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 .
Applicant’s amendments and reply have overcome the rejections under 35 USC § 112(b), the written description under 35 USC § 112(a), and in-part, the scope of enablement under 35 USC § 112(a).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 13, 2025 has been considered by the examiner.
Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 requires the ODN comprising at least one modified internucleotide linkage that comprises a phosphorothioate linkage or a phosphorodithioate linkage, which is recited under Table 1 in amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 14, 16, 18, 19, 21-23, 32, 34, and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a plant virus comprising ODN1826 to:
specifically bind to a receptor expressed on an immune cell selected from an antigen presenting cell, a tumor-associated macrophage (TAM), a B cell, a dendritic cell, a nature killer (NK) cell, recited in instant claims 14, 16, 18;
increase uptake of the ODN in a macrophage and not increase uptake of the ODN by tumor cells, induces activation of phagocytosis in an immune cell, recited in instant claim 19;
induce activation of phagocytosis in an immune cell, recited in instant claim 21;
modulates polarization of a macrophage toward a M1 phenotype, recited in instant claim 22;
induce secretion of a cytokine from an immune cell, recited in instant claim 23;
treating a disease or condition or inducing an immune response in a subject by administering to the subject the engineered plant VLP comprising ODN1826, recited in instant claim 32;
inducing phagocytosis of a target cell, recited in instant claim 34; and
modulating macrophage polarization, recited in instant claim 35,
does not reasonably provide enablement for a plant VLP comprising any oligodeoxynucleotide (ODN) recited in Table 1 of claim 1 that functions as asserted by the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant disclosure does not disclose sufficient characteristics of the claimed genus of ODNs recited in Table 1 that correlate with the features of ODN1826. The instant disclosure clearly shows CCMV-ODN2138 not stimulating bone marrow-derived macrophages (BMDMs), whereas ODN1826 or CCMV-ODN1826 increased the number BMDMs that attacked cancer cells and captured them by phagocytosis in Figure 4A. Figure 4C depicts M1 polarization of tumor-associated macrophages (TAMs) when exposed to ODN1826, but depicts M2 polarity when exposed to ODN2138. Figure 5 shows activation of TLR9 in KEK293 cells exposed to ODN1826, but not with ODN2138. Figure 6 demonstrates no efficacy against CT26 tumors when treated with ODN2138, however, treatment with free ODN1826 slowed tumor growth and treatment with CCMV-ODN1826 significantly inhibited tumor growth with an 80% drop in tumor volume. No other ODN besides 1826 demonstrated the claimed function in the working examples. There is no discussion or working example provided in the instant disclosure for demonstrating efficacy of the Table 1 ODNs.
The skilled artisan would not predict success for using any plant VLP comprising an ODN that differs from ODN1826. Vollmer et al. (Immunology. 2004; 113:212-223, of record) depict the sequences for ODN1826 and ODN2138 in Table 1. ODN1826 and ODN2138 are both 20 nucleotides in length and differ by four residues. Figure 3 of Vollmer et al. shows comparable antibody responses when either ODN1826 and ODN2138 are administered with an HBsAg antigen, see Figures 3a and 3b and neither ODN1826 or ODN2138 induced an adjuvanting effect in TLR9-/- mice (Figure 3d). Figure 3c depicts ODN1826 inducing a Th1 response and ODN2138 inducing a Th2 response. Therefore, Vollmer et al. demonstrate that ODN1826 and ODN2138 are similarly immunogenic.
While the scope of the instant claims removes ODN2138, there is no evidence that the ODN’s listed in Table 1 of claim 1 would possess the requisite structures to accomplish the requisite functions recited. ODN2138 and ODN1826 are structurally very similar, but have divergent actions, as evidenced by the instant working examples and the teachings of Vollmer et al. No other ODN besides 1826 demonstrated the claimed function.
For these reasons, it is determined that an undue quantity of experimentation would be required of the skilled artisan to make and use the instant invention.
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, 3, 8, 10, 14, 16, 18, 19, 21-23, 27, 32, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Rasochova et al. (USPgPub 2007/0041999, of record), Jie et al. (International Journal of Molecular Sciences. 2018 Mar 20; 19 (3): 920, of record), as evidenced by Krams et al. (USPgPub 2016/0008397, of record).
Rasochova et al. teach a cowpea chlorotic mottle virus (CCMV) comprising encapsulated CpG oligodeoxynucleotides, see Figures 7, 9, and 10, paragraphs [0018, 0096, 0122, 0149], and claims 26 and 29. These teachings correspond to instant claims 1 and 3. Paragraphs [0017, 0018, and 0096] state that the VLPs comprise targeting receptor binding sites and comprise CpG stimulate Th1 and secretion of cytokines IL-12 and IL-18 by macrophages and dendritic cells, as required by instant claims 14 and 23. Paragraphs [0096, 0099, 0103, 0109, 0110, 0149] and claim 32 of Rasochova et al. is drawn to a vaccine comprising the VLP, pharmaceutical carriers and methods of administering a subject the formulation to induce an immune response, as required by instant claims 27 and 32.
While Rasochova et al. do not mention a kit, recited in instant claim 36, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have incorporated these materials into a kit for ease of transport, storage, and preparation.
Rasochova et al. do not teach or suggest ODN1826, its corresponding sequence, or phosphorothioate linkages between all of the nucleotides, as required by instant claims 1, 8, and 10.
Jie et al. teach ODN1826, see Figure 1, for example. Section 4.2 of Jie et al. teach, “CpG
1826 (5’-tccatgacgttcctgacgtt-3’), where lowercase letters represent phosphorothioate linkages. The sequence of ODN1826 of Jie et al. is indistinguishable from the instant ODN1826 sequence recited in instant Table 1.
One of ordinary skill in the art prior to the effective filing date would have been motivated to have encapsulated the ODN1826 of Jie et al. in the CCMV VLP of Rasochova et al. to induce antitumor immunity, see the abstract and Figures 1-6 of Jie et al. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of success to have encapsulated the ODN1826 of Jie et al. in the CCMV VLP of Rasochova et al. because Rasochova et al. teach encapsulating any CpG, see Figures 7, 9, and 10, paragraphs [0018, 0096, 0122, 0149], and claims 26 and 30.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have maintained the phosphorothioate linkages of ODN1826 of Jie et al. encapsulated within the CCMV VLP of Rasochova et al. to confer enhanced thermal stability and nuclease resistance to the oligonucleotides, see paragraph [0101] of Krams et al.
Regarding instant claims 16, 18, 19, 21, and 22, paragraphs [0017, 0018, and 0096] of Rasochova et al. state that the VLPs comprise targeting receptor binding sites and comprise CpG stimulate Th1 and secretion of cytokines IL-12 and IL-18 by macrophages. Rasochova et al. do not mention a tumor-associated macrophage (TAM), as required by instant claim 16, or the induction of phagocytosis, as required by instant claims 21 or that the VLP modulates polarization of the macrophage toward an M1 phenotype, as required by instant claim 22. Rasochova et al. do not mention that the VLP increases uptake of the ODN in a macrophage compared to uptake of an ODN not encapsulated by the VLP, as required by instant claim 18 or that the VLP increases uptake of the ODN in a tumor-associated macrophage (TAM), but not significantly by tumor cells, as recited in instant claim 19.
However, products of identical composition cannot have mutually exclusive properties, see MPEP § 2112.01(II). The combined teachings of Rasochova et al. and Jie et al. teach a cowpea chlorotic mottle virus (CCMV) comprising an encapsulated CpG ODN1826, see Figures 7, 9, and 10, paragraphs [0018, 0096, 0122, 0149], and claims 26 and 30, which are all of the structures required by instant claims 16, 18, 19, 21, and 22.
MPEP § 2112.01(I) states:
Where the claimed and prior art products are identical or substantially identical in structure or composition,… a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Structure is inseparable from function.
In reply to the rejection of record, applicant summarizes the results of Jie et al., demonstrating better survival rates when the combination of M-M + CpG-ODN 1826 is administered and that CpG has only modest antitumor activity, with survival rates totaling 60% survival at 55 days and 50% survival at 80 days. Applicant emphasizes that Jie et al. describe the use of ODN1826 as an adjuvant.
It is noted that the paragraphs [0005 and 0047] and Table 2, listing ODN1826, describe CpG-ODN’s as immunoadjuvants. Therefore, the structure and function of CpG-ODN 1826 as an adjuvant, as taught by Jie et al., is consistent.
Applicant states that the instant CCMV-ODN1826 outperforms Jie’s free ODN1826 in in vitro and in vivo studies, including increasing the number of BMDMs that phagocytized cancer cells in Fig. 4A, Fig. 6E and [0244], decreasing in tumor cell survival in Fig. 4B, inhibiting tumor growth 80% by day 26 and prolonging survival from 26 to 42 days in Fig. 6D and [0243]. Applicant concludes that the skilled artisan would not have expected superior antitumor with CCMV-ODN1826 compared with free ODN1826.
Applicant’s arguments have been fully considered, but are found unpersuasive. The instant claims are drawn to a product with intended functions. (“[T]he patentability of...
composition claims depends on the claimed structure, not on the use or purpose of that structure.”). Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002).
The instant claims require a CCMV VLP encapsulating CpG ODN1826. Rasochova et al. teach CCMV encapsulating CpG ODNs. Jie et al. teach ODN1826. The combined composition of Rasochova et al. and Jie et al. results in CCMV encapsulating ODN1826. Products of identical composition cannot have mutually exclusive properties, see MPEP § 2112.01(II). Therefore, a comparison between free ODN1826 and the instant CCMV-ODN1826 is inconsonant. The combined composition of Rasochova et al. and Jie et al., CCMV encapsulating ODN1826 is identical or substantially identical in structure or composition to the instant CCMV-ODN1826 claimed and a prima facie case of obviousness has been established as per MPEP § 2112.01(I) and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rasochova et al., Jie et al., as evidenced by Krams et al., as applied to claims 1, 3, 8, 10, 14, 16, 18, 19, 21-23, 27, 32, and 36 above, and further in view of Yildiz et al. (Journal of Controlled Release. 2013; 172: 568-578, of record).
See the teachings of Rasochova et al., Jie et al., as evidenced by Krams et al. above. The references do not teach or suggest including additional therapeutic agents encapsulated within the VLP, as required.
Yildiz et al. teach that the cargo capacity of an empty CPMV VLP results in 130-155 dyes loaded into CMPV VLP particles, see section 3.1 and Figure 1. Figure 4B depicts CPMV-loaded with RNA and proflavine drug molecules.
One of ordinary skill in the art prior to the effective filing date would have been motivated to have added additional therapeutic agents within the cargo of the CPMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al., to increase therapeutic efficacy of the VLP. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of success to have added additional therapeutic agents within the cargo of the CPMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al. because Yildiz et al. describe CPMV VLPs loaded with multiple materials that remained chemically active with efficiently released cargo, see sections 3.2-3.3, and 3.5.
Applicant argues that since instant claim 1 is non-obvious, claim 26 is non-obvious for the same reasoning. However, since claim 1 remains prima facie obvious in view of Rasochova et al., Jie et al., as evidenced by Krams et al., claim 26 also remains prima facie obvious.
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Rasochova et al. as applied to claims 1, 3, 8, 10, 14, 16, 18, 19, 21-23, 27, 32, and 36 above, and further in view of Wang et al. (Advanced Materials. 2017 Aug; 29 (29): 1606036).
See the teachings of Rasochova et al., Jie et al., as evidenced by Krams et al. above. Paragraphs [0017, 0018, and 0096] of Rasochova et al. state that the VLPs comprise targeting receptor binding sites and comprise CpG stimulate Th1 and secretion of cytokines IL-12 and IL-18 by macrophages, as required by the first parts of claims 34 and 35.
Rasochova et al., Jie et al., as evidenced by Krams et al. do not mention phagocytic activity of the macrophage, as required by claim 34 or polarization of the macrophages toward an M1 phenotype, as required by claim 35.
Wang et al. teach increased quantities of M1 macrophages and tumor-associated macrophages (TAM) abundancy results in increased tumor growth inhibition in tumor stroma on page 10 of section 3, section 4.4 and phagocytosis of tumor-associated macrophages in section 2.1.2.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have enhanced polarization of macrophages toward an M1 polarity, as taught by Wang et al. to increase tumor growth inhibition. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have enhanced polarization of macrophages toward an M1 polarity, as taught by Wang et al. upon contact with the ODN-loaded CPMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al. because Rasochova et al. teach the CPMV VLPs stimulate Th1 and secretion of cytokines IL-12 and IL-18 by macrophages in paragraphs [0017, 0018, and 0096] and Wang et al. teach increased quantities of cytokines enhance M1 macrophage populations and anti-cancer immunity in the first paragraph of section 2.2.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have targeted the CCMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al. to the TAMs of Wang et al. because Wang et al. teach TAMs accumulate nanoparticles by direct cellular uptake and release the payload to neighboring tumor cells in section 4.4. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have targeted the ODN-CpG-loaded CCMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al. to the TAMs of Wang et al. because Wang et al. teach stimulation of TLR9 by CpG dampens the immunosuppressiveness of tumor microenvironment that results in improved anti-tumor activity on page 8 of section 2.1.2. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of success to have targeted the CCMV VLP of Rasochova et al., Jie et al., as evidenced by Krams et al. to the TAMs of Wang et al. because Wang et al. teach CPMV VLPs are phagocytized by tumor-associated macrophages (neutrophils) in the paragraph under Figure 8 in section 2.1.2.
Applicant argues that since instant claim 1 is non-obvious, claims 34 and 35 are non-obvious for the same reasoning. However, since claim 1 remains prima facie obvious in view of Rasochova et al., Jie et al., as evidenced by Krams et al., claims 34 and 35 also remain prima facie obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lizotte et al. (Nature nanotechnology. 2016 Mar;11 (3): 295-303) teach in situ vaccination with cowpea mosaic virus nanoparticles suppresses metastatic cancer.
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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671