DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 07/16/25 in response to the non-final Office Action mailed 03/27/2025. The amendment is non-compliant under 37 CFR 1.121 in that claims drawn to non-elected species, for example, claims 37 and 40-43, have an incorrect status identifier.
Status of Claims
2) Claims 31, 36, 39 and 49-54 have been amended via the amendment filed 07/16/25.
Claims 35 and 38 have been canceled via the amendment filed 07/16/25.
Claims 31, 36, 37 and 39-54 are pending.
The examination has been extended to the 23B-CRM197 additional pneumococcal conjugate species.
Claims 31, 36, 39 and 44-54 are under examination.
Prior Citation of Title 35 Sections
3) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action.
Prior Citation of References
4) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Substitute Specification
5) Acknowledgment is made of the substitute specification filed 07/16/25.
Oath/ Declaration
6) The instant application appears to be a continuation-in-part application of US 16/645,048 and the PCT application PCT/US2018/049306 and the provisional application 62/555,455 because claim 31, as amended, contains new subject matter relative to these prior applications. At least the limitations: “further comprises” ..... additional polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197 .... wherein the S. pneumoniae serotype is elected from the group consisting of ........ “23B” ...... wherein ..... ‘0.4 to 4 .../mL of each of the polysaccharides present ....... an amount from 0.5x to 3x the total amount of the polysaccharide’ require the further presence of a polysaccharide of serotype 23B of S. pneumoniae in the immunogenic composition administered in the claimed method in addition to the presence of the conjugated polysaccharide of the serotype 23B of S. pneumoniae of the recited structure and molecular weight. However, such administration of such an immunogenic composition comprising two polysaccharides of serotype 23B of S. pneumoniae, one of specific structure and size or molecular weight and another of no specific structure and size or molecular weight, each conjugated to CRM197 is not supported in these applications. A new oath or declaration along with the surcharge set forth in 37 CFR 1.16(f) re-designating the application as a continuation-in-part application is needed.
Effective Filing Date
7) Due to the issues set forth in the paragraph supra, instant claims are afforded the effective filing date of 09/22/2022.
Objection(s) Withdrawn
8) The objection to claim 31 set forth in paragraph 19 of the Office Action mailed 03/27/25 is withdrawn in light of Applicants’ claim amendment.
9) The objection to the specification set forth in paragraph 7 of the Office Action mailed 03/27/25 is withdrawn in light of Applicants’ amendments.
Objection(s) to Claims & Specification
10) Claim 31, as amended, and the specification are objected to for the following reason(s):
35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention. 37 C.F.R 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’
Claim 31, as amended, includes the limitations: “further comprises” ..... additional polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197 .... wherein the S. pneumoniae serotype is elected from the group consisting of ........ “23B” ...... wherein ..... ..... ‘0.4 to 4 .../mL of each of the polysaccharides present ....... an amount from 0.5x to 3x the total amount of the polysaccharide’. This requires the further presence of a polysaccharide of serotype 23B of S. pneumoniae in the immunogenic composition administered in the claimed method in addition to the presence of the conjugated polysaccharide of the serotype 23B of S. pneumoniae of the recited structure and molecular weight. However, there is no descriptive support and antecedent basis in the as-filed specification for these limitations. The support in the as-filed instant specification for an immunogenic composition comprising a polysaccharide of 23B serotype of S. pneumoniae having a repeating unit structure and molecular weight as claimed, the polysaccharide conjugated to CRM197 carrier protein and “further” comprising a polysaccharide-CRM197 conjugate comprising a polysaccharide of at least one of other serotype of S. pneumoniae is present in the original claim 20, which is set forth below:
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The paragraph bridging pages 4 and 5 of the original specification recites the following:
In one embodiment, the present invention provides a multivalent immunogenic
composition comprising unconjugated polysaccharides or polysaccharide-protein conjugates
from one or more of Streptococcus pneumoniae serotypes 23A and 23B, and unconjugated
polysaccharides or polysaccharide-protein conjugates from one or more of Streptococcus
pneumoniae serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18B, 18C, 19A, 19F, 20, 21, 22A, 22F, 23F, 24B, 24F, 27, 28A, 31,
33F, 34, 35A, 35B, 35F, and 38. However, neither the original claim 20, nor the above parts of the as-filed application provide descriptive support and antecedent basis for the immunogenic composition administered in the now claimed method of claim 31, wherein the composition is required to comprise the recited polysaccharide of 23B serotype of S. pneumoniae having the recited structure and molecular weight and ‘further’ comprising polysaccharide of 23B serotype of S. pneumoniae conjugated to CRM197.
Rejection(s) Moot
11) The rejections of claims 35 and 38 set forth in paragraph 9 of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite are moot in light of Applicants’ cancellation of the claims.
12) The rejection of claims 35 and 38 set forth in paragraph 11 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claim 1 of US patent 11850278 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is moot in light of Applicants’ cancellation of the claims.
13) The rejection of claims 35 and 38 set forth in paragraph 12 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9, 21 and 1 of US patent 11759511 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450:19-29, Available online 8 August 2017, of record) is moot in light of Applicants’ cancellation of the claims.
14) The rejection of claims 35 and 38 set forth in paragraph 13 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 29-31, 21-28 and 1 of US patent 11524076 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is moot in light of Applicants’ cancellation of the claims.
15) The rejection of claims 35 and 38 set forth in paragraph 14 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9, 21 and 1 of US patent 11964023 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is moot in light of Applicants’ cancellation of the claims.
16) The provisional rejection of claims 35 and 38 set forth in paragraph 15 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 33, 34, 20, 21, 19, 23, 24 and 35-44 of the co-pending application 17934396 is moot in light of Applicants’ cancellation of the claims.
17) The provisional rejection of claims 35 and 38 set forth in paragraph 16 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 36, 53, 31 and 38-52 of the co-pending application 17935871 is moot in light of Applicants’ cancellation of the claims.
18) The rejection of claim 35 set forth in paragraph 18 of the Office Action mailed 03/27/2025 under 35 U.S.C § 102(a)(1) as being anticipated by WO 2015121783 A1 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is moot in light of Applicants’ cancellation of the claim.
Rejection(s) Withdrawn
19) The rejection of claim 36 set forth in paragraph 9(c) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
20) The rejection of claims 49 and 50 set forth in paragraph 9(d) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
21) The rejections of claims 51-53 set forth in paragraphs 9(e) and 9(k) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite are withdrawn in light of Applicants’ claim amendments.
22) The rejection of claim 53 set forth in paragraph 9(f) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
23) The rejections of claim 54 set forth in paragraphs 9(g), 9(h) and 9(l) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
24) The rejection of claim 31 set forth in paragraph 9(j) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
25) The rejection of claims 36, 39 and 44-53 set forth in paragraph 9(n) of the Office Action mailed 03/27/2025 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments to the base claim.
Rejection(s) Maintained
26) The rejection of claims 31, 36, 39 and 46-52 set forth in paragraph 11 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claim 1 of US patent 11850278 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
Applicants’ statement has been noted. A proper response to a non-statutory obviousness type double patenting that is not a provisional rejection must include filing of a terminal disclaimer or a traversal of the merits of the rejection.
27) The rejection of claims 31, 36, 39 and 46-52 set forth in paragraph 12 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9, 21 and 1 of US patent 11759511 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450:19-29, Available online 8 August 2017, of record) is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
Applicants’ statement has been noted. A proper response to a non-statutory obviousness type double patenting that is not a provisional rejection must include filing of a terminal disclaimer or a traversal of the merits of the rejection.
28) The rejection of claims 31, 36, 39 and 46-52 set forth in paragraph 13 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 29-31, 21-28 and 1 of US patent 11524076 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
Applicants’ statement has been noted. A proper response to a non-statutory obviousness type double patenting that is not a provisional rejection must include filing of a terminal disclaimer or a traversal of the merits of the rejection.
29) The rejection of claims 31, 36, 39 and 46-52 set forth in paragraph 14 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9, 21 and 1 of US patent 11964023 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
Applicants’ statement has been noted. A proper response to a non-statutory obviousness type double patenting that is not a provisional rejection must include filing of a terminal disclaimer or a traversal of the merits of the rejection.
30) The provisional rejection of claims 31, 36, 39 and 44-54 set forth in paragraph 15 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 33, 34, 20, 21, 19, 23, 24 and 35-44 of the co-pending application 17934396 is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
31) The provisional rejection of claims 31, 36, 39 and 44-54 set forth in paragraph 16 of the Office Action mailed 03/27/2025 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 36, 53, 31 and 38-52 of the co-pending application 17935871 is maintained.
Applicants request that this rejection be held in abeyance until the claims are otherwise found allowable.
32) The rejection of claims 31, 36 and 47-52 set forth in paragraph 18 Office Action mailed 03/27/2025 under 35 U.S.C § 102(a)(1) as being anticipated by WO 2015121783 A1 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is withdrawn in light of Applicants’ claim amendments.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First paragraph
33) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL. The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
34) Claim 31 and the dependent claims 36, 39 and 44-54 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 31, as amended, includes the limitations: “further comprises” ..... additional polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197 .... wherein the S. pneumoniae serotype is elected from the group consisting of ........ “23B” ...... wherein ..... ‘0.4 to 4 .../mL of each of the polysaccharides present ....... an amount from 0.5x to 3x the total amount of the polysaccharide’. This requires the further presence of a polysaccharide of serotype 23B of S. pneumoniae in the immunogenic composition administered in the claimed method in addition to the presence of the conjugated polysaccharide of the serotype 23B of S. pneumoniae of the recited structure and molecular weight. However, there is no descriptive support in the as-filed specification for these limitations. The support in the as-filed instant specification for an immunogenic composition comprising a polysaccharide of 23B serotype of S. pneumoniae having a repeating unit structure and molecular weight as claimed, the polysaccharide conjugated to CRM197 carrier protein and “further” comprising a polysaccharide-CRM197 conjugate comprising a polysaccharide of at least one of other serotype of S. pneumoniae is present in the original claim 20, which is set forth below:
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The paragraph bridging pages 4 and 5 of the original specification recites the following:
In one embodiment, the present invention provides a multivalent immunogenic
composition comprising unconjugated polysaccharides or polysaccharide-protein conjugates
from one or more of Streptococcus pneumoniae serotypes 23A and 23B, and unconjugated
polysaccharides or polysaccharide-protein conjugates from one or more of Streptococcus
pneumoniae serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18B, 18C, 19A, 19F, 20, 21, 22A, 22F, 23F, 24B, 24F, 27, 28A, 31,
33F, 34, 35A, 35B, 35F, and 38. However, neither the original claim 20, nor the as-filed application provide descriptive support for the immunogenic composition administered in the now claimed method of claim 31, wherein the composition is required to comprise the recited polysaccharide of 23B serotype of S. pneumoniae having the recited structure and molecular weight and ‘further’ comprising polysaccharide of 23B serotype of S. pneumoniae conjugated to CRM197. Therefore, the above-identified limitations in the amended claim 31 and the currently claimed scope of the claim and those dependent therefrom are considered to be new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are invited to point to the descriptive support in specific pages and lines of the disclosure, as originally filed, for the limitation identified above, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
Rejection(s) under 35 U.S.C § 102
35) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
36) Claims 31, 36, 39, 46-52 and 54 are rejected under 35 U.S.C § 102(a)(1) or 102(a(2) as being anticipated by WO 2019050815 A1 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record).
WO 2019050815 A1 disclosed a method of inducing an immune response to a S. pneumoniae capsular polysaccharide comprising administering to a human an immunologically effective amount of an immunogenic composition comprising one or more S. pneumoniae polysaccharide-CRM197 carrier protein conjugates including the serotype 23B S. pneumoniae polysaccharide conjugated to CRM197 carrier protein. The degree of conjugation of the conjugates was between 3 to 13, the polysaccharide to the carrier protein mass ratio was from 0.5 to 1.5 or from 0.8 to 1.2, and the molecular weight of the polysaccharide was between 50 kDa and 300 kDa or between 100 kDa and 300 kDa, The composition administered in the method of the prior art further comprised serotype 23A S. pneumoniae polysaccharide conjugated to CRM197, 150 mM sodium chloride, 20 mM L-histidine buffer, 0.125 mg aluminum phosphate, and 0.05 to 2% w/v polysorbate-20 and it was formulated to comprise 0.4 to 4 microgram of the polysaccharide, except for serotype 6B polysaccharide which if present, comprised 0.8 to 8 microgram/mL of polysaccharide; and CRM197 carrier protein in an amount from about 0.5x to 3x of the total amount of polysaccharide. Less than 15% or 25% of free (non-covalently associated) polysaccharide was present in the composition compared to the total amount of the polysaccharide. The immunogenic composition is formulated into a single dosage formulation. See claims 25, 26 and 16-24; second full paragraph of page 4; first full paragraph of page 20; and the paragraph bridging pages 19 and 20 as well as pages 39 and 40. The repeating unit of the prior art S. pneumoniae serotype 23B capsular polysaccharide is expected to necessarily have the structure recited in instant claim 31 as is evidenced by the teachings of Ravenscroft et al. For instance, Ravenscroft et al. taught the serotype 23B pneumococcal capsular polysaccharide repeating unit to be having the structure: ->4)-beta-D-Glcp-(1->4)-[Gro-(2->P->3)]-beta-D-Galp-1->4)-beta-L-Rhap-(1->. See title; 3rd full sentence from bottom of Abstract on page 19 and Figure 9.
Claims 31, 36, 39, 46-52 and 54 are anticipated by WO 2019050815 A1. The reference of Ravenscroft et al. is not used as a secondary reference in combination with WO 2015121783 A1, but rather is used to show that every element of the claimed subject matter is disclosed by WO 2015121783 A1 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978).
Conclusion
37) No claims are allowed.
For clarity and sufficient antecedence, it is suggested that Applicants replace the limitation ‘the polysaccharide’ in the last but one line of claim 1 with the limitation --the serotype 6B polysaccharide--.
In line 2 of claims 44 and 45, for proper antecedence, it is suggested that Applicants insert the limitation –the-- after the limitation ‘... carbon position of’.
In line 2 of claim 53, for proper antecedence, it is suggested that Applicants insert the limitation –the-- after the limitation ‘... carbon position of’.
38) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
39) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 7.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Gary Nickol, can be reached at (571) 272-0835. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
40) Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
October, 2025