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

`

`Complete and send this form, together with applicable fee(s), by mail or fax, or Via EFS—Web.
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`PART B - FEE(S) TRANSMITTAL
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`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddress)
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`7590
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`ALSTON & BIRD LLP
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`01/13/2021
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`(Date)
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`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`16/746,028
`
`0 1/ 17/2020
`
`JOHN MALONEY
`
`06685 9/542422
`
`4075
`
`TITLE OF INVENTION: STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`APPLN. TYPE
`
`ENTITY STATUS
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`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$1200
`
`$0.00
`
`$0.00
`
`$1200
`
`04/ 13/2021
`
`EXAMINER
`
`ART UNIT
`
`CLAS S-SUBCLASS
`
`PACKARD, BENJAMIN J
`
`1612
`
`424-621000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1363).
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`3 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/ 122) attached.
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`PTOL—85 Part B (08-18) Approved for use through 01/31/2020
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`US. Patent and Trademark Office; US. DEPARTMENT OF COMlVIERCE
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`2
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`www usptugov
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`UNITED STATES DEPARTMENT OF COMIVIERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO Box I450
`Alexandria. Virginia 2231371450
`
`
`16/746,028
`01/17/2020
`JOHN MALONEY
`066859/542422
`4075
`
`826
`
`7590
`
`01/13/2021
`
`ALSTON & BIRD LLP
`
`BANK OF AMERICA PLAZA
`101 SOUTH TRYON STREET
`SUITE 4-000
`
`CHARLOTTE’ NC 28280-4000
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`PACKARDBENJAMINJ
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`v
`
`1612
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`DATE MAILED: 01/13/2021
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`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
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`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
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`4
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`

`

`,
`
`, ,
`
`16/746,028
`
`MALONEY et aI.
`
`BENJAMIN J PACKARD
`
`1612
`
`Yes
`
`- The MAILING DA TE of this communication appears an the cover sheet wit/7 the correspondence address-
`All claims being allowable, PROSECUTION ON THE MERITS IS (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 GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
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`1.2} This communication is responsive to response filed 11/13/20.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`Primary Examiner, Art Unit 1612
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`restriction requirement and election have been incorporated into this action.
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`6C] DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
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`Attachment(s)
`1.I:] Notice of References Cited (PTO-892)
`2.. Information Disclosure Statements (PTO/SB/08).
`Paper No./Mail Date See Continuation Sheet.
`3.I:I Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`.
`4.CI Interview Summary (PTO-413)
`Paper No./Mail Date.
`/BENJAMIN J PACKARD/
`
`5. [:I Examiner's Amendment/Comment
`6. [:I Examiner's Statement of Reasons for Allowance
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`7. CI Other
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`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
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`_
`Part of Paper No/Mall Date 20210106
`
`5
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 16/746,028
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTO/SB/O8), Paper No./Mail Date:
`2pgs (11/9/20), 1pg(11/19/20), 1pg (12/16/20)
`
`6
`
`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/746 028
`Application Number
`
`Fi'ing Date
`
`John Maloney
`Firs‘Named '"Venwr
`
`Art Unit
`1612
`
`Modified P'l'O/SB/08 Form
`
`
`
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Benjamin J. Packard
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LE'I'I'ERS), title of the article (when appropriate), title of the item (book,
`magazine, journal, 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.
`I'''''''''''I
`
`
`
`IIIIIIIIIII
`VAN GOUDOEVER et al., “ESPGHAN/ESPEN/ESPR/CSPEN gurdelines on pediatric
`parenteral nutrion: Amino acids " C|i_n_i_<_:_a_|__i\_l__L_|tri_t_ion_,__37:231572323
`(2918): _____________________________________
`
`Exela Pharma Sciences, LLC, PGR2020-00068, (PTAB June 8, 2020).
`
`
`intravenous drug products to address drug shortages," 8 pages, (2017), retrieved from Exhibit
`1087, Petition for Post Grant Review of US. Patent No. 10,583,155, Eton Pharmaceuticals,
`Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068, (PTAB June 8, 2020).
`
`
`
`WORTHI
`
`Enteral N
`
`GASSER et al., “Parenteral Nutrition: Macronutrient Composition and Requirements," Support
`
`
`
`Lille, .%7(6)i6-12..1...(..2.9.95.).-....................................
`
`c'it'ize'ii' Petition,"LEEH'r'fié'ii'callé'iji't'é'ri'i's'é'r'vices',"iné'f, 1'é'535%?"(20"1'Eif'iéiiiéve'ai'r'éifi'Exhibit"""""""""
`1092, Petition for Post Grant Review of US. Patent No. 10,583,155, Eton Pharmaceuticals,
`'t‘..Ell§I!I‘.§..§EI§tiE§
`L'TELEiFEBZOZO 09968 PM?!
`8: 2020
`
`
`Declara ton of Madan Chila UN, (2020),
`x |
`|
`93,
`e Ition forPos Grant Reviewo
`
`
`
`
`
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`PGR2020-00068, (PTAB June 8, 2020).
`
`Excerpt from "Parenteral Formulations [Chapter 30]", Bentley's Textbook of Pharmaceutics: An
`
`
`Adaptation Eds San'a K .Jain et al pp 410-415 (2012)
`
`
`
`
`
`
`
`320 Declaration ofJudy K. He, (2020), Exhibit 1105, Petition for Post Grant Review of US. Patent
`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)
`
`
`
`Modified P't‘O/SB/Ux Form
`
`Application Number
`
`16/746 028
`
`Complete if Known
`
`Fi'ing Date
`
`Firs‘Named '"Venwr
`John Maloney
`Art Unit
`1612
`
`Examiner Name
`Benjamin J. Packard
`
`
`
`|.........................Fig-2'1...............l
`
`Declaration of Barrett Rabinow, (2020), Exhibit 1003, Petition for Post Grant Review of US.
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`E9829§9.:99.9§§..KEIAEAHn§.§z..%9%9).-...................................................................................................................
`
`
`
`Examiner
`Signature
`LEGAL02/39845197V1
`
`Date
`Considered
`
`8
`
`

`

`PTOISBISOEFS (02—1 3)
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`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMITI'AL
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`Apphcat'm
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`6/746,028
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`F"'"9
`Date
`
`- 020—01—17
`
`Woke" .Number
`(If applicable)
`
`I66859/542422
`
`A”.
`Unit
`
`1612
`
`enjamin J. Packard
`Examlner
`F'rSt Named John Maloney
`
`Inventor
`Name
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`This is a Request for Continued Examination (RCE) under 37 CFR 1.114 of the above-identified application.
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`Privacy Act Statement
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information
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`EFS - Web 2.1.16
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`11
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`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`Modified P'I'O/SB/08 Form
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/746 028
`Application Number
`
`Fi'ing Date
`
`John Maloney
`Firs‘Named '"Venwr
`
`Ait Unit
`1612
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Benjamin J. Packard
`
`
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`Document Number
`
`Number Kind Code2 (”WWI
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant ot Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`[
`|
`|
`05-07-2002 lThibault et al.
`|
`|us 6,382,442 B1
`[ 292
`
`
`[m
`......I...!l§.
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials 4
`
`.
`
`'
`
`Include name of the author (in CAPITAL LE'I'I'ERS), title of the article (when appropriate), title of the item (book,
`magazine, journal, serial, symposium, catalog, etc), date, page(s), volume—issue number(s), publisher, city
`and/or count where nublished.
`
`
`
`ELCYS (Cysteine Hydrochloride), NDA 210660, Orange Book: Approved Drug Products With
`
`Therapeutic Equivalence Evaluations, 3 pages, (2019).
`
`
`
`
`Hospital pp 136-142 (2004-2006)
`
`
`
`
`"Neonatal Parenteral Nutrition," Intensive Care Nursery House Staff Manual, UCSF Children's
`
`
`
`
`“AMINOSYN [label information] , Hospira, Inc., 11 pages, Exhibit 1009, Petition for Post Grant
`
`Review of US. Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences,
`
`LLC, PGR2020-00064, (PTAB May 19, 2020).
`
`
`Grant Review of US. Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma
`
`
`
`
`'
`LC, PG 2020-000
`PTAB
`9, 202
`
`I
`“Guidance for Industry. Q8(R2) Pharmaceutical Development, US. Dept. of Health and
`
`Human Services, FDA, CDER, CBER, 29 pages, (2009).
`
`information]", Sandoz Inc., 11 pages, Exhibit 1005, Petition for Post Grant Review of US.
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`
`
`I
`
`Examiner
`Signature
`LEGAL02/3 9818195V1
`
`Date
`Considered
`
`12
`
`12
`
`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`Modified P'l'O/SB/08 Form
`
`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/746 028
`Application Number
`
`Fi'ing Date
`
`John Maloney
`Firs‘Named '"Venwr
`
`Alt Unit 1612
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Benjamin J. Packard
`
`243
`
`ffadavit of Christopher Butler, Exhibit 1004, Petition for Post Grant Review of US. Patent No.
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`(PTAB May 19 2020)
`
`
`
`—f
`
`
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGRzozo-oooe4,
`
`KERS, MICHAEL J. Parenteral Preparatlons, Remlngton: The Selence and Practlce of
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`Pharmacy, 21st ed., Ed. David B. Troy, Baltimore: Lippincott Williams & VIfiIkins, pp. 802 and
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`I
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`VALLONE et aI., Food and Drug Admlnlstratlon Inspectlon and Llcensing ofManufacturlng
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`Chi” 6‘ 3'- NQWXQIKI WIRE! DEKISEILIIIC- 99- 31.52.1340 (1.29.1.2;
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`l
`
`olved Oxygen from We
`
`215, (19
`
`275 CLARK et al., “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:
`
`1.2...0 6.151286 1.3.9.9. 29.97.)..-............................... Copyright Registratlon Number for Alpsalan Yaman, Engineering Consideratlons in Sterlle
`
`'Zedl Controlled T” I," Pediat'
`
`Powder Processes," Sterile Pharmaceutical Products: Process Engineering Applications, Ed.
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`(1995)
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`xhibit 10
`Declaratlon of Barrett Rabinow,
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`(PTAB May 19, 2020).
`
`
`
`‘
`, Petition for Post Grant Review ofUS. Patent No.
`303 ‘Declaration ofDaniel Ingles, Exhibit 1078, Petition for Post Grant Review ofUS. Patent No.
`
`I I I I I I I I I I I I I I
`
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
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`Declaratlon of Harry Warren" Johnson, Exhlbit 1022, Petition for Post Grant Review of US.
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
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`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
`LEGAL02/3 9818195V1
`
`Date
`Considered
`
`13
`
`13
`
`

`

`Substitute for form 1 449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Modified P'l'O/SB/08 Form
`
`Application Number
`
`Complete if Known
`
`
`Fi'ing Date
`
`First Named Inventor
`Alt Unit
`
`Examiner Name
`
`
`
`nutrition: Calcium, phosphorus and magnesium," Clinical Nutrition, 372360-2365, (2018).
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`302 Eton Pharmaceuticals, |nc.'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. De|.,
`filed March 16, 2020), retrieved from Exhibit 1077, Petition for Post Grant Review of US.
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`FOX, CHARLES J. J., “On the CoeffiCients ofAbsorption of Nitrogen and Oxygen in Distilled
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`and Related Areas ofMolecular Biology, Vol. 11, Ed. F. F. Nord, New York: lnterScience
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`with Use of Potassium Acetate 40 meq/20 ml Injection Particularly n Neonatal Patients and
`Patients