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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
The status of the claims stands as follows:
Pending claims: 16-30
Withdrawn claims: 28-30
Canceled claims: 1-15
Claims currently under consideration: 16-27
Currently rejected claims: 16-27
Allowed claims: None
Election/Restrictions
Applicant's election with traverse of Group I (claims 16-27) in the reply filed on 10/29/2025 is acknowledged. The traversal is on the ground(s) that a European examiner examining the corresponding PCT application claims did not require any restriction on the basis of a lack of unity (Applicant’s Remarks, p. 2, ¶2). This is not found persuasive because (i) the treatment of claims in a different jurisdiction does not control examination under US law, and (ii) restriction due to a lack of unity of invention is at examiner’s discretion and is not required. That a foreign examiner did not restrict comparable claims has no bearing on the rationale for the present restriction.
The requirement is still deemed proper and is therefore made FINAL.
Claims 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/29/2025.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112(b)
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 17, 21, 24, and 26 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.
Regarding claim 17, the word “preferably” renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 21, four instances of the word “especially” render the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 21, 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).
Regarding claim 24, five instances of the word “especially” render the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 24, 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).
Regarding claim 26, the word “especially” renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d).
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 16-20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al. (U.S. 2020/0138836 A1) in view of Snow et al. (U.S. 2019/0343139 A1) and Donnelly et al. (Donnelly, J. K., O’Sullivan, A. C., and Delaney, R. A. M., “Reverse Osmosis – Concentration Applications,” Journal of the Society of Dairy Technology, Vol. 27, No. 3, July, 1974).
Regarding claim 16, Sprenger et al. discloses human milk oligosaccharide (HMO) ([0067]) that may be isolated via “filtration technology” from milk ([0083]).
Sprenger et al. does not disclose concentrating aqueous solutions of HMOs by subjecting an aqueous solution comprising at least one HMO to a reverse osmosis process by means of a reverse osmosis membrane and concentrating the HMO to a final osmotic pressure of at least 70 bar as measured with a freezing point osmometer.
However, Snow et al. discloses a membrane filtration device that performs reverse osmosis on a skim milk fraction in order to concentrate HMOs ([0066]). Donnelly et al. discloses a method for concentrating an aqueous milk solution comprising subjecting the aqueous milk solution to a reverse osmosis process by means of a reverse osmosis membrane and concentrating the solution (p. 131, column 2, ¶4 - ¶6; p. 130, Table 2, 995, 999, where Na-rejection falls within the definition of “reverse osmosis membrane” as presently defined in the specification at p. 2, ll. 31-36) to a final osmotic pressure of at least 70 bar (p. 129, Table 1, where osmotic pressure of a reverse osmosis feed solution “can range to over 70 kg/cm2”, or over 68.6 bar).
It would have been obvious to one having ordinary skill in the art to incorporate the specific method instruction from Snow et al. and Donnelly et al. in isolating an HMO as recited in Sprenger et al. Since Sprenger et al. teaches generally a process of isolating HMOs from milk via “filtration technology” but does not elaborate on such a process, a skilled practitioner would be motivated to consult more specific references, including Snow et al. and Donnelly et al., to supplement the general instruction in Sprenger et al. The clarification in Snow et al. that reverse osmosis may constitute the filtration device and the detail in Donnelly et al. regarding concentrating skim milk via reverse osmosis to achieve an osmotic pressure in the feed material up to over 68.6 bar, renders the claimed method obvious to a skilled practitioner.
Lastly, the claimed method does not require an actual step of measuring the solution with a freezing point osmometer but instead merely requires a parameter to be met upon processing that falls within the scope of the claimed limitation should a freezing point osmometer be used. The osmotic pressure range disclosed in Donnelly et al. is considered to encompass the claimed range of pressures, including when measured by a freezing point osmometer.
As for claim 17, Sprenger et al. discloses the HMO as comprising 2’-fucosyllactose ([0082]).
As for claim 18, Donnelly et al. discloses the method wherein water is not evaporated (p. 131, column 1, ¶2; p. 131, column 2, ¶4 - ¶8).
As for claim 19, Donnelly et al. discloses the reverse osmosis membrane as having an NaCl retention between 93 and 99.6% (p. 130, Table 2, 995, 999, where Na-rejection is 97 and 99, respectively).
As for claim 20, Donnelly et al. discloses the reverse osmosis membrane as being a dairy reverse osmosis membrane (p. 131, column 2, ¶6, where skim milk is processed).
Regarding claim 27, Sprenger et al. discloses human milk oligosaccharide (HMO) ([0067]) that may be isolated via “filtration technology” from milk ([0083]).
Sprenger et al. does not disclose utilizing a reverse osmosis membrane in a reverse osmosis process for concentrating aqueous solutions of HMOs to a final osmotic pressure of at least 70 bar as measured with a freezing point osmometer.
However, Snow et al. discloses a membrane filtration device that performs reverse osmosis on a skim milk fraction in order to concentrate HMOs ([0066]). Donnelly et al. discloses a method for concentrating an aqueous milk solution comprising subjecting the aqueous milk solution to a reverse osmosis process by means of a reverse osmosis membrane and concentrating the solution (p. 131, column 2, ¶4 - ¶6; p. 130, Table 2, 995, 999, where Na-rejection falls within the definition of “reverse osmosis membrane” as presently defined in the specification at p. 2, ll. 31-36) to a final osmotic pressure of at least 70 bar (p. 129, Table 1, where osmotic pressure of a reverse osmosis feed solution “can range to over 70 kg/cm2”, or over 68.6 bar).
It would have been obvious to one having ordinary skill in the art to incorporate the specific method instruction from Snow et al. and Donnelly et al. in isolating an HMO as recited in Sprenger et al. Since Sprenger et al. teaches generally a process of isolating HMOs from milk via “filtration technology” but does not elaborate on such a process, a skilled practitioner would be motivated to consult more specific references, including Snow et al. and Donnelly et al., to supplement the general instruction in Sprenger et al. The clarification in Snow et al. that reverse osmosis may constitute the filtration device and the detail in Donnelly et al. regarding concentrating skim milk via reverse osmosis to achieve an osmotic pressure in the feed material up to over 68.6 bar, renders the claimed method obvious to a skilled practitioner.
Lastly, the claimed method does not require an actual step of measuring the solution with a freezing point osmometer but instead merely requires a parameter to be met upon processing that falls within the scope of the claimed limitation should a freezing point osmometer be used. The osmotic pressure range disclosed in Donnelly et al. is considered to encompass the claimed range of pressures, including when measured by a freezing point osmometer.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al. (U.S. 2020/0138836 A1) in view of Snow et al. (U.S. 2019/0343139 A1) and Donnelly et al. (Donnelly, J. K., O’Sullivan, A. C., and Delaney, R. A. M., “Reverse Osmosis – Concentration Applications,” Journal of the Society of Dairy Technology, Vol. 27, No. 3, July, 1974) as applied to claim 16 above, and further in view of Chassagne et al. (U.S. 2019/0248824 A1).
As for claim 21, Sprenger et al., Snow et al., and Donnelly et al. disclose the method of claim 16. According to rationale detailed previously in relation to claim 16, the combination of references is considered to teach or render obvious subjecting an aqueous solution to a reverse osmosis process by means of a dairy RO membrane and concentrating (Donnelly et al., p. 131, column 2, ¶4 - ¶6; p. 130, Table 2, 995, 999, where Na-rejection falls within the definition of “reverse osmosis membrane” as presently defined in the specification at p. 2, ll. 31-36) to a final osmotic pressure of at least 70 bar (Donnelly et al., p. 129, Table 1, where osmotic pressure of a reverse osmosis feed solution “can range to over 70 kg/cm2”, or over 68.6 bar), where the solution may comprise at least one HMO that is 2’-FL (Sprenger et al., [0082]-[0083]). The osmotic pressure range disclosed in Donnelly et al. is considered to encompass the claimed range of pressures, including when measured by a freezing point osmometer.
The cited prior art does not disclose crystallizing the HMO from the concentrated solution and separating the crystals from the mother liquor.
However, Chassagne et al. discloses crystallization of HMOs from aqueous organic solvent ([0003]) and separation from a mother liquor by filtration ([0036], [0074]).
It would have been obvious to one having ordinary skill in the art to further process a concentrated HMO solution to form crystals that are recovered by filtration. Sprenger et al. discloses that the HMO may be used in a “syrup form of crystals” ([0132]), which suggests crystallization and recovery of crystallized HMO material. Since Sprenger et al. does not detail the performance of such a process, a skilled practitioner would be motivated to consult Chassagne et al. for more specific instruction. Since Chassagne et al. discloses crystallization of HMOs ([0003]) and separation from a mother liquid by filtration ([0036], [0074]), a skilled practitioner would find the incorporation of such steps into the metho of Sprenger et al. to be obvious.
As for claim 22, Donnelly et al. discloses concentrating the aqueous solution by evaporation of water in an evaporating device following concentration via reverse osmosis (p. 138, column 2, ¶1, 1.1 pre-concentration before transport to drying plant), which renders the performance of an evaporation step after reverse osmosis treatment and before crystallization obvious.
As for claim 23, Chassagne et al. discloses that acetic acid is “one of the solvents typically used in oligosaccharide crystallization” ([0042]), which renders addition of acetic acid to the RO-concentrated solution obvious in order to crystallize the HMOs.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al. (U.S. 2020/0138836 A1) in view of Snow et al. (U.S. 2019/0343139 A1) and Donnelly et al. (Donnelly, J. K., O’Sullivan, A. C., and Delaney, R. A. M., “Reverse Osmosis – Concentration Applications,” Journal of the Society of Dairy Technology, Vol. 27, No. 3, July, 1974) as applied to claim 16 above, and further in view of Chassagne et al. (U.S. 2019/0248824 A1), Schroven et al. (U.S. 2015/0183814 A1), and Khanzhin (U.S. 2020/0123184 A1).
As for claim 24, Sprenger et al., Snow et al., and Donnelly et al. disclose the method of claim 16. According to rationale detailed previously in relation to claim 16, the combination of references is considered to teach or render obvious subjecting an aqueous solution to a reverse osmosis process by means of a dairy RO membrane and concentrating (Donnelly et al., p. 131, column 2, ¶4 - ¶6; p. 130, Table 2, 995, 999, where Na-rejection falls within the definition of “reverse osmosis membrane” as presently defined in the specification at p. 2, ll. 31-36) to a final osmotic pressure of at least 70 bar (Donnelly et al., p. 129, Table 1, where osmotic pressure of a reverse osmosis feed solution “can range to over 70 kg/cm2”, or over 68.6 bar), where the solution may comprise at least one HMO that is 2’-FL (Sprenger et al., [0082]-[0083]). The osmotic pressure range disclosed in Donnelly et al. is considered to encompass the claimed range of pressures, including when measured by a freezing point osmometer.
The cited prior art does not disclose adding acetic acid to the concentrated solution, crystallizing the HMO from the concentrated solution, separating the crystals from the mother liquor, re-dissolving the crystals, subjecting the solution to diafiltration, or spray-drying the material.
However, Chassagne et al. discloses crystallization of HMOs from aqueous organic solvent ([0003]) and separation from a mother liquor by filtration ([0036], [0074]). Schroven et al. discloses dissolving dry crystalline HMO in water and then spray-drying ([0036]-[0037]). Khanzhin discloses diafiltration of an HMO solution with an NF membrane to remove organic compounds ([0071], [0068], [0092]).
It would have been obvious to one having ordinary skill in the art to further process a concentrated HMO solution to form crystals that are recovered by filtration. Sprenger et al. discloses that the HMO may be used in a “syrup form of crystals” ([0132]), which suggests crystallization and recovery of crystallized HMO material. Since Sprenger et al. does not detail the performance of such a process, a skilled practitioner would be motivated to consult Chassagne et al. for more specific instruction. Since Chassagne et al. discloses crystallization of HMOs ([0003]) and separation from a mother liquid by filtration ([0036], [0074]), a skilled practitioner would find the incorporation of such steps into the method of Sprenger et al. to be obvious. Chassagne et al. further discloses that acetic acid is “one of the solvents typically used in oligosaccharide crystallization” ([0042]), which renders addition of acetic acid to the RO-concentrated solution obvious in order to crystallize the HMOs.
As for the redissolution and spray-drying, Chassagne et al. discloses the removal of organic solvent ([0036]). Schroven et al. similarly discloses the removal of organic solvents via dissolution and spray-drying of crystalline HMO material ([0035]-[0037]; [0025]-[0027]). MPEP 2144.06 I and II indicate that combining or substituting equivalents known for the same purpose is prima facie obvious. Since the aim of the dissolution/spray-drying steps taught in Schroven ([0027]) are the same as the drying methods taught in Chassagne et al. ([0036], [0044]-[0046]), the combination/substitution of such method steps with those of Chassagne et al. would be obvious. As such, the claimed method steps of re-dissolving the HMO crystals and spray-drying in a spray drying unit to obtain a spray-dried product containing at least one HMO would be obvious. Adding acetic acid to water as the re-dissolution solvent would be obvious in light of the instruction in Chassagne et al. that acetic acid is known for such a purpose ([0042]).
Chassagne et al. further discloses a preference for removing organic solvent ([0042]) via several different drying methods ([0044]-[0046]). Khanzhin discloses removal of organic compounds via diafiltration ([0071], [0092]). MPEP 2144.06 I and II indicate that combining or substituting equivalents known for the same purpose is prima facie obvious. Since the aim of the diafiltration step taught in Khanzhin is the same as the drying methods taught in Chassagne et al., the combination/substitution of such a method step with those of Chassagne et al. would be obvious. As such, the claimed method step of subjecting the re-dissolved material to a diafiltration process with a NF membrane wherein acetic acid is at least partially removed from the solution would be obvious.
As for claim 25, Donnelly et al. discloses concentrating the aqueous solution by evaporation of water in an evaporating device following concentration via reverse osmosis (p. 138, column 2, ¶1, 1.1 pre-concentration before transport to drying plant), which renders the performance of an evaporation step after reverse osmosis treatment and before subsequent processing obvious.
As for claim 26, Khanzhin discloses diafiltration of an HMO solution with an NF membrane to remove organic compounds ([0071], [0068], [0092]), where incorporation of such a step was shown to be obvious as detailed previously in relation to claim 24. Reduction of the acetic acid content by applying NF membranes in a diafiltration process would thus be obvious.
Conclusion
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793