Serial No. 13/536,525
`
`WSGR Reference No. 34550- 718.305
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In re the Application of:
`
`Inventors:
`
`Gregory T. Went
`
`Group Art Unit: 1627
`
`Serial No.:
`
`13/536,525
`
`Filed:
`
`June 28, 2012
`
`Title: Methodfor Administering an
`NMDA Receptor Antagonist to a
`Subject
`
`
`
`Examiner: Carter, Kendra D.
`
`Confirmation No.: 1096
`
`Customer No.: 94584
`
`
`
`Certificate of Electronic Filin
`
`I hereby certify that this Preliminary Amendment and all
`marked attachments are being deposited by Electronic Filing on
`September 6, 2012 by using the EFS-Web patent filing system
`and addressed to: Commissioner for Patents, PO. Box 1450,
`Alexandria, VA 22313-1450.
`
`By: EQM QM
`
`Linda Anders
`
`
`
`Commissioner For Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Madam:
`
`PRELIMINARY AMENDMENT
`
`Applicants respectfully request entry of the proposed amendments prior to examination
`
`and allowance of the pending claims.
`
`An Amendment to the Specification begins on page 2 of this paper.
`
`A Complete Listing of Claims begins on page 3 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`IPR2015—00410
`
`Petitioners' Ex. 1027
`
`Page 1
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 1
`
`
`
`WSGR Reference No. 34550- 718.305
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In re the Application of:
`
`Inventors:
`
`Gregory T. Went
`
`Group Art Unit: 1627
`
`Serial No.:
`
`13/536,525
`
`Filed:
`
`June 28, 2012
`
`Title: Methodfor Administering an
`NMDA Receptor Antagonist to a
`Subject
`
`
`
`Examiner: Carter, Kendra D.
`
`Confirmation No.: 1096
`
`Customer No.: 94584
`
`
`
`Certificate of Electronic Filin
`
`I hereby certify that this Preliminary Amendment and all
`marked attachments are being deposited by Electronic Filing on
`September 6, 2012 by using the EFS-Web patent filing system
`and addressed to: Commissioner for Patents, PO. Box 1450,
`Alexandria, VA 22313-1450.
`
`By: EQM QM
`
`Linda Anders
`
`
`
`Commissioner For Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Madam:
`
`PRELIMINARY AMENDMENT
`
`Applicants respectfully request entry of the proposed amendments prior to examination
`
`and allowance of the pending claims.
`
`An Amendment to the Specification begins on page 2 of this paper.
`
`A Complete Listing of Claims begins on page 3 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`IPR2015—00410
`
`Petitioners' Ex. 1027
`
`Page 1
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 1
`
`
`
`Serial No. 13/536,525
`
`WSGR Reference No. 34550- 718.305
`
`AMENDMENT TO THE SPECIFICATION
`
`After Paragraph [00101], please insert the following paragraph and table:
`
`--Compositions described herein provide a dC/dT of 2.1 ng/mL/hr or less, as shown, e.g.,
`
`in the following table, which summarizes the pharmacokinetic properties of memantine in
`
`exemplary IR and SR formulations:
`
`Active Agents
`Permutation Type
`
`Mamantine
`IR Administration
`
`Memanfine
`SR Formulation
`
`Quantityidose
`(mg}
`Dosing Freq (hr)
`Tmax
`‘
`T112
`Vd (L)
`
`(so/“:17 4hr
`CmaxlCmaanZ-
`16
`Crmax2-16
`CmeanZ-‘IG
`
`Ratio Data
`min
`max
`
`Average
`SD
`
`Cratio.var 11%)
`
`1!)
`12
`3
`60
`600
`
`4.0
`
`1.6
`36.?
`18.8
`
`gm
`7.75
`2799
`
`14.84
`4.99
`
`34%
`
`nglrrfl
`
`28
`243
`24
`60
`600
`
`2.1
`
`1.7
`29.3
`17.4
`
`m
`3.47
`8.06
`
`524
`1.34
`
`26%
`
`ng/ml
`
`2
`
`IPR2015—00410
`Petitioners' EX. 1027
`
`Page 2
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 2
`
`
`
`Serial No. 13/536,525
`
`WSGR Reference No. 34550- 718. 305
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings in the above-referenced
`
`patent application. The foregoing amendments are without prejudice and do not constitute an
`
`admission regarding the patentability of the amended subject matter and should not so be
`
`construed.
`
`Listing of Claims
`
`1.
`
`
`(Currently Amended) A method of treating a patient with a neurological disorder selected
`
`from the group consisting of Alzheimer's disease1 dementia, Parkinson's disease, and neuropathic
`
`pain, comprising:
`
`administering to said subject once daily a sustained release oral dosage form comprising
`
`22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a
`
`component that sustains release of said memantine or salt thereof,
`
`wherein said sustained release memantine provides a change in mean plasma
`
`concentration of memantine as a function of time (dC/dT) that is: (a) less than about 50%
`
`of the dC/dT provided by the same quantity of an immediate release form of memantine,
`
`determined in a time period between O-TmaX of the immediate release form of
`
`memantine; and (b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours;
`
`wherein dC/dT is measured in a single—dose human PK study.
`
`2.
`
`(Original) The method of claim 1, wherein the dC/dT of 2.1 ng/mL/hr or less is
`
`determined in a time period of 2 to 4 hours.
`
`3.
`
`4.
`
`5.
`
`(Canceled).
`
`(Canceled).
`
`The method of claim 1, wherein the sustained release oral dosage form comprises 25 mg
`
`to 30 mg memantine or a pharmaceutically acceptable salt thereof.
`
`3
`
`IPR2015—00410
`Petitioners' EX. 1027
`
`Page 3
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 3
`
`
`
`6.
`
`The method of claim 5, wherein the dC/dT of 2.1 ng/mL/hr or less is determined in a time
`
`period of 2 to 4 hours.
`
`Serial No. 13/536, 525
`
`WSGR Reference No. 34550- 718.305
`
`7.
`
`8.
`
`9.
`
`(Canceled).
`
`(Canceled).
`
`(Original) The method of claim 1, wherein the sustained release oral dosage form
`
`comprises 28 mg memantine or a pharmaceutically acceptable salt thereof.
`
`10.
`
`(Original) The method of claim 9, wherein the dC/dT of 2.1 ng/mL/hr or less is
`
`determined in a time period of 2 to 4 hours.
`
`1 1.
`
`(Canceled).
`
`12.
`
`(Canceled).
`
`13.
`
`(Currently Amended) A method of treating a patient with a neurological disorder selected
`
`from the group consisting of Alzheimer's disease, dementia, Parkinson's disease, and neuropathic
`
`pain, comprising:
`
`administering to said subject once daily a sustained release oral dosage form comprising
`
`22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a
`
`component that sustains release of said memantine or salt thereof,
`
`wherein said sustained release memantine provides a change in mean plasma
`
`concentration of memantine as a function of time (dC/dT) that is: (a) less than about 50%
`
`of the dC/dT provided by the same quantity of an immediate release form of memantine,
`
`determined in a time period between 0 hours and 6 hours of administration of memantine;
`
`and (b) 2.1 ng/ml/hr or less, determined in a time period of O to 4 hours; Wherein dC/dT is
`
`measured in a single-dose human PK study.
`
`14.
`
`(Original) The method of claim 13, wherein the dC/dT of 2.1 ng/mL/hr or less is
`
`determined in a time period of 2 to 4 hours.
`
`15.
`
`(Canceled).
`
`4
`
`IPR2015—00410
`
`Petitioners' EX. 1027
`
`Page 4
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 4
`
`
`
`Serial No. 13/536,525
`
`WSGR Reference No. 34550- 718.305
`
`16.
`
`(Canceled).
`
`17.
`
`(Original) The method of claim 13, wherein the sustained release oral dosage form
`
`comprises 25 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof.
`
`18.
`
`(Original) The method of claim 17, wherein the dC/dT of 2.1 ng/mL/hr or less is
`
`determined in a time period of 2 to 4 hours.
`
`19.
`
`(Canceled).
`
`20.
`
`(Canceled).
`
`21.
`
`(Original) The method of claim 13, wherein the sustained release oral dosage form
`
`comprises 28 mg memantine or a pharmaceutically acceptable salt thereof.
`
`22.
`
`(Original) The method of claim 21, wherein the dC/dT of 2.1 ng/mL/hr or less is
`
`determined in a time period of 2 to 4 hours.
`
`23.
`
`(Canceled).
`
`24.
`
`(Canceled).
`
`25.
`
`(Canceled).
`
`26.
`
`(Canceled).
`
`27.
`
`(Canceled).
`
`28.
`
`(Canceled).
`
`29.
`
`(Canceled).
`
`30.
`
`(Canceled).
`
`IPR2015—00410
`
`Petitioners' EX. 1027
`
`Page 5
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 5
`
`
`
`Serial No. 13/536,525
`
`WSGR Reference No. 34550- 718.305
`
`REMARKS
`
`By the foregoing amendment, claims 1 and 13 are amended to recite the neurological
`
`conditions Alzheimer's disease, dementia, Parkinson's disease, and neuropathic pain from
`
`originally presented claims 3 and 15, respectively. Claims 3, 4, 7, 8, 11, 12, 15, 16, 19, 20 and
`
`23-30 are canceled without prejudice. The specification has been amended to add the table set
`
`forth in Figure 2 of United States Provisional Patent Application 60/701,857, from which this
`
`application claims priority and which is incorporated into the instant application by reference in
`
`the first paragraph of the instant specification.
`
`In addition, Applicants submit herewith a substitute drawing sheet to replace Figures 2B
`
`and 2C. Entry of the claim amendment and replacement drawing sheet, and favorable
`
`consideration of the instant application, are respectfully requested.
`
`CONCLUSION
`
`This Preliminary Amendment is submitted prior to the examination of this application on
`
`the merits. Since the present amendment does not introduce new matter,
`
`its entry prior to
`
`examination of the present application is respectfully requested.
`
`Should the Examiner have any questions, the Examiner is encouraged to contact the
`
`undersigned attorney at (858) 350—2332. If additional fees are believed to be required, the
`
`Commissioner is authorized to charge any additional fees to Deposit Account No. 23-2415
`
`(Attorney Docket No. 34550-718305).
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`Professional Corporation
`
`Date:
`
`ii Q! 20/1
`
`By: W
`
`
`
`Matthew V. Grum mg
`Reg. No. 44,427
`
`650 Page Mill Road
`Palo Alto, CA 94304
`Direct Dial: (858) 350-2332
`Customer No. 94584
`
`6
`
`IPR2015—00410
`Petitioners' Ex. 1027
`
`Page 6
`
`IPR2015-00410
`Petitioners' Ex. 1027
`Page 6
`
`
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