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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/22/2025 has been entered.
Claim Status
Claims 119, 121-123, 137, 152, 154-155, 157-171, 173-180 and 182-184 are pending.
Claim 137 remains withdrawn as being drawn to an unelected invention.
Claims 153, 156, 172 and 181 are newly cancelled.
Claims 119, 123, 137, 152, 154-155, 157-160, 163, 168, 171, 173, 175, 179 and 182 are newly amended.
Claims 183-184 are new.
Claims 119, 121-123, 152, 154-155, 157-171, 173-180 and 182-184 are examined on the merits.
Response to Applicant Arguments- Claim Objections
In response to applicant’s amendments dated 04/22/2025 the claim objections of record are withdrawn. However, applicant’s amendments to the claims necessitate new claim objections, which are presented below.
Claim Objections
Claim 163 is newly objected to because of the following informalities: in line two of the claim in order to improve syntax “plant and expression” should be changed to “plant, expression”. Similarly, in line three of the claim a comma should be added between “plant and increased”. Appropriate correction is requested.
Claim 183 is newly objected to because of the following informalities: in lines three and four of the claim “a phytohormone biosynthetic enzyme” should be changed to “the phytohormone biosynthetic enzymes” in order to match the language of the independent claim. Appropriate correction is required.
Response to Applicant Arguments - 35 USC § 112 (Indefiniteness)
In response to applicant’s arguments and amendments to the claims dated 04/22/2025 the indefiniteness rejections of record are withdrawn. However, applicant’s amendments to the claims necessitate new indefiniteness rejections which are presented below.
Claim Rejections - 35 USC § 112 (Indefiniteness)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 119, 121-123, 152, 154-155, 157-171, 173-180 and 182-184 are newly rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 119 recites the following which render the claim indefinite: “the symbiont forming inoculum comprising a plant cell or a bacterial cell each of which comprise a polynucleotide encoding phytohormone biosynthetic enzymes and a polynucleotide of interest, wherein the phytohormone biosynthetic enzymes are heterologous to the plant cell and the bacterial cell and are a cytokinin biosynthetic enzyme and an auxin biosynthetic enzyme”
This is indefinite because given the specific language of the claim the scope of the claimed polynucleotides encoding phytohormone biosynthetic enzymes is not clear.
While the scope of biosynthetic enzymes outside of this context is clear, given the specific language used in the claims including the additional limitations drawn to the biosynthetic enzymes the scope imparted by the recitation of “biosynthetic enzymes” is not clear.
Specifically, applicant claims a inoculum comprising a plant or bacterial cell which comprise a polynucleotide encoding phytohormone biosynthetic enzymes. Applicant then states that “the phytohormone biosynthetic enzymes are heterologous to the plant cell and the bacterial cell”.
The use of this language creates indefiniteness because it is not clear whether the polynucleotide encoding the biosynthetic enzymes must be heterologous to either the plant cell when introduced into the plant cell or heterologous to the bacterial cell when introduced into the bacterial cell or instead if the polynucleotide must be heterologous to both the plant cell and the bacterial cell regardless of whether the inoculum is made up of plant or bacterial cells.
To clarify, the use of the phrase “the phytohormone biosynthetic enzymes are heterologous to the plant cell and the bacterial cell” is indefinite because it introduces more than one scope of the claim. First, while the recitation of “heterologous to the plant cell and the bacterial cell” may appear clear, simply limiting the sequences to those that are heterologous to both the plant and bacterial cell of the inoculum, the recitation of “inoculum comprising a plant cell or a bacterial cell” earlier in the claim makes clear that the inoculum can be either a plant cell or a bacterial cell.
As such, there appears to be two distinct scopes of the claims imparted by the limitation recited above. A first broad scope in which the biosynthetic enzymes are heterologous to the cell forming the inoculum whether it is a plant cell or a bacterial cell. This scope is supported by the additional limitation found in claim 154 which states that “wherein the polynucleotide encoding the phytohormone biosynthetic enzymes is from a bacterial species and/or a plant species”.
A second scope is narrower and is drawn to biosynthetic enzymes which are heterologous to plant and bacterial cells which form the inocula and this scope is supported by the plain meaning of heterologous to the inoculum, given that the inoculum can be both a plant or a bacterial cell.
In order to ensure compact prosecution, the phrase “wherein the phytohormone biosynthetic enzymes are heterologous to the plant cell and the bacterial cell” is being interpreted to mean that the sequences encoding the phytohormone biosynthetic enzymes are heterologous to which ever cell comprises the symbiont forming inoculum.
All dependent claims are rejected for depending on an indefinite claim and failing to limit the scope to definite subject matter. This includes claims 154 and 155 because even though these claims limit the phytohormone biosynthetic enzymes to those from bacterial and/or plant species or to enzymes which catalyze specific reactions, scope of the claims remain unclear. Specifically, with respect to claim 154 it is unclear if a plant cell comprising phytohormones from another plant species which are identical to the endogenous enzymes are heterologous or if instead in this context heterologous means plant phytohormone biosynthetic enzymes in an inoculum comprising a bacterial cell or similarly bacterial phytohormone biosynthetic enzymes in a plant cell. Therefore, even though this claim limits the scope of the enzymes to those from plant or bacterial cells the exact scope imparted on the claim remains unclear. With respect to claim 155, even though this claim recites specific enzyme names and includes E.C. numbers which indicate which reaction these enzymes catalyze, this does not clarify the scope because these enzymes are found in at least plants, bacteria and fungi.
In claim 171, the use of parenthesis and e.g. renders the claim indefinite. This is because the claim recites a broad limitation, for example a Type IV Secretion System which is then followed by an abbreviation for that system (T4SS) but this is followed by specific examples of these system, e.g., T4ASS, (e.g., VirB/D4). Given these recitations it is unclear if the broad limitation applies, the narrow limitation applies or if some in-between scope applies. As such claim 171 is rejected as indefinite.
In claim 182, the recitation of “a protein (polypeptide/peptide) or a polynucleotide” renders the claim indefinite. This is because the plain meaning of protein includes polypeptides and peptides and as such the scope imparted by including (polypeptide/peptide) in the claim is not clear. Does this mean that the meaning of protein is more broad and polypeptide/peptide narrows the claims? Or instead is this recitation simply demonstrating the plain meaning of protein? As such the scope of the claim is unclear and claim 182 is rejected as indefinite.
In claim 183, the recitation of “a separate promoter as that which is operably linked to the polynucleotide encoding a phytohormone biosynthetic enzyme” renders the claim indefinite. This is because claim 183 depends on claim 168, which depends on claim 157, which depends on independent claim 119 and the limitation of “a promoter…which is operably linked to the polynucleotide encoding a phytohormone biosynthetic enzyme and/or the polynucleotide of interest” is not found in any of these claims. Therefore, this phrase lacks antecedent basis and as such claim 183 is rejected as indefinite.
Of note claim 155, would have been rejected as indefinite due to the E.C. numbers in parenthesis following the biosynthetic enzyme names, however the E.C. numbers identify enzymes as catalyzing a specific reaction, this appears to be the same scope as the general enzyme names which are recited in the claim. Therefore, even though it may appear at first glance that the inclusion of the E.C. numbers creates a broad-narrow limitation in the claim it appears that these numbers impart the same scope as the enzyme names and therefore these do not create a broad-narrow limitation and the claims are not rejected as indefinite.
Response to Applicant Arguments - 35 USC § 101
In response to applicant’s amendments to the claims dated 04/22/2025, the 35 USC 101 rejections of record are withdrawn.
Response to Applicant Arguments – Enablement
In response to applicants arguments and amendments to the claims dated 04/22/2025 the enablement rejections of record against the product claims are withdrawn (119, 121-123, 154-155, 157-171, 173 and 183-184).
However, with respect to the method claims (152, 174-180, and 182) these arguments and amendments are not found to be persuasive and are summarized addressed below. Given the amendments to the method claims the enablement rejections of record have been modified to address these amendments and these rejections are presented below.
As a result of the amendments the claims are drawn to methods of using symbiont forming inocula that are bacterial or plant cells comprising polynucleotides encoding biosynthetic enzymes and a polynucleotide of interest that are heterologous to the plant and bacterial cell, as such given the state of the art with respect to phytohormone biosynthesis and plant and bacterial cell transformation these inocula and their use would not require undue experimentation.
Applicants have provided sufficient evidence in the examples demonstrating that an expression product produced by a symbiont can be delivered to a host plant and therefore there is adequate enabled guidance for a skilled artisan to make and use the invention without undue experimentation.
The specification specifically describes transforming plant cells with heterologous cytokinin biosynthetic enzymes and heterologous auxin biosynthetic enzymes along with a polynucleotide of interest. It would therefore not be undue experimentation for a person skilled in the art to implement the methods described in detail in the specification to produce these cells and thereby producing the symbiont forming inoculum as claimed herein.
With respect to arguments summarized in 1 above, these arguments are not found to be persuasive because while the claims have been amended to improve clarity, the method claims would still require a skilled artisan to use undue experimentation in order to use these methods.
Specifically, while applicant has provided guidance on how to generate transgenic plant and bacterial cells comprising the required sequences applicant has not provided any guidance on how to use transformed plant cells or any transformed bacterial cell except agrobacterium cells to deliver a compound of interest into a target host plant.
Given this lack of enabled guidance and the state of the art at the time of filing the skilled artisan would be required to solve numerous problems in order to use the claimed methods.
These problems include, which plant cells should be used to generate the inocula, does the origin of the plant cells used to produce the inocula need to be optimized for each target host plant species, what are the best conditions to transplant the plant cell based inocula onto the target host plant, how to get the plant cell inocula to transport the expression product of the polynucleotide of interest into the target host plant and many others. These same questions would need to be answered with a bacterial cell based endosymbiont forming inoculum when that inoculum was formed from bacterial cells that are not agrobacterium.
Given that the instant disclosure does not appear to answer these questions and the state of the art does not appear to provide answers to these questions the ordinary artisan would be required to answer these themselves. This would take trial and error experimentation, which in this case would be undue, because rather than providing guidance on how to use these methods with the broadly claimed genus of endosymbiont forming inocula the instant disclosure appears to amount to an invitation to experiment in using the claimed inocula to perform an interesting but unenabled method. As such applicant’s arguments summarized in 1 above, are not persuasive as they relate to the modified enablement rejections against the method claims presented below.
With respect to 2. above, applicant’s arguments are not found to be persuasive because while applicant and the state of the art have provided guidance on Agrobacterium mediated transformation of plants (example 6 appears to be drawn to Agrobacterium mediated transformation of tomato plants with the flowering locus T “product”, which appears to be the TT3 gene) applicant has not provided guidance sufficient to use the claimed methods with the broadly claimed genus of endosymbiont forming inocula. This genus appears to consist of any plant or bacterial cell whatsoever which has been transformed with genes encoding auxin and cytokinin biosynthetic enzymes and any other polynucleotide of interest and there is no guidance the specification including but not limited to a reduction to practice that would allow the ordinary artisan to use the broadly claimed endosymbiont forming inocula (except for agrobacterium) without undue experimentation.
Finally, with respect to applicants arguments summarized in 3. above, applicants arguments are not found to be persuasive because while the instant disclosure and the state of the art provide enabled guidance on making the claimed genus of endosymbiont forming inocula both the disclosure and the state of the art do not provide guidance on how to use these transgenic cells in methods of delivering a product of interest to a target plant cell. As such the ordinary artisan would be required to use undue experimentation in order to solve myriad problems and use the claimed invention, see response to applicant arguments summarized in 1. above.
As such these arguments are not found to be persuasive and claims 152, 174-180, and 182 remain rejected as lacking enablement.
Claim Rejections - 35 USC § 112 –Enablement
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 01/30/2025 as applied to claims 119, 121-123 and 152-183. Applicant’s arguments filed on 04/22/2025 have been fully considered but they are not persuasive, see above.
Claims 152, 174-180 and 182 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 enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 152 is drawn to a method of delivering a compound of interest to a host plant. These methods require an endosymbiont forming inoculum, which is at least one bacterial cell or plant cell which can divide autonomously and is capable of forming an undifferentiated autonomously dividing multicellular structure, where the bacterial or plant cell comprises heterologous polynucleotide(s) encoding an auxin biosynthetic enzyme, a cytokinin biosynthetic enzyme and a polynucleotide of interest.
This inoculum is transplanted or inoculated onto at least one site on a host plant and cultured to form a symbiont on the host plant, wherein the polynucleotide of interest is expressed in the symbiont and an expression product of interest or a product made therefrom is transported into the host plant.
Claims 174-180 and 182 which depend on claim 152 further limit this claim to methods having specific polynucleotides of interest which may have specific effects on the host plant, to above ground target sites and to multiple transplanting events. Importantly these claims do not appear to limit the scope of the method of claim 152, such that they are drawn to methods which have sufficient enabled guidance for a skilled artisan to use these methods without undue experimentation.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
These methods are inherently broad because the genus of endosymbiont forming inocula claimed in claim 119 is broad.
Specifically, claim 119 is broadly drawn to any bacterial cell or any plant cell capable of autonomously dividing or forming an undifferentiated structure as long as these cells comprise a polynucleotide encoding any auxin biosynthetic enzyme, any cytokinin biosynthetic enzyme and a nucleic acid of interest as long as the biosynthetic enzymes are heterologous to the plant or bacterial cell.
Further, the methods of claim 152 and its dependent claims comprise other aspects which render them broad.
These methods are drawn to those that deliver a compound of interest to any host plant, regardless of species, genetic history, developmental stage, or any other factor.
These methods are drawn to those that deliver any expression product regardless of size, shape or any other characteristic.
Transplanting is broad and the inoculum could be transplanted to any site on any host plant for any amount of time.
The inoculum can be any bacterial cell or plant cell which comprises any auxin gene and any cytokinin gene and another polynucleotide of interest.
While some of the dependent claims limit the expression products delivered, and another limits the transplanting to at least two sites or a single site at least twice, this genus remains very broad as none of the claims address the breadth of host plants or the time of transplantation and those that do address the location of transplanting or the delivery of specific expression products are broad in the other areas.
With respect to the methods of claims 152, 174-180 and 182, in contrast to the breadth of this genus, Applicant has provided general guidance for co-culture of a disarmed Agrobacterium tumefaciens carrying a binary vector with a host plant (Instant Specification, 92). However, applicant does not appear to provide any enabled guidance for the use of plant cells or non-agrobacterium bacterial cells to deliver an expression product or a product produced from an expression product to a host plant of interest.
Given the breadth of the claimed methods, and the limited guidance the ordinary artisan would be unable to use the claimed methods without undue experimentation.
The claimed methods are drawn to a large genus, while guidance is provided for only a single embodiment. Given that the methods require the composition of claim 119, these methods are incredibly broad and require inocula having incredibly diverse and divergent structures. Further, this genus is drawn to methods of delivering any one of a nearly infinite group of compounds to any plant whatsoever. Given the single enabled embodiment and the incredibly diverse and divergent structures encompassed by the composition of claim 119 and the incredibly broad method step of culturing a symbiont forming inocula at, at least one site on a host plant. It is clear that the ordinary artisan would be required to use trial and error experimentation to screen all plant and bacterial cells comprising the required polynucleotides encoding a phytohormone biosynthetic enzyme and a gene of interest. Again, the applicant’s disclosure provides a simple motivation to investigate cells comprising biosynthetic enzymes and the uses of disarmed Agrobacterium but does not provide any guidance and therefore in order to use the claimed methods, the ordinary artisan would be required to perform extensive experimentation that would be undue.
This is amount of experimentation is undue and represents an invitation to experiment rather than enabled guidance.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims. Therefore, claims 152, 174-180 and 182 remain rejected as lacking enablement.
Response to Applicant Arguments - 35 USC § 112 (Improper Dependence)
In response to applicant’s amendments to the claims dated 04/22/2025 the improper dependence rejections of record are withdrawn.
Response to Applicant Arguments - 35 USC § 102
Applicants arguments and amendments to the claims dated 04/22/2025 have been fully considered but are not found to be persuasive.
Applicant’s arguments are summarized as follows:
van der Graaff describes plants, which are fully differentiated structures, transformed with genes encoding iaaH and iaaM, which are then crossed with a plant transformed with a gene encoding ipt-161 to produce plants comprising genes encoding both iaaH/iaaM and ipt-161.
van der Graaff fails to provide any evidence that the cells of any of the callus tissue comprised an auxin gene and a cytokinin gene both of which are heterologous to the callus cells or that the callus would have been capable of autonomous division when no longer attached to the hypocotyl.
The callus tissue of van der Graaff produced shoots which are differentiated structures and therefore the callus tissue is not undifferentiated.
With respect to 1. above, applicant’s argument is not found to be persuasive because while van der Graaff teaches mutant plants comprising the iaaH, iaaM and ipt genes van der Graaff also teaches that these plants produced callus tissue on the hypocotyl just below the rosette leaves and additionally they produced callus which formed at the base of the hypocotyl and these calli developed vigorously, demonstrating their ability to divide (van der Graaff, Pages 248-249, Section titled Combined Effect of Cytokinin and Auxin Overproduction causes formation of Aerial Rosettes; van der Graaff, Pages 248-249, Sentence spanning pages). Further, this second callus tissue was not reported to produce any other structures, just to divide rapidly and therefore van der Graaff teaches vigorously growing undifferentiated callus tissue which forms at the base of the hypocotyl. For these reasons applicant’s arguments summarized in 1. above, are not found to be persuasive.
With respect to 2. above, applicant’s arguments are not found to be persuasive because van der Graaff does provide evidence that the callus tissue comprised the auxin gene and cytokinin gene. Additionally, the ability to divide autonomously is an intrinsic characteristic of callus tissue which is demonstrated by the vigorous division of the callus tissue found at the base of the hypocotyl of the plants of van der Graaff.
van der Graaff discloses that the double transgenic plants were obtained by pollinating the stigma of iaaM/iaaH plants with pollen from homozygous ipt plants and then selecting for plants displaying a strong auxin phenotype (van der Graaff, page 242, Column 2, First Complete Paragraph). Given this breeding strategy and that the ipt mutants were homozygous it is clear that progeny produced using this pollen would have the ipt mutant allele and that by selecting for plants showing the strong auxin phenotype van der Graaff were able to select for plants comprising both the ipt mutant (homozygous mutant pollen would confer at least one mutant ipt allele) and the iaaM/iaaH mutant genes (selecting for the auxin phenotype would select for the presence of the mutant iaaM/iaaH alleles).
Therefore, these plants and the callus tissues which formed spontaneously on the hypocotyls of these plants comprise the auxin and cytokinin genes. Further, given that the callus tissue formed spontaneously and was growing vigorously and further that an intrinsic characteristic of callus tissue is that after induction it can divide autonomously it is clear that the callus tissue of van der Graaff is capable of autonomous division.
With respect to 3. above, applicant’s arguments that the callus tissue of van der Graaff produced shoots which are undifferentiated structures and therefore the callus tissue is not undifferentiated is not found to be persuasive because van der Graaff discloses that the doubly transgenic plants produce two different callus tissues, one which produced shoots and a second at the base of the hypocotyl which grew vigorously but does not differentiate to produce other structures. As such applicant’s arguments are not found to be persuasive.
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 and 166 remain rejected and claims 173 and 184 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Graaff.
Claim 119 is drawn to a symbiont forming inoculum comprising an autonomously dividing plant cell capable of forming an undifferentiated autonomously dividing multicellular structure or a bacterial cell comprising a polynucleotide encoding heterologous cytokinin and auxin biosynthetic enzymes.
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 this limitation of the claim.
With respect to claim 119 van der Graaff discloses a symbiont forming inoculum for producing a biomolecule (van der Graaff does not use this term, instead van der Graaff discloses plants, plant parts, plant tissues including callus tissue and plant cells from doubly transgenic Arabidopsis thaliana plants which comprise the TRYPTOPHAN MONOOXYGENASE and INDOLEACETAMIDE HYDROLASE phytohormone biosynthetic enzymes from Agrobacterium tumafaciens and the Agrobacterium tumafaciens ipt gene. These plants have totipotency and produce dedifferentiated plant cells and structures as demonstrated below)(van der Graaff, Page 248, Column 2, Last 8 Lines; van der Graaff, Page 248, Column 1, Lines 5-11; van der Graaff, Page 241, Column 1, First Complete Paragraph; van der Graaff, page 252, Column 2, Fourth Citation).
Further, van der Graaff discloses the symbiont forming inoculum comprising a plant cell (root cells and hypocotyl cells which produced callus among all of the other cells that comprise the doubly transgenic plant)(van der Graaff, Page 248, Column 1, Lines 5-8 and Column 2, Last Paragraph) which comprises a polynucleotide encoding phytohormone biosynthetic enzymes (doubly transgenic plants and cells comprise the iaaM/iaaH construct which is a polynucleotide encoding the TRYPTOPHAN MONOOXYGENASE and INDOLEACETAMIDE HYDROLASE phytohormone biosynthetic enzymes as well as the ipt gene from Agrobacterium tumafaciens)(van der Graaff, Page 248, Columns 1- 2, Section titled Combined Effect of Cytokinin and Auxin Overproduction Causes Formation of Aerial Rosettes; van der Graaff, page 241, Column 1, First Complete Paragraph; van der Graaff, Page 252, Fourth Citation).
van der Graaff also discloses that these plants comprise a polynucleotide of interest (nearly any polynucleotide could be considered a polynucleotide of interest, however 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), wherein the phytohormone biosynthetic enzymes are heterologous to the plant cell (Agrobacterium tumafaciens phytohormone-biosynthetic genes iaaM and iaaH and Agrobacterium tumafaciens ipt)(van der Graaff, Page 241, Column 1, First Complete Paragraph; van der Graaff, Page 252, Fourth citation; van der Graaff, page 248, Column 2, Whole Column) and are a cytokinin biosynthetic enzyme (ipt)(van der Graaff, Page 242, Column 2, First Complete Paragraph) and an auxin biosynthetic enzyme (Agrobacterium tumafaciens phytohormone-biosynthetic genes iaaM and iaaH)(van der Graaff, Page 241, Column 1, First Complete Paragraph).
Finally, van der Graaff discloses that the plant cell is an autonomously dividing plant cell (van der Graaff, discloses cells in a callus tissue from the double transgenic iaaM/iaaH-40*ipt plants. Importantly, van der Graaff discloses that under tissue culture conditions callus tissue formed in bolting double transgenic plants. This demonstrates that the double transgenic plant cells are autonomously dividing plant cells)(van der Graaff, Page 248, Column 2, Last 8 lines) capable of forming an undifferentiated autonomously dividing multicellular structure (Claim 123 makes clear that callus tissue is an undifferentiated autonomously dividing multicellular structure formed by the plant cell and van der Graaff discloses callus tissue from double transgenic iaaM/iaaH-40*ipt plants)(van der Graaff, Page 248, Column 2, Last 8 lines).
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, Van der Graaff discloses that the transformed plant cells comprise the kanamycin resistance gene, a gene of interest, which is expressed in the transgenic plants as evidenced by their ability to grow on kanamycin selective media (van der Graaff, Page 241, Column 2, Last Two Paragraphs).
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.
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 and which act as plant growth regulators (Van der Graaff, Page 241, Column 2, First Paragraph).
With respect to claim 166, 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 linked to their native promoters and that the ipt gene was crossed into this plant from a second plant where this gene was expressed and produced a strong cytokinin phenotype as such it would be linked to a different promoter (Van der Graaff, Page 241, Column 2, Second Full Paragraph; van der Graaff, Page 242, Column 2, First Complete Paragraph; van der Graaff, Pages 248-249, Last Paragraph of Column 1 – First Paragraph in Column 1).
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.
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.
Claims 157-160, 162, 165, 168 and 183 are newly rejected under 35 U.S.C. 103 as being unpatentable over van der Graaff in view of Nilsson, Physiologia plantarum 100.3 (1997).
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 165, van der Graff teaches all of the limitations of claim 119, see anticipation rejection above.
With respect to claim 168, van der Graff teaches all of the limitations of claim 157 taught above, see above.
With respect to claim 183, van der Graff teaches all of the limitations of claim 168 taught above, see above.
With respect to claims 157-160, 162, 165, 168 and 183, 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, wherein the plasticity peptide is linked to a promoter or wherein the polynucleotide is linked to the same or a separate promoter as that which is operably linked to the polynucleotide encoding the phytohormone biosynthetic enzyme and/or the polynucleotide of interest. Nor does van der Graaff teach the symbiont forming inoculum expressing nisin or wherein the polynucleotide of interest encodes a polypeptide operably linked to a targeting sequence.
With respect to claims 157-160, 162, 165, 168 and 183 Nilsson teaches me 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) which produce opine compounds (Nilsson, Page 465, Column 1, First Full Paragraph; Nilsson, Page 466, Column 1, First Complete Paragraph). Therefore, these genes are responsible for triggering tumor growth which would harbor a symbiont and supply that symbiont with nutrients.
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 because this would allow the endosymbiont forming cells to modulate host gene expression to produce tumors and nutrients allowing for the endosymbiont forming inoculum to live within the host and modulate host characteristics. Further, the choice to have the endosymbiont forming inoculum also express a nisin gene comprising a localization signal which can be transported into the host plant to modify a characteristic represents a simple design choice. The endosymbiont forming inoculum could be used to deliver many different products to the host plant and nisin would have been an obvious choice given its antimicrobial properties.
This would have been motivating to the ordinary artisan because the plant cells of van der Graaff produce undifferentiated callus tissue which is self-maintaining but the expression of the rol genes would allow these cells to interact with other organisms and allow these cells to act as an intermediary which can be used to modify the host plant without the need for transformation or the generation of transgenic host plants. Further nisin given its antimicrobial properties would have been an obvious choice to introduce into the host plant because it give the advantages of a transgenic pathogen resistant plant without the regulation and challenges of producing a transgenic crop. As such claims 157-160, 162, 165, 168 and 183 are rejected as obvious under van der Graaff in view of Nilsson.
Claims 167 and 169-170 are newly rejected under 35 U.S.C. 103 as being unpatentable over van der Graaff.
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.
With respect to claim 169, van der Graaff teaches all of the limitations of claim 166, 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 170, van der Graaff teaches all of the limitations of claim 167 taught above, see 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).
However, with respect to claims 167 and 169-170, van der Graaff does not explicitly teach these genes operably linked to a single promoter.
In the instant case 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. 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.
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. 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 claim 167 is rejected as obvious.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662