The examiner says your formulation is an obvious combination of known ingredients.
But your test results may help you challenge that rejection.
The key is not just showing that the formula works better. It is showing a result that someone in the field would not have expected.
Orexo v. Actavis is a good pharmaceutical example.
The patent covered a tablet placed under the tongue to treat opioid dependence. Clinical studies reported in the patent showed a 66% improvement in bioavailability compared with an earlier product.
In plain terms, more of the drug was absorbed and available for the body to use.
The lower court held the claims invalid as obvious.
In 2018, the Federal Circuit reversed. The formulation used tiny drug particles attached to larger particles of citric acid. The earlier references did not suggest that arrangement, and the lower court had wrongly discounted its unexpectedly improved performance.
That does not mean every better-performing formula deserves a patent.
The comparison matters. Test against the closest earlier formulation, not a product that is easy to beat. Then explain why the result was unexpected and tie it to the features your claims cover.
The breadth of the claims matters, too. A strong result at one concentration does not automatically support claims covering a much wider range.
For pharmaceutical, cosmetic, and herbal-product companies, the practical takeaway is to bring the formulation team and patent counsel together before planning comparative tests.
What should the new formula be compared with?
What would someone in the field have expected?
Do the results support the protection the company wants?
When drafting, describe the formulation, the relevant ranges, and how it is made. Include relevant comparative data and explain what it shows.
Already filed? You may still be able to submit new test results as evidence. But they cannot fill in formulation details that should have been in the original application.
An obviousness rejection does not always mean the application should be abandoned.
Before narrowing the claims or walking away, review the rejection and the research together. There may be evidence worth putting in front of the examiner.
Sources:
USPTO, MPEP 716.02, Allegations of Unexpected Results
https://www.uspto.gov/web/offices/pac/mpep/s716.html
Orexo AB v. Actavis Elizabeth LLC, Federal Circuit, September 10, 2018
https://www.cafc.uscourts.gov/opinions-orders/17-1333.opinion.9-10-2018.pdf
USPTO, MPEP 608.04, New Matter
https://www.uspto.gov/web/offices/pac/mpep/s608.html
