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 25l 2009
`
`I hereby certify that this paper is being electronically
`Submitted on the date indicated above to the
`Commissioner for Patents. US. Patent and
`Trademark Office (Non-Fee Amendment)
`
`By
`Typed
`
`at, C‘ M7»
`ame: J” ne Massey Licata, Reg. No. 32,257
`
`Commissioner for Patents
`U.S. Patent and Trademark Office
`
`(Non—Fee Amendment)
`
`Replx to Restriction Reggirement and
`Preliminarx 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.
`
`EWfiumIfimthbefilMB
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`Page],0f187
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`
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`Elysium Health Exhibit 1003
`Page 1 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 2
`
`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:
`
`——This
`
`application
`
`claims
`
`benefit
`
`of
`
`priority
`
`to
`
`PCT/US2006/015495,
`
`from U.S. Patent Application Serial No. 11/113,701,
`
`filed ‘April 20,
`
`2006, which claims benefit
`
`filed April
`
`25, 2005, which is a continuation—in—part of PCT application No.
`
`PCT/U82005/004337,
`
`filed February 09, 2005, which claims benefit
`
`under
`
`35 U.S.C.
`
`§1l9 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.——
`
`EWfiumIfimthbefilMB
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 3
`
`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 frmn a natural or synthetic
`
`source .
`
`Claim 32
`
`(new): The composition of claim 30, wherein said
`
`composition is formulated for oral administration.
`
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`Elysium Health Exhibit 1003
`Page 3 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 4
`
`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
`
`a Restriction Requirement under
`
`35 U.S.C.
`
`121
`
`and 372.
`
`The
`
`Examiner suggests that restriction of the present
`
`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;
`
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`Elysium Health Exhibit 1003
`Page 4 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 5
`
`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 N025 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
`
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`Page 5 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 6
`
`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
`
`SEQ 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
`
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`Page 6 of 187
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`

`

`Attorney Docket No.:
`Inventors:
`
`DC0317US.NP
`Charles M. Brenner
`
`Serial No.:
`
`Filing Date:
`Page 7
`
`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 1x3 a composition comprising nicotinamide
`
`riboside in admixture with a carrier.
`
`Respectfully submitted,
`
`Jaimém
`
`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
`
`EWfiumIfimthbefilMB
`
`Page 7 of 187
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`Elysium Health Exhibit 1003
`Page 7 of 187
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`

`

`Electronic Acknowledgement Receipt
`
`5947189
`
`Application Number:
`
`11912400
`
`International Application Number:
`
`Confirmation Number:
`
`Title of Invention:
`
`Nicotinamide Riboside Kinase Compositions and Methods for Using the Same
`
`
`
`First Named Inventor/Applicant Name:
`
`Charles M. Brenner
`
`Customer Number:
`
`26259
`
`Jane Massey Licata/Patricia O'Reilly
`
`Filer Authorized By:
`
`Jane Massey Licata
`
`Attorney Docket Number:
`
`DC0317US.NP
`
`Receipt Date:
`
`25-AUG-2009
`
`Filing Date:
`
`20-Nov-2007
`
`Time Stamp:
`
`12:42:23
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`File Listing:
`
`Document
`Number
`
`Document Descri
`
`tion
`
`p
`
`Miscellaneous Incoming Letter
`
`DC317USNP_TRANS.pdf
`
`OSfSe Information:
`
`Pages
`Multi
`Part /.zip (if appl.)
`
`File Size(Bytes)/
`Message Digest
`122999
`
`e9a2bc2d14d6a5e42bb5413171477cfefc0
`
`All
`
`ll
`
`
`
`Page80f187
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`Elysium Health Exhibit 1003
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`

`

`DC317USNP_RSR.pdf
`
`f952edf52379ba6769a7bd26d2e32ea591 d
`
`479247
`
`Multipart Description/PDF files in .zip description
`
`ApplicantArguments/RemarksMadeinanAmendment
`
`Information:
`
`
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe 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.
`
`Total Files Size (in bytes)
`
`602246
`
`New Applications Under 35 U.S.C. 111
`lfa 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
`lfa 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/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
`lfa 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 ofthe 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.
`
`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.
`
`Filing Date
`
`Examiner
`
`Customer No. Group Art Unit Confirmation No.
`
`11/912,400
`
`October 24, 2007
`
`Kagnew H. Gebreyesus
`
`Invention: NICOTINAMIDE RIBOSIDE KINASE COMPOSITIONS AND METHODS FOR USING THE SAME
`
`COMMISSIONER FOR PATENTS:
`
`Transmitted herewith is an amendment in 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
`
`
`
`= 0
`
`CLAIMS PRESENT
`PREV. PAID FOR
`AFTER AMENDMENT
`$0.00
`$25.00
`x
`0
`I
`26
`3
`I
`-
`=
`TOTAL CLAIMS
`
`I
`1
`-
`8
`INDEP. CLAIMS
`X
`$105.00
`$0.00
`
`Multiple Dependent Claims (check if applicable)
`[I
`$0.00
`
`$0.00
`TOTAL ADDITIONAL FEE FOR THIS AMENDMENT
`
`FEE
`
`
`
`No additional fee is required for amendment.
`
`Please charge Deposit Account No.
`A check in the amount of
`
`in the amount of
`to cover the filing fee is enclosed.
`
`The Director is hereby authorized to charge payment of the following fees associated with this
`
`communication or credit any overpayment to Deposit Account No.
`
`50-1619
`
`Any additional filing fees required under 37 CFR. 1.16.
`
`Any patent application processing fees under 37 CFR 1.17.
`
`E] Payment by credit card. Form PTO-2038 is attached.
`WARNING: Information on this form may become public. Credit card information should not be
`included on this form. Provide credit card information and authorization on PTO-2038.
`
`
`Signature
`
`If E
`f;
`Jane Massey Licata
`Reg, No, 32,257
`-
`Lmata & ,Tyrre" P'C'
`66 E. Mam 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
`I 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
`
`W“.
`
`
`
`Signature ofPerson Mailing Correspondence
`
`
`
`Typed or Printed Name ofPerson Mailing Correspondence
`
`Elysium Hea’i‘t‘fimiftfi‘ii °it 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
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paerwork Reduction Act of 1995, no ersons are reuired to resond to a collection of information unless it disla s a valid OMB control number.
`
`PATENT APPLICATION FEE DETERMINATION RECORD
`Substitute for Form PTo-875
`
`Application or DOCket Number
`11/912,400
`
`Fi'ing Date
`11/20/2007 D To be Mailed
`
`APPLICATION AS FILED — PART I
`
`OTHER THAN
`
`I] BASIC FEE
`37CFR1.16a, b,or c
`
`I] SEARCH FEE
`37CFR1.16k, i,or m
`D EXAMINATION FEE
`(37 CFR 1.16(0), (p), or (q))
`TOTAL CLAIMS
`37 CFR 1.16 i
`INDEPENDENT CLAIMS
`37 CFR1.16 h
`
`DAPPL'CAT'ON SIZE FEE
`(37 CFR Mas»
`
`(Column 1)
`NUMBER FILED
`N/A
`
`(Column 2)
`NUMBER EXTRA
`N/A
`
`SMALL ENTITY |X|
`RATE (3;)
`FEE (3;)
`N/A
`
`OR
`
`SMALL ENTITY
`RATE (3;)
`FEE (3;)
`N/A
`
`N/A
`
`_
`I
`man8 20—
`I
`_
`manS3—
`If the specification and drawings exceed 100
`sheets of paper, the application size fee due
`is $250 ($125 for small entity) for each
`additional 50 sheets or fraction thereof. See
`35 U.S.C. 41 a 1 G and 37 CFR 1.16 S.
`
`[I MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR1.16(j))
`* If the difference in column 1 is less than zero, enter“0" in column 2.
`
`APPLICATION AS AMENDED — PART II
`
`(Column 1)
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`*
`
`08/25/2009
`
`Total (37 CFR
`
`Inde endent
`
`*
`
`-
`
`-
`
`El Application Size Fee (37 CFR 1.16(s))
`
`(Column 2)
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`M
`
`21
`
`,M
`
`(Column 3)
`
`OTHER THAN
`
`OR
`
`SMALL ENTITY
`
`ADDITIONAL
`FEE (1;)
`
`ADDITIONAL
`FEE ($)
`
`RATE “I”
`
`T
`-
`_
`
`XX 6969
`
`
`
`'—
`IJ
`
`ZL
`
`EDZL
`
`IJ
`
`E<
`
`AMENDMENT
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`(Column 1)
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`(Column 2)
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`(Column 3)
`
`ADDITIONAL
`FEE ($)
`
`1.16 i
`
`37 CFR 1.16 h
`
`Minus W
`
`D Application Size Fee (37 CFR 1.16(s))
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`ADDITIONAL
`FEE (53)
`
`RATE ($)
`
`X 69
`X 69
`
`OR
`
`OR
`
`TOTAL
`ADD‘L
`FEE
`
`* If the entry in column 1 is less than the entry in column 2, write “0" in column 3.
`** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 20, enter “20".
`*** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter
`The “Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`This collection of information is required by 37 CFR 1.16. 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 1.14. 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, US. Patent and Trademark Office, US.
`Department of Commerce, PO. 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.
`
`Legal Instrument Examiner.
`/LAMONT MCLAUCHLIN/
`
`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`

`

`
`
`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
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`11/912,400
`
`11/20/2007
`
`Charles M. Brenner
`
`DC0317US.NP
`
`8483
`
`26259
`7590
`LICATA & TYRRELL P.C.
`66 E. MAIN STREET
`MARLTON, NJ 08053
`
`10/29/2009
`
`EXAMINER
`GEBREYESUS, KAGNEW H
`
`ART UNIT
`
`1656
`
`PAPER NUMBER
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`10/29/2009
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`poreilly @ licataandtyrrell.c0m
`
`PTOL—goA (Rev. 04/07)
`
`Elysium Healtlll)EXhlilgit
`
`age
`
`0
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`Elysium Health Exhibit 1003
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`
`
`Application No.
`
`Applicant(s)
`
`11/912,4OO
`
`BRENNER, CHARLES M.
`
`Office Action Summary
`
`Examiner
`
`KAGNEW H. GEBREYESUS
`
`Art Unit
`
`1656 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)IXI Responsive to communication(s) filed on 8/25/09.
`
`2a)I:I This action is FINAL.
`
`2b)IZI This action is non-final.
`
`3)I:I Since this 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 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)IZI Claim(s) 30-32 is/are pending in the application.
`
`4a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I Claim(s) _ is/are allowed.
`
`6)IXI Claim(s) M is/are rejected.
`
`7)I:I Claim(s) _ is/are objected to.
`
`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`. U
`
`10)IZ The drawing(s) filed on 24 October 2007 is/are: a)I:I accepted or b)IZI 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).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attach ment(s)
`
`1) IZI Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date See Continuation Sheet.
`.S. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper N0(S)/Ma“ Date- _
`5) I:I Notice of Informal Patent Application
`6) D Other:
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20091006
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`Continuation Sheet (PTOL-326)
`
`Application No. 11/912,400
`
`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 .
`
`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`Application/Control Number: 11/912,400
`
`Page 2
`
`Art Unit: 1656
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`DETAILED ACTION
`
`Applicants reply filed on August 25, 2009 to the restriction requirement mailed on
`
`August 07, 2009 is acknowledged.
`
`Applicants noted that the claims were grouped as Groups 1-10 and 17-19 and that the
`
`claims were intended to be restricted into Groups 1-13. The Examiner acknowledges this
`
`typographical error. Accordingly reference will be made as Groups 1-13 from hereon.
`
`With regards to the requirement for restriction, Applicants state that they disagree with
`
`the restriction requirement, however Applicants do not provide a reason for their traversal.
`
`Therefore the election will be construed as an election without traverse. Furthermore Applicants
`
`canceled claims 1-13, 20-23 and 26-29 without prejudice. Applicants have added claims 30-32
`
`which encompass the subject matter of Group 13 comprising previous claims 26-28. Claims 30-
`
`32 are present for examination. The requirement for restriction is made final.
`
`Priority
`
`Priority is acknowledged for this application which claims benefit of priority to which
`
`claims benefit under 35 U.S.C. 119 to US. Provisional Patent Application Serial No. 60/543,347
`
`filed on February 10, 2004.
`
`Information Disclosure Statement
`
`The information disclosure statement
`
`filed on 11/20/2007, 11/26/2007, 12/07/2007 and
`
`1/26/2009 for which a copy of the patent publication has been submitted in this application has
`
`been considered as shown by the Examiners signature.
`
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`Application/Control Number: 11/912,400
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`Page 3
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`Art Unit: 1656
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`Oath/Declaration
`
`The oath or declaration submitted on November 20, 2007 has been reviewed and is in
`
`compliance with 37 CFR 1.63.
`
`Objection -Drawings
`
`The drawings were received on October 24, 2007. These drawings appear to have a
`
`sequence “Hsapi_MIBP” which appears to correspond to Nrk2 (SEQ ID NO: 6) described in the
`
`brief description of the drawings (page 8). Applicants should reconcile the nomenclature in the
`
`drawing with that used in the brief description of the drawings in the specification.
`
`Claim Rejections - 35 USC § 1 02
`
`The following is a quotation of the appropriate paragraphs of 35 USC. 102 that form the
`
`basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless i
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on
`sale in this country, more than one year prior to the date of application for patent in the United States.
`
`Claims 30, 31 and 32 are rejected under 35 U.S.C.102(b) as being anticipated by
`
`Saunders et al 1 (Tiazofurin is phosphorylated by three enzymes from Chinese Hamster Ovary
`
`Cells. Cancer Research 50, 5269-5274, Sept. 1, 1990 or Saunders et al 2 Phosphorylation of 3-
`
`Deazaguanosine by nicotinamide riboside kinase in Chinese Hamster Ovary Cells). Both
`
`references are cited in Applicant’s IDS. Saunders et al 1’ 2 teach use of nicotinamide riboside to
`
`reverse the effects of tiazofiirin on adenosine kinase def1cient rat cells and in CHO cells (see
`
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`Application/Control Number: 11/912,400
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`Page 4
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`Art Unit: 1656
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`table 1 for example). Saunders et al I teach that the preparation of nicotinamide riboside was
`
`performed by enzymatic degradation of nicotinamide dinucleotide (NAD). The nicotinamide
`
`riboside was eluted with water as described in Saunders et al 2 below.
`
`Saunders et al
`
`2
`
`teach that
`
`the growth inhibitory activity of 3-deazaguanosine is
`
`substantially reversed by nicotinamide riboside kinase in a mutant line (TGR-3) of Chinese
`
`Hamster Ovary Cells deficient in hypoxanthine guanine phosphoribosyltransferase (EC 2.4.2.8)
`
`(see abstract and in the “Materials and Method” section and table 1 on page 6595).
`
`Both Saunders et al 1’ 2 teach the preparation and purification of nicotinamide riboside on
`
`page 6594. Briefly, 20 mM nicotinamide mononucleotide (NMN) was treated with 20 units of
`
`5’nucleotidase enzyme; The enzyme was removed after 1hr. of treatment by denaturation with
`
`0.8 N perchloric acid. The solution was adjusted to pH 8 after 15 minutes in 0°C, and the salt
`
`removed by centrifiJgation, the supernatant was removed by passage through 1X 20cm column
`
`and elution with water (which can be considered a carrier). The above procedure results in a
`
`composition comprising isolated nicotinamide riboside in water thus anticipate claims 30 and 3 1.
`
`Claim 32 is include because the claim only recites that the composition is formulated for
`
`oral administration without specifying the dose or application of such a formulation. Therefore in
`
`absence evidence to the contrary claim 32 drawn to a composition comprising nicotinamide
`
`riboside in admixture with a carrier (in this case water) can be considered a formulation suitable
`
`for oral administration. Thus claims 30-32 are anticipated.
`
`Claims 30, 31, 32 are rejected under 35 U.S.C. 102(b) as being anticipated by Tanimori
`
`(2002) (Bioorganic. Med. Chem Lett. 12: 1 135-1 137 cited in IDS included herein).
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`Application/Control Number: 11/912,400
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`Page 5
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`Art Unit: 1656
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`Tanimori et al teach chemical synthesis (therefore synthetic synthesis) of nicotinamide
`
`riboside and analogues (see column 2 of page 1135). Tanimori et a1 teach that nicotinamide
`
`riboside (NAR) was synthesized using commercially available B-D-ribofilranose 1,2,3,5-
`
`tetraacetate reacted with nicotinamide in the presence of trimethylsilyl trifluoromethansulfonate
`
`(TMSOTf) in acetonitril at room temperature for an hour followed by the addition of methanol.
`
`Tanimori et al. (page 1135, column 1, paragraph 1) teach that nicotinamide riboside is a
`
`precursor of nicotinamide mononucleotide (B-NMN) which is a component used for chemical or
`
`enzymatic preparation of NAD+, a co-factor important for cellular oxidation reduction reactions
`
`(page 1135, column 1, paragraph 1).
`
`Tanimori et al fithher teach that the final form of the nicotinamide riboside (NAR)
`
`produced as colorless syrup which is fithher processed to a white solid form (see column 2 in
`
`page 1136). Claims 32 recites that the composition is formulated for oral administration without
`
`specifying the dose or application of such a formulation. Thus the syrup or the white solid form
`
`of nicotinamide riboside produced by Tanimori et a1 would anticipate claim 32 absence evidence
`
`to the contrary.
`
`Relevant reference:
`
`Stubberfield et al (NAD+ depletion and cytotoxicity in isolated hepatocytes (Biochemical
`Pharmacology 1988; 37(20): 3967-74 not included). Stubberfleld et a1 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 lead to cell death.
`Therefore administering nicotinamide riboside can be used to prevent or treat depletion of
`
`NAD--.
`
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`Application/Control Number: 11/912,400
`
`Page 6
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`Art Unit: 1656
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KAGNEW H. GEBREYESUS Whose telephone number is
`
`(571)272-2937. The examiner can normally be reached on 8:30am-5:30pm.
`
`If attempts to reach the examiner by telephone are unsuccessful,
`
`the examiner’s
`
`supervisor, ANDREW WANG can be reached on 571-272-0811. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`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
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Kagnew H Gebreyesus/
`Examiner, Art Unit 1656
`1 0/07/2009
`
`/Andrew Wang/
`Supervisory Patent Examiner, Art Unit 1656
`
`Elysium Health Exhibit 1003
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`Elysium Health Exhibit 1003
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`

`
`
`Application/Control No.
`
`11/912,400
`Examiner
`
`KAGNEW H. GEBREYESUS
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`BRENNER, CHARLES M.
`Art Unit
`
`1656
`
`Page 1 0“
`
`Notice of References Cited
`
`Document Number
`Country Code-Number-Kind Code
`
`Z
`
`Classification
`
`cc(PCP
`
`Document Number
`Country Code-Number-Kind Code
`
`Um,_..(D
`MMYWY
`
`Country
`
`FOREIGN PATENT DOCUMENTS
`
`Classification
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`Saunders et al 1 Tiazofurin is phosphorylated by three enzymes from Chinese Hamster Ovary Cells. Cancer Research 50,
`5269-5274, Sept. 1, 1990
`
`- U
`
`
`
`
`
`
`ccccccccccc
`‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P
`
`
`
`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 aI NAD+ depletion and cytotoxicity in isolated hepatocytes. Biochemical Pharmacology 1988; 37(20): 3967-