6, 2007 |
| Breast |
PCT/US2007/023385 |
PCT |
November 6, 2007 |
| Cervical |
PCT/US2007/023387 |
PCT |
November 6, 2007 |
| Cancer General |
PCT/US2007/023459 |
PCT |
November 6, 2007 |
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Prostate cancer specific biomarker panels (Precision Profiles™) for early cancer detection and predicting cancer survival.
| Pending Patent Applications |
| Indication |
Application Number |
Country |
Filing Date |
| Prostate Cancer-Early Detection |
61/142789 |
U.S. |
January 6, 2009 |
| Prostate Cancer-Early Detection |
61/150666 |
U.S. |
February 6, 2009 |
| Prostate Cancer-Early Detection |
61/163354 |
U.S. |
March 25, 2009 |
| Prostate Cancer-Early Detection |
61/170017 |
U.S. |
April 16, 2009 |
| Prostate Cancer-Early Detection |
61/178342 |
U.S. |
May 14, 2009 |
| Prostate Cancer-Survival |
PCT/US2009/049935 |
PCT |
July 8, 2009 |
-
Melanoma specific biomarker panels (Precision Profiles™) for predicting cancer survival.
| Pending Patent Applications |
| Indication |
Application Number |
Country |
Filing Date |
| Melanoma-Survival |
61/110786 |
U.S. |
November 3, 2008 |
Disease specific biomarker panels (Precision Profiles™) in autoimmune including rheumatoid arthritis, multiple sclerosis, transplant rejection and immunosuppression.
| Pending Patent Applications |
| Indication | Application Number | Country | Filing Date |
| Rheumatoid Arthritis | 11/529010 | U.S. | September 27, 2006 |
| Rheumatoid Arthritis | 2006294477 | Australia | September 27, 2006 |
| Rheumatoid Arthritis | 2624359 | Canada | September 27, 2006 |
| Rheumatoid Arthritis | 06836158.3 | Europe | September 27, 2006 |
| Multiple Sclerosis | 11/155930 | U.S. | June 16, 2005 |
| Multiple Sclerosis | 11/454553 | U.S. | June 16, 2006 |
| Multiple Sclerosis | 2006259306 | Australia | June 16, 2006 |
| Multiple Sclerosis | 2612492 | Canada | June 16, 2006 |
| Multiple Sclerosis | 09154300.9 | Europe | June 16, 2006 |
| Multiple Sclerosis | 11/827892 | U.S. | July 13, 2007 |
| Multiple Sclerosis |
2007272824 |
Australia |
July 13, 2007 |
| Multiple Sclerosis |
2658171 |
Canada |
July 13, 2007 |
| Multiple Sclerosis |
07810433.8 |
Europe |
July 13, 2007 |
| Transplant Rejection | 11/897160 | U.S. | August 28, 2007 |
| Transplant Rejection |
2661487 |
Canada |
August 28, 2007 |
| Transplant Rejection |
07837480.8 |
Europe |
August 28, 2007 |
| Lupus |
12/524677 |
U.S. |
January 25, 2008 |
| Lupus |
2008209462 |
Australia |
January 25, 2008 |
| Lupus |
Not yet assigned |
Canada |
January 25, 2008 |
| Lupus |
08724851.4 |
Europe |
January 25, 2008 |
| Osteoarthritis | PCT/US2009/048684 | PCT | June 25, 2009 |
Disease specific biomarker panels (Precision Profiles™) in infectious disease including sepsis.
| Issued Patents |
| Patent Number |
Country |
Issue/Grant Date |
Earliest Priority Date Date |
| 234094 |
India |
May 5, 2009 |
December 19, 2002 |
| Pending Patent Applications |
| Application Number | Country | Filing Date |
| 10/742458 | U.S. | December 19, 2003 |
| 2003303238 | Australia | December 19, 2003 |
| PI0317612-6 | Brazil | December 19, 2003 |
| 2511237 | Canada | December 19, 2003 |
| 200380109850 | China | December 19, 2003 |
| 03808491.9 | Europe | December 19, 2003 |
| 3792/CHENP/20 | India | December 19, 2003 |
| 2004-562300 | Japan | December 19, 2003 |
| 2005/006804 | Mexico | December 19, 2003 |
Disease specific biomarker panels (Precision Profiles™) in other inflammatory diseases including eye diseases.
| Pending Patent Applications |
| Indication | Application Number | Country | Filing Date |
| Ocular |
12/520675 |
U.S. |
December 18, 2007 |
| Ocular |
2007339334 |
Australia |
December 18, 2007 |
| Ocular |
Not yet assigned |
Canada |
December 18, 2007 |
| Ocular |
07863065.4 |
Europe |
December 18, 2007 |
Other patents.
| Issued Patents |
| Patent Number | Country | Issue/Grant Date |
| 7,074,586 | U.S. | July 11, 2006 |
| Pending Patent Applications |
| Application Number | Country | Filing Date |
| 11/804175 | U.S. | May 16, 2007 |
| 2007254206 |
Australia |
May 16, 2007 |
| 2652239 |
Canada |
May 16, 2007 |
| 07795008.7 |
Europe |
May 16, 2007 |
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