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Mimedx Group Inc. v. Nutech Medical Inc.

Representative Claim(s)

U.S. Patent No. 8,597,687

  1. A method for permitting direct, visual determination of the orientation of a placental tissue graft by user, wherein the placental tissue graft has a first side and a second side, said method comprising: placing an asymmetric label on a portion of at least one side of said tissue graft, which label visibly distinguishes one side from the other side, thereby permitting direct, visual determination of the orientation for application of said tissue graft; and ascertaining the orientation of the placental tissue graft by direct visual determination.

U.S. Patent No. 8,709,494

  1. A dehydrated, laminated tissue graft consisting essentially of one or more washed and/or substantially cleaned amnion layers and one or more washed and/or substantially cleaned chorion layers, wherein at least one of the amnion layers contains its fibroblast cell layer, and further wherein the amnion layer and the chorion layer are directly laminated to each other.
  2. A dehydrated, laminated tissue graft, wherein the tissue graft consists essentially of one or more amnion layers and one or more chorion layers wherein each of the amnion and chorion layers: are separated from a placenta to provide separate layers of amnion and chorion, washed and substantially cleaned without removal of the fibroblast cell layer from the amnion layer, and are layered directly over each other and are laminated and heat dehydrated together to provide the dehydrated, laminated tissue graft.
  3. A dehydrated, laminated, placental tissue graft which is a laminate comprising two or more separated and washed layers which layers are selected from amnion and/or chorion wherein the layers are directly laminated to each other and at least one of said layers is an amnion layer which retains an epithelial cellular layer.
  4. A dehydrated, laminated, placental tissue graft which is a laminate comprising two or more separated and washed layers which layers are selected from amnion and/or chorion wherein the layers are directly laminated to each other and at least one of said layers is an amnion layer which retains a fibroblast cellular layer

Posture:

Motion to dismiss.

Exception Category: Natural Phenomenon

U.S. Patent No. 8,597,687

“Applying step one of Mayo, the court determines that Claim 1 is ‘directed to’ a natural phenomenon, i.e., placental tissue.”

U.S. Patent No. 8,709,494

“Applying step one of Mayo, the court determines that [the claims are] ‘directed to’ a natural phenomenon, i.e., placental tissue.”

Significantly More: Yes / No

Yes, with respect to Claims 1-7 of ’687 Patent and Claims 1-5, 9-10 of ’494 Patent. No, with respect to Claims 6-8 of ’494 Patent.

U.S. Patent No. 8,597,687

“The court finds that Claim 1 sets out a process – adding an asymmetrical label – that is ‘novel and useful’ and that causes the placental tissue to be physically ‘transformed’ from such tissue as it exists in nature.”

U.S. Patent No. 8,709,494

“Merely cutting [the placental] tissue into pieces to be used as a graft is, as stated in the patent application itself, not ‘novel’ and therefore, without more, does not ‘transform’ that naturally occurring tissue into a patent-eligible invention.”

“[S]eparating the layers, washing or otherwise cleaning them, and/or dehydrating them, are not ‘novel’ and accordingly do not ‘transform’ the naturally occurring tissue into a patent-eligible invention.”

“[G]iving the term ‘directly laminated to each other’ the meaning – ‘directly adhered to each other’ – ascribed to that term by MIMEDX, the court finds that [Independent Claims 1, 9, and 10] set out a method that is ‘novel and useful’ and that ‘transforms’ the naturally occurring tissue into a patent-eligible invention.”

“[T]he court finds that separating the layers from the placenta and from each other, washing or otherwise cleaning them, layering them directly over each other and laminating and heat dehydrating them, are not steps that are ‘novel’ and accordingly the method described in [Claim 6] does not ‘transform’ the naturally occurring tissue into a patent-eligible invention.”