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 .
Priority
Acknowledgment is made of applicant’s claim for priority based on a provisional application filed as 63/154,313 on 02/26/2021.
All claims are given the priority date of 02/26/2021.
Application Status
Receipt is acknowledged of amendment, filed 05/06/2026. Claims 1-19 are currently pending.
Election/Restriction
Applicant’s election of Group I, drawn to claims 1-10, in the reply filed on 05/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/06/2026.
Therefore, claims 1-10 are currently under examination.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 09/26/2023 have been received and all references have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, specifically at Page 29, paragraph 3 of the specification filed on 08/09/2023. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “and or” within the claim. The claim should be amended to recite “and/or”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 4 is 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.
Claim 4 is indefinite for being incomplete in themselves. It is noted that “Figure 1” recited in claim 4 is merely populated exclusively by sequences, and there is no reason, other than inconvenience, that the sequences cannot be recited in the claims.
See MPEP 2173.05(s): “Where possible, claims are to be complete in themselves.
Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” (emphasis added). Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, and 7-10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Baker et al (WO 2012/153135 A1) as evidenced by Grunweller et al (Nucleic Acids Res. 2003 Jun 15;31(12):3185-93) and Segura-Ibarra et al (J Control Release. 2017 September 28; 262: 18–27).
Regarding claim 1, Baker teaches an antisense oligonucleotide as a miR-145 inhibitor which showed an increased expression of BMPR2 [008 and 0031-0032] and (Page 77, Figure 19C).
Regarding claims 2 and 5, Baker teaches that the antisense oligonucleotides targeting miR-145 comprise a combination of LNA and DNA nucleotides in order to confer enhanced thermal stability [008 and 0037]. Grunweller is only cited to show that LNA of the antisense oligonucleotide would increase stability in bodily fluids as well as in vivo stability (Page 3185, Column 2).
Regarding claim 7, Baker teaches the ASO is delivered to a cell in an expression vector [0046].
Regarding claim 8, Baker teaches the administration of the composition by intradermal, subcutaneous, intramuscular, intraperitoneal, intraarterial, or intravenous injection [0057] as well as through inhalation such as by dry, powder or liquid aerosol [0010-0011].
Regarding claim 9, Baker teaches the composition comprised within a nanocapsule and aerosolized for administration via inhalation [0055].
Regarding claim 10, Baker teaches the composition comprised within a nanocapsule and suitable injection administration [0055]. Segura-Ibarra is only cited to show that nanotherapeutics, such as nanocapsules, are suitable for intracardiac administration (Page 3, Paragraph 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al (WO 2012/153135 A1) as evidenced by Grunweller et al (Nucleic Acids Res. 2003 Jun 15;31(12):3185-93) and Segura-Ibarra et al (J Control Release. 2017 September 28; 262: 18–27) in view of Liang et al (Nucleic Acids Research, 2017, Vol. 45, No. 16; 9528-9546) and Chew et al (WO 02/16398 A2).
The teachings of Baker are as described and applied above.
Regarding claims 3, 4 and 6, Baker teaches that the antisense oligonucleotides targeting miR-145 comprise a combination of LNA and DNA nucleotides in order to confer enhanced thermal stability [008 and 0037]. Baker teaches the composition comprised within a nanocapsule and suitable injection administration [0055]. Segura-Ibarra is only cited to show that nanotherapeutics, such as nanocapsules, are suitable for intracardiac administration (Page 3, Paragraph 1). Therefore, the nanocapsules would be a biologically compatible carrier of the composition.
Baker does not teach that the antisense oligonucleotide works by interacting with BMPR2 itself but instead it inhibits the miR-145 that interacts with and suppresses BMPR2.
Liang teaches that by targeting the 5’UTR inhibitory elements, such as the upstream open reading frame, can prevent inhibitory proteins from binding or altering disruptive secondary structures, thereby allowing translation initiation factors to access the start codon more efficiently and increase expression of the encoded protein (Page 9532, Column 1 bridging Column 2).
Liang does not teach the specific use of the antisense oligonucleotide to target the uORF-6 of BMPR2.
Chew teaches oligonucleotides targeting SEQ ID NO: 1 which comprises 100% sequence identity to instant SEQ ID NO: 35 (which is identified in the instant specification as uORF-6 of BMPR2 at Page 4, Paragraph 4) (Chew Page 7, Paragraph 5 and Page 13, Paragraph 3; See Appendix I).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baker to include the antisense oligonucleotide to specifically target the uORF-6 of BMPR2 as taught by Liang and Chew because Baker teaches it is within the ordinary skill in the art to use an miR inhibitor to inhibit the miRNA that target and suppress BMPR2, Liang teaches that by targeting the 5’UTR inhibitory elements directly, such as the upstream open reading frame, can prevent inhibitory proteins from binding or altering disruptive secondary structures, thereby allowing translation initiation factors to access the start codon more efficiently and increase expression of the encoded protein and Chew teaches oligonucleotides that target SEQ ID NO: 1 which comprises 100% identity to instant SEQ ID NO: 35 identified in the instant specification as the uORF-6 of BMPR2.
One would have been motivated to make such a modification in order to receive the expected benefit of direct targeting of the uORF-6 of BMPR2 using antisense oligonucleotides as taught by Liang and Chew.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
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