IP Library Granted Patent US 12,691,091
Granted Patent B2
US 12,691,091 · App. 17/613,719 · Granted Jul 28, 2026

Compositions comprising cetylated fatty acids for use in the treatment of gastric mucosa, diabetes and high blood glucose levels

Inventors: Andrea Lacorte (Pisa, IT); Germano Tarantino (Pisa, IT); Elisa Brilli (Pisa, IT)
Assignee: PHARMANUTRA S.P.A.
A61K31/231A61K31/05A61K47/10A61P1/04
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,691,091
App. No.
17/613,719
Filed
Nov 23, 2021
Granted
Jul 28, 2026
Kind
B2
Art Unit
1624
USPC
514/549
Abstract

A composition is described comprising a mixture of at least one cetylated fatty acid or a mixture of cetylated fatty acids and an antioxidant in reduced percentages by weight, and related methods for treatment of arthritis and of inflammatory joint and musculoskeletal pain. Furthermore a composition is described comprising a mixture of at least one cetylated fatty acid or a mixture of cetylated fatty acids and, optionally, an antioxidant, and related treatment methods for protecting the gastric mucosa and for regulating the blood glucose levels. Additionally, a method is described for preparing the at least one cetylated fatty acid or mixture of cetylated fatty acids and for preparing compositions comprising the cetylated fatty acids and the antioxidant.

Claims (24)

1 . A method for protective treatment of a disorder or symptom deriving from and/or related with damaging gastric mucosa, selected from gastric ulcers, gastroesophageal reflux (GERD), and heartburn, the method comprising

administering to a subject in need a composition in an effective amount to obtain gastric mucosal protection of the subject, the composition comprising:

(a) a mixture of at least one cetylated fatty acid, comprising, cetylated myristic acid and cetylated oleic acid, at a myristic:oleic mole ratio of about 2.1:1

(b) at least one antioxidant at a % by weight from 0.001% to 0.3% with respect to the total weight of the composition, and

(c) a vegetable oil selected from olive oil, corn oil, mixtures thereof;

wherein the composition optionally further comprises at least one pharmaceutical or food grade additive and/or excipient.

2 . The method according to claim 1 , wherein said mixture of at least one cetylated fatty acid further comprises lauric acid, palmitic acid, palmitoleic acid, stearic acid, linoleic acid, eicosanoic acid, and mixtures thereof.

3 . The method according to claim 1 , wherein in said mixture of cetylated myristic acid and cetylated oleic acid the mole ratio between the cetylated myristic acid and cetylated oleic acid is from 4:1 to 1:1.

4 . The method according to claim 1 , wherein said at least one antioxidant is selected from tert-butyl-hydroquinone (TBHQ), a mixture comprising tocopherol, lecithin, ascorbyl palmitate and citric acid, and a mixture of tocopherols and a natural extract of rosemary.

5 . The method according to claim 4 , wherein the mixture comprising tocopherol, lecithin, ascorbyl palmitate and citric acid comprises a-tocopherol 10-15% by weight, lecithin >50% by weight, ascorbyl palmitate 8-10% by weight and citric acid <1% by weight.

6 . The method according to claim 1 , wherein said at least one antioxidant is present at a % by weight from 0.001% to 0.5% 0.1% with respect to the total weight of the composition.

7 . The method according to claim 1 , wherein said composition comprises: cetylated myristic acid and cetylated oleic acid and tert-butyl-hydroquinone (TBHQ).

8 . The method according to claim 7 , wherein the mole ratio between the cetylated myristic acid and cetylated oleic acid is from 4:1 to 1:1.

9 . The method according to claim 7 , wherein the mole ratio between the cetylated myristic acid and cetylated oleic acid is from 3:1 to 1.5:1.

10 . The method according to claim 7 , wherein the tert-butyl-hydroquinone (TBHQ) is present at a % by weight comprised from 0.001% to 0.5% with respect to the total weight of the composition.

11 . The method according to claim 7 , wherein the tert-butyl-hydroquinone (TBHQ) is present at a % by weight comprised from 0.005% to 0.1%, with respect to the total weight of the composition.

12 . The method according to claim 1 , wherein said composition is formulated for oral use.

13 . The method according to claim 1 , wherein the administering is performed by

administering said composition as a coadjuvant of one or more additional compositions for protective treatment of the disorder or symptom deriving from and/or related with damaging the gastric mucosa.

14 . The method according to claim 1 , wherein said fatty acid of at least one cetylated fatty acid is selected from myristic acid, oleic acid or cetylated myristic acid and cetylated oleic acid and mixtures thereof.

15 . The method according to claim 1 , wherein in said mixture the mole ratio between the cetylated myristic acid and cetylated oleic acid is from 3:1 to 1.5:1.

16 . The method according to claim 1 , wherein said at least one antioxidant comprises tert-butyl-hydroquinone (TBHQ).

17 . The method according to claim 1 , wherein said at least one antioxidant is present at a % by weight from 0.005% to 0.1%, with respect to the total weight of the composition.

18 . The method according to claim 1 , wherein the vegetable oil further comprises, sunflower oil, or mixtures with high oleic or olein content.

Assignments (3)
MERGER Recorded Jul 22, 2025
From: ALESCO S.R.L.; PHARMANUTRA S.P.A.
To: PHARMANUTRA S.P.A.
Reel/Frame 072168/0863 →
MERGER Recorded Jul 3, 2025
From: ALESCO S.R.L.
To: PHARMANUTRA S.P.A.
Reel/Frame 071606/0116 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 10, 2022
From: LACORTE, ANDREA; TARANTINO, GERMANO; BRILLI, ELISA
To: ALESCO S.R.L.; PHARMANUTRA S.P.A.
Reel/Frame 058975/0770 →
Priority Claims (1)
IT 102019000007329 · May 27, 2019 · national
Continuity (1)
Related Publication 20220226274A1 · Jul 21, 2022
References Cited (218)
US 4113881A · Diehl · 1978 [cited by applicant]
US 4393133A · Knowles et al. · 1983 [cited by applicant]
US 5888563A · Mehansho et al. · 1999 [cited by applicant]
US 6039978A · Bangs et al. · 2000 [cited by applicant]
US 6361800B1 · Cooper et al. · 2002 [cited by applicant]
US 6417227B1 · Lord et al. · 2002 [cited by applicant]
US 8404745B2 · Barathur et al. · 2013 [cited by applicant]
US 9861670B2 · Clements et al. · 2018 [cited by applicant]
US 10597608B2 · Lacorte et al. · 2020 [cited by applicant]
US 12246036B2 · Lacorte et al. · 2025 [cited by applicant]
US 12297406B2 · Lacorte et al. · 2025 [cited by applicant]
US 12383525B2 · Lacorte et al. · 2025 [cited by applicant]
US 20020058705A1 · Gonzales Bravo et al. · 2002 [cited by applicant]
US 20030181521A1 · Leonard et al. · 2003 [cited by applicant]
US 20050100636A1 · Botteri et al. · 2005 [cited by applicant]
US 20050261257A1 · Vermeer · 2005 [cited by applicant]
US 20070065521A1 · Venkataraman et al. · 2007 [cited by applicant]
US 20070148258A1 · O'Neill et al. · 2007 [cited by applicant]
US 20070148259A1 · Gupta · 2007 [cited by applicant]
US 20090186939A1 · Chan et al. · 2009 [cited by applicant]
US 20090326060A1 · Chan et al. · 2009 [cited by applicant]
US 20100021573A1 · Gonzalez et al. · 2010 [cited by applicant]
US 20110054030A1 · Petraglia et al. · 2011 [cited by applicant]
US 20110294665A1 · Makino · 2011 [cited by applicant]
US 20120265119A1 · Barathur et al. · 2012 [cited by applicant]
US 20130157974A1 · Ziegler et al. · 2013 [cited by applicant]
US 20140121156A1 · Hausman · 2014 [cited by applicant]
US 20140322314A1 · Fawzy · 2014 [cited by examiner]
US 20150250885A1 · Lacorte et al. · 2015 [cited by applicant]
US 20160008415A1 · Clements et al. · 2016 [cited by applicant]
US 20160310445A1 · Vermeer · 2016 [cited by applicant]
US 20170056465A1 · Tobin et al. · 2017 [cited by applicant]
US 20170080023A1 · Agam · 2017 [cited by examiner]
US 20170112178A1 · Perrin et al. · 2017 [cited by applicant]
US 20170202802A1 · Fernandez et al. · 2017 [cited by applicant]
US 20180098962A1 · Bromley · 2018 [cited by applicant]
US 20190016991A1 · Lacorte et al. · 2019 [cited by applicant]
US 20200085710A1 · Denda et al. · 2020 [cited by applicant]
US 20200206157A1 · Lacorte et al. · 2020 [cited by applicant]
US 20200246377A1 · Lacorte et al. · 2020 [cited by applicant]
US 20220211655A1 · Lacorte · 2022 [cited by examiner]
US 20220220414A1 · Lacorte et al. · 2022 [cited by applicant]
US 20250270472A1 · Lacorte et al. · 2025 [cited by applicant]
CN 106343566A · 2017 [cited by applicant]
CN 108137472A · 2018 [cited by applicant]
EP 0679394A2 · 1995 [cited by applicant]
EP 2380578A1 · 2011 [cited by applicant]
EP 2886129A1 · 2015 [cited by applicant]
GB 2552952A · 2018 [cited by applicant]
JP S5841813A · 1983 [cited by applicant]
JP S6351312A · 1988 [cited by applicant]
JP H04154724A · 1992 [cited by applicant]
JP H08253415A · 1996 [cited by applicant]
JP 2002515866A · 2002 [cited by applicant]
JP 2003342159A · 2003 [cited by applicant]
JP 2007523056A · 2007 [cited by applicant]
JP 2009525277A · 2009 [cited by applicant]
JP 2015523409A · 2015 [cited by applicant]
NZ 332959A · 2001 [cited by applicant]
WO 1997031620A2 · 1997 [cited by applicant]
WO 0064436A1 · 2000 [cited by applicant]
WO 03018731A1 · 2003 [cited by applicant]
WO 2004019923A1 · 2004 [cited by applicant]
WO 2004084829A2 · 2004 [cited by applicant]
WO 2004084829A3 · 2005 [cited by applicant]
WO 2005044189A2 · 2005 [cited by applicant]
WO 2007089577A2 · 2007 [cited by applicant]
WO 2010079514A1 · 2010 [cited by applicant]
WO WO2010117194A2 · 2010 [cited by examiner]
WO 2012161572A1 · 2012 [cited by applicant]
WO 2014009806A1 · 2014 [cited by applicant]
WO 2014160279A1 · 2014 [cited by applicant]
WO 2016131993A2 · 2016 [cited by applicant]
WO 2017029580A1 · 2017 [cited by applicant]
WO 2018034797A1 · 2018 [cited by applicant]
WO 2018221534A1 · 2018 [cited by applicant]
WO 2019021232A1 · 2019 [cited by applicant]
WO 2019025922A1 · 2019 [cited by applicant]
WO 2020240438A1 · 2020 [cited by applicant]
WO 2020240441A1 · 2020 [cited by applicant]
WO 2020240443A1 · 2020 [cited by applicant]
WO 2024184848A1 · 2024 [cited by applicant]
European Food Safety Authority, Scientific Opinion on the Safety of ‘Cetyl Myristoleate Complex’ as a food ingredient, EFSA Journal, 8 (Year: 2010). [cited by examiner]
Shimoyama (Challenges to Unravel Mechanisms of GERD, Gastroesophageal Reflux Disease—Theory and Research) (Year: 2018). [cited by examiner]
Ulatowski et. al. (Neurobiology of Disease, 84, 78-83) (Year: 2015). [cited by examiner]
Machine Translation of WO2010117194A2 (Year: 2010). [cited by examiner]
Advisory Action for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Dec. 20, 2022. 4 Pages. [cited by applicant]
Aoun, M. et al. “High Dephosphorylated-Uncarboxylated MGP in Hemodialysis patients: risk factors and response to vitamin K2, a pre-post intervention clinical trial”, BMC Nephrology, Jun. 2017, vol. 18, 191. 10 pages. [cited by applicant]
Barisani et al. “Iron overload and gene expression in HepG2 cells: analysis by differential display” [cited by applicant]
Barpanda P et al. “Sodium iron pyrophosphate: a novel 3.0V iron-based cathode for sodium-ion batteries”, Electrochemistry Communications, vol. 24, Oct. 2012, pp. 116-119. [cited by applicant]
Breymann, Prof. Dr. Christian. Preventing and Treating Iron Deficiency Anaemia in Pregnant Women. Are we doing our best? Presentation in Zurich, Switzerland, May 15, 2017. 27 pages. [cited by applicant]
Commission Directive 96/77/EC of Dec. 2, 1996; last amendment M7 Commission Directive 2006/129/EC of Dec. 8, 2006. 165 pages. [cited by applicant]
Commission Regulation (EU) No. 231/2012 of Mar. 9, 2012. Specifications for food additives listed on Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council. Official Journal of… [cited by applicant]
“Coordination Complex” from Wikipedia, through the Wayback Machine dated Nov. 18, 2016. 10 pages. [cited by applicant]
The Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of Dec. 16, 2008 on food additives. Dated: Mar. 22, 2023. pp. 346. [cited by applicant]
Cutcliffe T et al., “Vitamin K2 may reverse calcification of blood vessels in people with kidney disease” [cited by applicant]
Decision of Rejection for Japanese Application No. 2020-502672 filed on Jul. 26, 2018 on behalf of Pharmanutra S.P.A. Dated Jan. 4, 2023. 9 pages. [cited by applicant]
“E number” from European Food Safety Authority, Downloaded Jul. 21, 2023. 1 page. Website: www.efsa.europa.eu/en/glossary/e-number#:~:text=A%20number%20used%20in%20the,has%20been%20apprvoed%20for%20use. [cited by applicant]
E322-Lechitins: on the web site of INCHEM (Internationally Peer Reviewed Chemical Safety Information), World Health Organization, the following Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on F… [cited by applicant]
Erni, I. Oswald N. et al. “Chemical characterization of iron (III)-hydroxide-dextrin complexes. A comparative study of commercial preparations with alleged reproductions used in the examination of bioavailability”, Arzn… [cited by applicant]
EUR-Lex, Access to European Union Law, Document 51977PC0304. Proposal for a Council Directive amending for the first time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifier… [cited by applicant]
Final Office Action for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Aug. 11, 2022. 18 Pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Dec. 1, 2021 15 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Feb. 22, 2023. 18 pages. [cited by applicant]
Firdaus S et al. “Green synthesis of silver nanoparticles using Carica Papaya fruit extract under sunlight irradiation and their colorimetric detection of mercury ions”, 2nd International Symposium on Frontier of Applie… [cited by applicant]
“Food additives” from European Food Safety Authority, Downloaded Jul. 21, 2023. 9 pages. Website: www.efsa.europa.eu/en/topics/topic/food-additives. [cited by applicant]
“Food additives” from European Food Safety Authority (EFSA), Downloaded though the Wayback Machine for Jul. 17, 2017. 2 pages. Website: www.efsa.europa.eu/en/topics/topic/food-additives. [cited by applicant]
Garrelds, I. M. et al. “Time dependent production of cytokines and eicosanoids by human monocytic leukaemia U937 cells; effects of glucocorticosteroids” [cited by applicant]
Geisser, P. et al. Review: The Pharmacokinetics and Pharmacodynamics of Iron Preparations. Pharmaceutics, (Jan. 2011) 3, pp. 12-33. Doi.org/10.3390/pharmaceutics3010012. Website: mdpi.com/journal/pharmaceutics. [cited by applicant]
Geisser, Peter. Safety and Efficacy of Iron(III)-hydroxide Polymaltose Complex. Arzneimittel-Forschung (Drug Research) 2007: 57 (6a): 439-452. [cited by applicant]
Gupta A., et al. “Dialysate iron therapy: Infusion of soluble ferric pyrophosphate via the dialysate during hemodialysis” Kidney International (1999); 55(5):1891-1898. [cited by applicant]
Huang, Z.B. et al. “HMGB1 release by human liver L02 and HepG2 cells induced by lipopolysaccharide” [cited by applicant]
Ilbert, Marianne et al., “Review: Insight into the evolution of the iron oxidation pathways”, Biochimica et Biophysica Acta, 1827 (2013), pp. 161-175. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2018/055586 filed on Jul. 26, 2018 on behalf of Pharmanutra S.P.A. Mail Date: Jan. 28, 2020 7 pages. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2018/055634 filed on Jul. 27, 2018 on behalf of Pharmanutra S.P.A. Mail Date: Feb. 4, 2020 8 pages. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2020/055028 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Nov. 16, 2021 7 pages. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2020/055031 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Nov. 16, 2021 9 pages. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2020/055037 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Nov. 16, 2021 6 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB2018/055586 filed on Jul. 26, 2018 on behalf Pharmanutra S.P.A. Mail Date: Oct. 25, 2018 11 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB2018/055634 filed on Jul. 27, 2018 on behalf Pharmanutra S.P.A. Mail Date: Dec. 4, 2018 12 pages. [cited by applicant]
“Iron Dextran” from DrugBank, DrugBank Accession No. DB00893, dated Nov. 26, 2022, 14 pages. [cited by applicant]
“Iron polymaltose” from Wikipedia, Downloaded: Jul. 23, 2023. 5 pages. Website: en.wikipedia.org/wiki/Iron_polymaltose. [cited by applicant]
“Iron Sucrose” from Wikipedia, through the Wayback Machine dated Oct. 22, 2016. 1 page. [cited by applicant]
Kidney disease— [cited by applicant]
Liu, H.Z. et al. “The U937 cell line induced to express CD14 protein by 1,25-dihydroxyvitamin D3 and be sensitive to endotoxin stimulation” [cited by applicant]
Miki, K. et al. “Extracellular activation of arginase-1 decreases enterocyte inducible nitric oxide synthase activity during systemic inflammation” [cited by applicant]
Muriuki J.M. et al., “Malaria is a cause of iron deficiency in African children” [cited by applicant]
Neven E. et al., “Iron and vascular calcification. Is there a link” [cited by applicant]
Nicoll, R. et al. “A Review of the Effect of Diet on Cardiovascular Calcification”, Int. J. Mol. Sci., (2015), vol. 16, pp. 8861-8883. ISSN 0004771926. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Feb. 2, 2023. 17 Pages. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Nov. 10, 2021 17 pages. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Jul. 26, 2022 18 pages. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: May 12, 2021 30 pages. [cited by applicant]
Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on Sucrose esters of fatty acids, e 473 and sucroglycerides, E 474 based on a request from the Commission… [cited by applicant]
Ozcelik, Berrin. “Fungi/Bactericidal and Static Effect of Ultraviolet Light in 254 and 354 nm wavelengths” [cited by applicant]
Pepys, M. et al., C-reactive protein: a critical update [cited by applicant]
Restriction Requirement for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Aug. 20, 2021 10 pages. [cited by applicant]
Rincon, M. “Interleukin-6: from an inflammatory marker to a target for inflammatory diseases” Trends in Immunology, Nov. 2012, vol. 33, No. 11, pp. 571-577. [cited by applicant]
Saliou, C. et al. “Selective inhibition of NF-KB activation by the flavonoid hepatoprotector silymarin in HepG2, Evidence for different activating pathways” [cited by applicant]
“Salt (chemistry)” from Wikipedia, through the Wayback Machine dated Feb. 11, 2016. 4 pages. [cited by applicant]
Search of Search Food Additives Database for “E473” from European Food Safety Authority, Downloaded Jul. 21, 2023. 3 pages. Website: food.ec.europa.eu/safety/food-improvement-agents/additives/database_en. [cited by applicant]
Shelley, C. S. et al. “During Differentiation of the Monocytic Cell Line U937, PurAlpha Mediates Induction of the CD11c Beta2 Integrin Gene Promoter” [cited by applicant]
SiderAL product page on Pharmanutra website. 2 pages. Printed Jul. 21, 2023. Website: www.pharmanutra.it/en/brand/pharmanutra/sideral/. [cited by applicant]
Sideral.it website. Printed May 19, 2023. 11 pages. [cited by applicant]
Smith, E. M.; Tangpricha, V. “Vitamin D and Anemia: Insights into an Emerging Association”. Curr Opin Endocrinol Diabetes Obes, Dec. 2015, 22(6), 432-438. 14 pages. [cited by applicant]
Sonou, T. et al., “Magnesium prevents phosphate-induced vascular calcification via TRPM7 and Pit-1 in an aortic tissue culture model”. Hypertension Research, (2017), vol. 40, pp. 562-567. ISSN 0004771924. [cited by applicant]
Spiegel D.M. et al., “Long-term effects of magnesium carbonate on coronary artery calcification and bone mineral density in hemodialysis patients: a pilot study” [cited by applicant]
Strober W. “Trypan blue exclusion test of cell viability” [cited by applicant]
Toblli, J.E. et al., Iron(III)-hydroxide Polymaltose Complex in Iron Deficiency Anemia. Review and Meta-analysis. Arzneimittel-Forschung (Drug Research) 2007: 57 (6a): 431-438. [cited by applicant]
Villarroel P. et al. “Interleukin 6 and lipopolysaccharide modulate hepcidin mRNA expression by HepG2 cells” [cited by applicant]
Wikipedia page for “International Numbering System for Food Additives” dated Dec. 22, 2016 (16 pp). [cited by applicant]
Wikipedia page for “E number” dated Jul. 17, 2017 (29 pp). [cited by applicant]
Zughaier, S.M. et al. “The role of vitamin D in regulating the iron-hepcidin-ferroportin axis in monocytes” [cited by applicant]
Final Office Action for U.S. Appl. No. 16/631,426, filed Jan. 15, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Nov. 16, 2023. 17 Pages. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Oct. 4, 2023. 25 pages. [cited by applicant]
O'Neill, W.C. et al. “Plasma pyrophosphate and vascular calcification in chronic kidney disease”, Nephrol Dial Transplant (2010), 25: 187-191. Doi: 10.1093/ndt/gfp362. [cited by applicant]
O'Neill, W.C. et al. “Treatment with pyrophosphate inhibits uremic vascular calcification”, Kidney Int, Mar. 2011, 76(5): 512-517. 15 pages. Doi: 10.1038/ki.2010.461. [cited by applicant]
Shah, R.B. et al., “Pharmaceutical characterization and thermodynamic stability. Assessment of a colloidal iron drug product: Iron sucrose”, International Journal of Pharmaceutics, 464 (Jan. 17, 2014), pp. 46-52. [cited by applicant]
Fragala M.S. et al: “Influences of a dietary supplement in combination with an exercise and diet regimen on adipocytokines and adiposity in women who are overweight”, European Journal of Applied Physiology, vol. 105, No… [cited by applicant]
International Search Report for International Application No. PCT/IB2020/055028 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Sep. 9, 2020 4 pages. [cited by applicant]
International Search Report for International Application No. PCT/IB2020/055031 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Aug. 28, 2020 5 pages. [cited by applicant]
International Search Report for International Application No. PCT/IB2020/055037 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Sep. 10, 2020 4 pages. [cited by applicant]
Written Opinion for International Application No. PCT/IB2020/055028 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Sep. 9, 2020 6 pages. [cited by applicant]
Written Opinion for International Application No. PCT/IB2020/055031 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Aug. 28, 2020 8 pages. [cited by applicant]
Written Opinion for International Application No. PCT/IB2020/055037 filed on May 27, 2020 on behalf of Alesco S.R.L. Mail Date: Sep. 10, 2020 5 pages. [cited by applicant]
Bagirova, V.L. et al. (1998) No. 6. C. 34-36. Russian original + English extract. 8 pages. (D6). [cited by applicant]
Barot, B.S. et al. Physicochemical and structural characterization of iron-sucrose formulations: a comparative study. Pharmaceutical Development and Technology. (Published online May 23, 2013) 19 (5): 513-520. 9 pages. [cited by applicant]
First Notification of Office Action for Chinese Application No. 202080039453.9 on behalf of Alesco S.R.L Pharmanutra S.P.A. Issued on Feb. 3, 2024. 3 pages. English translation only. [cited by applicant]
First Notification of Office Action for Chinese Application No. 202080039535.3 on behalf of Alesco S.R.L Pharmanutra S.P.A. Issued on Feb. 2, 2024. 9 pages. Original + English translation. [cited by applicant]
First Notification of Office Action for Chinese Application No. 202080039600.2 on behalf of Alesco S.R.L Pharmanutra S.P.A. Issued on Feb. 2, 2024. 10 pages. Original and English translation. [cited by applicant]
Gomez-Ramirez, Susana et al. Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals. (2018). 11, 97. 23 pages. DOI:10.3390/ph11040097. Website: mdpi.com/journal/pharmaceutical. [cited by applicant]
Search Report from the Intellectual Property Office of Singapore for Application No. 11202112774X filed on May 27, 2020. Mailed on Aug. 17, 2023. 2 pages. Issued in English. [cited by applicant]
Search Report from the Intellectual Property Office of Singapore for Application No. 11202112779Y filed on May 27, 2020. Mailed on Aug. 17, 2023. 2 pages. Issued in English. [cited by applicant]
The Eurasian Patent Office Application No. 202193083/28, Conclusion on patentability of the invention. Mailed on Dec. 19, 2022. 11 pages. Russian and partial English translation. [cited by applicant]
The Eurasian Patent Office Application No. 202193083/28, Conclusion on patentability of the invention. Mailed on Jul. 19, 2023. 18 pages. Russian and partial English translation. [cited by applicant]
Wikipedia, The Free Encyclopedia, “Pourbaix diagram”, (Dec. 11, 2017). Downloaded on Mar. 29, 2024. 8 pages. [cited by applicant]
Wikipedia, The Free Encyclopedia, “Sucrose”, (Dec. 31, 2017). Downloaded on Mar. 29, 2024. 24 pages. [cited by applicant]
Wikipedia, The Free Encyclopedia, “Sucrose esters”, (Nov. 16, 2017). Downloaded on Mar. 29, 2024. 7 pages. [cited by applicant]
Written Opinion from the Intellectual Property Office of Singapore for Application No. 11202112774X filed on May 27, 2020. Mailed on Aug. 21, 2023. 7 pages. Issued in English. [cited by applicant]
Written Opinion from the Intellectual Property Office of Singapore for Application No. 11202112779Y filed on May 27, 2020. Issued on Aug. 21, 2023. 7 pages. Issued in English. [cited by applicant]
Basson, M.D. Hierarchies of Healing in Gut Mucosal Injury.Journal of Physiology and Pharmacology, (2017), 68, 6, 789-795. [cited by applicant]
Birrell M. A. et al., “Anti-inflammatory effects of PGE2 in the lung: role of the EP4 receptor subtype” [cited by applicant]
Buthelezi N. M. D. et al., “Destructive and non-destructive techniques used for quality evaluation of nuts: A review” [cited by applicant]
Cho J. et al., “Prostaglandin E2 Induces IL-6 and IL-8 Production by the EP Receptors/Akt/NF-KB Pathways in Nasal Polyp-Derived Fibroblasts” [cited by applicant]
Chung, B. et al. “Oncostatin M is a potent inducer of hepcidin, the iron regulatory hormone”, [cited by applicant]
Clamp, J.R, et al. The Gastric Mucosal Barrier, Methods Find Exp Clin Pharmacol., (1989), 11 Suppl 1:19-25. Abstract Only. [cited by applicant]
“Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels: Guidance for Industry”, U.S. Dept of Health and Human Services, Food and Drug Administration, Cente… [cited by applicant]
Hinson R. G. et al., “Elevated interleukin 6 is induced by prostaglandin E2 in a murine model of inflammation: Possible role of cyclooxygenase-2” [cited by applicant]
Liu X.-H. et al., “Cross-Talk between the Interleukin-6 and Prostaglandin E2 Signaling systems Results in Enhancement of Osteoclastogenesis through Effects on the Osteoprotegerin/Receptor Activator of Nuclear Factor-KB … [cited by applicant]
McCarty, M.F. et al. “Bioavailable dietary phosphate, a mediator of cardiovascular disease, may be decreased with plant-based diets, phosphate binder, niacin, and avoidance of phosphate additives”, Nutrition, (Jul.-Aug.… [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 17/614,294, filed Nov. 24, 2021 on behalf of Alesco S.R.L et al. Mailed on Aug. 28, 2024. 23 pages. [cited by applicant]
Non-Final Office Action issued for U.S. Appl. No. 17/613,886, filed Nov. 23, 2021 on behalf of Alesco S.R.L. and Pharmanutra S.P.A. Mailed on Aug. 1, 2024. 25 pages. [cited by applicant]
Notice of Allowance for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Jul. 31, 2024. 15 pages. [cited by applicant]
Notice of Allowance for U.S. Appl. No. 16/635,516, filed Jan. 30, 2020 on behalf of Pharmanutra S.P.A. Mail Date: Nov. 20, 2024. 10 pages. [cited by applicant]
Notice of Allowance issued for U.S. Appl. No. 17/613,886, filed Nov. 23, 2021 on behalf of Alesco S.R.L. and Pharmanutra S.P.A. Mailed on Jan. 8, 2025. 10 pages. [cited by applicant]
Notice of Reasons for Refusal for Japanese Application No. 2021-570463 filed May 27, 2020. Mailed on May 7, 2024. Original and Machine translation. 13 pages. [cited by applicant]
Office Action Summary (Examination Result) for United Arab Emirates Application No. P6002147/2021 filed on Nov. 24, 2021. 5 pages. [cited by applicant]
“Peroxide value” from Wikipedia, through the Wayback Machine, Archive Date: Apr. 24, 2017, 2 pages. [cited by applicant]
Pignitter, M. and Somoza, V.; Critical Evaluation of Methods for the Measurement of Oxidative Rancidity in Vegetable Oils. Journal of Food and Drug Analysis, vol. 20, No. 4, (2012), pp. 772-777. DOI:10.6227/jfda.2012200… [cited by applicant]
Podolsky, D.K. Mucosal Immunity and Inflammation V. Innate mechanisms of mucosal defense and repair: the best offense is a good defense. The American Physiological Society, (1999), 277.3, G495-G499. [cited by applicant]
Search Report for United Arab Emirates Application No. P6002147/2021 filed on Nov. 24, 2021. 2 pages. [cited by applicant]
Second Notification of Office Action for Chinese Application No. 202080039535.3 on behalf of Alesco S.R.L Pharmanutra S.P.A. Issued on Nov. 6, 2024. 10 pages. Original + English translation. [cited by applicant]
Wallace, John L., Prostaglandins, NSAIDs, and Gastric Mucosal Protection: Why Doesn't the Stomach Digest Itself?, Physiol. Rev, 88, (2008), 1547-1565. [cited by applicant]
Wautier J. et al., “Pro- and Anti-Inflammatory Prostaglandins and Cytokines in Humans: A Mini Review” [cited by applicant]
Werther, J.L., The gastric mucosal barrier. Mt Sinai J. Med., (Jan. 2000), 67 (1), 41-53. Abstract Only. [cited by applicant]
Wikipedia page for “Gastric mucosal barrier”. Retrieved for Dec. 22, 2016 through the Wayback Machine. [cited by applicant]
World Health Organization, Eastern Mediterranean Region: Health promotion and disease prevention through population-based interventions, including action to address social determinants and health inequality. Retrieved f… [cited by applicant]
World Health Organization, Eastern Mediterranean Region: Health promotion and disease prevention through population-based interventions, including action to address social determinants and health inequality. Retrieved o… [cited by applicant]
Yang, Ines et al., Survival in hostile territory: the microbiota of the stomach. FEMS Microbiology Reviews, (Sep. 2013), 37(5): 736-761. [cited by applicant]
Notice of Allowance for U.S. Appl. No. 17/614,294, filed Nov. 24, 2021 on behalf of Alesco S.R.L. et al. Mail Date: Apr. 9, 2025 12 pages. [cited by applicant]
“Commission Implementing Regulation (EU) 2022/187 of 10 Feb. 10, 2022 authorising the placing on the market of cetylated fatty acids as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the … [cited by applicant]
Communication pursuant to Article 94(3) EPC for EP Application No. 20742895.4 filed Apr. 27, 2020 on behalf of Alesco S.r.l et al. Mailed on Apr. 8, 2024. 5 pages. [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB2024/052210 filed on Mar. 7, 2024. Mailed on Sep. 9, 2025. 7 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB2024/052210 filed in Mar. 7, 2024 on behalf of Pharmanutra S.P.A. Mailed on Jun. 26, 2024. 10 pages. [cited by applicant]
International Specialty Products et al: “PVM/MA decadiene crosspolymer: a new thickener/stabilizer (International Specialty Products, Michael w Helioff)”, Research Disclosure, Kenneth Mason Publications, Hampshire, UK, … [cited by applicant]
Motilva, V. et al.: “Mechanisms of increased gastric protection after NSAID-administration in rats consuming virgin olive oil diets”, Jan. 29, 2008, vol. 3, No. 1, (Jan. 20, 2008). (Jan. 29, 2008), pp. e9-e16, XP0224388… [cited by applicant]
Musson, D.S. et al., “Bovine bone particulates containing bone anabolic factors as a potential xenogenic bone graft substitute”, Journal of Orthopaedic Surgery and Research, (Feb. 20, 2019), 14:60. 11 pages. [cited by applicant]
“Rules for Conformity Assessment of Medical Devices according to Directive 93/42/EEC” (transposed by Italian legislative decree No. 46/97), (Feb. 14, 1997) 16 pages. RINA Services S.p.A. [cited by applicant]