Attorney Docket No. PRD2901USNP
`
`CERTIFICATE OF EFS TRANSMISSION
`
`I hereby certify that this paper (along with any paper referred to as being attached or enclosed) is being transmitted
`to the United States Patent and Trademark Office on the date shown below Via the “Electronic Filing System” in
`accordance with 37 C.F.R. § 1.6(a)(4).
`
`Signature
`
`Kristin Miele
`
`Type or print name
`
`/Kristin Miele/
`
`June 12, 2015
`
`In The United States Patent And Trademark Office
`
`Applicants: An Vermeulen et al.
`
`Art Unit:
`
`1627
`
`Serial No.:
`
`12/337,144
`
`Examiner:
`
`Claytor, D. Renee
`
`Filed:
`
`12/17/2008
`
`Confirmation Number: 3172
`
`For: DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE
`PALIPERIDONE ESTERS
`
`Commissioner for Patents
`P. O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`AMENDMENT
`
`This paper is in response to the Notice of Allowance dated March 13, 2015.
`
`Entry of the following amendment is respectfully requested.
`
`Amendments to the Claims are reflected in the listing of claims which begins
`
`on page 2 of this paper.
`
`Remarks/Arguments begin on page 8 of this paper.
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 001
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 001
`
`
`
`CERTIFICATE OF EFS TRANSMISSION
`
`I hereby certify that this paper (along with any paper referred to as being attached or enclosed) is being transmitted
`to the United States Patent and Trademark Office on the date shown below Via the “Electronic Filing System” in
`accordance with 37 C.F.R. § 1.6(a)(4).
`
`Signature
`
`Kristin Miele
`
`Type or print name
`
`/Kristin Miele/
`
`June 12, 2015
`
`In The United States Patent And Trademark Office
`
`Applicants: An Vermeulen et al.
`
`Art Unit:
`
`1627
`
`Serial No.:
`
`12/337,144
`
`Examiner:
`
`Claytor, D. Renee
`
`Filed:
`
`12/17/2008
`
`Confirmation Number: 3172
`
`For: DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE
`PALIPERIDONE ESTERS
`
`Commissioner for Patents
`P. O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`AMENDMENT
`
`This paper is in response to the Notice of Allowance dated March 13, 2015.
`
`Entry of the following amendment is respectfully requested.
`
`Amendments to the Claims are reflected in the listing of claims which begins
`
`on page 2 of this paper.
`
`Remarks/Arguments begin on page 8 of this paper.
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 001
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 001
`
`
`
`Amendments to the Claims:
`
`Attorney Docket No. PRD2901USNP
`
`This listing of claims replaces all prior versions, and listings, of claims in the
`
`captioned application.
`
`Listing of Claims:
`
`1.
`
`(Currently Amended) A dosing regimen for administering paliperidone palmitate to
`
`a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder,
`
`or schizophreniform disorder comprising
`
`(1) administering intramuscularly in the deltoid of a patient in need of treatment a
`
`first loading dose of about 150 mg-eq. of paliperidone as paliperidone
`
`palmitate formulated in a sustained release formulation on the first day of
`
`treatment;
`
`(2) administering intramuscularly in the deltoid muscle of the patient in need of
`
`treatment a second loading dose of about 100 mg-eq. of paliperidone as
`
`paliperidone palmitate formulated in a sustained release formulation on the 6th
`
`to about 10th day of treatment; and
`
`(3) administering intramuscularly in the deltoid or gluteal muscle of the patient in
`
`need of treatment a first maintenance dose of about 25 mg-eq. to about 150
`
`mg-eq. of paliperidone as paliperidone palmitate in a sustained release
`
`formulation a month (:7 days) after the second loading dose. en—abeut—the
`
`34th—te—abeut—Hee%8th—elay—ef—treatment—.
`
`2.
`
`(Currently Amended) The dosing regimen of claim 1 wherein after administration
`
`ithe fir_stmaintenance dose ef—a—sustaineel—release—elfififermulatien—ef
`
`paliperidene—palmitate—is—administered, subseguent maintenance doses of from
`
`about 25 mg-eg. to 150 mg-eg. are administered in the deltoid or gluteal muscle of
`
`the psychiatric patient in need of treatment at monthly (:7 days) intervals after—the
`
`3Gm—day—ef—treatment.
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 002
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 002
`
`
`
`Attorney Docket No. PRD2901USNP
`
`3. (Previously Presented) The dosing regimen of claim 1 wherein the sustained
`
`release formulation is an aqueous nanoparticle suspension.
`
`4.
`
`(Currently Amended) A dosing regimen for administering paliperidone palmitate
`
`to a psychiatric patient in need of treatment for psychotic disorder comprising
`
`(a) administering intramuscularly in the deltoid of a patient in need of
`
`treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone
`
`palmitate formulated in a sustained release formulation on the first day of treatment;
`
`(b) administering intramuscularly in the deltoid muscle of the patient in need of
`
`treatment a second loading dose of about 100 mg-eq. of paliperidone as
`
`paliperidone palmitate formulated in a sustained release formulation on the eighth
`
`day of treatment; and
`
`(c) administering intramuscularly in the deltoid or gluteal muscle of the patient
`
`in need of treatment a first maintenance dose of about 25 mg-eq. to about 150 mg-
`
`eq. of paliperidone as paliperidone palmitate in a sustained release formulation a
`
`month (:7 days) after the second loading dose. en—abeut—thefiaéth—elay—ef—treatmene
`
`5. (Previously Presented) The dosing regimen of claim 4 wherein the sustained
`
`release formulation is an aqueous nanoparticle suspension of.
`
`6. (Cancelled)
`
`7. (Cancelled)
`
`8. (Cancelled)
`
`9. (Cancelled)
`
`10. (Cancelled)
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 003
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 003
`
`
`
`Attorney Docket No. PRD2901USNP
`
`11. (Cancelled)
`
`12. (Cancelled)
`
`13. (Previously Presented) The dosing regimen of claim 4 wherein the psychiatric
`
`patient is in need of treatment for psychotic disorder wherein the psychotic disorder
`
`is schizophrenia.
`
`14. (Canceled)
`
`15. (Previously Presented) The dosing regimen of claim 4 wherein the psychiatric
`
`patient is in need of treatment for a psychotic disorder wherein the psychotic disorder
`
`is schizoaffective disorder.
`
`16.
`
`(Currently Amended) A dosing regimen for administering paliperidone palmitate
`
`to a renally impaired psychiatric patient in need of treatment for schizophrenia,
`
`schizoaffective disorder, or schizophreniform disorder comprising
`
`(a) administering intramuscularly in the deltoid of a renally impaired psychiatric
`
`patient in need of treatment a first loading dose of from about 75 mg-eq. of
`
`paliperidone as paliperidone palmitate formulated in a sustained release
`
`formulation on the first day of treatment;
`
`(b) administering intramuscularly in the deltoid muscle of the patient in need of
`
`treatment a second loading dose of from about 75 mg-eq. of paliperidone as
`
`paliperidone palmitate formulated in a sustained release formulation on the 6th
`
`to about 10th day of treatment; and
`
`(c) administering intramuscularly in the deltoid or gluteal muscle of the patient in
`
`need of treatment a first maintenance dose of about 25 mg-eq. to about 75
`
`mg-eq. of paliperidone as paliperidone palmitate in a sustained release
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 004
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 004
`
`
`
`Attorney Docket No. PRD2901USNP
`
`formulation a month (:7 days) after the second loading dose. en—aleeut—the
`
`34th—te—abeut—the—38th—day—ef—treamqent7
`
`17.
`
`(Currently Amended) The dosing regimen of claim 16 wherein a_fterthe f_irst
`
`maintenance dose eLa—sustained—release—fermtm—efpaliperidene—palnmtate—Is
`
`administered—menthly, subseguent maintenance doses of from about 25 mg- eg.t
`
`150 mg-eg. are administered'In the deltoid or gluteal muscle of the psychiatric
`
`patient in need of treatment at monthly (i7) intervals after—the-agm-day—ef—treatment.
`
`18. (Previously Presented) The dosing regimen of claim 16 wherein the sustained
`
`release formulation is an aqueous nanoparticle suspension.
`
`19.
`
`(Currently Amended) A dosing regimen for administering paliperidone palmitate
`
`to a renally impaired psychiatric patient in need of treatment for psychotic disorder
`
`comprising
`
`(a) administering intramuscularly in the deltoid of a renally impaired
`
`psychiatric patient in need of treatment a first loading dose of from about 75 mg-eq.
`
`of paliperidone as paliperidone palmitate formulated in a sustained release
`
`formulation on the first day of treatment;
`
`(b) administering intramuscularly in the deltoid muscle of the patient in need of
`
`treatment a second loading dose of from about 75 mg-eq. of paliperidone as
`
`paliperidone palmitate formulated in a sustained release formulation on the eighth
`
`day of treatment; and
`
`(c) administering intramuscularly in the deltoid or gluteal muscle of the patient
`
`in need of treatment a first maintenance dose of about 25 mg-eq. to about 50 mg-eq.
`
`of paliperidone as paliperidone palmitate in a sustained release formulation a month
`
`(i7 days) after the second loading dose. en—abeut—the—é’yéth—day—ef—treatnqente
`
`20. (Previously Presented) The dosing regimen of claim 19 wherein the sustained
`
`release formulation is an aqueous nanoparticle suspension.
`
`5
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 005
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 005
`
`
`
`Attorney Docket No. PRD2901USNP
`
`21. (Cancelled)
`
`22. (Previously Presented) The dosing regimen of claim 4 wherein the psychiatric
`
`patient is in need of treatment for of a psychotic disorder wherein the psychotic
`
`disorder is schizophrenia.
`
`23. (Canceled)
`
`24. (Previously Presented) The dosing regimen of claim 4 wherein the psychiatric
`
`patient is in need of treatment for a psychotic disorder wherein the psychotic disorder
`
`is schizoaffective.
`
`25-33 (Cancelled)
`
`34 (New) The dosing regimen of claim 4 wherein after administration of the first
`
`maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150
`
`mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in
`
`need of treatment at monthly (i7 days) intervals.
`
`35 (New) The dosing regimen of claim 19 wherein after administration of the first
`
`maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150
`
`mg-eq. are administered_in the deltoid or gluteal muscle of the psychiatric patient in
`
`need_of treatment at monthly (i7 days) intervals.
`
`36. (new) The dosing regimen of claim 1, 4, 16 or 19 wherein the formulation is an
`
`aqueous nanoparticle suspension comprises
`
`(a) from 3 to 20% (w/v) of the paliperidone palmitate having an average
`
`particle size (d50) of from about 1600nm to about 900 nm;
`
`(b) from 0.5 to 3% (w/v) of a wetting agent wherein the wetting agent is
`
`polysorbate 20;
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 006
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 006
`
`
`
`Attorney Docket No. PRD2901USNP
`
`(c) one or more buffering agents sufficient to render the composition neutral to
`
`very slightly basic (pH 8.5);
`
`(d) from 0.5 to 3% (w/v) of a suspending agent wherein the suspending agent
`
`is polyethylene glycol 4000; and
`
`(e) up to 2% (w/v) preservatives; and
`
`(f) water q.s. ad 100%.
`
`37. (New) The dosage regimen of claim 36 wherein the concentration of paliperidone
`
`palmitate is 156 mg/ml in the aqueous nanoparticle suspension.
`
`38. (New) The dosing regimen of claim 1, 4, 16 and 19 wherein the sustained
`
`release depot formulation is an aqueous nanoparticle suspension consists
`
`essentially of
`
`(a) 156 mg/ml of the paliperidone palmitate having an average particle size
`
`(d50) of from about 1600nm to about 900 nm;
`
`(b) 12mg/ml of polysorbate 20;
`
`(c) one or more buffering agents sufficient to render the composition neutral to
`
`very slightly basic (pH 8.5);
`
`(d) 30 mg/ml of a suspending agent wherein the suspending agent is
`
`polyethylene glycol 4000; and
`
`(f) water q.s. ad 100%..
`
`39. (New) The dosage regimen of claim 38 wherein in the buffering agents
`
`contained in the aqueous nanoparticle suspension are citric acid monohydrate,
`
`disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate
`
`monohydrate, sodium hydroxide.
`
`40. (New) The dosage regimen of claim 38 wherein in the pH of the aqueous
`
`nanoparticle suspension is in the range of pH 7 to 7.5.
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 007
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 007
`
`
`
`Attorney Docket No. PRD2901USNP
`
`Status of the Claims
`
`REMARKS/ARGUMENTS
`
`Claims 1-33 were originally filed in the present application. Claims 1, 2, 4, 16,
`
`17 and 19 have been amended. Claims 34-40 have been added. Claims 6-12, 14,
`
`21, 23 and 25-33 have been cancelled. After entry of this amendment, claims 1-5,
`
`13, 15-20, 22, 24 and 34-40 will be pending.
`
`Amendments to the Claims
`
`Claims 1, 4, 16 and 19 have be amended to more clearly describe what
`
`applicants’ invention. The first maintenance dose is now described as being from
`
`about 25 mg-eq. to 150 mg-eq. administered monthly (:7 days). Support for this
`
`amendment may be found on page 7, lines 23-25 and page 8, lines 18-20. No new
`
`matter is added by these amendments. Entry and consideration of these
`
`amendments is respectfully requested.
`
`Claim 2 and 17 have been amended by clarify that the subsequent
`
`maintenance doses will be from about 25 mg-eq. to 150 mg-eq. administered
`
`monthly (:7 days). Support for this amendment can be found on page 7, lines 29-31
`
`and page 8, lines 18-20 of the specification. No new matter is added by these
`
`amendments. Entry and consideration of these amendments is respectfully
`
`requested.
`
`New claims 34 and 35 have been added to clarify that the subsequent
`
`maintenance doses will be from about 25 mg-eq. to 150 mg-eq. administered
`
`monthly (:7 days). Support for this amendment can be found on page 7, lines 29-31
`
`and page 8, lines 18-20 of the specification. No new matter is added by these new
`
`claims. Entry and consideration of these claims is respectfully requested.
`
`New claims describe formulations of suitable aqueous nanoparticle
`
`suspensions. Support for these new claims may be found on pages 10-16 and Table
`
`2, on page 22 of the specification. No new matter is added by these new claims.
`
`Entry and consideration of these claims is respectfully requested.
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 008
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 008
`
`
`
`Attorney Docket No. PRD2901USNP
`
`W
`
`Applicants respectfully request reconsideration and allowance of claims 1-5,
`
`13, 15-20, 22, 24 and 34-20. The Commissioner is hereby authorized to charge any
`
`deficiency or credit any overpayments necessitated by this Amendment to Deposit
`
`Account No. 10-0750/PRD2901 USN P/HBW.
`
`Respectfully submitted,
`
`Johnson & Johnson
`One Johnson & Johnson Plaza
`New Brunswick, NJ 08933-7003
`Phone: (732) 524-2976
`Dated: 12 June 2015
`
`By:
`
`/Hal Brent Woodrow/
`
`Ha' 8' WOOdrOW’ Reg' NO' 32501
`
`Mylan V. Janssen (IPR2020-00440) EX. 1018 p. 009
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1018 p. 009
`
`
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