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 Applicant’s amendment filed 10/12/25 in response to the non-final Office Action mailed 07/11/25.
Status of Claims
2) Claim 33 has have been amended via the amendment filed 10/12/25.
Claim 31 has been canceled via the amendment filed 03/13/2025.
Claims 1-5, 7-9, 11-17, 20-30 and 33 are pending.
Claims 1-5, 7-9, 11-17, 20, 21 and 33 are under examination.
Information Disclosure Statements
3) Acknowledgment is made of Applicants’ information disclosure statements filed 07/10/25 and 10/31/25. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
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 31 set forth in paragraph 6(A) of the Office Action mailed 01/06/25 and maintained in paragraph 31 of the Office Action mailed 07/11/25.
Objection(s) Withdrawn
7) The objection to claim 33 set forth in paragraph 6(A) of the Office Action mailed 01/06/25 and maintained in paragraph 31 of the Office Action mailed 07/11/25 is withdrawn in light of Applicants’ claim amendment. A new objection is set forth in this Office Action to address the claim as amended currently.
Objection(s) Maintained
8) The objection to claims 1 and 11 and the specification set forth in paragraph 34 of the Office Action mailed 07/11/25 is maintained.
Applicants contend that these claims recite doses that are properly supported in the specification as has been noted multiple times and no more is required. Applicants allege that the Office Action is inserting components that are not recited in these claims such as the asserted presence of free polysaccharides. Applicants further state that no further explanation is provided.
Applicants’ arguments have been considered, but are not persuasive. Applicants are referred to paragraph 34 of the Office Action mailed 07/11/25, which provided a detailed explanation. Additionally, claim 33 as amended currently and set forth below, provides further evidence in support of the Office’s rejection and explanation.
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Claim 33 now depends from claim 1. Claim 1 requires that the capsular polysaccharides are indirectly coupled to the one or more carrier proteins through PEGylated linkers. The recited ‘a homo-multi-functional PEGylated linker is ‘contained’ in the immunogenic composition and is encompassed by the immunogenic composition of claims 1 and 11, both of which recite a dose that is at issue. Accordingly, a dose of 10 micrograms or less as claimed in claim 1 and a dose of 4 micrograms as claimed in claim 11 includes this homo-multi-functional PEGylated linker element of the claimed ‘immunogenic composition’, which homo-multi-functional PEGylated linker element is not required to be a component of the conjugates of the capsular polysaccharides of the 25 different serotypes of S. pneumoniae that are indirectly coupled to one or more carrier proteins through PEGylated linkers. The recited ‘a homo-multi-functional PEGylated linker’ ‘contained’ in the immunogenic composition of claim 33 encompasses one that is free and unlinked to one or more carrier proteins indirectly coupled to the capsular polysaccharides of the 25 different serotypes of S. pneumoniae. Thus, there is no need for the Office to insert components since Applicants themselves have provided an example where the dependent claim 33 inserts an element that is not required to be a component associated with, attached to, coupled to, or linked to one or more carrier proteins indirectly coupled to the capsular polysaccharides of the 25 different serotypes of S. pneumoniae. The objection stands.
Objection(s) to Specification and Claim(s)
9) Claim 33, as amended, and the specification are objected 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 CFR 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 33, as amended, is set forth below:
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The amended claim 33 now depends from claim 1. The immunogenic composition of the amended claim 33 is recited as containing a homo-multi-functional PEGylated linker. This permits the immunogenic composition to ‘contain’ a homo-multi-functional PEGylated linker unlinked to the one or more carrier proteins, i.e., as a free homo-multi-functional PEGylated linker in the immunogenic composition. However, there is no antecedent basis and descriptive support for the immunogenic composition of claim 1 containing therein a homo-multi-functional PEGylated linker that is unlinked to the one or more carrier proteins, i.e., not being a component of the capsular polysaccharides indirectly coupled to the one or more carrier proteins through PEG linkers, i.e., not being a part of the conjugates of the 25 different capsular polysaccharides. Note that the independent claim 1 requires at least one of the PEGylated linkers to be linked to one or more carrier proteins that are being indirectly coupled to the capsular polysaccharides of 25 different serotypes of S. pneumoniae through PEG linkers. Scope-wise and meaning-wise, a homo-multi-functional PEGylated linker being ‘contained in the immunogenic composition’ unlinked to the one or more carrier proteins is not the same as the at least one of the PEGylated linkers as recited in claim 1, i.e., which is linked to one or more carrier proteins.
Rejection(s) Moot
10) The rejection of claim 31 set forth in paragraph 17 of the Office Action mailed 01/06/25 and maintained in paragraph 21 of the Office Action mailed 07/11/25 under the judicially created doctrine of obviousness-type double patenting over claims 1-14 of US patent 12053515 B2 (of record) is moot in light of Applicants’ cancellation of the claim.
11) The rejection of claim 31 set forth in paragraph 19(A) of the Office Action mailed 01/06/25 and maintained in paragraph 22 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, is moot in light of Applicants’ cancellation of the claim.
12) The rejection of claim 31 set forth in paragraph 24 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph is moot in light of Applicants’ cancellation of the claim.
13) The rejection of claim 31 set forth in paragraph 26 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, is moot in light of Applicants’ cancellation of the claim.
14) The rejection of claim 31 set forth in paragraph 28 of the Office Action mailed 07/11/25 under 35 U.S.C § 103 as being unpatentable over Fairman et al. (US 11951165 B2 filed 07/01/2019, of record) (‘185) in view of WO 201827177 A1, published 12/13/2018 (WO ‘177, of record) is moot in light of Applicants’ cancellation of the claim.
15) The provisional rejection of claim 31 set forth in paragraph 29 of the Office Action mailed 07/11/25 under the judicially created doctrine of obviousness-type double patenting over claims 15, 1-15 and 16-24 of the co-pending 19070661 application in view of Porambo et al. (US 20200282040 A1 filed 09/07/2017, of record) is moot in light of Applicants’ cancellation of the claim.
Rejection(s) Withdrawn
16) The rejection of claim 33 set forth in paragraph 19(A) of the Office Action mailed 01/06/25 and maintained in paragraph 22 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, is withdrawn in light of Applicants’ claim amendment. A new rejection is set forth in this Office Action to address the claim as amended currently.
17) The rejections of claim 33 set forth in paragraphs 26(a) and 26(d) of the Office Action mailed 07/11/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, are withdrawn in light of Applicants’ claim amendment.
18) The rejection of claims 1-5, 7-9, 11, 12, 15-17, 20 and 21 set forth in paragraph 26 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, is withdrawn
Double Patenting Rejection(s) Maintained
19) The rejection of claims 1-5, 7-9, 11-17, 20, 21 and 33 set forth in paragraph 17 of the Office Action mailed 01/06/25 and maintained in paragraph 21 of the Office Action mailed 07/11/25 under the judicially created doctrine of obviousness-type double patenting over claims 1-14 of US patent 12053515 B2 (of record) is maintained.
Applicants contend that Applicants’ composition is directed to serotypes 1, 2, 3, 4, 5, 6B, 6C, 7F, 8, 9N, 9V, 10A, 12F, 14, 15A, 15B, 15C, 16F, 18C, 19A, 22F, 23F, 24F, 33F, and 35B, whereas US Patent No. 12,053,515 is directed to serotypes 1, 2, 3, 4, 5, 6B, 6C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20, 22F, 23B, 23F, 24F, 33F and 35B. Serotypes 11A, 17F, 19F, 20, and 23B of the US cited patent are not present in Applicants’ claims. Applicants argue that the composition of the US patent is very clearly different from Applicants’ claimed composition and does in no way suggest Applicants’ composition as recited in the claims. Nevertheless, if deemed necessary, upon the otherwise allowance of the claims, Applicant will submit an eTerminal Disclaimer.
Applicants’ arguments have been carefully considered, but are not persuasive. The independent claim 1 is set forth below:
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The transitional limitation “comprising” similar to the limitations such as “having” “including,” “containing,” or “characterized by” represents open-ended claim language and therefore does not exclude additional, unrecited elements. See M.P.E.P 2111.03 [R-1]. See Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). On the other hand, the limitation “consisting of” represents closed claim language and excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948). In the instant case, the ‘515 patent’s composition “comprises” therein the conjugates of PEGylated capsular polysaccharides of all of the recited 25 different serotypes of S. pneumoniae as claimed by Applicants. Clearly, the identified claims of the ‘515 patent read on Applicants’ claims.
The following statement of Applicants’ has been noted:
Nevertheless, if deemed necessary, upon the otherwise allowance of the claims, Applicant will submit an eTerminal Disclaimer.
It is noted that the interpretation of the open claim language “comprising” documented on page 4 of 5 of the Australian Examination report No. 2 (Applicants’ IDS), set forth below, is also consistent with that of the Office [Emphasis added]:
..... the term ‘comprising’ is considered non-exhaustive in this context. Therefore, an immunogenic composition ‘comprising’ 25 different serotypes comprises the 25 serotypes and can comprise of other serotypes.
20) The provisional rejection of claims 1-5, 7-9, 11-17, 20, 21 and 33 set forth in paragraph 29 of the Office Action mailed 07/11/25 under the judicially created doctrine of obviousness-type double patenting over claims 15, 1-15 and 16-24 of the co-pending 19070661 application in view of Porambo et al. (US 20200282040 A1 filed 09/07/2017, of record) is maintained.
Applicants contend that Applicants’ composition is directed to serotypes 1, 2, 3, 4, 5, 6B, 6C, 7F, 8, 9N, 9V, 10A, 12F, 14, 15A, 15B, 15C, 16F, 18C, 19A, 22F, 23F, 24F, 33F, and 35B, whereas the cited US patent application is directed to serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F and 38. Serotypes 11A, 17F, 19F, 20 of the cited US patent application and serotypes 6A, 6D, 7B, 7C, 11A, 17F, 19F, 20, 21, 22A, 23A, 23B, 27, 28A, 31, 34, 35A, 35F and 38 of Porambo are not present in Applicants’ claims. Applicants argue that these are clearly different compositions and do not suggest Applicants’ claimed invention.
Applicants’ arguments have been carefully considered, but are not persuasive. Applicants’ are referred to the paragraph supra with regard to the transitional limitation “comprising”, which is similar to the limitations such as “having” “including,” “containing,” or “characterized by” represents open-ended claim language and therefore does not exclude additional, unrecited elements. See M.P.E.P 2111.03 [R-1]. See Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). On the other hand, the limitation “consisting of” represents closed claim language and excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948). In the instant case, the composition claimed in the co-pending ‘661 application as modified by Porambo et al. renders obvious the instantly claimed composition as set forth previously. The rejection stands.
The following statement of Applicants’ has been noted:
Nevertheless, if deemed necessary, upon the otherwise allowance of the claims, Applicant will submit an eTerminal Disclaimer.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph Maintained
21) 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.
22) The rejection of claims 1, 11, 2-5, 7-9, 12-17, 20, 21 and 33 set forth in paragraph 24 of the Office Action mailed 07/11/25 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph is maintained.
Applicants contend that the claims recite that the composition contains recited doses that is properly supported in the specification and no more is required.
Applicants’ arguments have been carefully considered, but are not persuasive. Applicants are referred to the explanation set forth at paragraph 24) of the Office Action mailed 07/11/25. See also paragraph 8) of the instant Office Action supra. The rejection stands.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph Maintained
23) 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.
24) The rejection of claims 13 and 14 set forth in paragraph 26(b) of the Office Action mailed 07/11/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, is maintained.
Applicants state that they have made the amendment requested by the Office. However, claims 13 and 14 remain unamended. The rejection stands.
Rejection(s) under 35 U.S.C § 103 Maintained
25) 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 of this title, 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 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., 148 USPQ 459, 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 unobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C § 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicants are advised of the obligation under 36 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
26) The rejection of claims 1-5, 7-9, 11-17, 20, 21 and 33 set forth in paragraph 28 of the Office Action mailed 07/11/25 under 35 U.S.C § 103 as being unpatentable over Fairman et al. (US 11951165 B2 filed 07/01/2019, of record) (‘185) in view of WO 201827177 A1, published 12/13/2018 (WO ‘177, of record) is maintained.
It is noted that this specific rejection remains unaddressed by Applicants.
On pages 7-9 of their Remarks filed 10/12/25, Applicants present arguments on a non-existent obviousness rejection of claims 1-5, 7-9, 11-17, 20, 21 and 33 over “Fairman (U.S. Application Publication No. 2018/0333484 in view of W177 ...”. No such rejection under 35 U.S.C § 103 was made in the Office Action mailed 07/11/2025.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
27) 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.
28) Claim 33 is rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AlA), 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 33, as amended, is set forth below:
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The amended claim 33 now depends from claim 1. The immunogenic composition of the amended claim 33 is recited as containing a homo-multi-functional PEGylated linker. This permits the immunogenic composition to ‘contain’ a homo-multi-functional PEGylated linker unlinked to the one or more carrier proteins. However, there is no descriptive support for the immunogenic composition of claim 1 containing therein a homo-multi-functional PEGylated linker that is unlinked, unconnected or uncoupled to the one or more carrier proteins, i.e., not being a component of the capsular polysaccharides of the 25 serotypes of S. pneumoniae indirectly coupled to the one or more carrier proteins through PEG linkers, i.e., not being a part of the conjugates of the capsular polysaccharides. Note that the independent claim 1 requires at least one of the PEGylated linkers to be linked to one or more carrier proteins that are being indirectly coupled to the capsular polysaccharides of 25 different serotypes of S. pneumoniae through PEG linkers. Scope-wise and meaning-wise, a homo-multi-functional PEGylated linker being ‘contained in the immunogenic composition’ unlinked to the one or more carrier proteins is not the same as the at least one of the PEGylated linkers recited in claim 1, i.e., which is linked to one or more carrier proteins. Therefore, the above-identified limitations and the currently claimed scope of the claim constitute new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are requested to point to the descriptive support in the specification as filed, for the new limitation(s), 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, which, with respect to newly added or amended claims, requires Applicants to show support in the original disclosure for the new or amended claims.
Relevant IDS Material(s)
29) The Australian Examination report No. 2 (Applicants’ IDS) on page 4 of 5 documented that an immunogenic composition comprising capsular polysaccharides of 25 different serotypes of S. pneumoniae, i.e., serotypes 1, 2, 3, 4, 5, 6B, 6C, 7F, 8, 9N, 9V, 10A, 12F, 14, 15F, 15B, 16F, 18C, 19A, 19F, 22F, 23F, 24F, 33F and 35B coupled to a carrier protein, when administered, inherently generates a minimal immune response to the carrier protein and provides effective treatment or prevention to infection by S. pneumoniae bacteria.
Conclusion
30) No claims are allowed.
31) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are 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
32) 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, Examiner’s Supervisor 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.
33) 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) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
January, 2026