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
1. Claims 1, 4-9 and 12-17, are pending. Claims 2-3 and 10-11, are canceled. Claims 1, 4-9 and 12-17, are examined in the instant application to the extent of SEQ ID NO: 6 and 7. Sequences in Table 1 are not elected by original presentation. Therefore, the sequences set forth in Table 1 are not 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All previous rejections not set forth below have been withdrawn.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 Objections
Specification objection is withdrawn.
Claim objections is added in view of Status of Rejections from action:
In regard to Claims 1, 4-9 and 12-17, under 101 is removed in view of amendments. Because the Applicant added by mutating the target gene.
In regard to Claims 1, 4-9 and 12-17, under 112(b) Indefinite is added in view of amendment.
In regard to Claims 1, 4-9 and 12-17, under 112(a) Written Description is modified in view of amendment.
In regard to Claims 1, 4-9 and 12-17 under 112(a) Enablement is modified in view of amendment.
In regard to Claims 1, 4-9 and 12-17 under 102 is withdrawn in view of amendment. The prior art does not teach on SEQ ID NOs 6 or 7, or fragments from the sequences in table 1.
Claim Objections
Claims 1, 6 and 13-14, are objected to because of the following informalities:
In regard to claim 1: if the recited steps are the only steps required to achieve the claimed method, a “wherein” clause referring to the claimed objectives set forth in the preamble should be inserted at the end of the claim.
Claims 6 and 14 recite various plants. Plants not having at least 90% sequence identity to SEQ ID NO:7 should be deleted.
Claim 8: the method of claim 1 does not indicate that a plant cell having increased pathogen resistance and/or abiotic stress tolerance was obtained. It is suggested “wherein said plant cell having the decreased or inactivated expression of the Parakletos protein has increased pathogen resistance and/or abiotic stress tolerance” is inserted at the end of claim 1.
Claim 13, refers to the plant cells according to claim 1. However, claim 1 is a method claim. Additionally, claim 1 does not recite “one or more plant cells”.
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, 4-9 and 12-17, 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 regard to claim 1, where is the decreasing or inactivating expression of the Parakletos protein taking place?
In claim 1, “affect” encompasses both increase and decrease. This is inconsistent with the “decreased or inactivated” objective. See also claim 9.
In regard to claim 5, the recitation of “modifying the genome”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 5-6, 14-15 and 17, the phrase " of “preferably” and “more preferably” the claims are not limited by either of the limitations and renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c).
Dependent claims are included.
Correction and/or clarification is required.
Claim Rejections - 35 USC § 112(a)(Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-9 and 12-17, 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.
Applicant’s disclosure is as follows.
Applicant transforms a plant cell by agrobacterium with pK2GW7 containing the full-length protein 72 (i.e.. Parakletos protein), (SEQ ID NO: 2, Amino acid) also known as thylakoid proteins (see page 3 lines 5-24 and page 12 example 1). Transformed plants resulted in “transient overexpression of the 72 protein in the leaf tissue has thus made the leaf tissue more susceptible, i.e., less resistant, to infection by the pathogen P. infestans.” (see page 14 lines 4-6). Applicant shows that silencing protein 72 “provided the leaf with increased resistance to P. infestans.” (see example 1 page 15 lines 19-20). In example 2, Applicant shows that silencing of 72 protein (SEQ ID NO: 2 full-length amino acid) in Nicotiana benthamiana resulted in increased ROS production (see page 14 lines 26-30). In example 3, Applicant shows a sequence alignment of SEQ ID NO: 5 being a common motif shared by other plants (see pages 16-41). In example 3B, Applicant shows a sequence alignment of SEQ ID NO: 13 being a common motif shared by other plants (see pages 42-43). In example 4, Applicant shows that silencing of 72 protein (SEQ ID NO: 2 full-length amino acid) in Nicotiana benthamiana resulted in increased resistance to Pseudomonas syringae (see page 43 lines 9-24). In example 5, Applicant shows deletion of 72 protein (SEQ ID NO: 15 full-length amino acid) in Arabidopsis thaliana and Solanum tuberosum resulting in increased ROS production (see page 44). In example 6, Applicant shows that silencing of 72 protein (SEQ ID NO: 2 full-length amino acid) in Nicotiana benthamiana resulted in increased resistance to Dickeya dadantii 3937 Soft rot bacteria (see page 44 lines 26-30). In examples 7-9, Applicant shows that silencing of 72 protein (SEQ ID NO: 15 full-length amino acid) in Solanum tuberosum resulted in increased resistance to P. infestans late blight, Alternaria solani, and salt tolerance (see pages 45-46).
The claimed invention lacks adequate written description for the following reasons. Claims 1, 4-9 and 12-17, are directed to a method of obtaining a plant cell having increase pathogen resistance and/or abiotic stress tolerance, by decreasing or inactivating the expression of the Parakletos protein, wherein the protein is encoded by a gene sequence having at least 90-99% sequence identity to SEQ ID NO: 6 (genomic DNA) or SEQ ID NO: 7 (open reading frame).
SEQ ID NO: 6 and SEQ ID NO: 7 were isolated from the natural occurring Nicotiana benthamiana plant. The Applicant shows blast results of SEQ ID NO: 5 as being 69-100% sequence identical with other plants, (see pages 16-21). However, the specification does not describe conserved motifs shared by all plants. From the disclosure of SEQ ID NO: 6 and 7 one skilled in the art cannot predict the structures of other genes having 90-99% sequence identity from other sources and their allelic variants having increased pathogen resistance and/or abiotic stress tolerance activity.
Furthermore, Applicant does not teach how the expression of SEQ ID NO:6 or 7 can be decreased or inactivated as commensurate in scope with the claims. The claims are not limited to any particular compound or sequence for decreasing or inactivating SEQ ID NO:6 or 7. SEQ ID NO:12 is an immunity-activating peptide flagellin flg22 (Ex. 2). It is unpredictable what other compounds would decrease or inactivate SEQ ID NO:6 or 7.
Additionally, the 90-99% sequence identity to SEQ ID NOs: 6 or 7 encompasses genes obtained from sources other than Nicotiana benthamiana, whereby their structures and identities are not disclosed, so long as they share at least 90-99% sequence identity to a portion of SEQ ID NOs: 6 or 7. The claims encompass mutants, derivatives, and allelic variants of SEQ ID NOs: 6 or 7 and thus imply that structural variants exist in nature, yet no structural variant has been disclosed having similar activity. The implication is that there is a gene and a protein other than that disclosed which exists in nature, but the structure thereof is not known. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine such allelic variants of other Parakletos proteins, that would result in similar phenotype especially given that SEQ ID NOs: 6 or 7 is just a motif and not the full-length sequence, absent further guidance.
Taken into consideration of the scope of deleting and inhibiting activity of amino acid sequence having at least 90% of SEQ ID NOs: 6 or 7. Applicant has not adequately described or shown examples of deleting, inhibiting, or removing activity from sequences with at least 90% sequence identity to SEQ ID NOs: 6 or 7 resulting in effectively increasing pathogen resistance and/or abiotic stress tolerance. Therefore, this suggests that Parakletos protein variants, may function differently if sequence and structure changes, showing the unpredictability of all variants at the time of filling. Applicant failed to disclose a representative number of species within the scope of the genus.
For example, Hamel et al. (The Chloroplastic Protein THF1 Interacts with the Coiled-Coil Domain of the Disease Resistance Protein N' and Regulates Light-Dependent Cell Death. 2016. Plant physiology vol. 171,1: 658-74. doi:10.1104/pp.16.00234 (previously cited)), teaches on Thylakoid Formation1 (THF1) protein which is known “to be involved in plant-pathogen interactions, as it is a direct target of the phytotoxin ToxA, a cell death-inducing protein of the necrotroph Pyrenophora tritici-repentis” (see page 659 right column middle section). Hamel et al. mentions that “the CC domains of I2-5, I2-28, and the L proteins did not induce strong cell death and did not affect THF1 levels more than Tm-2aCC, which did not induce cell death” (see page 664 and figure 6). Suggesting that not all thylakoid proteins behave the same. Since it would cause undue burden to identify Parakletos proteins having 90-99% sequence identity to SEQ ID NOs: 6 or 7, it would not allow one skilled in the art to predictably produce a method for producing a plant cell having increased pathogen resistance and/or abiotic stress tolerance activity.
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.
Applicant’s traversals do not address the above rejection.
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 1, 4-9 and 12-17, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification enables Agrobacterium transformation and silencing a plant with SEQ ID NO: 2 or 15 (full-length 72 protein), resulting in Nicotiana benthamiana, Arabidopsis thaliana, and Solanum tuberosum having increased pathogen resistance against P. infestans, Pseudomonas syringae, Dickeya dadantii, and Alternaria solani (see examples 1-2 and 4-9). Additionally, the specification teaches that knocking out the activity of 72 protein shows increase in ROS levels and increased salt tolerance. However, the claims are not enabled for silencing sequence with at least 90-99% sequence identity to SEQ ID NOs: 6 or 7 or all types of pathogens and/or abiotic stresses. 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(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. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
(A) The breadth of the claims
The breadth of the claims encompass a method of obtaining a plant cell or plant having increased resistance to all pathogens and tolerance to all abiotic stresses by inhibiting the expression of any sequence having at least having at least 90-99% sequence identity to SEQ ID NOs: 6 or 7 by any method.
(B)The nature of the invention
The nature of the claimed invention is directed to decreasing or inactivating the expression of a Parakletos protein having 90-99% sequence identity to SEQ ID NO:6 or 7 to confer increased resistance to P. infestans, Pseudomonas syringae, Dickeya dadantii, and Alternaria solani, and increased salt tolerance in a plant.
(C) The state of the prior art;
The state of the prior art does not teach any sequence whereby decreasing or inactivating its expression results in increased resistance to all pathogens and tolerance to all abiotic stresses. The state of the prior art does not teach a function for SEQ ID NOs: 6 or 7 nor a Parakletos gene. The state of the prior art does not teach a class of compounds for decreasing or inactivating expression of SEQ ID NO:6 or 7.
(D) The level of one of ordinary skill;
The level of one of ordinary skill in the art is high.
(E) The level of predictability in the art
It is unpredictable what Parakletos sequences are within 90-99% sequence identity to SEQ ID Nos. 6 and 7. It is unpredictable how the function of a Parakletos protein can be determined for the 90-99% sequence identity scope. It is unpredictable what pathogen resistance and what abiotic stress tolerance are conferred by decreasing or inactivating a sequence having 90-99% sequence identity to SEQ ID NO:6 or 7.
(F) The amount of direction provided by the inventor
The specification provides no guidance as to what sequences having 90-99% sequence identity to SEQ ID NOs: 6 or 7 are Parakletos proteins. The specification provides no guidance as to resistance to other pathogens and tolerance to other abiotic stresses by decreasing or inactivating the expression of SEQ ID NO:6 or 7. The specification provides no other compounds for decreasing or inactivating expression of SEQ ID NO:6 or 7.
(G) The existence of working examples
Applicant discloses only resistance to P. infestans, Pseudomonas syringae, Dickeya dadantii, and Alternaria solani, and increased salt tolerance by decreasing or inactivating expression of SEQ ID NO:6 or 7. Applicant only discloses SEQ ID NO:12 as the compound for decreasing or inactivating expression of SEQ ID NO:6 or 7.
(H) The quantity of experimentation needed to make or use the invention
The claimed invention lacks adequate enabling experimentation for the following reasons. Claims 1, 4-9 and 12-17, are directed to a method of obtaining a plant cell having increase pathogen resistance and/or abiotic stress tolerance, by decreasing or inactivating the expression of the Parakletos protein, wherein the protein is encoded by a gene sequence having at least 90-99% sequence identity to SEQ ID NO: 6 (genomic DNA) or SEQ ID NO: 7 (open reading frame).
SEQ ID NO: 6 and SEQ ID NO: 7 were isolated from a Nicotiana benthamiana plant. The Applicant shows blast results of SEQ ID NO: 5 as being 69-100% sequence identical with other plants, (see pages 16-21). The claims are not limited to targeting SEQ ID NO:5. It is unpredictable how the expression of SEQ ID NO:6 or 7 can be decreased or inactivated in a manner that would confer resistance to pathogens and tolerance to abiotic stresses.
Additionally, Applicant does not teach how the expression of SEQ ID NO:6 or 7 can be decreased or inactivated as commensurate in scope with the claims. The claims are not limited to any particular compound or sequence for decreasing or inactivating SEQ ID NO:6 or 7. SEQ ID NO:12 is an immunity-activating peptide flagellin flg22 (Ex. 2). No guidance is provided as to what other compounds would decrease or inactivate SEQ ID NO:6 or 7.
Applicant has not enabled resistance to all pathogens and tolerance to all abiotic factors. Different pathogens affect different plant physiological processes and target different proteins. Neither the state of the prior art nor Applicant’s working examples teaches that decreasing or inactivating expression of a single sequence would confer resistance to all plant pathogens, e.g., viruses, and tolerance to all abiotic stresses, e.g., heavy metals.
Given the lack of sufficient guidance, examples of operable embodiments, 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
Prosecution Insights