SV '1D~0~5;)//'7 ll 5
`
`Express Mail Label Number
`
`CASE 100-7932/PCT
`FILING BY "EXPRESS MAIL" UNDER 37 CFR 1.10
`\8. aao9
`€1Y\Av.
`Date ofheposi?
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`IN RE U.S. PATENT No. 5,665,772
`
`ISSUED: SEPTEMBER 9, 1997.
`
`INVENTORS: SYLVAIN COTTENS AND
`
`RICHARD SEDRANI
`
`FOR: O-ALKYLA TED RAPAMYCIN DERIVATIVES AND THEIR USE, PARTICULARLY AS
`
`IMMUNOSUPPRESSANTS
`
`MS: Patent Ext.
`Director for Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`TRANSMITTAL LETTER FOR PATENT TERM EXTENSION APPLICATION
`
`Sir:
`
`Enclosed in triplicate is ijn application for the extension of U.S. Patent No. 5,665,772
`
`under 35 U.S.C. §156.
`
`The Director is hereby authorized to charge the Application Fee of $1,120.00 prescribed
`
`by 37 .C.F .R. § 1.200)( 1 ), as well as any additional fees which may be required in connection with
`
`the filing of this Application for Patent Term Extension, to Applicant's Deposit Account No. 19-
`
`0134 in the name of Novartis. Two additional copies of this transmittal letter are being submitted
`
`for charging purposes.
`
`Respectfully submitted,
`
`~~h~
`
`Attorney for Applicants
`Reg. No. 47,666
`
`Novartis Pharmaceuticals Corp.
`Patents Pharma
`One Health Plaza, Building 101
`East Hanover, NJ 07936-1080
`(862) 778-2614
`
`Date: 5:; / /-;J / 01
`
`

`

`FILING BY "EXPRESS MAIL" UNDER 37 CFR 1.10
`
`£\I ]/Jlco ~5;),//1 u 5
`
`Express Mail label Number
`
`tn.4~ It Joo q
`1:iaT of oe6osit
`
`·
`
`CASE 100-7932
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`IN RE U.S. PATENT NO. 5,665,772
`
`ISSUED: September 9, 1997
`
`INVENTORS: Sylvain Cottens and Richard Sedrani
`
`FOR: O-ALKYLATED RAPAMYCIN DERIVATIVES AND THEIR USE,
`PARTICULARLY AS IMMUNOSUPPRESSANTS
`
`MS Patent Ext.
`Director for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`PATENT TERM EXTENSION APPLICATION UNDER 35 U.S.C.§156
`
`Sir:
`
`Pursuant to 35 U.S.C.§156 and 37 C.F.R.§1.710 et seq., Novartis AG ("Applicant"), a
`
`Corporation organized under the laws of Switzerland, hereby requests an extension of the patent
`
`term due to regulatory review of U.S. Patent No. 5,665,772, which was granted on September 9,
`1997.
`
`Applicant asserts that it is the owner of the entire right, titl~ and interest in U.S. Patent
`
`No. 5,665,772 by virtue of an assignment from the inventors, Sylvain Cottens and Richard Sedrani,
`
`to Sandoz LTD, which later changed its name to Novartis AG. The assignment and name change
`
`to Novartis AG is recorded in the U.S. Patent and Trademark Office at Reel 008422, Frame 0042
`
`on March 24, 1997. A copy of the assignment is attached hereto as Appendix A. A copy of the
`
`Power of Attorney evidencing that Novartis AG b~ing the owner of the entire right, title and interest
`
`in and to U.S. Patent No. 5,665,772 appoints Gregory C. Houghton as its agent to act in its interest
`
`in this matter is attached hereto as Appendix B.
`
`In accordance with 35 U.S.C.§156 and 37 C.F.R.§1.740, Applicant provides the following
`
`information in support of its request for a patent term extension. The following sections are
`
`numbered analogously to 37 C.F.R.§1.740.
`
`05/19/2009 NHGUYEN100000088198134
`01 fC:1457
`1120.00 DA
`
`5665772
`
`

`

`(1)
`
`Identification of the Approved Product
`The approved product is Afinitor®, which contains the active ingredient everolimus, having
`the chemical name 40-O-(2-hydroxyethyl)-rapamycin and having the chemical structure
`
`2.
`
`Identification of the Federal Statute under which Regulatory Review Occurred
`
`The approved product was subject to regulatory review under the Federal Food, Drug and
`
`Cosmetic Act, Section 505 (New Drugs).
`
`3.
`
`The Date of Permission for Commercial Marketing
`
`The approved product received permission for commercial marketing under Section 505 of
`
`the Federal Food, Drug and Cosmetic Act (21 U.S.C.§355(c)) on March 30, 2009. A copy of the
`
`FDA approval letter is attached hereto as Appendix C.
`
`4.
`
`Active Ingredient Statement
`
`The sole active ingredient in Afinitor® is everolimus, which has not been previously approved
`
`for commercial marketing or use under Section 505 of the Federal Food, Drug and Cosmetic Act,
`
`the Public Health Service Act, or the Virus-Serum Toxin Act prior to the approval of NOA 22-334 by
`
`the United States Food and Drug Administration on March 30, 2009.
`
`A medical device known as The XI ENCE™ V Everolimus Eluting Coronary Stent System,
`
`which may also be distributed as the PROMUS™ Everolimus Eluting Coronary Stent System, was
`
`approved by the Federal Food, Drug and Cosmetic Act under the ~uthority of Section 515 on July 8,
`
`2008. This medical device is indicated for improving coronary luminal diameter in patients with
`
`symptomatic heart disease. A copy of the of the FDA's premarket approval letter (PMA) is attached
`
`hereto as Appendix D.
`
`-2-
`
`

`

`5.
`
`Statement of Timely Filing
`
`The last day on which this application could be submitted is_ May 29, 2009, which is 60 days
`
`after the approval of NDA 22-334 on March 30, 2009. This application is timely filed on or prior to
`
`May 29, 2009.
`
`6.
`
`Identification of Patent for which Extension is Sought
`
`This application seeks to extend the term of U.S. Patent No. 5,665,772, which issued
`
`September 9, 1997 to Sylvain Cottens and Rich~rd Sedrani, the term of which would otherwise
`
`expire on September 9, 2014.
`
`7.
`
`Patent Copy
`
`A complete copy of U.S. Patent No. 5,665,772, identified in paragraph 6 above, is attached
`
`as Appendix E.
`
`8.
`
`Post-Issuance Activity Statement
`
`No Reexamination certificate, no terminal disclaimer, or Reissue has been issued or
`
`requested with respect to U.S. Patent No. 5,665,772. Two maintenance fees have become due
`
`since the patent has issued and both have been paid in a timely manner. Copies of the
`
`maintenance fee statements received by the United States Patent & Trademark Office indicating
`
`that the respective maintenance fees were timely paid, are attached hereto as Appendix F.
`
`A Request for a Certificate of Correction for U.S. Patent No. 5,665,772 was mailed to the
`
`United States Patent and Trademark Office on March 30, 1998. A copy of the Request is attached
`
`hereto as Appendix G. · The United States Patent and Trademark Office issued the Certificate of
`
`Correction for U.S. Patent No. 5,665,772 on June 30, 1998. A copy of the Certificate of Correction
`
`is attached hereto as Appendix H.
`
`9.
`Statement Showing How the Claims of the Patent for which Extension is Sought
`Cover the Approved Product
`
`Claims 1, 2 , 3 and 10 of U.S. Patent No. 5,665,772 claim compounds which include the
`
`approved product, Afinitor®.
`
`-3-
`
`

`

`Claims 1-3 claim compounds, including everolimus, the active ingredient in the approved
`product. The active ingredient, everolimus, is the compound of claim 1 wherein R1 is hydroxy(Cr
`a)alkyl. Further, the active ingredient, everolimus, is the compound of claims 2 and 3, wherein R1 is
`hydroxy(C1-3)alkyl.
`
`Claim 10, as corrected by the Certificate of Correction, claims everolimus by its chemical
`
`name, which is 40-O-(2-hydroxyethyl)-rapamycin. The Certificate of Correction is attached hereto
`
`as Appendix H.
`
`Claim 7 claims pharmaceutical compositions containing a compound of claim 1, which as
`
`shown above, includes everolimus, the active ingredient of the approved product. Claim 7 claims a
`
`pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1
`
`and a pharmaceutically acceptable carrier therefor.
`
`-4-
`
`

`

`10.
`
`Statement of the Relevant Dates to Determine the Regulatory Review Period
`
`The relevant dates and information pursuant to 35 U.S.C.§156(g) to enable the Secretary of
`
`Health and Human Services to determine the applicable regulatory review period are as follows:
`
`(i) The patent for which extension of the term thereof is sought claims a human drug
`
`product. The human drug product is a composition containing everolimus.
`
`(A) An lnvestigational New Drug Application for everolimus as an antiproliferative drug with
`
`an application as an anti-cancer agent was submitted on November 22, 2002. This was assigned
`
`IND 66,279. A request was made to cross-reference a previously filed lnvestigational New Drug
`
`Application for everolimus' use as an immunosuppressant. This cross-reference was to include
`
`safety data such as carcinogenicity data to support IND 66,279. The previously filed lnvestigational
`
`New Drug Application for everolimus as an antiproliferative drug with an application as an
`
`immunosupressant was submitted on November 15, 1996, was received by the Department of
`
`Health and Human Services.on November 19, 1996, was assigned IND No. 52,003, and became
`
`effective on December 19, 1996.
`
`A copy of the IND letter, dated Dec. 18, 2002, to the FDA regarding IND 66,279 and a fax
`
`communication, dated Dec. 18, 2002, to the FDA regarding the cross-referencing of IND 52,003,
`
`and a fax communication, dated Dec. 19, 2002, from the FDA regarding IND 66,279 are attached
`
`as Appendix I. A copy of the IND application cover letter and table of contents, dated Nov. 15,
`
`1996, concerning IND 52,003 and a copy of the acknowledgement letter, dated Nov. 26, 1996, from
`
`the FDA concerning IND 52,003 are attached as Appendix J. A copy of the IND application cover
`
`letter and table of contents, dated Nov. 22, 2002, concerning IND 66,279 and a copy of the
`
`acknowledgment/approval fax, dated Dec. 19, 2002 (copy also included in Appendix I), from the
`
`FDA concerning IND 66,279 are attached as Appendix K.
`
`(B) A New Drug Application for Afinitor® was received by the Department of Health and
`
`Human Services on June 30, 2008 and granted NOA No. 22-334·.
`
`(C) NOA No. 22-334 was approved on March 30, 2009.
`
`- 5 -
`
`

`

`11.
`
`Brief Description of Activities Undertaken During the Regulatory Review Period
`
`As a brief description of the activities undertaken during the applicable regulatory review
`period, attached hereto as Appendix L is a chronology of the major communications between the
`u:s. Food and Drug Administration and the Applicant in IND No. 66,279 and NOA No. 22-334 and
`in IND 52,003 (the cross-referenced IND).
`
`/
`
`-6-
`
`

`

`12.
`
`Opinion of Eligibility for Extension
`
`Applicant is of the opinion that U.S. Patent No. 5,665,772 is eligible for extension under
`
`35 U.S.C.§156 and 37 C.F.R.§1.720 because it satisfies all of the requirements for such extension
`
`as follows:
`
`(a) 35 U.S.C.§156(a) and 37 C.F.R.§1.720(a)
`
`U.S. Patent No. 5,665,772 claims, everolimus, the active ingredient of a human drug
`
`product and pharmaceutical compositions containing the active ingredient. MPEP 2751
`
`states:
`
`"A patent is considered to claim the product at least in those situations
`
`where the patent claims the active ingredient per se, or claims a
`
`composition or formulation which contains the active ingredient(s) and
`
`reads on the composition or formulation approved for commercial
`
`marketing or use"
`
`As pointed out in Section 9 of this Patent Term Extension Application, U.S. Patent No.
`
`5,665,772 claims both the active ingredient per se (claims 1-3 and 10) and a composition containing
`
`the active ingredient (claim 7).
`
`(b) 35 U.S.C.§156(a)(1) and 37 C.F.R.§1.720(9)
`
`The term of U.S. Patent No. 5,665,772 (expiring September 9, 2014) has not expired
`
`before the submission of this application.
`
`(c) 35 U.S.C.§156(a)(2) and 37 C.F.R.§1.720(b)
`
`The term of U.S. Patent No. 5,665,772 has never been extended.
`
`(d) 35 U.S.C.§156(a}(3) and 37 C.F.R.§1.720(c)
`
`The application for extension of the term of U.S. Patent No. 5,665,772 is submitted by
`
`the authorized attorney of the owner of record thereof in accordance with the requirements
`
`of 35 U.S.C.§156(d) and 37 C.F.R.§1.740.
`
`- 7 -
`
`

`

`{e) 35 U.S.C.§156(a)(4) and 37 C.F.R.§1.720(d)
`
`The approved product, Afinitor®, has been subjected to a regulatory review period under
`
`35 U.S.C. § 156(g)(1) before its commercial marketing or use.
`
`(f) 37 C.F.R.§1.720(h)
`
`No other patent has been extended for the ·same regulatory review period for the
`
`approved product, Afinitor® .
`
`(g) 35 U.S.C.§156(a)(5)(A) and 37 C.F.R.§1.720(e)(1)
`
`The permission for the commercial marketing or use of the approved product, Afinitor® is
`
`the first received permission for commercial marketing or use of Afinitor® under Section 505,
`
`the provision of law under which the applicable regulatory review occurred.
`
`As set forth in paragraph 4 above, a medical device known as The XIENCE™ V.
`
`Everolimus Eluting Coronary Stent System, which may also be distributed as the
`
`PROMUS™ Everolimus Eluting Coronary Stent System, was approved by the Federal Food,
`
`Drug and Cosmetic Act under the authority of Section 515 on July 8, 2008. This medical
`
`device is indicated for improving coronary luminal diameter in patients with symptomatic
`
`heart disease.
`
`13.
`
`Length of extension claimed under 37 C.F.R.§1.740(a)(12)
`
`The length of extension of the patent term of U.S. Patent No. 5,665,772 requested by
`
`Applicant is 1,826 days (5 years), which length was calculated in accordance with 37 C.F.R.§1.775
`
`as follows:
`
`(a) The regulatory review period under 35 U.S.C.§156(g)(1)(B) began on December 19,
`
`1996 (the effective date of the cross-referenced IND 52,003) and ended on March
`
`30, 2009, amounting to a total of 4,484 days which is the sum of (i) and (ii) below:
`
`(i) The period of review under 35 U.S.C.§156(g)(1)(B)(i), the "Testing Period,"
`
`began on December 19, 1996 and ended on June 30, 2008 which is 4,211
`
`days;
`
`-8-
`
`

`

`(ii) The period for review under 35 U~S.C.§156(g)(1)(B)(ii), the "Application
`
`Period," began on June 30, 2008 and ended on March 30, 2009, which is 273
`
`days;
`
`(b) The regulatory review period upon which the period for extension is calculated is the
`entire regulatory review period as determined in subparagraph (13)(a) above (4,484
`
`days) less:
`
`(i) The number of days in the regulatory review period which were on or before
`
`the date on which the patent issued (Sept. 9, 1997), i.e., 264 days, and
`
`(ii) The number of days during which the Applicant did not act with due diligence,
`
`i.e., zero days, and
`
`(iii) One-half of the number of days remaining in the period in subparagraph
`
`(13)(a)(i) after subtracting the number of days in subparagraphs (13)(b)(i) and
`
`(13)(b)(ii), which is one-half of (4211 - [264 + O]) or 1974 days;
`
`which results in a period of 4,484 -[264 + 0 + 1974 days]= 2,246 days.
`
`(c) The number of days as determined in subparagraph (13)(b), when added to the
`
`original term (September 9, 2014), would result in the date of October 19, 2020.
`
`(d) Fourteen (14) years when added to the date of the NOA Approval Letter (March 30,
`
`2009) would result in the date of March 30, 2023.
`
`(e) The earlier date as determined by subparagraphs (13)(c) and (13)(d) is October 19,
`
`2020.
`
`(f) Since the original patent was issued after September 24, 1984, the extension
`
`otherwise obtainable is limited to not more than five (5) years. Five years, when
`
`added to the original expiration of U.S. Patent No. 5,665,772 (September 9, 2014),
`
`results in the date September 9, 2019.
`
`(g) The earlier date as determined in subparagraphs (13)(e) and (13)(f) is September 9,
`
`2019.
`
`-9-
`
`

`

`14.
`
`Duty of Disclosure Acknowledgement Under 37 C.F.R.§1.740(a)(13)
`
`Applicant acknowledges a duty to disclose to the Director of the United States Patent and
`Trademark Office and the Secretary of Health and Human Services any information which is
`
`material to the determination of entitlement to the extension sought.
`
`15.
`
`Fee Charge
`
`The prescribed fee for receiving ·and acting upon this application is to be charged to
`
`Applicant's Deposit Account No. 19-0134 as authorized in the attached transmittal letter, submitted
`
`in triplicate.
`
`16.
`
`Correspondence Address Required by 37 C.F.R.§1.740(a)(15}
`
`All correspondence relating to this application for patent term extension should be
`
`addressed to:
`
`Novartis Pharmaceuticals Corp.
`Patents Pharma
`One Health Plaza, Bldg. 101
`East Hanover, NJ 07936-1080
`
`17.
`
`Certification Under 37 C.F.R.§1.740(b)
`
`The undersigned hereby certifies that the instant application, including its attachments and
`
`supporting papers, is being submitted as one original and two copies thereof in accordance with
`37 C.F.R.§1.740(b).
`
`Respectfully submitted,
`
`Novartis Pharmaceuticals Corp.
`Patents Pharma
`One Health Plaza, Building 101
`East Hanover, NJ. 07936-1080
`
`~L -~
`-~Houghton
`· Attorney for Applicant
`Reg. No. 47,666
`(862) 778-2614
`
`- 10 -
`
`

`

`T.· -~. RDATION FORM COVER SH(-·_ T
`.PATENTS ONLY
`MAY 1 & 2009 ~
`
`y
`
`y
`
`U.S. DEPARTMENT OF COMMERCE
`Patent and Trademark Office
`
`Appendix A
`
`y
`
`y
`
`ants and Trademarks: Please record the 1..ttached original documents qr copy thereof.
`
`1. Name of conveying party(ies):
`
`2. Name and address of receiving party(ies)
`
`SYLVAIN COTTENS, RICHARD SEDRANI
`
`Additional name(s) of conveying party(ies) attached? CJ Yes ~ No
`
`3. Nature of conveyance:
`
`:x6a Assignment
`
`a Merger
`
`a Security Agreement
`0 Other _______________ _
`
`O Change of Name
`
`Name:NOVARTIS AG (formerly SANDOZ LT
`·-------~--------
`Internal Address: CH-4 0 O 2
`Basle, Switzerland
`
`Street Address: --------------
`
`. City: _______ State: ____ ZIP: __ _
`
`Execution Date: MARCH 13 , 19 9 5
`
`Additional name(s) & address(es) attached? a Yes a No
`
`4. Application number(s) or patent number(s):
`
`If this document is being filed together with a new application, the execution date of the application is: ______ _
`
`A. Patent Application No.{s)
`Case 100-7932/PCT
`Serial No. 08/416,673
`Filed 4/7 /95
`
`8. Patent No.(s)
`
`Additional numbers attached? a Y~ No
`
`5. Name and address of party to whom correspondence
`concerning document should be mailed:
`
`Name: Robe rt S • Honor
`
`Internal Address: NOVARTIS 90R~.
`
`Patent and Trademark Dept.
`
`StreetAddress: 59 Route lO
`
`· 6. Total number of applications and patents involved: (W
`
`7. Total fee (37 CFA 3.41) ............. $_4_0_._o_o __ _
`
`O Enclosed
`
`JQC Authorized to be charged to deposit account
`.,.
`8. Deposit account number:
`
`19-0134
`
`City: E
`
`liaoover
`
`State: __._N .... J.___ ZIP: 019 3 6
`
`{Attach duplicate copy of this page if paying by deposit account)
`
`DO NOT USE THIS SPACE
`
`~. Statement and signature.
`_ \ - \ - ~ n ....\r--t
`To the best of my knowledge and belief, the foregoing information is true and correct and any attached copy is a true copy of
`. n n
`the original document.
`Linda C. Rothwell ~ ~,~ 3/20/97
`r-;a
`Date
`Name of Person Signing
`Signature
`Total number of pages including cover sheet. attachments, and document: ~
`
`Mail documents to be recorded with required coversheet Information to:
`Commissioner of Patents & Trademarks. Box Assignments
`Washington, D.C. 20231
`
`

`

`·1sA
`
`Case 100-7932/PCT
`
`A S S I G N M E N T
`
`I/We
`
`Sylvain Cottens and Richard Sedrani
`
`for good and valuable consideration, the receipt and adequacy of -which is
`hereby acknowledged, do hereby sell and assign to SANDOZ LTD. {also known
`as SANDOZ AG), a Company organised under· the laws of the Swiss Con£ edera(cid:173)
`tion, of 4002 Basle, Switzerland, its successors and assigns, all my/our
`. right, title and interest, in and for the United States of America, in and
`to the
`0-ALKYLATED RAPAMYCIN DERIVATIVES AND THEIR USE, PARTICULARLY
`AS IMMUNOSUPPRESSANTS
`invented by meius and described in the specification for United States
`Letters Patent therefor, executed on even date herewith, and all United·
`States Letters Patent which may be granted therefor, and all divisions,
`reissues, continuations and extensions thereof, the said interest being
`the entire ownership of the said Letters Patent when gran~ed, to be held
`and enjoyed. by the said SANDOZ LTD., its successors, assigns or other
`legal representatives, to the full end of the term for which said Letters
`Patent may be granted, as fully and entirely as the same would have been
`held and enjoyed by me/us if this assignment and sale had not been made;
`And I/we hereby authorize and request the Commissioner of Patents to
`issue said Letters.Patent to the said SANDOZ LTD.
`
`Signed this
`
`day of rla,.tt 11 19~\ &;!fen s I'
`
`Sylvain Cottens
`
`Signed this
`
`day of
`
`Signed this
`
`day of
`
`Signed·this
`
`day of
`
`fla)\.62._ I ~ l 9~_r ~~
`
`Richard Se.drani
`
`19
`
`19
`
`

`

`Appendix B
`
`DECLARATION AND POWER OF ATTORNEY
`FOR UNITED STATES PATENT APPLICATION
`
`Case No.
`
`100-7932/PCT
`
`As a below named inventor, I hereby declare that:
`
`My residence, post office address and citizenship are as stated below next to my name,
`
`and
`
`I believe that I am the original, first and sole inventor (if only one name is listed below)
`
`or an original, first and joint inventor (if more than one name is listed below) of the subject
`
`11;atter which is claimed and for which a United States patent is sought on the invention
`
`entitled
`
`0-ALKYLATED RAPAMYCIN DERIVATIVES AND THEIR USE, PARTICULARLY
`AS IMMUNOSUPPRESSANTS
`
`the specification of which
`[ J is attached hereto.
`[ ] was filed on
`and, if these brackets contain an X [ ], was amended on
`
`19
`
`as application Serial No. 0/
`
`19
`
`[X] was filed as Patent Cooperation Treaty internation application No. PCT/EP93/02604
`
`on September 24
`
`, 19 93
`
`, if these brackets contain an X ( ], was
`
`amended under Patent Cooperation Treaty Article 19 on
`and, if these brackets contain an X [ J, was amended on
`[ J entered the national stage in the United States and was accorded Serial No.
`, and if these brackets contain an X [
`on
`, 19
`
`, 19
`
`, 19
`
`was amended on
`
`I hereby state thar I have reviewed and understand the contents of the above-identified
`
`specifiction including the claims, as amended by any amendment(s) referred to above.
`
`I acknowledge my duty to disclose all information which is known by me to be material
`
`to patentability as defined in Title 37, Code of Federal Regulations, § 1.56.
`
`I hereby claim the benefit under Title 35, United States Code, §I 19 of any foreign
`
`application(s) for patent or inventor's certificate indicated below and of any Patent
`
`Cooperation Treaty international application(s) designating at least one country other than the
`
`United States indicated below and have also identified any foreign application(s) for
`
`- I -
`
`

`

`Case No. 100-7932/PCT
`
`patent or inventor's certificate and Patent Cooperation Treaty international application(s)
`
`designating at least one country other than the United States for the same subject matter and
`
`having a filing date before that of the application for said subject matter the priority of which
`
`is claimed:
`Country:
`
`Number:
`
`Filing Date:
`
`Great Britain
`
`9221220.8
`
`October 9 1 1992
`
`Priori!Y Claimed:
`[X] Yes[ ] No
`[ ] Yes( ] No
`
`[ ) Yes[ ) No
`
`[ ] Yes[ ] No
`] Yes[ ] No
`
`] Yes[ ] No
`
`I hereby claim the benefit under Title 35, United States Code, § 120 of any United
`
`States application(s) listed below and of any Patent Cooperation Treaty international
`
`application(s) designating the United States listed below and, insofar as the subject matter of
`
`each of the claims of this application is not disclosed in said prior application(s) in the
`
`manner required by the first paragraph of Title 35, United States Code. § 112. I acknowledge
`
`my duty to disclose all information known to me to be material to patentability as defined in
`
`Title 37, Code of Federal Regulations, § 1.56 which became available between the filing
`
`date(s) of the prior application(s) and the national or Patent Cooperation Treaty international
`
`filing date of this application:
`Application
`
`Serial No.
`none.
`
`Status (Pending,
`
`Abandoned, Patented)
`
`- 2 -
`
`

`

`~ -
`
`I hereby appoint the following:
`
`ROBERT S. HONOR
`THOMASO.MCGOVERN
`MELVYN M. K.ASSENOFF
`JOSEPH J. BOROVIAN
`DIANE E. FURMAN
`CARL W. BATTLE
`ANDREW N. PARFOMAK
`JOHN L. CHIATALAS
`CAROL A. LOESCHORN
`MICHAEL P. MORRIS
`THOMAS C. DOYLE
`
`Case No. 100-7932/PCT
`
`Reg. No. 22,801
`Reg. No. 25,741
`Reg. No. 26,389
`Reg. No. 26,631
`Reg. No. 31,104
`Reg. No. 30,731
`Reg. No. 32,431
`Reg. No. 31,818
`Reg. No. 35,590
`Reg. No. 34.513
`. Reg. No. 22,340
`
`respectively and individually, as my attorneys and/or agents, with full power of substitution
`
`and revocation, to prosecute this application and to transact all business in the Patent and
`
`Trademarks Office connected therewith. Please address all communications to ROBERT S.
`
`HONOR, SANDOZ CORPORATION, 59 Route 10, East Hanover, New Jersey 07936-1080,
`
`whose telephone number is 201-503-8485.
`
`I hereby declare that all statements made herein of my own knowledge are true and that
`
`all statements made on information and belief are believed to be true; and further that these
`
`statements were made with the knowledge that willful false statements and the like so made
`
`are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`
`States Code and that such willful false statement may jeopardize the validity of the
`
`application or any patent issuing thereon.
`
`Sole inventor or
`first joint inventor:
`
`Full name
`
`Signature
`Date
`Citizenship
`Residence
`
`Sylvain Cottens
`7_4-,
`:;4rfql i
`Ula,d, t~ 1 /Hr(cid:173)
`Switzerland
`In den Reben 12, CH-4108 Witterswil,
`Switzerland
`P.O. Address: same. as above
`
`IMPORTANT: Before this declaration is signed, the patent application (the specificateion, the claims and this
`declarations) must be read and understood by each person signing it, and no changes may be made in the
`application after this declaration has been signed.
`
`- 3 -
`
`

`

`Second joint inventor,
`if any:
`
`Third joint inventor,
`if any:
`
`Fourth joint inventor,
`if any:
`
`Fifth joint inventor
`if any:
`
`Full name
`
`Richard Sedrani
`
`Case No. 100-7932/P<
`
`Signature
`Date
`Citizenship
`Residence
`
`I~ '.),S""
`
`/!fl.~ /,Zg&J. Ql~
`..
`na_"-c.a,_ 11:,
`Luxembourg
`Herrengrabenweg 15, CH-4054 Basle,
`Switzerland
`P.O. Address : same as above
`
`Full name
`
`Signature
`Date
`Citizenship
`Residence
`
`P.O. Address:
`
`Full name
`
`Signature
`Date
`Citizenship
`Residence
`
`P.O. Address:
`
`Full name
`
`Signature
`Date
`Citizenship
`Residence
`
`P.O. Address:
`
`- 4-
`
`

`

`PTO/SB/81 (01-09)
`Approved for use through 11/30/2011. 0MB 0651-0035
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the PapelWOlk Reduction Act of 1995, no persons are required to respond to a collectlon of Information unless it displays a valid 0MB control number.
`"I
`
`POWER OF ATTORNEY
`OR
`REVOCATION OF POWER OF ATTORNEY
`WITH A NEW POWER OF ATTORNEY
`AND
`CHANGE OF CORRESPONDENCE ADDRESS
`'-
`I hereby revoke all previous powers of attorney given in the above-identified application.
`
`08/416673
`April 7, 1995
`Cotten, Sylvain
`0-ALKYLATED RAPAMYCIN
`
`1202
`Bond, Robert
`100-7932
`
`~
`
`I
`
`r
`
`(cid:143)
`!Zl
`
`Application Number
`Flllng Date
`First Named Inventor
`Title
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`A Power of Attorney is submitted herewith.
`OR
`I hereby appoint Practitioner(s) associated with the following Customer
`Number as my/our attomey(s) or agent(s) to prosecute the application
`identified above, and to transact all business in the United States Patent
`and Trademark Office connected therewith:
`OR
`I hereby appoint Practitioner(s) named below as my/our attorney(s) or agent(s) to prosecute the application identified above, and
`to transact all business in the United States Patent and Trademark Office connected therewith:
`
`I
`
`01095
`
`(cid:143)
`
`Practitioner(s) Name
`
`Registration Number
`
`Please recognize or change the correspondence address for the above-identified application to:
`!Zl The address associated with the above-mentioned Customer Number.
`(cid:143)
`I
`(cid:143)
`
`OR
`
`The address associated with Customer Number:
`OR
`Firm or
`Individual Name
`Address
`
`I
`
`City
`Country
`Telephone
`
`I State
`
`1 Email
`
`I
`
`I
`
`I Zip I
`
`I am the:
`ApplicanUlnventor.
`OR
`
`Signature
`Name
`
`J
`
`(cid:143)
`!Zl Assignee of record of the entire interest. See 37 CFR 3. 71.
`Statement under 37 CFR 3. 73(b) (Form PTOISB/96) submitted herewith or filed on
`/J/
`SIG~WRE of ~pllcant or Assignee of Record
`J
`..,.......---.:n-
`- <:. ,:j...,,.,
`-
`I Date
`I Yl-:;..1 /0C/
`-
`.I-.r '
`GreQl!ff\t en HouQhton .//
`I Telephone l 862 778-2614
`Patent Attorney, Novartis
`Title and Company
`t«UE: Signatures of all the invenlors or assignees of record of the entire Interest or their representatlve(s) are required. Submit muttiple forms if more than one
`signature Is required, see below'.
`1
`
`!Zl "Total of
`
`forms are submitted.
`
`This collectlon of !nformatlon Is required by 37 CFR 1.31, 1.32 and 1.33, The informa1!on is required to obtain or retain a benefit by lhe public which is to file (and by Iha
`USPTO to process} an app!i<:ation. Conflderrtiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 3 minutes to complete,
`induding gathering, prepartng, and submitting !he completed applicalion form to the USPTO. Time will vary depending upon the individual case. Any comments on
`the amount or 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 OfflCe, 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, call 1-800-PT0-9199 and select option 2.
`
`

`

`Under the Pa
`
`rk Redudlon Act of 1995. no
`
`PT0/$8196 (03-09)
`Approved for use through 04/3012009. 0MB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`d to a collection of information unless it dis a s a valid 0MB oonlrol number.
`
`Applicant/Patent Owner: Novartis AG
`App Ii cation No./Patent No.: 08/416,673 / 5,665,772
`
`STATEMENT _UNDER 37 CFR 3.73(b)
`-------------------------------------------
`Titled: O-ALKYLATED RAPAMYCIN DERIVATIVES AND THEIR USE, PARTICULARLY AS
`IMMUNOSUPPRESSANTS
`
`Filed/Issue Date: April 7, 1995 I September 9, 1997
`
`, ______________________ ,a Corporation
`Novartis AG
`(Type of Assignee, e.g .. oorpora1ion, partnership, university, government agency, etc.
`(Name of Assignee)
`
`states that it is:
`[8J
`
`1.
`
`the assignee of the entire right, title, and interest in;
`
`2.
`
`(cid:143)
`3. D
`
`an assignee of less than the entire right, title, and interest in
`(The extent (by percentage) of its ownership interest is _____ %};or
`
`the assignee of an undivided interest in the entirety of (a complete assignment from one of the joint inventors was made)
`
`A.
`
`the patent application/patent identified above, by virtue of either:
`[Rj An assignment from the inventor{s) of the patent application/patent identified above. The assignment was recorded in
`, Frame 0042
`, or for which a
`the United States Patent and Trademark Office at Reel 008422
`copy therefore is attached.
`OR
`8. D A chain of title from the inventor(s), of the patent application/patent identified above, to the current assignee as follows:
`To: ____________________ _
`1. From:
`
`The document was recorded in the United States Patent and Trademark Office at
`Reel _________ Frame_________ or for which a copy thereof is attached.
`
`2. From:
`
`To:
`
`The document was recorded in the United States Patent and Trademark Office at
`Reel _________ Frame________ orforwhich a copy thereof is attached.
`
`3. From:
`
`To: ---------------------
`The document was recorded in the United States Patent and Trademark Office at
`Frame ________ _. or for which a copy thereof is attached.
`Reel
`
`Additional documents in the chain of title are listed on a supplemental sheet(s).
`
`D
`D
`
`As required by 37 CFR 3.73(b)(1)(i), the documentary evidence of the chain of title from the original owner to the assignee was,
`or concurrently is being, submitted for recordation pursuant to 37 CFR 3. 11.
`
`[NOTE: A separate copy {i.e., a true copy of the original assignment document(s}) must be submitted to Assignment Division in
`accordance with 37 CFR Part 3, to record the assignment in the records of the USPTO. See MPEP 302.0SJ
`
`Gregory C. Houghton
`Patent Attorney
`Printed or T ped Name
`Title
`This collection of information is required by 37 CFR 3. 73{b). The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to
`process) an application. Confidentiality Is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to oornplete, induding
`gathering, preparing, and submitting the completed· app