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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/6/26 has been entered.
Claim 19,49,50 are amended and claims 20,25-35,39-40,43-45,47-48 are cancelled. Claims 51-53 are added. Claims 19,21-24,36-38,41-42,46,49-53 are pending.
The previous 112 second paragraph rejection is withdrawn due to the amendment.
Claim Rejections - 35 USC § 103
Claim(s) 19,21-22,24,36-38,41,46,49-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen ( 2011/0218327) in view of Sun ( CN 104256053) and Sherwood ( 2007/0148305).
For claim 19,21-22,49-53, Hansen discloses a isolate Beta lactoglobulin product. The product is purified from whey to obtain composition comprising at least 85% lactoglobulin when compared to the amount of proteins in the beta-lactoglobulin. Since the amount of lactoglobulin is at least 85%, it is obvious the total protein is at least 85% which meet the claimed at least 80%. Hansen also discloses in paragraph 0124 that the specific combination of pH and salt concentration of the first elution buffer may be reflected in the amount of alpha lactalbumin in the beta-lactoglobulin obtained. The amount is at most 5%. The amounts of other products such as immunoglobulin g is at most 2% in the beta-lactoglobulin product. The amount of carbohydrate can be at most 2% and the amount of fat is at most 5% ( see paragraphs 0124-0127). Thus, Hansen also discloses the amount of total protein relative to total solids. If the amount of beta-lactoglobulin is at least 85%, then the other solids can be other proteins, carbohydrate, fat etc.. As disclosed in paragraph 0155, the amount of beta-lactoglobulin is at least 85% so the total protein even not counting other protein is at least 80% relative to total solids. The product is eluted from whey solution adjusting to pH of 4.5 or below and eluted with buffer having a pH of 4 or less. Thus, it is obviously inherent the pH of the eluted protein solution is less than 4.5. Hansen does not disclose that the protein eluted from the column is denatured. Thus, the protein has degree of denaturation within the range claimed because at most 10% is 10% or less including 0. The amount of fat in the beta-lactoglobulin product is at most 2%. For claims 37,41, 49,50,51,52, Hansen discloses the amount of fat in the beta-lactoglobulin product is at most 2%. This disclosure indicates the amount of fat can be less because at most means 2% or less. For claims 36, 49,50,51,52, Hansen the amount of lactoglobulin is at least 95%. For claims 19, 53, the limitation of “ poder is prepared by spray drying and the spray-drying comprises fluid bed drying is a processing parameter which does not determine the patentability of the product. ( see paragraphs 0009-0013,0028-0031,0097-0099,0122,0127, 0155)
Hansen does not disclose a powder, the water amount and the colony-forming units as in claim 19, the property as in claims 24,38, the powder as in claims 38, 41,46 and the colony forming units as in claims 50,53.
Sun discloses a method for producing beta lactoglobulin powder from whey. Sun teaches to isolate beta lactoglobulin from liquid whey and spray drying to obtain the powder. Sun discloses that the moisture content of the beta lactoglobulin is less than 5%. ( see abstract, paragraph 0027)
Sherwood discloses a protein drink composition comprising whey protein. The composition is treated to inactivate microbes. The final product exhibits storage shelf stability which is unexpectedly long. The treatment to inactivate or remove microbes may includes aseptic packaging, ozonation, radiation, ultra violet light, high pressure processing, filtration, membrane permeation etc.. The plate count for microbes is negligible and typically zero after storage. The protein drink may be prepared as a dry preparation such as powder. ( see paragraph 0038, 0040,0055,0057,0068)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to dry the product of Hansen as taught in Sun when desiring to form a powder. One of ordinary skill in the art would have been motivated to form powder as taught in Sun for easy of storage and long shelf stability. It would have been obvious to one of ordinary skill in the art to follow the guideline of Sun for the moisture content. With regard to the tryptophan emission and heat stability, Hansen in view of Sun discloses the same protein powder. Thus, it is obviously inherent the powder would have the same emission and stability in absence of evidence showing otherwise. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to subject the protein in Hansen to a microbial reduction step as taught in Sherwood to obtain a product having a reduction in microorganism to ensure the safety and stability of the product. It would have been obvious to one of ordinary skill in the art to follow the guideline of Sherwood for the reduction to obtain shelf stability. Sherwood discloses the plate count for microbes is negligible and typically zero after storage for 1 year.
Claim(s) 23,42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Sun and Sherwood as applied to claims 19,21-22,24,36-38,41,46,49-53 above, and further in view of Zeller (2006/0040033).
Hansen in view of Sun does not disclose the bulk density.
Zeller discloses a non-carbohydrate foaming compositions. Zeller teaches to form the composition by spray drying an aqueous solution to obtain the powder. The dried protein powder has a bulk density of .45g/cc. ( see paragraph 0045)
The bulk density of protein as claimed is typical for protein powder as shown in Zeller. It would have been obvious to one of ordinary skill in the art to follow the guideline of Zeller for appropriate bulk density of protein powder.
Claim(s) 19,21,22,24,36-38,41,46,49-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis ( 6998259) in view of Sherwood ( 2007/0148305)
For claims 19,21,22,36,41,46,49,50,53, Davis discloses a product with trade name BiPro whey protein isolate comprising 85-95% beta-lactoglobulin with typical range of 97.5% plus/minus 1, 5% maximum powder, 1% maximum fat with typical range of .6 plus/minus .2. The product is undenatured and is fully soluble over the pH range 2 to 9. The amount of protein is relative to total solids as disclosed in table on col. 3. The product has a moisture content of 5% maximum; thus, it’s a powder. For claims 19, 53, the limitation of “ powder is prepared by spray drying and the spray-drying comprises fluid bed drying is a processing parameter which does not determine the patentability of the product.
Davis does not disclose the colony forming units as in claims 19,50,52 and the property as in claims 24,38 and the lipid amount as in claims 37.
Sherwood discloses a protein drink composition comprising whey protein. The composition is treated to inactivate microbes. The final product exhibits storage shelf stability which is unexpectedly long. The treatment to inactivate or remove microbes may includes aseptic packaging, ozonation, radiation, ultra violet light, high pressure processing, filtration, membrane permeation etc.. The plate count for microbes is negligible and typically zero after storage. The protein drink may be prepared as a dry preparation such as powder. ( see paragraph 0038, 0040,0055,0057,0068)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to subject the protein in Davis to a microbial reduction step as taught in Sherwood to obtain a product having a reduction in microorganism to ensure the safety and stability of the product. It would have been obvious to one of ordinary skill in the art to follow the guideline of Sherwood for the reduction to obtain shelf stability. Sherwood discloses the plate count for microbes is negligible and typically zero after storage for 1 year. With regard to the tryptophan emission and heat stability, Davis discloses the same protein powder. Thus, it is obviously inherent the powder would have the same emission and stability in absence of evidence showing otherwise. Davis discloses the maximum amount of fat is 1%. Thus, it would have been obvious to one skilled in the art to have very low amount of fat depending on the fat content desire.
Claim(s) 23,42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Sherwood as applied to claims 19,21-22,24,36-38,41,46,49-53 above, and further in view of Zeller (2006/0040033).
Davis in view of Sherwood does not disclose the bulk density.
Zeller discloses a non-carbohydrate foaming compositions. Zeller teaches to form the composition by spray drying an aqueous solution to obtain the powder. The dried protein powder has a bulk density of .45g/cc. ( see paragraph 0045)
The bulk density of protein as claimed is typical for protein powder as shown in Zeller. It would have been obvious to one of ordinary skill in the art to follow the guideline of Zeller for appropriate bulk density of protein powder.
Response to Arguments
Applicant's arguments filed 3/6/26 have been fully considered but they are not persuasive.
In the response, applicant argues that Hansen does not disclose total protein in amount of at least 80% of total solid. Applicant asserts that the BLG fractions described in Hansen are salt-rich eluates obtained by eluting by eluting bound protein with salt-rick eluents. Applicant present calculation on pages 4-5 of the response and conclude that the amount of protein is at most 5.7% relative to total solids. This argument is not persuasive. The conclusion that the BLG fractions are salt-rich eluate is applicant’s own deduction. There is no disclosure that the BLG fractions contain the salt. Applicant’s calculation is based on the assumption that all the salt used in the elution is present in the fractions and this assumption is not supported by the any disclosure in Hansen or any factual evidence. It's applicant own conclusion. Hansen also discloses in paragraph 0124 that the specific combination of pH and salt concentration of the first elution buffer may be reflected in the amount of alpha lactalbumin in the beta-lactoglobulin obtained. The amount of alpha lactalbumun is at most 5%. The amounts of other products such as immunoglobulin g is at most 2% in the beta-lactoglobulin product. The amount of carbohydrate can be at most 2% and the amount of fat is at most 5% ( see paragraphs 0124-0127). Thus, Hansen discloses the amount of total protein relative to total solids. If the amount of beta-lactoglobulin is at least 85%, then the other solids can be other proteins, carbohydrate, fat etc.. As disclosed in paragraph 0155, the amount of beta-lactoglobulin is at least 85% so the total protein even not counting other protein is at least 80% relative to total solids. In paragraph 0129, Hansen discloses “ the adsorbent may be washed after the BLG elution to remove salt”. This disclosure indicates that the salt is not eluted with the elution of BLG. Applicant does not point to any disclosure in Hansen to support the calculation that the total salt is eluted and included in the eluted BLG fractions.
Applicant further argues Hansen does not disclose the pH and denaturation. Hansen does not disclose that the protein is denature; thus, the degree of protein denaturation is 0 which is encompassed in the claimed range. The product is eluted from whey solution adjusting to pH of 4.5 or below and eluted with buffer having a pH of 4 or less. Thus, it is obviously inherent the pH of the eluted protein solution is less than 4.5.
Applicant argues that Sun contains no disclosure or teaching of the pH of the retentate or permeate B. This argument is not persuasive because Sun is only relying upon to show spray-drying of liquid to obtain a powder. It would have been obvious to one of ordinary skill in the to perform such step when desiring to obtain a powder. Applicant has not argued why the modification would not have been obvious.
Applicant argues that paragraph 0006 in Sun supports the argument that removal of salts may lead to pH changes and denaturation. The examiner cannot find the disclosure pointed out by applicant in paragraph 0006 of Sun. Furthermore, there is no evidence to support that the salting out method and the isotropic precipitation is the same processing step disclosed in Hansen to conclude that denaturation and pH change occur in the Hansen process.
Applicant states the claimed BLG powder exhibits unexpected results over Hansen in view of Sun. However, applicant has not submitted any evidence to show unexpected result over the prior art. Applicant states that the examiner did not consider the evidence. It is not that the evidence is not considered. The evidence is considered but it’s not persuasive because it’s not a showing against the prior art of record. Applicant continues to argue the unexpected result based on applicant’s calculation of the salt content in the BLG fractions. The argument is not persuasive based on the calculation as explained above. Applicant has not submitted any comparative data against the Hansen in view of Sun product. The vast amount of salt is based on applicant’s own assumption. It’s not disclosed in Hansen.
The argument directed at the Kale reference is not considered because the reference is no longer used in the rejection. The obviousness of forming the Hansen product into a powder is set forth in the rejection and applicant does not argue why such modification would not have been obvious. The specific drying method such as spray drying or fluid bed drying is processing parameter which does not determine the patentability of the product.
Conclusion
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May 15, 2026
/LIEN T TRAN/Primary Examiner, Art Unit 1793
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