Informed Prior Art Analysis for Traditional Knowledge based Inventions

Prior art forms the core of novelty and inventive step analysis and also plays an important role in the assessment of other requirements. For negating novelty, the basic principle is: all elements of an invention must be present in a single prior art, expressly or inherently, supplemented by knowledge of a skilled artisan. For making an invention obvious, combination of prior art elements that form part of the invention must be obvious to a person skilled in the art. The role of prior art is quite straight forward, it must directly, inherently or through combination have elements of the invention.

The draft traditional knowledge guidelines of the patent office seem to defy the basic principles of prior art. The examples provided seem to draw subjective inferences, based mostly on emotions, TRADITIONAL KNOWLEDGE CANNOT BE PATENTED, rather than on objective analysis. While I am tempted to discuss every example, I am limiting myself to just one, in an attempt to abide by the space and time regulations of our administrator. This example, when I discussed in my recent patent law class, was filled with ominous threats and emotional outbursts. While I enjoyed the discussion, the extreme emotions was, I must confess, a surprise.
Invention
The invention relates to a composition comprising Ginger, Radish, Celery and Black seed for enhancing male fertility.
Prior art 
Independent use of Ginger, Radish, Celery andBlack seed as Aphrodisiac is known and Spermatogenic in Ayurveda and Unani systems of medicine.
Inventive Step Analysis
The claims of alleged invention relate to a composition. Though none of the prior arts disclose a composition comprising a combination of the four extracts as claimed in the present application, it can be objected from prior art documents that the use of the single ingredients ginger, radish, celery and black seed as aphrodisiac and/or spermatogenic is well-known in the prior art.
Broad example and generic analysis, where does that leave us. Contrary to its guidelines on novelty, the patent office has in this analysis, directly or indirectly, accepted that the invention question is novel. However, it provides that the invention may be objected based on lack of inventive step as each ingredient is individually known for the specified spermatogenic function in the prior art. The patent office’s analysis can be so straight forward only in one instance, when the inventor makes an admixture of Ginger, Radish, Celery and Black seed. No inventor or patent attorney, aware of prior art,  would be optimistic enough to think that such a claim will get through, though such a claim  may be included in the patent application for strategic purposes.
What about other instances where the inventor develops a composition with the same ingredients to enhance efficacy; identifies specific concentrations  of each ingredient in the composition for optimal results; picks four out of hundred materials known for spermatogenic effect; discovers a composition that is easily deliverable and mutually synergistic;overcomes problems with mixing different ingredients; and so on …
Contrary to the analysis of the patent office, the answer is not so straight forward in all the aforesaid instances. The claims seem more patentable than unpatentable because the said compositions would not be obvious to a person skilled in the art based on knowledge of the role of individual ingredients. This is the essence of selection patents and holding otherwise without due analysis would be contrary to the well accepted rule against mosaicing, especially in hindsight. While objecting first and hearing out the applicant seems like a plausible idea, should this objection be based on a general guideline or analysis of a specific invention in the light of prior art?
Compounding the problematic approach of the patent office is the lack of applicant’s access to prior art and ambiguities in the prior art. It seems to have become a phenomenon that any invention that has even an indirect reference to traditional knowledge documented in TKDL must be prima facie objected. Most often, these references give vague and general information, which is far from being informed enough to enable a person skilled in the art to develop the invention in question. More on nature of TK prior art in my next post.
All I am asking for is objective analysis as opposed to subjective determination or objection. Any comments?
Authored by Dr. Kalyan
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