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 the Claims
Claims 1-3 and 5-20 are pending. Claims 12-19 have been withdrawn from consideration. Claims 1-3, 5-11 and 20 are under examination. Claim 4 has been canceled. The previous objections to the claims have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 102 and 103 rejections have been modified in view of applicant’s amendments to the claims.
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 11 an 20 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11, line 5 and recites “wherein the at least one carotenoid is in a saponified pigment concentrate.” It is unclear if the carotenoid itself must be saponified or a concentrate of other saponified pigments can comprise unsaponified carotenoid. Example 7 of the instant specification recites an example where marigold oleoresin, an ester of carotenoid, was saponified according to the composition in Table 3 where free carotenoid and fatty acid derivatives were released (p15). For the purpose of examination, claim 11 will be interpreted as: wherein the at least one carotenoid has been saponified to form a saponified pigment concentrate.
Claim 20 is rejected here because it depends from claim 11.
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 1, 3, 5-6, 11 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jani (IN 201921014975A) evidenced by Pharmacompass (Peceol | Drug Information, Uses, Side Effects, Chemistry; https://www.pharmacompass.com/chemistry-chemical-name/peceol, 2026).
Regarding claim 1, Jani discloses a microemulsion formulation of lutein comprising oil, surfactant, co-surfactant, permeation enhancer and one or more inactive excipients (p4, lines 13-15). Jani discloses the oil can be peceol (p8, lines 12-15). As evidenced by Pharmacompass, peceol is a long chain fatty acid ester with a 18 carbon chain length (p1, image).
Jani discloses the surfactant can be Tween 80, which encompasses polysorbate and is a nonionic surfactant (p8, lines 22-28). Jani discloses the permeation enhancer can be lecithin (p9, lines 19-22). Jani refers to the lecithin as a permeation enhancer and the instant claims refer to lecithin as a bio emulsifier. Regardless of how the prior art labels lecithin, it would still act as a bio emulsifier when included in the microemulsion of the prior art.
Jani’s combination of oil, surfactant, co-surfactant, permeation enhancer (emulsifier) and one or more active excipients is considered to meet the claim limitation of a microemulsion base since it comprises the microemulsion ingredients minus ingredient that the microemulsion is intended to deliver (lutein). Jani’s requirements for the microemulsion base do not include water. Therefore the addition of water is not required.
Regarding claim 3, Jani discloses the surfactant can be Tween 80, an nonionic surfactant, which encompasses polysorbate and polyoxyethylene (p8, lines 22-28).
Regarding claims 5 and 6, Jani discloses the co-surfactant can be short chain alcohols including ethanol (p9, lines 8-10).
Regarding claim 11, Jani discloses the lutein as an ingredient in the microemulsion (p4, lines 13-15). Jani discloses lutein is a carotenoid with a yellow pigment (p7, line 24). Jani discloses an embodiment where the microemulsion comprises L-ascorbic acid, a nutrient (p12, lines 10-12).
Jani does not disclose the carotenoid is saponified in a pigment concentrate, however, the carotenoid of claim 11 is optional and the limitations of claim 11 can be met with a nutrient, such as L-ascorbic acid. Therefore the limitations of claim 11 are considered to be met with the L-ascorbic acid (a nutrient).
Regarding claim 20, claim 20 recites further limitations on the carotenoid of claim 11. However, the carotenoid of claim 11 is optional and the limitations of claim 11 can be met with a nutrient, such as L-ascorbic acid as detailed in the claim 11 rejection above. Therefore the limitations of claim 20 are considered to be met when the limitations of claim 11 are met with a nutrient as opposed to a pigment.
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 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jani (IN 201921014975A) as evidenced by Pharmacompass (Peceol | Drug Information, Uses, Side Effects, Chemistry; https://www.pharmacompass.com/chemistry-chemical-name/peceol, 2026) as applied to claim 1 above and further in view of Warner (US 2005/0266058 A1).
Regarding claim 2; Jani discloses the microemulsion base of claim 1 as discussed in the 102 rejection above.
Jani does not disclose the long chain fatty acid is ethyl oleate.
Warner, in the field of microemulsion formulations, discloses making a microemulsion with an oil phase and at least one surfactant [0007]. Warner discloses the formulations can include appropriate emulsifying agents [0024]. Warner discloses the surfactants can be Tweens, short chain alcohols, preferably non-ionic surfactants [0032]. Warner discloses the oil phase of the microemulsion can be essential oils and vegetable oils, including eugenol, rose oil, eucalyptus oil, oleic acid, ethyl oleate and mixtures thereof [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substituted the ethyl oleate of Warner for the peceol of Jani since Warner discloses both are appropriate for the oil phase of a microemulsion. Substituting equivalents known for the same purpose is prima facie obvious. MPEP 2144.06 II.
As to the claim 2 language "the microemulsion base is configured to form a stable microemulsion upon combination with a saponified pigment by utilizing water present in the saponified pigment", this language is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the microemulsion base of Jani in view of Warner is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Regarding claim 8, Jani discloses the microemulsion base of claim 1 as discussed in the 102 rejection above.
Jani does not disclose the addition of at least one essential oil.
Warner, in the field of microemulsion formulations, discloses making a microemulsion with an oil phase and at least one surfactant [0007]. Warner discloses the formulations can include appropriate emulsifying agents [0024]. Warner discloses the surfactants can be Tweens, short chain alcohols, preferably non-ionic surfactants [0032]. Warner discloses the oil phase of the microemulsion can be essential oils and vegetable oils, including eugenol, rose oil, eucalyptus oil, oleic acid, ethyl oleate and mixtures thereof [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the essential oils of Warner with the microemulsion base of Jani since Warner discloses essential oils are appropriate for inclusion the oil phase of a microemulsion.
Jani’s requirements for the microemulsion base do not include water. Therefore the addition of water is not required.
As to the claim 8 language "wherein the microemulsion base…is configured to utilize water present in a saponified pigment", this language is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the microemulsion base of Jani in view of Warner is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jani (IN 201921014975A) as evidenced by Pharmacompass (Peceol | Drug Information, Uses, Side Effects, Chemistry; https://www.pharmacompass.com/chemistry-chemical-name/peceol, 2026) as applied to claim 1 above and further in view of Warner (US 2005/0266058 A1) and Baseeth (US 2016/0324150 A1).
Regarding claim 7, Jani discloses the oil phase from 25-50 wt% (p8, lines 10-18), which falls within the claimed range of 12.5-50 wt%.
Jani does not disclose the oil phase is ethyl oleate.
Warner, in the field of microemulsion formulations, discloses making a microemulsion with an oil phase and at least one surfactant [0007]. Warner discloses the formulations can include appropriate emulsifying agents [0024]. Warner discloses the surfactants can be Tweens, short chain alcohols, preferably non-ionic surfactants [0032]. Warner discloses the oil phase of the microemulsion can be essential oils and vegetable oils, including eugenol, rose oil, eucalyptus oil, oleic acid, ethyl oleate and mixtures thereof [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substituted the ethyl oleate of Warner for the peceol of Jani since Warner discloses both are appropriate for the oil phase of a microemulsion. Substituting equivalents known for the same purpose is prima facie obvious. MPEP 2144.06 II.
Jani discloses Tween 80 as surfactant, which encompasses polysorbate and polyoxyethylene (non-ionic surfactants) from 10-40 wt% (p8, line 20-p9, line 4). The combination of polysorbate and polyoxyethylene from 10-40 wt% (each surfactant from greater than 0 wt% up to less than 40 wt%) encompasses the claimed ranges of a first non-ionic surfactant from 11.5-20.5 wt% and a second non-ionic surfactant from 16.5-29 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Jani discloses lecithin as a permeation enhancer (p9, lines 18-22).
Jani does not disclose lecithin from 14-25 wt% nor propylene glycol from 7.5-14 wt%.
Baseeth, in the field of microemulsion compositions, discloses a composition comprising lecithin, fatty acids, a cosurfactant and an acidifier [0018]. Baseeth discloses the co-surfactant may be propylene glycol [0027]. Baseeth discloses the lecithin present in the composition from 15-40.5 wt% [0031], which overlaps with the claimed range of 14-25 wt%. Baseeth discloses the co-surfactant (propylene glycol) from 5-30 wt% of the composition [0031], which encompasses the claimed range of 7.5-14 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the quantity of lecithin disclosed by Baseeth in the composition of Jani, which also comprises lecithin, because both Baseeth and Jani are drawn to microemulsions with lecithin as an emulsifier and Baseeth discloses 15-40.5 wt% lecithin is an appropriate amount for use in a microemulsion.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the propylene glycol co-surfactant of Baseeth for the co-surfactant of Jani because it is prima facie obvious to substitute equivalents known for the same purpose. MPEP 2144.06 II. In the instant case the propylene glycol of Baseeth is known in the art as a co-surfactant, as are the co-surfactants of Jani.
Jani’s requirements for the microemulsion base do not include water. Therefore the addition of water is not required.
As to the claim 7 language "wherein the microemulsion base…is configured to emulsify at least 50% saponified pigment by utilizing water present in the saponified pigment", this language is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the microemulsion base of Jani in view of Warner and Beseeth is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Additionally it is noted that claim 7 does not require a saponified pigment.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jani (IN 201921014975A) evidenced by Pharmacompass (Peceol | Drug Information, Uses, Side Effects, Chemistry; https://www.pharmacompass.com/chemistry-chemical-name/peceol, 2026) as applied to claim 1 above and further in view of Baseeth (US 2016/0324150 A1).
Regarding claim 9, Jani does not disclose the addition of an acid selected from propionic, formic or lactic acid.
Baseeth, in the field of microemulsion compositions, discloses a composition comprising lecithin, fatty acids, a cosurfactant and an acidifier [0018]. Baseeth discloses the acidifier may be propionic acid, lactic acid [0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the acidifier of Baseeth in the composition of Jani because both are drawn to microemulsions comprising lecithin, fatty acids, and co-surfactants.
Jani’s requirements for the microemulsion base do not include water. Therefore the addition of water is not required.
As to the claim 9 language "wherein the microemulsion base… is configured to form a stable microemulsion upon combination with a saponified pigment by utilizing water present in the saponified pigment", this language is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the microemulsion base of Jani in view of Beseeth is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Additionally it is noted that claim 9 does not require a saponified pigment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jani (IN 201921014975A) evidenced by Pharmacompass (Peceol | Drug Information, Uses, Side Effects, Chemistry; https://www.pharmacompass.com/chemistry-chemical-name/peceol, 2026) as applied to claim 1 above and further in view of Jain (Jain J, Fernandes C, Patravale V. Formulation development of parenteral phospholipid-based microemulsion of etoposide. AAPS PharmSciTech. 2010 Jun;11(2):826-31. doi: 10.1208/s12249-010-9440-x. Epub 2010 May 13. PMID: 20464537; PMCID: PMC2902297).
Regarding claim 10, Jani discloses the microemulsion has a pH between 6.1-6.7 (Results Table pp19-20).
Jani does not disclose the microemulsion is stable in the range of pH 2-12.
Jain, in the field of microemulsions, discloses microemulsions are suitable for intravenous and intramuscular administration at a pH range from 2-12 (p827, RH col, pH Measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the pH range of Jain with the microemulsion of Jani since a pH range of 2-12 is acceptable for intravenous and intramuscular administration.
Response to Arguments
Applicant's arguments filed 02 March 2026 have been fully considered. To the extent they apply to the above rejections they are not persuasive.
Applicant argues Jani is inapplicable to the instant invention because the instant invention requires a microemulsion base which does not require the addition of water. Applicant argues Jani’s microemulsion requires water as a constant component and therefore Jani cannot anticipate or render obvious a water-free microemulsion base as claimed. Remarks p2.
This argument is not persuasive. The claims are drawn to a microemulsion base, while the definition in Jani that applicant relies upon for their argument is for a microemulsion. Regardless, Jani discloses a formulation for a microemulsion of lutein with the components recites in Example 1 (p14, top of page). As can be seen in the table water is used “qs”, or as much as needed. However, the quantities recited in the microemulsion of Example 1 of Jani allow for no added water. For example one could select 20% lutein, 40% oil Capmul MCM, 20% Tween 80, 17% Trascutol, 1.5% DMSO and 1.5% L-ascorbic acid to form the microemulsion.
Applicant argues the Examiner contends that a person of ordinary skill would subtract lutein from Jani’s microemulsion in order to create a “base.” However, this is not suggested anywhere in Jani’s disclosure. Indeed, the position is not legally sound. Because Jani fails to teach all of each of the limitations of the claimed invention, Applicant respectfully submits that all rejections based on Jani should be withdrawn. Remarks p2.
This argument is not persuasive. What applicant has defined as the “microemulsion base” is the same as the ingredients disclosed by Jani in order to build Jani’s final microemulsion. The fact that applicant has chosen to call this a microemulsion base does not change the nature of the combination of ingredients.
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Applicant argues the claimed microemulsion base achieves superior pigment dispersion and absorption, enabling lower dosages and improved bioavailability, which are not predictable from the cited references. Remarks p2.
This argument is not persuasive. In response to applicant's argument that the microemulsion base achieves superior pigment dispersion and absorption, enabling lower dosages and improved bioavailability, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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