DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The response and amendment to the claims filed 4-15-2026 has been entered. Claims 46 and 47 have been added. Claims 1-45 have been canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 4-15-2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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(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.
Claims 46 and 47 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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.
It is noted that the response filed 4-15-2026 does not point to the specification by page and line number where the particular invention is described, including the wherein clause.
The claims are drawn to:
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As to elements (b), (c) and (d) the specification teaches that to induce GMMA formation the membrane structure has been modified by the deletion of genes encoding key structural components, specifically tolR (see page 7, lines 8-17). No other mutations are provided that provide for structural membrane modifications that produce GMMAs. Therefore, elements (b), (c) and (d) are broader than disclosed as the specification does not teach GMMAs without the tolR deletion.
As to the amount of the O-antigens from S. sonnei and S. flexneri, the specification at page 54, lines 11-15 indicates that:
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The specification thus discloses different doses such as 3.75 ug, 7.5 ug or 15 ug/O-antigen from each of the claimed GMMA can be used. However, the specification does not teach that each of 1b, 2a and 3a will be used at 3.75 ug of O-antigen and the S. sonnei be dosed at a different amount. While the specification indicates that different doses of O-antigen of GMMAs can be used, it does not specify the particular combination now recited. The combinations that can be arrived at from combining the different doses and the different GMMAs does not provide description for the particular dosing combination as now claimed.
Novozymes A/S v. DuPont Nutrition Biosciences APS, 107 USPQ2d 1457 (Fed. Cir. 2013)
In considering whether the description was sufficient, the Federal Circuit considered the claimed invention "as a integrated whole" rather than merely element by element:
While the 2000 application provides formal textual support for each individual limitation recited in the claims of the '723 patent, it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim—as we must—as an integrated whole rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any "blaze marks" that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.
The court makes clear here that written description is not satisfied merely by ensuring that each individual claim limitation is disclosed in the original disclosure. Rather, the written description requires disclosure of the patented claim as a whole. Here, there is no readily apparent dosing combination as claimed.
The dosing issue is best resolved by Applicant pointing to the page and line number where the specific dosing of each of the individual elements can be found.
Claims 46 and 47 are rejected under 35 U.S.C. 112(b), 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.
As to claims 46 and 47, the claims recite the term “derived from” and it is unclear what the derivation is from. It is noted that the specification teaches that GMMA vesicles are released by ΔtolR mutants and obtained from their culture supernatants.
Claim Rejections - 35 USC § 103
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.
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.
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, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), 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 nonobviousness.
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Gerke et al (WO 2016/202872; of record) in view of Mancini et al (Sci Rep 11, 906, pages 1-10 (published January 13, 2021).
Gerke et al teach multivalent Shigella GMMA in an ALHYDROGELTM formulation containing GMMA from S. sonnei and S. flexneri 1b, 2a, 3a and 6 (see page 35, lines 24-25). Additionally, the GMMA are mixed in the same concentration and then formulated with aluminum hydroxide (page 35, lines 33-36). Gerke et al teach an immunogenic composition comprising GMMA purified from a Shigella sonnei 53G ΔtolR, ΔhtrB, virG::.nadAB mutant, (b) GMMA purified from a Shigella flexneri 2a 2457T ΔtolR, ΔmsbBl mutant, (c) GMMA purified from a Shigella flexneri 3a 6885 ΔtolR, ΔmsbBl mutant, (d) GMMA purified from a Shigella flexneri 6 10.8537 ΔtolR, ΔmsbBl mutant, (e) GMMA purified from a Shigella flexneri lb STANSFIELD ΔtolR, ΔmsbBl mutant and (f) an aluminum adjuvant, wherein the GMMA comprise modified lipid A (see page 36, lines 24-30) and wherein the S. flexneri strains are cured of the virulence plasmid that contains msbB2. Gerke et al teach that the Shigella strains may have mutations including one or more mutations resulting in inactivation of htrB, msbB1 and/or msbB2 (see page 5, lines 5-10). Gerke et al teach that in S. sonnei, the O-antigen is absent with the virulence plasmid is removed and loss of the virulence plasmid leads to loss of the msbB2 gene (see page 5) in S. flexneri. Gerke et al teach that any suitable amount of GMMA per unit dose. Gerke et al teach the desirability of modification of lipid A to detoxify LPS Gerke et al differ by not modifying the Shigella sonnei 53G ΔtolR, ΔhtrB, virG::nadAB mutant to include ΔmsbB2::cat Δmsb B::erm.
Mancini et al teach S. sonnei ΔtolR::kan, virG::nadAB msbB1::cat, msbB2::ery) see page 2, Table 1. Mancini et al teach that anti-LPS and protein specific IgM resulted to be lower for mice immunized with the ΔhrtB OAg+ GMMA as compared to the ΔmsbB OAg+ GMMA (see page 4, see serological response).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute the GMMAs from S. sonnei ΔtolR::kan, virG::nadAB msbB1::cat, msbB2::ery) of Mancini et al for the GMMAs of Shigella sonnei 53G ΔtolR, ΔhtrB, virGr.nadAB mutant in the composition of Gerke et al because Gerke et al teach that GMMAs from msbB1 and/or msbB2 deletion mutants can be used to detoxify LPS in place of or in addition to htrB. It further would have been prima facie obvious to optimize the amount of each of the GMMAs in the immunogenic composition by O-Ag present in order to provide for an optimum immune response and because Gerke et al teach that the GMMAs can be included in any suitable amount in the immunogenic composition and as such the 3.75 ug of O-antigen from each S. flexneri is prima facie obvious. It is noted that erm and ery both stand for the antibiotic “erythromycin”. Thus, the immunogenic compositions as a whole are prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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