DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`Listing of Claims:
`
`1.
`
`(Previously presented) A tamper-evident closure assembly for use with a medical device,
`
`the assembly comprising:
`
`a connector having a proximal end that defines a connection interface;
`
`a tamper element removably affixed to the connector such that the tamper element forms
`
`one integral piece with the connector, the tamper element configured to be separated from the
`
`connector upon application of a removal force; and
`
`a cap having an interior surface defining a receptacle, the cap being configured to engage
`
`with the tamper element, such that at least a portion of the connector is within the receptacle,
`
`wherein upon application of the removal force, the tamper element is separated from the
`
`connector and retained within the receptacle of the cap, and the connector being removable from
`
`the receptacle,
`
`wherein the interior surface of the cap defines a retention member configured to prevent
`
`the tamper element from being removed from the receptacle, the retention member having a
`
`distally facing retaining surface, the interior surface of the cap and the retaining surface of the
`
`retention member defining a locking portion of the receptacle, and
`
`wherein a proximal end of the tamper element defines a proximally facing surface that is
`
`configured to abut the retaining surface to prevent the tamper element from moving past the
`
`retention member out of the locking portion.
`
`2.
`
`(Original)
`
`The assembly of claim 1, wherein the tamper element is affixed to the
`
`connector via a protrusion extending from the tamper element to the connector, such that a gap is
`
`defined between the tamper element and the connector.
`
`3.
`
`(Previously presented) A tamper-evident closure assembly for use with a medical device,
`
`the assembly comprising:
`
`a connector having a proximal end that defines a connection interface;
`
`Page 2 of 14
`
`

`

`DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`a tamper element removably affixed to the connector such that the tamper element forms
`
`one integral piece with the connector, the tamper element configured to be separated from the
`
`connector upon application of a removal force; and
`
`a cap having an interior surface defining a receptacle, the cap being configured to engage
`
`with the tamper element, such that at least a portion of the connector is within the receptacle,
`
`wherein upon application of the removal force, the tamper element is separated from the
`
`connector and retained within the receptacle of the cap, and the connector being removable from
`
`the receptacle,
`
`wherein the tamper element is affixed to the connector via a protrusion extending from
`
`the tamper element to the connector, such that a gap is defined between the tamper element and
`
`the connector, and
`
`wherein the connector further defines a groove configured to receive the protrusion
`
`extending from the tamper element to the connector when the protrusion is affixed to the
`
`connector.
`
`4.
`
`(Previously presented) The assembly of claim 1, wherein the retention member has a
`
`sloped surface and the retaining surface is adjacent the sloped surface,
`
`wherein the sloped surface is configured to allow the tamper element to slidably move
`
`past the retention member into the locking portion.
`
`5.
`
`(Original)
`
`The assembly of claim 4, wherein the tamper element in the locking
`
`portion is disposed closer to one end of the cap than to another end of the cap.
`
`6.
`
`(Previously presented) The assembly of claim 4, wherein the interior surface of the cap
`
`further defines a projection configured to contact the tamper element when the tamper element is
`
`within the locking portion of the receptacle.
`
`Page 3 of 14
`
`

`

`DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`7.
`
`(Original)
`
`The assembly of claim 1, wherein when the tamper element is separated
`
`from the connector and retained within the cap, the tamper element is visible inside the
`
`receptacle from at least one angle.
`
`8.
`
`(Original)
`
`The assembly of claim 1, wherein the connection interface includes a Luer
`
`connector.
`
`9.
`
`(Original)
`
`The assembly of claim 1, wherein the interior surface of the cap further
`
`defines a post configured to contact the connector when the connector and the tamper element
`
`are retained in the receptacle of the cap, the post being configured to decrease movement of the
`
`connector within the cap after being inserted into the receptacle.
`
`10.
`
`(Previously presented) A tamper-evident closure assembly for use with a medical device,
`
`the assembly comprising:
`
`a connector having a proximal end that defines a connection interface;
`
`a tamper element removably affixed to the connector such that the tamper element forms
`
`one integral piece with the connector, the tamper element configured to be separated from the
`
`connector upon application of a removal force; and
`
`a cap having an interior surface defining a receptacle, the cap being configured to engage
`
`with the tamper element, such that at least a portion of the connector is within the receptacle,
`
`wherein upon application of the removal force, the tamper element is separated from the
`
`connector and retained within the receptacle of the cap, and the connector being removable from
`
`the receptacle,
`
`wherein the cap further includes a first ratcheting ramp configured to contact a
`
`corresponding second ratcheting ramp on the connector,
`
`wherein when the connector is rotated in a screwing direction, the first ratcheting ramp
`
`contacts the second ratcheting ramp on the connector, such that the cap is also rotated in the
`
`screwing direction,
`
`Page 4 of 14
`
`

`

`DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`and when the connector is rotated in an unscrewing direction opposite the screwing
`
`direction, the first ratcheting ramp slidably contacts the second ratcheting ramp on the connector,
`
`such that the first ratcheting ramp slides along the second ratcheting ramp and the cap is not
`
`rotated in the unscrewing direction.
`
`11.
`
`(Original)
`
`The assembly of claim 1, wherein the cap further defines a fitment
`
`configured to engage with a housing.
`
`12.
`
`(Original)
`
`The assembly of claim 1, wherein the tamper element is a ring.
`
`13.
`
`(Previously presented) A kit for a tamper-evident closure assembly, the kit comprising:
`
`a connector having a proximal end that defines a connection interface;
`
`a cap having an interior surface defining a receptacle;
`
`a tamper element affixed to the connector such that the tamper element forms one integral
`
`piece with the connector, the tamper element configured to engage with the cap within the
`
`receptacle; and
`
`a housing configured to receive the cap, the cap being removably secured to the housing,
`
`wherein the interior surface of the cap defines a retention member configured to prevent
`
`the tamper element from being removed from the receptacle, the retention member having a
`
`distally facing retaining surface, the interior surface of the cap and the retaining surface of the
`
`retention member defining a locking portion of the receptacle, and
`
`wherein a proximal end of the tamper element defines a proximally facing surface that is
`
`configured to abut the retaining surface to prevent the tamper element from moving past the
`
`retention member out of the locking portion.
`
`14.
`
`(Original)
`
`The kit of claim 13, further comprising a plurality of caps, and where the
`
`housing is configured to receive any one of the plurality of caps.
`
`Page 5 of 14
`
`

`

`DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`15.
`
`(Original)
`
`The kit of claim 13, wherein the tamper element is configured to attach to
`
`a medical device.
`
`16.
`
`(Previously presented) The kit of claim 13, wherein the tamper element is affixed to the
`
`connector, the connector being configured to attach to a medical device.
`
`17.
`
`(Original)
`
`The kit of claim 16, wherein the tamper element is configured to separate
`
`from the connector when a removal force is applied to the tamper element or to the connector.
`
`18.
`
`(Previously presented) The kit of claim 17, wherein the tamper element is configured to
`
`remain within the receptacle when the tamper element is separated from the connector.
`
`19.
`
`(Original)
`
`The kit of claim 13, wherein the cap defines a fitment and the housing
`
`defines a fixture, wherein the fitment is configured to engage with the fixture, such that the cap is
`
`retained in the housing.
`
`20.
`
`(Original)
`
`The kit of claim 19, wherein the fitment includes a plurality of teeth and
`
`the fixture includes a plurality of teeth, wherein the plurality of teeth on the fitment of the cap are
`
`configured to releasably engage with the plurality of teeth on the fixture of the housing.
`
`21.
`
`(Previously presented) A tamper-evident closure assembly for use with a medical device,
`
`the assembly comprising:
`
`a connector having a proximal end that defines a connection interface;
`
`a tamper element removably affixed to the connector such that the tamper element forms
`
`one integral piece with the connector, the tamper element configured to be separated from the
`
`connector upon application of a removal force; and
`
`a cap having an interior surface defining a receptacle, the cap being configured to engage
`
`with the tamper element, such that at least a portion of the connector is within the receptacle,
`
`Page 6 of 14
`
`

`

`DOCKET N0.: 098993.021961
`
`Application N0.: 15/892,181
`Office Action Dated: September 28, 2020
`
`PATENT
`
`wherein upon application of the removal force, the tamper element is separated from the
`
`connector and retained within the receptacle of the cap, and the connector being removable from
`
`the receptacle,
`
`wherein the interior surface of the cap defines a retention member configured to prevent
`
`the tamper element from being removed from the receptacle,
`
`wherein the tamper element is affixed to the connector via a protrusion extending from
`
`the tamper element to the connector, and
`
`wherein the protrusion is disposed distally of the retention member.
`
`22.
`
`(Previously presented) The assembly of claim 21, wherein the entire protrusion is
`
`disposed distally of the retention member.
`
`23.
`
`(Previously presented) The assembly of claim 3, wherein the protrusion is affixed to a
`
`radially outwardly facing surface, of the connector, that defines the groove.
`
`24.
`
`(Previously presented) The assembly of claim 10, wherein the first ratcheting ramp
`
`defines a sloped proximally facing surface that is configured to contact a sloped distally facing
`
`surface defined by the corresponding second ratcheting ramp.
`
`25.
`
`(New) The assembly of claim 1, wherein the entire tamper element is distally spaced
`
`from the connection interface of the connector.
`
`26.
`
`(New) The assembly of claim 1, wherein the entire proximally facing surface is flat, and
`
`the tamper element has an axial length less than an axial length of the connector.
`
`Page 7 of 14
`
`

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.

We are unable to display this document.

PTO Denying Access

Refresh this Document
Go to the Docket