Intellectual Property and Patent & Trade Mark Protection

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华钟
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hi! I have a question about inventiveness. can anybody give me some suggestions?

hi! I am a chinese patent attorney. I have a question about inventiveness. can anybody give me some suggestions?

In priot art, it has been demonstrated that a compound has an effect to inhibit a desease in vitro, but there has been no answer to wether this compound can have the same effect in vivo. In fact, there are plenty examples that effective compound in vitro has no effect in vivo in pharmaceutical field. It is true that a test in vivo is a common technical means, but is it reasonable that the test in vivo does not involve an inventive step?

what do you think ? can you give me some suggestion to help me to persuade the examiner to accept the inventiveness of the test in vivo?

thanks a lot !

hope to communicate with everyone in the forum about intellectual property. if you have any problem about chinese patent law , I can help you. :} welcome to write to me!
- 28 Jul 2009, 10:53 am
华钟 wrote: > hi! I am a chinese patent attorney. I have a question about > inventiveness. can anybody give me some suggestions? > > In priot art, it has been demonstrated that a compound has an > effect to inhibit a desease in vitro, but there has been no answer to > wether this compound can have the same effect in vivo. In fact, > there are plenty examples that effective compound in vitro has no > effect in vivo in pharmaceutical field. It is true that a test in > vivo is a common technical means, but is it reasonable that the > test in vivo does not involve an inventive step? > > what do you think ? can you give me some suggestion to > help me to persuade the examiner to accept the inventiveness of the > test in vivo? > > thanks a lot ! > > hope to communicate with everyone in the forum about > intellectual property. if you have any problem about chinese patent > law , I can help you. :} welcome to write to me!
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Andreas Noack Group moderator
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Re: hi! I have a question about inventiveness. can anybody give me some suggestions?
Dear 钟华,

first of all I have to confess that I'm no pharmacologist. Still I would like to give you my opinion.

If it is known in the art that a special compound is effective for a special task in vitro, I assume testing the effectivenes in vivo is possible without being inventive. This does not mean that it is simple, and it may consume many efforts and resources. But I belive you could give a skilled person the compound and the task, and he or she will return with a 'yes' or a 'no'.
There is still a question whether there is a 'reason to try'. But why would scientists screen thousends of compounds for effectiveness in vitro, if a positive result would not give them a reason to try it in vivo?

We have come a long way from the discovery that penicillin kills germs in vitro. Still saying that trying is inventive after the effectiveness in vitro is known would mean to ignore this gained knowledge.

But of course there may be arguments for inventiveness, for example serious burdens or prejudice. If a compound is known to be of extreme hight toxity, ore there are other reasons to expect that testing the compound would really be a waste of efforts, the situation may be different.

And of course, if the effectiveness in vivo depends on additives or dosage, this has to be considered.

Honest Regards
A. Noack
- 04 Aug 2009, 10:12 pm
Andreas Noack wrote: > Dear 钟华, > > first of all I have to confess that I'm no pharmacologist. Still I > would like to give you my opinion. > > If it is known in the art that a special compound is effective for a > special task in vitro, I assume testing the effectivenes in vivo is > possible without being inventive. This does not mean that it is > simple, and it may consume many efforts and resources. But I belive > you could give a skilled person the compound and the task, and he or > she will return with a 'yes' or a 'no'. > There is still a question whether there is a 'reason to try'. But why > would scientists screen thousends of compounds for effectiveness in > vitro, if a positive result would not give them a reason to try it in > vivo? > > We have come a long way from the discovery that penicillin kills > germs in vitro. Still saying that trying is inventive after the > effectiveness in vitro is known would mean to ignore this gained > knowledge. > > But of course there may be arguments for inventiveness, for example > serious burdens or prejudice. If a compound is known to be of extreme > hight toxity, ore there are other reasons to expect that testing the > compound would really be a waste of efforts, the situation may be > different. > > And of course, if the effectiveness in vivo depends on additives or > dosage, this has to be considered. > > Honest Regards > A. Noack
华钟
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Re^2: hi! I have a question about inventiveness. can anybody give me some suggestions?
Hi! Thanks for all your advice. That's really helpful.

Actually, the question relates to a reexamination case. The compound involved in the case is not a synthesized compound, but a compound extracted from a plant, so it's hard to give examples suggested by Andreas Hübel (still thank you!).

I considered all your advice and prepared the observation for the case.

In the argument part, my main point focuses on that in medical field, due to the complexity and huge cost of in-vivo test, and non-foreseeability between in-vitro and in-vivo, and the low proportion of effective compounds in-vivo versus in-vitro, effectiveness in vitro may show a possibility of effectiveness in vivo, but also imply a more than 50% possibility of non-effectiveness in vivo, so it does not give a sufficient motivation which would prompt a person skilled in the art to test the compound in vivo. Furthermore, I emphasize that the concentration of the compound in the target organ is really very low which in fact means a prejudice that the compound shall be expected to be ineffective in vivo.

The observation has been just submitted. After I get the response, I will tell you. Thanks again.

Truly regards,
zhonghua
This post was modified on 01 Sep 2009 at 11:51 am.
- 01 Sep 2009, 11:50 am
华钟 wrote: > Hi! Thanks for all your advice. That's really helpful. > > Actually, the question relates to a reexamination case. The compound > involved in the case is not a synthesized compound, but a compound > extracted from a plant, so it's hard to give examples suggested by > Andreas Hübel (still thank you!). > > I considered all your advice and prepared the observation for the > case. > > In the argument part, my main point focuses on that in medical field, > due to the complexity and huge cost of in-vivo test, and > non-foreseeability between in-vitro and in-vivo, and the low > proportion of effective compounds in-vivo versus in-vitro, > effectiveness in vitro may show a possibility of effectiveness in > vivo, but also imply a more than 50% possibility of non-effectiveness > in vivo, so it does not give a sufficient motivation which would > prompt a person skilled in the art to test the compound in vivo. > Furthermore, I emphasize that the concentration of the compound in > the target organ is really very low which in fact means a prejudice > that the compound shall be expected to be ineffective in vivo. > > The observation has been just submitted. After I get the > response, I will tell you. Thanks again. > > Truly regards, > zhonghua

Intellectual Property and Patent & Trade Mark Protection

hi! I have a question about inventiveness. can anybody give me some suggestions?

Re: hi! I have a question about inventiveness. can anybody give me some suggestions?

Re^2: hi! I have a question about inventiveness. can anybody give me some suggestions?