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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/13/2026 has been entered.
Status of the Claims
Claims 4, 12, 14-21, and 25-27 have been cancelled. Claims 1 and 9 have been amended. Claims 2-3, 5-8, 10-11, 13, and 22-24 are as previously presented. Therefore, claims 1-3, 5-11, 13, and 22-24 are currently pending and have been considered below.
Response to Amendment
Applicant’s filing of a terminal disclaimer overcomes the previously set-forth double patenting rejection.
Claim Interpretation
Claim 1 recites, “wherein the delipidation unit and the protein-enrichment unit are modular units in fluid connection when connected by a tube connector.” Claim 3 recites, “[t]he device of claim 1, wherein there is a tube connector between the delipidation unit and the protein-enrichment unit.” Claim 3 is interpreted as complying with 35 U.S.C. § 112(d); accordingly, claim 3 is understood to further limit claim 1. Therefore, the claim 1 limitation, “wherein the delipidation unit and the protein-enrichment unit are modular units in fluid connection when connected by a tube connector” in interpreted as not requiring a tube connector to be present between the delipidation unit and the protein-enrichment unit, in view of claim 3 and the claim 1 language “when connected by a tube connector.”
Claims 2, 5 – 6, 8, and 22 recite the term “about” with a numerical value or range. Applicant’s specification recites the following with regard to the term “about:” “Reference to "about" a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. For example, description referring to "about X" includes description of "X". In some embodiments, the term "about" when used in association with a measurement, or used to modify a value, a unit, a constant, or a range of values, refers to variations of +/- 10%, 5%, 2% or 1%” [page 30, lines 11-15 of Applicant’s specification filed 9/22/2023]. The term “about” is being interpreted to indicate a variation of +/- 10% of the value or range.
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.
Claims 1 – 3, 5 – 11, and 22 – 23 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger (US 2018/0343880) in view of Behringer et al. (US 5,503,865) and Chen et al. (CN 107361148).
Regarding claim 1, Metzger discloses a device for protein enrichment of human breast milk (“Embodiments of the present disclosure are directed to the manufacture of MCC via the fractionation of skim milk into casein-rich retentate (i.e., MCC), and whey protein rich permeate using membrane microfiltration (MF) and/or diafiltration (DF)” [0019]; the device is capable of being utilized with human breast milk), comprising:
i. a delipidation unit, comprising a first reservoir (Fig. 1B, “milk source 102 (e.g., one or more milk tanks)” [0024]) configured to receive breast milk, wherein the first reservoir is connected to a first filter (Fig. 1B, “first filter unit 104” [0024]);
a first filter (Fig. 1B, “first filter unit 104” [0024]), wherein the first filter has a pore size of less than or equal to 1 µm (“the microfiltration membrane of the first filter unit 104 may include, but is not limited to, a polymeric spiral-wound filtration membrane having a pore size between 0.1 and 1.00 μm” [0031]), wherein the first filter is in fluid connection with the first reservoir (Fig. 1B, “the first filter unit 104 may be placed in fluidic communication with the milk source 102 via the processing line 118. In this regard, the MF unit 104 may receive the milk and apply a first filtration process” [0030]), wherein the first filter is configured to receive breast milk from the first reservoir (Fig. 1B);
a pressure valve, wherein the pressure valve is in fluid connection with the first reservoir and the first filter, and wherein the pressure valve is configured to provide positive air pressure to the delipidation unit (Fig. 1B, “valve unit 123” [0072] supplies air pressure from “carbon dioxide supply unit 120” [0073]; “system 100 includes one or more valve units 123. The one or more valve units 123 may serve to selectively fluidically couple two or more of the sub-systems or components of system 100. For example, one or more valve units 123 may be placed between two or more of the milk source 102, the first filter unit 104, the first holding tank 110, the additional filter unit 112, the heat exchanger 106, the second holding tank 116, and the carbon dioxide supply unit 120); and
an output wherein the output is configured to deliver the fat-reduced filtrate provided by the first filter (Fig. 1B, output is located between valve 123 and first holding tank 110); and
ii. a protein-enrichment unit, wherein the protein-enrichment unit comprises:
a second reservoir (Fig. 1B, “first holding tank 110” [0073]) configured to receive the fat-reduced filtrate from the output of the delipidation unit (Fig. 1B); and
a second filter (Fig. 1B, “filter unit 112” [0024]), wherein the second filter has a nominal molecular weight limit of less than or equal to 100 kDa (“ filter unit 112 includes an ultrafiltration membrane” [0059]; “ the ultrafiltration membrane may include, but is not limited to, an ultrafiltration membrane having a molecular weight cutoff between 1 kDa and 30 kDa. More specifically, the ultrafiltration membrane may include, but is not limited to, an ultrafiltration membrane having a molecular weight cutoff between 5 kDa and 20 kDa” [0059]), and wherein the second filter is configured to provide a protein-enriched retentate and a protein-reduced filtrate (“the term “ultrafiltration (UF)” is generally defined by a filtration process that fractionates a mixture of casein, lactose, and minerals into a casein-rich retentate (i.e., a mineral-reduced MCC)” [0058]; casein is a protein); and
wherein the delipidation unit and the protein-enrichment unit are in fluid connection (Fig. 1B shows wherein the delipidation unit, comprising first reservoir 102, first filter 104, and pressure valve 123, and the protein-enrichment unit, comprising second reservoir 110, are in fluid connection; as described in the claim-interpretation section above, a tube connector is not required to be present in claim 1; since the delipidation unit and the protein-enrichment unit of Metzger are in fluid connection as described above, they will also be in fluid connection when connected by a tube connector).
In addition to structural limitations, claim 1 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. The functional limitations are: wherein the first filter is “configured to provide a fat-enriched retentate and a fat-reduced filtrate from the breast milk.” When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. The courts have held that: (1) "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and (2) a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP § 2114.
Metzger does not expressly disclose wherein the device is a modular device, and wherein the delipidation unit and the protein-enrichment unit are modular units.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the device is a modular device, and wherein the delipidation unit and the protein-enrichment unit are modular units, because the court has held that making components separable may be considered obvious to a person of ordinary skill in the art. MPEP § 2144.04-V-C. Furthermore, Applicant's disclosure indicates that the claimed "modular" configuration is not critical to the invention. Applicant's specification states, "In some variations, the delipidation unit and the protein-enrichment unit are integrated as components of the device. In other variations, these units can also be configured as separate modules or modules that can be combined to form a structural unit" (para. [0034] of the published application).
Metzger does not expressly disclose wherein the first reservoir has a capacity of less than or equal to 2 L, or wherein the second reservoir has a capacity of less than or equal to 2 L.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the first reservoir has a capacity of less than or equal to 2 L and wherein the second reservoir has a capacity of less than or equal to 2 L, because the courts have held the following: In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04-IV-A.
Metzger does not expressly disclose wherein the delipidation unit is hermetically sealed and maintains sterility, or wherein the protein-enrichment unit is hermetically sealed.
Behringer is directed to processes for the preparation of concentrated milk products [Title]. Behringer discloses utilizing containers that are “closed hermetically” (the homogenized mixture may be packaged in containers which are closed hermetically” [Col. 2, lines 34-36]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the delipidation unit is hermetically sealed and maintains sterility, and wherein the protein-enrichment unit is hermetically sealed, because it is well-known that an air-tight environment reduces the risk of foreign objects entering the environment, and also prevents the contents of the container from evaporating. One of ordinary skill in the art would be motivated to reduce contamination and evaporation at any stage in the treatment of milk, and would be able to do so by utilizing a hermetically-sealed environment.
Metzger does not expressly disclose wherein the pressure valve comprises an air filter.
Chen is directed to a milk processing technique [Title]. Chen discloses wherein a pressure valve comprises an air filter (“nitrogen supply device comprises a nitrogen source, compressor and air filter are connected in turn” [page 11 of attached translation]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the pressure valve comprises an air filter, in order to prevent particulates from being present in the airflow, to reduce contamination.
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Fig. 1B of Metzger
Regarding claim 2, Metzger does not expressly disclose wherein the device is configured to maintain a temperature of between about 4 and about 10 degrees Celsius.
However, Metzger discloses wherein the device is configured to maintain a temperature of between about 1.0 and about 7.2 degrees Celsius (“milk source 102 may maintain the milk at a temperature between 1.0° C. and 7.2° C” [0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the device is configured to maintain a temperature of between about 4 and about 10 degrees Celsius, because in the case 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 3, Metzger discloses wherein there is a connector between the delipidation unit and the protein-enrichment unit (Fig. 1B shows wherein valve 123 of the delipidation unit is connected to filter 110 of the protein-enrichment unit).
Metzger does not expressly disclose wherein the connecter is a tube connector.
However, the connector being a tube connector describes a particular shape of the connector. The courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. MPEP § 2144.04-IV-B.
Regarding claim 5, Metzger does not expressly disclose wherein the pressure valve is configured to supply between about 0.5 bar and about 4 bar of absolute pressure to the first reservoir and first filter.
However, Metzger discloses wherein the pressure valve is configured to supply pressure as follows: “CO2 may be injected into the MCC at a selected pressure. For example, CO2 may be injected into flowing MCC in the processing line 118 (or into the first holding tank 110) at a pressure between 10 kPa and 800 kPa” [0044]; a pressure between 10 kPa and 800 kPa corresponds to a pressure between 0.1 bar and 8 bar.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the pressure valve is configured to supply between about 0.5 bar and about 4 bar of absolute pressure to the first reservoir and first filter, because 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05-I.
Regarding claim 6, Metzger does not expressly disclose wherein the pressure valve is configured to supply between about 0.1 bar and about 4 bar of absolute pressure to the second reservoir and second filter.
However, Metzger discloses wherein the pressure valve is configured to supply pressure as follows: “CO2 may be injected into the MCC at a selected pressure. For example, CO2 may be injected into flowing MCC in the processing line 118 (or into the first holding tank 110) at a pressure between 10 kPa and 800 kPa” [0044]; a pressure between 10 kPa and 800 kPa corresponds to a pressure between 0.1 bar and 8 bar.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the pressure valve is configured to supply between about 0.1 bar and about 4 bar of absolute pressure to the second reservoir and second filter, because 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05-I.
Regarding claim 7, Metzger discloses wherein the device comprises a second pressure valve, wherein the second pressure valve is in fluid connection with the second reservoir and the second filter, wherein the second pressure valve is configured to provide positive air pressure to the protein enrichment unit (Fig. 1B, “valve unit 123” [0072] supplies air pressure from “carbon dioxide supply unit 120” [0073]; “system 100 includes one or more valve units 123. The one or more valve units 123 may serve to selectively fluidically couple two or more of the sub-systems or components of system 100. For example, one or more valve units 123 may be placed between two or more of the milk source 102, the first filter unit 104, the first holding tank 110, the additional filter unit 112, the heat exchanger 106, the second holding tank 116, and the carbon dioxide supply unit 120).
Regarding claim 8, Metzger does not expressly disclose wherein the second pressure valve is configured to supply between about 0.5 and about 4 bar of absolute pressure to the second reservoir and second filter.
However, Metzger discloses wherein the pressure valve is configured to supply pressure as follows: “CO2 may be injected into the MCC at a selected pressure. For example, CO2 may be injected into flowing MCC in the processing line 118 (or into the first holding tank 110) at a pressure between 10 kPa and 800 kPa” [0044]; a pressure between 10 kPa and 800 kPa corresponds to a pressure between 0.1 bar and 8 bar.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the second pressure valve is configured to supply between about 0.5 and about 4 bar of absolute pressure to the second reservoir and second filter, because 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05-I.
Regarding claim 9, Metzger does not expressly disclose wherein the second pressure valve comprises an air filter.
Chen discloses wherein a pressure valve comprises an air filter (“nitrogen supply device comprises a nitrogen source, compressor and air filter are connected in turn” [page 11 of attached translation]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the second pressure valve comprise an air filter, in order to prevent particulates from being present in the airflow, to reduce contamination.
Regarding claim 10, Metzger discloses wherein the protein enrichment unit further comprises a second output and a third reservoir, wherein the second output is configured to deliver the protein-reduced filtrate to the third reservoir (Fig. 1B, second output is located downstream of filter unit 112; third reservoir is “second holding tank 116” [0070]).
Regarding claim 11, Metzger discloses wherein the delipidation unit is configured to agitate and/or stir breast milk in the first reservoir and/or wherein the protein enrichment unit is configured to agitate and/or stir breast milk in the second reservoir (“the CO2-treated MCC may be stirred for a selected time (e.g., 0.5 to 4 hours) to reach equilibrium” [0045]).
Regarding claim 22, Metzger discloses wherein the first filter has a pore size of between about 0.1 and about 1 µm (“the microfiltration membrane of the first filter unit 104 may include, but is not limited to, a polymeric spiral-wound filtration membrane having a pore size between 0.1 and 1.00 μm” [0031]).
Regarding claim 23, Metzger does not expressly disclose wherein the second filter has a nominal molecular weight limit of less than or equal to 10 kDa.
However, Metzger discloses the following regarding the second filter: “filter unit 112 includes an ultrafiltration membrane” [0059]; “the ultrafiltration membrane may include, but is not limited to, an ultrafiltration membrane having a molecular weight cutoff between 1 kDa and 30 kDa. More specifically, the ultrafiltration membrane may include, but is not limited to, an ultrafiltration membrane having a molecular weight cutoff between 5 kDa and 20 kDa” [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the second filter has a nominal molecular weight limit of less than or equal to 10 kDa, because 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05-I.
Claims 13 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger (US 2018/0343880) in view of Behringer et al. (US 5,503,865) and Chen et al. (CN 107361148), further in view of Fournell et al. (US 2013/0059050).
Regarding claim 13, Metzger does not expressly disclose wherein the first filter is a cellulose filter.
Fournell is directed to microfiltration of human milk [Title]. Fournell discloses wherein a cellulose filter is utilized in the processing of human milk (“Diatomaceous earth comprises fossilized remains of diatoms, a type of hard-shelled algae. These fossilized remains are highly permeable and porous, and accordingly, are suitable for filtration applications. However, synthetically produced materials may also be employed (e.g., polymeric materials, etc.) provided they do not chemically modify or react with the milk in an undesired fashion. Examples of useful filter aids may include silica, wood cellulose and perlite” [0091]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the first filter is a cellulose filter. This is the simple substitution of one known element for another to achieve predictable results.
Regarding claim 24, Metzger does not expressly disclose wherein the first filter is a cellulose filter with a pore size of 0.2-0.4 µm.
However, Metzger discloses the following regarding the first filter: “the microfiltration membrane of the first filter unit 104 may include, but is not limited to, a polymeric spiral-wound filtration membrane having a pore size between 0.1 and 1.00 μm” [0031]. Additionally, Fournell discloses wherein a cellulose filter is utilized in the processing of human milk (“Diatomaceous earth comprises fossilized remains of diatoms, a type of hard-shelled algae. These fossilized remains are highly permeable and porous, and accordingly, are suitable for filtration applications. However, synthetically produced materials may also be employed (e.g., polymeric materials, etc.) provided they do not chemically modify or react with the milk in an undesired fashion. Examples of useful filter aids may include silica, wood cellulose and perlite” [0091]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the first filter is a cellulose filter with a pore size of 0.2-0.4 µm. The use of a cellulose filter is the simple substitution of one known element for another to achieve predictable results. Additionally, in the case 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Response to Arguments
Applicant's arguments filed 7/13/2026 have been fully considered but they are not persuasive. Please see the advisory action mailed 7/8/2026 for the examiner’s response to applicant’s arguments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH KERR whose telephone number is (571)272-3073. The examiner can normally be reached M - F, 8:30 AM - 4:30 PM.
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/ELIZABETH M KERR/Primary Examiner, Art Unit 3761
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