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
1. The Election filed 5/7/2026, in response to the Office Action of 1/6/2026, is acknowledged and has been entered. Claims 30 and 34-43 are pending. Claims 32-33 have been cancelled by the Applicant. Applicant elected the species of the MHC-II restricted antigen comprising the sequence set forth in SEQ ID NO:1 and the MHC-I restricted antigen comprising the sequence set forth in SEQ ID NO:34. Claim 30 is amended to require all of SEQ ID NOs:1-33 to be administered, therefore all species of MHC-II-restricted antigens (SEQ ID NOs:1-33) are rejoined for examination. Claims 30 and 34-43 are currently being examined as drawn to the rejoined and elected species.
Priority
2. Application is a divisional of 16/760,138 filed on 4/29/2020 which claims the benefit and priority of PCT/US2018/059384 filed on 11/6/2018 and provisional application 62/582,097 filed on 11/6/2017. The present claims add no new subject matter and priority is granted to 62/582,097 and the effective filing date of 11/6/2017.
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.
3. Claims 30 and 34-43 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 treating a solid tumor in a subject previously immunized to CMV, does not reasonably provide enablement for treating any solid tumor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims are drawn to a method of treating a solid tumor in a subject in need thereof by the administration of immunogenic MHC-II restricted antigens from a human CMV protein, wherein each MHC-II restricted antigen comprises a sequence set forth in SEQ ID NOs:1-33, an antigen that recruits a naturally-occurring pre-existing immune response to CMV to the solid tumor, wherein the MHC-II restricted antigen is not expressed by any of the cancer cells of the solid tumor, and wherein the antigen is recognized by one or more components of the pre-existing immune response.
The specification discloses seventeen in vivo experiments all beginning with immunization of a C57Bl/6 mice to murine CMV. The specification fails to disclose any example of a non-immunized model being treated with the present claimed method. Further, the specification on page 10 clarifies that a “preexisting immune response” is one that is present prior to the initiation of treatment with cancer:
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And further, the specification describes recruiting an immune response as requiring the pre-existing immune response to be present.
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Relevant art teaches Cytomegalovirus is a common disorder but prevalence of the virus shows only about half of adults by the age of 40 have been exposed to the virus. (https://www.cdc.gov/cytomegalovirus/about/index.html, last visited 5/26/2026).
One cannot extrapolate the disclosure of the specification to the scope of the claims because the nature of the invention requires that the subject in need of treatment has been exposed to CMV prior to the initiation of the cancer treatment, the breadth of the claims is drawn to a method of treating solid tumors in subjects that have not been exposed to CMV by administering CMV peptides to recruit a preexisting CMV immune response, guidance from the specification indicates the mechanism of action of the invention requires a subject to have a pre-existing immune response to CMV, and the specifications’ working examples all include immunization to CMV prior to the initiation of treatment with the present claimed method.
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that the MHC-II restricted antigens will predictably function as claimed to treat a solid tumor in a subject in need of treatment but previously not exposed to CMV.
Therefore, in view of the novel nature of the invention, the breadth of the claims, lack of guidance in the specification, and the absence of working examples for treating CMV-naïve subjects, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
Examiner Suggestion: Amend claim 30 to recite “A method of treating a solid tumor in a subject in need thereof, where the subject has been previously immunized to CMV,”
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kumar (Mol. Ther. Oncolytics, 2016, 3:16012) discloses a method of treating hepatocellular carcinoma by transfecting human HepG2 cancer cells with a wildtype-CMV strain AD169, then injecting the cancer cells into mice. (Kumar, Fig. 1). Kumar is not cited as prior art since the treatment relies completely on the AD169 strain of CMV and searching disclosed that SEQ ID NOs:17 and 18 were not included in the AD169 strain which are required for the instant claimed invention.
Cobbold (WO2012/123755 A1, pub. 9/20/2012) discloses a method of treating malignant diseases by re-directing an immunotherapeutic response using immunodominant antigens to human CMV derived from the pp65 protein, glycoprotein B protein, and IE1 protein, including epitopes that matches the instant claimed SEQ ID NOs:1-13, 15, 27-29, 31 and 34. (Cobbold, pgs. 29-30). Cobbold is not cited as prior art because the method of Cobbold discloses the CMV antigens as attached to targeting moieties for delivery to the tumor site and for the lack of the disclosure of SEQ ID NOs: 14, 16-26, 30, and 32-33.
Li Pira (Intern’l Immunol., 2004, 5:635-642) discloses the use of CMV specific pp65 peptides that match the instant claimed SEQ ID NOs:1-15 (Table 2) to induce a CD4 response. Li Pira is not cited as prior art because the treatment was not directed to treating a malignancy.
Pachnio (J. Immunol., 2015, 195:3803-3815) discloses the instant claimed SEQ ID NOs:20-24 and 32-33 derived from the glycoprotein B, H, and L proteins. (Table 1). Pachnio is not cited as prior art because it is not directed to the treatment of cancer and does not disclose SEQ ID NOs:1-19 and 25-31.
Conclusion
8. Claims 30 and 34-43 are rejected.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642
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