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 SEQ ID NO: 15 in the reply filed on 3/24/2026 is acknowledged.
Claim Objections
Claims 7-11, 27-35 are objected too for reciting non-elected subject matter, i.e. methods of administering bacteria having a 16S rRNA sequence other than SEQ ID NO: 15.
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 7-11, 27-35 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 the relapse of cancer, the art of record contains no description of methods of doing so using the claimed bacteria. Related bacteria with rRNAs falling within the claimed scope have been used to treat certain gastrointestinal and autoimmune disease (e.g. WO 2014/121302, cited by applicants) but not cancer or tumor relapse. A review of cancer and tumor relapse (Santos de Frutos et al, 2021, of record) does not mention the use of bacteria at all, but rather teaches the targeting of dormant or quiescent cells via other pharmaceuticals. A paper directed to the claimed bacterial methods (Peled et al 2017, of record) teaches an association between the presence of the recited bacteria in stool and a decrease in relapse amongst stem cell transplant patients. However, the reference also teaches this was only a starting point for future therapies (Conclusion). Thus, the relevant art is silent with regard to functionally treating cancer relapse with bacteria comprising the claimed rRNA sequences. Further, the teachings of Peled et al provide clear evidence that treatment or prevention of cancer relapse with the claimed bacteria was 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 claimed invention without explicit guidance from the specification or significant empirical experimentation.
Amount of direction provided by the inventor and existence of working examples: The instant specific does not provide any in vivo results or examples of preventing cancer relapse using the claimed bacteria. The instant specification does provide evidence for the same association as set forth above in Peled et al, i.e. between a decrease in relapse in a subset of cancer patients and the claimed bacteria.
Thus, although the specification suggests a method by which one might attempt to prevent or decrease cancer relapse, there is no evidence that the method contemplated would actually produce the claimed results. In order to make the invention as claimed, the skilled artisan would have to further develop the methods of and bacteria capable of functioning in the wide variety of cancers and tumors recited in the claims.
Nature of the invention and Breadth of the claims: The claims are directed to methods of treating the relapse of cancer by administration of bacteria, the properties of which have been outlined above. The claimed rRNAa recite a broad variance of potential sequences, only 85% identity to SEQ ID NO: 15 (1439 bp) is required. In a nucleotide that is 1439 residues, that corresponds to changing up to 215 residues to any other, at any position. The claims are not limited to any particular cancer, tumor, type of relapse, mode of administration or even a bacterial genus. Thus, the claimed methods encompass a divergent genus of methods of treating the relapse of any known cancer or tumor. As the claims encompass such broad, generic claims, it is incumbent upon the disclosure to set forth the manner and process treating cancer relapse in a breadth of patients and cancer types that are 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 manipulating bacteria is high, the level of skill in the art of using such bacteria to treat cancer relapse is low. One would not be able to practice the claimed methods 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, nor does the instant specification. All of the teachings in the instant application are directed to an association between the bacteria and cancer relapse, with additional prophetic statements suggesting how this knowledge might be further developed for application in cancer relapse therapy. Given the broad scope of the claims, the early developmental stage and the unpredictability of the art at the time of filing, practicing the claimed methods 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.
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