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 .
Claim Status Summary
Claims 1- 21 are pending.
Claims 1- 4, 8- 11, and 15- 18 are withdrawn.
Claims 5- 7, 12- 14, and 19- 21 are examined on the merits.
Claims 5- 7, 12- 14, and 19- 21 are rejected.
No Claims are allowed.
Claims 1- 4, 8- 11, and 15- 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2026 June 10.
Applicant’s election without traverse of invention Group II, species (A) Huntington's Disease; species (B) SEQ ID NO: 134; species (C) SEQ ID NO: 2; species (D) SEQ ID NO: 91; and species (E) a vector in the reply filed on 2026 June 10 is acknowledged.
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)(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.
Claim(s) 5, 6, 7, 12, 13, 14, 19, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hsu (Hsu US 20250283112 A1, effectively filed 2022 May 13).
Applicant is reminded they elected the species a vector mode of delivery.
Regarding claim 5, Hsu teaches claim limitation “A method of editing the target RNA sequence of claim 1 in a cell, the method comprising” with the following passages “The present disclosure provides a hybrid RNA molecule comprising a targeting region and a donor RNA [trans-splicing template] … the present disclosure is useful in methods of modifying a target RNA, which methods are also provided.” [0006]; and “the target sequence in the target RNA can be: (i) a nucleotide sequence in an exon … (iv) a nucleotide sequence in an intron;” [0060]; and “A hybrid RNA molecule is introduced into a cell (a target cell) comprising a target RNA” [0146].
Hsu further teaches the claim limitation “a) providing to the cell a vector comprising the trans-splicing template polynucleotide of claim 1,” and the claim limitation “b) providing to the cell a vector comprising a polynucleotide translating the Cas7-11 enzyme sequence of claim 1” and the claim limitation “c) providing to the cell a vector comprising a polynucleotide expressing the guide RNA sequence of claim 1” with the following passages “The present disclosure provides a recombinant expression vector comprising a DNA molecule of the present disclosure, … comprising: a) a first nucleotide sequence encoding a hybrid RNA molecule of the present disclosure; and b) a second nucleotide sequence encoding a CRISPR-Cas effector polypeptide” [0127]; and “A suitable Type III CRISPR-Cas effector polypeptide is a Cas7-11 polypeptide” [0073]. The claim limitation of the gRNA of claim 1 recites “a guide RNA sequence that is complementary to a portion of the intron or exon sequence of the target RNA sequence that is upstream, downstream, or overlapping of the portion of the intron or exon sequence that is complementary to the cargo guide sequence.” This limitation’s broadest interpretation includes any sequence complimentary to the target RNA. Furthermore, the term “coupled” (in claim 1) is broadly interpreted to include the meaning “complexed with,” for example a Cas enzyme functions by complexing with (coupling) a gRNA.
Hsu further teaches the claim limitation “d) editing the target RNA sequence via 3′ trans-splicing” with the following passages “the target sequence in the target RNA can be: … (iii) a nucleotide sequence in a 3′ splice sequence;” [0060]; and “FIG. 6A-6C schematically depict 3′ trans-splicing (FIG. 6A)” [0012].
Regarding claim 6, Hsu teaches elements of claim 5 and further teaches the claim limitation “A method of treating or preventing a genetically inherited disease in a subject in need thereof, the method comprising administering to the subject an effective amount of” with the following passages and “a method of the present disclosure comprises administering to an individual in need thereof an effective amount of a hybrid RNA molecule of the present disclosure,” [0147]; and “A method of the present disclosure can be used to treat any genetic disease” [0159].
Hsu further teaches the claim limitation “a) vector comprising the trans-splicing template polynucleotide of claim 1” and claim limitation “b) a vector comprising a polynucleotide translating the Cas7-11 enzyme sequence of claim 1” and claim limitation “c) a vector comprising a polynucleotide expressing the guide RNA sequence of claim 1” as described above (in claim 5).
Applicant is reminded they elected the species Huntington’s Disease.
Regarding claim 7, Hsu teaches elements of claim 6 and further teaches the instant claim limitation “Examples of diseases that can be treated using a method of the present disclosure include Huntington's Disease,” [0158].
Applicant is reminded they elected the species a vector mode of delivery.
Regarding claim 12, Hsu teaches claim limitation “A method of editing the target RNA sequence of claim 8 in a cell, the method comprising” with the following passages “The present disclosure provides a hybrid RNA molecule comprising a targeting region and a donor RNA [trans-splicing template] … the present disclosure is useful in methods of modifying a target RNA, which methods are also provided.” [0006]; and “the target sequence in the target RNA can be: (i) a nucleotide sequence in an exon … (iv) a nucleotide sequence in an intron;” [0060]; and “A hybrid RNA molecule is introduced into a cell (a target cell) comprising a target RNA” [0146].
Hsu further teaches the claim limitation “a) providing to the cell a vector comprising the trans-splicing template polynucleotide of claim 8” and the claim limitation “b) providing to the cell a vector comprising a polynucleotide translating the Cas7-11 enzyme sequence of claim 8” and the claim limitation “c) providing to the cell a vector comprising a polynucleotide expressing the guide RNA sequence of claim 8” with the following passages “The present disclosure provides a recombinant expression vector comprising a DNA molecule of the present disclosure, … comprising: a) a first nucleotide sequence encoding a hybrid RNA molecule of the present disclosure; and b) a second nucleotide sequence encoding a CRISPR-Cas effector polypeptide” [0127]; and “A suitable Type III CRISPR-Cas effector polypeptide is a Cas7-11 polypeptide” [0073].
Hsu further teaches the claim limitation “d) editing the target RNA sequence via 5′ trans-splicing” with the following passages “the target sequence in the target RNA can be: … (ii) a nucleotide sequence in a 5′ splice sequence;” [0060]; and “FIG. 6A-6C schematically depict … 5′ trans-splicing (FIG. 6B)” [0012]. The claim limitation of the gRNA of claim 1 recites “a guide RNA sequence that is complementary to a portion of the intron or exon sequence of the target RNA sequence that is upstream, downstream, or overlapping of the portion of the intron or exon sequence that is complementary to the cargo guide sequence.” This limitation’s broadest interpretation includes any sequence complimentary to the target RNA. Furthermore, the term “coupled” (in claim 8) is broadly interpreted to include the meaning “complexed with,” for example a Cas enzyme functions by complexing with (coupling) a gRNA.
Regarding claim 13, Hsu teaches elements of claim 12 and further teaches the claim limitation “A method of treating or preventing a genetically inherited disease in a subject in need thereof, the method comprising administering to the subject an effective amount of” with the following passages and “a method of the present disclosure comprises administering to an individual in need thereof an effective amount of a hybrid RNA molecule of the present disclosure,” [0147]; and “A method of the present disclosure can be used to treat any genetic disease” [0159].
Hsu further teaches the claim limitation “a) a vector comprising the trans-splicing template polynucleotide of claim 8” and claim limitation “b) vector comprising a polynucleotide translating the Cas7-11 enzyme sequence of claim 8” and claim limitation “c) a vector comprising a polynucleotide expressing the guide RNA sequence of claim 8” as described above (in claim 12).
Applicant is reminded they elected the species Huntington’s Disease.
Regarding claim 14, Hsu teaches elements of claim 13 and further teaches the instant claim limitation “Examples of diseases that can be treated using a method of the present disclosure include Huntington's Disease,” [0158].
Applicant is reminded they elected the species a vector mode of delivery.
Regarding claim 19, Hsu teaches claim limitation “A method of editing the target RNA sequence of claim 15 in a cell, the method comprising” with the following passages “The present disclosure provides a hybrid RNA molecule comprising a targeting region and a donor RNA [trans-splicing template] … the present disclosure is useful in methods of modifying a target RNA, which methods are also provided.” [0006]; and “the target sequence in the target RNA can be: (i) a nucleotide sequence in an exon … (iv) a nucleotide sequence in an intron;” [0060]; and “A hybrid RNA molecule is introduced into a cell (a target cell) comprising a target RNA” [0146].
Hsu further teaches the claim limitation “ a) providing to the cell a vector comprising the trans-splicing template polynucleotide of claim 15” with the following passages “as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents… reference to "a hybrid RNA molecule" includes a plurality of such molecules” [0050]; and “the target sequence of a MECP2 target RNA can be intron 1, intron 2, or intron 3.” [0162].
Hsu further teaches the claim limitation “b) providing to the cell a vector comprising a polynucleotide translating the first Cas7-11 enzyme sequence of claim 15” and the claim limitation “c) providing to the cell a vector comprising a polynucleotide translating the second Cas7-11 enzyme sequence of claim 15” and the claim limitation “d) providing to the cell a vector comprising a polynucleotide expressing the guide RNA sequence of claim 15” with the following passages “as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents… reference to "a hybrid RNA molecule" includes a plurality of such molecules” [0050] (this describes Hsu’s embodiment of their system with multiple Cas7-11 enzyme complexes); and “The present disclosure provides a recombinant expression vector comprising a DNA molecule of the present disclosure, … comprising: a) a first nucleotide sequence encoding a hybrid RNA molecule of the present disclosure; and b) a second nucleotide sequence encoding a CRISPR-Cas effector polypeptide” [0127]; and “A suitable Type III CRISPR-Cas effector polypeptide is a Cas7-11 polypeptide” [0073]. The claim limitation of the gRNA of claim 1 recites “a guide RNA sequence that is complementary to a portion of the intron or exon sequence of the target RNA sequence that is upstream, downstream, or overlapping of the portion of the intron or exon sequence that is complementary to the cargo guide sequence.” This limitation’s broadest interpretation includes any sequence complimentary to the target RNA. Furthermore, the term “coupled” (in claim 15) is broadly interpreted to include the meaning “complexed with,” for example a Cas enzyme functions by complexing with (coupling) a gRNA.
Hsu further teaches the claim limitation “e) editing the target RNA sequence via internal trans-splicing.” with the following passages “the target sequence in the target RNA can be: … (i) a nucleotide sequence in an exon (e.g., a nucleotide sequence encoding all or a portion of a polypeptide)” [0060]; and “FIG. 6A-6C schematically depict … internal trans-splicing (FIG. 6C)” [0012].
Regarding claim 20, Hsu teaches elements of claim 19 and further teaches the claim limitation “A method of treating or preventing a genetically inherited disease in a subject in need thereof, the method comprising administering to the subject an effective amount of” with the following passages and “a method of the present disclosure comprises administering to an individual in need thereof an effective amount of a hybrid RNA molecule of the present disclosure,” [0147]; and “A method of the present disclosure can be used to treat any genetic disease” [0159].
Hsu further teaches the claim limitation “a) a vector comprising the trans-splicing template polynucleotide of claim 15” and claim limitation “b) vector comprising a polynucleotide translating the first Cas7-11 enzyme sequence of claim 15” and claim limitation “c) vector comprising a polynucleotide translating the second Cas7-11 enzyme sequence of claim 15” and claim limitation “d) a vector comprising a polynucleotide expressing the guide RNA sequence of claim 15” as described above (in claim 19).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (Hsu US 20250283112 A1, effectively filed 2022 May 13) as applied to claims 19 and 20 above.
Hsu teaches all of the elements of claims 19 and 20 as described above.
Hsu further teaches “Examples of diseases that can be treated using a method of the present disclosure include Huntington's Disease,” [0158].
It would have been obvious for a person having ordinary skill in the art (PHOSITA) at the time of filing to have used Hsu’s trans-splicing method of treating a genetically inherited disease to further use the disease explicitly taught by Hsu in an alternative embodiment because is simply combining prior art elements according to known methods to yield predictable results. Hsu taught all of the elements of the method in different embodiments. Therefore, a PHOSITA would have recognized Hsu’s Huntington’s Disease was treatable with Hsu’s method. Therefore, they would have predicted the successful combination thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cheng (Cheng US 20230407281 A1, effectively filed 2019 May 16) discloses a similar invention as the instant invention that could reliably be used as prior art. Cheng discloses “The disclosure describes non-naturally occurring, engineered Type III-E [Cas7-11] CRISPR-Cas systems, components, and methods for targeted modification of DNA, RNA, and protein substrates” and “The CRISPR systems described herein can be used to modulate gene expression… such as RNA splicing (e.g., alternative splicing),” [0179].
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/AARON DUREL WARD/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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