1
`
`EXELA 2020
`Eton Pharmaceuticals v. Exela Pharma Sciences
`PGR2020-00086
`
`

`

`nact
`
`IV , COfA/Ied b7-
`01/09 0
`””3 ’ ”y
`
`Application No.
`
`16/773,641
`Examiner
`BENJAMIN J PACKARD
`
`Applicant(s)
`
`Maloneyetal.
`
`1612
`
`AIA (FITF) Status
`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
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1.2} This communication is responsive to IDS filed 12/16/20.
`C] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`
`
`anary Examiner, Art Unit 1612
`
`:1 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`restriction requirement and election have been incorporated into this action.
`
`; the
`
`.32} 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 PPeredback@uspto.gov.
`
`:1 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`Certified copies:
`
`a) DAII
`
`b) D Some
`
`*c) D None of the:
`
`1. C] Certified copies of the priority documents have been received.
`2. [:1 Certified copies of the priority documents have been received in Application No.
`
`3. CI 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( )).
`
`* Certified copies not received:
`
`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 of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`51:] CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`C]
`including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in 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).
`
`6C] DEPOSIT OF and/or INFORMATION about 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.[:] Notice of References Cited (PTO-892)
`2.. Information Disclosure Statements (PTO/SB/08).
`Paper No./Mail Date 1pg (12/16/20).
`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. [:1 Examiner's Amendment/Comment
`6. [:1 Examiner's Statement of Reasons for Allowance
`
`7. C] Other
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`_
`Part of Paper No/Mall Date 20201219
`
`2
`
`

`

`Substitute for form 1 449B/PTO
`
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/773 641
`Application Number
`
`Fi'ingDa‘e
`January 27,2020
`
`FirstNamed Inventor
`John Maloney
`
`AIt Unit
`1612
`
`(Use as many sheets as necessary)
`Examiner Name
`Benjamin J. Packard
`Attorney Docket Number
`066859/543316
`
`
`
`Modified P't'O/SB/08 Form
`
`Include name of the author (in CAPITAL LETTERS), 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.
`
`"ELCYS (cysteine hydrochloride injection), for intravenous use [Label and Highlights of
`Prescribing Information]," Exela Pharma Sciences, _LLC, 9 pages, (2019).
`
`“Guidance for Industry. Q1A(R2) Stability TestIng of New Drug Substances and Products,"
`U. S. Dept. of Health and Human Services FDA CDER CBER, 25 pages (2003).
`
`
`
`
`
`
`
`“International Conference on Harmonisation; Guidance on 06A Specifications. Test
`Procedures and Acceptance Criteriafor New Drug Substances and New'Drug Products.
`
`
`
`
`
`,“Stability Stu Ies, Handbook of Modern
`armaceu Ica Analysis, Ed. Satinder
`
`_'a and Stephen Scypinski, 2nd ed. ,Vol. 10, Amsterdam: Elsevier, 459-467 and 485-486,
`
`
`
`aration of Dr. Robert J. Kuhn, Exhibit 2001, Patent Owner's Preliminary Response, Eton
`
`
`
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064, US. Patent No.
`
` aratIon of Dr. Robert J. Kuhn, ExhibIt 2001, Patent Owner's Preliminary Response, Eton
`
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068, US. Patent No.
`
`
`10, 583 155, (September18 2020).
`
`
`
`
`
`aratIon of Daniel Ingles, Ethbit 1078, Petition for Post Grant Review of US. Patent No.
`
`
`10, 653, 719, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00086,
`
` aration of Harry "Warren" Johnson, dated August 24 2020, Exhibit 1116, Petition for Post
`
`
`Grant Review of U. S. Patent No. 10, 653, 719, Eton Pharmaceuticals, Inc. v. Exela Pharma
`
`aratIon of Mark Hartman [redacted], Exela Pharma Sciences, LLC v. Sandoz, Inc., No. 19-
`
`cv-OO318—MR (W.D.N.C. December 6, 2019), ECF No. 26- 1.
`
`
`
`
`
`
`_ANGILLE, STEPHEN E., “Particulate Matter in Injectable Drug Products," PDA Journal of
`
`
`Pharmaceutical Science and Technology 67(3)'186—200 (2013)
`
`
`
`Examiner
`Signature
`LEGAL02/40218622V1
`
`Date
`Considered
`
`3
`
`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`
`
`Modified P'I'O/SB/08 Form
`
`Complete if Known
`
`Application Number
`
`16/773 641
`
`Filing Date
`First Named Inventor
`Art Unit
`
`January 27, 2020
`John Maloney
`1612
`
`Examiner Name
`Attorney Docket Number
`
`Benjamin J. Packard
`066859/543316
`
`Patent Owner's Preliminary Response, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences,
`LLC, PGR2020-00064, US. Patent No. 10,478,453, (August 28, 2020).
`
`Patent Owner's Sur-Reply to Petitioner's Replyto Patent Owner's Preliminary Response, Eton
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064, U. S. Patent No.
`
`Patent Owner's Sur-Reply to PetItioner's Reply to Patent Owners Preliminary Response, Eton
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068, US. Patent No.
`10 583 155 (October26 2020)
`
`Petitioners Reply to Patent Owner's Pre ImInary Response, Eton Pharmaceu icals, Inc. v.
`Exela Pharma Sciences, LLC, PGR2020-00064, US. Patent No. 10,478,453, (September 28,
`
`
`
`RIGNALL, ANDY, “ICHQ1A(R2) Stability Testing of New Drug Substance and Product and
`|CHQ1 C Stability Testing of New Dosage Forms, " ICH Quality. An Implementation Guide, Ed.
`Andrew Teasdale et al., Hoboken, NJ: John VWey & Sons, Inc., pp. 3-14, 26-31 and 37-38,
`(201 s).
`
`The Merck Index. An Encyclopedia of ChemIcaIs, Drugs, and Biologicals, Ed. Maryadele .J.
`O'NeiletaL, 14th ed., Whitehouse Station. Merck&Co., Inc, pp. 2782-2783, (2006).
`
`Transcript of Telephone Conference, Exhibit 1083, Eton Pharmaceuticals, Inc. v. Exela
`Pharma Sciences LLC PGR2020-00064 U 8 Patent No 10478 453 (September21 2020)
`
`WarnIng Letterfrom US. Food and Drug AdmInIstratIon to Mr. Ian Reed, PfIzer, HospIra Inc,
`dated February 14, 2017.
`
`Examiner
`Signature
`LEGAL02/40218622V1
`
`Date
`Considered
`
`4
`
`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/773 641
`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
`LEGAL02/3 9845200V1
`
`Date
`Considered
`
`5
`
`

`

`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
`
`16/773 641
`
`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
`LEGAL02/3 9845200V1
`
`Date
`Considered
`
`6
`
`

`

`PTOISBISOEFS (02—1 3)
`Doc code: RCEX
`Approved for use through 11/30/2020. OMB 0651-0031
`Doc description: Request for Continued Examination (RCE)
`us. Patent and Trademark Office; us. 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)TRANSMITI'AL
`(Submitted Only via EFS-Web)
`
`Apphcat'm
`Number
`
`6/773,641
`
`F"'"9
`Date
`
`- 020—01—27
`
`Woke" .Number
`(If applicable)
`
`I66859/543316
`
`A”.
`Unit
`
`1612
`
`enjamin J. Packard
`Examlner
`F'rSt Named John Maloney
`
`Inventor
`Name
`
`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 any utility or plant application filed prior to June 8,
`1995, or to any design application. The Instruction Sheet for this form is located at WWW.USPTO.GOV
`
`
`SUBMISSION REQUIRED UNDER 37 CFR 1.114
`
`Note: If the RCE is proper, any previously filed unentered amendments and amendments enclosed with the RCE will be entered in the order
`in which they were filed unless applicant instructs otherwise. If applicant does not wish to have any previously filed unentered amendment(s)
`entered, applicant must request non—entry of such amendment(s).
`
`El Previously submitted. If a final Office action is outstanding, any amendments filed 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
`
`g Enclosed
`
`|:| Amendment/Reply
`
`|Z|
`
`Information Disclosure Statement (IDS)
`
`|:| Affidavit(s)l Declaration(s)
`
`MISCELLANEOUS
`
`I: Suspension of action on the above-identified application is requested under 37 CFR 1.103(0) for a period of months
`(Period of suspension shall not exceed 3 months; Fee under 37 CFR 1.17(i) required)
`
` |: Other
`
`
`
`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 underpayment of fees, or credit any overpayments, to
`Deposit Account No
`160605
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`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT REQUIRED
`
`FEES
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`X Patent Practitioner Signature
`
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`Applicant Signature
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`EFS - Web 2.1.16
`
`7
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`

`

`PTOISBISOEFS (02—1 3)
`Doc code: RCEX
`Approved for use through 11/30/2020. OMB 0651-0031
`Doc description: Request for Continued Examination (RCE)
`us. Patent and Trademark Office; us. 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
`
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`Signature of Registered U.S. Patent Practitioner
`
`'ryan 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 which is to
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`EFS - Web 2.1.16
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`9
`
`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`Modified P'I'O/SB/08 Form
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`16/773 641
`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 9818646V1
`
`Date
`Considered
`
`10
`
`10
`
`

`

`Substitute for form 1 449B/PTO
`
`Complete if Known
`
`Modified P'l'O/SB/08 Form
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Application Number
`
`
`Fi'ing Date
`
`First Named Inventor
`Alt Unit
`Examiner Name
`
`240
`
`“Total Parenteral Nutrition (TPN) - Administration in Adult Ward Areas and Intensive Care of
`St. George Hospital Only," St. George/Sutherland Hospitals and Health Services, NSW
`Government Health South Eastern Sydney Local Health Network, 10 pages, (2013). [Retrieved
`from the Internet May 11, 2020: <URL:
`https://www.aci.health.nsw.gov.au/_data/assets/pdf_fiIe/0006/306438/stgeorgeTota|_Parenter
`aI_Nutrition ICU Adu|t_Wards SGSHHS CL|N089.pdf>].
`
`
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`John Maloney
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`
`Fi'ing Date
`
`John Maloney
`Firs‘Named '"Venwr
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`
`Examiner Name
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`Benjamin J. Packard
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`LEGAL02/3 9818646V1
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`Date
`Considered
`
`14
`
`14
`
`