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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 09/17/2025 is acknowledged. The traversal is on the ground(s) that the “subject matter is neither taught nor suggested by the combination of cited references. As such, the technical feature linking Groups I-III is a special technical feature because it makes a contribution over the cited references (alone or in combination” (Response, page 2, para 1).
This is not found persuasive because the technical feature does not include any specific sequence including SEQ ID NO: 14. The common technical feature comprises simultaneously introducing into a plant cell an endonuclease designed for a desired genome modification (EDTGM) and a TaWOX, wherein said endonuclease and said TaWOX are introduced as protein or as its encoding mRNA; and allowing the EDTGM to modify the genome of said plant cell (see, for example, applicant’s Abstract). The invention becomes obvious in the light of the prior arts cited in the Office action dated 8/8/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-28 are pending.
Claims 16-28 are withdrawn from examination as being part of non-elected inventions.
Claims 1-15 are being examined.
All previous objections and rejections not set forth below have been withdrawn in view
of applicant’s amendments to the claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “a method for increasing efficiency of regenerating a genome edited plant cell into a plant…”. It is suggested to replace “into”, in line 2, with “in”.
Claim 1 also recites “a TaWOX”, in line 4. It is suggested to use the full form of TaWOX when the term is used in the claim set for the first time.
Appropriate correction is required.
Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Both claim 5 and claim 6 are dependent on claim 1 and are drawn to a TaWOX polypeptide comprising the sequence represented by SEQ ID NO: 14.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. (US 2020/0231977 A1) in view of Demirer et al. (Nanotechnology to advance CRISPR–Cas genetic engineering of plants, 2021, Nat. Nanotechnol., 16:243-250; published on 12 March 2021).
Claim 1 is drawn to a method for increasing regeneration efficiency of a plant by simultaneously introducing an endonuclease designed for a desired genome modification (EDTGM) and a TaWOX into a plant cell, wherein said endonuclease and said TaWOX are introduced as protein or as its encoding mRNA; wherein said TaWOX comprises at least 85% sequence identity to SEQ ID NO: 14.
Ye et al. teaches a method for improving transformation efficiency of a plant. The method comprises using a nucleic acid (which reads on to mRNA) encoding TaWOX5 protein (page 5, para 0124) comprising the amino acid sequence of SEQ ID NO: 2 (abstract; page 5, para 0124). It also teaches targeted genome editing using CRISPR-Cas technique (page 6, para 0149, line 1-3). Instant SEQ ID NO: 14 has at least 85% (as recited in claims 1 and 15) and at least 90% (as recited in claim 4) (99.4%) sequence identity to the naturally occurring (as recited in claim 9) TaWOX5 protein consisting of SEQ ID NO: 2, as taught by Ye et al. (page 10, para 0223; page 10, para 0228), as shown below.
RESULT 3
US-16-617-930-2
Sequence 2, US/16617930
Publication No. US20200231977A1
GENERAL INFORMATION
APPLICANT: INSTITUTE OF CROP SCIENCE, CHINESE ACADEMY
APPLICANT: OF AGRICULTURAL SCIENCES
TITLE OF INVENTION: METHOD FOR IMPROVING TRANSFORMATION EFFICIENCY
TITLE OF INVENTION: OF PLANT AND METHOD FOR TRANSFORMING PLANT
FILE REFERENCE: FA0392-18046
CURRENT APPLICATION NUMBER: US/16/617,930
CURRENT FILING DATE: 2019-11-27
PRIOR APPLICATION NUMBER: CN201710422896.6
PRIOR FILING DATE: 2017-06-07
NUMBER OF SEQ ID NOS: 24
SEQ ID NO 2
LENGTH: 210
TYPE: PRT
ORGANISM: Triticum aestivum
Query Match 99.4%; Score 1104; Length 210; Best Local Similarity 99.5%;
Matches 209; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MEALSGRVGVKCGRWNPTAEQVKVLTELFRAGLRTPSTEQIQRISTHLSAFGKVESKNVF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MEALSGRVGVKCGRWNPTAEQVKVLTELFRAGLRTPSTEQIQRISTHLSAFGKVESKNVF 60
Qy 61 YWFQNHKARERHHHKKRRRVASCSPDSSSNDEETGRAAAAEPADLVLQPPESKREARGYN 120
|||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||
Db 61 YWFQNHKARERHHHKKRRRVASCSPDSSSNDEETGRAAAAEPADLVLQPPESKREAGGYN 120
Qy 121 HHPRIMTCYVREVAEQEEATTWERPTREVETLELFPLKAACYDLELEADRFSRYVRSGEQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 HHPRIMTCYVREVAEQEEATTWERPTREVETLELFPLKAACYDLELEADRFSRYVRSGEQ 180
Qy 181 QCREISFFDVATGRDPPLELRLCSFDRYLV 210
||||||||||||||||||||||||||||||
Db 181 QCREISFFDVATGRDPPLELRLCSFDRYLV 210
99.4% sequence identity is interpreted as “substantially similar”, as recited in claim 9.
Ye et al. also describes a fusion protein by fusing TaWOX protein (SEQ ID NO: 2) with any other desired protein (page 9, para 0201; page 10, para 0209), which reads on to a “reporter protein”, as recited in claim 7.
Ye et al. describes regenerating plants from genome edited (transformed) plant cells (page 14, para 0287, line 8-10), as recited in claim 15. It also teaches increased regeneration efficiency from 0% (without TaWOX5 gene) up to 86.2% (with TaWOX5 fused with GUS reporter protein, as recited in claim 7) in immature embryos of maize variety B73 (page 14, para 0286, line 3-4; Table 4; page 14, para 0290, Table 5) transformed with vectors containing the TaWOX5 gene (page 14, para 0287, line 3-12) in “difficult to culture” (read on to “recalcitrant”, as recited in claim 14) maize variety B73 (page 15, para 0294, line 1-6), as recited in claim 13. Maize variety B73 is a well-known recalcitrant variety which does not either respond to transformation at all or respond very poorly.
However, Ye et al. does not explicitly describe simultaneously introducing an endonuclease designed for a desired genome modification (EDTGM) and a TaWOX, wherein said endonuclease and said TaWOX are introduced as protein or as its encoding mRNA into a plant cell.
Demirer et al. describes that transient expression of the CRISPR–Cas complex has been shown to result in fewer off-target mutations in bread wheat (Triticum aestivum L.) plant, no heritable DNA integration and hence a reduction of the regulatory burden (page 3, para 5, line 6-8). It teaches DNA-free genome editing in which the CRISPR-Cas complex is introduced directly into plant cells as preassembled ribonucleoproteins (RNPs) transfection using either protoplast transfection or particle bombardment (page 3, para 6, line 1-3), as recited in claim 12. It discusses the need to overcome low genome editing efficiencies (
≤
10
%
)
using such a method outside of a few well studied species (page 3, para 6, line 4-5).
Demirer et al. describes Cas9 and Cas12a endonucleases (reads on to EDTGM) used for genome editing using CRISPR-Cas technique (page 4, last para and page 5, first para), as recited in claim 10. It is known in the art, before the effective filing date of the invention, that both Cas9 and Cas12a (also known as Cpf1) belong to class 2 CRISPR-Cas endonuclease1, as recited in claim 11.
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the method described by Ye et al. by directly introducing an endonuclease (e.g. Cas9 or Cas12a) and the TaWOX5 polypeptide into a plant cell using particle bombardment, as described by Demirer et al., with a realistic goal to modify the genome of a plant cell and increase the regeneration efficiency of the genome edited plant cell (as recited in claim 15) while reducing off-target mutations and no heritable DNA integration and hence a reduction of the regulatory burden, as described by Demirer et al.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to directly introduce a specific endonuclease (e.g. Cas9 or Cas12a) and the TaWOX5 polypeptide into a plant cell using particle bombardment with a realistic goal to increase genome editing and regeneration efficiency of the genome edited plant cell while reducing off-target mutations and without any heritable DNA integration, and hence a reduction of the regulatory burden.
Regarding claims 2-3 and 8, Ye et al. teaches TaWOX5 protein, which is known to be a transcription factor2. It is an inherent property of a TaWOX5 mRNA to encode a TaWOX5 protein which inherently comprises Wuschel-like InterPro family IPR044555 domain (as recited in claims 2 and 8), a WUS-box motif, and an ERF-associated amphiphilic repression (EAR) motif2 (as recited in claim 3) without needing any active step by the Applicant.
Regarding claims 5-6, Using any functional equivalent (functional homolog) of TaWOX5 polypeptide comprising more than 99.4% sequence identity, as described above, would have been an experimental design choice of an ordinarily skilled artisan. There are several functional homologues of the TaWOX5 polypeptide (e.g. OsTaWox5) described by Ye et al. (page 13, para 0279, line 7-8). Some of the functional homologues known in the prior art including GenBank Accession No. KF038331 comprise 100% sequence identity to instant SEQ ID NO: 14.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou can be reached at 571-272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Primary Examiner, Art Unit 1663
1Stella et al. (Class 2 CRISPR–Cas RNA-guided endonucleases: Swiss Army knives of genome editing, 2017, Nat. Struct. Mol. Biol., 24:882–892) provides the evidence that both Cas9 and Cas12a (Cpf1) belong to class 2 CRISPR-Cas endonuclease (abstract; page 882, left column, para 1, line 12-13).
2Li et al. (Identification of the WUSCHEL-Related Homeobox (WOX) Gene Family, and Interaction and Functional Analysis of TaWOX9 and TaWUS in Wheat, 2020, Int. J. Mol. Sci., 21:1581) provides the evidence that the WUSCHEL-related homeobox (WOX) proteins are transcription factors (Abstract) comprising several motifs and domains including WUS-Box motif and the EAR motif (page 4, para 5, line 10-12).