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August 16, 2017

Comments

Why was the "dehydrated" claim limitation not also significant for this rejected "in nature" type of proposed 101 rejection?

The claimed subject matter appears to fall into the "manufacture" category of Section 101.

Applying the criteria of Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887) as approved in Diamond v Chakrabarty 447 U.S. 303 (1980) in order to qualify the claim should be directed to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity "having a distinctive name, character [and] use."

The claimed product indeed has a distinctive name, being a dehydrated, laminated tissue graft, and cannot be called either an amnion or a chorion. It has a distinctive character, being a cleaned and laminated structure and being dehydrated. It has a distinctive new use since the MiMedx® allografts of the patentees produced from the Company’s proprietary PURION® Process for amniotic membrane tissue can be stored at room temperature for five years without the need for refrigeration or freezing. The grafts can be utilized right out of the package without a complicated thawing process. These critical qualities of the MiMedx® allografts allow hospitals, clinics, and surgeons to immediately provide the appropriate treatment while effectively manage their inventory of allografts. It is gratifying to find that the language of new utility in the patent specification is closely reproduced in the website of the patentees and that it apparently represents medical and commercial reality.

It follows that the claimed subject matter falls as a matter of substance and not mere outward form within the eligible "process" category of Section 101. Any attempt by the Federal Circuit to deny patentability would raise "separation of powers" issues in clear and inescapable form. The need to consider positive eligibility before considering the judicial exceptions should be apparent to anyone who has completed legal education, but is strikingly and inappropriately ignored.

Let's not get ahead of ourselves - this is denial of a motion to dismiss; there's a lot that needs to happen for this decision (or this post) to become more significant than that.

My reason for the post is that the Supreme Court has led the question of subject matter eligibility into the playground of fanciful lawyers representing people accused of infringement making arguments attacking patent validity. District courts in the first instance are considering these arguments, which can be much broader and categorical than they were prior to the Court's recent subject matter caselaw. There is an old saying that eating sausage may be discouraged by watching the process by which sausage is made. Our current situation is the opposite: it may be that only by looking at the sausage making that the Court has enabled and encouraged will courts at all levels be able to fully appreciate the folly of this approach.

Dr. Noonan,

For the result of your post to be reached, the Court has to be receptive to the fact that they have engaged in folly to begin with.

Do they have that capacity?

Well, I remain...

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