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[JR2009]

Say that a known compound has been tested in a particular disease using a particular animal model and its activity did not prove beneficial to treat such disease. The results are reported in a paper. The compound and its use are not patented for this disease.

A different group now tests this same compound in a different animal model for the same disease, and shows drastically different activity that IS beneficial therapeutically. The animal model used is more relevant to the human disease process due to the mode of administration and dosage that  more closely mimick the human disease.

Could one argue that the use of the this known compound to treat this disease is novel and non-obvious over the earlier publication?

Thank you.

[CriterionD]

Maybe someone else can chime in, but I don't really get the sense that you provide enough detail to draw a good conclusion.

My guess is that, an answer would depend on issues like why was the known compound initially tested in the particular disease (and would analysis have lead to a logical conclusion that it should also be tested in a different animal), and how was it tested the first time around as compared to the second time around.

[JR2009]

Thank you for the reply. Here are more details.

The compound is known to inhibit a cellular enzyme X that produces Y. Studies have suggested that Y may play a role in this infectious disease and X-inhibitors have been widely used to study the role of Y in its pathology. One study however did look at the compound's effect on the progression of this disease in a pig model. In this model the pigs where inoculated with pathogen directly into the organ being studied, in high doses and the compound was administered prior to infection and under continuous infusion. The results showed that the compound had no protective effect.

Now, the current findings were obtained using a mouse model, where the pathogen is inoculated in 3 different ways that mimick the mode of infection in humans (i.e. not directly into the affected organ). Furthermore, the compound is administered 48hs after inoculation, also mimicking the clinical setting. The compound has consistently shown a curative effect in all 3 models of infection.

Thank you again for your insight.

[JustAnotherExaminer]

If no prior paper had been published:
A KSR rejection would be applicable if the invention is directed towards utilizing a known compound to achieve a predictable result.

Since a prior paper has been published:
The fact that the paper says "don't use A for treating B because of xyz" is evidence that trying to use A for treating B has been attempted and would be obvious.  Which is what, I presume, you'd be claiming.  I personally love "teaching away" arguments in those types of scenarios.

At the end of the day, though, it's gonna come down to what you're claiming and what that paper discloses.

[JR2009]

Thanks- yes the "teaching away" argument is one we've considered. Is it generally successful?

[JustAnotherExaminer]

Not very, especially after KSR.

For instance, let's say the paper says "We tried using compound A to treat B in pigs but found no significant results".  My motivation would go something like this: "One would be motivated to utilize A to treat B in humans because they could expect no significant results". 

At first you'll think I'm off my rocker and crazy, because no medical doctor would ever use A to treat B if they weren't expecting significant results.  However, what if your objective is for it to have no significant results?   

[Isaac]

Not very, especially after KSR.

There is nothing in KSR that suggests that teaching away arguments are not effective.  I would agree that the argument in this case does not seem particularly persuasive.   If compound A was instead fatal to pigs, perhaps a better argument could be made.

For instance, let's say the paper says "We tried using compound A to treat B in pigs but found no significant results".  My motivation would go something like this: "One would be motivated to utilize A to treat B in humans because they could expect no significant results".

what if your objective is for it to have no significant results?   

I'm going to assume that you do not examine in the "unpredicatable arts".  I don't believe such a rationale is likely to support a rejection to a claim drawn to "a method of treating disease Z" that recites something like "injecting an effective amount of A."  I think a better rejection would be based on the known inhibition effect, and that trying the compound in a second model would be obvious in face of neutral results.

I have no opinion on whether JR2009's invention is non obvious, but the analysis here seems simplistic.

[lacerda70]

No one has mentioned novelty?  I haven't read the paper reporting the initial results obviously, but it seems pretty likely that a 102 rejection could be made (demonstration of efficacy is not required for 102 - a reference warning that compound A has no effect in treating disease X can be legally sufficient to anticipate a claim to use of A in treating X).  I guess if you're only claiming treatment in humans you're out of 102 though.

I don't know what the aptly named Justanotherexaminer is smoking, but teaching away is one of the ONLY ways to demonstrate nonobvious post KSR (unexpected results being the other significant way).  Isaac's response is essentially correct, although I think a paper demonstrating that the claimed compound is ineffective in treating the claimed disease is pretty strong evidence of nonobviousness unless the skilled person wouldn't consider the animal model tested to be at all representative of the disease in humans (in which case why was this publishable?).

[Naveen Chaklan]

i think the product as such cant be patented and the patent may be granted relation to application of compund to treat the infectious disease. on the other hand the the method of cure or treatment is also not patentable