UNITED STATES PATENT AND TRADEMARK OFFICE
`
`JUL
`
`5 2011
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.usplo.gov
`
`Michael J. Jaro
`Medtronic, Inc.
`710 Medtronic Parkway
`MIS LC340
`Minneapolis, MN 55432
`
`Dear Mr. Jaro:
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,306,141
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of U.S. Patent No. 6,306,141
`for a period of 1,270 days. While a courtesy copy of this letter is being forwarded to the Food
`and Drug Administration (FDA), you should directly correspond with the FDA regarding any
`required changes to patent expiration dates.
`
`Inquiries regarding this communication should be directed to Raul Tamayo by telephone at
`(571) 272-7728, or bye-mail at raul.tamayo@uspto.gov.
`
`Mary C. Till
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: T ALENT® Abdominal Stent
`Graft System
`FDA Docket No.: FDA-2008':E-0568
`
`Attention: Beverly Friedman
`
`Edwards Exhibit 1025, p. 1
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(12)
`
`CERTIFICATE EXTENDING PATENT TERM
`UNDER 35 U.S.C. § 156
`
`(68)
`
`PATENT NO.
`
`(45)
`
`ISSUED
`
`(75)
`
`INVENTOR
`
`(73)
`
`PATENT OWNER
`
`6,306,141
`
`October 23,2001
`
`James E. Jervis
`
`Medtronic, Inc.
`
`(95)
`
`PRODUCT
`
`T ALENT® Abdominal Stent Graft System
`
`This is to certify that an application under 35 U.S.C. § 156 has been filed in the United
`States Patent and Trademark Office, requesting extension of the term of U.S. Patent No.
`6,306,141 based upon the regulatory review of the product TALENT® Abdominal Stent
`Graft System by the Food and Drug Administration. Since it appears that the requirements
`of the law have been met, this certificate extends the term of the patent for the period of
`
`(94)
`
`1,270 days
`
`from Oct<?ber 23,2018, the original expiration date of the patent, subject to the payment of
`maintenance fees as provided by law, with all rights pertaining thereto as provided by
`35 U.S.C. § 156(b).
`
`I have caused the seal of the United States Patent and
`Trademark Office to be affixed this 30th day of June 2011.
`
`D~jJ:~~
`
`David J. Kappos
`Under Secretary of Commerce for Intellectual Property and
`Director of the United States Patent and Trademark Office
`
`Edwards Exhibit 1025, p. 2
`
`

`

`•
`
`1"'"
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAR 2 3 2011
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313·1450
`WWW.usplo.gov
`
`Michael J. Jaro
`Medtronic, Inc.
`710 Medtronic Parkway
`MIS LC340
`Minneapolis, MN 55432
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,306,141
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that U.S. Patent No. 6,306,141, claims of which cover the
`medical device T ALENT® Abdominal Stent Graft System, is eligible for patent term extension
`under 35 U.S.C. § 156. The period of extension has been determined to be 1,270 days.
`
`A single request for reconsideration of this final determination as to the length of extension of the
`term of the patent may be made if filed within one month of the date of this notice. Extensions
`of time under 37 CFR § 1. 136(a) are not applicable to this time period. In the absence of a
`request for reconsideration, the Director will issue a certificate of extension, under seal, for a
`period of 1,270 days.
`
`The period of extension, if calculated using the Food and Drug Administration determination of
`the length of the regulatory review period published in the Federal Register of September 4,2009
`(74 Fed. Reg. 45865), would be 1,274 days. Under 35 U.S.C. § 156(c):
`
`Period of Extension
`
`=
`
`RRP - PGRRP - DD - Y2 (TP - PGTP)\
`4,024 days - 1,657 - 0 - Y2 (3,843 - 1,657 days)
`1,274 days (3.5 years)
`.
`
`Since the regulatory review period began April 11, 1997, before the patent issued
`(October 23,2001), only that portion of the regulatory review period occurring after the date the
`patent issued has been considered in the above determination of the length of the extension period
`35 U.S.C. § 156(c). (From April 11, 1997, to and including October 23,2001, is C657 days; this
`period is subtracted from the number of days occurring in the testing phase according to the FDA
`determination of the length of the regulatory review period.) No determination of a lack of due
`diligence under 35 U.S.C. § 156(c)(1) was made.
`
`I Consistent with 35 U.S.C. § 156(c), "RRP;' is the total number of days in the regulatory
`review period, "PGRRP" is the number of days of the RRP which were on and before the date on
`which the patent issued, "DD" is the number of days of the RRP that the applicant did not act
`with due diligence, "TP" is the testing phase period described in paragraphs (1)(B)(i), (2)(B)(i),
`(3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g) of 35 U.S.C. § 156, and "PGTP" is the number
`of days of the TP which were on and before the date on which the patent issued, wherein half
`days are ignored for purposes of the subtraction of Y2 (TP - PGTP).
`
`Edwards Exhibit 1025, p. 3
`
`

`

`U.S. Patent No. 6,306,141
`
`Page 2
`
`However, the 14 year exception of35 U.S.C. § 156(c)(3) operates to limit the term of the
`extension in the present situation, because it provides that the period remaining in the term of the
`patent measured from the date of approval of the approved product plus any patent term ..
`extension cannot exceed fourteen years. The period of extension calculated above, 1,274 days,
`would extend the patent from October 23,2018, to April 19, 2022, which is beyond the 14-year
`limit (the approval date is April 15, 2008, thus the 14 year limit is April 15, 2022). The period of
`extension is thus limited to April 15, 2022, by operation of35 U.S.C. § 156(c)(3). Accordingly,
`the period of extension is the number of days to extend the term of the patent from its original
`expiration date, October 23, 2018, to and including April 15, 2022, or 1,270 days.
`
`The limitations of 35 U.S.C. 156(g)(6) do not operate to further reduce the period of extension
`determined above.
`
`Upon issuance of the certificate of extension, the following information will be published in the
`Official Gazette:
`
`U.S. Patent No.:
`
`6,306,141
`
`Granted:
`
`Original Expiration Date2
`
`:
`
`Applicant:
`
`Owner of Record:
`
`Title:
`
`October 23,2001
`
`October 23,2018
`
`James E. Jervis
`
`Medtronic, Inc.
`
`Medical Devices Incorporating SIM Alloy Elements
`
`Product Trade Name:
`
`T ALENT® Abdominal Stent Graft System
`
`Term Extended:
`
`1,270 days
`
`Expiration Date of Extension:
`
`April 15,2022
`
`Any correspondence with respect to this matter should be addressed as follows:
`
`By mail:
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`By FAX:
`
`(571) 273-7728
`
`2Subject to the provisions of35 U.S.C. § 41(b).
`
`Edwards Exhibit 1025, p. 4
`
`

`

`U.S. Patent No. 6,306,141
`
`Page 3
`
`Telephone inquiries related to this determination should be directed to Raul Tamayo at (571)
`272-7728.
`
`Mary C. TIl
`.
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: T ALENT® Abdominal Stent
`Graft· System
`Docket No.: FDA-2008-E-0568
`
`Attention: Beverly Friedman
`
`Edwards Exhibit 1025, p. 5
`
`

`

`l
`
`l"'~ Department of Healtb and Human Services
`
`'C,.#+'::::::'l~.'-... MAY 1 4 2010
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`Re: Talent Abdominal Stent Graft System
`Docket No. FDA-2008-E-0568
`
`The Honorable David 1. Kappos
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`Mail Stop Hatch-Waxman PTE
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Director Kappos:
`
`This is in regard to the patent term extension application for U.S. Patent No. 6,306,141 filed by
`Medtronic, Inc. under 35 U.S.C. § 156. The patent claims Talent Abdominal Stent Graft System,
`premarket approval application (PMA) P070027.
`
`In the September 4,2009, issue of the Federal Register (74 Fed. Reg. 45865), the Food and Drug
`Administration published its determination of this product's regulatory review period, as required
`under 35 U.S.C. § 156(d)(2)(A). The notice provided that on or before March 3, 2010, 180 days
`after the publication of the determination, any interested person could file a petition with FDA
`under 35 U.S.C. § 156(d)(2)(B)(i) for a determination of whether the patent term extension
`applicant acted with due diligence during the regulatory review period.
`
`The 180-day period for filing a due diligence petition pursuant to this notice has expired and
`FDA has received no such petition. Therefore, FDA considers the regulatory review period
`determination to be final.
`
`Please let me know if we can provide further assistance.
`
`Sincerely yours,
`
`~a.
`
`Jane A. Axelrad
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`cc: Michael J. Jaro
`Medtronic, Inc.
`Vice President and Chief Patent Counsel
`710 Medtronic Parkway MIS LC340
`Minneapolis, MN 55432
`
`Edwards Exhibit 1025, p. 6
`
`

`

`Federal Register/Vol. 74, No. 171/Friday, September 4, 2009/Notices
`
`45865
`
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the act: November 17,2005.
`FDA has verified the applicant's claim
`that the new drug application (NDA)
`21-911 for BANZEL was initially
`submitted on November 17,2005.
`3. The date the application was
`approved: November 14, 2008. FDA has
`verified the applicant's claim that NDA
`21-911 was approved on November 14,
`2008.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its application for patent extension,
`this applicant seeks 819 days of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`Management (see ADDRESSES) written or
`electronic comments and ask for a
`redetermination by November 3, 2009.
`Furthermore. any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`March 3, 2010. To meet its burden, the
`petition must contain sufficient facts to
`merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong., 2d sess.,
`pp. 41-42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Comments and petitions should be
`submitted to the Division of Dockets
`Management. Three copies of any
`mailed information are to be ~ubmitted,
`except that individuals may submit one
`copy. Comments are to be identified
`with the docket number found in
`brackets in the heading of this
`document. Comments and petitions may
`be seen in the Division of Dockets
`Management between 9 a.m. and 4 p.m.,
`Monday through Friday.
`Dated: June 23, 2009.
`Jane A. Axelrad,
`Associate Director for Policy, Center for Drug
`Evaluation and Research.
`[FR Doc. E9-21428 Filed 9-3-09; 8:45 am)
`BILUNG CODE 416lHl1-S
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket No. FDA-2008-E-oS68]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; TALENT ABDOMINAL
`STENT GRAFT SYSTEM
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`TALENT ABDOMINAL STENT GRAFT
`SYSTEM and is publishing this notice
`of that determination as required by
`law. FDA has made the determination
`because of the submission of an
`application to the Director of Patents
`and Trademarks, Department of
`Commerce, for the extension of a patent
`which claims that medical device.
`ADDRESSES: Submit written comments
`and petitions to the Division of Dockets
`Management (HFA-305), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. Submit
`electronic comments to http://
`www.regulations.gov.
`FOR FURTHER INFORMATION CONTACT:
`Beverly Friedman, Office of Regulatory
`Policy, Food and Drug Administration,
`10903 New Hampshire Ave., Bldg. 51,
`rm. 6222, Silver Spring, MD 20993-
`0002, 301-796-3602.
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Public Law 98-
`417) and the Generic Animal Drug and
`Patent Term Restoration Act (Public
`Law 100-670) generally provide that a
`patent may be extended for a period of
`up to 5 years so long as the patented
`item (human drug product, animal drug
`product, medical device, food additive,
`or color additive) was subject to
`regulatory review by FDA before the
`item was marketed. Under these acts, a
`product's regulatory review period
`forms the basis for determining the
`amount of extension an applicant may
`receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For medical devices,
`the testing phase begins with a clinical
`investigation of the device and rulJ.S
`until the approval phase begins. The
`approval phase starts with the initial
`submission of an application to market
`the device and contin1,.les until
`permission to market the device is
`granted. Although only a portion of a
`
`regulatory review period may count
`toward the actual amount of extension
`that the Director of Patents and
`Trademarks may award (half the testing
`phase must be subtracted as well as any
`time that may have occurred before the
`patent was issued), FDA's determination
`of the length of a regulatory review
`period for a medical device will include
`all of the testing phase and approval
`phase as specified in 35 U.S.C.
`156(g)(3)(B).
`FDA recently approved for marketing
`the medica:l device, TALENT
`ABDOMINAL STENT GRAFT SYSTEM.
`The TALENT ABDOMINAL STENT
`GRAFT SYSTEM is indicated for the
`endovascular treatment of abdominal
`aortic aneurysms with or without iliac
`involvement having: Iliac/femoral
`access vessel morphology that is
`compatible with vascular access
`techniques, devices, and/or accessories;
`a proximal aortic neck length of ~ 10
`millimeters (mm); proximal aortic neck
`angulation :5 60° distal iliac artery
`fixation length of~ 15 mm; an aortic
`neck diameter of 18 to 32 mm and iliac
`artery diameters of 8 to 22 mm; and
`vessel morphology suitable for
`endovascular repair. Subsequent to this
`approval, the Patent and Trademark
`Office received a patent term restoration
`application for TALENT ABDOMINAL
`STENT GRAFT SYSTEM (U.S. Patent
`No. 6,306,141) from Medtronic, Inc.,
`and the Patent and Trademark Office
`requested FDA's assistance in
`determining this patent's eligibility for
`patent term restoration. In a letter dated
`February 18, 2009, FDA advised the
`Patent and Trademark Office that this
`medical device had undergone a
`regulatory review period and that the
`approval of TALENT ABDOMINAL
`STENT GRAFT SYSTEM represented
`the first permitted commercial
`marketing or use of the product.
`Thereafter, the Patent and Trademark
`Office requested that FDA determine the
`product's regulatory review period.
`FDA has determined that the
`applicable regulatory review period for
`TALENT ABDOMINAL STENT GRAFT
`SYSTEM is 4,024 days. Of this time,
`3,843 days occurred during the testing
`phase of the regulatory review period,
`while 181 days occurred during the
`approval phase. These periods of time
`were derived from the following dates:
`1. The date an exemption under
`section 520(g) of the Federal Food, Drug,
`and Cosmetic Act (the act) (21 U.S.c.
`360j(g)) involVing this device became
`effective: April 11, 1997. FDA has
`verified the applicant's claim that the
`date the investigational device
`exemption (IDE) required under section
`
`Edwards Exhibit 1025, p. 7
`
`

`

`45866
`
`Federal Register/Vol. 74, No. I71/Friday, September 4, 2009/Notices
`
`National Institutes of Health
`
`Government-Owned Inventions;
`Availability for licensing
`AGENCY: National Institutes of Health,
`Public Health Service, HHS.
`ACTION: Notice.
`
`520(g) of the act for human tests to begin DEPARTMENT OF HEALTH AND
`became effective April 11, 1997.
`HUMAN SERVICES
`2. The date an application was
`initially submitted with respect to the
`device under section 515 of the act (21
`U.S.C. 360e): October 18, 2007. FDA has
`verified the applicant's claim that the
`premarket approval application (PMA)
`for TALENT ABDOMINAL STENT
`GRAFT SYSTEM (PMA P070027) was
`initially submitted October 18, 2007.
`3. The date the application was
`approved: April 15, 2008. FDA has
`verified the applicant's claim that PMA
`P070027 was approved on April 15,
`2008.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its application for patent extension,
`this applicant seeks 1,183 days of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`Management (see ADDRESSES) written or
`electronic comments and ask for a
`redetermination by November 3,2009.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`March 3, 2010. To meet its burden, the
`petition must contain sufficient facts to
`merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong., 2d sess.,
`pp. 41-42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Comments and petitions should be
`submitted to the Division of Dockets
`Management. Three copies of any
`mailed information are to be submitted,
`except that individuals may submit one
`copy. Comments are to be identified
`with the docket number found in
`brackets in the heading of this
`document.
`Comments and petitions may be seen
`in the Division of Dockets Management
`between 9 a.m. and 4 p.m., Monday
`through Friday.
`Dated: June 8, 2009.
`Jane A. Axelrad,
`Associate Director for Policy, Center for Drug
`Evaluation and Research.
`[FR Doc. E9-21424 Filed 9-3-09; 8:45 am]
`BILUNG CODE 416G-Ol-S
`
`SUMMARY: The inventions listed below
`are owned by an agency of the U.S.
`Government and are available for
`licensing in the U.S. in accordance with
`35 U.S.C. 207 to achieve expeditious
`commercialization of results of
`federally-funded research and
`development. Foreign patent
`applications are filed on selected
`inventions to extend market coverage
`for companies and may also be available
`for licensing.
`ADDRESSES: Licensing information and
`copies of the U.S. patent applications
`listed below may be obtained by writing
`to the indicated licensing contact at the
`Office of Technology Transfer, National
`Institutes of Health, 6011 Executive
`Boulevard, Suite 325, Rockville,
`Maryland 20852-3804; telephone: 3011
`496-7057; fax: 301/402-0220. A signed
`Confidential Disclosure Agreement will
`be required to receive copies of the
`patent applications.
`Antigenic Chimeric Tick-Borne
`Encephalitis ViruslDengue Virus Type 4
`Recombinant Viruses
`Description of Technology: The tick(cid:173)
`borne encephalitis virus (TBEV)
`complex is a group of viruses that can
`cause severe neutrotropic disease and
`up to thirty percent (30%) mortality.
`While these viruses can be found in
`many parts of the world, the largest
`impact of the disease occurs in Europe
`and Russia, where approximately
`fourteen thousand (14,000) hospitalized
`TBEV cases occur annually. TBEV is in
`the family Flaviviridae, genus flavivirus
`and is composed of a positive-sense
`single stranded RNA genome that
`contains 5' and 3' non-coding regions
`and a Single open reading frame
`encoding ten (10) proteins. At present,
`a vaccine or FDA approved antiviral
`therapy is not available.
`The inventors have previously
`developed a WNV IDengue4Delta30
`antigenic chimeric virus as a live
`attenuated virus vaccine candidate that
`contains the WNV premembrane and
`envelope (prM and E) proteins on a
`dengue virus type 4 (DEN4) genetic
`background with a thirty nucleotide
`deletion (Delta30) in the DEN4 3'-UTR.
`Using a similar strategy, the inventors
`
`have generated an antigenic chimeric
`virus, TBEVIDEN4Delta30. This
`chimeric virus also contains attenuating
`mutations within the E and
`nonstructural NS5 proteins. Preclinical
`testing results with the derived virus
`indicate that chimerization of TBEV
`with DEN4DeJta30 and introduction of
`the attenuating mutations decreased
`neuroinvasiveness and neurovirulence
`in mice. The TBEV/DEN4deJta30
`vaccine candidate was safe,
`immunogenic, and provided protection
`in monkeys against challenge with TBE
`viruses.
`This application claims live
`attenuated chimeric TBEV/DEN4DeJta30
`vaccine compositions. Also claimed are
`methods of treating or preventing TBEV
`infection in a mammalian host, methods
`of producing a subunit vaccine
`composition, isolated polynucleotides
`comprising a nucleotide sequence
`encoding a TBEV immunogen, methods
`for detecting TBEV infection in a
`biological sample and infectious
`chimeric TBEV.
`Applications: Development of Tick(cid:173)
`Borne Encephalitis Virus vaccines,
`therapeutics and diagnostics.
`Advantages: Live attenuated chimeric
`vaccine, known regulatory pathway,
`potential for lasting immunity with
`fewer doses.
`Development Status: Vaccine
`candidates have been synthesized and
`preclinical studies have been
`performed.
`Inventors: Alexander G. Pletnev,
`Amber R. Engel, Brian R. Murphy
`(NIAID).
`Patent Status: U.S. Provisional
`Application No. 61/181,982 filed 28
`May 2009 (HHS Reference No. E-078-
`2009/0-US-Ol).
`Licensing Status: Available for
`licensing.
`Licensing Contact: Peter A. Soukas,
`J.D.; 301-435-4646;
`soukasp@mail.nih.gov.
`Collaborative Research Opportunity:
`The NlAID is seeking statements of
`capability or interest from parties
`interested in collaborative research in
`preclinical study of the long-term
`immunity induced by the TBEV/DEN4
`vaccine candidate against highly
`virulent TBE viruses and in the clinical
`trials of this vaccine in humans. Please
`contact Michael Piziali, NIAID Office of
`Technology Development, at 301-496-
`2644 for more information.
`Monoclonal Antibodies That React
`With the Capsule of Bacillus
`anthracis
`Description of Technology: Bacillus
`anthracis is the causative agent of
`anthrax and is surrounded by a
`
`Edwards Exhibit 1025, p. 8
`
`

`

`DEPARTMENT OF HEALTH &. HUMAN SERVICES
`
`AUG 1 9 2009
`
`Food and Drug Administration
`Rockville MD 20857
`
`Re: Talent Abdominal Stent Graft System
`Docket No.: FDA-2008-E-0568
`
`The Honorable Jon Dudas
`Undersecretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`Mail Stop Hatch-Waxman PTE
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Director Dudas:
`
`This is in regard to the application for patent term extension for U.S. Patent No. 6,306,141, filed
`by Medtronic, Inc., under 35 U.S.C. section 156 et seq. We have reviewed the dates contained in
`the application and have determined the regulatory review period for Talent Abdominal Stent
`Graft System, the medical device claimed by the patent.
`
`The total length of the regulatory review period for Talent Abdominal Stent Graft System is
`4,024 days. Of this time, 3,843 days occurred during the testing phase and 181 days occurred
`during the approval phase. These periods of time were derived from the following dates:
`
`I.
`
`The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act
`involving this device became effective: April 11, 1997.
`
`FDA has verified the applicant's claim that the date the investigational device exemption
`(IDE) required under section 520(g) of the Federal Food, Drug, and Cosmetic Act for
`human tests to begin became effecti ve on April 11, 1997.
`
`2.
`
`The date the application was initially submitted with respect to the device under section
`515 of the Federal Food, Drug, and Cosmetic Act: October 18, 2007.
`
`FDA has verified the applicant'S claim that the premarket approval application (PMA) for
`Talent Abdominal Stent Graft System (PMA P070027) was initially submitted on
`October 18, 2007.
`
`3.
`
`The date the application was approved: April 15,2008.
`
`FDA has verified the applicant's claim that PMA P070027 was approved on April .15,
`2008.
`
`Edwards Exhibit 1025, p. 9
`
`

`

`..
`
`. 1
`
`Dudas - Talent Abdominal Stent Graft System - page 2
`
`This determination of the regulatory review period by FDA does not take into account the
`effective date of the patent, nor does it exclude one-half of the te~ting phase as required by 35
`U.S.c. section I 56(c)(2).
`
`Please let me know if we can be of further assistance.
`
`Sincerely yours,
`
`o~§\ L Ct
`
`In:::lrad
`Associate Dir~Ctor for Policy
`Center for Drug Evaluation and Research
`
`cc:
`
`11ichael J. Jaro
`11edtronic, Inc.
`Vice President and Chief Patent Counsel
`710 11edtronic Parkway :MIS LC340
`11inneapolis, 11N 55432
`
`Edwards Exhibit 1025, p. 10
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAR 2 5 2009
`
`Commissioner for Patents
`United States Patent and Trademark Office
`.
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.\llPto.gov
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`Attention: Beverly Friedman
`
`Dear Ms. Axelrad:
`
`Transmitted herewith is a copy of the application for patent term extension of U.S. Patent No.
`6,306,141. The application was filed on June 11,2008, under 35 U.S.C. § 156.
`
`The patent claims a product that was subject to regulatory review under the Federal Food, Drug
`and Cosmetic Act. Subject to final review, the subject patent is considered to be eligible for
`patent term extension. Thus, a determination by your office of the applicable regulatory review
`period is necessary. Accordingly, notice and a copy of the application are provided pursuant to
`35 U.S.C. § 156(d)(2)(A).
`
`Inquiries regarding this communication should be directed to Raul Tamayo at (571) 272-7728
`(telephone) or (571) 273-7728 (facsimile).
`
`\_~cdu
`
`Mary C. TIl
`Legal Advisor
`Office of Patent Legal Administration
`Office of the Deputy Commissioner
`for Patent Examination Policy
`
`cc:
`
`Michael 1. Jaro
`Medtronic, Inc.
`710 Medtronic Parkway
`MIS LC340
`Minneapolis, MN 55432
`
`RE: T ALENTTM Abdominal Stent Graft System
`Docket No.: FDA-2008-E-0568
`
`Edwards Exhibit 1025, p. 11
`
`

`

`"stJ,V1CIS ("1 DEPARTMENT OF HEALTH 8< HUMAN SERVICES
`
`"+~ ... ,::::i;
`
`FEB-- 1 8 2009 -
`
`Food and Drug Administration
`Rockville MD 20857
`
`Re: Talent Abdominal Stent Graft System
`Docket No. FDA-2008-E-0568
`
`The Honorable Jon Dudas
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`Mail Stop Hatch-Waxman PTE
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Director Dudas:
`
`This is in regard to the application for patent term extension for U.S. Patent No.
`6,306,141 filed by Medtronic, Inc. under 35 U.S.C. § 156. The medical device claimed
`by the patent is Talent Abdominal Stent Graft System, which was assigned premarket
`approval (PMA) No. P070027.
`
`A review of the Food and Drug Administration's official records indicates that this
`product was subject to a regulatory review period before its commercial marketing 'or use,
`as required under 35 U.S.C. § I 56(a)(4). Our records also indicate that it represents the
`first permitted commercial marketing or use of the product, as defined under 35 U.S.c. §.
`I 56(f)(1 ).
`
`The PMA was approved on April 15, 2008, which makes the submission of the patent
`term extension application on June 11,2008, timely within the meaning of 35 U.S.C. §
`I 56(d)(1 ).
`
`Should you conclude that the subject patent is eligible for patent term extension, please
`advise us accordingly. As required by 35 U.S.C. § 156(d)(2)(Afwe will then-determine
`the applicable regulatory review period, publish the determination in the Federal
`, Register, a.nd notify you of our determination.
`
`Please let me know if we can be of further assistance.
`
`Sincerely yours,
`
`~tl~
`
`Jane A. Axelrad
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`Edwards Exhibit 1025, p. 12
`
`

`

`Dudas - Talent Abdominal Stent Graft System
`Patent No. 6,306,141
`Page 2
`
`cc: Michael J. Jaro
`Medtronic, Inc.
`Vice President and Chief Patent Counsel
`710 Medtronic Parkway MIS LC340
`Minneapolis, MN 55432
`
`Edwards Exhibit 1025, p. 13
`
`

`

`fI/C~~~ UNITED STATES PATENT AND TRADEMARK OFFICE
`
`JUL
`
`1 2008
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria. VA 22313-1450
`www.wplo.gov
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`Attention: Beverly Friedman
`
`The attached application for patent term extension of U.S. Patent No. 6,306,141 was filed on
`June 11,2008, under 35 U.S.C. § 156.
`
`The assistance of your Office is requested in confirming that the product identified in the
`application, T ALEN'fTM Abdominal Stent Graft System, has been subject to a regulatory review
`period within the meaning of 35 U.S.c. § 156(g) before its first commercial marketing or use and
`that the application for patent term extension was filed within the sixty-day period beginning on
`the date the product was approved. Since a determination has not been made whether the patent
`in question claims a product which has been subject to the Federal Food, Drug and Cosmetic Act,
`or a method of manufacturing or use of such a product, this communication is NOT to be
`considered as notice which may be made in the future pursuant to 35 U.S.C. § 156(d)(2)(A).
`
`Our review of the application to date indicates that the subject patent would be eligible for
`extension of the patent term under 35 U.S.c. § 156.
`
`Inquiries regarding this communication should be directed to Raul Tamayo at (571) 272-7728
`(telephone) or (571) 273-7728 (facsimile).
`
`Mar;rC:Thl
`Legal Advisor
`Office of Patent Legal Administration
`Office of the Deputy Commissioner
`for Patent Examination Policy
`
`cc:
`
`Michael J. Jaro
`Medtronic, Inc.
`710 Medtronic Parkway
`MIS LC340
`Minneapolis, MN 55432
`
`Edwards Exhibit 1025, p. 14
`
`

`

`llnder the
`
`/
`
`PTO/SB121 (01-08)
`Approved for use through 0613012008. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`e .. "",.,;, . AN nf 1995 nn n"",nn' . ,u" rPn"i .... ~ to r"~nnnri In a N'lil >r1inrtof'
`unless it rii"nl"v,\ aYa!id OMR N'lntrnl number.
`Application Number
`08/483,291 (Pat No. 6,306,141)
`
`TRANSMITTAL
`FORM
`
`(to be used for al/ correspondence after initial filing)
`
`"- Total Number of Pages in This Submission 1139
`
`Filing Date
`
`First Named Inventor
`
`Art Unit
`
`Examiner Name
`
`06107/1995
`
`James E. Jervis
`
`Attorney Docket Number
`
`1951288.00284
`
`ENCLOSURES
`
`(Check all that apply)
`
`"
`
`./
`
`0
`
`D
`
`Fee Transmittal Form
`
`Drawing(s)
`
`D
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`Fee Attached
`
`AmendmenUReply
`
`After Final
`
`Provisional Application
`
`Affidavits/declaration(s)
`
`Change of Correspondence Address
`
`Extension of Time Request
`
`D After Allowance Communication to TC
`D Appeal Communication to Board
`D Appeal Communication to TC
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`0
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`of Appeals and Interferences
`
`(Appeal Notice, Brief,. Reply Brief)
`
`Proprietary Information
`
`Other Enclosure(s) (please Identify
`below):
`Express Mail Certification, Application for
`Patent Term Extension under 37 USC 156,
`including exhibits
`
`D
`D licensing-related Papers
`[{] Petition
`D Petition to Convert to a
`D
`D Power of Attorney, Revocation
`D
`D Terminal Disclaimer
`D
`D Express Abandonment Request D Request for Refund
`D Information Disclosure Statement D CD, Number of CD(s)
`D Landscape Table on CD
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`Document(s)
`
`D Certified Copy of Priority
`D Reply to Missing Partsl
`D Reply to Missing Parts
`
`Incomplete Application
`
`under 37 CFR