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 19 May 2025 are acknowledged and have been fully considered. Claims 39-58 are currently pending. Claim 39 is amended; claims 1-38 are cancelled; claims 45-46, 51, and 57-58 are withdrawn; no claims are new.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.
Response to Arguments
Applicant’s arguments of unexpected results, see the declaration, filed 19 May 2025, with respect to the rejection(s) of claim(s) 39, 41-44, 47-50, and 52-56 under 35 U.S.C. 103 over Hu et al. in view of Bustos-Garza et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Esfanjani et al.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 39, 41-44, 47-50, and 52-53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esfanjani et al. (Journal of Food Engineering, 2015, Vol. 165, 149-155) as evidenced by PubChem (“Safranal”) and Hu et al. (Food Chemistry, 2015, Vol. 182, 275-281; of record).
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 protein-based shell is selected from the group consisting of water-soluble proteins (more specifically whey protein (Claim 44, Applicant’s elected species)).
Esfanjani et al. teach nano-encapsulation of saffron extract in multi-layer particles comprising whey protein and pectin (Title). Esfanjani et al. further teach these particles being formed by the addition of an emulsion comprising the saffron extract into an aqueous solution of whey protein, followed by the addition into an aqueous solution of pectin (Pg. 150 right column last paragraph), resulting in particles comprising at least one compound having a protein shell coated with a polysaccharide encapsulating the shell. Esfanjani et al. further teach the particles having a size of 536.3 nm (Table 1 WPC-pectin-Seq-10).
As such, claims 39 and 44 are anticipated.
Claim 41 is drawn to the composition of claim 39, wherein the concentration of said compound in said particle is 0.01 mg/g to 500 mg/g.
Esfanjani et al. further teach mixing the extract and solutions to have an extract to wall material weight ratio of 1:3.5 (Pg. 149 right column fifth paragraph). Based on the approximately 96% encapsulation efficiency disclosed in Table 1, this corresponds to the particles comprising 27.4% by weight saffron extract or 274 mg/g, as calculated by examiner, overlapping with the instantly claimed range.
As such, claim 41 is anticipated.
Claim 42 is drawn to the composition of claim 39, wherein said at least one compound is soluble in an organic solvent.
Esfanjani et al. further teach the saffron extract comprising the compound safranal (Pg. 149 left column first paragraph).
As evidenced by PubChem, safranal is miscible in ethanol (Sec. 3.2.4), i.e., soluble in an organic solvent.
As such, claim 42 is anticipated.
Claim 43 is drawn to the composition of claim 39, wherein said at least one compound is a lipophilic compound.
As further evidenced by PubChem, safranal is soluble in oil (Sec. 3.2.4), i.e., a lipophilic compound.
As such, claim 43 is anticipated.
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, Esfanjani et al. teach “Saffron has been used in a wide variety of industries including food, pharmaceutical, and cosmetics due to its natural colorant, antioxidant, and therapeutic properties” (Pg. 149 left column first paragraph), further teaching “The W/O/W multiple emulsion stabilized by biopolymers is a major food system for creating spherical spray dried powder particles in which hydrophilic ingredients are encapsulated in the inner aqueous phase” (Pg. 149 right column second paragraph). As such, Esfanjani et al. indicate that the composition is suitable for use as an edible composition, dietary supplement, pharmaceutical composition, and cosmetic composition.
As such, claim 47 is anticipated.
Claim 48 is drawn to the composition of claim 39, being in the form of a powder.
Esfanjani et al. further teach spray drying of the emulsion to result in a powder (Sec. 2.5 on pg. 151).
As such, claim 48 is anticipated.
Claim 49 is drawn to the composition of claim 48, wherein said powder comprises 1% to 80% (w/w) of said 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 said at least one compound.
Esfanjani et al. further teach mixing the extract and solutions to have an extract to wall material weight ratio of 1:3.5 (Pg. 149 right column fifth paragraph). Based on the approximately 96% encapsulation efficiency disclosed in Table 1, this corresponds to the particles comprising 27.4% by weight saffron extract or 274 mg/g, as calculated by examiner, overlapping with the instantly claimed range.
As such, claims 49-50 are anticipated.
Claim 52 is drawn to the composition of claim 39, having a polydispersity index of 0.05 to 0.5.
Esfanjani et al. are silent as to the polydispersity index of the particles, but disclose the size distribution of the particles in Fig. 1b (WPC-pectin-seq).
Hu et al. teach a population of nanoparticles having a polydispersity index of approximately 0.25 (Table 1), further disclosing the particle size distribution in Fig. 1.
When the particle size distributions of Esfanjani et al. and Hu et al. are scaled to each other and overlayed, as depicted below, the WPC-pectin-seq of Esfanjani et al. distribution indicated by the arrow is narrower than the distribution of Hu et al. (solid line with squares), indicating that the polydispersity index of the particles of Esfanjani et al. is necessarily smaller than 0.25, overlapping with the instantly claimed range.
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As such, claim 52 is anticipated.
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.
Esfanjani et al. do not explicitly teach the compound being at least 85% surrounded by the protein.
However, Esfanjani et al. teach “Microencapsulation is a technique for coating of bioactive materials in the form of micro- and nano-particles and, providing protection or controlling the release of the entrapped ingredients” (Pg. 149 left column second paragraph), indicating that the bioactive materials are fully coated.
As such, claim 53 is anticipated.
Claim 56 is drawn to the composition of claim 39, wherein said composition is stable at a temperature between 25 and 40°C.
Esfanjani et al. are silent as to the stability of the composition at a temperature between 25 and 40°C.
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 stability of the composition is a property inherent to the composition as evidenced by the instant specification. As Esfanjani et al. teach the instantly claimed nanoparticle composition, the instantly claimed stability is necessarily present.
As such, claim 56 is anticipated.
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, 43, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Esfanjani et al. as applied to claims 39, 41-44, 47-50, 52-53, and 56 above, and further in view of Bustos-Garza et al. (Food Research International, 2013, Vol. 54, 641-649; of record).
The teachings of Esfanjani 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 (more specifically astaxanthin (claim 43, Applicant’s elected species)) 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 protein-based shell is selected from the group consisting of water-soluble proteins.
Esfanjani et al. does not teach the encapsulated compound comprising Applicant’s elected species of astaxanthin.
However, Bustos-Garza et al. teach encapsulation of the bioactive compound astaxanthin to improve delivery to humans (Pg. 641 left column third paragraph). Bustos-Garza et al. further teach encapsulation of astaxanthin in biopolymers including whey protein (Abstract).
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 Esfanjani et al. to encapsulate astaxanthin as taught by Bustos-Garza et al. It would have been obvious to substitute one bioactive compound suitable for encapsulation within biopolymers such as whey protein for another to yield the predictable result of a nanoparticle for the delivery of astaxanthin, with a reasonable expectation of success.
As such, claims 39 and 43 are rejected as prima facie obvious.
Claim 54 is drawn to the composition of claim 39, wherein said at least one compound has a zeta potential of -50 mV to -10 mV.
Esfanjani et al. and Bustos-Garza 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 composition as evidenced by the instant specification. As Esfanjani et al. and Bustos-Garza et al. teach the instantly claimed nanoparticle encapsulating astaxanthin, the instantly claimed zeta potential is necessarily present.
As such, claim 54 is rejected as prima facie obvious.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Esfanjani et al. as applied to claims 39, 41-44, 47-50, 52-53, and 56 above, and further in view of Huang et al. (Food Research International, 2016, Vol. 87, 1-9; of record).
The teachings of Esfanjani 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.
Esfanjani et al. are silent as to the thickness of the polysaccharide coating.
However, Huang et al. teach similar 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 nanoparticles of Esfanjani 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 of Esfanjani et al. with the known polysaccharide shell thickness of Huang et al. 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 Esfanjani et al. as applied to claims 39, 41-44, 47-50, 52-53, and 56 above, and further in view of Joye et al. (Current Opinion in Colloid & Interface Science, 2014, Vol. 19, 417-427).
The teachings of Esfanjani 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 protein-based shell is selected from the group consisting of water-soluble proteins.
Esfanjani et al. do not teach the polysaccharide coating comprising Applicant’s elected species of maltodextrin.
Joye et al. teach biopolymer-based nanoparticles (Title) including polysaccharide nanoparticles (Abstract). Joye et al. further teach both pectin 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 nanoparticles of Esfanjani et al. to include maltodextrin as the polysaccharide coating. It would have been obvious to substitute one polysaccharide biopolymer 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 said plurality of particles have a zeta potential of 14 mV to 100 mV.
Esfanjani et al. and Joye 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 the particles is a property inherent to the composition as evidenced by the instant specification. As Esfanjani 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.
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 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 at least partially included in the protein-based shell. Claim 18 of Application ‘565 recites the particle of claim 17, 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. Claim 22 of Application ‘565 recites the particle of claim 17 wherein the protein-based shell comprises a protein selected from whey protein, soya protein, pea protein, fava bean protein, and potato protein, or any combination thereof.
Claims 17-18 and 21-22 of Application ‘565 together overlap with instant claim 39 and 44.
Claim 25 of Application ‘565 recites the particle of claim 17 wherein the biological compound is selected from a group including a protein, overlapping with instant claim 43.
Claims 1-2, 7, 9, 12-14, and 16 of Application ‘565 recite a method that 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.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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