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
This application is a national stage entry of 35 U.S.C. 371 of PCT/JP2023/011709 (filed on 03/24/2023), which claims benefit to foreign application JAPAN 2022-050212 (filed on 0325/2022).
Claims Status
The preliminary amendment filed on 9/16/2024 has been received and entered into the application. Claims 1-11 are pending and have been examined on the merits.
Drawings
The drawings filed on 09/16/2024 are objected to because they contain color images, but there is no granted petition for color drawings.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claims 1-7 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cawood et al (US 2021/0163987 A1; as cited in IDS filed on 09/22/2025).
Cawood et al discloses nucleic acid molecules comprising cap and rep genes both operably linked with the same promoter and host cells comprising the nucleic acid molecule (See, Abstract).
Regarding claim 1, Cawood et al discloses a nucleic acid molecule comprising a promoter, a rep and a cap gene in 5’ to 3’, such that the cap gene and the rep gene are both operably linked with an internal ribosome entry site (IRES) (See, ¶0024-0028). This reads on, a nucleic acid construct comprising…an adeno-associated (AAV) Cap protein-coding sequence operably linked to the promoter.
Cawood et al discloses the cap and rep genes are both operably linked with the same promoter upstream of the cap and rep genes, and in some embodiments is an inducible promoter (See, ¶0086). This reads on, …comprising an inducible promoter.
Regarding claims 2 and 6, following the discussion above, Cawood et al further discloses the inducible promoter element comprises a plurality of Tet operator sequences which there Tet repressor protein (TetR) is capable of binding, such that in a bound state, transcription is suppressed and in the presence of doxycycline or tetracycline suppression is alleviated and the promoter allows for transcription (See, ¶0088-0089). This reads on, wherein the inducible promoter is a promoter to which a tetracycline response element sequence is operably linked, of claim 2. This also reads on, wherein the inducible promoter is a promoter to which a tetracycline response element sequence is operably linked, of claim 6.
Regarding claims 3-4 and 10, following the discussion above, Cawood et al discloses a mammalian cell comprising the nucleic acid molecule of the invention, plasmid or vector. The nucleic acid molecule may be stably integrated into the nuclear genome of the cell. Where the mammalian cell can be HEK-293, HEK-293T, or HEK-293E (See, ¶0144-0148). This reads on, a cell comprising the nucleic acid construct according to claim 1, of claim 3. This also reads on, wherein the cell is derived from a human 293 cell, of claim 4. This further reads on, a cell comprising the nucleic acid construct according to claim 2, of claim 10.
Regarding claim 5, following the discussion above, Cawood et al discloses a method for producing AAVs comprising, (a) introducing Transfer plasmid of transgene flanked by ITRs into an AAV packaging cell, the AAV packaging cell comprising the nucleic acid molecule of the invention, and helper genes for packaging the Transfer plasmid into the cell genome, This reads on, …culturing an AAV producer cell, wherein the AAV producer cell comprises nucleic acid construct comprising inducible promoter and an AAV Cap protein-coding sequence operably linked to the promoter, as that is the nucleic acid molecule of the invention.
(b) culturing the cell under conditions such that AAVs are assembled and secreted by the cell, This reads on, …(b) inducing the expression of the AAV Cap protein in the cell obtained by step (a); (c) culturing the cell obtained by step (b) to produce recombinant AAV vector.
and (c) harvesting packaged AAVs from the supernatant (See, ¶0155-0159). While the proposed method of Cawood et al is for harvesting the secreted AAVs, to produce these, Cawood et al would need to produce recombinant AAVs that secret the nucleic acid construct. Therefore, the method reads on, a method for producing a recombinant AAV vector.
Regarding claims 7 and 11, following the discussion above, Cawood et al disclosed the inducible promoter element comprises a plurality of Tet operator sequences which there Tet repressor protein (TetR) is capable of binding, such that in a bound state, transcription is suppressed and in the presence of doxycycline or tetracycline suppression is alleviated and the promoter allows for transcription (See, ¶0088-0089). Therefore, Cawood et al teaches inducing the expression of the AAV Cap protein by contacting the cell with doxycycline or tetracycline of claims 7 and 11.
Therefore claims 1-7 and 10-11 are anticipated by Cawood et al.
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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cawood et al (US 2021/0163987 A1; as cited in IDS filed on 09/22/2025) as applied to claims 1-7 and 10-11 above.
The teachings of Cawood et al are set forth above.
Regarding claims 8-9, following the discussion above, Cawood et al does not teach the time frame of which the AAV producer cell is induced after the culturing if the AAV producer cell in the method of producing recombinant AAV vector.
While Cawood et al is silent on when the cells are induced after culturing, the time frame of induction after in the beginning of culturing of the AAV producer cell is considered to be prima facie obvious, as the instant claim requires 6 to 36 hours after the start of step (a) (claim 8) or 8 to 24 hours after the start of step (a) (claim 9). One of ordinary skill in the art would have been able to induce the AAV producer cells to produce a recombinant AAV vector. As such, the timing of induction of the AAV producer cells after culturing begins for the limitations would have been a matter of routine optimization (See, MPEP 2144.05).
Therefore, claims 8-9 are rendered obvious by Cawood et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Caroline M Lara whose telephone number is (571)272-4262. The examiner can normally be reached 7:00 to 4:30pm M-Th.
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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