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 1-3, 6, 8, 10, 13, 15-17. 19. 23-25, 29, 30, 34, 47 and 49 are pending examination.
Drawings
The drawings are objected to because Figures 2A-2D are missing y-axes labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-3, 6, 8, 10, 13, 15-17, 19, 21, 23-25, 29, 30, 34, 47 and 49 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.
Regarding claim 1, the recitation “wherein the protein composition comprises at least 50% by dry weight of a plurality of plant proteins, fungal proteins, algal proteins, bacterial proteins, protozoan proteins, invertebrate proteins” renders the claim indefinite. It is not clear if the protein composition must comprise each of the claimed types of proteins or if Applicants intend to claim “wherein the protein composition comprises at least 50% by dry weight of a plurality of proteins selected from the group consisting of plant proteins, fungal proteins, algal proteins, bacterial proteins, protozoan proteins, invertebrate proteins and combinations thereof.” Moreover, it is not clear what the term “plurality” is in reference to. For example, does the recitation “plurality of plant proteins” mean more than one type of plant protein is present or more than one plant protein molecule?
With respect to the prior art, a protein composition comprising at least 50% by dry weight of protein selected from the group consisting of plant proteins, fungal proteins, algal proteins, bacterial proteins, protozoan proteins, invertebrate proteins and combinations thereof will meet the claim the limitation.
Claims 2, 3, 6, 8, 10, 13, 15-17, 19, 21, 23-25, 29, 30, 34, 47 and 49 are rejected as being dependent from a rejected base claim.
Claim Rejections - 35 USC § 103
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 1-3, 6, 8, 10, 13, 15-17, 19, 21, 23-25, 29, 30, 34 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Howard (GB 1 597 783- cited on IDS dated January 9, 2025).
Regarding claims 1, 2, 13, 17 and 29, Howard disclose a soy protein composition comprising 90 % protein on a dry basis (i.e., dry weight of plant proteins) and made by a process comprising the steps of: (a) obtaining a source soybean protein (e.g., soy protein concentrate, soy protein isolate); (b) mixing the soybean protein source with water; (c) adjusting the pH to a range of approximately 6.5 to 11 to obtain a solubilized protein solution; (c) heating the solubilized protein solution at temperature ranging from 45° to 95°C for a time of 15 to 60 minutes; (d) separating the soluble proteinaceous material (i.e., solubilized protein solution) from any insoluble material; (e) adjusting the pH of the soluble proteinaceous material (i.e., solubilized protein solution) to 6.5 to 7.0; (f) isolating the soy protein composition from the solubilized protein solution by adding a water soluble organic solvent to precipitate out the soy protein composition (i.e., separate the solid phase from the liquid phase); and (g) freeze-drying the soy protein composition (p. 1/L46-49, p.3/L12-44, Figure 1).
Note, Howard discloses step (d) can be conducted before or after step (c) of heating (p.3/L28-30).
Regarding claim 3, Howard discloses all of the claim limitations as set forth above. Given Howard discloses a soy protein composition made by a process identical to the claimed process, inherently the soy protein composition would have one or more of the properties: (a) an isoflavone content of less than about 15 ppm; (b) a saponin content of less than about 75 ppm; and (c) a phospholipid content of less than about 500 ppm.
Regarding claim 6, Howard discloses all of the claim limitations as set forth above. Given Howard discloses a soy protein composition made by a process identical to the claimed process, inherently the soy protein composition would have a luminance of at least 86 on a scale from 0 to 100; and/or a chroma value of less than 14.
Regarding claim 8, Howard discloses all of the claim limitations as set forth above. Given Howard discloses a soy protein composition made by a process identical to the claimed process, inherently the soy protein composition would have a phospholipid content of less than 0.5% by dry weight.
Regarding claim 10, Howard discloses all of the claim limitations as set forth above. Howard discloses freeze-drying the soy protein composition to obtain a dry protein material (i.e., a powder, p.3/L39-43).
Regarding claim 15, Howard discloses all of the claim limitations as set forth above. While Howard does not explicitly disclose the amount of protein in the solubilized protein solution, given Howard discloses a process of making a soy protein product identical to the claimed method, including a step of solubilizing the protein, inherently the solubilized protein would contain at least about 60% of the protein of the source protein (i.e., soy protein isolate or soy protein concentrate).
Alternatively, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production, If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP §2133 I). Here, Howard discloses a soy protein composition made by a process identical to that of the product-by-process of claim 1.
Regarding claim 16, Howard discloses all of the claim limitations as set forth above. Howard discloses the soluble proteinaceous material is separated from any insoluble material by centrifugation (p.3/L28-30).
Regarding claim 19, Howard discloses all of the claim limitations as set forth above. Howard discloses cooling the heated soluble proteinaceous material before adding an organic solvent to the solution (i.e., a temperature in the range of 10° to 25° C-p. 5/L44-48).
Regarding claim 21, Howard discloses all of the claim limitations as set forth above. Given the step of cooling (i.e., step (e)) is optional, the limitations of claim 21 are satisfied. The
Regarding claim 23, Howard discloses all of the claim limitations as set forth above. Howard discloses the step of separating the solid phase from the liquid phase to form the proteins composition is accomplished by centrifugation (p. 5/L5-9)
Regarding claim 24, Howard discloses all of the claim limitations as set forth above. Howard discloses wherein the organic solvents used for precipitating the protein are ethanol, methanol, 2-propanol and acetone (p. 3/L35-38).
Regarding claim 25, Howard discloses all of the claim limitations as set forth above. Howard discloses resolubilizing the soy protein composition at a pH of 9.0 (p. 30-31). Howard discloses the resolubilized soy protein composition can function as a binder (p. 1/L30-31),
Regarding claim 30, Howard discloses all of the claim limitations as set forth above. Howard discloses the source protein is a full-fat or defatted soybean proteinaceous material (e.g., soybean flakes, meal or flour, soy protein isolates and soy protein concentrates- p.2/L46-49).
Regarding claim 34, Howard discloses all of the claim limitations as set forth above. Given Howard discloses a soy protein composition made by a process identical to the claimed process, inherently the soy protein composition would have one or more of the claimed saponin content, isoflavone content, phospholipid content, lipid content, phosphorus content, calcium content, magnesium content, iron content, ash content, phytic acid or phytate content, foaming capacity, emulsifying activity index; and or emulsion stability index.
Regarding claim 47, Howard discloses all of the claim limitations as set forth above. Howard discloses a food or meat analog product (i.e., food product) comprising the soy protein composition of claim 1 (p.4/L23-55, claims 14 and 15).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Howard (GB 1 597 783- cited on IDS dated January 9, 2025) as applied to claim 1, and further in view of Kizer et al. (WO 2017120597 A1).
Regarding claim 49, Howard discloses all of the claim limitations as set forth above. While Howard discloses a food analog product comprising the soy protein composition of claim 1 (claim 14), the reference is silent with respect to a milk replica comprising an emulsion of fat and water.
Kizer et al. teach a dairy milk analog comprising a refined non-animal protein (e.g., soy protein), lipid, and aqueous component (e.g., water)([0012]). Kizer et al. teach dairy milk analog is made by emulsifying the refined non-animal protein, lipid and aqueous component together ([0012]).
Kizer et al. teach the refined non-animal protein is made by a method comprising the steps of obtaining a protein preparation, extracting the protein preparation at an extraction pH to obtain an aqueous protein solution, separating the aqueous protein solution form non-aqueous components, adding salt and precipitating the protein from the aqueous protein solution at precipitation pH to obtain a precipitating, separating the precipitate non non-precipitated component and washing the protein precipitate to obtain a refined protein component ([0014]).
Howard and Kizer et al. are combinable because they are concerned with the same field of endeavor, namely refined or modified non-animal protein used in food analogs. Given Kizer et al. teach it was known to used refined non-animal proteins in dairy milk analogs (i.e., milk replicas) and since Kizer et al. teach refining non-animal protein by a method substantially similar to that of Howard et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used the soy protein composition of Howard in a dairy milk analog with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Duane Smith can be reached at 571-272-1166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759