IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No.:
`
`DC0317US .NP
`
`Inventors:
`
`Charles M. Brenner
`
`Serial No.:
`
`11/912,400
`
`Filing Date:
`
`November 20, 2007
`
`Examiner:
`
`Kagnew H. Gebreyesus
`
`Customer No.:
`
`26259
`
`Group Art Unit:
`
`Confirmation No.:
`
`1656
`
`8483
`
`Title:
`
`Nicotinamide Riboside Kinase Compositions
`and Methods for Using the Same
`
`Electronically submitted via EFS-Web
`Date: August 25, 2009
`
`| hereby certify that this paper is being electronically
`Submitted on the date indicated above to the
`Commissioner for Patents, U.S. Patent and
`Trademark Office (Non-Fee Amendment)
`
`acicmdude
`By
`TypedName: Jdne MasseyLicata, Reg. No. 32,257
`
`Commissioner for Patents
`U.S. Patent and Trademark Office
`(Non-Fee Amendment)
`
`Reply to Restriction Requirement and
`Preliminary Amendment
`
`This
`
`is
`
`in reply to the Restriction Requirement mailed
`
`August 7,
`
`2009 setting a one
`
`(1) month period for
`
`response.
`
`Please enter the following remarks into the record.
`
`Amendments
`
`to the Specification begin at page 2 of
`
`this
`
`paper.
`
`Amendments
`
`to the Claims are reflected in the listing of
`
`claims which begin on page 3 of this paper.
`
`Remarks being on page 4 of this paper.
`
`Elysium Health Exhibit 1003
`Page 1of 187
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`
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`Elysium Health Exhibit 1003
`Page 1 of 187
`
`

`

`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 2
`
`DC0317US .NP
`Charles M. Brenner
`11/912 ,400
`November 20, 2007
`
`Amendments to the Specification:
`Please replace the paragraph beginning at
`
`line 7 of page 1
`
`with the following rewritten paragraphs:
`
`to
`priority
`of
`benefit
`claims
`application
`--This
`
`PCT/US2006/015495,
`filed April 20,
`2006, which claims benefit
`
`from U.S. Patent Application Serial No. 11/113,701,
`
`filed April
`
`25, 2005, which is a continuation-in-part of PCT application No.
`PCT/US2005/004337,
`filed February 09, 2005, which claims benefit
`
`under
`
`35 U.S.C.
`
`§119
`
`to U.S. Provisional Patent Application
`
`Serial No. 60/543,347, filed on February 10, 2004, whose contents
`
`are incorporated herein by reference in their entireties.--
`
`Elysium Health Exhibit 1003
`Page 2 of 187
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`Elysium Health Exhibit 1003
`Page 2 of 187
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`

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`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 3
`
`DC0317US .NP
`Charles M. Brenner
`11/912 ,400
`November 20, 2007
`
`This listing of claims will replace all prior versions, and
`
`listings, of claims in the application:
`
`Listing of Claims:
`
`Claims 1-29 (canceled).
`
`Claim 30
`
`(new):
`
`A
`
`composition
`
`comprising
`
`isolated
`
`nicotinamide riboside in admixture with a carrier.
`
`Claim 31
`
`(new): The composition of claim 30, wherein the
`
`nicotinamide riboside is isolated from a natural or synthetic
`
`source.
`
`Claim 32
`
`(new): The composition of claim 30, wherein said
`
`composition is formulated for oral administration.
`
`Elysium Health Exhibit 1003
`Page 3 of 187
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`Elysium Health Exhibit 1003
`Page 3 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 4
`
`DC0317US .NP
`Charles M. Brenner
`11/912 ,400
`November 20, 2007
`
`REMARKS
`
`Claims
`
`1-13,
`
`20-23
`
`and
`
`26-29
`
`are
`
`pending
`
`in
`
`this
`
`application. Claims 1-13, 20-23 and 26-29 have been canceled.
`
`Claims 30-32 have been added. No
`
`new matter has been added.
`
`Applicant
`
`respectfully
`
`requests
`
`reconsideration
`
`of
`
`the
`
`restriction requirement
`
`in view of the following remarks.
`
`As an initial point, Applicant notes that
`
`the grouping of
`
`claims is not consecutive.
`
`In so far as all the claims have been
`
`placed into a Group, Applicant will
`
`assume
`
`for
`
`the sake of
`
`facilitating the
`
`prosecution
`
`of
`
`this Application that
`
`the
`
`Examiner intended to restrict the claims into Groups 1-13 rather
`
`than Groups 1-10 and 17-19. Accordingly, Applicant will refer to
`
`Groups 1-13 hereafter.
`
`The claims of the present application have been subjected to
`
`121
`35 U.S.C.
`a Restriction Requirement under
`Examiner suggests that restriction of the present
`
`The
`and 372.
`invention into
`
`the following groups is required:
`Group 1, claims 1-5 and 8, drawn to an isolated nucleic acid
`of
`SEQ
`ID
`NO:
`1,
`vectors,
`and
`composition
`comprising
`pharmaceutical
`acceptable carrier
`comprising a polynucleotide
`encoding
`SEQ
`ID NO:34 where
`said
`polynucleotide
`sequence
`comprises SEQ ID NO:1 or variant thereof encoding a nicotinamide
`
`riboside;
`Group 2, claims 1-5 and 8, drawn to an isolated nucleic acid
`of
`SEQ
`ID
`NO:
`2,
`vectors,
`and
`composition
`comprising
`pharmaceutical
`acceptable carrier
`comprising a polynucleotide
`encoding
`SEQ
`ID NO:34 where
`said
`polynucleotide
`sequence
`comprises SEQ ID NO:2 or variant
`thereof encoding a nicotinamide
`
`riboside;
`
`Elysium Health Exhibit 1003
`Page 4 of 187
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`Elysium Health Exhibit 1003
`Page 4 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 5
`
`DC0317US .NP
`Charles M. Brenner
`11/912,400
`November 20, 2007
`
`Group 3, claims 1-5 and 8, drawn to an isolated nucleic acid
`
`of
`
`SEQ
`
`ID
`
`NO:
`
`3,
`
`vectors,
`
`and
`
`composition
`
`comprising
`
`pharmaceutical acceptable carrier
`
`comprising a polynucleotide
`
`encoding
`
`SEQ
`
`ID NO:34 where
`
`said polynucleotide
`
`sequence
`
`comprises SEQ ID NO:3 or variant thereof encoding a nicotinamide
`
`riboside,
`
`Group 4, claims
`
`6,
`
`7,
`
`9,
`
`10,
`
`11 and 29 are drawn to an
`
`isolated eukaryotic nicotinamide riboside kinase polypeptides
`
`having an amino acid sequence comprising SEQ ID NO:34 where said
`
`polypeptide sequence comprises SEQ ID NO:4 or variants thereof
`
`and compositions comprising the same;
`
`Group
`
`5,
`
`claims
`
`6,
`
`7,
`
`9,
`
`10,
`
`11
`
`and 29
`
`are drawn to
`
`nicotinamide
`
`riboside kinase polypeptides of
`
`SEQ ID NO:5 or
`
`variants of SEQ ID NO:5 and compositions comprising the same;
`
`Group
`
`6,
`
`claims
`
`6,
`
`7,
`
`9,
`
`10,
`
`11
`
`and 29 are drawn to
`
`nicotinamide
`
`riboside kinase polypeptides of
`
`SEQ ID NO:6 or
`
`variants of SEQ ID NO:6 and compositions comprising the same;
`
`Group 7, claims 12 and 13 in part are drawn to method of
`treating cancer with a composition comprising the a nicotinamide
`
`riboside kinase gene of SEQ ID NO:4 and a prodrug;
`Group 8, claims 12 and 13 in part are drawn to method of
`treating cancer with a composition comprising the nicotinamide
`
`riboside kinase gene of SEQ ID NO:
`5 and a prodrug;
`Group 9, claims 12 and 13 in part are drawn to method of
`treating cancer with a composition comprising the nicotinamide
`
`riboside kinase gene of SEQ ID NO:6 and a prodrug;
`Group 10, claim 20 is drawn to identifying a nicotinamide
`riboside related pro-drug by determining whether
`a candidate
`
`Elysium Health Exhibit 1003
`Page 5 of 187
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`Elysium Health Exhibit 1003
`Page 5 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 6
`
`DC0317US .NP
`Charles M. Brenner
`11/912,400
`November 20, 2007
`
`agent
`
`is phosphorylated by
`
`the nicotinamide
`
`riboside kinase
`
`polypeptides comprising SEQ ID NO:34;
`
`Group 11, claims 21, 23 are drawn to a prodrug identified by
`
`an in vitro phosphorylation assay or by a cell based assay;
`
`Group 12, claim 22 is drawn to identifying a nicotinamide
`
`riboside related pro-drug by contacting a first test cell which
`
`expresses a
`
`recombinant nicotinamide riboside kinase comprising
`
`SBQ ID NO:34 with a nicotinamide riboside-related test agent
`
`determining whether a candidate agent causes cell death; and
`
`Group
`
`13,
`
`claims
`
`26-28
`
`are
`
`drawn
`
`to a pharmaceutical
`
`composition comprising nicotinamide riboside in admixture with a
`
`pharmaceutical composition.
`
`The Examiner contends that the inventions do not relate to a
`
`single general
`
`inventive concept under
`
`PCT Rule 13.1 because,
`
`under PCT Rule 13.2,
`
`they lack the same or corresponding special
`
`technical feature. The Examiner acknowledges that
`
`the technical
`
`feature linking the inventions in groups 1-13 is the isolated
`
`polynucleotide
`
`sequences
`
`and
`
`encoded
`
`nicotinamide
`
`riboside
`
`kinases and the use of these molecules in a method of
`
`treating
`
`cancer and/or identifying a natural or synthetic source of these
`
`molecules.
`
`However,
`
`it
`
`is
`
`suggested
`
`that
`
`each
`
`of
`
`the
`
`polynucleotide sequences
`
`and encoded proteins are structurally
`
`distinct from each other, such that each sequence is distinct and
`
`restriction for examination purposes
`
`is proper.
`
`The Examiner
`
`asserts that Applicant
`
`is required to elect one of the Groups to
`
`be examined.
`
`Applicant
`
`respectfully disagrees with
`
`this
`
`restriction
`
`requirement. However,
`
`in the interest of facilitating the search
`
`and
`
`examination of
`
`this application, Applicant
`
`has
`
`canceled
`
`Elysium Health Exhibit 1003
`Page 6 of 187
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`Elysium Health Exhibit 1003
`Page 6 of 187
`
`

`

`Attorney Docket No.:
`Inventors:
`Serial No.:
`Filing Date:
`Page 7
`
`DC0317US .NP
`Charles M. Brenner
`11/912 ,400
`November 20, 2007
`
`claims 1-13,
`
`20-23 and 26-29 without prejudice,
`
`reserving the
`
`right
`
`to file continuing applications for the canceled subject
`
`matter,
`
`and
`
`added new claims
`
`30-32
`
`drawn
`
`to a
`
`composition
`
`comprising isolated nicotinamide riboside in admixture with a
`
`carrier. Support for claims 30-32 is found at page 57
`
`(lines 18-
`
`23),
`
`the passage spanning page 60
`
`(line 18) and page 61
`
`(line 23)
`
`and claims 26 and 27 as previously presented.
`
`In so
`
`far
`
`as
`
`new claims
`
`30-32
`
`relate to compositions
`
`comprising nicotinamide
`
`riboside, Applicant hereby elects
`
`to
`
`prosecute the subject matter of Group 13, as currently presented
`
`in claim 30-32, drawn to a composition comprising nicotinamide
`
`riboside in admixture with a carrier.
`
`Respectfully submitted,
`
`AJorensAedes
`Jane Massey Licata
`Registration No. 32,257
`
`Date: August 25, 2009
`
`Licata & Tyrrell P.C.
`66 E. Main Street
`Marlton, New Jersey 08053
`(856) 810-1515
`Email: JMLicata@licataandtyrrell.com
`
`Elysium Health Exhibit 1003
`Page 7 of 187
`
`
`
`Elysium Health Exhibit 1003
`Page 7 of 187
`
`

`

`Electronic AcknowledgementReceipt
`
`Title of Invention:
`
`Nicotinamide Riboside Kinase Compositions and Methods for Using the Same
`
`U.S. National Stage under 35 USC 371
`
`First Named Inventor/Applicant Name:
`
`Charles M. Brenner
`
`Customer Number:
`
`26259
`
`Jane MasseyLicata/Patricia O'Reilly
`
`Filer Authorized By:
`
`Jane MasseyLicata
`
`Attorney Docket Number:
`
`DCO317US.NP
`
`Receipt Date:
`
`Filing Date:
`
`25-AUG-2009
`
`20-NOV-2007
`
`Time Stamp:
`
`12:42:23
`
`Application Type:
`
`Paymentinformation:
`
`Submitted with Payment
`
`File Listing:
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`122999
`
`Information:
`
`Miscellaneous Incoming Letter
`
`DC317USNP_TRANS.pdf
`
`e9a2bc2d14d6a5e42bb541317147/cfefcd
`O5f5e
`
`Elysium Health Exhibit 1003
`Page 8 of 187
`
`

`

`DC317USNP_RSR.pdf
`
`£952edf52379ba6769a7bd26d2e32ea591d
`
`479247
`
`ee
`
`Multipart Description/PDF files in .zip description
`
`the application.
`
`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 shownon this AcknowledgementReceiptwill establish the international filing date of
`
`Applicant Arguments/Remarks Made in an Amendment
`
`Information:
`
`This AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe 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 componentsfora 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 shownonthis
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`
`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/EO/903indicating acceptanceof 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.
`
`Elysium Health Exhibit 1003
`Page 9 of 187
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`Elysium Health Exhibit 1003
`Page 9 of 187
`
`

`

`
`
`
`
`AMENDMENT TRANSMITTAL LETTER (Small Entity)
`Applicant(s): Charles M. Brenner
`
`Docket No.
`DC0317US.NP
`
`
`
`Application No. Customer No.| Group Art Unit|Confirmation No.Filing Date Examiner
`
`
`
`
`
`Typed or Printed Name ofPerson Mailing Correspondence
`
`No additional fee is required for amendment.
`in the amountof
`Please charge Deposit Account No.
`to coverthe filing fee is enclosed.
`A check in the amount of
`The Director is hereby authorized to charge paymentof the following fees associated with this
`communication or credit any overpayment to Deposit Account No.
`50-1619
`Any additionalfiling fees required under 37 C.F.R. 1.16.
`Any patent application processing fees under 37 CFR 1.17.
`Paymentby credit card. Form PTO-2038is attached.
`WARNING: Information on this form may becomepublic. Credit card information should not be
`included on this form. Provide credit card information and authorization on PTO-2038.
`
`11/912,400
`
`October 24, 2007
`
`Kagnew H. Gebreyesus
`
`Invention: NICOTINAMIDE RIBOSIDE KINASE COMPOSITIONS AND METHODSFOR USING THE SAME
`
`COMMISSIONER FOR PATENTS:
`
`Transmitted herewith is an amendmentin the above-identified application.
`
`Applicant claims small entity status. See 37 CFR 1.27
`
`The fee has been calculated and is transmitted as shown below.
`
`CLAIMS AS AMENDED
`
`CLAIMS REMAINING
`
`HIGHEST#
`
`NUMBER EXTRA
`
`ADDITIONAL
`
`RATE
`
`AFTER AMENDMENT
`PREV. PAID FOR
`CLAIMS PRESENT
`FEE
`.
`0
`x
`$25.00
`$0.00
`3
`|
`TOTAL CLAIMS
`.
`0
`x
`$105.00
`$0.00
`1
`|
`INDEP. CLAIMS
`
`Multiple Dependent Claims (checkif applicable)
`$0.00
`
`TOTAL ADDITIONAL FEE FOR THIS AMENDMENT
`$0.00
`
`
`
`
`
`
`Oo;
`
`4
`
`
`
`Signature
`
`Jane MasseyLicata
`Reg. No. 32,257
`‘
`Licata & Tyrrell P.C.
`66 E. Main Street
`Marlton, NJ 08053
`Tel: 856-810-1515
`Fax: 856-810-1454
`Email: JMLicata@licataandtyrrell.com
`
`Dated: August 25, 2009
`
`this correspondence is being deposited with the
`| certify that
`United States Postal Service with sufficient postage as first class
`mail in an envelope addressed to "Commissioner for Patents, P.O.
`Box 1450, Alexandria, VA 22313-1450"[37 CFR 1,8(a)] on
`pate)
`
`
`
`Signature ofPerson Mailing Correspondence
`
`
`Elysium Health'Exhibit 1003
`Page 10 of 187
`
`
`
`Elysium Health Exhibit 1003
`Page 10 of 187
`
`

`

`PTO/SB/06 (07-06)
`Approved for use through 1/31/2007. 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 unlessit displays a valid OMB control number.
`
`Filing Date
`Application or Docket Number
`PATENT APPLICATION FEE DETERMINATION RECORD
`Substitute for Form PTO-875 11/20/2007|LJ To be mailed11/912,400
`
`
`
`APPLICATION AS FILED — PART|
`OTHER THAN
`
`
`
`(Column 1) SMALL ENTITY [IK]—oR(Column 2) SMALL ENTITY
`
`
`rere|Leeo] reo[|Luce] ee
`L] Basic FEE
`N/A
`N/A
`N/A
`NIA
`37 CFR 1.16(a),
`
`(b), or (c
`
`(m
`
`L] SEARCH FEE
`(i), or
`37 CFR 1.16(k),
`CT EXAMINATION FEE
`(37 CFR 1.16(0), (p), or (q))
`TOTAL CLAIMS
`37 CER 1.16(i
`INDEPENDENT CLAIMS
`37 CER 1.16(h
`
`Oo
`
`APPLICATION SIZE FEE
`(37 CFR 1.16(s))
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`_
`.
`minus 20 =
`_
`minus 3 =
`If the specification and drawings exceed 100
`sheets of paper, the application size fee due
`is $250 ($125 for small entity) for each
`additional 50 sheets or fraction thereof. See
`35 U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s).
`
`[_] MULTIPLE DEPENDENTCLAIM PRESENT(37 CFR 1.16(j))
`* If the difference in column 1 is less than zero, enter “O” in column 2.
`
`APPLICATION AS AMENDED- PARTII
`
`OTHER THAN
`
`(Column 3)
`
`SMALL ENTITY
`
`(Column 2)
`(Column 1)
`HIGHEST
`CLAIMS
`ADDITIONAL
`ADDITIONAL
`PRESENT
`NUMBER
`REMAINING
`
`08/25/2009|acter PREVIOUSLY EXTRA FEE($) FEE($)
`
`
`
`AMENDMENT
`PAID FOR
`rg
`3 minus|=24
`Independent
`F
`ee
`
`The “Highest Number Previously Paid For” (Total or Independent) is the highest number found in the appropriate box in column 1.
`
`(Column 2)
`(Column 1)
`HIGHEST
`CLAIMS
`NUMBER
`REMAINING
`PREVIOUSLY
`AFTER
`PAID FOR
`AMENDMENT
`KE
`cfieee
`3
`ee f=
`a
`37 CFR 1.16(h
`:
`Zz
`CJ Applicati
`Wi
`pplication Size Fee (37 CFR 1.16(s))
`
`
`
`[_] Application Size Fee (37 CFR 1.16(s))
`C] FIRST PRESENTATION OF MULTIPLE DEPENDENTCLAIM (37 CFR 1.16(j))
`
`S2
`
`(Column 3)
`
`PRESENT
`EXTRA
`
`<x | FIRST PRESENTATION OF MULTIPLE DEPENDENTCLAIM (37 CFR 1.16(j))
`
`* If the entry in column 1 is less than the entry in column 2, write “O” in column 3.
`** If the “Highest NumberPreviously Paid For’ IN THIS SPACEis less than 20, enter “20”.
`*** If the “Highest NumberPreviously Paid For’ IN THIS SPACEis less than 3, enter “3”.
`
`Legal Instrument Examiner:
`/LAMONT MCLAUCHLIN/
`
`This collection of information is required by 37 CFR 1.16. The information is required to obtain or retain a benefit by the public whichistofile (and by the USPTO to
`process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering,
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`If you need assistance in completing the form, call 1-800-PTO-9199 andselect option 2.
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`Elysium Health Exhibit 1003
`Page 11 of 187
`
`Elysium Health Exhibit 1003
`Page 11 of 187
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
` FILING DATE
`
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
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`CONFIRMATIONNO.
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`11/912,400
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`11/20/2007
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`Charles M. Brenner
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`DC0317US.NP
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`8483
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`LICATA & TYRRELLP.C.
`
`66 E. MAIN STREET
`MARLTON,NJ 08053
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`ne
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`EXAMINER
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`GEBREYESUS, KAGNEW H
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`ART UNIT
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`1656
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`PAPER NUMBER
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`
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` NOTIFICATION DATE
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`DELIVERY MODE
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`10/29/2009
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`poreilly @licataandtyrrell.com
`
`PTOL-90A (Rev. 04/07)
`
`Elysium Heawehey
`
`age
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`120
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`Elysium Health Exhibit 1003
`Page 12 of 187
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`11/912,400
`Examiner
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`KAGNEWH. GEBREYESUS
`
`BRENNER, CHARLES M.
`Art Unit
`
`1656 So
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timelyfiled
`after SIX (6) MONTHSfrom the mailing date of this communication.
`If NO period forreply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for replywill, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three monthsafter the mailing date of this communication, even if timely filed, may reduce any
`eamed patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)X] Responsive to communication(s) filed on 8/25/09.
`2a)L] This action is FINAL.
`2b)X] This action is non-final.
`3)L] Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)X] Claim(s) 30-32 is/are pending in the application.
`4a) Of the above claim(s)
`is/are withdrawn from consideration.
`5)L] Claim(s)_____ is/are allowed.
`6)X] Claim(s) 30-32 is/are rejected.
`7)L] Claim(s)__ is/are objectedto.
`8)L] Claim(s)____ are subject to restriction and/or election requirement.
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`Application Papers
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`6) C] Other: U.S. Patent and Trademark Office
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`9)L] The specification is objected to by the Examiner.
`10)X] The drawing(s) filed on 24 October 2007is/are: a)[_] accepted or b)X] objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`11)] The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)L] Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or(f).
`a)LJAll b)L_] Some*c)L] Noneof:
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`1.L] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies ofthe certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action foralist of the certified copies not received.
`
`Attachment(s)
`1) Xx] Notice of References Cited (PTO-892)
`2) [1] Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`3) IX] Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date See Continuation Sheet.
`
`4) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date. _
`5) L] Noticeof Informal Patent Application
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
`
`Part of Paper No./Mail Date 20091006
`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`Continuation Sheet (PTOL-326)
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`Application No. 11/912,400
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`Continuation of Attachment(s) 3). Information Disclosure Statement(s) (PTO/SB/08), Paper No(s)/Mail Date :11/20/2007,
`11/26/2007, 12/07/2007 and 1/26/2009 .
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`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`Application/Control Number: 11/912,400
`Art Unit: 1656
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`Page 2
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`DETAILED ACTION
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`Applicants reply filed on August 25, 2009 to the restriction requirement mailed on
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`August 07, 2009 is acknowledged.
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`Applicants noted that the claims were grouped as Groups 1-10 and 17-19 and that the
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`claims were intended to be restricted into Groups 1-13. The Examiner acknowledges this
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`typographical error. Accordingly reference will be made as Groups 1-13 from hereon.
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`With regards to the requirement for restriction, Applicants state that they disagree with
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`the restriction requirement, however Applicants do not provide a reason for their traversal.
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`Therefore the election will be construed as an election without traverse. Furthermore Applicants
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`canceled claims 1-13, 20-23 and 26-29 without prejudice. Applicants have added claims 30-32
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`which encompassthe subject matter of Group 13 comprising previous claims 26-28. Claims 30-
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`32 are present for examination. The requirementfor restriction is made final.
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`Priority
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`Priority is acknowledged for this application which claims benefit of priority to which
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`claims benefit under 35 U.S.C. 119 to U.S. Provisional Patent Application Serial No. 60/543,347
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`filed on February 10, 2004.
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`Information Disclosure Statement
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`The information disclosure statement
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`filed on 11/20/2007, 11/26/2007, 12/07/2007 and
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`1/26/2009 for which a copy of the patent publication has been submitted in this application has
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`been considered as shown by the Examiners signature.
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`Elysium Health Exhibit 1003
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`Application/Control Number: 11/912,400
`Art Unit: 1656
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`Page 3
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`Oath/Declaration
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`The oath or declaration submitted on November 20, 2007 has been reviewed andis in
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`compliance with 37 CFR 1.63.
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`Objection -Drawings
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`The drawings were received on October 24, 2007. These drawings appear to have a
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`sequence “Hsapi_MIBP” which appears to correspond to Nrk2 (SEQ ID NO: 6) described in the
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`brief description of the drawings (page 8). Applicants should reconcile the nomenclature in the
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`drawing with that used in the brief description of the drawingsin the specification.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section madein this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country orin public use or on
`sale in this country, more than one yearprior to the date of application for patent in the United States.
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`Claims 30, 31 and 32 are rejected under 35 U.S.C. 102(b) as being anticipated by
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`Saunderset al ' (Tiazofurin is phosphorylated by three enzymes from Chinese Hamster Ovary
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`Cells. Cancer Research 50, 5269-5274, Sept. 1, 1990 or Saunderset al 2 Phosphorylation of 3-
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`Deazaguanosine by nicotinamide riboside kinase in Chinese Hamster Ovary Cells). Both
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`references are cited in Applicant’s IDS. Saunders et a
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`1,2
`1”
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`teach use of nicotinamide riboside to
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`reverse the effects of tiazofurin on adenosine kinase deficient rat cells and in CHO cells (see
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`Elysium Health Exhibit 1003
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`Application/Control Number: 11/912,400
`Art Unit: 1656
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`Page 4
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`table 1 for example). Saunders et al ' teach that the preparation of nicotinamide riboside was
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`performed by enzymatic degradation of nicotinamide dinucleotide (NAD). The nicotinamide
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`riboside was eluted with water as described in Saundersetal ” below.
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`Saunders et al
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`* teach that
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`the growth inhibitory activity of 3-deazaguanosine is
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`substantially reversed by nicotinamide riboside kinase in a mutant line (TG*-3) of Chinese
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`Hamster Ovary Cells deficient in hypoxanthine guanine phosphoribosyltransferase (EC 2.4.2.8)
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`(see abstract and in the “Materials and Method” section and table 1 on page 6595).
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`Both Saunderset al '* teach the preparation and purification of nicotinamideriboside on
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`page 6594. Briefly, 20 mM nicotinamide mononucleotide (NMN) wastreated with 20 units of
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`5’nucleotidase enzyme; The enzyme was removedafter lhr. of treatment by denaturation with
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`0.8 N perchloric acid. The solution was adjusted to pH 8 after 15 minutes in 0°C, andthe salt
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`removed by centrifugation, the supernatant was removed by passage through 1X 20cm column
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`and elution with water (which can be considered a carrier). The above procedure results in a
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`composition comprising isolated nicotinamide riboside in water thus anticipate claims 30 and 31.
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`Claim 32 is include because the claim only recites that the composition is formulated for
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`oral administration without specifying the dose or application of such a formulation. Therefore in
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`absence evidence to the contrary claim 32 drawn to a composition comprising nicotinamide
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`riboside in admixture with a carrier (in this case water) can be considered a formulation suitable
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`for oral administration. Thus claims 30-32 are anticipated.
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`Claims 30, 31, 32 are rejected under 35 U.S.C. 102(b) as being anticipated by Tanimori
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`(2002) (Bioorganic. Med. Chem Lett. 12:1135-1137 cited in IDS includedherein).
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`Elysium Health Exhibit 1003
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`Application/Control Number: 11/912,400
`Art Unit: 1656
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`Page 5
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`Tanimori et al teach chemical synthesis (therefore synthetic synthesis) of nicotinamide
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`riboside and analogues (see column 2 of page 1135). Tanimori et al teach that nicotinamide
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`riboside (NAR) was synthesized using commercially available $-D-ribofuranose 1,2,3,5-
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`tetraacetate reacted with nicotinamide in the presence of trimethylsilyl trifluoromethansulfonate
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`(TMSOTHF) in acetonitril at room temperature for an hour followed by the addition of methanol.
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`Tanimori et al. (page 1135, column 1, paragraph 1) teach that nicotinamide riboside is a
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`precursor of nicotinamide mononucleotide (B-NMN) whichis a component used for chemical or
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`enzymatic preparation of NAD+,a co-factor important for cellular oxidation reduction reactions
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`(page 1135, column 1, paragraph 1).
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`Tanimori et al further teach that the final form of the nicotinamide riboside (NAR)
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`produced as colorless syrup which is further processed to a white solid form (see column 2 in
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`page 1136). Claims 32 recites that the composition is formulated for oral administration without
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`specifying the dose or application of such a formulation. Thus the syrup or the white solid form
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`of nicotinamide riboside produced by Tanimori et al would anticipate claim 32 absence evidence
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`to the contrary.
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`Relevant reference:
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`Stubberfield et al (NAD+ depletion and cytotoxicity in isolated hepatocytes (Biochemical
`Pharmacology 1988; 37(20): 3967-74 not included). Stubberfield et al teach Activation of
`poly(ADP-ribose)polymerase by DNA damaging agents causes a depletion of intracellular
`NAD+and subsequent lowering of ATP pools, which if extensive may leadto cell death.
`Therefore administering nicotinamideriboside can be used to preventor treat depletion of
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`NAD+.
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`Application/Control Number: 11/912,400
`Art Unit: 1656
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`Page 6
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to KAGNEW H. GEBREYESUS whose telephone number is
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`(571)272-2937. The examiner can normally be reached on 8:30am-5:30pm.
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`If attempts to reach the examiner by telephone are unsuccessful,
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`the examiner’s
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`supervisor, ANDREW WANGcan bereached on 571-272-0811. The fax phone numberfor the
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`organization where this application or proceedingis assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct-uspto.gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system,call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/Kagnew H Gebreyesus/
`Examiner, Art Unit 1656
`10/07/2009
`
`/Andrew Wang/
`Supervisory Patent Examiner, Art Unit 1656
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`Elysium Health Exhibit 1003
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`
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`Notice of References Cited
`
`Application/Control No.
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`11/912,400
`Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`BRENNER, CHARLES M.
`Art Unit
`
`U.S. PATENT DOCUMENTS
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`c}clc|/c}]c}cPIPPIPIe? Flefell
`lelefeintelele|_| c}cPIP?
`Classification
`Abstract included. |
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`Document Number
`Country Code-Number-Kind Code
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`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
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`Country
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`FOREIGN PATENT DOCUMENTS
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`NON-PATENT DOCUMENTS
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`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`U
`
`Saunders et al 1 Tiazofurin is phosphorylated by three enzymes from Chinese Hamster Ovary Cells. Cancer Research 50,
`5269-5274, Sept. 1, 1990
`
`Saunders et al 2 Phosphorylation of 3-Deazaguanosine by nicotinamide riboside kinase in Chinese Hamster Ovary Cells.
`
`Tanimori et al, Bioorganic. Med. Chem Lett. 12:1135-1137, 2002
`
`Stubberfield et al NAD+ depletion and cytotoxicity in isolated hepatocytes. Biochemical Pharmacology 1988; 37(20): 3967-74
`
`*A copyof this referenceis not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US orforeign.
`U.S. Patent and Trademark Office
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`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20091006
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`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`Form PTO-1449 Modified
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`Docket No.
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`Serial No.
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`11912400 - GAU:
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`Sheet
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`1
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`List of Patents and Publications
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`