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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 12, and 14-15 and species: a composition comprising an expression vector that induces the expression of at least one peptide, SEQ ID NO: 119, and a method for the treatment and/or prevention of cancer comprising administering the vaccine or immunogenic composition in the reply filed 10/01/2025 is acknowledged.
Claims 3-5, 9-13 and 16-20 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 10/01/2025.
Claims 1-2, 6, and 14 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to the specification for a list of references not contained within a proper information disclosure statement is hereby withdrawn,
Objections to the specification for embedded hyperlink(s) and/or other forms of browser-executable codes are hereby withdrawn in view of the substitute specification filed 02/18/2026.
Objections to claim 6 due to minor informalities is hereby withdrawn in view of amendments to the claims to correct the issue.
Withdrawn Rejections
Rejections of claims 1-2, 6-7 and 14 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more are hereby withdrawn in view of amendments to add a new limitation to the claims.
Modified Rejections Necessitated by Amendment
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 applicant regards as his invention.
Claims 1-2, 6, and 14 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.
Instant claims 1-2, 6, and 14 recite that a “peptide is bound to an antibody which is specific for dendritic cells”. It is unclear what the antibody that is bound to the peptide would be, nor how it would be specific for dendritic cells. The instant claims do not provide clarity on what type of antibody is encompassed by the claims. Additionally, the claims provide very little detail on how this peptide can be “specific for dendritic cells”. This limitation was previously present in now cancelled claims 8 and 15; adding the limitation to the independent claim does not clarify what is encompassed by the terminology because it introduces a limitation to the claim that is not described.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the claims are sufficient to overcome the indefiniteness rejection. This is not found persuasive.
The indefinite language upon which the rejection was based upon was recited in claims 8 and 15, which have since been cancelled. Applicant amended the claims to take the limitation defined by the indefinite language and introduce it into instant claim 1. This amendment to the claims still does not ascertain what is intended by the terminology, and instead extends the indefiniteness into the independent claim.
As such, the rejection has been modified in light of amendments to the claims.
New Rejections Necessitated by Amendment
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.
Claims 1-2, 6, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al. (WO 2017191264 A1, in PTO-892 filed 11/18/2025), in view of Yang et al. 2010 (in instant PTO-892).
Rauch et al. teaches polypeptides “suitable for use in treatment or prophylaxis of an infection with Norovirus or a disorder related to such an infection. In particular, the present invention concerns a Norovirus vaccine. The invention further concerns a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptides, compositions and vaccines”, see Abstract. Rauch et al. teaches SEQ ID NO: 2350, which is a 100% homology match to instant SEQ ID NO: 119 and is an antigen derived polypeptide. This meets the limitations of instant claim 1 wherein the peptide sequence is taught. Rauch et al. also teaches that the sequence for the polypeptide comes from an antigen or immunogen that “may be derived from a pathogen, such as from bacteria or virus particles etc., or from a tumor or cancerous tissue. The antigen or immunogen stimulates the body's adaptive immune system to provide an adaptive immune response”, see page 18. Thus, Rauch et al. creates a peptide derived from tumor antigen or cancerous tissue, then creates vaccine using the known cancerous peptide sequence to program and trigger an immune response to cancer.
However, Rauch et al. does not teach that the peptide can be bound to an antibody bound for dendritic cells. Yang et al. remedies this deficiency.
For the purposes of examination, the Examiner is interpreting the limitation of “the peptide is bound to an antibody which is specific for dendritic cells” in instant claim 1 as any protein or peptide structure comprising a tumor associated antigen, is bound to an antibody, and localizes in dendritic cells.
Yang et al. teaches the use of dendritic cell vaccines comprising multiple tumor-associated antigens derived from cancers such as hepatocellular carcinomas, see Abstract. These vaccines have previously shown success in stimulating T-cell immunity against both viral infection and tumor growth in “a variety of strategies, including pulse with peptide, protein, or tumor cell lysate, and transfection with viral vector–mediated tumor-associated antigen (TAA) gene have been attempted to deliver the antigen to DC (dendritic cells)”, see Introduction. Yang et al. found that the generation of tumor associated antigen peptide bound to antibodies in vaccines not only arrived at dendritic cells, but also “indicated that a multiple TAA–modified DC-based cancer vaccine may be a useful application to tumor immunotherapy protocol” by showing how their invention “stimulate[d] both CD4+ and CD8+ T cells. High levels of production by AFP/HBsAg-DCs suggest that the co-transfected DC presents antigen through both the MHC class I and class II pathways simultaneously… The cytokine production patterns reflect the induction of polyclonal populations of activated T cells by AFP/HBsAg-DCs, rather than the cytokine profile of an individual T cell. Similar levels of IL-12 production by AFP/HBsAg suggests that IL-12 stimulates proliferation of activated CD8+ T cells and supports the memory type of CD8+ T-cell effectors that are capable of activation in an antigen-specific manner”, see Discussion.
It would be obvious at the time of the instant invention to use the peptide taught by Rauch et al., which is derived from hepatocellular carcinomas and can be used in immunotherapies to treat diseases like cancer, with the dendritic cell based vaccine taught by Yang et al. which shows that tumor associated antigens can be formed into peptides and associated with antibodies, which can then be administered to a subject via cancer vaccine therapy to elicit an immune response and target a particular cancer of interest. One would be motivated to combine the peptide sequence of Rauch et al. with the dendritic cell targeting vaccine with the expectation of creating a vaccination therapy using dendritic cells in an effective strategy for immunotherapy to produce a targeted therapeutic catered specifically for a particular tumor identity.
Therefore, claims 1-2, 6, and 14 are rejected as obvious over Rauch et al. and Yang et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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