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Do We Have a Patent or Not?

 

Lisa F. CritesIt was January 2013, and only a couple of months after returning from the Republican National Convention in Tampa.  I received a call from my Washington DC patent attorney, Chris Brody, stating my patent application had also been denied by the US Patent & Trademark office. I asked Mr. Brody what options we had based on this first denial. He said we could easily appeal.

As you may remember, we initially filed for a patent in 2010 to attain a basic patent pending status. Within a year’s time, we were under deadline to finalize or transfer the filing to a Patent Cooperation Treaty (PCT) application which subsequently gave us the right to file in the US, as well as every foreign country known to man, within the next 18 months. Instead of sticking with the original PCT plan to protect our product overseas, we ultimately chose to file a national stage application for both the product as well as ‘method of use,’ but only in the United States. Though we were already selling in several other countries, we didn’t feel it would be cost effective to put additional moneys into the pockets of foreign countries when we essentially couldn’t keep them from duplicating The SHOWER SHIRT™ either way.

Nevertheless, our national stage application had been rejected. Mr. Brody sent us several patent examples as to why the US Patent & Trademark office rejected the application. Essentially, we went through more than 100 examples of existing patents and differentiated their designs and ‘method of use’ from ours. After a few weeks, we filed our appeal. Within only a few days, Mr. Brody had received a letter to say we were in fact approved for our patent. Huh? After three years of filing the various categories of patent applications which were ultimately denied, within two weeks of filing the official appeal, we were being issued a patent? I will never forget Mr. Brody phoning me after receiving the official patent award notification, but this time to say, “Lisa, this is your lucky day.”

The SHOWER SHIRT is now recognized as US Patent #8,516,613 by the United States Patent and Trademark Office and the only patented shower shirt garment for mastectomy patients on the United States market. Our patent award was reported on the CNN website, the Miami Herald, and Florida Today. Yes, in fact, “that was my lucky day.”

Florida Today Article on Patent Award: http://www.floridatoday.com/article/20130725/HEALTH02/307250024

 

Stay Tuned,

 

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant

Health/Medical Broadcast Journalist

The Republican National Convention

 

Lisa F. CritesSoon after my guest column hit FLORIDA TODAY with comments on the upcoming November 2012 presidential election, I was asked to be a part of the Huffington Post’s ‘Entrepreneurs Start-Up’ exhibition at the Republican National Convention (RNC) in Tampa, FL.

It was somewhat ironic as I was raised in a staunch democratic family, married a staunch Republican, but was registered as Independent. With that said, I would acknowledge any party affiliation needed if it allowed me to participate in the Republican National Convention (RNC). Luckily, party lines didn’t come into play as the Huffington Post was only focused on providing networking exposure and support to innovative start-up companies looking to gain contacts. Needless to say, the ‘start-up exhibition’ was fascinating. There were all categories of organizations; from transportation to technology companies, medical equipment to surgical devices. Since the RNC events were essentially spread across the city of Tampa, we saw only a portion of the convention programs.  Nevertheless, an experience I was honored to be part of and will never forget.

I briefly met Arianna Huffington, head of the Huffington Post, who held a private reception for exhibitors. This was an extremely busy event so there was not much time to converse. I was really hoping to pull her into a corner and discuss the whole Medicare, male versus female penile implant versus The SHOWER SHIRT™ issue, but in hindsight, I guess not necessarily appropriate at the RNC venue.

2012-08-29 13.12.52

      The SHOWER SHIRT display booth at the Huffington Post – Republican National Convention Exhibit

I’ve enclosed an article written by Space Coast Medicine & Healthy Living on The SHOWER SHIRT Co. being one of only a few companies in the state of Florida chosen to attend the Republican National Convention: http://www.theshowershirt.com/wp-content/uploads/2014/03/Space-Coast-Medicine-Healthy-Living.pdf

In the meantime, and as promised, exactly four months after presenting to the Healthcare Common Procedural Coding (HCPCS) committee in Baltimore requesting our own HCPCS code, we received the final decision as to whether our product was going to be awarded. DENIED! “If at first you don’t succeed, try, try again,” was definitely becoming a daily theme with The SHOWER SHIRT team.

Stay Tuned,

 

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant

Health/Medical Broadcast Journalist

My ‘Somewhat Controversial’ Guest Column

 

Lisa F. CritesWhen I returned from Washington DC, I attended a St. Patricks’ day event at a local attorney’s office. I was discussing my recent trip to Washington with a few lawyers and gave an overview of my many meetings, presentation to CMS (Medicare) in Baltimore, the CBS Morning Show experience, etc. I actually was laughing about the last several years and my indirect approach in trying to get to the right person in the right position to gather the right information I needed for the mountain of government paperwork and applications involved. I was complaining about the time and effort necessary to make sure The SHOWER SHIRT Co. was following proper guidelines in the patent application process, the Medicare application process, and in trying to attain a proper Healthcare Common Procedure System (HCPCS) code.

One of the attorneys, Jerome Hoffman, who often works with my then significant other and now husband, “Phil”, suggested I write about my experience and submit as a newspaper guest column. Mr. Hoffman stated he thought the column would give great insight into how difficult it was to invent a medical device, bring it to market and subsequently fight ‘red tape’ to attain Medicare reimbursement. Since our presence in the marketplace had continued to grow, I felt the idea had merit. The SHOWER SHIRT™ had been on the US market for a year, and with Walmart.com adding the garment to their product line, I believed we had the credibility needed to write a solid substantive guest column. In addition, from a timing standpoint, it was perfect; it was spring 2012 and every politician who had their sights on the election was already campaigning on ‘growing small businesses.’ I had plenty to say in terms of ‘growing a small business,’ and how difficult it was, especially when this small business had to continually deal with the US government. Coincidentally, Bob Stover, the managing editor of FLORIDA TODAY was also at that same event; I mentioned Mr. Hoffman’s guest column idea and he said he would run my column.

When I arrived home, I began putting pen to paper in terms of the entire process. Before I knew it, I had more than 2,500 words on paper. This was an issue as Mr. Stover said no more than 500 words. It took longer to whittle the column down than it did to write it in the first place. Enclosed is that FLORIDA TODAY guest column. In looking back, what fun; every time I read the column it makes me smile, but also gives me pause as I wonder if The SHOWER SHIRT Co. will ever get to where we need to be in this never-ending government Medicare battle.

FLORIDA TODAY Guest Column:                                                                                        http://www.theshowershirt.com/images/guest-column.pdf

Stay Tuned,

 

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant

Health/Medical Broadcast Journalist

Government Committee Presentations & CBS in Washington

This Blog is dedicated to my childhood friend, Lee Anne Swinger, who lost her battle with breast cancer this week. After a year of struggling, I know you are resting in peace.

Lisa F. CritesAlong with the Medicare coverage application, our company had also applied for a government product code under the Healthcare Common Procedural Coding System (HCPCS) for The SHOWER SHIRT™.  We felt this might help support our Medicare application initiatives. We headed to Washington DC in May 2012 to appear before the Centers for Medicare and Medicaid Services (CMS) HCPCS committee and argue why The SHOWER SHIRT deserved a HCPCS code.

I was not a fan, nor had much experience maneuvering in and around Washington DC, a  concern while planning for this upcoming CMS presentation. Luckily, my attorney’s firm hired to help with the Medicare process drove us to Baltimore to the national CMS building for the meeting. The security process was outrageous even getting through the gates, much less the building. The security guards were checking under vehicles for, what we assumed, were explosives.  For that matter, there were a myriad of vehicles they wouldn’t give permission to drive onto, or park on property, and instructed to park miles away.  Luckily, since we had a driver, we were dropped off at the door (after extensive car and body scanning), and picked up in that same place, many, many hours later.  I was essentially hoping this already stressful day would be a short one and that I would be chosen as one of the first presenters. In contrast, I was the twentieth (out of 25) to present to the committee. It was a very, very, very long day.

One after another CEO and/or President spoke to this national committee as to why they needed a HCPCS code for their product. I became more and more nervous as every hour ticked by. To calm my nerves, I tried doing yoga in the bathroom, meditating, jogging in place, but nothing calmed me. I finally walked outside and sat and prayed for my higher power to calm my nerves to get through the presentation. A few minutes before I presented, I had a warm calmness come over my body. Once I was on the podium, something told me to focus on speaking to the men on the panel. I did just that.

With eight women and five men on the panel, I began my presentation. It was interesting as each female looked me squarely in the eyes with interested facial expressions. However, the men would not look directly at me. Thus, I did what ‘my voice’ told me to do, and focused directly on presenting to them. I looked at each one and asked the same question.

Would you want your mother, sister, or daughter in the shower with a trash bag after breast cancer and amputation of the breasts? Or, would you rather them utilize a product designed to protect surgical drain sites while showering after mastectomy surgery?”

Their reaction to my question became somewhat comical; the men clearly were so uncomfortable that each one would briefly look my way while I asked my question, but then quickly turn red faced and promptly looked away. What I quickly realized were many of these committee members did not know the clinical process of mastectomy surgery and that women utilized trash bags for protection while showering post-surgery.  At the same time, it is my opinion if those individuals (primarily the men) were going to be on the committee to decide what products attained government HCPCS codes, they should be prepared to hear and see the good, bad, and ugly of disease and illness.

If you will remember, this is the same committee who gave HCPCS codes to penile implants for Medicare coverage (something our government spent more than $172-million dollars from 2006 to 2011). Enclosed is a recent story written by an Orlando Sentinel reporter on that example of government waste.

Orlando Sentinel: Penis Pumps are Medicare Waste:                                                 http://www.newsmax.com/Newsfront/penis-pumps-medicare-waste/2014/01/14/id/546981

In hindsight, everything worked out quite well in Washington that week. It was an action packed week of meetings with government officials and attorneys, and to top it off, we attained a guest appearance on the CBS Morning Show in Washington. In looking back, it was one of the most stressful weeks of my life, but one which clearly helped me gain strength and momentum on both a personal and professional level.

CBS- Washington DC

                                 Washington DC – CBS                                     http://www.wusa9.com/news/article/205376/45/Shower-Shirt-Help-Breast-Cancer-Patients-Keep-Bandages-Dry

 

Stay Tuned,

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant

Health/Medical Broadcast Journalist

United States Congressmen & Senators

Lisa F. CritesIn January 2012, I received a second letter from the Centers for Medicare and Medicaid Services (CMS) stating my re-application for Medicare coverage had been denied, and The SHOWER SHIRT™ product was still deemed a ‘convenience’ item for breast cancer patients, versus the ‘medical necessity’ title it needed to be for Medicare coverage.

After saying a few four letter words, I regrouped and contacted my friend Dixie Samson who works as a political lobbyist. Dixie was kind enough to share contacts with U.S. Senator Bill Nelson’s office, Florida Senator Mike Haridopolos’ office, and U.S. Congressman Bill Posey’s office. I then reached out to each of their Chiefs of Staff and asked for support to better navigate through the Medicare approval process. I signed documents for access to my personal records for a thorough background check, and gave permission to obtain The SHOWER SHIRT Co.’s public Medicare coverage application documents.

In addition, I forwarded to them newspaper, magazine and television features on The SHOWER SHIRT™ to give a better idea of the reasons behind the product and the need for Medicare coverage. I then met with the various representatives and within a few weeks, had letters of support from two of the political offices. Essentially, they all had the same reaction to my story, making comments such as, “This just makes sense for Medicare to reimburse.” Senator Nelson’s office stated they would rather not write a letter of recommendation – but wanted to “stay on top of the process with CMS until fruition.”                                                

Florida Senator Mike Haridopolos – Letter of Support

US Congressman Bill Posey Letter of Support

I had a more lengthy conversation with Congressman Posey and his staff. I loved his personal comment directing his staff to “write a letter to CMS and ask why they were discriminating against breast cancer patients.” This statement came after I revealed Medicare covers shower coverings and dressings for end stage renal disease patients going through dialysis treatment, but not for breast cancer patients.

mike haridopolos and lisa                                                      Senator Mike Haridopolos & Me                                                 

Coincidentally, the same week I was told we had no Medicare coverage I heard from my patent attorney. He stated our existing patent application which gave us patent pending status for the previous year was about to expire and we needed to decide on a plan of action. As much as I liked my unexpected cheerleader patent attorney, Mr. Brody, I knew that plan of action was going to cost money. It seemed like a two-thousand dollar call every time I picked up the phone to talk to him about the next plan of action. Since I was not sure exactly how to proceed (as I didn’t know if we should tackle a domestic or international patent), we opted to file a patent under the Patent Cooperation Treaty (PCT) application process. The PCT application reserved our right to file in foreign countries as well as the United States for another 18 months. This gave us more time to figure out our best plan of action, without too much financial pain.

In the meantime, I was still working as a media strategy consultant with multiple clients, while traveling across the country to as many breast cancer conferences that both my pocketbook and schedule would allow.

I kept saying to myself, “All I wanted to do was keep women out of the shower with trash bags post-mastectomy. I never imagined it was going to be so difficult trying to attain Medicare coverage to keep these mastectomy patients protected.”

Stay Tuned,

 

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant

Health/Medical Broadcast Journalist

Becoming A Known Quantity

Lisa F. CritesWith 2011 coming to an end, The SHOWER SHIRT™ had officially been on the market for one year, though only presented to the breast cancer/mastectomy garment industry seven months earlier. Both our retail sales and wholesale contracts were continuing to grow, but we were still not where I wanted to be.

Since the inception of this project, the rational side of my brain had continued to believe since this was a “needed” product for mastectomy patients, it would be a simple roll-out followed by sales to every mastectomy boutique in the country. With that rational thought process not necessarily happening, I was beginning to understand comments by other inventors and business owners. Comments such as, “It takes at least five years for a product to become a known quantity,” or contrasting statements such as, “Just because you build it, doesn’t mean the masses will come.” The product was not needed by the masses, only for those unfortunate individuals like me who were diagnosed with breast cancer and chose to undergo mastectomy surgery. I was trying to find our position in the market. I was still searching for the strong spots with decreasing emphasis on the weaker areas of the market.

I would frequently receive pep talks from my patent attorney, Chris Brody. He would often say (in his very slow methodical lawyer voice), “Lisa, you have no idea how far ahead of the game you are. You invented a product, brought it to market, and Walmart picked it up within eight months.” He would then discuss the many inventors who had subsequently failed to bring products to market. He would periodically state, “Unfortunately, certain individuals just don’t know when to give up.” I was glad I was not in that category of individuals as it’s just not in my nature to give up either. Nevertheless, whether he knew it or not, Mr. Brody (as I called him) was an unexpected cheerleader. My friends and family members had cheered me on, but they were required to, Mr. Brody was not. 

In the meantime, surgeons from around the country had begun to read about The SHOWER SHIRT and reached out asking if I had contemplated the garment  being used by other patient populations. Some felt the product would support End Stage Renal Disease patients undergoing dialysis treatments who needed catheter protection from water while showering. Others suggested rotator cuff patients, bariatric patients with drains, cardiac patients with external defibrillators,  along with SAVI catheter patients going through radiation treatment. This was something I had not thought about but began doing research.

Fox Atlanta 3                                     Good Day Atlanta – FOX 5                         

          http://www.youtube.com/watch?v=udNCWDQaigU

I was still fighting for Medicare coverage, something which was a painfully slow process, but required at this point. In addition, my journalism background continued to help our media relations initiatives, which supported our lack of a marketing budget. We had multiple newspaper and magazine articles featuring the product, along with a myriad of broadcast television features. I was extremely excited to have been asked to be a guest on the Good Day Atlanta morning show, located at the FOX News affiliate in Atlanta.

 

Stay Tuned,

 

Lisa F. Crites

Shower Shirt Principal/Inventor

Corporate Healthcare Consultant & Media Strategist

Health/Medical Broadcast Journalist

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