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
1. Claims 1-5, 20, 22-24, and 28 are pending and under examination on the merits.
Claims 25-27 and 29-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on October 05, 2025.
Claims 6-19 and 21 are cancelled.
Restrictions/Elections
2. The Office acknowledges receipt of Applicant’s restriction election filed October 05, 2025. Applicant elects Group I, claims 1, 4-5, 20, 22-24, and 28, with traverse.
However, Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement. Thus, Applicant’s traversal is not considered persuasive. However, upon further consideration, claims 2-3 have been rejoined with Group I and are considered to the extent of the elected species. Claims 25-27 and 29-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.
The restriction requirement is deemed proper and is made FINAL.
Priority
3. This application is a 371 of International Application No. PCT/US2022/028143 filed on May 06, 2022. The Office acknowledges receipt of Applicant’s domestic priority documents Provisional Application No. 63/188,622 filed on May 14, 2021 and Provisional Application No. 63/326,383 filed on April 01, 2022.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on November 03, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered to the extent of the English translations provided.
Specification
5. The disclosure of the specification is objected to because of the following:
Paragraph [8] contains a typographical error; “1/2” should be inserted between “7 and” and “half weeks”.
Appropriate correction is required.
Claim Objections
6. Claims 4 and 20 are objected to because of the following:
Claims 4 and 20 contain the same grammatical error; it is suggested Applicant insert the word “stage” between “flowering” and “twice”. Alternatively, it is suggested Applicant delete “a” from between “reaches” and “flowering”. It is recommended Applicant amend the claim as most appropriate.
Applicant is advised that should claim 4 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 23 contains a grammatical and/or typographical error; it is recommended Applicant delete the article “a” from between “from” and “Streptomyces”. As written, the claim implies there are multiple species named “Streptomyces sp. Strain A19249”.
Claim 23 contains a grammatical error; it is standard in the biological arts to italicize the formal names of genera and species. Accordingly, it is recommended Applicant italicize “Streptomyces”.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
7. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
8. Claims 23-24 are rejected 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.
The metes and bounds of claims 23-24 are indefinite because it is unclear if Applicant intends to encompass a single, specific cholesterol oxidase gene (i.e., the choM cholesterol oxidase from Streptomyces sp. Strain A19249, found at GenBank Acc. No. A19124)[61] or any cholesterol oxidase gene present in Streptomyces sp. Strain A19249. Corbin et al. (Appl Environ Microbiol. 1994; 60(12):4239-4244 (V)) describes a “choM” gene which encodes a 547 amino acid protein in Streptomyces sp. strain A19249 (Abstract). Though the specification states the recited cholesterol oxidase can be a choM from Streptomyces sp. strain A19249[3],[61], the claims are not limited or restricted to any exemplary embodiments described in the specification and the claim does not recite choM or any specific cholesterol oxidase from Streptomyces sp. strain A19249. The sequence and structure of the claimed cholesterol oxidase is unknown and renders the claims indefinite.
The metes and bounds of claim 24 are indefinite because it is unclear what sequence is represented by “GenBank Accession No. A19124”, because no such “GenBank Accession No. A19124” was discovered during the Examiner’s search of the art. If Applicant intends to recite the cholesterol oxidase(s) present in Streptomyces sp. Strain A19249 as suggested in paragraph [61] of the specification, it is recommended Applicant amend claim 24 to mirror the language recited in claim 23 when defining the claimed oxidase.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
9. 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.
Written Description
10. Claims 1, 2-5, 20, 22-24, and 28 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.
The independent claim is directed broadly to a method for increasing production in a crop plant comprising obtaining a crop plant wherein a chloroplast of said plant has a cholesterol esterase. The independent claim is broad and encompasses both any plant and any cholesterol esterase. The recitations encompassing any plant, and any cholesterol esterase lack adequate written description.
Applicant describes the Streptomyces sp. Strain A19249 cholesterol oxidase found at GenBank Accession No. A19124[3] as well as several other cholesterol oxidases[61]. However, Applicant does not provide the sequences for said cholesterol oxidases. Applicant also describes the accumulation of starch in the leaves[128-129], increased growth and/or biomass[135], reduced time to flowering[135] of transgenic tobacco expressing undisclosed chloroplast-targeted cholesterol oxidases.
Issue #1: Applicant has not described the sequence or structure of the recited chloroplast-targeted cholesterol oxidase or any cholesterol oxidase sufficient for increasing the production of starch, a root biomass, a leaf biomass, a number of flowers, a number of seeds, or a total biomass.
As stated above, claim 1 is broad and encompasses any and all cholesterol oxidases. The state of the art indicates at least 12 distinct bacterial cholesterol oxidases (MacLachlan et al., Journal of Steroid Biochemistry and Molecular Biology. 2000; 72(5):169-195 (U)), the specification indicates the presences of roughly 30 naturally-occurring cholesterol oxidases[61], and a search for “cholesterol oxidase” in the Uniprot database reveals over 100 proteins annotated as cholesterol oxidases (or synonymous names) found in bacterial, fungal, mammalian, and plant species (see Uniprot search notes). Furthermore, the state of the art (Corbin et al., Plant Physiology. 2001; 126(3):1116–1128 (Applicant’s IDS)) teaches that expressing a chloroplast-targeted cholesterol oxidase in transgenic tobacco may not result in any enhanced or improved growth phenotypes in comparison to an untransformed tobacco plant (Abstract; pp. 1119-1120, “Phenotypic Characterization of Transgenic ChoM Tobacco Plants”).
The state of the art does not teach the ubiquity of cholesterol oxidases in enhancing growth phenotypes or starch accumulation when localized to the chloroplast of a crop plant. Applicant’s Examples do not indicate the structure of the recited cholesterol esterase that is allegedly capable of conferring the claimed phenotypes when located in the chloroplast of a crop plant. Therefore, Applicant has not described sufficient structural features that would allow one of skill in the art to distinguish the claimed cholesterol esterase from those insufficient for or incapable of conferring the claimed phenotypes. While one skilled in the art at the time of filing can express virtually any cholesterol oxidase in the chloroplast of virtually any crop plant, one skilled in the art cannot predict, from neither Applicant’s disclosure or the teachings of the prior art, which cholesterol oxidases will confer the desired phenotype to a crop plant when located in the chloroplasts thereof. Thus, the specification does not describe species over the full scope of the claimed protein sequences.
MPEP § 2163 states that the written description requirement for a claimed genus may be
satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by 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 claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within genera, as here in which the recitation of all cholesterol oxidases, one must describe a sufficient variety of species to reflect the variation within the genera. One of skill in this art cannot envision the structure of any other sequences with the required function other than the few species provided by Applicant and the prior art. Therefore, since only a few species are provided to represent the genera, the claims encompassing the same clearly fail the written description requirement. 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.
Dependent claims 2-5, 20, and 28 do not address the limitation regarding all cholesterol oxidases. Thus, these claims also lack adequate written description.
Regarding claims 22-24, though Applicant restricts the scope of the encompassed cholesterol oxidases to those found in actinomyces and Streptomyces species, Applicant does not provide a structure and/or sequence for these enzymes. Accordingly, these claims fail to provide sufficient structure to allow one of skill in the art to readily distinguish the claimed protein from cholesterol oxidases insufficient to confer the claimed phenotypes. Therefore, claims 22-24 also lack adequate written description. Further regarding claim 24: the claim attempts to limit the cholesterol oxidase to having the sequence of GenBank Accession No. A19124. As discussed in the indefinite rejection above, there is no such accession number in GenBank. Note that if a correct accession number was cited, then reference to the GenBank accession would amount to an improper incorporation by reference (paragraph [140] states all publications, patents and patent applications cited herein are incorporated by reference). The sequence in the GenBank accession would be subject matter that is essential to claim 24. Such ‘essential material’ can only be incorporated by reference to a U.S. patent or U.S. patent application publication (37 C.F.R. 1.57(d)).
Issue #2: Applicant has not disclosed cholesterol oxidases shown to increase starch production, plant biomass, flowering, or seed production in all crop plant species.
The independent claim is broad and encompasses all crop plants. As defined by Applicant, “crop plants” refer to any plant cultivated for human or animal consumption or utilization and includes at least 4 dozen distinct plant species from distinct genera[35]. The limitations encompassing all plants lack adequate written description for the reasons below.
Applicant describes the accumulation of starch in the leaves[128-129], increased growth and/or biomass[135], reduced time to flowering[135] of transgenic tobacco expressing undisclosed chloroplast-targeted cholesterol oxidases. Applicant does not disclose the structure of the recited enzymes. Applicant does not disclose the expression of any cholesterol oxidase in any plant besides tobacco.
As stated above, the state of the art does not teach the ubiquity of cholesterol oxidases in enhancing starch production, flowering, or growth when expressed or localized in tobacco chloroplasts (Corbin et al., Plant Physiology. 2001; 126(3):1116–1128 (Applicant’s IDS)). Applicant does not disclose or describe any features of the cholesterol oxidase(s) recited in the Examples as being responsible or sufficient for conferring the desired growth phenotypes in a crop plant. Thus, the specification does not describe species over the full scope of the claimed crop plants. Given the large number of cholesterol oxidases (see above) and the physiological variability present in over 48 plant species, one of ordinary skill in the art could not predict, with any reasonable expectation of success, which of the encompassed cholesterol oxidases will provide the claimed phenotype in any crop plant. Thus, Applicant has not described sufficient relevant identifying characteristics to allow one of ordinary skill in the art to predictably determine which crop plants will exhibit the desired growth phenotypes when the chloroplast of said plant contains a cholesterol oxidase. 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.
Dependent claims 2-5, 20, 22-24, and 28 do not address the limitation regarding all crop plants. Therefore, claims 2-5, 20, 22-24, and 28 also lack adequate written description.
Enablement
11. Claims 1, 2-5, 20, 22-24, and 28 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 the choM cholesterol oxidase from Streptomyces sp. strain A19249, does not reasonably provide enablement for all cholesterol oxidases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
When determining whether a claimed invention complies with the enablement requirement, factors to consider include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above.
The claimed invention is not enabled for the following reasons.
Applicant provides only one working example of transgenic tobacco plants engineered to express a chloroplast-localized cholesterol oxidase (see: Examples 1-3). Applicant provides only one working example of plants comprising chloroplast-localized cholesterol oxidase wherein the plant is grown under suitable conditions wherein the plant increases production of a starch, a root biomass, a leaf biomass, a number of flowers, a number of seeds, or a total biomass compared to a wild-type crop plant[129], [135-136], [138-139].
Issue #1: Applicant provides no guidance as to the structure of recited chloroplast-localized cholesterol oxidase or the sequence encoding it.
Issue #2: Applicant provides insufficient guidance regarding the growing conditions “suitable” for yielding the claimed phenotypes in any crop plant expressing the chloroplast-localized cholesterol oxidase.
The specification describes plants grown indoors at “20%” of outdoor light intensity (see: Example 3) and plants grown outdoors under natural sunlight (see: Example 4). In neither case does the specification describe the light intensity or duration in discrete units (e.g., lux, lumens, etc.), nor does the specification describe the temperature, humidity, or watering conditions. The state of the art teaches that transgenic tobacco plants expressing a chloroplast-localized cholesterol oxidase may exhibit indistinguishable growth phenotypes when compared to plants lacking said oxidase (pp. 1119-1120, “Phenotypic Characterization of Transgenic ChoM Tobacco Plants”; Corbin et al., Plant Physiology. 2001;126(3):1116–1128 (Applicant’s IDS)). This example teaches that not all growing conditions are suitable and/or not all chloroplast-localized cholesterol oxidases are sufficient for producing improved or increased growth characteristics in transgenic plants comprising said oxidase. Furthermore, the crop plants encompassed by the scope of the claims (e.g., cotton, rice, orchids, etc.) require distinct environmental and growth conditions for optimal growth. Thus, one of ordinary skill in the art could not predict which cholesterol oxidases are required or sufficient to confer the claimed phenotypes nor could one predict the growth conditions required to achieve said phenotypes in view of the teachings of Corbin. Because Applicant provides insufficient guidance regarding the sequence/structure of the claimed cholesterol oxidases and insufficient guidance regarding the conditions suitable to achieve the claimed growth phenotypes, one of ordinary skill in the art could not predict which cholesterol oxidases or conditions are required or sufficient to produce the instant invention without engaging in extensive and undue experimentation. The effects of unknown cholesterol oxidases on unknown plants under unknown conditions are not predictable in view of the prior art and Applicant’s disclosure. Thus, claim 1, directed to a method encompassing any cholesterol oxidase in any plant under unknown conditions is not enabled.
In making this determination, the Office has weighed each of the Wands factors. The breadth of the claims is to a method of increasing crop production in a plant. The nature of the invention comprises a chloroplast-localized cholesterol oxidase. The level of one of ordinary skill in the plant biotechnology art is high. The state of the prior art does not teach chloroplast-targeted cholesterol oxidases as increasing, improving, or enhancing the claimed growth phenotypes. Applicant does not describe the structure and/or sequence of any cholesterol oxidases sufficient for conferring the claimed phenotypes. Applicant does not sufficiently describe the growth conditions suitable or required for the claimed phenotypes. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all of the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Dependent claims 2-5, 20, 22-24, and 28 do not address the limitation regarding all crop plants. Dependent claims 2-5, 20, and 28 do not address the limitation regarding the structure of the claimed cholesterol oxidase. Though dependent claims 22-23 limit the claimed oxidase to those present in actinomycetes species and Streptomyces sp. Strain A19249, neither claim nor the prior art provides a structure for the recited oxidase. Due to the reason described in the indefinite rejection of claim 24 under 35 U.S.C. 112(b), claim 24 also fails to provide sufficient structure to the claimed oxidase. Finally claims 2-5, 20, 22-24, and 28 fail to provide sufficient structure or description to the growth conditions required to achieve the claimed phenotypes. Therefore, claims 2-5, 20, 22-24, and 28 are also not enabled.
12. Claims 1-5, 20, 22-24, and 28 are rejected under 35 U.S.C. 112(a), because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention, because the specification does not provide evidence that the claimed biological materials are (1) known and readily available to the public; and (2) reproducible from the written description.
It is unclear if the cholesterol oxidase suitable for increasing production in a crop plant is known and publicly available or can be reproducibly isolated without undue experimentation. The specification fails to present the exact sequence of the same. Therefore, a suitable deposit for patent purposes is suggested. Without a publicly available deposit of the above expression vector, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Without knowing the structure and sequence of the claimed cholesterol oxidase, exact replication of: (1) the claimed protein; and/or (2) the claimed protein’s amino acid sequence is an unpredictable event.
Regarding claim 23, Corbin et al. (Appl Environ Microbiol. 1994; 60(12):4239-4244 (V)) describes a “choM” gene which encodes a 547 amino acid protein in Streptomyces sp. strain A19249 (Abstract). Though the specification states the recited cholesterol oxidase can be a choM from Streptomyces sp. strain A19249[3],[61], the claims are not limited or restricted to any exemplary embodiments described in the specification and the claim does not recite choM or any specific cholesterol oxidase from Streptomyces sp. strain A19249. Therefore, the structure and sequence of the claimed cholesterol oxidase is unknown and exact replication of: (1) the claimed protein; and/or (2) the claimed protein’s amino acid sequence is an unpredictable event.
Regarding claim 24, the sequence of “GenBank Accession No. 19124” is indefinite as discussed above in the rejection of the claims under 35 U.S.C. 112(b). Therefore, the structure and sequence of the claimed cholesterol oxidase is unknown and exact replication of: (1) the claimed protein; and/or (2) the claimed protein’s amino acid sequence is an unpredictable event.
If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request: (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application: (c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
Currently there is no mention of any deposit under the Budapest treaty in the specification. Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Claim Rejections - 35 USC § 102
13. 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.
14. Claims 1-5, 20, 22-24, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corbin et al. (Plant Physiology. 2001; 126(3):1116–1128 (Applicant’s IDS); hereinafter “Corbin 2001”) as evidenced by Corbin et al. (Appl Environ Microbiol. 1994; 60(12):4239-4244 (V); hereinafter “Corbin 1994”), in view of Stevens et al. (Pesticides - Advances in Chemical and Botanical Pesticides. 2012; 12:269-308 (W)), and further in view of Heyer et al. (Phytochemistry. 2004; 65(22): 2967-2976 (X)).
Regarding claim 1, Corbin 2001 teaches a method for obtaining a crop plant, comprising the steps of: obtaining a tobacco crop plant wherein the chloroplast of the crop plant has a Streptomyces cholesterol oxidase, that transgenic plants expressing said chloroplast-targeted cholesterol oxidase maintained a greater accumulation of stanols (Abstract; Materials and Methods), and that cholesterol oxidase has potent activity of the cotton boll weevil Anthonomus grandis (p. 1120, “Insecticidal Activity of ChoM-Expressing Transgenic Plants”).
Corbin 2001 is silent to increasing production of starch, biomass, flowers, or seeds in said plant.
However, Stevens teaches the use of Streptomyces cholesterol oxidase as a botanical pesticide that inhibits growth of Heliothis virescens, H. zea, Pectinophora gossypiella, and cotton boll weevil (p. 272, Table 1).
Additionally, Heyer teaches that the action of a 3-hydroxysteroid oxidase enzyme within transgenic tobacco facilitates enhanced accumulation of sterol, 3-ketosteroid and stanol, wherein said enhanced steroid pool correlates directly with altered thylakoid membrane-associated biochemical processes, in which the in vitro rate of whole chain photosynthetic electron transport is enhanced (p. 2974, Table 5; pp. 2973-2974, “2.4. The modulation of photosynthetic electron transport capacity in chloroplasts obtained from transgenic plants expressing a 3-hydroxysteroid oxidase”) and suggests that the phenotypes of plants expressing a chloroplast-targeted cholesterol oxidase may differ under varying environmental conditions (p. 2970, left column, first full paragraph). The Office notes 3-hydroxysteroid oxidase is an alternative name for the cholesterol oxidase described by Corbin 2001 as disclosed by Heyer (p. 2970, left column, first full paragraph).
The combination of Corbin 2001, Stevens, and Heyer teaches a method for obtaining a crop plant, comprising the steps of: obtaining a tobacco crop plant wherein the chloroplast of the crop plant has a Streptomyces cholesterol oxidase and growing the plant under suitable conditions wherein the crop plant increases a root, leaf, or total biomass compared to a wild-type crop plant.
The level of ordinary skill in the plant biotechnology art is high as evidenced by Corbin 2001, Stevens, and Heyer. It would have been prima facie obvious for one of ordinary skill in the art, at the time of the effective filing date, to express the cholesterol oxidase taught by Corbin 2001 in the chloroplast of a crop plant. One of ordinary skill would have been motivated to do so for reasons disclosed by Corbin 2001, Stevens, and Heyer prior to the effective filing date of the instant application. For example, Corbin 2001’s and Steven’s disclosures that cholesterol oxidase has potent insecticidal activity against the cotton boll weevil and other insect pests provides sufficient motivation for one of ordinary skill to express a chloroplast-targeted cholesterol oxidase in a crop plant to increase said plant’s resistance to insects. In increasing a plant’s resistance to insect pests, the expression of a chloroplast-targeted cholesterol oxidase would increase the biomass of said plant by reducing the amount of the plant consumed by the pest. Additionally, both Corbin 2001 and Heyer disclose an increased accumulation of sterols and stanols in plants expressing a chloroplast-targeted cholesterol oxidase and Heyer teaches that said increase in sterols and stanols correlates to increased rates of photosynthetic activity. Accordingly, one of ordinary skill in the art would be motivated to express a chloroplast-targeted cholesterol oxidase in a crop plant to increase the photosynthetic activity of said plant. In increasing a plant’s photosynthetic activity, the expression of a chloroplast-targeted cholesterol oxidase would increase the biomass of said plant. Thus, the combination of Corbin 2001, Stevens, and Heyer provides motivation for one of ordinary skill in the art to express a chloroplast-localized cholesterol oxidase in a crop plant to increase said plant’s photosynthetic activity and resistance to insect pests, which would inherently result in the increased growth and/or biomass of said plant. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Regarding claim 2, the teachings of Corbin 2001 are as discussed above. Corbin 2001 is silent to the growing the plant at a silent that would not be suitable for a crop plant.
However, as stated above, the combined teachings of Corbin 2001, Stevens, and Heyer teaches that expressing a chloroplast-targeted cholesterol oxidase enhances photosynthetic capacity under suitable environmental conditions. Furthermore, the presence of environmentally controlled plant growth chambers allows the growth of virtually any plant at any latitude; the claim does not require the claimed plant be grown outside. Therefore, the combination of Corbin 2001, Stevens, and Heyer renders obvious this claim limitation.
Regarding claim 3, the teachings of Corbin 2001 are as discussed above. Corbin is silent to the lighting conditions under which the plants are grown.
However, Heyer teaches tobacco plants growth under artificial lighting conditions (p. 2975, (“3.1. Tobacco transformation and plant growth”).
The claims do not define “light limiting conditions” and the specification does not provide a definition for “light limiting conditions”. The specification describes plants grown indoors with about 20% of outdoor light intensity[133]; however, the specification provides no reference by which one could determine what said outdoor light intensity may be. Thus, the term “light limiting conditions” is broad and is herein interpreted to comprise conditions under which the plants are grown indoor under artificial light for the purpose of compact prosecution. Thus, the combination of Corbin 2001, Stevens, and Heyer teach this claim limitation. Applicant is respectfully requested to clarify the intended recitation and is reminded that no new matter may be added.
Regarding claims 4 and 20, the teachings of Corbin 2001 are as discussed above. While Corbin 2001 is silent to the flowering rate of the crop plants, the phenotype of a plant is determined by its genetics and growth conditions. Therefore, the claimed flowering phenotype is inherent to the plant taught by Corbin 2001 in view of the teachings of Stevens and Heyer.
Regarding claim 5, the teachings of Corbin 2001 are as discussed above. Growing a crop plant for a plurality of crop cycles is routine in the art and well-within the means of one of ordinary skill. Therefore, this limitation is obvious in view of the cited art.
Regarding claims 22-23, in addition to the teachings discussed above, the cholesterol oxidase taught by Corbin 2001 is from the actinomycete Streptomyces sp. strain A19124 (p. 1116, first full paragraph). See: Corbin et al. (Appl Environ Microbiol. 1994; 60(12):4239-4244 (U)), which describes a “choM” gene which encodes a 547 amino acid protein in Streptomyces sp. strain A19249 (Abstract).
Regarding claim 24, the recitation of the “sequence of GenBank Accession No. A19124” is indefinite as discussed above in the rejection of the claims under 35 U.S.C. 112(b). However, the specification describes this sequence as corresponding the to choM cholesterol oxidase from Streptomyces sp. strain A19249[3],[61]. For the purpose of compact prosecution, the sequence of GenBank Accession No. A19124 is herein interpreted to comprise the sequence of the Streptomyces sp. strain A19249 choM cholesterol oxidase. Accordingly, this limitation is taught by Corbin 2001, as discussed immediately above in the rejection of claims 22-23.
Regarding claim 28, the teachings of Corbin 2001 are as discussed above. While Corbin 2001 is silent to the maturity rate of the crop plants, the phenotype of a plant is determined by its genetics and growth conditions. Therefore, the claimed maturing phenotype is inherent to the plant taught by Corbin 2001 in view of the teachings of Stevens and Heyer.
Conclusion
15. No claim is allowed.
Examiner’s Contact Information
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663