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 January 22, 2026.
Currently, claims 1, 4-5, 12, 14-15, 27-28, 32, 38, and 40 are pending in the instant application. Claims 5, 28, 32, and 40 are withdrawn from further consideration as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Accordingly, claims 1, 4, 12, 14-15, 27, and 38 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - Improper Markush Grouping
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected for containing an improper Markush grouping of alternatives for the reasons as set forth in the Office action mailed on July 22, 2025 and for the reasons set forth below.
Applicant's arguments filed on January 22, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as currently amended recite a proper Markush grouping as they no longer recite four or more bases but only recite three bases. Contrary to applicant’s argument, the amended claims are not sufficient to overcome the instant rejection because the species do not have a commonly shared structural similarity, nor do they have a common use. For instance, “GAA” requires unit recognition reagents 6, 13, and 14, whereas “CGG” requires unit recognition reagents 3, 4, and 5. That is, the recited “unique recognition reagent sequence” species recognize/bind very different repeat units associated with different pathological diseases. Accordingly, this rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. in view of Bahal and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 and for the reasons set forth below.
Applicant's arguments filed on January 22, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because the combination of the cited references does not suggest the claimed genetic recognition reagent forming a triplex structure from a double-stranded RNA hairpin. In so arguing, applicant merely addresses Ly’s abstract and Figures 5-6. That is, applicant did not provide any persuasive rebuttal arguments as to how the combined teachings of Ly, Bahal, and Ficht fail to render obvious the instantly claimed structural limitations. Note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Note that a double-stranded hairpin structure comprising “CUG” repeats hybridizing with a 5’-CAG or (3’-GAC) gPNA oligomer “via strand invasion” was known and taught by Bahal.
It is further noted that the newly added limitation “where the sequence of three bivalent nucleobases binds to both hybridized strands of a double-stranded RNA hairpin to form a triplex structure, wherein the double-stranded RNA hairpin is formed from a repeat expansion sequence associated with a repeat expansion disease” is a mere property that is inherent to “3-4-8” (JB3-JB4-JB8) as expressly evidenced by the instant specification’s disclosure that “a triplex “hairpin” structure” is induced by “the listed recognition reagent” in “Table C”, which expressly contains “3-4-8”. See paragraph 0073. Since the 3-4-8 structure rendered obvious in the instant rejection is expressly disclosed as being inherently able to from a triplex hairpin structure as evidenced by the instant specification’s disclosure, it is concluded that the 3-4-8 structure rendered obvious in the instant rejection inherently satisfies the aforementioned limitation, absent objective evidence to the contrary.
Applicant points out paragraphs 0073 and 0077 of the published application and argues that the claims as amended are not obvious because the claimed reagent can from a triplex hairpin structure. It is noted that the paragraphs pointed out by applicant are not sufficient to rebut the instant ground of rejection for the reasons stated above. To briefly reiterate, the triplex hairpin structure formation was taught and known as evidenced by Bahal, and furthermore, the very same paragraph, paragraph 0073, appears to disclose that the 3-4-8 structure inherently has the ability to form the instantly claimed structure.
In view of the foregoing, this rejection is maintained.
Double Patenting
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-39, 41, and 50-57 of U.S. Patent No. 10,221,216 B2 for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 31-36 of U.S. Patent No. 10,370,415 B2 in view of Bahal and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,236,130 B2 in view of Bahal and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,319,349 B2 in view of Bahal and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,603,369 B2 in view of Ly et al., Bahal, and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
Claims 1, 4, 12, 14-15, 27, and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,859,242 B2 in view of Ly et al., Bahal, and Ficht et al. for the reasons as set forth in the Office action mailed on July 22, 2025 because applicant did not provide any rebuttal arguments addressing the supposed errors of this rejection.
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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/DANA H SHIN/Primary Examiner, Art Unit 1635
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