Utility Patent Application Transmittal %
`
`Address To
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`
`First Named Inventor
`
`Name
`
`Danziger Strasse 2
`
`Mailing Address
`——
`any
`
`Country
`Postal Code
`Germany
`City of Residence
`Felsberg
`State of Residence
`
`Country of Residence
`
`Citizenship
`Title of Invention
`
`United States of America
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`
`
`
`
`Assignee Information*
`
`Name
`
`Com an
`
`Address
`
`B. BRAUN MELSUNGEN AG
`
`Carl—Braun—Strasse 1
`
`
`
`*Complete this section if applicant wants the patent application publication to include assignee information. Providing this information
`does not substitute for compliance with any requirement of Part 3 of 37 CFR to have an assignment recorded by the Patent Office.
`
`
`
`
`
`
`
`
`
`
`Application Elements
`See MPEP chapter 600 concerning utility patent application contents.
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Statements verifying identity of above copies
`
`
`b. m A copy from a prior application (37 CFR 1.63(d))
`
`(for Continuation or Divisional Application)
`
`
`i. D DELETION OF |NVENTOR(S)
`Signed statement attached deleting inventor(s)
`named in the prior application (see 37 CFR
`
`t.63(d) and 1.33(b).)
`
`
`
`
`
`
`
`
`
`USPTO Filing Fee (as calculated infra)
`
`
`3‘
`
`1.
`
`2. D Applicant claims small entity status
`See 37 CFR 127
`
`Specification
`21
`Total number of pages
`Both the claims and abstract must start on a new page
`(For infonnalion on the preferred arrangement, see MPEP 608.01(a))
`
`6.
`
`Application Data Sheet (37 CFR 1.76)
`
`7. E] CD-ROM or CD-R in duplicate, large table or
`Computer Program (Appendix)
`E] Landscape Table on CD
`8. D Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. — c. are required)
`
`a. [J
`b.
`
`Computer Readable Form (CRF)
`Specification Sequence listing on:
`
`4.
`
`5.
`
`Drawing(s) (35 U.S.C. 113)
`
`Total number of sheets
`
`Oath or Declaration
`
`10
`
`i. D CD—ROM or CD-R (2 copies), or
`
`ii. E]
`
`Paper
`
`a. D Newly executed (original or copy)‘ or D Unexecuted
`
`c. E]
`
`Page 1 OH
`
`1
`
`B. Braun 2005
`
`1
`
`B. Braun 2005
`
`

`

`Accompanying Application Parts
`
`9. [J Assignment
`a. D Recordation Form Cover Sheet
`
`37 CFR 3.73lb) Statement (when there is an assignee)
`
`18.
`
`CertificateofMailing
`a. E First Class Mail, or
`b. E]
`Express Mail
`Label Number
`
`Via EFS
`
`
`Utility Patent Application Transmittal %
`
`
`
`
`
`
`
`
`
`
`
`12.
`English Translation Document (if applicable)
`ED
`
`13.
`information Disclosure Statement
`
`a. D Copies of citations attached
`
`14.
`Preliminary Amendment
`
`16.DUDE
`15.
`Return Receipt Postcard (MPEP 503)
`
`(Should be specifically itemized)
`Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`
`Nonpublication Request under 35 USC 122(b)(2)(B)(i)
`
`1o_
`
`11.
`
`Power of Attorney
`
`[3 No Power of Attorney
`
`19. D Other:
`
`20.
`
`If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first
`sentence of the specification following the title, or in an Application Data Sheet under 37 CFR 1.76:
`'
`
`Continuation E] Divisional D Continuation-in-part(ClP) of priorapplication No.
`
`[35/668,667
`(XX/YYY.YYY)
`
`Prior application information:
`
`Examiner
`
`Flick, Jason E.
`
`Art Unit:
`
`3763
`
`Request Not To Publish*
`
`21_ E] Applicant hereby requests that the attached application not be published under 35 U.S.C. 122(b).
`Applicant hereby certifies that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`*Warning
`This request must be signed in compliance with 37 CFR 1.33(b) and submitted with the application upon filing.
`
`If applicant rescinds a request that an application not
`Applicant may rescind this nonpublication request at any time.
`be published under 35 U.S.C. 122(b), the application will be scheduled for publication at eighteen months from the
`earliest claimed filing date for which a benefit is claimed.
`
`
`
`If applicant subsequently files an application directed to the invention disclosed in the attached application in
`another country, or under a multilateral international agreement, that requires publication of applications eighteen
`months after filing, the applicant must notify the United States Patent and Trademark Office of such filing within
`forty-five (45) days after the date of the filing of such foreign or international application. Failure to do so will result
`in abandonment of this application {35 U.S.C. 122(b)(2)(B)(iii)).
`
`22 D Applicant hereby requests the publication of this patent application earlier than as set forth in 37 CFR 1.211(a)
`pursuant to 37 CFR 1.219 as provided in 87 CFR 1.215(c).
`
`Request To Publish Early
`
`Page 2 of 4
`
`2
`
`

`

`
`Utility Patent Application Transmittal %
`
`Fee
`
`$280
`
`Rate
`X WO
`x 420
`
`H l
`
`l
`
`Fee Calculation
`
`Utility Patent Application Fee
`Claims as Filed
`
`#Al lowed
`
`#Extra
`
`N
`
`lI
`
`(A)0 llll
`Multiple Dependent Claims (check if applicable)
`
`.1
`
`‘TI0
`Total Claims
`
`Total lndep. Claims
`
`#Filed
`
`u
`
`Number of Drawing SheetsIITotal Pages
`
`
`
`
`Number of Specification Pages
`
`-
`
`‘n- small entity must be selected to et Filin Fee discount Basic Filin Fee
`21
`
`Application Size Fee
`
`Processing fee for publication or republication as set forth in 37 CFR 1.17(i)I!
`
`Early publication fee as set forth in 37 CFR 1.18(d)
`
`Pre-Grant Publication Fee
`
`Assignment Recordal Fee
`Enter Number of Properties Affected by Recordal
`Examination Fee
`
`II
`
`x Aa
`
`Search Fee
`
`Examination Fee
`
`Search Fee
`
`TOTAL
`
`$720
`
`5600
`
`$1600
`
`E] DepositAccount
`
`
`[X] Credit Card
`[I Check E] Money Order E] Other:
`
`Deposit Account Number
`
`11—1159
`
`Method of Payment
`
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`D Charge the fee(s) set forth above
`[3 Charge any additional fee(s) or underpayments of fee(s) under 37 CFR 1.16 and 1.17
`D Charge fee(s) indicated above, except for the filing fee
`Ed Credit any overpayments
`WARNING: information on this form may become public. Credit card information should not be included
`on this form. Provide credit card information and authorization on form PTO-2038.
`
`Amount Grand Total
`
`81600
`
`
`
`Page 3 of 4
`
`3
`
`

`

`Utility Patent Application Transmittal
`
`Docket Number
`
`1131—024.205
`
`Customer Number
`
`22145
`
`Correspondence Address
`
`
`
`-—
`
`
`
`
`
`Phone Number
`
`
`E-mail Address
`
`Certificate of Mailing by Express Mail
`
`Certificate of Mailing by First Class Mail
`
`Patent Application,
`this
`that
`certify
`hereby
`l
`accompanying documents, and fee are being deposited
`with the United States Postal Service "Express Mail Post
`Office to Addressee" service under 37 CPR 1.10 in an
`envelope addressed to Commissioner for Patents, PO.
`Box 1450, Alexandria, Virginia 22313-1450 on the date
`indicated below:
`
`
`(Date ofMailing)
`
`(73pm! or Printed Name ofPerson Mailing Correspondence)
`
`(Signature ofPerson Mailing Correspondence)
`
`Vin EFS
`
`I hereby certify that this Patent Application, accompanying documents, and fee
`are being deposited with the United States Postal Sen/ice with sufficient postage
`as first class mail in an envelope addressed to Commissioner for Patents, PG.
`Box 1450, Alexandria, Virginia 22313—1450 on the date indicated below:
`
`(Dare ofMailing)
`
`(Name ofPerson Mailing Correspondence)
`
`(Signature ofPerson Mailing Correspondence)
`
`Certificate of Transmission
`
`l hereby certify that this Patent Application, accompanying documents, and fee
`authorization are being facsimile transmitted to the United States Patent and
`Trademark Office on the date indicated below:
`
`("If-rpm” Mail,, 1‘fl".ling LabeI Number)
`
`(Date of Trurmnissinn)
`
`(Name ofl’ersan Transmitting Correspondence)
`
`(Signature ofPerson Transmitting Correspondence)
`
`Signature instructions
`
`Select the name of the person who will electronically sign the Patent Application from the drop—down box below.
`
`Etatpractitioner is not present in the drop-down list you must close this form and select 'Add Practitioner...in the Form Manager's
`l
`l y menu
`
`sign the submission.
`sthe 'eSi n' button to electronicall
`Verify that the signatory information“Is correct annpd
`lfyou prefer to SIgn the form manually, simply doonp cliscck the'e ign' button; just print an manually SIgn.
`
`Signatory Drop—Down Box i Tom H. Dan
`
`I
`
`Signatory Capacity
`
`Attorney for Applicantis a
`
`'
`
`
`
`
`
`
`
`
`
`E—mail Address
`
`Tdao@koslaw.com
`
`Page 4 of 4
`
`4
`
`

`

`PTO/AiA/14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`_
`
`_
`
`Tillie of invention
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`
`Secrecy Order 37 CFR 5.2
`
`37 CFR 52 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`D Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`
`Given Name
`Kevin
`
`Middle Name
`
`document may be printed and included in a paper filed application.
`
`
`inventor information:
`
`inventor
`1
`
`
`Legal Name
`
`
`Prefix
`
`
`Family Name
`
`
`Woehr
`
`
`'
`
`
`
`
`
`Residence information (Select One) 0 US Residency @ Non US Residency 0 Active US Military Service
`
`Feisberg
`
`Country of Residence i
`
`Mailing Address of Inventor:
`
`cm,
`
`Felsbelg
`
`inventor
`
`2
`
`State/Province -
`
`Legal Name
`
`
`Prefix Given Name
`Middle Name
`Family Name
`-"--
`Residence information (Select One) O US Residency @ Non US Residency 0 Active US Military Service
`
`
`
`Mailing Address of inventor:
`
`Address 2
`
`C
`
`its!
`
`StatelProvince
`
`inventor information blocks may be
`inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`Correspondence information:
`
`EFS Web 2.2.7
`
`5
`
`

`

`PTO/AW14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`1131-024205
`
`—
`
`
`
`
`
`Attorney Docket Number
`_
`
`.—
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`[:1 An Address is being provided for the correspondence Information of this application.
`Customer Number
`22145
`
`Email Address
`
`KOS_Docketing@koslaw.com
`
`fill
`;_
`
`
`
`
`Application Information:
`
`Title of the Invention
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`
`
`
`Attorney DocketNumber- Small Entity Status Claimed
`
`Application Type
`Nonprovisional
`
`
`
`
`Total Number of Drawing Sheets (if any)
`
`Publication information:
`
`
`Suggested Figure for Publication (if any)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`El
`
`
`Request Not to Publish. I hereby request that the attached application not be published under
`
`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`
`
`
`
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. if both sections are completed the customer
`Number will be used for the Representative Information during processing.
`
`22145
`
`Please Select One:
`Customer Number
`
`@ Customer Number
`
`O Limited Recognition (37 CFR 11.9)
`
`
`
`Domestic Benefit/National Stage information:
`
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate
`National Stage entry from a PCT application. Providing this information in the application data sheet constitutes the
`
`specific reference required by 35 USS. 119(e) or 120, and 37 CFR 1.78.
`
`
`Prior Application Status i Pending
`
`
`Prior Application Number
`Continuity Type
`Application Number
`i
`13668667
`l Continuation of
`
`Prior Application Status i Pending
`EFS Web 2.2.7
`
`Filing Date (YYYY-MM-DD)
`
`6
`
`

`

`PTO/AlA/14 (03—13)
`Approved for use through 01/31/2014. OMB 0851-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Title of Invention
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`Attorney Docket Number
`_
`_
`
`
`
`
`Application Number
`13668667
`
`
`
`Continuity Type
`Continuation of
`
`
`
`Prior Application Number
`13667261
`
`Filing Date (YYYY-MM—DD)
`2012-1 1-02
`
`Prior Application Status
`
`Patented
`
`Application
`
`.
`
`.
`
`PriorApplication
`
`Filing Date
`
`issue Date
`
`13667261
`
`Continuation of
`
`13407395
`
`8460247
`
`2013-06-1 1
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Patent Number
`8308691
`
`
`
`
`
`Foreign Priority information:
`
`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`
`constitutes the claim for priority as required by 35 U.S.C. 11903) and 37 CFR 1.5.5(d). When priority is claimed to a foreign application
`that is eligible for retrieval under the priority document exchange program (PDX)i the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(h)(1) and (2). Under the PBX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(t).
`
`
`Filing Date (YYYY—MM-DD)Countryi Access Codel (if applicable)
`
`
`
`
`
`
`Hat-024.205
`
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`
`
`
`
`
`
`
`
`
`
`2012—02—28
`
`
`
`
`
`Issue Date
`Prior Application
`Application
`Filing Date
`
`
`
`
`
`
` Number Contrnurty Type Number
`
`
`(YYYY-MM-DD)
`
`
`2010-04-27
`13407395
`Continuation of
`12768155
`8419688
`2013-04—16
`
`
`
`
`
`
`
`
`1
`Prior Application Status
`Patented
`
`
`
`
`
`
`Filing Date
`Issue Date
`Application
`.
`.
`Prior Application
`
`
`
`(YYYY—MM-DD)
`Number
`Contmurty Type
`Number
`(YYYY-MMDD)
`2012-11—13
`12768155
`Continuation of
`11592595
`2006-11—03
`
`
`
`
`
`Application Number
`
`
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`EFS Web 2.2.7
`
`7
`
`

`

`PTO/AiA/M (03-13)
`Approved for use through 01/31/2014. OMB 0651 -0032
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Papenrvork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`
`
`
`
`Title of invention
`
`
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`
`
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`
`
`1:) 16, 2013.
`
`
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`
`
`16, 2013, will be examined under the first inventor to file provisions of the NA.
`
`
`Authorization to Permit Access:
`
`1:) Authorization to Permit Access to the instant Application by the Participating Offices
`
`if checked. the undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO),
`the Japan Patent Office (JPO), the Korean intellectual Property Office (KIPO), the World intellectual Property Office (WIPO),
`and any other intellectual property offices in which a foreign application claiming priority to the instant patent application
`is filed access to the instant patent application. See 37 CFR 1,14(c) and (h). This box should not be checked if the applicant
`does not wish the EPO, JPO, KiPO, WlPO, or other intellectual property office in which a foreign application ciaiming priority
`to the instant patent application is filed to have access to the instant patent application.
`
`in accordance with 37 CFR 114(0), access may be provided to information concerning the date 0 ffiling this Authorization.
`
`in accordance with 37 CF R 1.14(h)(3), access will be provided to a copy of the instant patent application with respect
`to: 1) the instant patent application—as—filed; 2) any foreign application to which the instant patent application
`claims priority under 35 U.S.C. 119(a)-(d) if a copy of the foreign application that satisfies the certified copy requirement of
`37 CFR 1.55 has been filed in the instant patent application; and 3) any US. application—as-filed from which benefit is
`sought in the instant patent application.
`
`Applicant information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
`
`to have an assignment recorded by the Office.
`
`EFS Web 2.2.7
`
`8
`
`

`

`PTO/AlA/14 (03-13)
`Approved for use through 01/31/2014. OMB 065141032
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`Application Number
`
`
`1131-0211205
`
`
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`Title of invention
`
`
`
`
`
`Applicant
`1
`if the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address or the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`
`
`
`
`(9 Assignee
`
`0 Legal Representative under 35 U.S.C. 117
`
`0 Joint Inventor
`
`
`0 Person to whom the inventor is obligated to assign.
`O Person who shows sufficient proprietary interest
`
`if applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Name of the Deceased or Legally incapacitated inventor :l
`1
`
`
`If the Applicant is an Organization check here.
`>14
`
`
`
`Ciganizafic’” Name
`
`I B. BRAUN MELSUNGEN AG
`
`Mailing Address Information For Applicant:
`
`c- _-—
`cum_——
`
`Email Address
`
`
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`
`Non-Applicant Assignee Information:
`
`Providing assignment information in this section does not subsitute for compliance with any requirement of part 3 of Title 37 of CFR to have an assignment recorded by the Office.
`
`Complete this section only if non-applicant assignee information is desired to be included on the patent application publication in
`accordance with 37 CFR 1.215(b). Do not include in this section an applicant under 37 CFR 1.46 (assignee, person to whom the
`inventor is obligated to assign, or person who otherwise shows sufficient proprietary interest), as the patent application publication will
`include the name of the applicant(s).
`
`
`
`
`
`
`
`if the Assignee is an Organization check here.
`El
`
`EFS Web 2.2.7
`
`9
`
`

`

`PTO/AlA/14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Attorney Docket Number
`11131-024205
`Application Data Sheet 37 CFR 1.76
`Application Number
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`Title of Invention
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`CATHETER ASSEMBLY AND COMPONENTS THEREOF
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`Prefix
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`Given Name
`Middle Name
`Family Name
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`Mailing Address Information For Non—Applicant Assignee:
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`Suffix
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`Address 1
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`Address 2
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`City
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`.a
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`Additional Assignee Data may be generated within this form by selecting the Add button.
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`Signature:
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`NOTE: This form must be signedin accordance with 37 CFR 1 3.3 See 37 CFR 1.4 for signature requirements and
`certifications.
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`Date (YYYY-MM-DD)Signature 2013-10-24
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` First Name
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`Tmo
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`Registration Number _4641
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`Additional Signature may be generated within this form by selecting the Add button
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`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
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`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
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`EFS Web 2.2.7
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`Attorney Docket No.: 1131-024.205
`Via EFS
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`CATHETER ASSEMBLY AND COMPONENTS THEREOF
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`CROSS—REFERENCE TO RELATED APPLICATION
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`[0001]
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`This is a continuation of application Ser. No. 13/668,667, filed November 5,
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`2012, which is a continuation of application Ser. No. 13/667,261, filed November 2, 2012, which
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`is a continuation of application Ser. No. 13/407,395, filed February 28, 2012, which is a
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`continuation application of application Ser. No. 12/768,155, filed April 27, 2010, which is a
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`continuation of application Serial No. 11/592,595, filed on November 3, 2006, the entire contents
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`of which are hereby expressly incorporated herein by reference.
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`Technical Field
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`[0002]
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`Catheter assemblies are generally discussed herein with particular discussions
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`extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a
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`needle wiper.
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`BACKGROUND
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`[0003}
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`Insertion procedure for an IV catheter assembly contains four basic steps: (1) the
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`healthcare worker inserts the needle and catheter together into the patient's vein; (2) after
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`insertion into the vein with the needle point, the catheter is forwarded into the vein of the patient
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`by the healthcare worker pushing the catheter with his or her finger; (3) the healthcare worker
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`withdraws the needle by grasping the hub end (opposite the point end) while at the same time
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`applying pressure to the patient’s skin at the insertion site with his or her free hand to stop the
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`flow of blood through the catheter; and (4) the healthcare worker then tapes the exposed end of
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`the catheter (the catheter hub) to the patient’s skin and connects it to the source of the fluid to be
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`administered into the patient's vein.
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`[0004]
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`The problem is that, immediately after the withdrawal of the needle from the
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`patient's vein,
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`the healthcare worker, who is at
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`this time involved in at
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`least two urgent
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`procedures, must place the exposed needle tip at a nearby location and address the tasks required
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`to accomplish the needle withdrawal.
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`It is at this juncture that the exposed needle tip creates a
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`danger of an accidental needle stick, which, under the circumstances,
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`leaves the healthcare
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`worker vulnerable to the transmission of various dangerous blood—borne pathogens, including
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`AIDS and hepatitis.
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`Attorney Docket No: l l3l—024.205
`Via EFS
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`[0005]
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`Other needle types similarly expose healthcare workers to risks of accidental
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`needle sticks. For example, a doctor administering an injection, using a straight needle, a Huber
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`needle, an epidural needle, etc., may place the used needle on a tray for subsequent disposal by a
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`nurse. For the period between placing the used needle on a tray or a work station to the time it is
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`discarded, the used needle is a potential source for disease transmissions for those that work near
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`or around the needle.
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`‘
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`[0006]
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`Accordingly, all needles should be covered immediately following use to ensure
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`greater worker safety.
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`ideally, the procedure for covering the needle tip should be passive, self
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`activating, or at least simple to perform.
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`In addition, the device for covering the needle should
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`be reliable and robust.
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`[0007]
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`More advantageously, a valve should be incorporated in the catheter assembly to
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`minimize blood exposure following successful catherization.
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`In addition, as blood comes in
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`contact with the needle and is deposited on the needle, the needle assembly should further
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`incorporate means for wiping the needle of the deposited blood upon retracting the needle.
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`W
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`[0008]
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`In accordance with aspects of the present invention, there is provided a catheter
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`assembly comprising:
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`a first hub comprising a housing comprising an exterior surface and an
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`interior surface defining an interior cavity; a tube attached to the first hub and extending distally
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`of the first hub; a second hub comprising a housing comprising an exterior surface and an
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`interior surface defining an interior cavity; a needle having a needle tip attached to the second
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`hub and projecting distally of the second hub and into the tube; a valve comprising a top surface,
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`a skirt depending therefrom, and an opening on the top surface having the needle projecting
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`therethrough; a valve opener comprising an actuating end, at least one leg extending proximally
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`therefrom, and a wiper comprising a perimeter defining an opening and the needle in contact
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`with the perimeter for wiping the needle as the needle is retracted away from the tube.
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`[0009]
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`Other aspects of the present invention include a catheter assembly comprising: a)
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`a catheter hub comprising a housing comprising an exterior surface and an interior surface
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`defining an interior cavity; b) a catheter tube attached to the catheter hub and extending distally
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`of the catheter hub; c) a needle hub comprising a housing; d) a needle having a needle tip
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`attached to the needle hub and projecting distally of the needle hub and into the catheter tube; e)
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`Attorney Docket No.: l131-024.205
`Via EF S
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`a valve for limiting blood backfiow positioned in the interior cavity of the catheter hub; t) a
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`valve opener for opening the valve positioned proximally of the valve; and g) a tip protector
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`positioned adjacent the valve opener for blocking the needle tip, wherein the tip protector
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`comprises:
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`(1) a tip protector housing having an interior surface; (2) a first arm extending from a
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`distal wall of the tip protector housing biased towards the interior surface of the catheter hub; (3)
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`a second arm extending from a proximal wall of the tip protector housing biased towards the
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`interior surface of the catheter hub; and (4) a third arm extending from the proximal wall of the
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`tip protector housing biased against a side of the needle.
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`[0010]
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`In accordance with other aspects of the present invention, there is provided a
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`catheter assembly comprising: a catheter hub comprising a housing defining an interior cavity
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`and having a catheter tube extending distally thereof; a needle hub comprising a housing defining
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`an interior cavity and having a needle having a needle tip extending distally thereof; the needle
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`projecting into the catheter tube; a hemostatic valve positioned within the interior cavity of the
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`catheter hub having an opening; a valve opener positioned adjacent the hemostatic valve and
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`comprising an actuating end comprising a cone section and a pair of legs defining a gap
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`extending proximally thereof; a wiper having the needle passing therethrough for wiping the
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`needle as the needle is retracted from the catheter tube; and wherein a tip protector comprising an
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`arm and a wall comprising an opening and is positioned in the gap defined by the two legs.
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`[0011]
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`In accordance with other aspects of the present invention, there is provided a
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`method of wiping blood from a needle during a process of emplacing a catheter using a catheter
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`assembly. The method comprises puncturing a person’s vasculature with a sharp distal tip of the
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`needle of the catheter assembly. The needle extends distally from a first hub including a housing
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`having an exterior surface and an interior surface defining an interior cavity. The method further
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`comprises penetrating the vasculature with the catheter of the catheter assembly. The catheter is
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`disposed about the needle and extends distally from a second hub including a housing having an
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`exterior surface and an interior surface defining an interior cavity. The first and second hubs
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`releasably engage one another. The method further comprises withdrawing the needle from the
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`vasculature while maintaining the catheter within the vasculature by disengaging the first hub
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`from the second hub and moving the first hub proximally with respect to the second hub. The
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`proximal movement causes the needle to withdraw from the catheter. The method further
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`comprises wiping blood from the needle as it withdraws by passing the needle through a wiper.
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`Attorney Docket No: l 131-024.205
`Via EFS
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`The wiper has a continuous perimeter defining an opening. The perimeter is in contact with the
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`needle for wiping the needle.
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`[0012]
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`In accordance with other aspects of the present invention, there is provided a
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`method of cleaning an exterior of a needle during a process of emplacing a catheter using a
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`catheter assembly. The method comprises inserting the needle of the catheter assembly into a
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`person’s vasculature at an access site. The needle extends distally from a proximal hub. The
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`method further comprises inserting the catheter of the catheter assembly into the vasculature at
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`the access site. The catheter is disposed about the needle and extends distally from a distal hub.
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`The proximal and distal hubs releasably engage one another. The method further comprises
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`disengaging the proximal hub from the distal hub and moving the proximal hub proximally with
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`respect to the distal hub. The proximal movement draws the needle out of the vasculature and
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`the catheter while the catheter remains within the vasculature. The method further comprises
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`passing the needle through a wiper as it withdraws. The wiper removes blood from the exterior
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`of the needle. The wiper has a continuous perimeter defining an opening. The perimeter is in
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`contact with the exterior of the needle for wiping the needle.
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`[0013]
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`Still yet
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`in accordance with other aspects of the present
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`invention include
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`provisions for registering a pair of legs on the valve opener to the catheter hub by forming two
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`axially extending undercut within the interior wall surface of the catheter hub for cooperating
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`with the two legs.
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`[0014]
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`In a preferred embodiment of the present invention, a raised bump or projection is
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`formed within the interior cavity of the catheter hub for retaining a tip protector within the
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`catheter hub during retraction of the, needle hub away from the catheter hub.
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`[0015]
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`In yet other aspects of the present invention, a wiper in the form of an O-ring is
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`us