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 1-3, 5-12 and 16-20, are pending.
Claims 10-12 and 16-18, are withdrawn for being directed to non-elected inventions and not examined on its merits.
Claims 4 and 13-15, are canceled.
Claims 1-3, 5-9, and 19-20, 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All previous rejections not set forth below have been withdrawn.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 Objection
Specification objection is withdrawn in view of amendment.
Status of Rejections from action:
In regard to Claims 19-20 under 101 is withdrawn in view of amendment. The Applicant added SEQ ID NO: 1, with is a non-naturally occurring sequence.
In regard to Claims 1-3, 5, 8-9, and 19-20 under 102 is withdrawn in view of amendment. The Applicant added SEQ ID NO: 1, with contains specific point mutations that is free from the art.
In regard to Claim 7 under 103 is withdrawn in view of amendment. The Applicant added SEQ ID NO: 1, with contains specific point mutations that is free from the art.
Claim Objections
Claims 1, 6 and 20 are objected to because of the following:
In regard to claims 1, 6, and 20 part (b), there seems to be an “a” missing in front of leucine. Additionally, part (c) there is an extra space between “at” and “position”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3, recites “an alanine or a leucine at position 401” or “402”, which depends from claim 1, is unclear how it further limits SEQ ID NO; 1 and 5-22, when an alanine or leucine is already present in said positions. For example, SEQ ID NO: 9 where a leucine is already found in position 402, how is it further limited by claim 3 (b).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. See also claim 20 as it depends from claim 19.
10. Claims 8-9 REMAIN 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 genetically modified Arabidopsis and Nicotiana benthamiana with SEQ ID NO: 1 having mutations at positions (Q400C/E401L/R506C), (see page 28 paragraph [0133], figure 1 and page 36 paragraph [0157] and figure 6), to increase gene expression of NPR1 and pathogen resistance against Pseudomonas syringae pv. maculicola ES4326.
Claims encompasses any phenotype
In regard to claims 8-9, the claims encompass a large genus of increased resistance to all biotic and abiotic stress, however the specification describes genetically modifying Arabidopsis and Nicotiana benthamiana with SEQ ID NO: 1 having mutations at positions (Q400C/E401L/R506C), resulting in pathogen resistance against Pseudomonas syringae pv. maculicola ES4326.
The scope of biotic and abiotic stressors includes all damage caused by living organisms (biotic) and non-living environmental factors (abiotic). This covers, but is not limited to, damage from insects, fungi, animals, hail, drought, salinity, heat, frost, and flooding. The Applicant has not described a representative number of species from the genus of pathogens or abiotic stresses to which the plants will have increased resistance.
There is no single "super gene" that grants simultaneous resistance to all pathogens and growth enhancement under all stress conditions. Therefore, one skilled in the art would find it hard to believe that the claimed plant would confer resistance to the large genus of pathogens or abiotic conditions.
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.
Response to Arguments
11. Applicants argues that the specification describes how to make a nucleic acid encoding a npr1(SAL) protein (i.e., a npr1 protein having cysteine substitutions at positions corresponding to positions 400 and 506 of the Arabidopsis thaliana NPR1 protein).
However, the arguments are unpersuasive, because the Applicant has not described a representative number of phenotypes that arise from claimed sequences and would lead one to believe the invention is in Applicants possession. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 1-3, 5-9, and 19-20 REMAIN rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for only genetically modified Arabidopsis and Nicotiana benthamiana with SEQ ID NO: 1 having mutations at positions (Q400C/E401L/R506C), (see page 28 paragraph [0133], figure 1 and page 36 paragraph [0157] and figure 6), to increase gene expression of NPR1 and pathogen resistance against Pseudomonas syringae pv. maculicola ES4326, does not reasonably enable the scope of resistance to all biotic and abiotic stressors includes all damage caused by living organisms (biotic) and non-living environmental factors (abiotic). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
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 claims broadly encompass genetically modifying a plant with NPR1 (SAL) protein (SEQ ID NO: 1).
(B) The nature of the invention.
The nature of the claimed invention is directed to a plant being genetically modified with NPR1(SAL) protein, resulting in the plant conferring pathogen resistance against Pseudomonas syringae pv. maculicola ES4326.
(C) The state of the prior art
The state of the art is High.
(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 1-3, 5-7, and 19-20 are directed to genetically modifying a plant with a nucleic acid encoding the npr1(SAL) protein having SEQ ID NO: 1. While one skilled the art can readily introduce SEQ ID NO: 1, one skilled in the art would not be able to predictably make and identify the desired phenotype of the resultant plant, when the phenotype is not disclosed.
Here, the claims encompass a large genus of increased resistance to all biotic and abiotic stress, however the specification has only provided enabling guidance on genetically modifying Arabidopsis and Nicotiana benthamiana with SEQ ID NO: 1 having mutations at positions (Q400C/E401L/R506C), resulting in conferring pathogen resistance against Pseudomonas syringae pv. maculicola ES4326.
The specification has not provided enabling guidance as to how one skilled in the would identify the stress condition, if the stress condition is not identified. The scope of biotic and abiotic stressors includes all damage caused by living organisms (biotic) and non-living environmental factors (abiotic). This covers, but is not limited to, damage from insects, fungi, animals, hail, drought, salinity, heat, frost, and flooding.
The Applicant has not provided enough working examples on other undisclosed phenotypes besides conferring pathogen resistance as seen above. The specification does not teach or provide guidance as to what pathogens or environmental stressors the plant is resistant to. The specification also does not provide working examples on the increased biotic and abiotic resistance the plant confers.
While the sequences purportedly confer resistance to pathogen infection or environmental stress, the specification fails to identify which specific pathogens or stresses are targeted. Without explicit teaching or guidance, determining utility required undue experimentation through random phenotypic screening, which is not permissible. Therefore, one skilled in the art without undue experimentation would not be able to make and use said plant without a claimed phenotype.
Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples with all plants comprising any gene scope, 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.
Response to Arguments
In response to Applicant's argument that “one skilled in the art can readily make a nucleic acid encoding any of SEQ ID NOs: 1 and 5-22” (Remarks 04/27/2026, pg. 9) is unpersuasive.
In this instant case, the issue is not making the coding sequences, it is using the modified plant. The claims encompass a vast genus of phenotypes (abiotic, biotic stress, resistance to any pathogen), and that the specification has not taught which phenotypes to expect based on expression of the sequences.
Because of this, the skilled artisan has to randomly test and screen an infinite number of phenotypes. If a person has to do this then the specification has failed to adequately teach making and/or using the invention. Thus, the specification fails to adequately enable the phenotype and does not provide enough working examples or guidance of the invention as broadly claimed.
Therefore, the rejection is maintained.
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.
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/CHRISTIAN JOSE ORDAZ/Examiner, Art Unit 1663
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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