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 Application/Amendment/Claims
This Office action is in response to the communications filed on August 25, 2025.
Currently, claims 1-29 are pending in the instant application. Claims 28-29 are currently amended to be a treatment method, which is patentably indistinct from the inventive group II in the election/restriction requirement mailed on February 13, 2025. Hence, claims 21-26 and 28-29 are withdrawn from further consideration as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-20 and 27 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Response to Arguments
Applicant’s arguments with respect to previous rejections of record have been considered but are moot because they do not pertain to the new rejections set forth hereinbelow.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 and 27 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.
Claims 1-20 and 27 now recite “wherein the composition is configured to be administered to the mammal at a time interval of at least 50 days or at least 70, 90 or 120 days between administrations.” The claims do not particularly point out and distinctly claim the structural features/limitations that are required to be “configured to be administered to the mammal at a time interval of at least 50 days between administrations.” That is, the only structural limitation recited for the claimed composition is the “anti miR-134 oligonucleotide”, and there is no structural limitation as to the compositions’ structural configuration for providing “a time interval of at least 50 days between administrations” or “at least 70 days”, “at least 90 days”, or “at least 120 days” between administration. As such, the structural limitation required for providing the interval (50, 70, 90, 120 days) between administration cannot be clearly ascertained, thereby rendering the structural of the claimed composition indefinite.
Claims 6-7 depend from claim 1, which is currently amended to recite that the “anti miR-134 oligonucleotide” comprising “7” contiguous nucleotides has at least 80% sequence identity with SEQ ID NO:7, which is 19 nucleotides in length. It is noted that the oligonucleotide of “7” contiguous nucleotides complementary to SEQ ID NO:1 will not satisfy the “at least 80%” sequence identity to SEQ ID NO:7. For instance, a 7-mer sequence at positions 16-22 of SEQ ID NO:1 will only provide only about 26% sequence complementarity to the 19-mer sequence of SEQ ID NO:7 in view of the fact that only the 5-mer at positions 16-20 would be complementary to positions 1-5 of SEQ ID NO:7.
In addition, it is found that SEQ ID NO:4 is a 31-mer sequence that comprises SEQ ID NO:7. Hence, “7 to 22 contiguous nucleotides complementary to SEQ ID NO:4” will not comprise at least 80% sequence identity with SEQ ID NO:7 because the nucleotide sequence complementary to SEQ ID NO:4 will be complementary to, not identical to, SEQ ID NO:7. Accordingly, claims 6-7 recite structurally impossible/conflicting limitations, thereby rendering the structural metes and bounds of the “anti miR-134 oligonucleotide of any one of claims 1 to 5” unclear.
Claim 7 recites that the oligonucleotide comprises SEQ ID NO:6 or variants having at least 80% sequence identity with SEQ ID NO:6. It is noted that SEQ ID NO:6 is a 15-mer sequence. It is noted that SEQ ID NO:6 has only about 53% sequence identity with SEQ ID NO:7. As such, it is clear that claim 7 recites structurally impossible, conflicting limitations pertaining to the oligonucleotide, thereby rendering the claim indefinite.
Claim 12 recites that the oligonucleotide of claim 1 is “10” nucleotides in length. It is noted that a 10-mer sequence cannot satisfy the “at least 80%” sequence identity with SEQ ID NO:7, which is a 19-mer sequence. Hence, claim 12 recites structurally impossible, conflicting limitations pertaining to the oligonucleotide, thereby rendering the claim indefinite.
Claim 14 recites that the length of the oligonucleotide of claim 1 is “7 to 10 nucleotides.” It is noted that a 7-10-mer sequence cannot satisfy the “at least 80%” sequence identity with SEQ ID NO:7, which is a 19-mer sequence. Hence, claim 14 recites structurally impossible, conflicting limitations pertaining to the oligonucleotide, thereby rendering the claim indefinite.
Claim 16 recites that the anti miR-134 oligonucleotide of claim 1 is SEQ ID NO:8, which is a 15-mer nucleotide sequence of 5’-TGGTCAACCAGTCAC, whereas SEQ ID NO:7 is a 19-mer sequence of 5’-CCTCTGGTCAACCAGTCAC comprising the 15-mer sequence of SEQ ID NO:8 as underlined. Now, it is noted that applicant has expressly acknowledged on the record that “15 oligonucleotides that are common with SEQ ID. No: 7” does not have at least 80% sequence identity. See page 10 of the remarks filed on August 25, 2025. Hence, it appears that applicant deems the 78.95% sequence identity level between the 15-mer and the 19-mer does not qualify as the instantly recited “at least 80%” sequence identity level. As such, claim 16 that is expressly deemed as not satisfying the structural limitation of claim 1 as acknowledged on the record by applicant is found to recite structurally incompatible, inconsistent limitations, thereby rendering the claim indefinite.
Claims 17-18 recite “wherein the anti miR-134 oligonucleotide is administered”. The instant claims are directed to a composition. Hence, it is unclear how the actively recited method step relates to and further defines the claimed composition.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8-12, 15-16, 19-20, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elmen et al. (US 2010/0004320 A1, of record).
Solely for compact prosecution purpose, SEQ ID NO:8 having 78.95% sequence identity with SEQ ID NO:7 will be interpreted as satisfying the “at least 80%” sequence identity level recited in the instant claims in view of the fact that SEQ ID NO:8 is expressly claimed in claim 16.
Elmen teaches making a mixmer anti-miR-134 oligonucleotide of SEQ ID NO:121 in Table 2 at page 41 as copied below.
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It is noted that the above sequence is 100% identical to SEQ ID NO:8 claimed claim 16.
Elmen teaches that the disclosed oligonucleotide can comprise 5-methylcytosine and phosphorothioate linkages and is formulated as a pharmaceutical composition for treating a disease, wherein the oligonucleotide is administered “monthly or yearly, or even once every 2 to 10 years”. See paragraphs 0188, 0201, and 0326-0328.
It is noted that “for use in the treatment of a neurological disorder” recited in claim 27 is mere intended use of the claimed anti miR-134 oligonucleotide, wherein intended use is not a claim limitation, unless there is objective evidence that Elmen’s oligonucleotide formulated as a pharmaceutical composition is incapable of the intended use.
In addition, since all structural limitations of the instantly rejected claims as interpreted above are met by Elmen’s composition, it necessarily follows that the prior art’s composition is inherently configured for administration a time interval of at least 120 days, absent objective evidence to the contrary. Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, claims 1-6, 8-12, 15-16, 19-20, and 27 as interpreted in this rejection are described by Elmen et al.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8-13, 15-16, 19-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Elmen et al. (US 2010/0004320 A1, of record) in view of Kauppinen et al. (US 2011/0077288 A1, of record) and Henshall et al. (US 2014/0235696 A1, of record).
Solely for compact prosecution purpose, SEQ ID NO:8 having 78.95% sequence identity with SEQ ID NO:7 will be interpreted as satisfying the “at least 80%” sequence identity level recited in the instant claims in view of the fact that SEQ ID NO:8 is expressly claimed in claim 16.
Elmen teaches making a mixmer anti-miR-134 oligonucleotide of SEQ ID NO:121 in Table 2 at page 41 as copied below.
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It is noted that the above sequence is 100% identical to SEQ ID NO:8 claimed claim 16.
Elmen teaches that the disclosed oligonucleotide can comprise 5-methylcytosine and phosphorothioate linkages and is formulated as a pharmaceutical composition for treating a disease, wherein the oligonucleotide is administered “monthly or yearly, or even once every 2 to 10 years”. See paragraphs 0188, 0201, and 0326-0328.
Elmen does not teach that the oligonucleotide can be designed as “a totalmer”.
Kauppinen teaches that an oligonucleotide that inhibits miRNA activity can be “a totalmer or a mixmer”, wherein each dose/dosage is “a single administration” and wherein “the dosage interval” between each administration is at least “50” days, “70” days, “90” days, and “120” days. See paragraphs 0010, 0012, 0031, and 0078.
Henshall teaches that an antagomir of miR-134 or an antisense oligonucleotide that inhibits miR-134 is useful “in treating or preventing a neuronal pathology”. See paragraphs 0006, 0022-0023, 0027, 0050, and 0061.
It would have been obvious to one of ordinary skill in the art before the effective filing date to design Elmen’s mixmer of SEQ ID NO:121 as a totalmer. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make an alternative miR-134 inhibitory oligonucleotide, because a mixmer and a totalmer was art-recognized, functionally equivalent alternative antisense oligonucleotide designs for inhibiting miRNA activity as taught by Kauppinen. It would also have been obvious to one of ordinary skill in the art to reasonably expect the mixmer or totalmer comprising Elmen’s SEQ ID NO:121 to be configured for administrations at an interval of at least 120 days because it was art-recognized knowledge that miRNA inhibitory oligonucleotides can be administered at the dosage interval of 120 days as taught by Kauppinnen, and because an “yearly” administration of Elmen’s mixmer of SEQ ID NO:121 was also taught. In addition, one of ordinary skill in the art would have had reasonably understood and expected that Elmen’s SEQ ID NO:121 in the form of a mixmer or totalmer would be useful in the treatment of a neurological disorder as evidenced by the teachings of Henshall.
Accordingly, claims 1-6, 8-13, 15-16, 19-20, and 27 taken as a whole would have been prima facie obvious before the effective filing date.
Double Patenting
The text of the judicially created doctrine not included in this action can be found in a prior Office action.
Claims 1-6, 8-13, 15-16, 19-20, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,803,200 B2 in view of Kauppinen et al. (US 2011/0077288 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by and/or obvious over the ‘200 patent claims, which are drawn to using SEQ ID NO:5, which is 100% identical in sequence to SEQ ID NO:7 claimed in the instant case. Now, in order to use the “agent for inhibiting the activity of miR-134” that is SEQ ID NO:5 in the “method for treating epilepsy” as claimed in the ‘200 patent, the instantly claimed composition and the manufacturing method of the claimed composition are necessary, wherein it would have been obvious to formulate SEQ ID NO:5 of the ‘200 patent claims comprising SEQ ID NO:5 as “a totalmer or mixmer” in view of Kauppinen’s teachings, which also teach administering an anti-miRNA oligonucleotide at an interval of about 120 days. Since all structural limitations of the instantly rejected claims are met by the agent comprising SEQ ID NO:5 claimed in the ‘200 patent claims, it necessarily follows that the agent of the ‘200 patent claims is inherently configured for administration a time interval of at least 120 days, absent objective evidence to the contrary.
In the remarks filed on August 25, 2025, applicant argues that the rejection over the ‘200 patent claims is rendered moot in view of the claim amendments. Contrary to applicant’s argument, the limitation pertaining to “wherein the composition is configured to be administered” is not structurally claimed. Since the therapeutic agent comprising SEQ ID NO:5 required by the ‘200 patent claims fully satisfies the structural limitations recited in the instant claims, it necessarily follows that the agent of the ‘200 patent claims would inherently satisfy the aforementioned “wherein” clause, absent objective evidence to the contrary.
Claims 1-6, 8-13, 15-16, 19-20, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,066,664 B2 in view of Kauppinen et al. (US 2011/0077288 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by and/or obvious over the ‘664 patent claims. That is, in order to use the “agent for inhibiting the activity of miR-134” in the “method of treating a neurological condition” as claimed in the ‘664 patent, the instantly claimed composition and the manufacturing method of the claimed composition are necessary, wherein it would have been obvious to formulate the “agent” of the ‘664 patent claims comprising SEQ ID NO:5 as “a totalmer or mixmer” in view of Kauppinen’s teachings, which also teach administering an anti-miRNA oligonucleotide at an interval of about 120 days. Since all structural limitations of the instantly rejected claims are met by the agent comprising SEQ ID NO:5 as encompassed by the ‘664 patent claims, it necessarily follows that the agent of the ‘664 patent claims is inherently configured for administration a time interval of at least 120 days, absent objective evidence to the contrary.
In the remarks filed on August 25, 2025, applicant argues that the rejection over the ‘664 patent claims is rendered moot in view of the claim amendments. Contrary to applicant’s argument, the limitation pertaining to “wherein the composition is configured to be administered” is not structurally claimed. Since the therapeutic agent comprising SEQ ID NO:5 encompassed by the ‘664 patent claims fully satisfies the structural limitations recited in the instant claims, it necessarily follows that the agent of the ‘664 patent claims would inherently satisfy the aforementioned “wherein” clause, absent objective evidence to the contrary.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635