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
Claims 1, 2, 8-10, 12-15, 17-20, 22-25 and 27 are pending and examined. Claims 3-7, 11, 16, 21 and 26 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 8-10, 12-15, 17-20, 22-25 and 27 REMAIN rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while arguably enabling for A. tumefaciens strain EHA105 comprising the plasmid designated “pVIRD5specKO” and a method for introducing said plasmid into a banana plant cell, does not reasonably provide enablement for the bacterium as broadly claimed or its use in the genus of plant cells as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
The instant claims are drawn broadly to an Agrobacterium that transfers nucleotide sequences to a plant cell comprising a nucleotide sequence encoding vir genes wherein the expression of Vir5D is reduced or destroyed by insertion or mutation and deletion and a T-DNA sequence encoding at least a CRISPR-associated endonuclease.
Meanwhile, the specification teaches that virD5 was knocked out using a spectinomycin resistance cassette resulting in plasmid pVIRD5specKO and strain EHA105virD5 (p. 62). This strain was not impaired in transient expression of reporter genes in banana cells (see Example 2). This strain led to non-transgenic gene edited cells (p. 66; see also p. 68).
Here, the specification fails to teach or provide guidance for making and using the broad genus of Agrobacterium as instantly claimed for transferring nucleic acids to any conceivable plant species, and further fails to provide working examples of Agrobacterium that are capable of transferring nucleic acids into any plant type as broadly claimed.
This guidance is critical in light of the state of the art, which teaches that Agrobacterium can genetically transform various host cell including numerous dicot and some monocot angiosperm species and gymnosperms with the efficiency in some monocots including important crops lagging far behind (Hwang et al, 2017, The Arabidopsis Book, e0186, doi:10.1199/tab.0186, 1-31; p. 12, col. 2, last ¶; p. 20, ¶ 1).
Or see Hwang et al which teaches that one major limitation of Agrobacterium mediated transformation is that it cannot be efficiently used for many economically important plant species or elite varieties of particular species (2013, Plant Pathology, 62:1384-1397; see p. 1385, col. 1, ¶ 1).
Moreover, Gelvin teaches that the genetics of T-DNA integration is complex and that merely altering the levels of vir genes in Argobacterium strains does not predictably alter the ability of Agrobacterium to transfer and integration of T-DNA to plant cells, and that the chromosomal background of the Agrobacterium plays an important role in transformation efficiency (2003, Microbiology and molecular biology reviews, 67.1, 16-37; see p. 23, col. 2 ¶ 4 through p. 24, col. 1, ¶ 3).
Thus, in light of the breadth of the claims, the state of the art, and the fact that the specification only teaches a single strain of Agrobacterium that is modified for transforming a single plant species, the skilled artisan would resort to trial and error experimentation which is tantamount to excessive and impermissible undue experimentation.
Response to Arguments
Applicant traverses the rejection of the claims because the art in general teaches Agrobacterium-mediated transformation is well-known and routine and because Huang 2013 supports the notion that Agrobacterium-mediated transformation is commonly used across plants (Applicant reply dated 22 May 2026, Section 1).
First, Applicant should note that the rejections do not rest solely on the supposed state of the art (Applicant reply dated 22 May 2026, p. 9, ¶ 1). Rather, the rejection is based on the breadth of the claims, the lack of working examples, the lack of guidance presented and the level of skill in the art (i.e., an analysis of the In re Wands factors).
Second, the proffered arguments are not persuasive because while Applicant contends Hwang explains that the leguminous crops soybean and cowpea can be transformed by Agrobacterium and notes that some strains are not as effective as others (Hwang, p. 1396, col. 1, ¶), Applicant stops short of noting in the same sentence that Hwang teaches many soybean and cowpea cultivars cannot be cultivated in vitro and are resistant to A. tumefaciens transformation.
Thus, it is not merely an issue of whether transformation is inefficient because the art teaches that Agrobacterium is incapable of effectively transforming the genus of plant species as claimed.
Applicant makes similar arguments with respect to Hwang 2017 and Gelvin 2003 (Applicant reply dated 22 May 2026, p. 11, sections 2 and 3), but these arguments are unpersuasive because the art when viewed as a whole stands for the proposition that the genus of Agrobacterium as claimed will not predictably transform the genus of plants as claimed. The referral to specific passages in Hwang by Applicant fails to rebut this position.
For example, Gelvin on page 24 at column 1 reinforces the unpredictability in the art with respect to Agrobacterium transformation by teaching:
one may conclude that increasing the copy number of virA or virG or decreasing the dependence of the encoded proteins on phenolic inducers would generally increase the transformation efficiency of the resulting strains. However, the situation is likely to be more complex. Belanger et al. (23) showed that individual virA genes may be particularly suited to function in certain genetic backgrounds, and Krishnamohan et al. (183) recently demonstrated that Ti plasmids may have evolved to optimize specific combinations of virA, virG, and vir boxes. As noted above, the Ti-plasmid pTiBo542 in the C58 chromosomal background is hypervirulent on certain legume species, possibly because of the associated virG gene (41, 146, 159), but not in its native Bo542 chromosomal background (143). Recent results from my laboratory indicate that vir gene induction and T-strand production by and transformation efficiency of particular Agrobacterium strains may not correlate well. A. tumefaciens A277, containing the Ti plasmid pTiBo542 within the C58 chromosomal background, is considerably more virulent than are strains A348 and A208, containing the Ti plasmids pTiA6 and pTiT37, respectively, in the same chromosomal background. However, vir gene induction by plant exudates and T-strand production are highest in A. tumefaciens A208 (L.-Y. Lee and S. B. Gelvin, unpublished data). These data further suggest that increased vir gene induction and T-strand production may not necessarily be reliable predictors of transformation efficiency.
Or, see Gelvin on page 19 at the penultimate paragraph of column 1:
The molecular and genetic basis for the host range of a given Agrobacterium strain remains unclear. Early work indicated that the Ti plasmid, rather than chromosomal genes, was the major genetic determinant of host range (207, 315). Several virulence (vir) loci on the Ti plasmid, including virC (367, 368) and virF (220, 267), were shown to determine the range of plant species that could be transformed to yield crown gall tumors. The virH (formerly called pinF) locus appeared to be involved in the ability of Agrobacterium to transform maize, as established by an assay in which symptoms of maize streak virus infection were determined following agroinoculation of maize plants (153). Other vir genes, including virG, contribute to the “hypervirulence” of particular strains (41, 146)…However, it is now clear that host range is a much more complex process, which is under the genetic control of multiple factors within both the bacterium and the plant host. The way one assays for transformation can affect the way one views host range. For example, many monocot plant species, including some cultivars of grasses such as maize (152), rice (39, 40, 85, 139, 265, 321), barley (317), and wheat (42), can now be genetically transformed by many Agrobacterium strains to the phenotype of antibiotic or herbicide resistance. However, these plant species do not support the growth of crown gall tumors. Host range may further result from an interaction of particular Ti plasmids with certain bacterial chromosomal backgrounds.
Thus, the art teaches that Agrobacterium strains may not be predictably used for any host as they have particular host ranges for reasons that are not understood. The fact that the Agrobacterium is widely used does little to overcome the fact that the skilled artisan would be required to engage in systematic screening and testing to practice the invention in light of the breadth of the claims, the lack of guidance and working examples and the state of the art.
Claims 1, 2, 8-10, 12-15, 17-20, 22-25 and 27 REMAIN rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims 1, 2, 8-10, 12-15, 17-20, 22-25 and 27 are drawn broadly to any Agrobacterium that transfers nucleotide sequences to a plant cell comprising a nucleotide sequence encoding vir genes wherein the expression of Vir5D is reduced or destroyed by insertion or mutation and deletion and a T-DNA sequence encoding at least a CRISPR-associated endonuclease.
Meanwhile, the specification describes that virD5 was knocked out using a spectinomycin resistance cassette resulting in plasmid pVIRD5specKO and strain EHA105virD5 (p. 62). This strain was not impaired in transient expression of reporter genes in banana cells (see Example 2). This strain led to non-transgenic gene edited cells (p. 66; see also p. 68).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the specification fails to describe a representative number of species from the broad genus of Agrobacterium as instantly claimed for transferring nucleic acids to any conceivable plant species, and further fails to provide working examples of Agrobacterium that are capable of transferring nucleic acids into any plant type as broadly claimed.
This description is critical in light of the state of the art, which describes that Agrobacterium can genetically transform various host cell including numerous dicot and some monocot angiosperm species and gymnosperms with the efficiency in some monocots including important crops lagging far behind (Hwang et al, p. 12, col. 2, last ¶; p. 20, ¶ 1).
Or see Hwang et al which describes that one major limitation of Agrobacterium mediated transformation is that it cannot be efficiently used for many economically important plant species or elite varieties of particular species (p. 1385, col. 1, ¶ 1).
Moreover, Gelvin describes that the genetics of T-DNA integration is complex and that merely altering the levels of vir genes in Argobacterium strains does not predictably alter the ability of Agrobacterium to transfer and integration of T-DNA to plant cells, and that the chromosomal background of the Agrobacterium plays an important role in transformation efficiency (see p. 23, col. 2 ¶ 4 through p. 24, col. 1, ¶ 3).
Thus, in light of the breadth of the claims, the state of the art, and the fact that the specification only describes a single strain of Agrobacterium that is modified for transforming a single plant species, the skilled artisan would not be of the opinion that Applicant was in possession of the genus of bacterium or the genus of plant cells comprising said bacterium as broadly claimed.
Response to Arguments
Applicant traverses the rejection for the same reasons as provided for the rejection of the claims for failing to comply with the scope of enablement requirement: the art in general teaches Agrobacterium-mediated transformation is well-known and routine and because Huang 2013 supports the notion that Agrobacterium-mediated transformation is commonly used across plants (Applicant reply dated 22 May 2026, Section 1).
However, this argument is not persuasive because rather than assess the In re Wands factors to determine whether scope of enablement requirement is satisfied, the inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976). see MPEP 2163.04.
In the instant matter, and as addressed supra, the fact is the specification fails to describe a representative number of species from the broad genus of Agrobacterium as instantly claimed for transferring nucleic acids to any conceivable plant species, and further fails to provide working examples of Agrobacterium that are capable of transferring nucleic acids into any plant type as broadly claimed.
Returning to the Applicant’s previous argument, while Hwang explains that the leguminous crops soybean and cowpea can be transformed by Agrobacterium and notes that some strains are not as effective as others (Hwang, p. 1396, col. 1, ¶), Applicant stops short of noting in the same sentence that Hwang teaches many soybean and cowpea cultivars cannot be cultivated in vitro and are resistant to A. tumefaciens transformation.
Thus, it is not merely an issue of whether transformation is inefficient as the art teaches that Agrobacterium is incapable of effectively transforming the genus of plant species as claimed such that one would recognize Applicant does not possess the genus of bacterium and plants as claimed.
Applicant makes similar arguments with respect to Hwang 2017 and Gelvin 2003 (Applicant reply dated 22 May 2026, p. 11, sections 2 and 3), but these arguments are unpersuasive because the art when viewed as a whole stands for the proposition that the genus of Agrobacterium as claimed will not predictably transform the genus of plants as claimed. The referral to specific passages in Hwang by Applicant fails to refute this position.
For instance, Gelvin on pages 19 and 24 at column 1 reinforces the unpredictability in the art with respect to Agrobacterium transformation (see section 5 supra).
Thus, the art describes that Agrobacterium strains may not be predictably used for any host as they have particular host ranges for reasons that are not understood. The fact that the Agrobacterium is widely used does little to overcome the fact that one would recognize Applicant does not possess the genus of bacterium and plants as claimed in light of the state of the art and the breadth of the claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 13, 15, 17-20 and 24 REMAIN rejected, and claims 1, 2, 8-10, 12, 14, 22, 23, 25 and 27 are NOW rejected, under 35 U.S.C. 103 as being unpatentable over Gelvin et al (Pub. No. US 2022/0112510 A1) and Hamada et al (Pub. No. US 2017/0137833 A1) and Wang et al (2018, New Phytologist, 217:726-738) and view of Hu et al (2021, Plant Biotechnology, 19:654-656) and Zhou et al (2020, J Integr Plant Biol., 62(3)269-286) and Rodrigues et al (2021, PNAS, 118:1-8).
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, 2, 8-10, 12-15, 17-20, 22-25 and 27 are drawn broadly to bacterium from the genus Agrobacterium capable of transferring nucleotide sequences to a plant comprising a nucleotide sequence encoding vir genes wherein the expression of Vir5D is reduced or destroyed by insertion or mutation and deletion and a T-DNA sequence encoding at least a CRISPR-associated endonuclease that introduces a mutation in a first target sequence resulting in a selectable trait and introducing at least one mutation in a second target sequence, wherein the nucleotide sequence is a plasmid such as a Vir-helper plasmid, a method of generating a plant comprising contacting said plant with said bacterium, wherein the genome of the plant does not comprise any integrated T-DNA sequence, generating a plant therefrom, wherein the plant cell is banana plant cell and the target sequence is ACO1 or PPO2 OR ALS.
It should be noted that introducing at least one mutation in a first target sequence “that results in a selectable trait” is an intended use of the targeting the sequence such that if one introduces a mutation they will necessarily produce a selectable trait.
Gelvin et al teach mutant Agrobacterium strains generated by mutagenesis targeting the VirD2 gene for transient expression of T-DNA encoded transgenes which do not stably integrate into the plant genome (see Abstract; see ¶ 0009). Gelvin et al teach that is advantageous to generate Agrobacterium strains that can effectively transfer T-DNA but not integrate to deliver genome engineering reagents (¶ 0008).
Gelvin et al specifically claim an Agrobacterium strain comprising a VirD2 mutant comprising insertions or deletions that would reduce or destroy expression and a method of using said strain for genome editing in a plant wherein said genome editing is CRISPR/Cas9 (see claims 1, 2, 13, 14, 16, 17 and 18). Gelvin et al also teach that Agrobacterium strains may use CRISP/Cas to mutate a first target PDS1 gene and an additional second target PDS2 gene as encompassed by newly amended claim 1 parts (i) and (ii) (¶ 016).
Gelvin et al teach, in fact, that the use of this strain results in mutations to the PDS2 gene in N. benthamiana wherein the vector comprises a sgRNA scaffold to express sgRNAs and a Vir helper plasmid (see ¶ 0071 and 0072; see also Figure 10; see claim 14). Because this gene is mutated it results in a selectable trait for which one can screen.
Thus, while Gelvin et al reasonably teach, suggest and provide motivation for a bacterium comprising nucleotide sequences encoding vir genes and T-DNA sequence encoding CRISPR to mutate at least one target sequence in a plant cell, the issue is whether one would mutate VirD5 as opposed to VirD2 as taught by Gelvin et al, and whether one would use said bacterium to mutate an additional target sequence such as ACO1 or ALS in a banana plant cell.
To this point, Hamada et al teach there is a need in the art for Agrobacterium with increased gene targeting efficiency by providing an Agrobacterium that has lost or reduced chromosomal insertion ability (see Abstract; see also ¶ 0014). Hamada et al teach, in fact, that mutated VirD5 has T-DNA nuclear translocation ability and lacks chromosomal insertion ability (e.g., see Example 1; see also Table 3).
Or see Wang et al which teaches confirms that VirD5is required for Agrobacterium infection, reduces stable transformation efficiency and does not affect transient transformation efficiency (see Abstract).
Regarding claim 13, Hu et al teaches CRISPR/Cas9 mediated genome editing of MaACO1 to promote the shelf life of banana fruit which is a main staple food in developing countries (see Abstract; see also p. 654, col. 1, ¶ 1; see also p. 656, col. 1, penultimate ¶).
Regarding claims 1, 14 and 15, Zhou et al teaches the successful inhibition of ALS using CRISPR/Cas9 to create transgene-free herbicide resistant plants (p. 6, ¶ 2). Zhou et al also teaches that traditional breeding of banana is difficult but that CRISPR/Cas9 maybe successfully used to genetically improve one of the most economically important fruit crops. Thus, Zhou et al teaches introducing at least one mutation in a first ALS target sequence that results in a selectable trait.
Regarding claim 18, Rodriques et al teach that base editing was known in the art and uses either a nuclease-dead Cas9 or Cas9 nickase that can still bind the target DNA but does not induce double stranded breaks yet still results in mutations (p. 2, col. 1, ¶ 1 and 2).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to substitute using VirD2 with reduced activity as taught by Gelvin et al by instead using VirD5 with reduced activity, for example, as taught by Hamada et al and Wang et al because they are functionally equivalent to one another and thus merely a design choice.
It is noted that the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958). See MPEP 2144.06
Factors that will support a conclusion that the prior art element is an equivalent are: (1) the prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co. , 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. 2000); or (2) a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Caterpillar Inc. v. Deere & Co. , 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); or (3) there are insubstantial differences between the prior art element and the corresponding element disclosed in the specification. IMS Technology, Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1436, 54 USPQ2d 1129, 1138 (Fed. Cir. 2000). See MPEP 2183.
Here, VirD5 with reduced activity is considered functionally equivalent to VirD2 with reduced activity because (1) they each perform an identical function in so far as they result in transient expression of T-DNA encoded transgenes which do not stably integrate into the plant genome; (2) one would have recognized that this feature is useful for transient expression; and (3) there are insubstantial differences between the two as each result in transient expression of T-DNA encoded transgenes which do not stably integrate into the plant genome.
One would have a reasonable expectation of success in doing so because each Gelvin et al, Hamada et al and Wang et al demonstrate that reducing or destroying activity of vir genes leads to the successfully transient expression of nucleic acid sequences of interest, and in particular, effectively utilize the CRISPR/Cas9 system to induce mutations in a gene of interest.
Additionally, and prior to the effective filing date of the instant invention, it would have been prima facie obvious to one of ordinary skill in the art to apply the teachings of Gelvin et al and Hamada et al and Wang et al to introduce mutations into two target sequences such as the ACO1 and ALS gene, for example, as taught by Hu et al and Zhou et al, because to do so would result in a transgene free plant that is also herbicide tolerant with improved shelf life in one of the most economically important fruit crops which banana.
One would have a reasonable expectation of success in doing so because each of Hu et al and Zhou et al teach the successful use of CRISPR/Cas9 in banana.
One would have found it prima facie obvious to follow the teachings of Gelvin et al and Hamada et al and Wang et al by instead using a base editor as encompassed by instant claim 18 because to do so is a functional design choice that is not substantially different from using CRISPR/Cas9 that does not have a base editor.
Response to Arguments
It should be noted that Applicant has failed to explain why it would not be obvious to substitute using VirD2 with reduced activity as taught by Gelvin by instead using VirD5 with reduced activity, for example, as taught by Hamada and Wang because they are functionally equivalent to one another and thus merely a design choice.
Instead, Applicant argues there is no motivation to arrive that the instant invention based on the failure of the art to teach certain limitations of the claims (Applicant reply dated 22 May 2026, p. 16, ¶ 1 and 2; see also p. 17, ¶ 3).
Applicant’s argument is not persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Here, Applicant merely argues what is allegedly not taught by the prior art as opposed to explaining why it would not be obvious to modify the method of Gelvin by instead using VirD5 with reduced activity, for example, as taught by Hamada and Wang.
Moreover, Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a “selectable marker” is edited) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues there is no basis for one to arrive at the invention with a reasonable expectation of success because the instant invention is highly advantageous (Applicant reply dated 22 May 2026, p. 16, penultimate ¶).
Nevertheless, the Office is unpersuaded because the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). See MPEP 716.01(c)(II).
Here, Applicant merely alleges there is no reasonable expectation of success without providing evidence to support the position. This is in contrast to the Office’s position which provides one has a reasonable expectation of success in arriving at the instant invention because each of Gelvin, Hamada and Wang demonstrate that reducing or destroying activity of vir genes leads to the successful transient expression of nucleic acid sequences of interest, and in particular, effectively utilize the CRISPR/Cas9 system to induce mutations in a gene of interest.
Applicant traverses the rejection by arguing what is or is not taught by Hu, Zhou and Rodrigues (Applicant reply dated 22 May 2026, p. 16-17).
Again, and as noted above, Applicant merely argues what is allegedly not taught by the prior art as opposed to explaining why it would not be obvious to modify the method of Gelvin by instead using VirD5 with reduced activity, for example, as taught by Hamada and Wang, and fails to do so as well for why it would be obvious to follow the teachings of Gelvin et al and Hamada et al and Wang et al to introduce mutations into two target sequences such as the ACO1 and ALS gene, for example, as taught by Hu et al and Zhou.
This response is critical because the result of combining the aforementioned cited prior art is a transgene free plant that is also herbicide tolerant with improved shelf life in one of the most economically important fruit crops which banana.
Finally, Applicant's general allegation that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “co-editing” of a “selectable marker”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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