throbber
1
`
`EXELA 2019
`Eton Pharmaceuticals v. Exela Pharma Sciences
`PGR2020-00086
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), by mail or fax, or via EFS-Web.
`
`By mail, send to: By fax, send to:=(571)-273-2885Mail Stop ISSUE FEE
`
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATIONFEE(if required). Blocks 1 through 5 should be completed where appropriate. All
`further correspondenceincluding the Patent, advance orders and notification of maintenance fees will be mailedto the current correspondence addressas indicated unless corrected
`below ordirected otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS"for maintenancefee notifications.
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have ils own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sutficient postage forfirst class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being transmitted to
`the USPTO via EFS-Webor byfacsimile to (571) 273-2885, on the date below.
`(Typed or printed name)
`(Signature)
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`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block 1 for any change of address)
`
`01/13/2021
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`7590
`826
`ALSTON & BIRD LLP
`BANK OF AMERICA PLAZA
`101 SOUTH TRYON STREET
`SUITE 4000
`CHARLOTTE, NC 28280-4000
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEYDOCKETNO.
`
`CONFIRMATION NO.
`
`16/746,028
`
`01/17/2020
`
`JOHN MALONEY
`
`066859/542422
`
`4075
`
`TITLE OF INVENTION: STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODSOF USE
`
`
`
`
`
`APPLN. TYPE PUBLICATION IEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE
`
`DATE DUE
`
`
`
`
`
`nonprovisional
`
`UNDISCOUNTLED
`
`$1200
`
`$0.00
`
`$0.00
`
`$1200
`
`04/13/2021
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`PACKARD, BENJAMIN J
`
`1612
`
`424-621000
`
`2. For printing on the patent front page, list
`(1) The namesof up to 3 registered patent attorneys
`1
`or agenls OR, allernatively,
`J Change of correspondence address (or Change of Correspondence
`(2) The nameofasingle firm (having as a membera
`Address form PTO/SB/122) attached.
`registered attorney or agent) and the names of upto=.2
`2 registered patent attorneys or agents. If no nameis
`listed, no namewill beprinted.
`
`1. Change of correspondenceaddressor indication of "Kee Address” (37
`CFR1.363).
`
` (I "Fee Address" indication (or "Fee Address” Indication form PTO/
`
`SB/47; Rev 03-09 or more recent) allached. Use of a Customer
`Numberis required.
`. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(printor type)
`PLEASE NOTE:Unless an assigneeis identified below, no assignee data will appear on the patent. If an assignee is identified below, the document must have been previously
`recorded,orfiled for recordation, as set forth in 37 CFR 3.11 and 37 CFR 3.81(a). Completion of this form is NOT a substitute forfiling an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
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`Ga
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`(LV individual LJ Corporation or other private group entity (J Government
`Please check the appropriate assignee category or categories (will not be printed onthe patent) :
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`(_lissue Fee
`Publication Fee(if required)
`[_JAdvance Order - # of Copies
`4b. Methodof Payment: (Pleasefirst reapply any previously paidfee shown above)
`(I Electronic Payment via EFS-Web
`(_] Enclosed check
`(_I Non-electronic paymentbycredit card (Attach form PTO-2038)
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` (J The Directoris hereby authorized to charge the required fee(s), any deficiency, or credit any overpayment to Deposit Account No.
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`5. Changein Entity Status (from status indicated above)
`J Applicant certifying micro entity status. See 37 CFR 1.29
`Applicant asserting small entity status. See 37 CFR 1.27
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`J Applicant changing to regular undiscounted fee status.
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`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and ISB), issue
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`NOTE:If the application was previously under micro entity status, checking this box will be taken
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`NOTE:Checking this box will be taken to be a notification of loss of entitlement to small or micro
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`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements andcertifications.
`
`Date
`
`Registration No.
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`Authorized Signature
`
`Typed orprinted name
`
`PTOL-85 Part B (08-18) Approved for use through 01/31/2020
`
`Page 2 of 3
`OMB0651-0033
`
`2
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`2
`
`

`

`geste
`
`
`
`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
`
`
`
`066859/542422
`
`4075
`
`16/746,028
`
`01/17/2020
`
`JOHN MALONEY
`
`826
`
`7590
`
`01/13/2021
`
`ALSTON & BIRD LLP
`BANK OF AMERICA PLAZA
`101 SOUTH TRYON STREET
`SUITE 4000
`CHARLOTTE, NC 28280-4000
`
`PACKARD, BENJAMIN J
`
`-
`
`1612
`DATE MAILED:01/13/2021
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)Q)to eliminate the requirement
`that the Office provide a patent term adjustment determination with the notice of allowance. See Revisions to Patent
`Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer providing an initial
`patent term adjustment determination with the notice of allowance. The Office will continue to provide a patent term
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`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
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`PTOL-85 (Rev. 02/11)
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`Page 3 of 3
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`3
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`

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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Managementand Budget
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
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`4
`
`4
`
`

`

`.
`
`-
`
`16/746 ,028
`
`MALONEYetal.
`
`BENJAMIN J PACKARD
`
`1612
`
`Yes
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITSIS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANTOF PATENTRIGHTS.This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`4} This communication is responsive to responsefiled 11/13/20.
`C7 A declaration(s\affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`:
`
`.C Anelection was made by the applicantin responseto a restriction requirementsetforth during the interview on
`restriction requirement and election have been incorporatedinto this action.
`
`; the
`
` CF Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or(f).
`
`5. D Examiner's Amendment/Comment
`
`(¥] The allowed claim(s) is/are 1-27 . As a result of the allowed claim(s), you may be eligible to benefit from the Patent Prosecution
`Highway program at a participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
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`Certified copies:
`a) CJAlI b)() Some=*c} () Noneofthe:
`
`1. (J Certified copies of the priority documents have been received.
`2. () Certified copies of the priority documents have been received in Application No.
`3. (] Copiesof the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`
`* Certified copies not received:
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`Applicant has THREE MONTHS FROM THE "MAILING DATE"of this communication to file a reply complying with the requirements
`noted below.Failure to timely comply will result in ABANDONMENT ofthis application.
`THIS THREE-MONTHPERIODIS NOT EXTENDABLE.
`
`5.) CORRECTED DRAWINGS(as "replacement sheets") must be submitted.
`CJ
`including changes required by the attached Examiner's Amendment / Commentor in the Office action of
`Paper No./Mail Date
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`Identifying indicia such as the application number(see 37 CFR 1.84{(c)) should be written on the drawingsin the front (not the back) of each
`sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6.C DEPOSIT OFand/or INFORMATIONabout the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1.C) Notice of References Cited (PTO-892)
`2.{Y} Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date See Continuation Sheet.
`3.2 Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4.C) Interview Summary (PTO-413),
`Paper No./Mail Date.
`/BENJAMIN J PACKARD/
`Primary Examiner, Art Unit 1612
`
`6. CF Examiner's Statement of Reasons for Allowance
`
`7. CD Other
`
`:
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`.
`Part of Paper No./Mail Date 20210106
`
`5
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 16/746,028
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTO/SB/08), Paper No./Mail Date:
`2pgs (11/9/20), 1pg(11/19/20), 1pg (12/16/20)
`
`6
`
`

`

`| E
`
`Substitute for form 1449B/PTO
`
`Modified P'LO/SB/08 Form
`
`Complete if Known
`
`16/746.028
`Application Number
`
`Filing Date
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`
`Art Unit
`1612
`Examiner Name
`Benjamin J. Packard
`
`(Use as many sheets as necessary)
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials *
`
`:
`
`Include nameof the author (in CAPITAL LETTERS),title of the article (when appropriate), title of the item (book,
`magazine, joumal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher, city
`and/or country where published.
`
`
`|Petition for Post Grant Review of U.S. Patent No. 10,583,155, Eton Pharmaceuticals,Inc. v.
`xela Pharma Sciences, LLC, PGR2020-00068, (PTAB June 8, 2020).
` VAN GOUDOEVER et al., “ESPGHAN/ESPEN/ESPRICSPEN guidelines on pediatric
`
`parenteral nutrion: Amino acids," Clinical Nutrition,37:2315-2323, (2018),
`Healthcare Professional Letter from Baxter Healthcare Corporation, "Temporary importation of
`intravenous drug products to address drug shortages," 8 pages, (2017), retrieved from Exhibit
`1087, Petition for Post Grant Review of U.S. Patent No. 10,583,155, Eton Pharmaceuticals,
`
`
`
`Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068, (PTAB June 8, 2020).
`
`
`
`310 bass et al., “Parenteral Nutrition: Macronutrient Composition and Requirements,” Support
`Line, 27(6):6-12, (2005).
`
`Citizen Petition, Lachman Consultant Services.inc 12 pages, (2018), retrieved from Exhibit
`1092, Petition for Post Grant Review of U.S. Patent No. 10,583,155, Eton Pharmaceuticals,
`
`
`la Pharma Sciences,
`LLC, PGR2020 00068
`PTAB J
`
`
`Declaration of Madan Chilakuri, (2020),
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`PGR2020-00068, (PTAB June 8, 2020).
`
`
`
`|—|* 8 Reet et al., “Evaluation ofthe Children with Acute Acetaminophen Overdose and Intravenous
`
`USP XxXI, The United States Pharmacopeia, Twenty-First Revision, The U.S. Pharmacopeial
`Convention, Inc., pp. 19-20, 268-269, and 1375, (1985).
`
`| 317 PecoJOSEPH i“NutrientsandAssociatedSubstances,”Remington:TheScienceand
`
`Practice of Pharmacy, 21 Ed., Ed. David B. Troy, Philadelphia: Lippincott Williams & Wilkins,
`
`
`
`
`N-Acetylcysteine Treatment,” Pak J Med Sci., 34(3):590-594, (2018).
`|LEE et al., “Intravenous N-Acetylcysteine improves Transplant Free Survival in Early Stage
`319
`
`Non-Acetaminophen Acute Liver Failure,” Gastroenterology, 137(3):856-864,
`(2009).
`
`|Declaration of Judy K. He, (2020), Exhibit 1105, Petition for Post Grant Review of U.S. Patent
`320
`No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068,
`(PTAB June 8, 2020).
`
`Examiner
`Signature
`LEGAL02/39845197v1
`
`Date
`Considered
`
`7
`
`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Benjamin J. Packard
`
`Modified P'LO/SB/08 Form
`
`Complete if Known
`
`Application Number
`
`16/746 028
`
`Filing Date
`
`January 17, 2020
`First Named Inventor
`
`John Maloney
`Art Unit
`1612
`Examiner Name
`
`
`
`sesesaeensaenensaeansase|* Declaration of Barrett Rabinow, (2020), Exhibit 1003, Petition for Post Grant Review of U.S.IPGR2020-00068, (PTABJUNe8,02)a assesssstastesssetnseentstintnstnsientvetasieninetasies teense
`
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`Examiner
`Signature
`LEGAL02/39845197v1
`
`Date
`Considered
`
`8
`
`

`

`PTO/SB/30EFS (02-18)
`Doc code: RCEX
`Approved for use through 11/30/2020. OMB 0651-0031
`Doc description: Request for Continued Examination (RCE)
`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 contains a valid OMB control number.
`
`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMITTAL
`(Submitted Only via EFS-Web)
`
`
`
`
`Application|}6/746,028 Filing|bo20-01-17 Art|he12DocketNumber| }¢¢959/542422
`Number
`Date
`(if applicable)
`Unit
`enjamin J. Packard
`First Named John Maloney
`Examiner
`Name
`Inventor
`
`
`This is a Request for Continued Examination (RCE) under 37 CFR 1.114 of the above-identified application.
`Request for Continued Examination (RCE) practice under 37 CFR 1.114 does not apply to anyutility or plant application filed prior to June 8,
`1995, or to any design application. The Instruction Sheetfor this form is located at WWW.USPTO.GOV
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`SUBMISSION REQUIRED UNDER 37 CFR 1.114
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`Note: If the RCE is proper, any previously filed unentered amendments and amendments enclosed with the RCE will be entered in the order
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`Oo Previously submitted. If a final Office action is outstanding, any amendmentsfiled after the final Office action may be considered as a
`submission even if this box is not checked.
`
`| Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`
`[_] Other
`
`[_] Other
`
`DX] Enclosed
`
`[_] Amendment/Reply
`
`fx]
`
`Information Disclosure Statement (IDS)
`
`[] Affidavit{s)/ Declaration(s)
`
`MISCELLANEOUS
`
`
`
`
`CO Suspension of action on the above-identified application is requested under 37 CFR 1.103{c) for a period of months
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`[_] Other
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`FEES
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`The RCE fee under 37 CFR 1.17(e) is required by 37 CFR 1.114 when the RCE is filed.
`><] The Director is hereby authorized to charge any underpaymentof fees, or credit any overpayments, to
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`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT REQUIRED
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`Patent Practitioner Signature
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`Applicant Signature
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`EFS - Web 2.1.16
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`

`

`PTO/SB/30EFS (02-18)
`Doc code: RCEX
`Approved for use through 11/30/2020. OMB 0651-0031
`Dec description: Request for Continued Examination (RCE)
`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 contains a valid OMB control number.
`
`Registration Number
`
`
`Signature of Registered U.S. Patent Practitioner
`
`Bryan L. Skelton
`
`This collection of information is required by 37 CFR 1.114. The information is required to obtain or retain a benefit by the public whichis to
`file (and by the USPTOto 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
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`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department cf Commerce,
`P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the form, call 7-800-PTO-9199 and select option 2.
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`EFS - Web 2.1.16
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`
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be
`advised that:
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information
`solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office
`is to process and/or examine your submission related to a patent application or patent.
`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
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`5.
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`Tt.
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`8.
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`The information on this form will be treated confidentially to the extent allowed under the Freedom ofInformation
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`EFS - Web 2.1.16
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`

`Substitute for form 1449B/PTO
`
`Modified P'LO/SB/08 Form
`
`Complete if Known
`
`
`
`16/746.028
`Application Number
`
`Filing Date
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`
`Art Unit
`1612
`Examiner Name
`Benjamin J. Packard
`
`(Use as many sheets as necessary)
`
`Examiner]
`Initials*
`
`Cite
`No.1
`
`Document Number
`
`NumberKind Code? (¢krcwn,
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passagesor Relevant
`Figures Appear
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials *
`
`:
`
`Include nameof the author (in CAPITAL LETTERS),title of the article (when appropriate), title of the item (book,
`magazine, joumal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher, city
`and/or country where published.
`
`
`"Aluminum in large and small volume parenterals usedin total parenteral nutrition," Food and
`Drug Administration, 21 C.F.R. § 201.323, 89-90, (2003),
`
`
`"American Regent Announces the Launch and Availability of Selenious Acid Injection, USP,”[|_|
`Press Release, American Regent,
`Inc., 6 pages,
`(2019)
`
`
`No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`
`
`
` ELCYS(Cysteine Hydrochloride)," NDA 210660, Orange Book: Approved Drug Products with
`Therapeutic Equivalence Evaluations,3 pages, (2019).
`
`
`
`
`
`
`Review of U.S. Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences,
`
`LLC, PGR2020-00064, (PTAB May 19, 2020).
`
`
`fAminosyn Sulfite Free [drug information]," RX List,45 pages, Exhibit 1052, Petition for Post
`Grant Review of U.S. Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma
`
` Guidance for Industry: Q8(R2) Pharmaceutical Development,” U.S. Dept. of Health and
`Human Services, FDA, CDER, CBER, 29 pages, (2009).
`
`
`KL-CYSTEINE HYDROCHLORIDE - cysteine hydrochloride injection, solution [label
`information]", Sandoz Inc., 11 pages, Exhibit 1005, Petition for Post Grant Review of U.S.
`
`
`
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`Examiner
`Signature
`LEGAL02/39818195v1
`
`Date
`Considered
`
`12
`
`12
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`16/746.028
`Application Number
`
`Filing Date
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`Art Unit 1612
`
`Examiner Name
`Benjamin J. Packard
`
`(Use as many sheets as necessary)
`
`Modified P'LO/SB/08 Form
`
`1 (
`
`|——|fosieasristopherButler,Exhibit1004,PetitionforPostGrantReviewofU.S.PatentNo.|
`
`
`
`0,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064.,
`
`PTAB May 19, 2020)
`
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`
`
`
`
`KERS, MICHAEL J.,
`"Parenteral Preparations," Remington: The Science and Practice of
`Pharmacy, 21st ed., Ed. David B. Troy, Baltimore: Lippincott Williams & Wilkins, pp. 802 and
`
`
`
`
`
`g
`"Fi
`VALLONE etal.,
`
`Facilities," Drug Biotechnology Regulation: Scientific Basis and Practices, Ed. Yuan-yuan H.
`(1991).
`. New York: Marcel Dekker, Inc., pp. 315-340,
`
`
`
`
`BLOCK etal., “Methionine, Cysteine, Cystine, and Taurine Interrelationships in Human
`(1969).
`Plasma,” The American Journal of Clinical Nutrition, 22(1):33-37,
`
`
`
`CAIRNS, DONALD, Siabiliy of Drugs and Medicines," Essentials of Pharmaceutical
`
`
`Chemistry, 4th ed., London: Pharmaceutical Press, pp. 217-238, (2012).
`
`
`
`CLARKetal., “Effects of Two Different Doses of Amino Acid Supplementation on Growth and
`Blood Amino ‘Acid Levels in Premature Neonates Admitted to the Neonatal Intensive Care Unit:
`120nO) 2801296,
`(2007).
`
`
`
`
`
`
`Copyright Registration Number for Alpsalan Yaman,
`"Engineering Considerations in Sterile
`Powder Processes," Sterile Pharmaceutical Products: Process Engineering Applications, Ed.
`Kenneth E. Avis, Buffalo Grove: Interpharm Press,
`
`Inc., (1995)
`
`
`
`, Petition for Post Grant Review of U.S. Patent No.
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`
`(PTAB May 19, 2020).
`
`
`
`Declaration of Daniel Ingles, Exhibit 1078, Petition for Post Grant Review of U.S. Patent No.
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`
`Declaration of Harry "Warren" Johnson, Exhibit 1022, Petition for Post Grant Review of U.S.
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`PGR2020-00064, (PTAB May 19, 2020).
`
`
`Drug Facts & Comparisons, "Dietary Reference Intakes of Vitamins and Minerals" and
`Intravenous Nutitional Therapy," St. Louis: Clinical Drug Information, LLC, pp. 3-4 and 133-
`155, (2015).
`
`
`
`
`
`Examiner
`Signature
`LEGAL02/39818195v1
`
`Date
`Considered
`
`13
`
`13
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`16/746.028
`Application Number
`
`Filing Date
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`Art Unit 1612
`
`Examiner Name
`Benjamin J. Packard
`
`(Use as many sheets as necessary)
`
`Modified P'LO/SB/08 Form
`
`
`
`302
`
`|Eton Pharmaceuticals, Inc.'s Answer and Affirmative Defenses to Complaint, (May 6, 2020),
`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., No. 1:20-cv-00365-MN, (D. Del.,
`
`filed March 16, 2020), retrieved from Exhibit 1077, Petition for Post Grant Review of U.S.
`
`
`P

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