`
`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
`
`
`16/773,641
`01/27/2020
`John Malnney
`066859/543316
`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®alstoncom
`
`PTOl.-90A (Rev. 04/07)
`
`Eton Ex. 1122
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`Off/09 ACIIO” Summary
`
`Application No.
`16/773,641
`Examiner
`BENJAMIN J PACKARD
`
`Applicant(s)
`Maloney et al.
`Art Unit
`1612
`
`AIA (FITF) Status
`Yes
`
`- 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 6/2/2020.
`
`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 Expa/te Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`1—27 is/are pending in the application.
`
`5a) Of the above Claim(s)
`
`is/are withdrawn from consideration.
`
`I] Claim(s)
`
`is/are allowed.
`
`Claim(s) 1—27 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 7998 15/2/20). 2998 35/11/20).
`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
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

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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-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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`

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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 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 Nutrition, 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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`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 4
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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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`

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`Application/Control Number: 16/773,641
`Art Unit: 1612
`
`Page 5
`
`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
`
`the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
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`

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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.
`
`/BENJAM|NJ PACKARD/
`Primary Examiner, Art Unit 1612
`
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`Page 1 of 1
`
`Application/Control No.
`16/773,641
`
`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
`
`Eton Ex. 1122
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`
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`

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`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Search Notes
`
`16/773,641
`
`||||||||||||
`
`"IN"
`
`H
`
`"H
`
`Examiner
`
`BENJAMIN J PACKARD
`
`Maloney et al.
`
`Art unit
`
`1612
`
`GPO - Searched*
`
`A61 K 33/06
`A61 K 33/06
`
`CPC Combination Sets - Searched*
`
`04/27/2020 _
`07/20/2020 _
`
`* See search history printout included with this form or the SEARCH NOTES box below to determine the scope of
`the search.
`
`Search Notes
`
`Search Notes
`
`Palm inventor search
`
`East search
`
`STN search- caplus- terms: l-cysteine, aluminum
`
`STN and East searches updated
`East search
`
`Google scholar search
`
`03/26/2020
`
`03/26/2020
`
`03/26/2020
`
`04/27/2020
`07/20/2020
`
`07/20/2020
`
`US Classification - Searched*
`Primary Examiner, Art Unit 1612
`
`/BENJAM|N J PACKARD/
`
`US. Patent and Trademark Office
`
`Page 1 of 2
`
`Part of Paper No.: 20200720
`
`Eton Ex. 1122
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`Eton Ex. 1122
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`

`

`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Search Notes
`
`16/773,641
`
`||||||||||||
`
`"IN"
`
`H
`
`"H
`
`Examiner
`
`BENJAMIN J PACKARD
`
`Maloney et al.
`
`Art unit
`
`1612
`
`07/20/2020 _
`
`Interference Search
`
`US C'aSS/CPC US Subclass/CPO GrOUP
`Symbol
`A61 K
`A61 K
`
`33/06
`33/06
`
`04/27/2020 _
`
`Primary Examiner, Art Unit 1612
`
`/BENJAM|N J PACKARD/
`
`US. Patent and Trademark Office
`
`Page 2 of 2
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`Part of Paper No; 20200720
`
`Eton Ex. 1122
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`

`

`Attorney’s Docket No. 066859/543316
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No: 3992
`John Maloney et 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 COMPOSITIONS FOR INJECTION
`AND METHODS OF USE
`
`Submitted via EFS-Web
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`
`CITATION UNDER 37 C.F.R. § 1.97
`
`Attached is a list of documents on form PTO—SBOS.
`
`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 1\/[PEP. 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 US. patents, US. 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
`
`documents previously 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 above to said application(s) includes
`
`those application(s) properly identified in the table below:
`
`
`
` 16/248,460
`
`Pending
`Issued
`Issued
`
`16/746,028
`l6/665,702
`
`01-17-2020
`10-28-2019
`01-15-2019
`
`10,583,155
`10,478,453
`
`LEGAL02/39818692v1
`
`/EENJAMIN J PACKARD/
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`/E,J.P/
`
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`Eton Ex. 1122
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`

`

`In re: John Maloney et al.
`Appl. No: 16/773,641
`Filed: January 27, 2020
`Page 2
`
`Customer N0. 826
`ALSTON & BIRD LLP
`Bank of America Plaza
`
`101 South Tryon Street, Suite 4000
`Charlotte, NC 28280-4000
`
`Tel Research Triangle Area Offi ce (919) 862—2200
`Fax Research Triangle Area Office (919) 862-2260
`
`Respectfully submitted,
`
`/bry an 1. skelton/
`
`Bryan L. Skelton
`Registration No. 50,893
`
`ELECTRONICALLY FILED USING THE EFS-VVEB ELECTRONIC FILING SYSTEM OF THE UNITED STATES PATENT &
`TRADEMARK OFFICE ON June 2, 2020.
`
`LEGAL02/398I8692VI
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`,I’EJLP/
`
`Eton Ex. 1122
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`Eton Ex. 1122
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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 lnventor
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`Attorney Docket Number
`
`
`Document Number
`
`Number Kind Code1 WWW
`
`Pages, Columns, Lines, Whore
`Relevant Passages or Relevant
`Figures 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.
`
`ELCYS (Cysteine Hydrochloride), NDA 210660, Orange Book: Approved Drug Products wrth
`
`I I I I I I
`
`.
`.
`iii) EH56 'é'r'é'fii"'r€éiiié"uf6i
`,
`gBank, 3 page , E
`,
`No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`.(E’
`x.
`
`“AMIN SYN [
`Review Of U.S. Patent No. 10,478,453, Eton P armaceuticals, Inc. V. Exela Pharma sciences,
`
`278 “Aminosyn Sulfite 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)
`
`I I i I I E
`
`
`
`information]", Sandoz Inc., 11 pages, Exhibit 1005, Petition for Post Grant Review of US.
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`xaminer
`
`Date
`
`/EENJAMIN J PACKARD/
`LEGAL02/39818646V1
`
`07/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E,J.P/
`
`Eton Ex. 1122
`13 of 22
`
`Eton Ex. 1122
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`

`

`Modified PTO/SB/08 FOIm
`
`Substitute for form 1449B/PTO
`
`Complete if Known
`
`Application Number
`
`INFORMATION DISCLOSURE
`
`
`Fi'ing Date
`
`STATEMENT BY APPLICANT
`
`FirstNamed Inventor
`
`
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`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:
`
`
`
`
`ffadaVIt of Christopher Butler, Exhibit 1004, Petition for Post Grant ReVIew ofU.S. Patent No.
`0,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`PTAB Ma 19 2020)
`
`1 (
`
`243
`
`I
`0,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`PTAB May 19 2020
`_____________________________
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`1 (
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`I I I I I
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`I I I I I I I I I
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` CONNAUGHTON and FIORELLO, Argon or Nitrogen. Which is Best forYourAppIication?,
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`10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064,
`IEIé§.II./!§¥..1.9.i.2..929)........................................................................................................................................................
`
`Examiner
`
`/BENJAMIN J PACKARD/
`LEGAL02/39818646V1
`
`Date
`
`,.
`07/20/2029
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E.J.P/
`
`Eton Ex. 1122
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`'
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`Eton Ex. 1122
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`

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`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`16/773 641
`Application Number
`
`Fi'ing Date
`
`FirstNamed |nventor
`
`
`
`
`
`(Use as many sheets as necessary) Examiner Name
`
`Attorney Docket Number
`
`Declaration of Harry "Warren" Johnson, Exhibit 1022, Petition for Post Grant Revrew of US.
`Patent No. 10,478,453, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`
`
`
`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,
`
`(PTAB May
`_,___2
`
`
`., ofi'i'iiébéémments of'KBéaib'non 6i'N.tr6§'éii"é'fia"6$&§en In Diéiiiiéa' """""""""
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`
`
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`I
`"""I
`
`
`
`
`||V Drug:A
`| gan Oxyge -
`ontai
`Formula
`KASRAIAN et
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`Case Study of Danofloxacin Injectable," Pharmaceutical Development and Technology,
`
`
`
`
`
`' U?.I.tl.9.i1iil§.'..9IPh rmaeeuiieal 99.19.99 119' 913(9):..493 495
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`ialysis
`MCHALSKY e aiii',"i"fiié6iu'éiibn of'A'I-u'minum té'véié'ifi
`
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`MIHATSCH et al., “ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral
`nutrition: Calcium, phosphorus and magnesium," Clinical Nutrition, 37:2360-2365, (2018).
`
`Examiner
`
`[BENJAMIN J PACKARD/
`Signature
`LEGAL02/39818646V1
`
`Date
`
`Considered
`
`07 20 2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E.J.P/
`
`Eton Ex. 1122
`15 of 22
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`Eton Ex. 1122
`15 of 22
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`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`Application Number
`
`INFORMATION DISCLOSURE
`
`
`Fi'ing Date
`
`Modified PTO/SB/08 FOIm
`
`STATEMENT BY APPLICANT
`
`FirstNamed lnventor
`
` Attorney Docket Number
`
`Pediatric TPN Journal of Parenteral Science & Technology 43(3)'132—139 (1989)
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`Peptide Degradation Pathways," BioProcess International, 23 pages, (2011). [Retrieved from
`the Internet May 11, 2020: <URL:
`https://bioprocessint| .com/manufacturing/formuIation/biopharmaceuticaI-product-stabiIity-
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`PATRICK, AD, "The Degradatlve Metabolism of L-Cystelne and L-Cystlne In vrtro by Liver In
`
`Remington. Theléclence and
`Practice of Pharmacy, 21st ed., Ed. David B. Troy, Baltimore: Lippincott VIfiIIiams &Wi|kins, pp.
`1047-1057, (2006).
`
`RABINOW et aI., “Aluminum in Parenteral Products: Analysis, Reduction, and Implications for
`
`Examiner
`[BENJAMIN J PACKARD!
`agnmure
`LEGAL02/39818646V1
`
`Date
`Considered
`
`071/29 mom
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`/E,J.P/
`
`Eton Ex. 1122
`16 of 22
`
`Eton Ex. 1122
`16 of 22
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`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`16/773 641
`Application Number
`
`Fi'ing Date
`January 27, 2020
`
`Modified PTO/SB/08 FOIm
`
`STATEMENT BY APPLICANT
`
`Firs‘Named '"Vem‘"
`
`(Use as many sheets as necessary)
`
`Attorney Docket Number
`
`J°hn Mammy
`1612
`
`Benjamin J. Packard
`066859/543316
`
`Examiner Name
`1(1 '1 32,".(2902). ___________________________
`
` WATERMAN
`of Pharmac uticals
`Pharmaceutic IDevelopmenta d Technol
`
`
`
`Oxida ve Degradati
`
`.........................
`
`261
`
`P
`
`.........................
`Grove: I”I‘EIPIIE‘IID..E.i§55.x..I”9.x: Pl?:..269'304.x..I1 9.9.5)-
`
`267 IYU eta|., ""L'iii'diéié't'é'fiaingi'PiiéiméEeuticaI duality by De'é'ign,"THE'M'ri'éUBu'i'riéi,"'1"6(4')"2'77'11"""I""""""I
`
`
`
`783 (2014)
`
`
`Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and
`Packaging, 3rd ed., Eds. Sandeep Nema and John D. Ludwig, New York: Informa Healtchare,
`pp. 222-253, (2010).
`
`'
`
`E
`
`.
`[BENJAMIN J PACKARD/
`LEGAL02/39818646V1
`
`D t
`
`(37/20/2020
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`/E,J.P/
`
`Eton Ex. 1122
`17 of 22
`
`Eton Ex. 1122
`17 of 22
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`

`

`
`
`Substitute for form 1449B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BYAPPLICANT
`
`Modified PTO/SB/08 FOIm
`
`Complete if Known
`
`
`Fi'ingDa‘e
`
`FirstNamed'nvenmr
`
`Jommamey
`
`
`(Use as many sheets as necessary)
`Examiner Name
`Benjamin J. Packard
`Attorney Docket Number
`066859/543316
`
`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)
`
`
`
`
`
`
`
`
`
`
`,
`mp raw | 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 al., Parenteral Nutrition: Macronutrlent Composmon and Requ1rements, 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).
`
`
`
`
`
`
`é'ifiiacd'fié'iéii.......I...........I
`
`BOULLAH'III'
`.
`Remington: The-Swen
`
`
`Practice of Pharmacy, 21 Ed., Ed. David B. Troy, Philadelphia: Lippincott VWliams & 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.‘.t:. (20.18)."
`
`
`
`
`
`..il.‘ Rhfiflfifiiflfilfll’.
`.Efii'
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`.....
`Declaration ofJudy K.
`é'"'("2"o"2 )',"E'x i
`It
`"1"o
`,"Eetttrori'iS'E'Eosi'Cr'é'fitE'évré'i'l/o
`.
`.
`
`No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, PGR2020-00068,
`
`(PTAB June 8, 2020).
`
`
`
`Examiner
`
`Signature
`LEGAL02/39845200V1
`
`(IBENJAMIN J PACKARD/
`
`Date
`
`Considered
`
`Q 7 f2 0 [2 (320
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`/E,J.P/
`
`Eton Ex. 1122
`18 of 22
`
`Eton Ex. 1122
`18 of 22
`
`

`

`Substitute for form 1449B/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`16/773 641
`Application Number
`
`Fi'ing Date
`January 27, 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
`066859/543316
`
`I.........................‘mgéuim
`
`
` Decla tion ofBarrett bino
`
`Patent No. 10,583,155, Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC,
`I
`I
`8.93.2192.9:99.Q§§.y..IEIAEAHHEELEQZQ). .............................................................................................................................
`
`”——S'gna‘ure
`BENJAMIN J PACKARD
`cons'dered
`0 7 / 2 0 / 2 033 0
`LEGAL02/39845200V1
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/E,J.P/
`
`Eton Ex. 1122
`19 of 22
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`Eton Ex. 1122
`19 of 22
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`

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`EAST Search History
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`EAST Search History (Prior Art)
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`Eton Ex. 1122
`20 of 22
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`7/20/2020
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`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
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`from the films, placed on open 5 ml glass vials containing 3.5 g silica gel beads
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`2004 _ Elsevler
`9).
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`Structural holes will have considerably larger volume than in silicate glasses, and hence large
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