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.