35 USC 103 “obviousness” rejections: The recent Federal Circuit case of Leo Pharmaceutical Products, Ltd. v. Rea, 2013 WL 4054937 raises an interesting question. Is the Federal Circuit starting to develop a new set of criteria to protect against hindsight bias? The Federal Circuit held that “to avoid the trap of hindsight”, examiners should also consider the probative evidence of non-obviousness. This includes evidence of long-felt needs, and the length of time between the prior art publication dates and the claimed invention. A large time gap between the prior art publications, and the invention, is an indicia of non-obviousness.
According to Leo Pharmaceuticals, how long must the time gap be?
If the prior art citations are about 14-22+ years old, then this is too long. This long a time delay suggests non-obviousness. This is because such a long-known potential combination was actually obvious, then someone should have disclosed it sooner.
This ruling suggests a novel (but risky) “shoot the moon” type of patent defense strategy. That is, Leo pharmaceuticals suggests to find out how far back in time the relevant citations actually extend. If the citations are only 5 years old, but are based on 30 year old earlier citations, then:
- Explore the roots of the 5-year-old prior art citation
- Trace it back to the original 30-year-old prior art
- Disclose the 30-year-old prior art citations
- Make a Leo type argument
The logic seems sound. Something that was known 30 years ago was also known 5 years ago. The fact that nobody combined the citations until the invention, despite a long-felt need, suggests non-obviousness.
Showing of non-obviousness: old citations not combined despite long-felt need
This is a long-shot legal strategy. This strategy is also better suited for patent trials, rather than patent prosecution. The problem here is that patent examiners must follow the Manual of Patent Examining Procedure (MPEP). The USPTO slants the MPEP to help examiners find reasons to reject patents. It often omits applicant-helpful cases, such as Leo pharmaceuticals v. Rea. At the same time, it tends to cite other marginal, but examiner friendly cases. To a patent examiner, if you can’t cite an MPEP reference number, it doesn’t exist. If a case is in the MPEP, good luck arguing that the case is obsolete.
Thus USPTO examiners, who must follow the MPEP, will generally ignore this approach. However, Leo Pharmaceuticals represents a valid legal precedent. It might work in a Federal Court trial. Would it work for PTAB IPR?