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 .
Response to Election/Restrictions and Status of Claims
Applicant’s election without traverse of the invention of Group I (Claims 1-6 and 16-18), drawn to method comprising (a) preparing a paste from flesh of fermented Kalamon olives; subjecting said paste to a separation process yielding oil, a semisolid fraction, and an aqueous phase; and (i) harvesting aqueous phase (composition A); and optionally drying the semisolid fraction to obtain composition S, in the reply filed 11/04/2025, is acknowledged by the Examiner.
Claims 14-15 are cancelled. Claims 7-13 and 19-20 are withdrawn pursuant to 37 C.F.R. 1.142(b) as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are Claims 1-6 and 16-18, and are herein acted on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/28/2025 and 04/05/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the Examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites “(ba)”, but it is unclear what Applicant is indicating with “(ba)” step. The examiner suggest deleting (ba). Clarification is required.
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.
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 2 and 3 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.
Claim 2 is further rejected for indefiniteness for reciting that “washing said semisolid fraction obtained in (b)…combining said water with said aqueous phase…thereby obtaining a washed and dried composition S of (c)(i), and a combined aqueous phase yielding composition A of step (c)(ii).” The recitation is unclear because Claim 1 (c)(i) refers to harvesting the aqueous phase to give a composition A, therefore, making it unclear how a dried composition S is obtained in this step. Claim 1 (c)(ii) recites an optional step of drying the semisolid fraction to give composition S. As such, it is unclear how combining the wash water with the aqueous phase would result would yield the composition is Claim 1 (c)(ii).
Claim 3 is indefinite because it refers to the encapsulation of an aqueous phase (Composition A), which is not concentrated. One skilled in the art would not be able to ascertain the step of encapsulation of the aqueous phase without concentrating the aqueous phase to yield a concentrated liquid or powder that can be incorporated in a capsule formulation.
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 1-2, 5-6, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Frankel et al. (J. Agric. Food Chem. 2013, 61, 5179-5188), and in view of Ibarra et al. (US 2008/0014322 A1), hereinafter Ibarra, as evidenced by De Angelis et al. (Food Microbiology 52 (2015) 18-30), hereinafter De Angelis.
Frankel describes the olive oil production process to obtain extra virgin olive oil (EVOO) enriched in polyphenol and byproducts generated as sources of antioxidants, wherein the process involves collecting, washing, and crushing of olives, malaxation of olive paste, centrifugation, storage, and filtration (Abstract).
Regarding Claim 1 step (a), Frankel teaches the preparation of olive paste by crushing the olives (p. 5180, Crushing section). Frankel teaches applying centrifugation to separate the olive oil fraction from the solid material and water, reading on step (b) (p. 5180-5181, Centrifugation section). Frankel further teaches that large volumes of water are used in the three-phase mill to aid the separation of olive oil and generate two byproducts, i.e. olive mill wastewater (OMWW), also known as vegetation water or alpechin, and a solid waste called pomace or orujo (p. 5182, Olive oil byproducts section). Frankel teaches that phenolic extracts from OMWW can be used as natural alternatives to commercial synthetic antioxidants for applications in food, nutraceutical, and medical products (p. 5182, Olive Mill Wastewater section). As such, Frankel teaches Claim 1 step (c)(i). The Examiner notes that the drying step recited in step (c)(ii) is optional.
Regarding Claim 1, Frankel recognizes the large presence of olives in the mediterranean area, but does not expressly recite fermented Kalamon olives, also known as Kalamata olives (p. 5181, Storage section).
Ibarra is in the same field of interest and teaches the process of obtaining olive polyphenol concentrate from a by-product of olive oil extraction (Abstract). Ibarra teaches olive fruit can contain a significant amount of polyphenols including oleuropein [0007]. Olive polyphenols have been found to have a positive effect on human health, for example, hydroxytyrosol acts in vitro against both Gram-positive and Gram-negative bacteria, which are the cause of infections in the respiratory and intestinal tracts [0012]. Ibarra relates the high content of hydroxytyrosol and hydroxytyrosol derivatives (oleuropein, oleuropeinaglycone, demethyloleuropein and hydroxytyrosol glucosides) in Greek, Portuguese, Italian and Spanish table olives, particularly pointing to a high level of hydroxytyrosol in Kalamata and Spanish-style green olives [0011]. Ibarra teaches that lactic acid fermentation of olives brings about complete hydrolysis of oleuropein and luteolin 7-glucoside to hydroxytyrosol, tyrosol and luteolin, with the reaction catalyzed by β-glucosidase and esterase from Lactobacillus plantarum strains [0010].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Ibarra to Frankel, and use Kalamata olives from the mediterranean area if a composition comprising high amounts of polyphenols is desired, for example, in food, nutraceutical, and medical product application. One would use fermented Kalamata olives wherein the oleuropein and luteolin 7-glucoside are hydrolyzed to inter alia hydroxytyrosol, which Ibarra has taught to act against both Gram-positive and Gram-negative bacteria.
Regarding Claim 2, Frankel describes adding wash water to the olive paste to recover more complex phenolic compounds (p. 5180-5181, Centrifugation section). Addition of water is also illustrated in Fig. 1 of Frankel.
Regarding the drying step, Frankel teaches obtaining the pomace and filter cake, which comprises of solid material, but does not expressly teach a drying step (Abstract; p. 5183, Olive Oil Byproducts Generated by Storage and Filtration of EVOO Section). Ibarra cures the deficiency by teaching drying the wet olive paste and then dry comminuting at a low temperature; wherein the paste ca be formed from whole olive fruit, orujo and alpeorujo [0020]. Ibarra teaches an embodiment wherein the ultrafiltered olive polyphenols permeate and nanofiltered olive polyphenols retentate or a mixture of them can be subjected to a further vacuum concentration using a vacuum dryer system to remove water, and after milling, obtain the powder concentrate (Figs. 6-7; [0066]-[0069]; Example 2).
Drying is a known technique in the art. Ibarra and Frankel both teach filtration steps to separate the bulk of liquid. Ibarra teaches using a dryer system and milling to obtain a powder concentrate. Hence, one with ordinary skill in the art would have added the known technique of drying taught by Ibarra to the teaching of Frankel. It can be expected that using this technique would allow ease of milling to obtain a powder form. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding Claims 5 and 18, Frankel is silent on the presence of autochthonous yeasts. Ibarra has taught the fermentation of olives with Lactobacillus plantarum strains, but not the yeasts [0010]. However, autochthonous yeasts are endogenous to olives and starts the fermentation process together with lactic acid bacteria, as evidenced by De Angelis (p. 19, 1st paragraph). Frankel therefore renders obvious the feature of the claim “wherein said fermentation occurs in the presence of autochthonous yeasts” as it is an inherent property. One would perform that fermentation prior to the preparation of paste in order to ensure near maximal hydrolysis of oleuropein and luteolin 7-glucoside to hydroxytyrosol, which will be extracted at higher yield after fermentation.
Regarding Claim 6, Frankel does not teach the specific geographic source of the olives, i.e. where the olives are grown. However, this limitation is not related to subject matter eligibility issues. See MPEP 2106.05b. The geographic source of the olives is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular source was significant.
Regarding Claim 16, Frankel has taught separation of the olive oil fraction from the solid material and vegetation water (p. 5180-5181, Centrifugation section).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Frankel in view of Ibarra, as applied to Claim 1, and further in view of FENÒLIA®, (Obtained from Wayback Machine on 11/26/2025, Published Aug. 17, 2017 from URL: <https://web.archive.org/web/20170817011455/ https://www.fenolia.it/en/enteric-coated-capsules-hydroxytyrosol-from-olive-extract-antioxidant-and-anti-inflammatory-properties.php>,) as evidenced by Martinez et al. (Medicines 2018, 5, 13), hereinafter Martinez, and Jumanga Olives (Obtained from Wayback Machine URL:<https://web.archive.org/web/20190301090616/https://www.jumangaolives.com.au/technicalinfo/olive-variety-information/ on 11/26/2025, Published Mar. 1, 2019).
The teachings of Frankel and Ibarra have been set forth supra.
Frankel is silent on the encapsulation.
Ibarra recognizes that the olive polyphenols concentrate obtained may be used in many foods to increase the shelf life, and can also be used as a supplement and as nutraceuticals in the manufacture of pills, capsules, and other such products [0078].
Regarding Claims 3(d)(i) and (ii) and 4(e)(i) and (ii), FENÒLIA® discloses enteric coated capsules food supplement, containing hydroxytyrosol (HT), which has antioxidant and anti-inflammatory properties (1st paragraph). Fenolia® contains 7.5 mg of HT per capsule (2nd paragraph). Fenolia teaches that the enteric coated hard shell capsule formulation ensures enteric release, maximizing the absorption values of HT, which ensure production of pro-inflammatory molecules, arachidonic-lipoxygenase enzyme activity etc. (3rd to 5th paragraphs).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to incorporate composition A or S of Frankel in view of Ibarra in a enteric coated hard capsule to orally deliver olive active ingredients as supplement or nutraceuticals, while ensuring enteric release. One would incorporate, for instance, dry powder or concentrate comprising HT in an amount starting at 7.5 mg. Kalamata olives contain about 250-760 mg of HT per kg olive, as evidenced by Martinez (p. 3, Section 2, 2nd paragraph); Kalamata olive fruit weigh about 4-6 g per fruit, as evidenced by Jumanga Olives. By Examiner’s calculation, at an average of ~0.5g HT per 1kg olive, each Kalamata olive with an average weight of 5g would contain 2.5 mg HT. Therefore one skilled in the art wishing to incorporate extract or powder comprising 7.5 mg of HT would start with at least 3 fermented Kalamata olives. Importantly, the amounts of composition A and S are experimental parameters considered to be a result-effect variable that is within the skill of the ordinary artisan to modify and is commonly carried out in the art as part of routine optimization in formulations.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Frankel in view of Ibarra, as applied to Claims 1 and 5 above, and further in view of De Angelis et al. (Food Microbiology 52 (2015) 18-30), hereinafter De Angelis.
The teachings of Frankel and Ibarra have been set forth supra.
Regarding Claim 17, Frankel is silent on the fermentation time span. Ibarra has taught the fermentation of olives with Lactobacillus plantarum strains, but not the time span [0010].
De Angelis describes table olives as the fermented fruit of the Olea europaea L., cultivated in the Mediterranean countries, mainly Spain, Italy, Greece and Turkey (p. 18, Introduction, 2nd paragraph). De Angelis describes one protocol to remove bitter phenolic compound taste to involve brining and fermenting for 8-12 months until they lose their bitterness (p. 19, 1st paragraph). De Angelis also teaches fermentation for 75-90 days (p. 21, Section 2.10; Fig. 2). After 90 days of fermentation, the olives fermented with yeast and lactic acid bacteria (SYL) showed the highest overall appreciation, with sweeter taste compared with the other table olives. These time frames overlap with 3-12 months in Claim 5 (i). With regards to the 4-6 months fermentation time frame in Claim 17, De Angelis also states that the fermentation period depends on the type of cultivar, NaCl content and temperature (p. 19, 1st paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teaching of De Angelis with Frankel and Ibarra, and ferment olives with autochthonous yeast and lactic acid bacteria beginning at 3 months, and optimize the fermentation time as needed depending on the type of cultivar, NaCl content and temperature. One would adjust the time according to the desired level of sweetness and/or complete removal of bitterness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yokota et al. (US 2008/0260880 A1).
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792