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 .
The response and amendment to the claims filed 4-10-2026 has been entered into the record. Claims 1-30 are pending.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 4-17-2023. It is noted, however, that applicant has not filed a certified copy of the IN202323028039 application as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 15-30) in the reply filed on 4-10-2026 is acknowledged.
Claims 1-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4-10-2026.
Claim Objections
Claims 26 and 27 are objected to because of the following informalities: while abbreviations (i.e. (SEC-MALS) are permitted in the claims, they must be first preceded in the first instance by the text which they represent. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 15-30 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 15 and every claim dependent thereon, the claims are confusing in that the polysaccharide is not related to the carrier protein in the body of the claim and it is unclear what is conjugated to what. There is the protein in the conjugate in the preamble and a carrier protein in the body. There is no antecedent basis back to the preamble for the carrier protein. Is that the same or different than the protein in the conjugate. Also, the claim recites the composition comprises at least three distinct carrier proteins, are these part of the conjugate or not ? “Pneumococcal” lacks proper antecedent basis in the claim. The claim also lacks antecedent basis of “dose of the composition” as “dose” lacks antecedent basis in the claim. Finally, the Markush group of carrier proteins is prima facie indefinite in that it uses “or” and “and” multiple times, so it is unclear what is includes or excluded by the list. The use of the term “such as” is also indefinite because it is unclear whether the limitation is included or excluded by the claim. As to claim 15 it is unclear what is meant by “distinct” carrier proteins. Clearly the art teaches that CRM197 and diphtheria toxoid are related by sequence. What properties define distinct ? As the dependent claims (16-30) do not resolve this issue, they are likewise rejected.
As to claim 16,17 and 18, the term “pneumococcal polysaccharide-carrier protein conjugate” lacks clear antecedent basis in claim 15.
As to claim 25, the claim in indefinite in that the composition comprises at least one additional S. pneumoniae polysaccharide serotype 9A, 9N and 9L, when claim 15 comprises these serotypes. So how are these additional ?
As to claim 27, the claims recite the conditional phrase “preferably in the range” and it is unclear if the preferred range is a limitation of the claims or not.
As to claims 27 and 30, the claims are confusing because as they depend on claim 15, which does not require the presence of these conjugates recited in the claims. As such, the metes and bounds of the claim are indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Vesikari et al (The Pediatric Infectious Disease Journal, 28(4):S66-76, 2009).
Vesikari et al teach a 10-valent pneumococcal conjugate vaccine. The 10-valent vaccine contained 1 ug of each capsular polysaccharide for pneumococcal serotypes 1, 2, 6B, 7F, 9V, 14 and 23F and 3 ug for serotype 4, all conjugated to protein D of H. influenza, 3ug of capsular polysaccharide of serotype 18C conjugated to tetanus toxoid and 3ug of capsular polysaccharide of serotype 19F conjugated to diphtheria toxoid (see Materials and Methods, Vaccines and Vaccinations; page S67, column 1). As such, Vesikari et al anticipate the claimed invention.
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.
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.
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.
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.
Claims 15, 16, 19, 20, 21, 26, 27, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Burki et al (WO 2020/157772).
Burki et al teach that the art is replete with examples of multivalent S. pneumoniae polysaccharide-carrier conjugates where the composition comprises a single carrier or multiple different carriers (see pages 2-4). Burki et al teach the need for additional vaccines comprising novel conjugates in view of the variances in different geographical regions (see paragraph bridging pages 4-5). Burki et al teach that a multivalent conjugate vaccine comprising combination of diphtheria toxoid (DT) and tetanus toxoid (TT) as carriers in a mixed carrier vaccine formulation where polysaccharides are from S. pneumoniae is provided by the art (see page 2, lines 23-25). Burki et al also teach that the art discloses various vaccine S. pneumoniae carrier protein conjugate combinations that are 13 and 15-valent using the carrier protein CRM197 (see page 2, lines 26-31). Burki et al also teach that the use the combination of DT, TT and protein D as carrier proteins in S. pneumoniae conjugates have been provided by the art (see paragraph griding pages 2-4). Burki et al also teach a mixed carrier combination of CRM197 and DT and a combination of 4 different carrier proteins CRM197, PsaA, DT and TT (see page 5, lines 17-20). Burki et al teach that the conjugates can be prepared using known techniques including formation of reactive aldehyde groups, CADP chemistry with or without spacers, adipic acid dihydrazide (ADH) chemistry (see pages 13-14). The conjugates can be purified by size exclusion chromatography and other methods (see page 14, line29 – page 30, line 7). Burki et al teach the size of the polysaccharides before conjugation and the molecular weight of the conjugates (page 16, line 16-28).
Burki et al teach a 20-valent mixed carrier vaccine composition comprising S. pneumoniae polysaccharides 1, 3, 4, 5, 6A, 6B, 6C/D, 7F, 9V, 11A, 12F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23F and 35B and the carrier proteins CRM197, PsaA and TT (see page 6, lines 15-22) and page 33, lines 1-7). Burki et al teach wherein each polysaccharide conjugate has a molecular weight ranging from about 1,000 kDa to about 15,000 kDa and the ration of protein to polysaccharide (protein/PS) is in the rage from 0.5 to 1.5) (see page 43, lines 9-14). Burki et al teach the composition further comprises one or more of a carrier, diluents, buffer, preservative, stabilizer, adjuvant and excipients (page 17, lines 18-28). Burki et al teach that the carrier proteins are conjugate to individual polysaccharides and then different conjugates combined (see page 18). Burki et al teach that the single does of about 0.5 mL formulated to containing 2.2 to 4.4 ug of each pneumococcal polysaccharide serotypes and amount of individual carriers (see paragraph bridging pages 19-20). Burki et al differ by not exemplifying a 20-valent vaccine formulation comprising a mixed carrier with the 4 different carrier proteins CRM197, PsaA, DT and TT combination.
However, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing to formulate a vaccine composition comprising the 20 different S. pneumoniae serotypes having each individually conjugated to one of the four carrier proteins to provide a vaccine composition comprising a 20-valent mixed carrier conjugate comprising a combination of four different carrier proteins CRM197, PsaA, DT and TT because Burki et al teach mixed carrier vaccine 20-valent polysaccharide-carrier protein vaccines each having the desired amount of polysaccharide and carrier protein to induce an immunoprotective response because Burki et al that the 20-valent vaccine was desirable and specifically calls out the combination of the four different carrier proteins CRM197, PsaA, DT and TT. The selection of individual carrier protein – polysaccharide conjugates in the final formulation to provide for an optimum immune response is prima facie obvious. It further would have obvious to formulate the vaccine as set forth above with additional components such as, carriers, stabilizers, buffers, surfactants, lyophilization excipients and adjuvants (i.e. aluminum phosphate) according to Burki et al.
The selection of the amount of each conjugate, the total polysaccharide content and the total carrier content are results effective variables and it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) Additionally, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 15, 16, 17, 18, 19, 20, 21, 24, 25, 26, 27, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al (WO 2024/110827, with priority to November 21, 2022) in view of Burki et al (WO 2020/157772) and Faridmoayer et al (US 2020/179505).
Gallagher et al teach various 21-, 22-, 23-, 24- and 25-valent conjugate compositions (see page 70, lines10-33). Gallagher et exemplify different combinations of different serotypes at pages 71-77. Gallagher et al teach serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 6E, 6F, 6G, 6H, 7A, 7B, 7C, 7F, 8, 9A, 9L, 9V, 9N, 10A, 10B, 10C, 10F, 11A, 11B, 11C, 11D, 11E, 11F, 12A, 12B, 12F, 13, 14, 15A, 15B, 15C, 15F, 16A, 16F, 17A, 17F, 18A, 18B, 18C, 18F, 19A, 19B, 19C, 19F, 20A, 20B, 21, 22A, 22F, 23A, 23B, 23F, 24A, 24B, 24F, 25A, 25F, 27, 28A, 28F, 29, 31, 32A, 32F, 33A, 33B, 33C, 33D, 33E, 33F, 34, 35A, 35B, 35C, 35F, 36, 37, 38, 39, 40, 41A, 41F, 42, 43, 44, 45, 46, 47A, 47F or 48 for conjugation to a carrier proteins (see page 4). Preferably, the capsular saccharide is from a Streptococcus pneumoniae serotype selected from the group consisting of serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 7C, 7F, 8, 9V, 9N, 10A, 10B, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24B, 24F, 27, 29, 31, 33B, 33F, 34, 35B, 35F, 38, 72 and 73 (page 14, second full paragraph). The capsular may be activated using a method described to make them capable of reacting and then incorporated into glycoconjugates. Gallagher et al teach desirable molecular weights of the conjugates (see page 21, lines16 to page 23, line 29). Gallagher et al teach the ratio of the saccharide to carrier protein (see page 25, lines 15-35). Gallagher et al teach desirable characteristics of the conjugate having less that about 15% of free saccharide compared to the total amount of saccharide. Gallagher et al teach various carrier proteins that can be used in the glycoconjugates, including DT, TT, CRM179 and protein D (see page 53). Gallagher et al teach the combination of serotypes:
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At pages 71 and 72. Gallagher et al teach that preferably the saccharides are each individually conjugated to a carrier protein. Gallagher et al teach that the carrier proteins may be the same or different and that the compositions may include a small amount of free carrier (see page 79. Gallagher et al teach suitable amounts of glycoconjugates in the immunogenic composition wherein the immunogenic amount 0.5 ug to about 100 ug of any particular saccharide antigen.(see pages 78-81). The carrier amounts are disclosed at pages 81-82. Gallagher et al differs by not teaching a 21-valent or 30-valent immunogenic composition comprising different polysaccharides conjugated to different carriers, where the carriers are DT, TT and CRM197. Gallagher et al teach different formulations of the immunogenic compositions one or more of a buffer, salt, divalent cation, non-ionic detergent, cryoprotectant. In some embodiments the buffer has a pKa for about 3.5 to abut 7.5 and the buffer is phosphate, succinate, histidine or citrate and particularly exemplify succinate and histidine buffers. The salt is selected from magnesium chloride, potassium chloride and sodium chloride and the sodium chloride is exemplified at 150 mM (see page 93, lines 9-24). The surfactant may be polysorbate -20, -40-60-80 -85 etc. In an exemplified embodiment the final concentration of polysorbate 20 in the formulation is at least 0.0001 to 10% polysorbate 20 w/w (see page 94, lines 15-31). Gallagher et al differs by not teaching that the 21-valent immunogenic compositions comprise at least 3 different carriers selected from DT, TT and CRM197.
Burki et al teach that the art is replete with examples of multivalent S. pneumoniae polysaccharide-carrier conjugates where the composition comprises a single carrier or multiple different carriers (see pages 2-4). Burki et al teach the need for additional vaccines comprising novel conjugates in view of the variances in different geographical regions (see paragraph bridging pages 4-5). Burki et al teach that a multivalent conjugate vaccine comprising combination of diphtheria toxoid (DT) and tetanus toxoid (TT) as carriers in a mixed carrier vaccine formulation where polysaccharides are from S. pneumoniae is provided by the art (see page 2, lines 23-25). Burki et al also teach that the art discloses various vaccine S. pneumoniae carrier protein conjugate combinations that are 13 and 15-valent using the carrier protein CRM197 (see page 2, lines 26-31). Burki et al also teach that the use the combination of DT, TT and protein D as carrier proteins in S. pneumoniae conjugates have been provided by the art (see paragraph griding pages 2-4). Burki et al also teach a mixed carrier combination of CRM197 and DT and a combination of 4 different carrier proteins CRM197, PsaA, DT and TT (see page 5, lines 17-20). Burki et al teach that the conjugates can be prepared using known techniques including formation of reactive aldehyde groups, CADP chemistry with or without spacers, adipic acid dihydrazide (ADH) chemistry (see pages 13-14). The conjugates can be purified by size exclusion chromatography and other methods (see page 14, line29 – page 30, line 7). Burki et al teach the size of the polysaccharides before conjugation and the molecular weight of the conjugates (page 16, line 16-28). Burki et al teach a 20-valent mixed carrier vaccine composition comprising S. pneumoniae polysaccharides 1, 3, 4, 5, 6A, 6B, 6C/D, 7F, 9V, 11A, 12F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23F and 35B and the carrier proteins CRM197, PsaA and TT (see page 6, lines 15-22) and page 33, lines 1-7). Burki et al teach wherein each polysaccharide conjugate has a molecular weight ranging from about 1,000 kDa to about 15,000 kDa and the ration of protein to polysaccharide (protein/PS) is in the rage from 0.5 to 1.5) (see page 43, lines 9-14). Burki et al teach the composition further comprises one or more of a carrier, diluents, buffer, preservative, stabilizer, adjuvant and excipients (page 17, lines 18-28). Burki et al teach that the carrier proteins are conjugate to individual polysaccharides and then different conjugates combined (see page 18). Burki et al teach that the single does of about 0.5 mL formulated to containing 2.2 to 4.4 ug of each pneumococcal polysaccharide serotypes and amount of individual carriers (see paragraph bridging pages 19-20). Burki et al differ by not exemplifying a 20-valent vaccine formulation comprising a mixed carrier with the 4 different carrier proteins CRM197, PsaA, DT and TT combination.
Faridomayer et al (US 2020/0179505) teaches that carrier proteins that can be used in S. pneumoniae glycoconjugates are TT, DT, CRM197, protein D and detoxified exotoxin A from P. aeruginosa. Faridomayer et al each capsular saccharide serotype can be conjugated to a carrier protein independently selected from these carrier proteins and where the composition comprises 2, 3, 45, or 6 different carrier proteins (see 7, column 2, paragraph [0100]).
As to claim 15, and 19, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing to conjugate each of the individual serotypes of the 21-valent compositions of Gallagher et al to a carrier protein wherein the carrier proteins selected from the TT, DT, CRM197, protein D and detoxified exotoxin A as taught by Faridomayer et al and Burki et al to form a 21-valent serotype immunogenic composition having at least 3 different carriers because Burki et al teach that such formulations are immunogenic and Faridomayer et al teach that compositions having multiple different carriers are within the art. As to claim 17 and 19, it would have been prima facie obvious at the time of filing to select the carriers TT, DT and CRM197 from among the lists, as all of these carriers have been shown to be effective in immunogenic compositions in the art. As to claim 18, it additionally, would have been prima facie obvious to add the 24F serotype conjugate to the 21-valent formulation as Gallagher et al teach the 24F is useful in another immunogenic composition and contemplates up to 25-valent vaccine compositions. Thus, the immunogenic compositions of claim 18 is prima facie obvious. It would have been prima facie obvious to optimize the particular carrier-polysaccharide combination for inclusion in the vaccine composition as it is well known in the art that the carrier combination can have effects on the immunogenicity of the attached saccharide. As such, it would have been prima facie obvious to combine the various serotype-carrier protein combinations in the vaccine as claimed because the carrier proteins function equivalently and the selection of one among a few is prima facie obvious.
As to claims 15,16, 19, 20, 24, 25, 29, and 30, it would have been prima facie obvious to all S. pneumoniae serotypes polysaccharides or any subset thereof of and individually conjugate each serotype to different carrier proteins where the composition comprises, 3 to 6 different carrier proteins as Gallagher et al teach making the conjugates from these serotypes with the same or different carrier proteins and conjugate select any number of polysaccharides to individually conjugate to different carrier proteins to form a greater that 25-valent composition because Burki et al teach the need for additional vaccines comprising novel conjugates in view of the variances in different geographical regions. The combination of different conjugates individually conjugated to a carrier protein provide for a composition having a valency of greater than 30 different serotypes is prima facie obvious because Burki et al teach the need for additional vaccines comprising novel conjugates in view of the variances in different geographical regions and Gallagher et al teach the serotypes of interest.
As to claims, 26 and 27, Gallagher et al teach molecular weights of the glycoconjugates between 250 kDa and 20,000 kDa and provide for other ranges, it would have been prima facie obvious to one having skill in the art at the time the invention was made to optimize the saccharide and glycoconjugate molecular weight in the composition in order to obtain optimal immunogenicity of the individual conjugate. Additionally, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, the selection of the amount of each polysaccharide in the conjugate, the total polysaccharide content and the total carrier content are results effective variables and it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989).
Claims 22, 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al (WO 2024/110827, with priority to November 21, 2022), Burki et al (WO 2020/157772) and Faridmoayer et al (US 2020/0179505) as applied to claims 15, 16, 17, 18, 19, 20, 21, 26, 27, 29 and 30 above and further in view of Kapre et al (US 12,053,515; with priority to at least Feb 10, 2022).
The combination of Gallagher et al, Burki et al and Faridmoayer et al is set forth surpa. The combination differs by not teaching the presence of a preservative 2-phenoxyethanol in the rage of 2.5 mg-5mg per 5 ml dose and does not teach the buffer formulation elements of b.thru g. of claims 22 and 23.
Kapre et al teach multivalent pneumococcal glycoconjugate vaccines containing serotype 24F. Kapre et al teach that the vaccine composition and comprise a multi-valent glycoconjugate S. pneumoniae vaccine can be in the form of a unit single dose vial or a multiple dose vial or a pre-filled syringe. The composition may comprise the preservative 2-phenoxyethanol in multidose formulation and preferable ranges in the amount from 4-20 mg/ml which is equivalent to 2-10 mg/ 0.5 ml dose. Kapre et al contemplate 30-valent or grater than 30-valent immunogenic compositions wherein the compositions comprise the emerging serotype 24F (see column 7, lines 53-67). Kapre et al teach that the individual purified glycoconjugates can be compounded to formulate the immunogenic composition which can be used as a vaccine (see column 7, lines 37-44). Kapre et al teach that the 0.5 ml dose formulated to contain 2.2 ug of each conjugate except for 6B at 4.4 ug, 0.2mg-1mg aluminum phosphate adjuvant, sodium chloride, histidine and buffer as excipients (see column 8, lines 30-36). Kapre et al teach the liquid formulation comprising 0.125 mg-0.150 mg elemental aluminum (0.5-0.625 mg aluminum phosphate (column 9, lines 33-35).
As to claim 28, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing to formulate the vaccine compositions comprising the glycoconjugates as combined supra with a preservative according to Kapre et al because Kapre et al teach that such can be included in multi-dose compositions and one of skill in the art would have been motivated to do so to prevent bacterial growth in the multi-dose vial.
As to claims 22 and 23, it would have been prima facie obvious to formulate the formulate the vaccine compositions comprising the glycoconjugates as combined supra with an aluminum phosphate adjuvant comprising 0.125 mg-0.150 mg elemental aluminum, histidine buffer, sodium chloride according to Kapre et al and add one or more of a buffer, salt, divalent cation, non-ionic detergent/surfactant and cryoprotectant according to Gallagher et al to arrive a formulation comprising aluminium phosphate adjuvant, a buffer having a pKa of bout 3.5 to abut 7.5 such as succinate and histidine; the sodium chloride at 150 mM the surfactant may be polysorbate -20 in the formulation is at least 0.0001 to 10% polysorbate 20 w/w because Kapre et al and Gallagher et al teach that these are conventionally included in formulations in the art. It would have been prima facie obvious to optimize the amounts of each of adjuvant, histidine, succinate, polysorbate, sodium chloride and pH to arrive at the formulation in order to optimize stability of the formulation for unit dosage and multi-dosage stability upon formulation and storage. Additionally, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Citation of Relevant Prior Art
Abeygunawardana et al (US 2020/0197503) is cited to teach formulations of S. pneumoniae glycoconjugates comprising histidine buffer, pH, polysorbate-20, saline, aluminum phosphate adjuvant (see paragraphs [0216] – [0227]).
Cannon et al (Vaccine 39:7494-7502, 2021 available online November 25, 2021) is cited to teach formulations of S. pneumoniae glycoconjugates comprising succinate buffer, sodium chloride, polysorbate 80 and aluminum phosphate adjuvant (see page 7496, column 1, first paragraph).
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645
37 C.F.R. Rule 1.105 Request
The examiner requires the submission, from individuals identified under § 1.56(c), or any assignee, of such information as may be reasonably necessary to properly examine or treat the matters in US Application number 18/637,620.
A copy of the published Indian application, any Indian patent resulting therefrom, and any English language equivalents for which this patent application claims as a “Patent of Addition” at page 1 of the specification as reiterated herein:
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by any of the inventors or the Applicant, that relates to the claimed invention. In addition, Applicants should provide a copy of IN 140/DEL/2011. This information is materially necessary for the examiner to examine the instant application.
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
/Patricia Duffy/Primary Examiner, Art Unit 1645
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