DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on March 27, 2026.
Currently, claims 1-2, 5, 83, 87, 120, 155, and 168 are pending and 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
Claims 2 and 5 remain rejected under pre-AIA 35 U.S.C. 112, first paragraph as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as amended are sufficient to overcome the rejection as the amended limitations are supported by the specification by pointing out pages 56, 57, and 66. In response, it is noted that the passages specifically pointed out by applicant are merely generic without a particular relevance to the instantly claimed oligonucleotide targeting SNP rs6446723. That is, there is no written description in the passages pointed out by applicant that can objectively rebut the ground of rejection set forth in the last Office action, which expressly referred to the very specific teaching pertaining to “4 mismatches” for oligonucleotides targeting the instantly claimed SNP. Since applicant’s arguments merely pointing out generic description are not found persuasive, this rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious because the examiner had not met the burden of showing how one of ordinary skill in the art would have arrived at the three specific modification motifs as specifically arranged based on the teachings of Bennett and Freier. Contrary to applicant’s argument, the last Office action sets forth a detailed rationale as to the prima facie obviousness of applicant’s elected modification motif of “eekk-d8-kkeee”, wherein the 4-8-5 gapmer was an art-recognized structure and furthermore, the specific combination of the 4-mer modification motif of “eekk” in the 5’ wing region with the 5’-mer modification motif of “kkeee” in the 3’ wing region was deemed one of the “newly designed” wing modification motifs as evidenced by Freier’s “XXXX10” compound in Table 53 having the “eekk” in the 5’ wing in combination with the “kkeee” in the 3’ wing flanking the DNA gap region. That is, although the exact same “eekk-d8-kkeee” that is elected by applicant is not explicitly disclosed in Freier as Freir only explicitly disclosed “eekk-d7-kkeee”, the elected modification motif is an obvious variation when one pursues the 4-8-5 gapmer motif. Regarding the non-elected motif, “eeekk-d7-kkeee”, it was known in the art that the 5-mer “newly designed” wing region modification motifs for each of the 5’ wing and the 3’ wing is “eeekk” and “kkeee”, respectively, as evidenced by the compounds having 5’-mer wings in Freier’s Table 53. That is, “eeekk” is the one and only 5-mer newly designed modification motif for the 5’ wing region of a gapmer, and similarly, “kkeee” is the one and only 5-mer newly designed modification motif for the 3’ wing region of a gapmer, wherein “5-7-5” gapmer structure was an art-recognized gapmer structure for oligonucleotides targeting the HTT SNP rs6446723 as taught by Bennett. See page 13. Note that a “person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR. International Co. v. Teleflex Inc., 550 US 398, 421, 82 USPQ2d 1385, at 1397 (U.S. Supreme Court, 2007). As such, the mere fact that the same modification motifs recited in the instant claims are not explicitly disclosed in the cited art is not sufficient to show that a person of “ordinary creativity”, who is “not an automaton”, would not have been able to arrive at applicant’s elected species as well as non-elected species.
Applicant argues that the claims are not obvious because the examiner used impermissible hindsight because one of ordinary skill in the art has no reason to shorten Bennett’s SEQ ID NO:30 by two nucleotides and apply the claimed modification motifs. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Regarding the alleged nonobviousness of truncating the 19-mer sequence of Bennett’s SEQ ID NO:30 to 17 nucleotides in length, applicant’s attention is directed to the fact that Bennett expressly taught that the HTT SNP-targeting oligonucleotides are not whatsoever limited to the 19-mer sequence but can be short than 19 nucleotides in length including a 17-mer sequence or as short as a 15-mer sequence as set forth in the last Office action. Furthermore, the 17-mer gapmer structures of 4-8-5 and 5-7-5 claimed in the instant claims were art-recognized structures, wherein the specific modification motifs in each wing as arranged in the claims are nothing but prima facie obvious as such combination of “eekk” with “kkeee” was explicitly disclosed by Freier, and the 5-mer motif of “eeekk” for the 5’ wing region was the one and only newly designed modification motif as explained above. Hence, a person of ordinary skill in the relevant art with “ordinary creativity” having the knowledge and teachings provided by Bennett and Freier would have obtained the claimed subject matter with a reasonable expectation of success without any disclosure gleaned from the instant specification.
In view of the foregoing, this rejection is maintained.
Double Patenting
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 8,957,040 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,752,142 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,926,556 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,202,599 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,344,275 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Claims 1-2, 83, 87, 120, 155, and 168 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,865,413 B2 in view of Bennett et al. in view of Freier et al. for the reasons as set forth in the Office action mailed on October 1, 2025 and for the reasons stated below.
Applicant's arguments filed on March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103(a) rejection. In response, it is noted that applicant’s arguments provided in the §103(a) rejection are not found persuasive as explained above. Hence, this rejection is maintained.
Allowable Subject Matter
The modification motif, “ekek-d8-kekee”, is not deemed obvious under pre-AIA U.S.C. 103(a) when the combined teachings of Bennett and Frier (citations of record) are considered.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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