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

`

`rrect
`Not Corrected bili
`otice of
`Alowabilily
`
`Application No.
`16/773,641
`Examiner
`BENJAMIN J PACKARD
`
`Applicant(s)
`
`Maloneyetal.
`
`1612
`
`AIA (FITF) Status
`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 responsiveto IDS filed 12/16/20.
`C7 A declaration(s\affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`:
`
` 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
`
`.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
`
`(¥] 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.
`
`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:
`
`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
`.
`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 1pg (12/16/20).
`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 20201219
`
`2
`
`

`

`Substitute for form 1449B/PTO
`
`
`Complete if Known
`
`Modified P1'O/SB/U8 Form
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`16/773.641
`Application Number
`
`Filing Date
`January 27, 2020
`
`First Named Inventor
`John Maloney
`
`Art Unit
`1612
`(Use as many sheets as necessary) Benjamin J. Packard Examiner Name
`
`Attorney Docket Number}
`066859/543316
`
`
`
`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.
`
`|
` aration of Mark Hartman[redacted], Exela Pharma Sejepecs LLC v. Sandoz, Inc., No. 19-
`
`
`:
`|"ELCYS(cysteine hydrochloride injection), for intravenous use [Label and Highlights of
`327
`Prescribing Information]," Exela Pharma Sciences,LLC, 9 pages, (2019),
`349
`|*Guidancefor 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).
`
`
`Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:
`
`345 EaConferenceonHarmonisation;GuidanceonQ6ASpecifications:Test
`
`
`
`
`
`Pharmaceutica Analysis, Ed. Satinder [|
`, “Stability Studies,” Handbook of Modern
`Ahuja and ‘Stephen Scypinski, 2nd ed., Vol. 10, Amsterdam: Elsevier, 459-467 and 485-486,
`eo
`eaneeeneneneneentunenesneitaneteneneitanntieititstntineiennintieenenenanaieneeaneneeneieabeeee
`Declaration of Dr. Robert J. Kuhn, Exhibit 2001, Patent Owner's Preliminary Response, Eton
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064, U.S. 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, U.S. Patent No.
`
`
`10,583 155, Beptember13 2020)...
`
`
`
`
`
`aration of Daniel Ingles, Exhibit 1078, Petition for Post Grant Review of U.S. Patent No.
`10,653,719, Efon 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, Efon rT2020) Inc. v. Exela Pharma
`
`
`
`cv-00318-MR (W.D.N.C. December 6, 2019), ECF No. 26-1.
`
`
`LANGILLE, STEPHEN E., “Particulate Matter in Injectable Drug Products,” PDA Journal of
`
`
`Pharmaceutical Science and Technology, 67(3):186—200,
`(2013)
`
`
`
` Parenteral and Enteral Nutrition, 34(3):346-347, (2010).
`
`Examiner
`Signature
`LEGAL02/40218622v1
`
`Date
`Considered
`
`3
`
`

`

`Substitute for form 1449B/PTO
`
`
`Complete if Known
`
`Modified P1'O/SB/U8 Form
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`dated February 14, 2017.
`
`16/773.641
`Application Number
`
`Filing Date
`January 27, 2020
`
`First Named Inventor
`John Maloney
`
`Art Unit
`1612
`(Use as many sheets as necessary) Benjamin J. Packard Examiner Name
`
`Attorney Docket Number}
`066859/543316
`
`
`
`
`
`Patent Owner's Preliminary Response, Efon Pharmaceuticals, Inc. v. Exela Pharma Sciences,
`LLC, PGR2020-00064, U.S. Patent No. 10,478,453, (August 28, 2020).
`
`Patent Owner's Sur-Reply to Petitioner's socito 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 Owner's Preliminary Response, Eton
`Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068, U.S. Patent No.
`
`Petitioner's Reply to Patent Owner's Preliminary Response, Eton Pharmaceuticals, Inc. v.
`Exela Pharma Sciences, LLC, PGR2020-00064, U.S. Patent No. 10,478,453, (September 28,
`
`RIGNALL, ANDY, “ICHQ1A(R2) Stability Tesiing of New Drug Substance and Product and
`ICHQ1C Stability Testing of New Dosage Forms,” [CH Quality: An Implementation Guide, Ed.
`Andrew Teasdale et al., Hoboken, NJ: John Wiley & Sons, Inc., pp. 3-14, 26-31 and 37-38,
`
`The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, Ed. Maryadele J.
`O'Neil et al., 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.S. Patent No. 10,478,453, (September 21, 2020)
`
`Warning Letter from U.S. Food and Drug Administration to Mr. lan Reed, Pfizer, Hospira Inc,
`
`Examiner
`Signature
`LEGAL02/40218622v1
`
`Date
`Considered
`
`4
`
`

`

`| E
`
`Substitute for form 1449B/PTO
`
`Modified P'LO/SB/08 Form
`
`Complete if Known
`
`16/773.641
`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
`LEGAL02/39845200v1
`
`Date
`Considered
`
`5
`
`

`

`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
`
`16/773,641
`
`Filing Date
`
`January 27, 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
`LEGAL02/39845200v1
`
`Date
`Considered
`
`6
`
`

`

`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|}6773641 Filing|bo20-01-27 Art|he12DocketNumber| })¢6959/543316
`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
`
`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).
`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.
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`| Consider the arguments in the Appeal Brief or Reply Brief previously filed on
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`[_] Other
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`[_] Other
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`DX] Enclosed
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`[_] Amendment/Reply
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`fx]
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`Information Disclosure Statement (IDS)
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`[] Affidavit{s)/ Declaration(s)
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`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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`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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`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.
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`EFS - Web 2.1.16
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`9
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`

`

`Substitute for form 1449B/PTO
`
`Modified P'LO/SB/08 Form
`
`Complete if Known
`
`
`
`16/773.641
`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
`LEGAL02/39818646v1
`
`Date
`Considered
`
`10
`
`10
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`Modified P'LO/SB/08 Form
`
`16/773.641
`Application Number
`
`Filing Date
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`Art Unit 1612
`
`Examiner Name
`
`(Use as many sheets as necessary)
`
`Benjamin J. Packard
`
`
`ee)5
`
`
`
`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:/Avww.aci.health.nsw.gov.au/__data/assets/pdf_file/0006/306438/stgeorgeTotal_Parenter
`al_Nutrition_ICU_Adult_Wards_ SGSHHS_CLIN0O89_pdf>].
`
`.,
`
`"Parenteral Preparations,"
`
`Remington: The
`
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`14
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`14
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