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 .
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: the limitation ‘wherein the miR-144 antagomir or miR-451 antagomir has a nucleotide sequence of any one of SEQ ID NOs: 7-22’ is incorrect because miR-144 and miR-451 cannot both contain SEQ ID NO: 7-22. The specification indicates that miR-144 and miR-451 have different nucleotide sequences. Thus, they cannot both be any one of SEQ ID NOs: 7-22. See Tables 2-4. Suggest amending the claim so each miR sequence corresponds to their respective SEQ ID NOs:. Appropriate correction is required.
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over UNIV YANGZHOU CN105854017 (('017), cited on an IDS, see English translation, pages 1- 40) taken with Olson et al. (US 20140011859, cited on an IDS).
'017 teaches a method of treating beta-thalassemia in a subject comprising providing a reagent to the subject, wherein the reagent reduces expression level of miR- 144/451 genes or the amount of miR-144/451 (pages 7-17 and 35-39 of English translation). '017 provides antisense sequences for miR-144 and miR-451 (page 17). Claim 7 of '017 on pages 36-37 recite a method of treating beta-thalassemia using a reagent that reduces expression and/or function of the mature sequence of miR-144 and miR-451, wherein the reagent is shRNA, siRNA, RNAi, antisense sequence, LNA technology and CRISPR-Cas9.
'017 does not specifically teach using an antisense oligonucleotide that is complementary to a miR-144 and/or miR-451 (also known as miR-144 antagomir or miR-451 antagomir) in the method.
However, antagomirs (RNA sequences) were well known to a person of ordinary skill in the art to reduce expression and/or function of a microRNA in a cell or a subject as taught by Olson (pages 1-11). Olson teaches using anti-mir 451 (also known as miR-451 antagomir) to treat a disorder (polycythemias) in a subject.
It would have been prima facie obvious to a person of ordinary skill in the art before the time of the effective filing date to combine the teaching of '017 taken with Olson to use an antisense oligonucleotide that is complementary to miR-144 and an antisense oligonucleotide that is complementary to miR-451 to treat beta-thalassemia in a subject in need thereof to observe an additive effect in treating thalassemia in a subject in need thereof.
‘017 teaches an antisense sequence that would read on instant SEQ ID NO: 10 (Qy) (pages 16-17).
Antisense sequence of miR-451a (Db) mature sequence: 5' –
(Db) AACTCAGTAATGGTAACGGTTT-3'
(Qy) 1 guaaugguaacgguuu 16
The length of the sequence is not limited to any particular sequence length because of the limitation ‘has a nucleotide sequence of any one of SEQ ID NOs: 7-22’ reads on any nucleotide sequence comprising any SEQ ID NO: 7-22. One of ordinary skill in the art would have been motivated to use any sequence that has the seed sequence (a short highly, conserved region of RNA that is essential for recognizing and binding to a target mRNA) of either miR to reduce expression of either miR in the subject in need thereof. Since reducing either microRNA can treat beta-thalassemia as taught by '017, one of ordinary skill in the art would have been motivated to combine the teaching as a simple substitution to treat beta thalassemia using miR-144 and miR-451 antagomirs to reduce expression of miR-144 and miR-451 in the subject. See also MPEP 2143(I)A: Combining prior art elements according to known methods to yield predictable results and B: (B) Simple substitution of one known element for another to obtain predictable results). With respect to the limitation removing excess free α-globin in beta-thalassemic erythroid cells comprising contacting the erythroid cells with an effective amount' in the pre- amble of claim 1, the method made obvious by '017 taken with Olson would inherently have this functional limitation or be a latent property of the method because '017 taken with Olson makes obvious the claimed method steps. In addition, the specification does not appear to provide a definition for the term 'effective amount'. In view of the BRI, the amount reads on any amount that reduces expression and/or function of miR-144 and miR-451 reads on the term.
Therefore the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Response to Arguments
Applicant's arguments filed 7/15/26 have been fully considered but they are not persuasive.
Applicant argues that the combination of Yangzhou and Olson does not teach or suggest the use of a miR-144 antagomir and a miR-451 antagomir in the treatment of beta-thalassemia as claimed. The combination of these two references fail to make claims 1 and 2 obvious (see MPEP 2143.03).
Applicant’s arguments are not found persuasive because the amendment to the claimed method (beta-thalassemic erythroid cells and the miR-144 antagomir or miR-451 antagomir has a nucleotide sequence of any one of SEQ ID NOs: 7-22) is made obvious by Yangzhou and Olson. See the 103 rejection set forth above, incorporated herein.
The arguments does not explain how the rejection should be withdrawn in view of MPEP2143.03 All Claim Limitations must be considered. The Office has addressed all of the limitations of the pending claims.
Conclusion
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.
See attached PTO-326 for disposition of claims.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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