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 . Claims 1-2, 4-23, and 28-30 are pending; claims 1-2, 4-10 and 28 are examined; claims 11-23 and 29-30 are withdrawn.
Applicant’s arguments, filed 08 January 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 (new)
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 1-2, 4-10 and 28 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 1 recites the limitation "the granulate product" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites a granulated product in line 1. To obviate this issue, it is suggested for the last two lines to recite --- the granulated product ---.
Claim Rejections - 35 USC § 103 (maintained)
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 1-2 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Saunois et al. (US 2018/0369193 A1, 12/27/2018, IDS reference) (hereinafter Saunois) in view of Heo (KR 102214624 B1, 02/15/2021) (hereinafter Heo).
Saunois discloses a composition to be used as a functional food, comprising an extract of avocado ([0030]). The extract obtained may be provided in liquid form, but may also be further dried according to known methods, with or without a support such as maltodextrin ([0067]). The composition may be formulated in the forms of various preparations suitable for oral administration ([0096]), incorporated in a dietary supplement or in a nutraceutical composition, which may contain 10-100% of the avocado extract ([0098]). Exemplary forms include powder ([0140]).
Saunois differs from the instant claims insofar as not explicitly disclosing wherein the avocado extract is from fermented avocado.
However, Heo discloses a composition comprising an extract of avocado (p.3, ¶2). The avocado extract is prepared from fermented avocado (p.5, ¶5), and is good for eye health, heart disease reduction, cholesterol lowering effects, contains important antioxidants, and is rich in vitamins and minerals (p.4, ¶¶15-17). The composition may be in a formulation of granules (p.2, ¶12).
Saunois discloses avocado extract but does not limit the sources of the extract. Accordingly, it would have been obvious to one of ordinary skill in the art to have included a fermented avocado extract (i.e. avocado fermentate) in the composition of Saunois, to provide antioxidants, vitamins and minerals as taught by Heo.
Regarding the claim reciting a “granulated product,” it is noted that powders are considered a granular product and thus meets the claimed limitation under the broadest reasonable interpretation. Moreover, as noted by page 6 of the instant Specification, a granulated product is preferably particles having a diameter of less than 2mm (i.e. pass through a 10 mesh sieve) (p.6, lines 12-13). As such, a powder meets the limitation of a granulated product as instantly claimed.
Regarding claim 1 reciting 3% to 6% weight of water, although Saunois does not explicitly disclose a final weight of water, since Saunois discloses wherein the avocado extract may be dried according to methods known to persons skilled in the art, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed water amounts through routine experimentation based on method of drying and drying time desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 4-9 reciting various weight ratios, although Saunois does not explicitly disclose a specific weight ratio of the avocado extract to the support such as maltodextrin, since avocado extract is an active ingredient and maltodextrin is acting as support, these are result effective variables. It would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed weight ratio through routine experimentation depending on the effect of avocado extract and amount of support desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Response to Arguments
Applicant mainly asserts on pp. 7-9 of Remarks filed 08 January 2026 that amended claim 1 requires a combined presence of: a defined avocado fermentate-to-binder weight ratio between 1:5 and 1:1, and a narrowly controlled residual water content of 3-6% by weight in the final granulated product. This combination defines a functional stability window, rather than an isolated optimization of a single known parameter. Neither Saunois or Heo, alone or in combination, recognizes either the avocado fermentate-to-binder weight ratio or the residual water content of a final granulated product as critical parameters affecting the stability of fermented avocado. Absent recognition of the surprising and unexpected results – and of residual water content and fermentate-to-binder ratio as critical parameters to obtain the same – a person of ordinary skill in the art would not have had a reasonable expectation of success in arriving at the claimed invention based on the combination of cited references.
The Examiner does not find the Applicant’s persuasive. Although Saunois does not explicitly disclose utilizing a certain avocado extract to binder weight ratio or a water content in the final product in order to achieve a functional stability window, rationale different from Applicant’s is permissible. It is not necessary for the prior art to suggest the combination to achieve the same advantage or result discovered by the Applicant. See MPEP § 2144(IV). Thus, it is not necessary for Saunois to disclose an avocado extract to binder weight ratio or a residual water content in the final product for affecting a stability window. Moreover, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. In this instant case, Heo provides the motivation to include a fermented avocado extract. Finally, it should be noted that Applicant has not provided support that such weight ratio and residual water content provide improved stability window. Pages 7-8 of Applicant’s Remarks are merely opinions with conclusory statements. Conclusory statements, unsupported by objective factual evidence, were not found to be of substantial evidentiary value. See MPEP § 716.01(c). In this instant case, Applicant has not provided any showings comparing the claimed ranges with amounts outside of the claimed ranges and showing that the claimed ranges results in superior properties not seen with amounts outside of the claimed ranges. Thus, Applicant has not provided objective support that the claimed ranges are critical. Therefore, Applicant’s assertion is unpersuasive since Applicant has not shown with objective evidence that the claimed ranges are critical.
Claims 10 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Saunois et al. (US 2018/0369193 A1, 12/27/2018, IDS reference) (hereinafter Saunois) in view of Heo (KR 102214624 B1, 02/15/2021) (hereinafter Heo), further in view of Park et al. (US 2014/0364513 A1, 12/11/2014) (hereinafter Park).
The disclosures of Saunois and Heo are discussed in detail in the rejection above, and their collective teachings (showing that the composition may be formulated in the forms of various preparations suitable for oral administration) differ from those of the instant claims insofar as they do not specifically disclose a particle size such that 100% of the particles have a diameter of less than 2 mm, or wherein the composition comprises isomalt.
However, Park discloses a method of making oral formulations comprising slightly wetted granules ([0001]) that conveniently allows taking without water or while lying down ([0002]), comprising active ingredient in a powdered state ([0036]) and one or more binder such as maltodextrin and isomalt ([0039]). The slightly wetted granules may be made into desired size by sieving during or after drying ([0046]) with a 30-mesh sieve ([0045]), which provides a mesh size of 600 µm ([0131]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Saunois as slightly wetted granules, with a particle size of 600 µm or less, to allow convenience of taking without water or while lying down as taught by Park.
Regarding claim 28, it would have been obvious to one of ordinary skill in the art to have selected isomalt and maltodextrin as the support in the composition of Saunois since each is a known and effective supporting binder as taught by Park. “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I).
Response to Arguments
Applicant mainly asserts on pp. 9-11 of Remarks that Park does not teach a granulated fermented avocado product, nor a granulated fermented avocado product meeting amended claim 1 (including 3-6% residual water), and therefore does not render the claimed subject matter obvious. In addition, Park does not provide any teaching that would lead a person of ordinary skill in the art to select Applicant’s binders (corn maltodextrin or isomalt) in combination with the claimed avocado fermentate-to-binder ratio and the claimed residual water content, in order to obtain the unexpected long-term stability achieved by Applicant.
The Examiner does not find the Applicant’s assertions to be persuasive. Saunois and Heo have been addressed in detail above, including allegations of unexpected results. Regarding Park, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. "Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations." See MPEP § 2141(III). In this instant case, as discussed above, Saunois discloses the combination of avocado extract and maltodextrin as support. Park discloses maltodextrin and isomalt as suitable binders (i.e. support). As discussed in the rejection, it would have been obvious to one of ordinary skill in the art to have selected a combination of maltodextrin and isomalt as the support since each is a known and effective binder as taught by Park. “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I). As such, Applicant’s assertions are unpersuasive.
Claims 1-2 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 110710659 A, 01/21/2020) (hereinafter Wang).
Wang discloses compositions usable as supplements, comprising fructooligosaccharides and a comprehensive vegetable powder (claim 1) comprising fermented avocado (claim 2). The formulation of the dietary supplement is preferably in the form of granule (claim 10). An embodiment of the formulation provides 25% of fructo-oligosaccharide and 15% of comprehensive fruit and vegetable powder prepared by fermenting, inter alia, avocado (p.13, ¶2). The fruit and vegetable powder may also contain maltodextrin (p.5, ¶1). Methods of preparing the comprehensive fruit and vegetable powder includes a step of freeze-drying or evaporating water at low temperature, mixing materials, and granulating the mixed materials (p.13, ¶¶3-6).
The prior art is not anticipatory insofar as the form of the formulation must be selected from a lists of alternative forms in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 1 reciting an amount of water in the final granulated product, Wang does not explicitly disclose a water amount in the granular product. However, since Wang discloses wherein the preparation of the comprehensive fruit and vegetable powder comprises evaporating water and mixing and granulating the mixed materials, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed water amounts (i.e. from 3-6% by weight) through routine experimentation based on amounts of drying time desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 4-9 reciting various weight ratios of avocado fermentate to a binder, the claimed ratios would have been obvious to one of ordinary skill in the prior art since they overlap with the weight ratio of the prior art (i.e. 15% comprehensive fruit and vegetable powder comprising fermented avocado, to 25% fructo-oligosaccharide). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Response to Arguments
Applicant mainly asserts on pp. 11-13 of the Remarks that Wang does not disclose or suggested a granulated or solid product, nor does it contemplate transforming a fermented avocado into a granulated matrix. Although Wang discloses fructo-oligosaccharides in combination with fermented avocado, fructo-oligosaccharides in Wang are used as nutritional or prebiotic ingredients in an aqueous system, not as binders in the sense of Applicant’s claims. Applicant further asserts Wang does not disclose or suggest a fermentate-to-binder weight ratio or residual water content as recited in amended claim 1. The ratios cited by the Examiner in Wang merely reflect the relative proportion of ingredients in a liquid nutritional formulation, and do not correspond to a ratio defining the structural relationship between a fermented matrix and a binder in a granulated product. Thus any numerical overlap between the relative amounts disclosed in Wang and the claimed fermentate-to-binder ratio is incidental and does not relate to the same physical system, technical function, or surprising results obtained by Applicant.
The Examiner does not find the Applicant’s assertions to be persuasive. As discussed in the rejection above, Wang explicitly discloses in claim 10 wherein the formulation is in the dosage form of granules. Moreover, Applicant agrees that Wang discloses a combination of fructo-oligosaccharide in combination with fermented avocado as instantly claimed. As discussed in the rejection above, the claimed weight ratios of avocado fermentate to binder would have been obvious to one of ordinary skill in the prior art since they overlap with the weight ratio of the prior art (i.e. 15% fermented avocado powder to 25% fructo-oligosaccharide). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding Applicant’s assertion about the purpose of Wang’s disclosure, as addressed above, it is not necessary for the prior art to suggest the combination to achieve the same advantage or result discovered by the Applicant. See MPEP § 2144(IV). In this instant case, it is not necessary for Wang to disclose a combination of fructo-oligosaccharide in combination with fermented avocado for the same reason as the Applicant’s, which was to define a structural relationship.
Finally, Applicant’s allegations about overlap between the relative amounts disclosed in Wang not relating to the same physical system, technical function, or surprising results obtained by Applicant is merely an opinion with conclusory statements. Conclusory statements, unsupported by objective factual evidence, were not found to be of substantial evidentiary value. See MPEP § 716.01(c). Similarly, regarding Applicant’s alleged unexpected results, Applicant has made statements of unexpected results, but has not provided any showings to support the alleged unexpected results, specifically any objective evidence to support the criticality of the claimed ranges. Thus such assertions are not found to be persuasive. As supported by MPEP § 2113 (II), once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence to establish an nonobvious difference between the claimed product and the prior art product. See also In re Marosi, 710 F.2d 799, 803, 218, USPQ 289, 292-33 (Fed. Cir. 1983). In this case, Applicant does not appear to have provided objective evidence to establish wherein the claimed composition provides a nonobvious difference. As such, the Applicant’s assertion is unpersuasive.
Claims 10 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 110710659 A, 01/21/2020) (hereinafter Wang) in view of Park et al. (US 2014/0364513 A1, 12/11/2014) (hereinafter Park).
The disclosure of Wang is discussed in detail in the rejection above, and differs from those of the instant claims insofar as it does not specifically disclose a particle size such that 100% of the particles have a diameter of less than 2 mm, or wherein the composition comprises isomalt.
However, Park discloses a method of making oral formulations comprising slightly wetted granules ([0001]) that conveniently allows taking without water or while lying down ([0002]), comprising active ingredient in a powdered state ([0036]) and one or more binder such as maltodextrin and isomalt ([0039]). The slightly wetted granules may be made into desired size by sieving during or after drying ([0046]) with a 30-mesh sieve ([0045]), which provides a mesh size of 600 µm ([0131]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Wang as slightly wetted granules, with a particle size of 600 µm or less, to allow convenience of taking without water or while lying down as taught by Park.
Regarding claim 28, it would have been obvious to one of ordinary skill in the art to have included isomalt in the composition of Wang in order to form the wetted granules as taught by Park.
Response to Arguments
Applicant mainly asserts on pp. 13-15 that Park describes the use of moisture as a processing aid during granulation but is silent as to the residual water content of the final granulated product and does not recognize residual moisture as a parameter functionally linked to long-term stability. Applicant further asserts none of the combination of cited references, in any combination, teach or suggest the unexpected and surprising results obtainable with the presently claimed invention which provides a long-term stability of fermented avocado products, nor teach or suggest the claimed solution, which resides in granulating a fermented avocado using specific binders, within defined fermentate-to-binder ratios, and while controlling the residual water content of the final product. As demonstrated in the experimental section of the application, the claimed granulated product exhibits unexpected long-term stability, maintaining its physicochemical properties and preserving a high content of highly bioavailable nutrients over time.
The Examiner does not find the Applicant’s assertion to be persuasive. The rejection does not rely on Park to recognize the use of residual water content as a parameter functionally linked to long-term stability. Moreover, in any case, it is not necessary for Wang or Park to suggest a combination to achieve the same advantage or result discovered by the Applicant. See MPEP § 2144(IV).
Applicant’s assertions about residual water content as a parameter functionally linked to long-term stability, maintaining its physicochemical properties and preserving a high content of highly bioavailable nutrients over time, are merely opinions with conclusory statements. Conclusory statements, unsupported by objective factual evidence, were not found to be of substantial evidentiary value. See MPEP § 716.01(c). Similarly, regarding Applicant’s alleged unexpected results, Applicant has made statements of unexpected results, but has not provided any showings to support the alleged unexpected results, specifically any objective evidence to support the criticality of the claimed ranges. Thus such assertions are not found to be persuasive. As supported by MPEP § 2113 (II), once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence to establish an nonobvious difference between the claimed product and the prior art product. See also In re Marosi, 710 F.2d 799, 803, 218, USPQ 289, 292-33 (Fed. Cir. 1983). In this case, Applicant does not appear to have provided objective evidence to establish wherein the claimed composition provides a nonobvious difference. As such, the Applicant’s assertion is unpersuasive.
Conclusion
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612