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, 11-24, 43-44, and 89 and species: a method of generating an immune response to a tumor-associated antigen in a subject or treating cancer in a subject, SEQ ID NO: 2, UL128, at least 10% of the CD8+ T cells elicited by the CMV vector are restricted by MHC-E or an ortholog, a recombinant human CMV vector, and a human subject, in the reply filed 06/17/2025 is acknowledged.
Claims 12-23, 43-44, 89, and 144 are withdrawn from consideration pursuant to 37 CFR1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 06/17/2025.
Claims 1, 11, and 24 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to the drawings due to poor resolution of the images are hereby withdrawn in view of replacement sheets filed by Applicant on 12/10/2025.
Objections to claims 1, 11, and 24 due to minor informalities are hereby withdrawn in view of amendments to the claims to correct them.
Modified 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, 11, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Picker et al. (US 2018/0133321 A1, in IDS filed 08/11/2022) , in view of Delcayre et al. (US 2009/104225 A1, in IDS filed 08/11/2022).
Picker et al. teaches a method of treating cancer in a subject, the method comprising administering to the subject a CMV vector in an amount effective to elicit a CD8+ T cell response to at least one heterologous antigen, see reference’s claim 13. Picker et al. also discloses encoding a tumor-associated antigen in an amount effective to elicit a CD8+ T cell response to the tumor-associated antigen wherein the tumor antigen is related to a cancer selected from the group consisting of: acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, chronic lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma, malignant melanoma, breast cancer, lung cancer, ovarian cancer, prostate cancer...", see reference’s claim 8. Picker et al. also teaches that the CMV vector does not express an active UL128, UL130, UL146, and UL147 protein or orthologs thereof, see reference’s claim 1. Additionally, Picker et al. teaches a CMV vector encoding a tumor virus antigen, wherein the CMV vector does not express an active UL128, UL130, UL146, and UL147 protein or orthologs thereof, see reference’s claims 5 and 8.
Picker et al. teaches that while generating an immune response to at least one heterologous antigen in a subject, the methods involve administering to the subject a CMV vector of the type disclosed herein in an amount effective to elicit a CD8+ T cell response to the at least one heterologous antigen. In some embodiments, at least 10% of the CD8+ T cells elicited by the vector are restricted by MHC-E or an ortholog thereof. In additional embodiments, fewer than 10% of the CD8+ T cells elicited by the vector are restricted by polymorphic MHC-class Ia or an ortholog thereof. In yet other embodiments, at least 10% of the CD8+ T cells elicited by the vector are restricted by MHC-II or an ortholog thereof, see paragraph 0009.
However, Picker et al. does not teach the instantly claimed sequence for the tumor associated antigen. Delcayre et al. remedies this deficiency.
Delcayre et al. teaches an invention which relates to compositions, kits, and methods for cancer prophylaxis and therapy using recombinant MVA viruses encoding tumor-associated antigens. The recombinant MVA viruses can induce B- and T-cell responses, see Abstract. Delcayre discloses an isolated tumor-associated antigen peptide ARAASLSLGFLFLLF (SEQ ID NO: 2) for prostatic acid phosphatase, see paragraph 0160. Delcayre’s SEQ ID NO: 2 is a 100% sequence identity match to instant SEQ ID NO: 2. Delcayre does not disclose that the peptide encompassed in SEQ ID NO: 2 is an MHC-E or MHC-II supertope peptide that is capable of being recognized by CD8+ T cell receptors. However, as Delcayre discloses a peptide of the identical chemical structure, the claimed characteristic or function is also necessarily disclosed.
It would be obvious at the time of the instant invention to use the methods taught by Picker et al., which uses a cytomegalovirus (CMV) encoding a tumor associated antigen to generate an immune response to treat cancer, with the specific tumor associated antigen sequence taught by Delcayre et al., which teaches a method wherein recombinant viruses encode the instantly claimed sequence as a tumor associated antigen to trigger an immune response that treats cancer. One would be motivated to combine the teachings of Picker et al. and Delcayre et al. with the expectation of using the instantly claimed sequence in a method that would generate an immune response that would elicit a CD8+ T cell response to treat cancer as both references are directed towards using viruses encoding a tumor associated antigen to trigger an immune response to treat cancer and teach that the method can be tailored to specific tumor associated antigens to target particular cancers of interest.
Therefore, claims 1, 11, and 24 are rejected as obvious over Picker et al. and Delcayre et al.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant argues there is no teaching or suggestion in either Picker or Delcayre that would prompt one of ordinary skill in the art to select the particular recited peptides out of the 94 potential options presented in Delcayre. This is not found persuasive.
As discussed above, Picker teaches a method of treating cancer in a subject, the method comprising administering to the subject a CMV vector in an amount effective to elicit a CD8+ T cell response to at least one heterologous antigen. Picker et al. teaches that while generating an immune response to at least one heterologous antigen in a subject, the methods involve administering to the subject a CMV vector of the type disclosed herein in an amount effective to elicit a CD8+ T cell response to the at least one heterologous antigen. This sets up a method of treatment, wherein one of ordinary skill in the art can choose a specific CMV vector to elicit the immune response. Delcayre is brought into the reference as it is a 100% match to the claim SEQ ID NO: 2. The number of other sequences taught in the reference does not preclude one of ordinary skill in the art from selecting SEQ ID NO: 2 as any antigen would work to generate an immune response when placed in a vector, and all belong to the same field of endeavor of creating a product that generates an immune response. The instant claims are drawn towards a method of generating an immune response towards a tumor associated antigen. As such, using a wide variety of tumor associated antigens in the vector would be considered routine and conventional in the art as a skilled artisan would have considered a wide variety of antigen targets that could be used to generate an immune response. Applicant is reminded that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005).
Given that the method for generating an immune response using a CMV vector to treat cancer is disclosed at the time of filing and that the specific CMV tumor-associated antigen is well known in the art, it would have been obvious for one of ordinary skill to combine the two to create a targeted treatment for treating cancer by triggering the immune response to attack particular targets based on which sequence the tumor-associated antigen contains. Both the references consider the end goal of treating a disease and provide the necessary components to tailoring a specific treatment prior to the filing date.
Applicant argues that the supertope peptides of the amended claims also represent notable progress over the cited references and address a long-felt need but unsolved technical problem to overcome immunological tolerance and to elicit T cell responses to self-antigens. This is not found persuasive.
The instant claims have been amended to correct abbreviation issues with the acronym “CMV”. It is unclear how these amendments represent the notable progress the instant invention has made over the prior art. Additionally, the references of the prior art have taught the invention in its entirety and as such, would result in addressing immunological tolerance and T cell responses to self-antigens. The references in the prior art teach the same sequences and methods. Given that structure confers function of proteins, the proteins of the prior art would confer the same advantages when used in the same methods as claimed.
The evidence of unexpected results must be commensurate in scope with the claimed invention (see MPEP §716.02(d)). There is no unexpected result since the prior art has already taught that the methods had similar effects in generating an immune response impacting CD8+ T cells elicited by the vector and one would expect that combining both the method and the sequence containing the tumor-associated antigen produce a better, more targeted approach in the product. Please see MPEP 7106.0 (a), I, which states that “a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).“ The evidence provided by Applicant of unexpected results falls into the additive sweetness combination example and does not show a greater than expected outcome and therefore, the instant invention is obvious over the combination of references.
Therefore, the rejection is maintained.
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.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675