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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 05/04/2026.
Election/Restrictions
Applicant’s election in the Reply filed on 05/04/2026 of Group II, claims 28 and 35-47 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 § 818.03(a)).
Applicant has elected in the Reply filed on 05/04/2026 the following species:
A. the auxotrophic polypeptide is LEU2 (claims 36-37)
B. the gene is CFTR (claim 40)
Claims 1, 18, 20-21, 26, 28 and 35-47 are pending.
Claims 1, 18, 20-21 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/04/2026.
Claims 28 and 35-47 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 - 2nd paragraph
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28 and 35-47 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims 35-47 depend directly or indirectly from claim 28.
Claim 28, states "wherein said (i) and said (ii)" which lacks antecedent basis. Clarification and/or correction is required.
Claim 28 is indefinite and unclear in their recitation for being incomplete by omitting essential steps or ingredients, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 28 lacks any active method steps.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 28 and 35-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea (mental processes), without significantly more. Claims 35-47 depend directly or indirectly from claim 28.
The claim 28 limitations directed to an abstract idea (mental processes) are determining translation of a functional reporter polypeptide in a cell expressing a polynucleotide comprising: (i) a nucleic acid sequence encoding a reporter polypeptide comprising a heterologous nucleic acid sequence introducing an in-frame premature stop codon comprising an adenosine preventing translation of said functional reporter polypeptide; and (ii) an additional nucleic acid sequence heterologous to said reporter polypeptide having at least 60 % complementarity to said nucleic acid sequence comprising said in-frame premature stop codon; wherein said (i) and said (ii) are transcribed as a single transcript and wherein conversion of said adenosine to inosine by RNA editing enables translation of said functional reporter polypeptide, wherein when said cell is not expressing an ADAR capable of editing RNA in said cell the method comprises expressing in said cell a polynucleotide comprising a nucleic acid sequence encoding ADAR capable of editing RNA in said cell prior to said determining, wherein said translation above a predetermined threshold indicates said (ii) is a suitable antisense for site-directed RNA editing of said in-frame premature stop codon.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Claim Rejections - 35 USC § 102
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.
Claims 28 and 35-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mali et al. (09/07/2018) PCT International Patent Application Publication WO 2018/161032 A1 cited in the 1/30/2025 IDS (hereinafter referred to as "Mali").
With regards to claims 28 and 35-47, Mali teaches:
a) as in claims 28 and 35-47, a method of identifying an antisense suitable for site-directed RNA editing, the method comprising determining translation of a functional reporter polypeptide in a cell expressing a polynucleotide comprising: (i) a nucleic acid sequence encoding a reporter polypeptide comprising a heterologous nucleic acid sequence introducing an in-frame premature stop codon comprising an adenosine preventing translation of said functional reporter polypeptide; and (ii) an additional nucleic acid sequence heterologous to said reporter polypeptide having at least 60 % complementarity to said nucleic acid sequence comprising said in-frame premature stop codon; wherein said (i) and said (ii) are transcribed as a single transcript and wherein conversion of said adenosine to inosine by RNA editing enables translation of said functional reporter polypeptide, wherein when said cell is not expressing an ADAR capable of editing RNA in said cell the method comprises expressing in said cell a polynucleotide comprising a nucleic acid sequence encoding ADAR capable of editing RNA in said cell prior to said determining, wherein said translation above a predetermined threshold indicates said (ii) is a suitable antisense for site-directed RNA editing of said in-frame premature stop codon; wherein said reporter polypeptide is an auxotrophic polypeptide; wherein said auxotrophic polypeptide is LEU2; wherein said reporter polypeptide is LEU2; wherein said reporter polypeptide confers resistance to an antibiotic; wherein said heterologous nucleic acid sequence introducing said in-frame premature stop codon is a specific nucleic acid sequence of a gene associated with a disease; wherein said gene is CFTR; wherein said heterologous nucleic acid sequence introducing said in-frame premature stop codon is 15 -120 nucleic acids long; wherein said at least 60 % complementarity is at least 80 % complementarity; wherein said (ii) comprises a mismatch with said adenosine; wherein said (ii) is 15 - 120 nucleic acids long; wherein said (i) is upstream of said (ii); being devoid of a nucleic acid linker between said (i) and said (ii); wherein said cell is a yeast cell (see Abstract, Figure 16 and [0147] to [0284]).
Thus, Mali anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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