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 .
Claim Status
Claims 1-37 are pending.
Claims 1-37 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: In at least line 18 on page 3 of the specification there is a blank where a deposit number should be.
Appropriate correction is required.
Claim Objections
Claim 10 is objected to because of the following informalities: the claim recites a potato plant regenerated from the tissue culture of the potato plant of claim 9. It is clear that the claim refers to a potato plant regenerated from a tissue culture of the potato plant of claim 9, however substituting “a” for “the” in front of tissue culture of the potato plant of claim 9 would improve syntax. Appropriate correction is requested.
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 1-37 are 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.
In claim 1, the recitation “a representative potato tuber, plantlet, or tissue culture of the variety has been deposited under Accession No.” renders the claims indefinite. The claim is directed to plants of a potato variety ‘UNR-01’. There is no art accepted meaning for potato variety ‘UNR-01’, therefore, the application is relying on the deposit of “a representative potato tuber, plantlet, or tissue culture of the variety” to describe the genetic and phenotypic characteristics of the claimed variety. However, given that the claim does not recite the Accession Number of the deposited seed and further that the specification does not indicate that the deposit was made and does not include the deposit information, it does not appear that this sample of seed has been deposited.
Even if this deposit was made, without amending the independent claim to recite the accession number the scope of the claimed invention (potato variety UNR-01) would remain unclear and therefore indefinite.
For these reasons, the metes and bounds of claim 1 is not defined and claim 1 is rejected as indefinite. Claims 2-37 are rejected for depending on an indefinite claim and failing to limit the scope of the claims to definite subject matter.
In claims 1-2, 6, 10-11, 13-17, 24 and 26-27 are rejected as being indefinite in their recitation “UNR-01” because the recitation does not clearly identify the claimed variety. 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.
Further, there is no trait table which describes “UNR-01” and the breeding history which describes the production of “UNR-01” is extremely limited and does not make clear whether “UNR-01” is an inbred variety, hybrid variety, a uniform and stable line or a mosaic organism having distinct genetics in all of its cells as is often found in the first generation of plants comprising a gene editing cassette. As such the specific characteristics of plants of this variety are not clear.
This is particularly relevant because without an understanding of the characteristics of variety ‘UNR-01’ the scope of claims drawn to the variety is not clear but also the scope of progeny potato plants and other potato plants derived from ‘UNR-01’ are not clear.
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.
Claims 3-5, 7-9, 12, 18-23, 25 and 28-37 are rejected for depending on an indefinite claim and failing to recite additional limitations that would render the claims definite.
Claim 2 is rejected as being indefinite in the recitation of “A potato plant, or a plant part thereof produced by growing the potato tuber, plant, plantlet, plant part, or plant cell of claim1” because the scope of a plant produced by growing the plant of claim 1 is not clear. It is not clear if the scope of a plant produced by growing the plant of claim 1 includes progeny plants or if the plant produced by growing the plant of claim 1 is the plant of claim 1. As such the scope of the claim is not clear and therefore claim 2 is rejected as indefinite.
Claims 3-10 are rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
In claim 3, the recitation of “and comprising a genetically inactivated StMYB93 gene” renders the claim indefinite. This is because the claim is drawn to a potato plant having all of the physiological and morphological characteristics of the plant of claim 2, which is drawn to a potato plant produced by growing the potato plant of variety ‘UNR-01’. Given applicant’s description it appears that the claimed invention is a potato variety having an inactivated StMYB93 gene and that the defining characteristic of UNR-01 is that it possesses an inactivated StMYB93 gene, although as made clear in the indefiniteness analysis drawn to the name UNR-01 above, the exact scope imparted by this name is not clear. This is supported by claim 11 which recites “wherein the potato seed comprises the genetically inactivated StMYB93 gene that is present in variety ‘UNR-01’”. As such it appears that all of the physiological and morphological characteristics of UNR-01 would include an inactivated StMYB93. Therefore, the scope of the claim is not clear because it is not clear how the recitation of “and comprising a genetically inactivated StMYB93”, further limits the claim.
In claims 3, 6, 10 and 24 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.
Claim 25 is rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
In claim 24 the recitation of “backcross progeny plants that comprise the additional trait and in some examples all of the physiological and morphological characteristics of potato variety ‘UNR-01’ when grown in the same environmental conditions” renders the claim indefinite. The use of “and in some examples” leads to indefiniteness because it is not clear whether or not the claimed method requires the backcross progeny plants to comprise all of the physiological and morphological characteristics of the claimed potato variety.
Claim 25 is rejected for depending on an indefinite and failing to limit the scope of the claim to definite subject matter.
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.
DEPOSIT REJECTION
Claims 1-37 are 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 claim(s) 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. All dependent claims are included in this rejection unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to plants, plantlets, plant parts, plant cells of potato variety ‘UNR-01’ and plants and plant parts derived from said variety, and methods that utilize said potato variety. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit.
The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant intends to make a deposit of the potato variety (see page 3 of the specification) but the deposit does not appear to have been made as there is no information on the accession number, date of deposit or record of the viability test. Further, while the specification states that the deposit will be made to meet all of the requirements of 37 C.F.R. 1.801-1.809, it does not appear that all of the restrictions on the deposit will be irrevocably removed upon allowance.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
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 1-37 are 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 or a detailed and specific breeding history which provides description of the genetic characteristics of the claimed variety, for example whether the potato is inbred, hybrid or a mosaic comprising at least different StMYB93 alleles in each cell, 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 as noted above 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 (wild type may appear to variety Atlantic from which StMYB93 mutant plants were produced but there is no statement stating what wild type plants are), reduced-sugar levels equal to wildtype tubers (again the specific wild-type variety is not clear and also reduced-sugar levels equal to wildtype appears to be contradictory as how can the variety have reduced-sugar levels that are similar to wild-type if the reduced-sugar is not in contrast to wild-type what is it in contrast to?), 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’ these appear to be non-limiting embodiments of the claimed variety as opposed to specific description. This is because it is not clear if ‘UNR-01’ is an inbred line, hybrid line, if all ‘UNR-01’ plants must have the inactivated StMYB93 gene, see indefiniteness rejection above, if the inactivated StMYB93 gene must have a deletion of about 1.2 kb, what conditions the plants must be grown in to show those phenotypes and many other factors that must be provided to adequately describe a variety.
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 it does not represent a detailed breeding history and no trait table is provided. While this description does not represent either a trait table or breeding history or provide the information normally conveyed through those means, it does show 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 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. 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.
Therefore, 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.
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 diverge 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.
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 Lashbrooke, The Plant Cell 28.9 (2016) in view of 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, 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, Lashbrooke does not teach potato plants comprising a modification of the StMYB93 gene.
With respect to claim 1, Verdaguer teaches that very little is known about the regulation and deposition of suberin and wax in potato but that 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 characterize 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 mutate the StMYB93 gene of Lashbrooke using the methods of Verdaguer (as applied to StNAC103) in order to modulate the deposition of suberin in potato. This would have been obvious because 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 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 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 Lashbrooke and Verdaguer the ordinary artisan would have found it obvious to produce a 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 Lashbrooke in view of Verdaguer.
With respect to claim 2, Lashbrooke in view of Verdaguer collectively teach all of the limitations of claim 1, see above. These limitations include the ‘UNR-01’ potato plant (See claim interpretation at beginning of the obviousness rejections).
With respect to claim 3, Lashbrooke in view of 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).
With respect to claim 4, Lashbrooke in view of 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 5-37 are rejected under 35 U.S.C. 103 as being unpatentable over Lashbrooke, in view of Verdaguer and Hoopes, US 10,561,114 B1, Patented February 18, 2020.
With respect to claims 5-37, Lashbrooke in view of Verdaguer collectively teach all of the limitations of claims 1-4, see above.
With respect to claims 5-37, Lashbrooke in view of Verdaguer do not explicitly teach a tissue culture produced from the potato plant (Claim 5), a potato plant regenerated from the tissue culture (Claim 6), an F1 potato plant regenerated from the tissue culture (Claim 7), a potato light sprout (Claim 8), a potato plant produced by growing the light sprout (Claim 9), a plant regenerated from the tissue culture of the potato plant of claim 9 (Claim 10), a potato seed produced by growing the potato plant of claim 1 (claim 11), a potato plant produced by growing the seed of claim 11 (Claim 12), a potato plant regenerated from tissue culture of the potato plant of claim 12 (Claim 13), the potato plant of claim 1 further comprising a transgene (Claim 14), an F1 hybrid seed of variety UNR-01 produced by crossing ‘UNR-01’ with a different potato plant (Claim 15), a potato plant or plant part produced by growing the F1 seed of claim 15 (Claim 16), the potato plant of claim 1 further comprising a locus conversion (Claim 17), 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), an F1 hybrid seed produced by the method of claim 18 (Claim 21), a method of producing a potato plant comprising transforming a gene encoding an additional trait into the potato plant of claim 1 (Claim 22), a potato plant produced by the method of claim 22 (Claim 23), a method of introducing an additional trait into ‘UNR-01’ comprising using backcrossing (Claim 24), a potato plant produced by the method of claim 24 (Claim 25), a method of producing a progeny seed of ‘UNR-01’ comprising applying plant breeding techniques to the potato plant of claim 1 (Claim 26), to methods of producing a hybrid potato plant derived from ‘UNR-01’ (claim 27), a hybrid plant produced by the method of claim 27 (Claim 28), to methods of producing a commodity plant product comprising, obtaining the potato plant of claim 1 and producing a commodity product therefrom (Claim 29), a food product made from the tuber of claim 1 (Claim 31), a heat-processed tuber product obtained from the potato tuber of claim 1 (Claim 31), a process producing 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 process 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) and 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.
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 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 6).
With respect to claim 9, Hoopes teaches a plant produced by growing the potato light sprout (Hoopes, Column 31, Claim 7).
With respect to claim 10, Hoopes teaches a plant produced from tissue culture of the plant produced by growing the potato light sprout (Hoopes, Column 31, Claim 8).
With respect to claim 11, Hoopes teaches a 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 13, Hoopes teaches growing F1 seed to produce plants teaches regenerating plants from tissue culture of other plants (Hoopes, Column 31, Claim 8; Hoopes, Column 14, Lines 59-61).
With respect to claim 14, Hoopes teaches potato plants further comprising an additional gene which can be conferred by introducing a transgene into the plant (Hoopes, Column 1, Line 63- Column 2, Line 7).
With respect to claim 15, Hoopes teaches F1 hybrid potato seed produced by crossing one potato plant with another (Hoopes, Column 32, Claim 9).
With respect to claim 16, Hoopes teaches F1 hybrid potato plants and teaches F1 hybrid potato seed produced by crossing one potato plant with another (Hoopes, Column 1, Lines 50-53; Hoopes, Column 32, Claim 9).
With respect to claim 17, Hoopes teaches a potato plant further comprising a single locus conversion by backcrossing or genetic transformation (Hoopes, Column 1, Line 63- Column 2, Line 7).
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 21, Hoopes teaches F1 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 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 claim 23, Hoopes teaches potato plants comprising a gene conferring an additional trait introduced by transforming a gene encoding that trait into the potato plant (Hoopes, Column 1, Line 45).
With respect to claim 24, Hoopes teaches backcrossing methods to produce single gene converted plants (Hoopes, Column 3, Lines 28-34; Column 8, Line 66- Column 9, Line 18).
With respect to claim 25, Hoopes teaches potatoes produced using backcrossing methods to produce single gene converted plants (Hoopes, Column 3, Lines 28-34; Column 8, Line 66- Column 9, Line 18).
With respect to claim 26, Hoopes teaches methods of producing progeny potatoes by applying breeding techniques to potatoes (Hoopes, Column 7, Line 63- Column 7, Line 10).
With respect to claim 27, Hoopes teaches methods of single-seed descent which produce potatoes by creating an F1 progeny plant, then crossing that to produce an F2 progeny plant and growing that plant for generations (Hoopes, Column 10 Lines 38-49).
With respect to claim 28, Hoopes teaches potatoes produced by single-seed descent which produce potatoes by creating an F1 progeny plant, then crossing that to produce an F2 progeny plant and growing that plant for generations (Hoopes, Column 10 Lines 38-49).
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 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 (Hoopes, Column 16, Lines 16-54).
At the time of filing it would have been obvious to modify the plant collectively taught by Lashbrooke in view of 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 Lashbrooke in view of 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 Lashbrooke in view of 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 6-37 are rejected as obvious under Lashbrooke in view of Verdaguer and Hoopes.
Conclusion
No claims are allowed.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663