Undue Experimentation Rejection Reversed in Biotech Patent Appeal

Written by Mark Terry

Another recent decision by the Board of Patent Appeals and Interferences (BPAI) overturned a rejection by a patent examiner who attempted a 35 U.S.C. §112 rejection of a biotechnology invention that discloses a method for killing malignant melanoma cancer cells (Ex parte Chada). As a Miami-based Board Certified Intellectual Property Attorney, I continuously review new BPAI decisions so that I can skillfully draft proactive and intelligent patent applications based on the latest patent office holdings for my clients.

Geneticist Sunil Chada applied for a patent that describes a technique for activating a gene in Melanoma cancer cells (MDA-7) that is key to compelling the carcinomas to produce two proteins, PKR and UPR, that suppress and prevent the spread of the metastatic cells. The patent examiner asserted that practicing the method would require undue experimentation and pulling from his tool box the §112 justification for rejecting the invention: “…a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains… and shall set forth the best mode contemplated by the inventor of carrying out his invention.”

The examiner also pointed to a prior invention, (Bottaro, U.S. 6,326,446 B1, Dec 4, 2001), as having disclosed PKR as ineffective in suppressing or preventing the viral infection of cells. Here, the examiner misinterpreted the teachings of Bottaro, which describes a method of preventing the destruction of healthy human cells by the HIV virus, where Chada shows us just the opposite intention – instigating the destruction of cancer-ridden skin cells. Thus, the two inventions are diametrically opposed in their fundamental goals. Anyone with a basic understanding of how the HIV virus leads to AIDS and works to destroy healthy and desirable human cells should be readily able to comprehend that in most other cases of viral infection the opposite effect would be required to diminish the ability of a virus to spread by working to destroy infected cells. As the BPAI deftly points out, “…a skilled worker would recognize that killing cancer cells or virus-infected cells before they can further spread the cancer or virus infection would be therapeutically effective, and in fact is the objective of most anti-cancer and anti-viral therapies.” Thus, there is no logical connection between an inhibitive method for cell protection and another disarming method for cell destruction.

In its conclusion, the BPAI stated, “The Examiner has not provided evidence or sound scientific or logical reasoning sufficient to support a conclusion that practicing the claimed method would require undue experimentation.” This is yet another example of a patent examiner missing the mark in rejecting an applicant’s claims.


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