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 .
Status of the Application
Claims 1-5, 9-13, and 15-19 are pending
Claims 1-5, 9-13, and 15-19 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/08/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Provisional Application No. 62/651,029 filed on 03/30/2018, U.S. Provisional Application No. 62/754,801 filed on 11/02/2018, PCT Application No. PCT/US2019/024783, and U.S. Application No. 17/043,966 (abandoned) filed on 09/30/2020.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 9-13, and 15-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cooley et al. (WO 2017/117430, as disclosed in IDS).
Cooley et al. is drawn towards “compounds for activating the activating transcription factor 6 (ATF6) arm of the unfolded protein response (UPR), or activating the transcriptional targets of ATF6, in the endoplasmic reticulum of a cell, the compounds being of any of formulas (I) through (IX)” (see abstract). Regarding claim 4, Cooley et al. teaches such activation in an animal or human (claim 18). Cooley et al. teaches compound 147 (Table 1, pg. 26):
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Cooley et al. teaches administering such compounds in a therapeutically effective amount, including “dosages from about 0.05 to about 5000 mg, preferably from about 1 to about 2000 mg, and more preferably between about 2 and about 2000 mg per day can be used.” (pg. 45, first paragraph). Cooley et al. teaches that “ER stress and UPR activation is directly implicated in many cardiovascular disorders including ischemic-reperfusion injury, cardiac hypertrophy and failure, and atherosclerosis. Significant evidence indicates that ATF6 activation is a potential therapeutic strategy to ameliorate pathologic heart dysfunction associated with these diseases. Activation of A TF6 is well-established to exert cardioprotective effects against ischemia-reperfusion injury in both in vitro and in vivo models.” (pg. 23, second paragraph). Cooley et al. teaches treating proteostasis imbalance in liver disease and amyloid diseases including Alzheimer’s disease (pg. 1, fourth and fifth paragraph; pg. 3, first paragraph). Cooley et al. teaches that “the therapeutic potential for our small molecule ER proteostasis regulators to attenuate proteotoxic extracellular aggregation associated with human amyloid diseases including Alzheimer's disease, Creutzfeldt-Jakob disease and related prion diseases, Light Chain Amyloidosis, the TTR amyloidosis and other amyloid diseases, e.g. gelsolin and lysozyme amyloidoses.” (pg. 22, first paragraph).
Therefore, the reference is deemed to anticipate the instant claims above.
Claim Rejections - 35 USC § 103
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 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 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 2-3 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cooley et al. (WO 2017/117430, as disclosed in IDS) as applied to claims 1, 4-5, 9-13, and 15-16 above, and further in view of Zhao et al. (US 2006/0246037, as disclosed in IDS).
The teachings of Cooley et al. are presented above.
Cooley et al. does not teach the composition in the form of an implant or stent.
Zhao et al. is drawn towards methods for treating neurodegenerative diseases such as Alzheimer’s disease and effecting overexpression of an active form of ATF6 in the cell (see abstract). Zhao et al. teaches formulations comprising the active agent in a pharmaceutically acceptable diluent in a carrier, which can be in the form of an implant for parenteral or intrathecal administration (paragraphs 0197, 0199).
It would have been obvious to one of ordinary skill in the art to formulate a composition comprising a compound of Formula (I) and a pharmaceutically acceptable excipient in the form of an implant or stent, as suggested by Zhao et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such dosage forms are conventionally used in the art as taught by Zhao et al. (paragraph 0197), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Conclusion
Claims 1-5, 9-13, and 15-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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