DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of group I, consisting of claims 1-14, in the reply filed on 1 May 2026 is acknowledged. The traversal is on the ground(s) that there is no serious search burden introduced by group II, claims 15-20. This is not found persuasive because while group I is directed to genetically engineered (i.e. transgenic) Fusarium resistance in strawberries (Fragaria spp.), group II is directed to a different, and much broader, category of plants requiring additional search; claims of group II encompass Fusarium resistances in any and all plants, and any and all transfer of sequences of numerous molecular variants of low similarity to those described by Applicant.
There are many plant species that are susceptible to Fusarium, diverse natural and biotechnological methods of ‘introducing a nucleic acid’, and a large number of potential genes and protein variants possible when only <100% sequence similarity is required. Such claims require different, and additional search, over those of group I.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-14 are under examination on the merits.
Claims 15-20 are withdrawn as non-elected subject matter.
Priority
Claims 1-14 receive the U.S. effective filing date 3 Aug 2023.
Drawings
The drawings are objected to because of lack of clarity in subject matter depicted and/or poor-quality resolution.
Figure 2, which is intended to provide an objective visual reference for disease scoring does not provide sufficient clarity to determine the differences among ratings. The image provided does not clearly depict individual plants nor provide a replicable reference or control cultivar for visual comparison of experimental material.
Because the provision of an objective visual scale for measurement of disease is critical to understanding the scope of the claims in the instant application, and Figure 2 does not clearly depict the scale required by the claims, Figure 2 is objected to.
Figures 3 & 4 are of low resolution, which makes several text areas illegible (i.e. small numerical text to the left, between ‘Consensus’ and ‘Conservation’ and ‘Sequence logo’). Additionally, domain designations in the upper left corner of images are pixelated and/or difficult to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [p.20, ¶105; p.21-22, ¶107]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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.
Claims 1-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-14 are drawn to Fusarium resistance as measured using Area Under the Disease Process Curve (rAUDPC) score. Claims recite limitation to specific rAUDPC values of <0.04. Claims recite that a ‘plant or plant part’ is to have an average Fusarium wilt resistance score.
The claims do not expressly recite what symptom of Fusarium infection is being measured to report the progress of the disease with the unitless measure rAUDPC. The claims do not indicate how an individual plant (i.e. singular) is to have an average (i.e. requiring multiple individuals) rAUDPC score. Such rAUDPC scores include multiple time point measurements, but these are for a singular individual. Requiring an average score to determine resistance classification implies that multiple individuals (i.e. clones) are required.
This claim language also makes it unclear if rAUDPC scores are variable enough to require averaging values of multiple clones to classify a genotype as being below the rAUDPC threshold value recited, and potentially infringing. It is not clear if environmental or observer error would be enough to impact ‘average of a plant’ and therefore require observations/ratings of multiple clones to ascertain if a particular line is within Applicant’s claimed range.
Because the claim language is unclear with respect to (a) the objective measures used to arrive at rAUDPC ratings and (b) what is meant by ascertaining ‘average Fusarium wilt resistance’ of an individual plant, we refer to the written description.
With respect to (a); Applicant defines rAUDPC as area under the disease process curve divided by days rated, and refers to Table 6 and Figure 2 [Specification, ¶73].
Table 6 indicates use of an ordinal scale with subjective ratings assigned by the observer based on differences such as ‘some slight wilt’ vs. ‘moderate wilt’, ‘full vigor’ vs. ‘moderate vigor’, and ‘entire plant has collapsed and is desiccated’ vs. ‘dead plant’. No quantitative descriptors are used to provide guidance on number of, percentage of, or area of diseased tissue associated with the subjective rating scale, beyond the images provided in Figure 2.
Figure 2 is a low-resolution image that does not indicate the identity of the plants pictured. Reference to Figures 5-8 indicate the cultivar ‘Inspire’ is the susceptible control and that ‘PS 3.108’ is the resistant control used for comparative purposes. However, it is unclear if plants depicted are replicates (i.e. clones) of a single genotype or different genotypes, or if they are check comparisons or experimental lines. In particular, based on the image provided, it is not clear how one would objectively discriminate between the plants shown as rating 5 & 10, the plants rating 1 & 3, or the plants rating 7 & 9 – these ratings, which determine the ultimate rAUDPC value, appear visually similar.
With respect to several of the plants provided as models for rating, is not possible to clearly distinguish foliage of one plant from its neighbor, or from the backdrop.
Turning to the written description, in describing disease assays Applicant indicates transgenic plants are artificially inoculated with Fusarium and observed in growth chamber and greenhouse settings [¶116 & ¶277-279]. Applicant does not report on humidity conditions or water status during fungal disease trials. Applicant does not report whether plants were replicated, indicate for how long observations were made, or how many time points were included in calculation of rAUDPC. In particular, the length of observation time and end point chosen are critical details to time-series studies. It is not clear if measurements were carried through harvest, or stopped prematurely as no indication is given regarding fruit set or yield of transgenic plants.
Further, Applicant does not indicate if the subjective measurements taken were recorded by a single observer, or multiple observers. Applicant does not indicate if clones were replicated, or only single plants were used for observation (i.e. unreplicated disease scores). As such, it is unclear how or if these variable factors influence rAUDPC scores necessary to determine if a plant would be encompassed by Applicant’s claims.
With respect to (b); Applicant indicates both experimental lines and control plants ‘Inspire’ and ‘PS 3.108’ were screened [¶116 & ¶277-279] but does not indicate if material was replicated. No indication is given whether phenotypic values reported in Figures 2 & 5-8 are for single plants, or are an average of clonal replicates. If they are clonal replicates, Applicant is silent as to sampling procedures and guidance as to how many replicates should be used to arrive at an appropriate average of rAUDPC to classify a plant as either resistant being <0.04 and potentially infringing, or is outside of the scope of their claims.
Furthermore, Applicant indicates re-screening of transgenic material was performed to ascertain stability of the phenotypes observed. This is depicted in Figure 8, which shows re-testing of favorable lines having native FUS1 expression (Figure 6), native FUS1 and FUS4 (Figure 7), and constitutive FUS1 expression (Figure 5).
Review and comparison of these tables indicates notable differences in rAUDPC scores, even within the highly controlled environment of a greenhouse.
Figure 8 shows that all 13 lines re-tested with native FUS1 expression were rated as below 0.04 rAUDPC score even though Figure 6 indicates that only 6 of those lines were rated below 0.04 rAUDPC. This indicates that over half of the material re-tested using the rAUDPC scoring method changed ranking from the ‘susceptible’ (i.e. outside scope of current claim language) to ‘resistant’ (i.e. within scope of current claim language) category when Applicant attempted to repeat ranking/scoring of material using their system. This indicates a high level of variance from environmental factors, or scoring/phenotyping procedures, impacting reported rAUDPC scores.
Figure 7 shows that all 6 lines re-tested with native FUS1 and FUS4 expression were initially rated as well below 0.04 rAUDPC score, with all lines apparently <0.01 scores. However, re-testing of these 6 lines (Figure 8) resulted in all material being >0.01 rAUDPC score. Upon re-testing, three lines were reported as >0.02 rAUDPC (i.e. more than doubled rating) and one line shifted from the ‘resistant’ to ‘susceptible’ category of >0.04 rAUDPC (line p6145-22). This indicates at least one line (17% of material) categorically changed from being encompassed by Applicant’s claims to being outside of the scope of claims based on subjective phenotype/rAUDPC ratings, even when conducted by the same research team in a highly controlled growing environment.
Providing a clear, objective visual key to disease scoring is critical to the instant Application because this determines whether material is encompassed by claim limitations. Applicant does not provide a replicable, quantitative metric for ascertaining this necessary feature.
Because the scope of the claims varies based on this subjective nature of the ordinal disease rating scale used to arrive at critical rAUDPC values, one reading the instant application would not have a clear understanding of the metes and bounds of the claims. Absent further definition, one would not be able to ascertain under what conditions any particular plant may be infringing Applicant’s claimed phenotypic range(s).
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.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for sequences of 100% identity to SEQ ID NO.1, 2 & 28 in Fragaria x ananassa, does not reasonably provide enablement for those of <100% identity to them in any and all Fragaria species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 1, from which all other claims depend, encompasses the overexpression and production of disease resistant plants via FUS1 in any and all Fragaria species.
Turning to the specification for support to such broad claim, we find Applicant only describes the genetic manipulation and transfer of Fusarium resistance in F. X ananassa [Specification, ¶274].
Because of this, claim 1 and its dependents are rejected as not having been fully enabled, as generating disease resistant, transgenic plants in such a variable polyploid genus of species is not described by Applicant. Further, prior art does not appear to show any use of FUS1, with ability to confer Fusarium resistance in strawberry species other than or outside of the cultivated F. X ananassa, or as have been described.
Therefore, without guidance from the specification as to the methods of making such plants across a diverse and variable polyploid genus such as Fragaria, it would require undue experimentation to make and use such transgenic plants, if it is even possible to do so.
Claim 1, from which all other claims depend, encompasses alleles of FUS1 which encode proteins conferring resistance to Fusarium and having as little as 90% sequence identity to SEQ ID NO.2.
A review of sequence search information reveals that there appear to be no reports of polypeptides conferring Fusarium resistance of less than 100% identity to the claimed polypeptides of SEQ ID NO.2 reported by Applicant. Thus, prior art does not provide structural description of proteins conferring Fusarium resistance having less than 100% identity to SEQ ID NO.2.
Proteins with 90% identity to the 1,202-residue long SEQ ID NO.2 encompass polypeptides with approximately 120 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 1,202-amino-acids-long polypeptide of SEQ ID NO.2 would require describing 12020 polypeptide sequences; a representative number of which were not described by the Applicant at the time of filing.
Similarly, dependent claims recite a nucleotide with only 75% identity to the 5,520 bp long SEQ ID NO.1, or the 4,025 bp long SEQ ID NO.28, both presented as encoding allelic variants of the protein of SEQ ID NO.2. This encompasses nucleic acids with ~1,006-1,380 variable nucleotide substitutions, of which a representative number were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of requiring only 90% identity to SEQ ID NO.2, and also a broad range of nucleic acids as a result of requiring only 75% identity to encoding SEQ ID NO.1 & 28. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the FUS1 protein. Making random changes in proteins is unpredictable, and therefore one would not be enabled to isolate or derive such proteins as FUS1 conferring Fusarium resistance with less than 100% identity to SEQ ID NO.2 with any reasonable certainty that it would function properly.
It has been shown within the art that highly similar Fusarium resistance alleles have different functionality, owing to variation in coding sequences. It has been demonstrated that mutation of genes through introduction of indels and/or SNP variation can lead to gain or loss of Fusarium resistance [see p.1106, col.2, ¶3 in Li et al. Nat Genet 51, 1106–1112 (2019); Published 10 Jun 2019].
Because of this, claim 1 and its dependents are rejected as not having been fully enabled, as such variable proteins conferring Fusarium resistance are not described in the specification, nor taught by the existing art. Even with extensive studies directed to Fusarium diseases in crop plants [See Buerstmayr et al. (2009) for wheat, Chitwood-Brown et al. (2021) for tomato, Mesterhazy et al. (2011) for maize, Verma et al. (2025) for pea, Das et al. (2024) for banana] no variants of FUS1, with ability to confer Fusarium resistance in strawberry or other plants, have been described with less than 100% identity to Applicant’s SEQ ID NO.2, or the encoding SEQ ID NO.1 & 28.
Therefore, without guidance from the specification as to which proteins of 90% identity to SEQ ID NO.2 confer Fusarium resistance, it would require undue experimentation to find these proteins and their encoding sequences, if it is even possible to do so.
Claims 1-14 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, from which all other claims depend, encompasses the overexpression and production of disease resistant plants via FUS1 in any and all Fragaria species.
Turning to the specification for support to such broad claim, we find Applicant only describes the genetic manipulation and transfer of Fusarium resistance in F. X ananassa [Specification, ¶274].
Because of this, claim 1 and its dependents are rejected as not having been fully enabled, as generating disease resistant, transgenic plants in such a variable polyploid genus of species is not described by Applicant. Further, prior art does not appear to show any use of FUS1, with ability to confer Fusarium resistance in strawberry species other than or outside of the cultivated F. X ananassa, or as have been described.
Therefore, without guidance from the specification as to the methods of making such plants across a diverse and variable polyploid genus such as Fragaria, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Claim 1, from which all other claims depend, encompasses alleles of FUS1 which encode proteins conferring resistance to Fusarium and having as little as 90% sequence identity to SEQ ID NO.2.
A review of sequence search information reveals that there appear to be no reports of polypeptides conferring Fusarium resistance of less than 100% identity to the claimed polypeptides of SEQ ID NO.2 reported by Applicant. Thus, prior art does not provide structural description of proteins conferring Fusarium resistance having less than 100% identity to SEQ ID NO.2.
Proteins with 90% identity to the 1,202-residue long SEQ ID NO.2 encompass polypeptides with approximately 120 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 1,202-amino-acids-long polypeptide of SEQ ID NO.2 would require describing 12020 polypeptide sequences; a representative number of which were not described by the Applicant at the time of filing.
Similarly, dependent claims recite a nucleotide with only 75% identity to the 5,520 bp long SEQ ID NO.1, or the 4,025 bp long SEQ ID NO.28, both presented as encoding allelic variants of the protein of SEQ ID NO.2. This encompasses nucleic acids with ~1,006-1,380 variable nucleotide substitutions, of which a representative number were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of requiring only 90% identity to SEQ ID NO.2, and also a broad range of nucleic acids as a result of requiring only 75% identity to encoding SEQ ID NO.1 & 28. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the FUS1 protein. Making random changes in proteins is unpredictable, and therefore one would not be enabled to isolate or derive such proteins as FUS1 conferring Fusarium resistance with less than 100% identity to SEQ ID NO.2 with any reasonable certainty that it would function properly.
It has been shown within the art that highly similar Fusarium resistance alleles have different functionality, owing to variation in coding sequences. It has been demonstrated that mutation of genes through introduction of indels and/or SNP variation can lead to gain or loss of Fusarium resistance [see p.1106, col.2, ¶3 in Li et al. Nat Genet 51, 1106–1112 (2019); Published 10 Jun 2019].
Because of this, claim 1 and its dependents are rejected as not having been fully described, as such variable proteins conferring Fusarium resistance are not described in the specification, nor taught by the existing art. Even with extensive studies directed to Fusarium diseases in crop plants [See Buerstmayr et al. (2009) for wheat, Chitwood-Brown et al. (2021) for tomato, Mesterhazy et al. (2011) for maize, Verma et al. (2025) for pea, Das et al. (2024) for banana] no variants of FUS1, with ability to confer Fusarium resistance in strawberry or other plants, have been described with less than 100% identity to Applicant’s SEQ ID NO.2, or the encoding SEQ ID NO.1 & 28.
For these reasons, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Their disclosure does not support that they were in possession of functional analogs of FUS1 within Fragaria having as little as 90% identity to SEQ ID NO.2 or with as little as 75% identity to SEQ ID NO.1 & 28.
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.
Claims 1-8, 10-11 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson [U.S. Plant Patent PP35,166; Published 30 March 2023] in view of Pincot [G3, Volume 8, Issue 5, 1 May 2018, Pages 1817–1828; Published 1 May 2018] and Ricardo [Hortscience 38(2):277–280, 2003; Published April 2003].
Claims are drawn to transgenic strawberry (i.e. genetically engineered) plants comprising FUS1 and FUS4 alleles, which are resistant to Fusarium and have rAUDPC scores of greater than 0.01. Claims are drawn to allelic variants of the naturally occurring FUS1 & FUS4 genes, wherein the encoded protein can be as little as 90% identical to claimed sequences, and the encoding genes can be as little as 75% identical to claimed sequences.
Broadest reasonable interpretation of these claims is that any transgenic strawberry plant, being modified for any characteristic, and carrying some form of native FUS1 and FUS4 resistance would be encompassed. This is because claims as currently written only require that a strawberry be transgenic and comprise the naturally occurring FUS1 and FUS4 or allelic variants thereof (i.e. sequences <100% identity). Although implied, the claims do not clearly state or recite a limitation that the transgene is specifically recombinant FUS1 and/or FUS4 per se.
Further, claims are being interpreted that all prior art lines of strawberry which are resistant to the known, dominant form of Fusarium wilt carry FW1 and either the resistant or susceptible allelic forms of FW1 and its associated causative genes.
Nelson teaches a Fusarium resistant strawberry plant ‘BG-12.3258’ [col.8, l. 24].
Nelson does not teach the allele (FW1) conferring the Fusarium resistance of ‘BG-12.3258’, transgenic strawberry plants, clone the causative gene(s) involved, or report the sequence of the resistance protein encoded by the FW1 locus/allele.
Pincot teaches the FW1 allele, which is naturally occurring in cultivated and wild strawberry germplasm and confers strong Fusarium resistance via its protein product. Pincot teaches that in screening 565 accessions representative of important strawberry breeding germplasm, one-third of material possesses the FW1 resistance allele or variants thereof [p.1822, col.1, ¶2]. The FW1 allele exhibits a high level of heritability and they teach it is likely to encode a protein with an identifying molecular signature of a leucine-rich repeat, typical of plant disease resistance genes [p.1820, col.2, ¶3; p.1822, col.2, ¶3—p.1823, col.2, ¶1]. They teach that the FW1 resistance allele can be identified in cultivars developed as early as 1935 by the University of California (UC) breeding program [id]. They teach that alleles of FW1 are widely present in known, commercially available elite cultivars used including ‘Fronteras’ and ‘Portola’. They teach FW1 is likely to be inherently present in much of the modern, elite strawberry germplasm from the UC breeding program [p.1822, col.2, ¶1].
Ricardo teaches the creation of transgenic strawberry plants. They teach the genetic engineering of the cultivar ‘Parajo’ which is a variety released by the UC breeding program that was widely grown in the 1980s. They teach that genetic transformation can be used to transfer desirable agronomic traits [p.277, col.1, ¶1 & col.2, ¶2].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Fusarium resistant strawberry plants, including resistant cultivars such as ‘BG-12.3258’ taught by Nelson and other elite cultivars harboring FW1, taught by Pincot. It would be obvious to generate transgenic strawberry plants and transfer desirable agronomic traits into elite cultivars as described in Ricardo. Such transgenic, resistant cultivars having the FW1 allele would carry FUS1 & FUS4.
One of ordinary skill in the art would have been motivated to create transgenic plants with FUS1 and/or FUS4 because of the commercial and agronomic value of being able to rapidly transfer non-native or recombinant genes into strawberry using biotech approaches. One doing such would clearly want to use elite, disease resistant material, such as ‘Parajo’, or other cultivars released by, or related to, the UC breeding program. Production of transgenic (i.e. genetically engineered) forms of commercially relevant or elite disease-resistant crop varieties is routine to plant breeders.
Regarding claims 1-3, 8 & 14; Applicant states that the source of the resistance they identify (i.e. FUS1 & FUS4) are three different strawberry lines, including ‘BG-12.3258’; this indicates their study is based on the molecular characterization of existing resistance to the dominant form of Fusarium affecting strawberry [Specification, ¶104]. Applicant admits they are not identifying a unique or non-obvious new source of resistance, but characterizing an existing resistance found in multiple, previously released Fusarium-resistant strawberry lines.
Pincot teaches disease resistance in previously released Fusarium-resistant strawberry lines is predominately due to FW1. The FW1 allele confers Fusarium resistance in ‘Fronteras’, ‘Portolo’, ‘Shasta’, and other material released from the UC breeding program, and would reasonably include Fusarium-resistant material derived from plants having FW1 [p.1818, col.2, ¶2; p.1822, col.1, ¶2]. They describe LRR enzymes conferring significant resistance to Fusarium at the same genomic location (i.e. chromosome 2) being indicated by Applicant.
The FW1 allele taught by Pincot reasonably appears to be the allele present in ‘BG-12.3258’ and thus inherently carrying the encoding sequences for FUS1 and/or FUS4, as well as alleles (i.e. variants <100% identity) of the underlying genes now claimed by Applicant, absent evidence to the contrary. Such naturally occurring alleles would be regulated by native promoters (i.e. Applicant’s claim 8).
Pincot indicates widespread distribution of FW1 over various generations and pedigrees of strawberry owing to prevalent historical use of germplasm carrying FW1 alleles [p.1822, col.1, ¶2]. This indicates FW1, and therefore FUS1 and FUS4, are likely inherent to Fusarium resistant germplasm, particularly that released by the UC breeding program. Pincot indicates no other loci or alleles on chromosome 2 were identified as associated with Fusarium-resistant strawberry cultivars, other than FW1 [p.1823, col.2, ¶.2; p.1825, col.1, ¶.1—col.2, ¶.2]. This indicated at the time of filing any Fusarium resistant strawberry plant with alleles mapped to chromosome 2 as carrying the FW1 locus, and either the functional or non-functional (i.e. variant of) resistance allele, absent evidence to the contrary.
The generation of transgenic (i.e. genetically engineered) plants, in elite germplasm released by the UC breeding program (i.e. ‘Parajo’) is described by Ricardo. It is reasonable to consider such material would comprise FW1 and its FUS1 and FUS4, even if only having non-functional allelic variants thereof (i.e. sequences <100% identity). This is because ‘Parajo’ is directly from a breeding program where presence of the FW1 locus was clearly established at the time of filing. A transgenic (i.e. genetically engineered) ‘Parajo’ plant or plant part would obviously comprise the native genes and allelic variants FUS1 and FUS4 comprising FW1. This meets the requirement of a transgenic (i.e. genetically engineered) Fragaria comprising FUS1 or some allelic variant thereof (i.e. <100% identity to SEQ ID NO.2).
Regarding claims 4-7 & 10-11; Applicant’s claims recite plants which are resistant and have rAUDPC scores ranging from <0.01—0.04. Applicant presents limitations in terms of phenotypic response. To demonstrate this, the specification provides comparison to the resistant check variety ‘PS3.108’ whose identity is unclear, but is used to represent plants with native FUS1 and FUS4 alleles and promoters. The rAUDPC scores of this resistant check having native alleles are shown in Applicant’s Fig. 5-8.
Absent details of the identity of ‘PS3.108’ claims are being interpreted to refer to a Fusarium-resistant variety representative of the native FW1 allele present in elite material released by the UC breeding program. The specification indicates native Fusarium resistant germplasm (i.e. ‘PS3.108’) to have rAUDPC scores <0.01—0.04 [Spec, Fig.7 & Fig.8]. Thus, it appears that rAUDPC scores of <0.01—0.04 are inherent to plants carrying FW1 resistances. Without further detail regarding identity of ‘PS3.108’, the disclosure is being interpreted as indicating any native Fusarium-resistant germplasm carrying FW1 is within the limiting range claimed by Applicant, as stated above [p.16, ¶.2].
As such, transforming (i.e. genetically engineering) elite strawberry germplasm which is resistant to Fusarium by virtue of having FW1 would reasonably generate plants with rAUDPC scores <0.01—0.04. This is because the claimed range is not different from that presented by non-transgenic plants with native resistance inherent to carrying FW1 (i.e. Fusarium resistant UC lines). If one were to compare such lines to a non-transgenic, susceptible check then the resistant variety would reasonably be expected to have increased FUS1 expression (i.e. FW1 resistance). Pincot describes such comparison and identification of resistant/susceptible plants in teaching the characterization of FW1 [p.1818, col.2, ¶2; p.1819, col.1, ¶3—col.2, ¶1].
Because claims are drawn merely to the generation of any transgenic strawberry plant which carries some native form of FUS1 and/or FUS4, and it would be obvious to one skilled in plant breeding to use elite, Fusarium-resistant germplasm as starting material for genetic modification, claims 1-8, 10-11 & 14 are rejected.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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