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 .
This office action is in response to the application filed on April 4, 2024.
Election/Restrictions
Applicant's election with traverse of Group I, claims 29-51, in the reply filed on March 16, 2026 is acknowledged. The traversal is on the ground(s) that the “special technical feature” should not be defined as in the restriction requirement and should instead be defined as the specific ED mineral-transfer configuration using two milk-derived streams as diluate and concentrate, together with the at least 30 cell-pair stack requirement. This is not found persuasive because the methods of the two groups are for different purposes and the diluate streams in the electrodialysis processes of each group are different, as the diluate stream of Group I specifically contains at least a portion of a UF permeate from a milk feed while the diluate stream of Group II requires only broadly a stream from a milk feed and dairy materials. Therefore, the specific configuration is different and the special technical feature remains as recited in the previous restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 52-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 16, 2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) with a filing date of October 6, 2021. The certified copy of EP 21201319 has been filed in the present application, received on April 4, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The present application is a 371 National Stage Application of PCT/ EP2022/077842 which has a filing date of October 6, 2022.
Status of Application
Claims 29-58 were originally presented and subject to a restriction requirement. Claims 29-58 are pending; claims 52-58 are withdrawn; claims 1-28 are canceled. Claims 29-51 are presented for examination.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is less than 50 words and contains the implied phrase of “the invention relates to.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 29, 30, 32, 35, 36, 39, 42, 45-48, 51, and 52 are objected to because of the following informalities:
Claim 29 recites “the first mineralized ED concentrate stream of step b)” in line 4 of step d) and claim 42 recites “the mineralized ED concentrate(s) of step b)” while claim 29 in step b) recites “a first mineral-enriched ED concentrate stream.” Thus, the language for further iterations should be “mineral-enriched” instead of “mineralized.”
Claim 29 in line 7 of step d needs a piece of punctuation at the end of the line, such as a semi-colon or comma.
Claim 30 ends in a comma, should be a period.
Claim 32 is objected to because the proper Markush language is not used. The claim recites “selected from the group consisting of skimmed milk, semi-skimmed milk, and whole milk, or a protein concentrate thereof, or a dilution thereof” (emphasis added), whereas the proper Markush language is “selected group from the group consisting of A, B, C, D, and E,” or alternatively as “is A, B, C, D, or E.” See MPEP 803.02.
Claims 35 and 36 recite “NF retentate,” “RO retentate,” “NF permeate,” and “RO permeate.” At the first iteration of an acronym in a claim set, the full term should be written out then followed by the acronym in parentheses, e.g. “nanofiltration (NF) retentate.” “NF” and “RO” are understood to be nanofiltration and reverse osmosis, respectively, per the instant specification.
Claim 36 recites, in lines 2-3, “derived from of the UF permeate,” should read either “derived from the UF permeate” or “derived of the UF permeate."
Claim 39 recites “of lactose-reduced milk intermediate liquid of step d)” twice in lines 2 and 4, should read “of the lactose-reduced milk intermediate liquid of step d)” since it is referring to an earlier recited component.
Claims 45-48 recite “of lactose-reduced milk product,” should read “of the lactose-reduce milk product” since it is referring to an earlier recited component.
Claim 51 recites “according claim 50,” should read “according to claim 50.”
Claim 52 recites “a non-protein-nitrogen,” should read “a non-protein nitrogen” (no hyphen in between protein and nitrogen) to align with the earlier claim language of claims 49 and 50.
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 29-51 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 29 is rendered indefinite because it is directed a “method of producing a lactose-reduced milk product” yet there is no method step that actually produces a lactose-reduced milk product. The last step, step d, of claim 29 produces a lactose-reduced milk intermediate liquid, and claims 30 and 31 recite a further step, step e, of processing the lactose-reduced milk intermediate liquid, but there is no indication in the claims that any of these steps produce a lactose-reduced milk product. Therefore, it is unclear how the lactose-reduced milk product is produced and the claim is thereby rendered indefinite. For the purposes of examination, the lactose-reduced milk intermediate liquid will be interpreted as the lactose-reduced milk product.
Claim 29 recites the limitations "the ED stack" in line 8 of step b and “the minerals” in lines 4 and 6 of step d. There is insufficient antecedent basis for this limitation in the claim.
Claims 29 and 36 recite “comprises or even consists of” and/or “comprising, or even consisting of” in steps b and c (each twice) of claim 29 and line 2 of claim 36, which renders the claim indefinite because it’s unclear whether the claim is intending to be inclusionary (comprising) or exclusionary (consists of) – it cannot be both. The transitional phrases at issue as currently presented are unclear in their meaning. See MPEP 2111.03. For the purposes of examination, the claims will be interpreted as comprises/comprising.
Claims 29 and 36 recite the phrase “preferably” in the third to last line of claim 29 and line 3 of claim 36, which renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
Claim 39 recites the limitations "the solids" in line 2 and “the mineral” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 41 and 49 refer to a percentage without defining the base unit for the protein content and the non-protein nitrogen content. Claim 50 merely recites a protein content of “1-15” without giving a unit or indicating that it’s a percentage. In any case, it is presumed that the protein content is at minimum intended to be a percentage, as aligning with the protein content recitation in claims 41, 49, and 52. It is noted that the claim limitation is unclear as to whether the % is based on weight, volume, molar, etc., and as such, the claims fail to distinctly claim the subject matter of the invention and is therefore indefinite. For the purposes of examination, the claim will be interpreted as percent by weight.
Claim 42 recites the limitation “the mineralized ED concentrate(s) of step b) or c)” in line 4. There is insufficient antecedent basis for this limitation in the claim. Steps b and c of claim 29 recite “a mineral-enriched ED concentrate stream.” A concentrate is assumed to be different from a concentrate stream.
Claim 44 recites the limitation "the ED system" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 45 recites the limitation "the solids" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites the limitation "the protein" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation "the mineral" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 48 recites the limitation "the water" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 30-35, 37, 38, 40, 43, and 51 are rejected as being dependent on a rejected base claim.
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 29-51 are rejected under 35 U.S.C. 103 as being unpatentable over Ur Rehman et al. (US PG Pub. 2019/0223461; listed on IDS dated July 12, 2024) in view of Batchelder (US Patent 5,223,107), herein after referred to as Ur Rehman and Batchelder, respectively.
Regarding claim 29, Ur Rehman teaches a method of producing a dairy composition, the method comprising the steps of:
a) ultrafiltering a milk product (i.e., milk feed) to produce (i.e., subjecting a milk feed to ultrafiltration (UF) to provide) a UF retentate fraction and a UF permeate fraction;
b) performing an electrochemical process using a stream which comprises: the UF permeate fraction (i.e., a portion of the UF permeate; as defined in the instant specification), to provide a lactose fraction, a positively charged fraction, and a negatively charged fraction then combining the positively charged fraction and the negatively charged fraction to form a mineral stream (i.e., a mineral-enriched ED concentrate stream) (Constructive Example 1: [0092]);
d) forming a dairy composition by combining the UF retentate fraction, the positively charged fraction, and the negatively charged fraction (the positive and negative fractions being the mineral-enriched ED concentrate stream and subjected to a reverse osmosis step to produce a concentrated mineral fraction) (i.e., at least the minerals of the first mineralized ED concentrate stream) (claim 3).
Ur Rehman teaches that the electrochemical process is an electrodialysis process ([0026]; claim 6). Ur Rehman additionally teaches that the UF retentate is enriched with respect to milk protein and the UF permeate is enriched with respect to lactose (as compared to the other components in the UF permeate stream) (table in Constructive Example 1).
The stream entering the electrodialysis process taught by Ur Rehman is considered a diluate stream since it comprises the claimed required components.
Ur Rehman is silent as to that the dairy composition is a lactose-reduced milk product, however, since the lactose fraction produced by the method is not combined to make the final dairy composition, made from skim milk, the final dairy composition necessarily has less lactose as compared to the starting feed and is therefore considered to be a lactose-reduced milk intermediate liquid/product.
Ur Rehman is silent as to that the ED stack used in step b contains at least 30 cell pairs.
Batchelder, in the same field of invention, teaches a dialysis process of whey-based material (e.g., milk) wherein the ED stack contains 200 cell pairs (col. 5 lines 62-68). Batchelder teaches suitable amounts of cell pairs for ED stacks in ED processes where Ur Rehman is silent, thereby offering a guideline as to a suitable amount of cell pairs. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the ED process of Ur Rehman to have the amount of cell pairs of Batchelder, thereby arriving at the claimed invention, with the reasonable expectation that the amount of cell pairs is suitable for use in the claimed ED process.
Regarding claims 30 and 31, Ur Rehman teaches that the lactose-reduced milk intermediate liquid/product of step d) is further processed by packaging the composition for retail distribution and sale [0030].
Regarding claim 32, Ur Rehman teaches that the milk feed is skim milk (Constructive Example 1: [0092]).
Regarding claim 33, Ur Rehman teaches that the starting milk product (i.e., milk feed) has a protein content of 3-4 wt.% [0024], while the UF retentate has a protein content of 12.6 wt.% (table in Constructive Example 1). This is a 215-320% increase from the protein content of the milk feed to the protein content of the UF retentate, thereby meeting the claim limitation of at least 20% higher.
Regarding claim 34, Ur Rehman is considered to teach, as set forth above with regard to claim 29, that the UF permeate is the diluate stream of step b, thereby meeting the claim limitation of making up at least 50% w/w of the diluate stream.
Claims 35-37 are met through the rejection of claim 29 as set forth above. Claim 29 requires the selection of a portion of the UF permeate or other liquids; by selecting a portion of the UF stream to meet claim 29, claims 35-37 are also considered to be met.
Regarding claim 38, modified Ur Rehman is silent as to that the demineralization rate of the electrodialysis step is at least 60%.
However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the process of modified Ur Rehman is substantially identical to that of the claimed process, the prior art process must necessarily possess the same properties and characteristics as the process claimed. Therefore, the process taught by modified Ur Rehman is considered to possess the demineralization rate as claimed because the process is substantially the same and thus must necessarily exhibit the same properties.
Regarding claims 39, 40, and 45-48, as best understood with regard to the 112(b) rejection of claim 29 above, Ur Rehman teaches that the lactose-reduced milk intermediate liquid/product is made only from the milk feed, and as such, the product is entirely a component of the starting milk feed. Therefore, all of the solids, protein, minerals, and water in the liquid/product must necessarily originate from the milk feed, thereby meeting the claim limitations.
Regarding claims 41 and 49, as best understood with regard to the 112(b) rejection of claim 29 above, Ur Rehman teaches that the final dairy composition (i.e., the lactose-reduced milk intermediate liquid being the same as the lactose-reduced milk product) has a protein content of 3-10 wt.% [0087], which meets the claim limitation of having a protein content of 1-15 wt.%.
Regarding claim 42, Ur Rehman teaches that the lactose-reduced intermediate liquid comprises the UF retentate, as set forth above, but is silent as to the amount being 30-80 wt.%.
However, where 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). Since concentration of a component in a composition or process is a known variable that affects various properties of a resulting product, this is a result-effective variable. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range through no more than routine optimization, as varying the concentration of the UF retentate would achieve recognized results. Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05.II. Thus, the parameters of the amounts of UF retentate in the liquid taught by Ur Rehman renders obvious the instant claim limitations.
Regarding claims 43 and 44, modified Ur Rehman teaches that the ED stack contains 200 cell pairs (Batchelder: col. 5 lines 62-68), thereby meeting the claim limitation of claim 43 of at least 100 cell pairs and overlapping with the claim limitation of claim 44 of 30-1000 cell pairs. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Regarding claims 50 and 51, modified Ur Rehman teaches a dairy composition (i.e., lactose-reduced milk product) obtained by the method of claim 29 having:
a fat content of 0.1-5 wt.%,
a lactose content of less than or equal to about 4 wt.%, and
a protein content of 3-10 wt.% [0087].
The protein content taught by Ur Rehman meets the claimed range of 1-15 wt.%, the lactose content meets the claimed limitation of at most 3.8 wt.% (since “about 4 wt.%” is considered to read on 3.8 wt.%), and the fat content overlaps with the claimed limitation of at most 4 wt.%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Ur Rehman is silent as to the non-protein nitrogen content, the pH, and the sodium content.
However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the process and composition of modified Ur Rehman is substantially identical to that of the claimed process and composition, the prior art product and process must necessarily possess the same properties and characteristics as the product and process claimed. Therefore, the product and process taught by modified Ur Rehman is considered to possess the non-protein nitrogen content, pH, and sodium content as claimed because the product and process are substantially the same and thus must necessarily exhibit the same properties.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Holst et al., US PG Pub. 2013/0142904, teaches lactose-reduced milk products.
Holst et al., US PG Pub. 2020/0178550, teaches lactose-reduced milk products.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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