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 .
Claim Objections
Claims 11 and 23 are objected to because of the following informalities:
Claim 11 recites “rosemary extract, and hydrogen peroxide” and should properly read “rosemary extract, hydrogen peroxide”
Claim 23 recites a food product “essentially free of another a protein” and should properly read “essentially free of another protein”.
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 1-24 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 a protein in “substantially” purified form. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, any protein which has been purified is interpreted to meet the limitation.
Claims 1 and 11 recite the term “for example” (e.g.). The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-24 depend from independent Claim 1 and are therefore also rejected.
Claims 6 and 7 recite a limitation wherein “the substantial amount is an amount that leads to production of an undesirable level of a volatile sulfur-containing compound”. It is unclear what is considered an “undesirable level” of a volatile sulfur-containing compound. For the purposes of examination, any detectable amount of volatile sulfur compounds is considered to be an “undesirable level”.
It is additionally unclear if the “substantial amount” of protein refers to the protein prior to the “process that results in the production of the food product” (step b of Claim 1) or the protein within the food that “comprises a substantial amount of protein” (Claim 1, Lines 1-2). For the purposes of examination, the limitations are interpreted to apply to step b.
It is additionally unclear whether the production of an “undesirable level” of sulfur-containing compound occurs in the presence or absence of the oxidizing agent of Claim 1 step b), i.e. whether the presence of the oxidizing agent of Claim 1, step b) prevents the production of the Claimed “undesirable levels” of sulfur compounds. For the purposes of examination, production of sulfur compounds in the absence of the oxidizing agent is interpreted to meet the limitations of the Claim.
Claim 10 recites a mixture comprising “more than 0.9% by mass of a lipid and an antioxidant”. It is unclear if the 0.9% limitation refers to the lipid or the combination of a lipid and an antioxidant. For the purposes of examination, the limitation is interpreted as applying to the lipid.
Claim 14 recites a molar ratio. However, no basis for the ratio is provided. For the purposes of examination, the molar ratio is interpreted as the ratio of hydrogen peroxide to β -lactoglobulin of less than 4.
Claim 17 recites “high temperature heating”. No basis of comparison is provided for what constitutes “high temperature”.
Claim 22 recites a “milk or barista beverage”, and additionally a “soft serve/shake mix/frozen dessert mix/creamer”. It is unclear if the milk or barista beverage, and the soft serve/shake mix/frozen dessert mix/creamer, are intended to be claimed in the alternative. For the purposes of examination, milk, a barista beverage, soft serve, shake mix, frozen dessert mix, or creamer are interpreted to meet the limitation of the claim.
Claims 23 and 24 recite a food product “essentially free” of a protein other than the protein comprising a sulfur-comprising amino acid. It is unclear how much alternative protein may be provided while remaining “essentially free” of an alternative protein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6, 11, 12, 13, 17, 18, 19, 20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Attabi (“Effect of Hydrogen Peroxide on Volatile Sulfur Compounds in UHT Milk”, https://food.global-summit.com/europe/abstract/2015/effect-of-hydrogen-peroxide-on-volatile-sulphur-compounds-in-uht-milk, 2015)
Regarding Claims 1, 11, 12, and 13, Al-Attabi teaches that hydrogen peroxide, which is an oxidizing agent, can be added to milk (Page 25) prior to the milk undergoing a heating process (Slides 23 and 24). Al-Attabi teaches that the heating process results in the generation of sulfur compounds (Slide 4) from denatured β-lactoglobulin.
Note that regarding Claim 1, the limitations of a “substantially purified” protein (step a) and combining “one of more ingredients” (step b) are optional. Additionally, note that any food which has undergone the claimed method is interpreted to meet the limitation of a food product comprising a “substantial amount” of a sulfur-comprising amino acids. Additionally, note that where Al-Attabi teaches heating according to claims 17-20, the method of Al-Attabi is interpreted to result in “exposing the sulfur-comprising amino acid” as claimed.
Regarding Claim 4, Al-Attabi teaches the use of milk, which comprises milk proteins.
Regarding Claim 6, Al-Attabi teaches that processing of the milk results in an undesirable level of volatile sulfur compounds (Page 4).
Regarding Claim 17, 18, and 19, Al-Attabi teaches heating at 95 °C for 6 seconds (Page 9), which lies within the claimed range(s). Note that the claim does not require that only a single heating step is performed.
Regarding Claim 20, Al-Attabi teaches heating at 145 °C for 6 seconds (Page 9), which lies within the claimed range(s). Note that the claim does not require that only a single heating step is performed.
Regarding Claim 22, Al-Attabi teaches a milk product (Page 25).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Attabi as applied to Claim 1, above, and in view of US Dairy Export Council (https://usdairyexcellence.org/wp-content/uploads/2025/02/en_2023-RTD-Monograph.pdf?_t=1742168497, 2017)
Regarding Claim 2, Al-Attabi teaches the treatment of milk according to Claim 1 but does not address the treatment of proteins isolated from a natural source.
US Dairy Export Council teaches that milk protein isolates can be subjected to UHT treatment (Page 4). Note that US Dairy Council teaches that the milk protein isolates are derived from conventional dairy, and is therefore that the protein is isolated from a natural source (Page 1, “The Ready-to-Drink Beverage Market”). US Dairy Export Council teaches that milk protein isolates provide a high-quality source of protein to consumers.
It would have been obvious to have modified the method of Al-Attabi to treat a milk protein isolate derived from a natural source as taught by US Dairy Export Council. One would have been motivated to make such a modification since Al-Attabi teaches the treatment of milk (and milk proteins) undergoing UHT processing, and US Dairy Export Council teaches that milk protein isolates derived from natural sources may undergo UHT processing. One additionally would have been motivated to make such a modification to provide for a high quality protein beverage.
Claim(s) 3, 5, 7, 8, 10, 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Attabi as applied to Claim 1, above, and in view of Geistlinger (US 2021/0329941 A1).
Regarding Claim 3 and 5, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address the use of a recombinant protein.
Geistlinger teaches that a recombinant β-lactoglobulin [0164] can be used for a dairy substitute product such as milk [0199]. Geistlinger teaches that the use of such products avoids concerns regarding animal welfare and the environment [0004].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to utilize a milk product utilizing a recombinant β-lactoglobulin as taught by Geistlinger in the method of Al-Attabi. One would have been motivated to make such a modification to produce a product without the animal welfare and environmental concerns of conventional milk.
Regarding Claim 7, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address the use of a recombinant protein.
Geistlinger teaches that a recombinant β-lactoglobulin [0164] can be used for a dairy substitute product such as milk [0199]. Note that Geistlinger teaches that the β-lactoglobulin is isolated [0252]. Geistlinger teaches that the use of such products avoids concerns regarding animal welfare and the environment [0004].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to utilize a milk product utilizing a recombinant β-lactoglobulin as taught by Geistlinger in the method of Al-Attabi. One would have been motivated to make such a modification to produce a product without the animal welfare and environmental concerns of conventional milk.
Modified Al-Attabi does not address what percentage of the β-lactoglobulin is combined with oxidizing agent.
However, it would have been obvious to have combined any amount of the β-lactoglobulin protein with an oxidizing agent, including the amounts as claimed. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 8, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address the use of pH or ionic strength adjusting agents.
Geistlinger teaches that a recombinant β-lactoglobulin [0164] can be used for a dairy substitute product such as milk [0199], and that the pH and ionic strength of the product match the conventional food [0200]. Geistlinger teaches that the use of such products avoids concerns regarding animal welfare and the environment [0004].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to utilize a milk product utilizing a recombinant β-lactoglobulin as taught by Geistlinger in the method of Al-Attabi, and additionally to have adjusted the pH and ionic strength of the milk product, since Geistlinger teaches that the pH and ionic strength of the milk product can match that of conventional milk. One would have been motivated to make such a modification to produce a product without the animal welfare and environmental concerns of conventional milk.
Regarding Claim 10, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address the lipid content of the milk.
Geistlinger teaches that whole milk has antioxidants [0242] and greater than 3.25% milk fat [0199].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to utilize a milk product having the lipid and antioxidant content as claimed. One would have been motivated to make such a modification since Geistlinger teaches that such content is typical for a milk product.
Regarding Claim 21, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address a supplemented or substitute product.
Geistlinger teaches that a recombinant β-lactoglobulin [0164] can be used for a dairy substitute product such as milk [0199]. Geistlinger teaches that the use of such products avoids concerns regarding animal welfare and the environment [0004].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to modify Al-Attabi to utilize the substitute diary product of Geistlinger, and therefore provide for a “supplemented or substitute diary product” a claimed. Note that the instant Specification at [0074] teaches that any food product that has been supplemented with a protein comprising a sulfur-comprising amino acid is a supplemented food product.
Regarding Claims 23 and 24, Al-Attabi teaches that denatured β-lactoglobulin is a source of an undesirable flavor in pasteurized milk. Al-Attabi does not address the presence of other proteins.
Geistlinger teaches that a recombinant β-lactoglobulin [0164] can be used for a dairy substitute product such as milk [0199]. Geistlinger teaches the use of “at least one” recombinant protein, including β-lactoglobulin [0206]. Geistlinger teaches that the diary substitute avoids concerns regarding animal welfare and the environment [0004].
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to utilize a milk product utilizing a recombinant β-lactoglobulin as taught by Geistlinger in the method of Al-Attabi. One would have been motivated to make such a modification to produce a product without the animal welfare and environmental concerns of conventional milk. Where Geistlinger teaches the use of “at least one” of a milk protein, it additionally would have been obvious to have provided β-lactoglobulin as the only protein.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Attabi in view of Geistlinger as applied to Claim 8, above, and further in view of Olsen (https://www.healthline.com/health/ph-of-milk, 2018, reference is made to the provided excerpt).
Regarding Claim 9, modified Al-Attabi teaches the method as discussed above in regard to Claim 8 but does not discuss the pH of the milk.
Olsen teaches that conventional milk has a pH of 6.7-6.9 (“The pH levels of different types of milk”).
Therefore, it would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to adjust the pH to within the claimed range. One would have been motivated to make such a modification since Olsen teaches that such a pH would match that of conventional milk.
Claims 14, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Attabi as applied to Claim 1, above, taken with evidentiary reference of Ng-Kwai-Hang (“Different amounts of β-lactoglobulin A and B in milk from heterozygous AB cows”, DOI: 10.1016/0958-6946(95)00069-0, July 1996).
Regarding Claims 14, 15, and 16, Al-Attabi teaches the use of 10-300 mg/L of hydrogen peroxide in milk (Page 13). Note that the molecular weight of hydrogen peroxide is 34.014 g/mol. Al-Attabi therefore teaches the use of 0.29-8.8 mmol of hydrogen peroxide per liter of milk.
Ng-Kwai-Hang teaches that β-lactoglobulin comprises 60% of the whey protein in cows (Introduction, Line 1). Ng-Kwai-Hang additionally teaches that whey protein in cow’s milk ranges from 0.7-0.74% of the milk. Ng-Kwai-Hwang therefore teaches that milk comprises 0.42-0.44% β-lactoglobulin, which is 4.2-4.4 grams/L.
Note that absent evidence to the contrary, the percentages are interpreted as weight percents. Additionally, note that β-lactoglobulin has a molecular weight of approximately 18,400 g/mol.
Ng-Kwai-Hwang therefore teaches that 1 liter of milk comprises 0.22-0.24 mmol of β-lactoglobulin (e.g. 4.2 grams /18,400 g/mol * 1000 mmol/mol).
Al-Attabi therefore teaches a ratio of hydrogen peroxide to β-lactoglobulin of 1.2-40, which overlaps the claimed range.
Conclusion
The following art made of record is considered pertinent to the Applicant’s disclosure
Zabbia (“Undesirable Sulphur and Carbonyl Flavor Compounds in UHT Milk : A Review”, DOI: 10.1080/10408398.2010.487166, 2012)
Zabbia discloses that oxidants such as potassium iodate (Page 25, Column 2, Paragraph 1) may be added to milk to reduced odors and flavors resulting from sterilization.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH LIU whose telephone number is (571)270-5685. The examiner can normally be reached 12-8 Eastern Time.
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/D.L./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791