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. 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 s 1-11 are 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. Regarding claim 1, the text “ an IRE1a endonuclease activity inhibitor” renders claims reading upon said text indefinite as this limitation merely states a functional characteristic without providing any indication about how the functional characteristic is provided. It is unclear whether the claim requires some other structure to be added to the composition to provide the functional characteristic. There is nothing inherently wrong with defining some part of an invention in functional terms; however, a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. Functional descriptions of chemical compounds/compositions must be coupled with a known or disclosed correlation between function and structure. This deficiency is not cured in claims 2-11. Regarding claim 2, the clause “wherein the inhibitor …kinase activity” renders claims reading upon said text indefinite as this limitation merely states a functional characteristic without providing any indication about how the functional characteristic is provided. It is unclear whether the claim requires some other structure to be added to the composition to provide the functional characteristic. There is nothing inherently wrong with defining some part of an invention in functional terms; however, a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. Functional descriptions of chemical compounds/compositions must be coupled with a known or disclosed correlation between function and structure. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claim(s) 1-7 and 11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Takahara , Ikuko , et al. "Toyocamycin attenuates free fatty acid-induced hepatic steatosis and apoptosis in cultured hepatocytes and ameliorates nonalcoholic fatty liver disease in mice." PloS one 12.3 (2017): e0170591 ( Takahara ). Takahara teaches the intraperitoneal administration of 0.25 mg/kg/day toyocamycin to a mouse (Animals, page 5/18) . A rtisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. In construing process claims and references, it is the identity of manipulative operations which leads to finding of anticipation. In the instant case, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. The prevention of ADPKD, ADPLD, and/or ARPKD is not an active methodological step in the process but is rather a consequence of the administration of a therapeutically effective amount of toyocamycin (e.g., 0.25 mg/kg/day) to the mammal (e.g., mouse). Takahara teaches all of the instantly claimed elements. Thus, claims 1-7 and 11 are anticipated. Conclusion Claims 1-11 are pending. Claims 1-11 are rejected. No claims are allowed. Contacts Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PATRICK T LEWIS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0655 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday to Friday, 10 AM to 4 PM EST (Maxi Flex) . 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, FILLIN "SPE Name?" \* MERGEFORMAT Renee Claytor can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8394 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PATRICK T LEWIS/ Primary Examiner, Art Unit 1691 /PL/