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 1-7, 10-12 and 14-23 are pending. Claims 8, 9 and 13 have been cancelled.
Election/Restriction
Applicant’s election of the Invention of Group I and the species of increasing/overexpressing ITPK1 in the reply filed on 26 May 2026 and 27 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Claim 4 is withdrawn from further consideration as it is not directed to an elected species. Therefore, claims 1-3, 5-7, 10-12 and 20-23 are currently examined.
Specification
The disclosure is objected to because it contains an embedded hyperlinks and/or other forms of browser-executable code (e.g., see ¶ 0144). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 6 is objected to for the following reason: the limitation “and/or the one or more gene and/or gene products thereof” appears to be redundant as the claim already recites gene and/or gene product.
Appropriate action is advised.
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 1-3, 5-7, 10-12 and 20-23 are 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 overexpressing the IPTK gene having accession no. EC 2.7.4.21, does not reasonably provide enablement for making and using engineered plants overexpressing the genus of ITPK genes as broadly claimed. 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:
The claims are broadly drawn to an engineered plant comprising increased inositol pyrophosphate and/or synthesis thereof in any conceivable manner, wherein the plant comprises increased expression of an inositol tetrakisphosphate kinase (ITPK) or ITPK1 gene having any nucleic acid structure, wherein phosphate starvation response is up to 1000 fold more than a wild-type plant and can also have reduced Pi accumulation capability or is reduced by up to 1000 fold, wherein the plant has more than one modified developmental pathway and/or hormone signaling pathway, wherein the ITPK gene is modified and has increased expression, and a method of growing said plant.
Meanwhile, the specification teaches transgenic Arabidopsis plants overexpressing ITPK1 corresponding to Accession No. AT5G16760.1 led to “changes” in leaf growth, coloration and “morphology”, onset of senescence and delayed time to flowering in addition to significantly reduced primary and lateral root length and root number suggesting that PP-InsPs are key modulators of grown and development (¶ 0270 and 0271; see also ¶ 0273). Plants also have elevated PP-InsPs and a 2-4 fold decrease in Pi accumulation (¶ 0275 and 0279).
However, and aside from teaching the overexpression of a specific nucleic acid encoding an ITPK1 protein, the specification fails to teach or provide guidance for engineering a plant in any other conceivable way to increase inositol pyrophosphate, fails to teach that the genus of structures encompassing ITPK1 as broadly claimed that retain function, and further fails to teach any modification, in fact, to said gene that “increases” its expression.
This guidance is critical because the claims encompass not only the exemplified ITPK1 of the instant specification but also fragments or sequences having as little as 70% identity to the gene (e.g., see ¶ 0102, 0104 and 0105). However, the specification fails to teach which structures within the ITPK1 gene are critical for functionality or that increase expression such that the skilled artisan would resort to trial and error experimentation to determine whether the plants as claimed could be predictably made and used.
Moreover, the specification fails to teach, in fact, that the phosphate starvation response is up to 1000 fold more than a wild-type plant but at the same time can also reduce Pi accumulation capability or reduce it by up to 1000 fold. This guidance is paramount because the specification only teaches that overexpression of a particular ITPK1 structure leads to a 2-4 fold decrease in Pi accumulation.
Additionally, while the specification arguably teaches the claimed plant is modified in a developmental pathway and a hormone signaling pathway, the working examples are not nearly commensurate in scope with what is claimed as the claims encompass modifying any conceivable developmental pathway and/or hormone signaling pathway.
In fact, Cridland et al (2025, The Plant Journal, 123:1-15) recognizes in the first column of page 12 that the effect of overexpressing ITPK1 on other phenotypes is unknown:
Given Pi deficiency and insect herbivory have such a negative impact on crop health and yield in agriculture, additional studies that clarify the impact of PP-InsPs in other signaling path-ways as well as how specific InsPs contribute to plant defense merit further exploration.
Therefore, in light of the breadth of the claims, the lack of working examples, the state of the art and the inadequate guidance in the specification, the skilled artisan would be required to engage in impermissible undue trial and error experimentation in order to predictably arrive at the plants and methods as claimed.
Claims 1-3, 5-7, 10-12 and 20-23 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.
Claims 1-3, 5-7, 10-12 and 20-23 are broadly drawn to an engineered plant comprising increased inositol pyrophosphate and/or synthesis thereof in any conceivable manner, wherein the plant comprises increased expression of an inositol tetrakisphosphate kinase ITPK or ITPK1 gene having any nucleic acid structure, wherein phosphate starvation response is up to 1000 fold more than a wild-type plant and can also have reduced Pi accumulation capability or is reduced by up to 1000 fold, wherein the plant has more than one modified developmental pathway and/or hormone signaling pathway, wherein the ITPK gene is modified and has increased expression, and a method of growing said plant.
Meanwhile, the specification describes transgenic Arabidopsis plants overexpressing ITPK1 corresponding to Accession No. AT5G16760.1 led to “changes” in leaf growth, coloration and “morphology”, onset of senescence and delayed time to flowering in addition to significantly reduced primary and lateral root length and root number suggesting that PP-InsPs are key modulators of grown and development (¶ 0270 and 0271; see also ¶ 0273). Plants also have elevated PP-InsPs and a 2-4 fold decrease in Pi accumulation (¶ 0275 and 0279).
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.
Here, and aside from describing the overexpression of a specific nucleic acid encoding an ITPK1 protein, the specification fails to describe engineering a plant in any other conceivable way to increase inositol pyrophosphate, fails to describe a representative number of species from the exhaustive genus of structures encompassing ITPK1, and further fails to describe any modification, in fact, to said gene that “increases” its expression.
This description is critical because the claims encompass not only the exemplified ITPK1 of the instant specification but also fragments or sequences having as little as 70% identity to the gene (e.g., see ¶ 0102, 0104 and 0105). However, the specification fails to describe which structures within the ITPK1 gene are critical for functionality or that increase expression such that the skilled artisan would not be of the opinion that Applicant possesses the plants and methods as claimed.
Moreover, the specification fails to describe, in fact, that the phosphate starvation response is up to 1000 fold more than a wild-type plant but at the same time can also reduce Pi accumulation capability or reduce it by up to 1000 fold. This description is paramount because the specification only describes that overexpression of a particular ITPK1 structure leads to a 2-4 fold decrease in Pi accumulation.
Additionally, while the specification arguably describes the claimed plant is modified in a developmental pathway and a hormone signaling pathway, the working examples are not nearly commensurate in scope with what is claimed as the claims encompass modifying any conceivable developmental pathway and/or hormone signaling pathway.
In fact, Cridland et al describe in the first column of page 12 that the effect of overexpressing ITPK1 on other phenotypes is unknown:
Given Pi deficiency and insect herbivory have such a negative impact on crop health and yield in agriculture, additional studies that clarify the impact of PP-InsPs in other signaling path-ways as well as how specific InsPs contribute to plant defense merit further exploration.
Therefore, in light of the breadth of the claims, the lack of working examples, the state of the art and the failure of the specification to describe a structure function correlation for ITPK1, and the failure to describe modification that increase ITPK1 expression, the skilled artisan would not be of the opinion that Applicant possesses the plants and methos as claimed.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-3, 5-7, 10-11 and 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuo et al (2018, The Plant Journal, 95:613-630).
Instant claims 1-3, 5-7, 10-11 and 20-23 are drawn to an engineered plant comprising increased inositol pyrophosphate and/or synthesis, wherein the plant comprises increased expression of an inositol ITPK or ITPK1, wherein phosphate starvation response is up to 1000 fold more than a wild-type plant and can also have reduced Pi accumulation capability or is reduced by up to 1000 fold, wherein the plant has more than one modified developmental pathway and/or hormone signaling pathway, and a method of growing said plant.
Kuo et al discloses overexpression of ITPK1 in an engineered plant leading to reduced shoot Pi content, decreased Pi uptake and the downregulation of several PSR genes (p. 616, col. 2, ¶ 1; see also p. 617, col. 1, ¶ 1).
Here, the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Here, there are no structural differences between the engineered plant as disclosed by Kuo et al and the instantly claimed plant. Therefore, an engineered plant comprising increased inositol pyrophosphate and/or synthesis, wherein the plant comprises increased expression of an inositol ITPK or ITPK1, wherein phosphate starvation response is up to 1000 fold more than a wild-type plant and can also have reduced Pi accumulation capability or is reduced by up to 1000 fold, wherein the plant has more than one modified developmental pathway and/or hormone signaling pathway, and a method of growing said plant is anticipated by Kuo et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-7, 11 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adepoju et al (2019, “Inositol Trisphosphate Kinase and Diphosphoinositol Pentakisphosphate Kinase Enzymes Constitute the Inositol Pyrophosphate Synthesis Pathway in Plants”, bioRxiv preprint doi: https://doi.org/10.1101/724914).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 1-3, 5-7, 11 and 20-23 are drawn to are drawn to an engineered plant comprising increased inositol pyrophosphate and/or synthesis, wherein the plant comprises increased expression of an inositol ITPK or ITPK1, wherein phosphate starvation response is up to 1000 fold more than a wild-type plant and can also have reduced Pi accumulation capability or is reduced by up to 1000 fold, wherein the plant has more than one modified developmental pathway and/or hormone signaling pathway, and a method of growing said plant.
Adepoju et al teach that inositol pyrophosphate signaling molecules are of agronomic importance as they can control complex responses to the limited nutrient phosphate and that understanding its function is an important advance that can help design future strategies to increase phosphate efficiency in plants (see p. 3, ¶ 1).
Adepoju et al teach ITPK1 recombinant enzymes in vitro most likely act in concert to catalyze the last two reactions in the PP-InsP synthesis pathway which are important in the Pi sensing pathway (p. 5, ¶ 1). The ITPK1 gene has Gene ID AT5G16760, the same accession number as the ITPK1 as taught by the instant specification (see Supplemental Table 1; see also instant specification ¶ 0270).
Adepoju et al teach ITPK1 encodes an ATP-grasp domain containing proteins that are very structurally similar to the kinase domain of human PPIP5k, and that cloned and recombinantly expressed ITPK1 in E. coli has functionality (p. 8, ¶ 1 and 2).
Adepoju et al teach Arabidopsis ITPKs can convert InsP6 to a more phosphorylated product and that the ITPK family of enzymes possess an ATP-grasp fold and have been previously described as multifunctional inositol phosphate kinases capable of phosphorylating different isomers of InsP3 and Ins(3,4,5,6)P4 in plants (p. 12, last ¶ bridging p. 13).
Adepoju et al teach given the importance of seed InsP6 and Pi in agriculture, delineation of the PP-InsP synthesis pathway has important ramifications for future approaches to control Pi sensing in plants (p. 14, last ¶).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify the teachings of Adepoju et al to express ITPK1 in an engineer plant because Adepoju et al expressly suggests doing so as a strategy to increase phosphate efficiency in plants.
One would have a reasonable expectation of success in doing so because the nucleic acid sequence for ITPK1 was known in the art and because genetic transformation methods are conventional and well-known.
Because Adepoju et al teach and suggest arriving at the engineered plant as encompassed by claims 1 and 2 with a reasonable expectation of success, and because there are no structural differences between the plant as suggested by Adepoju et al and that as instantly claimed, it necessarily follows that the resulting engineered plant will be phenotypically indistinguishable from the plant of the instant invention.
Conclusion
No claim is allowed.
Claim 12 appears to be free of the prior art. The closest prior art is that which is referenced above but does not reasonably teach, suggest or provide motivation for modifications to ITPK1 to increase its expression.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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