`
`Applicants:
`
`Solomon et al.
`
`Atty Docket: 3766/1004
`
`Serial No.:
`
`12/610,141
`
`Art Unit:
`
`3767
`
`Date Filed:
`
`October 13, 2009
`
`Examiner:
`
`Carpenter.
`
`Invention:
`
`Sterilization Caps and Systems and Associated Methods
`
`Commissioner for Patents
`
`Washington, DC 20231
`
`DECLARATION OF Jorge Parada, MD, MPH, FACP, FIDSA)
`IN CONNECTION WITH APPLICANTS’ RESPONSE
`
`[37 C.F.R. § 1.132]
`
`Dear Sir:
`
`In connection with the response to the Office Action dated November 16, 2011, in
`
`the above matter, the undersigned Jorge Parada, MD hereby declares as follows:
`
`1.
`
`I am the Medical Director of the Loyola University Medical System Infection
`
`Control Prevention and Control Program of Loyola University Chicago, Illinois, and a
`
`Professor of Medicine at the University’s Stritch School of Medicine. I am also a Senior
`
`Research Associate at the Center of Management of Complex Chronic Care at Hines
`
`Veterans Affairs (VA) in Hines, Illinois. I am an active clinician, researcher and teacher.
`
`Ihave co-authored over 50 articles on infectious disease, and have presented hundreds of
`
`times at major international and national scientific meetings and as invited speaker at
`
`other medical centers. These articles and presentations includes several that have focused
`
`on the microorganisms that cause catheter related bloodstream infections. My further
`
`credentials are set forth in my Curriculum Vitae, which is attached as Exhibit A hereto.
`
`1
`
`CCI 2002
`
`1
`
`CCI 2002
`
`
`
`2.
`
`I am familiar with and have reviewed the guidelines and recommendations for the
`
`prevention of intravascular catheter—related infections promulgated by organizations
`
`including the CDC, Infusion Nursing Society, The Joint Commission, the Institute for
`
`Safe Medical Practices, and by various thought leaders. These guidelines and
`
`recommendations are listed in Exhibit B hereto.
`
`3.
`
`All of these guidelines and recommendations specifically address the needleless
`
`injection site and require disinfection and cleaning of the needleless injection site with an
`
`antiseptic. None of these guidelines and recommendations, however, provides any
`
`guidance that specifically addresses disinfection of the male luer at the end of the IV
`
`administration line.
`
`4.
`
`Furthermore, historically, there has been no reliable way of disinfecting the male
`
`luer without risking introduction of toxic antiseptic into the path of fluid into the patient’s
`
`bloodstream.
`
`5.
`
`, Therefore, historically, the need to disinfect the male luer has not been
`
`appreciated. I can further attest that it has not been common practice to attempt
`
`disinfecting the male luer in daily practice in hospitals, infusion centers, or in home iv
`
`programs.
`
`6.
`
`However, I was the co-investigator of a recent study at Loyola University Medical
`
`Center, presented in April 2011 at the Society for Healthcare Epidemiology (SHEA),
`
`sponsored by Catheter Connections, the licensee of rights to the application herein. This
`
`study shows male luer colonization with the microbes known to cause catheter related
`
`bloodstream infections. This study is the first to evaluate the microbiology of male luers
`
`
`
`used clinically and shows that failure to disinfect the male luer creates a serious risk of
`
`infection. The poster and abstract of this study is attached as Exhibit C.
`
`7.
`
`I hereby declare that all statements made herein are of my own knowledge and
`
`that all statements made on information and belief are true; and further that these
`
`statements are being made with the knowledge that willful false statements and the like
`
`so made are punishable by fine or imprisonment or both under Section 1001 of Title 18 of
`
`the United States Code and that such willful false statements may jeopardize the validity
`
`of the application or any patent issued thereon.
`
`A/J/Z/
`
`gnature
`
`Dated: December 14, 2011
`
`Jorge Parada, MD
`
`
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