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
Applicant’s election without traverse of Group I (claims 1-5) in the reply filed on August 14th, 2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election requirement is still deemed proper for the reasons of record and is therefore made FINAL.
Claims 1-12 are pending of which claims 6-12 (Group II and claims 11 and 12 reciting dependency to claim 10) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to (a) nonelected invention(s), there being no allowable generic or linking claim.
Pending claims 1-5 have been examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on July 26, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is February 4th, 2020.
Information Disclosure Statement
The information disclosure statements filed February 1, 2023 and December 22, 2025 fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of missing documents (see crossed out references on each IDS). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
JP ‘199469 is re-listed on the PTO-892 to correct a typographical artifact regarding the foreign document number.
Please note the annotation to the Non-Patent Literature Document 1 on IDSs submitted on July 26th, 2022 and February 1st, 2023.
Drawings
The drawings were received on July 26th, 2022 and August 14th, 2023. These drawings are acceptable.
Claim Rejections - 35 USC § 112
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 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: in claim 1 step b: the volume/volume ratio of 1-10 mM phytic acid added to the mixture obtained in step a, or a target concentration of phytic acid in the mixture that can be used to calculate said volume/volume ratio. From the language of claim 1 step b, the examiner understands that 1-10 mM phytic acid is added to the mixture. If the applicant wishes to recite the target concentration of phytic acid in the mixture after the addition of phytic acid, then the applicant must do so explicitly.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 step e) recites the broad recitation pH between 6 and 8, and the claim also recites “preferably” between 6 and 6.5 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claims 2-5, it is unclear what is the characteristic referred to in the process. What is meant by “characterised” in the process step? What characteristic of the process? Suggest, removing the word “characterised” and reciting in the affirmative the process in step a) or step b) or step e) or the lavender aerial parts are of the species Lavandula angustifolia in the respective dependent claims.
Claim Rejections - 35 USC § 103
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Oger et al. (US-20180371000-A1), and further in view of Graf (JAOCS 1983, 60 (11), 1861-1867).
Independent instant Claim 1 recites:
“A process for obtaining an aqueous extract of lavender aerial parts, comprising the following steps a) bringing the lavender aerial parts into contact with water; b) adding phytic acid at a concentration of between 1 and 10 mM to the mixture obtained in a) at a pH of between 10 and 11; c) then adjusting the pH of the mixture obtained in b) to a value of between 6 and 8; d) purifying the mixture obtained in c) so as to eliminate the residual solid plant matter and obtain a purified aqueous crude extract; and e) checking the pH and readjusting it if necessary to a value between 6 and 8, preferably between 6 and 6.5”.
Dependent instant Claim 2 recites the lavender aerial parts are dried and then ground, before contacting water in a plant material/water ratio of between 3 and 20% (weight/weight). Dependent instant Claim 3 recites “step b) treatment with phytic acid at a concentration of 3 mM is carried out with stirring for a time of at least 1 hour and at a temperature of between 20 and 80°C”. Dependent instant Claim 4 recites “step e) is preceded by at least one filtration of the aqueous crude extract obtained in d) and preferably by successive filtrations of the aqueous crude extract by lowering the filtration threshold from 20-50 m to 0.10-0.30 m”. Dependent instant Claim 5 recites the lavender aerial parts are of the species Lavandula angustifolia.
Oger et al. recites:
“A method for obtaining an aqueous extract enriched with small RNA having a maximum length of 150 nucleotides, from plant material, comprising the following steps: a) the plant material is put in contact with water; b) tetrasodium ethylenediaminetetraacetic acid (EDTA) is added to the mixture obtained in a) at a pH between 10.5 and 11; c) then, the pH of the mixture obtained in b) is adjusted to a value between 6 and 8; d) the mixture obtained in c) is purified to eliminate the residual solid plant material and to obtain a purified aqueous raw extract; and e) the pH is checked and readjusted if necessary to a value between 6 and 8” (Oger et al., claim 1; instant claim 1).
Oger et al. further recites for step e) that the pH is readjusted to between 6 and 6.5 (Oger et al., claim 21; instant claim 1).
Although the use of phytic acid in the above method is not explicitly taught by Oger et al., Oger et al. recites that the tetrasodium ethylenediaminetetraacetic acid (EDTA) added in this step is useful in the extraction procedure because of its ability to complex with divalent ions such as calcium. Oger et al. recites:
“The tetrasodium EDTA will weaken and destructure the pecto-cellulose membranes of the plant cells by sequestering by complex formation of the divalent ions such as the calcium ions which form ionic bridges between the pectin molecules surrounding the cellulose microfibrils. The consequence of this is to promote the release of the cell content during the extraction. The step of treatment with EDTA is essential for enriching the extract with low molecular weight RNA. The step of treatment with EDTA lasts preferably at least 1 h, at a temperature between 20 and 80° C. During this step, the mixture obtained in a) is advantageously stirred” (Oger et al., Description, paragraphs [0045] and [0046]; instant claims 1 and 3).
Phytic acid would have been obvious to try an alternative to EDTA, because phytic acid is also able to complex with divalent ions such as calcium (Graf, Uses in Food Industry, paragraph 3, and Medical Applications, paragraph 5; instant claims 1 and 3).
Concerning the concentration range of EDTA, Oger et al. recites “The method according to claim 1, wherein the concentration of tetrasodium EDTA is between 2 and 15 mM” (Oger et al., claim 9) .The instantly claimed phytic acid concentrations of 1-10 mM (instant claim 1 step b) and 3 mM (instant claim 3) overlap with or fall within the EDTA concentration range recited by Oger et al. If not obvious to try over Oger et al., the concentrations of phytic acid recited in instant claims 1 and 3 would have been obvious over routine optimization. A routine optimization procedure can involve measuring the mass of solid phytic acid with a balance and preparing the phytic acid solution using volumetric glassware to control phytic acid concentration, running the extraction procedure recited by Oger et al. using phytic acid instead of EDTA, and measuring the resulting low molecular weight RNA concentration and extraction yield (instant Figure 2, instant specification, paragraphs [22], [70], and [71]).
Although lavender plant materials such as those from Lavandula angustifolia are not explicitly recited by Oger et al., they within the range of plant materials recited by Oger et al. for the extraction method: The invention relates to a method implemented for obtaining an aqueous extract enriched with small RNA having a maximum length of 150 nucleotides, from plant material. … In general, plant material is a plant, a living organism which is part of the plant kingdom, characterized by a very low motility, which feeds on mineral substances and absorbs carbon dioxide, including plants whose life cycle generally takes place in an aquatic environment, such as algae” (Oger et al., Description, paragraphs [0029] – [0031]; instant claims 1 and 5). The aerial parts of lavender are understood to include stems, flowers, and seeds (instant specification, paragraph [26]). These aerial parts are also within the range of plant materials recited by Oger et al.: “Advantageously, for the implementation of the method, the plant material according to the invention is a whole plant or preferably a plant part (fruit, leaves, roots, bulbs, germs, seeds . . . )” (Oger et al., Description, paragraph [0032]; instant claims 1 and 5). Furthermore, Oger et al. recites examples of plant taxonomic families from which the seeds can originate: “The seeds can also be used as starting plant material for obtaining an aqueous extract enriched with low molecular weight RNA. … For information and in a non-limiting manner, these seeds can originate from plants of the family of the Chenopodiaceae, … or of the Lamiaceae”(Oger et al., Description, paragraph [0035]). Lamiaceae is broadly understood in the art as the family to which the lavender species Lavandula angustifolia belongs. Therefore, it would have been obvious to try applying the extraction method recited by Oger et al. to the seeds (an aerial part) of the lavender species Lavandula angustifolia (instant claims 1 and 5).
Oger et al. recites “The method according to claim 1, wherein in step a), plant material is put in contact with water in a plant material/water ratio from 4 to 20% (weight/weight)” (Oger et al., claim 2; instant claim 2) and “The method according to claim 1, wherein the plant material is crushed before being put in contact with water in step a)” (Oger et al., claim 10; instant claim 2), where crushing and grinding are both broadly understood as compressing and breaking a material (instant claim 2). Grinding the plant material before contacting with water would be obvious to one of skill in the art because grinding would increase the surface-area to volume ratio of the plant material making the plant material more accessible to extraction solvent (instant claim 2). Drying the plant material before grinding would also be obvious to one of skill in the art because drying would make the plant material more brittle, enabling grinding into smaller pieces, and increasing the surface-area to volume ratio of the plant material (instant claim 2).
Oger et al. recites “The method according to claim 1, to wherein step e) is preceded by at least one filtration of the aqueous raw extract obtained in d)” (Oger et al. claim 5; instant claim 4) and “The method according to claim 5, wherein the at least one filtration of the aqueous raw extract obtained in d) is performed by successive filtrations of the aqueous raw extract by lowering the filtration cutoff from 20-50 μm to 0.1-0.30 μm” (Oger et al., claim 22; instant claim 4).
Regarding the overlapping ranges presented above between the instantly claimed invention and the referenced invention of Oger et al.: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range)” (MPEP § 2144.05, heading I).
Oger et al. and Graf are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the small molecular weight RNA extraction procedure, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the extraction procedure), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Oger et al. in view of Graf, the invention as a whole, drawn to a small molecular weight RNA extraction procedure as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655