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 Claims
The amendments and arguments filed 17 December 2025 are acknowledged and have been fully considered. Claims 39-58 are currently pending. Claim 39 is amended; no claims are cancelled; claims 45-46, 51, and 57-58 are withdrawn; no claims are new.
Claims 39-44, 47-50, and 52-56 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 39, 41-44, 47-50, 53-54, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. (US 2016/0038428) as evidenced by PubChem (“beta-Lactoglobulin”).
Claim 39 is drawn to a composition comprising a plurality of particles, each particle having a diameter of 50 nm to 1000 nm, and comprising
at least one compound having a protein-based shell at least partially surrounding the at least one compound; and
a coating comprising a polysaccharide encapsulating the at least one shelled compound,
wherein said at least one compound is a lipophilic compound and wherein said protein-based shell is selected from the group consisting of water-soluble proteins.
Harel et al. teach encapsulation of hydrophobic (i.e., lipophilic) compounds in a protein shell followed by a matrix comprising a polysaccharide (Abstract). Harel et al. further teach the size of the coated hydrophobic droplets preferably in the range of 0.3 to 0.7 micron (par. [0039]), i.e., 300 to 700 nm, overlapping with the instantly claimed range. Harel et al. additionally teach the protein shell preferably comprising β-lactoglobulin (Par. [0037]), further teaching preparation of aqueous solutions of β-lactoglobulin (Par. [0065]), indicating that it is a water-soluble protein.
As such, claim 39 is rejected as prima facie obvious.
Claim 41 is drawn to the composition of claim 39, wherein the concentration of the at least one compound in the particle is 0.01 mg/g to 500 mg/g.
Harel et al. further teach in Example 2 (Par. [0067]) a composition comprising a maximum of 49.3% by weight of omega 3 fish oil (i.e., the at least one compound) as calculated by examiner, corresponding to a composition comprising up to 493 mg/g, overlapping with the instantly claimed range.
As such, claim 41 is rejected as prima facie obvious.
Claim 42 is drawn to the composition of claim 39, wherein the at least one compound is soluble in an organic solvent.
Harel et al. further teach that “‘hydrophobic’ and ‘lipophilic’ are used herein interchangeably, and refer to a material whose solubility is greater in non-polar solvent having a dielectric constant of less than about 15, for example, long chain alcohols, than in an aqueous solution” (Par. [0027]), indicating that the hydrophobic encapsulated ingredient is soluble in organic solvents.
As such, claim 42 is rejected as prima facie obvious.
Claim 43 is drawn to the composition of claim 39, wherein the at least one compound is selected from a group including astaxanthin (Applicant’s elected species).
Harel et al. further teach the encapsulated hydrophobic ingredient being astaxanthin (Pars. [0028] and [0030]).
As such, claim 43 is rejected as prima facie obvious.
Claim 44 is drawn to the composition of claim 39, wherein said protein-based shell is whey protein (Applicant’s elected species).
Harel et al. teach the protein shell preferably being β-lactoglobulin. As evidenced by PubChem, β-lactoglobulin is a whey protein (Description on pg. 1).
As such, claim 44 is rejected as prima facie obvious.
Claim 47 is drawn to the composition of claim 39 being selected from the group consisting of an edible composition, dietary supplement, pharmaceutical composition, agrochemical composition, or a cosmetic composition.
Claim 47 is an intended use claim and does not impart any further structural limitations on the composition.
Nevertheless, Harel et al. further teach the composition being used as a nutraceutical composition (i.e., dietary supplement), incorporated into breakfast cereals (i.e., an edible composition), or as a pharmaceutical composition (Par. [0023]).
As such, claim 47 is rejected as prima facie obvious.
Claim 48 is drawn to the composition of claim 39, being in the form of a powder.
Harel et al. further teach the composition being dried via freeze drying or other drying methods (Par. [0046]), which would result in a dry powder.
As such, claim 48 is rejected as prima facie obvious.
Claim 49 is drawn to the composition of claim 48, wherein said powder comprises 1% to 80% (w/w) of the at least one compound.
Claim 50 is drawn to the composition of claim 48, wherein said powder has a content of 0.5 mg/g to 500 mg/g of the at least one compound.
As the composition of Example 2 (par. 0067]) comprises 49.3 wt% (493 mg/g) of the at least one compound calculated based on a dry basis, applying the drying methods of Harel et al. to the composition of Example 2 would necessarily result in a powder composition comprising between 1% to 80% (w/w) of the at least one compound and having a content of 0.5 mg/g to 500 mg/g of the at least one compound.
As such, claim 49-50 are rejected as prima facie obvious.
Claim 53 is drawn to the composition of claim 39, wherein said partially surrounding is at least 85% of the total surface of said at least one compound.
Harel et al. further teach the protein shell coating at least 90% of the hydrophobic compound (Par. [0061]).
As such, claim 53 is rejected as prima facie obvious.
Claim 54 is drawn to the composition of claim 54, wherein said at least one compound has a zeta potential of -50 mV to -10 mV.
Harel et al. are silent as to the zeta potential of the at least one compound.
However, as discussed in MPEP 2112.01 “Products of identical chemical composition cannot have mutually exclusive properties (Citing In re Spada, 911 F.2d 705 (Fed. Cir. 1990)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In the instant case, the zeta potential of astaxanthin is a property inherent to the compound as evidenced by the instant specification. As Harel et al. teach the instantly claimed particle encapsulating astaxanthin, the instantly claimed zeta potential is necessarily present.
As such, claim 54 is rejected as prima facie obvious.
Claim 56 is drawn to the composition of claim 39, wherein said composition is stable at a temperature between 25 and 40°C.
Harel et al. further teach the composition being stable for an extended period of time (Par. [0061]).
As such, claim 56 is rejected as prima facie obvious.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. as applied to claims 39, 41-44, 47-50, 53-54, and 56 above, and further in view of Huang et al. (Food Research International, 2016, Vol. 87, 1-9; of record).
The teachings of Harel et al. have been set forth above.
Claim 40 is drawn to the composition of claim 39, wherein a thickness of said coating is between 1 and 30 nm.
Harel et al. are silent as to the thickness of the coating.
However, Huang et al. also teach core-shell nanoparticles encapsulating bioactive compounds in a protein core with a polysaccharide shell (Abstract). Huang et al. further teach stable nanoparticles having a polysaccharide shell with a thickness between 15 to 30 nm (Pg. 4 left column), overlapping with the instantly claimed range.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Harel et al. to have a polysaccharide shell with a thickness between 15 to 30 nm. It would have been obvious to combine the known nanoparticles with the known polysaccharide shell thickness to yield the predictable result of a stable core-shell nanoparticle for the encapsulation of a bioactive compound, with a reasonable expectation of success.
As such, claim 40 is rejected as prima facie obvious.
Claims 39 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. as applied to claims 39, 41-44, 47-50, 53-54, and 56 above, and further in view of Hu et al. (Food Chemistry, 2015, Vol. 182, 275-281; of record) and Joye et al. (Current Opinion in Colloid & Interface Science, 2014, Vol. 19, 417-427; of record).
The teachings of Harel et al. have been set forth above.
Claim 39 is drawn to a composition comprising a plurality of particles, each particle having a diameter of 50 nm to 1000 nm, and comprising
at least one compound having a protein-based shell at least partially surrounding the at least one compound; and
a coating comprising a polysaccharide (more specifically maltodextrin (Applicant’s elected species)) encapsulating the at least one shelled compound,
wherein said at least one compound is a lipophilic compound and wherein said protein-based shell is selected from the group consisting of water-soluble proteins.
Harel et al. do not teach the polysaccharide coating comprising Applicant’s elected species of maltodextrin.
Harel et al. further teach the polysaccharide coating comprising pectin, alginic acid and salts thereof, chitosan, dextran, pullulan, or carrageenan (Par. [0011]).
Hu et al. also teach nanoparticles with a protein core and polysaccharide shell for encapsulating hydrophobic bioactive molecules (Abstract) further teaching that a shell consisting only of the polysaccharide is suitable for protein core – polysaccharide shell nanoparticles (pg. 276 left column)
Joye et al. teach biopolymer-based nanoparticles (Title) including polysaccharide nanoparticles (Abstract). Joye et al. further teach pectin, alginate, chitosan, dextran, pullulan, carrageenan, and maltodextrin as suitable polysaccharides for use in nanoparticles (Table 2 on pg. 419).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the particles of Harel et al. to comprise a shell consisting only of a polysaccharide as taught by Hu et al., wherein the polysaccharide is maltodextrin as taught by Joye et al. It would have been obvious to substitute one polysaccharide biopolymer shell suitable for forming nanoparticles for another, with a reasonable expectation of success.
As such, claim 39 is rejected as prima facie obvious.
Claim 55 is drawn to the composition of claim 39, wherein the particles have a zeta potential of 14 mV to 100 mV.
Harel et al. are silent as to the zeta potential of the particles.
However, as discussed in MPEP 2112.01 “Products of identical chemical composition cannot have mutually exclusive properties (Citing In re Spada, 911 F.2d 705 (Fed. Cir. 1990)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In the instant case, the zeta potential of particles is a property inherent to the composition as evidenced by the instant specification. As Harel et al. in view of Hu et al. and Joye et al. teach the instantly claimed nanoparticle with a maltodextrin coating, the instantly claimed zeta potential is necessarily present.
As such, claim 55 is rejected as prima facie obvious.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. as applied to claims 39, 41-44, 47-50, 53-54, and 56 above, and further in view of Masarudin et al. (Nanotechnology Science and Applications, 2015, Vol. 8, 67-80).
The teachings of Harel et al. have been set forth above.
Claim 52 is drawn to the composition of claim 39, having a polydispersity index (PDI) of 0.05 to 0.5.
Harel et al. are silent as to the PDI of the composition.
However, Masarudin et al. that for nanoparticles for delivery of compounds, a low PDI is indicative of greater particle stability (Pg. 71 left column first paragraph).
And, as discussed by MPEP 2144.05, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the PDI of the nanoparticles is clearly a result-effective variables, determining the stability. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal PDI in order to best achieve the desired results.
As such, claim 52 is rejected as prima facie obvious.
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 39, 43-44, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 9, 12-14, 16-18, 21-22, and 25 of copending Application No. 17/926,565 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 17 of Application ‘565 recites a particle comprising a protein-based shell and a biological compound, wherein the biological compound is distributed not only in the center of the particle but also partially included in the protein shell, wherein the protein is selected from the group of whey protein, soya protein, pea protein, fava bean protein, potato protein, and any combination thereof. Claim 18 of Application ‘565 recites the particle of claim 17 further comprising a polysaccharide coating encapsulating the particle. Claim 21 of Application ‘565 recites the particle of claim 17 having a diameter in the range from 70 to 700 nm.
Claims 17-18 and 21 of Application ‘565 render instant claims 39 and 44 obvious.
Claim 25 of Application ‘565 recites the particle of claim 17, wherein the biological compound is selected from a group including a protein rendering obvious instant claim 43.
Claims 1-2, 7, 9, 12-14, and 16 of Application ‘565 recite a method that normal operation of the method would produce the composition of instant claims 39, 43-44, and 48.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed 17 December 2025 have been fully considered but are moot in view of the new grounds of rejection set forth above, necessitated by Applicant’s amendment to the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/ Examiner, Art Unit 1611
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