DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed January 7, 2026 has been entered. Claim 13 is new. Claims 1-13 are pending.
The previous rejection of claim 3 under 35 U.S.C. 112 (b) has been withdrawn in light of Applicant’s amendment and remarks filed January 7, 2026.
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.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Holst et al. (US 2012/0015082).
Regarding claims 1 and 11, Holst et al. disclose an aseptically packaged milk product (Abstract, [0124], [0230]) having a long shelf life.
Holst et al. disclose the aseptically packaged milk product has a furosine content of between 1 and 10 mg/liter of milk (approximately mg/kg milk-([0213], [0235]). 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 §2144.04 I).
Holst et al. disclose the aseptically packaged milk product is made by a process that includes an enzyme inactivation step ([0141]). Holst et al. disclose the enzyme inactivation step reduced the combined activity of plasmin and plasminogen in the treated milk by at least 99% ([0141]). Here a reduction of at least 99% is considered to include 100% reduction (i.e., plasmin activity of 0 µmol/g.h).
Holst et al. is silent with respect the amount of tyrosine after 135 days storage time, β-lactoglobulin and α-lactalbumin in the milk. However, Holst et al. disclose a process wherein the percentage of β-lactoglobulin that is denatured in the process is significantly less than milk processed by UHT processes ([0030],Figure 4). In addition, Holst et al. disclose the aseptically packaged milk product is made by process comprising the steps of: (a) providing a milk, i.e., whole or skim milk; (b) physically separating microorganisms from the milk using microfiltration to obtain a partly sterilized milk; (c) exposing a first composition comprising said partly sterilized milk to a high temperature treatment wherein the first composition is heated to a temperature in the range of 140°-180°C for a period of at most 200 msec and cooling; and (d) aseptically packaging the high temperature treated first composition ([0031]-[0040], [0054], [0069]-[0070]). Given Holst et al. disclose a process of making a milk product substantially similar to the presently disclosed invention, intrinsically, the milk would comprise β-lactoglobulin, α-lactalbumin and tyrosine (after 135 days storage time) in the claimed amounts.
Regarding claims 2-5, 12 and 13, Holst et al. disclose all of the claim limitations as set forth above. Given, Holst et al. disclose the milk is bovine milk, i.e., skim milk or whole milk, inherently the ratio of casein to whey protein and content of protein, ash, lactose and fat in the milk would fall within the claimed ranges.
Regarding claim 6, Holst et al. disclose all of the claim limitations as set forth above. Holst et al. disclose the aseptically packaged milk product is sterile ([0222]).
Regarding claims 7 and 8, Holst et al. disclose all of the claim limitations as set forth above. Given Holst et al disclose the aseptically packaged milk product is sterile ([0222]), inherently the product would be free of active microbes and their spores.
Regarding claim 9, Holst et al. disclose all of the claim limitations as set forth above. Holst et al. does not disclose a milk that has been process by UHT treatment. However, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself (MPEP §2113 I).
Regarding claim 10, Holst et al. disclose all of the claim limitations as set forth above. Given Holst et al. disclose the aseptically packaged milk product has a shelf-life of at least 182 days when kept at 25°C ([0188]), it necessarily follows the milk product would have a shelf-life of at least 2 months up to 6 months at room temperature (20°C).
Response to Arguments
Applicant's arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicant submits the Examiner’s reliance on inherency under MPEP §2112 is misplaced.
Regarding furosine, Holst et al. disclose the aseptically packaged milk product has a furosine content of between 1 and 10 mg/liter of milk (approximately mg/kg milk-([0213], [0235]). The range disclosed by Holst et al. overlaps the entire claimed range of about 3 to about 9 mg/kg milk.
Regarding β-lactoglobulin and α-lactalbumin, given Holst et al. disclose the milk is bovine milk wherein the bovine milk can be full fat milk, semi-skim milk or skim milk ([0047]-[0053]), the milk would necessarily comprise the β-lactoglobulin and α-lactalbumin in the claimed amounts. Holst et al. disclose only about 18% of the β-lactoglobulin in the milk is denatured after undergoing a microfiltration and heat treatment (see Figure 4) Therefore, about 78% of the β-lactoglobulin would remain native.
Regarding tyrosine equivalent, given Holst et al. disclose a process wherein the enzyme inactivation step reduces the combined activity of plasmin and plasminogen in the treated milk by at least 99% (i.e., 100%-[0141]), it necessarily follows the tyrosine equivalent would fall within the claimed range. The present disclosure teaches the tyrosine equivalent is used to determine the degree of proteolysis during storage. If the plasmin inactivation is effective, no proteolysis is detected (i.e., 50 mg/L or less tyrosine equivalent).
Applicant submit Holst et al. fails to achieve the claimed “plasmin activity of 0 µmol/g*h.” Applicant argues, given Example 1 of Holst et al. describes heat treatment of the microfiltered permeate of 15 seconds, significantly shorter than the minimum 30 seconds Holst et al. identifies as necessary for enzyme inactivation ([0133]), one of ordinary skill in the art would not expect the resulting product to possess a plasmin activity of 0.
In this case, while Holst et al., at paragraph [0133], states that in a preferred embodiment, the enzyme inactivation step comprises keeping the liquid to be treated at a temperature in the range of 70°-90°C for a period in the range of 30-500 seconds, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments (MPEP §2123 I). There is no evidence on the record that the milk of Example 1 would not have a plasmin activity of 0.
Applicant explains Holst et al. utilizes a microfiltration pore size of 0.8 micrometers and in the art, this pore size is associated with microbial removal. Applicant submits the permeate, which comprises both casein micelles and soluble whey protein (including β-lactoglobulin), is heat treated. Applicant argues the filtration process renders the claimed combination of plasmin activity of 0 µmol/g*h and about 0.20 g/100 ml to about 0.35 g/100 ml of native B-lactoglobulin physically unattainable.
Holst et al. disclose only about 18% of the β-lactoglobulin in the milk is denatured after undergoing a microfiltration and heat treatment (see Figure 4) Therefore, about 78% of the β-lactoglobulin would remain native. Therefore, Holst et al. teaches obtaining a milk product that both has a plasmin activity of 0 µmol/g*h and about 0.20 g/100 ml to about 0.35 g/100 ml of native B-lactoglobulin obtainable.
Applicants assert “a person of ordinary skill in the art would have had a reasonable expectation of failure-not success-in attempting to modify Holst to achieve the claimed combination of properties.”
As discussed above, Holst et al. disclose a milk product that comprises or inherently has includes the claimed components and properties. The Examiner does not suggest modifying the process of Holst et al. to achieve the claimed aseptically packed long shelf-life milk product.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759