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, 5, 6, 9, 12, 18, 24, 35, 37, 40-42, 46, 48, 56, 60, 62-64, 69-70, 81 and 83, are pending. Claims 2-4, 7-8, 10-11, 13-17, 19-23, 25-34, 36, 38-39, 43-45, 47, 49-55, 57-59, 61, 65-68, 71-80 and 82, are cancelled. Claims 24, 35, 37, 40-42, 46, 48, 56, 62-64, 69 and 70, are withdrawn. Claims 1, 5-6, 9, 12, 18, 60, 81 and 83, are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendments
Status of Rejections from action:
The rejection for Claims 1, 5-6, 9, 12, 18, 60, 81 and 83 under 112(b) is modified in view of amendment.
The rejection for Claims 1, 5-6, 9, 12, 18, 60, 81 and 83 under 112(a) is modified in view of amendment.
The rejection for Claims 1, 5-6, 9, 12, 18, 60, 81 and 83 under 112(a) enablement is added.
The rejection for Claims 1, 5-6, 9, 12, 18, 60, 81 and 83 under 103 is withdrawn in view of amendment. Applicant amend claims to require both SEQ ID NOs: 1 and 10.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). A certified copy of Application No. AU2020904574, filed on December 09, 2020, has been received.
Claim Objections
Claims 1, 5-6, 9, 12, 18, 60, 81 and 83 objected to because of the following:
In regard to claim 1, the recitation of “transgene encoding” in parts (i) and (ii) are redundant, because the preamble already recites “transgene encoding”. Applicant is advised to remove “transgene encoding” from parts i and ii.
In regard to claim 1, parts i and ii, the recitation of “comprises amino acids having a sequence as provided in” should be amended to “comprises an amino acid sequence having the sequence”. Additionally, the recitation “or an amino acid sequence which is at least 95% identical to” should be amended to “or an amino acid sequence which has at least 95% sequence identity to”.
In claim 1, “and” should be inserted before the last “wherein” clause.
In regard to claims 9 and 12, the recitation of “comprises amino acids having a sequence which is at least 97% identical to” should be amended to “comprises an amino acid sequence having a sequence which has at least 97% sequence identity to”. Additionally, claims 9 and 12, section b), recites “comprises a sequence which is at least 97% identical to” should be amended to “comprises a sequence which has at least 97% sequence identity to”.
In regard to claim 81 parts i and ii, the recitation of “comprises amino acids having a sequence which is at least 99% identical to” should be amended to “comprises an amino acid sequence having a sequence which has at least 99% sequence identity to”.
In regard to claim 83 parts i and ii, the recitation “comprises amino acids having a sequence provided as” should be amended to “comprises the amino acid sequence having the sequence provided as”.
Appropriate correction is required.
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.
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, 5-6, 9, 12, 18, 60, 81 and 83 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.
In claim 1, the recitation “at least 95% identical…” is unclear if Applicant is refereeing to sequence identity or evolutionary relatedness. It is suggested that “95% identical” is amended to “95% sequence identity”.
In regard to claim 60, the recitation of “A seed of a plant” lacks antecedent basis. The Applicant is advised to amend to “A seed of the plant” for proper antecedent basis.
In claims 9 and 12, the recitation “at least 97% identical…” is unclear if Applicant is refereeing to sequence identity or evolutionary relatedness. It is suggested that “97% identical” is amended to “97% sequence identity”.
In claim 81, the recitation “at least 99% identical…” is unclear if Applicant is refereeing to sequence identity or evolutionary relatedness. It is suggested that “99% identical” is amended to “99% sequence identity”.
Correction and/or clarification is required
Claim Rejections - 35 USC § 112(Written Description)(Amended)
Claims 1, 5-6, 9, 12, 18, 60, 81 and 83, 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.
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.
Applicant’s disclosure is as follows.
Applicant discloses the transgenic wheat comprising SEQ ID NO: 1 (CD882879, CS(Hope3B) allele) renamed to TaPMP-B3a and/or SEQ ID NO: 10 (D8LAL2 same in Marquis and CS(Hope3B)) renamed to TaPMPB4a, resulting in enhance resistance against rust species (pgt21-0 Pt race 122-1,2,3,5 (PBI# 351)), (see Examples 7-8). Additionally, Applicant has shown SEQ ID NO: 1 (CD882879) and/or SEQ ID NO: 10 (D8LAL2) in wheat, sorghum, and nicotiana spp.
Applicant claims any transgene gene having as little as 95% sequence identity conferring resistance to all races of stem rust and/or powdery mildew.– Only shown 100% CD882879 (SEQ ID NO: 1) and/or D8LAL2 (SEQ ID NO: 10) is resistant against rust species (pgt21-0 Pt race 122-1,2,3,5 (PBI# 351)).
The claimed invention lacks adequate written description for the following reasons. Claims 1, 5-6, 9, 12, 18, 60, 81 and 83, are directed to a transgenic plant comprising a polypeptide conferring enhanced resistance against stem rust, leaf rust, and powdery mildew (see Examples 7-8) obtained from any source having any structure. Additionally, this amino acid having at least 95% sequence identity to SEQ ID NO: 1 and 10, the 95% scope encompasses CD882879 and D8LAL2 genes encoding sequences obtained from sources other than Triticum aestivum, whereby their structures and identities are not disclosed, so long as they share at least 95% sequence identity to SEQ ID NO: 1 (CD882879) and/or SEQ ID NO: 10 (CD8LAL2).
The only Sr2 genes disclosed are from either wheat, barley, rice, maize, and sorghum. The disclosure of the orthologs do not share at least 95% sequence identity to SEQ ID NO: 1. For example, SEQ ID NOs: 3 and 5-9 only have 55%, 53%, 26.2%, 29.2%, 31.1%, and 28.4%, respectively, do not share sequence identity to SEQ ID NO: 1. Therefore, one skilled in the art cannot predict variants having at least 95% sequence identity with enhanced fungal resistance.
Furthermore, from the disclosure of SEQ ID NOs: 1 and 10, one skilled in the art can generate sequence having at least 95% sequence identity, however one skilled in the art cannot predict the required regions to retain resistance activity of a gene having at least 95% sequence identity from other sources and their allelic variants.
However, the specification does not describe a Sr2 polypeptide with at least 95% identity to SEQ ID NOs: 1 and 10, which leads to a functional polypeptide which confers enhanced fungal resistance.
While one skilled in the art can generate a population of sequences having 95% sequence identity to SEQ ID NOs: 1 and 10, it is unpredictable which species within the population would also have stem rust and/or powdery mildew resistance activity. The disclosure of SEQ ID NOs: 1 and 10 are not representative of sequences having 95% sequence identity to SEQ ID NOs: 1 and 10 and having stem rust and/or powdery mildew resistance activity. No common structure or motif is disclosed.
For example, Märkle et al., (Evolution of resistance (R) gene specificity. Essays Biochem 30 September 2022; 66 (5): 551–560 (previously cited)), describes that “[t]wo non-synonymous (nucleotide change causing amino acid change) mutations, resulting in theAvr3aEM allele, render R3a unable to recognise this variant”, (see page 553 1st paragraph). Suggesting that 95% would encompass mutations that would render the resistance gene non-functional or not recognize the pathogen.
Furthermore, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical lacking adequate description of other polypeptides with as little 95% sequence identity to SEQ ID NOs: 1 and 10, respectively.
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(1) here are the alignments one has high sequence similarity and the rest is below 95% (2) these search results do not describe structures that confer functionality. Therefore, based on the state of the art the skilled artisan would not know the structures found within sequence having as little as 95% sequence identity to SEQ ID NOs: 1 and 10 that confers pathogen resistance against stem rust and/or powdery mildew.
Because of the lack of a description of a representative number of structures/sequences, the absence of information in the art on conserved regions required for activity, and the impact of 5% variation of SEQ ID NOs: 1 and 10, one skilled in the art would not know the structures that confer the various traits. Therefore, Applicant has not sufficiently to shown possession of sequences with as little as 95% sequence identity to SEQ ID NOs: 1 and 10 as claimed.
In regard to claims 1, 5 and 6, Applicant does not clarify the species of rust and powdery mildew. One skilled in the can produce a polypeptide with resistance to a specific species, however one skilled in the art cannot determine if the polypeptide has resistance to an unknown species of rust or powdery mildew let alone all species of rust or powdery mildew. In the prior art has yet to produce one gene that will have resistance to all species of rust or powdery mildew.
The specification lacks adequate description for all species of stem rust and powdery mildew. Specifically, the Applicant fails to describe a representative number of species that SEQ ID NOs: 1 and 10 confer resistance against. Applicant only mentions the rust species pgt21-0 Pt race 122-1,2,3,5 (PBI# 351) and fails to describe which species of powdery mildew SEQ ID NOs: 1 and 10 are resistant towards. Therefore, the Applicant has not sufficiently to shown possession of sequences with as little as 95% sequence identity to SEQ ID NOs: 1 and 10 having pathogen resistance to all species of stem rust and powdery mildew as claimed at the time of filing.
For example, Periyannan et al. (An overview of genetic rust resistance: From broad to specific mechanisms. 2017. PLoS pathogens vol. 13,7 e1006380, doi:10.1371/journal.ppat.1006380 (U)), describes that “[r][ace-specific resistance genes are effective against some but not all races of a rust pathogen and generally conform to the classical gene-for-gene model, where resistance depends on a specific genetic interaction between host-resistance (R) genes and pathogen avirulence (Avr) genes” (p.1 1st paragraph). Periyannan et al. describes that resistance genes are race specific and not resistant to all pathogen species.
Applicant needs to satisfy through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural properties. Therefore, Applicant has not sufficiently to shown possession of the invention as claimed.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are responded below:
Applicant argued that by comparing the highly divergent but functional homologous sequences are provided in the specification and that a skilled person can use sequence alignment “would recognize that conserved regions” from non-critical ones, thereby “still maintaining the polypeptide’s function”.
(Remarks, December 18, 2025, page 10).
This argument has been fully considered but not found persuasive.
MPEP states "An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000)." (MPEP, 2163/II,A,3, (a)).
In the instant case, The Office agrees there is adequate information for one skilled in the art to reproduce SEQ ID NO:1 and 10, however while one skilled in the art can generate a population of sequences having 95% sequence identity to SEQ ID NOs: 1 and 10, it is unpredictable which species within the population would also have stem rust and/or powdery mildew resistance activity. The disclosure of SEQ ID NOs: 1 and 10 are not representative of sequences having 95% sequence identity to SEQ ID NOs: 1 and 10 and having stem rust and/or powdery mildew resistance activity. No common structure or motif is disclosed.
However, the specification does not describe a Sr2 polypeptide with at least 95% identity to SEQ ID NOs: 1 and 10, which leads to a functional Sr2 polypeptide. A polypeptide with at least 95% identity to SEQ ID NOs: 1 and 10 would have 18 and 20, respectively, amino acid substitutions relative to SEQ ID NOs: 1 and 10.
These polypeptides would encompass 1918 and 1920 distinct protein variants. In the absence of describing where in the sequence of SEQ ID NOs: 1 and 10 such variations can be sustained, one of skill in the art would not be led to believe that Applicant possesses this vast genus of amino acid sequences that retain functional activity, or to the make the polypeptide which would retain the activity of SEQ ID NOs: 1 and 10, and lead to pathogen resistance.
It is unclear which of these combinations would result in a sequence having at least 95% sequence identity with enhance resistance to rust and mildew. Furthermore, Applicant has not disclosed, which areas to retain, since mutations outside of the transmembrane domains can alter activity without touching the conserved regions.
Furthermore, while the Applicant states that homologs with as little as 26% identity have said function. However, Applicant has failed to describe or test any specific variants within the narrower 95%-99% identity range. High sequence identity does not automatically guarantee functional equivalence; in many proteins, a single point mutation (even in a non-conserved region) can cause misfolding or complete loss of function.
At least for these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)(Enablement)(New)
Claims 1, 5-6, 9, 12, 18, 60, 81 and 83, 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 transgenically expressing wheat comprising SEQ ID NO: 1 (CD882879, CS(Hope3B) allele) renamed to TaPMP-B3a and/or SEQ ID NO: 10 (D8LAL2 same in Marquis and CS(Hope3B)) renamed to TaPMPB4a, resulting in enhance resistance against rust species (pgt21-0 Pt race 122-1,2,3,5 (PBI# 351)) (See Examples 7-8). Additionally, Applicant has shown SEQ ID NO: 1 (CD882879) and/or SEQ ID NO: 10 (D8LAL2) in wheat, sorghum, and Nicotiana spp. However, the specification is not enabled for sequences having as little as 95% sequence identity to SEQ ID NOs: 1 and 10. 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/or use the invention commensurate in scope with these claims.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original); see also In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”) “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Wands, supra.
Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Factors to consider include “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. To comply with 35 USC 112(a) enablement, one skilled in the art must be able to make and use the claimed invention.
(A) The breadth of the claims
The breadth of the claims encompasses any plant comprising any polypeptide, or polypeptide having any structure within 95% sequence identity to SEQ ID NOs: 1 and SEQ ID NOs: 10 to confer pathogen resistance to stem rust and/or powdery mildew. However, the specification has only taught expressing SEQ ID NO: 1 (CD882879) and SEQ ID NOs: 10 (D8LAL2) in wheat, sorghum, and nicotiana spp. confers resistance against rust species (pgt21-0 Pt race 122-1,2,3,5 (PBI# 351)) (See Examples 7-8).
(B) The nature of the invention.
The nature of the claimed invention is directed to any plant comprising any polypeptide having at least 95% sequence identity to SEQ ID NO: 1 and 10, achieved by expressing said sequences, to confer pathogen resistance.
(C) The state of the prior art
The state of the prior art does not teach the polypeptides or the structures with 95% sequence identity to SEQ ID NOs: 1 and 10 that confer function for said polypeptide. Additionally, the art does not teach conserved regions or alignments of said polypeptide.
(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claimed invention lacks adequate enabling guidance for the following reasons. Claims 1, 5-6, 9, 12, 18, 60, 81 and 83, are directed to a plant comprising a polypeptide with SEQ ID NOs: 1 and 10 resulting in conferred pathogen resistance, wherein the polypeptide is obtained from any plant source.
Additionally, the claims encompass an amino acid sequence having at least 95% sequence identity to SEQ ID NOs: 1 and 10. Furthermore, the scope of the claims encompasses polypeptides obtained from sources other than wheat so long as they share at least 95% sequence identity to SEQ ID NOs: 1 and 10.
The only polypeptides taught is from SEQ ID NO: 1 (CD882879, CS(Hope3B) allele) renamed to TaPMP-B3a and/or SEQ ID NO: 10 (D8LAL2 same in Marquis and CS(Hope3B)) renamed to TaPMPB4a, having the function of conferring pathogen resistance. The specification does not teach the adequate amount of direction or guidance regarding the features of SEQ ID NOs: 1 and 10 which confer functional activity. From the disclosure of SEQ ID NOs: 1 and 10, one skilled in the art cannot predict the structures of other polypeptides from other plant species.
(1) Applicant has not taught the polypeptide is found in other plant species and has the same function (2) Applicant has not taught the structures (i.e., 95% to SEQ ID NOs: 1 and 10) that confer functional activity.
Applicant does not teach common structures or motifs for resistance genes shared by wheat CS(Hope3B)) plant or any other plant that would allow one skilled in the art to predict their structures of polypeptides with 95% sequence identity to SEQ ID NOs: 1 and 10 or from any other wheat plant having the same pathogen resistance.
The specification fails to TEACH, or fails to provide GUIDANCE for making variants with at least 95% sequence identity will have the same pathogen resistance. The lack or guidance and the lack of working examples means one skilled in the cannot make and use a polypeptide having as little as 95% sequence identity to SEQ ID NOs: 1 and 10.
Furthermore, claims 1, 5-6, 9, 12, 18, 60, 81 and 83 encompass a polypeptide having an amino acid sequence with at least 95% identity to SEQ ID NOs: 1 and 10. This requires the specification to teach amino acid sequences encoding such polypeptides.
However, the specification does not teach or provide guidance for making a polynucleotide encoding a polypeptide with at least 95% identity to SEQ ID NOs: 1 and 10, which leads to a functional polypeptide.
Because 95% sequence identity to SEQ ID NOs: 1 and 10 encompasses deletions, additions, substitutions, and any combination thereof anywhere within SEQ ID NOs: 1 and 10. Applicant provides no guidance as to which region(s) of SEQ ID NOs: 1 and 10 can be mutated and which regions(s) of SEQ ID NOs: 1 and 10 must be conserved for stem rust and/or powdery mildew resistance activity. While one skilled in the art can make mutations to SEQ ID NOs: 1 and 10, further guidance is needed to readily identify operable embodiments, or readily eliminate inoperable embodiments, without resorting to random trial and error requiring undue experimentation. To require one skilled in the art to make each sequence mutation within said 95% sequence identity, introduce each sequence into a plant cell, grow each plant cell into a plant, and test each mutated sequence for stem rust and/or powdery mildew resistance activity in all aspects of plant growth would not be routine experimentation.
A polypeptide with at least 95% identity to SEQ ID NOs: 1 and 10 would have 18 and 20, respectively, amino acid substitutions relative to SEQ ID NOs: 1 and 10. These polypeptides would encompass 1918 and 1920 distinct protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NOs: 1 and 10 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polypeptide which would retain the activity of SEQ ID NOs: 1 and 10, and lead to conferring pathogen resistance against stem rust and/or powdery mildew.
Therefore, while the examples teach that certain specific SEQ ID NOs: 1 and 10 in wheat, sorghum, and nicotiana spp. resulting in pathogen resistance (rust species (pgt21-0 Pt race 122-1,2,3,5 (PBI# 351)), the specification fails to teach motifs, catalytic domains, etc. in these sequences that confers the specifically claimed function of conferring pathogen resistance. Applicant has not shown one structure/sequence having 95% sequence identity that retain function and thus confer pathogen resistance.
For example, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical lacking adequate enabling guidance of other polypeptides with as little 95% sequence identity to SEQ ID NOs: 1 and 10, respectively.
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Therefore, because the art fails to teach the structures required for polypeptides with as little as 95% sequence identity having functional activity, a person skilled in the art would be unable to predictably make, and thus use, the claimed amino acid sequences as the specification fails to teach the critical domains and motifs that are required for functional activity.
Additionally, Märkle et al., (Evolution of resistance (R) gene specificity. Essays Biochem 30 September 2022; 66 (5): 551–560 (previously cited)), mentions that “[t]wo non-synonymous (nucleotide change causing amino acid change) mutations, resulting in theAvr3aEM allele, render R3a unable to recognise this variant”, (see page 553 1st paragraph). Suggesting that 95% would encompass mutations that would render the resistance gene non-functional or not recognize the pathogen, making it unpredictable to determine the claimed function with a gene having at least 95% sequence identity without undue experimentation.
Because of the lack of representative sequences, the lack of information on conserved regions required for activity, and the impact of 5% variation of SEQ ID NOs: 1 and 10, there is not enough guidance to predictably make and/or use the claimed sequences to predictably produce plants having pathogen resistance against stem rust and/or powdery mildew.
In regard to claims 1, 5 and 6, Applicant does not clarify the species of rust and powdery mildew. One skilled in the can produce a polypeptide with resistance to a specific species, however one skilled in the art cannot predictably determine if the polypeptide has resistance to an unknown species of rust or powdery mildew. In the prior art has yet to produce one gene that will have resistance to all species of rust or powdery mildew.
The specification lacks adequate enabling guidance for all species of stem rust and powdery mildew. Specifically, the Applicant fails to teach examples on all the species that SEQ ID NOs: 1 and 10 confer resistance against. Applicant only mentions the rust species pgt21-0 Pt race 122-1,2,3,5 (PBI# 351) and fails to teach which species of powdery mildew SEQ ID NOs: 1 and 10 are resistant towards. Therefore, the Applicant has not sufficiently to shown enabling guidance on the sequences with as little as 95% sequence identity to SEQ ID NOs: 1 and 10 having pathogen resistance to all species of stem rust and powdery mildew as claimed at the time of filing.
For example, Periyannan et al. (An overview of genetic rust resistance: From broad to specific mechanisms. 2017. PLoS pathogens vol. 13,7 e1006380, doi:10.1371/journal.ppat.1006380 (U)), teach that “[r][ace-specific resistance genes are effective against some but not all races of a rust pathogen and generally conform to the classical gene-for-gene model, where resistance depends on a specific genetic interaction between host-resistance (R) genes and pathogen avirulence (Avr) genes” (p.1 1st paragraph). Periyannan et al. teach that resistance genes are race specific and not resistant to all pathogen species.
Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples regarding the structure of polypeptides having at least 95% sequence identity to SEQ ID NOs:1 and 10 which confer functional activity, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JOSE ORDAZ whose telephone number is (703)756-1967. The examiner can normally be reached 8:30 am-5:00 pm.
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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663