When nutraceutical and cosmetic companies consider filing patent applications, the first question usually asked is if the product or method is “new” enough to justify the expense. A patent attorney would refine that question to ask if the product or method has been done before (is it novel?) and if it is an obvious variation of known ideas about other products or methods (is it non-obvious?).
Additionally, the patent attorney would consider whether the product or method for which patent protection is sought is “patent eligible subject matter.” Separate and apart from considerations of whether the product or method is both novel and non-obvious, certain categories of subject matter are not considered eligible for patent protection. Ineligible subject matter includes laws of nature (including nature-based or natural products), natural phenomena and abstract ideas (including mathematical concepts or organizing human activity). Eligible subject matter in the U.S. includes “any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof.” In recent years, the U.S. Supreme Court and the U.S. Patent and Trademark Office have made a sharper distinction between what is considered patent eligible subject matter and what is not. For nutraceutical and cosmetic companies, the issue of subject matter eligibility tends to arise fairly often.
Hypothetical Company
Consider a hypothetical nutraceutical and cosmetic company we will call Healthy Eating Habits (HEH). HEH markets healthy foods and encourages a healthy lifestyle. In particular, HEH recommends a bitterberry juice squeezed from the bitterberries imported from a small tropical country. The bitterberry juice is produced and marketed without any sugar added. HEH has discovered that when bitterberry juice is used as a meal replacement, users feel healthier and also experience weight loss.
HEH publishes a book regarding the benefits of meal replacement using bitterberry juice. Interested readers begin to connect to the company and with each other in on-line chat rooms and other social media. A program is developed by HEH that organizes interested participants into small groups to discuss the HEH book and the bitterberry juice meal replacement program. The small groups meet weekly through phone calls or via any number of online meeting fora. These meetings result in participants’ more faithful compliance with the bitterberry juice meal replacement program, and more significant weight loss by participants compared to that of users of the bitterberry juice meal replacement program who do not meet in a small groups.
One of the HEH founders, when moving a large container of bitterberry juice, accidentally spilled a drop that landed on her sandaled toe. Within minutes, the drop of spilled bitterberry juice cleared up a recent outbreak of fungus on the founder’s toe. She was so excited at the discovery, she used an eyedropper to place drops of bitterberry juice on the toe fungus of others in the business. Within a few minutes of application, each case of toe fungus was eradicated.
U.S. Patent Application
After making the discovery about the use of bitterberry juice for curing toe fungus, but before making public its plans to sell and market bitterberry juice as a meal replacement, before publishing the HEH book, and before forming any on-line groups, HEH had the foresight to consider patenting aspects of its proposed business methods and products. Knowing that there would be significant commercial value in getting a valid U.S. patent, but not wanting to employ a reputable patent attorney, HEH used an on-line do-it-yourself patent service to prepare and file a non-provisional patent application at the U.S. Patent and Trademark Office (USPTO).
The patent application included a first claim directed to a composition of pure bitterberry juice without any sugar added, a second claim directed to a method of providing pure bitterberry juice as a meal replacement, a third claim directed to a method of grouping participants in a healthy eating program of ingesting pure bitterberry juice as a meal replacement program such that the group participants are more compliant and experience more weight loss, and a fourth claim directed to a method of treating toe fungus on a human by applying a single drop of pure bitterberry juice topically to the infected area.
Analysis
The USPTO assigned the patent application to an examiner. When it was time for examination (normally about two years after filing the application), the Examiner reviewed each claim to determine if it was appropriately directed to patent eligible subject matter.
The examiner found that the first claim, directed to a composition of pure bitterberry juice without any sugar added, was not patent eligible. More specifically, the claim was directed to a nature-based or natural product. There was no difference in the claim from the bitterberry juice found in nature. HEH did not invent the bitterberry plant or the bitterberry juice. Thus, the claim did not recite patent eligible subject matter.
The examiner then found the second claim, directed to a method of ingesting pure bitterberry juice as a meal replacement, was not patent eligible. Although this claim was directed to a method (not a composition), the method was merely a use of the same nature-based ineligible product recited in the first claim. There were no added preservatives or any different characteristics of the bitterberry juice than what is found in nature. As the claim did not add any additional features that could qualify the claim for a judicial exception to the rule regarding nature-based products, this claim was considered ineligible subject matter for a patent.
Next, the examiner found that the third claim, directed to a method of grouping participants in a healthy eating program of ingesting pure bitterberry juice as a meal replacement program such that the group participants are more compliant and experience more weight loss, was not patent eligible. The U.S. Supreme Court and the USPTO have determined that patent eligible subject matter does not include methods of organizing human activity that include, for example, financial hedging, insurance, mitigating risk, commercial or legal interactions (such as agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors or business relations), or managing personal behavior or relationships or interactions between people (such as social activities, teaching, and following rules or instructions). In this case, HEH was claiming a method of organizing human behavior merely to teach and reinforce the concept of ingesting pure bitterberry juice as a meal replacement program. The claim did not include significantly more than the abstract idea itself. Thus, the claim was not patent eligible.
Finally, the examiner found the fourth claim, directed to a method of treating toe fungus on a human by applying a single drop of pure bitterberry juice topically to the infected area, to be patent eligible. Although the claim recites a nature-based product (pure bitterberry juice) the claim as a whole is focused on a process of practically applying the product to treat a particular disease (toe fungus) and not on the product itself. Thus, the claim qualified as eligible subject matter for patent protection. The examiner was then able to continue her examination of the claim for novelty and non-obviousness.
Assuming that the HEH patent application clears the other statutory hurdles, the USPTO will allow a patent to issue with claims related to methods of treating toe fungus with pure bitterberry juice. Although getting only one claim to issue in a patent was probably not what was hoped for by HEH, the company did not employ a U.S. patent attorney to help them with the original patent application or the interactions with the patent examiner. Had they done so, minor amendments to the application and claims may have been possible to bring them into an acceptable realm of subject matter eligibility.
For example, in the first patent application claim, although the pure bitterberry juice was “without any sugar added,” the product actually sold to consumers included a preservative, which affects the bitterberry juice so that it takes longer to spoil (a few weeks) than the natural juice (a few days). This property of slower spoiling is a markedly different characteristic from the bitterberry juice found in nature, and should have been included in the patent application. Had it been included in the first patent application claim, that claim may have been considered patent eligible.
If the same property had been included in the second claim directed to a method of ingesting pure bitterberry juice as a meal replacement, it too may have been considered patent eligible. In addition, the eligibility of the claim would have been strengthened if it included more details regarding what was found to be particularly effective in treating a disease or condition, such as the specific amount of bitterberry juice that is ideally ingested, or a specific schedule for meal replacement.
The third claim, directed to a method of organizing human activity, would not be easily salvageable.
Conclusion
Nutraceutical and cosmetic companies have long been aware of patentability risks related to filing new applications. Companies mitigate those risks by performing patentability searches in the patent and non-patent literature. Subject matter eligibility is an equally important consideration when filing patent applications. Companies should ensure that their claims are drafted in such a manner that they will pass review for subject matter eligibility. NIE
Jason J. Jardine is a Partner with Knobbe, Martens, Olson and Bear LLP. He is a chemist who represents nutraceutical, pharmaceutical and biotechnology companies and is particularly skilled in taking distressed patents that are languishing at the U.S. Patent and Trademark Office and getting them approved, launched, leveraged and/or sold.
