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 .
DETAILED ACTION
1. Claims 31-37 are pending and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following: The status of parent Application No. 16/916757 should be updated in paragraph [0001] of the specification.
Appropriate correction is required.
Claim Objections
3. Claims 31-37 are objected to because of the following: In claim 1, “Ptr1” should be spelled out the first time it is recited, with the acronym in parentheses.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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.
5. Claims 31-37 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 claims 31, 36 and 37, the recitation of “Ptr1” is unclear because it is not known what sequence(s) are encompassed by this recitation. This term is not defined either by structure or function, and it does not appear to be an art-recognized term. It is suggested a SEQ ID NO. be recited.
In claim 31, “enhanced” is a relative term lacking a comparative basis.
In claim 31, there is no nexus between the “enhanced disease resistance” and the Ptr1 polynucleotide. Does the presence of the Ptr1 polynucleotide indicative of enhanced disease resistance? It would appear that the Ptr1 polynucleotide is expressed, rather than merely being present, to produce the enhanced disease resistance phenotype.
In claim 31, does the candidate plant display enhanced disease resistance before it is analyzed for the presence of a Ptr1 polynucleotide? How is the candidate plant selected?
In claim 31, in the “identifying” step, “a Ptr1 polynucleotide” should be amended to “the Ptr1 polynucleotide” for proper antecedence to the previous step.
In claims 36 and 37, “a Ptr1 polynucleotide” should be amended to “the Ptr1 polynucleotide” for proper antecedence.
In claim 37, the first recitations of “the transgenic plant” and “the transgenic plant cell” lack antecedence.
Dependent claims are included.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
6. 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.
7. Claims 31-37 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.
Applicant discloses that Pseudomonas syringae pv. tomato (Pst) causes bacterial speck disease in domesticated tomato (Background). There are two races of Pst, defined by the difference in their ability to cause disease on tomato varieties expressing the resistance gene Pto. Race 0 strains express type III effectors AvrPto or AvrPtoB, are recognized by Pto, and are unable to cause disease on Pto-expressing tomato varieties. Race 1 strains do not have the avrPto or avrPtoB genes and are not recognized by Pto. Pto was originally identified in Solanum pimpinellifolium and has been introgressed into processing-type tomato varieties. Pseudomonas tomato race 1 (Ptr1) from S. lycopersicoides provides resistance against Race 1 strains [0017]. Ptr1 is not present in S. pennellii and S. lycopersicum [0019]. AvrRpt2 is the effector recognized by Ptr1. Ptr1 also provides resistance against Ralstonia pseudosolanacearum strain that expresses an AvrRpt2 homolog (RipBN). Ptr1 ortholog exists in Nicotiana benthamiana and potato and both mediate recognition of AvrRpt2 and RipBN. (Example 16). Even though Ptr1 orthologs are also found in three species of pepper [0218], no information is given with regard as to whether these Ptr1 orthologs mediate recognition of affectors AvrRpt2 and RipBN. In apple and Arabidopsis, recognition of AvrRpt2 is mediated by Mr5 and RPS2 proteins, which are not Ptr1 orthologs.
The claimed invention lacks adequate written description for the following reasons. Applicant does not adequately describe the structures of the claimed genus of Ptr1 polynucleotides and polypeptides. The disclosure of Ptr1 from S. lycopersicoides, tobacco and pepper, all of which are Solanaceous plants, do not allow one skilled in the art to determine the structures of Ptr1 sequences from other sources, or that they exist in other sources, such as in other dicots or in monocots. Applicant is pre-empting and capturing innovations beyond what is described. This is precisely the situation in University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997), which teaches that the disclosure of the sequence encoding a rat insulin protein does not provide adequate written description for the sequence encoding a human insulin protein. Likewise, the disclosure of a tomato Ptr1 sequence does not provide adequate written description for a grape or rice Ptr1 sequence, if they even exist. Applicant failed to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. 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 a 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. See MPEP Section 2163 of Chapter 2100 where it is taught that
[T]he claimed invention as a whole may not be adequately described where aninvention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
There is no disclosure of a structure common to Ptr1 sequences that mediate recognition of affectors AvrRpt2 and RipBN—no correlation between structure and function. The nucleotide-binding leucine-rich repeat (NLR) region shown to be possessed by Ptr1 is not unique to Ptr1 sequences [0006]. It is suggested Applicant recites a SEQ ID NO.
Additionally, there is an inadequate disclosure of the disease and the plant wherein expression of the Ptr1 sequence in said plant would impart disease resistance. Pseudomonas syringae pv. tomato is not representative of all plant diseases and does not allow one skilled in the art to predict other diseases whereby expression of Ptr1 would impart resistance. It is unpredictable what Ptr1 sequence would confer disease resistance in which plant. The disclosure that the Ptr1 ortholog from potato mediates recognition of AvrRpt2 and RipBN when transiently expressed in N. glutinosa leaves [0227] does not allow one skilled in the art to predict other Ptr1 sequences for conferring disease resistance in other plants. Additionally, tomato or Solanaceous plants are not representative of all monocots and dicots and do not allow one skilled in the art to predict other plants wherein expression of Ptr1 from any source would impart disease resistance. Neither the state of the prior art nor Applicant’s disclosure teaches that all plant diseases can be addressed by expression of any Ptr1. Thus, the genus of plant diseases and plants in the claimed method are not adequately described.
Given the breadth of the claims and lack of guidance of the specification, the specification fails to provide an adequate written description of the genus of Ptr1 sequences, diseases and plants as encompassed by the claims. Accordingly, the claimed methods lack adequate written description under current Written Description guidelines (Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111. See also the Written Description Guidelines, Revision 1, March 25, 2008.)
8. Claims 31-37 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.
Enablement 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. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Applicant’s disclosure is as set forth in the written description rejection above. The claimed invention is not enabled for the following reasons. First of all, because there is no correlation between structure and function for Ptr1, as indicated in the written description rejection above, one skilled in the art would not be able to identify a Ptr1 sequence to utilize in the claimed method to impart disease resistance to a plant without undue experimentation. Secondly, the scope of “disease resistance” encompasses all plant diseases, including those caused by bacteria, fungi, viruses and nematodes. Applicant’s working examples only show resistance to P. syringae pv. tomato Race 1. Because different pathogens have different mechanisms for infecting a plant, and Applicant has not shown that Ptr1 would counter all pathogenic infections, Applicant has not enabled “disease resistance” as commensurate in scope with the claims. Thirdly, the scope of “plant” encompasses all plants, both monocots and dicots. Neither the state of the prior art nor Applicant’s disclosure teaches Ptr1 is utilized by all plants to counter pathogenic attacks. Applicant’s working examples show that S. lycopersicoides, potato and tobacco, all of which are Solanaceous plants, possess Ptr1, and their resistance to P. syringae pv. tomato Race 1 is due to their ability to recognize affectors AvrRpt2 and RipBN. It is unpredictable that other plants require recognition of affectors AvrRpt2 and RipBN by Ptr1 to be disease resistant. Thus, Applicant has not enabled all plants as commensurate in scope with the claims.
In making this determination, the Office has weighed each of the Wands factors. The state of the prior art is not highly developed with regard to Ptr1 sequences and their ability to confer disease resistance in plants. The nature of the invention is the use of poorly defined sequences that can confer disease resistance. Ptr1 sequences are not well characterized. The breadth of the claims encompasses all plants, all plant diseases, and both disclosed and undisclosed Ptr1 sequences. The state of the art for determining the presence of functional Ptr1 sequences in other plants is highly unpredictable. No common structure or motif for Ptr1 sequences is disclosed. The amount of direction or guidance is insufficient with regard to structural characterization of the Ptr1 sequences. Though Applicant provides working examples, they are not commensurate in scope with the claims. Applicant provides insufficient direction or guidance to identify Ptr1 sequences and make the claimed plant having the desired disease resistance. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Claim Rejections - 35 USC § 102
9. 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 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.
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
11. Claims 31-33, 36 and 37 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Martin et al. (US20170107531 (Applicant’s IDS)).
Because “Ptr1” is not defined by a particular SEQ ID NO., and “Ptr1” is not an art-recognized term, the recitation “Ptr1” is not given patentable weight here.
Re claim 31, Martin teaches a method of identifying a candidate plant suitable for breeding that displays enhance disease resistance, said method comprising providing a candidate plant; analyzing the candidate plant for the presence of a resistance polynucleotide in its genome; identifying, based on said analyzing, the resistance polynucleotide; and breeding the identified plant with at least one other plant [0100]. The resistance polynucleotide is a receptor-like kinase (RLK) encoded by the Solyc02g072470 gene in the qRph1 region (qRph1 is a QTL associated with resistance to bacterial speck disease caused by Pseudomonas syringae pv. tomato (Pst)) [0023].
Re claim 32, Martin teaches the analyzing step comprises isolating genomic DNA from the plant, analyzing genomic DNA from the plant for the presence of the resistance polynucleotide, and detecting the resistance polynucleotide [0019].
Re claim 33, Martin teaches the breeding step comprising crossing the plant that has the resistance polynucleotide with another plant [0023].
Re claim 36, Martin teaches the providing step comprises providing a transgenic plant transformed with a nucleic acid molecule comprising the resistance polynucleotide [0078].
Re claim 37, Martin teaches the providing step comprises transforming a plant cell with a nucleic acid construct comprising a nucleic acid molecule comprising the resistance polynucleotide, a 5’ heterologous DNA promoter sequence, and a 3’ terminator sequence, all of which are operably coupled to permit transcription of the nucleic acid molecule, and growing the transformed plant cell into a transgenic plant under conditions effective to express the nucleic acid molecule ([0067], [0070], [0038]).
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
12. No claim is allowed. SEQ ID NO:18 encoding SEQ ID NO:19 is free of the prior art.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached on M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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