Substitute for form 1449/PTO
`
`Equivalent of Form PTO/SB/08a/b (07-09)
`Complete if Known
`
`Filing Date
`March 13, 2023
`First Named Inventor
`Dennis Mark MCDAID
`Art Unit
`To Be Assigned
`Examiner Name
`To Be Assigned
`Attorney Docket Number|4384.0010005
`
`
`
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`(Use as many sheets as necessary)
`
`
`
`
`
`
`
`
`U.S. PATENT DOCUMENTS
`pies. conumns, Lanes, Where
`Publication Date
`Document Number
`Cite
`Examiner
`NameofPatentee or
`
`
`
`
`initials* 2(fknown)|MM-DD-YYYYNo! ; Applicant of Cited Document elevantPassages or Relevant
`
`im
`0.
`Number-Kind Code
`Figures Appear
`
`||USI PHILLIPS;Jeffrey Owen
`
`||use LOS; Mario Atilio
`
`
`US3_|US-9051100-B2 06-09-2015|SUZUKI; Yoshihiro
`
`|| uss KUMAR:Ashish etal.
`
`
`||US6 MITTAL;Bhupesh Kumaretal.
`
`||us7 PROEHL;Gerald T. etal.
`
`||uss TANEIJA; Rajneesh etal.
`
`US9_|US-20140271853-Al__| 09-18-2014|HALL: Warrenetal.
`
`||Us HEPBURN:Bonnie et al.
`
`
`||usi2 SUTHERLAND:D.C., et al.
`
`|«| US13_|US-11207307-B2 12-28-2021|FALLIN;Kenetal.
`|__| uS14|US-20050220870-A1|10-06-2005_|HEPBURN;Bonnieetal.
`
`US15|US-20050098526-A1 05-12-2005 CATALIN;Robertino
`
`
`FOREIGN PATENT DOCUMENTS
`
`Foreign Patent Document
`Publication
`5
`Cite
`Nameof Patentee or
`Date
`3
`a
`Examiner
`:
`.
`_
`_
`1
`Ce
`aon
`Applicant of Cited Document
`MM.DD-YYVY
`Country Code Number
`No.
`initials
`(if known)
`Kind Code’
`
`ES-2283172-Al 10-16-2007|UNIV GRANADA[ES]
`
`GB-2189698-A 11-04-1987|HAESSLE AB [SE]
` FP3_|WO-200151050-Al|07-19-2001|UNIV MISSOURI[US]
`
`FP4|WO-2008016887-A2_| 02-07-2008|GRACEWAY PHARMALLC [US]
`WO-2013139377-Al_| 09-26-2013|BAGO SA LABOR[AR]et al.
`
`WO-2017218894-Al|12-21-2017|CUTISPHARMAINC[US]
`EP-1905426-Bl 09-05-2012|BAGO SA LABOR[AR]
`
`
`FP8|EP-2201952-Al 06-30-2010|UNIV MISSOURI[US]
`
`Pages, Columns, Lines,
`‘Where Relevant Passages or
`Relevant Figures Appear
`
`Examiner Signature| ate Considered |
`
`*EXAMINER:Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Draw line throughcitation if not in conformance and
`not considered. Include copy of this form with next communication to applicant. | Applicant’s unique citation designation number(optional). ? See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 For Japanese patent documents, the indication of the yearof the reign of the Emperor must precede the serial number of the patent document. ° Kind
`of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. ° Applicant is to place a check mark here if
`English language Translationis attached.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/S.R.H/
`
`

`

`Substitute for form 1449/PTO
`
`Equivalent of Form PTO/SB/08a/b (07-09)
`Complete if Known
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Art Unit
`(Use as many sheets as necessary)
`To Be Assigned
`
`Examiner Name
`To Be Assigned
`Attorney Docket Number|4384.0010005
`
`March 13, 2023
`
`Filing Date
`
`Publishing, United Arab Emirates (2018).
`Dis. Child. 61(2):159-163, BMJ, United Kingdom (1986).
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials*
`
`Cite No.!
`
`Include name of 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
`
`International Search Report and Written Opinion for International Application No.
`PCT/IB2020/059280, European Patent Office, Netherlands, mailed on January 19, 2021, 18 pages
`
`EPO machinetranslation of ES 2281172 Al (document FP1), European Patent Office,
`Netherlands, January 13, 2021, 12 pages.
`
`ALLISON,M.E.and Walker, V., “The sodium and potassium intake of 3 to 5 year olds,” Arch.
`
`DETTMAR,P.W., et al., “Administration of an alginate based gastric reflux suppressant on the
`bioavailability of omeprazole,” GI Café 7(2): page 1, Square Pharmaceuticals Ltd., Bangladesh
`(2014) (total 4 pages).
`
`HIGUERA-DE-LA-TIJERA,F., “Efficacy of omeprazole/sodium bicarbonate treatment in
`gastroesophagealreflux disease: a systematic review,” MedWave 18(1):e7179, Medwave
`Estudios Limitada, Chile (2018) (7 pages).
`
`LEIMAN,D.A., et al., “Alginate therapy is effective treatment for GERD symptoms: a systematic
`review and meta-analysis,” Dis. Esophag. 30(5):1-9, Oxford Academic Press, United Kingdom
`(2017).
`
`MANABE,N., et al., “Efficacy of adding sodium alginate to omeprazole in patients with
`nonerosive reflux disease: a randomizedclinical trial,” Dis. Esophag. 25(5):373-380, Oxford
`Academic Press, United Kingdom (2011).
`
`OLIVIERA,A.C., et al., “Potassium urinary excretion and dietary intake: a cross-sectional
`analysis in 8-10 year-old children,” BMC Pediatrics 15:60, BioMed Central, United Kingdom
`(2015) (10 pages).
`
`RANVIRSINGH,T.A., et al., “Formulation and Evaluation of Floating Alginate Beads on Anti
`Ulcer Drug,” Int. J. Pharm. Sci. Rev. Res. 21(2):120-124, Global Research Online, India (2013).
`
`SAIED, N., et al., “Assessment of Sodium and Potassium Intakes in Children Aged 6 to 18 Years
`by 24h Urinary Excretion in City of Rabat, Morocco,” J. Nutr. Metab. 2018:8687192, Hindawi
`
`Examiner Signature| ate Considered |
`
`*EXAMINER:Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Draw line throughcitation if not in conformance and
`not considered. Include copy of this form with next communication to applicant. | Applicant’s unique citation designation number(optional). ? See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 For Japanese patent documents, the indication of the yearof the reign of the Emperor must precede the serial number of the patent document. ° Kind
`of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. ° Applicant is to place a check mark here if
`English language Translationis attached.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/S.R.H/
`
`

`

`Substitute for form 1449/PTO
`
`Equivalent of Form PTO/SB/08a/b (07-09)
`Complete if Known
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Art Unit
`(Use as many sheets as necessary)
`To Be Assigned
`
`Examiner Name
`To Be Assigned
`Attorney Docket Number|4384.0010005
`
`March 13, 2023
`
`Filing Date
`
`2020.
`
`
`Include name of the author (in CAPITAL LETTERS),title of the article (when appropriate), title of the item (book,
`Examiner
`Initials*
`Cite No.!|magazine, journal, serial, symposium,catalog, etc.), date, page(s), volume-issue number(s), publisher, city and/or country
`where published
`
`NON PATENT LITERATURE DOCUMENTS
`
`TIAN, N., et al., “Sodium and potassium intakes among USinfants and preschool children, 2003-
`2010,” Am. J. Clin. Nutr. 98:1113-1122, American Society for Nutrition, United States (2013).
`
`Highlights of Prescribing Information for “KONVOMEP™(omeprazole and sodium bicarbonate
`for oral suspension)”, initial U.S. Approval 2004, the U.S. Food and Drug Administration, United
`States, revised August 2022.
`
`DELLAGRECA,M.., et al., “Degradation of lansoprazole and omeprazole in the aquatic
`environment,” Chemosphere 63:1087-1093, Elsevier, Netherlands (2006).
`
`Non-Final Office Action, mailed April 28, 2022, in U.S. Application No. 17/061,630,filed
`October 2, 2020.
`
`Notice of Allowance mailed December14, 2022, in U.S. Application No. 17/061,630,filed
`October 2, 2020.
`
`Notice of Allowance mailed July 7, 2023, in U.S. Application No. 17/061,630,filed October2,
`
`Examiner Signature
`
`Date Considered
`
`12/14/2024
`
`*EXAMINER:Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Draw line throughcitation if not in conformance and
`not considered. Include copy of this form with next communication to applicant. | Applicant’s unique citation designation number(optional). ? See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 For Japanese patent documents, the indication of the yearof the reign of the Emperor must precede the serial number of the patent document. ° Kind
`of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. ° Applicant is to place a check mark here if
`English language Translationis attached.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/S.R.H/
`
`