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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 28-38 in the reply filed on May 22, 2026 is acknowledged. Claims 23-27 and 39-42 have been cancelled by the Applicant.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
28-38
Withdrawn claims:
None
Previously canceled claims:
1-22
Newly canceled claims:
23-27, 39-42
Amended claims:
None
New claims:
None
Claims currently under consideration:
28-38
Currently rejected claims:
28-38
Allowed claims:
None
Information Disclosure Statement
The information disclosure statements filed 01/08/2024 and 10/06/2025 fail to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has only been considered in part. The references that are lined through do not appear to be relevant to the claimed invention. The Examiner requests and explanation of relevancy for the references to consider them.
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.
Claim 33 is 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 33 recites the limitation “clarifying the lactase digested permeate through a depth filter”. This limitation renders the claim indefinite because it is unclear if the solution subjected to filtration is the permeate/lactase mixture, the lactase that has been removed from the permeate/lactase mixture, or the permeate that has had the lactase removed. For the purposes of examination, it is presumed that claim 33 refers to filtering the permeate that has had the lactase removed.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ur-Rehman (US 2007/0166447 A1).
Regarding claim 28, Ur-Rehman teaches a method of separating components from milk (Abstract) where animal sources of milk include human ([0018]), the method comprising:
passing skim milk through ultrafiltration to obtain an ultrafiltration permeate then nanofiltration to obtain a nanofiltration (NF) permeate ([0020]) then mixing the nanofiltration permeate with lactase enzyme ([0030]);
(b) and (c) subjecting the lactose-free milk to microfiltration to remove bacteria, spores, and lactase enzyme (i.e., removing lactase and filtering to purify and concentrate; [0033]).
Although Ur-Rehman does not teach that the resulting composition is a human milk oligosaccharide composition, a human milk permeate would necessarily comprise human milk oligosaccharides.
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 30-32 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ur-Rehman (US 2007/0166447 A1).
Regarding claim 30, Ur-Rehman teaches that the NF permeate is heated to 146[Symbol font/0xB0]F (equivalent to 63.3[Symbol font/0xB0]C) the cooled to below 42[Symbol font/0xB0]F (equivalent to 5.6[Symbol font/0xB0]F) prior to the treatment with lactase ([0030]). Thus, one of ordinary skill would recognize that the NF permeate necessarily passes through the claimed temperature range of “about 45[Symbol font/0xB0]C to about 55[Symbol font/0xB0]C” prior to the addition of the lactase.
Regarding claim 31, although Ur-Rehman does not teach the amount of lactase added to the permeate composition, Ur-Rehman does teach that the lactase treatment causes the hydrolysis of lactose into galactose and glucose, which increases the sweetness of the composition ([0062]). One of ordinary skill in the art would have adjusted the amount of lactase added to the permeate during routine optimization to determine the amount of lactase needed to convert lactose into other sweeteners to arrive at the desired sweetness of the permeate composition. MPEP §2144.05(II)(A) states “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). Thus, the claimed range would be obvious.
Regarding claim 32, Ur-Rehman teaches that the NF permeate is heated to 146[Symbol font/0xB0]F (equivalent to 63.3[Symbol font/0xB0]C) the cooled to below 42[Symbol font/0xB0]F (equivalent to 5.6[Symbol font/0xB0]F) prior to the treatment with lactase ([0030]). Thus, one of ordinary skill would recognize that the NF permeate passes through the claimed temperature range of “about 20[Symbol font/0xB0]C to about 30[Symbol font/0xB0]C” prior to the addition of the lactase, which would necessarily occur before the lactase is removed from the composition.
Regarding claim 34, Ur-Rehman teaches that the lactose-free milk is subjected to microfiltration to remove bacteria, spores, and lactase enzyme (i.e., removing lactase and filtering to purify and concentrate; [0033]) and that microfiltration is performed with a molecular weight cut off between 10 kDa and 200 kDa (equivalent to 10,000 Dalton to 200,000 Dalton; [0021]), which encompasses the claimed value of “about 50,000 Dalton”.
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 35, Ur-Rehman teaches of using diafiltration with a molecular exclusion range of 1000 to 10,000 Daltons to further concentrate the UF retentate (which encompasses the claimed range of “about 2,000 to about 3,000 Daltons”; [0070]), which has been subjected to microfiltration ([0021]) and that microfiltration is performed with a molecular weight cut off between 10 kDa and 200 kDa (equivalent to 10,000 Dalton to 200,000 Dalton; [0021]), which encompasses the claimed value of “about 50,000 Dalton”.
Although Ur-Rehman does not teach performing the diafiltration after the treatment with lactase, MPEP §2144.04(IV)(C) states “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”, In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Thus, it would have been obvious to perform diafiltration to concentrate the lactose-free milk that has been subjected to microfiltration.
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 36, Ur-Rehman teaches of concentrating the lactose-free material using reverse osmosis ([0043]) and that reverse osmosis systems use membrane filters having a molecular exclusion range of 100-180 Daltons ([0069]), which falls within the claimed range of “≤ 600 Daltons”. Although Ur-Rehman does not explicitly teach performing both microfiltration and reverse osmosis to concentrate the lactose-free milk, one of ordinary skill would have found it to perform microfiltration first to remove larger particles from the milk before performing reverse osmosis. It is known in the art that large particles can clog filters. Thus, one of ordinary skill would have found it obvious to perform microfiltration prior to reverse osmosis.
Claims 29 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Ur-Rehman (US 2007/0166447 A1) in view of Sallomons (US 2014/0336140 A1).
Regarding claim 29, Ur-Rehman does not teach wherein the pH of the permeate is adjusted to a pH of about 4.3 to about 4.7 prior to or concurrent with the addition of lactase.
However, in the same field of endeavor, Sallomons teaches a method of providing human milk oligosaccharides (Abstract) by reacting with galactosidase ([0009]). where the pH of the enzyme reaction mixture ranges between 4 and 6 ([0048]), which encompasses the claimed range of “about 4.3 to about 4.7”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the lactase (i.e., a galactosidase) reaction of Ur-Rehman with the use of the pH as taught by Sallomons. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious, see MPEP §2143(D).
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 37, Ur-Rehman does not teach wherein the concentration of human milk oligosaccharides after purification is at least 5% w/w.
However, in the same field of endeavor, Sallomons teaches that the composition comprises human milk oligosaccharides, in particular galactooligosaccharides ([0001]) and that a composition made by the invention that comprises at least 5% by weight of galactooligosaccharides ([0053]), which matches the claimed range of “at least 5% w/w”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of Ur-Rehman to result in a final HMO concentration of at least 5% by weight as taught by Sallomons. One of ordinary skill would have been motivated to make this modification because Sallomons teaches that galactooligosaccharides are not degraded by the small intestine, so they reach the colon largely intact where they serve as prebiotic stimulating growth for beneficial bacteria.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Ur-Rehman (US 2007/0166447 A1) in view of Perreault (US 2007/0192878 A1).
Regarding claim 33, Ur-Rehman does not teach clarifying the permeate with through a depth filter, wherein the depth filter is about 1 to about 5 micron.
However, in the same field of endeavor, Perreault teaches of clarification of milk using depth filtration (Abstract) where the filter retains particles preferably in the range of 1-5 microns ([0097]), which matches the claimed range of “about 1 to about 5 micron”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of Ur-Rehman with the addition of depth filtration as taught by Perreault. One of ordinary skill would have been motivated to make this modification because Perreault teaches that depth filtration can be used in the dairy industry for bacterial removal ([0034]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Ur-Rehman (US 2007/0166447 A1) in view of Elster (US 2018/0104279 A1, filed 04/15/2016).
Regarding claim 38, Ur-Rehman does not teach wherein the concentration of human milk oligosaccharides after purification is about 1% to about 5% w/w.
However, in the same field of endeavor, Elster discloses a human milk composition comprising from about 0.4% to about 3.8% human milk oligosaccharides ([0011]), which overlaps with the claimed range of “about 1% to about 5% w/w”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of Ur-Rehman to result in a human milk composition comprising from about 0.4% to about 3.8% human milk oligosaccharides as taught by Elster. One of ordinary skill would have been motivated to make this modification because Elster teaches that the composition, by virtue of HMO content, optimizes gut flora ([0066]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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