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 .
Priority
This application is a 371 of PCT/EP2021/076973 which claims the benefit of FR 2010088 and EP 21183653.1 as reflected in the filing receipt mailed on 18 August 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 7, 9, and 10 are objected to because of the following informalities:
Claims 7 and 9 state “liquid medium (C2)”; while, the remainder of the claims format the liquid medium designation without the parenthetical. For the purpose of consistency amongst the claims, “liquid medium (C2)” is interpreted as “liquid medium C2”.
Claim 10 states “precipitate P1” which appears to be a typographical mistake. Claim 10 is interpreted to state “first precipitate P1”.
Appropriate correction is required.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
If the language of the claim is such that a person of ordinary skill in the art could
not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 USC 112(b) is appropriate, see MPEP 2173.02.
Claim 1, lines 4-5 state “a first precipitate” and line 6 states “a first precipitate P1”. It is unclear as to whether the first precipitate in lines 4-5 is the same as or different from the first precipitate in line 6. It is also unclear as to whether or not there is a difference between the first precipitate in the solution mixture and the first precipitate once separated. The instant specification appears to not provide guidance as to the difference between the instantly claimed first precipitates. The instant specification page 16, lines 18-25 state “[t]he second precipitate P2 is distinct from the first precipitate P1”; therefore, all the of precipitates are interpreted as having differing materials and the liquid mediums are interpreted to comprise solid materials in liquid.
Claim 1, lines 5-6 state “step (b) of separation of the first precipitate from the liquid medium C1, so as to obtain a liquid medium F1 comprising purified ferulic acid and a first precipitate P1”. It is unclear as to how the separated from the precipitate liquid medium F1 also comprises “a first precipitate P1”. It is also unclear as to whether or not one precipitated substance is separated from liquid medium C1; while, other precipitated substances remain in liquid medium F1 thus leading to a first precipitate P1. The instant specification page 16, lines 18-25 state “[t]he second precipitate P2 is distinct from the first precipitate P1”; therefore, all the of precipitates are interpreted as having differing materials and the liquid mediums are interpreted to comprise solid materials in liquid.
Claims 7, 9, and 10 also lack clarity because they are also drawn to precipitates and liquid mediums. In addition, for the purpose of clarity and consistency amongst the claims and instant specification, the second precipitate is interpreted as “second precipitate P2”.
Claims 2-12 depend from base claim 1 and are included in this rejection as they
do not correct the informalities identified in base claim 1.
Claim Rejections - 35 USC § 102
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.
Claim 12 is are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cabrera Pino et al. (US20180242579, hereinafter Cabrera Pino).
Cabrera Pino discloses the claim 12 limitations of a composition comprising at least one oligomer of ferulic acid, such as diferulic acid, see Claims 16 and 17; Paras. [0019];[0109];[0146].
In regard to “that is obtained according to the process of claim 10”, see MPEP 2113(I) stating “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”. Cabrera Pino discloses a composition comprising diferulic acid and a product and it’s properties are inseparable, see MPEP 2112.01; therefore, the process of production is not given patentable weight.
Claim Rejections - 35 USC § 103
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Abu-Omar et al. (WO2018195422, hereinafter Abu-Omar).
Abu-Omar teaches the claims 1-9 limitations of a liquid mixture containing ferulic acid extracted from agricultural biomass is treated to precipitate byproducts of the extraction process such as any lignin and polysaccharides in order to obtain purified ferulic acid, see Paras. [0027]-[0028];[0035];[0042]-[0047], meeting:
The liquid medium C in instant application claim 1;
The biosourced ferulic acid in instant application claim 2;
The extraction/separation/purification process starts by adding powdered alumina aka aluminum oxide to the ferulic acid solution before acidification with phosphoric acid to a pH of about 3-6 to selectively precipitate lignin and polysaccharides, while the ferulic acid remains in solution with other suspended solids that are removed by further purification/extraction/filtration, see Paras. [0044]-[0047], meeting:
Step (a), the first precipitate, the first complexing agent containing aluminum, and the liquid medium C1 in instant application claim 1;
Within the pH range in instant application claim 5;
The aluminum complexing agent in instant application claim 6;
The acidified solution containing ferulic acid and solids is filtered or centrifuged to remove the precipitated byproducts including lignin and polysaccharides which precipitate as solid materials to obtain a purified ferulic acid solution containing other suspended solids that are removed by further purification/extraction/filtration, see Paras. [0044]-[0047], meeting:
Step (b), the liquid medium F1, precipitates, and the purified ferulic acid in instant application claim 1;
Further purification of the liquid medium containing ferulic acid involves solvent extraction and precipitation, where the mixture is heated to between about 60-100 °C, the solution is further acidified to a pH of between about 1-5 by addition of an acid, such as phosphoric acid, then filtered to remove precipitate solids before extraction with a liquid-liquid extraction, where water and an organic solvent are used, see Paras. [0045]-[0047];[0083]. Then the organic solvent is removed by evaporation to yield solid or semi-solid ferulic acid subjected to further purification depending on the use and product purity requirements, such as the concentration of ferulic acid in the filtrate can be increased from 1-10 g/L to 10-35 g/L by evaporating a portion of the aqueous filtrate prior to cooling to precipitate solid ferulic acid with a purity of between about 60-99% by mass, see Paras. [0045]-[0047];[0083], meeting:
Within the range of the purified ferulic acid in instant application claim 3;
Within the temperature range in instant application claim 4;
The second complexing agent of phosphoric acid, the second solids precipitate separated/filtered out of the heated liquid containing ferulic acid and suspended solids, and a variety of concentrated extracted liquids containing ferulic acid in instant application claim 7, in instant application claim 8, and in instant application claim 9.
Abu-Omar does not teach:
The limitations of instant application claims 1-9 in one single express embodiment; and,
The precise order of process limitation steps in instant application claims 1-9.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Abu-Omar to rearrange the purification process steps in any order and to duplicate/repeat process steps to obtain a purified ferulic acid from a variety of solutions containing ferulic acid and suspended solids, see MPEP 2144.04 VI., and to select the use of precipitation agents, such as sodium/potassium hydroxide, carbonates, bicarbonates, and ammonium, aluminum, and phosphate, see MPEP 2144.07, with a reasonable predictability of success for the purpose of subjected the ferulic acid solution to further purification depending on the use and product purity requirements, see Abu-Omar, Paras. [0042]-[0047].
By applying “routine optimization” and “predictable results” to select the optimal process parameters needed to achieve the desired purity, one of ordinary skill in the art would have been motivated to make these modifications because Abu-Omar provides a finite number of identified, predictable solutions. A person of ordinary skill in the art has good reason to purify the ferulic acid solution by pursuing the known options within their technical grasp for the benefit of subjected the ferulic acid solution to further purification depending on the use and product purity requirements, see Abu-Omar, Paras. [0042]-[0047] and MPEP 2141.
Selection of a known material, such as a precipitating agent, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as pH, temperature, and purification ranges, “or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929), see MPEP 2144.05.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Abu-Omar et al. (WO2018195422, hereinafter Abu-Omar), as applied to claims 1-9 in the 35 USC 103 rejection above, in view of Bunzel et al. (“Semipreparative isolation of dehydrodiferulic and dehydrotriferulic acids as standard substances from maize bran”, 2004, Journal of Separation Science, Vol. 27, Pgs. 1080-1086, hereinafter Bunzel).
Abu-Omar does not teach the limitations in instant application claims 10 and 11.
Bunzel relating to a method for the isolation of diferulic and triferulic acids in quantities and purity that comply with the requirements for their use as standard substances, see Abstract, teaches a process for extracting diferulic and triferulic acids aka oligomers of ferulic acid present in the residue of insoluble maize fiber by acidifying to less than a pH of 2 with HCl to liberate phenolic acids that are then extracted into a diethyl ether, that is evaporated down, then a liquid-liquid extraction with diethyl ether, NaHCO3 aqueous solution, acidified again to less than a pH of 2 with HCl, then extracted with diethyl ether again before evaporation to dryness, redissolving in MeOH/H2O, then separated to obtain compositions of diferulic and triferulic acids, see Pg. 1081, 2.2-Pg. 1082, 2.6, Fig. 1, meeting the limitations of step (A) and step (B) in instant application clam 10 and in instant application claim 11.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified the various ferulic acid separation residues from the biomass materials of Abu-Omar to further isolate the ferulic acid residue to separate oligomers, as taught by Bunzel with a reasonable predictability of success for the purpose of subjected the ferulic acid residue to further reaction and purification to create/isolate oligomers that comply with the requirements for their use as standard substances, see Bunzel, Abstract, Pg. 1081, Col. 1, First-Second Para., Pg. 1085, 4 Concluding Remarks.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since both Abu-Omar and Bunzel teach ferulic acid separated residues, a person of ordinary skill in the art has good reason to subject the ferulic acid residue to further reaction and purification by pursuing the known options within their technical grasp for the benefit of subjected the ferulic acid residue to further reaction and purification to create/isolate oligomers that comply with the requirements for their use as standard substances, see Bunzel, Abstract, Pg. 1081, Col. 1, First-Second Para., Pg. 1085, 4 Concluding Remarks, and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Conclusion
No claims are allowed.
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/YO/Examiner, Art Unit 1692
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691