DETAILED ACTION Election/Restrictions Applicant's election with traverse of species Group II, SEQ ID NO: 103, in the reply filed on November 17, 2025 is acknowledged. Applicant’s arguments have been carefully considered but fail to persuade. Applicant’s arguments are directed to the following: Applicant requests that the election of species is actually a restriction . Applicant requests that the restriction be withdrawn. The requirement for an election of species, dated July 16, 2025, is not a restriction requirement. Thus, there is no restriction requirement to be withdrawn. Applicant asserts that since the Office did not cite art to show that there is no special technical feature linking the groups, that the requirement is improper. In response, prior art is not the only means by which it can be shown that there is no special technical feature linking the groups. In this case, the groups do not share the special technical feature because they are directed to different technical features. (PCT Rule 13.2 requires that the same special technical feature be among the groups.) The three constructs outlined in the election of species do not share the same technical feature of a combination of self-assembling polypeptide with viral antigen, a combination of a self-assembling polypeptide with viral antigen and CD40L polypeptide, and combination of a self-assembling polypeptide with CD40L. Each combination represents a different technical feature because they do not share the combination structure. The self-assembling polypeptides, viral antigens, and CD40L polypeptides each represent a different technical feature because they do not share structure. Therefore, the election of species is maintained. Claims Summary Claim 91 is directed to a nanoparticle comprising: From about 7 to about 120 monomers, each monomer comprising at least about 70% sequence identity to SEQ ID NO: 23 (elected species), or a functional fragment thereof; and A CD40L (CD40 ligand) polypeptide; the polypeptide comprises at least 70% sequence identity to SEQ ID NO: 103 (elected species), or a functional fragment thereof; the polypeptide is encoded by a nucleic acid sequence comprising at least 70% sequence identity to SEQ ID NO: 102 , or a functional fragment thereof that comprises at least about 70% sequence identity to SEQ ID NO: 102 (claim 119) SEQ ID NO: 23 is 167 aa (amino acids) in length and represents a self-assembling 3BVE scaffold , which is ferritin from H. pylori . SEQ ID NO: 103 is 261 aa in length and represents a CD40 ligand. SEQ ID NO: 102 encodes SEQ ID NO: 103. Please note that the limitation of claim 119 is essentially a product-by-process limitation because it specifies the nucleic acid sequence (SEQ ID NO: 102) that encodes CD40L (SEQ ID NO: 103) (see paragraph [0079] of the published application) . As long as the CD40L of claim 119 comprises SEQ ID NO: 103, or a functional fragment of SEQ ID NO: 103, then the nucleic acid sequence from which it is coded does not carry patentable weight. According to MPEP 2113, the patentability of a product does not depend on its method of production. The structure implied by the process steps should be considered, however, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claims 91, 93 and 119 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 91 and 119 recite “at least about 70% sequence iden tity”. The combination of terms “at least ” and “ about” does not clearly set forth the metes and bounds of the claims . The term “at least” conveys a clear cutoff , whereas the term “about” provides leeway. Claim 91 includes an embodiment of a “functional fragment” of a monomer comprising at least about 70% sequence identity to SEQ ID NO: 23. SEQ ID NO: 23 is 167 aa in length and represents a self-assembling 3BVE scaffold, which is ferritin from H. pylori . It appears that a functional fragment would retain the function of self-assembly. However, the claim does not state such, and the specification is not entirely clear in its definition of functional fragments . Similarly, claim 93 includes an embodiment of a “functional fragment” of a CD40L polypeptide comprising at least 70% identity to SEQ ID NO: 103. It appears that a functional fragment would retain the ability to bind CD40. However, the claim does not state such, and the specification is not entirely clear in its definition of functional fragments . Again, claim 119 includes an embodiment of a nucleic acid sequence comprising at least 70% sequence identity to SEQ ID NO: 102, or a functional fragment thereof that comprise at least about 70% sequence identity to SEQ ID NO: 102. It appears that the functional fragment would retain the ability to encode SEQ ID NO: 103, but the claim does not state such, and the specification is not entirely clear in its definition of functional fragments. Paragraph [0073] of the published application indicates that “functional fragment” means “ any portion of a polypeptide or nucleic acid sequence from which the respective full-length polypeptide or nucleic acid relates that is of a sufficient length and has a sufficient structure to confer a biological affect that is at least similar or substantially similar to the full-length polypeptide or nucleic acid upon which the fragment is based. ” The terms “similar” and “substantially similar” in the context of a biological effect are relative and subject to individual interpretation. The metes and bounds of the claims cannot be determined. Th is rejection would be overcome by reciting, in the claims, the function that is required of the “functional fragment” , and removing the term “about” when referencing “at least”. 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 the first paragraph of pre-AIA 35 U.S.C. 112: 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 his invention. Claims 91, 93 and 119 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims encompass a large genus of monomers having at least about 70% sequence identity to H. pylori ferritin represented by SEQ ID NO: 23, functional fragments of SEQ ID NO: 23, and functional fragments of sequences having at least about 70% to SEQ ID NO: 23. SEQ ID NO: 23 is 167 aa. A sequence having at least 70% sequence identity has about 50 aa changes. The claims also encompass a large genus of CD40L polypeptides that have at least 70% sequence identity to SEQ ID NO: 103, functional fragments of SEQ ID NO: 10 3, and functional fragments of sequences having at least about 70% to SEQ ID NO: 103. SEQ ID NO: 103 is 261 aa. A sequence having at least 70% sequence identity has about 78 aa changes. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making th e claimed product, or any combination thereof. In this case, the only factor present in the claim s is a partial structure in the form of a recitation of percent identity. There is no identification of any particular portion of the structure that must be conserved. There is no recited function for variants of the monomer or the variants of CD40L, nor for the “functional fragments”. Applicant has not provided any indication of where SEQ ID NO: 23 can be modified by 50 aa, nor where SEQ ID NO: 103 can be modified by 78 aa. Without a function and a structure-function nexus, one would not be put in possession of these variants and functional fragments. Acco rdingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Claim Rejections - 35 USC § 103 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. 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. Claim 91 is rejected under 35 U.S.C. 103 as being unpatentable over Wucherpfennig et al. ( US 2018/0353581 A1 , “Wucherpfennig”) in view of Tang et al. ( Cancer Immunol Immunother , 2009, 58:1949-1957, “Tang”). Wucherpfennig discloses nanoparticles comprising 24 subunits of self-assembling monomeric H . pylori ferritin joined to an antigen, MIC alpha 3-domain protein , for the treatment of cancer (see abstract, paragraphs [0010] and [0077]). Wucherpfennig’s ferritin amino acid sequence comprises SEQ ID NO: 16 , which is 99.3% identical to Applicant’s SEQ ID NO: 23, with the first amino acid of the sequence missing, but other wise identical . Also disclosed is the use of any adjuvant in combination with the nanoparticle, such as, covalently linking an adjuvant to the MIC alpha 3-domain protein (see paragraphs [0078] and [0113] ). However, Wucherpfennig does not specifically disclose CD40L polypeptide. It would have been obvious to have linked the CD40L polypeptide to Wucherpfennig’s antigen with a reasonable expectation of success , motivated by the improvement of immunogenicity afforded to the construct by the inclusion of CD40L. Tang discloses an i mmunoconjugate of CD40L with target antigen (in an a denovirus vector and as a protein ), for the improved immunogenicity of vaccines for cancer in older individuals (see abstract). Advantages of linking CD40L to the antigen include provision of the CD40L signal which is often lacking in older individuals but necessary for B-cell expansion and CD8 effector cells, improved presentation of the antigen by class I MHC, and increased immunogenicity of the antigen (see pages 1951-1952, bridging paragraph) . Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. C laim s 93 and 119 are rejected under 35 U.S.C. 103 as being unpatentable over Wucherpfennig et al. (US 2018/0353581 A1, “Wucherpfennig”) in view of Tang et al. ( Cancer Immunol Immunother , 2009, 58:1949-1957, “Tang”) as applied to claim 1 above, and further in view of Faustman and Vanamee ( WO 2016 / 029043 A1, “Faustman”). The teachings of Wucherpfennig and Tang are outlined above, neither of which disclose Applicant’s SEQ ID NO: 103 as the amino acid sequence of CD40L. However, it would have been obvious to have used any known sequence of CD40L with a reasonable expectation of success, given that Tang is not limited to any particular sequence for CD40L. Faustman’s CD40L sequence, used to treat cancer, is represented by SEQ ID NO: 140 is 99.7% identical to SEQ ID NO: 10 3 . An alignment is of Faustman’s SEQ ID NO: 140 with Applicant’s SEQ ID NO: 103 is provided below. As noted above, the limitation of claim 119 is essentially a product-by-process limitation because it specifies the nucleic acid sequence (SEQ ID NO: 102) that encodes CD40L (SEQ ID NO: 103) (see paragraph [0079] of the published application). As long as the CD40L of claim 119 comprises SEQ ID NO: 103, or a functional fragment of SEQ ID NO: 103, then the nucleic acid sequence from which it is coded does not carry patentable weight. According to MPEP 2113, the patentability of a product does not depend on its method of production. The structure implied by the process steps should be considered, however, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In this case, Faustman’s amino acid sequence (which is 99.7% identical to Applicant’s SEQ ID NO: 3) meets the limitation of a CD40L polypeptide encoded by SEQ ID NO: 102. Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Alignment of Faustman’s SEQ ID NO: 140 (“Db”) with Applicant’s SEQ ID NO: 103 (“Qy”) Conclusion No claim is allowed. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 57 1 -27 0 -0 684 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /STACY B CHEN/ Primary Examiner, Art Unit 1672