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 .
DETAILED ACTION
Applicant canceled claims 3, 4 and 8-10
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.
Claim Interpretation
As previously stated, based on the reading of present specification (pg.5, lines 4-20), the term “lysolecithin” is interpreted by the Examiner to mean a lecithin that has been hydrolyzed such that 50 wt.% or more of the phospholipids in the lecithin have been converted to lysophospholipids (which examples include lysophosphatidylcholine, lysophosphatidylethanolamine, lysophosphatidylinositol, lysophosphatidylglycerol and lysophosphatidylserine or a mixture of two or more thereof).
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.
Claim(s) 1, 2, 5-7, 11 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Skiff et al (US 2010/0136175 A1) in view of Yang et al (US 2017/0311632 A1) and Sekikawa et al (US 2009/0285952 A1) (with Lee et al (US 2017/0247647 A1), which is being cited here merely to support the Examiner’s assertion that lysolecithin has a HLB ranging from 8 to 16).
Skiff teaches (abstract, claims 1 and 2) an edible, clear, high flavor oil loaded, thermodynamically stable microemulsion, which can be used for the flavoring of clear beverages, comprising: (a) at least 20 wt.% of a flavor oil, (b) 10-30 wt.% of a surfactant system having a HLB between 6 and 18 and (c) a hydrophilic phase formed of water and/or water-soluble co-solvent, wherein the surfactant system is a combination of lecithin and a sugar ester of a fatty acid. (here, the hydrophilic phase formed of water and/or water-soluble co-solvent teaches instant polar phase comprising at least one polar non-aqueous solvent, and the flavor oil, which naturally would not be included in the hydrophilic phase, teaches instant non-polar phase comprising a flavor oil). In claims 6-8, Skiff also teaches that the water-soluble co-solvent can be propylene glycol (instant polar non-aqueous solvent of claims 1, 6, 18 and 19) or glycerin (another name for glycerol) (instant polar non-aqueous solvent of claims 1, 6 and 18).
Skiff does not teach instant lysolecithin of the surfactant system. Yang teaches ([0074]) a lysolecithin composition which is an ideal emulsifier useful in preparing flavor emulsion, clear liquid beverages and liquid beverage concentrates and that unlike many other emulsifiers, its lysolecithin composition is stable at a low pH. Yang teaches that a clear beverage prepared from its lysolecithin composition does not turn cloudy at a low pH during its shelf life (e.g., at least 6 months). Yang further teaches ([0190]-[0191], [0005] and [0023]) that unlike conventional lysolecithin which gives off-taste and off-odors, the off-odors and off-flavors are insignificant when its inventive lysolecithin composition is used as an emulsifier in beverages. Yang even teaches ([0092]-[0093] that its inventive lysolecithin composition can be used together with one or more co-emulsifiers including lecithin. Yang teaches (see Example 2, [0154]) that its lysolecithin composition has 72.1 mol % LPC (lysophosphatidylcholine), 9.5 mol % PC (phosphatidylcholine), 2.1% GPC (glycerophosphocholine) and 11.9% lysophosphatidylethanolamine (in its claim 8, Yang also teaches that its lysolecithin composition contains 50 wt.% or greater of lysophospholipids). Thus, Yang’s lysolecithin composition of its Example 2 meets the definition for instant lysolecithin (see Paragraph 2 above). Since both Skiff and Yang aim to provide a clear beverage containing flavor oils, since Skiff’s surfactant is to have a HLB value that ranges from 6 to 18 and Yang’s lysolecithin has a HLB value of 8-16 (as evidenced by Lee et al ([0035])), and since the surfactant system of Skiff’s microemulsion contains lecithin (with which Yang’s lysolecithin composition can be used together), it would have been obvious to one skilled in the art to use Yang’s lysolecithin composition of Example 2 in Skiff’s surfactant system containing lecithin with a reasonable expectation of obtaining a clear flavored beverage which would not turn cloudy at low pH during its shelf-life and would not produce off-odors and off-flavors. Thus, Skiff in view of Yang teaches renders obvious instant surfactant system comprising lysolecithin and lecithin.
As to instant limitation of the flavor oil being present in an amount of 20-46 wt.%, as already stated above, Skiff teaches that its clear flavor microemulsion comprises at least 20 wt.% of a flavor oil. Such range overlaps with instant range of 20-46 wt.%, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Alternatively, under the general guideline (i.e., at least 20 wt.% for the amount of the flavor oil) given by Skiff, instant range 20-46 wt.% would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
As to instant limitation of lysolecithin being present in the amount of 15-30 wt.%, Yang teaches ([0022]) that the lysolecithin composition (as an emulsifier) can be used in the amount of 0.1-30 wt.% of a flavor emulsion. Such range overlaps with instant range 15-30 wt.%, thus rendering instant ranges prima facie obvious. In re Wertheim, supra.
As to instant limitation of lecithin being present in the amount of 3-10 wt.%, Skiff teaches (see claim 5) that the lecithin (which is included in its surfactant system) is present in the amount of 0.5-10 wt.% (based on the total weight of the microemulsion). Such range overlaps with instant range 3-10 wt.%, thus rendering instant range prima facie obvious. In re Wertheim, supra.
As to instant limitation of the mass ratio of lysolecithin and lecithin being between 10:1 to 1:2, Skiff in view of Yang does not explicitly teach such limitation. However, Sekikawa teaches (see abstract, [0035] and claims 1-2) that for transparent emulsified flavor composition containing both enzyme degraded lecithin (such as lysolecithin) and lecithin, the ratio of lysolecithin to lecithin ranges from 9:1 to 1:9. Such range overlaps with instant range (10:1 to 1:2) for the mass ratio of lysolecithin and lecithin, thus rendering instant range prima facie obvious. In re Wertheim, supra (besides, as already discussed above, Yang teaches that the lysolecithin composition can be used in the amount of 0.1-30 wt.% based on the total weight of the flavor emulsion, and Skiff teaches that its lecithin is present in the amount of 0.5-10 wt.% based on the total weight of the microemulsion (claim 5). Skiff also teaches (claim 1) that the total amount of the surfactant system used in its microemulsion should be in the range of 10-30 wt.%. Under these general guidelines, instant range (10:1 to 1:2) for the mass ratio of lysolecithin and lecithin would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra).
Thus, Skiff in view of Yang and Sekikawa renders obvious instant claims 1, 2, 5, 6 and 17-19.
With respect to instant claim 7, Skiff teaches (claim 11) that the water-soluble co-solvent (instant polar non-aqueous solvent) can be present in the amount of 30 wt.% or more relative to the weight of microemulsion. Such range overlaps with instant range of 10-60 wt.%, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Skiff in view of Yang and Sekikawa renders obvious instant claim 7.
With respect to instant claim 11, Skiff teaches ([0048]-[0049]) that its flavor microemulsion is prepared by the following steps : (i) first admixing water, propylene glycol (instant polar non-aqueous solvent) and a sugar ester surfactant to form a pre-microemulsion; (ii) separately mixing a selected flavor oil with lecithin (which is to be used together with Yang’s lysolecithin composition as already discussed above) until a well-dispersed clear/translucent system is formed; (iii) at room temperature and under gentle stirring, adding a specified amount of pre-microemulsion formed from step (i) to the flavor oil/lecithin mixture (which is to be flavor oil/lecithin/lysolecithin mixture according to the teaching of Skiff in view of Yang); and (iv) after a few minutes of mixing, a clear and stable flavor microemulsion will result. Thus, those steps taught by Skiff in view of Yang teach instant step (a) of mixing a non-polar phase comprising a flavor oil and a polar phase comprising at least one polar non-aqueous solvent (propylene glycol) in the presence of a surfactant system comprising lysolecithin and lecithin and instant step (b) of stirring the mixture obtained after instant step (a). Thus, Skiff in view of Yang and Sekikawa renders obvious instant claim 11.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5-7, 11 and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7 and 8 of copending Application No. 18/550,934 in view of Yang et al (US 2017/0311632 A1), Skiff et al (US 2010/0136175 A1) and Sekikawa et al (US 2009/0285952 A1).
Claims 1-2 and 7 of copending App.’934 teaches a flavor delivery system (which is in the form of a microemulsion or nanoemulsion) comprising a flavor composition comprising (i) a surfactant system comprising lysolecithin, lecithin, a sugar ester, a monoglycerol ester, a polyglycerol ester or mixtures thereof, (ii) a non-polar phase comprising a flavor oil and (iii) a polar phase comprising at least one polar non-aqueous solvent and further comprising water. It would be obvious to one skilled in the art to use a mixture of lysolecithin and lecithin as the surfactant system in the flavor composition of claim 1 of App.’934 with a reasonable expectation of success.
With respect to instant amount (20-46 wt.%) for the flavor oil, claim 3 of App.’934 teaches that its flavor oil is present in the amount of at least 1 wt.%. Such range overlaps with instant range of 20-46 wt.%, thus rendering instant range prima facie obvious. In re Wertheim, supra. Alternatively, under the general guideline (i.e., at least 1 wt.% for the amount of the flavor oil) given by claim 3 of App.’934, instant range 20-46 wt.% would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra.
With respect to instant amount (15-30 wt.%) for the lysolecithin, although claims of App.’934 do not teach instant range for the amount of lysolecithin, as already discussed above, Yang, a reference which teaches a lysolecithin composition as an ideal emulsifier useful in preparing clear liquid beverages (containing flavor oil) that do not turn cloudy at a low pH during the shelf life, teaches ([0022]) that the lysolecithin composition can be used in the amount of 0.1-30 wt.% of a flavor emulsion. It would be obvious to one skilled in the art to use 0.1-30 wt.% of lysolecithin in the flavor composition of claim 1 of App.’934 with a reasonable expectation of achieving clear liquid beverages (containing flavor oil) which do not turn cloudy at low pH during the shelf life. The range 0.1-30 wt.% for the amount lysolecithin as taught by Yang overlaps with instant range 15-30 wt.%, thus rendering instant ranges prima facie obvious. In re Wertheim, supra.
With respect to instant amount (3-10 wt.%) for the lecithin, claims of App.’934 do not teach such limitation. Skiff teaches (abstract, claims 1 and 2) an edible, clear, high flavor oil loaded, thermodynamically stable microemulsion, which can be used for the flavoring of clear beverages, comprising: (a) a flavor oil, (b) a surfactant system comprising lecithin and (c) a hydrophilic phase formed of water and/or water-soluble co-solvent, and Skiff teaches (claim 5) that the lecithin can be used in the amount of 0.5-10 wt.% (based on the total weight of the microemulsion). It would be obvious to one skilled in the art to use 0.5-10 wt.% lecithin in the flavor composition of claim 1 of App.’934 with a reasonable expectation of obtaining clear, high flavor oil loaded, thermodynamically stable microemulsion. The range 0.5-10 wt.% for the amount of lecithin as taught by Skiff overlaps with instant range 3-10 wt.%, thus rendering instant range prima facie obvious. In re Wertheim, supra.
With respect to instant mass ratio of lysolecithin and lecithin being between 10:1 to 1:2, claims of App.’934 do not teach instant range (10:1 to 1:2) for the mass ratio of lysolecithin and lecithin. Sekikawa teaches (see abstract, [0035] and claims 1-2) that for transparent emulsified flavor composition containing both enzyme degraded lecithin (such as lysolecithin) and lecithin, the ratio of lysolecithin to lecithin ranges from 9:1 to 1:9. Such range overlaps with instant range (10:1 to 1:2) for the mass ratio of lysolecithin and lecithin, thus rendering instant range prima facie obvious. In re Wertheim, supra (besides, as already discussed above, Yang teaches that the lysolecithin composition can be used in the amount of 0.1-30 wt.% based on the total weight of the flavor emulsion, and Skiff teaches that its lecithin is present in the amount of 0.5-10 wt.% based on the total weight of the microemulsion (claim 5). Under these general guidelines, instant range (10:1 to 1:2) for the mass ratio of lysolecithin and lecithin would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra).
Thus, claims 1-3 and 7 of App.’934 in view of Yang, Skiff and Sekikawa render obvious instant claims 1, 2, 5 and 17.
With respect to instant claims 6, 18 and 19, claims 1-3 and 7 of App.’934 do not name any specific polar non-aqueous solvent. Skiff, which teaches a similar flavor oil-containing microemulsion that can be used for the flavoring of clear beverages, teaches (claims 6-8) using propylene glycol as the water-soluble co-solvent in its hydrophilic phase (polar phase) formed of water and/or water-soluble co-solvents. It would be obvious to one skilled in the art to use propylene glycol as the at least one polar non-aqueous solvent in the polar phase of the flavor composition of claim 1 of App..’934 with a reasonable expectation of success. Thus, claims 1-3 and 7 of App.’934 in view of Yang, Skiff and Sekikawa render obvious instant claims 6, 18 and 19.
With respect to instant claim 7, claims 1-3 and 7 of App.’934 do not teach the amount of the at least one polar non-aqueous solvent in the polar phase of the flavor composition. Skiff teaches (claim 11) that the water-soluble co-solvent (such as propylene glycol – a polar non-aqueous solvent) can be used in the amount of 30 wt.% or more relative to the weight of microemulsion. It would be obvious to one skilled in the art to use 30 wt.% or more of propylene glycol as the at least one polar non-aqueous solvent in the polar phase of the flavor composition in claim 1 of App.’934 with a reasonable expectation of success. The range 30 wt.% or more for the amount of propylene glycol overlaps with instant range of 10-60 wt.% for the amount of the polar non-aqueous solvent, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, claims 1-3 and 7 of App.’934 in view of Yang, Skiff and Sekikawa render obvious instant claim 7.
With respect to instant claim 11, claim 8 of App.’934 teaches a method for preparing a flavor delivery system, wherein the method comprises the following steps:
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Although claim 8 of App.’934 does not explicitly mention instant stirring step, it is a common practice in the art to stir after mixing the ingredients. It would have been obvious to stir after the mixing step of claim 8 of App.’934 with a reasonable expectation of achieving even, uniform mixture. Thus, claims 1-3, 7 and 8 of App.’934 in view of Yang, Skiff and Sekikawa render obvious instant claim 11.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argue that instant claims are patentable over the disclosures of Skiff and Yang as the references do not disclose or suggest the claimed composition having the recited features. Applicant also argue that Sekikawa does not remedy the deficiency of Skiff and Yang because Sekikawa does not provide any suggestion for one skilled in the art to modify Skiff with the teachings of Yang. Applicant specifically argue that Skiff describes a surfactant system having HLB between 6 and 18, which indicates that the HLB refers to the combination of surfactants used in the surfactant system, not the HLB of the individual materials. Applicant argue that Skiff only disclose that the combination of sugar ester and lecithin has HLB in the recited range and there is no disclosure or suggestion that other combinations of materials have HLB in the disclosed range. Applicant argue that even if lysolecithin has HLB between 6 and 18, there is no suggestion that the combination of lysolecithin and lecithin will have the HLB recited in Skiff. The Examiner disagrees. As pointed out by applicant, Skiff’s surfactant system (lecithin and sugar ester) has HLB value comprised between 6 and 18. Since lysolecithin has a HLB value between 8 and 16, and since such range fall within the HLB range (between 6 and 18) of Skiff’s surfactant system, when Yang’s lysolecithin is added to Skiff’s surfactant system (already having HLB value of 6-18), the HLB value for the resulting surfactant mixture would still have to be comprised between 6 and 18.
Applicant next argue that present Examples (flavor emulsions of Samples 1-7 (see Table 1) that were made into beverage compositions A-G, respectively (see Table 5) show that microemulsions encompassed by instant claims have a good balance of droplet size (in the range of 20-100 nm) and turbidity (in the range of 0.1-9 NTU) when made into model beverages (see Table 8). Applicant also argue that in addition to desirable droplet size and turbidity, good storage stability is also achieved as shown in Table 12 of present specification. Applicant argue that such a result would not have been predictable on the bases of Skiff and Yang. The Examiner disagrees. First of all, there is no comparison shown in present specification that directly and fairly compares instant flavor microemulsions of Samples 1-7 and comparative flavor microemulsions, which are the same as instant flavor microemulsions (i.e., using the same components in the same amounts) except for not having instant lysolecithin (such comparison will fairly and directly show superior result of using lysolecithin). Secondly, even if such direct, fair comparison were shown, the result of desirable droplet size (20-100 nm) and turbidity (0.1-9 NUT) as well as good storage stability, as asserted by applicant, are nothing unexpected because Yang already teaches ([0077], [0096] and [0176]) that a liquid beverage containing the lysolecithin composition is clear, having a turbidity of 5 NTU or less (e.g., 2 NTU or less or 1 NTU or less) and also teaches that a clear beverage prepared from the lysolecithin composition is stable and does not turn cloudy at low pH during its shelf life up to 6 months (see [0074]). Furthermore, Skiff’s invention is also drawn to a clear, thermodynamically stable, flavor microemulsion with the droplet size of less than 140 nm (see [0001], [0003] and [0052]).
Applicant argue that the present claims as amended are patentably distinct over the claims of copending App. 18/550,934 for at least reason that the claims of copending application do not recite the features of the amended claim 1. The Examiner believes that such argument is already answered above in Paragraph 8. Citing MPEP 804(I)(B)(1)(b)(i), applicant further argue that since the only remaining rejection once the present claim amendments are entered will be the present double patenting rejection, which is based on an application having a later patent term filing date compared to present application, the double patenting rejection should be withdrawn. However, applicant’s such argument is moot since present double patenting rejection is not the only remaining rejection.
For the reasons explained above, instant 103 rejection and instant double patenting rejection still stand.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
May 18, 2026
Prosecution Insights