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, 5-9 & 20-22 are under examination on the merits.
Claims 2-4 & 10-19 are cancelled.
Priority
Claims 1, 5-9 & 20-22 receive the U.S. effective filing date of 02/09/2021
The previous objection to claim 1 is withdrawn in view of Applicant’s amendment to the specification.
The previous rejection of claims 1-11 & 20 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter with respect to the PAO1 variant being referred to is withdrawn in view of Applicant’s amendment to the claims.
The previous rejection of claims 1-3, 10-11 & 20 under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention is withdrawn in view of Applicant’s amendment to the claims.
The previous rejection of claims 1, 5-9 & 20-22 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claims and arguments.
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, 5-9 & 20-22 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 claims contain 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.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 21 Nov 2025, as applied to claims 1-3, 5-11 & 20. Applicant's arguments filed 19 Feb 2026 have been fully considered but they are not persuasive.
Claims 1, 5-9 & 20-22 are directed to methods of increasing Liberibacter disease resistance by decreasing activity of a negative regulator of immune function, specifically PAO1. These claims fail written description requirement because they are directed to a broad genus of protein sequences not supported by the limited species provided by SEQ ID NO.87 & 84.
Claims 1 & 21 require proteins with 90% identity to SEQ ID NO.87 & SEQ ID NO.84, respectively. All other claims depend from these limitations of claims 1 & 21. Proteins with only 90% similarity to SEQ ID NO.87 & 84 would include a large genus of proteins, with varying structure and function. Thus, the claim is broad and reads on numerous unspecified polypeptides.
Regarding claim 1, proteins with 90% identity to the 495-residue long SEQ ID NO.87 encompasses polypeptides with approximately 49 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 495-amino-acids-long protein of SEQ ID NO.87 would require describing 4920 polypeptide sequences; the full scope of plants having said variants, which includes tomatoes, tobacco and other Solanaceous plants other than potato based on sequence search, with 90% identity to SEQ ID NO.87 were not in Applicant’s possession at the time of filing.
Regarding claim 21, proteins with 90% identity to the 497-residue long SEQ ID NO.84 encompasses polypeptides with approximately 49 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 497-amino-acids-long protein of SEQ ID NO.84 would require describing 4920 polypeptide sequences; the full scope of plants having said variants, which includes tomatoes, tobacco and other Solanaceous plants other than potato based on sequence search, with 90% identity to SEQ ID NO.84 were not in Applicant’s possession at the time of filing.
It is reasonable to consider that such wide breadth of structurally variable proteins would have correspondingly variable functionality.
Applicant describes PAO1 as SEQ ID NO.87 & 84 for their study of Citrus and potato [0084, 0087], but does not indicate which specific regions, functional domains, or portions of related amino acid sequences can vary from an endogenous form of PAO1 and still have the same physiological function in planta. There is no description of how varying sequence similarity used in conjunction with gene silencing impacts plant disease resistance, secondary or tertiary structure of encoded proteins, or enzymatic and biological functions including response to Liberibacter infection.
Genes can be silenced through the use of a variety of forms of siRNA molecules, potentially targeting different complementary nucleotide regions of the encoding genes. They have not described the full scope of siRNAs capable of decreasing the activity of the gene or its encoded protein.
There is no description in the specification of how the structures of SEQ ID NO.87 & 84 relates to variant proteins’ ability to confer Liberibacter resistance. One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the two disclosed species.
Hence, Applicant has not, in fact, described variant proteins that encode a PAO conferring Liberibacter resistance over the full scope of the claims, and the specification fails to provide adequate written description of the claimed invention. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant urges previous rejection of claims 1-3, 5-11 & 20 is improper because claim amendments now recite a specific disease, and a specific crop plant [Remarks, p.4, par.7]. Applicant is silent in response to the previous rejection of claims based on sequences less than 100% identical to those described.
This is not found persuasive because Applicant has not addressed the lack of written description provided for proteins of less than 100% identity to SEQ ID NO.87 & 84, which encode PAO1 [Non-final Rejection, p.9, par.2 – p.11, par.3]. Significant portions of the previous 112(a) sequence-identity rejection are restated above.
Amendment of the previously presented claims, which recited sequence similarity as low as 70%, to now read ‘at least 90% identical’ does not obviate the need to address the lack of written description for the full scope of plants encompassed by sequences of less than 100% similarity to SEQ ID NO.87 & 84. Additionally, amendment to 90% similarity does not obviate the need to address the full scope of the siRNAs capable of decrease the target gene.
Applicant is advised to amend claims to reflect the plants and siRNAs corresponding to described endogenous PAO1 proteins, which appear limited to those of 100% identity to SEQ ID NO.87 & 84.
Conclusion
No claims are 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663
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