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 without traverse of Group II and certain species in the reply filed on 3/9/2026 is acknowledged.
Claims 1, 17, 20-30, 33, 36, 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/9/2026.
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 15, 16, 18, 31, 32, 34, 35, 37-39, 41-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988) and include the following:
State of the prior art and level of predictability in the art: In spite of considerable interest in treating cancer with DNA nanoparticles or CpG oligos, the art of record contains no description of methods of treating cancer by implanting a device comprising DNAs comprising a cell ligand and CpG oligos wherein the CpGs are released under force. Chang et al (US 2015/0004193, of record) teach devices comprising all of the recited components, but do not teach that the devices are efficacious to treat cancer (Chang et al is directed towards using CpG oligos as an adjuvant for HIV vaccines). Adamus et al (Contemp Oncol, 2017, cited by applicants) teach the disappointing results of CpG/TLR9 agonist monotherapy in clinical cancer trials, even with CpGs that do not need to be “released” from a larger device in order to be active as a TLR9 agonist, as required by the instant claims. Likewise, Krieg et al (Nuc Acid Ther., 2012, cited by applicants) teach CpG monotherapy or in combination has largely been disappointing at the clinical stage, particularly stage II and III (pages 81-83 in particular). Although they do not teach the use of the recited devices, Adamus and Krieg et al are relevant to the claimed methods because the recited CpG oligos are apparently the only components with potential anti-tumor or anti-cancer activity. Thus, the art cited in support of the claimed methods is silent with regard to using the recited devices to treat cancer and the structural and functional features that provide the basis for using the claimed devices in cancer treatments are not well understood. This clearly evidences that the claimed cancer treatment methods were at an early stage of development at the time of filing and that the skilled artisan would not know how to make and use the recited devices to treat cancer without explicit guidance from the specification or significant empirical experimentation.
Amount of direction provided by the inventor and existence of working examples: With regard to methods of treating cancer, the instant specification is entirely prophetic. In the working examples, the specification teaches ways to make a device that could be used in the claimed methods, but does not provide any actual trials of the device in animal models of cancer or human clinical trials.
Although the specification suggests a method by which one might attempt to treat cancer, there is no evidence that the method contemplated would actually produce an efficacious result in vivo. Thus, in order to make and the invention as claimed, the skilled artisan would have to further develop the methods of making and using the recited devices and the required components (CpG oligos, DNA nanostructures, cell ligands) such that the wide variety of cancers and tumors recited in the claims could be treated.
Nature of the invention and Breadth of the claims: The claims are directed to methods of treating cancer, the properties of which have been outlined above. The claims are not limited to any particular cancer or tumor type. The claims are not limited to any particular CpG, cell ligand, or configuration that would lead to release of the CpG’s by a force Thus, the claimed methods encompass a divergent genus of treating any given cancer or tumor using a wide variety of potential devices that need only comprise CpG oligos releasable by a force, a cell ligand, and a substrate. As the claims encompass a wide variety of methods, it is incumbent upon the disclosure to set forth the manner and process of making and using the recited devices in a variety of cancer treatment methods that is commensurate with the scope of protection sought.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the level of skill in the art of making DNA nanostructures that comprise CpGs and a cell ligand is high, the level of skill in the art of using such DNA nanostructures, or devices that comprise them, to treat cancer is low. One would not be able to make and use the recited devices to treat cancer given no more than the teachings available at the time of filing without undue experimentation. The art of record does not provide a single working example of the claimed methods of treating cancer. Likewise, all of the teachings in the instant application are prophetic statements suggesting how the technology could be used to treat cancer. Given the broad scope of the claims, the early developmental stage and the unpredictability of the art at the time of filing, making and using the instant invention would clearly require undue experimentation. Therefore, the claims are properly rejected under 35 USC 112, first paragraph, as lacking enablement.
Given the above analysis of the factors which the courts have determined are critical in determining whether a claimed invention is enabled, it must be considered that undue and excessive experimentation would have to be conducted by the skilled artisan in order to practice the claimed invention.
Claim Objections
Applicant is advised that should claim 15 be found allowable, claim 41 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 41 merely repeats the implanting feature found in claim 15.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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