Granted Patent
B2
US 12,605,435 · App. 18/419,900 · Granted Apr 21, 2026
Multivalent pneumococcal polysaccharide-protein conjugate composition
Inventors:
Kyungjun An (Seoul, KR); Dongsoo Ham (Suwon-si, KR); Hun Kim (Suwon-si, KR); Sunghyun Kim (Yongin-si, KR); Jinhwan Shin (Seoul, KR); Robert Hopfer (Roaring Brook Township, PA); Richard D. Kensinger (Henryville, PA); Moe Kyaw (Swiftwater, PA); Philippe Talaga (Lyons Cedex, FR)
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Abstract
Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM 197 , wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and 22F are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM 197 . Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.
Claims (15)
1 . A monovalent pneumococcal conjugate composition comprising a serotype 9N conjugate, wherein the serotype 9N conjugate comprises a protein carrier conjugated to a capsular polysaccharide from Streptococcus pneumoniae serotype 9N, wherein the protein carrier is CRM 197 , wherein the capsular polysaccharide from serotype 9N is conjugated to CRM 197 in a state where the capsular polysaccharide from serotype 9N is activated to have a degree of oxidation of 2-19 and a molecular weight of 200-700 kDa, and wherein the monovalent pneumococcal conjugate composition comprises less than 45% of a free capsular polysaccharide from serotype 9N based on the total amount of the capsular polysaccharide from serotype 9N.
2 . The monovalent pneumococcal conjugate composition of claim 1 , wherein the capsular polysaccharide from serotype 9N is conjugated to CRM 197 in a state where the capsular polysaccharide from serotype 9N is activated to have a degree of oxidation of 5-10.
3 . The monovalent pneumococcal conjugate composition of claim 1 , wherein the monovalent pneumococcal conjugate composition comprises less than 40% of a free capsular polysaccharide from serotype 9N based on the total amount of the capsular polysaccharide from serotype 9N.
4 . The monovalent pneumococcal conjugate composition of claim 1 , wherein the serotype 9N conjugate has a molecular weight of 500-4,000 kDa.
5 . The monovalent pneumococcal conjugate composition of claim 1 , wherein the ratio of the capsular polysaccharide from serotype 9N to CRM 197 in the serotype 9N conjugate is 0.1-5 (w/w).
6 . The monovalent pneumococcal conjugate composition of claim 5 , wherein the ratio of the capsular polysaccharide from serotype 9N to CRM 197 in the serotype 9N conjugate is 0.5-2.5 (w/w).
7 . The monovalent pneumococcal conjugate composition of claim 1 , wherein 15-60% of the serotype 9N conjugate has a K d of 0.3 or below as measured in a CL-4B column.
8 . The monovalent pneumococcal conjugate composition of claim 1 , wherein the capsular polysaccharide from serotype 9N is conjugated with the CRM 197 by adding 0.02-0.19 μg of periodate per 1 μg of sugar, and wherein the serotype 9N conjugate has a molecular weight of 500-4,000 kDa, a molecular weight distribution of 15-60% with a K d of 0.3 or below as measured in a CL-4B column, and a saccharide/protein ratio of 0.5-2.5.
9 . The monovalent pneumococcal conjugate composition of claim 1 , further comprising an adjuvant.
10 . The monovalent pneumococcal conjugate composition of claim 9 , wherein the adjuvant is an aluminum-based adjuvant.
11 . The monovalent pneumococcal conjugate composition of claim 10 , wherein the adjuvant is selected from the group consisting of aluminum phosphate, aluminum sulfate, and aluminum hydroxide.
12 . The monovalent pneumococcal conjugate composition of claim 11 , wherein the adjuvant is aluminum phosphate.
13 . A vaccine comprising the monovalent pneumococcal conjugate composition of claim 1 and a pharmaceutically acceptable excipient.
14 . The vaccine of claim 13 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2 μg to 2.5 μg of the capsular polysaccharide from serotype 9N.
15 . The vaccine of claim 14 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of the capsular polysaccharide from serotype 9N.
Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 24, 2024
From: AN, KYUNGJUN; HAM, DONGSOO; KIM, HUN; KIM, SUNGHYUN; SHIN, JINHWAN
To: SK BIOSCIENCE CO., LTD.
Reel/Frame 066228/0811 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 23, 2024
From: TALAGA, PHILIPPE
To: SANOFI PASTEUR
Reel/Frame 066218/0354 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 23, 2024
From: HOPFER, ROBERT; KENSINGER, RICHARD D.; KYAW, MOE
To: SANOFI PASTEUR INC.
Reel/Frame 066218/0425 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 23, 2024
From: SANOFI PASTEUR
To: SANOFI PASTEUR INC.
Reel/Frame 066218/0451 →
Priority Claims (1)
KR 10-2018-0045246
· Apr 18, 2018
· national
Continuity (4)
Continuation
16966584
Provisional Application
62626509
· Feb 5, 2018
References Cited (176)
US 5153312A
· Porro
· 1992
[cited by applicant]
US 5773007A
· Penney et al.
· 1998
[cited by applicant]
US 6132723A
· Malcolm
· 2000
[cited by applicant]
US 6168796B1
· Malcolm
· 2001
[cited by applicant]
US 7709001B2
· Hausdorff et al.
· 2010
[cited by applicant]
US 7862823B1
· Leroy
· 2011
[cited by applicant]
US 7955605B2
· Prasad
· 2011
[cited by applicant]
US 20030099672A1
· Schultz
· 2003
[cited by applicant]
US 20110212124A1
· Boutriau et al.
· 2011
[cited by applicant]
US 20120052088A1
· Davis et al.
· 2012
[cited by applicant]
US 20120328659A1
· Denoel et al.
· 2012
[cited by applicant]
US 20130266609A1
· Boutriau
· 2013
[cited by applicant]
US 20150343076A1
· Park et al.
· 2015
[cited by applicant]
US 20210283247A1
· Hausdorff et al.
· 2021
[cited by applicant]
US 20220031828A1
· An et al.
· 2022
[cited by applicant]
US 20220265803A1
· An et al.
· 2022
[cited by applicant]
AU 2007200116A1
· 2007
[cited by applicant]
AU 2010235979A1
· 2010
[cited by applicant]
CA 2153730A1
· 1997
[cited by applicant]
CA 2153733A1
· 1997
[cited by applicant]
CN 1060408A
· 1992
[cited by applicant]
CN 1255861A
· 2000
[cited by applicant]
CN 101180079A
· 2008
[cited by applicant]
CN 101785857A
· 2010
[cited by applicant]
CN 101818185A
· 2010
[cited by applicant]
CN 102068690A
· 2011
[cited by applicant]
CN 102858365A
· 2013
[cited by applicant]
CN 103599529A
· 2014
[cited by applicant]
CN 103623401A
· 2014
[cited by applicant]
CN 103656631A
· 2014
[cited by applicant]
CN 103656632A
· 2014
[cited by applicant]
CN 107029225A
· 2017
[cited by applicant]
EP 0497524B1
· 1992
[cited by applicant]
EP 2932979A1
· 2015
[cited by applicant]
IN 201917040656
· 2019
[cited by applicant]
KR 1020180027353A
· 2018
[cited by applicant]
TW 201008577A
· 2010
[cited by applicant]
TW I341210B
· 2011
[cited by applicant]
WO 9640225A1
· 1996
[cited by applicant]
WO 9851339A1
· 1998
[cited by applicant]
WO 0056359A2
· 2000
[cited by applicant]
WO 0200249A2
· 2002
[cited by applicant]
WO 02080965A2
· 2002
[cited by applicant]
WO 03051392A2
· 2003
[cited by applicant]
WO 2006032499A1
· 2006
[cited by applicant]
WO 2009000824A2
· 2008
[cited by applicant]
WO 2009000826A1
· 2008
[cited by applicant]
WO 2009000825A2
· 2008
[cited by applicant]
WO 2010125480A1
· 2010
[cited by applicant]
WO 2011100151A1
· 2011
[cited by applicant]
WO 2013191459A1
· 2013
[cited by applicant]
WO 2014027302A1
· 2014
[cited by applicant]
WO 2014092377A1
· 2014
[cited by applicant]
WO 2014118201A1
· 2014
[cited by applicant]
WO 2015110940A2
· 2015
[cited by applicant]
WO 2015110941A2
· 2015
[cited by applicant]
WO 2015110942A2
· 2015
[cited by applicant]
WO 2016207905A2
· 2016
[cited by applicant]
WO 2017067962A1
· 2017
[cited by applicant]
WO 2017085586A1
· 2017
[cited by applicant]
WO 2017173415A2
· 2017
[cited by applicant]
WO 2018027123A1
· 2018
[cited by applicant]
WO 2018027126A1
· 2018
[cited by applicant]
WO 201806444A1
· 2018
[cited by applicant]
WO 2018064444A1
· 2018
[cited by applicant]
WO 2019050813A1
· 2019
[cited by applicant]
WO 2019050815A1
· 2019
[cited by applicant]
WO 2019050816A1
· 2019
[cited by applicant]
WO 2019050818A1
· 2019
[cited by applicant]
WO 2019070994A1
· 2019
[cited by applicant]
WO 2019152921A1
· 2019
[cited by applicant]
WO 2019152925A1
· 2019
[cited by applicant]
WO 2021021729A1
· 2021
[cited by applicant]
Bethell et al., “A Novel Method of Activation of Cross-linked Agaroses with 1, 1′-Carbonyldiimidazole Which Gives a Matrix for Affinity Chromatography Devoid of Additional Charged Groups”, The Journal of Biological Chem…
[cited by applicant]
Extended European Search Report dated Mar. 18, 2022 for corresponding European Patent Application No. 19748037.9, 12 pages.
[cited by applicant]
Extended European Search Report dated Mar. 18, 2022 for European Patent Application No. 19747393.7, 12 pages.
[cited by applicant]
Anderson et al., “Non-interference between two protein carriers when used with the same polysaccharide for pneumococcal conjugate vaccines in 2-year-old children,” Vaccine, 2003, vol. 21, No. 13-14, pp. 1554-1559.
[cited by applicant]
Sigurdardottir et al., “Immune response to octavalent diphtheria- and tetanus-conjugated pneumococcal vaccines is serotype- and carrier-specific: the choice for a mixed carrier vaccine,” The Pediatric Infectious Disease…
[cited by applicant]
Wuorimaa et al., “Tolerability and immunogenicity of an eleven-valent pneumococcal conjugate vaccine in healthy toddlers,” The Pediatric Infectious Disease Journal, 2001, vol. 20, No. 3, pp. 272-277.
[cited by applicant]
Extended European Search Report dated Mar. 16, 2022 for European Patent Application No. 19788873.8, 14 pages.
[cited by applicant]
International Search Report dated Jul. 16, 2019 for International Application No. PCT/KR2019/004717, 20 pages with English translation.
[cited by applicant]
Google Translation of WO-2013/191459-A1 dated Dec. 27, 2013, entitled “Polyvalent Pneumococcal Polysaccharide-Protein Conjugate Composition”.
[cited by applicant]
Office Action dated Aug. 1, 2022 for U.S. Appl. No. 17/047,563, 38 pages.
[cited by applicant]
Dagan et al., “Reduction of Antibody Response to an 11-Valent Pneumococcal Vaccine Coadministered with a Vaccine Containing Acellular Pertussis Components”, Infection and Immunity, Sep. 2004, vol. 72, No. 9, pp. 5383-53…
[cited by applicant]
N. Renggli-Zulliger (Authorized Officer), International Search Report and Written Opinion dated Nov. 4, 2020 for International Application No. PCT/US2020/043729, 12 pages.
[cited by applicant]
Final Office Action dated Mar. 1, 2023 for U.S. Appl. No. 17/047,563, 20 pages.
[cited by applicant]
Final Office Action for U.S. Appl. No. 17/500,716 dated Dec. 16, 2024, 16 pages.
[cited by applicant]
Office Action for U.S. Appl. No. 17/630,841 dated Dec. 6, 2024, 18 pages.
[cited by applicant]
Office Action for U.S. Appl. No. 18/598,439 dated Dec. 13, 2024, 10 pages.
[cited by applicant]
Written Opinion and Search Report dated Sep. 6, 2024 for Taiwan Patent Application No. 112144714, 12 pages including (Machine) English translation.
[cited by applicant]
International Search Report and Written Opinion dated Oct. 24, 2017 from International Application No. PCT/US2017/045483 (Authorized Officer, Blaine R. Copenheaver), 10 Pages.
[cited by applicant]
Durando et al., “Experience with pneumococcal polysaccharide conjugate vaccine (conjugated to CRM197 carrier protein) in children and adults”, Clinical Microbiology Infection, Oct. 1, 2013, vol. 19, Suppl. 1, pp. 1-9.
[cited by applicant]
Daniels et al., “A Review of Pneumococcal Vaccines: Current Polysaccharide Vaccine Recommendations and Future Protein Antigens”, J Pediatr Pharmacol Ther, 2016, vol. 21, No. 1, pp. 27-35.
[cited by applicant]
International Search Report and Written Opinion dated Oct. 30, 2017 from International Application No. PCT/US2017/045479 (Authorized Officer, Shane Thomas), 9 Pages.
[cited by applicant]
Jakobsen et al., “Intranasal Immunization with Pneumococcal Polysaccharide Conjugate Vaccines Protects Mice against Invasive Pneumococcal Infections”, Infection and Immunity, Aug. 1999, vol. 67, No. 8, pp. 4128-4133.
[cited by applicant]
Prymula et al., “Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-bli…
[cited by applicant]
Fattom et al., “Serum Antibody Response in Adult Volunteers Elicited by Injection of Streptococcus pneumoniae Type 12F Polysaccharide Alone or Conjugated to Diphtheria Toxoid”, Infection and Immunity, Jul. 1990, vol. 58…
[cited by applicant]
Andrews et al., “Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study”, Lancet Infect. Dis., Jul. 18, 2014, 8 pages.
[cited by applicant]
Juergens et al., “Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association w…
[cited by applicant]
Nurkka et al., “Serum and salivary anti-capsular antibodies in infants and children vaccinated with octavalent pneumococcal conjugate vaccines, PncD and PncT”, Vaccine, 2002, vol. 20, pp. 194-201.
[cited by applicant]
Pfizer, “PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Suspension for intramuscular injection”, Prevnar 13 Full Prescribing Information, 2010, 47 pages.
[cited by applicant]
Vesikari et al., “Immunogenicity of the 10-Valent Pneumococcal Non-typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Compared to the Licensed 7vCRM Vaccine”, The Pediatric Infectious Disease Journal,…
[cited by applicant]
Wuorimaa et al., “Tolerability and immunogenicity of an 11-valent pneumococcal conjugate vaccine in adults”, Vaccine, 2001, vol. 19, pp. 1863-1869.
[cited by applicant]
International Search Report and Written Opinion dated Apr. 15, 2019 from International Application No. PCT/US2019/016506 (Authorized Officer, Shane Thomas), 11 Pages.
[cited by applicant]
Extended European Search Report dated Mar. 10, 2020 for European Patent Application No. 17837752.9, 12 pages.
[cited by applicant]
Dagan et al., “Tolerability and immunogenicity of an eleven valent mixed carrier
[cited by applicant]
International Search Report and Written Opinion dated Jul. 1, 2019 from International Application No. PCT/US2019/016511 (Authorized Officer, Lee W. Young), 9 pages.
[cited by applicant]
Martens et al., “Serotype-specific mortality from invasive
[cited by applicant]
Sanofi's Opposition to Pfizer's Motion to Amend dated Nov. 16, 2018 from IPR Trial No. IPR2018-00187 for U.S. Pat. No. 9,492,559 (
[cited by applicant]
Loek Van Alphen, “Exhibit 1101, Declaration of Loek Van Alphen, PH.D. in Support of Sanofi's Opposition to Motion to Amend” dated Nov. 14, 2018 from IPR Trial No. IPR2018-00187 for U.S. Pat. No. 9,492,559 (
[cited by applicant]
Loek Van Alphen, “Exhibit 2073, Deposition of Loek Van Alphen, PH.D.” dated Dec. 10, 2018 from IPR Trial No. IPR2018-00187 for U.S. Pat. No. 9,492,559 (
[cited by applicant]
Peter R. Paradiso, “Exhibit 1116, Deposition of Peter R. Paradiso, PH.D.” dated Jan. 10, 2019 from IPR Trial No. IPR2018-00187 for U.S. Pat. No. 9,492,559 (
[cited by applicant]
Peter R. Paradiso, “Exhibit 2074, Declaration of Peter R. Paradiso, PH.D in Support of Pfizer's Reply in Support of Motion to Amend” dated Dec. 18, 2018 from IPR Trial No. IPR2018-00187 for U.S. Pat. No. 9,492,559 (
[cited by applicant]
Chen et al., “Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China”, BMJ …
[cited by applicant]
International Search Report and Written Opinion dated Apr. 11, 2020 from International Application No. PCT/US2020/043729, (Authorized Officer, N. Renggli-Zulliger), 12 pages.
[cited by applicant]
Beall et al., “A Population-Based Descriptive Atlas of Invasive Pneumococcal Strains Recovered Within the U.S. During 2015-2016”, Frontiers in Microbiology, Nov. 19, 2018, vol. 9, 19 pages.
[cited by applicant]
Van der Linden et al., “Increase of serotypes 15A and 23B in IPD in Germany in the PCV13 vaccination era”, BMC Infectious Diseases, May 5, 2015, vol. 15, No. 1, p. 207, 12 pages.
[cited by applicant]
Yano et al., “Characterization of Gene Use and Efficacy of Mouse Monoclonal Antibodies to
[cited by applicant]
Buchwald et al., “A Peptide Mimotope of Type 8 Pneumococca Capsular Polysaccharide Induces a Protective Immune Response in Mice”, Infection and Immunity, 2005, vol. 73, No. 1, pp. 325-333.
[cited by applicant]
Malcolm et al., “Chapter 21: Surface Layers from Bacillus alvei as a Carrier for a
[cited by applicant]
Malcolm et al., “Chapter 13: Crystalline Bacterial Cell Surface Layers (S-Layers) as Combined Carrier/Adjuvants for Conjugate Vaccines”, In: Sleytr U.B., Messner P., Pum D., Sára M. (eds.), Immobilised Macromolecules: A…
[cited by applicant]
Malcolm et al., “S30: Improved Immunogenicity Using Oligosaccharide Conjugate Vaccines”, Glyco XIII: XIIIth International Symposium on Glycoconjugates; Seattle, USA, Aug. 20-26, 1995, Glycoconjugate Journal, 1995, vol. …
[cited by applicant]
Jahn-Schmid et al., “Toward selective elicitation of TH1-controlled vaccination responses: vaccine applications of bacterial surface layer proteins”, Journal of Biotechnology, 1996, vol. 44, pp. 225-231.
[cited by applicant]
Thanos et al., “Invasive Infektion durch Streptococcus pneumoniae Serotyp 8 im Säuglingsalter”, Monatsschr Kinderheilkd, 2013, vol. 161, pp. 1177-1179, with English abstract.
[cited by applicant]
Office Action dated Aug. 10, 2020 for U.S. Appl. No. 16/322,698, 23 pages.
[cited by applicant]
Office Action dated Mar. 25, 2021 for U.S. Appl. No. 16/322,698, 13 pages.
[cited by applicant]
Office Action dated Mar. 15, 2021 for U.S. Appl. No. 16/322,726, 21 pages.
[cited by applicant]
Boot et al., “Simultaneous vaccination with Prevenar and multicomponent vaccines for children: Interference or no interference?”, Human Vaccines, 2009, vol. 5, No. 1, pp. 15-17.
[cited by applicant]
Kolberg et al., “Monoclonal antibodies with specifities for Streptococcus pneumoniae group 9 capsular polysaccharides”, FEMS Immunology and Medical Microbiology, 1998, vol. 20, pp. 249-255.
[cited by applicant]
Non-Final Office Action dated Jul. 16, 2024 for U.S. Appl. No. 17/500,716, 5 pages.
[cited by applicant]
Nuriev et al., “Immunochemical and Protective Properties of Conjugated Capsular Polysaccharide of
[cited by applicant]
Office Action dated Jul. 9, 2024 for Japanese Patent Application No. 2023-117178, 6 pages with English translation.
[cited by applicant]
Kovtun et al., “Next Generation Pneumococcal Conjugate Vaccines Efficacy in Different Regions of the World”, Current Pediatrics, 2014, vol. 13, No. 1, pp. 18-25 with English Abstract.
[cited by applicant]
Non-Final Office Action dated Jul. 5, 2023 for U.S. Appl. No. 17/047,563, 10 pages.
[cited by applicant]
Notice of Allowance and Examiner-Initiated Interview Summary dated May 12, 2021 for U.S. Appl. No. 16/966,552, 20 pages.
[cited by applicant]
Notice of Allowance dated Sep. 7, 2021 for U.S. Appl. No. 16/322,726, 13 pages.
[cited by applicant]
Notice of Allowance dated Oct. 29, 2021 for U.S. Appl. No. 16/322,726, 18 pages.
[cited by applicant]
Notice of Allowance dated Sep. 14, 2021 for U.S. Appl. No. 16/966,552, 14 pages .
[cited by applicant]
Notice of Allowance and Applicant-Initiated Interview Summary dated Sep. 23, 2021 for U.S. Appl. No. 16/322,698, 8 pages.
[cited by applicant]
Notice of Allowance dated Oct. 20, 2021 for U.S. Appl. No. 16/322,698, 14 pages.
[cited by applicant]
Notice of Allowance and Examiner-Initiated Interview Summary dated Dec. 8, 2023 for U.S. Appl. No. 17/047,563, 9 pages.
[cited by applicant]
Fredman, Jeffrey N., et al. (Administrative Patent Judges for U.S. Patent and Trademark Office, Patent Trial and Appeal Board, “Judgment—Final Written Decision on Remand Denying Patent Owner's Motion to Amend as to Prop…
[cited by applicant]
Gutman, Siegmund Y., et al. (Counsel for Appellees Sanofi Pasteur Inc. et al.), “Appellees Sanofi Pasteur Inc., and SK Chemicals Co., Ltd's Responsive Brief,”
[cited by applicant]
Chinese Search Report for Chinese Application No. 202080061473.6 dated Apr. 28, 2025, 4 pages including English translation.
[cited by applicant]
Lourie et al. (Circuit Judges for U.S. Court of Appeals for the Federal Circuit), “Decision on Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017-02131, IPR2017-021…
[cited by applicant]
Notice of Allowance and Fee(s) Due for U.S. Appl. No. 18/598,439 dated Apr. 10, 2025, 12 pages.
[cited by applicant]
Notice of Allowance and Fee(s) Due for U.S. Appl. No. 18/598,439 dated Jul. 14, 2025, 43 pages.
[cited by applicant]
Office Action for U.S. Appl. No. 17/630,841 dated Jun. 18, 2025, 36 pages.
[cited by applicant]
Preliminary Office Action and Search Report dated Nov. 7, 2025 for Brazilian Patent Application No. BR112020014978-0, 5 pages including partial informal English translation.
[cited by applicant]
Office Action for U.S. Appl. No. 17/630,841 dated Nov. 6, 2025, 23 pages.
[cited by applicant]