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`Herriot
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`Tabuteau
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`Title of Invention
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`USE OF PAMIDRONATE, OLPADRONATE AND RELATED COMPOUNDS
`FOR THE TREATMENT OF PAIN
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`401 East 64th Street, Apt. 4D
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`1-646-688-2824
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`Herriot Tabuteau
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`The invention was made by an agency of the United States Government or under a contract with an agency of the United
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`EFS - Web 1.0.1
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`Doc Code: TR.PROV
`Document Description: Provisional Cover Sheet (SB16)
`
`PTO/SB/16 (11-08)
`Approved for use through 09/30/2010 OMB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
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`/Herriot Tabuteau/
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`Date (YYYY-MM-DD)
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`2012-05-15
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`First Name
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`Herriot
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`Last Name
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`Tabuteau
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`

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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Utility Patent Application (Provisional)
`
`USE OF PAMIDRONATE, OLPADRONATE AND RELATED COMPOUNDS FOR THE TREATMENT OF PAIN
`
`Inventor: Herriot Tabuteau
`
`Correspondence Address:
`Herriot Tabuteau
`401 East 64th Street, Apt. 4D
`
`New York, NY 10065
`
`BACKGROUND OF THE INVENTION
`Complex regional pain syndrome type I (CRPS-I), also known as reflex sympathetic dystrophy
`(RSD), and complex regional pain syndrome type II (CRPS-11), also known as causalgia, are debilitating
`pain syndromes. They are characterized by severe pain in a limb accompanied by allodynia,
`hyperalgesia, edema, changes in skin blood flow and abnormal sudomotor activity.
`These disorders are often difficult to treat and there exists a need for additional therapeutic
`options.
`
`DESCRIPTION OF THE INVENTION
`Disclosed are pharmaceutical compositions and methods for the treatment of any type of pain
`including, but not limited to, postoperative pain, cancer pain, arthritic pain, lumbosacral pain,
`musculoskeletal pain, neuropathic pain, chronic pain, etc.
`Disclosed are pharmaceutical compositions and methods for the treatment of complex regional
`pain syndrome type I and type II (CRPS-I and CRPS-II).
`One embodiment is a pharmaceutical composition comprising pamidronate, neridronate,
`olpadronate, alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound
`for the treatment of pain.
`Another embodiment is a pharmaceutical composition comprising pamidronate, neridronate,
`olpadronate, alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound
`for the treatment of CRPS-I and CRPS-II.
`The terms pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate,
`zoledronate, or another bisphosphonate compound, as used in this application refer to these
`compounds or their pharmaceutically acceptable salts, and any of their polymorphic forms.
`Other names for pamidronate, neridronate, olpadronate, alendronate, ibandronate,
`risedronate, and zoledronate may include but are not limited to parnidronic add, neridronic acid,
`olpadronic add, alendronic acid, ibandronic acid, risedronic add, and zoledronic add, respectively.
`Another embodiment is a method for the treatment of treatment of pain comprising
`administering to an individual pamidronate, neridronate, olpadronate, alendronate, ibandronate,
`risedronate, zoledronate or another bisphosphonate compound.
`
`4
`
`

`

`Yet another embodiment is a method for the treatment of treatment of CRPS-I and CRPS-II
`comprising administering to an individual pamidronate, neridronate, olpadronate, alendronate,
`ibandronate, risedronate, zoledronate or another bisphosphonate compound.
`Any suitable route of administration may be employed for providing an individual with an
`effective dosage of the pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate,
`zoledronate or another bisphosphonate compound. For example, oral, rectal, parenteral, transderrnal,
`sublingual, subcutaneous, intrathecal, intramuscular and the like may be employed as appropriate.
`Dosage forms for the pamidronate, neridronate, olpadronate, alendronate, ibandronate,
`risedronate , zoledronate or another bisphosphonate compound in the present embodiments include
`but are not limited to tablets, coated tablets, cachets, capsules, caplets, troches, dispersions, sustained
`release formulations, suspensions, solutions, patches and the like.
`In addition to the common dosage forms set forth above, the pamidronate, neridronate,
`olpadronate, alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound
`may also be administered by controlled release or sustained release means and/or delivery devices.
`The effective amount of pamidronate, neridronate, olpadronate, alendronate, ibandronate,
`risedronate zoledronate or another bisphosphonate compound in the treatment of pain, CRPS-1 and
`CRPS-II will vary depending on various factors known to the treating physicians, such as the severity of
`the condition to be treated, route of administration, formulation and dosage forms, physical characters
`of the pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate „ zoledronate or
`another bisphosphonate compound used, and age, weight and response of the individual patients.
`In some embodiments the daily oral dose of pamidronate is about 10 mg to about 1,000 mg,
`about 50 mg to about 500 mg, about 100 mg to about 500 mg, or about 150 mg to about 300 mg. In
`some embodiments the parenteral dose of pamidronate is about 5 mg to about 500 mg, about 5 mg to
`about 200 mg, or about 10 mg to about 150 mg.
`In some embodiments the daily oral dose of neridronate is about 10 mg to about 1,000 mg,
`about 50 mg to about 500 mg, about 100 mg to about 500 mg, or about 150 mg to about 300 mg. In
`some embodiments the parenteral dose of neridronate is about 5 mg to about 500 mg, about 5 mg to
`about 200 mg, or about 10 mg to about 150 mg.
`In some embodiments the daily oral dose of alendronate is about 0.5 mg to about 200 mg,
`about 1 mg to about 100 mg, about 5 mg to about 100 mg, or about 2 mg to about 50 mg. In some
`embodiments the parenteral dose of alendronate is about 1 mg to about 100 mg, about 1 mg to about
`40 mg, or about 2 mg to about 30 mg.
`In some embodiments the daily oral dose of olpadronate is about 0.5 mg to about 200 mg,
`about 1 mg to about 100 mg, about 5 mg to about 100 mg, or about 2 mg to about 50 mg. In some
`embodiments the parenteral dose of olpadronate is about 1 mg to about 100 mg, about 1 mg to about
`40 mg, or about 2 mg to about 30 mg.
`In some embodiments the daily oral dose of ibandronate is about 0.25 mg to about 100 mg,
`about 0.5 mg to about 50 mg, about 2.5 mg to about 50 mg, or about 1 mg to about 25 mg. In some
`embodiments the parenteral dose of ibandronate is about 0.5 mg to about 50 mg, about 0.5 mg to
`about 20 mg, or about 1 mg to about 15 mg.
`In some embodiments the daily oral dose of risedronate is about 0.25 mg to about 100 mg,
`about 0.5 mg to about 50 mg, about 2.5 mg to about 50 mg, or about 1 mg to about 25 mg. In some
`embodiments the parenteral dose of risedronate is about 0.25 mg to about 25 mg, about 0.25 mg to
`about 10 mg, or about 0.5 mg to about 7.5 mg.
`In some embodiments the daily oral dose of zoledronate is about 0.005 mg to about 20 mg,
`about 0.1 mg to about 10 mg, about 0.5 mg to about 10 mg, or about 0.2 mg to about 5 mg. In some
`embodiments the parenteral dose of zoledronate is about 0.25 mg to about 25 mg, about 0.25 mg to
`about 10 mg, or about 0.5 mg to about 7.5 mg.
`
`5
`
`

`

`The dose of pamidronate„ neridronate, olpadronate„ alendronate, ibandronate, risedronate,
`zoledronate or another bisphosphonate compound may be administered in a single or divided dose.
`
`CLAIMS
`
`1. A pharmaceutical composition comprising either parnidronate, neridronate, olpadronate,
`alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound for
`the treatment of pain.
`2. A method for the treatment of pain comprising administering to an individual either
`pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate or
`another bisphosphonate compound.
`3. The composition according to claim 1 where the daily oral dose of pamidronate is about 150 mg
`to about 300 mg,
`4. The composition according to claim 1 where the daily oral dose of neridronate is about 150 mg
`to about 300 mg,
`5. The composition according to claim 1 where the daily oral dose of alendronate is about 2 mg to
`about 50 mg.
`6. The composition according to claim 1 where the daily oral dose of olpadronate is about 2 mg to
`about 50 mg.
`7. The composition according to claim 1 where the daily oral dose of ibandronate is about 1 rug to
`about 25 mg.
`8. The composition according to claim 1 where the daily oral dose of risedronate is about 1 mg to
`about 25 mg.
`9. The composition according to claim 1 where the daily oral dose of zoledronate is about 0.2 mg
`to about 5 mg.
`10. The method according to claim 2 where the daily oral dose of pamidronate is about :1.50 mg to
`about 300 mg.
`11. The method according to claim 2 where the daily oral dose of neridronate is about 150 mg to
`about 300 mg.
`12. The method according to claim 2 where the daily oral dose of alendronate is about 2 mg to
`about 50 mg.
`13. The method according to claim 2 where the daily oral dose of olpadronate is about 2 mg to
`about 50 mg.
`14. The method according to claim 2 where the daily oral dose of ibandronate is about 1 mg to
`about 25 mg.
`15. The method according to claim 2 where the daily oral dose of risedronate is about 1 mg to about
`25 mg.
`16. The method according to claim 2 where the daily oral dose of zoledronate is about 0.2 mg to
`about 5 mg.
`17, A pharmaceutical composition comprising either parnidronate, neridronate, olpadronate,
`alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound for
`the treatment of CRPS-I or CRPS-II.
`18, A method for the treatment of CRPS-I or CRPS-ll comprising administering to an individual either
`pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate or
`another bisphosphonate compound.
`19, The composition according to claim 17 where the daily oral dose of parnidronate is about 150
`mg to about 300 mg.
`
`6
`
`

`

`17 where the daily
`oral dose of neridronate is about 150 mg
`
`17 where the daily
`oral dose of aiendronate is about 2 mg to
`
`17 where the daily
`oral dose of olpadronate is about 2 mg to
`
`17 where the daily
`oral dose of ibandronate is about 1 mg to
`
`17 where the daily
`oral dose of risedronate is about 1. rug to
`
`17 where the daily
`oral dose of zoledronate is about 0.2 mg
`
`20. The composition according to claim
`to about 300 mg.
`21. The composition according to claim
`about 50 mg.
`22. The composition according to claim
`about 50 mg.
`23. The composition according to claim
`about 25 mg.
`24. The composition according to claim
`about 25 mg.
`25. The composition according to claim
`to about 5 mg.
`ihere the daily oral 26. The method according to claim 18 If,
`about 300 rug.
`
`about 300 mg.
`'here the daily oral
`28, The method according to claim 18
`y
`dose of aiendronate is about 2 mg to
`about 50 mg.
`'here the daily oral
`29, The method according to claim 18
`y
`dose of olpadronate is about 2. mg to
`about 50 mg,
`30, The method according to claim 18 y
`dose of ibandronate is about 1 mg to chere the daily oral
`about 25 mg,
`31, The method according to claim 18 y
`dose of risedronate k about 1 mg to chere the daily oral
`about 25 mg.
`32. The method according to claim 18
`about 5 mg.
`
`
`
`
`dose of pamiclronate is about 150 mg to
`
`ihere the daily oral
`dose of neridronate is about 150 mg to
`27. The method according to claim 18 v,
`
`
`
`y kere the daily oral
`dose of zoledronate is about 0.2 mg to
`
`7
`
`

`

`Electronic Patent Application Fee Transmittal
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`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`USE OF PAMIDRONATE, OLPADRONATE AND RELATED COMPOUNDS FOR
`THE TREATMENT OF PAIN
`
`First Named Inventor/Applicant Name:
`
`Herriot Tabuteau
`
`Filer:
`
`Herriot Tabuteau
`
`Attorney Docket Number:
`
`Filed as Small Entity
`
`Provisional Filing Fees
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`2005
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`1
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`125
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`125
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`61647478
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`International Application Number:
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`6925
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`Title of Invention:
`
`USE OF PAMIDRONATE, OLPADRONATE AND RELATED COMPOUNDS FOR
`THE TREATMENT OF PAIN
`
`First Named Inventor/Applicant Name:
`
`Herriot Tabuteau
`
`Herriot Tabuteau
`
`401 East 64 Street Apt. 4D
`
`Correspondence Address:
`
`-
`
`New York (cid:9)
`
`NY (cid:9)
`
`10065
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`US (cid:9)
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`646-431-1431
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`ht@antecip.com
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`Herriot Tabuteau
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION
`NUMBER
`61/647,478
`
`I
`
`G or (cid:9)
`FILIN
` DATE
`371(c)
`05/15/2012
`
`I
`
`ART
`GRUPNIT
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`I
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`FIL FEE RECD
`125
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`I (cid:9)
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`Herriot Tabuteau
`401 East 64th Street, Apt. 4D
`New York, NY 10065
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O.Box 1450
`Alexandria, VirgLnia 22313-1450
`www.uspto.gov
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`ATTY.DOCKET.NO (cid:9)
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`ITOT CLAIMS I IND CLAIMS
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`CONFIRMATION NO. 6925
`FILING RECEIPT
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`000000005 425833
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`Date Mailed: 05/24/2012
`
`Receipt is acknowledged of this provisional patent application. It will not be examined for patentability and will
`become abandoned not later than twelve months after its filing date. Any correspondence concerning the application
`must include the following identification information: the U.S. APPLICATION NUMBER, FILING DATE, NAME OF
`APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to collection. Please verify
`the accuracy of the data presented on this receipt. If an error is noted on this Filing Receipt, please submit
`a written request for a Filing Receipt Correction. Please provide a copy of this Filing Receipt with the
`changes noted thereon. If you received a "Notice to File Missing Parts" for this application, please submit
`any corrections to this Filing Receipt with your reply to the Notice. When the USPTO processes the reply
`to the Notice, the USPTO will generate another Filing Receipt incorporating the requested corrections
`Applicant(s)
`
`Herriot Tabuteau, New York, NY;
`Power of Attorney: None
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`If Required, Foreign Filing License Granted: 05/22/2012
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 61/647,478
`Projected Publication Date: None, application is not eligible for pre-grant publication
`Non-Publication Request: No
`Early Publication Request: No
`** SMALL ENTITY **
`Title
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`USE OF PAMIDRONATE, OLPADRONATE AND RELATED COMPOUNDS FOR THE TREATMENT
`OF PAIN
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`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
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`Since the rights granted by a U.S. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent
`in a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing
`of patent applications on the same invention in member countries, but does not result in a grant of "an international
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`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
`protection is desired.
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`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from specific
`foreign countries to ensure that patent rights are not lost prematurely.
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`Applicants also are advised that in the case of inventions made in the United States, the Director of the USPTO must
`issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent application
`serves as a request for a foreign filing license. The application's filing receipt contains further information and
`guidance as to the status of applicant's license for foreign filing.
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`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically, the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.
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`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish
`to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative,
`this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual property in specific
`countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may
`call the U.S. Government hotline at 1-866-999-HALT (1-866-999-4158).
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`LICENSE FOR FOREIGN FILING UNDER
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`Title 35, United States Code, Section 184
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`Title 37, Code of Federal Regulations, 5.11 & 5.15
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`GRANTED
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`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted under
`37 CFR 5.13 or 5.14.
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`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof unless
`it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR 1.53(d). This
`license is not retroactive.
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`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject matter
`as imposed by any Government contract or the provisions of existing laws relating to espionage and the national
`security or the export of technical data. Licensees should apprise themselves of current regulations especially with
`respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of
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`Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of
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`NOT GRANTED
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`No license under 35 U.S.C. 184 has been granted at this time, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR 5.12,
`if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months has lapsed
`from the filing date of this application and the licensee has not received any indication of a secrecy order under 35
`U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).
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`SelectUSA
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`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage, facilitate, and accelerate business investment. To learn more about why the USA is the best
`country in the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
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`PTO/SB/80 (11-08)
`Approved for use through 11/30/2011. OMB 0651-0035
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
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`POWER OF ATTORNEY TO PROSECUTE APPLICATIONS BEFORE THE USPTO
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`9
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`I hereby revoke all previous powers of attorney given in the application identified in the attached statement under
`37 CFR 3.73(b).
`appoint:
`I hereby
`Fil Practitioners
`associated with the Customer Number:
`ri Practitioner(s)
`OR
`
`named below (if more than ten patent practitioners are to be named, then a customer number must be used):
`
`45200
`
`Name
`
`Registration
`Number
`
`Name
`
`Registration
`Number
`
`as attorney(s) or agent(s) to represent the undersigned before the United States Patent and Trademark Office (USPTO) in connection with
`any and all patent applications assigned only to the undersigned according to the USPTO assignment records or assignment documents
`attached to this form in accordance with 37 CFR 3.73(b).
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`Please c