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 .
Priority
This application is a CON of PCT/US2023/035707 (10/23/2023);
This application has PRO 63/508,856 (06/16/2023);
PCT/US2023/035707 has PRO 63/381,521 (10/28/2022).
Status
Claims 8, 52-69 are pending. Any rejection not reiterated in this action is withdrawn.
Claim Interpretation
Applicant amended independent claims 8 and 68 to include the new language “administering to the subject 17α-ethynyl-androst-5-ene-3β,7β,17β-triol in an amount sufficient to decrease DNA methylation of at least one CpG site …” which is being interpreted as administering any amount of the compound as the specification teaches that the administration of the compound to a subject causes a decrease in DNA methylation generally.
New Claim Rejections - 35 USC § 103
Claims 8, 52-71 are rejected under 35 U.S.C. 103 as being unpatentable over Reading et al. (Neurodegener. Dis.Manag. (2021) 11(4), 289–298, Published 12 Jul 2021) in view of Shen et al. (J Neurol Neurosurg Psychiatry 2019;90:590–598).
Regarding claims 8 and 68, Reading describes “NE3107 (17α-ethynyl-androst-5-ene-3β,7β,17β-triol, formerly HE3286) is an oral small molecule” that acts as an anti-inflammatory that inhibits neurodegeneration pathways in several disease models including Parkinson’s and glaucoma as well as in human clinical trials where it was neuroprotective (p. 291). Although Reading teaches the compound is useful as a therapy in Alzheimer’s patients to “decrease cognitive decline and improve function in Alzheimer’s subjects, and slow disease progression” (Abstract), Reading does not teach identifying a subject having mild cognitive impairment (MCI).
Shen teaches that MCI and AD share pathological inflammatory mechanisms and that anti-inflammatory strategies would be beneficial. (p. 596).
One of ordinary skill in the art following Reading’s teaching regarding NE3107’s anti-inflammatory action that inhibits neurodegeneration, was neuroprotective, and useful in decreasing cognitive decline would have considered utilizing the therapeutic in patients not diagnosed with Alzheimer’s disease but experiencing cognitive decline and thus mild cognitive impairment. One of ordinary skill in the art would have had an expectation of success because of Shen’s teaching that AD and MCI share inflammation mechanism, Reading’s teaching of the utility of the compound in models of disease, and Reading’s teaching that the compound was neuroprotective and reduced AD risk. Thus, one of ordinary skill in the art would have found it prima facie obvious to administer NE3107 to a subject having MCI and arrive at the claimed invention.
Regarding claims 52-67, 69 including “wherein” clauses relating to the resulting effects of “administering”, these limitations are all considered intended results that would be the natural result of administering the compound as taught by Reading.
Regarding claims 70-71 specifying the subject does not have AD, one of ordinary skill in the art would have considered administering NE3107 as a neuroprotective that reduces inflammation and cognitive decline in subjects that have not been diagnosed with AD and arrive at the claimed invention with a reasonable expectation of success.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant argues that MCI is not the same as AD and thus the claims are not prima facie obvious. This argument is not persuasive because as detailed in the new 103 rejection above, one of ordinary skill in the art following the teaching of Reading in view of Shen would have considered utilizing the compound as a neuroprotective and to reduce inflammation including in subjects with MCI.
Applicant argues that the claims are further distinguished by the specific CpG sites recited. As detailed in the claim interpretation section, the recitation of the sites relates only to the amount administered and thus does not distinguish from the prior art. Furthermore, this argument is not persuasive because the administration of NE3107 as rendered obvious and administered to the patient would inherently have the effect to decrease DNA methylation as in the claim and would be “the natural result of the combination of prior art elements.” – See MPEP 2112.
Applicant argues an unexpected result of NE3107 acting to decrease DNA methylation at specific claimed CpG sites. This argument is not persuasive because the combination of the prior art suggests the claimed invention for treating AD, regardless of the properties of affecting DNA methylation. As per MPEP 2145 II., Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) and “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
New Double Patenting Rejections
Claims 8, 52-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 8217025 in view of Reading et al. (Neurodegener. Dis.Manag. (2021) 11(4), 289–298, Published 12 Jul 2021) and Shen et al. (J Neurol Neurosurg Psychiatry 2019;90:590–598). Although the claims at issue are not identical, they are not patentably distinct from each other because 8217025 claim 1 is to a method of identifying a compound for treating a condition in a mammal and dependent claim 14 claims where the compound is 17α-ethynylandrost-5-ene-3β,7β,17β-triol. The disclosure supporting the claims describe the conditions as including improving cognitive abilities (Example 26). One of ordinary skill in the art construing the scope of the claims would have considered the specification’s teaching of the particular conditions and in view of the secondary references (as detailed in the 35 USC 103 rejection supra) arrive at the claimed invention with a reasonable expectation of success.
Claims 8, 52-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8354396 in view of Reading et al. (Neurodegener. Dis.Manag. (2021) 11(4), 289–298, Published 12 Jul 2021) and Shen et al. (J Neurol Neurosurg Psychiatry 2019;90:590–598). Although the claims at issue are not identical, they are not patentably distinct from each other because 8354396 claim 1 is to a method of treating inflammation by administering 17α-ethynylandrost-5-ene-3β,7β,17β-triol. The disclosure supporting the claims describe the conditions as including improving cognitive abilities (Example 26). One of ordinary skill in the art construing the scope of the claims would have considered the specification’s teaching of the particular conditions and in view of the secondary references (as detailed in the 35 USC 103 rejection supra) arrive at the claimed invention with a reasonable expectation of success.
Claims 8, 52-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18511027 (reference application) in view of Reading et al. (Neurodegener. Dis.Manag. (2021) 11(4), 289–298, Published 12 Jul 2021) and Shen et al. (J Neurol Neurosurg Psychiatry 2019;90:590–598). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim is to a method of treating neurodegenerative condition by administering 17α-ethynylandrost-5-ene-3β,7β,17β-triol. The disclosure supporting the claims describe the conditions as including neurodegeneration (Specification pages 16-18). One of ordinary skill in the art construing the scope of the reference application claims would have considered the specification’s teaching of the particular conditions and in view of the secondary references (as detailed in the 35 USC 103 rejection supra) arrive at the claimed invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8, 52-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of copending Application No. 19055380 (reference application) in view of Reading et al. (Neurodegener. Dis.Manag. (2021) 11(4), 289–298, Published 12 Jul 2021) and Shen et al. (J Neurol Neurosurg Psychiatry 2019;90:590–598). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim is to a method of treating neurodegenerative condition by administering 17α-ethynylandrost-5-ene-3β,7β,17β-triol. One of ordinary skill in the art construing the scope of the reference application claims would have considered the specification’s teaching of the particular conditions and in view of the secondary references (as detailed in the 35 USC 103 rejection supra) arrive at the claimed invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks - Double Patenting Rejections
Applicant similarly argues that the claims as amended are not obvious over copending applications because the amended claim language is not present in the copending applications. This argument is not persuasive because as detailed in the 35 USC 103 rejection supra, one of ordinary skill in the art would have combined the teaching of Reading with the copending claims in view of Shen and arrive at the claimed invention with a reasonable expectation of success. Furthermore, as per MPEP 803.02, a double patenting rejection is proper, for example, until a terminal disclaimer is filed or the claims are amended to be patentably distinct.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626