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, arguments, and declaration filed 13 January 2026 are acknowledged and have been fully considered. Claims 1-2 and 4-14 are currently pending. Claims 1-2 and 6 are amended; claim 3 is cancelled; claims 10-12 and 14 are withdrawn; no claims are new.
Claims 1-2, 4-9, and 13 are examined on the merits herein.
Objections/Rejections Withdrawn
Applicant’s arguments, see Remarks at pg. 8 and Declaration at pars. 5-6, filed 13 January 2026, with respect to the rejection of claims 1-2, 4-9, and 13 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Müller et al., Serini et al., and Calder, discussed below.
Additionally, the rejection of claim 2 under 35 U.S.C. 112(d) is withdrawn in view of Applicant’s amendment to the claim; and the objection to claim 6 for minor informalities is withdrawn in view of Applicant’s amendment to the claim.
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 1, 4-9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Müller et al. (US 8,663,692; of record) in view of Serini et al. (Nutrients, 2019, Vol. 11, 1400) and Calder (Annals of Nutrition and Metabolism, 2016, Vol. 69, 8-21), as evidenced by Ham et al. (JAOCS, 1998, Vol. 75, 1445-1446), Knothe (JAOCS, 2002, Vol. 79, 847-854), and Agathos et al. (Annals of the New York Academy of Sciences, 1987, Vol. 506, 657-661; of record).
Claim 1 is drawn to a capsule, comprising:
a matrix comprising:
a lipid component having a melting temperature from greater than or equal to 40°C to less than or equal to 55°C, wherein the lipid component is from greater than or equal to 20% to less than or equal to 60% by weight of the total weight of the capsule;
an unsaturated fatty acid, wherein the unsaturated fatty acid is from greater than or equal to 20% to less than or equal to 30% by weight of the total weight of the capsule;
an excipient, wherein the excipient is from greater than or equal to 10% to less than or equal to 12% by weight of the total weight of the capsule; and
an antioxidant agent incorporated in the matrix; and
wherein the matrix has an iodine index greater than or equal to 60g Iodine/100g as measured according to the ASTM D1959-97 standard indicating the matrix has a high affinity to reactive oxygen species.
Claim 4 is drawn to the capsule of claim 1, wherein the unsaturated fatty acid comprises a polyunsaturated fatty acid, and wherein the polyunsaturated fatty acid is at least 60% by weight of the total weight of the unsaturated acid.
Claim 6 is drawn to the capsule of claim 1, wherein the unsaturated fatty acid is selected from the group consisting of C16-C24 acids.
Claim 7 is drawn to the capsule of claim 1, wherein the excipient is a surfactant.
Claim 8 is drawn to the capsule of claim 1, wherein the antioxidant agent is selected from a group including polyphenols
Claim 13 is drawn to a skin care product comprising the capsule of claim 1.
Müller et al. teach in Claim 1 a lotion for topical application comprising lipid particles comprising a matrix prepared from
a lipid which is solid at 37°C, overlapping with the instantly claimed melting point range of 40°C to 55°C; and
a lipid which has a melting point below 4°C,
wherein particles comprise the liquid and solid lipids in a proportion between 80:20 and 0.1:99.9, overlapping with the instantly claimed weight ranges.
Müller et al. further teach the particles comprising a surfactant such as Tween 80 present in an amount of 10% by weight of the particle (Example 6 cols. 18-19) as calculated by examiner, overlapping with the instantly claimed range.
The particle of Müller et al. differs from the instantly claimed particles in the following ways:
the particle of Müller et al. does not comprise an unsaturated fatty acid;
the particle of Müller et al. does not comprise an antioxidant incorporated in the matrix; and
Müller et al. are silent as to the iodine index of the matrix.
Yet, as to 1: Serini et al. teach that docosahexaenoic acid (DHA) is a long chain (22 carbons) omega-3 polyunsaturated fatty acid that is suitable for treating inflammatory skin disorders through topical application (Pg. 2 second paragraph), further teaching DHA as suitable for delivery in solid lipid nanoparticles (Abstract).
And as taught by Calder, DHA has a melting point of -44°C (Introduction on pg. 4).
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 particle of Müller et al. to include DHA as taught by Serini et al. It would have been obvious to substitute one liquid lipid with a melting point below 4°C suitable for topical delivery via solid lipid particles to obtain the predictable result of a composition suitable for treating inflammatory skin disorders, with a reasonable expectation of success.
As to 2: Müller et al. further teach the lipid particles comprising active agents dispersed within the lipid matrix of the particle (Col. 5 lines 59-66).
Serini et al. further teach that the inclusion of the polyphenol antioxidant resveratrol in the lipid matrix of the nanoparticles has a synergistic effect with DHA (Pg. 7 first paragraph).
THerfore, 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 Müller et al. to include an antioxidant in the lipid matrix. It would have been obvious to combine the known particles with the known use of resveratrol in the lipid matrix of particles to yield the predictable result of a lipid particle with an increase efficacy of DHA, with a reasonable expectation of success.
And, as to 3: As evidenced by Ham et al. that DHA has an iodine index of 463.57 (Table 2).
And as evidenced by Knothe, the iodine index for a mixture is equal to the sum of the mass percentage of each component times the iodine index for that component (Equations 1 and 2 on pg. 848).
As such, the DHA in the particles of Müller et al. and Serini et al. contributes between 0.46357 and 370.856 to the iodine index of the matrix, as calculated by examiner based on the weight ratios taught by Müller et al. As such, Müller et al. as modified by Serini et al. necessarily teach particles having an iodine index of greater than 60.
Based on all of the foregoing, claims 1, 4, 6-8, and 13 are rejected as prima facie obvious.
Claim 5 is drawn to the capsule of claim 1, wherein the antioxidant agent is from greater than or equal to 5% to less than or equal to 20% by weight of the total weight of the capsule.
Müller et al. and Serini et al. do not teach the capsule comprising between 5% and 20% by weight of the antioxidant.
However, as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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 concentration of the antioxidant is clearly a result-effective variables, determining the extent of the synergistic effect on the activity of DHA. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of the antioxidant in order to best achieve the desired results.
As such, claim 5 is rejected as prima facie obvious.
Claim 9 is drawn to the capsule of claim 1, further comprising an active ingredient incorporated in the matrix, wherein the active ingredient is a natural extract.
Müller et al. further teaches the capsules comprising cyclosporin (Example 6 cols. 18-19). As evidenced by Agathos et al., cyclosporin is extracted from the fungus Tolypocladium inflatum (pg. 657 first paragraph), i.e., a natural extract.
As such, claim 9 is rejected as prima facie obvious.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Müller et al., Serini et al., and Calder as applied to claims 1, 4-9, and 13 above, and further in view of Warren et al. (US 2011/0159074; of record) and Guiramand et al. (WO 2018/109216).
The teachings of Müller et al., Serini et al., and Calder have been set forth above.
Claim 2 is drawn to the capsule of claim 1, wherein the lipid component comprises:
a first component comprising: mimosa wax; jojoba seed wax; and sunflower seed wax; and
a second component comprising: transesterification products of polyglycerol; mimosa wax; jojoba seed wax; and sunflower seed wax.
Claim 2 is interpreted as reading on a lipid component comprising mimosa wax; jojoba seed wax; sunflower seed wax; and transesterification products of polyglycerol as the two components would be combined into one matrix in the process of making the capsules disclosed in pars. [0093-0103] of the instant specification.
Müller et al., Serini et al., and Calder do not teach the lipid component comprising mimosa wax; jojoba seed wax; sunflower seed wax; and transesterification products of polyglycerol.
However, Warren et al. teach wipes comprising a lotion for skincare (Title), wherein the lotion comprises solidifying agents including waxes and fatty esters having a melting point of 35°C or greater (Par. [0038]) such as jojoba wax and pentaerythrityl distearate (i.e., a transesterification product of polyglycerol) and combinations thereof (Par. [0039]).
Guiramand et al. teach cosmetic compositions comprising solid fatty substances (Title, Abstract), further teaching the solid fatty substance being the mixture of mimosa, jojoba, and sunflower plant waxes sold under the name Acticire by Gattefossé (Pg. 4 lines 26-27), further teaching this mixture having a melting point of 38.2°C (Pg. 31 lines 30-31).
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 Müller et al., Serini et al., and Calder to include mimosa wax, jojoba seed wax, sunflower seed wax, and pentaerythrityl as taught by Warren et al. and Guiramand et al. It would have been obvious to substitute one combination of lipids that are solid at 37°C suitable for use in a topical composition for another to obtain the predictable result of a particle composition for treating the skin, with a reasonable expectation of success.
As such, claim 2 is rejected as prima facie obvious.
Claim 6 is ADDITIONALLY rejected under 35 U.S.C. 103 as being unpatentable over Müller et al., Serini et al., and Calder as applied to claims 1, 4-9, and 13 above, and further in view of Bliss Lifesciences (IN 201721026441).
The teachings of Müller et al., Serini et al., and Calder have been set forth above.
Claim 6 is drawn to the capsule of claim 1, wherein the unsaturated fatty acid is selected from the group consisting of C16-C24 fatty acids, more specifically fatty acids 18:1, 18:2, and 18:3 (Applicant’s elected species).
Müller et al., Serini et al., and Calder do not teach the fatty acid being Applicant’s elected species of the combination of fatty acids 18:1, 18:2, and 18:3.
However, Bliss Lifesciences teaches fatty acid compositions to be used in compositions including skin care (Abstract), further teaching the ratio between omega-6 and omega-3 fatty acids preferably being between 1:1 and 4:1 (Field of Invention). Bliss Lifesciences further teaches in Example 1 the combination of alpha-linolenic acid (i.e., 18:3), linoleic acid (i.e., 18:2), and oleic acid (i.e., 18:1) which provides a 1:1 ratio of omega-3 and omega-6 fatty acids.
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 Müller et al., Serini et al., and Calder to include fatty acids 18:1, 18:2, and 18:3 as taught by Bliss Lifesciences. It would have been obvious to substitute one fatty acid suitable for skincare for another to obtain the predictable result of a skin care composition, with a reasonable expectation of success.
As such, claim 6 is rejected as prima facie obvious.
Claim 8 is ADDITIONALLY rejected under 35 U.S.C. 103 as being unpatentable over Müller et al., Serini et al., and Calder as applied to claims 1, 4-9, and 13 above, and further in view of Kunz (US 2018/0339051; of record).
The teachings of Müller et al., Serini et al., and Calder have been set forth above.
Claim 8 is drawn to the capsule of claim 1, wherein the antioxidant agent is vitamin E, vitamin C, and superoxide dismutase (Applicant’s elected species).
Müller et al., Serini et al., and Calder do not teach Applicant’s elected species of antioxidant agent.
However, Kunz also teaches topical antioxidant compositions (Abstract). Kunz further teaches polyphenols (e.g., resveratrol), ascorbic acid (i.e., vitamin C), tocopherol (i.e., vitamin E), and superoxide dismutase as suitable antioxidants (Par. [0087]).
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 Müller et al., Serini et al., and Calder to include vitamin C, vitamin E, and superoxide dismutase as taught by Kunz. It would have been obvious to substitute one antioxidant suitable for use in topical compositions for another to obtain a topical composition with antioxidant activity, with a reasonable expectation of success.
As such, claim 8 is rejected as prima facie obvious.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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