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 .
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-13, and the species of gamma-irradiated tumor cells (claim 11) in the reply filed on May 8, 2026 is acknowledged. Applicant’s traversal is on the grounds that the composition of Derouazi (WO 2017157964) which comprises at least one tumor antigen, at least one toll-like receptor agonist, at least one cytokine, and a pharmaceutically acceptable vehicle is different from the instantly claimed composition because Derouazi teaches that this combination is provided as a covalently linked complex. This is not found persuasive because the instant claims do not specify the formulation of the composition and the Examiner was able to provide art which satisfied the limitations of Group 1, thereby demonstrating that the special technically feature lacks novelty. Therefore, a lack of unity exists between the restricted groups.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12 and 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 8, 2025.
Claims 1-11 and 13 are examined on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/CA2022/050792, filed on May 19, 2022. The instant application claims benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) to U.S. provisional application 63/190504, filed on May 19, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 25, 2025 are in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 13 is 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.
Claim 13, which depends from claims 2 and 1, recites the limitation "the dead tumor cells" in line 1. There is insufficient antecedent basis for this limitation in the claim. Based on the dependency from claims 2 and 1, there is no prior recitation of dead tumor cells. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9, 11, and 13 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Ali et al. (US 20170042995, hereafter “Ali”) as evidenced by Ali et al. (2009, Infection-mimicking materials to program dendritic cells in situ. Nat. Mater., 8(2), 151-158, hereafter “Ali 2009”), Okano et al. (2005, In vivo manipulation of dendritic cells overcomes tolerance to unmodified tumor-associated self antigens and induces potent antitumor immunity. J. of Immun., 174(5), 2645-2652, hereafter “Okano”), and Dranoff et al. (1993, Vaccination with irradiated tumor cells engineered to secrete murine granulocyte-macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. PNAS, 90(8), 3539-3543, hereafter “Dranoff”).
With regard to claim 1, Ali discloses a composition used as a cancer vaccine (Para. [0004], [0159], [0284]) which comprises an inhibitor of an immune-inhibitory protein, a scaffold, a cell recruitment composition, and a bioactive composition (Para. [0005]). Ali further discloses that the composition can comprise a target antigen composition (Para. [0014]) which can be a cancer derived antigen (Paras. [0018], [0020-0021]) such as a tumor antigen (Para. [0058]), which is considered to reasonably read on a tumor-associated antigen (TAA), that the cell recruitment composition can comprise a cytokine (Para. [0013], [0053], [0064], [0169]), and that the composition further comprises a toll-like receptor agonist (Paras. [0024], [0046-0048], [0168]). Ali additionally discloses that the composition can be pharmaceutically formulated (Para. [0332]), which is considered to reasonably ready on comprising a pharmaceutically acceptable vehicle. See also Para. [0289] disclosing compounds for use in the composition.
With regard to claim 2, Ali discloses that the composition is a material-based cancer vaccine (Paras. [0004], [0045], [0068], [0284]).
With regard to claim 3, Ali discloses that the composition can comprise irradiated tumor cells (Para. [0022], [0231], [0291], claim 38) which is considered to reasonably read on a TAA which comprises dead tumor cells.
With regard to claims 4 and 5, Ali discloses that the composition comprises a TLR9 agonist (Para. [0047-0048]) which can be a CpG-ODN (Paras. [0047-0048], [0055], [0190]).
With regard to claim 6, Ali discloses use of CpG-ODN 1826 (Para. [0179], [0226]).
With regard to claim 7, Ali discloses that the cytokine can be an interleukin (Paras. [0241], [0280], [0290]).
With regard to claim 9, Ali discloses that the invention can be used to kill cancer cells (Para. [0029]), slow cancer progression, reduce tumor size, prolong survival time of a cancer patient, and/or treat cancer (Para. [0162] and can be used for the treatment of melanoma (Paras. [0171], [0176], [0284], [0308]) which is considered to reasonably read on preventing, inhibiting, or slowing melanoma development. See also Para. [0133] disclosing utilization of a melanoma model to test the invention and Ali’s working examples.
With regard to claims 11 and 13, Ali teaches that the composition can comprise irradiated tumor cells and provides an example of irradiated melanoma cells, specifically B16-F10 cells (Paras. [0022], [0231], [0291]). See also Para. [0289] disclosing compounds for use in the composition. Ali’s exemplary embodiments are drawn to use of the vaccine composition for treatment in a B16 melanoma model (Para. [0133]) and, as detailed above in claim 9, Ali teaches that the vaccine prevents, inhibits, or slows melanoma development.
Although Ali teaches irradiated tumor cells including melanoma B16-F10 cells, Ali is silent as to use of gamma-irradiation or gamma-irradiated tumor cells. However, Ali cites Ali 2009 as related to Ali’s material based cancer vaccine (Para. [0171], [0306]). Ali 2009 teaches use of vaccines comprising irradiated B16-F10 cells that express GM-CSF and cites Okano as describing the irradiated B16-F10 cell based vaccine (pg. 158, left col., 2nd to last para.). Okano cites Dranoff as describing a GM-CSF producing irradiated tumor cell vaccine used for treatment of B16 melanoma (Pg. 2650, right col, 1st full para.) and Dranoff evidences irradiation of tumor cells using a 137C source (Pg. 3540, left col., “Vaccinations”), which is considered to reasonably read on gamma irradiation. Thus, a skilled artisan, following the citations of Ali, would have recognized that Ali’s disclosed irradiated tumor cells, which can be B16-F10 cells, could be gamma irradiated.
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.
The factual inquiries 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.
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ali (US 20170042995) in view of Kourko et al. (2019, IL-27, IL-30, and IL-35: a cytokine triumvirate in cancer. Front. Oncol., 9, 969, found in IDS dated 04/25/2025, hereafter “Kourko”).
With regard to claim 8, which depends from claims 7 and 1, Ali teaches a composition used as a cancer vaccine (Para. [0004], [0159], [0284]) which comprises an inhibitor of an immune-inhibitory protein, a scaffold, a cell recruitment composition, and a bioactive composition (Para. [0005]). Ali further teaches that the composition comprises a target antigen composition (Para. [0014]) which can be a cancer derived antigen (Paras. [0018], [0020]) such as a tumor antigen (Para. [0058]), which is considered to reasonably read on a tumor-associated antigen (TAA), the cell recruitment composition comprises a cytokine (Para. [0013], [0053], [0064], [0169]), that the composition further comprises a toll-like receptor agonist (Paras. [0024], [0046-0048], [0168]) and that the composition can be pharmaceutically formulated (Para. [0332]), which is considered to reasonably ready on a pharmaceutically acceptable vehicle. Additionally, Ali teaches that the cytokine can be an interleukin (Paras. [0241], [0280], [0290]). Ali teaches that the cytokines can be used as a vaccine adjuvant (Para. [0287]). See also Para. [0289] disclosing compounds for use in the composition.
While Ali provides an exemplary list of interleukins which includes IL-12 (Para. [0241], [0280]), Ali is silent as to use of IL-27.
Kourko teaches IL-27 belongs to the IL-12 family and that IL-12, which has anti-tumor effects, is problematic for therapeutic use due to toxicity which has led to investigation of cytokines related to IL-12 for anti-tumor effects. Kourko further teaches that IL-27 is an alternative to IL-12 due to potent anti-tumor activity (Pg. 2, left col., 1st para.) that can suppress cancer cell proliferation, migration, and invasion and enhance cancer cell death and has shown to be anti-proliferative in melanoma cells. Kourko additionally teaches that IL-27 can be used in combination with a TLR agonist in cancer therapy (Pg. 4, right col, 1st full para.).
Therefore, it would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to use IL-27 as taught by Kourko in the vaccine composition which comprises an interleukin, a TLR agonist, and can be used for treatment of melanoma as taught by Ali with a reasonable expectation of success. A skilled artisan would have been motivated to choose IL-27 as Kourko teaches use of IL-27 as an alternative cytokine which avoids the toxic effects of IL-12 and which is anti-proliferative to cancel cells. One having ordinary skill in the art would have had a reasonable expectation of success as Kourko teaches use of IL-27 as an IL-12 replacement which is antiproliferative in melanoma cells and can be used in combination with a TLR agonist as cancer therapy.
With regard to claim 10, which depends from claims 4 and 1, as detailed above, Ali teaches a composition comprising a TAA, a TLR agonist, and a cytokine which can be pharmaceutically formulated. Ali teaches that the TLR agonist can be a TLR9 agonist (Para. [0047-0048]), specifically CpG-ODN 1826 (Para. [0179], [0226]). Ali further teaches that CpG-ODN 1826 has been successfully used in mouse melanoma vaccination models (Para. [0179]).
While Ali provides an exemplary list of interleukins which includes IL-12 (Para. [0241], [0280]), Ali is silent as to use of IL-27.
Kourko teaches IL-27 belongs to the IL-12 family and that IL-12, which has anti-tumor effects, is problematic for therapeutic use due to toxicity which has led to investigation of cytokines related to IL-12 for anti-tumor effects. Kourko further teaches that IL-27 is an alternative to IL-12 due to potent anti-tumor activity (Pg. 2, left col., 1st para.) that can suppress cancer cell proliferation, migration, and invasion and enhance cancer cell death and has shown to be anti-proliferative in melanoma cells. Kourko additionally teaches that IL-27 can be used in combination with a TLR agonist in cancer therapy (Pg. 4, right col, 1st full para.).
Therefore, it would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to use IL-27 as taught by Kourko in the vaccine composition which comprises an interleukin, a TLR agonist which is CpG-ODN 1826, and can be used for treatment of melanoma as taught by Ali with a reasonable expectation of success. A skilled artisan would have been motivated to choose IL-27 as Kourko teaches use of IL-27 as an alternative cytokine which avoids the toxic effects of IL-12 and which is anti-proliferative to cancel cells. One having ordinary skill in the art would have had a reasonable expectation of success as Kourko teaches use of IL-27 as an IL-12 replacement which is antiproliferative in melanoma cells and can be used in combination with a TLR agonist, like CpG-ODN 1826, as cancer therapy.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Derouazi and Belnoue (WO 2017157964, found in IDS dated April 25, 2024). Derouazi and Belnoue teach a composition comprising an immune checkpoint inhibitor and a complex comprising a cell penetrating peptide, at least one antigen or antigenic epitope, and at least one TLR peptide agonist (Pg. 11, Pg. 36, Pg. 131) which comprises a pharmaceutically acceptable carrier (Pg. 132, line 18) and which is formulated for use as a vaccine (Pg. 132, line 27) for prevention and/or treatment of cancer (Pg. 132, line 25). Derouazi and Belnoue teach that the at least one antigen or antigenic epitope can be a tumor associated antigen (Pg. 56, lines 25-27) and that the vaccine can additionally comprise a cytokine including Il-27 and a compound able to bind to toll-like receptors including TLR9 (Pg. 134), which is considered to reasonable read on a toll-like receptor agonist.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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