AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`34.
`
`(currently amended): A method of treating a bipolar disorder selected from the
`
`group consisting of bipolar disorder I, bipolar disorder II, bipolar disorder with or without
`
`psychotic features, mania, acute mania, bipolar depression and miJrnd episodes thereof in a
`
`patient partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt thereof
`
`monotherapy comprising separate administration of a first amount of at least one compound
`
`selected from the group consisting of aripiprazole, or a metabolite of aripiprazole selected from
`
`the group consisting of dehydroaripiprazole, 2,3 dichloro 4 [ 4 [4 (2 mm 1,2,3,4
`
`tetrahydroquinolin 7 ylmcy) butyl] piperazin 1 yl) phenyl sulfate (DM 1458), 7 [ 4 [4 (2,3
`
`dichloro 4 hydrmcyphenyl) 1 piperazinyl]butmcy) 3,4 dihydro 2 (lH) quinolinone (DM 1451),
`
`7 [ 4 [4 (2,3 dichlorophenyl) 1 piperazinyl]butmcy) 3,4 dihydro 4 hydrmcy 2 (lH) quinolinone
`
`(DM 1452), 1~ (2,3 dichloro 4 [ 4 [4 (2 mm 1,2,3,4 tetrahydroquinolin 7 ylmcy) butyl]
`
`piperazin 1 yl) phenoxy) D glucopyaranuronic acid (DM 1454) and 1 (2,3
`
`dichlorophenyl)piperazine (DCPP) and a second amount of at least one mood stabilizer selected
`
`from the group consisting of lithium andor a salt thereof, wherein the amount of lithium is about
`
`0.01 to about 500 parts by weight and the amount of aripiprazole is about 1 part by weight
`
`administration is effective to treat the mood disorder in the patient.
`
`35. - 36.
`
`(cancelled)
`
`37.
`
`(previously presented): The method of claim 35, wherein aripiprazole is
`
`anhydrous aripiprazole crystals B.
`
`3
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`1201 of 1328
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`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`38. - 40.
`
`(cancelled)
`
`41.
`(currently amended): The method of claim 33, wherein the bipolar disorder is
`bipolar disorder r.
`
`42.
`
`(currently amended): The method of claim 33, wherein the bipolar disorder is
`
`mania with bipolar disorder I.
`
`43.
`
`(currently amended): The method of claim 34, wherein the bipolar disorder is
`
`bipolar disorder II.
`
`44.
`
`(currently amended) The method of claim 34, wherein the bipolar disorder is
`
`mania with bipolar disorder II.
`
`45.
`
`(new): The method of claim 33, wherein the bipolar disorder is mixed episode
`
`associated with bipolar disorder I.
`
`46.
`
`(new): The method of claim 34, wherein the bipolar disorder is mixed episode
`
`associated with bipolar disorder I.
`
`4
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`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`REMARKS
`
`Claims 32, 34 and 41-44 are amended herein. New claims 45-46 are added. Support is
`
`found, for example, at page 34, line 26 to the last line and the original claims. No new matter is
`
`presented.
`
`Response to Claim Rejections - 35USC§112
`Claims 33-37 and 41-44 are rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112
`
`(1).
`
`second paragraph, as being indefinite.
`
`According to the Examiner, there is no antecedent basis for the recitation of "the mood
`
`disorder" in line 15 of claims 33 and 34.
`
`Claims 33 and 34 are amended herein, thereby obviating the rejection. Accordingly,
`
`reconsideration and withdrawal of the rejection are respectfully requested.
`
`(2).
`
`Claims 41, and 43 rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA),
`
`second paragraph, as being indefinite.
`
`According to the Examiner, claims 41 and 43 recite "wherein the bipolar disorder is
`
`bipolar disorder" which renders the claims vague and indefinite.
`
`Claims 41 and 43 are amended to recite wherein the bipolar disorder is bipolar disorder I
`
`and bipolar disorder II, respectively, thereby obviating the rejection. Accordingly,
`
`reconsideration and withdrawal of the rejection are respectfully requested.
`
`Response to Claim Rejections - 35USC§103
`
`(1).
`
`Claims 33-35, 41-44 are rejected under 35 U.S.C. §103(a) as being unpatentable
`
`over Kowatch et al. (CNS Spectrum, April 2003, Vol. 8, No. 4, pp 273-280, PT0-1449), in view
`
`of Clinical Trial Report, CN138-00ST (2002) (April 2003 published, PT0-892).
`
`5
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`1203 of 1328
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`Alkermes, Ex. 1076
`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`(2).
`
`Claim 37 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Kowatch
`
`et al. (CNS Spectrum, April 2003, Vol. 8, No. 4, pp. 273-280, PT0-1449), in view of Clinical
`
`Trial Report, CN138-00ST (2002) (April 2003 published, PT0-892) as applied to claims 33-35,
`
`41-44 above, and further in view of Takuji et al. (WO 03/026659, PTO 1449).
`
`(3).
`
`Claim 36 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Kowatch
`
`et al. (CNS Spectrum, April 2003, Vol. 8, No. 4, pp. 273-280, PT0-1449), in view of Clinical
`
`Trial report, CN138-00ST (2002) (April 2003 published, PT0-892) as applied to claims 33-35,
`
`41-44 above, in view of Jordan et al. (US 2002/0173513, PT0-1449).
`
`Kowatch et al. is relied on essentially for the reasons of record. The Examiner recognizes
`
`that Kowatch et al. do not explicitly teach a method of treating bipolar disorder, mania
`
`employing aripiprazole, and Lithium. The Examiner points out that Kowatch teaches that
`
`atypical antipsychotics are efficient in treatment of manic phase of bipolar disorder at page 277,
`
`right column, lines 9-12.
`
`To remedy the deficiency of Kowatch et al., the Examiner relies on the Clinical Trial
`
`Report, CN138-00ST as teaching that aripiprazole is useful in treating acute mania episode. See
`
`April, 2003, Clinical Trial Report, CN138-00ST (2002).
`
`It is the Examiner's position that it would have been obvious to a person of ordinary skill
`
`in the art at the time of invention to treat a bipolar disorder, acute mania in a patient partially
`
`nonresponsive to lithium therapy by employing a combination of atypical antipsychotic agent,
`
`aripiprazole with lithium because Kowatch teaches that addition of an atypical antipsychotic to
`
`lithium gives better overall response in the method of treating bipolar disorder i.e., one can treat
`
`patients more effectively than monotherapy. The Examiner asserts that it is generally considered
`
`prima facie obvious to combine compounds each of which is taught by the prior art to be useful
`
`6
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`1204 of 1328
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`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`for the same purpose, in order to form a composition which is used for the very same purpose
`
`i.e., for treating bipolar disorder, mania. The idea for combining them flows logically from their
`
`having been used individually in the prior art. As shown by recited teachings of Kowatch et al.
`
`and Clinical Trial Report, the instant claims contain two compounds aripiprazole, and lithium
`
`used for treating bipolar disorder, mania, manic phase of bipolar disorder. Thus, the Examiner
`
`considers that it would have been obvious to administer aripiprazole and lithium with a
`
`reasonable expectation of success of treating bipolar disorder in a patient who is partially
`
`nonresponsive to monotherapy to treat bipolar disorder, mania, manic phase of bipolar disorder.
`
`The Examiner did not find the arguments presented in the Amendment and evidence filed
`
`July 1, 2011 to be persuasive. With respect to the Declaration of Dr. Tsuyoshi Hirose, the
`
`Examiner provides the following comments.
`
`1)
`
`First, in Table 1, the Locomotor Counts for (Vehicle 1 + lithium chloride +
`
`methamphetamine) are (12666.3±1175.9), (See row 5, in Table), whereas the Locomotor Counts
`
`for the same combination is (Vehicle 1 + lithium chloride + methamphetamine) are
`
`(15142.0±11400.6), (See row 9, in Table). The Examiner asserts that it is not clear how can the
`
`same amount of lithium chloride give different Locomotor Counts. Further, the Examiner
`
`questions if the Locomotor Counts for (Vehicle 1 + lithium chloride + methamphetamine)
`
`(15142.0±11400.6) (See row 9, in Table) is supposed to be (15142.0±1140.6) i.e., ±1140.6 or
`
`±11400.6?
`
`2)
`
`Second, in Table 1, for the Olanzapine, lithium chloride group, Locomotor Counts
`
`for (Vehicle 1 +lithium chloride+ methamphetamine) are (15142.0±11400.6), (See row 9, in
`
`Table) which is even higher than the Locomotor Counts for (Vehicle 1 + Vehicle 2 +
`
`methamphetamine) which (14368.0±2278.4) i.e., lithium chloride has negative effect, which
`
`7
`
`1205 of 1328
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`Alkermes, Ex. 1076
`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`contradicts that Li chloride is known to treat mania according to prior art. Further, the Examiner
`
`asks if Locomotor Counts for (Vehicle 1 + lithium chloride + methamphetamine)
`
`(15142.0±11400.6) is supposed to be (15142.0±1140.6) i.e., ±1140.6 or ±11400.6?
`
`3)
`
`The Examiner did not consider the data in Table 1 to be persuasive with respect to
`
`synergistic effect for the combination of aripiprazole and lithium chloride. According to the
`
`Examiner, for example, from Table 1, data, (vehicle 1+vehicle2+methamphetamine) can have
`
`Locomotor Counts of 16713.8 (17552.3-838.5), (vehicle 1 +lithium chloride+methamphetamine)
`
`can have Locomotor Counts of 13988.5 (15111.1-1122.6), and (aripiprazole +lithium
`
`chloride+methamphetamine) can have Locomotor Counts of 13842.2(12666.3+1175.9). From
`
`this one can conclude lithium chloride alone has Locomotor counts which is very close to the
`
`combination of (lithium chloride and aripiprazole ), and is just an additive effect of the
`
`combination (which is expected) and not a synergistic effect.
`
`The Examiner further asserts that Kowatch et al. teaches that the addition of an atypical
`
`antipsychotic to a mood stabilizer may decrease bipolar disorder symptoms and improve overall
`
`response rates, and the overall response rate is significantly higher (i.e., synergistic) in the
`
`combination group, and also teaches that the combination is more effective than mood stabilizer
`
`alone in treating acute mania i.e., instead of using Lithium alone.
`
`4) According to the Examiner, Applicant's remarks "that the combination of aripiprazole
`
`and lithium, having the synergistic effect, is superior to the combination disclosed in Kowatch et
`
`al., olanzapine and lithium, in terms of the locomotion suppressing effect (suppressing effect on
`
`manic conditions of bipolar disorder" is not persuasive because as discussed above, allegedly the
`
`data for olanzapine, lithium chloride group is not clear.
`
`8
`
`1206 of 1328
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`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`The Examiner further relies on Takuji et al and Jordan et al as in the previous Office
`
`Action.
`
`Applicants traverse the rejection for the reasons of record, which are incorporated herein
`
`by reference and further in view of the following.
`
`Applicants submit that the Examiner's comments numbered 1) to 4) above on pages 8-11
`
`of the Office Action are erroneous as follows.
`
`First, the Examiner has made an error with respect to paragraph 1) above in stating that
`
`the Locomotor Counts for (Vehicle 1 + lithium chloride + methamphetamine) are
`
`(12666.3±1175.9), (See row 5, in Table). The vehicle counts referred to by the Examiner are
`
`actually for aripiprazole +lithium chloride+ methamphetamine in row 5 of Table 1 in the
`
`Declaration.
`
`Further, Applicants submit that the Locomotor Counts for (Vehicle 1 + lithium chloride +
`
`methamphetamine) (15142.0±11400.6) (See row 9, in Table) is supposed to be
`
`(15142.0±1140.6). A Supplemental Declaration can be submitted to correct the typographical
`
`error if necessary.
`
`Regarding paragraph 2) above, the Examiner remarked regarding the locomotor counts of
`
`15142.0 and 14368.0 that "lithium chloride has negative effect, which contradicts that Li
`
`chloride is known to treat mania according to prior art".
`
`Applicants disagree. Applicants consider that the Examiner noticed that lithium chloride
`
`did not have a positive effect. The reason therefor is that the dose taken in the test was such that
`
`lithium chloride when used alone should not give the ordinary positive effect.
`
`Regarding paragraphs 2), 3) and 4) above, in general, two test paradigms for investigating
`
`a synergistic effect of two drugs, which are:
`
`9
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`1207 of 1328
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`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`(i) Investigating whether the drugs co-used at a dose where each of said drugs renders
`
`little (medium) response in the objected test regime when used alone would enhance the objected
`
`response to an unpredictable degree; or
`
`(ii) Investigating whether the drugs co-used at a dose where each of said drugs renders no
`
`effect on the parameter for response in the objected test regime when used alone would generate
`
`the objected response.
`
`In the present test using aripiprazole and lithium chloride, Applicants have established,
`
`employing the doses which fail to exert the effect in a single-use, i.e., the test paradigm (ii)
`
`recited above, that the desired effect is obtained only if both of the pharmacological activity of
`
`each drug co-exists. It is hence evident that the co-existence of the pharmacological action of
`
`each drug is indispensable for an effect to be exerted on bipolar disorder and mania: These drugs,
`
`in other words, clearly have a synergistic effect.
`
`As is clearly indicated from the results in the previously submitted Declaration, the
`
`combination of aripiprazole and lithium, having the synergistic effect, is superior to the
`
`combination disclosed in Kowatch et al, olanzapine and lithium, in terms of the locomotion
`
`suppressing effect (suppressing effect on manic conditions of bipolar disorder). Said remarkable
`
`synergistic effect in the animal model of bipolar disorder is unpredictable from the disclosure of
`
`the prior art references, which fail to teach or suggest a synergistic effect achieved by an atypical
`
`antipsychotic and mood stabilizer. Thus, for this additional reason, the claimed invention is non-
`
`obvious over the cited prior art references.
`
`In view of the above, the present invention could not have been expected from the
`
`disclosure in the cited references. Thus, the claimed invention is not rendered obvious by the
`
`cited references, taken alone or in combination.
`
`10
`
`1208 of 1328
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`Alkermes, Ex. 1076
`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`Accordingly, Applicants respectfully request withdrawal of the rejections under 35
`
`U.S.C. § 103.
`
`Response to Obviousness- Type Double Patenting Rejections
`
`(1).
`
`Claims 33-37, and 41-44 are provisionally rejected on the ground of non-statutory
`
`obviousness-type double patenting as being unpatentable over claims 54-56, 58-62 of copending
`
`Application No. 10/540,577, in view of Kowatch et al. (CNS Spectrum, April 2003, Vol.8, No.4,
`
`pp 273-280, PT0-1449).
`
`Applicants defer responding to the provisional obviousness-type double patenting
`
`rejection.
`
`(2).
`
`Claims 33-37, and 41-44 are provisionally rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 53-68 of copending
`
`Application No. 14/252,907, in view of Kowatch et al. (CNS Spectrum, April 2003, Vol. 8, No.
`
`4, pp 273-280, PT0-1449).
`
`Applicants defer responding to the provisional obviousness-type double patenting
`
`rejection.
`
`(3).
`
`Claims 33-37, and 41-44 are provisionally rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-3, 5-7 of copending
`
`Application No. 12/202208, in view of Kowatch et al. (CNS Spectrum, April 2003, Vol.8, No.4,
`
`pp 273-280, PT0-1449).
`
`Applicants defer responding to the provisional obviousness-type double patenting
`
`rejection.
`
`11
`
`1209 of 1328
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`Alkermes, Ex. 1076
`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`(4).
`
`Claims 33-37, and 41-44 are rejected on the ground of nonstatutory obviousness-
`
`type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 7,053,092, in
`
`view of in view of Kowatch et al. (CNS Spectrum, April 2003, Vol.8, No.4, pp 273-280, PTO-
`
`1449).
`
`Applicants traverse the rejection.
`
`US '092 describes a treatment method by carbostyril derivatives including aripiprazole in
`
`a patient suffering from a central nervous system disorder associated to 5-HT1A receptor subtype.
`
`USP '092 however fails to give any disclosure or even suggestion on the present
`
`inventive concomitant use of aripiprazole or a metabolite thereof and a mood stabilizer.
`
`Kowatch et al fails to remedy the deficiencies of USP '092 for the reasons of record,
`
`which are incorporated herein by reference, and additionally in view of the following.
`
`As is clearly indicated from the results in the previously filed Declaration, the
`
`combination of aripiprazole and lithium, having the synergistic effect, is superior to the
`
`combination disclosed in Kowatch et al, olanzapine and lithium, in terms of the locomotion
`
`suppressing effect (suppressing effect on manic conditions of bipolar disorder). Said remarkable
`
`synergistic effect in the animal model of bipolar disorder is unpredictable from the disclosure of
`
`the prior art references, which fail to teach or suggest a synergistic effect achieved by an atypical
`
`antipsychotic and mood stabilizer. Thus, for this additional reason, the claimed invention is non-
`
`obvious over the cited prior art references.
`
`In view of the above, the present invention could not have been expected from the
`
`disclosure in the cited references. Thus, the claimed invention is not rendered obvious by the
`
`cited references, taken alone or in combination.
`
`12
`
`1210 of 1328
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`Alkermes, Ex. 1076
`
`

`
`AMENDMENT UNDER 37 C.F.R. § 1.111
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`Accordingly, Applicants respectfully request withdrawal of the obviousness-type double
`
`patenting rejection.
`
`Conclusion
`
`In view of the above, reconsideration and allowance of this application are now believed
`
`to be in order, and such actions are hereby solicited. If any points remain in issue which the
`
`Examiner feels may be best resolved through a personal or telephone interview, the Examiner is
`
`kindly requested to contact the undersigned at the telephone number listed below.
`
`The USPTO is directed and authorized to charge all required fees, except for the Issue
`
`Fee and the Publication Fee, to Deposit Account No. 19-4880. Please also credit any
`
`overpayments to said Deposit Account.
`
`Respectfully submitted,
`
`/Jennifer M. Hayes/
`Jennifer M. Hayes
`Registration No. 40,641
`
`SUGHRUE MION, PLLC
`Telephone: 202.293.7060
`Facsimile: 202.293.7860
`
`WASHINGTON OFFICE
`
`23373
`
`CUSTOMER NUMBER
`
`Date: August 20, 2014
`
`13
`
`1211 of 1328
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`Alkermes, Ex. 1076
`
`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`19909981
`
`10556600
`
`International Application Number:
`
`Confirmation Number:
`
`3822
`
`Title of Invention:
`
`Carbostyril derivatives and mood stabilizers for treating mood disorders
`
`First Named Inventor/Applicant Name:
`
`Tetsuro Kikuchi
`
`Customer Number:
`
`23373
`
`Filer:
`
`Jennifer Hayes/Amber A. Thompson
`
`Filer Authorized By:
`
`Jennifer Hayes
`
`Attorney Docket Number:
`
`Q81665
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`20-AUG-2014
`
`02-AUG-2006
`
`08:21 :48
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
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`Document
`Number
`
`Document Description
`
`File Name
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`67690
`
`1
`
`Q81665Amendmentl 11.pdf
`
`yes
`
`13
`
`7d 1e13ecde20ab9e6c7d7b625508259d1 2
`2b8d6f
`
`1212 of 1328
`
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`
`

`
`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Amendment/Req. Reconsideration-After Non-Final Reject
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
`
`1
`
`2
`
`5
`
`1
`
`4
`
`13
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`67690
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
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`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`1213 of 1328
`
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`
`

`
`PTO/SB/06 (09-11)
`Approved for use through 1/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`PATENT APPLICATION FEE DETERMINATION RECORD
`Application or Docket Number
`Filing Date
`Substitute for Form PT0-875
`10/556,600
`
`08/02/2006 D To be Mailed
`
`ENTITY:
`
`[8J LARGE D SMALL D MICRO
`
`APPLICATION AS FILED - PART I
`
`(Column 1)
`
`(Column 2)
`
`NUMBER FILED
`
`NUMBER EXTRA
`
`RATE($)
`
`FEE($)
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`minus 20 =
`
`minus 3 =
`
`*
`
`*
`
`N/A
`
`N/A
`
`N/A
`
`x $
`
`x $
`
`=
`
`=
`
`FOR
`D BASIC FEE
`(37 CFR 1.16(a), (b), or (c))
`D SEARCH FEE
`(37 CFR 1.16(k), (i), or (m))
`D EXAMINATION FEE
`(37 CFR 1.16(0), (p), or (q))
`TOTAL CLAIMS
`(37 CFR 1.16(i))
`INDEPENDENT CLAIMS
`(37 CFR 1.16(h))
`
`0APPLICATION SIZE FEE
`(37 CFR 1.16(s))
`
`If the specification and drawings exceed 100 sheets
`of paper, the application size fee due is $31 O ($155
`for small entity) for each additional 50 sheets or
`fraction thereof. See 35 U.S.C. 41 (a)(1 )(G) and 37
`CFR 1.16(s).
`D MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR 1.16(j))
`
`* If the difference in column 1 is less than zero, enter "O" in column 2.
`
`TOTAL
`
`APPLICATION AS AMENDED - PART II
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`08/20/2014
`
`Total (37 CFR
`1.16(j))
`Independent
`(37 CFR 1 .16(h))
`
`<(
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`* 9
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`** 37
`
`Minus
`
`* 2
`
`Minus
`
`***6
`
`PRESENT EXTRA
`
`= 0
`
`= 0
`
`f--
`z
`w
`:;:;;:
`0
`z
`w
`:;:;;: D Application Size Fee (37 CFR 1.16(s))
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`RATE($)
`
`ADDITIONAL FEE($)
`
`x $80 =
`
`x $420 =
`
`TOTAL ADD'L FEE
`
`0
`
`0
`
`0
`
`PRESENT EXTRA
`
`RATE($)
`
`ADDITIONAL FEE($)
`
`x $
`
`x $
`
`=
`
`=
`
`TOTAL ADD'L FEE
`
`LIE
`/GOIGA DUCKETT/
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`Total (37 CFR
`1.16(i))
`Independent
`(37 CFR 1 .16(h))
`
`*
`
`*
`
`Minus
`
`**
`
`Minus
`
`***
`
`=
`
`=
`
`f--
`z
`w
`:;:;;:
`0
`z D Application Size Fee (37 CFR 1.16(s))
`w
`:;:;;: D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
`<(
`
`* If the entry in column 1 is less than the entry in column 2, write "O" in column 3.
`**If the "Highest Number Previously Paid For" IN THIS SPACE is less than 20, enter "20".
`
`*** If the "Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter "3".
`
`The "Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`
`This collection of 1nformat1on 1s required by 37 CFR 1.16. The 1nformat1on 1s required to obtain or retain a benefit by the public which 1s to file (and by the US PTO to
`process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1 .14. This collection is estimated to take 12 minutes to complete, including gathering,
`preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S.
`Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, ca/11-800-PT0-9199 and select option 2.
`
`1214 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION
`
`In re application of
`
`Tetsuro KIKUCHI, et al.
`
`Appln. No.: 10/556,600
`
`Confirmation No.: 3822
`
`Filed: August 2, 2006
`
`Docket No: Q81665
`
`Group Art Unit: 1627
`
`Examiner: KANTAMNENI, SHOBHA
`
`For: CARBOSTYRILDERIVATIVES AND MOOD STABILIZERS FOR TREATING
`MOOD DISORDERS
`
`SUPPLEMENTAL AMENDMENT UNDER 37 C.F.R. § 1.111
`
`MAIL STOP AMENDMENT
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`This Supplemental Amendment is being filed to correct errors in the claims of the
`
`Amendment previously filed on August 20, 2014.
`
`In response to the Office Action dated May 20, 2014, please amend the above-identified
`
`application as follows on the accompanying pages.
`
`TABLE OF CONTENTS
`
`AMENDMENTS TO THE CLAIMS .............................................................................................. 2
`
`REMARKS ...................................................................................................................................... 4
`
`1215 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`SUPPLEMENTAL AMENDMENT UNDER 37 C.F.R. § 1.111 Attorney Docket No.: Q81665
`Appln. No.: 10/556,600
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`LISTING OF CLAIMS:
`
`1-32.
`
`(canceled).
`
`33.
`
`(currently amended): A method of treating a bipolar disorder in a patient
`
`partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt thereof
`
`monotherapy comprising administration of an amount of a composition comprising aripiprazole,
`
`and[[/]] lithium or a salt thereof in a pharmaceutically acceptable carrier, wherein the amount of
`
`lithium is about 0.01 to about 500 parts by weight and the amount of aripiprazole is about 1 part
`
`by weight.
`
`34.
`
`(currently amended): A method of treating a bipolar disorder in a patient
`
`partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt thereof
`
`monotherapy comprising separate administration of a first amount of aripiprazole, and a second
`
`amount of lithium or a salt thereof, wherein the amount of lithium is about 0.01 to about 500
`
`parts by weight and the amount of aripiprazole is about 1 part by weight.
`
`35. - 36.
`
`(cancelled)
`
`2
`
`1216 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`SUPPLEMENTAL AMENDMENT UNDER 37 C.F.R. § 1.111 Attorney Docket No.: Q81665
`Appln. No.: 10/556,600
`
`37.
`
`(previously presented): The method of claim 35, wherein aripiprazole is
`
`anhydrous aripiprazole crystals B.
`
`38. - 40.
`
`(cancelled)
`
`41.
`
`(previously presented): The method of claim 33, wherein the bipolar disorder is
`
`bipolar disorder I.
`
`42.
`
`(previously presented): The method of claim 33, wherein the bipolar disorder is
`
`mania with bipolar disorder I.
`
`43.
`
`(previously presented): The method of claim 34, wherein the bipolar disorder is
`
`bipolar disorder II.
`
`44.
`
`(previously presented): The method of claim 34, wherein the bipolar disorder is
`
`mania with bipolar disorder II.
`
`45.
`
`(previously presented): The method of claim 33, wherein the bipolar disorder is
`
`mixed episode associated with bipolar disorder I.
`
`46.
`
`(previously presented): The method of claim 34, wherein the bipolar disorder is
`
`mixed episode associated with bipolar disorder I.
`
`3
`
`1217 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`SUPPLEMENTAL AMENDMENT UNDER 37 C.F.R. § 1.111 Attorney Docket No.: Q81665
`Appln. No.: 10/556,600
`
`REMARKS
`
`Further to the Amendment filed on August 20, 2014, this Supplemental Amendment is
`
`being filed to correct errors in the claims. Specifically, in claims 33 and 34 "aripiprazole" is
`
`reinserted to correct an error in deletion in the previous amendment. Additionally, in claim 33,
`
`"lithium" is reinstates in the 3rd line from the bottom and the erroneous "/" is deleted.
`
`No new matter is presented.
`
`The Examiner is requested to consider the present claims in conjunction with the remarks
`
`in the Amendment filed on August 20, 2014, which are incorporated by reference herein.
`
`Conclusion
`
`In view of the above, reconsideration and allowance of this application are now believed
`
`to be in order, and such actions are hereby solicited. If any points remain in issue which the
`
`Examiner feels may be best resolved through a personal or telephone interview, the Examiner is
`
`kindly requested to contact the undersigned at the telephone number listed below.
`
`The USPTO is directed and authorized to charge all required fees, except for the Issue
`
`Fee and the Publication Fee, to Deposit Account No. 19-4880. Please also credit any
`
`overpayments to said Deposit Account.
`
`SUGHRUE MION, PLLC
`Telephone: 202.293.7060
`Facsimile: 202.293.7860
`
`WASHINGTON OFFICE
`
`23373
`
`CUSTOMER NUMBER
`
`Date: September 19, 2014
`
`Respectfully submitted,
`
`/Jennifer M. Hayes/
`Jennifer M. Hayes
`Registration No. 40,641
`
`4
`
`1218 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION
`
`In re application of
`
`Tetsuro KIKUCHI, et al.
`
`Appln. No.: 10/556,600
`
`Confirmation No.: 3822
`
`Filed: August 2, 2006
`
`Docket No: Q81665
`
`Group Art Unit: 1627
`
`Examiner: KANTAMNENI, SHOBHA
`
`For: CARBOSTYRIL DERIVATIVES AND MOOD STABILIZERS FOR TREATING
`MOOD DISORDERS
`
`STATEMENT OF SUBSTANCE OF INTERVIEW
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Please review and enter the following remarks summarizing the interview conducted on
`
`September 19, 2014:
`
`REMARKS
`
`An Examiner's Interview Summary Record (PT0-413) has not yet been mailed.
`
`During the interview, the following was discussed:
`
`1.
`
`2.
`
`3.
`
`4.
`
`Brief description of exhibits or demonstration: None.
`
`Identification of claims discussed: Claims 33 and 34.
`
`Identification of art discussed: None.
`
`Identification of principal proposed amendments: See Supplemental Amendment
`
`submitted herewith.
`
`5.
`
`Brief Identification of principal arguments: None.
`
`1219 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`STATEMENT OF SUBSTANCE OF INTERVIEW
`Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`6.
`
`Indication of other pertinent matters discussed: Applicants' representative
`
`indicated that a Supplemental Amendment was being submitted to correct errors in the claims
`
`previously filed on August 20, 2014.
`
`7.
`
`Results of Interview: None.
`
`It is respectfully submitted that the instant STATEMENT OF SUBSTANCE OF
`
`INTERVIEW complies with the requirements of 37 C.F.R. §§1.2 and 1.133 and MPEP §713.04.
`
`It is believed that no petition or fee is required. However, if the USPTO deems
`
`otherwise, Applicant hereby petitions for any extension of time which may be required to
`
`maintain the pendency of this case, and any required fee, except for the Issue Fee, for such
`
`extension is to be charged to Deposit Account No. 19-4880.
`
`Respectfully submitted,
`
`/Jennifer M. Hayes/
`Jennifer M. Hayes
`Registration No. 40,641
`
`SUGHRUE MION, PLLC
`Telephone: 202.293.7060
`Facsimile: 202.293.7860
`
`WASHINGTON OFFICE
`
`23373
`
`CUSTOMER NUMBER
`
`Date: September 19, 2014
`
`1220 of 1328
`
`Alkermes, Ex. 1076