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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 3, 2026 has been entered. Claims 1-6, 9-14 and 16-21 are pending. Claims 1-2, 9, 16 and 20-21 have been amended. Claims 7 and 15 have been canceled.
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 1-6 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mittal et al. (US 2015/0164123 A1; June 18, 2015) in view of Sher et al. (US Patent No. 6,998,143 B1; Feb. 14, 2006).
Regarding claim 1, Mittal teaches a method of in-situ complexation of an exogenous mineral with milk casein in liquid form for fortification in a dairy product with increased bioavailability of the exogenous mineral ([0017]-[0019], [0026], [0160], See Complex I: [0021]-[0108]), wherein the method comprises:
subjecting at least one material to hydration and dissolution at a heated temperature above room temperature (e.g. from 40-60 C; [0075], [0139]), wherein the material is a milk or milk derivative comprising milk protein, or casein ([0035]-[0037]), wherein the milk casein is in a micellar structure from the mammal ([0046], [0057]-[0058]),
cooling the at least one material to a temperature of 2-10 C ([0139]), thus overlapping the claimed range of 5-25 C, and
adding exogenous phosphorus (Abstract, [0066]-[0069]) and an exogenous mineral ([0048]-[0049]), wherein the mineral comprises ferrous salts of iron ([0047]-[0052]), to the at least one material to form a composition comprising a soluble complex (See Complex I: [0021]-[0108]; See Complex II: [0139]-[0152]).
Therefore, as Mittal teaches the method as described above, Mittal teaches a soluble complex comprising at least a portion of the exogenous mineral, at least a portion of the milk casein and at least a portion of the exogenous phosphorus, wherein the soluble complex has micellar structure (See Complex I: [0021]-[0108]).
While Mittal teaches the method as described above, Mittal is silent with respect to the step of subjecting the at least one material to high shear mixing and homogenization.
Sher discloses an iron fortification process, wherein a caseinate source is dissolved in an aqueous solution and further mixed until the solution is substantially homogenous, e.g. subjecting the material to mixing and homogenization (col 3 lines 66 - col 4 line 5).
As Sher recognizes the importance of the at least one material to be thoroughly mixed and homogenized before fortification with an exogenous mineral, it would have been obvious to one of ordinary skill in the art to subject the at least one material in Mittal to high shear mixing and homogenization in order to provide a homogenous mixture that can be easily combined with the exogenous phosphorus and exogenous mineral. The high shear mixing and homogenization ensures that the at least one material is uniformly dispersed in the mixture and would have been obvious to one of ordinary skill based upon the teachings in Sher.
With respect to the method not including any clarification step, Mittal teaches that a clarification step may be applied, but does not require a clarification step ([0088], [0107]). Sher further teaches no clarification step in the iron fortification process. Therefore, it would have been obvious to one of ordinary skill in the art to have the process of Mittal not include a clarification step if there was no need or want to remove precipitated or unwanted matter.
Regarding claim 2, as stated above, Mittal teaches that the at least one material to which the phosphorus and mineral are added is a milk comprising the milk casein ([0035]-(0037]), wherein the milk comprises protein and calcium ([0019]-[0020]), and the protein comprises whey and the milk casein ([0053]; See also Complex I: [0021]-[0108]).
Mittal further teaches that the milk has a weight ratio of the protein to the calcium equal to 45:1 ([0040]), which overlaps the claimed ranges of less than 45:1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Further, it would have been obvious to one of ordinary skill in the art vary the ratio of the protein to calcium depending on the desired mineral bioavailability as Mittal teaches that the amount of calcium is related to the mineral bioavailability ([0027]-[0029]).
Regarding claim 3, Mittal teaches that the composition does not have to comprise caseinate (See Complex I: [0021]-[0108]).
Regarding claim 4, Mittal teaches that the method does not have to add a pH regulator and the composition does not comprise a pH regulator as Mittal teaches that a pH regulator is only used if a calcium removal step needs to be performed.
Therefore, it would have been obvious to start with a low-level calcium milk source to avoid performing a calcium removal step ([0078]-[0090]).
Regarding claim 5, Mittal teaches that the at least one material can be whole milk, skim milk, low lactose milk, ultrafiltration retentate, concentrate milk, and mixtures thereof ([0072]).
Regarding claim 6, Mittal discloses that the phosphorus added is dipotassium phosphate ([0069]).
Regarding claim 19, Mittal teaches that the at least one starting material does not have to comprise caseinate (See Complex I: [0021]-[0108]).
Regarding claim 20, Mittal teaches that the exogenous phosphorus and exogenous mineral, or ferric iron salt, are added to the at least one material at a pH of between 5.8 and 10.5 and a temperature of 2-8 C ([0104]-[0105]), thus overlapping the claimed pH range of 6.5-7.3 and claim temperature of 5-70 C. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 21,Mittal further teaches that at least one additional ingredient, calcium, is present during the adding of the phosphorus and mineral, or ferric iron salt, to the milk composition to form the soluble complex ([0021]-[0024], [0039]-[0046]).
Claims 9-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mittal et al. (US 2015/0164123 A1; June 18, 2015).
Regarding claim 9, Mittal teaches a composition comprising calcium, a mineral that can be ferric iron salt, and protein (See Complex I: [0021]-[0108]), wherein the protein comprises whey and casein ([0053]).
Mittal further teaches that the composition comprises a soluble complex comprising at least a portion of the casein, at least a portion of the mineral and phosphorus (See Complex I: [0021]-[0108]), wherein the composition has a weight ration of the protein to the calcium equal to 45:1 ([0040]), while the claim requires a range between 40:1 and 10:1.
However, it would have been obvious to one of ordinary skill in the art vary the ratio of the protein to calcium depending on the desired mineral bioavailability as Mittal teaches that the amount of calcium is related to the mineral bioavailability ([0027]-[0029]). It would have been obvious to increase the calcium content depending on the desired mineral bioavailability and the nutritional composition of the milk product. This is merely routine experimentation that is well within the ordinary skill in the art.
As stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 10, Mittal teaches that the casein is in the form found in milk ([0033]).
Regarding claim 11, Mittal teaches that the composition does not have to comprise caseinate (See Complex I: [0021]-[0108]).
Regarding claim 12, Mittal teaches that the composition does not comprise a pH regulator as Mittal teaches that a pH regulator is only used if a calcium removal step needs to be performed.
Therefore, it would have been obvious to start with a low-level calcium milk source to avoid performing a calcium removal step ([0078]-[0090]).
Regarding claim 13, Mittal teaches that the composition comprises a milk from a mammal ([0035]-[0037]), wherein the milk comprises at least a portion of the whey and casein ([0053]), and wherein the milk can be whole milk, skim milk, low lactose milk, ultrafiltration retentate, concentrate milk, and mixtures thereof ([0072]).
Regarding claims 14 and 17, Mittal teaches that the phosphorus is dipotassium phosphate ([0069]).
Regarding claim 16, Mittal teaches that the soluble complex has a similar (e.g. equal) mineral bioavailability as ferrous sulfate ([0032]).
Further, it would have been obvious to one of ordinary skill in the art to vary the processing conditions and milk composition (e.g. amount of protein and calcium present) to result in a composition having a higher amount of mineral bioavailability as Mittal teaches that such parameters affect that amount of exogenous mineral available to form the soluble complex (See Complex I: [0021]-[0108]).
Regarding claim 18, as stated above, Mittal teaches that the mineral comprises iron, such as ferric iron ([0047]-[0052]).
With respect to the ratio of phosphorous to ferric iron being between 5:1 and 70:1, it would have been obvious to one of ordinary skill in the art vary the ratio of the phosphorous to ferric iron depending on the desired mineral bioavailability as Mittal teaches that the amount of mineral bounded is related to the mineral bioavailability and the desired use of the composition ([0027]-[0029], [0065]). It would have been obvious to vary the ratio of phosphorous to ferric iron depending on the desired mineral bioavailability and the nutritional composition of the milk product. This is merely routine experimentation that is well within the ordinary skill in the art.
As stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Response to Arguments
Applicant’s amendment has overcome the 112(b) rejection from the previous Office Action and therefore it has been withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but were not found persuasive.
Applicant argues on page 7 that Mittal teaches non-micellar iron-casein complexes and not a process of creating a micellar complex directly within native milk casein micelles.
This is not found persuasive as Mittal teaches using a milk or milk derivative comprising milk protein, or casein ([0035]-[0037]), wherein the milk casein is in a micellar structure from the mammal ([0046], [0057]-[0058]). Mittal further teaches adding exogenous phosphorus (Abstract, [0066]-[0069]) and an exogenous mineral ([0048]-[0049]), wherein the mineral comprises ferrous salts of iron ([0047]-[0052]), to the milk or milk derivative to form a composition comprising a soluble complex (See Complex I: [0021]-[0108]; See Complex II: [0139]-[0152]). Therefore, Mittal teaches a soluble complex comprising at least a portion of the exogenous mineral, at least a portion of the milk casein and at least a portion of the exogenous phosphorus, wherein the soluble complex has micellar structure (See Complex I: [0021]-[0108]).
Mittal teaches that the milk casein has a micellular structure. While Mittal teaches that some of the casein micelles can be broken down, Mittal does not teach that all the micelles are broken down as all the calcium is not removed and therefore there the soluble complex would have part of a micellular structure ([0046], [0057], [0058]), thus meeting the claimed language “the soluble complex has micellar structure”. The claims do not limit the soluble complex to only having micellar structure and therefore this argument is not found persuasive.
Applicant further argues on page 7 that the skilled person would not have expected that a soluble micellar complex can be formed directly in milk without any clarification step.
This is not found persuasive as Mittal teaches that a clarification step may be applied, but does not require a clarification step ([0088], [0107]). Sher further teaches no clarification step in the iron fortification process. Therefore, it would have been obvious to one of ordinary skill in the art to have the process of Mittal not include a clarification step if there was no need or want to remove precipitated or unwanted matter.
The examiner notes that a showing or description of unexpected results regarding the soluble complex being completely micellular or not requiring a clarification step would aid in overcoming the current 103 rejection.
For the reasons stated above, a 103 rejection is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Nikki Dees can be reached at (571) 270-3435. 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.
/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791
Prosecution Insights