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 1-6, 11-15 and 17-25 are pending and examined. Claims 7-10 and 16 have been cancelled.
The rejection of claims 7-10, 16 and 17 for being directed to a naturally occurring product/phenomenon without significantly more is withdrawn in light of the amendments.
The rejection of claims 1-17 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendments.
Claim Objections
Claim 20 is objected to for reciting the limitation “wherein aid”. Applicant is advised to amend the limitation.
Specification
The specification is objected to for failing to recite the deposit information and date.
Appropriate action is advised.
Improper Markush Grouping
Claims 20, 22 and 25 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The claims nucleic and amino acid sequences appear to represent different genes conferring resistance to different Peronospora farinosa races. Therefore, these sequences do not share a substantial feature or a common use that flows from the shared substantial structural feature.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Response to Arguments
Applicant traverse the rejection of the claims because the sequences have at least 96% sequence identity to each other as shown in Table 4 (Applicant reply dated 6, last ¶).
This argument is not persuasive because the claimed sequences do not, in fact, have at least 96% identity to each other (see sequence search results dated 26 May 2026; SEQ ID NO: 9 and 21 have at least 26 nucleotide differences). Moreover, there is no evidence of the record that these sequences are the same genes and have the same function to confer resistance to the Pfs as claimed.
Compounding this issue is the fact that the T73 gene corresponding to SEQ ID NO: 21 does not confer resistance to all tested Pfs, and because the specification has failed to describe whether the other claimed sequences confer similar resistance or resistance to different Pfs.
Claim Rejections - 35 USC § 112
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.
Claims 1-6, 11-15 and 17 REMAIN rejected, and claims 18-25 are NOW 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 making a spinach plant comprising the coding sequence of SEQ ID NO: 21, does not reasonably provide enablement for making and/or using the plants and methods as broadly claimed wherein said plants are resistant to downy mildew as broadly claimed. 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/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
The claims are broadly drawn to a spinach plant that is resistant to any race of Peronospora farinosa (Pf) that comprises one or more resistance genes encoding proteins comprising an amino acid domain having at least 98% sequence identity to SEQ ID NO: 2, seeds produced from said plants, one or more resistance genes encoding proteins comprising an amino acid domain having at least 98% sequence identity to SEQ ID NO: 10 or a coding sequence having at least 98% sequence identity to SEQ ID NO: 7 or the sequences of SEQ ID NO: 21 or 22 and methods of providing resistance comprising introducing said gene or crossing a plant comprising said gene with another plant, methods for selecting said plant.
Meanwhile, the specification teaches the identification of a novel candidate dominant resistance gene “CC-NBS-LRR” including T72 comprising the domain of SEQ ID NO: 2 and having the nucleic and amino acid sequence of SEQ ID NO: 21 and 22, respectively (p. 6, last ¶). Plants comprising this gene were found susceptible to Pfs 8 and 9, and resistant to Pfs 1-7, 10 and 12-19 (Table 2).
However, the specification fails to teach that the one or more resistance genes comprising any structure as broadly claimed so long as it comprises SEQ ID NO: 2 retains functional activity and confers resistance to any Pf race. In other words, the claims encompass other “resistance” genes that are not defined by a structure other than the claimed domain and which are not taught in the specification to have functional activity.
Moreover, the specification fails to teach the critical domain or motifs a resistance gene that confers resistance to any Pf race, and further fails to provide working examples of plants comprising said genus of genes.
This guidance is essential in light of the fact that the instant specification teaches that the genes as encompassed by the claims does not provide resistance to the Pfs as broadly claimed. For example, the nucleic acid sequence of SEQ ID NO: 21 and which encodes the amino acid sequence of SEQ ID NO: 22 and comprises the CC-NBS-LRR domain of SEQ ID NO: 2 does not confer resistance to all Pfs (e.g., see Table 2).
In light of this finding and the fact that all resistance genes are only required to comprise SEQ ID NO: 2, and the fact that the resistance genes as encompassed by the claims have sequence variation (e.g., see Tables 3 and 4), the skilled practitioner would be unable to predictably make the plants or practice the methods as claimed wherein the resistance genes vary from SEQ ID NO: 21 or 22, respectively.
This guidance is also critical because the art identified 139 NBS-LRR genes in the spinach genome that have been classified into six categories based on receptor domains, coiled coil motifs and LRRs with coiled coiled/NBS/LRR and NBS/LRR representing 40 and 36% of the genes, respectively (Xu et al, 2017, Nature Communications,8:1-10; see p. 4, col. 2, last ¶).
In fact, the art teaches that even small changes in the amino acid sequence in the LRR may lead to a loss of LRR function resulting in changes in plant resistance to pathogens (Gao et al, 2022, Int. J. Mol. Sci., 23:1-10; see p. 5, last ¶ bridging p. 6).
Because the skilled artisan appreciates that even slight changes to CC-NBS-LRR genes can alter function, the skilled practitioner would not expect to predictably make a plant comprising a gene encoding a protein comprising an amino acid sequence having at least 98% sequence identity to SEQ ID NO: 2 or wherein the gene comprises a nucleic acid sequence having as little as 96% sequence identity to SEQ ID NO: 21 or an amino acid sequence having as little as 96% sequence identity to SEQ ID NO: 22 that retains functional activity to confer Pf resistance as broadly claimed.
Therefore, in light of the breadth of the claims, the failure of the specification to teach a structure-function correlation for the resistance genes as claimed, the state of the art which teaches that even small changes alter function and the lack of working examples the skilled practitioner would resort to impermissible undue trial and error experimentation to make the plants and practice the methods as claimed which is tantamount to excessive experimentation.
Response to Arguments
Applicant traverses the rejection because the claims do not require resistance to every Pf race (Applicant reply dated 01 September 2026, p. 8, last ¶).
This argument is not persuasive as the Office has not stated the claims require resistance to all Pfs. Rather, the Office has argued that the claims encompass spinach plants comprising resistance to all known and unknown Pfs. Here, the specification has failed to teach which genes confer resistance to corresponding Pfs, and has also specifically taught that the exemplary plant does not even have resistance to all of the Pfs as taught in the specification.
Applicant argues ample guidance has been provided by way of eight resistance genes comprising three LRR motifs as found in SEQ ID NO: 2 and which are highly conserved (Applicant reply dated 01 September 2026, p. 9, ¶ 1).
This argument is not persuasive because it is not commensurate scope with what is claimed. Here, the claims are not limited to the eight resistance genes but encompass a much broader genus of resistance genes that are only required to comprise variants of SEQ ID NO: 2.
Applicant argues the quantity and nature of any experimentation is routine (Applicant reply dated 01 September 2026, p. 9, ¶ 2).
This argument is not persuasive as the Office has rejected the claims in light of all of the Wands factors which also include (1) the lack of guidance presented in the specification with respect to the structure and corresponding function that confer resistance; (2) the limited number and specific nature of the working examples; (3) the nature of the invention; (4) the state and unpredictability of the prior art as noted supra; and (5) the breadth of the claims which encompass a vast genus of genes having an undefined structure notwithstanding a limited 98 amino acid region.
Applicant argues Gao supports enablement of the claims while the teachings of Xu fail outside the scope of what is claimed (Applicant reply dated 01 September 2026, p. 9, penultimate ¶).
Applicant’s arguments regarding Gao are not commensurate in scope to the claims as they pertain only to a domain and do not address the fact that alterations to other regions in the protein may abolish function. For example, a protein as encompassed by claim 1 may be 995 amino acids in length as evidenced by SEQ ID NO: 10 yet the domain of SEQ ID NO: 2 is only 98 residues in length.
This means the resistance gene as encompassed by claim 1 may have 897 different residues not including the variation as permitted in the domain of SEQ ID NO: 2. However, the specification fails to teach any of the critical structures or motifs in the remaining protein that is encoded by a resistance gene as broadly encompassed by the claims and that retains function and confers resistance to the genus of Pfs as encompassed by the claims.
Moreover, and regarding the teachings of Xu, Applicant’s own specification on page 3 supports the position of the Office:
The majority of disease resistance genes in plants encode nucleotide-binding site leucine-rich repeat proteins, also known as NBS-LRR proteins (encoded by R genes). These proteins are characterized by nucleotide-binding site (NBS) and leucine-rich repeat (LRR) domains as well as variable amino- and carboxy-terminal domains and are involved in the detection of diverse pathogens, including bacteria, viruses, fungi, nematodes, insects and oomycetes. There are two major subfamilies of plant NBS-LRR proteins defined by the Toll/interleukin-1 receptor (TIR) or the coiled-coil (CC) motifs in the amino- terminal domain and are both involved in pathogen recognition. Most known resistances in spinach were identified from a single dominant gene (NBS-LRR), called Locus 1, which is highly variable. Although many alleles have been identified in many different wild spinach accessions, it is still unknown whether they are functional or not, e.g. provide Pfs resistance.
Thus, based on the teachings of Xu and Applicant’s own specification which indicate that additional structures are required for functionality and detection of specific pathogens, and the fact that the specification demonstrates that even when the domain of SEQ ID NO: 2 is possessed that resistance is not present, one would be left to engage in systematic screening and testing to determine whether the at least one resistance gene as encompassed by the claims confers resistance to the genus of Pfs as claimed.
Claims 1-6, 11-15 and 17 REMAIN rejected, and claims 18-25 are NOW 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.
Instant claims 1-6, 11-15 and 17-25 are broadly drawn to a spinach plant that is resistant to any race of Pf that comprises one or more resistance genes encoding proteins comprising an amino acid domain having at least 98% sequence identity to SEQ ID NO: 2, seeds produced from said plants, one or more resistance genes encoding proteins comprising an amino acid domain having at least 98% sequence identity to SEQ ID NO: 10 or a coding sequence having at least 98% sequence identity to SEQ ID NO: 7 or the sequences of SEQ ID NO: 21 or 22 and methods of providing resistance comprising introducing said gene or crossing a plant comprising said gene with another plant, methods for selecting said plant
Meanwhile, the specification describes the identification of a novel candidate dominant resistance gene “CC-NBS-LRR” including T72 comprising the domain of SEQ ID NO: 2 and having the nucleic and amino acid sequence of SEQ ID NO: 21 and 22, respectively (p. 6, last ¶). Plants comprising this gene were found susceptible to Pfs 8 and 9, and resistant to Pfs 1-7, 10 and 12-19 (Table 2).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the specification fails to describe that the one or more resistance genes comprising any structure as broadly claimed so long as it comprises SEQ ID NO: 2 retains functional activity and confers resistance to any Pf race. The specification further fails to describe that these sequences can be “modified” to confer resistance as encompassed by claims 11 and 12.
Moreover, the specification fails to describe the critical domain or motifs a resistance gene that confers resistance to any Pf race, and further fails to provide working examples of plants comprising said genus of genes.
This description is essential in light of the fact that the instant specification describes that the genes as encompassed by the claims do not provide resistance to the Pfs as broadly claimed. For example, the nucleic acid sequence of SEQ ID NO: 21 and which encodes the amino acid sequence of SEQ ID NO: 22 and comprises the CC-NBS-LRR domain of SEQ ID NO: 2 does not confer resistance to all Pfs (e.g., see Table 2).
In light of this finding, and the fact that all resistance genes are only required to comprise SEQ ID NO: 2, and the fact that the resistance genes as encompassed by the claims have sequence variation (e.g., see Tables 3 and 4), the skilled practitioner would not be of the opinion that Applicant possess the plants or the methods as claimed wherein the resistance genes vary from SEQ ID NO: 21 or 22, respectively.
This description is also critical because the art identified 139 NBS-LRR genes in the spinach genome that have been classified into six categories based on receptor domains, coiled coil motifs and LRRs with coiled coiled/NBS/LRR and NBS/LRR representing 40 and 36% of the genes, respectively (Xu et al, see p. 4, col. 2, last ¶).
In fact, the art describes that even small changes in the amino acid sequence in the LRR may lead to a loss of LRR function resulting in changes in plant resistance to pathogens (Gao et al, see p. 5, last ¶ bridging p. 6).
Because the skilled artisan appreciates that even slight changes to CC-NBS-LRR genes can alter function, the skilled practitioner would not be led to believe that Applicant possesses a plant comprising a gene encoding a protein comprising an amino acid sequence having at least 98% sequence identity to SEQ ID NO: 2 or wherein the gene comprises a nucleic acid sequence having as little as 96% sequence identity to SEQ ID NO: 21 or an amino acid sequence having as little as 96% sequence identity to SEQ ID NO: 22 that retains functional activity to confer Pf resistance as broadly claimed.
Therefore, in light of the breadth of the claims, the failure of the specification to describe the structures that confer downy mildew resistance as broadly claimed, the lack of working examples and the state of the art, the skilled practitioner would not believe that Applicant was in possession of the plants and methods as claimed.
Response to Arguments
Applicant argues the written description requirement is satisfied because the specification describes eight resistance genes comprising three LRR motifs as found in SEQ ID NO: 2 and which play an important role in providing Pf resistance (Applicant reply dated 01 September 2026, p. 10, last ¶).
This argument is not persuasive because it is not commensurate scope with what is claimed. Here, the claims are not limited to the eight resistance genes but encompass a much broader genus of resistance genes that are only required to comprise variants of SEQ ID NO: 2.
Moreover, this argument is not persuasive because if this is, in fact, the critical domain or motif that is required for functionality then the specification has failed to describe the difference between the structures in this domain that confer resistance from the structures that do not confer resistance to Pf races as disclosed in the specification.
In other words, one of skill in the art would not be of the opinion that the “resistance genes” as broadly encompassed by claim 1 and which are only required to have variants of the domain as claimed would retain functionality and confer resistance to any “Pf” race as broadly claimed let alone the Pfs as listed in Table 2.
Applicant’s own arguments even support the position of the Office that the scope of the claims are not adequately described (Applicant reply dated 01 September 2026, p. 11, ¶ 1). Namely, claim 1 encompasses resistance to Pfs 8 and 9 yet Applicant seemingly admits that the claims as they stand do not describe spinach plants with resistance to said Pfs.
Applicant traverses the rejection of the claims because the claims do not require resistance to every Pf race (Applicant reply dated 01 September 2026, p. 11, ¶ 2).
This argument is not persuasive as the Office has not stated the claims require resistance to all Pfs. Rather, the Office has argued that the claims encompass spinach plants comprising resistance to all known and unknown Pfs. Here, the specification has failed to describe which genes confer resistance to which Pfs, and has also specifically described that the exemplary plant do not even have resistance to all of the Pfs as described in the specification.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
