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`~ EXPRESS MAIL LABEL NO: ER493074446US
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`PTO/SB/16 (8-00)
`Approved for use through 10/31/2002. 0MB 0651-0032 ~ (.D
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`C\J
`lJffiler ~e Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control number.
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`[ +]
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`
`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
`This is a request for filine; a PROVISIONAL APPLICATION FOR PATENT under 37 CFR l.53(c).
`INVENTOR(S)
`Residence
`Given Name (first and middle
`[ifanyl)
`(City and either State or Foreil!ll Country)
`Family Name or Surname
`Brewton, AL
`Raulerson
`J. Daniel
`Levittown, PA
`Schweikert
`Timothy
`senaratelv numbered sheets attached hereto
`Additional inventors are being named on the
`TITLE OF THE INVENTION (280 characters max)
`
`Luer Cleaner
`CORRESPONDENCE ADDRESS
`Direct all correspondence to:
`Joseph E. Maenner
`Name
`Monte & McGraw, P.C.
`Conmanv Name
`4092 Skinnack Pike P.O. Box 650
`Address
`State PA
`Skinnack
`Citv
`Telephone 610-584-9400
`Country USA
`ENCLOSED APPLICATION PARTS (check all that annlv)
`X Drawings, 5 sheets
`l:L Specification, 12 pages
`Other:
`METHOD OF PAYMENT OF FILING FEES FOR THIS PROVISIONAL APPLICATION FOR PATENT
`_ Applicant claims small entity status. See 37 CFR 1.27.
`FILING FEE
`X The Commissioner is hereby authorized to charge filing fees or credit Deposit Account AMOUNT($)
`$160.00
`Number 502434 (Attach duplicate copy of this page if paying by deposit account).
`The invention was made by an agency of the United States Government or under a contract with an agency
`of the United States Government.
`.A_ No .
`
`I Zip 19474
`I Fax 610-584-9783
`
`Yes, the name of the U.S. Government agency and the Government contract number are:
`
`Assignee:
`
`Respectfully submitted, "'}
`
`Date July 14, 2004
`
`SIGN~TURE d N f~ Registration No.: 41,964
`NAME: mstJ~-'MAENNER
`
`Docket Number: MED-0080
`
`TELEPHONE 610-584-9400
`
`Customer Number 33941
`
`USE ONLY FOR FILING A PROVISIONAL APPLICATION FOR PATENT
`
`BAXTER EXHIBIT 1013
`Page 1 of 19
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`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`TITLE OF THE INVENTION
`
`Luer Cleaner
`
`FIELD OF THE INVENTION
`
`The present invention relates to an apparatus for cleaning male threads on a luer connector.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The accompanying drawings, which are incorporated herein and constitute part of this
`
`specification, illustrate the presently preferred embodiments of the invention, and, together with the
`
`general description given above and the detailed description given below, serve to explain the
`
`features of the invention. In the drawings:
`
`Fig. 1 is a perspective view of a luer cleaner according to a first preferred embodiment of
`
`the present invention, with a luer being inserted into the luer cleaner.
`
`Fig. 2 is an exploded view of the luer cleaner shown in Fig. 1.
`
`Fig. 3 is a sectional view of the luer cleaner shown in Fig. 1.
`
`Fig. 4 is an enlarged front view of a scrubber disc shown inside the luer cleaner.
`
`Fig. 5 is a sectional view of the scrubber disc of Fig. 4, taken along line 5-5 of Fig. 4.
`
`Fig. 6 is a sectional view of a luer scrubber according to a second preferred embodiment of
`
`the present invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`In the drawings, like numerals indicate like elements throughout. Certain terminology is
`
`used herein for convenience only and is not to be taken as a limitation on the present invention.
`
`1
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`BAXTER EXHIBIT 1013
`Page 2 of 19
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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`The tenninology includes words specifically mentioned, derivatives thereof, and words of similar
`
`import. The following describes preferred embodiments of the invention. However, it should be
`
`understood based on this disclosure, that the invention is not limited by the preferred embodiments
`
`described herein.
`
`Referring now to Fig. 1, a luer cleaner 100 according to a first embodiment of the present
`
`invention is shown. The luer cleaner 100 is inserted over a luer 190 and rotated axially about the
`
`luer 190. The luer 190 includes male threads 192 that are used to secure the luer 190 to another
`
`connection. The luer 190 is preferably connected to a medical device, such as a hemodialysis
`
`catheter 194, or other medical device that incorporates a luer connection with internal, female
`
`threads. Prior to connection of the luer 190 with the other medical device, the luer 190 is inserted
`
`into an open end of the luer cleaner 100. As the luer cleaner 100 is rotated about the luer 190,
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`antiseptic fluid contained in the luer cleaner 100 is forced from a reservoir in the luer cleaner 100,
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`over the luer 190, to clean debris and other contaminants that may be present on or around the luer
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`threads 192.
`
`Referring now to Figs. 2 and 3, the luer cleaner 100 includes an open end 104, a closed end
`
`106, and a longitudinal axis 107 extending therethrough between the open end 104 and the closed
`
`end 106. The open end 104 includes a generally tubular body 108 having a longitudinal passage
`
`110 that extends toward the closed end 106. Preferably, the body 108 is constructed from polyvinyl
`
`chloride or some other suitable biocompatible material. The body 108 includes an exterior portion
`
`112 that may optionally include a plurality of gripping ribs 114 extending therefrom, away from the
`
`longitudinal axis 107. The gripping ribs 114 allow a user to grip the body 108 during use of the
`
`cleaner 100. The interior of the body 108 includes at least one, and preferably two, diametrically
`
`2
`
`BAXTER EXHIBIT 1013
`Page 3 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`opposed alignment notches 116 that extend from the longitudinal passage 110 away from the
`
`longitudinal axis 107.
`
`The body 108 further includes a guide member 117 that extends partially into the
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`longitudinal passage 110 along the longitudinal axis 107 toward the open end 104. The guide
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`member 117 preferably includes a male luer taper 118 to engage a female luer connection on the
`
`luer 190. The guide member 117 prevents fluid from the reservoir that has been forced into the
`
`longitudinal passage 110 from entering the catheter 194 through the interior of the luer 190. The
`
`guide member 117 is preferably integrally molded with the body 108, as seen in the cross-section
`
`view of Fig. 3.
`
`At least one, and preferably, four passages 119 are disposed within the body 108 between
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`the exterior portion 112 of the body 108 and the guide member 117 ( although only two passages
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`119 are shown in Fig. 3). The passages 119 are preferably parallel to the longitudinal axis 107 and
`
`each passage 119 is disposed ninety degrees apart from each adjacent passage 119.
`
`The body 108 also includes an annular rib 120 that extends from the body 108, away from
`
`the open end 104 of the luer cleaner 100. The rib 120 extends outwardly of the passages 119, with
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`a lip 122 being formed between the rib 120 and the exterior portion 112 of the body 108.
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`A tubular connector 123, having an approximately "T-shaped" cross section, is fixedly
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`connected to the body 108, distal from the open end 104 of the luer connector 100. The connector
`
`123 includes a rib 124 that extends circumferentially around the connector 123, and is sized to
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`engage the connector 123 with the rib 120 of the body 108, as is seen in Fig. 3. The connection
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`between the connector 123 and the body 108 may be an interference fit, a threaded connection, an
`
`adhesive-based connection, or some other suitable connection known to those skilled in the art.
`
`3
`
`BAXTER EXHIBIT 1013
`Page 4 of 19
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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`The connector 123 also includes a connector passage 125 that extends through the connector
`
`123, generally along the longitudinal axis 107. When the connector 123 and the body 108 are
`
`engaged with each other, a generally circular throughway 126 is formed between the body 108 and
`
`the connector 123 that provides fluid communication between the connector passage 125 and the
`
`passages 119 in the body 108.
`
`A scrubber 130 is disposed within the longitudinal passage 110. The scrubber 130 is
`
`preferably constructed from at least one, and preferably a plurality, of scrubber discs 131. Details
`
`of the scrubber disc 131 are shown in Figs. 4 and 5. Each scrubber disc 131 includes an annular
`
`ring 132, with each ring 132 having a plurality of scrubber bristles 134 extending therefrom toward
`
`the longitudinal axis 107. Preferably, the rings 132 and scrubber bristles 134 are constructed from
`
`polypropylene or some other suitable biocompatible material. The bristles 134 extend sufficiently
`
`far toward the center of each ring 132 so as to engage the luer threads 192 of the luer 190 when the
`
`luer 190 is inserted into the cleaner 100.
`
`Preferably, the ring 132 for each scrubber disc 131 includes at least one, and preferably two
`
`diametrically opposed, alignment posts 136 that extend from the outer perimeter of the ring 132
`
`away from the center of the ring 132. Each post 136 is sized and shaped to fit into the alignment
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`notch 116 cut into the body 108. Each post 136 engages the alignment notch 116 in a generally
`
`tight, frictional fit so that each ring 132 remains within the longitudinal passage 110 after insertion
`
`into the longitudinal passage 110.
`
`Each ring 132 also includes at least one, and preferably, a plurality, of through-passages 140
`
`that allow fluid to pass from one side of each ring 132 to an opposing side of each ring 132. As
`
`seen in Fig. 4 four through-passages 140 are preferred, with each through-passage 140 being
`
`disposed at ninety degree spacings from each adjacent through-passage 140, although those skilled
`
`4
`
`BAXTER EXHIBIT 1013
`Page 5 of 19
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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`in the art will recognize that more or less than four through-passages 140 may be used. However, it
`
`is preferred that each through passage 140 fluidly communicates with a passage 119 in the body
`
`108, so that fluid communication exists between all of the passages 140 and the connector passage
`
`125.
`
`Further, a plurality of radially extending channels 142 extends along an exterior of each ring
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`132 from the outer perimeter of the ring 132 to the inner diameter of the ring 132, with each
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`channel 142 fluidly communicating with a through-passage 140. As can be discerned from Figs. 4
`
`and 5, four channels 142 are disposed at ninety degree spacings apart from each adjacent channel
`
`142, with channels 142 disposed on either side of each ring 132, although those skilled in the art
`
`will recognize that, for each through-passage 140, a channel 142 is preferably disposed on either
`
`face of the ring 132.
`
`With a plurality of rings 132 disposed adjacent one another, as shown in Fig. 2, the channels
`
`142 in adjacent rings 132 form passages 146 that provide fluid communication between each
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`through-passage 140 and the longitudinal passage 110 to allow fluid to be transmitted through the
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`passages 146 to the longitudinal passage 110. Fluid communication is now present between the
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`longitudinal passage 110 and the connector passage 125.
`
`A sealing ring 150 is disposed between the rings 132 and the open end 104 of the luer
`
`cleaner 100. The sealing ring 150 preferably has an internal diameter that is approximately the
`
`same as the external diameter of the luer 190 to prevent fluid forced from the reservoir and into the
`
`longitudinal passage 110 from flowing out of the luer cleaner 100 between the luer 190 and the.
`
`body 108 of the cleaner 100. The sealing ring 150 is preferably constructed from Kraton ™ or other
`
`suitable, flexible material, so that the sealing ring 150 generally provides a seal around the luer 190
`
`when the luer 190 is inserted into the luer cleaner 100.
`
`5
`
`BAXTER EXHIBIT 1013
`Page 6 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCK.ET NO.:
`MED-0080
`
`A cap 152 is disposed on the open end 104 of the luer cleaner 100 to retain the sealing ring
`
`150 and the scrubber rings 132 within the luer cleaner 100. The cap 152 is preferably annular, with
`
`a generally circular central opening 154 that is sized to allow the luer 190 to be inserted
`
`therethrough. The cap 152 is preferably fixedly connected to the body 108, such as with an
`
`adhesive, although those skilled in the art will recognize that the cap 152 may be retained by other
`
`methods, such as by interference fit, or a threaded connection.
`
`The closed end 106 of the luer cleaner 100 includes a generally bulbous body 160
`
`constructed from Kraton ™, 1064 PVC, or some other suitable, compressible material. The body
`
`160 includes an open end 162 that is fixedly connected to the connector 123 and a closed end 164
`
`disposed away from the open end 162. The interior of the bulbous body 160 defines a reservoir
`
`166. A fluid 168 is disposed within the reservoir 166 such that the reservoir 166 fluidly
`
`communicates with the longitudinal passage 110 of the generally tubular body 108 through the
`
`connector passage 125, the circular throughway 126, the passages 119, the through-passages 140,
`
`and the passages 146.
`
`Preferably, the fluid 168 is a fluid having antiseptic properties, such as alcohol. More
`
`preferably, the fluid 168 is sufficiently viscous to remain in the reservoir 166 in the absence of a
`
`compressive force on the body 160 of the reservoir 166. Such a preferred fluid 168 is isopropyl
`
`alcohol in a polymer suspension, such as polyvinyl alcohol, sold commercially by GOJO Industries
`
`as PURELL®, although those skilled in the art will recognize that other fluids, including, but not
`
`limited to, betadine or hydrogen peroxide, or any combination thereof, may be used instead.
`
`In use, as shown in Fig. 1, the luer 190, such as on a proximal end of a catheter 194, is
`
`inserted into the open end 104 of the luer cleaner 100. The sealing ring 150 engages the external
`
`6
`
`BAXTER EXHIBIT 1013
`Page 7 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`portion of the luer 190, restricting fluid 156 from being forced out of the open end 104 of the luer
`
`cleaner 100.
`
`After the luer 190 is fully inserted into the open end 104 of the luer cleaner 100, the bulbous
`
`body 160 is then compressed, forcing the fluid 168 in the reservoir 166 out of the reservoir 166,
`
`through the longitudinal passage 110 of the generally tubular body 108 through the connector
`
`passage 125, the circular throughway 126, the passages 119, the through-passages 140, and the
`
`passages 146, to the longitudinal passage 110 and to the exterior of the luer 190. The luer 190 is
`
`rotated about the longitudinal axis 107 of the luer cleaner 100, in a preferably back-and-forth
`
`motion, so that the bristles 134 on the scrubber discs 131, in conjunction with the fluid 168, clean
`
`contaminants from the exterior of the luer 190, including the luer threads 192. After several
`
`seconds of scrubbing the luer 190, the luer 190 is removed from the luer cleaner 100, and the luer
`
`cleaner 100 may be discarded. The luer 190 is now disinfected and may be connected to an external
`
`medical device.
`
`In an alternate embodiment of a luer cleaner 200, shown in Fig. 6, a fluid 268 may be
`
`retained in a frangible container 270 disposed within the reservoir 166. The fluid 268 may be
`
`significantly less viscous than the fluid 168 described above with respect to the luer cleaner 100.
`
`The frangible container 270 prevents the fluid 268 from flowing out of the reservoir 166 prior to
`
`use.
`
`To use the luer cleaner 200, the luer 190 is inserted into the open end 104 as described
`
`above with respect to the luer cleaner 100. The user compresses the reservoir 166 toward the
`
`longitudinal axis 107, breaking the frangible container 270, and allowing the fluid 268 to flow from
`
`the reservoir 166 and to the longitudinal passage 110 as described above with respect to the luer
`
`cleaner 100.
`
`7
`
`BAXTER EXHIBIT 1013
`Page 8 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`The frangible container 270 may be constructed from a material that is easily broken open
`
`under compression. The fluid 268 may be the same as the fluid 168 described above, or the fluid
`
`268 may be a less viscous fluid, such as, for example, isopropyl alcohol without any suspension.
`
`It will be appreciated by those skilled in the art that changes could be made to the
`
`embodiments described above without departing from the broad inventive concept thereof. It is
`
`understood, therefore, that this invention is not limited to the particular embodiments disclosed, but
`
`it is intended to cover modifications within the spirit and scope of the present invention as defined
`
`by the appended claims.
`
`8
`
`BAXTER EXHIBIT 1013
`Page 9 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`CLAIMS
`
`What is claimed is:
`
`1. A luer cleaner comprising:
`
`a generally hollow body having:
`
`an open first end, a closed second end, and a longitudinal axis extending
`
`therethrough between the first end and the second end,
`
`wherein the first end is sized to receive therein a luer and wherein the first
`
`end includes a plurality of bristles extending generally toward the longitudinal axis
`
`sufficiently to engage the luer disposed therein; and
`
`wherein the second end comprises a compressible reservoir containing a
`
`fluid, wherein, when the second end is compressed, the fluid is transmitted from the
`
`reservoir toward the first end.
`
`The luer cleaner according to.claim 1, wherein the fluid is an antiseptic fluid.
`
`The luer cleaner according to claim 1, wherein the plurality of bristles comprises at
`
`least one ring disposed in the open end, and wherein the plurality of bristles extend
`
`from the at least one ring toward the longitudinal axis.
`
`The luer cleaner according to claim 3, wherein the at least one ring comprises a
`
`plurality of rings.
`
`The luer cleaner according to claim 1, wherein the reservoir is constructed from
`
`The luer cleaner according to claim 1, wherein the first end further comprises a
`
`collar disposed therein proximate to the second end.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`9
`
`BAXTER EXHIBIT 1013
`Page 10 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`7.
`
`The luer cleaner according to claim 1, wherein the body further comprises an
`
`exterior portion, wherein the exterior portion comprises a plurality of ribs extending
`
`therefrom, away from the longitudinal axis.
`
`The luer cleaner according to claim 1, further comprising a centering post disposed
`
`along the longitudinal axis.
`
`The luer cleaner according to claim 1, wherein the fluid is retained in a frangible
`
`8.
`
`9.
`
`capsule.
`
`10.
`
`The luer cleaner according to claim 1, wherein, in the absence of compression of the
`
`reservoir, the fluid is sufficiently viscous to remain within the reservoir.
`
`11.
`
`The luer cleaner according to claim 1, comprising a means of communicating the
`
`fluid from the reservoir to the first end.
`
`12.
`
`A method of cleaning a luer comprising:
`
`providing a luer cleaner comprising:
`
`a generally hollow body having:
`
`an open first end, a closed second end, and a longitudinal axis
`
`extending therethrough between the first end and the second end,
`
`wherein the first end is sized to receive therein a luer and wherein the
`
`first end includes a plurality of bristles extending generally toward the
`
`longitudinal axis sufficiently to engage the luer disposed therein; and
`
`wherein the second end comprises a compressible reservoir adapted to
`
`receive and retain a fluid, wherein, when the second end is compressed, the
`
`fluid is transmitted toward the first end;
`
`10
`
`BAXTER EXHIBIT 1013
`Page 11 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`A TIORNEY DOCKET NO.:
`MED-0080
`
`inserting a luer into the open end, wherein the plurality of bristles engage an
`
`exterior of the luer; and
`
`compressing the second end and transmitting the fluid to the luer and to the
`
`plurality of bristles.
`
`13.
`
`The method according to claim 12, further comprising rotating the luer about the
`
`longitudinal axis.
`
`14.
`
`The method according to claim 13, wherein rotating the luer about the longitudinal
`
`axis further comprises reciprocatingly rotating the luer in each of two directions.
`
`15.
`
`A luer cleaner comprising:
`
`a generally hollow body having:
`
`an open first end, a closed second end, and a longitudinal axis extending
`
`therethrough between the first end and the second end,
`
`means for scrubbing a luer disposed at the first end; and
`
`means for retaining a fluid at the second end and for transmitting the fluid
`
`from the second end toward the first end.
`
`11
`
`BAXTER EXHIBIT 1013
`Page 12 of 19
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`

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`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`
`ABSTRACT OF THE DISCLOSURE
`
`A luer cleaner is disclosed. The luer cleaner includes a generally hollow body having an
`
`open first end, a closed second end, and a longitudinal axis extending therethrough between the
`
`first end and the second end. The first end is sized to receive therein a luer and includes a
`
`plurality of bristles extending generally toward the longitudinal axis sufficiently to engage the
`
`luer disposed therein. The second end comprises a compressible reservoir containing a fluid,
`
`wherein, when the second end is compressed, the fluid is transmitted from the reservoir toward
`
`the first end.
`
`12
`
`BAXTER EXHIBIT 1013
`Page 13 of 19
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`

`

`EXPRESS MAIL LABEL NO.: ER493074446US
`Title of the Invention: Luer Cleaner
`Inventors: Raulerson et al Filing Date: July 14, 2004
`Serial No.:
`Attorney Docket No.: MEO-0080
`Attorney: Joseph E. Maenner, Monte & McGraw, P.C.
`4092 Skippack Pike, P.O. Box 650 Skippack, PA 19474
`Sheet I of 5
`
`/ 8
`
`0
`LL
`
`BAXTER EXHIBIT 1013
`Page 14 of 19
`
`

`

`EXPRESS MAIL LABEL NO.: ER493074446US
`Title of the Invention: Luer Cleaner
`Inventors: Raulerson et al Filing Date: July 14, 2004
`Serial No.:
`Attorney Docket No.: MED-0080
`Attorney: Joseph E. Maenner, Monte & McGraw, P.C.
`4092 Skippack Pike, P.O. Box 650 Skippack, PA 19474
`Sheet 2 of 5
`
`100
`
`164
`/
`
`106
`
`160
`
`107
`
`112
`
`FIG. 2
`
`BAXTER EXHIBIT 1013
`Page 15 of 19
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`

`

`EXPRESS MAIL LABEL NO.: ER493074446US
`Title of the Invention: Luer Cleaner
`Inventors: Raulerson et al Filing Date: July 14, 2004
`Serial No.:
`Attorney Docket No.: MED-0080
`Attorney: Joseph E. Maenner, Monte & McGraw, P.C.
`4092 Skippack Pike, P.O. Box 650 Skippack, PA 19474
`Sheet 3 of 5
`
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`BAXTER EXHIBIT 1013
`Page 16 of 19
`
`

`

`EXPRESS MAIL LABEL NO.: ER493074446US
`Title of the Invention: Luer Cleaner
`Inventors: Raulerson et al Filing Date: July 14, 2004
`Attorney Docket No.: MEO..()()80
`Serial No.:
`Attorney: Joseph E. Maenner, Monte & McGraw, P.C.
`4092 Skippack Pike, P.O. Box 650 Skippack, PA 19474
`Sheet 4 of 5
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`BAXTER EXHIBIT 1013
`Page 17 of 19
`
`

`

`EXPRESS MAIL LABEL NO.: ER493074446US
`Title of the Invention: Luer Cleaner
`Inventors: Raulerson et al Filing Date: July 14, 2004
`Serial No.:
`Attorney Docket No.: MED-0080
`Attorney: Joseph E. Maenner, Monte & McGraw, P.C.
`4092 Skippack Pike, P.O. Box 650 Skippack, PA 19474
`Sheet 5 of S
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`0
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`LL
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`BAXTER EXHIBIT 1013
`Page 18 of 19
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`PATENT APPLICATION SERIAL NO. _ _ _ _ _ _ _ _
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`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
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`07/16/2004 tlAHltEDl 00000152 502434
`01 FC:1005
`160.00 DA
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`60587790
`
`PT0-1556
`(5/87)
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`BAXTER EXHIBIT 1013
`Page 19 of 19
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