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 .
This office action is in response to amendments received on May 22nd, 2026.
Claims 1-5 are pending and were examined on the merits.
Any objections or rejections not reiterated below are hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) filed May 22nd, 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein for the lined-thought document has not been considered. There is no copy of Non-Patent Literature document 1 in the file history of the instant application, only a copy of supplementary information from that document. The examiner notes the following regarding this IDS:
Certain documents are listed as “References cited in the International Search Report of PCT/US/PCT/EP2021/051734”. Although this listing is incomplete, the two documents cited in the International Search Report of PCT/US/PCT/EP2021/051734 are listed in the Foreign Documents section of the IDS.
The translations of the foreign documents listed on the IDS have been considered. The examiner did not find the original untranslated copies of these documents in the file history.
Non-Patent Literature Document 2 has been considered to the extent the document has been provided: an abstract.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed May 22nd, 2026, with respect to the rejection of claims 1-5 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 1-5 under 35 U.S.C. 112(b) has been withdrawn. The applicant has amended claim 1 step b) to explicitly recite a concentration of phytic acid in a mixture it is added to, the applicant has clarified the pH range for claim 1 step e), the applicant has removed the term “characterized” from claims 2-6, instead further limiting the process recited in claim 1 in the affirmative.
Pending Objections and Rejections
Specification
The use of the terms Agilent, ACQUITY, WATERS, OPTIMA, ThermoFisher (registered as Thermo Fisher), Invitrogen, Abnova, Cliniscience, Nikon, QImaging, Brookfield, Gransil, Xirona, Wacker-Belsil, and Unipure, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 5 is objected to because of the following informalities: the term “Lavandula angustifolia. Appropriate correction is suggested.
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), abbreviated “Oger”; and further in view of Graf (JAOCS 1983, 60 (11), 1861-1867).
Applicant's arguments filed May 22nd, 2026 have been fully considered but they are not persuasive. The rejection of claims 1-5 under 35 U.S.C. 103 is maintained for the reasons articulated below.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to the applicant’s argument that phytic acid would not have been obvious as an alternative to EDTA in the procedure recited by Oger, Oger recites the mechanism of EDTA in the extraction procedure as complex formation with divalent calcium ions which form ionic bridges between the pectin molecules surrounding the cellulose microfibrils (Oger, Description, paragraphs [0045] and [0046]). Graf teaches phytic acid also complexing with divalent ions such as calcium (Graf, Industrial Applications, Uses in Food Industry, paragraph 3). One of ordinary skill in the art could have substituted EDTA with phytic acid, with the predictable effect of complexing calcium ions which form ionic bridges between the pectin molecules surrounding the cellulose microfibrils. It is within the knowledge of one of skill in the art to use EDTA or phytic acid as described above at basic pH, in an effort to deprotonate the EDTA or phytic acid, to increase the availability of lone-pair electrons on these compounds for chelating calcium, a divalent cation (instant claim 1, step b). Subsequently adjusting the pH to between 6 and 8 is disclosed in the primary prior art reference (Oger et al., claim 1; instant claim 1 step c). The primary prior art reference Oger also teaches readjustment of the pH to between 6 and 6.5 after obtaining a purified aqueous extract (Oger et al., claims 1 and 21; instant claim 1 step e).
Although the prior art does not disclose an appropriate pH to use if substituting EDTA with phytic acid, in the process disclosed by Oger (Oger et al., claims 1 and 21), this pH parameter is obvious to one of skill in the art over routine optimization. The precise pH could be adjusted by one of skill in the art by adding hydrochloric acid and/or sodium hydroxide and measuring pH using a laboratory pH probe. One of skill in the art could measure the efficiency of the extraction under different pH parameters by measuring the concentration of the desired compound extracted using techniques inducing HPLC (for small molecules), or electrophoresis for nucleic acid separation and optical absorbance or fluorescence measurements for nucleic acid quantitation. Therefore, the pH range recited in claim 1 step b is obvious to one of skill in the art over routine optimization.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., selective separation of nucleic acids, RNA extraction) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the applicant’s assertion that the office action has not shown that lavender aerial parts, from Lavandula angustifolia, are taught or suggested by the cited references in combination with amended claim 1, it is not clear from the claims how the lavender aerial parts from Lavandula angustifolia would not be predictable to use as a botanical material for the instantly claimed extraction, as they are encompassed by the teachings of the prior art through certain disclosed plant parts (Oger et al., Description, paragraph [0032]) and the disclosure of plants of the Lamiaceae family (Oger et al., Description, paragraph [0035]).
Regarding the applicant’s assertion that the office action has not shown that filtration is taught or suggested by the cited references in combination with amended claim 1, filtration is taught by Oger et al. in claim 22, as recited in the previous office action (instant claim 4). It is within the knowledge of one of skill in the art to transition from larger to smaller filtration thresholds to avoid clogging the filters in the process of filtration (instant claim 4).
Regarding the applicant’s assertion that the office action has not shown that defined operating parameters, in the dependent claims, are taught or suggested by the cited references in combination with amended claim 1, the applicant has not pointed out why any of these parameters are critical for the process recited in the instant claims. The examiner has presented the obviousness of the instantly claimed plant material/water ratio over priori art (Oger et al., claim 2; instant claim 2). Regarding temperatures and filtration thresholds (instant claims 3 and 4, respectively), one of skill in the art could have manipulated extraction temperature using a thermometer and a hot plate, and could have manipulated filtration threshold through the use of laboratory vacuum filter papers of syringe filters with varying thresholds. One of skill in the art could measure the efficiency of the extraction under different parameters by measuring the concentration of the desired compound extracted using techniques inducing HPLC (for small molecules), or electrophoresis for nucleic acid separation and optical absorbance or fluorescence measurements for nucleic acid quantitation. Therefore, the instantly claimed temperatures (claim 3) and filtration thresholds (claim 4), are obvious to one of skill in the art over routine optimization.
Regarding the applicant’s assertion that the office action has not shown where Oger or Graf recognize the concentration of phytic acid recited in instant claim 1 step b and claim 3, the concentration of phytic acid is obvious over routine optimization. One of skill in the art could measure the mass of phytic acid using an analytical balance and the volume of the phytic acid solution using volumetric glassware. Therefore, one of skill in the art could adjust the concentration of phytic acid. One of skill in the art could measure the efficiency of the extraction under different phytic acid concentrations by measuring the concentration of the desired compound extracted using techniques inducing HPLC (for small molecules), or electrophoresis for nucleic acid separation and optical absorbance or fluorescence measurements for nucleic acid quantitation. Therefore, the concentration of phytic acid is obvious over routine optimization (instant claims 1 and 3).
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).
The rejection of claims 1-5 under 35 U.S.C. 103 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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