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 .
Second Non-Final Rejection
In order to properly address the breeding history of the instant variety in the art rejections a second non-final rejection is presented as follows.
Claim Status
Claims 1-9, 11-12, 18-20 and 29-38 are pending.
Claims 10, 13-17, 21 and 23-28 are newly cancelled.
Claims 1-5, 7-9, 11, 18, 22, 29-33 and 35-37 are newly amended.
Claim 38 is new.
Claims 1-9, 11-12, 18-20 and 29-38 are rejected.
Response to Applicant Arguments - Specification
In response to Applicant’s amendments to the specification dated 07/10/2026, the objections to the specification of record are withdrawn.
Response to Applicant Arguments – Claim Objections
Applicant’s cancellation of claim 10 on 07/10/2026 renders the claim objection of record against that claim moot and it is withdrawn.
Response to Applicant Arguments – Indefiniteness
In response to Applicant’s arguments and amendments to the claims dated 07/10/2026, the indefiniteness rejections of record are withdrawn, with two exceptions.
Applicant has not provided a detailed trait table on the physiological and morphological such that the characteristics of “UNR-01” are clear and therefore, the rejections of record on the grounds that “UNR-01” is indefinite and “all of the physiological and morphological characteristics of” potato plants of potato variety ‘UNR-01’ are maintained. Applicant’s arguments with respect to these rejections are summarized and addressed below.
Applicant’s remarks are drawn to the following concept:
Potato is vegetatively or clonally propagated and ‘UNR-01’ is phenotypically stable across at least 5 generations. Further, the variety was produced by genome editing of the ‘Atlantic’ cultivar of potato by Agrobacterium mediated transformation which produced a 1.2 kb deletion in the StMYB93 gene (Stmyb93-20) and therefore the breeding history of the claimed variety is clear. Finally, Applicant has provided Table 1 in paragraphs 4-5 of the Vulavala Declaration which provides distinguishing characteristics of the instant cultivar from the parent variety.
This argument is not found to be persuasive because while Applicant has provided information on the stability of the variety, the steps taken to produce the variety and some of the phenotypic distinctions between this instant variety and its parent Applicant has not provided a description such that all of the phenotypic and morphological characteristics of the claimed variety are clear.
Specifically, while Applicant makes clear that the instant variety was produced by transforming the ‘Atlantic’ variety and provides a table identifying differences in sprout initiation, sprout growth, tuber dormancy, total tuber weight per plant, number of tubers per plant, individual tuber weight, skin quality after storage, apparent tuber shrinkage, reducing sugars, above-ground biomass, wound healing suberin, sprout morphology, apical dominance and plant canopy, Applicant’s disclosure does not provide a description of the phenotypical and morphological characteristics of the instantly claimed variety.
To demonstrate, Applicant states in lines 24-26 of page 3 of the specification that “In some examples, the morphological and physiological characteristics of ‘UNR-01’ include similar sugar levels and wound healing to that of potatoes cv. Atlantic” further, in the last paragraph on page 10 of Applicant Remarks dated 07/10/2026, Applicant states that “Relative to the parent variety (wild-type ‘Atlantic’), the primary distinguishing characteristics of ‘UNR-01’ is delayed sprouting resulting from extended tuber dormancy; however, additional distinguishing traits are provided n paragraphs 4-5, Table 1, and figures 1 and 2 of the Vulavala Declaration”.
Both of these statements use variety ‘Atlantic’ as a reference and then describe some differences between the instantly claimed variety and ‘Atlantic’, importantly these statements are open ended indicating that the varieties may be similar but failing to state that the two varieties share all traits except those described in Table 1. Therefore, while the two varieties are similar and definitely differ in the traits described in table 1 of the Vulavala declaration, given the specification, all of the physiological and morphological characteristics of the instantly claimed variety are not clear and as such the term “UNR-01” which is not known in the art is indefinite.
Thus, Applicant’s arguments are not found to be persuasive, and the rejections of record are maintained.
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 01/13/2026 as applied to claims 1-37. Applicant’s arguments filed on 07/10/2026 have been fully considered but they are not persuasive, see above.
Claims 1-9, 11-12, 18-20 and 29-37 remain rejected and claim 38 is 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 pre-AIA the applicant regards as the invention.
Claims 1, 3, 6, 9 and 38 are rejected as being indefinite in their recitation “UNR-01” because the recitation does not clearly identify the claimed variety.
The specification does not provide a description of the claimed variety which includes the physiological and morphological characteristics of the variety. While figures 1-6 and 8 provide some description of the variety and Applicant includes several statements in the specification of characteristics of the variety, these statements all include non-limiting language. For examples lines 19-26 on page 3 of the specification include the following description of the claimed variety:
The disclosure provides potato plants including or consisting of all of the morphological and physiological characteristics of 'UNR-01 ', such as the characteristics shown in FIGS. 1-6 and 8, for example, reduced sprouting suppression phenotype, broken apical dominance resulting in the formation of multiple branches, larger number of tubers smaller in size, and a genetic deletion of about l .2kB in an StMYB93 gene. In some examples, the morphological and physiological characteristics of 'UNR-01' include similar sugar levels and wound healing to that of potatoes cv. Atlantic.
This language indicates that while plants of ‘UNR-01’ can have a “reduced sprouting suppression phenotype, broken apical dominance, larger number of tubers smaller in size and a genetic deletion of about 1.2kB in an StMYB93 gene” these metrics are mostly comparisons and there is no reference state and as such the meaning of these characteristics is not clear. Then, Applicant states that “in some examples, the morphological and physiological characteristics of ‘UNR-01’ include similar sugar levels and wound healing to that of potatoes cv. Atlantic” indicating that in other examples the variety has a different set of characteristics.
Lines 8-20 of page 20 provide the following description of the phenotypes of ‘UNR-01’
The 'UNR-01' variety has the following phenotypes:
1. Sprout suppression for more than 14 months - Good for long term storability and food security
2. Less desiccation and shrinkage of tubers - Very good for any type of potato usage (frozen/fresh/chips) and maintaining yields by weight
3. Wound healing characteristics similar to wild type - Unchanged Curing Process
4. Reduced-sugar levels equal to wildtype tubers - Unchanged frying characteristics
5. A larger number of smaller tubers - Can be used as seed tubers or as
fresh market "baby" potatoes.
'UNR-01' also has a genetic inactivation of StMYB93, by a deletion of about
20 1.2 kb of a StMYB93 gene.
Again this description appears to rely on comparison to an unknown reference and while this represents a group of phenotypes of the variety it does not provide a description of the characteristics of the variety such that the structure encompassed by the use of the term “UNR-01” in the claims is clear.
Further, there is no trait table which describes the phenotypic and morphological characteristics of “UNR-01”. While, Applicant has provided the steps used to produce the claimed variety from variety ‘Atlantic’ and provided a list of non-limiting traits that differ between the two varieties, Applicant has not provided a trait table or other description of all of the morphological and physiological characteristics of the claimed variety. Stated different given the description in the specification, while some of the differences between the instant variety and the parent variety are clear all of the physiological and morphological characteristics of the claimed variety are not clear and as such the scope imparted by the use of the term “UNR-01” is not clear.
Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “UNR-01” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith are unclear without the deposit.
While, Applicant has provided a deposit of the claimed variety which describes the genetic characteristics of the variety, this deposit of plantlets does not provide all of the morphological and physiological characteristics of the claimed variety.
Claims 2, 4-5, 7-8, 11-12, 18-20 and 29-37 are rejected for depending on an indefinite claim and failing to recite additional limitations that would render the claims definite.
In claims 3, 6 and 9 the claims all recite “all of the physiological and morphological characteristics of” potato plants of potato variety ‘UNR-01’ (The individual claims refer either to potato variety’UNR-01’ to the plant of claim 2 which is a plant produced by growing the plant of potato variety ‘UNR-01’). As described in the indefiniteness rejections above drawn to the name of the claimed potato variety, the physiological and morphological characteristics of potato variety ‘UNR-01’ are not clear as such the scope imparted to the claims by the recitations of “all of the physiological characteristics of” ‘UNR-01’ are not clear and therefore these claims are rejected as indefinite.
Of note, the specification states that the characteristics of the variety are described in Figures 1-6 and 8 for example (Specification, Page 3, Lines 19-26). However, these figures are drawn to several black and white images of a potato variety and figures presenting data about gene expression levels and wound periderm characteristics and fail to adequately describe the morphological and physiological characteristics of potato variety UNR-01.
Response to Applicant Arguments – Enablement
In response to Applicant’s arguments and amendments to the claims dated 07/10/2026, including the paragraph spanning pages 11-12 of Applicant Remarks dated 07/10/2026 which states that the deposit will be irrevocably and without restriction released to the public upon issuance of a patent, the enablement rejections of record are withdrawn.
Response to Applicant Arguments – Written Description
Applicant’s arguments and amendments to the claims dated 07/10/2026 have been fully considered but are not found to be persuasive and the rejections of record are maintained.
Applicant’s arguments are summarized and addressed below.
Applicant Arguments are summarized as follows:
The office argues that the plants Applicant presents as ‘UNR-01’ do not appear to be stable and characteristics of these plants are not clear, therefore Applicant allegedly did not have possession of the claimed variety. However, given that potato variety ‘UNR-01’ is propagated clonally, all plants are genetically identical and the deposited material is uniform and stable.
In view of the specification which describes traits and clonal propagation of cultivar ‘UNR-01’, a person of ordinary skill in the art would conclude that Applicant was in possession of plants of cultivar ‘UNR-01’. While the office asserts that the traits of ‘UNR-01’ are allegedly unclear because it is unclear what the “wild type” comparison refers to the Vulavala declaration confirms that the term ‘wild type’ as used in the specification refers to the parent cultivar, ‘Atlantic’.
With respect to the argument summarized in 1. above, this argument is not found to be persuasive because while the variety may be clonally propagated and therefore all plants genetically identical, the characteristics of the claimed variety remain unclear, see the response to Applicant arguments summarized in 2. above, for details.
With respect to the argument summarized in 2. above, while clarifying that ‘wild type’ refers to variety ‘Atlantic’ clarifies portions of the scope of the claimed invention, the specific morphological and physiological characteristics of the claimed variety remain unclear and therefore, given the description provided in the specification and the state of the art the ordinary artisan would be not be able to determine if they were in possession of the claimed potato variety and therefore Applicant has not demonstrated possession of the claimed invention.
Specifically, Applicant states in lines 24-26 of page 3 of the specification that “In some examples, the morphological and physiological characteristics of ‘UNR-01’ include similar sugar levels and wound healing to that of potatoes cv. Atlantic” further, in the last paragraph on page 10 of Applicant Remarks dated 07/10/2026, Applicant states that “Relative to the parent variety (wild-type ‘Atlantic’), the primary distinguishing characteristics of ‘UNR-01’ is delayed sprouting resulting from extended tuber dormancy; however, additional distinguishing traits are provided n paragraphs 4-5, Table 1, and figures 1 and 2 of the Vulavala Declaration”.
Both of these statements use variety ‘Atlantic’ as a reference and then describe some differences between the instantly claimed variety and ‘Atlantic’, importantly these statements are open ended indicating that the varieties may be similar but failing to state that the two varieties share all traits except those described in Table 1. Therefore, while the two varieties are similar and definitely differ in the traits described in table 1 of the Vulavala declaration, given the description provided in the specification, all of the physiological and morphological characteristics of the instantly claimed variety are not clear.
Therefore, all of the physiological and morphological characteristics of the claimed variety are not clear, it is not clear that Applicant is in possession of the claimed variety and Applicant’s arguments are not found to be persuasive. The rejections of record against claims 1-9, 11-12, 18-20 and 29-37 are maintained and new rejections are applied to new claim 38.
Claim Rejections - 35 USC § 112(a) (Written Description)
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.
Written Description
Claims 1-9, 11-12, 18-20 and 29-37 remain rejected and claim 38 is newly 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
The claims are broad in scope in the following aspects:
The claims all require potato variety ‘UNR-01’.
As discussed above, in the indefiniteness rejections the specific characteristics of potato variety ‘UNR-01’ are unclear. This same issue presents written description issues.
Applicant has not adequately described potatoes of variety ‘UNR-01’ such that the ordinary artisan would be able to identify if they were in possession of the claimed variety. In many cases a trait table and breeding history provided in applications drawn to plant varieties are sufficient to adequately describe the claimed variety.
In the instant case, neither a trait table nor a detailed description of the phenotypic and morphological characteristics of the claimed variety are provided. Applicant states in the specification that the morphological and physiological characteristics of the claimed variety are described in Figures 1-6 and 8 but these figures are drawn to several black and white images of a potato variety and figures presenting data about gene expression levels and wound periderm characteristics and fail to adequately describe the morphological and physiological characteristics of potato variety UNR-01.
Later in the specification applicant states that ‘UNR-01’ has the following characteristics, sprout suppression for more than 14 months, less desiccation and shrinkage of tubers (although no reference state is provided for comparison), would healing characteristics similar to wild type (‘Atlantic’), a larger number of smaller tubers and a genetic inactivation of StMYB93 by a deletion of about 1.2 kb of a StMYB93 gene (Specification, Page 20, Lines 8-20). While this provides some description of ‘UNR-01’s, these appear to be non-limiting embodiments of the claimed variety as opposed to specific description. This is because while the instantly claimed variety differs from ‘Atlantic’ in the above-described traits, Applicant’s list of differences is not limiting and therefore the instant variety can differ the reference by any number of other differences.
In example 1 of the specification, applicant describes a process of using gene editing to modify potato cultivar ‘Atlantic’ by targeting the StMYB93 gene (Specification, Page 66, Line 10- Page 69, Line 24). In example 2, applicant describes characteristics of the modified plants and names them ‘UNR-01’ (Specification, Page 69, Line 26- Page 70, Line 27). Finally, in example 3 in the specification applicant describes DNA extraction and PCR analysis of an amplified genomic portion of StMYB93 from wild type and mutant plants and found several band sizes in StMYB93-20 (‘UNR-01’) (Specification, Page 71, Lines 1-14).
This description does not make clear the genetic and morphological characteristics of all ‘UNR-01’ plants because no trait table is provided and there is no detailed description of the phenotypic and morphological characteristics of the claimed variety.
The description also notes that ‘UNR-01’ was produced by transforming leaf discs from potato cultivar Atlantic (Specification, Page 66, Lines 22-27). It further shows that confirmed transgenic plants (those that had the presence of the NPTII transgene) were transferred into potting media and tubers were harvested from mature plants (Specification, Page 67). Leaves of these plants were used for genomic analysis of the StMYB93 gene (Page 67, Lines 21-27). This is very important because the leaves were isolated from T0 plants, these are the plants grown from the leaf discs that were transformed by agrobacterium.
Each cell in this disc may or may not have been transformed by the bacteria, the cassette encoding the transgenes would likely have landed in a separate genomic location in each cell that it landed in and very importantly, this cassette is a gene editing cassette. Gene editing using the NHEJ approach which appears to have been employed here used here is a relatively simple approach. A guide RNA targets an endonuclease to a specific target site where it makes a cut, the cell repair machinery of the target cell then tries to repair the break, this machinery is efficient and it is suspected that most times the repair is made correctly, however the principle behind this method is that this process of cutting and repair repeats until the repair machinery makes a mistake and repairs the break incorrectly leading to a mutation (Wyatt, Addgene Blog, 2020). This occurs independently in every cell which comprises the CRISPR machinery, producing random mutations and will continue until the guide RNA is unable to target to the enzyme to the target site (Emphasis added by examiner). One way to ensure this process has stopped is to select for progeny plants where a mutation at the target site is present but the gene editing cassette has been segregated out.
However, as noted in the Affidavit dated 07/10/2026 potato is vegetatively or clonally propagated and therefore (Affidavit, Page 2, Section 4, Breeding History and Figure 1). This leads to the following issues:
Rather than generating a subsequent generation of the transformed plant through sexual reproduction (T1) which would be produced from a single transformed reproductive cell and therefore have the same mutations in every cell, the claimed variety was produced through vegetative propagation. Given this and given that tubers form from stolons produced on axillary buds there does not appear to be any step in this breeding process where a single cell is selected and progeny are produced from that cell such that all of the cells in the plant share the same edit. In sexually reproducing plants this normally occurs during sexual reproduction. As such it appears that the plants of the claimed variety are mosaics comprising unique gene edits in each of the cells.
Given that the breeding history in the Affidavit dated 07/10/2026 states that the claimed variety was produced “after multiple rounds of in vitro antibiotic selection for the selectable marker contained in the T-DNA” the gene editing cassette appears to have been stably introduced into plants of the variety and has not been removed through outcrossing or some other process. As such and given the mosaic nature of the claimed variety as described in a. above, new edits may be produced in any cells which retain the target site.
These are issues because Applicant has claimed a variety and while Applicant has stated that the variety shows trait stability with no loss or phenotypic reversion after 5 generations given the description by applicant the claimed variety appears to be a mosaic which has instability due to the retention of gene editing machinery (Affidavit, Page 4, Section 6). Further, Applicant states in lines 19-20 on page 20 of the specification that ‘UNR-01’ also has a genetic inactivation of StMYB93, by a deletion of about 1.2kb of a StMYB93 gene.
Given the breeding history, in particular the concerns raised in a. and b. above, it is unclear how many cells in each plant comprise this deletion, what the penetrance of this allele in the population of “UNR-01’ plants and finally, given the genetic characteristics of the variety and the mechanism of reproduction how it is ensured that this allele is retained by the plants of the variety and correspondingly if plants produced by vegetative propagation from ‘UNR-01’ do not comprise this deletion are they still considered plants of the variety.
As noted previously, the plants that applicant describes being used for characterizing the gene editing events appear to have different edits in every different cell and may not actually have heritable edits. This is because the gene editing cassette appears to still be present in the cells that applicant is analyzing and as such the analysis could be capturing a transient state after which the mutation was correctly repaired or some other change was made.
Evidence for this is found in applicants example 3 which describes “several band sizes in StMYB93-20 (‘UNR-01’) indicating that there are different alleles in different cells that have different sizes and therefore separate into different bands under gel-electro phoresies. It is not clear how bands of different sizes amplified from the same primers could all show deletions of about 1.2kb (Specification, Page 71, Lines 1-7)
Therefore, the plants applicant presents as ‘UNR-01’ do not appear to be stable, any modifications to the StMYB93 allele are not necessarily heritable and the characteristics of these plants are not clear.
Applicant has not adequately described the structural features that are required to be retained by members of the claimed genus of ‘UNR-01’ plants as to establish a structure-function relationship between the physiological and morphological characteristic of a plant and the function of being a ‘UNR-01’ variety plant. Further, applicant has not adequately described the structural features of the claimed genus of ‘UNR-01’ plants that are required to distinguish members of the claimed genus of plants from other potato plants.
Further, claims 7, 11 and 33-34 are drawn to an F1 progeny of the plant of claim 1, given the heterozygous nature of potato and the instability of the instant variety as described in the analysis above, the genetic and morphological characteristics of this sexually produced offspring can be very removed from those characteristics of the instant variety. As such given the description by Applicant it does not appear that Applicant is in possession of the claimed genus of F1 plants.
The analysis will now turn to the second element of the court’s decision in Eli Lilly; namely, the description of a representative number of species. Given the breadth of the claim due to the indefinite nature of the recitation of ‘UNR-01’the claims are directed to potato plants having nearly infinitely distinct structures and as such the claims read on an extremely broad and highly diverged genus of potato plants. Thus, in view of the analysis presented above, a skilled artisan would appreciate that the claims are directed to extremely broad and highly diverged genus that are required to include potato plants of variety ‘UNR-01’.
In contrast, the Specification has not described or provided any working example of a potato variety having uniform and stable phenotypic and morphological characteristics. Given the large size and structural diversity associated with the claimed genus, Applicant’s disclosure is not representative of the claimed genus as a whole.
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Response to Applicant Arguments – Obviousness
While new obviousness rejections which address the breeding history of the instant variety, specifically the use of variety Atlantic as the parent, Applicant’s arguments and amendments to the claims dated 07/10/2026 remain relevant to the new rejections and these arguments have been fully considered but are not found to be persuasive.
Applicant’s arguments are summarized and addressed below.
Applicant’s arguments are drawn to the following concept:
The amended claim recites “A plant, or plant part thereof, or potato variety ‘UNR-01’, wherein representative plantlets of the variety have been deposited under NCMA Accession No. 202606073” and neither Lashbrooke nor Verdaguer teach plants of ‘UNR-01’ as represented by the biological deposit and therefore the claims are not obvious.
This is not found to be persuasive because while the deposit is one way of enabling and in some cases describing a claimed invention, or cultivars there are other ways of describing the invention. In the instant case Applicant has provided a breeding history and trait table in the Vulavala Affidavit dated 07/102026 (Affidavit, Pages 2-5).
This breeding history makes clear that the instant variety was produced by transforming variety ‘Atlantic’ with a gene editing cassette which has a gRNA targeting the editing machinery to the potato MYB93 gene (Affidavit, Page 2, Section 4; Drawings, Figure 7). The transformed leaf tissue the underwent multiple rounds of in vitro antibiotic selection for the selectable marker contained into the T-DNA, then plants were grown and clonally propagated from tubers.
As such potato variety ‘UNR-01’ is a potato variety produced by transforming variety ‘Atlantic’ with a gene editing cassette targeting MYB93. While neither of the references recite the claimed accession number in combination the references teach a potato produced by transforming variety ‘Atlantic’ with a gene editing cassette targeting MYB93.
Therefore, while the references do not recite the specific Accession number of the deposit, they do teach a potato variety that shares the same breeding history and corresponding genetics and morphological characteristics as the claimed variety. Applicant’s arguments are not found to be persuasive.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Atlantic Potato Fact Sheet. (2017, August 31). Wisc.Edu, in view of Lashbrooke, The Plant Cell 28.9 (2016) and Verdaguer, Journal of Experimental Botany 67.18 (2016).
Interpretation of ‘UNR-01’
As described in the indefiniteness rejections above, the scope of potato variety ‘UNR-01’ is unclear given the language of the claims and the description provided in the specification. Further, at the time of filing it does not appear that this name had any meaning in the art. In order to ensure compact prosecution, the following interpretation of ‘UNR-01’ is provided.
The term ‘UNR-01’ is interpreted to refer to any potato plant comprising a modification of a StMYB93 gene.
With respect to claim 1, Atlantic Potato Fact Sheet teaches the potato variety Atlantic which is the standard variety for potato chip quality in the U.S. and Canada which is acceptable for French frying, boiling and baking and which was first released in 1976 (Atlantic Potato Fact Sheet).
With respect to claim 1, Atlantic Potato Fact Sheet does not teach transforming this variety with a DNA editing construct targeting StMYB93.
With respect to claim 1, Lashbrooke teaches that suberin, is a polymer that is deposited as a rough matrix in response to surface damage and during normal growth of various plant structures including potato tubers (Lashbrooke, Page 2097, Abstract). Further, Lashbrooke teaches that the MYB family of transcriptional regulators are involved in suberin biosynthesis or polymer assembly (Lashbrooke, Page 2097, Abstract). Specifically, Lashbrooke identifies potato StMYB93 as a member of a clade of MYB factors which have conserved expression between species and which have expression patterns consistent with suberin deposition in seeds (Lashbrooke, Page 2102, Column2, Last Paragraph; Lashbrooke, Page 2104, Column 1, Line 1- Column 2, Last line). Lashbrooke also demonstrates that plants having mutant MYB genes have reduced content of the constituents of the seed coat polymer that are considered characteristic elements of the suberin polymer (Lashbrooke, Pave 2107 Column 2, Last Paragraph).
Therefore, with respect to claim 1, Lashbrooke teaches the potato StMYB93 gene and highlights the potential role of this gene in suberin content.
With respect to claim 1, Verdaguer teaches that very little is known about the regulation and deposition of suberin and wax in potato but this process appears to be carefully regulated in a complex network (Verdaguer, Page 5415, Abstract). Verdaguer, also teaches the importance of suberin and the phellem which prevents dehydration and facilitates resistance to wounds and to pathogen infection (Verdaguer, Page 5416, Column 1, First Paragraph of the Introduction). Further, Verdaguer teaches that silencing of a transcription factor that is induced in the potato tissue where suberin is deposited lead to up-regulation of genes related to biosynthesis and transport of suberin and wax (Verdaguer, Page 5415, Abstract). In teaching this Verdaguer teaches potato tubers from plants having mutations which reduce the activity of the StNAC103 transcription factor (Verdaguer, Page 5418, Column 1, Second complete paragraph).
Verdaguer teaches that the only other transcription factor that has been characterized to have a clear effect on apoplastic lipids, those that make up the suberin layer in phellem tissues, is a MYB family gene (Verdaguer, Page 5423, Column 1, First Paragraph). Interestingly while AtMYB41 works as an activator of suberin related genes and suberin deposits, StNAC103, the transcription factor Verdaguer focuses on, represses suberin biosynthesis and potato lines where SNAC103 was silenced showed upregulation of suberin biosynthesis genes (Verdaguer, Page 5423, Column 2, First Paragraph of the Results Section).
Therefore, Verdaguer teaches that MYB and NAC transcription factors play a role in the complex gene regulatory network controlling suberin deposition in potato.
At the time of filing it would have been obvious to modify the dominant potato chip variety potato Atlantic of Atlantic Potato Fact Sheet to mutate the StMYB93 gene of Lashbrooke using the methods of Verdaguer (as applied to StNAC103) in order to modulate the deposition of suberin in one of the most important potato varieties. This would have been obvious because Atlantic Potato Fact Sheet is drawn to a commercially important potato variety and both Lashbrooke and Verdaguer are drawn to understanding and modifying the deposition of suberin in plant tissues and both discuss the role of potato transcription factors in regulating this deposition. Further, Verdaguer emphasizes the importance of the phellem in potato tubers and the role that suberin plays in this tissue. Given the importance of this molecule in potato tubers and the effect that it may have on the longevity and resistance of potato tubers to wounding and infection the ordinary artisan would have found it obvious to make a mutation in the StMYB93 gene which Lashbrooke identifies as important to suberin biosynthesis and deposition in order to modify the deposition and biosynthesis of this gene in potato.
Given that Verdaguer indicates that suberin biosynthesis and deposition is tightly controlled and that at least one transcription factor represses the deposition of suberin the ordinary artisan would have found it obvious to mutate the StMYB93 gene in Atlantic potatoes in order to determine if this mutant would produce a desirable phenotype. In fact, the ordinary artisan would have been motivated to make this mutation because it may produce a desirable and valuable potato having greater shelf life and stability due to greater resistance to wounding and greater resistance to pathogen infection. Additionally, the ordinary artisan would have been motivated to make this mutation in combination with the Stnac103 mutant of Verdaguer in Atlantic potatoes in order to investigate the additive effects of these genes on suberin deposition and as a way of modulating suberin content in potato tubers in order to produce the most desirable tuber, which could then be marketed for this enhanced characteristic.
Therefore, given the teachings of Atlantic Potato Fact Sheet, Lashbrooke and Verdaguer the ordinary artisan would have found it obvious to produce an Atlantic potato plant having a mutation in a StMYB93 gene and would have been motivated to make this modification. Claim 1 is rejected as obvious under Atlantic Potato Fact Sheet, Lashbrooke and Verdaguer.
With respect to claim 2, Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer collectively teach all of the limitations of claim 1, see above. These limitations include the ‘UNR-01’ potato plant which includes tubers (See claim interpretation at beginning of the obviousness rejections).
Additionally, Verdaguer teaches tubers, specifically that silencing the transcription factor StNAC103 was correlated with an increase in suberin and wax load and up-regulation of genes related to the biosynthesis and transport of suberin and wax in tubers (Verdaguer, Page 5415, Abstract).
With respect to claim 3, Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer collectively teach all of the limitations of claim 1, see above. These limitations include ‘UNR-01’ potato plant and plants having all of the physiological and morphological characteristic of those plants, namely an inactivated StMYB93 gene (See claim interpretation at beginning of the obviousness rejections).
Additionally, Verdaguer teaches propagating potato plants and therefore teaches generating progeny plants from tubers (Verdaguer, Page 5417, Column 1, First Paragraph of Materials and Methods).
With respect to claim 4, Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer collectively teach all of the limitations of claim 1, see above. These limitations include tubers of ‘UNR-01’ potato plants.
Therefore, claims 1-4 are rejected as obvious under Lashbrooke in view of Verdaguer.
Claims 5-9, 11-12, 18-20 and 29-37 are rejected under 35 U.S.C. 103 as being unpatentable over Atlantic Potato Fact Sheet in view of Lashbrooke, Verdaguer and Hoopes, US 10,561,114 B1, Patented February 18, 2020.
With respect to claims 5-9, 11-12, 18-20 and 29-38, Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer collectively teach all of the limitations of claims 1-4, see above.
With respect to claims 5-9, 11-12, 18-20 and 29-38, Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer do not collectively or individually teach a tissue culture produced from the potato plant (Claim 5), a potato plant regenerated from the tissue culture (Claim 6), an F1 progeny of the plant of claim 1 (Claim 7), a potato light sprout (Claim 8), a potato plant produced by growing the light sprout (Claim 9), F1 seed or seed from self-fertilization harvested from the plant of claim 1 (claim 11), a potato plant produced by growing the seed of claim 11 (Claim 12), a method of producing potato seed, comprising crossing the plant of claim 1 with itself of another potato plant and harvesting seed (Claim 18), a potato seed produced by the method of claim 18 (Claim 19), a potato plant produced by growing the seed of claim 19 (Claim 20), a method of producing a potato plant comprising transforming a gene encoding an additional trait into the potato plant of claim 1 (Claim 22), to methods of producing a commodity plant product comprising, obtaining the potato plant of claim 1 or a part thereof and producing a commodity product therefrom (Claim 29), a food product made from the tuber of claim 2 (Claim 30), a heat-processed tuber product made from the potato tuber of claim 2 (Claim 31), a method of producing F1 potato seed comprising crossing the potato plant of claim 1 with a different plant and harvesting the seed (Claim 32), an F1 potato seed produced by the method of claim 32 (Claim 33), an F1 potato plant produced by germinating the seed of claim 33 (Claim 34), a method of producing a genetic marker profile comprising extracting nucleic acids from an F1 seed of claim 33 (Claim 35), a method of plant breeding comprising isolating nucleic acids from the F1 potato seed of claim 33 and identifying one or more polymorphism from the isolated nucleic acids and selecting a plant having the polymorphisms for sue in a plant breeding method (Claim 36), a method of plant breeding comprising isolating nucleic acids from the plant of claim 34, identifying one or more polymorphisms from the isolated nucleic acids and selecting a plant having these polymorphisms wherein the plant is used in a plant breeding method and the method of claim 32, further comprising crossing a F1 plant germinated from the F1 seed with itself or a plant of potato variety ‘UNR-01’.
With respect to claim 5, Hoopes teaches a tissue culture produced from a potato plant (Hoopes, Column 31, Claim 4).
With respect to claim 6, Hoopes teaches a plant regenerated from the tissue culture and comprising all of the physiological and morphological characteristics of the potato cultivar used to produce the tissue culture(Hoopes, Column 31, Claim 5).
With respect to claim 7, Hoopes teaches plants regenerated from the tissue culture are identical to the plant used to produce the cultivar and further teaches the production of F1 plants from plants of the cultivar which would include the regenerated plants (Hoopes, Column 31, Claim 5; Hoopes, Column 1, Lines 50-53).
With respect to claim 8, Hoopes teaches a potato light sprout produced by growing a potato plant regenerated from the tissue cultured tuber which includes are identical to the plant used to produce the cultivar and further teaches the production of F1 plants from plants of the cultivar which would include the regenerated plants (Hoopes, Column 31, Claim 6; Hoopes, Column 31, Claim 4).
With respect to claim 9, Hoopes teaches a plant produced by growing the potato light sprout having all of the physiological and morphological characteristics of the potato cultivar (Hoopes, Column 31, Claims 7-8).
With respect to claim 11, Hoopes teaches F1 seed produced by growing the potato plant and crossing it with another plant (Hoopes, Column 32, Claim 9).
With respect to claim 12, Hoopes teaches growing F1 seed to produce plants and teaches a plant produced by growing the seed produced by growing the potato plant and crossing it with another plant (Hoopes, Column 32, Claim 9; Hoopes, Column 14, Lines 59-61).
With respect to claim 18, Hoopes teaches a method of producing potato seed comprising crossing a potato with itself or a second potato plant and harvesting the resultant seed (Hoopes, Column 32, Claim 9).
With respect to claim 19, Hoopes teaches a seed produced by crossing a potato with itself or a second potato plant and harvesting the resultant seed (Hoopes, Column 32, Claim 9).
With respect to claim 20, Hoopes teaches F1 plants and teaches F1 seed produced by crossing a potato with itself or a second potato plant and harvesting the resultant seed (Hoopes, Column 1, Lines 50-53; Hoopes, Column 32, Claim 9).
With respect to claim 22, Hoopes teaches a method of producing potato plants comprising transforming a gene conferring an additional trait into the potato plant (Hoopes, Column 1, Line 45).
With respect to claims 29-31, Hoopes teaches methods for producing food products from potato plants including potato chips and French fries (Hoopes, Column 29, Lines 26-43).
With respect to claim 32, Hoopes teaches a process for producing F1 potato seed comprising crossing a potato plant with a different potato plant and harvesting seed (Hoopes, Column 32, Claim 9).
With respect to claim 33, Hoopes teaches F1 potato seed produced by crossing a potato plant with a different potato plant and harvesting seed (Hoopes, Column 32, Claim 9).
With respect to claim 34, Hoopes teaches F1 potato plants and F1 potato seed produced by crossing a potato plant with a different potato plant and harvesting seed (Hoopes, Column 32, Claim 9; Hoopes, Column 1, Line 52).
With respect to claims 35-37, Hoopes teaches the use of molecular markers and the use of QTL mapping which intrinsically requires isolating and analyzing DNA for the presence of a marker and which can employ DNA from F1 plants (Hoopes, Column 16, Lines 16-54).
With respect to claim 38, Hoopes teaches a process for producing F1 potato seed comprising crossing a potato plant with a different potato plant and harvesting seed (Hoopes, Column 32, Claim 9). Hoopes further teaches crossing F1 hybrid seed with itself or another plant to produce F2 plants (Hoopes, Column 6, Lines 42-58).
At the time of filing it would have been obvious to modify the plant collectively taught by Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer in order to apply the different techniques and produce the many different products of Hoopes. This is because Hoopes teaches a plant of a potato cultivar and then teaches beneficial and standard practices in the art to produce useful and desirable plants from that cultivar, methods of breeding that cultivar as well as products produced from that cultivar. Given that the plant of Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer is selected from desirable suberin phenotypes it would have been obvious to use the techniques of Hoopes in order to produce the commercially and agronomically valuable derived plants as taught in Hoopes. The ordinary artisan would have been motivated to combine these teachings because of the agronomic and economic value of plant of Atlantic Potato Fact Sheet in view of Lashbrooke and Verdaguer and the additional value conferred through the use of standard potato breeding methods to produce desirable progeny and derived plants from a starting potato variety.
Claims 5-9, 11-12, 18-20 and 29-38 are rejected as obvious under Atlantic Potato Fact Sheet in view of Lashbrooke, Verdaguer and Hoopes.
Conclusion
No claims are allowed.
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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.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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