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 .
Election/Restrictions
I. Claims 1-4, drawn to a method for generating a transgenic plant, comprising upregulating or downregulating a gene encoding a PheXTH2 protein in a plant, classified in C12N 15/8201, for example.
II. Claims 5-10, drawn to a method for regulating a culm cell wall thickness of a plant, comprising regulating an expression level or an activity of a PheXTH2 protein or an encoding gene thereof in the plant by genetic engineering, classified in C12N 15/8216, for example.
Applicant’s election without traverse of Group II (claims 5-10) in the reply filed on June 25, 2026 is acknowledged.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 25, 2026
Status of the claims
Claims 1-10 are pending.
Claims 1-4 have been withdrawn.
Claims 5-10 are under examination.
Claim Rejections - 35 USC § 112 – 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 5-10 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 5-7 are directed to a method for regulating a culm cell wall thickness of a plant, comprising regulating an expression level or activity of a Phyllostachys edulis-derived PheXTH2 protein or an encoding gene thereof in the plant by genetic engineering, including limitations directed to increasing or decreasing cell wall thickness through altered PheXTH2 expression.
The specification identifies PheXTH2 and provides an exemplary nucleic acid sequence and protein sequence. The specification also describes transformation of Arabidopsis thaliana with a PheXTH2 containing construct and reports an increase in interfascicular fiber wall thickness in the resulting transgenic plants. However, the disclosure does not reasonably demonstrate possession of the full scope of claims 5-7. In particular, the specification provides only a limited number of experimental embodiments involving expression of PheXTH2 in Arabidopsis. The specification does not provide sufficient representative species, constructs, expression levels, development conditions or experimental results to demonstrate possession of the broader genus of plants and the full range of methods encompassed by claims 5-7. Further, the specification does not adequately demonstrate possession of methods in which PheXTH2 expression is decreased to regulate or decrease culm cell wall thickness. The disclosed experimental evidence principally concerns overexpression and an observed increase in interfascicular fiber cell wall thickness. A disclosure of one direction of modulation does not, by itself, demonstrate possession of the opposite functional relationship where the claimed invention encompasses both increased and decreased expression and corresponding changes in cell wall thickness.
The specification also does not establish that the disclosed PheXTH2 activity produces the claimed cell wall phenotype throughout the full scope of the plants encompassed by the claims. The disclosed evidence is limited principally to Arabidopsis and the specification does not provide sufficient representative data demonstrating that the claimed relationship necessarily occurs in monocotyledonous plants, woody plants, bamboos, or other plant species encompassed by the claims.
Claims 8-10 further recite nucleic acids, transformed cells or plants comprising PheXTH2 related sequences and uses thereof for regulating culm or cell wall thickness.
Although the specification provides an exemplary PheXTH2 nucleic acid sequence, the disclosure does not provide sufficient representative species or structural/functional information to support the full breadth of the claimed subject matter. For example, disclosure of one particular expression construct does not necessarily demonstrate possession of every nucleic acid construct, vector, promoter, host cell, transformed plant or expression configuration encompassed by the claims, nor does the specification provide sufficient representative examples demonstrating that the claimed constructs will produce the recited cell wall phenotype in the full range of the plants encompassed by the claims. The specification therefore provides, at most, an exemplary embodiment rather than an adequate written description of the entire scope of claims 8-10.
The specification demonstrates one particular PheXTH2 overexpression experiment in Arabidopsis, but the claims encompass a much broader genus of plants, expression configurations and functional outcomes without sufficient representative examples. Accordingly, one of ordinary skill in the art would not have understood from the specification, as filed, that Applicant was in possession of the full scope of the claimed methods.
Claim Rejections - 35 USC § 112 - Enablement
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 5-10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
.The enablement requirement is satisfied only when the specification teaches those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. See In re Wands, 858 F. 2d 731 (Fed. Cir. 1988). Relevant considerations include the breadth of the claims, nature of the invention, state of the prior art, level of skill in the art, predictability of the art, amount of direction provided by the specification, presence or absence of working examples, and quantity of experimentation required.
Claims 5-7 are directed to a method for regulating a culm cell wall thickness of a plant, comprising regulating an expression level or activity of a Phyllostachys edulis-derived PheXTH2 protein or an encoding gene thereof in the plant by genetic engineering, including limitations directed to increasing or decreasing cell wall thickness through altered PheXTH2 expression.
The specification provides an experimental example in which PheXTH2 is expressed in Arabidopsis and an increase in interfascicular fiber cell wall thickness is observed. However, the claims extend beyond this particular experimental embodiment to plants and conditions for which the specification provides no demonstrated working examples. The specification does not provide sufficient guidance concerning, for example, the appropriate PheXTH2 expression level for different plant species, the promoter or regulatory sequences required to obtain the claimed phenotype in different plants, the developmental state at which PheXTH2 must be expressed, the extent to which the phenotype depends on the genetic background of the host plant, whether increasing PheXTH2 expression reliably increases culm cell wall thickness in monocots or woody plants or whether decreasing PheXTH2 expression reliably produces the opposite phenotype.
The specification therefore does not provide an adequate teaching that the claimed functional relationship between PheXTH2 expression and culm cell wall thickness can be practiced across the full scope of the claims. Moreover, the relationship between XTH activity and plant cell wall architecture is biologically complex and may depend, for example, on the particular XTH family member, host species and expression level. The specification does not establish that PheXTH2 will produce the claimed result in every plant encompassed by the claims.
Consequently, practicing the full scope of claims 5-7 would require undue experimentation.
Claims 8-10 further recite nucleic acids, transformed cells or plants comprising PheXTH2 related sequences and uses thereof for regulating culm or cell wall thickness.
The specification provides only an exemplary construct and an exemplary transformed plant system. It does not provide sufficient guidance to enable one skilled in the art to practice the full breadth of the claims without substantial experimentation. The required experimentation would not merely involve routine construction of a nucleic acid vector. Rather, for plants outside the disclosed experimental system, substantial empirical optimization would be required to determine whether PheXTH2 expression is obtained at the appropriate level and developmental location and whether such expression produces the claimed alteration in culm or interfascicular fiber cell wall thickness. The specification demonstrates one particular PheXTH2 overexpression experiment in Arabidopsis, but the claims encompass a much broader genus of plants, expression configurations and functional outcomes without sufficient representative examples or guidance demonstrating that the claimed PheXTH2 expression/cell wall thickness relationship is predictable across that full scope.
Accordingly, the specification does not enable the full scope of claims 8-10 without undue experimentation.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kushwah et al (Plant Physiology, 182:1946-1964, 2020), in view of Peng et al (PLOS ONE, Vol. 8, Issue 11, pages 1-12, November 2013), in view of Wang et al (Genes, 9, 273, pages 1-22, 2018).
With regard to claim 5, Kushwah et al teach that xyloglucan endotransglucosylase/hydrolase (XTH) proteins play a role in plant cell wall formation. Kushwah et al teach XTH4 and XTH9 using both loss of function and gain of function plants and showed that altered XTH activity affects secondary wall development, including secondary wall thickening and the number and organization of secondary wall layers (see, for example, page 1959, second column, last full paragraph).
Peng et al teach rapidly growing shoots of Phyllostachys edulis and teaches cell wall related genes in rapidly growing bamboo shoots. Peng et al teach high expression of genes encoding expansins and XTHs, indicating that XTH is associated with the rapid growth and development of bamboo shoots (see, for example, page 7, last paragraph to page 8, bridging paragraph).
Wang et al further teach that XTH genes constitute a multigene family of plant cell wall modifying enzymes (see, for example, page 1, last paragraph). Wang et al identified XTH genes and classified the proteins into recognized XTH subfamilies based upon phylogenetic relationships (see, for example, page 2, first paragraph). Wang et al teach that XTH proteins reconstruct plant cell walls by cutting and/or rejoining xyloglucan and thereby regulate cell wall composition and organization (see, for example, page 16, last paragraph).
It would have been obvious for a person of ordinary skill in the art to apply the teachings of Kushwah et al concerning manipulation of XTH genes to alter secondary wall characteristics to Phyllostachys edulis, which Peng et al expressly identify as a plant in which XTH genes are highly expressed during rapid shoot growth. Wang et al would have reinforced the expectation that XTH members constitute a conserved functional family of cell wall remodeling enzymes and therefore would have provided a reasonable basis for selecting an XTH homolog from the relevant plant.
One of ordinary skill in the art would have been motivated to identify and manipulate a Phyllostachys edulis XTH homolog to modify culm cell wall characteristics because the prior art teaches that there is a functional relationship between XTH activity and secondary wall formation and that there is an association between XTH expression and rapidly developing bamboo shoots.
With regard to claims 6-7, Kushwah et al teach both loss of function and gain of function approaches and demonstrate that altered XTH4 and XTH9 function affects cell wall formation and thickness (see, for example, page 1946, ‘Abstract’; page 1959, second column, second paragraph to page 1960, second column, second paragraph).
Wang et al further teach that XTH genes constitute a multigene family of plant cell wall modifying enzymes (see, for example, page 1, last paragraph). Wang et al identified XTH genes and classified the proteins into recognized XTH subfamilies based upon phylogenetic relationships (see, for example, page 2, first paragraph). Wang et al teach that XTH proteins reconstruct plant cell walls by cutting and/or rejoining xyloglucan and thereby regulate cell wall composition and organization (see, for example, page 16, last paragraph).
Peng et al teach rapidly growing shoots of Phyllostachys edulis and teach cell wall related genes in rapidly growing bamboo shoots. Peng et al teach high expression of genes encoding expansins and XTHs, indicating that XTH is associated with the rapid growth and development of bamboo shoots (see, for example, page 7, last paragraph to page 8, bridging paragraph).
The combined references would have been obvious to one of ordinary skill in the art seeking to regulate culm cell wall thickness in bamboo. Kushwah et al provides the express teachings enhancing or reducing the expression level by teaching that both increased and decreased XTH function can alter cell wall characteristics. The selection of PheXTH2 would have been an obvious selection of one member of a known, conserved XTH gene family known for its association in cell wall thickness as discussed above.
With regard to claims 8-9, Kushwah et al teach that XTH genes encode proteins involved in plant cell wall thickening and both loss of function and gain of function approaches in Arabidopsis thaliana (see, for example, page 1946, ‘Abstract’).
The teachings of Peng et al provide motivation to apply the XTH technology to Phyllostachys edulis because Peng et al teach cell wall related genes, including XTH genes, that are expressed during bamboo shoot development (see, for example, page 7, last paragraph to page 8, bridging paragraph).
It would have been obvious to one of ordinary skill in the art to select an XTH gene from P. edulis, including an XTH homolog corresponding to the claimed PheXTH2, and employ the known genetic engineering techniques of Kushwah et al to provide a method for regulating a culm cell wall thickness of a plant. The skilled artisan would have been motivated to make such a combination because Peng et al teach XTH genes as expressed cell wall related genes in P. edulis, while Kushwah et al teach that genetic manipulation of XTH genes produces measurable changes in cell wall characteristics, including cell wall thickness.
With regard to claim 10, Kushwah et al teach wherein the plant is Arabidopsis thaliana (see, for example, page 1961, second column, first paragraph) and Peng et al teach wherein the plant is Phyllostachys edulis (see, for example, page 9, first column, second paragraph).
It would have been obvious to regulate a culm cell wall thickness of a plant by genetically manipulating an expression level of a P. edulis XTH gene. One of ordinary skill in the art would have reasonably expected that increasing or decreasing expression or activity of an XTH member could alter cell wall thickness because Kushwah et al teach such effects with XTH4 and XTH9. The particular identification of PheXTH2 represents selection of a particular member of the XTH family for carrying out the known function of P. edulis. Such selection would have been an obvious design choice where the artisan was practicing the known XTH mediated regulation of cell wall development in bamboo. A person of ordinary skill in the art would have had a reason to combine the disclosed teachings to identify an XTH homolog expressed in P. edulis and manipulate that homolog based upon the demonstrated relationship between XTH function and cell wall development. The combination would have involved the predictable use of known genetic engineering and plant breeding techniques to achieve a predictable modification of a plant cell wall phenotype.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH O. ROBINSON whose telephone number is (571)272-2918. The examiner can normally be reached Monday - Friday, 9:00 a.m. - 5:30 p.m. EST.
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KEITH O. ROBINSON
Primary Examiner
Art Unit 1661
/KEITH O. ROBINSON/Primary Examiner, Art Unit 1661
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