APPLICATION. NO.'
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`10/259,949
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`FILING DATE.
`09/30/2002
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`. CONFIRMATION NO.
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`J. Michaei'Ramstack
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`000 166.0073-USO I ·
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`5406 ..
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`UNITED STATES OEI'ARTi\JEN'I' OF C'.OMMERCE
`Uuitvd Str.t .. ., Pattsut :tnd TrudUJnurk Offlt.:u
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`Atl<l,..oH: COMMISSIONER Of•' PA'l'"NT~ ANU THAUJ!;MAIII{S
`WAohin!fl.on. D.C. 211~81
`WWW,Utll'tO.gov'
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`26853 .
`7590
`0410912003
`COVINGTON & BURLING
`ATTN: PATENT DOCKETING
`120 l PENNSYLVANIA A VENUE, N. W.
`WASHINGTON, DC 20004-2401·
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`'
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`EXAMINER
`BENNE_TT, RACHEL M ·
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`~---'-A_R_T_u_N_I_T----~----P_A_PE_R_N_l_JM--BE_R __ ~I .
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`1615
`DATE MAILED: 04/0912003
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`Please. find\ bel(lw and/or attached an Office communication concerning this application or proc'?eding.
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`I'T0-90C (Rev. 07-01)
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`I.
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`LUYE1016
`IPR of Patent No. 6,667,061
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`Office Action Summary
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`.
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`Application No.
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`Applicant(s)
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`10/259,949
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`. RAMST ACK ET AL.
`Art Unit
`Examiner
`Raphel M. Bennett
`1615
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A :SHORTENED STATUTORY PERIOD FOR REPLY IS SET.TO EXPIRE ;J MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
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`Extensions of lim~ may be available under the provisions of 3'f CFR 1.136(a). In no event, however, may a reply be timely filed
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`after SIX (6) MONTHS from the mailing data of this communication.
`IJ the period for reply spec:ified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`If NO period for reply is specified above, the maximum statutory period will apply and will axpire SIX (6) MONTHS from the mailing date of this communication. .
`Failure to reply within the set or extended period for reply will, by statute, cause the application lo become ABANDONED (35 U.S.C. § 133).
`- J\ny reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`e•arned palentlerm adjustment. See 37 CFR 1.704(b).
`Status
`1)181 Responsive to communication(s) filed on 08 Januarv 2003 .
`2a)[] This action is FINAL.
`2b)~ This action is ·non-final.
`.Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`3)[]
`closed in accord.ance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims ·
`4)[~ Claim(s) 1-21. 41-42 is/are pending in the application.
`· 4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)[] Claim(s) __ is/are allowed.
`6)~ Claim(s) 1-21. 41¥42 is/are rejected.
`7)[] Claim(s) ___ is/ar~. objected to.
`B)[] Claim(s) _._._are subject to restriction and/or election requirement.
`A.ppli •:ation Papers
`9:d:J The specification is objected to by the. Examiner.
`1 0)[] The drawing(s) filed on __ is/are: a)D accepted or b)O objected to by the Exami~er.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`11)[] The proposed drawing correction filed on __ · _is: a)O approved b)O disapproved by the Examiner.
`If approved, corrected drawings are required_ln reply to this Office action.
`12)[] The oath or deplaration is objected to by the Examiner,
`Priority under 35 U.S.C. §§ 119 and 120
`13)[] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`a)O All b)O Spme * c)D None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies pf the certified copies of the priority documents have been received·in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`~See the attached detailed Office action for a list of the certified copies not receiv/ed.
`14)[] Acknowledgment is made of a claim for domestic priority under 35 u.s.c. § 119(e) (to a provisional application).
`· a) D The translation of the foreign language provisional application has been received ..
`15)[gl Acknowledg.ment is made of a claim for domestic priority under 35 U;S.C. §§ 120 and/or 121·.
`Attai:hrnent(s)
`
`1l ~ Notice of References Cited (PT0-892)
`21 ·o Notice of Draftspersoil's Patent Drawing Review (PT0-948)
`. 3) 0 Information Disclosure Statement(s) (PT0-1449) Paper No(s) __ .
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`4) D Interview Summary (PT0-413) Paper No(s). _·_ ..
`5) D Notice .of Informal Patent Application ( PT0-152)
`6) 0 Other:
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`U.S. Paten·: lnd Trademark Office
`PT0 4 32l5 (Rev. 04-01)
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`Office Action Summary
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`Part of Paper No. 4
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`LUYE1016
`IPR of Patent No. 6,667,061
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`Appli.cation!Control Number: 1 0/259,949
`Art.Unlt: ,1615. '
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`DETAILED ACTION
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`The examiner acknowledges receipt of Amendn1ent A filed 1/8/03.
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`Election/Restrictions
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`Page 2
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`Applic~nt' s election of Group I in Paper No. 3. is acknowledged. Because applicant did
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`1.
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`not distinctly aHd specifically point out the supposed errors"in the restriction requirement,_ the
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`election has been treated as an election without traverse (MPEP § 818.03(a)).
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`Double Patenting
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`The nonstatutory double patenting rejection is based on a judicially created doctrine
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`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustifie.d or ..
`i1nproper timewise extension of the .. right to exclude .. granted by a patent and to prevent possible
`harassment by·· multiple assig~ees. See In re Goodman, 11 F.3d 1046,29 USPQ2d 2010 (Fed.
`Cir. .1993); In re Longi, 759.F.2d ·887, 225 USPQ645 (Fed. Cir. 1985)~.Jn re VanOrnum, 68o
`F.2d937, 214.USPQ 761.(CCPA 1982); In re Vogel, 422-F.2d 438, 164 USPQ-619 (CCPA
`l970);and, In re Thorington, 418 F.2d 528, 163 USPQ ·6~4 (CCPA 1969).
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`A timely :filed tern1inal disclaimer in (;Ompliance with 3 7 CFR 1. 3~ I (c) maybe used to
`overconle an actual or provisional rejection based on a nonstatutory double patenting ground
`provided t~e.conflicting application or patent is shown to be con:tmonly owned with this
`·application. See 37 CFR I.l"30(b),
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`Effectiv'e January :1, 1994,-a.registered attorney or agent of record may sign aterminal
`disclaimer.- ·A terminat"disclairner signed by the assignee 1nust fully comply with 37
`CFR l.73(b).
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`3
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`Claims 1-21, 41-42 are rejected u~1de·r the judi~ially created doctrine of obviousness-type
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`double pateri~ing as being unpatentable over clain1s 1-:21, ofU.S. Patent No. 6,495, 164.
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`Although the conflicting clain1s are not identical, they are n9t patentably distinct from each other
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`bec·ause both cl~im a composition .suitable for injection through a needle into a host; comprising:
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`micropa~icles comprising a polymeric birider, and injection vehicle, wherein the microparticles
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`are suspended in said injection vehicle at a concentration of greater than 30 rng/ml. to form a
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`. suspension, wh~rein a fluid phase of said suspension has a viscosity greater than about60cp and
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`less th~n about 600 cp at 20 deg C., wherein the viscosity of said fluid phase of said suspension
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`AppliCation/Contro1 Number: ·1 0/259,949
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`provides injec.tablility of the composition through a n~edle ranging in dia~eter from 18-2~
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`gauge.
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`Clai111 R~jections - 3 5 USC§ 103 ·
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`4.
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`The following is a quotation of35 u.s.·c~ 103(a) which forms the basis for all
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`. obviousness rejections set forth in this Office action:
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`(a) A p~tent may not be obtained though the invention is !lot identically disclosed or described as set forth in
`section 102 of this title, if the differences between the .subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made. to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by tire ·
`manner 'in which the invention was made.
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`5.
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`Claims 1-21, 41-42 are rejected under 35 U.S. C. 103(a) as·beingunpatentab1e over Kino
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`etal. (5656299), and further in view of Roorda et al. (US 5540912).
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`Kino discloses a sustained release microsphere preparation, which is produced by
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`including ·a h~rdrophobic antipsycotic drug into -a base cmnposed of a high molecular weight
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`polynleric bin'der such as polylactic 'acid, poly(lacti'c-co-glycolic) acid or the like and a process
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`for the production (abstract). The microspheres have an average particle size of about 0.5 to
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`400~nt (see col. 2 lines 30-34). The hydrophobic antipsychotic drug may be risperidone (see col.
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`2lines 38-49). The.poly(lactic-co-glycolic) acid is used in a compositional ratio of lactic acid to
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`_ glycolic acid in ·a ratio from about _1 00:0 to 50:50 (see col. 3 lines 1 0-18). A viscosity enhancing
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`agent, such as sodium carboxymethylcellulose, may be adde~ ·to the ~icrospheres, along with an
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`density enhancingagent, such as sorbitol or a tonicity adjusting agent such as sodium chloride.
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`Polysorbate 80 may also be added as a wetting agent. The sustained release microsphere
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`prepara.tion m;ay be used preferably in the form of an aqueous suspension (see col. 4lines 38-60).
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`The preparation is intramuscularly or subcutaneously adn1inistered to a patient in need thereof
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`(see col. 7 lines ~5-45 and col. 8 lines 1-8). Sustained release injections of the tnicrospheres can
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`LUYE1016
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`Applicat1on/Cont~ol Number: 10/259,949
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`be made into more stable injections by further ·adding a filler, such as sorbitol, dispersing the
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`mixture and then subjecting the dispersion to freeze drying or spray drying to obtain a solid
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`preparation which can be tised by. addi'ng distilled water for injection or an appropriate dispersion
`mediutn a~ th~ tin1e of injection (see col. 4 lines 52-60). The process for producing the.
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`microspheres ,comprises making an oil layer comprising a polymeric ~in~er containing the ·
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`atitipsychotic ,drug, adding the oil layer to a water layer, subjecting the resulting mixture to an
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`. emulsifi~ation treatment to o~tainan 0/W type emulsion and subsequently renloving the solvent
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`in the oil-layer by an in-water drying n1ethod (see col. 3 lines 27-50). Kino does not disclose· the
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`viscosity to be greater than about 60 cp and less than about 600 cp.
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`Absen~t unexpected results, it would have been obvious to one having ordinary skill in the
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`art at the time of the invention to determine the optimal viscosity for application. The desired
`· .. viscosity for ~my given formulation or use may vary~ for example, according to the preference of
`the physician, the manner of app1ication and type of applicator used, the amount of formulation
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`needed, the area to which the formulation is applied, and similar considerationJ. The desired ·
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`viscosity will .also vary with the·co~centration of the particles in the suspension, since the
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`presence of the partic1es contributes to the viscosity of the suspension .. Both the prior art and the
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`· instant -claims are drawn to a composition suitable for inJection through a needle host comprising
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`riiicroparticles comprising a polyme~ic binder in combination with a viscosity enhancing agent, a
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`density'erihancing agent, a tonicity adjusting agent, a wetting .agent and an active agent.
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`Therefore, absent unexpected results regarding the critic~lity of the viscosity,. Kino discloses all
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`the limitations of the jnstant claims.
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`Application/Control Number: 10/259,949
`Art'U nit: 1615
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`Page 5
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`Correspondence
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`Any i~quiry concerning this communication or earlier communications fi·om the
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`examiner should be directed to Racll.el M. Bennett whose telephone number is (703) 308-8779.. ·
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`The examiner can normally be reached on Monday through Friday, 8:00A.M. to 4:30P.M ..
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`If atte~npts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Thurman K. Page can be reached on (703) 308-2927. The .fax phone nun1bers fort~e ·
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`organization where this application or proceeding is assigned are (703) 305-3592 for regular
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`communications and (703) 308-7924 for After Final con1n1unications.
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`·Any inquiry of a general nature or relating to the status of this application or proceeding
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`should-he dire:cted to the receptionist who-se telephone number is (703) 308-1234.
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`R. Bennett
`April 4, 2003 ·
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`--hruf\M,
`· . . AGE
`SUPERVJsORv-
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`MINER
`TEcfOLOGY CE TER 1600 .
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`__ ........
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`Notice of References Cited
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`•.
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`Application/Control No.
`10/259,949
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`Exa'miner
`· Rachei
`M. Bennett
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`Applicant{s)/Patent Under
`Reexamination
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`· RAMSTACK ET AL.
`Art Unit
`1615
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`Page 1 of 1
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`Document Number
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`A US-5656299 .
`B US-6495164
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`C: US-
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`Date
`MM-YYYY
`06-1997
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`12-2002
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`U.S. PATENT DOCUMENTS .
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`Name
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`Kino et al.
`Ram stack et al.
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`424/469
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`424/469
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`NON-PATENT DOCUMENTS
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
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`. *A ccpy of ·~us reference 1s.not bemg furnished With this Office achon. (See MPEP § 707.05(a).)
`. ~atel> in MM-YYYY format are public11tion dales. Classifications may be US or fureign.
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`U . .S. Patent und Trademark Office
`PT0-:-892 (Rev. 01-2001)
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`Notice of References Cited
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`Part·of Paper No. 4
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`LUYE1016
`IPR of Patent No. 6,667,061