`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF CONIMERCE
`United Slates Patent and Trademark Office
`Address: CONJNHSSIONER FOR PATENTS
`PO Box 1450
`Alexandria, Virginia 2231371450
`wwwuspto gov
`
`
`16/746,028
`01/17/2020
`JOHN MALONEY
`066859542422
`4075
`
`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®alstoncom
`
`PTOl.-90A (Rev. 04/07)
`
`Eton Ex. 1121
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`Off/09 ACIIO” Summary
`
`Examiner
`BENJAMIN J PACKARD
`
`Art Unit
`1612
`
`AIA (FITF) Status
`Yes
`
`Application No.
`16/746,028
`
`Applicant(s)
`MALONEY et al.
`
`- The MAILING DA TE ofthis communication appears on the cover sheet with the correspondence address —
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date ofthis 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 months after 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). Responsive to communication(s) filed on 5/28/2020.
`
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)[:] This action is FINAL.
`2b)
`This action is non-final.
`
`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`
`4)C] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`1—29 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`[1 Claim(s)
`
`is/are allowed.
`
`Claim(s) 1—29 is/are rejected.
`
`) )
`
`6
`
`D Claim(s)
`
`is/are objected to.
`
`) )
`
`
`
`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aLLowabLe, 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/indexjsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)|j The specification is objected to by the Examiner.
`
`is/are: a)C] accepted or b)l:] objected to by the Examiner.
`11)[:] The drawing(s) filed on
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85( ).
`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)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(
`Certified copies:
`
`)-(d) or (f).
`
`a)D All
`
`b)D Some**
`
`C)CI None of the:
`
`1C] Certified copies of the priority documents have been received.
`
`2C] Certified copies of the priority documents have been received in Application No.
`
`3B 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( )).
`** 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/OSa and/or PTO/SB/OSb)
`2)
`Paper No(s)/Mai| Date 199 15/13/20 ,4993 15/28/201, 299$ 16/11/201
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`3) E] Interview Summary (PTO-413)
`Paper N0(s)/Mai| Date
`4) CI Other'
`
`Part of Paper No./Mai| Date 20200720
`
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`Application/Control Number: 16/746,028
`Art Unit: 1612
`
`Page 2
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`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-AIA 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 ordinary skill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
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`Application/Control Number: 16/746,028
`Art Unit: 1612
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`Page 3
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`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 presumes that the subject matter of the various claims was commonly owned as of the
`
`effective filing 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 effective filing 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] Clinical
`
`Nutrition 230 (2013)), and Bohrer (Influences of the Glass Packing on the Contamination of
`
`Pharmaecutical Products in Aluminum Part II: Amino Acids for Parenteral Nutrion, 15 J Trace Elements
`
`Med & Bioloby 103 (2001), Nakayama et al (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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`2.5. The label further states the product contains no more than 5,000 mcg/L (5,000 ppb) of aluminum.
`
`Sandoz Label further 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 when stored for a long period (pg 107, Conclusion).
`
`Bohrer does not teach the application of L-cysteine formulations.
`
`Nakayama et al teaches a method to prevent leaching 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 degrade in the presence of air (pg 347).
`
`Waterman teaches preventing oxidative degradation by applying a nitrogen headspace to 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
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`Application/Control Number: 16/746,028
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`treated glass as taught by Nakayama et aI. 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).
`
`Examiner interviews 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
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`the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
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`Application/Control Number: 16/746,028
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`Page 6
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`USPTO Customer Service Representative or access to the automated information system, call 800-786-
`
`9199 (IN USA OR CANADA) or 571—272—1000.
`
`/BENJAM|NJ PACKARD/
`Primary Examiner, Art Unit 1612
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`Page 1 of 1
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`Application/Control No.
`16/746,028
`
`Examin er
`BENJAMIN J PACKARD
`
`Applicant(s)/Patent Under
`Reexamination
`MALONEY et al.
`Art Unit
`1612
`
`U.S. PATENT DOCUMENTS
`
`Notice ofReferences Cited
`
`Document Number
`Country Code-Number-Kind Code
`US-4385086-A
`
`Date
`MM-YYYY
`05-1983
`
`Name
`
`CPC Classification
`
`US Classification
`
`Nakayama; Muneo
`
`C09 D4/00
`
`427/387
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`FOREIGN PATENT DOCUMENTS
`
`CPO Classification
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`- .
`
`
`
`
`
`—I
`
`—
`I—
`I—
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`US. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20200720
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`Application/Control No.
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`Applicant(s)/Patent Under Reexamination
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`Search ”0’95
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`16/746,028
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`MALONEY et al.
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`Examiner
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`BENJAMIN J PACKARD
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`Art unit
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`GPO - Searched*
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`07/20/2020 _
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`Palm inventor search
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`East search
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`03/26/2020
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`STN- Caplus search, terms: l-cycsteine, aluminum, contaminate
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`US Classification - Searched*
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`STN plus and East searches updated
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`/BENJAM|N J PACKARD/
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`MALONEY et al.
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`07/20/2020 _
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`Interference Search
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`US C'aSS/CPC US Subclass/CPO GrOUP
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`A61 K
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`EAST Search History
`
`EAST Search History (Prior Art)
`
`Search Query
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`DBs
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`C:\Users\bpackard\Documents\EAST\Workspaces\16746028-3.wsp
`
`Eton Ex. 1121
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`7/20/2020
`
`silica coated glass aluminum leach - Google Scholar
`
`infrared reflectance spectra at semi—transparent SEQZ rich films on silicate glasses:
`influence cf the substrate and fiim thickness
`200:3- - Eieevler
`F Geettiwfiiaricliirti, i’vi Free, ltri Guglielmi... » Jeurnai cf ricnwcryetallirte
`In the region where the silicate network absorbs strongly, the optical constants of the silica and
`are likely to have optical constants intermediate between those of soda lime and silica and to
`above by increasing the coating thickness until the curve of the coated glass was similar
`713?
`{it} Cited by 21
`Related articles Ali9versicns
`
`Alginate—magnesium aluminum silicate films: Effect of plasticizers an film pracerties,
`drug permeation and drug release from seated tablets
`T Pcngjanyakul, S Puttipipetknacltcrn - lnternatienal journal at ..,, 2007' « Elsevier
`from the films, placed on open 5 ml glass vials containing 3.5 g silica gel beads
`ofACT 10%, Avicel ® PH102 30%, Flowlac ® 100 58.8%, colloidal silicon dioxide 0.2
`that plasticizers could penetrate between the chains of SA and the silicate layers of
`$5:
`9E3 Cited by 70 Related articles All?versiens
`
`were consisted
`to describe
`
`Leaching behavicur cf siliccn nitride materials in sulphuric acid containing KF
`d Schilm, lei Herrmartn, G Michael _ qurnel of the Eurcpeart Ceramic
`2004 _ Elsevler
`9).
`The Oxygen content in the inner layer is a strong hint for residual hydrated silica structures
`On the one hand they are able to form [SiF 6 ] 2- complexes with silicon which results in a further
`dissolution of the Si
`This corrosion behaviour is also known from silicate glasses.15, 16
`if?
`5353 Cited bylS Related articles All5versiens
`
`Bieactivity cf sci-gel biaac’tive glass seated alumina implants
`M l-lamadcuche, A Meunier,“ -
`Research: An {Efficient
`2000 _ Wiley Criline Library
`evolution of osteoid tissue percentage, for single and double layer 583- coated implants, showed
`a Melt-derived silicate glasses (Bioglass) and silica-free glasses have been tested in this
`of
`aluminum could inhibit mineralization through a sur— face potential of silica change from
`“if?
`553 Cited by 57 Related articles Allfiversicne
`
`teaching and mechanical properties at cabal glasses deveicced as matrices for
`immebiiizaticn nigh-level wastes
`2001 — Eleevier
`FM Ezz‘Eldin - Nuclear instruments and Methods in Pnysice Research
`Structural holes will have considerably larger volume than in silicate glasses, and hence large
`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
`i? 53E} Cited byttl
`Related articles All'i’versicns
`
`A new process fcr silica creating
`tiled m icpscienceicpcrg;
`it Nagayama, ll llcndam « chmai cf the
`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
`soda lime silicate glass and the
`4. The LPD silica film has a great alkali barrier effect
`ff
`5?? Cited by 369 Related articles Alifiversions
`
`A glassi’slliccn ccmpcsite intraccrticai electrode array
`KE dense, PK Campbell, RA Hermann - Annals cl bicmedical engineering, 1992 m Springer
`The polyimide coat— ing appears as a thin ring around the silicon needle
`locations were near the
`tips of the needles, under the area that had been coated with platinum thermomigration fabrication
`method required the use of a semiconduct— ing material such as silicon to produce
`$13?
`535} Cited by415 Related articles AllSversicns
`
`Ccrresicn inhibiticn of aluminum and aluminum alloys by seiubie chromates, chromate
`castings, and chromate—free castings
`MW Kendig, RS Buchheit - Ccrrcsicn, 2003 ~ ccrrcsicnjcurnalcrg
`(2017) Correlation between
`(2018) Ce(lll) corrosion inhibitor release from silica and boehmite
`mechanical properties and corrosion behavior of an Al 6061 alloy coated by 5% CH 3
`(2016)
`Microbial reduction of Cr(Vl) in the presence of chromate conversion coating constituents
`‘fi
`95} Cited b31434 Related articles Alieversicns
`3’9
`
`https://scholar.google.com/scholar?start=10&q=silica+coated+glass+aluminum+leach&hl=en&as_sdt=0,47&as_yhi=2016
`
`1/2
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`silica coated glass aluminum leach - Google Scholar
`
`Siiice—rici‘r pereus substrates with reduced tendencies fer breaking or cracking
`WP Marshall, JJ Hemmei, HW Search“. u US Patent
`1936 A Georgie Patents
`The silica concentrations of the leaching solutions were determined by taking one milliliter samples
`ASTM method D 2343, "Standard Test Method for Tensile Properties of Glass Fiber Strands
`of
`2) fibers were not impregnated as per the standard; the only fiber coating was the
`‘33.?
`SE} Cited by 44 Related articles All2versions
`239
`
`Effects of poiishing, etching, cleaving, and water ieeehing on the UV iaser damage at
`fused eiiisa
`1993 v spiedigi‘taiiitzrarytcrg
`induced Damage in
`Jivi Yeshiyarrsa, FY Genin, A fieiiecm «
`AA Tesar, NJ Brown, JR Taylor, CJ Stolz, “Subsurface polishing damage of fused silica: nature
`and effect on laser damage of coated surfaces”, in Laser Induced Damage in Optical Materials
`BC Bunker, “Molecular mechanisms for corrosion of silica and silicate glasses". J. of
`“if?
`95/ Cited by 56 Related articles All5versicns
`3%»
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`Eton Ex. 1121
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`Eton Ex. 1121
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`
`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`App'ica‘i“ Number
`
`Fi'ingDa‘e
`
`FirstNamed '"Venmr
`
`J°hn Manner
`
`
`(Use as many sheets as necessary)
`Examiner Name
`Benjamin J. Packard
`Attorney Docket Number
`066859/542422
`
`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 ofU.S. Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v.
`Exela Pharma Sciences LLC PGR2020-00068 (PTAB June 8 2020)
`
`
`
`
`
`
`
`
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`
`,
`mp Ira'ry r portatio of
`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,
`
`
`
`
`GASSER et aI., Parenteral Nutrition: Macronutrrent Composrtlon and Requrrements, 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 US. Patent No. 10,583,155, Eton Pharmaceuticals,
`Exela Pharma S ' nces LLC, PGR2020 00068 PTAB June 8 2020).
`
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`é'ifiiacd'fié'iéii.......I...........I
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`BOULLAH'III'
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`Remington: The-Scren
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`
`Practice of Pharmacy, 21 Ed., Ed. David B. Troy, Philadelphia: Lippincott VIfiIliams & Wilkins,
`pp. 1688-1693 (2005).
`
`
`
`
`
`
`YESIL et al., “Evaluation of the Children with Acute Acetaminophen Overdose and Intravenous
`N-Acetylcysteine Treatment " Pak J Med Sci
`3f:§§?.2§997.§9.‘}r. (20.18)."
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`Declaration ofJudy K.
`éf'k'é'o'z )',"E'x i
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`
`No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068,
`
`(PTAB June 8, 2020).
`
`
`
`Examiner
`
`[/BENJMfIN J PACMRB/
`Signature
`LEGAL02/39845197V1
`
`Date
`
`Considered
`
`0 ’7 /2 G /2 02 Q
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E,J.P/
`
`Eton Ex. 1121
`14 of 20
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`Eton Ex. 1121
`14 of 20
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`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`16/746 028
`Application Number
`
`Fi'ing Date
`January 17, 2020
`
`Modified PTO/SB/08 FOIm
`
`
`
`STATEMENT BY APPLICANT
`
`Firs‘Named '"Vem‘"
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Attorney Docket Number
`
`J°hn Mammy
`1612
`
`Benjamin J. Packard
`066859/542422
`
`I.........................‘mgéuim
`
`
` Decla tion ofBarrett bino
`
`Patent No. 10,583,155, Eton Pnarmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`I
`I
`8.9.3.3292.9.999%..IEIAEAHHEELEQZQ). .............................................................................................................................
`
`Examiner
`/BENJAMIN J PACKARD]
`S'gnaiure
`LEGAL02/39845197V1
`
`Date .
`0°"S'dered
`
`0 7 I530 1’2 0? o
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E,J.P/
`
`Eton Ex. 1121
`15 of 20
`
`Eton Ex. 1121
`15 of 20
`
`

`

`(Use as many sheets as necessary)
`
`Attorney Docket Number
`
`Benjamin J. Packard
`066859/542422
`
`Examiner
`Initials *
`
`.
`
`'
`
`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.
`
`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/O006/306438/stgeorgeTotaI_Parenter
`
`Substitute for form 1449B/PTO
`
`Complete if Known
`
`App'ica‘i“ Number
`
`INFORMATION DISCLOSURE
`
`
`Fi'ingDa‘e
`
`STATEMENT BY APPLICANT
`
`FirstNamed '"Venmr
`
`J°hn Ma'mey
`
`Modified PTO/SB/08 FOIm
`
`Examiner Name
`
`
`
`Peptide Degradation Pathways," BioProcess International, 23 pages, (2011). [Retrieved from
`the Internet May 11, 2020: <URL:
`https://bioprocessint|.com/manufacturing/formulation/biopharmaceutical-produot—stabiIity-
`considerations-part-1/>].
`
`Examiner
`
`[BENJAMIN J PACKARD/
`LEGAL02/39789674V1
`
`Date
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`/E,J.P/
`
`Eton Ex. 1121
`16 of 20
`
`Eton Ex. 1121
`16 of 20
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`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`Application Number
`
`Fi'ing Date
`
`FirstNamed lnventor
`
` Attorney Docket Number
`
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`Examiner Name
`
`Document Number
`
`Number Kind Code1 WWW
`
`Pages, Columns, Lines, Whom
`Relevant Passages or Relevant
`Flgures Appear
`
`Examiner
`Initials it
`
`.
`
`'
`
`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 ublished.
`
`.
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`'éi'é'fii"'r€éiiié"uf6i
`i6Fi56
`iii)
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`gBank, 3 page , E
`,
`No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`.(E’
`x.
`ELCYS (Cysteine Hydrochloride), NDA 210660, Orange Book: Approved Drug Products wrth
`
`“AMIN SYN [
`Review Of U.S. Patent N0. 10,478,453, Eton P armaceuticals, Inc. V. Exela Pharma Sciences,
`
`“Aminosyn Sulflte Free [drug Information]," RX List, 15 pages, Exhibit 1052, Petition for Post
`Grant Review ofU.S. Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma
`Sciences LLC PGR2020-00064 (PTAB May 19 2020)
`
`information]", Sandoz Inc., 11 pages, Exhibit 1005, Petition for Post Grant Review of US.
`
`Examiner
`
`{BENJAMIN J PACKARD /’
`Signature
`LEGAL02/39818195V1
`
`Date
`
`Considered
`
`if) "i [20 / 2029
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/E,J.P/
`
`Eton Ex. 1121
`17 of 20
`
`Eton Ex. 1121
`17 of 20
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`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`16/746 028
`Application Number
`
`Fi'ing Date
`
`FirstNamed lnventor
`
`257
`
`
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`Attorney Docket Number
`
`263
`
`VALLONE et aI., "Food and Drug Administration Inspection and Licensing of Manufacturing
`Facilities," Drug Biotechnology Regulation: Scientific Basis and Practices, Ed. Yuan-yuan H.
`Chiu et al New York' Marcel Dekker Inc pp 315-340 (1991)
`
`
`
`.
`
`
`
`‘Removal of Dissolved Oxygen from Wa er.
`
`............
`7.2.1.5.... 5.9
`........
`
`CAIRNS, Do'NALb, Stability of braggand Medicines
`Chemistry, 4th ed., London: Pharmaceutical Press, pp. 217-238, (2012).
`CLARK et al., “Effects of Two Different Doses of Amino Acid Supplementation on Growth and
`Blood Amino Acid Levels in Premature Neonates Admitted to the Neonatal Intensive Care Unit:
`
`A Randomized Controlled Trial "Pediatrics 12Q_(6)_:_1.286-1296 (299])
`
`""""""
`___________
`
`
`terile
`ngineering COI’ISI erations in
`umber forAIpsa an Yaman,
`Copyright Registration
`Powder Processes," Sterile Pharmaceutical Products: Process Engineering Applications, Ed.
`Ifififl.fl?ih..!§;fiVi3i BUTEISEEIQY? liliémflfifmflfiéit.'“C-i (1.9.9.5)-
`
`Declaration of Daniel Ingles, Exhibit 1078, Petition for Post Grant ReVIew of US. Patent No.
`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`
`
`
`
`
`
`
`
`
` Copyright Registration Number for Drug Facts & Comparisons, St. Louis: Clinical-Drug-"""""""""""I""""""I
`
`
`
`
`
`
`
`"Intravenous Nutitional Therapy," St. Louis: Clinical Drug Information, LLC, pp. 3-4 and 133-
`155, (2015).
`
`Examiner
`Signature
`
`_
`/BENJAMIN J PACKARD/
`
` LEGAL02/39818195V1
`
`Date
`Considered
`
`07 20 2029
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E,J.P/
`
`Eton Ex. 1121
`18 of 20
`
`Eton Ex. 1121
`18 of 20
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`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`Application Number
`
`Fi'ing Date
`
`FirstNamed |nventor
`
`
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`Attorney Docket Number
`
`
`302 Eton Pharmac uticals,|
`.
`nswerand
`ative Defenses to Com Iai
`,
`,
`,
`
`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., No. 1:20-cv-00365-MN, (D. De|.,
`filed March 16, 2020), retrieved from Exhibit 1077, 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)
`
`
`
`
`General Advice, NDA 210660, Letter from Department of Health and Human Servrces to Exela
`Pharma Sciences, LLC, August 4, 2017.
`
`
`
`GUZMAN BARRON, E.S., “Thiol Groups of Biological Importance," Advances in Enzymology
`
`
`
`and Related Areas of Molecular Biology, Vol. 11, Ed. F. F. Nord, New York: InterScience
`
`
`Publishes, Inc
`p_.___201-26_6_,___(_1951)
`
`
`
`19.1.9.1-
`9.7
`.......................................................
`
`
`
`
`Health Care Provrde'i'Let't'é'F'i'r'ém'ESZéi'é Pharma Sciences, RiskBi'Eia'ter'iiiEi'Kiumm
`
`with Use of Potassium Acetate 40 meq/20 ml Injection Particularly n Neonatal Patients and
`
`Patients with Renal Impairment," 3 pages, (2017).
`
`
` KASRAIAN et aI., “Developing an Injectable Formula Containing an Oxygen-Sensitive Drug: A
`
`Case Study of Danofloxacin Injectable," Pharmaceutical Development and Technology,
`4(4):475-480,
`
`
`
`
`
`
` GHAN/ SPEN/E
` CSPEN gui e Ines on pediatric parenteral
`
`
`
`hosphorus nd magn
`"
`'
`' al Nutr"
`0-23
`8).
`
`
`"Revié'ilik'éy A'fifil'iééti'é'fiiilé'. 21 dé06'6r'ig'i'€666,"5e"fi't'é'r
`
`for Drug-"Evaluation
`
`Petition for Pos Grant Review ofU.S. Pa en
`0. 10,4 8,453, Eton Pharmaceu was, no. v.
`
`
`
`Exela Pharma Sciences, LLC, PGR2020-00064, (PTAB May 19, 2020).
`
`Examiner
`{IBENJAEVEIN J PACKARD/I
`Signature
`LEGAL02/39818195V1
`
`Date.
`Consrdered
`
`Q7f2Q/2029
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E.J.P/
`
`Eton Ex. 1121
`19 of 20
`
`Eton Ex. 1121
`19 of 20
`
`

`

`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`16/746 028
`Application Number
`
`Fi'ing Date
`
`FirstNamed |nventor
`
`
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`Attorney Docket Number
`
`
` Practice of Pharmacy, 21st ed., Ed. David B. Troy, Baltimore: Li
`
`
`
`
`RABINOW et al., “Aluminum in Parenteral Products: An
`
`a'Iysis, Fié'd'uEiion, and-Implicati
`PSdiatric TPN " J09.ifl§.'..9.f.f?§.i§“i§.i§.l.§0ience 8:.IEEIJHRl9.9xt.flc§.(§)5.132-..1..§9..t..(19§9)-
`
`
`“Iiiiéiéifiéé'éiéiuéf'fiéw Much isi'166"iiiiu'éii5i"r3'iié'rifia Mgauiaauiihg, 12
`
`
`
`
`TEASDALE et al., "Impurities in New Drug Su