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
Newly submitted claims 185-188 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the invention of claims 185-188 includes endosymbiont forming inocula which are drawn to bacterial cells. The originally claimed invention was drawn to endosymbiont forming inocula comprising polynucleotides or plant cells, not bacterial cells, see claims 119 and 123 of the claims dated, 08/15/2022.
During a telephone conversation with Sherry Murphy on July 9, 2026 an election was made without traverse to prosecute the invention of symbiont forming inocula comprising a plant cell which corresponds with the original claims. This invention is found in claim parts of 119, specifically the entire claim with the exception of part B) and in claims 121-123, 154-155, 157-167, 169-170, 173, 184 and 187.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 152, 171, 174-180, 182, 185-186 and 188 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Status
Claims 119, 121-123, 137, 152, 154-155, 157-167 and 169-171, 173-180, 182 and 184-188 are pending.
Claim 137 remains withdrawn as being drawn to an unelected invention and claims 152, 171, 174-180, 182, 185-186 and 188 are newly withdrawn as being drawn to an unelected invention.
Claims 168 and 183 are newly cancelled.
Claims 119, 152, 159, 161, 163, 165-167, 169-171, 177, 180 and 182 are newly amended.
Claims 185-188 are new.
Claims 119, 121-123, 154-155, 157-167 and 169-170, 173, 184 and 187 are rejected.
Response to Applicant Arguments- Claim Objections
In response to Applicant’s arguments and amendments dated 04/10/2026, the claim objection of record against claim 163 is withdrawn. In response to Applicant’s cancellation of claims 183 in the amendment dated 04/10/2026, the claim objection against claim 183 is rendered moot and is withdrawn.
Response to Applicant Arguments - 35 USC § 112 (Indefiniteness)
In response to applicant’s cancellation of claim 183 dated 04/10/2026 the rejection against that claim is rendered moot and withdrawn. Further, in response to Applicant’s arguments and amendments to the claims dated 04/10/2026 the indefiniteness rejections of record are withdrawn.
Response to Applicant Arguments – Enablement
In response to Applicant’s arguments and amendments to the claims dated 04/10/2026 the enablement rejections of record are withdrawn.
Response to Applicant Arguments - 35 USC § 102
With respect to the anticipation rejections of record against claims 119, 121-123, 154-155, 161, 173 and 184, Applicant’s arguments and amendments to the claims dated 04/10/2026 have been fully considered but are not found to be persuasive, see below for summary and response to these arguments. With respect to claim 166, in response to Applicant’s amendments to the claim on 04/10/2026 the anticipation rejection of record against this claim is withdrawn, however this amendment necessitates a new obviousness rejection against claim 166. Further, the amendment of claim 119 and the introduction of new claim 187, require a new anticipation rejections against claims 165 and 187.
Applicant’s arguments are summarized as follows:
Independent claim 119 has been amended and van der Graaff fails to teach a plant cell comprising i) a polynucleotide encoding phytohormone biosynthetic enzymes, ii) at least one selectable or screenable marker, and iii) a polynucleotide of interest, wherein the polynucleotide of interest is different from the at least one selectable or screenable marker, and the polynucleotide of interest does not encode a phytohormone biosynthetic enzyme (Remarks 04/10/2026, .
These arguments are not found to be persuasive because Applicant’s argument appears to focus on the amendment that the polynucleotide of interest does not encode a phytohormone biosynthetic enzyme or a selectable or screenable marker but given the breadth encompassed by a polynucleotide of interest van der Graaff does disclose a polynucleotide of interest that does not encode a selectable or screenable marker or a phytohormone biosynthetic enzyme. The breadth of this genus is demonstrated in claims 121 and 161, the latter of which makes clear that any polynucleotide which encodes an RNA molecule which is a bioactive molecule is considered to be a polynucleotide of interest and importantly the genus appears far more broad even than any RNA molecule.
Mapping the claim limitations to the disclosure of van der Graaff demonstrates that van der Graaff discloses all of the limitations of claim 119, see below. As such Applicant’s arguments are not found to be persuasive.
Specifically, van der Graaff discloses the following:
While van der Graaff does not use the term symbiont forming inoculum, van der Graaff discloses plants, plant parts, plant tissues including callus tissue which are composed of plant cells (van der Graaff, Page 248, Column 2, Last 8 lines). These cells comprise the following:
The cells of van der Graaff are from doubly transgenic Arabidopsis thaliana plants which comprise the following exogenous phytohormone biosynthetic enzymes:
The auxin biosynthetic enzymes TRYPTOPHAN MONOOXYGENASE and INDOLEACETAMIDE HYDROLASE from Agrobacterium tumafaciens (van der Graaff, Page 248, Column 2, Last 8 Lines; van der Graaff, Page 248, Column 1, Lines 5-11).
The Agrobacterium tumafaciens ipt gene. These plants have totipotency and produce dedifferentiated plant cells and structures as demonstrated below)(van der Graaff, Page 241, Column 1, First Complete Paragraph; van der Graaff, page 252, Column 2, Fourth Citation).
van der Graaff discloses that these plants comprise a selectable marker, specifically, van der Graaff discloses that the plants comprising the phytohormone biosynthetic enzymes also comprise the kanamycin resistance gene(van der Graaff, Page 242, Column 1, First Complete Paragraph).
van der Graaff also discloses that these plants comprise a polynucleotide of interest (nearly any polynucleotide could be considered a polynucleotide of interest and as such given that van der Graaff discloses plants comprising other genes, the plant cells of van der Graaff comprise polynucleotides of interest)(van der Graaff, Page 242, Column 1, First Complete Paragraph).
Therefore, when mapped out in this way it is clear that van der Graaff discloses the instantly claimed symbiont forming inoculum.
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 119, 121-123, 154-155, 161, 173 and 184 remain rejected and claim 187 is newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Graaff, "Increased endogenous auxin production in Arabidopsis thaliana causes both earlier described and novel auxin-related phenotypes." Journal of Plant Growth Regulation 22.3 (2003): 240-252.
Claim 119 is drawn to a symbiont forming inoculum comprising:
An autonomously dividing plant cell capable of forming an undifferentiated autonomously dividing multicellular structure comprising:
A polynucleotide encoding the following phytohormone biosynthetic enzymes which are heterologous to the plant cell.
An auxin biosynthetic enzyme.
A cytokinin biosynthetic enzyme.
A selectable or screenable marker.
A polynucleotide of interest which is different from the selectable or screenable marker and does not encode a phytohormone biosynthetic enzyme.
Importantly an inherent characteristic of plant cells is that they have totipotency, the ability to dedifferentiate and then re-differentiate into another cell type. This means that an inherent property of plant cells is their capability of forming an undifferentiated autonomously dividing multicellular structure and therefore any plant cell is interpreted to meet that limitation of the claim.
With respect to claim 119 van der Graaff discloses a symbiont forming inoculum for producing a biomolecule. Specifically, van der Graaff discloses the following:
While van der Graaff does not use the term symbiont forming inoculum, van der Graaff discloses plants, plant parts, plant tissues including callus tissue which are composed of plant cells (van der Graaff, Page 248, Column 2, Last 8 lines). These cells comprise the following:
The cells of van der Graaff are from doubly transgenic Arabidopsis thaliana plants which comprise the following exogenous phytohormone biosynthetic enzymes:
The auxin biosynthetic enzymes TRYPTOPHAN MONOOXYGENASE and INDOLEACETAMIDE HYDROLASE from Agrobacterium tumafaciens (van der Graaff, Page 248, Column 2, Last 8 Lines; van der Graaff, Page 248, Column 1, Lines 5-11).
The Agrobacterium tumafaciens ipt gene. These plants have totipotency and produce dedifferentiated plant cells and structures as demonstrated below)(van der Graaff, Page 241, Column 1, First Complete Paragraph; van der Graaff, page 252, Column 2, Fourth Citation).
van der Graaff discloses that these plants comprise a selectable marker, specifically, van der Graaff discloses that the plants comprising the phytohormone biosynthetic enzymes also comprise the kanamycin resistance gene(van der Graaff, Page 242, Column 1, First Complete Paragraph).
van der Graaff also discloses that these plants comprise a polynucleotide of interest (nearly any polynucleotide could be considered a polynucleotide of interest and as such given that van der Graaff discloses plants comprising other genes, the plant cells of van der Graaff comprise polynucleotides of interest)(van der Graaff, Page 242, Column 1, First Complete Paragraph).
Therefore, when mapped out in this way it is clear that van der Graaff discloses the instantly claimed symbiont forming inoculum.
With respect to claim 121, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Further, van der Graaff discloses that the inoculum further comprises at least one gene that is transcribed into a RNA, see above.
With respect to claim 122, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Further, as noted above, van der Graaff discloses that the transformed plant cells comprise other genes that are not the plant biosynthetic enzymes and the selectable markers and therefore discloses a gene of interest. Given that many other genes are expressed in these plant cells including all of those essential for plant growth it is clear that van der Graaff discloses symbiont forming inocula wherein the polynucleotide of interest is expressed.
With respect to claim 123, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Further, van der Graaff discloses that the transgenic Arabidopsis plants form calli at the base of the hypocotyl, in fact the transgenic plants for calli just below the rosette leaves and in addition form callus at the base of the hypocotyl (van der Graaff, Page 248, Column 2, First Full Sentence).
With respect to claim 154, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Further, van der Graaff discloses that the iaaM and iaaH genes were from bacteria and the ipt gene (ipt-161) is also from a bacterium (van der Graaff, Page 240, Column 1, First Full Sentence; van der Graaff, Page 248, Column 1, Last Paragraph – Column 2, First Paragraph; van der Graaff, Page 252, Column 2, Fourth Citation).
With respect to claim 155, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Importantly, van der Graaff discloses an iaaH gene from bacteria and an ipt gene (ipt-161) which was also from a bacterium (van der Graaff, Page 240, Column 1, First Full Sentence; van der Graaff, Page 248, Column 1, Last Paragraph – Column 2, First Paragraph; van der Graaff, Page 252, Column 2, Fourth Citation).
With respect to claim 161, van der Graaff discloses the endosymbiont forming inoculum of claim 121, see above. Further, van der Graaff discloses that the transgenic plants also produce ethylene and therefore possess and express the bioactive molecules that produce ethylene (van der Graaff, Page 241, Column 2, First Paragraph). Importantly, the bioactive molecules which produce ethylene include enzymes which are encoded by RNA molecules and therefore an inherent characteristic of the plants of van der Graaff is the expression of a bioactive RNA molecule.
With respect to claim 173, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Of note, Arabidopsis thaliana, the plant disclosed in van der Graaff is the angiosperm model organism and is a flowering plant.
With respect to claim 184, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. As noted above, van der Graaff discloses transgenic Arabidopsis thaliana cells comprising bacterial iaaH, iaaM and ipt genes.
With respect to claim 187, van der Graaff discloses the endosymbiont forming inoculum of claim 119, see above. Further, van der Graaff discloses that the transgenic plants also produce ethylene and therefore possess and express the bioactive molecules that produce ethylene (van der Graaff, Page 241, Column 2, First Paragraph). Importantly, the bioactive molecules which produce ethylene include enzymes which are encoded by RNA molecules and therefore an inherent characteristic of the plants of van der Graaff is that they comprise polynucleotides of interest which encode RNA molecules.
Claim 165 is newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Graaff, "Increased endogenous auxin production in Arabidopsis thaliana causes both earlier described and novel auxin-related phenotypes." Journal of Plant Growth Regulation 22.3 (2003): 240-252 as evidenced by Press release. NobelPrize.org. Nobel Prize Outreach 2026. Fri. 17 Jul 2026.
With respect to claim 165, van der Graaff discloses all of the limitations of claim 119 see anticipation rejection above.
With respect to claim 165, van der Graaff does not explicitly disclose polynucleotides of interest which encode a polypeptide operably linked to a targeting sequence. However, Press release makes clear that these are an inherent characteristic of proteins including those in plants (Press release, Page 1, Third Paragraph, Paragraph begins with “These questions”; Press release, Page 1, Fourth Paragraph, Paragraph begins with “The principles”).
Press release, which is drawn to the work of Blobel describes the intrinsic sequences in newly synthesized proteins which govern their travel to the and across the membrane of the endoplasmic reticulum and other similar sequences which direct proteins to other intracellular organelles (Press release, Page 1, Third Paragraph, Paragraph begins with “These questions”).
van der Graaff discloses plants and plant callus tissues which comprise a polynucleotide of interest (nearly any polynucleotide could be considered a polynucleotide of interest and as such given that van der Graaff discloses plants comprising other genes, the plant cells of van der Graaff comprise polynucleotides of interest)(van der Graaff, Page 242, Column 1, First Complete Paragraph). Press release demonstrates that an inherent characteristic of plant polypeptide sequences are the presence of intrinsic targeting sequences.
Therefore claim 165 is rejected as anticipated by van der Graaff as evidenced by Press release.
Response to Applicant Arguments - 35 USC § 103
With respect to the obviousness rejections of record against claims 167 and 169, Applicant’s arguments and amendments to the claims dated 04/10/2026 have been fully considered but are not found to be persuasive and the rejections of record are maintained, see below for summary and response to these arguments.
With respect to claims 157-160, 162-164 and 170, in response to Applicant’s amendments to the claims including claim 119 on 04/10/2026, the obviousness rejections of record against the claims are withdrawn, however the amendments to the claims necessitate new obviousness rejections against these claims. Applicant arguments which remain relevant to the new grounds of rejection are summarized and addressed with the arguments directed towards claims 167 and 169, below.
Applicant’s arguments are summarized as follows:
van der Graaff does not teach a plant cell comprising i) a polynucleotide encoding phytohormone biosynthetic enzymes, ii) at least one selectable or screenable marker, and iii) a polynucleotide of interest, wherein the polynucleotide of interest is different from the at least one selectable or screenable marker, and the polynucleotide of interest does not encode a phytohormone biosynthetic enzyme (Remarks, Page 4, Third Complete Paragraph).
Nilsson is a review article that summarizes the results concerning the expression and function of the rol genes in the Agrobacterium rhizogenes infection process that the combination of Nilsson with van der Graaff would not have suggested or provided any guidance or motivation to one of ordinary skill in the art for using a plant cell or bacterial cell as a symbiont forming inoculum (Remarks, Page 3, Last Paragraph).
With respect to Applicant’s arguments summarized in 1. above, these arguments are not found to be persuasive because van der Graaff does disclose all of the limitations of independent claim 119, see response to Applicant Arguments section drawn to the anticipation rejections of record above.
With respect to Applicant’s arguments summarized in 2. above, these arguments are not found to be persuasive because while Applicant urges that upon seeing the teachings of van der Graaff and Nilsson the ordinary artisan would not have found any guidance or motivation “for using a plant cell” this limitation is not found anywhere in the claims. Instead independent claim 119 is drawn to a composition, comprising a symbiont forming inoculum for a variety of functions including producing a biomolecule, further, dependent claims 167 and 169 depend on claim 119 and further limit the claim to compositions having certain arrangements of promoters with the required phytohormone biosynthetic enzymes. None of these claims require any use of the cells and further, the combined teachings of van der Graaf in view of Nilsson would have provided guidance or motivation to the ordinary artisan to produce the endosymbiont forming inoculum which would inherently produce RNA and correspondingly inherently produce biomolecules.
Therefore, Applicant’s arguments are not found to be persuasive and the rejections of record against claims 167 and 169 are maintained.
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.
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 166 is newly rejected and claims 167 and 169 remain rejected under 35 U.S.C. 103 as being unpatentable over van der Graaff.
With respect to claim 166, van der Graaff teaches all of the limitations of claim 119, see anticipation rejection above.
Further, van der Graaff teaches the use of a constitutive promoter to drive expression of the kanamycin resistance gene of interest (van der Graaff, Page 241, Paragraph spanning columns).
With respect to claim 167, van der Graaff teaches all of the limitations of claim 119, see anticipation rejection above.
Relevantly, van der Graaff teaches Arabidopsis thaliana plants comprising bacterial iaaH, iaaM and ipt genes, see anticipation rejection above.
Further, van der Graaff discloses that the transgenic plants also produce ethylene and therefore possess and express the bioactive molecules that produce ethylene (van der Graaff, Page 241, Column 2, First Paragraph). Importantly, the bioactive molecules which produce ethylene include enzymes which are encoded by RNA molecules and therefore an inherent characteristic of the plants of van der Graaff is that they comprise polynucleotides of interest which encode RNA molecules. Given these genes are expressed in order to produce the ethylene biosynthetic enzymes these genes are linked to promoters which are required for expression and therefore the RNA encoding polynucleotide of interest is operably linked to a promoter.
With respect to claim 169, van der Graaff teaches all of the limitations of claim 119, see anticipation rejection above.
Further, van der Graaff teaches the use of a constitutive promoter to drive expression of the kanamycin resistance gene of interest (van der Graaff, Page 241, Paragraph spanning columns).
With respect to claims 166, 167 and 169, van der Graaff does not explicitly teach the polynucleotides encoding the auxin biosynthetic enzyme or the polynucleotide of interest is operably linked to a constitutive promoter or where the genes encoding the phytohormone biosynthetic enzymes are operably linked to a single promoter.
It would have been obvious at the time of filing to modify the plant of van der Graaff in order to use a single constitutive promoter for the biosynthetic genes instead of multiple promoters because this represents a simple design choice and the use of the constitutive promoter would ensure high levels of expression of all of the genes of interest. Further, it would have been obvious to use this same logic and use a constitutive promoter to drive expression of the gene of interest.
At the time of filing the ordinary artisan would have recognized that by transforming the Arabidopsis plants with a construct comprising all three of the phytohormone-biosynthetic genes that these genes could be expressed using a single constitutive promoter which would allow for easier cloning and selection of transformed plants as well as the ability to avoid the crossing steps required to introduce the ipt gene into the plants of van der Graaff. Further, the ordinary artisan would have found it obvious to overexpress the gene of interest for a variety of reasons including overexpression analysis of gene function and to produce higher concentrations of the product from gene of interest so that this valuable product could be easily isolated in high concentrations and then put to further use.
The ordinary artisan would have been motivated to modify the plants of van der Graaff for these reasons and because it would allow for the more efficient generation of plants having these modifications to these phytohormone-biosynthetic pathways and rapid isolation of products from genes of interest in these callus tissues or other plant structures. As such it would have been obvious to modify the method of van der Graaff in order to drive expression of the three phytohormone-biosynthetic enzymes off of a single promoter and claims 166-167 and 169 are rejected as obvious.
Claim 170 is newly rejected under 35 U.S.C. 103 as being unpatentable over van der Graaff in view of Gatz, "Promoters that respond to chemical inducers." Trends in Plant Science 3.9 (1998): 352-358.
With respect to claim 170, van der Graaff teaches all of the limitations of claim 167, see obviousness rejection above.
With respect to claim 170, van der Graaff does not explicitly teach the use of constitutive promoters.
With respect to claim 170, Gatz teaches that it is important to produce the correct expression level and pattern of genes of interest and that this can be accomplished using the correct promoter (Gatz, Page 352, Abstract). Further, Gatz teaches that inducible promoters offer a range of options for transgene design for application in experimental and field use (Gatz, Page 352, Abstract). Further, Gatz teaches the use of an inducible promoter to drive expression of the ipt gene (Gatz, Page 354, Column 1, Last three lines). Gatz teaches that this allowed for careful expression of this gene at a specific time in order to produce the desired effect.
At the time of filing it would have been obvious to modify the endosymbiont forming inoculum of van der Graaff to use the inducible promoter of Gatz. This would have been obvious because the endosymbiont forming inoculum of van der Graaff includes a polypeptide encoding several phytohormone biosynthetic enzymes including ipt and Gatz teaches the use of an inducible promoter is particularly effective in driving the expression of ipt because low amounts of ipt can produce a visibly altered phenotype. Therefore combining these references would allow for the precise regulation of ipt expression in the endosymbiont forming inoculum and therefore would allow for precise control of the phenotypic characteristics of the endosymbiont forming inoculum.
The ordinary artisan would have been motivated to make this modification because it would allow for an optimized level of cytokinins to be produced in the endosymbiont forming inoculum in order to produce the ideal morphological characteristics.
Therefore claim 170 is rejected as obvious under van der Graaff in view of Gatz.
Claims 157-160 and 162-164 are newly rejected under 35 U.S.C. 103 as being unpatentable over van der Graaff in view of Nilsson, "Getting to the root: the role of the Agrobacterium rhizogenes rol genes in the formation of hairy roots." Physiologia plantarum 100.3 (1997): 463-473, Pina, "Cell-to-cell transport through plasmodesmata in tree callus cultures." Tree Physiology 29.6 (2009): 809-818 and Zhang, "Inhibitory effects of nisin on Staphylococcus aureus and Xanthomonas." Material Science and Environmental Engineering (2016).
With respect to claim 157, van der Graaff teaches all of the limitations of claim 119, see anticipation rejection above.
With respect to claim 158, van der Graff teaches all of the limitations of claim 157 taught above, see above.
With respect to claim 159, van der Graff teaches all of the limitations of claim 157 taught above, see above.
Further, van der Graff teaches that the iaaH/iaaM transgenes were inserted into the target Arabidopsis plants in a T-DNA vector.
With respect to claim 160, van der Graff teaches all of the limitations of claim 159 taught above, see above.
Further, van der Graff teaches that the iaaH/iaaM transgenes were inserted into the target Arabidopsis plants in a T-DNA vector.
With respect to claim 162, van der Graff teaches all of the limitations of claim 121, see anticipation rejection above.
With respect to claim 163, van der Graff teaches all of the limitations of claim 122 see anticipation rejection above.
With respect to claim 164, van der Graff teaches all of the limitations of claim 163 taught above, see above.
With respect to claims 157-160 and 162-164, van der Graaff does not explicitly teach plant cells further comprising a polynucleotide encoding a plasticity polypeptide, including plasticity peptides selected from the group of 6b, rolB, rolC and orf13. Nor does van der Graaff teach transplanting the inoculum onto a host plant or were the bioactive molecule of interest is nisin.
With respect to claims 157-160 and 162-164, Nilsson teaches the function of the Agrobacterium rol genes in plants (Nilsson, Page 463, Abstract).
Specifically, Nilsson teaches that these genes are responsible for the hairy root disease in which plants grow a tumor (neoplastic outgrowths) (Nilsson, Page 465, Column 1, First Full Paragraph; Nilsson, Page 466, Column 1, First Complete Paragraph). Nilsson further, teaches using evidence from transgenic tobacco plants expressing rolA, rolB and rolC that expression of the rol genes modulates phytohormone content in transgenic plants. Specifically, increased rolB led to formation of callus in the absence of auxin and also led to increased formation of adventitious roots and it appears that rolB functions by regulating cells’ sensitivity to auxins (Nilsson, Page 467, Column 2, First Complete Paragraph; Nilsson, Page 466, Column 2, Last Paragraph; Nilsson, Page 467, Column 2, First Complete Paragraph). Finally, rolC appears to affect cytokinin availability and activity in some manner and that rolC also downregulates GA metabolism (Nilsson, Page 468, Column 1, Last Two Sentences; Nilsson, Page 469, Column 1, First Paragraph).
To summarize, Nilsson teaches that the rol genes induce changes in phytohormone activity and concentration that lead to increased auxin and increased cytokinin activity and their associated phenotypes.
With respect to claims 157-160 and 162-164, Pina teaches that calli can be grafted and that proteins of interest can be transported between a callus to another tissue and that this transportation occurs through plasmodesmata (Pina, Page 809, Summary).
With respect to claims 157-160 and 162-164, Zhang teaches that nisin is an effective antimicrobial peptide with 34 amino acids which has been used to preserve dairy products, vegetables and meats (Zhang, Page 555, Column 1, Introduction). Further, Zhang teaches that nisin is an effective antibiotic against S. aureus and Xanthomonas bacteria. Although, Zhang states that nisin was more effective against S. aureus in the abstract on page 555, Figure 1 in column 2 on page 556 demonstrates that similar to S. aureus nisin shifts the growth curve of Xanthomonas bacteria to the right, significantly delaying the growth of the bacteria and demonstrating the antibacterial effects of nisin (Zhang, Page 555, Abstract; Zhang, Page 556, Column 2, Section 3.1; Zhang, Page 556, Column 2, Figure 1).
At the time of filing it would have been obvious to the ordinary artisan to modify the endosymbiont forming plant cells of van der Graaff by introducing a construct into those cells that would express the Agrobacterium rol genes taught by Nilsson. It would further have been obvious to use this easily produced callus tissue by grafting it to important crop plants to deliver proteins of interest as taught in Pina. Finally it would have been obvious to deliver nisin to those crop plants using this method because of the antibacterial properties of this protein taught by Zhang would confer increased pathogen tolerance to bacterial pathogens including Xanthomonas bacteria.
This would have been obvious because it is combining prior art elements according to known methods to yield predictable results.
This rationale requires that the Examiner resolve the Graham factual inquiries and articulate the following:
a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference.
a finding that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately.
a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
With respect to these inquiries and this obviousness rejection the Examiner states the following:
As described above, van der Graaff teaches all of the limitations of the claims except symbiont forming inocula comprising a rolB or rolC plasticity polypeptide, symbiont forming inocula comprising a gene encoding nisin, transplantation of the callus tissue (symbiont forming inoculum) onto a plant which confers increased resistance or tolerance to a Xanthomonas pathogen. Importantly, Nilsson teaches transforming plant cells which formed callus tissues with the rolB and rolC genes, Pina teaches that callus tissue can be grafted to other plant tissue and deliver proteins of interest to the other plant tissue and Zhang teaches that nisin is a small polypeptide with antibiotic properties that has been shown to be effective in preserving vegetables, meats and dairy products. Therefore, all of the limitations are taught in the prior art.
Combining these elements would require known methods, specifically transforming the cells of van der Graaff with the rolB and rolC genes of Nilsson which Nilsson teaches, importantly plant transformation is well known in the art and predictable. Combining the methods would also require transplanting callus tissues which was known in the art, as taught by Pina. Finally, the combination of methods would require transforming the callus tissue with a gene of interest which was also known in the art as demonstrated by Pina, in this case with the gene encoding the nisin polypeptide which was also known in the art. To summarize, combining these methods would require plant transformation steps and a callus transplantation step which were both known in the art and predictable at the time of filing.
The ordinary artisan would have found that the results of the combination were predictable, transforming callus tissue was well known and highly predictable and the functions of the genes being transformed into that tissue were also known in the art. Further, transplanting the callus tissue of van der Graaff is simply using the same method of Pina with different tissues and is therefore predictable. Finally, the use of nisin as the protein of interest instead of the fluorescein of Pina is simply switching two proteins with known functions and is therefore predictable. As such at the time of filing given the teachings of van der Graaff, Nilsson, Pina and Zhang the ordinary artisan would have recognized that the effects of combining these teachings was predictable.
At the time of filing the ordinary artisan would have been motivated to combine these teachings because combining these teachings produces an endosymbiont forming inoculum which could deliver the pathogen resistance trait to plants of interest without transforming those plants or performing any other sort of genetic manipulation to the target plants. This would have been motivating because of the strict regulation of transgenic plants and the complexity and challenge with producing stable transgenic lines producing a specific trait without introducing negative off-target effects to the plants comprising this new trait. The combined method of these teachings avoids those complexities and produces a flexible and streamlined method to confer new traits to target plants and therefore the ordinary artisan would have been motivated to make these combinations.
Therefore, claims 157-160 and 162-164 are rejected as obvious under van der Graaff in view of Nilsson, Pina and Zhang.
Conclusion
All examined claims are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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