`
`EXELA 2019
`Eton Pharmaceuticals v. Exela Pharma Sciences
`PGR2020-00086
`
`
`
`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable fee(s), by mail or fax, or via EFS-Web.
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`(Date)
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`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
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`APPLN. TYPE PUBLICATION IEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE
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`DATE DUE
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`nonprovisional
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`UNDISCOUNTLED
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`$1200
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`04/13/2021
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`EXAMINER
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`ART UNIT
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`CLASS-SUBCLASS
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`PACKARD, BENJAMIN J
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`1612
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`424-621000
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`2. For printing on the patent front page, list
`(1) The namesof up to 3 registered patent attorneys
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`J Change of correspondence address (or Change of Correspondence
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`registered attorney or agent) and the names of upto=.2
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` (I "Fee Address" indication (or "Fee Address” Indication form PTO/
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`PTOL-85 Part B (08-18) Approved for use through 01/31/2020
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
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`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`
`
`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
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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
`
`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).
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`5. D Examiner's Amendment/Comment
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`(¥] 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
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`Applicant has THREE MONTHS FROM THE "MAILING DATE"of this communication to file a reply complying with the requirements
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`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
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`7. CD Other
`
`:
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`.
`Part of Paper No./Mail Date 20210106
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`5
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`
`
`Continuation Sheet (PTOL-37)
`
`Application No. 16/746,028
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`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
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`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMITTAL
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`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
`
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`Information Disclosure Statement (IDS)
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`[] Affidavit{s)/ Declaration(s)
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`PTO/SB/30EFS (02-18)
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`Bryan L. Skelton
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`result in termination of proceedings or abandonmentof the application or expiration of the patent.
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`The information provided by youin this form will be subject to the following routine uses:
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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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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`EFS - Web 2.1.16
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`11
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`11
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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*
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`Cite
`No.1
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`Document Number
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`NumberKind Code? (¢krcwn,
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
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`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