`
`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 LEONARD MERMEL, D.O., Sc.M, A.M. (Hon.)
`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 Leonard Mermel hereby declares as
`
`follows:
`
`1.
`
`I am a Professor of Medicine at the Warren Alpert Medical School of
`
`Brown University and Medical Director, Dept. of Epidemiology & Infection
`
`Control, Rhode Island Hospital. I co-authored the 2002 and 2011 CDC
`
`Guidelines for the Prevention of Intravascular Catheter-Related Bloodstream
`
`Infections, the 2001 and 2009 Infectious Diseases Society of America Guidelines
`
`for the Management of Intravascular Catheter—Related Infections, and I have co—
`
`authored over 100 articles and textbook chapters dealing with infection control
`
`and infectious diseases. Several of my peer-reviewed publications relate to novel
`
`infection control technology.
`
`I lecture nationally and internationally on infectious
`
`‘1
`
`'
`
`CCI 2001
`
`CCI 2001
`
`1
`
`
`
`diseases and infection control. My research interest is the epidemiology and
`
`prevention of healthcare-associated infections, particularly those associated with
`
`intravascular catheters. My further credentials are set forth in my Curriculum
`
`Vitae, which is attached as Exhibit A hereto.
`
`2.
`
`l am familiar with and have reviewed the guidelines and recommendations
`
`for the prevention of intravascular catheter-related infections promulgated by
`
`organizations including the CDC, lnfusion Nursing Society, Society for
`
`Healthcare Epidemiology of America 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 recommend disinfection and cleaning of the
`
`needleless injection site with an antiseptic. To the best of my knowledge, these
`
`guidelines and recommendations, however, do not specifically addresses
`
`disinfection of the male luer at the end of the N administration line.
`
`4.
`
`Therefore, historically, the need to disinfect the male luer has not been
`
`appreciated.
`
`5.
`
`However, a recent study sponsored by Catheter Connections (the licensee
`
`of rights to the application herein) and presented in April 2011 at the Society for
`
`Healthcare Epidemiology (SHEA) National Scientific Meeting, demonstrated male
`
`luer colonization with the microbes known to cause catheter—related bloodstream
`
`infections. The findings of this study suggest that failure to disinfect the male luer
`
`may increase the risk of such infections. The poster and abstract of this recent
`
`study is attached as Exhibit C.
`
`
`
`6.
`
`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.
`
`Dated: December 14, 2011
`
`Leonard Mermel, DO, ScM, AM (Hon),
`FACP, FlDSA, FSHEA
`
`
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