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`Docket No.-: ooo166.0073-u~eq;2900 . ·
`(PATENT)
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`IN THE UNITED ST AT~ES PATENT AND TRADEMARK OFFICE ·
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`In re Patent Ap-plication of:
`J. Michael Ramstack, Ph.D., eta!.
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`Application No~: 1 0/259,949-Conf. #5406 ·
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`Group Art Unit: 1615-
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`Filed: September 30, 2002
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`Examiner: R. Bennett
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`For: PREPARATION OF INJECT ABLE
`SUSPENSIONS I-lAVlNG IMPROVED
`INJECT ABILITY
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`TRANSMITTAL LETTER
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`Commissioner for Patents
`Washington, DC 20231
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`Dear Sir: .
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`Enclosed are the following items for filing in connection with the above-referenced
`Pateni'App1ication: .
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`1. ·Amendment Transmittal (in duplicate);
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`· 2. ·.Fee Transmitta·I;
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`3. Reply Under 37 C.F.R. § 1.111;'
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`4. Ten11inal Disclaimer to Obviate a Double Patenting Rejectioi1 Over a Prior
`Patent;
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`. 5. Statement Under 3 7.-CFR 3~73(b); ·
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`:.6. Copy of Declaration ofMark A. Tray; Ph.D. Under 37 C.F.R. § IJ 32 liled in
`parent App1. No. 09/577,875~
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`7. Ch~ck No. 312256 in the amou_nt of$110 to cover the fee for the Tcnninal
`Disclaimer; and
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`LUYE1017
`IPR of Patent No. 6,667,061
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`Application No.: 1 0/259,949-Conf. #5406
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`Docket No.: 000 166.0073-USO 1
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`8. Return receipt postcard.
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`It is· not believed that extensions of time or fees (or net addition of claims are required
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`beyond those. that may otherwise be provided for in documents accompanying this paper.
`However; if additional extensions of time are ne~essary to prevent abandonment of this
`appiication, then such extensions of time are h~reby petitioned under 37 C.F.R. § 1.136(a)~ and
`any fees· required therefor (inCluding fees tor net addition of claims) are hereby authorized to be
`charged to our Deposit Account No. 50-0740, referencing our Docket No. 000 166.0073-USO l.
`A duplicate copy of this paper is enclosed.
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`Dated: May 14, 2003
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`Respectfully submitted,
`
`BYJ~~~-=~~~-=~~
`Andrea G. Reister
`Registration NCl.: 36,253
`COVINGTON & BURLING
`1201 PennsylvariiaAvenue, N.W.
`Wa,shington, DC 20004-2401
`(202) 662-6000
`Attorneys for Applicant
`
`\'
`
`LUYE1017
`IPR of Patent No. 6,667,061
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`IN THE UNITEDST~TES. PATENT AND TRA.DEJVIARK o·FFICE
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`Group Art Unit: 1615 jl . ~
`.··~~4Pf
`Examiner: R. Bennett·
`·
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`ln re Patent Application of
`J. Michabl Ramstack, Ph.D., ct al
`
`Application No.: 1 o/259,949-Conf #5406
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`Filed: September 30;2002
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`For: PREPARJ\ TlON OF INJECTABLE
`:. SU:SPENSfONS HAVING IMPROVED
`INJECTABII.ITY ..
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`REPLY UNDER 37 C.F.R. § 1.111.
`
`Commissioner for Patents
`Washington, DC 20231
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`Dear Sir:
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`· In response to the Office Action dated April 9, 2003 (Paper No.4), AppJicants
`provide t~e following remarks.
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`· It is not believed that extensions oftime.or fees for net addition of claim's are required
`beyond those that may otherwise be provided for in documents accompanying this paper.
`However, if additional extensions of time are necessary to prevent abandonment of this
`applicatio'n, then such extensions. of time are hereby petitioned under 37 C~F.R. § '1.136(a), and
`any fees requ1red •therefor (including fees for net addition of claims) are hereby authorized to. be
`charged t(l our Deposit Account No. 50-0740 referencing our Docket No. 000 f66.0073-USO I.
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`REI\'IARKS/ ARGUM.ENTS
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`Recopsideration of this Application is rcspectful1y requested. Claims 1-21, 41, and
`42 are currently pe~ding for the examirier's considenition, with claim 1. being the only
`independent claim. Basedon the following Rema_rks, Applicai1ts respectfully request that the
`examiner reconsider all dutstanding objections and rejections and they be withdrawn.
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`LUYE1017
`IPR of Patent No. 6,667,061
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`Application No.: 10/259,949-Conf. #5406
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`2
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`Docket No.: 000166.0073-USOl
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`Obviousues.~t-Type Double Patenti11g
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`The Examiner has r~jected claims 1.:.21,41, and 42 imder the judicially created
`· doctrine of obviousness-type double patenting as being unpatentable over claims 1-21· ofU .S.
`Patent No. 6,495,164 ("the '164 patent''). Filed herewith is a Terminal DisClaimer to Obviate a
`Double Patenting Rejection Over a Prior.Patent.executed by the assignee of the above-captioned
`application for the '164 patent ("Disclaimer"). A Statement Under 37 C~F.R. § 3. 73(b)
`establishing the right to act on behalf of the assignee with regard to the above-captioned
`application is also filed herewith. The f)ling of a temtinal disclaimer to obviate a rejection based
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`on noilstaUltorydouble patenting is not an admission of the proprietary of the rejection. Quad
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`. Environmental Technologies Corp. v. Union Sanitary District, 946 F.2d 870 (Fed. Cir. 1,991).
`The filing of a terminal disclaitner serves the statutory function of removing the rejection of .
`double patenting, and raises neither a presumption nor estoppel on the merits of the rejection.
`ld.; M.P.E.P. § 804.02. Based upon filing of the Disclaimer and accompanying fee, Applicants
`respectfu,lly submit that the obviousness-type double patenting rejection should be withdrawn.
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`RejectiOJI Utule'r 35 U.S.C § 103(a)'
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`The examiner has rejected claims 1~21, 41, and 42 under 35 U:S.C. § 103(a) as being
`unpatentable over U.S. Patent No. 5,656,299 to Kino et al. ("the Kino patent") in view of U.S.
`Patent N~. 5,540,912 to Roorda eta!. ("the Roordapatent"). Applicants respectfully subn1it that
`none ofthe cited documents or other documents of record discloses or suggests the relatio~ship"
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`between increased viscosity and improved irijectability, or the claimed methods by which the
`compositions having improved injectability are produced. For at least this reason Applicants
`respectfu,lly subtnit that the§ H)3 rejection cannotpr~perlybe maintained.
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`' · As ~oted by the Examiner in paragraph. 5 of the' Off~ce Action, the Kino patent "does
`not disclose the viscosity to be greater than.about 60 cp and less than about600 cp." I~ fact~ the
`. Kino pat~nt does not explicitly disclose the viscosity of the injection vehicles used in the Test
`Examples, nor ·does Othe Kino patent provide any information about injectability, or the
`relationship between injectability and viscosity of the injection vehicle. This is evident from
`paragrapl1 3 of. the Declaration of Mark A. Tracy, Ph.D. Under 37 C.F.R. § 1.132 ("the Tracy
`Declaration") filed iri parent application number 09/577,875 (now U.S·. Patent. No. 6,495, 164), a
`copy of which is ·filed herewith.
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`LUYE1017
`IPR of Patent No. 6,667,061
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`Application No.: 10/259,949-Conf. #5406
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`Docket No.: 000166.0073-USOl
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`As evident from the Tracy Declaration, all of the injection vehicles of the Test
`Examples of the Kino. patet1t have a viscosity.significantly less'than 20 cp at 20°C. Particularty,
`as stated_ in paragraph 4 of theTra~y Declaration, the viscosity of the physiological saline
`inj·ectio~ vehicle as the fluid phase of a s·uspension containing the microspheres of e?ch of Test
`Examples i, 3, and.4 ofthe Kino patent is approxiniately one (1) cp at 20°C. As·stated in
`paragraph 5 oftheTra~y D~cla.nition, the viscosityofthe carboxymethyl ce11ulose (CMC)
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`injection vehicle as the fluid phase of a suspens-ion containing the microspheres of Test Example
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`2 of the Kino patent is less than 7 cp at 20°C.
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`The Examiner is biking the position that, "absent unexpected results regarding the
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`criticality of the viscosity, Kino:discloses all the lin1itations ofthe instant claims." However, as
`l}Oted abo~e, the Examiner" recognizes thatthe.Ki~o patent does. notdisclos.e the viscositY to be
`greater t~1an about 60 cp and less than about 600 cp, and the TracyDeclaration eviden~es thatall .
`of the Test.Examples of the Kino patent have a viscosity significantly lessthan 20 cp.
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`. Applicants respectfully submit tl1atthe-"criticality" of the viscosity to the improveme~ts
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`in injectability of the present i~vention is discussed throughout the above-captioned application .
`as origi~ally filed. For example, as noted on page 8, Ji~es 12-16 of the above-captioned
`application: ·
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`"The inventors have unexP.ectedly discovered that injectability is itnpr.oved, and
`in. vivo injectability failures significantly and un~xpectedly reduced, by increasing the
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`viscosity of the· fluid phase of an injectable suspension. This is in contrast to
`co'nvent_ional t.eachings that anincr~·ase in t.~e·viscosity hinders injectabilityand
`syringeability. "·
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`I\1oreo~er, as noted on·page 12, line 15, through page 18, line 7 ofthe above-captioned
`application as originally filed, the in vi~o studies "showed a dramatic improv~ment in
`injectability. with increased injection vehicle viscosity." Based on the experiments and data
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`reported ;:n these pages of the application; 1t is evident that viscosities of at least about.20 cp are
`necessary .for successful and medically acceptable injectability rates. Af viscosities of less than
`or equal to about 11 cp, in vivo il~ectability .failures increase significantly.
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`LUYE1017
`IPR of Patent No. 6,667,061
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`

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`Application No.: 10/259,949-Conf. #5406
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`'4
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`Docket No.:0001 66.0073-'USOJ
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`Applicants respectfully submit that at least the 1)assages cited above from the above-
`captimied application as originally filed demonstrate the relati~:mship and importance of viscosity
`to injectability, and should more than suffice for a showing of"criticality" of viscosity.
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`That such criticality is unexpected is demonstrated by the conventional teachings. that
`·an increase in the.viscosity hinders injectability and syringeability. ll1e Examiner is referred to.
`page 2, line 4 through page 3, line 25 of the application as originally filed that discusses
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`conventional teachings as set forth in the Floyd eta/. Chapter referred to therein (the Floyd et al.
`chapter is ~ited as iten1s BG and BH in the Infonnation Disclosure Statement filed with the
`above-captioned application on September 30, 2002).: For example, as stated on page 2, lines 16- ·
`18 of the application as-originally filed, "[a]s described in the Fioyd eta/. Chapter, increase in
`the viscosity, density~ particle size, and concentration of solids in suspension hinders the
`syringeability of suspensions." As described on page 3, lines 16-25 of the applicationas
`originally filed, the viscostty of conventional injection vehicles is typically kept low, in order to
`facilitate mixing, resuspension of the particles with the vehicle, and to 'make the suspension
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`easier to inject (i.e:: low force on the syringe plunger). A n1ore viscous system requires greater .
`force or stress to make it :flow at the .same rate as a less viscous system. As stated on page 3,
`lines 23-25 of the application as originally filed,"[ c ]onventional parenteral suspensions are
`dilute, with limitations for viscosity because of syringeability and injectability constraints."
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`. Applicants respectfully subn1it that at least the passages cited above from the above-
`captioned application as origina11y filed demonstrate that it was unexpected to increase viscosity
`and impr.ove injectability,.and should more than suffice for a showing of"unexpected results"
`relating to viscosity and injectability as claimed.
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`For at ]east the foregoing reasons, Applicants respectfully submit that the rejection
`under§ l03(a) cannot properlybe.maintaine.d.
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`Other Matters
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`Applicants filed an Infom1ation.Disclosure Statement and ·accompanying Form
`PTO/SB/08 on September 30, 2002. Applicants ·respectfully r~quest that a copy of the initialed ·
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`LUYE1017
`IPR of Patent No. 6,667,061
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`Application No.: 10/259,949.:.Conf. #5406
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`.Docket No.:.000166.0073-US01
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`Form PTO/SB/08 be fmwarded to Applicants with the next communication, as an initialed copy
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`has not yet been received.
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`CONCLUSION
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`Ail of the stated grounds of objection and rejection have been properly traversed,
`accdm·ni.~datt?d, or rendered moot. Applicants therefore respectfully request that 'the Examiner
`. re.considcr all presently outstanding objections and rejections and that they be withdrawn.
`· 'Applicants believe that a full and complete response has been made to the outstanding Office_
`Action and, as :such, the present application is in condition for allowance. If the Examiner ··
`believes, Jar any reason, thatpersomil communication will expedite prosecution of this
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`application, the Examiner is invited to. telephone the undersigned at ~he number provided ..
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`In view of the above, each:ofthe presently pending claims in this application is
`·believed to be in immediate condition for allowance. Accordingly, the Examiner is respectfully
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`ISSUe.
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`Dated: J\1ay 14, 2003.
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`Respectfully submitted,
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`BU'\vtL .
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`Andrea G. Reister
`Registration No.: 6,253
`COVINGTON & URLING
`1201 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2401
`(202) 662-6000.
`Attorneys for Applicant
`
`LUYE1017
`IPR of Patent No. 6,667,061