12/11/2016: US patent was granted. 9,498,413 Anti-microbials and methods of use thereof for would healing. November 22, 2016 This established that protocatechuic acid is a broad spectrum antibiotic. I also secured this same reagent as one that promotes rapid wound healing. The application included 32 claims, but the US patent office only will review two or three at at time. This makes their work easiler and the applicant has to pay again for each subsequent review. I have been told, the US patent office is the only division of the Federal Government that makes money. So we will return to secure other claims for which we have scientific evidence; biofilm destroying reagent to coat implants and reduce infection; spray disinfectan, creams and soaps for killing bacteria on skin; i.e. Acne. The next hurdle is the regulations with the FDA and EPA before we could go to market. Good thing I am young.
11/23/2016: US patent was issued after a multi year saga. The research started more than 10 years ago and resulted in certain claims being granted in 2012. However the patent office examiner did not allow all claims, specifically the direct intra articular injection of these dyes that are found in plants. So more time and money was spent and now the issue is settled. US 9, 486, 468 B2 was issued November 8, 2016 granting claims stating that intra articular of anthocyanins and or anthocyanidins to stimulate the synovium (joint lining) to make a growth hormone; IGF-1. The result there in will improve the nutrition and protect the cartilage in the joint and potentially heal the arthritic joint. The sage is not over yet in that subsequent research showed that the active ingredient is the primary metabolite of those dyes; protocatechuic acid (PCA). I now have supporting research to expand the claims to include the injection of PCA. So back to the patent office with more money and time. These are just the first of many hurdles, as I now face the FDA reglations before available for marketing.
9/29/2016: Regulators gone wild. I was with a famous orthopedic researcher today for lunch. He is head of orthopedic research at two of America’s most prestigious universities. Now listen to this. He has a grant funded to study spinal cord injuries that will start soon, so there is no money available presently. He wanted to study the rat’s spinal cord anatomy so that when the project starts, he will know exactly the approach and technique to this heretofore unexplored anatomy. So he asked around the laboratory for any dead rats. None were available. So with his own money he purchased some rats and humanely euthanized them. He then dissected the spine and spinal cord to see how best to perform their up coming research. The regulators at his institution learned of this and called him in for an explanation. He had violated the regulations by not registering his use of the rats, especially killing them. He received a 6 week “sanction” and cessation from research activities as the punishment. Rats are killed every day in every city in America. It is legal. Home Depot sells the poisons and traps. People spend their own money to do this with no research in mind. This is legal. No reprisals and no regulators.
7/8/2016: I was granted additional claims on my previous patent: 8,263,069 Composition including anthocyanins and anthocyanidins for prevention and or treatment of articular cartilage associated conditions. September 11, 2012. The claims now include the direct intra articular injection of the phytochemical anthocyanin. I now will submit an application for the phase I metabolite; protocatechuic acid for intra articular injection. The claims allowed were: A method of inhibiting interleukin-1 (IL-1) induced glycosaminoglycoside (GAG) release in an arthritic joint of a subject, comprising administering into the arthritic joint of the subject, an intra-articular injection, a composition that is a solution consisting of an anthocyanin, glucose and a pharmaceutically acceptable carrier, wherein said glucose is a 5% solution, and wherein the anthocyanin is cyanidin-3-glucoside and said cyanidin-3-glucoside is administered at a dose of 0.002 mg to 100 mg per joint The method according to claim 1, wherein the composition increases gene expression of IGF-l in the arthritic joint. The method according to claim 1, wherein inhibiting interleukin-1 (IL-1) induced glycosaminoglycoside (GAG) release in the arthritic joint of a subject is associated with a chondroprotective effect in the joint of a subject. The method according to claim 1, wherein inhibiting interleukin-1 (IL-1) induced glycosaminoglycoside release in the arthritic joint of a subject is associated with a chondronutritive effect in the joint of a subject. The method of claim 1 wherein the joint is a synovial joint. A method for treating damaged cartilage in an arthritic joint in a subject, comprising the intra-articular injection of a composition consisting of an anthocyanin, glucose and a pharmaceutically acceptable carrier into the arthritic joint of a subject, wherein said glucose is a 5% solution, and wherein the anthocyanin is cyanidin-3-glucoside said cyanidin-3-glucoside is administered at a dose of 0.002 mg to 100 mg per joint The method according to claim 6, wherein the composition stimulates the production of insulin-like growth factor -1 (IGF-1) in the joint to regenerate the damaged cartilage. The method of claim 6 wherein the joint is a synovial joint.
6/24/2016: Lanny with Jerry Gilbert, now octarians and buddies for almost 70 years are partnering in business venture today in Washington, D.C. Making the rounds of Congressional staff, patent lawyers and wealth managment firms. Gerald Gilbert is retired lawyer of Hogan and Lovells; still smart and energenic as ever to help Lanny find regulatory pathway for recently issued patents.
6/15/2016: I learned today the my patent US 8,263,069 Composition including anthocyanins and anthocyanidins for prevention and or treatment of articular cartilage associated conditions. September 11, 2012 was granted expansion of the claims to include direct intra articular injection. This took 4 years of legal argument to overcome the original objections. This paves the way for intra articular injection of arthritic joints to change the distructive chemistry and preserve and protect the present state of the cartilage. To date there is not a sure way to restore articular cartilage, but working on it.
3/21/2016: I learned today that my US patent application for protocatechuic acid as a broad spectrum antibiotic and wound healing enhancer was granted. This allows me to seek additional claims as well as advance other uses; i.e. sterilization of the skin prior to surgery to reduce this source of bacterial infection. In addition, I will explore the sterilization of surgical implants at the time of surgery.