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 .
2. The Art Unit and the examiner of your application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Yunsoo Kim, Art Unit 1641, Technology Center 1600.
3. Claims 20-33 are pending upon entry of amendment filed on 2/23/26.
Upon entry of Applicant’s amendment to claims filed on 2/23/26, the restriction requirement mailed on 12/22/25 is moot.
Claims 20-33 are under consideration in the instant application.
The instant application comprises one independent claim and the claimed invention is an immunogenic conjugate comprising native outer membrane vesicle (nOMV) that comprises a surface saccharide moiety connected to a first antigen and a surface protein residue connected to a second antigen via a bivalent linker.
4. Applicant’s IDS filed on 3/28/24 has been acknowledged.
IN lack of copies of non-patent literatures and foreign patent literatures, the references have been crossed out. Further, the parent application 16/636,560 does not contain the copies, either. Applicant is required to provide copies of non-patent literature and foreign patent for consideration.
5. The oath filed on 3/28/24 has been acknowledged.
6. 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.
6. Claims 21, 23 and 28-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
The use of the term “optionally” in claim 21 and renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
Further, claims 23 recites improper Markush Group. Applicant is advised to recite “is selected from the group consisting of A, B, C and D” format.
In addition, claims 28-32 recites nOMV and First antigen, nOMV, bivalent linker, second antigen, nOMV, first antigen, second antigen and bivalent choices in table form. Applicant is advised to recite specific combination choices in (i)(ii) or (iii) instead of the table form as currently recited.
7. 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.
8. 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.
9. Claim(s) 20-22, 25-28 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerritzen et al (Biotechnology Advances, vol 35, p.565-574, 2017, IDS reference).
Gerritzen et al. teaches native outer membrane vesicles (nOMV) derived gram negative bacteria from E. coli, S. typhimurium, Shigella, or Neisseria menningitidis. The nOMV are linked to antigens via linkers (note Fig. 1, abstract, Table1). Further, Gerritzen et al. teach the nOMV carry saccharides, LPS on the surface and linker connects antigens. Therefore, the reference teachings anticipate the claimed invention.
10. 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 the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
11. Claims 20-33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gerritzen et al (Biotechnology Advances, vol 35, p.565-574, 2017, IDS reference) in view WO2006/082530 (IDS reference).
The teachings of the Gerritzen et al. have been discussed, supra.
The disclosure of the Gerritzen et al differs from the instant claimed invention in that it does not teach the use of bivalent linker of BS3 or SIDEA as in claims 24, 29-32 of the instant application.
The ‘530 publication teaches use of SIDEA in conjugation of OMVs and capsular saccharides (p.2-10) and such linker expands applicability of various antigens and adds molar access to modified saccharides (p.8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize SIDEA linker as taught by the ‘530 publication into the nOMV taught by the Gerritzen et al.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of specific SIDEA linker improves molar excess to saccharides and expands applicability with various antigens.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
13. Claims 20-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Pat. 12,005,109.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘109 patent recites immunogenic conjugates comprising an isolated, intact, native outer membrane vesicles comprises surface saccharides moiety connected to antigen from Neisseria, Plasmodium, Escherichia, Haemophillus and Shigella and linkers of BS3 and SIDEA.
14. No claims are allowable
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
May 5, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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