From: Lyons, Robert [e-mail address redacted] Sent: Wednesday, April 16, 2014 10:56 PM To: myriad-mayo_2014 Subject: 2014 Guidance Memorandum for Subject Matter Eligibility of Claims Relating to ... Natural Products - Comments 1. I disagree strongly with the PTO analysis of Example III.B., Claim 1 on page 7. According to the background, a patient must eat 30 pounds of leaves per day for 4 weeks to achieve therapeutic effect in treating breast cancer, but 1 teaspoon of purified amazonic acid achieves the same effect as 30 pounds of leaves. Nobody had previously been able to identify, isolate, extract, or purify the active ingredient in the leaf. It appears to me that the purified amazonic acid is markedly different from what is found in nature. Purified amazonic acid is not naturally occurring and is not found in nature in that state; it is the leaf that is the product of nature. The PTO also cannot blithely assume that the process of purifying the amazonic acid had no effect on its potency. If previous investigators had been able to identify, isolate, extract, and purify amazonic acid from the leaf but did not know about its therapeutic value, then the compound may not be new or satisfy the novelty or obviousness requirements, but it is not patent ineligible subject matter. 2. I also disagree with the PTO discussion of Example III.C. on page 9. The discussion recites “Factor a) is not satisfied, because…gunpowder…are not markedly different from what exists in nature.” The PTO analysis appears to assume that a mixture is not eligible subject matter if the various elements and compounds in the mixture have not been chemically altered from what is found in nature. I believe this is wrong. By the PTO reasoning, gunpowder itself would not be eligible subject matter for a patent, in spite of its tremendous utility. Gunpowder, as a mixture, is not a naturally occurring product of nature. The act of selecting the ingredients and mixing them in the proper proportions is invention. When nobody had previously appreciated the effect that can be achieved by mixing a particular selection of ingredients in the proper proportions, making the combination should be rewarded with patent protection. Almost every invention is a combination of old or known elements; it is making a combination to produce a useful product that was previously substantially unknown that’s patentable. Robert Lyons Registered Patent Attorney IP & Emerging Technologies Practice Group 1275 K Street, N.W., Suite 850 | Washington, DC 20005 121 Alhambra Plaza, 10th Floor | Coral Gables, FL 33314 Patent Law Building | 8951 Center Street | Manassas, VA 20110 Tel: 703.412.1000 | Toll Free: 1.800.4.PATENT (1.800.472.8368) Fax: 703.412.7000 | Toll Free: 1.888.4.PATENT (1.888.472.8368) [e-mail address redacted] | www.bplegal.com