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`USE OF PAMIDRONATE AND RELATED COMPOUNDS FOR THE
`TREATMENT OF COMPLEX REGIONAL PAIN SYNDROME
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`EFS - Web 1.0.1
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`Doc Code: TR.PROV
`Document Description: Provisional Cover Sheet (SB16)
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`/Herriot Tabuteau/
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`Date (YYYY-MM-DD)
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`2012-05-14
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`Herriot
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`Tabuteau
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`3
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`
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Utility Patent Application (Provisional)
`
`USE OF PAMIDRONATE AND RELATED COMPOUNDS FOR THE TREATMENT OF COMPLEX REGIONAL
`PAIN SYNDROME
`
`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-l), also known as reflex sympathetic dystrophy
`(RSD), and complex regional pain syndrome type II (CRPS-II), 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 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 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 add,
`olpadronic acid, alendronic acid, ibandronic acid, risedronic add, and zoledronic acid, respectively.
`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
`
`4
`
`
`
`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 CRPS-I 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 rng, about 100 rng to about 500 mg, or about 150 mg to about 300 rng. 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 :1.00 mg to about 500 mg, or about 150 rng to about 300 mg. In
`some embodiments the parenteral dose of neridronate is about 5 rng to about 500 mg, about 5 rng to
`about 200 rng, 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 rng,
`about 0.5 mg to about 50 rng, about 2.5 mg to about 50 mg, or about 1 rng to about 25 rng. 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 rng 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 rng 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.
`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 pamidronate, neridronate, olpadronate,
`alendronate, ibandronate, risedronate, zoledronate or another bisphosphonate compound for
`the treatment of CRPS-1 or CRPS-II.
`
`5
`
`
`
`7. The composition according to claim 1 where the daily oral dose of ibandronate is about 1 mg to
`
`2. A method for the treatment of CRP5-1 or CRPS-H comp
`rising 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.
`
`about 50 mg.
`
`about 25 mg.
`oral dose of risedronate is about 1 mg to
`8. The composition according to claim 1 where the daily
`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 150 mg to
`about 300 mg.
`dose of neridronate is about 150 mg to
`11, The method according to dam 2 where the daily oral
`about 300 mg.
`12, The method according to dam
`about 50 mg.
`13. The method according to claim
`about 50 mg.
`14. The method according to claim
`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.
`
`2 where the daily oral dose of olpadronate is about 2 mg to
`
`2 where the daily oral dose of ibandronate is about 1 mg to
`
`6. The composition according to claim 1 where the daily oral dose of olpadronate is about 2 mg to
`
`2 where the daily oral dose of alendronate is about 2 mg to
`
`6
`
`
`
`Electronic Patent Application Fee Transmittal
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`Application Number:
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`Filing Date:
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`Title of Invention:
`
`USE OF PAMIDRONATE AND RELATED COMPOUNDS FOR THE TREATMENT OF
`COMPLEX REGIONAL PAIN SYNDROME
`
`First Named Inventor/Applicant Name:
`
`Herriot Tabuteau
`
`Filer:
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`Herriot Tabuteau
`
`Attorney Docket Number:
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`Title of Invention:
`
`USE OF PAMIDRONATE AND RELATED COMPOUNDS FOR THE TREATMENT OF
`COMPLEX REGIONAL PAIN SYNDROME
`
`First Named Inventor/Applicant Name:
`
`Herriot Tabuteau
`
`Herriot Tabuteau
`
`401 East 64 Street Apt. 4D
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`Correspondence Address:
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`Provisional Cover Sheet (SB16)
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`Provisional_ Co ver -Sheet_CRPS-
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`** SMALL ENTITY **
`Title
`
`USE OF PAMIDRONATE AND RELATED COMPOUNDS FOR THE TREATMENT OF COMPLEX
`REGIONAL PAIN SYNDROME
`
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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.
`
`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.
`
`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.
`
`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.
`
`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).
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`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.
`
`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.
`
`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
`State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and
`page 2 of 3
`
`12
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`
`
`Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of
`Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`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).
`
`SelectUSA
`
`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.
`
`page 3 of 3
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`13
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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.
`
`POWER OF ATTORNEY TO PROSECUTE APPLICATIONS BEFORE THE USPTO
`
`9
`
`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).
`
`Please change the correspondence address for the application identified in the attached statement under 37 CFR 3.73(b) to:
`
`1 The address associated with Customer Number:
`OR
`— Firm or
`Individual Name
`Address
`
`45200
`
`City
`
`Country
`
`Telephone
`
`Assignee Name and Address:
`
`State
`
`Zip
`
`
`A copy of this form, together with a statement under 37 CFR 3.73(b) (Form PTO/SB/96 or equivalent) is required to be
`filed in each application in which this form is used. The statement under 37 CFR 3.73(b) may be completed by one of
`the practitioners appointed in this form if the appointed practitioner is authorized to act on behalf of the assignee,
`and must identify the application in which this Power of Attorney is to be filed.
`SIGNATURE of Assignee of Record
`Th individual whose signature and title is supplied below is authorized to act on behalf of the assignee
`Date (cid:9) 6 — x so — t a .
`Telephone 4 ci-C —6.0-- p.,rj...y.-
`
`Signature
`
`Name
`
`—.
`
`Herriot Tabuteau
`
`Inventor
`Title
`.
`_. (cid:9)
`o tile (and
`lection of information is required by 37 CFR 1.31, 1.32 and 1.33. The information is required to obtain or retain a benefit by the public which (cid:9)
`This (cid:9)
`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 3 minutes
`to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer,
`U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`14
`
`
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection
`with your submission of the attached form related to a patent application or patent. Accordingly,
`pursuant to the requirements of the Act, please be advised that: (1) the general authority for the
`collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary;
`and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark
`Office is to process and/or examine your submission related to a patent application or patent. If you do
`not furnish the requested information, th