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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, 20 in the reply filed on 6/29/26 is acknowledged.
Claims 16-19 are withdrawn from consideration as being directed to non-elected invention.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it’s too short. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim 1 is 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.
In claim 1: Line 1, the recitation “ the range” does not have proper antecedent basis.
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.
Claim(s) 1-4,6-11,13-15,20 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 claims 1-4,6-11,13-15,20 , 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 30%. 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 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 5 ( paragraphs 0098,0031). 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 4,11, 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 2,3,11,15, Hansen the amount of lactoglobulin is at least 95%. For claims 9,10,13,14 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. ( 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 claims 1,11, the property as in claims 6, the powder as in claims 1-15, the colony forming units as in claim 8 and the steps b, c of claim 20.
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, Hansen in view of Sun discloses the same protein powder. Thus, it is obviously inherent the powder would have the same emission 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) 5,12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Sun and Sherwood as applied to claims 1-4,6-11,13-15,20 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) 1-4,6-11,13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis ( 6998259) in view of Sherwood ( 2007/0148305)
For claims 1-4,6-11,13-15 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 9-10,12-13 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 1,8,11 and the property as in claim 6 and the lipid amount as in claims 4,11.
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 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) 5,12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Sherwood as applied to claims 1-4,6-11,13-15 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19,21-24,36-38,41-42,46,49-53 of copending Application No. 17/254757 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and co-pending applications are directed to beta-lactoglobulin isolate powder. The claims of the co-pending application are encompassed in the claims of the current application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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Thursday, July 16, 2026
/LIEN T TRAN/Primary Examiner, Art Unit 1793
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