UNITED STATES PATENT AND TRADEMARK OFFICE
`
`m.
`
`APPLICATION NUMBER
`61/403,680
`
`FILING OR 371(C) DATE
`09/20/2010
`
`40518
`LEVINE BAGADE HAN LLP
`2400 GENG ROAD, SUITE 120
`PALO ALTO, CA 94303
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`FIRST NAMED APPLICANT
`Amit Rajguru
`
`ATTY. DOCKET NO./TITLE
`EMKNPZ00700
`CONFIRMATION NO. 9172
`POA ACCEPTANCE LETTER
`
`Date Mailed: 01/11/2011
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 01/03/2011.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`/ddinh/
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1 of 1
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 1
`
`

`

`PT0/5111/0 (01.06)
`Approved for use through 12)31/2008. OMB 0651.0035
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1045. no persons are required to respond to a collection of information unless k displays a valid OMB =tidal number.
`POWER OF ATTORNEY TO PROSECUTE APPLICATIONS BEFORE THE USPTO
`
`I hereby revoke all previous powers of attorney given in the application identified in the attached statement under
`37 CFR 3.73(b).
`I hereby appoint:
`IZI Practitioners associated with the Customer Number
`
`40518
`
`OR
`Practitioner(s) named below (if more than ten patent practitioners are to be named. then a customer number must be used):
`
`Name
`
`Registration
`Number
`
`Name
`
`Registration
`Number
`
`.
`1
`as attorney(s) or agent(s) to represent the undersigned before the United gates Patent and Trademark Office (USPTO) in connection with
`any and all patent applications assigned gay to the undersigned according to the USPTO assignment records or assignment documents
`attached to this hem in accordance with 37 CFR 3.73(b).
`Please change the correspondence address for the applcation identified in the attached statement under 37 CFR 3.73(b) to:
`
`...I
`
`1
`
`The address associated with Customer Number
`
`40518
`
`i
`OR
`
`Firm or
`Individual Name
`Address
`
`City
`Country
`
`Telephone
`
`Assignee Name and Address:
`EMKINETICS, INC.
`49 Westdate Drive
`Santa Cruz, CA 95080
`
`State
`
`Zip
`
`Emai
`
`'the indivi
`
`Signature
`
`—1
`
`A copy of this form, together with a statement under 37 CFR 3.73(b) (Form PTO/313196 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 farm if the appointed practitioner is authorised 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
`whose si tnulure and title is supplied below is authorized to act on behalf of the assignee
`Date //A
`/e -
`Telephone ell r 4 54 7 (4 0 .
`
`•
`
`•
`
`•
`
`...
`
`......... .
`
`.
`
`by
`
`Christopher Hemianson
`Name
`Tide
`CEO
`....-
`of irdormatron
`-
`- --
`. --
`uxr,hecborr
`required to oblatn or retain a benefit by the public vdacit is to tide (and
`.
`1.33. The irrtorrnadon
`.
`.
`by die USPTO to process) an application. Confidentially is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 3 minutes
`*10
`to complete. including gathering. preparing. and submitting Ihe completed application form to the USPTO. Time
` vary depending upon the individual case. My
`comments on the amount of dine 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 ADORESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313.1450.
`if you need assistance in completing the (ann. call 14300-PT0-9199 and select calico; 2.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 2
`
`

`

`Attorney Docket No.: EMKNPZ00700
`
`PTO/SB/96 (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`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.
`
`STATEMENT UNDER 37 CFR 3.73(b)
`
`Applicant/Patent Owner: Amit RAJGURU et al.
` Filed/Issue Date: September 20, 2010
`Application No./Patent No.: 61/403,680
`Titled: METHOD AND APPARATUS FOR TRANSDERMAL STIMULATION OVER THE PALMAR AND PLANTAR
`SURFACES
`
`EMKinetics, Inc.
`(Name of Assignee)
`
`states that it is:
`
`, a
`
`corporation
`(Type of Assignee, e.g., corporation, partnership, university, government agency, etc.
`
`1.
`
`the assignee of the entire right, title, and interest in;
`
`2. 11 an assignee of less than the entire right, title, and interest in
`(The extent (by percentage) of its ownership interest is
`
`%); or
`
`3. 1=1
`
`the assignee of an undivided interest in the entirety of (a complete assignment from one of the joint inventors was made)
`
`the patent application/patent identified above, by virtue of either:
`
`A.
`
`An assignment from the inventor(s) of the patent application/patent identified above. The assignment was recorded in
`the United States Patent and Trademark Office at Reel 025491
` , Frame 0765
` , or for which a
`copy therefore is attached.
`
`OR
`B. El A chain of title from the inventor(s), of the patent application/patent identified above, to the current assignee as follows:
`
`1. From:
`
`To:
`
`The document was recorded in the United States Patent and Trademark Office at
`, Frame
`Reel
`, 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
`, or for which a copy thereof is attached.
`
`3. From:
`
`To:
`
`The document was recorded in the United States Patent and Trademark Office at
`Reel
`
`Frame
`
`or for which a copy thereof is attached.
`
`Additional documents in the chain of title are listed on a supplemental sheet(s).
`
`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 302.08]
`i e is sup lied below) is authorized to act on behalf of the assignee.
`The undersi ned (whos
`
`Signal re
`
`January 3, 2011
`Date
`
`Steven M. Giovannetti
`
`Attorney of Record
`Printed or Typed 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 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 1460, Alexandria, VA 22313-1460.
`
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 3
`
`

`

`Electronic Acknowledgement Receipt
`
`EFS ID:
`
`Application Number:
`
`9154723
`
`61403680
`
`International Application Number:
`
`Confirmation Number:
`
`9172
`
`Title of Invention:
`
`Method and apparatus for transdermal stimulation over the palmar and
`plantar surfaces
`
`First Named Inventor/Applicant Name:
`
`Amit Rajguru
`
`Therallova, LLC
`
`588 Teresita Boulevard
`
`Correspondence Address:
`
`-
`
`San Francisco
`
`CA
`
`94127
`
`US
`
`4155858508
`
`uspto@theranova.net
`
`Filer:
`
`Steven Michael Giovannetti/Kym Moore
`
`Filer Authorized By:
`
`Steven Michael Giovannetti
`
`Attorney Docket Number:
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`Application Type:
`
`Payment information:
`
`Submitted with Payment
`
`File Listing:
`
`03-JAN-2011
`
`20-SEP-2010
`
`18:17:25
`
`Provisional
`
`no
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 4
`
`

`

`Document
`Number
`
`1
`
`Document Description
`
`File Name
`
`EMKNPZ00700_20110103_POA
`.pdf
`
`File Size(Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`119105
`
`yes
`
`2
`
`709c576cd5dbal6ceabOd272aeed2803ce5
`c4696
`
`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Power of Attorney
`
`Assignee showing of ownership per 37 CFR 3.73(b).
`
`1
`
`2
`
`1
`
`2
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes):
`
`119105
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 5
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`m.
`
`
`
`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
`
`ATTY.DOCKET.NO
`
`
`
`ITOT CLAIMS I IND CLAIMS
`
`110
`
`NUMBER I 371(c) APPLICATION FILIN DATE G or I GRUPNIT ART I FIL FEE REC'D I
`
`
`
`
`
`
`
`09/20/2010
`
`61/403,680
`
`Therallova, LLC
`588 Teresita Boulevard
`San Francisco, CA 94127
`
`CONFIRMATION NO. 9172
`FILING RECEIPT
`
`00000000437900 2
`
`Date Mailed: 10/05/2010
`
`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)
`
`Amit Rajguru, Lafayette, CA;
`Daniel Rogers Burnett, San Francisco, CA;
`Christopher Hermanson, Santa Cruz, CA;
`Power of Attorney: None
`
`If Required, Foreign Filing License Granted: 09/30/2010
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 61/403,680
`Projected Publication Date: None, application is not eligible for pre-grant publication
`Non-Publication Request: No
`Early Publication Request: No
`** SMALL ENTITY **
`Title
`
`Method and apparatus for transdermal stimulation over the palmar and plantar surfaces
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`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
`page 1 of 3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 6
`
`

`

`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
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 7
`
`

`

`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).
`
`page 3 of 3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 8
`
`

`

`rn—L.
`—L.
`
`U.S. PTO
`61/403680
`09/20/2010
`PTO/SBI16 (12-08)
`Approved for use through 06/30/2010. OMB 0651-0032
`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.
`PROVISIONAL APPLICATION FOR PATENT COVER SHEET — Page 1 of 2
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c). •
`Express Mail Label No.
`
`C
`
`-a
`0
`
`Given Name (first and middle [if any])
`
`INVENTOR(S)
`Family Name or Surname
`
`Amit
`
`Daniel Rogers
`
`Christopher
`
`Rajguru
`
`Burnett
`
`Hermanson
`
`Residence
`(City and either State or Foreign Country)
`Lafayette, CA
`
`San Francisco, CA
`
`Santa Cruz, CA
`
`separately numbered sheets attached hereto.
`Additional inventors are being named on the
`TITLE OF THE INVENTION (500 characters max):
`
`METHOD AND APPARATUS FOR TRANSDERMAL STIMULATION OVER THE PALMAR
`AND PLANTAR SURFACES
`
`Direct all correspondence to:
`
`CORRESPONDENCE ADDRESS
`
`q The address corresponding to Customer Number:
`
`OR
`
`X
`
`Firm or
`Individual Name Therallova, LLC
`Address
`588 Teresita Boulevard
`
`San Francisco
`City
`Country USA
`
`State California
`Zip 94127
`Email uspto@theranova.net
`Telephone 415-585-8508
`ENCLOSED APPLICATION PARTS (check all that apply)
`
`q Application Data Sheet. See 37 CFR 1.76
`
`q CD(s), Number of CDs
`
`3
`X Drawing(s) Number of Sheets
`X Specification (e.g. description of the invention) Number of Pages 11
`Fees
`Due: Filing Fee of $220 ($110 for small entity). If the specification and drawings exceed 100 sheets of paper, an application size fee is
`due, which. is $270 ($135 for small entity) for each additional 50 sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s).
`also
`METHOD OF PAYMENT OF THE FILING FEE AND APPLICATION SIZE FEE FOR THIS PROVISIONAL APPLICATION FOR PATENT
`
`q Other (specify)
`
`X
`X
`
`II
`
`Applicant claims small entity status. See 37 CFR 1.27.
`A check or money order made payable to the Director of the United States Patent and Trademark Office
`is enclosed to cover the filing fee and application size fee (if applicable).
`Payment by credit card. Form PTO-2038 is attached.
`The Director is hereby authorized to charge the filing fee and application size fee (if applicable) or credit any overpayment to Deposit
`Account Number:
`
`$110.00
`
`TOTAL FEE AMOUNT ($)
`
`USE ONLY FOR FILING A PROVISIONAL APPLICATION FOR PATENT
`This collection of information is required by 37 CFR 1.51. 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 8 hours 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. ,
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 9
`
`

`

`PROVISIONAL APPLICATION COVER SHEET
`Page 2 of 2
`
`PTO/SB/16 (12-08)
`Approved for use through 06/30/2010. OMB 0651-0032
`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.
`
`The invention was made by an agency of the United States Government or under a contract with an agency of the United States Government.
`No.
`
`Yes, the name of the U.S. Government agency and the Government contract number are:
`
`WARNING:
`Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit card
`numbers (other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by
`the USPTO to support a petition or an application. If this type of personal information is included in documents submitted to the
`USPTO, petitioners/applicants should consider redacting such personal information from the documents before submitting them
`to the USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after publication of
`the application (unless a non-publication request in compliance with 37 CFR 1.213(a) is made in the application) or issuance of
`a patent. Furthermore, the record from an abandoned application may also be available to the public if the application is
`referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`PTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`SIGNATURE
`
`TYPED or PRINTED NAME
`
`Daniel F7vg rs Burnett
`
`TELEPHONE
`
`415-585-8508
`
`Date
`
`September 20, 2010
`
`REGISTRATION NO.
`(if appropriate)
`N/A
`
` Docket Number:
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 10
`
`

`

`PATENT APPLICATION
`
`METHOD AND APPARATUS FOR TRANSDERMAL LOW FREQUENCY
`
`STIMULATION
`
`Inventors:
`
`AMIT RAJGURU
`
`CHRISTOPHER HERMANSON
`
`DANIEL R. BURNETT
`
`Assignee:
`
`EMKinetics
`
`Status:
`
`Small Entity
`
`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 11
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`PATENT
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`METHOD AND APPARATUS FOR TRANSDERMAL LOW FREQUENCY
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`STIMULATION
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`BACKGROUND OF THE INVENTION
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`[0001] The present invention relates to the field of medical devices, in particular therapeutic
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`intervention devices for central and peripheral nerve modulation therapies, including both
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`excitation and blocking of nerve impulses. Of particular interest is the treatment and prevention
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`of urinary incontinence (UI) and overactive bladder (OAB) with the use of Low Frequency
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`Induction Therapy (LoFIT).
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`[0002] The OAB and UI market in the United States is well over a $12 billion a year industry.
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`It affects over 16% of all Americans, for a total U.S. market of approximately 34 million men
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`and women each year. Due to social stigmas attached to OAB and UI, as well as
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`misunderstanding of the signs and symptoms associated with OAB and UI, only 40% of those
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`affected (13.6M) seek treatment. Of those 13.6 million individuals, nearly 30% are unsatisfied
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`with their current therapy.
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`[0003] The use of pulsed electromagnetic stimulation (PES) has been well established as a
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`beneficial therapy in a variety of medical applications. The scientific principle behind this
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`technology is that an electric current passed through a coil will generate an electromagnetic field.
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`These fields, in turn, have been shown to induce current within conductive materials placed
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`within the field. When applied to the human body, pulsed electromagnetic stimulation has been
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`found to be an effective method of stimulating nerves resting within the electromagnetic field.
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`Building on recent data, which highlights the beneficial effects of invasive, needle-based
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`electrostimulation (ES) of the posterior tibial nerve in individuals with OAB and UI, there is
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`strong evidence for the treatment of these ailments with the use of LoFIT. In particular, ES has
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`been found to modulate bladder dysfunction through its action on the pudendal nerve and the
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`sacral plexus which provides the major excitatory input to the bladder.
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`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 12
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`[0004] Current treatment options for OAB and UI are exercise and behavioral modifications,
`pharmacological therapies, surgical intervention, and neuromodulation. Although each of these
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`treatment options targets the UI and OAB populations, each has severe limitations.
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`[0005] Exercise and behavioral modifications often require patients to adhere to stringent
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`routines, including scheduled voiding, maintenance of a bladder diary, and intense exercise
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`regiments. While this may be a viable option for a small group of highly dedicated individuals,
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`its daily impact on one's life makes it an unattractive option for most individuals.
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`[0006] Pharmacological intervention is the most widely prescribed therapy for OAB and UI.
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`Unfortunately, as with the ingestion of any chemical, patients are often subject to side effects
`from their drug therapy. This is especially detrimental in older and elderly patient populations
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`where interaction with other prescribed medications can have adverse effects. Further, there is a
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`high rate of dissatisfaction, approximately 30%, amongst individuals using pharmacological
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`treatment.
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`[0007] Surgical intervention is an extremely invasive treatment and often results in the long-
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`term, and in some cases permanent, requirement for catheterization. The high expense of these
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`procedures, coupled with the negative impact the procedures have on the patients quality of life,
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`make this an option only when all other treatment options have been exhausted.
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`[0008] Neuromodulation is another treatment alternative for OAB and UI patients. Sacral
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`nerve stimulation (SNS) has shown itself to be an effective treatment option for those with OAB
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`or UI. However, the procedure requires the permanent implantation of an electrical stimulation
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`device in the patient. One estimate puts the cost at nearly $14,000 with additional routine care
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`costs of $593 per patient per year. Additionally, SNS's risk of battery failure, implant infection,
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`and electrode migration, lead to a high reoperation rate and make this procedure unattractive.
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`[0009] More recently, the introduction of a posterior tibial nerve stimulator, often referred to as
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`SANS, has shown itself to be another neuromodulation alternative. Yet as is the case with other
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`forms of neuromodulation, this system is invasive in its nature. It requires the insertion of a
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`needle two inches into the patient's ankle region in order to stimulate the posterior tibial nerve.
`As well, it requires a minimum of 12 sessions for initial treatment, with the possibility of
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`additional sessions needed for maintenance. Despite its high cost and invasive nature, though, an
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`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 13
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`abundance of published peer-reviewed clinical trials demonstrate the safety and efficacy of the
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`SANS therapy.
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`REVIEW OF THE PRIOR ART
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`[0010] U.S. patent number 6,941,171 describes a method and system for treatment of
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`incontinence, urgency, frequency, and/or pelvic pain includes implantation of electrodes on a
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`lead or the discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be
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`stimulated. Stimulation pulses, either electrical or drug infusion pulses, are supplied by a
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`stimulator
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`implanted remotely, and through
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`the
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`lead or catheter, which
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`is tunneled
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`subcutaneously between the stimulator and stimulation site. This device, while holding some
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`therapeutic potential, is invasive in its delivery and requirement for implantation of device
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`components.
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`[0011] U.S. patent number 5,984,854 describes a method for treating urinary incontinence
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`which consists of delivering a train of current pulses through one or more magnetic stimulation
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`coils to induce a train of magnetic flux pulses, which then induce an eddy current within the
`body, thereby to stimulate a group of pelvic floor muscles, the pudendal nerve, the external
`urethral sphincter, or the tibial nerve. While this device describes the employment of pulsed
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`electromagnetic fields in the treatment of urinary incontinence, the application does not
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`contemplate the use of any specific component to facilitate the placement of the magnetic coils
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`over a targeted region of the body. That is, the application describes holding a coil over an
`intended region of the body, but does not contemplate the use of ergonomic wraps or other
`means for allowing an untrained user to apply the intended treatments. The application also does
`not call for the monitoring of the therapy using sensors to ensure that the nerve is actually being
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`stimulated and does not provide for adjustability of the device by the healthcare provider or user
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`in order to accommodate for commonly occurring physiologic and anatomic variations in nerve
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`locations.
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`[0012] U.S. patent number 6,735,474 describes a method and system for treatment of
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`incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or
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`more battery- or radio frequency-powered microstimulators beneath the skin of the perineum
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`Petitioner - Avation Medical, Inc.
`Ex. 1046, p. 14
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`and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via
`an external controller that can be used by a physician to produce patterns of output stimulation
`pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The
`stimulation program is retained in the microstimulator device or external controller and is
`transmitted when commanded to start and stop by a signal from the patient or caregiver. Again,
`this application involves the implantation of device components and is thus relatively invasive in
`nature. This patent also does not call for the monitoring of the therapy using sensors to ensure
`that the nerve is actually being stimulated and does not provide for adjustability of the device by
`the healthcare provider or user in order to accommodate for commonly occurring physiologic
`and anatomic variations in nerve locations.
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`[0013] U.S. patent application 20050171576 describes an electro-nerve stimulation apparatus
`includes a pulse generator, a first electrically conductive, insulated lead wire, a second
`electrically conductive, insulated lead wire, an electrically conductive transcutaneous electrode
`and an electrically conducti