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 1-8, in the reply filed on 05/29/2026 is acknowledged.
Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/2026.
Status of Claims
Claims 1-11 are pending. Claims 9-11 are withdrawn. Claims 1-8 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: The recitation of abbreviated language without first providing the non-abbreviated form. The abbreviated language recited in the claims are: IgA, IgM and MF. Appropriate correction is required.
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 1-8 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.
Claim 1 recites “preferably enriched in IgA and IgM” in the preamble. Should it be deemed that the preamble breathes life and meaning to the claim, as a whole, it is not readily apparent if said recitation is intended as a limitation. Claims 2-8 are also rejected for the same reason.
Claim 2 recites the broad recitation “in the range 5.6-6.2”, and the claim also recites “more preferably 5.6-6.0, and most preferably 5.6-5.8” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
The remainder of the claims, 3-8 are also rejected for the same reason.
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.
Claim(s) 1, 5-6, is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Pires:
Carter (Carter. Invited review: Microfiltration-derived casein and whey proteins from milk. Journal of Dairy Science, Volume 104, Issue 3, March 2021, Pages 2465-2479.)
Pires (Pires. Dairy By-Products: A Review on the Valorization of Whey and Second Cheese Whey. Foods May 12 2021, 10, 1067. https://doi.org/10.3390/foods10051067.)
Regarding claim 1: Carter teaches the microfiltration of skim milk. [Figure 2] The microfiltration of the milk results in a retentate and permeate. The retentate contains caseins. The permeate contains whey protein. Carter also teaches the use of the casein to make cheese. [Micellar Casein section] In the instant case, Carter does not expressly note that a casein-rich fraction and a whey fraction is created. However, it logically follows that such is the result of making cheese; wherein the casein fraction is cheese; and the whey fraction is the byproduct. This position is also supported by Carter’s disclosure. At paragraph bridging pages 2473-2474, Carter teaches that cheese whey protein, the byproduct of the cheese making process, contains residues of cheesemaking.
Carter does not teach subjecting the whey fraction obtained from the cheese making process to microfiltration.
Pires teaches subjecting cheese whey to microfiltration to make whey protein concentrates (WPC), whey protein isolates (WPI) and whey protein hydrolysates (WPH). [Section 4, and Figure 2.]
It would have been obvious to one of ordinary skill in the art before the effective filing date to have taken the cheese whey of Carter and subjecting it to microfiltration. One of ordinary skill in the art would have been motivated to do so to make whey protein concentrates (WPC), whey protein isolates (WPI) and whey protein hydrolysates (WPH). One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Pires establishes that it can be done.
Regarding claim 5: Carter nor Pires teach the use of a membrane having pore size of 50-100 nm in the microfiltration of the whey fraction. However, Carter teaches that the use of membrane of 100 nm to separate casein micelles, bacteria, fat globules and somatic cells from whey proteins (3-6 nm), lactose (1 nm), minerals and water. [Figure 1, and paragraph bridging pages 2465-2466.]
It would have been obvious for one of ordinary skill in the art before the effective filing date to use a membrane having 100 nm. One of ordinary skill in the art would have been motivated to do so a membrane having pore size of 50-100 nm. However, Carter teaches that the use of membrane of 100 nm to separate casein micelles, bacteria, fat globules and somatic cells from whey proteins (3-6 nm), lactose (1 nm), minerals and water. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Carter establishes that membrane size is result effective variable, and adjustment of result effective variable is routinely practiced in the art.
Regarding claim 6: Carter nor Pires teaches performing microfiltration of the whey fraction with a ceramic membrane using a cross-flow of 5-7 m/s.
Carter teaches the use of ceramic membrane in microfiltration for dairy processing. [1st full paragraph on page 2466.] And, Carter teaches that to reduce fouling on ceramic microfiltration, a cross-flow velocity of 5-7 m/s is applied.
It would have been obvious for one of ordinary skill in the art to us a ceramic membrane and apply a cross-flow velocity of 5-7 m/s in microfiltering the whey fraction. One of ordinary skill in the art would have been motivated to do so to reduce fouling. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Carter establishes that ceramic membrane can be used in dairy processing and that cross-flow velocity is a result effective variable, and adjustment of result effective variable is routinely practiced in the art.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Pires, in further view of Schafer:
Schafer (Schafer. Calcium reduced skim milk retentates obtained by means of microfiltration. Journal of Food Engineering. Vol. 247, 168-177, April 2019.)
Regarding claim 2: Carter nor Pires teach adjusting the pH of the skimmed milk to the range of 5.6-6.2. Schafer teaches that in order to generate skim milk retentates having a maximum reduced calcium content, while obtaining a permeate that can be processed like sweet whey, Schafer suggest to i) concentrate skim milk via microfiltration at pH 6.2, ii) acidify the corresponding retentate to pH 5.6, and iii) elute the serum calcium via a six stage microfiltration in the diafiltration mode. [1st paragraph under Conclusion section.]
It would have been obvious to one of ordinary skill in the art before the effective filing date to adjust the skim milk to pH 6.2. One of ordinary skill in the art would have been motivated to do so to generate skim milk retentates having a maximum reduced calcium content, while obtaining a permeate that can be processed like sweet whey. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Shafer demonstrated that it can be achieved.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Pires, in further view of Gielens:
Gielens (US PGPub No. 20210127697)
Regarding claim 3: Carter nor Pires teach the addition of a fat source to the casein, addition of a coagulant and an acidifier; and coagulation.
Gielens teaches a cheese making process. The process of Gielens includes the addition of a fat source to the casein (retentate), addition of a coagulant to result in a coagulation. [Claim 1] Gielens also teaches adding an acid to acid to milk to precipitate non-micellar casein proteins to be used in making the cheese. [0040-0044]
It would have been obvious for one of ordinary skill in the art before the effective filing date to add of a fat source to the casein, coagulant, and an acid. One of ordinary skill in the art would have been motivated to do so to make cheese. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Gielens demonstrates that cheese making can be attained with the noted process.
Claim(s) is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Pires, in further view of Heidebrecht:
Heidebrecht (Heidebrecht. Fractionation of casein micelles and minor proteins by microfiltration in diafiltration mode. Study of the transmission and yield of the immunoglobulins IgG, IgA and IgM. International Dairy Journal. 93, 2019, 1-10.)
Regarding claim 4: Carter nor Pires teach acidifying the whey fraction obtained from cheese to a pH range of 4-5 before the microfiltration step c).
Heidebrecht teaches that greater recover of immunoglobulins such as IgA, IgM and IgG is improved if the pH is close to the IEP (isoelectric point) measured for each of the immunoglobulins. [Last 2 paragraphs of Section 3.2] The IEP for IgA, IgM and IgG are: 4.5-6.8, 4., and 5.8. More specifically, Heidebrecht teaches when the pH is above the IEP, the rate of transmission is not great.
It would have been obvious for one of ordinary skill before the effective filing date to adjust the pH of whey fraction obtained from cheese to a pH range of 4-5 before the microfiltration step c) to a pH that is close to the IEP (isoelectric point) measured for each of the immunoglobulins. One of ordinary skill would have been motivated to do so to affect the transmission rate. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Heidebrecht establishes that transmission rate is dependent on pH, a result effective variable, and adjustment of result effective variable is routinely practiced in the art.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Pires, in further view of Heidebrecht2:
Heidebrecht2. (Heidebrecht2. Concentration of Immunoglobulins in Microfiltration Permeates of Skim Milk: Impact of Transmembrane Pressure and Temperature on the IgG Transmission Using Different Ceramic Membrane Types and Pore Sizes. Foods, 2018, 7(7), 101.)
Regarding claim 7: Carter nor Pires teaches performing the microfiltration of the whey fraction at 10-15°C.
However, Heidebrecht teaches that for microbiological reasons, milk protein fractionation with microfiltration is carried out at cold temperatures around 10 °C, which is below the growth optimum of microorganism in milk [3.4], and performed microfiltration of whey fraction at 10 °C. [Figure 6]
It would have been obvious to one of ordinary skill in the art before the effective filing date to perform the microfiltration of the whey fraction at 10 °C. One of ordinary skill in the art would have been motivated to do so to minimize or avoid microorganism growth. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Heidebrecht establishes that temperature and microorganism growth are result effective variable, and the adjustment of result effective variable is routine practiced in the art.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter in view of Radosavljević:
Radosavljević (Radosavljević. Application of Ion Exchange and Adsorption Techniques for Separation of Whey Proteins from Bovine Milk. Current Analytical Chemistry, 2019, Volume 0, Pages 1-14.)
Regarding claim 8: Carter teaches the microfiltration of skim milk. [Figure 2] The microfiltratioof the milk results in a retentate and permeate. The retentate contains caseins. The permeate contains whey protein. Carter also teaches the use of the casein to make cheese. [Micellar Casein section] In the instant case, Carter does not expressly note that a casein-rich fraction and a whey fraction is created. However, it logically follows that such is the result of making cheese; wherein the casein fraction is cheese; and the whey fraction is the byproduct. This position is also supported by Carter’s disclosure. At paragraph bridging pages 2473-2474, Carter teaches that cheese whey protein, the byproduct of the cheese making process, contains residues of cheesemaking.
Carter do not teach adjusting the pH of the whey fraction to 6.5-7 before subjecting it to anion exchange chromatography.
Radosavljević teaches the use of anion exchange chromatography on whey fractions. [3.1] Radosavljević also teaches that anion exchange chromatography enables adsorption of acidic whey proteins to the positively charged ion exchanger at the pH above their pI (Isoelectric point). And, according to Radosavljević, the pI of whey proteins falls in the narrow pH range of 4.7-5.4. And, Radosavljević uses a pH of 7.0. [Figure 1]
It would have been obvious for one of ordinary skill in the art before the effective filing date to have adjusting the pH of the whey fraction to a pH of 7 before subjecting it to anion exchange chromatography. One of ordinary skill in the art would been motivated to do so to enable adsorption of acidic whey proteins to the positively charged ion exchanger. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Radosavljević establishes that pH is a result effective variable when it comes to ion-exchange chromatography, and the and adjustment of result effective variable is routinely practiced in the art.
Conclusion
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/EMILY M LE/ Supervisory Patent Examiner, Art Unit 1793
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