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
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 parent Application No. CL1885-2021, filed on 07/15/2021.
DETAILED ACTION
Claims 23-37 of R. A. Mancilla Villalobos, et.al. US 18/574,647 (12/27/2023) are pending, under examination on the merits and are rejected.
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.
Claims 23-37 are rejected under 35 U.S.C. 112(b) as being indefinite because the claim term of “low concentration (less than 5% HT d.b)” recited by claim 1 and its depends claims is not clear.
The specification used the similar language as recited in claim as follows:
The present patent application proposes a process for obtaining concentrated HT extracts using extracts with low hydroxytrosol concentration (less than 5% HT d.b) derived from the olive industry as raw material. . .
Specification at page 2, line 15, emphasis added.
First, the term “low concentration” in claims is a relative term, the specification does not provide a standard for ascertaining the requisite degree. While the claimed “low concentration” is followed by “(less than 5% HT d.b)”, however, it is not clear whether the feature introduced by the parentheses is merely an exemplary of the claimed “low concentration”, and therefore not required, or (b) a required feature of the claimed “low concentration”?
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.
Claims 23-27 and 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over J. A. López Más, et al, WO2008090460A1 (2008)(“López”)1 evidenced with J. Fernández-Bolaños, et al, 50.23 Journal of Agricultural and Food Chemistry 6804-6811 (2002) (“Fernández-Bolaños”) in view of A. Aydi, et al, 60.1 Alexandria Engineering Journal 905-914 (2021)(“Aydi”)2 and the information disclosed from Dowex (2003)(“Dowex”)w
J. A. López Más, et al, WO2008090460A1 (2008)(“López”)
López teaches a process of producing hydroxytyrosol from olives and/or olive oil extraction by-products that is simple, effective, not expensive and that gives a high purity product free from organic solvents and suitable for use as additive for food, cosmetics etcetera. López at page 5, line 15-18, emphasis added.
López teaches that the process comprises:
(i). acidic hydrolysis in water of the starting materials at a temperature not exceeding 140ºC and the pH of the acidified mixture that undergoes the hydrolysis is within the range of 1.0 to 6.0. López at page 5, line 21-22 and 26-27, emphasis added. López teaches that the hydrolysis step is carried out using just water and mineral acid. López at page 7, line 16-18, emphasis added. López teaches that the starting material is residues of olives as obtained from olive oil extraction processes. López at page 6, line 1-2.
(ii). loading the extraction obtained from the above acid acidic hydrolysis in at least one chromatographic column of an acid activated anion exchange resin and of eluting the products retained in said chromatographic column with water. López at page 6, line 6-9, emphasis added. López also teaches that the acid activated anion exchange resin preferably is a weakly basic anion exchange resin. López at page 11, line 13-14, emphasis added. López further teaches examples of weakly basic anion exchange resin such as polyamine-type resins made from styrene/divinylbenzene. López at page 11, line 18-20.
López teaches working Examples, such as Examples 1-2 as follows:
EXAMPLE 1
hydroxytyrosol extraction from olive waste (orujillo), purification of the water phase
250 g of a sample of dry olive waste, orujillo, are mixed with 838 ml of demineralized water and 16.7 g of sulphuric acid (98%) The obtained mixture is kept in autoclave for 30 minutes at 121 ºC. After that, the aqueous phase is separated from the solid residue, by filtering on a filter. The solid phase, retained on the filter, is washed with 310 ml of demineralized water, and the water coming from this washing operation is collected with the aqueous phase previously recovered. The aqueous phase, approximately 860 ml, is then centrifuge refined to eliminate solid particles passed through the filter. After solid elimination, 835 ml of crude aqueous extract, containing 1.41 g of hydroxytyrosol, with a HPLC purity of 47.5%, are obtained.
EXAMPLE 2
Ion exchange hydroxytyrosol purification
A sample of 835 ml of crude aqueous extract containing 1.41 g of hydroxytyrosol obtained according to Example 1, is loaded on a column containing a ion exchange resin of the anionic type, previously activated by means of acetate cycle. For example, Diaion WA10 may be used. The liquid phase recovered at the end of the column, does not contain any hydroxytyrosol, which is instead continuously eluted with demineralised water until at least 90% of the initially charged hydroxytyrosol is recovered. The eluted phase contains approximately 1.27 g of hydroxytyrosol with an HPLC purity of about 80.85%.
López at page 14-15, Examples 1-2, emphasis added.
The López example comprises:
a). adjusting the pH of a sample of dry olive waste with sulphuric acid that is a pH regulator. As mentioned above that López teaches the sample of dry olive waste is obtained from olive oil extraction processes. The evidence from Fernández-Bolaños indicates that the concentration of hydroxytyrosol in dry olive waste is less than 2 w/w%. See Fernández-Bolaños Figure 2 at page 6806; further, the instant specification discloses that the concentration of hydroxytyrosol in the residues of olives as obtained from olive oil extraction is not more than 2%. Specification at page 2, line 1. While not specifies the pH value in his working examples, López teaches that the pH of the acidified mixture that undergoes the hydrolysis is within the range of 1.0 to 6.0. López at page 5, line 26-27;
b). contacting the aqueous extract with low hydroxytyrosol concentration with a weak base anion exchange resin; and
c). eluting the resin using water.
Difference Between López and Claims
The López Examples 1-2 differs from the instant claim 1 in that:
(i). López does not teaches to use hot water at a temperature between 50-100ºC, and
(ii). López does not specify the weak base anion exchange resin used in Example 2 is a resin selected from a polystyrene, styrene, divinylbenzene, polydivinylbenzene, polystyrene-DVB, or styrene-DVB matrix, however, López teaches that polyamine-type resins made from styrene/divinylbenzene can be used as a weakly basic anion exchange resin in his method. See López at page 11, line 18-20.
A. Aydi, et al, 60.1 Alexandria Engineering Journal 905-914 (2021)(“Aydi”)
Aydi measured the solubility of Hydroxytyrosol in water, ethanol and in binary solvent mixtures(ethanol +water) at five different temperatures (see Aydi at Abstract at line 4-6) and teaches that the solubility of Hydroxytyrosol increasing with increasing temperature. Aydi at page 907, right col. the last sentence and Table 1 at page 908, emphasis added.
The information disclosed from Dowex (2003)(“ Dowex DOWEX”)
Dowex teaches that:
DOWEX* MARATHON* WBA-2 resin is a high capacity, macroporous, weak base anion exchange resin of uniform bead size distribution. It is based on a styrene-divinylbenzene copolymer matrix with dimethylamine functional groups. DOWEX MARATHON WBA-2 is specifically designed to give high throughput and economical operation in both water and non-water applications.
Dowex at page 2 of 7, General Information, emphasis added.
Dowex also teaches that the recommended operating conditions for DOWEX* MARATHON* WBA-2 is at a temperature of 100ºC or less. Dowex at page 2 of 7, the last Table, emphasis added.
Obviousness Rationales of the Claims
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention in view of the teaching from López, Aydi and Dowex with an evidence from Fernández-Bolaños.
One ordinary skill seeking extraction of hydroxytyrosol from olive waste is motivated to conducting the López Example 1-2 method by election of the DOWEX* MARATHON* WBA-2 resin as the weak anion exchange resin because Dowex teaches that it is a polyamine-type resin made from styrene/divinylbenzene, has high capacity, give high throughput and economical operation in both water and non-water applications. One ordinary skill in the art has a motivation to do so with a reasonable expectation of success because López teaches that polyamine-type resins made from styrene/divinylbenzene can be used as a weakly basic anion exchange resin in his process. See López at page 11, line 18-20.
One ordinary skill is motivated to conduct the proposed method by eluting the resin with hot demineralised water at a temperature of between room temperature to 100°C (25-100°C). Thus arrive at a process meeting each and every limitation of claim 23 except the claimed temperature that is 50-100ºC. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Herein, the claimed 50-100ºC lie inside ranges of 25-100°C taught by prior arts, therefore, a prima facie case of obviousness exists. Thus, claim 23 is obvious.
One ordinary skill in the art has a motivation to do so with a reasonable expectation of success because:
(i). Aydi teaches that the solubility of Hydroxytyrosol in water increasing with increasing temperature. See Aydi Table 1 at page 908; Hydroxytyrosol can be quickly recovered from the resin with hot water, and
(ii). Dowex teaches that the recommended operating conditions for DOWEX* MARATHON* WBA-2 is at a temperature of 100ºC or less. Dow at page 2 of 7, the last Table.
Claim 24 is obvious because in the above proposed method sulphuric acid (sulfuric acid) is used as a pH regulator.
Claim 25-27
Claims 30-31 are obvious because the step recited in claim 30 is an optional step rather a required step.
Claims 32-33 are obvious because per Figure 1, López teaches his method is conducted in a continuous mode system. See López Figure 1.
Claims 34, 36 are obvious because one ordinary skill seeking hydroxytyrosol is motivated to further modify the above proposed method by concentration of the aqueous extraction solution and obtaining a concentrated product as taught by López. See López at page 6, line 14-15.
Claims 35 and 37 are obvious because one ordinary because one ordinary skill seeking hydroxytyrosol in solid form is also motivated to dry the concentrated product such as through freezing dry as taught by López to get a powder. See López at page 6, line 8.
Allowable Subject Matter
Claims 28-29 are free of the art record. The closest prior art of record is a combination of J. A. López Más, et al, WO2008090460A1 (2008)(“López”), A. Aydi, et al, 60.1 Alexandria Engineering Journal 905-914 (2021)(“Aydi”) and the information disclosed from Dowex (2003)(“Dowex”).
A combination of J. A. López Más, et al, WO2008090460A1 (2008)(“López”), A. Aydi, et al, 60.1 Alexandria Engineering Journal 905-914 (2021)(“Aydi”) and the information disclosed from Dowex (2003)(“Dowex”)
As detail discussed above in the 103 rejection that the combination of López, Aydi and Dowex teaches a process meeting each and every limitation of claim 1.
Difference between the Combination and Claims 28-29
The process taught by the combination of López, Aydi and Dowex differs from claims 28-29 in that functional groups of the resin used by the proposed process is not neutral functional groups.
Claims 28-29 are Not Obvious
Claims 28-29 are not obvious because none of López, Aydi and Dowex, or further in view a second art to motivate one ordinary skill art to modify the proposed method by replacing the acid activated anion exchange resin with a resin having neutral functional groups. Motivation lacks because López teaches that the weak base anion exchange resin is an acid activated anion exchange resin.
Conclusion
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/FRANK S. HOU/Examiner, Art Unit 1692
/AMY C BONAPARTE/Primary Examiner, Art Unit 1692
1 López has been cited by Applicant in the IDS form filed on 12/27/2023.
2 Available online 24 October 2020.
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