Amendments to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`application:
`
`Listing of Claims:
`
`Claim 1. (Original): A method for treating endocrine tumors, comprising administering to a
`subject in need thereof a therapeutically effective amount of an mTOR inhibitor.
`
`Claim 2. (Original) A method for inhibiting growth of endocrine tumors, comprising
`administering to a subject in need thereof a therapeutical effective amount of an mTOR
`
`inhibitor.
`
`Claim 3. (Original) A method for inhibiting or controlling endocrine tumors, comprising
`administering to a subject in need thereof a therapeutically effective amount of an mTOR
`
`inhibitor.
`
`Claim 4. (Original) A method for inducing endocrine tumor regression, comprising
`
`administering to a subject in need thereof a therapeutically effective amount of an mTOR
`inhibitor.
`
`Claim 5. (Original) A method for treating endocrine tumor invasiveness or symptoms
`
`associated with such tumor growth, comprising administering to a subject in need thereof a
`therapeutically effective amount of an mTOR inhibitor.
`
`Claim 6. (Original) A method for preventing metastatic spread of endocrine tumors or for
`preventing or inhibiting growth of micrometastasis, comprising administering to a subject in
`need thereof a therapeutically effective amount of an mTOR inhibitor.
`
`Claim 7. (Original) A method for the treatment of a disorder associated with endocrine
`tumors, comprising administering to a subject in need thereof a therapeutically effective
`amount of an mTOR inhibitor.
`
`Claim 8. (Currently Amended) A method according to any ono of Glaims 1 to 7claim 1,
`comprising administering in addition a therapeutically effective amount of at least one
`second drug substance.
`
`- 4 -
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 001
`
`

`
`Claim 9. (Original) A method according to claim 8, wherein a second drug substance is
`
`somastatin or a somastatin analogue.
`
`Claim 10. (Currently Amended) The use of an mTOR inhibitor for the manufacture of a
`
`medicament for use in a method according to any one of elairns 1 to Qclaim 1.
`
`Claim 11. (Currently Amended) A method according to any one of claims 1 to Qclaim 1, GF
`tho use aooording to olairn 1 O, wherein an mTOR inhibitor is selected from rapamycin or a
`rapamycin derivative.
`
`Claim 12. (Original) A method according to claim 10, wherein an mTOR inihibitor is 40-0-(2-
`hydroxyethyl)-rapamycin.
`
`- 5
`
`-
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 002
`
`

`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/094,173
`
`05/19/2008
`
`Peter Wayne Marks
`
`34678-US-PCT
`
`9572
`
`7590
`
`11/30/2010
`
`1095
`NOVARTIS
`CORPORATEINIBLLECTUALPROPERTY
`ONE HEALTH PLAZA 101/2
`EAST HANOVER, NJ 07936-1080
`
`EXAMINER
`
`JEAN-LOUIS, SAMIRA JM
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`MAILDATE
`
`DELIVERY MODE
`
`11/30/2010
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 003
`
`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/094,173
`
`Examiner
`
`MARKS ET AL.
`
`Art Unit
`
`SAMIRA JEAN-LOUIS
`1627
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire 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 to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`2b)~ This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)~ Claim(s) 1-12 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)~ Claim(s) 1-12 are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O 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 of 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 received.
`
`Attachment(s)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20101126
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 004
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 2
`
`DETAILED ACTION
`
`Election/Restrictions
`
`Claim 10 provides for the use of an mTOR inhibitor for the manufacture of a
`
`medicament for use in a method according to claim 1, but, since the claim does not set
`
`forth any steps involved in the method/process, it is unclear what method/process
`
`applicant is intending to claim. Given that the claim may have dual interpretation either
`
`as a method of preparation or as a method of treatment, the claim is being interpreted
`
`herein as optionally both a method of making and a method of treating.
`
`Restriction is required under 35 U.S.C. 121 and 372.
`
`This application contains the following inventions or groups of inventions, which
`
`are not so linked as to form a single general inventive concept under PCT Rule 13.1.
`
`In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to
`
`elect a single invention to which the claims must be restricted.
`
`I.
`
`Group I, claims 1-3 and 8-12 are drawn to a method for treating endocrine
`
`tumors, comprising administering to a subject in need thereof a therapeutically effective
`
`amount of an mTOR inhibitor.
`
`II.
`
`Group II, claim 4 is drawn to a method for inducing endocrine tumor
`
`regression, comprising administering to a subject in need thereof a therapeutically
`
`effective amount of an mTOR inhibitor.
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 005
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 3
`
`Ill.
`
`Group Ill, claims 5-6 are drawn to a method for treating endocrine tumor
`
`invasiveness or symptoms associated with such tumor growth, comprising administering
`
`to a subject in need thereof a therapeutically effective amount of an mTOR inhibitor.
`
`IV.
`
`Group IV, claim 7 is drawn to a method for the treatment of a disorder
`
`associated with endocrine tumors, comprising administering to a subject in need thereof
`
`a therapeutically effective amount of an mTOR inhibitor.
`
`V.
`
`Group V, claim 10 is drawn to the use of an mTOR inhibitor for the
`
`manufacture of a medicament for use in a method according to claim 1.
`
`The inventions listed as Groups I, II, Ill, IV, and V do not relate to a single
`
`general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they
`
`lack the same or corresponding special technical features.
`
`An international application should relate to only one invention or, if there is more
`
`than one invention, the inclusion of those inventions in one international application is
`
`only permitted if all inventions are so linked as to form a single general inventive
`
`concept (PCT Rule 13.1 ). With respect to a group of inventions claimed in an
`
`international application, unity of invention exists only when there is a technical
`
`relationship among the claimed inventions involving one or more of the same or
`
`corresponding special technical features.
`
`The expression "special technical features" is defined in PCT Rule 13.2 as
`
`meaning those technical features that define a contribution which each of the
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 006
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 4
`
`inventions, considered as a whole, makes over the prior art. The determination is made
`
`on the contents of the claims as interpreted in light of the description and drawings.
`
`Whether or not any specific technical feature makes a "contribution" over the prior art,
`
`and therefore constitutes a "special technical feature", should be considered with
`
`respect to novelty and inventive step.
`
`In this instant application, the common technical feature in all groups is the
`
`mTOR inhibitor. This compound cannot be said to be a special technical feature under
`
`PCT Rule 13.2 because it is shown in the prior art.
`
`In this case, Gibbons et al. (U.S. 2002/0183239 A1, cited by applicant and filed
`
`on an IDS 1449) teaches the use of a combination of mTOR and an antimetabolite
`
`neoplastic agent in the treatment of neoplasms, i.e. tumors (see abstract). Specifically,
`
`Gibbons et al. teach the use of compounds such as rapamycin for the aforementioned
`
`treatments. Consequently, Gibbons et al. render obvious applicant's invention.
`
`As a result, no special technical features exist among the different groups
`
`because the inventions in Groups I, II, Ill, IV, and V fail to make a contribution over the
`
`prior art with respect to novelty and inventive step. In conclusion, there is a lack of unity
`
`of inventions, and therefore restriction for examination purposes as indicated is proper.
`
`Species Election
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 007
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 5
`
`This application contains claims directed to more than one species of the generic
`
`invention. These species (i.e. mTOR inhibitors) possess divergent structures which
`
`would cause them to possess contrasting physical and chemical properties (see
`
`rapamycin vs. Temsirolimus). Thus, these species are deemed to lack unity of
`
`invention because they are not so linked as to form a single general inventive concept
`
`under PCT Rule 13.1.
`
`The species listed below do not relate to a single general inventive concept
`
`under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same special
`
`technical feature among the different species.
`
`The species are as follows:
`
`For Group I, II, Ill, IV, & V:
`
`1) Applicant is required to elect a particular mTOR inhibitor to be utilized in the
`
`aforementioned inventions. Alternatively, applicant may elect a particular mTOR
`
`inhibitor listed in claims 11 or 12.
`
`Applicant is required, in reply to this action, to elect a single species to which the
`
`claims shall be restricted if no generic claim is finally held to be allowable. The reply
`
`must also identify the claims readable on the elected species, including any claims
`
`subsequently added. An argument that a claim is allowable or that all claims are
`
`generic is considered non-responsive unless accompanied by an election.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration
`
`of claims to additional species which are written in dependent form or otherwise include
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 008
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 6
`
`all the limitations of an allowed generic claim as provided by 37 CFR 1.141. If claims
`
`are added after the election, applicant must indicate which are readable upon the
`
`elected species. MPEP § 809.02(a).
`
`The following claims 1-12 are generic.
`
`Applicant is also reminded that upon the cancellation of claims to a non-elected
`
`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
`
`or more of the currently named inventors is no longer an inventor of at least one claim
`
`remaining in the application. Any amendment of inventorship must be accompanied by
`
`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
`
`No telephone call was made due to the complexity of the election/restriction.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Samira Jean-Louis whose telephone number is 571-
`
`270-3503. The examiner can normally be reached on 7:30-5 PM EST M-Th.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 009
`
`

`
`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 7
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Samira Jean-Louis/
`
`Examiner, Art Unit 1627
`
`11/26/2010
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 010
`
`

`
`CASE PAT034678-US-PCT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`IN RE PCT NATIONAL STAGE APPLICATION OF
`
`Art Unit: 1627
`
`Marks, Peter Wayne et al.
`
`Examiner: Jean-Louis, Samira J
`
`INTERNATIONAL APPLICATION NO: PCT/EP06/068656
`
`FILED: November 20, 2006
`
`U.S. APPLICATION NO: 12/094173
`
`35 USC §371 DATE: May 19, 2008
`
`FOR: Neuroendocrine Tumor Treatment
`
`MS: Amendment
`Commissioner for Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE TO RESTRICTION REQUIREMENT
`
`Sir:
`
`In response to the Restriction Requirement under 35 USC 121 and 372 mailed
`
`November 30, 2010, response due within one month on December 30, 2010 and a petition for a
`
`one month extension of time is included with this response, thus extending the response due
`
`date to January 30, 2011, kindly enter the following response.
`
`Amendments to the claims begin on page 2 of this paper.
`
`Remarks/Arguments begin on page 4 of this paper.
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 011
`
`

`
`Amendments to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application:
`
`Listing of Claims:
`
`Claim 1. (Original): A method for treating endocrine tumors, comprising administering to a
`
`subject in need thereof a therapeutically effective amount of an mTOR inhibitor.
`
`Claim 2. (Original) A method for inhibiting growth of endocrine tumors, comprising administering
`
`to a subject in need thereof a therapeutical effective amount of an mTOR inhibitor.
`
`Claim 3. (Original) A method for inhibiting or controlling endocrine tumors, comprising
`
`administering to a subject in need thereof a therapeutically effective amount of an mTOR
`
`inhibitor.
`
`Claim 4. (Withdrawn) A method for inducing endocrine tumor regression, comprising
`
`administering to a subject in need thereof a therapeutically effective amount of an mTOR
`
`inhibitor.
`
`Claim 5. (Withdrawn) A method for treating endocrine tumor invasiveness or symptoms
`
`associated with such tumor growth, comprising administering to a subject in need thereof a
`
`therapeutically effective amount of an mTOR inhibitor.
`
`Claim 6. (Withdrawn) A method for preventing metastatic spread of endocrine tumors or for
`
`preventing or inhibiting growth of micrometastasis, comprising administering to a subject in need
`
`thereof a therapeutically effective amount of an mTOR inhibitor.
`
`Claim 7. (Withdrawn) A method for the treatment of a disorder associated with endocrine
`
`tumors, comprising administering to a subject in need thereof a therapeutically effective amount
`
`of an mTOR inhibitor.
`
`Claim 8. (Previously presented) A method according to claim 1, comprising administering in
`
`addition a therapeutically effective amount of at least one second drug substance.
`
`Claim 9. (Original) A method according to claim 8, wherein a second drug substance is
`
`somastatin or a somastatin analogue.
`
`-2-
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 012
`
`

`
`Claim 10. (Previously presented) The use of an mTOR inhibitor for the manufacture of a
`
`medicament for use in a method according to claim 1.
`
`Claim 11. (Previously presented) A method according to claim 1, wherein an mTOR inhibitor is
`
`selected from rapamycin or a rapamycin derivative.
`
`Claim 12. (Currently amended) A method according to claim 10, wherein an mTOR inihibitor
`
`inhibitor is 40-0-(2-hydroxyethyl)-rapamycin.
`
`- 3 -
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 013
`
`

`
`REMARKS/ARGUMENTS
`
`The Examiner has requested that a restriction is required under 35 U.S.C. 121 and 372.
`
`Further, the Examiner requests that Applicant elect from the following:
`
`Group I, claims 1-3 and 8-12 are drawn to a method for treating endocrine tumors, comprising
`
`administering to a subject in need thereof a therapeutically effective amount of an mTOR
`
`inhibitor.
`
`Group II, claim 4 is drawn to a method for inducing endocrine tumor regression, comprising
`
`administering to a subject in need thereof a therapeutically affective amount of an mTOR
`
`inhibitor.
`
`Group Ill, claims 5-6 are drawn to a method for treating endocrine tumor invasiveness or
`
`symptoms associated with such tumor growth, comprising administering to a subject in need
`
`thereof a therapeutically effective amount of an mTOR inhibitor.
`
`Group IV, claim 7 is drawn to a method for the treatment of a disorder associated with endocrine
`
`tumors, comprising administering to a subject in need thereof a therapeutically effective amount
`
`of an mTOR inhibitor.
`
`Group V, claim 1 O is drawn to the use of an mTOR inhibitor for the manufacture of a
`
`medicament for use in a method according to claim 1.
`
`Without traverse, Applicants elect Group I. The Examiner also request that a particular mTOR
`
`inhibitor be elected. Applicants elect the mTOR inhibitor listed in claim 12.
`
`Claims 1-3 and 8-12 are readable on the elected species. Claims 4-7 and 10 have been
`
`withdrawn based on the election required by the Restriction Requirement. Applicants
`
`respectfully maintain their right to file a divisional application toward any non-elected inventions.
`
`Should the Examiner have any questions, please contact the undersigned attorney.
`
`Respectfully submitted,
`
`4~ Attorney for Applicants
`
`Reg. No. 47,666
`
`Novartis Pharmaceuticals Corp.
`Patents Pharma
`One Health Plaza, Building 104
`East Hanover, NJ 07936-1080
`(862) 778-2614
`Date: January 3, 2011
`
`- 4 -
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 014
`
`

`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/094,173
`
`05/19/2008
`
`Peter Wayne Marks
`
`34678-US-PCT
`
`9572
`
`7590
`
`02/16/2011
`
`1095
`NOVARTIS
`CORPORATEINIBLLECTUALPROPERTY
`ONE HEALTH PLAZA 101/2
`EAST HANOVER, NJ 07936-1080
`
`EXAMINER
`
`JEAN-LOUIS, SAMIRA JM
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`MAILDATE
`
`DELIVERY MODE
`
`02/16/2011
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Roxane Labs., Inc.
`Exhibit 1002
`Page 015
`
`

`
`Office Action Summary
`
`Application No.
`
`12/094, 173
`
`Examiner
`
`Applicant(s)
`
`MARKS ET AL.
`
`Art Unit
`
`SAMIRA JEAN-LOUIS
`1627
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire 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 to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1 )IZ! Responsive to communication(s) filed on 03 Januarv 2011.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)[8J Claim(s) 1-12 is/are pending in the application.
`4a) Of the above claim(s) 4-7 and 11 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1-3.8-10 and 12 is/are rejected.
`7)[8J Claim(s) fl. is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)[8J Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)IZ! All b)O Some * c)O None of:
`1.IZI 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 of 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 received.
`
`Attachment{s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 05119108. 12104109.
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08·06)
`
`Office Action Summary
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`Part of Paper No./Mail Date 20110213
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 016
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 2
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`DETAILED ACTION
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`Priority
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`Acknowledgment is made of applicant's claim for foreign priority. Thus, the
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`priority date of the instant invention is November 21 rst, 2005 (the date of Foreign
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`application 052 3658.3).
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`IDS
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`The information disclosure statements (IDS) submitted on 05/19/08 and 12/04/09
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`are acknowledged and have been entered. The submission is in compliance with the
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`provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have
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`been considered by the examiner.
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`Claim Rejections - 35 USC§ 101
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`35 U.S.C. 101 reads as follows:
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`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title.
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`Claims 10 and 12 are rejected under 35 U.S.C. 101 because the claimed
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`recitation of a use, without setting forth any steps involved in the process, results in an
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`improper definition of a process, i.e., results in a claim which is not a proper process
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`claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App.
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`1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C.
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 017
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 3
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`1966). Consequently, the subject matter claimed by claim 10 does not fall into a single
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`statutory class of invention, as it claims both a method of making and a method of
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`using, but rather encompasses or overlaps two different statutory classes of invention.
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`The language of 35 U.S.C. 101 prohibits overlap between two different statutory classes
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`in a single claim as it is drafted so as to set forth the statutory classes of invention in the
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`alternative only. See Ex parte Lyell, 17 USPQ2d 1551 (Bd. Pat. App. & inter.1990).
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter, which the applicant regards as his invention.
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`Claims 10 and 12 provide for the use of an mTOR inhibitor for the manufacture of
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`a medicament for use in a method according to claim 1, but, since the claims do not set
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`forth any steps involved in the method/process, it is unclear what method/process
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`applicant is intending to encompass. Such claim is indefinite as it merely recites a use
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`without any active, positive steps delimiting how this use is actually practiced.
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`Claims 10 and 12 are rejected under 35 U.S.C. 112, second paragraph, as being
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`indefinite for failing to particularly point out and distinctly claim the subject matter which
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`applicant regards as the invention.
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 018
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 4
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`Objections
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`Claim 9 is objected to because of the following informalities: Claim 9 recites the
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`terms "somastatin" and "somastatin analogue" as opposed to the term "somatostatin"
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`recited in the specification. Appropriate correction is required.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless -
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
`
`Claims 1-3 and 12 are rejected under 35 U.S.C. 102(b) as being anticipated
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`by O'Reilly et al. (Proceedings of the American Association for Cancer Research
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`Annual Meeting, 03/2002, Vol. 43, pg. 71, cited by applicant and filed on an IDS
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`1449) as evidenced by Merck Manuals (Merck Manuals, Pancreatic endocrine
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`tumors, 2009, pgs. 1-4).
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`O'Reilly et al. teach the use of RAD001 (i.e. 40-0-(2-hydroxyethyl)-rapamycin;
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`elected species; instant claim 12) as a bioavailable hydroxyethyl ether derivative of
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`rapamycin that has demonstrated in vitro anti-proliferative activity against a panel of
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 019
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 5
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`human tumors (see pg. 71, #359). Importantly, O'Reilly et al. teach that RAD001 was
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`found to be a potent inhibitor of tumor growth in 10 different cell lines and in vivo against
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`pancreatic tumors (see pg. 71, #359). Persistent tumor regressions were observed and
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`O'Reilly et al. suggest that RAD001 may not only be effective against tumor cells, it may
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`also affect angiogenesis (see pg. 71, #359).
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`Merck Manual was provided to demonstrate that pancreatic cancer is
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`characterized by endocrine tumors that tend to produce hormones that lead to aberrant
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`functions (see pg. 1 ).
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`Accordingly, the teachings of O'Reilly et al. anticipate claims 1-3 and 12.
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`Claims 1-3, 8-9, and 12 are rejected under 35 U.S.C. 102(b) as being
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`anticipated by Wecbecker (WO 97/47317, cited by applicant and filed on an IDS
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`1449).
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`Weckbecker teaches a combination of a somatostatin analogue and a rapamycin
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`for the prevention and treatment of cell hyperproliferation (see abstract and pg. 1,
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`paragraph 1 ). Additionally, Weckbecker teaches that rapamycin or derivatives thereof
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`are desired given that such compounds are immunosuppressive and known to inhibit
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`cancer (see pg. 10, last paragraph and pg. 12, last paragraph). A preferred rapamycin
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`compound is 40-0-(2-hydroxy)ethyl-rapamycin (i.e. elected species; instant claim 12;
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`see pg. 12, paragraph 3). According to Weckbecker, such combination can be used for
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`preventing or treating cell hyperproliferation including GEP tumors (i.e. Gastroentero-
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 020
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 6
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`pancreatic neuroendocrine tumors: slow growing tumors of the pancreas and GI tract)
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`and pituitary adenomas (another type of endocrine tumor; see pg. 13 and pg. 14,
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`paragraph 2).
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`Accordingly, the teachings of Weckbecker anticipates claims 1-3, 8-9, and 12.
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`Conclusion
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`No claims are allowed.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Samira Jean-Louis whose telephone number is 571-
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`270-3503. The examiner can normally be reached on 7:30-6 PM EST M-Th. If
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`attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`Roxane Labs., Inc.
`Exhibit 1002
`Page 021
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`

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`Application/Control Number: 12/094, 173
`Art Unit: 1627
`
`Page 7
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