Summary
This Federal Circuit opinion reviews a Patent Trial and Appeal Board final written decision holding claims of U.S. Patent No. 10,828,310 unpatentable as anticipated and obvious. The court addresses claim construction disputes over the phrases "clinically proven effective" and "first product," concluding that the former is a functionally unrelated limitation that does not render the method claims patentable. While affirming the invalidity of claims 1–4, the court vacates and remands claims 5–8 for further proceedings under the corrected claim construction.
Topics
Practice areas
Questions Presented
- Whether the term “clinically proven effective” is a limiting limitation that can render the claims patentable.
- Whether “first product comprising rivaroxaban and aspirin” requires a single dosage form.
- Whether the Board properly articulated a reason for combining Foley and Plosker references in its obviousness analysis.
- Whether Bayer’s evidence of unexpected clinical results is a sufficient secondary consideration of non‑obviousness.
Holdings
- The term is non‑limiting; even if construed as limiting, it does not add a functional relationship and therefore cannot make the claims patentable.
- The phrase requires a single dosage form that contains both rivaroxaban and aspirin; it does not cover separate dosage forms administered together.
- The Board’s articulation was adequate; it explained that the dosage ranges taught by Foley and Plosker would have motivated a skilled artisan to combine them.
- The evidence is insufficient because it is not tied to the claimed invention; the limitation “clinically proven effective” is functionally unrelated, so the unexpected result does not provide a nexus.
- Claims 1–4 are affirmed as unpatentable; the judgment of unpatentability for claims 5–8 is vacated and the matter is remanded for further proceedings.
Key quotations
“The plain language of the claims requires a single dosage form that includes both rivaroxaban and aspirin. The claims recite “administration of a first product comprising rivaroxaban and aspirin,” not simply “administration of rivaroxaban and aspirin.”” (at 8)
“Secondary considerations of nonobviousness, including unexpected results, must be taken into account when present. However, there must be a nexus between the merits of the claimed invention and the objective evidence.” (at 11)
Factual background
Bayer owns the ’310 patent covering methods of administering rivaroxaban and aspirin to reduce cardiovascular events. The PTAB held the asserted claims unpatentable as anticipated or obvious. Bayer challenged the Board’s claim constructions and obviousness analysis.
Procedural history
The PTAB issued a final written decision finding claims 1–2 of U.S. Patent No. 10,828,310 anticipated and claims 1–8 obvious. Bayer appealed the Board's decision to the Federal Circuit.
Remand instructions
Remand to the Patent Trial and Appeal Board for further consideration of the obviousness arguments concerning claims 5–8 under the correct construction that “first product comprising rivaroxaban and aspirin” requires a single dosage form.