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 .
Specification
The disclosure is objected to because of the following informalities: please update the priority statement at the beginning of the Specification.
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Appropriate correction is required.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
When there are drawings, there shall be a “brief description of the several views of the drawings” (See 37 C.F.R. 1.74.).
The section heading “brief description of the several views of the drawings” as set forth in 37 C.F.R. 1.74 is missing. Please correct.
Claim Objections
Claim 17 is objected to because of the following informalities: it does not end with period. Appropriate correction is required.
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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.
Claim(s) 1, 7, 8, 14 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunker et al. (US 2004/0040448) in view of Adikane et al. (US 2019/0150465) and Zhao et al. (CN 103709246).
Regarding Claim 1, Dunker (‘448) teaches a method for alpha-filtering milk (See Abs., FIGs 1-3 and Claims.), the method comprising: separating whole milk into cream and skim milk (See FIG-1, paras. 19-20.);
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ultra-filtering the skim milk to produce an ultra-filtered retentate and an ultra-filtered permeate, wherein the ultra-filtered retentate comprises alpha-lactalbumin (See para. 20, FIG-1 and Claim #1.); nano-filtering the ultra-filtered permeate to produce a nano-filtered retentate and a nano-filtered permeate, wherein the nano-filtered retentate comprises lactose (See para. 22, FIG-1 and Claim #1.); and performing reverse osmosis on the nano-filtered permeate to produce a reverse osmosis retentate and a reverse osmosis permeate (See paras. 22 and 24, FIG-1 and Claim #1.), however, fails to expressly disclose performing ion exchange chromatography on the skim milk to produce an eluate and a modified skim milk.
Adikane (‘465) teaches separation of lactoferrin and lactoperoxidase by ion exchange chromatography being selective while subjecting skim milk to filtration having fouling problems (See Abs., paras. 2-4, 9-13.).
Zhao (‘246) teaches subjecting skim milk to ion exchange chromatography to separate lactoferrin and lactoperoxidase by a simple and low-cost method (See Abs., p. 2, l. 32+ and Claim 1.).
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to use ion exchange chromatography as taught by Adikane (‘465) and Zhao (‘246) for Dunker’s (‘448) process to provide a desired milk stream.
Regarding Claim 7, Dunker (‘448) teaches subjecting one or more of the ultra-filtrated retentate, the micro-filtered retentate, and the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Regarding Claim 8, Dunker (‘448) teaches the method discussed above, however, fails to expressly disclose performing ion exchange chromatography on the skim milk to produce an eluate and a modified skim milk, wherein the eluate comprises lactoferrin and lactoperoxidase.
Adikane (‘465) teaches separation of lactoferrin and lactoperoxidase by ion exchange chromatography being selective while subjecting skim milk to filtration having fouling problems (See Abs., paras. 2-4, 9-13.).
Zhao (‘246) teaches subjecting skim milk to ion exchange chromatography to separate lactoferrin and lactoperoxidase by a simple and low-cost method (See Abs., p. 2, l. 32+ and Claim 1.).
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to use ion exchange chromatography as taught by Adikane (‘465) and Zhao (‘246) for Dunker’s (‘448) process to provide a desired milk stream.
Regarding Claim 14, Dunker (‘448) teaches a method for producing a filtered milk product (See Abs., FIGs 1-3 and Claims.),
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the method comprising: separating whole milk into cream and skim milk (See FIG-1, paras. 19-20.); ultra-filtering the skim milk to produce an ultra-filtered retentate and an ultra-filtered permeate (See para. 20, FIG-1 and Claim #1.); nano-filtering the ultra-filtered permeate to produce a nano-filtered retentate and a nano-filtered permeate, wherein the nano-filtered retentate comprises lactose (See para. 22, FIG-1 and Claim #1.); performing reverse osmosis on the nano-filtered permeate to produce a reverse osmosis retentate and a reverse osmosis permeate (See paras. 22 and 24, FIG-1 and Claim #1.); and mixing at least a portion of each of the cream, the eluate, the ultra-filtered retentate, and the reverse osmosis retentate to form a mixture, the mixture comprising a filtered milk product (See para. 31+.), however, fails to expressly disclose performing ion exchange chromatography on the skim milk to produce an eluate and a modified skim milk, wherein the eluate comprises lactoferrin and lactoperoxidase.
Zhao (‘246) teaches producing milk with purified lactoferrin and lactoperoxidase using ion exchange chromatography (See Abs., p. 2, l. 32+ and Claim 1.).
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to use ion exchange chromatography to provide milk with lactoferrin and lactoperoxidase.
Regarding Claim 17, Dunker (‘448) teaches micro-filtering the modified skim milk prior to filtering the modified skim milk with the wide-pore filter to produce a micro-filtered retentate and a micro-filtered permeate, wherein the micro-filtered retentate comprises casein (See Abs., FIGs 1-3 and Claims.).
Regarding Claim 18, Dunker (‘448) teaches treating the milk product with a lactase enzyme (See para. 17.).
Regarding Claim 19, Dunker (‘448) teaches subjecting the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Regarding Claim 20, Dunker (‘448) teaches subjecting one or more of the ultra-filtrated retentate, the micro-filtered retentate, and the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Claim(s) 2-6, 9-13, 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunker et al. (US 2004/0040448) in view of Adikane et al. (US 2019/0150465) and Zhao et al. (CN 103709246) and Marella et al., Evaluation of commercially available, wide-pore ultrafiltration membranes for production of α-lactalbumin–enriched whey protein concentrate, Midwest Dairy Foods Research Center, Department of Dairy Science, and Department of Agricultural and Biosystems Engineering, South Dakota State University, Brookings 57007 (2011).
Regarding Claim 2, Dunker (‘448) teaches microfiltering skim milk with a wide-pore filter prior to ultra-filtering to produce a wide-pore retentate and a wide-pore permeate (See para. 20, FIG-1 and Claim #1.), however, fails to expressly disclose wherein a smallest molecule of the wide-pore retentate is between 25 kDa and 350 kDa.
Whether a membrane for separating dairy materials is described as “wide-pore” or “micro-pore” or “ultra-pore” is in part semantics.
Marella (2011) teaches using “wide-pore” ultrafiltration membranes for production of alpha-lactalbumin enriched whey protein concentrate that has been separated from beta-lactoglobumin wherein the wide-pore membrane openings are 25 kDa and 350 kDa (See FIGs 1 and 7 and pp. 1165-1166, 1173, where the openings are 50-100 kDa.).
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Marella gives a specific example as illustrated in FIG-7 where a beta-lactoglobumin rich stream is separated from an alpha-lactalbumin rich stream by means of a 50kDa “wide-pore”/micro membrane.
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It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date since Dunker’s (‘448) membranes that are described as being micro membranes fall within Applicant’s definition of “wide-pore” membranes as they separate the same or substantially the same materials. This is further supported by Marella (2011) which discusses “wide-pore” membranes for separating the same types of materials as described by Dunker (‘448) and claimed.
It thus would have been obvious to a person having ordinary skill in the art prior to the earliest effective filing date with Dunker (‘448) and Marella (2011) before them the filtering system as described by Dunker (‘448) would have the same streams as claimed. Making any adjustment and modifications in processing would have been within the skill set of a person having ordinary skill in the art.
Regarding Claim 3, Dunker (‘448) and Marella (2011) teach the method discussed above and Dunker (‘448) teaches wherein the micro-filtered retentate comprises casein (See para. 20, FIG-1 and Claim #1.), however, fails to expressly disclose wherein the wide-pore retentate comprises beta-lactoglobulin.
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date since Dunker’s (‘448) system is the same as claimed it would be capable of providing a wide-pore retentate that comprises beta-lactoglobulin (See para. 31+.).
Regarding Claim 4, Dunker (‘448) teaches combining at least a portion of each of the cream, the eluate, the micro-filtered retentate, the wide-pore retentate, the ultra-filtered retentate, and the reverse osmosis retentate to produce a milk product (See para. 31+.).
Regarding Claim 5, Dunker (‘448) teaches treating the milk product with a lactase enzyme (See para. 17.).
Regarding Claim 6, Dunker (‘448) teaches subjecting the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Regarding Claim 9, Dunker (‘448) teaches a method for alpha-filtering milk (See Abs., FIGs 1-3 and Claims.),
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the method comprising: separating whole milk into cream and skim milk (See FIG-1, paras. 19-20.); nano-filtering the ultra-filtered permeate to produce a nano-filtered retentate and a nano-filtered permeate, wherein the nano-filtered retentate comprises lactose (See para. 22, FIG-1 and Claim #1.); and performing reverse osmosis on the nano-filtered permeate to produce a reverse osmosis retentate and a reverse osmosis permeate (See paras. 22 and 24, FIG-1 and Claim #1.), however, fails to expressly disclose performing ion exchange chromatography on the skim milk to produce an eluate and a modified skim milk, wherein the eluate comprises lactoferrin and lactoperoxidase; micro-filtering the modified skim milk to produce a micro-filtered retentate and a micro-filtered permeate, wherein the micro-filtered retentate comprises casein, filtering the micro-filtered permeate with a wide-pore filter to produce a wide-pore retentate and a wide-pore permeate, wherein a smallest molecule of the wide-pore retentate is between 25 kDa and 350 kDa and wherein the wide-pore retentate comprises beta-lactoglobulin ultra-filtering the wide-pore permeate to produce an ultra-filtered retentate and an ultra-filtered permeate;.
Adikane (‘465) teaches separation of lactoferrin and lactoperoxidase by ion exchange chromatography being selective while subjecting skim milk to filtration having fouling problems (See Abs., paras. 2-4, 9-13.).
Zhao (‘246) teaches subjecting skim milk to ion exchange chromatography to separate lactoferrin and lactoperoxidase by a simple and low-cost method (See Abs., p. 2, l. 32+ and Claim 1.).
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to use ion exchange chromatography as taught by Adikane (‘465) and Zhao (‘246) for Dunker’s (‘448) process to provide a desired milk stream.
Whether a membrane for separating dairy materials is described as “wide-pore” or “micro-pore” or “ultra-pore” is in part semantics.
Marella (2011) teaches using “wide-pore” ultrafiltration membranes for production of alpha-lactalbumin enriched whey protein concentrate that has been separated from beta-lactoglobumin wherein the wide-pore membrane openings are 25 kDa and 350 kDa (See FIGs 1 and 7 and pp. 1165-1166, 1173, where the openings are 50-100 kDa.).
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Marella (2011) gives a specific example as illustrated in FIG-7 where a beta-lactoglobumin rich stream is separated from an alpha-lactalbumin rich stream by means of a 50kDa “wide-pore”/micro membrane.
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It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date since Dunker’s (‘448) membranes that are described as being micro membranes fall would within Applicant’s definition of “wide-pore” membranes as they separate the same or substantially the same materials. This is further supported by Marella (2011) which discusses “wide-pore” membranes for separating the same types of materials as described by Dunker (‘448) and claimed.
It thus would have been obvious to a person having ordinary skill in the art prior to the earliest effective filing date with Dunker (‘448) and Marella (2011) before them the filtering system as described by Dunker (‘448) would have the same streams as claimed. Making any adjustment and modifications in processing would have been within the skill set of a person having ordinary skill in the art.
Regarding Claim 10, Dunker (‘448) teaches combining at least a portion of each of the cream, the eluate, the micro-filtered retentate, the wide-pore retentate, the ultra-filtered retentate, and the reverse osmosis retentate to produce a milk product (See para. 31+.).
Regarding Claim 11, Dunker (‘448) teaches treating the milk product with a lactase enzyme (See para. 17.).
Regarding Claim 12, Dunker (‘448) teaches subjecting the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Regarding Claim 13, Dunker (‘448) teaches subjecting one or more of the ultra-filtrated retentate, the micro-filtered retentate, and the wide-pore retentate to a diafiltration step to produce a diafiltered permeate and a diafiltered retentate (See para. 19+, 27, FIG-1.).
Regarding Claim 15, Dunker (‘448) teaches the method discussed above, however, fails to expressly disclose filtering the modified skim milk with a wide-pore filter prior to ultra-filtering to produce a wide-pore retentate and a wide-pore permeate, wherein a smallest molecule of the wide-pore retentate is between 25 kDa and 350 kDa.
Whether a membrane for separating dairy materials is described as “wide-pore” or “micro-pore” or “ultra-pore” is in part semantics.
Marella (2011) teaches using “wide-pore” ultrafiltration membranes for production of alpha-lactalbumin enriched whey protein concentrate that has been separated from beta-lactoglobumin wherein the wide-pore membrane openings are 25 kDa and 350 kDa (See FIGs 1 and 7 and pp. 1165-1166, 1173, where the openings are 50-100 kDa.).
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Marella (2011) gives a specific example as illustrated in FIG-7 where a beta-lactoglobumin rich stream is separated from an alpha-lactalbumin rich stream by means of a 50kDa “wide-pore”/micro membrane.
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It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date since Dunker’s (‘448) membranes that are described as being micro membranes would fall within Applicant’s definition of “wide-pore” membranes as they separate the same or substantially the same materials. This is further supported by Marella (2011) which discusses “wide-pore” membranes for separating the same types of materials as described by Dunker (‘448) and claimed.
It thus would have been obvious to a person having ordinary skill in the art with Dunker (‘448) and Marella (2011) before prior to the earliest effective filing date the filtering system as described by Dunker (‘448) would have the same streams as claimed. Making any adjustment and modifications in processing would have been within the skill set of a person having ordinary skill in the art.
Regarding Claim 16, Dunker (‘448) teaches the method discussed above, however, fails to expressly disclose wherein the wide-pore retentate comprises beta-lactoglobulin.
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date since Dunker’s (‘448) system is the same as claimed it would be capable of providing a wide-pore retentate that comprises beta-lactoglobulin (See para. 31+.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T O'HERN whose telephone number is (571)272-6385. The examiner can normally be reached M-Th 5:00 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached on 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T O'HERN/ Primary Examiner, Art Unit 1793
January 23, 2026