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 Application
Claims 1-21 filed on 10/12/2023 are pending in the application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/30/2023 and 3/11/2024 were filed before the first Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1,6-8,12,16-18,20 and dependent claims 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.
Independent Claim 1 is interpreted as a product-by-process claim, directed to a soluble cascara powder product formed by separately processing and encapsulating cascara powders derived from different coffee cherry fruit batches and blending the powders to obtain a defined compositional profile. However, the claim fails to define the scope of the claimed product with reasonable certainty under the broadest reasonable interpretation. In particular, the recitation of “extracting dry cascara using pre-soaking” lacks boundary conditions or parameters, encompassing materially different treatments/treatment conditions leading to varied extract composition; the recitation of “extracting with a solvent” fails to identify the nature of the solvent and extraction conditions that would materially affect the composition of the extract; and the recitation of “sugar” is ambiguous as to whether this refers to total sugars or a particular sugar or an added sugar. As the claimed product is partly defined by compositional ranges, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required. Dependent claim 21 identifies the solvent in claim 1 but does not further define “using pre-soaking” or “sugar”.
Regarding claim 6, a person of ordinary skill in the art would not be reasonably apprised of the scope of “other encapsulating agents” and “anticaking agents” in making an encapsulated soluble cascara powder. All encapsulating agents and anticaking agents would not necessarily meet the claimed requirement of solubility, and broadly recited “anticaking agents” do not necessarily function as encapsulating materials. Clarification is required.
Claim 8 recites a content of sugar. It is not known whether the content refers of total sugars or a specific sugar.
Claim 16 recites “treating the coffee fruit with sonication in a solvent, but does not identify the nature of the solvent. As the nature of the solvent and extraction conditions would materially affect the composition of the extract, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed method.
Claims 17 and 18 recite “dewatering treatment on the separated coffee fruit after the sonication treatment “ and “no dewatering is performed” respectively. The scope of dewatering is unclear as no water addition step is indicated in claim 16. If this is intended to recite a drying step, the recitation should be accordingly amended. For purposes of examination, “dewatering” has not been considered.
Claim 20 recites “from a different processing method” which is undefined. One of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention.
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.
Claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (US2018289030A1) cited in an IDS in view of Faria et al. (Journal of Food and Drug Analysis 2020;28:337-355) and further in view of Heegar et al.( Food Chemistry 221 (2017) 969-975) cited in an IDS.
Regarding claim 1,2, 4-7 and 21, Muller discloses a method of making a cascara powder derived from coffee cherry fruit, (which typically has a soluble solids content of 15%-25%, as generally known for fruits such as grapes and cherries, meeting the requirement of at least 12%), by pulping and deseeding which is considered wet pulping to separate the coffee fruit from coffee beans ([0089]-[0091]) and drying to a water activity of 0.3-0.65 at 25 deg. C that is corresponding to a moisture content of about 5%-20%w/w (10%-15%w/w [0017]) and extracting the produced cascara (entire de-beaned fruit) and extraction with hot water at an exemplary 180 deg F(83 deg C) for 8-16 hours, close to the lower limit of solvent extraction temperature in claim 21 of 85 deg temperature for at least 120 minutes. The extract is concentrated to a Brix value(soluble solids content) of about 20 to 30 [0063] to form a concentrated extract.
Muller discloses spray drying the concentrated extract [0078], but does not specifically detail an encapsulation step. Faria (page 338 paragraph 1-2) however discloses microencapsulation of concentrated green coffee extract with maltodextrin or gum Arabic, as in claim 6, to protect bioactive compounds from the external environment, to prevent the interaction between core and food matrix nutrients, and/or to provide a controlled release of compounds. As the intended use of the claimed cascara product is in foods and beverages, it would have been obvious to one of ordinary skill in the art to have modified the method in Muller with encapsulating phenolics rich liquid extract in a protective carrier such as maltodextrin or gum Arabic in a spray drying step, with a reasonable expectation of retained antioxidant activity of cascara extract.
The powder extract in Muller comprises total phenolic acids in the amount of 5%-25% w/w [0085] corresponding to 50mg-250mg GAE/g and an exemplary 0.7-1.1% caffeine. The powder inherently contains fiber present in coffee fruit and sugars, which is modifiable by one of ordinary skill in the art. No unexpected effects of dietary fiber content and total sugars at the claimed level in a single extract powder or the blended product are described.
Modified Muller therefore discloses a cascara powder as claimed. Regarding “soluble” the claim does not recite a method of determining solubility. Muller discloses a partially soluble powder [0114] which one of ordinary skill in the art would have filtered to obtain a desired level of solubility, prior to spray drying. Motivation is available from the aqueous extracts prepared from cascara in Heeger et al. (page 970, 2.3)that are filtered to remove insoluble matter.
Muller does not disclose blending first and second cascara powder products. However, one of ordinary skill in the art would typically produce standardized cascara product by blending batches to obtain a desired level of phenolics and other nutrients, as routinely done in the art. This is driven by inherent variability in coffee fruit composition and the need to achieve consistent target compositional profiles normalizing batch-batch variability, and is considered an obvious modification of the method in modified Muller.
Accordingly, one would experimentally optimize the extraction process to achieve a desired phenolic acids content, solids content, in claims 2,4 and 5 and microbiological quality in claim 7 with a reasonable expectation of success.
Regarding claim 3, Muller suggests beverage application of the antioxidant-rich cascara extract [0181]. One of ordinary skill the art would routinely set addition levels in a serving of a beverage based on the desired level of phenolic acids, fiber, sugar and organoleptic properties of the beverage.
Regarding claim 7, Muller discloses a microbiological load in cascara powder of less than 540 CFU/g for yeast and zero aerobic count [0114], which falls within the claimed level.
Regarding claim 8 and 12 as discussed above with reference to claims 1 and 7, a product in modified Muller meets the claimed requirements [0114]. The powder extract in Muller comprises total phenolic acids in the amount of 5%-25% w/w [0085] corresponding to 50mg-250mg GAE/g and an exemplary 0.7-1.1% caffeine. The powder inherently contains fiber present in coffee fruit and sugars, which is modifiable by one of ordinary skill in the art. No unexpected effects of dietary fiber content and total sugars at the claimed level in a single extract powder or the blended product are described.
Regarding claims 9-11, modified Muller has a step of filtration as described above which would provide a desired level of clarity to an aqueous extract of cascara, motivating one of ordinary skill in the art to apply a filtration , centrifugation or other separation methods to produce a product with a desired turbidity/clarity.
Regarding claim 12, Muller discloses a microbiological load in cascara powder of less than 540 CFU/g for yeast and zero aerobic count [0114], which falls within the claimed level.
Regarding claims 13-15, Heeger discloses ORAC assay, ABTS assay and prooxidant potential as antioxidant activity correlating with phenolics content (Fig. 2 for example). It would have been obvious to one of ordinary skill in the art to standardize antioxidant activity of the cascara product in correlation with phenolics content, with a reasonable expectation of success.
Regarding claim 16, as discussed above, Muller discloses a method of making a cascara powder derived from coffee cherry fruit, (which typically has a soluble solids content of 15%-25%, as generally known for fruits such as grapes and cherries, meeting the requirement of at least 12%), by pulping and deseeding which is considered wet pulping to separate the coffee fruit from coffee beans ([0089]-[0091]) and drying to a water activity of 0.3-0.65 at 25 deg. C that is corresponding to a moisture content of about 5%-20%w/w (10%-15%w/w [0017]) and extracting the produced cascara (entire de-beaned fruit) and extraction with hot water at an exemplary 180 deg F(83 deg C) for 8-16 hours, close to the lower limit of solvent extraction temperature in claim 21 of 85 deg temperature for at least 120 minutes. The extract is concentrated to a Brix value(soluble solids content) of about 20 to 30 [0063] to form a concentrated extract.
Muller discloses spray drying the concentrated extract [0078], but does not specifically detail an encapsulation step. Faria (page 338 paragraph 1-2) however discloses microencapsulation of concentrated green coffee extract with maltodextrin or gum Arabic to protect bioactive compounds from the external environment, to prevent the interaction between core and food matrix nutrients, and/or to provide a controlled release of compounds. As the intended use of the claimed cascara product is in foods and beverages, it would have been obvious to one of ordinary skill in the art to have modified the method in Muller with encapsulating phenolics rich liquid extract in a protective carrier such as maltodextrin or gum Arabic in a spray drying step, with a reasonable expectation of retained antioxidant activity of cascara extract.
Modified Muller does not specifically disclose a sonication step of sonication in a solvent. However, sonication is routinely applied in extracting bioactive compounds from plant materials with the advantage that ultrasonic waves disrupt plant cell walls, increase solvent penetration to plant tissues and accelerate diffusion of intracellular compounds onto the solvent. One of ordinary skill in the art would have included a sonication step to facilitate higher extraction of phenolic compounds , caffeine and other soluble compounds from cascara, with a reasonable expectation of success. No unexpected effects of a sonication step are provided in the disclosure.
Regarding claim 17 and 18 a dewatering step is unclear. A meaningful comparison with prior art is therefore not possible.
Regarding claim 19, Muller suggests beverage application of the antioxidant-rich cascara extract [0181].
Regarding claim 20, Muller does not disclose blending first and second cascara powder products. However, one of ordinary skill in the art would typically produce standardized cascara product by blending batches to obtain a desired level of phenolics and other nutrients, as is routinely done in the art. This is driven by inherent variability in coffee fruit composition and the need to achieve consistent target compositional profiles normalizing batch-batch variability, and is considered an obvious modification of the method in modified Muller.
Claims 1-21 are therefore prima facie obvious in view of the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793