DETAILED ACTION
Election/Restrictions
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/2026 has been entered.
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 39-41, 44, 46, 51-52, 60-67 and 70 are rejected under 35 U.S.C. 35 U.S.C. 103 as being unpatentable over Lihme et al. (US 2017/0318835 A1) in view of Heeney et al. (US 2019/0159502 A1) and Wagner et al. (US 3,672,909).
Regarding claim 39, Lihme et al. teaches a BLG protein fraction separated from an ALA fraction in whey protein (paragraph 1), where the BLG fraction can be a powder (paragraph 185) and included as a component in a “sport nutrition,” preferably in the form of a beverage or a powder (paragraph 198). Since “sport nutrition” powder is well known to be available in the form of “instant beverage powder”, the BLG containing powder of Lihme et al. is construed to be the same. The BLG fraction includes minerals (paragraph 182).
The BLG fraction is isolated from other whey proteins, where the isolated fraction comprises e.g., at least 99.5% BLG relative to the total amount of protein in the fraction (paragraph 176). The relative amount is construed to be on weight basis (paragraph 177).
Regarding at least 91 wt% of the total amount of protein in the powder being BLG, the reference teaches BLG provides advantages of stabilizing beverages and serving as a carrier for vitamins and as a foaming agent, where the BLG is used in a beverage powder (paragraphs 195-198). While the relative amount of BLG to total protein is not explicitly recited, the reference does not teach or otherwise indicate that BLG cannot be a significant majority of the protein in the beverage powder.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the beverage powder of Lihme et al. to include BLG in an amount of at least 91 wt% of the total protein content in the beverage powder since the reference teaches adding substantially pure BLG to beverage powders, since there is no evidence of criticality or unexpected results associated with the claimed value, and the claimed value would have been used during the course of routine experimentation and optimization procedures due to factors such as those stated above, as well as desired flavor, texture/mouthfeel, and nutritional profile.
Lihme et al. does not teach the instant beverage powder comprises at least 10 wt% of the BLG and the degree of denaturation of BLG is at most 10%.
However, the reference acknowledges the importance of avoiding possible denaturing conditions in order to achieve the “highest possible potential of proteins” and “exploit the functional and bioactive properties of the proteins” (paragraph 3). The reference teaches inclusion of an isolated, substantially pure BLG powder in a beverage and/or edible powder as stated above. One of ordinary skill would have understood from the cited teachings that the amount of BLG in a beverage powder can be increased based on desired biological benefit(s), and to ensure the BLG is provided in sufficient amounts such that benefits are conferred onto the user.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the beverage powder of Lihme et al. to include at least 10 wt% BLG and to have a degree of BLG denaturation of at most 10% since the reference already teaches a beverage and/or powder comprising BLG to improve muscle recovery from heavy exercise (paragraph 198), where the BLG can be isolated, substantially pure BLG with minerals (paragraphs 176 and 182) without undesirable denaturing of the protein (paragraph 3), since there is no evidence of record indicating criticality or unexpected results associated with the claimed features and values, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as those stated above, as well as desired flavor, texture/mouthfeel, and nutritional profile.
Lihme et al. does not teach the instant beverage powder has a pH of 2.8-4.3
Heeney et al. teaches a nutritional protein composition (abstract) comprising BLG (paragraph 14), where the “whey protein used is stable…between pH 3.5 and 4.2” (paragraph 25), and the composition comprising an acidifier such as citric acid to adjust the final pH of the composition to 3.75-3.9 (paragraph 99). While the reference is directed to a liquid product, processes for obtaining instant powders are well known in the art e.g., spray-draying. One of ordinary skill would have understood that the composition of Heeney et al. would have been capable of being similarly formed into an instant powder.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to have a pH of 3.5-4.3 since the reference recognizes that pH can be adjusted as needed while ensuring minimal protein denaturation (paragraphs 77 and 188), since the prior art recognizes that BLG is stable in protein beverages having a pH within the claimed range, since inclusion of citric acid to lower pH would have also adjusted the flavor of the composition, since lower pH values are understood to facilitate preservation, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as flavor, stability of the protein components, mouthfeel/texture, and preservation.
Lihme et al. does not teach the beverage powder has a bulk density of at least 0.4 g/ml.
Wagner et al. teaches a method of converting powders of lower bulk density into powders having a bulk density of 3-4 times that of the original material (abstract), comprising applying roller pressure to the original powder to form densified flakes, then grinding the flakes to form the higher bulk density powder, the powder capable of being reconstituted in cold water (column 2 lines 22-33). Pressure can be varied from e.g., 20,000-140,000 psi (column 2 lines 47-48). The process is not limited to particular powders (column 2 lines 61-65). The reference recognizes an issue with powders having low bulk density, such as requiring large volumes for preparation of adequate amounts for normal consumption (column 1 lines 49-52), where increasing bulk density provides a powder that is “much more practical and convenient from the standpoint of consumer use if such products could be converted to a form whereby small, easily measured amounts…could be used for measuring out average servings” (column 1 lines 55-60). Examples include powders having increased bulk density of e.g., 0.84 g/ml, 0.6 g/ml, and 0.75 g/ml based on starting density and powder type (column 3 examples 1-3). The examples also indicate that densified powders exhibit enhanced solubility and reconstitution properties compared to the original powders.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to have increased bulk density of at least 0.4 g/ml since the prior art recognizes a method to increase said value, in order to provide the advantages of user convenience and enhanced reconstitution properties as taught by Wagner et al., since there is no evidence of record that the claimed values are critical or yield unexpected results, and since the values would have been used during the course of routine experimentation and optimization based on factors such as powder composition, pressure of the densification process, particle size, and reconstitution characteristics.
Regarding claim 40, the limitation “one or more of” is interpreted to mean at least one of the alternatives i-iv is required. For the sake of examination, the alternative “i. a sweetener” is chosen.
Lihme et al. does not teach the BLG fraction contains a sweetener.
Heeney et al. teaches the composition can include sweeteners (paragraph 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to include sweetener since the reference already teaches the BLG fraction can be used in a food or beverage product (paragraph 26), and therefore to provide a product having a desired flavor/degree of sweetness for palatability.
Regarding claims 41 and 60-66, Lihme et al. teaches the amount of BLG in the fraction can be at least 99 wt% (paragraph 176). Since the BLG fraction is used as the protein source in the beverage and/or powder, the fraction comprising at least 99 wt% BLG as stated above, Lihme et al. renders obvious the values recited by the respective claims in question for the same reasons stated for claim 39.
Regarding claims 44 and 70, Lihme et al. does not teach the powder has a bulk density of at least 0.6 g/ml (claim 44) and 0.40-0.90 g/ml (claim 70).
However, the combination with Wagner et al. as applied to claim 39 teaches the values as stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to have the claimed bulk density for the same reasons stated for claim 39.
Regarding claim 46, Lihme et al. teaches the BLG fraction includes minerals such as Ca, Mg, and K in an amount of less than 20% relative to the total amount of minerals in the starting material (paragraphs 182-183), but does not teach the sum of the amounts of said minerals is at most 10 mmol/g protein.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to comprise the amount of minerals as claimed since the reference already acknowledges minerals in the BLG fraction, where the amount present can vary based on the separation characteristics of the starting material, since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired nutritional content and characteristics of the ALA and BLG separation.
Regarding claim 51, it is noted that the limitation “room temperature” is interpreted to be 25oC as disclosed by the specification (page 28 line 27).
Lihme et al. teaches the BLG fraction has a pH value above 4.5 (paragraph 173).
The combination applied to claim 39 teaches the instant beverage powder comprising BLG has a pH of 3.75-3.9.
While the reference does not specify that the pH of the powder in a 10% w/w solution in demineralized water as claimed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to have the claimed feature since the reference already teaches the powder has a pH of above 4.5, and since water is generally understood to have a pH of about 7, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired flavor (e.g. sour or bitter based on pH using food grade acids or bases), and to prevent denaturization of desired proteins.
Regarding claims 52 and 67, Lihme et al. does not teach the powder has a degree of protein denaturation of at most 4% (claim 52) and at most 1% (claim 67). However, the reference teaches wanting to process/separate the BLG in a way that will minimize denaturation, and motivates one skilled in the art to minimize denaturation in order to achieve the “highest possible potential of proteins” and “exploit the functional and bioactive properties of the proteins” as stated for claim 39.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to have at most 4% denaturation since the prior art already acknowledges wanting to prevent excessive denaturation such that the biological function of the protein is retained, acknowledges BLG is heat stable at low pH, and for the same reasons stated for claim 39.
Claims 42-43, 45, and 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Lihme et al. in view of Heeney et al. and Wagner et al. as applied to claim 39 above, and in view of Mikkelsen et al. (US 10,834,934).
Regarding claim 42, Lihme et al. teaches the product can be a powder (paragraph 185), but does not specify the water content is at most 6 wt%.
Mikkelsen et al. teaches a protein powder composition (column 13 lines 10-14) comprising BLG (column 7 lines 44-45), particularly a “dry powder” containing at most 6% w/w water (column 13 lines 12-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to have the claimed water content since the prior art acknowledges the value for similar protein powders, since Lihme et al. similarly teaches a protein powder but does not provide a specific water content, where one of ordinary skill in the art would have looked to the relevant prior art for guidance on such values, to ensure desired characteristics of the final product e.g., texture, flowability, and shelf-life, since there is no evidence of unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as those explained above.
Regarding claim 43, the combination applied to claim 42 teaches the powder having at most 6% water. The same combination is applied to claim 43 and would have been obvious for the same reasons. Applicant’s specification defines a “dry powder” to be at most 10% water (page 10 line 25). Therefore, the combination reads on limitations i. and “dry powder”.
Regarding limitations ii. and iii., Lihme et al. teaches a substantially “pure” BLG powder having at least 91% BLG relative to the total protein, and including at least 5 wt% BLG in the powder would have been obvious as stated for claim 39.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to include at least 15 wt% total protein relative to total solids for the same reasons stated for claim 39.
Regarding claim 45, Lihme et al. teaches the fraction can comprise less than wt% non-BLG proteins, including alpha-lactalbumin (ALA), where the fraction comprises less than 15% ALA relative to the total amount of protein in the fraction (paragraphs 177-178). However, the reference does not teach CMP and the sum of the ALA and CMP comprising at least 40% of the non-BLG protein in the powder.
Mikkelsen et al. further teaches that it is desirable to include “significant amounts” of soluble CMP in the protein composition as it provides the advantage of contributing to emulsifying properties without forming a gel and therefore keeps the viscosity of the product low (column 5 lines 19-20 and 53-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to have the claimed amount of ALA and CMP since the prior art acknowledges the substances to be present and desired in protein compositions, since Lihme et al. already teaches the powder can be used in a beverage, since there is no evidence of unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired mouthfeel/texture of the product (when formed as a beverage).
Regarding claim 47, Lihme et al. does not teach the powder has an energy content in the range of from about 200-500 kcal/100 grams of powder.
Mikkelsen et al. teaches the product, formed as a beverage, can have a calorie density of at least 1 kcal/mL in order to ensure sufficient calorie density for particular consumers, where the caloric density can be adjust as needed by adding components such as fat (column 34 lines 28-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to have the claimed energy content since the prior art acknowledges the desire to adjust caloric density for particular consumers, since adjusting caloric density by adding certain components such as macronutrients is well understood in the art, since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired nutritional profile for specific consumers.
Regarding claim 48, the limitation “energy amount of…” is hereon interpreted to mean the percentage of calories contributed by the claimed material relative to the total caloric content of the product (page 12 lines 17-25).
Lihme et al. does not specifically teach the energy amount of the protein is at least 7E%. However, the reference teaches that the fraction contains “substantially pure” BLG, such as at least 91% BLG as explained for claim 39. Furthermore, the amount of BLG in the beverage powder is obvious as stated for the same claim.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to include the claimed energy amount of protein for the same reasons stated for claim 39, particularly since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as intended user and nutritional profile.
Regarding claim 49, the limitation “contribution of energy…” is hereon interpreted to mean a percentage of calories contributed the by claimed material relative to the total caloric content of the product. Lihme et al. does not teach the energy from lipid as claimed.
Mikkelsen et al. further teaches the product can be formulated to have a desired caloric density by including fat as stated for claim 47.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to include the claimed amount of E% from lipid for the same reasons stated for claim 47.
Regarding claim 50, Lihme et al. does not teach the energy from carbohydrate as claimed.
Mikkelsen et al. further teaches the product can be formulated with one or more carbohydrates which provide sweetness and nutritional energy to the product (column 22 lines 20-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. to include the claimed amount of E% from carbohydrates in order to similarly provide a product having a desired flavor, sweetness and/or caloric density.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Lihme et al. in view of Heeney et al. and Wagner et al. as applied to claim 39 above, and in view of Klostergaard (US 2,790,790).
Regarding claim 53, Lihme et al. does not specify the BLG has a crystallinity of at least 20%.
Klostergaard teaches that BLG is a “well-known crystalline protein” that is easily obtained with good purity (column 6 lines 41-42 and 49-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Lihme et al. such that the powder has a crystallinity of BLG of at least 20% since the prior art acknowledges crystalling BLG is a well-known protein that is easily isolated with high purity, where Lihme et al. already teaches high purity is desirable, and therefore as a matter of manufacturing preference for the particular form of the BLG in powder, since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as type of separation process used for isolation and desired purity.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Lihme et al. in view of Heeney et al. and Wagner et al. as applied to claim 39 above, and in view of Sherwood et al. (US 2015/0064317 A1).
Regarding claim 68, Lihme et al. does not teach the powder has a turbibidity of at most 200 NTU when 40 grams of the powder is dissolved in 100 grams of liquid.
Sherwood et al. teaches a protein beverage composition (abstract), where the turbidity, or clarity, of carbonated and non-carbonated protein beverages can be between 30-100 NTU, where the turbidity is affected by the beverage formula (paragraph 109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of Lihme et al. to have a turbidity of at most 200 NTU under the claimed conditions since the prior art recognizes protein beverages to have NTU values within the claimed range, since turbidity is acknowledged to be affected by composition, since there is no evidence that the claimed feature is critical or yields unexpected results, and therefore since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as visual appeal/clarity and composition.
Response to Arguments
The instant Office Action relies on new grounds of rejection for claim 39, particularly in view of Wagner et al. The reference teaches a method of densifying beverage powders to obtain significantly increased bulk density, thereby providing desirable characteristics to the powder. Bulk densities of at least 0.4 g/ml are disclosed. The reference replaces Neiss which is no longer relied upon.
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive.
Applicant argues the cited portions of Lihme regarding the BLG are directed to the fraction obtained form the whey material, not the amount of isolated BLG contained in the instant beverage powder. Applicant argues
This is not persuasive since the refence teaches the BLG fraction is used in a sport nutrition powder (paragraph 198), where the fraction is isolated and substantially pure i.e., the BLG fraction “may preferably comprise…non-beta-lactoglobulin proteins relative to the total amount of protein in the beta-lactoglobulin fraction…less than 0.05% [by weight]” (paragraphs 176-177). The claimed amount of BLG in the beverage powder would have been prima facie obvious since there is no evidence of criticality or unexpected results associated with the amount, and based on routine experimentation and optimization to ensure the BLG is provided in sufficient amounts such that benefits are conferred onto the user, as well as desired flavor, texture/mouthfeel, and nutritional profile of the beverage powder.
Applicant argues Heeney teaches a liquid product, not a powder, containing whey and casein, the BLG in the composition is not isolated but instead part of a mixture of proteins, and there is no disclosure or suggestion of an acidic beverage powder containing the claimed amount of isolated BLG.
This is not persuasive since adding isolated BLG to a beverage powder such that the claimed percentage of BLG to total protein is prima facie obvious as stated above. Further, the claimed composition does not exclude other proteins due to the presence of the transitional phrase “comprising”. Likewise, the limitation “at least 91% w/w of the total amount of protein…is BLG” indicates that the composition can include up to 9% w/w non-BLG protein. While Heeney may be directed to a liquid beverage containing a combination of proteins, this feature is not incorporated into the combination. Rather, the reference is cited to teach that beverage compositions can be acidified using known food acids to adjust the final pH of the composition to the claimed range. Absent evidence of criticality or unexpected results associated with the claimed pH range, modifying the beverage powder of Lihme to include sufficient acid to obtain the claimed pH would have also been prima facie obvious based on the above stated factors such as desired flavor, stability of other protein components, and preservation effects known to be associated with acidic pH.
Additionally, while Heeney discloses a preferred liquid composition, said disclosure is directed to a preferred embodiment. Powdered beverage compositions are known in the art, and Lihme already discloses a beverage powder comprising isolated BLG. See also MPEP 2123.
The evidence of record does not sufficiently show that the claimed composition and amounts produces new, unexpected, and useful function, see In re Levin, 84 U.S.P.Q. 232, 234 (C.C.P.A. 1950). Id. at 7. The following passage is quoted from Levin.
“This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re White, 39 F.2d 974, 17 C.C.P.A., Patents, 956; In re Mason et al., 156 F.2d 189, 33 C.C.P.A., Patents, 1144.”
Applicant’s argument against the dependent claims and their respective prior art references are not persuasive for the same reasons stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571)-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRYAN KIM/Examiner, Art Unit 1792
Prosecution Insights