LLP �y ?AX DEPT
`FROM l'l&C
`
`r� l7:04/NO.
`P 5
`8. 6' 02 17:06/
`(TUE)
`4260454860
`
`lN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`I 103326-0596
`
`Applicants : Lundgren et al.
`
`Ser-iaJ
`No.
`
`: 09/423,185
`
`Filed
`
`: November 3, 1999
`
`For
`
`: IMPROVED STABILITY FOR INJECTION SOLUTlONS
`
`Examiner
`
`: Azpuru, Carlos A.
`
`Grnup Art Unit
`
`: 1615
`
`OF TRANSMISSION UNDE'R 37 C.F.R.
`J.8
`CERTIFICATE
`
`certify that this paper is being facsimile
`I hereby
`transmitted to the U.S. Patent and Tradema:rk Office
`below at the facsimile numbc:r
`on the d&te indicated
`07.
`703·812-93
`32,224
`PTO Reg. No.
`
`John M Genova
`Attorney Name
`---Ul- v\-t. �
`
`Office of Petitions
`and Trademarks
`of Patents
`Commissioner
`Assistant
`D.C. 20231
`Washington,
`
`FAX RECEIVED
`
`AUG O 6 2002
`
`OFFICE:
`PETITIONS
`
`DISCLOSURE STATEMENT SUBMITTED WITH
`INFORMATION
`EXAMINATION (37 C.F.R.. §1.114)
`REQUEST FOR CONTINUED
`Sil':
`
`this communication in compliance
`with 37 C.F.R. §§1.56,
`1.97 and
`submit
`Applicants
`
`and a
`from Issue under 37 C.F.R. § l.313(c)(2)
`for Withdrawal of Application
`1.98. A Petition
`
`with th.is communication.
`concurrently
`are being submitted
`Examination
`for Continued
`Request
`
`io view of the
`of the claimed
`of the patentability
`Applicaots
`invention
`consideration
`request
`
`on Form PT0-1449.
`listed
`documents
`
`Bass and Spangenberg
`v.
`Fresenius Kabi USA, LLC
`U.S. Patent No. 8,476,010
`Exhibit 1029
`
`Exh. 1029
`
`

`
`FROM W&C L~P NY rAX D~PT
`
`(TUE) 8. 6' 0 2 17: 06/~"' 17 · 04/NO. 4 260454860 ° 6
`
`-
`
`The Form PT0-1449 identifies three documents. The first document is
`
`US 4.381,779 to Marguiles which is disclosed in EP 0 390 224 ("EP '224") a.t page 2, line 44.
`
`The document EP '244 was cited in an Information Disclosure Statement, mailed February 8,
`
`2001. in the referenced application. The application wos allowed over EP ' 244.
`
`The second document identified on the accompanying Form PT0- 1449 is a copy of ao
`
`Internet web page for Debioclip®. a device for the reconstitution and single-dose delivery of
`
`a !yo phll ized drug (http://www .debiotech.com/products/drgdd/de biocl.ip.htm 1). As n ored
`
`on the web pagt, the disposable p:re-filled glass syringe consists of a pharmaceutical
`
`grade hromobutyl rubber plunger and stopper. The relevant web page contains a
`
`copyright symbol with the year 2001. However, to date, Applicants ha\'e not been able to
`
`determine the earliest prior art date with respect to Debioclip.
`
`The third document identified on the accompanying Form PT0-1449 is a copy of an
`
`Internet web page for Diprivan® (propofol) injectable emulsion
`
`(http://www.diprivan.com/faq/faq.html). Diprivan is nn intravenous sedative-hypnotic agent
`
`commercially introduced in the United States in 1989, with a pre-filled glass syringe being
`
`introduced in mid- 1996. It is the first of a new class of intravenous antJsthetic agents- the
`
`alkylphenols. The active anesthetic agent in Diprivan, propofol (2,6-di-isopropylphenol) is
`
`formulated in an oil-m-water emulsion. Under the heading of question #2 of the Diprivan
`
`document, it is disclosed that "[t)be rubber plunger in the syringes and the bung of the vials is an
`
`elastomeric fotTilulation of 100% bromobutyl rubber". More accurately, the rubber in the
`
`syringes is a chlorinated butyl rubber whereas the bung of the vials is a brominated butyl rubber.
`
`-2-
`
`Exh. 1029
`
`

`
`FRO~ W&.C LLP NY FAX DEP'!'
`
`(TUE) 8. 6' 02 17:07/P~ 17:04/NO. 4260454860 P 7
`
`Applicants submit that the newly identified prior art is not more relevant than prior art of
`
`record, e.g., EP ' 244. Accordingly, it is submitted that the claimed invention is patentable for the
`
`reasons of record.
`
`TIME OF TRANSMITTAL OF INFORMATION DISCLOSURE STATEMENT
`
`This Information Disclosure Statement is being filed conctUTently with a Request for
`
`Continued Examination.
`
`Authorization is hereby given to charge Deposit Account No. 23-1703 for any fee due in
`
`connection with tlus communication.
`
`Dated: 1s ~~ 2,a)1,.-
`
`Respectfully submitted,
`
`--lJL M G---a------
`
`John M. Genova
`Reg. No. 32,224
`Attorney for Applicants
`
`Customer No. 007470
`Attorney Direct DiaJ: (2 12) 819-8832
`
`-3-
`
`Exh. 1029
`
`

`
`FRO'' i'i&C LLP NY FAX DEPT
`
`_,
`
`{TUE) 8. 6' 02 !6:57/ST 1' ·1)5~0. 4260454859 P J
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`1103326-0596
`
`Applicants
`
`Sl:rial Nu.
`
`Filed
`
`For
`
`: LWldgren et al.
`
`: 09/423,185
`
`: November 3, 1999
`
`: IMPROVED ST ABll..ITY FOR INJECTION SOLUTIONS
`
`Examiner
`
`: Azpuru, Carlos A.
`
`Group Art Unit
`
`: ] 615
`
`CERTIFICATE OFTRANS~11SSION UNDER 37 C.F.R. 1.8
`
`l hereby certify that thls paper is being facsimile
`transmitted to the U.S. Patent and Trademark Office
`on the date indicated below at the facsimile number
`703-872-9307.
`John M, Genova
`AnomcyNamc
`
`32.224
`PTOReg.No.
`
`---++L. V'1 ~
`
`St ature
`
`Office o f Petitions
`Assistant Commissioner of Patents and Trademarks
`Washington, D.C. 20231
`
`FAX RECElVED
`
`AUG 0 6 2002
`
`PETITIONS OFFICE
`
`INFORMATION DISCLOSURE STATEMENT SUBMlTTRD WlTH
`REQUEST FOR CONTINUED EXAMINATION (37 C.F.R §1.114}
`
`Sir:
`
`Applicants submit this communication in compliance with 37 C.F.R. §§ 1.56, 1.97 and
`
`l. 98. A Petition for Withdrawal of Application from Issue under 3 7 C.F .R. § l .313( c )(2) and a
`
`Request for Continued Examination are being submitted concurrently with thi)'; communication.
`
`Applicants request consideration of the patentability of the claimed invention in view of the
`
`documents listed on Form PT0-1449.
`
`l'lt;wvOo.• 1100'> •1 lt~l!JOII DOC) (IKI
`
`Exh. 1029
`
`

`
`~RQ" '''&." L' P NV "AX "' ~ ?-
`t • I ,;, • II v
`...
`• • :
`IJ~ ••
`
`ITUE) 8. 6'02 !6:57/ST ''·55/N0.4260454859 P 6
`
`The Form PT0- 144~ identifies three documents. The first document is
`
`US 4,381,779 to Marguiles which is disclosed in EP 0 390 224 (''EP '224") at page 2, line 44.
`
`The document EP '244 was cited in an Information Disclosure Statement, mailed February 8,
`
`2001 , in the referenced application. The application was allowed over EP '244.
`
`The second document identified on the accompanying Fonn PT0-144 9 is a copy of an
`
`Internet web page for Debioclip~. a device for the reconstitution and single-dose deli vt!ry of
`
`a lyophilized drug (http://www.debiotech.com/p roducts/drgdd/debioclip.btml). As no1ed
`
`on the web page, the disposable pre-filled glass syringe consists of a pharmaceutical
`
`grade bromobutyl rubber plunger and stopper. The relevant web page contains a
`
`copyright symbol with the year 2001 . However, to date, Applicants have not been able to
`
`detem1ine the earliest prior art date with respect to Debioclip.
`
`The third document identified on the accompanying Form PT0-1449 is a copy of an
`
`Internet web page for Diprivan® (propofol) injectable emulsion
`
`(http://www.diprivan.com/faq/faq.html). Diprivan is an intravenous sedative-hypnotic agen t
`
`commercially introduced in the United States in 1989, with a pre-filled glass syringe being
`
`introduced in mid-1996. It is the first of a new class of intravenous anesthetic agents - the
`
`alkylphenols. The active anesthetic agent in Diprivan, propofol (2,6-di-isopropylphenol) is
`
`formulated in an oil-in-water emulsion. Under the heading of question #2 of the Diprivan
`
`document, it is disclosed that "[t]he rubber plunger in the syringes and the bung of the vials is an
`
`elastomeric formulation of 100% bromobutyl rubber''. More accurately, the rubber in the
`
`syringes is a chlorinated butyl rubber whereas the bung of the vials is a brominated butyl rubber.
`
`-2-
`
`Exh. 1029
`
`

`
`?Rm! W&C LL? KY FAX DE?i
`
`ITUE) 8. 6' 02 16: 58/ST '' 55/NO. 4260454859 ? 7
`
`Applicants submil that the newly identified prior art is not more relevant than prior art of
`
`record, e.g., EP '244. Accordingly, it is submitted that the claimed invention is patentable for the
`
`reasons of record.
`
`TIME OF TRANSMITTAL OF INFORlY!ATION DISCLOSURE STATEMENT
`
`This Information Disclosure Statement is being fl..led concurrently with a Request for
`
`Continued ~xamination.
`
`Authorization is hereb)' given to charge Deposit Acco\Ult No. 23-1703 for any fee due in
`
`connection with this communication.
`
`Daled: ]S ~) . .CO""V
`
`Respectfully submitted,
`
`JA-: M 0--a------
`
`John M . Genova
`Reg. No. 32,224
`Attorney for Applicants
`
`Customer No. 007470
`Attorney Direct Dial: (212) 819-8832
`
`-3-
`
`Exh. 1029
`
`

`
`~RO~.\ 'i&C L~P KY ?AX DEPT
`
`(TUE) B. 6' 02 17: 07/~- • I: 0~/XO 4260454860 ? 8
`
`-·
`
`FOR1VI PT0-1449
`(REV. 2-82)
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`LNFORMATlON DISCLOSURE STATEMENT
`BY APPLICANT
`
`Atty. Docket No.
`1103326-0596
`Applicant:
`Lundgren ct al.
`
`Filing Date:
`3 November 1999
`
`UNITED STATES PATENT D0Cl1MEN1·s
`
`Page 1 of I
`
`I Scnal No.
`
`09/423.185
`
`I Group: 16!5
`
`*Examiner Document No.
`lrut1al
`
`Date
`
`Name
`
`Class
`
`Sub-Class Filing Date,
`if Appropriate
`
`~ 4
`
`3
`
`8
`
`1 7 7 9 3 May 1983 Mar guiles
`
`604
`
`202
`
`\./
`
`t Examiner Document No.
`fnillal
`
`Date
`
`Country
`
`Class
`
`Sub-Class Translation
`No
`Yes
`
`FOREIGN PATENT DOCUMENTS
`
`01 HER DOCUMENTS AND lNFORMATION (including Author, Title, Date, P~ent P':1se~. Etc.)
`
`·-
`
`~ate Considered:
`
`itial citation coQS- ei-ed, w ether or not citation is in confonn:utce with
`EP 609; Draw line through citatio
`of this form with next communication to a hcant.
`
`~FwyOM lllmS •I (gqn'XIII I'OOC) (;~
`
`FAX RECEIVED
`
`IAUG 0 6 2002
`
`PETITIONS OFFICE:
`
`Exh. 1029
`
`

`
`FRm~ ri&C Li.P NY. fAX DEPT
`
`{iUE) 8. 6' 02 17: 00/ST. I ,. 55/NO. 4260454~59 p 14
`
`~ .. ~::g:s a;n;col DIPRIVAN"
`=.:::e propotol
`
`· Q
`
`Pl8 0
`'"'~ 0
`C11r~n{ l~s 0
`
`irr ICU Scdclli<>"
`
`1. Does DlPRIV ANQ contain Sulfite?
`2. lJoes IJIPR1VAN contain Lat~!(!
`3. What is the phosphorus content of the D!PRlV AN fQ.rmulotion?
`4. What components of the DIPRIV Al'l" formulation contribute to tlte calQJ"J~
`loa9.?
`5. Is it nc:cessarv tQ use the~~~ spike QIQVided witl.l.thc:t.Dlf.RJ YAN v]al?
`6. &.w often must the tubing be changed when q~i.nistering DfPRlV ~l\?
`7. What re the manufacturingsgecifications ofthe DlPRJVA>J pre-filled
`syrin~e..._a.n.d. which inr~;9n c;ievjces does itfit'?
`8. '\YI:@t are the recommendations for monitoring lipids in pcnients rece iving
`Q.iQ.rivan?
`9.What is the dosing for Adult ICU Sedation with Djprivan'?
`1 O.~L~ffu..«l.~.hQ_~'2C~C.ted if a p_atient experiences an extravasation qf
`Diprivan?
`ll.What is a drug holiday and why should a pat)ent have one'!
`
`5torc:h 0
`
`1. Does DIPRIVAN? contain snHite?
`
`No, it does not. h noted in the prescribing informatio.n for DIPRlV AN,
`propofol is very slightly soluble in water and, thus, is formulated in a white,
`oil-in-water emulsion. In addition to the active component, propofol, the
`formulation also contains soybean oil (100 mglmL). glycerol (22.5 mg/mL),
`egg lecithin ( 12 mg/mL); and dis odium edetate (0.005%); with sodium
`hydroxide to adjust pH. The DIPRIV AN emulsion is isotonic and has a pH of
`7-8.5.
`
`2. Does DIPRIV AN contain Latex?
`
`The rubber plunger in the syringes and the bung of the vials is an elastomeric
`formulation of 100% bromo butyl rubber, a synthetic rubber. No form of natural
`rubber la.tex is used in the manufacture of these packaging components.
`
`3. Wbat is the phosphorus content of the DIPIUVAN formulntilon?
`
`http://www .dipri van .com/faq/faq.html
`
`Exh. 1029
`
`

`
`FROM W&C LLP NY, fAX DEPT
`
`!TUE) 8. 6' 02 17: 00/ST ' ~:55/NO. 426045~859 ° l5
`
`The emulsion vehicle used in the formulation of DTPRIV AN contains 15
`millimoles of phosphorus (bound in the lipid phase) per liter.
`
`4. What components ofthe DIPRIYAN formul ation contribute to tbe
`caloric load?
`
`The emulsion portion of the DIPRIV AN formulation is identical to that found
`in Intralipid 10% (Clintec Nutrition). In addition 10 the glycerol and egg
`lecithin descnoed in the l~ing, it contains 10% soybean oil which is
`composed of a mixture of neutral triglycerides of predominantly unsaturated
`fatty acids. The major component fatty acids are linoleic (50%), oleic (26%),
`palmitic (1 0%), linolenic (9%) and stearic (3.5%). Linoleic acid is an Omega-6
`fatty acid, linolenic acid is an Omega-3 fatty acid, and oleic acid is an Omega-9
`fatty acid. This formulation contains, on average, 3% w/v cholesterol and
`provides 1.1 kilocalories and 0.1 g offat per mL. Triglycerides account for
`slightly less than 85% of the total calories, while glycerol contributes ubout
`9%, and the phospholipid portion about 7%.
`
`5 . b it necessary to use tbe vent spike provided with the DIPRJV AN vial?
`
`The vent spike is provided as a "value added" item with the 50 mL vial and a
`stopcock is provided with the 100 mL vial as added value. It is not mandatory
`that either of these items be: used during administration from the vials, but
`venting of the vial must be achieved through some means Ia allow proper flow
`ofDIPRlVAN. When DIPRIVAN is administered directly from the vial, the
`vial rubber stopper should be disinfected using 70% isopropyl alcohol. A sterile
`giving set or a combination of a vent spike and sterile tubing must be used.
`Adm.iiristration should commence promptly and must be complclcd within 12
`hours after the vial has been spiked. The dedicated giving set and any unused
`portions of DIPRIV AN mu.st be discarded after 12 hours.
`
`6. How often must the tubing be changed when administering DIPRN AN?
`
`Strict aseptic technique must always be maintained during handling.
`DIPRlV AN injectable emulsion is a single-use parenteral product that contains
`0.005% disodium edetate to retard the rate of growth of microorgan1sms in the
`event of accidental extrinsic contamination. However, DIPRJV AN injectable
`emulsion can still support the growth of microorganisms as it is not an
`:mtimicrobially preserved product under USP standards. Therefore, time
`limitations for the administration ofDIPRlV AN from any one specific
`container have been established. These limitations pertain only to the specific
`components (v:ial, syringe, rubing, etc.) dedicated solely to the ad..rnjnistration
`ofDIPRIV AN- They do nor apply to devices or tubing which are in place to
`facilitate the administration of two or more solutions, including DlPRIV M ,
`which may then be admixed. When DIPRJV AN is administered directly from
`the vial, the vial rubber stopper should be disinfected using 70% isopropyl
`
`http://www .dipri van.com/faq/faq .html
`
`Exh. 1029
`
`

`
`(TUE) 8. 6' 02 17:0 1/ST .. < ·55/NO. 4 26045~~5_9_ P _ _1 6
`
`alcohol. A sterile vent spike and sterile tub ing must be used. Administration
`should commence promptly and must be t.:umplt:letl within 12 hours after the
`vial has been spiked. The dedicated tubing and any unu.o;eci portions of
`DlPRTV AN must be discarded after 12 hours. If withdrawing DIPRIV AN from
`a vial with a syringe, the vial rubber stopp er should be disinfected using 70%
`isopropyl alcohol. DIPRIV AN injection should be prepared for SINGLE
`P ATIENT USE ONLY . Administration should begin r romptly. Any unused
`portion ofDIPRIV AN, its container, dedicated tubing and/or solutions
`containing DIPRIV AN must be discarded within 6 hours after withdrawing
`DTPRJV AN from the vial.
`
`7. What are tbe manufacturing spectficaUons oftbe DIPRIV AN pre-filled
`syringe, and which infusioo devices does it fit?
`
`In mid-1996, a D IPRIV AN 50 mL pre-filled glass syringe was introduced
`which is suitable for providing continuou s infusion when placed in an
`appropriate infusion pump. To maximize the number of infusion pump d esigns
`in which this syringe would be compatible, the outside barrel diameter was
`made equal to that of the standard Becton- Dickinson 60 cc syringe.
`
`8.Wbllt ue the recommendations for monitoring lipids in patients
`r eceiving Diprivan?
`
`DIPRlV AN Injectable Emulsion is formulated in an oil-in-water emulsion,
`elevations in senun triglycerides m ay occur when DIPRN AN Injectable
`Emulsion is administered for extended p eriods oftime. Patients at risk of
`hyperlipidemia should be monitored for increases in serum triglycerides or
`serum turbidity. Administration of DIPRlV AN Injectable Emulsion should be
`adjusted if fat is being inadequately cleared from the body. A reduction in the
`quantity of concurrently administered lipids is indicated to compensate for the
`amount of lipid infused as p art of the DIPRN AN Injectable Emulsion
`formulation; 1 mL of DIPRIV AN Injectable Emulsion contains approximately
`0. I g of fat (1 .1 kcal).
`
`9.What is the dosing for Adult ICU Sedation with Diprivao?
`
`The dosing ofDIPRJV AN Injectable Emulsion should be individualized
`according to the patient's condition and response, blood lipid profile, and vital
`signs.
`
`For intubated, mech anically ventilated! adult patients:
`
`• Initiate dose slowly with a continuous infusion in order to titrate to
`desired c linical effect and minimize hypotension.
`• Initiation of sedation should begin at 5 ~glkg/min (0.3 mg/kg.lh).
`• The infusion rate should be increased by increments of 5 to l 0 flg/kglmin
`(0.3 to 0.6 mglkglh) until the desired level of sedation is achieved. A
`minimum period of 5 minutes between adjustments should be allowed
`
`bttp://www.diprivan.com/faq/faq.html
`
`Exh. 1029
`
`

`
`r~OM W&C LL? XV FAX D~?T
`
`- -::.- . -· .
`(TUE) 8. 6' 02 l7:01,ST 'c;:53/NO. ~260~54 859 P 17
`
`for onset of peak drug effect.
`• Most adult patients require maintenance rat~:s of 5 to 50 ~g/kglmin (0.3
`to 3 mg/kglh) or higher.
`
`Dosages ofDIPRIV AN Injectable Emulsion should be reduced in patients who
`have received large dosages of narcotics. Conversely, the DTPRIV AN
`Injectable Emulsion dosage requirement may be reduced by adequate
`management of pain with analgesic agents. As with other sedative med.Jcations,
`there is interpatient variability in dosage requirements, and these requirements
`may change with lime.
`
`Evaluation oflevel of sedation and assessment of CNS function should be
`carried out daily throughout maintenance to determine the minimum dose of
`DIPRIV AN Injectable Emulsion required for sedation.
`
`lO.Wbat effects can be expected if a patient exper iences au extr3vasation
`ofDiprivan?
`
`Intentional injection into subcutaneous or perivascullll' tissues of animals
`caused minimal tissue reaction. During the post-marketing period. there have
`been rare reports of local pain. swelling, blisters. and/or tissue necrosis
`following accidental extravasation ofDIPRIV AN Injectable Emuls10n.
`
`l l.Wbat is a drug holiday and why should a patient have one?
`
`DlP.Rl VAN Injectable Emulsion contains contains 0.005% disodium edetate to
`retard the rate of growth of microorganisms. EDT A is a strong chelator of trace
`metals- including zinc. Although with DIPRN AN Injectable Emulsion there
`are no reports of decreased zinc levels or zinc deficiency-related adverse
`events, DIPRIV AN Injectable
`
`Emulsion should not be infused for longer than S days witliout providing a drug
`holiday, a period oftime offDIPRN AN, to safely replace estimated or
`measured urine zinc losses.
`
`Home I f.l:e~cJblng !nformation( Product lnfocmatJonl Current Is~uesJ.n.J~U_S~I
`~nlmlql Commnn Clinki'l Ouest!oos I P.~us:t_~ I ~ I Fredbaclc I
`~pntact Us I ~<tr.ls .ThiLlli (Email Norltlcadon or Uadotqs to this_S,i.tc l Site M:~p
`
`J.J:!utllr>.fo,.,. at lo n
`Privacy !;tat e mcnt
`Thi» P"'duct Informat ion Is !mended for US Hulth Care professionals only.
`201135 01/01 Copyright Q2001 Asrr!!Zeneca LP, All rights reserved.
`
`~s !:;9rporate Site
`
`http://www.diprivan.com/faq/faq.html
`
`Exh. 1029
`
`

`
`L~ . ~y rAX DSPT
`FROM VI&.C '. :>
`
`(T~~) 8. 6' 02 ! 7 02. ·s~. "·55 'NO. ~ 26~~5~ ~59 ° 18
`
`Debioclip (Clt~ct)
`
`A new device for sufv and easy
`reconstitution of tyophilizad drug
`
`!.'_~.!_o the Chp'n'lect website:
`
`;ct'!!l!.e~:
`"--·--
`
`An Innovative system for lyophilize d drug reconsti tution
`
`Simple for e nd u ser
`
`easy o r use
`
`Easy and secure handling: Debiocllp® allows
`lyophlll<:ed product reco nstitution In 5 sim ple steps.
`QUICK, EASY AND SAFE.
`
`Aseptic handling
`
`Fully protectt:d, closed system. No risk of
`contamination during handling. Protection from aerosolization.
`The reconst1tued drug is ready for inj ection In the syringe.
`
`Tim e Saving
`
`Easy 5-step manipulation resulting in significant time saving. Compact
`kit presentation. No accessories required. Results in considerably less
`waste.
`
`Total drug uptake
`
`The accurate amount of product Is directly available due to exact
`positioning of the needle In the vial upon system activation: NO
`RESIDUE IN THE VIAL, thus reducing loss of active drug.
`
`No risk of mix-up
`
`The accurate quantity of the right solvent Is always guaranteed. The
`syringe already displays your logo, drug name and drug concentration.
`
`I njection comf ort a nd safety
`
`Injection of rubber or glass fragments avoided. Tamper evidence readily
`
`http://www .dcbiotech.chlproductsldrugdd/debioclip _page _l .html
`
`Exh. 1029
`
`

`
`;am~ W&.C LP. NY ?AX D~PT
`
`(TUE) 8. 6'0217: 02/ST. "·55~0.42604548.59 P 19
`
`apparent. Needle protection after use.
`I·Pmt??R;,j
`
`How It wo•LJ •
`. ....
`- ~
`'
`
`Ready for the pharmaceutical industry
`
`Innovative system
`
`An exc1us1ve, mnovatlve and patented system for the presentation or
`your lyophilized products.
`
`Avoid r egist rat ion ha ssles
`
`Your drug remains unchanged in its original standard vial. Debioclip®
`comes with a complete registration file and DMF.
`
`No manuractu.-ing change
`
`Debioclip™ comes already packaged In a sterile blister. All that Is
`needed, Is to place the vial In the av~llable space of the Deblocllp ™ in
`the blister.
`
`Guarantee of sterility
`
`The Deblocllp® Includes a pre-filled steam sterilized syringe. There is no
`contact between solvent and needle during storage. Shelf-life is
`guaranteed for more than three years.
`
`Low cost
`
`Debioclip® is a low cost pre-filled system, automatically assembled and
`sterilized In collaboration with a major manufacti.Jrer of medical devices.
`
`M a rketing advantag e
`
`Debiocllp® offers a key marketing advantage for the promotion of your
`lyophilized prodt.cts.
`
`Q.ebioiect ™: Another ~olution
`
`Already assembled with the vial, hence reducing the end-user procedure
`by one step. Contact us.
`
`A compact kit presentation
`
`http://www .debiotech.ch/productsldrugdd/debioclip _page _l.html
`
`Exh. 1029
`
`

`
`FROY W&C ~LP KY ?AX ~EPT
`
`(TUE) 8. 6' 02 17:02/S':' ·~:55~0. 42604546,59 P 2C
`
`The Debioclip® asep t ic connector
`ls I'Tldth:! u r ir1j~dlon m oulded polymer and is protected by seve!"lll patent
`applications.
`
`The d isp osable pre-f illed gl ass syringe
`Is made of:
`
`• A \JSP Type I glass barrel (available volumes ranging from 1 to 10
`ml) with a baked-on m edical grade silicone emulsion enablin g
`!>mooth sliding of t he plunger;
`• The adequate pre-tilled solvent for reconstitution of your
`lyophilized product or powder;
`• Pharmaceutical grade Bromoburyl rubber plunger and stopper
`which guarantees a perfect seal of the barrel;
`• A sharp needle (IV, IM or SC type, with or without luer
`connector}, silicone treated and fitted patented bypass chamber
`hub;
`• A POlypropylene flnqer grip;
`• A polypropylene plunger rod.
`
`Your p harmaceu tical product
`
`In lyophilized or powder form packaged in your standard glass vial.
`
`Ocb,otcch S.A., Av. de Sevelin 28, 1004 Lausanne, Swittertand.
`p Cupyl1ghl 2001 Pt:£1~t~~h .s.A. all rights reserved.
`lea
`r lcumers
`
`http://www .c.lebiotech.chlproducts/drugd d/debioclip _page _ l .h tml
`
`Exh. 1029
`
`

`
`FRO~~ VI&C LL? KY ~AX DE?T
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`(TUE) 8. 6' 02 17:11 I . 17: 04/NO. ~26045486C ;> 21
`
`WHITE & CASE
`
`115 5 AYEJiriUE OF THE AMERICAS
`
`N EW '!'OR~, NEW 'I'OI'tK 10030- 278 7
`
`TELEPHONE : <I •C! I C!I 619·6200
`rACS I M il.E: 11·2121 354•8 113
`
`D.R£CT DlAI.: 1·212·819-8830
`
`E-MAIL: JGenova@....tliiDca.o;e.eom
`
`... L HATT
`ANK&R.\
`.Aiftt C 1(0 1(
`80Me4Y/ M Ut1 • .-l
`HD ;H I /'111fH CITY
`t.O .,_ O KON G
`.JAN"'RT&
`111~d!JOKA I
`S I NGa.POI>(
`TOKYO
`
`•""""'~
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`
`lto!C:I ICO C I T Y'
`.1 1 n ~~>· u~o
`
`FACSIMILE TRANSMISSION
`
`Date:
`
`Jul)' 25, 2002
`
`No. of Pages (including cover):
`
`20
`
`To:
`
`Examiner Carlos Azpuru
`U.S. Patent and Trademark Office
`
`Fax Number:
`Conlee~ Number
`
`1-703-872-9307
`1·703-308-0237
`
`From;
`
`John M. Genova
`
`Roforonce No.:
`
`1103326-0596
`
`Re:
`
`U.S. Patent Appln. Serial No. 09/423,185
`
`Pl.EASE NOTE.: The: lnfonnadon contained In 1hl5 f<JCSimi:e me.r.s;~ge i8 prtvllegtld and conftdenllal. and is intended only for the use ot lhe
`individual n;;aml!d abov" <~nd othora w.a tuva boon s:pocillcaDy :~~lhorimd t.> roc:elvc it. If>""' ,.,.. nut the intcmded recipient. you are hereoy
`notified 'that any dl,eminatlon, dl5tr1bution or copying of this ccmmunicaUon Is s:ui~y prohibitsd. II you hove rcceiv&d lhi& communication in
`ern>r, or if ;any probloma occur wilh trvnamlaalon, please COfliOct sollder ll( call (21Z)I1S.7583. 'Thank you.
`
`Dear Examiner Azpuru,
`
`Undt:r cover of this facsimile cover sheet. we are submitting the following documents for
`filing in the referenced application:
`
`(I) Petition for Withdrawal of Application from Issue (2 pages)
`(2) Request for Continued Examination (1 page);
`(3) Information Disclosure Statement and Form PT0-1449 (4 pages); and
`( 4) three references (12 pages).
`
`Sincerely,
`
`John M. Genova
`Reg. No. 32,224
`
`!-i~WYUJJC OU9jl •I (l%c...Ol' OOC) (21t.)
`
`Exh. 1029
`
`

`
`ITUE) 8. 6' 02 ! 7:! i r ~ 17: 04/NO. 4260454860 ? 22
`rage ~~1
`
`ft '
`
`,
`
`TO:Auto·reply fax ~2128197583 CO~PANV:
`
`Auto-Reply Facsimile Transmission
`
`U N!TEI.) STATES
`P-\TENT AND
`TR·'\ DEMARK 0FFIC£
`
`TO:
`
`Fat Sender at 2128197583
`
`Fax Information
`Date Received:
`Total Pages:
`
`7125/02 4·47:30 PM (Eastern Deylighl T1me)
`20 Oncluding cover page)
`
`ADVISORY: This is an automatically generated return receipt confirmation of the facsimile transmission receM:d by
`the omce. Pft::tj::.-e checl< to make sure tftar me number of pages listed as received in Total Pages above matches
`what was intend9d to be sent. Applicants are advised tn retain this r&CBipt in ttle unlikely event that proof of this
`facstml/e transmission is necessary. Applicents are also advised to use tfle certificate of facsimile lransmissron
`procedures set fotth in 37 CFR 1.B(a) and (b), 37 CFR 1.6{1). Trademarf( Applicants, also see the TrademarK
`Manual or E:ramming Procedure (TMEP) section 305 et seq.
`
`Received
`Cover
`Page
`=======::>
`
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`Exh. 1029