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 .
Status of the Application
Receipt of the Response and Amendment after Final Office Action filed 05/21/2026 and the Request for Continued Examination filed 06/24/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 and 27-47
Withdrawn claims: None
Previously cancelled claims: 2-26
Newly cancelled claims: 30
Amended claims: 1, 29, and 37
New claims: 48
Claims currently under consideration: 1, 27-29, and 31-48
Currently rejected claims: 1, 27-29, and 31-48
Allowed claims: None
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/21/2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 27-29, and 31-48 are rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (WO 2018/189238 A1) in view of Ur-Rehman et al. (U.S. 2016/0353760 A1).
Regarding claim 1, Raj et al. discloses a method comprising (i) subjecting a mixture of a dairy product and a lactase enzyme to a peak temperature in the range of about 63-75°C (specifically, “at least about 65°C”) (p. 27, l. 13 – l. 19; p. 29, l. 3 – l. 7) for about 30 seconds – 10 minutes (specifically, between 4 and 10 minutes) (p. 27, l. 28 – l. 33) to form a dairy composition containing less than or equal to about 100 ppm of lactose (specifically, less than about 0.01%, or <100 ppm) (p. 5, l. 12 – l. 14), wherein an amount of the lactase is from about 0.01-5 wt.% by weight of lactose in the dairy product (specifically, 0.047 mg/mL enzyme and 4.7% lactose, or 47 mg/mL lactose, which equates to an amount of lactase of 0.1 wt.% by weight of lactose), and (ii) heat treating the dairy composition to deactivate the enzyme and sterilize the dairy composition (specifically, 95°C for 10 minutes, where the present specification indicates that sterilization can occur at a temperature in the range of 80-95°C for a time of about 2-15 minutes) (p. 57, l. 33 – p. 58, l. 11; Figure 16, columns 1-3; p. 30, l. 1 – l. 3, where the heat treatment may comprise UHT sterilization).
Raj et al. does not indicate that the method may be performed continuously or that the heat treating comprises UHT sterilization using direct steam injection.
Regarding the method being continuous, MPEP 2144.04 V E indicates that making a process continuous is prima facie obvious. Performing the method continuously, including both the lactase treatment and deactivation steps, would thus be obvious to a skilled practitioner.
Regarding the UHT sterilization step, Ur-Rehman et al. discloses a UHT process as being performed on milk ([0037]) using direct steam injection ([0038]).
It would have been obvious to one having ordinary skill in the art to perform UHT treatment via direct steam injection. Since Raj et al. does not disclose details regarding the nature of the UHT treatment step (p. 30, l. 1 – l. 3), a skilled practitioner would be motivated to consult Ur-Rehman et al. for clarification. Since Ur-Rehman et al. discloses UHT treatment of milk via direct steam injection ([0037]-[0038]), a practitioner would find performing the UHT treatment step of Raj et al. via direct steam injection to be obvious.
As for claim 27, Raj et al. discloses the peak temperature may be in the range of about 63-70°C (specifically, “at least about 65 °C”) (p. 27, l. 13 – l. 19; p. 29, l. 3 – l. 7) and the time period as being in the range of about 1 – 10 minutes (specifically, between 4 and 10 minutes) (p. 27, l. 28 – l. 33).
As for claim 28, Raj et al. discloses the time period as being in the range of about 1 – 5 minutes (specifically, between 4 and 10 minutes) (p. 27, l. 28 – l. 33).
As for claim 29, Raj et al. discloses the dairy product has a lactose content of about 0.5-5 wt.% (specifically, 4.7% lactose) (p. 57, l. 33) and the dairy composition as having a lactose content of less than or equal to about 50 ppm (specifically, less than about 0.01%, or <100 ppm) (p. 5, l. 12 – l. 14; p. 29, l. 12 – l. 13, where the dairy product is “lactose-free milk”).
As for claim 31, Raj et al. discloses the amount of the lactase enzyme by weight of lactose in the dairy product as being from about 0.025 to about 2 wt. % (specifically, 0.1 wt.%) (p. 57, l. 33 – l. 34).
As for claim 32, Raj et al. discloses the amount of the lactase enzyme in the mixture as being from about 2-1000 ppm (specifically, 0.047 mg/ml, or 47 ppm) (p. 57, l. 34).
As for claim 33, Raj et al. discloses heating “commercial pasteurized milk” to a temperature of 55°C (p. 57, l. 33 – p. 58, l. 4). Although Raj et al. does not explicitly disclose the step of continuously heating the mixture from a temperature of less than or equal to about 10°C to the peak temperature, commercial milk is conventionally stored at refrigeration temperatures, which fall within the range of less than or equal to about 10°C. The claimed step of heating the mixture from a temperature of less than or equal to about 10°C to the peak temperature would thus be obvious to a skilled practitioner. Performing the step continuously would be obvious in light of MPEP 2144.04 V E as discussed previously in relation to claim 1.
As for claim 34, Raj et al. discloses heating to a temperature of 55°C for the lactase treatment step and 95°C for the inactivation step (p. 58, l. 3-l. 5), which inherently involves a step of heating the dairy composition from the peak temperature to the temperature for heat treating in step (b). Performing the step continuously would be obvious in light of MPEP 2144.04 V E as discussed previously in relation to claim 1.
As for claim 35, Ur-Rehman et al. discloses UHT treatment typically occurs at 130-150°C for about 1-15 seconds ([0037]), which renders the claimed protocol of about 135-145°C for a time of about 1-10 seconds obvious.
As for claim 36, Ur-Rehman et al. discloses UHT treatment typically occurs at 130-150°C for about 1-15 seconds ([0037]), which renders the claimed protocol of about 148-165°C for a time of about 0.05-1 seconds obvious.
Regarding claim 37, Raj et al. discloses a method comprising (i) subjecting a mixture of a dairy product and a lactase enzyme to a peak temperature in the range of about 63-70°C (specifically, “at least about 65°C”) (p. 27, l. 13 – l. 19; p. 29, l. 3 – l. 7) for about 1 – 10 minutes (specifically, between 4 and 10 minutes) (p. 27, l. 28 – l. 33) to form a dairy composition containing less than or equal to about 100 ppm of lactose (specifically, less than about 0.01%, or <100 ppm) (p. 5, l. 12 – l. 14), wherein an amount of the lactase is from about 0.025-5 wt.% by weight of lactose in the dairy product (specifically, 0.047 mg/mL enzyme and 4.7% lactose, or 47 mg/mL lactose, which equates to an amount of lactase of 0.1 wt.% by weight of lactose), and (ii) heat treating the dairy composition to deactivate the enzyme and sterilize the dairy composition (specifically, 95°C for 10 minutes, where the present specification indicates that sterilization can occur at a temperature in the range of 80-95°C for a time of about 2-15 minutes) (p. 57, l. 33 – p. 58, l. 11; Figure 16, columns 1-3; p. 30, l. 1 – l. 3, where the heat treatment may comprise UHT sterilization).
Raj et al. does not indicate that the method may be performed continuously or that the heat treating comprises UHT sterilization using direct steam infusion.
Regarding the method being continuous, MPEP 2144.04 V E indicates that making a process continuous is prima facie obvious. Performing the method continuously, including both the lactase treatment and deactivation steps, would thus be obvious to a skilled practitioner.
Regarding the UHT sterilization step, Ur-Rehman et al. discloses a UHT process as being performed on milk ([0037]) using direct steam infusion ([0038]).
It would have been obvious to one having ordinary skill in the art to perform UHT treatment via direct steam infusion. Since Raj et al. does not disclose details regarding the nature of the UHT treatment step (p. 30, l. 1 – l. 3), a skilled practitioner would be motivated to consult Ur-Rehman et al. for clarification. Since Ur-Rehman et al. discloses UHT treatment of milk via direct steam infusion ([0037]-[0038]), a practitioner would find performing the UHT treatment step of Raj et al. via direct steam infusion to be obvious.
As for claim 38, Raj et al. discloses heating “commercial pasteurized milk” to a temperature of 55°C (p. 57, l. 33 – p. 58, l. 4). Although Raj et al. does not explicitly disclose the step of continuously heating the mixture from a temperature of less than or equal to about 10°C to the peak temperature, commercial milk is conventionally stored at refrigeration temperatures, which fall within the range of less than or equal to about 10°C. The claimed step of heating the mixture from a temperature of less than or equal to about 10°C to the peak temperature would thus be obvious to a skilled practitioner. Performing the step continuously would be obvious in light of MPEP 2144.04 V E as discussed previously in relation to claim 1. Raj et al. further discloses heating to a temperature of 55°C for the lactase treatment step and 95°C for the inactivation step (p. 58, l. 3-l. 5), which inherently involves a step of heating the dairy composition from the peak temperature to the temperature for heat treating in step (b). Performing the step continuously would be obvious in light of MPEP 2144.04 V E as discussed previously in relation to claim 1.
As for claim 39, Ur-Rehman et al. discloses UHT treatment typically occurs at 130-150°C for about 1-15 seconds ([0037]), which renders the claimed protocol of about 135-145°C for a time of about 1-10 seconds obvious.
As for claim 40, Ur-Rehman et al. discloses UHT treatment typically occurs at 130-150°C for about 1-15 seconds ([0037]), which renders the claimed protocol of about 148-165°C for a time of about 0.05-1 seconds obvious.
As for claim 41, Raj et al. discloses the dairy product as being low-fat milk (specifically, 1.5% fat) (p. 57, l. 33).
As for claim 42, Raj et al. discloses the diary product as comprising a fresh milk (p. 29, l. 15 – l. 16), which is indistinguishable from a combination of a UF permeate fraction and a UF retentate fraction. (Notably, claim 42 does not require the performance of an ultrafiltration step, but merely the provision of a dairy product meeting the claimed criteria.)
As for claim 43, Raj et al. discloses the dairy product has a fat content of from about 0.05-10 wt.% (specifically, 1.5% fat) (p. 57, l. 33).
As for claim 44, Raj et al. discloses the dairy product (milk) has a fat content of from about 1.5-2.5 wt.% (specifically, 1.5% fat) (p. 57, l. 33). Ur-Rehman et al. discloses milk having a protein content of 3.0% w/w and a mineral content of 0.52% w/w ([0050], Table 1). Such values fall within the claimed ranges of from about 2-15 wt.% protein and from about 0.5-2 wt.% minerals.
As for claim 45, Raj et al. discloses the dairy composition as comprising an ingredient (p. 37, l. 22 – l. 27) and that the lactase enzyme is a beta-galactosidase (p. 37, l. 10 – l. 11). Ur-Rehman et al. discloses packaging such a composition in a container (Abstract), which is conventional in the art and would consequently be obvious.
As for claim 46, Raj et al. discloses the lactase enzyme as being not deactivated at the peak temperature (p. 57, l. 33 – p. 58, l. 11; Figure 16, where reduction of lactose at the peak temperature indicates the lactase was not deactivated).
As for claim 47, Raj et al. discloses the lactase enzyme is deactivated at a temperature over 80°C (p. 58, l. 5).
As for claim 48, Raj et al. discloses the dairy composition as having a lactose content of less than or equal to about 50 ppm (specifically, less than about 0.01%, or <100 ppm) (p. 5, l. 12 – l. 14; p. 29, l. 12 – l. 13, where the dairy product is “lactose-free milk”).
Response to Arguments
Claim Rejections - 35 U.S.C. § 103 of claims 1 and 27-47 over Raj et al. and Ur-Rehman et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that the newly-claimed lactose concentration of less than or equal to 100 ppm would not be obvious in view of Raj et al., noting Figure 16 of the reference that discloses a lactose content of about 200 ppm (Applicant’s Remarks, p. 8, ¶3).
However, Raj et al. discloses achieving a lactose content of “less than about 0.01%”, or 100 ppm (p. 5, l. 12 – l. 14), which encompasses the claimed range. MPEP 2144.05 (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). Raj et al. further discloses the produced dairy product as being “lactose-free milk” (p. 29, l. 12 – l. 13), which renders obvious any lactose content approaching and including 0 ppm. No indication is apparent in Raj et al. that “lactose-free milk” should be interpreted as comprising any residual amount of lactose.
Applicant argued that Raj et al. discloses a process that occurs at a lower temperature than the claimed peak temperature, such that growth of undesired microorganisms may occur (Applicant’s Remarks, p. 8, ¶4 – p. 9, ¶2).
However, Raj et al. discloses performing the process at temperatures that overlap the claimed range, including “at least about 65 °C” (p. 29, l. 3 – l. 7), thus rendering the claimed temperature range obvious.
Applicant then argued that the claimed continuous process cannot be deemed prima facie obvious based on the batchwise process of Raj et al. (Applicant’s Remarks, p. 9, ¶4 – p. 10, ¶1).
Examiner maintains that a continuous process is properly deemed obvious in view of a batch process according to MPEP 2144.04 V E. Applicant did not provide rationale as to why the claimed continuous process should not be deemed obvious over the process of Raj et al. beyond merely asserting the position.
The rejections of claims 1, 27-29, and 31-47 have been maintained herein.
Conclusion
Claims 1, 27-29, and 31-48 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
