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 .
1) A request for continued examination under 37 C.F.R 1.114, including the fee set forth in 37 C.F.R 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R 1.114, and the fee set forth in 37 C.F.R 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R 1.114. Applicants’ submission filed on 11/20/25 has been entered.
Applicants’ Amendment
2) Acknowledgment is made of Applicants’ amendment filed 11/20/25 in response to the final Office Action mailed 08/20/25.
Status of Claims
3) Claims 19-23, 36, 40, 41 and 44 have been amended via the amendment filed 11/20/25.
Claims 19-28, 33, 34 and 36-44 are pending.
The examination and search have been extended to the 23B polysaccharide repeating unit species conjugated at the 2nd carbon position of beta-Glcp; and to the aluminum phosphate adjuvant, the aluminum hydroxide adjuvant, and the aluminum sulfate adjuvant further elements species.
Claim 22, as amended, now includes the additional 23A pneumococcal polysaccharide-CRM197 conjugate species previously elected and is therefore examined.
Claim 21, as amended, now includes a species other than the one elected by original presentation and therefore is withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 19, 20, 22-28 and 36-44 are under examination.
Potential Examiner’s Amendment Conveyed
4) In the interest of compact prosecution and to advance prosecution via a potential Examiner’s amendment instead of an Office Action, the potentially allowable subject matter was conveyed to Mr. Jonathan B. Fitzgerald. Mr. Fitzgerald opted for an Office Action. See attached interview summary.
Prior Citation of Title 35 Sections
5) 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
6) 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.
Rejection(s) Withdrawn
7) The rejection of claim 21 set forth at paragraph 32 of the Office Action mailed 08/20/25 under 35 U.S.C § 112(d) or pre-AIA , fourth paragraph is withdrawn in light of Applicants’ claim amendment.
8) The rejection of claim 19 set forth at paragraph 30(a) of the Office Action mailed 08/20/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph is withdrawn in light of Applicants’ claim amendment.
9) The rejection of claims 40 and 41 set forth at paragraph 30(b) of the Office Action mailed 08/20/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph is withdrawn in light of Applicants’ claim amendments.
10) The rejection of claims 20, 21, 23, 24 and 36-44 set forth at paragraph 30(c) of the Office Action mailed 08/20/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph is withdrawn in light of Applicants’ amendment to the base claim.
11) The provisional rejection of claim 21 set forth in paragraph 17 of the Office Action mailed 04/10/25 and maintained in paragraph 22 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 21, 20, 23, 24 and 19 of the co-pending application 17935864 is withdrawn in light of Applicants’ claim amendment.
12) The rejections of claim 21 set forth in paragraphs 17, 12, 13, 15 and 16 of the Office Action mailed 04/10/25 and maintained in paragraphs 24, 25, 27 and 28 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over the claims indicated therein of the US patents identified therein are withdrawn in light of Applicants’ claim amendment.
Rejection(s) Maintained
13) The provisional rejection of claims 19, 20, 23, 24 and 36-44 set forth in paragraph 17 of the Office Action mailed 04/10/25 and maintained in 22 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 21, 20, 23, 24 and 19 of the co-pending application 17935864 is maintained. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection, but with no arguments on the merits of the rejection. Applicants request that this rejection be held in abeyance until subject matter is otherwise found allowable.
14) The rejection of claims 19, 20, 23, 24 and 36-44 set forth at paragraph 11 of the Office Action mailed 04/10/25 and maintained in 23 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-30 of US patent 11491216 B2 (of record) is maintained. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection, but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
15) The rejection of claims 19, 20, 23, 24 and 37-44 set forth at paragraph 12 of the Office Action mailed 04/10/25 and maintained in 24 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-30 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. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
16) The rejection of claims 19, 20, 23, 24 and 37-43 set forth at paragraph 13 of the Office Action mailed 04/10/25 and maintained in 25 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 2-9 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. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
17) The rejection of claims 19. 20, 23, 24 and 37-43 set forth at paragraph 14 of the Office Action mailed 04/10/25 and maintained in 27 of the Office Action mailed 08/20/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-9 of US patent 11642406 B2 (of record) as evidenced by Ravenscroft et al. (Carbohydr. Res. 450: 19-29, Available online 8 August 2017, of record) is maintained.
Applicants state that they traverse the rejection but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
18) The rejection of claims 19, 20, 23, 24 and 37-43 set forth at paragraph 15 of the Office Action mailed 04/10/25 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 21-28, 33, 32, 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. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
19) The rejection of claims 19-21, 23, 24 and 37-43 set forth at paragraph 16 of the Office Action mailed 04/10/25 and maintained in 28 of the Office Action mailed 08/20/25 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. Claim 22, as amended, is now added to this rejection.
Applicants state that they traverse the rejection but with no arguments on the merits of the rejection and request that this rejection be held in abeyance until subject matter is otherwise found allowable.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
20) 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.
21) Claims 19, 20, 22-24 and 36-44 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 19, as amended, is indefinite for having insufficient antecedence in the limitation “b-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.
(b) Claim 20 is vague and indefinite in the limitations ‘a polysaccharide of a ...... S. pneumoniae serotype’. Unlike claim 19 wherein the polysaccharide is identified via a specific structure, the polysaccharide recited in claim 3 is not and therefore, it is unclear whether or not this polysaccharide is a cell wall polysaccharide, the C-polysaccharide, or a capsular polysaccharide of the recited serotype of S. pneumoniae. If the latter is the case as is disclosed at lines 1-10 of page 21 of the original specification, for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified limitations with --a capsular polysaccharide of a ...... S. pneumoniae serotype--.
(c) Claim 22, as amended, is ambiguous and indefinite in the phrase: the one or more additional polysaccharide-carrier protein “conjugates comprises the S. pneumoniae serotype 23A”. The recited “S. pneumoniae serotype 23A” represents and reads on S. pneumoniae serotype 23A bacteria. Claim 22 depends from claim 20, wherein each of the one or more additional polysaccharide-carrier protein conjugates comprises --a polysaccharide of a ..... S. pneumoniae serotype conjugated to CRM197--. It is unclear how the one or more additional polysaccharide-carrier protein “conjugates” in claim 22 can comprise S. pneumoniae serotype 23A bacteria. For the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified phrase with the phrase --the one or more additional polysaccharide-carrier protein conjugates is the S. pneumoniae serotype 23A capsular polysaccharide-CRM197 conjugate--.
(d) The dependent claim 36, as amended, is indefinite for having insufficient antecedence in the limitation “b-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.
(e) Analogous rejection applies to the dependent claim 44, as amended, with regard to the limitation “b-Rhap” in line 3 of the claim.
(f) Claims 20, 22, 23-28 and 36-44, which depend directly or indirectly from claim 19, are also rejected as being indefinite due to the indefiniteness identified supra in claim 19.
Conclusion
22) No claims are allowed.
Correspondence
23) 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 Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
24) 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
February, 2026