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, 2, 13, 14, 16, 18, 20, 21, 29, 30, 37, 38, 48-51, 53, 54, 65 and 66 are pending. Claims 3-12, 15, 17, 19, 22-28, 31-36, 39-47, 52, 55-64 and 67-72 have been cancelled.
The rejection of claims 12, 14, 16, 18, 20 and 21 for being directed to naturally occurring products and plants without significantly more is withdrawn in light of the amendments.
The rejection of claims 1, 2, 13, 14, 16, 18, 20, 21, 29, 30, 37, 38, 48-51, 53, 54, 65 and 66 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendments.
The rejection of claim(s) 1, 2, 20 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Sada et al (WO 2020/0166477) is withdrawn in light of the amendments as Sada et al fails to disclose the nucleic and amino acid sequences as claimed.
The rejection of claim(s) 1, 29, 48-51, 53, 54, 65 and 66 under 35 U.S.C. 103 as being unpatentable over Sada et al (WO 2020/0166477 A1) in view of Salas-Perez et al (2018, PLOS ONE, 13(4), 1-33) is withdrawn in light of the amendments.
The rejection of claim(s) 37 and 38 under 35 U.S.C. 103 as being unpatentable over Sada (Patent No. US 10,674,725 B1) in view of Salas-Perez et al (2018, PLOS ONE, 13(4), 1-33) is withdrawn in light of the amendments.
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, 2, 13, 14, 16, 18, 20, 21, 29, 30, 37, 38, 48-51, 53, 54, 65 and 66 REMAIN 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 arguably inhibiting expression of the polynucleotides of SEQ ID NO: 1 encoding CYP72A219 having the amino acid sequence of SEQ ID NO: 2, does not reasonably provide enablement for the plants, methods, products and kits as broadly claimed encompassing any conceivable plant comprising CYP721219. 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/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims broadly encompass any possible plant comprising a vast genus of polypeptides having as little as 90% sequence identity to SEQ ID NO: 2 or 4 or a polynucleotide having as little as 90% sequence identity to SEQ ID NO: 1 or 3, and wherein CYP72A219 can be reduced in any conceivable plant species to control growth.
Meanwhile, the specification teaches that CYP72A219 was identified as candidate gene for HPPD herbicide resistance in Amaranthus palmeri due to increased expression HPPD resistance plants, and that CYP72A219 gene expression was induced when plants were treated with tembotrione (¶ 0219 and 0220).
When CYP72A219 having the nucleotide sequence of SEQ ID NO: 1 or 3 was expressed in yeast formation of hydroxy-tembotrione metabolite occurred while the expression of SEQ ID NO: 5 and 7 did not (¶ 0223). The specification teaches that CYP72A219 is consistently upregulated in tembotrione resistant A. palmeri (¶ 0225).
However, the specification fails to teach the critical structures or motifs of CYP72A219 that confer functional activity, and thus fails to provide the requisite guidance for making the genus of polynucleotides and polypeptides as claimed, and in turn fails to teach predictably making the plants as broadly claimed or using the plants in the methods as claimed.
This guidance is critical because a nucleic acid sequence having as little as 90% identity to SEQ ID NO: 1 or 3 would have 155 nucleic acid substitutions relative to SEQ ID NO: 1 or 3, respectively, while a polynucleotide encoding a polypeptide with as little as 90% identity to SEQ ID NO: 2 or 4 would have 51 amino acid substitutions relative to SEQ ID NO: 2 and 4, respectively. These polynucleotide and polypeptides would encompass 3155 and 1951 distinct gene and protein variants, respectively.
However, in the absence of guidance indicating where in the sequence of SEQ ID NO: 1, 2, 3 and 4 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polynucleotides of SEQ ID NO: 1 or 3, or to the make the polypeptide which would retain the activity of SEQ ID NO: 2 or 4, and which results in plant having increased tolerance to any conceivable herbicide in any conceivable plant species.
Teaching the critical domains or motifs that confer CYP72A219 functional activity is critical in light of the state of the art, which provides that “CYP72A219” in olive trees are related to the immune response and belonging to a family of monooxygenases involved in diterpene synthesis (Ramirez-Terejo et al, 2021, BMC Genomics, 22:1-16; see p. 3, col. 2, last ¶).
Or see Kang et al and Kuwahara et al which teach that CYP72A21 in C. roseus and Panax ginseng, respectively, is a secologanin synthase (Kang et al 2021, Nature Communications, 12:1-12; see p. 4, col. 2; Kuwahara et al, 2019, Journal of Natural Medicines, 73:369-380; p. 379, col. 1).
Thus, based on the fact that CYP72A219 appears to have different functions in different plant species, the skilled artisan would be unable to predictably make the genus of nucleic and amino acid sequences to either confer or eliminate herbicide tolerance in all plants.
Therefore, in light of the breadth of the claims, the failure of the specification to teach the critical structures or motifs that confer CYP72A219 functional activity, the failure of the specification to teach which plants express CYP72A719 and have herbicide tolerance, the lack of working examples, and the state of the art which teaches that CYP72A219 function does not appear to be conserved among plants, the skilled artisan would resort to undue trial and error experimentation to arrive at the claimed plants, methods and products which is tantamount to excessive and impermissible experimentation.
Response to Arguments
Applicant traverses the rejection of the claims because SEQ ID NO: 1 and an allelic variant thereof (i.e., SEQ ID NO: 3) is overexpressed in herbicide resistant plants and that it would be routine screening is required to practice the invention over the full scope of the claims (Applicant reply dated 03 March 2026, p. 11, penultimate and last ¶).
This argument is not found persuasive for the reason as set forth above. Namely, the claims remain drawn to a large genus of sequences for which the specification fails to teach the critical domains or motifs that confer functional activity.
Moreover, the working examples provided share over 98% sequence identity. Thus, any structures lacking greater than 98% sequence identity would not possesses the required domains or motifs for the claimed functional activity. As such, the skilled artisan would arguably be able to make and use a sequence having at least 90% identity to SEQ ID NO: 2 and 4 and that would retain functional activity.
Couple with the fact that the prior art fails to teach structures within the sequences as claimed that confer functional activity, the skilled artisan would be left to impermissible and undue trial and error experimentation.
Claims 1, 2, 13, 14, 16, 18, 20, 21, 29, 30, 37, 38, 48-51, 53, 54, 65 and 66 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.
Instant claims 1, 2, 13, 14, 16, 18, 20, 21, 29, 30, 37, 38, 48-51, 53, 54, 65 and 66 are broadly encompass any possible plant comprising a vast genus of polypeptides having as little as 90% sequence identity to SEQ ID NO: 2 or 4 or a polynucleotide having as little as 90% sequence identity to SEQ ID NO: 1 or 3, and wherein said plants have tolerance to any possible herbicide, and wherein CYP72A219 can be reduced in any conceivable plant species to control growth.
Meanwhile, the specification describes that CYP72A219 was identified as candidate gene for HPPD herbicide resistance in A. palmeri due to increased expression HPPD resistance plants, and that CYP72A219 gene expression was induced when plants were treated with tembotrione (¶ 0219 and 0220).
When CYP72A219 having the nucleotide sequence of SEQ ID NO: 1 or 3 was expressed in yeast formation of hydroxy-temotrione metabolite occurred while the expression of SEQ ID NO: 5 and 7 did not (¶ 0223). The specification describes that CYP72A219 is consistently upregulated in tembotrione resistant A. palmeri (¶ 0225).
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.
However, the specification fails to describe: (1) a representative number of species from the genus of CYP72A219 polypeptides; (2) a representative number of plants comprising said polypeptides; and (3) a representative number of herbicides to which said plants have increased tolerance.
Moreover, the specification does not describe the critical structures or motifs of CYP72A219 that confer functional activity, and thus fails to adequately describe the genus of polynucleotides and polypeptides as claimed, and in turn fails to teach predictably making the plants as broadly claimed for using the plants in the methods as claimed.
This description is critical because a nucleic acid sequence having as little as 90% identity to SEQ ID NO: 1 or 3 would have 155 nucleic acid substitutions relative to SEQ ID NO: 1 or 3, respectively, while a polynucleotide encoding a polypeptide with as little as 90% identity to SEQ ID NO: 2 or 4 would have 51 amino acid substitutions relative to SEQ ID NO: 2 and 4, respectively. These polynucleotide and polypeptides would encompass 3155 and 1951 distinct gene and protein variants, respectively.
However, without describing where in the sequence of SEQ ID NO: 1, 2, 3 and 4 such variations can be sustained, the skilled artisan would not be of the opinion that Applicant possessed the broad genus of polypeptides as claimed and which yield a genus of plants having increased tolerance to any conceivable herbicide.
A description of the domains or motifs that confer CYP72A219 functional activity is critical in light of the state of the art, which describes that “CYP72A219” in olive trees are related to the immune response and belonging to a family of monooxygenases involved in diterpene synthesis (Ramirez-Terejo et al, p. 3, col. 2, last ¶).
Or see Kang et al and Kuwahara et al which describe that CYP72A21 in C. roseus and Panax ginseng, respectively, is a secologanin synthase (p. 4, col. 2; see Kuwahara et al, p. 379, col. 1).
Thus, based on the fact that CYP72A219 appears to have different functions in different plant species, the skilled artisan would not be led to believe that Applicant possesses the genus of nucleic and amino acid sequences that have predictable activity and either confer or eliminate any herbicide tolerance in all plants.
Therefore, in light of the breadth of the claims, the failure of the specification to describe the structures of a representative number of CYP72A219 polypeptides, the failure of the specification to describe the critical structures or motifs that confer CYP72A219 functional activity, the failure of the specification to describe which plants express CYP72A719 and have herbicide tolerance, the lack of working examples, and the state of the art which describes that CYP72A219 function does not appear to be conserved among plants, the skilled artisan would not be of the opinion that Applicant was in possession of the plants, methods and products as broadly claimed.
Response to Arguments
Applicant traverses the rejection of the claims because the claims do not recite a function for the nucleic and amino acid sequence structures (Applicant reply dated 04 March 2026, p. 12, last ¶).
This argument is not persuasive because it is not commensurate in scope with what is claimed. For example, claim 13 is directed to a method for producing a plant with herbicide tolerance by expressing the nucleic acid sequence of SEQ ID NO: 1 meaning that the nucleic acid sequence has the implicit function of conferring herbicide tolerance.
Moreover, this argument applies to claim 1: there is no way for the modified plant to have tolerance to any of the herbicides unless the expressed polynucleotide confers said tolerance (i.e., as a function). Otherwise, the claim lacks a nexus between expression of the polynucleotide and herbicide resistance. If this were the case, the claims would not be adequately described for a modified plant that has herbicide resistance which is unrelated to the expression of the claimed polynucleotide.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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