The company was founded in 1997 by cellular biologist John C. Herr to commercialize technology for sperm detection and quantification. Having identified a protein, SP-10, which is produced only in the testes, Herr developed a test kit that uses antibodies that bind to SP-10 to measure its levels in semen. The kit determines a man’s sperm count by using a platform similar to that of a home pregnancy test.
Herr hoped that his invention would provide an affordable way to identify male infertility early on and eliminate costly and unnecessary infertility testing of women.
The next step was to apply for a U.S. patent related to the testes-specific protein SP-10 and its use in determining sperm count. However, as is often the case, the U.S. Patent and Trademark Office examiner rejected all patent claims, citing the existence of “prior art”: pre-existing knowledge that disqualifies an invention for a patent.
Instead of relying exclusively on his patent attorney to argue the case, Herr requested a meeting with the patent examiner. He believed he could more readily and cost-effectively address the scientific basis of any objections.
The examiner’s objections were based on the existence of another testis-specific protein in the scientific literature. But that protein, Herr pointed out, had never been used to detect and quantify sperm. The examiner agreed that Herr’s use of a testis-specific protein was indeed novel.
The resolution: The obtained patent had high commercial value. “Our patent claims grew out of my scientific exchange with the examiner,” Herr said. “When I understood the examiner’s concerns, I realized how we and our attorneys could craft patent claims that would give us exclusivity in using not just SP-10 but any testis-specific protein in sperm detection and quantification.”
The strong patent enabled Herr to attract investors and build ContraVac. Because the patent precluded others from using any testis-specific protein to detect and quantify sperm, it also kept competitors at bay. “To get around our patent, one of our competitors had to do something very complex,” Herr said. “As a result, their manufacturing cost was 20 times ours, and their product was priced three times higher than ours.”
The lessons: An interview with the patent examiner can be an effective way to advance the prosecution of a patent application. Often, a one-on-one interaction with the examiner is a more efficient way of handling issues than an exchange of written communications.
An interview is often held between the patent examiner and the patent attorney, but if the grounds for patent rejection are scientific, the inventor’s presence can add value. If the invention is truly novel, the inventor likely has significant in-depth knowledge of the technology and the scientific landscape that can be leveraged to provide compelling scientific arguments to bolster the legal dialogue.
A conversation with an inventor can deepen the examiner’s understanding of the application. It can also be an educational experience for the applicant. “Had I not visited the patent office in person,” Herr said, “the discussion on prior art, novelty and utility might not have evolved as it did, and the four essential patent claims that eventually issued, and upon which the company was founded, might not have emerged.”
— Gosia Glinska
Glinska is a senior researcher at the Batten Institute at the University of Virginia Darden School of Business.