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
Applicant’s election of Group II in the reply filed on 4/2/2026 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)).
The election is made FINAL.
Claim Status
Claims 32-49 are pending.
Claims 32-40 and 43-49 are withdrawn as part of non-elected groups.
Claim 42-42 are being examined.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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.
The Applicant describes at least two embedded hyperlinks and/or other form of browser-executable codes (page 12, line 24 and 27-28).
Claim 41 recites “… at least one extract from a donor plant or a part thereof … wherein said extract comprises small RNAs in a concentration less than 10 mg/L, preferably less than 1 mg/L, more preferably less than 0.1 mg/L…”.
The Applicant does not define the term “extract”. The Examiner interprets the term as “a product (such as an essence or concentrate) prepared by extracting especially a solution (as in alcohol) of essential constituents of a complex material (such as meat or an aromatic plant)”, as per Merriam-Webster dictionary.
The Applicant describes “…said mixture of miRNAs is comprised in an extract obtained from a plant, that is a donor plant, and said miRNAs is not artificial but is endogenously produced by said donor plant, which is preferably a plant that is not genetically modified” (spec, p.2, line 29-31). The Applicant also describes “the application rate or dosage of the mixture of miRNAs is lower than or equal to 50 g/ha, preferably lower than or equal to 5 g/ha, more preferably lower than or equal to 0.5 g/ha, 5 still more preferably lower than or equal to 50 mg/ha wherein the concentration refers to the amount of small RNAs in grams per hectare, or lower than or equal to 100 mg/L, preferably lower than or equal to 10 mg/L, more preferably lower than or equal to 1mg/L, still more preferably lower than or equal to 0.1 mg/L, wherein the concentration refers to the amount of small RNAs in milligrams per Liter” (spec, p.5, line 3-9; p.6, line 27-33).
The Applicant also describes “extracts were prepared starting from different matrices/plant materials, such as several Leguminosae such as peas, soybean, beans, alfa alfa, and others” (spec, p.26, line 5-6) and “in these examples the extracts tested for potential agronomic effects have been obtained from a process that involves treating the plant or part thereof (the starting matrix/material from which small RNAs/miRNAs have to be extracted) for 1-12 hours with bicarbonate solution at a temperature of 50-100 °C and then precipitating the small RNAs with ethanol” (spec, p.26, line 10-13). The Applicant prepared a mixture (which is later termed as “extract) using the purified small RNAs which include any small RNA molecules (including fragmented mRNAs and tRNAs) other than miRNA. The Applicant does not describe quantifying concentration of miRNAs to be less than 10 mg/L in the “said extract” from a donor plant”, as recited in the claims.
The instant description does not provide support or antecedent basis for this limitation “said extract comprises small RNAs in a concentration less than 10 mg/L, preferably less than 1 mg/L, more preferably less than 0.1 mg/L wherein the concentration refers to the amount of small RNAs in milligrams per Liter” (claim 41, line 2-5) under 37 CFR 1.75(d)(1). As discussed above, it is the composition that the specification indicates as comprising small RNAs in concentration of 10 mg/L.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41-42 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.
Regarding claims 42-42, the terms "preferably" and “more preferably” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 42 recites, “said extract is characterized by a ratio between the relative expression level” renders the claim indefinite. The claim does not indicate how the extract is prepared, and therefore the concentrations/amounts of miR4995 and miR482-5p are not necessarily the same as it may be in the “initial” extract from the donor plant. Therefore, it is unclear what is meant by “relative expression level” of the recited miRNAs in the extract.
Claim Rejections - 35 USC § 112(a)
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.
Enablement
Claims 41-42 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 claims 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 Applicant describes that “the extracts (from “Leguminosae plants such as peas, soybean, beans, alfa alfa, and others”) were prepared by using several protocols known for this purpose. In particular, in these examples the extracts tested for potential agronomic effects have been obtained from a process that involves treating the plant or part thereof (the starting matrix/material from which small RNAs/miRNAs have to be extracted) for 1-12 hours with bicarbonate solution at a temperature of 50-100°C and then precipitating the small RNAs with ethanol” (page 26, line 5-13). The extracts contain many inorganic compounds (p. 27, line 14) like chloride, nitrate, phosphate, sulfate, magnesium, calcium, ammonium, potassium and sodium at an average rate of 1-34% (p. 27, line 22-24; p. 28, line 6-7). The extracts also contain many organic compounds like carbohydrates (p. 27, line 25) comprising glucose, xylose, galactose, mannose, ribose, and arabinose at an average rate of 1-30% (p. 28, line 2, line 7). The extracts are expected to contain many different types of RNAs including small RNAs and miRNAs, besides the specific miRNAs recited in the claims.
The Applicant does not describe or provide any guidance on how to quantify the miRNA concentration in the plant extract prepared from a donor plant. As written, claim 41 states that “said extract comprises small RNAs in a concentration less than 10 mg/L”, as opposed to the claimed composition.
Current status of the art also does not provide any guidance on how to measure the concentration of miRNA, more specifically miR4995 and/or miR482-p, in a plant extract. In the absence of further guidance, undue experimentation would be required by one skilled in the art to determine the concentration of miRNA within a plant extract.
Further, the specification does not teach the “agricultural purpose” for the recited miRNAs in the claimed composition. The Applicant describes that “the extracts are tested through in-vitro Vertical Plate bioassay which in this context has been used for a rapid evaluation of a phenotypically evident biological effect/potential/induction” (p. 28, line 14-16) to measure primary root length, fresh and dry plant biomass (p. 28, line 20-22) in Arabidopsis and root growth in corn (p. 29, line 26).
The observed trait(s)/phenotype(s) cannot be ascertained to be the result of the specific miRNAs, as recited in the claims, as opposed to the one or more of the organic and/or inorganic compounds (which can be considered as “co-formulants” and/or “adjuvants”) present in the extracts; especially the nitrate, phosphate and potassium (NPK) compounds which are known to positively influence plant growth.
Moreover, treating the extracts with RNase would degrade all RNA molecules including small RNAs and miRNAs and not just those specific miRNAs recited in the claims. Such a RNase treatment also would not affect the other organic and inorganic compounds in the plant extracts.
Agricultural compositions including plant extracts which invariably contain small RNAs including miRNAs are known to be useful for agricultural purposes and used to improve plant growth in many different plants (Godlewska et al., Plant extracts - importance in sustainable agriculture, 2021, Italian Journal of Agronomy, 16, Issue 2:1851; p. 4, Table 1). However, neither the specification, nor the state of the art at the time of filing, teaches how one skilled in the art would use a composition comprising the recited miRNAs, as the specification does not teach the “agricultural purpose” of the recited miRNAs. In the absence of further guidance, undue experimentation would be required by one skilled in the art to determine how to use the recited miRNAs of the claimed composition.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 41-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and product of nature without significantly more.
The claims are drawn to an agricultural composition comprising at least one extract from a donor plant and co-formulants and/or adjuvants, wherein the extract comprises small RNAs, including at least one miRNA recited in a Markush group (in claim 41). The extract from a plant, and the small RNAs therein, are products of nature. All the small RNAs and the miRNAs including the miR159, miR167, miR169, miR482 (miR482-5p), and miR4995 are known to be present and expressed in naturally occurring plants including naturally occurring wild mulberry plants and the extracts thereof (Jia et al., Identification of the Conserved and Novel miRNAs in Mulberry by High-Throughput Sequencing, 2014, PLoS ONE 9:e104409; p. 2, left column, para 3, line 2; p. 3, right column, para 2, line 6-16; Table 2). These miRNAs are also present in plant extracts. Therefore, the claims encompass a judicial exception. The claims recite the naturally occurring small RNA molecules which is not markedly different from its naturally occurring counterpart because it conveys the same genetic information and present in almost all, if not all naturally occurring plants and extracts thereof.
The claims do not recite an additional element which applies the JE in a particular practical application. Claim 41 in line 2 recites, “useful for agricultural purposes”. However, this recitation indicates an intended use, and does not actually indicate how the claimed composition is being used in a practical application. There is no active step recited in the claims. This judicial exception is not integrated into a practical application because merely placing/applying the product(s) present in a plant extract or describing the product(s) of nature as part of a plant extract does not add a meaningful limitation as it is merely a nominal or token component of the claim and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not recite any additional elements that add significantly more. Claim 41 in lines 3-5 recites that the extract comprises small RNAs in a concentration less than 10 mg/L….less than 0.1 mg/L. The exact amount of the miRNAs in any natural source, e.g., watermelon juice (reads on to “extract”), can be less than 10 mg/L (Liang et al., Effective detection and quantification of dietetically absorbed plant microRNAs in human plasma, 2015, The Journal of Nutritional Biochemistry, 26:505-512; p. 507, Table 2) depending on extraction procedure and/or the dilution factor. Liang et al. describes concentration of specific miRNAs (mostly 21 nucleotide long) including miR159, miR167 and miR169 present in naturally occurring watermelon juice to be 347.49, 25.33 and 12.99 pM, respectively, which translates into about 2.4 µg/L, 0.18µg/L, and 0.091 µg/L, respectively (assuming the molecular weight of a 21 nucleotide long sequence to be 7000). The concentration of all the 18 miRNA molecules present in the watermelon juice is 43695.57 pM (p. 507, Table 2), which translates into about 3.06 mg/L; i.e., less than 10 mg/L. Concentration of less than 10 mg/L encompasses trace amounts of the miRNAs in the extract. The claims do not recite a minimum concentration at which the small RNAs must be present, just that the concentration must be less than 10 mg/L.
Claim 41 recites that the composition comprises “co-formulants and/or adjuvants”. The specification does not limit what may be considered a “co-formulant or adjuvant”. A mulberry extract and the watermelon juice (as described above) comprising various ingredients other than small RNAs and miRNAs, dissolved/suspended in water are interpreted as co-formulants and/or adjuvants. Water can also be considered a co-formulant. Such “agricultural compositions” are not markedly different from the naturally occurring plant extracts, which include fruit juices, containing miRNAs (at a concentration less than 10 mg/L) and other “co-formulants” and/or “adjuvants”. The claimed agricultural composition reads on a natural occurring plant extract itself
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because all the recited miRNA components are naturally occurring in a plant and also present as parts of a composition comprising an extract from the plant.
Regarding claim 42, Jia et al. describes a naturally occurring leaves of a mulberry plant expressing both miR4995 and miR482 including miR482-5p (p. 7, Table 2). The ratio between the relative expression level, described as “reads” by Jia et al., of miR4995 (read in leaf- 10) and miR482 (read in leaf- 23) is about 0.5 (p. 7, Table 2).
Claim Rejections - 35 USC § 102(a)(1)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 41-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jia et al. in evidence of Pritchard et al. (MicroRNA profiling: approaches and considerations, 2015, Nat. Rev. Genet., 13(5): 358-369) and Liu et al. (A method for extracting high-quality total RNA
from plant rich in polysaccharides and polyphenols using Dendrobium huoshanense, PLoS ONE 13:e0196592).
Jia et al describes making an extract from mulberry plants in which miRNAs comprising miR159, miR167, miR169, miR482 (miR482-5p) and miR4996 are present (p. 3, right column, para 2, line 6-16; Table 2). The miRNAs are present in the “agricultural composition” of the plant extract which is used and as described by Jia et al. to isolate the miRNAs (p. 2, left column, para 3, line 10-13) to make small RNA library. Besides the miRNAs, the plant extract would comprise other ingredients, which are interpreted as “co-formulants” and/or “adjuvants” (as described above) that include water, carbohydrate, protein, fatty acids and other elements as present in the plant materials including in leaves, bark and flower, as used and described by Jia et al. (p. 2, left column, Table 2). Such ingredients including water are interpreted as “co-formulants” and “useful for agricultural purposes”.
It is well known in the art that amount of total RNA in a plant sample varies depending on the method and/or the type of plant tissue(s) used. Typically, the concentration of total RNA varies from 54.31 to 585.72 ng/μL (Liu et al, p.4, last para, last 7 lines). It is also known in the art that microRNA represent only a tiny fraction (about 0.01%) of the total RNA (Pritchard et al.; p.3, para 3, line 1). Thus, the concentration of naturally-occurring small RNAs, which include miRNAs, in the mulberry extract as described by Jia et al. would be in the range of 0.054 mg/L to 0.59 mg/L.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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, 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.
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.
/Jay Chatterjee/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
Prosecution Insights