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 .
Status of the Claims
Receipt of Remarks/Amendments filed on 05/05/2026 is acknowledged. Claims 14-15 are cancelled. Claims 7-13 and 19-20 are withdrawn. Claims 1-6 and 16-18, and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 05/05/2026
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 lists a step (e), but Claim 3 already lists a step (e).
Appropriate correction is required.
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 (Of record), and in view of Ibarra (Of record), as evidenced by De Angelis et al. (Of record).
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 can 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® (Of record), as evidenced by Martinez (Of record), and Jumanga Olives (Of record).
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 and 4, Ibarra teaches vacuum concentration using a vacuum dryer system to remove water, and after milling, obtain the powder concentrate (Figs. 6-7; [0066]-[0069]; Example 2). 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 (Of record).
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.
Response to Remarks:
The crux of Applicant’s argument appears to be based on the Frankel using the whole olive fruit, inclusive of pit, in preparing the paste, whereas the instant application excludes the pit (olive seed), making the claimed method different from that of the prior art. Applicant argues that using the whole olive fruit as starting material results to the semisolid fraction containing non-edible material originating from the seed. Applicant further claims that the claimed use of olive flesh therefore has a technical function and materially distinguishes the claimed method from conventional whole-fruit olive oil production processes.
The Examiner has considered the argument but found it unpersuasive. First, the claim recites “comprising” transitional language and does not exclude the pit/seed from the paste. Second, while Applicant argues that the prior art’s method would result in inedible product, the instantly claimed composition is not limited to edible products. Furthermore, Frankel teaches that the extracts and pomace obtained has application in food, nutraceutical and medical products, particularly of interest as antioxidant in foods to increase the shelf life (p. 5182, R. Col., 2nd to last paragraph; p. 5183, R. Col., 2nd paragraph; p. 5184, R. Col., 2nd paragraph).
As such, Applicant appears to claim non-enablement of Frankel, however, the allegation is unsupported by facts, which are specifically required to establish non-enablement of a reference. See MPEP §2121[R-6](I), which states, "When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980).”
Finally, regarding the statement that the claimed use of olive flesh therefore has a technical function and materially distinguishes the claimed method from conventional whole-fruit olive oil production processes, Applicant has yet to show side-by-side data showing difference between the function of the claimed invention with that of the closest prior art, Frankel.
Applicant alleges impermissible hindsight reconstruction of the claimed invention, no teaching or motivation to combine the references, particularly, no reason for a person of ordinary skill in the art to select fermented Kalamon olive flesh as the starting material, prepared a paste from that material, subjected that paste to separation, and harvested the resulting aqueous phase to obtain composition A; Applicant submits that fermented Kalamon olives are not selected merely because of an elevated phenolic concentration, but because the fermentation also provides lactic acid, which acts as a natural stabilizer for hydroxytyrosol.
The Examiner traverses. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Frankel concerns conventional extra virgin olive oil processing and by-product generation, and their uses as polyphenol sources. Ibarra concerns extraction and concentration of polyphenols from olive oil by-products, and is in the same field as Frankel. Ibarra and De Angelis both teaches the fermentation of olives with Lactobacillus plantarum strains. De Angelis is only relied on to teach the claimed fermentation time in Claims 5 and Claim 17.
As explained in the rejection supra, Ibarra teaches the type of olive, Kalamata, and how the olive polyphenols have been found to have a positive effect on human health, particularly pointing to a high level of hydroxytyrosol in Kalamata and Spanish-style green olives. 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. As such, the art teaches the lactic acid being argued. Further with regards to the lactic acid, it is noted that the lactic acid is not recited in the rejected claim. 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).
Applicant alleges no reasonable expectation of success.
Applicant opines that there is no reasonable expectation of success. It appears that Applicant is applying a standard of absolute predictability in order to find obviousness, which is not required. Rather, to find obviousness, only a reasonable expectation of success is required, which is provided supra and in the rationale in each of the previous Office Actions (to which Applicant's attention is directed). Please MPEP 2143.02 and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Additionally, the prior art as a whole has taught the claimed invention, and as such, there is a high expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Growables. Olive Oil Extraction Process. Obtained from URL: <https://www.growables.org/information/TropicalFruit/OliveExtraction.htm.> on 05/28/2026. Published 14 Feb. 2020.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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