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 Non-Final Office Action filed 12/22/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the 35 U.S.C. 112(b) rejections of claims 2-7, 9, 11, 16, and 17 have been withdrawn; (2) the 35 U.S.C. 102(a)(1) rejections of claims 1-7, 10, 11, 14-16, 25, and 26 over Raj et al. have been withdrawn; (3) the 35 U.S.C. 102(a)(1) rejection of claim 17 over Raj et al. as evidenced by Sizer has been withdrawn; (4) the 35 U.S.C. 103 rejections of claims 8, 9, 13, and 24 over Raj et al. have been withdrawn; and (5) the 35 U.S.C. 103 rejection of claims 12 over Raj et al. and Sizer has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-17 and 24-26
Withdrawn claims: None
Previously canceled claims: 18-23
Newly canceled claims: 2-17 and 24-26
Amended claims: 1
New claims: 27-47
Claims currently under consideration: 1 and 27-47
Currently rejected claims: 1 and 27-47
Allowed claims: None
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 and 27-47 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 2000 ppm of lactose (specifically, <0.20% residual lactose), 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 200 ppm (Fig. 16, columns 1 and 3, where the graphs appear to show a residual lactose content of about 200 ppm; p. 27, l. 28 – l. 29; p. 29, l. 12 – l. 13, where the dairy product is “lactose-free milk”).
As for claim 30, Raj et al. discloses the dairy composition as having a lactose content of less than or equal to about 100 ppm (p. 27, l. 28 – l. 29, “less than 0.1%”, or 1000 ppm, which encompasses the claimed range; 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 200 ppm of lactose (Fig. 16, columns 1 and 3, where the graphs appear to show a residual lactose content of about 200 ppm; p. 27, l. 28 – l. 29; p. 29, l. 12 – l. 13, where the dairy product is “lactose-free milk”), 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).
Response to Arguments
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(b) rejections of claims 2-7, 9, 11, 16, and 17 based on cancellation of the claims. Accordingly, the 35 U.S.C. § 112(b) rejections have been withdrawn.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 1-7, 10, 11, 14-16, 25, and 26 over Raj et al.; and claim 17 over Raj et al. as evidenced by Sizer: Applicant has overcome the 35 U.S.C. § 102(a)(1) rejections of claims 1-7, 10, 11, 14-16, 25, and 26 based on amendment and/or cancellation of the claims. Accordingly, the 35 U.S.C. § 102(a)(1) rejections have been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 8, 9, 13, and 24 over Raj et al.; and claim 12 over Raj et al. and Sizer: Applicant has overcome the 35 U.S.C. § 103 rejections of claims 8, 9, 12, 13, and 24 based on cancellation of the claims. Accordingly, the 35 U.S.C. § 103 rejections have been withdrawn. To the extent Applicant’s arguments are relevant to the claim 1 as presently amended and new claims 27-47, the arguments are addressed below.
Applicant first argued that the cited example in Raj et al. does not disclose time and temperature values that fall within the claimed ranges (Applicant’s Remarks, p. 9, ¶2 – p. 10, ¶1).
However, the present claim rejections rely on the broader instruction in Raj et al., wherein the temperature may be in a range of “at least about 65°C” (p. 27, l. 13 – l. 19; p. 29, l. 3 – l. 7) and the time may range from between 4 and 10 minutes (p. 27, l. 28 – l. 33), where such disclosed ranges overlap the claimed ranges. Applicant’s argument is thus unpersuasive.
Applicant further argued that neither Raj et al. nor Sizer teach step (b) limitations requiring continuous heat treatment via UHT sterilization conducted using direct steam injection (Applicant’s Remarks, p. 10, ¶2).
However, both limitations were deemed obvious as detailed in the claim rejection based at least in part on the following rationale: (i) MPEP 2144.04 V E indicates that making a process continuous is prima facie obvious, and (ii) Ur-Rehman et al. discloses a UHT process as being performed on milk ([0037]) using direct steam injection ([0038]). Applicant’s argument is thus unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claims 1 and 27-47 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793