DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 9/22/2025 wherein claim 1 has been amended.
Claims 1-3, 5, 7, 9-12, 21, 28 and 29 are presented for examination on the merits.
The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 9/22/2025 regarding the rejection of claim 1 made by the Examiner under 35 USC 112(b) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/26/2025.
In regards to the 112(b) rejection, Applicant asserts the following:
A) the w/w% of the component is relative to the total suspension and the limitation is not indefinite.
In response to A, the Examiner acknowledges that Applicant has support for w/w% for the respective components of the composition. However, claim 1(i) recites, “…the lipid having a melting point above 40oC, and an amount of 10-30% w/w of the total suspension…” The issue of indefiniteness is that the amount of 10-30%w/w is not specified as belonging to anything. The range is just a floating range. Although it appears to be a limitation to the concentration of the lipid, the prose of the claim does not specifically state as much. Amending to recite something like “and is present in an amount of 10-30% w/w of the total suspension” or something similar clarifying that the range is indeed for the lipid.
Applicant’s arguments filed 9/22/2025 regarding the rejection of claim 1 made by the Examiner under 35 USC 103 over Viladot et al. (ES 2384060) in view of Niculae et al. (RO 130098) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/26/2025.
In regards to the 112(b) rejection, Applicant asserts the following:
B) Viladot describes about far too many surfactants for the identified mixture of lecithin and polysorbate to be considered obvious. Viladot does not provide any working examples of a dual surfactant system comprising a polysorbate and a phospholipid not any working examples of a system that uses beta-carotene together with the surfactant system. Niculae is directed to UV filters, not food coloring compositions and the combination applied by the Examiner improperly uses hindsight
In response to B, a surfactant system comprising a poloxamer and a phospholipid remains obvious in view of Viladot and Niculae. Viladot teaches that their lipid nanoparticle system includes stabilizing surfactants such as poloxamer and phospholipids (e.g. lecithin). Example 1 of Viladot describes a solid lipid nanoparticle formulation with the particle including lecithin.
Niculae, like Vildaot, is directed to lipid nanoparticles. The ultimate end use of Niculae may be different from Viladot but this difference is not considered mitigating in the present case because the technology in both references are directed to stable solid lipid nanoparticles. How the lipid nanoparticles are ultimately used is not considered relevant to the determination of obviousness here because the end goal is overlapping.
Niculae teaches that surfactants are important for stabilizing the lipid nanoparticles and that the inclusion of surfactants is important for the prevention of encapsulated materials from being prematurely released. An exemplified surfactant system according to Niculae is one which comprises a mixture of polysorbate 20 and lecithin in a ratio of 4:66 to 1. Niculae teaches that this surfactant system yields physically stable lipid nanoparticles. It is noted that Vildaot, like Niculae, desires a stable lipid nanoparticle system. Thus, combining these teachings together would be obvious because 1) the surfactant system of Niculae yields a physically stable lipid nanoparticle and 2) Viladot desires stable solid lipid nanoparticles and broadly describes both surfactants as suitable in stabilizing solid lipid nanoparticles – their combination together would reasonably suggest a surfactant system such as that claimed.
As to the myriad of potential surfactant combinations, this is not mitigating because the claimed surfactant combination is identified by the prior art and would have reasonably motivated any person in its possession to modify Viladot. Combining prior art elements according to known methods to yield predictable results is supportive of a finding of obviousness. See MPEP 2143(I)(A).
Maintained Rejections, of Record
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites “…the lipid having a melting point above 40oC, and an amount of 10-35% w/w of the total suspension…” The claim recites “an amount of 10-35% w/w of the total suspension” which is unclear because it is not directly referencing anything in particular. Clarification of what the 10-35% is intended to limit is required (e.g. lipid, pigment, etc.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3, 5, 7, 9-12, 21 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viladot et al. (ES2384060, translation provided; of record) in view of Niculae et al. (RO130098, translation provided; of record).
Viladot describes a solid lipid nanoparticle (SLN) having a size of 100-200 nm (see page 6) (see instant claim 12) that comprises a solid lipid having a melting point above 37oC (sufficiently close to ‘above 40oC’) such as solid triglycerides including hydrogenated vegetable oils (see page 7) wherein vegetable oils include castor, sunflower and palm oils (see page 7) (see instant claims 1(a)(i), 5 and 29). Viladot teaches that their particles are to comprise a surfactant system to stabilize the SLNs wherein the surfactant include lecithin and polysorbate 80 and mixtures thereof (see pages 7 and 8) (see instant claims 1(b)(i)/(ii), 10 and 11). Regarding the source of lecithin as set forth by instant claim 11 (e.g. sunflower, soy bean, etc.) these are immaterial as they do not change the active principles’ (lecithin) chemical structure/function. However, it is observed that Viladot teaches that lecithin may be derived from soy (see page 44)
The SLN is to also comprise an oil soluble pigment (functional descriptor) such as beta-carotene and lycopene (see pages 12 and 16) (see instant claim 1(a)(ii) and 7). The SLN may include an antioxidant such as tocopherol (see pages 11 and 18) (see instant claims 2 and 28). The active ingredient (e.g. beta-carotene, tocopherol) is to be included in an amount of 0.001-30% (see page 10) (see instant claims 1 and 3). It is noted that overlapping concentrations are considered obvious. See MPEP 2144.05(I).
The SLN system of Viladot may be in the form of an aqueous suspension (see pages 23 and 25) and may be included in food products/composition (see pages 22, 23 and 41) (see instant claim 1).
Example 1 is relevant to the concentration of the lipid and the surfactant in the final SLN product. Example 1 provides the following ingredients (see pages 25-26):
PNG
media_image1.png
322
419
media_image1.png
Greyscale
. The SLN particles are free of water and so the amount of water should be excluded from the net weight determination. The net weight therefore of the SLN materials equals about 29g. The lipid of the particles includes caprylic/capric triglycerides, cetyl palmitate, glyceryl stearate which equates to 13.5g and thus the lipid is present in an amount of about 47% which lies within the range claimed (see instant claim 1). Example 1 includes surfactants lecithin, inulin lauryl carbamate and lauryldimonium hydroxypropyl hydrolyzed soy protein (see page 7 re being a surfactant) in an amount of 6.2g which equates to an amount of about 21% (see instant claim 1).
Regarding instant claim 21, collections of SLN particles having distinct pigments (e.g. beta-carotene, lycopene) would have been obvious as each are separately taught by the prior art. Such would essentially be a duplication of the basic framework of Viladot.
Although Viladot the surfactants polysorbate and phospholipid, Viladot fails to teach a ratio of polysorbate and lecithin of between 10:1 and 1:10 and in an amount of between 1-25% by weight.
Niculae is directed to lipid nanocarriers based on vegetable oils with photoprotection and antioxidant properties. The lipid nanocarriers are described as solid lipid nanoparticles (see abstract) wherein the nanoparticles are useful for the encapsulation of hydrophobic components and UV filter actives (see page 3). Niculae teaches that the hydrophobic components and UV filter actives include rice bran oil and raspberry seed oil which both comprise carotenoids (see pages 2-3) (see instant claim 1).
The solid lipid nanoparticles are to be stabilized by a cosurfactant system comprising polysorbate 20 and lecithin, wherein the polysorbate and lecithin are provided in a weight ratio of 4.66:1 and in a concentration of 3.5% (see pages 3 and 5, Example 1 and claim 4) (see instant claim 1). The combination of these surfactants produces solid lipid nanoparticles which exhibit excellent physically stability (see page 3). It would have been obvious to modify Viladot’s solid lipid nanoparticles such that it comprised the cosurfactants system of Niculae with a reasonable expectation for success in producing nanoparticles having excellent stability. See MPEP 2143(I)(D) which states that applying a known technique to a known product to yield predictable results is supportive of obviousness. It is further noted that the ratio of the surfactants and the concentration of the surfactants in the solid lipid nanoparticle composition are each taught by Niculae. See MPEP 2144.05(I).
Regarding the concentration of lipid and the pigment in the composition, these are obvious given that the concentration of the SLN in a final suspension would be an optimizable parameter. Modulation of the SLN concentration to meet the specifications of the final product would necessarily change the concentration of the lipid and pigment therein. Accordingly, differences in concentration would not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. 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. See MPEP 2144.05(II)(A).
Regarding instant claim 21, collections of SLN particles having distinct pigments (e.g. beta-carotene, lycopene) would have been obvious as each are separately taught by the prior art. Such would essentially be a duplication of the basic framework of Viladot and Niculae.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611