DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
1. Claims 1-5 and 28 are pending and under examination on the merits. The status identifiers for claims 2-3 are incorrect; the claims have been rejoined and are 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Claims 25-27 and 29-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6-24 are cancelled.
Response to Arguments – Objections to the Specification
2. Applicant’s arguments and amendments filed May 11, 2026 have not addressed the objection of record. Therefore, the objection is maintained.
Objections to the Specification
3. 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.
Response to Arguments – Claim Objections
4. Applicant’s arguments and amendments filed May 11, 2026 have overcome the objections of record.
Claims 20 and 23 have been cancelled; therefore, any objections to these claims have been rendered moot.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
5. Claims 23-24 have been cancelled; therefore, any rejections to these claims have been rendered moot.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 1-5 and 28 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 1-2 are indefinite because it is unclear what conditions are encompassed by the recitation of “suitable conditions”. Applicant has not provided a clear definition for said conditions and one of ordinary skill in the art could not reasonably predict what conditions are required to satisfy the claimed “suitability”.
The metes and bounds of claim 3 are indefinite because it is unclear what conditions are encompassed by a “light limiting condition”. The claims do not define a “light limiting condition” and the specification does not provide a definition for a “light limiting condition”. 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 condition” is unclear and is herein interpreted to comprise conditions under which the plants are grown indoor under artificial light for the purpose of compact prosecution. Applicant is respectfully requested to clarify the intended recitation and is reminded that no new matter may be added.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
8. Applicant’s arguments and amendments filed May 11, 2026 have overcome the Written Description rejections of record but are insufficient to overcome the rejections regarding the lack of enablement. Claims 23-24 have been cancelled; therefore, any rejections to these claims have been rendered moot.
Written Description
9. Applicant’s amendments limiting the scope of claim 1 to the choM cholesterol oxidase from Streptomyces sp. Strain A19249 provides adequate written description regarding the structure of the encompassed oxidase. Applicant’s remarks (p. 06, second paragraph under “III. Claim Rejections Under 35 U.S.C. 112(a)”) indicate the recited choM cholesterol oxidase is limited to a single structure/polypeptide sequence obtained from Streptomyces sp. Strain A19249. The Examiner notes that the choM cholesterol oxidase from Streptomyces sp. Strain A19249 is interpreted to be limited to the sequence taught by GenBank Accession No. U13981.1 (GenBank, NCBI. 1995; Accession No. U13981.1, Streptomyces A19249 cholesterol oxidase (choM) gene, complete cds (U)). If the Examiner’s interpretation regarding the structure/sequence of the choM cholesterol oxidase is incorrect, it is recommended Applicant clarify the structure of the encompassed sequence(s).
Enablement
10. Applicant’s arguments regarding the lack of enablement have been fully considered but are not persuasive and do not overcome all of the rejections of record.
Regarding the lack of enablement due to insufficient guidance regarding the structure of the recited chloroplast oxidase and/or the sequence encoding it, Applicant’s amendments limiting the scope of the encompassed structures/sequences to the choM cholesterol oxidase from Streptomyces sp. Strain A19249 are sufficiently enabling.
However, even though Applicant acknowledged the enablement rejection regarding growing conditions suitable for yielding the claimed phenotypes, Applicant has not provided any argument articulating any supposed errors in said rejection. Accordingly, the enablement rejection is maintained.
Claim Rejections - 35 USC § 112(a)
11. 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.
Enablement
12. 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 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. Applicant provides insufficient guidance regarding the growing conditions “suitable” for yielding the claimed phenotypes in any crop plant expressing the chloroplast-localized cholesterol oxidase.
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 in the Non-Final Rejection dated February 11, 2026 (p. 06, first full paragraph) and will be summarized herein as necessary.
Applicant describes the Streptomyces sp. Strain A19249 cholesterol oxidase found at “GenBank Accession No. A19124”[3] as well as several other cholesterol oxidases[61]. 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.
The claimed invention is not enabled for the following reasons.
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 specification also does not describe the conditions under which Applicant identified the accumulation of starch in the leaves of transgenic plants engineered to express cholesterol oxidase in chloroplasts (Examples 1-2). 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 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 and 28 fail to provide sufficient structure or description to the growth conditions required to achieve the claimed phenotypes. Therefore, claims 2-5, 20, and 28 are also not enabled.
Response to Arguments – Claim Rejections - 35 USC § 102
13. Applicant’s remarks and amendments filed May 11, 2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 USC § 102.
Claim Rejections - 35 USC § 102
14. 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.
15. Claims 1, 4, 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 GenBank ACCESSION No. U13981.1 (NCBI. 1995. ACCESSION No. U13981.1; Streptomyces A19249 cholesterol oxidase (choM) gene, complete cds (U)).
Corbin 2001 discloses transgenic tobacco plants expressing a chloroplast-targeted ChoM cholesterol oxidase maintained a greater accumulation of stanols (Abstract; Materials and Methods) and demonstrated potent activity against the cotton boll weevil Anthonomus grandis (p. 1120, “Insecticidal Activity of ChoM-Expressing Transgenic Plants”). The Office notes that the ChoM cholesterol oxidase disclosed by Corbin 2001 ((p. 1125, “Cholesterol Oxidase Genes”, first sentence) is the ChoM cholesterol oxidase from Streptomyces sp. Strain A19249 (see attached GenBank sequence for Streptomyces A19249 cholesterol oxidase (choM) gene; NCBI, 1995 (U)).
Regarding claim 1, Corbin 2001 teaches a method for increasing production in a crop plant, comprising the steps of: obtaining a tobacco crop plant wherein the chloroplast of the crop plant has a cholesterol oxidase (Abstract), wherein the cholesterol oxidase is ChoM from Streptomyces sp. Strain A19249, wherein the crop plant is selected from the group consisting of a potato, a tomato, a pepper, an eggplant, a chili, and tobacco; and growing the crop plant under conditions wherein the crop 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. In increasing a plant’s resistance to insect pests, the expression of a chloroplast-targeted cholesterol oxidase increases the total biomass of said plant by reducing the amount of the plant consumed by pests (p. 1120, “Insecticidal Activity of ChoM-Expressing Transgenic Plants”; Corbin 2001). Furthermore, it is known in the art that increasing the concentration of stanols in a plant correlates to increased rates of photosynthetic activity in said plant (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”; as evidenced by Heyer et al., Phytochemistry. 2004; 65(22):2967-2976 (previously cited)). Even though the effect of stanol accumulation on plant growth was not described at the time of publication of Corbin 2001, said effect (i.e., increased photosynthetic activity) is inherent to said accumulation and an inherent feature need not be recognized at the time of disclosure to support a rejection based on anticipation (see MPEP 2112.II).
Regarding claim 4, 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.
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.
Accordingly, the claimed invention is anticipated by the prior art.
Response to Arguments – Claim Rejections - 35 USC § 103
16. Applicant’s remarks and amendments filed May 11, 2026 have necessitated new grounds of rejection under 35 USC § 103.
Claim Rejections - 35 USC § 103
17. 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.
18. Claims 2, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Corbin et al. (Plant Physiology. 2001; 126(3):1116-1128 (Applicant’s IDS); hereinafter “Corbin 2001”), as applied to claims 1, 4, and 28 above, in view of of Stevens et al. (Pesticides - Advances in Chemical and Botanical Pesticides. 2012; 12:269-308 (previously cited)), and further in view of Heyer et al. (Phytochemistry. 2004; 65(22):2967-2976 (previously cited)).
The teachings of Corbin 2001 are as discussed above in the rejection of claims 1, 5, and 28 under 35 U.S.C. 102(a)(1). The recitation of “suitable conditions” is indefinite, as discussed above in the rejection of the claims under 35 U.S.C. 112(b). For the purpose of compact prosecution herein, “suitable conditions” is interpreted to encompass any growing and/or environmental conditions as would be reasonably understood by one of ordinary skill in the art.
Regarding claim 2, the teachings of Corbin 2001 are as discussed above. Corbin 2001 is silent to growing the plant at a latitude that would not be suitable for a crop 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 (Abstract; p. 272, Table 1).
Additionally, Heyer teaches tobacco plants growth under artificial lighting conditions (p. 2975, (“3.1. Tobacco transformation and plant growth”) and 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”). Heyer also 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.
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 cholesterol oxidase, wherein the cholesterol oxidase is choM from Streptomyces sp. Strain A19249, wherein the crop plant is a tobacco plant, 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, and wherein the suitable conditions includes growing the crop plant at a latitude that would not be suitable for 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 and to grow said plant under at any latitude. 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. 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 and Steven disclose that cholesterol oxidase has potent insecticidal activity against the cotton boll weevil and other insect pests, which is 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 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 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.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Conclusion
19. No claim is allowed.
Examiner’s Contact Information
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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