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Re: ohsaycanyousee82 post# 154914

Saturday, 06/30/2018 8:18:56 AM

Saturday, June 30, 2018 8:18:56 AM

Post# of 459958
ohsay...very helpful as it demonstrates the practice at using a level of abstraction convenient to most users. In my world I would expect that in every case/example a lab note book exists which points to and supports every claim. Therefore, the abstraction is converted to fact based reasoning process which can be subsequently proven. that's all. Agreed that knowing where to draw the line of facts vs fantasy and what must be taken as fact in patent apps.

If such abstraction practices were not applied we would end up with a string of facts/numbers and symbols that could not be clearly understood. I get it. That is not my concern. My concern remains are the examples (#5) based on real world evidence (RWE) or are they hypotheticals w/o facts? In one case such an app# can be read as a claim by the sponsor. If one took the text to court how would it be used? Is it an approximation or is it specification as in criteria for acceptance?

No need to get tangled. I read app. examples as an FDA agent would. Should and may are terms used often by regulatory bodies in some context they are sometimes incorrectly used instead of shall or must. I understand the patent app. example# statements are written as should or may statements (preferred but not required) and not shall or must statements (which are required and must be supported by objective evidence).
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