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`Page 1 of 225
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`Nexus Ex. 1002
`Page 1 of 225
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`“4 at dat
`UNITED STATES
`Le OL 00) pcrent ano TRADEMARK OFFICE
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`Page 1 of 2
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`soeccemrate yotai1499
`Alexandria, VA223153nears
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`ELECTRONIC PAYMENT RECEIPT
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`TSG?287
`
`RECEIPT DATE / TIME
`Ve/TS/V0N2 VS33.16 PM ET
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`ATTORNEY DOCKET#
`OGGSSG/HS9G7S
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Application Information
`
`APPLICATION TYPE=Utility - Nonprovisional Application PATENT#
`
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`under 25 USC Tiifa
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`CONFIRMATION #
`
`$793
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`FILED BY
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`aque! West
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`WOT
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`wi
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`1202
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`VERO
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`BASIC FRING FRE - UTIUITY (PAPER
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`PATENT APPL. EXAMINATION FEE
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`EACH CLAIM IN EXCESSOF 30
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`PROCESSING FEE, EACEPT IN
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`
`320.00
`
`SHOW)
`
`7OO.00
`
`140.00
`
`1
`
`:
`
`oe
`
`7
`
`320.00
`
`800.00
`
`1003.00
`
`140,00
`
`Nexus Ex. 1002
`Page 2 of 225
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`Page 2 of 225
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`Tai?
`
`Hi
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`REQUEST POR PRIORITIZED
`EAAMINATION
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`UTILITY PATENT APPL. SEARCH
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`Ree
`
`4200 00
`
`706.00
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`7
`
`1
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`Page 2 of 2
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`4200.00
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`700.00
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`TOTAL
`AMOUNT:
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`$7,180.00
`
`otad date oy the USPTO of ihe Inchcated dacurments, charach:
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`lar lo a Post Care, as
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`New Aplications Under 35 S.C. iit
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`ing acceptance of the agmicalion as a nahonal stage
`371 and other acplicable requirements a Form POT/DO/E
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`New International Application Filed wilh the USPTO as a Recelving Office
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`Nexus Ex. 1002
`Page 3 of 225
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`Nexus Ex. 1002
`Page 3 of 225
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`PTOUMASTT (08-12
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`Agoravedd for us
`s through PHQUORO, OMS US8t-00S
`LES. Patent atedTrademark CA
`U5. DEPARTMENT OF COMMERCE
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`SeennenienenARISESEEEEECLELAND
`fephays @ valid GME Cantal neineay,
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`neler tie Papapyork Asdatitt: Act oF G99, no Deysane ars raquiedd io ragpond to a cof
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`
`invention [METHODS OF USE
` Sone nono DOSERASO NOC OOSTOOOS CoN SOSAEERE
`
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`As the belowfamed inventor, | Nereby deciare that
`
`DECLARATION (37 GFR 1.93) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
` Oeaennnunaaannnny
`SanaaRAENSvnsnannanaaanAns
` nrcan au Aaa
`SASLSAAR
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`
`
`Title of
`| STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS POR AVECTION AND
`
`
`
`
`
`
`
`This declaration
`es
`Sees
`is directedto:
`
`vgacgtien
`,
`The attached application, ar
`SROES SEDEEEION.
`GF
`ce United Stetes aaplication ar PCT Interaatinnal applioation ouraber
`January 15, 2018
`fled on
`
`16/248,460
`
`
`
`
`
`The ahoveidentified spolication was mada of authorized to ba made by me.
`
`
`
`a
`+
`a
`y
`| believe that | an the ariginal inventar or an original joint inventor of a dainted invention in the applinalion.
`
`lt heraby acknowledge that any willldfalse sialement made in this destaration is punishable under 18 U.S.C. 1004
`i by fine or ivipsonment of not more than |five {5} years, or bath.
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`f Petiionasanplicantis cautioned to avoid submiling personal informationin ciocurnants Med in a patent application that may
`t contribute to identity theft. Personal information such as social senurily numbers, bank account rursbters, ar credit card rurnbers
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`Nexus Ex. 1002
`Page 4 of 225
`
`Nexus Ex. 1002
`Page 4 of 225
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`
`
`PTO/AIA/01 (06-12)
`Approved for use through 11/30/2020. OMB 0651-0032
`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 collectionof informationunless it displays a valid OMB control number.
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`DECLARATION(37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET(37 CFR 1.76)
`
`|SABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND
`Titleop
`invention|METHODS OF USE
`
`Asthe below namedinventor, | hereby declare that:
`
`This declaration
`
`is directed to:
`
`‘nati
`
`The attached application, or
`[|
`im] United States application or PCT international application number 16/248,460
`filed on YaNuary 15, 2019
`
`The above-identified application was made or authorized to be made by me.
`
`| believe that | am the original inventor or an original joint inventor of a claimed invention in the application.
`
`| hereby acknowledge that anywillful false statement made in this declaration is punishable under 18 U.S.C. 1001
`by fine or Imprisonment of not more thanfive (5) years, or both,
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`WARNING:
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`Petitioner/applicant is cautioned to avoid submitting personal information in documentsfiled in a patent application that may
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`a
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`Inventor: ArunaKog nti
`Signature:
`:
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`2
`Leoe
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`Date (Optional) :
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`Note: An application data sheet (PTO/SB/14 or equivalent), including naming the entire inventive entity, must accompanythis form or must have
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`Nexus Ex. 1002
`Page 5 of 225
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`Nexus Ex. 1002
`Page 5 of 225
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`
`Invention METHODS OF USE
`SONRERMn Soe
`nen ‘
`
`As the below named inventor, | heraby declare thet:
`
`a
`This declaration [|
`ae
`.
`“he allached sopication, or
`.
`.
`is directed fc:
`SRQEROG
`BARE
` ins apolication or PCT international apolication surniber
`f
`fled on, danuary 15, 2019
`
`6/248 460
`
`
`
`
`
`
`
`| The sbove-idaentified application was made ar authorized to be mde Dy me.
`
`
`
`
`een {O81}
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`Aggurowed dup use dipough THs
`y
`GSS} O32
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`US. Fatentand Traci OF
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` cle
`arenernAEEENLRLAAIEEREALAIN
`1 of information unfiiss § displays a valkt OMB contraninatar.
`Ureter tha Papenvork Reduction Act of 1995, na persche ars required to respond to. a So!
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
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`
`SOESONEAAAAAANSID
`HHOELAS
`SS
`SET SESEERscoscddocococoeeeSSESLRSERAAAAOOOONENEELENRRAEN
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`I STABLE, HIGHLY PUREL-OYSTEINE COMPOSITIONS FOR INJECT!ON AND
`Title of
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`WARNING:
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`cormaieas, inching gsthering, preparing, and siubstitt!
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`gammenis on the amount of time you squire bo cana
`tis
`yb ns thus Chey devise
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`'qis Stexarndda, Ve 2254 B4A50, |
`areSe
`BUR COMPLET
`Patent ad Trademark Offies, GS, Repariment of Cammveres, PG.
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`LEGAL NAME GF INVENTOR
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`inventor:
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`csen, Any
`ORGLS
`03 FORMS TO
`
`Nexus Ex. 1002
`Page 6 of 225
`
`Nexus Ex. 1002
`Page 6 of 225
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`od atdat
`UNITED STATES
`| URS] OPE OR ocrent ano TRADEMARK OFFICE
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`Page 1 of 4
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`souancria, ye Agaeo* 1488
`Heeeen eertienidgay
`
`ELECTRONIC ACKNOWLEDGEMENT RECEIPT
`
`APPLICATION #
`18/067,287
`
`RECEIPT DATE / TIME
`12/16/2022 03:33:16 PM ET
`
`ATTORNEY DOCKET#
`066859/589619
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Application Information
`
`APPLICATION TYPE—Utility - Nonprovisional Application PATENT#
`
`
`under 35 USC 111(a)
`
`CONFIRMATION #
`
`9793
`
`FILED BY Raquel West
`
`PATENT CENTER#
`
`61312420
`
`FILING DATE
`
`CUSTOMER #
`
`826
`
`CORRESPONDENCE
`ADDRESS
`
`-
`
`Documents
`
`FIRST NAMED John Maloney
`INVENTOR
`
`AUTHORIZED BY Bryan Skelton
`
`TOTAL DOCUMENTS: 11
`
`DOCUMENT
`
`PAGES
`
`DESCRIPTION
`
`SIZE (KB)
`
`589079ADS. ocd
`
`589819TRACKTodi
`
`589819PAM of
`
`588STSPAM-A.PE oct
`
`cit}
`
`589619_PAM-SPEC pdf
`
`{2-23
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`5
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`Apoication Data Sheet
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`ei74 KB
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`Track One Request
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`-
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`Preliminary Amendment
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`opeciication
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`Applicant Arqumenis/Remarks
`Made in an Amendment
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`168 KB
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`Nexus Ex. 1002
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`ine drawings
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`Oath or Declaration Hed
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`Change of Address
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`specication
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`Claims
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`Abstract
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`589619TRACK tcon-
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`589619TRACK ican-
`ABSTpdf
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`DOCUMENT
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`MESSAGE ONSEST(SNA-312)
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`Nexus Ex. 1002
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`PLISB OSS29 ALAS DAT DABTAAATEA
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`Page 3 of 4
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`S89619PAM-REMpci
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`589619TRACK ison-ABST pdf
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`POSCCOSS9AF5 1 CR4DESC4SQSBEAS /OCBSDESS TAT ESBSEOD
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`AAG TF] IGBRSGSSIDAPSESTEIS?TSEOTS
`
`i Receipt evidences receint on the noted date by the USPTO of ine incicated documents, charectarizad
`This Acknowlsdgerns
`
`
`
`ding page counts, where aonicable. iserves as eviderice of recejpl similar to a Posi Card, as
`ny the applicant
`described in MPEP 50:3.
`
`New Applications Under 35 WLS.itt
`fa naw applicalign is being fled and ine application includes ine necassary components for fing date (see 37 CFR LSS(b idk
`
`Nexus Ex. 1002
`Page 9 of 225
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`Nexus Ex. 1002
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`Page 4 of 4
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`and MPEP §96), a Filing Rese!
`Recent wil astablish the fling
`
`@ annlicadhan
`
`ROS) will be issued in due course and the daie shawn on this Ackraawiedgement
`
`National Stage of an international Application under $8 U.S.C. 374
`
`Hea fimely submission io enter ihe national stage of anivanesal aopiication is compllant wilh the conciifiaris of 95 LLS.c.
`due course.
`indceding acceptance af the agmicalon as a nabonal stage
`Fling Receipt in
`New International Application Filed with the USPTO as a Recelving Office
`
`aliorial aoplication includes the necessary comoonents for an
`wig fect anc iheip
`
`interrialtional Eling£rate |(Form POT/RO‘ 05) will be issued In due course, subject to prescriotions concerning national securiy,
`CT Article tT] and MRFEP 1819), a Notification of ihe Inernational Apolicatian Nurnber and of the
`
`
`and the date shownon this Acknowledgement Receipt will establish the international fling date of the application.
`
`Nexus Ex. 1002
`Page 10 of 225
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`Nexus Ex. 1002
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`
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`Doc Code: TRACK1.REQ
`DocumentDescription: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUESTFOR PRIORITIZED EXAMINATION
`UNDER37 CFR 1.102(e) (Page1 of 1)
`
`First Named
`
`Nonprovisional Application Number(if
`von
`John Maloney
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`APPLICANT HEREBYCERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17{i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have beenfiled with the request. The publication fee requirement is met
`becausethat fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been already been paid.
`| understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`| understand that the application may not contain, or be amended to contain, more than four
`independent claims, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension of time will cause an outstanding Track | request to be dismissed.
`
`3. The applicable box is checked below:
`
`forms are submitted.
`
`A request for continued examination has been filed with, or prior to, this form.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisionalutility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`{b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111{a).
`This certification and request is being filed with the plant application in paper.
`
`An executed inventor's oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, or the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`
`pate December 16, 2022
`sinane/Bryan L. Skelton/
`
`Nameegbryan L. Skelton Practitioner 20893
`
`
`
`(Print/Typed)
`Registration Number
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d} for signature requirements and certifications.
`Note:
`Submit multiple forms if more than one signature is required.*
`*Total of 1
`
`Nexus Ex. 1002
`Page 11 of 225
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`Nexus Ex. 1002
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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 result in termination of proceedings or abandonmentof the
`application or expiration of the patent.
`
`The information provided by youin this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may
`be disclosed to the Department of Justice to determine whether disclosure of these records is required by the
`Freedom of Information Act.
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`A record in this system of records may be disclosed, as a routine use, to a Memberof Congress submitting a
`requestinvolving an individual, to whom the record pertains, whenthe individual has requested assistance from
`the Memberwith respect to the subject matter of the record.
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to comply
`with the requirements of the Privacy Act of 1974, as amended, pursuantto 5 U.S.C. 552a(m).
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA aspart of that agency's
`responsibility to recommend improvements in records managementpractices and programs, underauthority of
`44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing
`inspection of records for this purpose, and any other relevant(/.e., GSA or Commerce)directive. Such
`disclosure shall not be used to make determinations aboutindividuals.
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record
`wasfiled in an application which became abandonedorin which the proceedings were terminated and which
`application is referenced by either a published application, an application open to public inspection or an issued
`patent.
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency,if the USPTO becomes awareofa violation or potential violation of law or regulation.
`
`Nexus Ex. 1002
`Page 12 of 225
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`Nexus Ex. 1002
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`1/5
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`Dissolved Oxygen Levels per Tray
`
`DO(ppm)
`
`14.0
`
`12.0
`
`10.0
`
`8.0
`
`6.0
`
`4.0
`
`2.0
`
`0.0
`
`RNOSS
`S.
`SH
`&
`ES
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`atesTray 1
`sedis Tray 2
`segeenTray 3
`assives:Tray 4
`
`amgiosTray 1
`
`seins: Tray 1
`
`sonTray 1
`wana[1gy 21
`
`Tray 2
`sentiesTray 2
`
`sottoTray 2
`
`Post HSR -Capping -
`Post Filling - During
`Final Dissolved
`Filled Vials
`Loading of Lyo
`Oxygen Compounding
`
`
`Post Filling -Pre HSR_
`
`FIG. I
`
`Nexus Ex. 1002
`Page 13 of 225
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`Nexus Ex. 1002
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`
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`2/5
`
`14.0
`
`12.0 10.0
`
`““Do(ppm)
`
`|
`;
`
`B.0
`
`6.0 ;
`:
`4.0
`
`\
`\
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` 1
`
`2
`
`3
`
`4
`
`17
`
`18
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`#19
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`20
`
`21
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`22
`
`23
`
`24
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`%37
`
`#38
`
`39
`
`40
`
`«“&s««PostFilling DO (ppm)
`Tray Number
`segs Com pounding DO (ppm)
`asaiess Post HSR DO (pom)
`«Lyo Loading DO (ppm)
`
`
`Nexus Ex. 1002
`Page 14 of 225
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`Nexus Ex. 1002
`Page 14 of 225
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`3/5
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`L-Cysteine Setup for Protocol and DO Testing Points
`
`Argan Overlay
`
`
`
`DO Testing
`
`DO Testing
`
`Pulses
`Wail
`
`Gas Stoppering with 3
`
`Further D.O. Testing after capping unless Senet
`otherwise stated,
`
`FIG. 3
`
`Nexus Ex. 1002
`Page 15 of 225
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`Nexus Ex. 1002
`Page 15 of 225
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`
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`4/5
`
`fhannyYarPiped
`
`ces
`
`2
`esWw
`
`SS
`Ree
`
`a
`
`FIG. 4
`
`Nexus Ex. 1002
`Page 16 of 225
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`Nexus Ex. 1002
`Page 16 of 225
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`5/5
`
`%y:%:Ya%,UlliVill,
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`1%|::Ns
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`FIG. 5
`
`Nexus Ex. 1002
`Page 17 of 225
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`Nexus Ex. 1002
`Page 17 of 225
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`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Appl. No.:
`Applicant(s):
`Filing Date:
`Art Unit:
`Examiner:
`Title:
`
`Confirmation No.: Unassigned
`Unassigned
`EXELA PHARMASCIENCES, LLC
`Herewith
`Unassigned
`Unassigned
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR
`INJECTION AND METHODS OF USE
`
`Docket No.:
`
`066859/589619
`
`CustomerNo.:
`
`826
`
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`PRELIMINARY AMENDMENT
`
`Sir:
`
`Please enter this Preliminary Amendment before calculating the claim fee and amend the
`
`above-identified application as follows:
`
`Amendments to the Specification begin on page 2 of this paper.
`
`Remarksbegin on page 3 ofthis paper.
`
`LEGAL02/42433776v1
`
`Nexus Ex. 1002
`Page 18 of 225
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`Nexus Ex. 1002
`Page 18 of 225
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`
`
`Application No.: Unassigned
`Preliminary Amdt. dated December 16, 2022
`Page 2
`
`Amendments to the Specification:
`
`Please amendthefirst paragraph ofthe specification as follows:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`This application is a continuation of U.S. application no. 17/950,964 filed September 22
`
`2022, which