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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1,4,6,8,10,12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang(Eugenol Nanoemulsion Stabilized with Zein and Sodium Caseinate by Self-Assembly) in view of Just-Borras(Effects of using cationic exchange for reducing pH on the composition and quality of sparkling wine (Cava)) and Kinoshita(WO2020/175618).
Regarding claims 1,8 Wang teaches a method for preparing protein nanoparticle microspheres, the method comprising(p.2991, materials and methods)
1)dispersing a protein powder(sodium caseinate) in water, adjusting the pH to 11.5, stirring (p.2991, Preparation of Stock Solution). Wang teaches centrifuging the composition to remove insoluble aggregates(p.2991, Particle size and Potential). As such, it would have been obvious to collect the first upper dispersion in order to remove insoluble aggregates.
2)adjusting the first upper dispersion in 1) to be neutral to yield a protein nanoparticle dispersion ( p.2991,; Preparation of Eugenol Emulsions, protein composition is adjusted to a pH of 7). Wang does not teach cation exchange to neutralize the composition. However, Just-Borras teaches that cation-exchange is a known method of reducing the pH of a solution such as wine(abstract). Therefore, since cation exchange is a known method of neutralizing a composition and an alternative to adjusting the pH with an acid as taught in Just-Borras, it would have been obvious to use cation exchange to neutralize the dispersion. Wang teaches centrifuging the composition to remove insoluble aggregates(p.2991, Particle size and Potential)
3)adding eugenol to the protein nanoparticle dispersion and stirring (p.2991, Preparation of Eugenol Emulsions). Wang teaches centrifuging the composition to remove insoluble aggregates(p.2991, Particle size and Potential). It would have been obvious to collect the first upper dispersion in order to remove insoluble aggregates.
Wang does not specifically teach a core/shell structure with a eugenol core and protein shell. However, Wang teaches the same method as claimed. Applicant is reminded that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
4) freeze drying the composition to yield protein nanoparticle microspheres (p.2991, Preparation of Eugenol Emulsions)
Wang does not specifically teach adding the core-shell nanoprotein dispersion to ultrapure water, dialyzing, centrifuging, collecting a second upper dispersion.
However, Kinoshita teaches a method of making nanoparticles comprising gum Arabic or gum ghatti and a bioactive ingredient such as eugenol. Kinoshita teaches that the resultant nanoparticles are dialyzed and ultrafiltered and then freeze dried(abstract, para 79,146). It would have been obvious to dialyze the nanoparticle composition of Wang in order to remove any contaminants or precipitates. It would want been obvious to adjust the dialysis time in order to effectively remove any contaminants from the composition. It would have been obvious to collect the second dispersion after dialyzing in order to remove unwanted contaminants or precipitates. It would have been obvious to dissolve the core-shell nanoprotein dispersion into ultrapure water in order to avoid contaminants or additional salts that would alter the final product.
Wang teaches centrifuging the composition to remove insoluble aggregates(p.2991, Particle size and Potential). As such, it would have been obvious to remove the precipitate and collect the second upper dispersion before freeze-drying in order to remove unwanted insoluble particles.
Regarding claim 4, Wang teaches that the eugenol accounts for 1% by volume of the protein nanoparticle dispersion(abstract).
Regarding claim 6, Wang teaches that the composition contains 2g NaCas/zein protein and 0.5 to 2ml eugenol(500 to 2000 µl)( eugenol p.2991, Preparation of Eugenol Emulsions), which equates to 0.1g to 0.4g:100µl mass to volume ratio of protein powder to eugenol.
Regarding claim 10, Wang teaches dissolving 2g of protein in 100ml of water, i.e a mass-volume ratio of protein powder to water of 1:50 g/ml(eugenol p.2991, Preparation of Stock Solutions).
Regarding claim 12, Kinoshita renders obvious dialyzing the protein nanoparticle but does not teach “wherein in 4), when a dialysis time is 24 hours, full- hollow protein nanoparticle microspheres are obtained; when a dialysis time is 18 hours, semi-hollow protein nanoparticle microspheres are obtained; and when a dialysis time is 12 hours, solid-like protein nanoparticle microspheres are obtained.”
However, applicant is reminded that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim(s) 2,3,5,7,11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang(Eugenol Nanoemulsion Stabilized with Zein and Sodium Caseinate by Self-Assembly) in view of Just-Borras(Effects of using cationic exchange for reducing pH on the composition and quality of sparkling wine (Cava)) and Kinoshita(WO2020/175618 further in view of Liu( Food-Grade Nanoemulsions: Preparation, Stability and Application in Encapsulation of Bioactive Compounds).
Regarding claims 2,3, Wang does not specifically teach adding sodium chloride following 2) and before adding eugenol to the protein nanoparticle dispersion. However, Liu teaches adding of less than 100mM sodium chloride to nanoparticle dispersions in order to agglomerate and stabilize particles(3.1.2, p.9-10). It would have been obvious to include less than 100mM of sodium chloride to the protein nanoparticle dispersion in Wang in order to achieve larger particle sizes as taught in Liu.
Wang teaches centrifuging the composition to remove insoluble aggregates(p.2991, Particle size and Potential). As such, it would have been obvious to remove the precipitate in order to yield dimension-enlarged protein nanoparticle dispersion.
Regarding claim 5, Wang teaches that the eugenol accounts for 1% by volume of the protein nanoparticle dispersion(abstract).
Regarding claim 7, Regarding claim 6, Wang teaches that the composition contains 2g NaCas/zein protein and 0.5 to 2ml eugenol(500 to 2000 µl)( eugenol p.2991, Preparation of Eugenol Emulsions), which equates to 0.1g to 0.4g:100µl mass to volume ratio of protein powder to eugenol.
Regarding claim 9, Wang does not specifically teach adding the core-shell nanoprotein dispersion to ultrapure water, dialyzing, centrifuging, and collecting a second upper dispersion.
However, Kinoshita teaches a method of making nanoparticles comprising gum Arabic or gum ghatti and a bioactive ingredient such as eugenol. Kinoshita teaches that the resultant nanoparticles are dialyzed and ultrafiltered and then freeze dried(production example 1). It would have been obvious to dialyze the nanoparticle composition of Wang in order to remove any contaminants or precipitates. It would want been obvious to adjust the dialysis time in order to effectively remove any contaminants from the composition.
Regarding claim 11, Wang teaches dissolving 2g of protein in 100ml of water, i.e a mass-volume ratio of protein powder to water of 1:50 g/ml.
Response to Arguments
Applicant's arguments filed 3/01/2026 have been fully considered but they are not persuasive.
The applicant argues that Wang does not teach that the protein is rice protein powder, casein protein powder, soybean protein powder, or a mixture thereof. However, Wang teaches that the protein powder can be in the form of sodium caseinate(p.2991, Preparation of Stock Solution).
The applicant argues that the cited references do not teach forming “nanoscale shells capable of allowing removal of an enclosed eugenol core though osmosis”. However, these features are not recited in the present claims. The claims only recite a eugenol core and a protein shell. Since the cited references teach the recited process steps, one of ordinary skill in the art would expect the composition to have the claimed properties including the shell and core feature. The applicant has not shown anything unexpected or demonstrated that the prior art would not have the claimed features.
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.
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
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