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 10/06/25 in response to the non-final Office Action mailed 06/04/25. Said amendment is non-compliant under 37 CFR 1.121 in that claims drawn to the non-elected species, previously withdrawn from consideration, have incorrect status identifiers. Additionally, claim 13 has been amended to replace the previous limitation ‘structure’ with the new plural limitation “structures” in line 3 of the claim, yet this change has not been indicated via marking as a required. Appropriate corrections are needed.
Status of Claims
2) Claims 18 and 51 have been canceled via the amendment filed 10/06/25.
Claims 13, 17, 40-50 and 57-61 have been amended via the amendment filed 10/06/25.
Claims 13, 17, 35-50 and 52-61 are pending and are under examination.
Substitute Specification
3) Acknowledgment is made of Applicants’ substitute specification filed 10/06/25.
Prior Citation of Title 35 Sections
4) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action References.
Prior Citation of References
5) 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.
Objection(s) Moot
6) The objection to claim 51 set forth at paragraph 19(a) of the Office Action mailed 06/04/25 is moot in light of Applicants’ cancellation of the claim.
Objection(s) Withdrawn
7) The objections to the specification set forth at paragraphs 7(a) and 7(b) of the Office Action mailed 06/04/25 are withdrawn in light of Applicants’ amendments.
Objection(s) Maintained
8) The objection to claim 47 set forth at paragraph 19(a) of the Office Action mailed 06/04/25 is maintained for the reason(s) set forth therein.
9) The objection to claims 47and 61 set forth at paragraph 19(b) of the Office Action mailed 06/04/25 is maintained for the reason(s) set forth therein. The redundant limitations ‘is between is between’ remain in these claims.
10) The objection to claim 48 set forth at paragraph 19(c) of the Office Action mailed 06/04/25 is maintained for the reason(s) set forth therein. The redundant limitations ‘wherein the wherein the’ remain in the claim.
Objection(s) to Claim(s) & Specification
11) 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.’
Claims 13 and 48, as amended, include the following new structures and the structure respectively:
PNG
media_image1.png
232
280
media_image1.png
Greyscale
which lack descriptive support and antecedent basis in the as-filed specification. Applicants do not point to specific part(s) of the as-filed specification for support, but state that the subject matter of the previously pending claim 18 has been added to claim 13. However, neither the previously pending claim 18, nor the as-filed specification provide descriptive support and antecedent basis for the now recited new structures or the new structure. The original claim 13, set forth below, provides descriptive support and antecedent basis for a structure that is different from the currently recited new structures or the new structure.
PNG
media_image2.png
224
539
media_image2.png
Greyscale
.
The original as-filed specification is not supportive of the structures or the structure currently recited in the amended claims 13 and 48.
Rejection(s) Moot
12) The rejection of claim 51 set forth at paragraph 9 of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is moot in light of Applicants’ cancellation of the claim.
13) The provisional rejection of claims 18 and 51 set forth in paragraph 11 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 21, 20 and 19 of the co-pending application 17934396 is moot in light of Applicants’ cancellation of the claims.
14) The provisional rejection of claims 18 and 51 set forth at paragraph 16 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 19 and 36-45 of the co-pending application 17935864 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.
Rejection(s) Withdrawn
15) The rejection of claims 43-47 and 57-61 set forth in paragraph 9(a) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the claims.
16) The rejections of claim 61 set forth in paragraphs 9(b) and 9(c) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite are withdrawn in light of Applicants’ amendment to the claim.
17) The rejection of claims 43-47 and 57-60 set forth in paragraph 9(d) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the claims.
18) The rejection of claims 40-42 set forth in paragraph 9(e) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the claims.
19) The rejection of claims 48-50 set forth in paragraph 9(f) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the claims.
20) The rejection of claim 17 set forth in paragraph 9(g) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the claim.
21) The rejection of claims 49, 50 and 52-61 set forth in paragraph 9(h) of the Office Action mailed 06/04/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite is withdrawn in light of Applicants’ amendment to the base claim.
22) The rejection of claims 13, 17, 35-46, 48-50 and 52-61 set forth in paragraph 18 of the Office Action mailed 06/04/25 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’ amendment to the claims and/or the base claim.
Rejection(s) Maintained
23) The provisional rejection of claims 13, 17, 35-50 and 52-61 set forth in paragraph 11 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 21, 20 and 19 of the co-pending application 17934396 is maintained.
Applicants request that this rejection be held in abeyance until subject matter is otherwise found allowable.
24) The rejection of claims 13, 17, 35-46, 48-50 and 52-61 set forth at paragraph 12 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9, 20 and 1 of US patent 11759510 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 subject matter is 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.
25) The rejection of claims 13, 17, 35-46, 48-50 and 52-61 set forth at paragraph 13 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9 and 1 of US patent 11759523 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 subject matter is 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.
26) The rejection of claims 13, 17, 35-46, 48-50 and 52-61 set forth at paragraph 14 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 34-38 and 40-49 of US patent 11116828 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 subject matter is 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 13, 17, 35-46, 48-50 and 52-61 set forth at paragraph 15 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 33, 32, 21-28, 20 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 subject matter is 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 provisional rejection of claims 13, 17, 18, 35-50 and 52-61 set forth in paragraph 16 of the Office Action mailed 06/04/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 19 and 36-45 of the co-pending application 17935864 is maintained.
Applicants request that this rejection be held in abeyance until subject matter is otherwise found allowable.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First paragraph
29) 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.
30) Claims 13 and 48 and the dependent claims 17, 35-47, 49, 50 and 52-61 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.
Claims 13 and 48, as amended, include the following new structures and the new structure respectively:
PNG
media_image1.png
232
280
media_image1.png
Greyscale
,
which lack descriptive support in the as-filed specification. Applicants do not point to specific part(s) of the as-filed specification for support, but state that the subject matter of previously pending claim 18 has been added to claim 13. However, neither the previously pending claim 18, nor the as-filed specification provide descriptive support for the now recited new structures or the new structure. The original claim 13, set forth below, is supportive of a structure that is different from the currently recited new structure.
PNG
media_image2.png
224
539
media_image2.png
Greyscale
.......
The original as-filed specification is also not supportive of the structures or the structure currently recited in the amended claims 13 and 48. Therefore, the above-identified structural limitations in the amended claims 13 and 48 and the currently claimed scope of the claims 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 § 112(b) or (Pre-AIA ), Second Paragraph
31) 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.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
32) Claims 13 and 48 and the dependent claims 17, 35-47, 49, 50 and 52-61 are rejected under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 13, as amended, is ambiguous or incorrect and indefinite in the plural limitation: the following “structures ....
PNG
media_image1.png
232
280
media_image1.png
Greyscale
” [Emphasis added].
Although not indicated via proper marking, claim 13 has been amended to replace the previous non-plural limitation ‘structure’ with the limitation “structures”. It is unclear how the recited S. pneumoniae serotype 23A polysaccharide repeating unit set forth supra can represent plural structures. Furthermore, the precise positions at which ->3 and ->4 are attached to different element(s) of the structures are unclear. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed and the metes and bounds of the claim.
(b) Analogous rejection applies to claim 48, as amended, with regard a similar ‘structure’ recited therein. The precise positions at which ->3 and ->4 are attached to different element(s) of the structures are unclear. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed and the metes and bounds of the claim.
(c) Claim 13, as amended, is indefinite for having insufficient antecedence in the limitation “...-Rhap”. See last line of the claim. For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to the above-identified limitation.
(d) Claim 13, as amended, is ambiguous and indefinite and has an improper antecedence issue with regard to the limitations “the serotype 23A polysaccharide”. See last but one line. Note that the prior recitation in the claim is of the polysaccharide that ‘has an S. pneumoniae serotype 23A polysaccharide repeating unit’”.
(e) Claims 17 and 35-47, which depend from claim 13, and claims 49-61 , which depend from claim 48, are also rejected as being indefinite due to the indefiniteness identified supra in claim 13 and claim 48.
Conclusion
33) No claims are allowed.
In line 3 of the amended claim 47, for proper antecedence, it is suggested that Applicants insert the limitation –the-- after the limitation ‘... carbon of’.
In line 5 of the amended claim 47, for proper antecedence, it is suggested that Applicants insert the limitation --the-- prior to each of the limitations ‘polysaccharide’ and ‘carrier protein’.
34) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
35) 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 8.00 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.
36) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to 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) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
October, 2025