`(PATENT)
`
`IN THE UNlTE:O STATES PATENT AND TRADEMARK Ol''FlCE
`
`In re application of: G ALLAGI-fER, Cynthia, et al. Examiner: MIKNIS, Zachary l
`Application No.:. 14/855,168
`Group Ait Unit: 8760
`Confirmation No.: 1675
`Filed: September 15,2015
`For: Cl-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND
`TREATMENT OF DISORDERS ASSOCIATED \VITH CJ ESTERASE INHIBITOR
`DEFICI:ENCY
`
`VIA EJ<'S WRB FILING- WWW.USJ>TO.GOV
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA22313-1450
`
`DECLARATION OF DR. 1\f{<=;.HAIU. M. :FRANK UNnER 37 C . .F.R. § 1.132
`
`Dear Commissioner:
`
`I, Michael M. Frank, hereby declare as follows:
`
`1 .
`
`1 am a co-author in the paper Jiang et al., "Subcutaneous infusion ofhtunan C 1
`
`inhibitor .in swine,'' Clinical Imrmm.ology 136:323- 328, published 8 June 20 l 0 ("Jiang")
`
`(hereinafter referred to as "Jiang").
`
`2.
`
`The studies described in this paper were dt:signed and conducled intny laboratory
`
`to compare plasma levels, assess the ti.me t.o peak levels and duration of mainterumce, and to
`
`assess the safety ofh\nrwn Cl inhibitoradm:iniste.red subcutaneously ve.rsLls intravenously. Jiang
`
`atp .. 324.
`
`3.
`
`CINRYZE',j) (ViroPbanna, Inc.), a purified preparation of human plasma-derived
`
`C 1 inhibitor was t)sed as the source of Cl inhibitor used in these studies.
`
`CSL EXHIBIT 1003
`CSL v. Shire
`
`Page 1 of 2
`
`
`
`Galiagher, eta!.
`In re
`AppL No.; 14i855, 168
`Filed
`September 15,2015
`Page
`2 of2
`
`Attorney's Docket No.: 2006685-1184
`
`4.
`
`CINRYZE'iP \vas prepared according to the instructions provided in the
`
`prescribing information. Accordingly, each 500 Uvial was reconstit1..1ted v,.'ith 5 1nL of ste1ile
`
`vvater to achieve a En a! C l-INH concentration of 100 U/mL The same I 00 U/mL preparation
`
`was administered to each animal, with some receiving the drug subcutaneously and some
`
`intravenouslv.
`"
`
`5.
`
`The pigs were dosed at 50 U/kg. As the pigs ranged in \\'eight from 16-23 kg, the
`
`total dose administered ranged from 800 U to 1150 U of C 1-INH. Accordingly, the volume of
`
`1 00 U/mL preparation adtninistered ranged from 8 mL to 11.5 mL.
`
`6.
`
`The intravt~nous administration of the 100 U/mL preparation was perfl1nned over
`
`a 30 minute injection time in order to simulate intravenous administration in humans.
`
`7.
`
`The subcutaneous administration of the 100 U/rnL preparation w·as performed b)''
`
`subcutaneous infusion delivered by continuous pump over a 60--minute per1od. This vms
`
`necessary due to the large volume of preparation administered to the pigs.
`
`8. All statements made herein of my own knowledge are true and all statements made on
`
`information and belief are believed to be true; and further these statements were nmde with the
`
`knowledge that \Viliful 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 present application or any patent
`
`issued in reliance thereon.
`
`Date:
`
`Page 2 of 2
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
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.
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
