`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`16/773,641
`
`01/27/2020
`
`John Maloney
`
`066859/5433 16
`
`3992
`
`ALSTON & BIRD LLP
`BANK OF AMERICA PLAZA
`101 SOUTH TRYON STREET
`
`CHARLOTTE, NC 28280-4000
`
`PACKARD,BENJAMIN J
`
`1612
`
`07/23/2020
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`usptomail @alston.com
`
`PTOT.-90A (Rev. 04/07)
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Application No.
`Applicant(s)
`16/773,641
`Maloneyetal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`BENJAMIN J PACKARD
`1612
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6} MONTHSfrom the mailing
`date of this communication.
`IfNO period forreply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three monthsafter the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)M Responsive to communication(s) filed on 6/2/2020.
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__.
`
`2a)C) This action is FINAL. 2b)MThis action is non-final.
`3)0) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporatedinto this action.
`4). Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparre Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims*
`1-27 is/are pending in the application.
`5)
`Claim(s)
`5a) Of the aboveclaim(s)
`is/are withdrawnfrom consideration.
`Claim(s)
`is/are allowed.
`Claim(s) 1-27 is/are rejected.
`(s)__ is/are objected to.
`____ are subject to restriction and/or election requirement
`* If any claims have been determined allowable, you may heeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Avww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`Application Papers
`10)2 The specification is objected to by the Examiner.
`11) The drawing(s) filed on __ is/are: a)() accepted or b)L) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`cc) None of the:
`bj Some**
`a)U All
`1.2 Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have beenreceived in Application No.
`3.1] 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)).
`™ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s}) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 7pgs (6/2/20), 2pgs (6/11/20).
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13}
`
`Office Action Summary
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`Part of Paper No./Mail Date 20200720
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AiA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined under the first
`
`inventor to file provisions of the AIA.
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
`
`1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
`
`examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the
`
`finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
`
`submission filed on 05/28/2020 has been entered.
`
`Applicants' arguments,filed 05/28/2020, have been fully considered. Rejections and/or
`
`objections not reiterated from previous office actions are hereby withdrawn. The following rejections
`
`and/or objections are either reiterated or newly applied. They constitute the complete set presently
`
`being applied to the instant application.
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
`
`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
`
`basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and
`
`the rationale supporting the rejection, would be the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
`
`set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is
`not identically disclosed as set forth in section 102, if the differences between the claimed invention
`and the prior art are such that the claimed invention as a whole would have been obvious before the
`effective filing date of the claimed invention to a person having ordinaryskill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 3
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966),
`
`that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are
`
`summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousness or
`
`nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the claims the
`
`examiner presumesthat the subject matter of the various claims was commonly ownedas of the
`
`effectivefiling date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
`
`of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that
`
`was not commonly owned as of the effectivefiling date of the later invention in order for the examiner
`
`to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art
`
`against the later invention.
`
`Claims 1-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandoz Label (2010)
`
`in view of Hernandez -Sanchez (Aluminum in Parenteral Nutrition: A Systematic Review, 67 Eur J Clinical
`
`Nutrition 230 (2013)), and Bohrer (Influences of the Glass Packing on the Contamination of
`
`Pharmaecutical Products in Aluminum PartIl: Amino Acids for Parenteral Nutrition, 15 J Trace Elements
`
`Med & Bioloby 103 (2001), Nakayama etal (US 4,385,086), Asquith et al (Biochimica et Biophysica Acta,
`
`345-357, 1696), and Waterman (Stabilization of Pharmaceuticals to Oxidative Degradation, 7
`
`Pharmaceutical Dev. & Tech. 1 (2002)).
`
`The Sandoz Label discloses L-Cysteine Hydrochloride injections, 50mg/mL, available in single-
`
`dose vials. Sandoz label notes the product contains water and air replaced with Nitrogen, with a pH 1.0-
`
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`Eton Ex. 1122
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`

`

`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 4
`
`2.5. The label further states the product contains no more than 5,000 mcg/L (5,000 ppb) of aluminum.
`
`Sandoz Labelfurther discloses a warning about aluminum which suggest premature neonates should not
`
`receive levels of more than 4mcg to 5 mcg/kg/day accumulate aluminum levels.
`
`Sandoz Label does not teach methods to remove aluminum contaminant.
`
`Hernandez-Sanchez teaches manufacturers of parenteral compositions should limit the
`
`aluminum content in formulations to limit patients’ exposure and to prevent cases of Al toxicity,
`
`especially in infants (pg 236 Discussion). Various steps to reduce aluminum content are discussed, but it
`
`is noted that few manufacturers have put the procedures into use (pg 237, Low-Al product options).
`
`Hernandez-Sanchez does not teach the instantly claimed methods to remove aluminum
`
`contaminant by modifying the glass container.
`
`Bohrer teaches it was known that cysteine, cystine, and aspartic acid release aluminum from
`
`standard glass containers whenstored for a long period (pg 107, Conclusion).
`
`Bohrer does not teach the application of L-cysteine formulations.
`
`Nakayama et al teaches a method to preventleaching of contaminants from the surface of glass
`
`by applying a coating of silicate (see for example claim 1 and Example 1).
`
`Bohrer does not teach the application of L-cysteine formulations.
`
`Asquith et al teaches cysteine was known to degradein the presenceof air (pg 347).
`
`Waterman teaches preventing oxidative degradation by applying a nitrogen headspaceto liquids
`
`(pg 27).
`
`Based on the teachings of Sandoz Label, the skilled artisan would recognize that aluminum was a
`
`known contaminant of L-Cysteine parenteral formulations and that the aluminum content should be
`
`minimized. Hernandez-Sanchez provides motivation to develop lower aluminum content formulations
`
`and provides teachings on how to achieve the desired results. The skilled artisan would recognize the
`
`teaching of Bohrer as another cause of contamination levels and would solve the problem by using
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 5
`
`treated glass as taught by Nakayama et al. Asquith et al provides motivation to correct the oxygen head
`
`space problem, with the solution provided by Waterman.
`
`Thus,it appears the contamination content problem was known to be caused by various
`
`elements of the overall process of developing and storing the product, and each step had known means
`
`to reduce the contamination. While such steps had not been applied in the industry, the skilled artisan
`
`would have recognized the solutions based on the art and would simply have to implement them into
`
`the overall process as outlined above.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner
`
`can normally be reached on Mon and Wed-Fri (8am-6pm).
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where
`
`this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent Application
`
`Information Retrieval (PAIR) system. Status information for published applications may be obtained
`
`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
`
`through Private PAIR only. For more information about the PAIR system, see https://ppair-
`
`my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact
`
`the Electronic Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a
`
`Eton Ex. 1122
`6 of 22
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`Eton Ex. 1122
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`

`

`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 6
`
`USPTO Customer Service Representative or access to the automated information system, call 800-786-
`
`9199 (IN USA OR CANADA)or 571-272-1000.
`
`/BENJAMIN J PACKARD/
`Primary Examiner, Art Unit 1612
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Page 1 of 1
`
`Application/Control No.
`16/773 ,641
`Examiner
`BENJAMIN J PACKARD
`
`Applicant(s)/Patent Under
`Reexamination
`Maloneyetal.
`Art Unit
`1612
`
`U.S. PATENT DOCUMENTS
`
`Notice ofReferences Cited
`
`>
`Oo2®
`
`Document Number
`Country Code-Number-Kind Code
`US-4385086-A
`
`Date
`MM-YYYY
`05-1983
`
`Nakayama; Muneo
`
`Co9D4/00
`
`427/387
`
`Document Number
`Country Code-Number-Kind Gode
`
`MM-YYYY
`
`Country
`
`FOREIGN PATENT DOCUMENTS
`
`CPC Classification
`
`*A copyofthis reference is not being furnished with this Office action. (Gee MPEP § 707.05(a).)
`Dates in MM-YYYYformat are publication dates. Classifications may be USorforeign.
`U.S. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20200720
`
`Eton Ex. 1122
`8 of 22
`
`Eton Ex. 1122
`8 of 22
`
`

`

`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Search Notes
`
`ll|
`
`ll | |
`
`US Classification - Searched*
`Primary Examiner, Art Unit 1612
`
`* See search history printout included with this form or the SEARCH NOTESbox below to determine the scope of
`the search.
`
`16/773,641
`
`senna
`
`BENJAMIN J PACKARD
`
`Maloneyetal.
`
`_
`
`1612
`
`CPC - Searched*
`
`A61K 33/06
`A61K 33/06
`
`CPC Combination Sets - Searched*
`
`04/27/2020 BP
`07/20/2020
`BPO
`
`Search Notes
`Search Notes[Date=
`Palm inventor search
`
`East search
`
`STN search- caplus- terms: I-cysteine, aluminum
`
`STN and East searches updated
`East search
`
`Google scholar search
`
`/BENJAMIN J PACKARD/
`
`U.S. Patent and Trademark Office
`
`Page 1 of 2
`
`Part of Paper No.: 20200720
`
`Eton Ex. 1122
`9 of 22
`
`Eton Ex. 1122
`9 of 22
`
`

`

`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`16/773,641
`
`senna
`
`BENJAMIN J PACKARD
`
`Maloneyetal.
`
`_
`
`1612
`
`07/20/2020 —__
`
`Interference Search
`US Class/CPC|W6 subclass/CPC Group
`Symbol
`AG1K
`
`Search Notes
`
`ll|
`
`ll | |
`
`AG1K
`
`33/06
`
`33/06
`
`04/27/2020
`
`/BENJAMIN J PACKARD/
`
`Primary Examiner, Art Unit 1612
`
`U.S. Patent and Trademark Office
`
`Page 2 of 2
`
`Part of Paper No.: 20200720
`
`Eton Ex. 1122
`10 of 22
`
`Eton Ex. 1122
`10 of 22
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`

`

`Attorney’s Docket No. 066859/543316
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No.: 3992
`John Maloneyet al.
`In re:
`Group Art Unit:
`1612
`Appl. No.: 16/773,641
`Examiner:
`Benjamin J. Packard
`Filed:
`January 27, 2020
`For:
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONSFOR INJECTION
`AND METHODS OF USE
`
`Submitted via EFS-Web
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`CITATION UNDER37 C.F.R.§ 1.97
`
`Attachedis a list of documents on form PTO-SB08.
`
`It is requested that the Examiner consider these documents and officially make them of
`
`record in accordance with the provisions of 37 C.F.R. § 1.97 and Section 609 of the MPEP. By
`
`identifying the listed documents, Applicant in no way makes any admission as to the prior art
`
`status of the listed documents, but is instead identifying the listed documents for the sake of full
`
`disclosure.
`
`Copies of all
`
`listed documents (other
`
`than U.S. patents, U.S. patent application
`
`publications, or patents or publications otherwise determined cumulative) are attached, except
`
`those (if any) that were previously submitted to, or cited by, the Office during the prosecution of
`
`any application(s) upon which the present application directly relies for an earlier effective filing
`
`date under 35 U.S.C. § 120.
`
`It is noted that 37 C.F.R. § 1.98(d) establishes that copies of
`
`documentspreviously submitted to, or cited by, the Office during prosecution of said application(s)
`
`are not required to be furnished; however, copies of such documents will be furnished upon
`
`request.
`
`In accordance with 37 C.F.R. § 1.98(d) the reference aboveto said application(s) includes
`
`those application(s) properly identified in the table below:
`
`
`
` 16/248,460
`
`16/746,028
`16/665,702
`
`01-17-2020
`10-28-2019
`01-15-2019
`
`10,583,155
`10,478,453
`
`Pending
`Issued
`Issued
`
`LEGAL02/39818692v1
`
`/BENTJAMIN J PACKARD/
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`11 of 22
`
`Eton Ex. 1122
`11 of 22
`
`

`

`In re: John Maloneyetal.
`Appl. No.: 16/773,641
`Filed: January 27, 2020
`Page 2
`
`Respectfully submitted,
`
`/bryan |. skelton/
`
`Bryan L. Skelton
`Registration No. 50,893
`
`Customer No. 826
`ALSTON & BIRD LLP
`Bank of America Plaza
`101 South Tryon Street, Suite 4000
`Charlotte, NC 28280-4000
`Tel Research Triangle Area Office (919) 862-2200
`Fax Research Triangle Area Office (919) 862-2260
`
`ELECTRONICALLYFILED USING THE EFS-WEB ELECTRONIC FILING SYSTEM OF THE UNITED STATES PATENT &
`TRADEMARK OFFICE ON June 2, 2020.
`
`LEGAL02/39818692v1
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`12 of 22
`
`Eton Ex. 1122
`12 of 22
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`Modified PTO/SB/08 Form
`
` Attorney Docket Number]
`
`ELCYS (Cysteine Hydrochloride)" NDA 210660, Orange Book: Approved Drug Products with | ~|
`
`
`INFORMATION DISCLOSURE_[File Date
`STATEMENT BY APPLICANT __[FistNemedinventor|John Maloney
`
`Ait Unit
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Benjamin J. Packard
`066859/543316
`
`U.S. PATENT DOCUMENTS
`
`Document Number
`
`Number Kind Code? “#7!
`
`Pages, Columns, Lincs, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner
`Initials *
`
`Include nameof 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.
`
`.
`
`
`No. 10,478,45
`(P
`
`
`
`| ReviewofU.S. PatentNo. 10,478,453, Eton Pharmaceuticals, Inc.v. Exela PharmaSciences,
`
`278 |‘Aminosyn Sulfite Free [drug information]," RX List, 15 pages, Exhibit 1052, 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)
`
`
`Human Services, FDA. CDER, CBER,29 s, (2009).
`
`
`
`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,
`
`sestnudtGR2020-00064, (PTAB May 19, 2020)
`
`
`
`Examiner
`
`/BENJAMIN J PACKARD /
`LEGAL02/398 18646v 1
`
`Date
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`13 of 22
`
`Eton Ex. 1122
`13 of 22
`
`

`

`Substitute for form 1449B/PTO
`
`Modified PTO/SB/08 Form
`
`Complete if Known
`
`066859/543316
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Application Number
`16/773,641
`Filing Date January 27, 2020
`First Named Inventor
`John Maloney
`Art Unit
`1612
`(Use as many sheets as necessary)
`Examiner Name Benjamin J. Packard
`
`Attorney Docket Number]
`
`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
`
`243
`
`|Affadavit of Christopher Butler, Exhibit 1004, 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)
`1
`
`|
`
`
`
`
`
`setnneeienenntneaheneeeeneefsa May 19, 20200,478,453, Eton Pharmaceuticals,Inc.v. ExelaPharmaSciences, LLC, PGR2020-00064, |
`
`
`
`
`
`
`“RemovalofDissolvedOxygen fromWater: A ComparisonofFouCommon|_|
`
`* Talanta, 41(2):211-215,(1994)
`LD, "Stability of Drugsand Medicines," EssentialsofPharmaceutical=|‘||
`
`
`
`
`
`
`ICONNAUGHTONand FIORELLO,“ArgonorNitrogen. Which is Best forYourApplication?,
`| =|
`
`
`
`is, Buffalo Grove: Interpharm Press, |
`
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`Examiner
`
`/BENJAMIN J PACKARD/
`LEGAL02/398 18646v 1
`
`Date
`
`*
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`14 of 22
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`Eton Ex. 1122
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`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`16/773,641
`Application Number
`
`Filing Date
`January 27, 2020
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT FirstNamedInventor|John Maloney
`Art Unit
`1612
`
`(Use as many sheets as necessary)
`
`Examiner Name
`Attorney Docket Number]
`
`Benjamin J. Packard
`066859/543316
`
`Modified PTO/SB/08 Form
`
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`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
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`
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`Signature
`LEGAL02/398 18646v 1
`
`Date
`Considered
`
`07/20/2026
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`16/773,641
`Application Number
`
`Filing Date
`January 27, 2020
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT FirstNamedInventor|John Maloney
`Art Unit
`1612
`
`Modified PTO/SB/08 Form
`
`
`
`Journal of Parenteral Science & Technology, 43(3):132-139, (1989)
`
`(Use as many sheets as necessary)
`
`Examiner Name
`Attorney Docket Number]
`
`Benjamin J. Packard
`066859/543316
`
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`Pediatric TPN,”
`
`Examiner
`/BENJAMIN J PACKARD/
`Signature
`LEGAL02/398 18646v 1
`
`Date
`Considered
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`16 of 22
`
`Eton Ex. 1122
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`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`Modified PTO/SB/08 Form
`
`
`INFORMATION DISCLOSURE_[File Date
`STATEMENT BY APPLICANT __[FistNemedinventor|John Maloney
`
`Ait Unit
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Attorney Docket Number]
`
`Benjamin J. Packard
`066859/543316
`
` 259 WATERMAN 4
`
`of Pharmaceuticals
`Pharmaceutical Development and Technol
`
`:
`
`
`
`
`NoQo = @ux wy°<® ==i®ismm_:@is3 ivisOD
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`
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`
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`
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`
`i
`
`E
`
`;
`/BENJAMIN J PACKARD/
`LEGAL02/398 18646v 1
`
`Dat
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`17 of 22
`
`Eton Ex. 1122
`17 of 22
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`16/773,641
`Application Number
`
`Filing Date
`January 27, 2020
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT FirstNamedInventor|John Maloney
`Art Unit
`1612
`
`Modified PTO/SB/08 Form
`
`
`
`
`
`(Use as many sheets as necessary)
`
`Examiner Name
`Attorney Docket Number]
`
`Benjamin J. Packard
`066859/543316
`
`Examiner
`Initials *
`
`‘
`
`Include nameof 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.
`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)
`
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`armacopeial
`
`|
`
`|
`
`Declaration of Judy K.
`No. 10,583,155, Eton Pharmaceuti
`(PTAB June 8, 2020).
`
`Examiner
`Signature
`LEGAL02/39845200v 1
`
`{BENJAMIN J PACKARD /
`
`Date
`Considered
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`18 of 22
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`Eton Ex. 1122
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`

`Application Number
`Filing Date
`INFORMATION DISCLOSURE
`
`
`STATEMENT BY APPLICANT First NamedInventor|John Maloney
`Art Unit
`1612
`
`16/773.641
`
`(Use as many sheets as necessary)
`
`Examiner Name
`Attorney Docket Number]
`
`Benjamin J. Packard
`066859/543316
`
`Substitute for form 1449B/PTO
`
`Modified PTO/SB/08 Form
`
`Complete if Known
`
`
`
`|eeeseensaeeeeesaneeansss\*
`
`
`
` Declaration of Barrett
`Rabino
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`-
`IPGR2020-00068, (PTABJUG8, 2020)aa assnssstetnnsatnesatnnsstennstetnstetnstntnsintanintasiatnnyeteta
`
`[sone|sewsausrnzexceapyemis|onz20/2020|Signature
`BENJAMIN J PACKARD,
`Considered
`07/20/2020
`LEGAL02/39845200v 1
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/B.J.P/
`
`Eton Ex. 1122
`19 of 22
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`EAST Search History
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`EAST Search History (Prior Art)
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`
`
`
`S126 "L-cysteine" parenteral --US-PGPUB;USPAT;USOCR; AND ON—2020/07/20
`aluminum ppb
` FPRS; EPO; JPO; DERWENT;
`08:13
`| | -IBM_TDB
`
`
`S25 "keysteine".clm.
`_US-PGPUB; USPAT; USOCR; AND
`ON
`2020/07/20
`‘parenteral aluminum = FPRS; EPO; JPO; DERWENT;
`“ppb
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`infrared reflectance spectra of semi-transparent SiO2 rich films on silicate glasses:
`influence of the substrate and film thickness
`F Geotii-Bianchini, M Prea, Mi Guglielmi... - Journal of non-crystalline ..., 2008 - Elsevier
`... In the region where the silicate network absorbsstrongly, the optical constants of the silica and...
`are likely to have optical constants intermediate between those of sodalime andsilica andto ...
`above byincreasing the coating thicknessuntil the curve of the coated glass wassimilar...
`ye
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`Aiginate-magnesium aluminum silicate films: Cifect of plasticizers on film properties,
`drug permeation and drug release from coated tablets
`T Pongianvakul, S Puttininatkhachorn - international journal of ..., 2007 - Elsevier
`... from the films, placed on open 5 ml glass vials containing 3.5 g silica gel beads ... were consisted
`of ACT 10%, Avicel ® PH102 30%, Flowlac ® 100 58.8%, colloidal silicon dioxide 0.2 ... to describe
`that plasticizers could penetrate between the chains of SA andthesilicate layers of ...
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`Leaching behaviour of silicon nitride materials in sulphuric acid containing KF
`J Schiim, M Heirmenn, G Michael - Journal of the European Geramic .... 2004 - Elsevier
`... The Oxygen contentin the inner layer is a strong hint for residual hydrated silica structures ... 9).
`On the one handthey are able to form [SiF 6 ] 2— complexes with silicon which results in a further
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`Bicactivity of sol-gel bioactive glass coated alumina impianis
`M Harmadouche, A Meunier... -... Research: An Officiad ..., 2000 - Wiley Online Library
`... evolution of osteoid tissue percentage, for single and double layer 58S- coated implants, showed
`a ... Melt-derived silicate glasses (Bioglass) and silica-free glasses have beentestedin this ... of
`aluminum could inhibit mineralization through a sur- face potential of silica change from ...
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`... Structural holes will have considerably larger volume thanin silicate glasses, and hencelarge
`cations could be ... expected to be in the near-neutral regime as well as near saturation with silica ...
`23] to concentrate in the gel layer while other elements, including silicon and boron...
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`H Nageyama, H Honda... - doumal of the ..., 1888 -ionscienosjop.arg
`... elements detected in over- all depth equivalent to the thickness of deposited layer were only
`silicon [Si] and ... compar- ing the effect of preventing sodium migration from the glass surface among
`sodalime silicate glass and the ... 4. The LPD silica film has a greatalkali barrier effect ...
`vv
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`KE Jones, PK Campbaill, RA Normann - Annais of blomedical anginearing, 1992 - Springer
`... The polyimide coat- ing appearsasa thin ring around the silicon needle ... locations were near the
`tips of the needles, under the area that had been coatedwith platinum ... thermomigration fabrication
`method required the use of a semiconduct- ing material such as silicon to produce ...
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`https://scholar.google.com/scholar?start=10&q=silicatcoated+glasstaluminum+leach&hl=en&as_sdt=0,47&as_yhi=2016
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