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 .
FINAL ACTION
Priority
Instant application 18/437,813 filed on 01/10/2024 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
The amendment filled 07/07/2026 has been entered.
Claims 17-18 and 21-31 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/10/2024 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 07/07/2026 has been entered.
Applicant cancelled claims 19, 20 and 32 and amended claim 17.
Regarding the 101 and 112 rejections, Applicants amendment has overcome the rejections (claim 32 directed to “Use of a self-emulsifying drug delivery formulation…” had been cancelled). Therefore, the 101/112 rejections of record are withdrawn.
Regarding the 102 and 103 rejections, Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
Applicant pointed that CN114522142 does not teach the limitations of cancelled claim 19 or 20.
The cancelled claims have been directed to specific coenzyme Q10 and specific carotenoids. Applicant amended claim 17 and added the limitations of cancelled claims 17 and 20 into claim 17.
The instant claim 17 recites:
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However, the amended claim 17 does not require coenzyme Q10 nor carotenoid.
A composition comprising tocotrienol as a lipophilic compound still meets the limitation of the amended claim 17.
CN114522142 discloses a nanometer stabilizer comprising vitamin E polyethylene glycol succinate (TPGS) 50%, natural sunflower oil 36%, sunflower seed natural phospholipid powder 13%, and sorbic acid 1% (see Example 1, page 3).
As evidenced by Ahsan, sunflower oil always comprises tocotrienol (see abstract and Fig 2).
Therefore, CN114522142 meets all the limitations of instant claim 17.
It should be noted that claim 17 does not require any specific concentration of tocotrienols, therefore, the amount of tocotrienol present in sunflower oil meets the instant claim limitations.
The 102 and 103 rejections are maintained.
Claim Interpretation
Claim 17 recites a self-emulsifying drug delivery formulation with improved oral bioavailability of lipophilic compound, comprising: lipophilic compound comprising a tocotrienol, coenzyme Q10, a carotenoid or a combination of two or more thereof; a Vitamin E polyethylene glycol 1000 succinate (TPGS); an oil carrier; and a phospholipid.
The improved oral bioavailability of lipophilic compound is interpreted as an inherent feature of the recited composition.
It should be noted that MPEP states “[T]he discovery of a previously unappreciated property of a prior art composition, or of as scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. Further, "where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristics relied on"); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 (MPEP 2183).
Further, MPEP states that “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.") (MPEP 2112 II).
The subsequent examination is based on the above claim interpretation.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 18, 21, 22, 25, 27, 28 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN114522142 evidenced by Ahsan (Ahsan H, et al., J Chem Biol. 2015 Jan 20; 8(2):45-59) and evidenced by Lončarević (Ivana Lončarević, et al., Journal of Food Engineering, Volume 171, 2016, Pages 67-77).
Please note that machine translation of the CN114522142 document has been provided.
CN114522142 teaches a nano stabilizer comprising vitamin E polyethylene glycol succinate, (TPGS), triglyceride or vegetable oil, and a phospholipid (see abstract and Example 1).
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Further, CN114522142 discloses a nanometer stabilizer comprising vitamin E polyethylene glycol succinate (TPGS) 50%, natural sunflower oil 36%, sunflower seed natural phospholipid powder 13%, and sorbic acid 1 %. (Example 1, page 3).
As evidenced by Ahsan, sunflower oil comprises tocotrienol (see abstract and Fig 2):
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Regarding instant claim 18, it should be noted that sunflower oil comprises alpha-tocotrienol, gamma-tocotrienol and delta-tocotrienol (see abstract).
Since claim 17 does not require any specific concentration of tocotrienols, therefore, the amount of tocotrienol present in sunflower oil meets the instant claim limitations.
Regarding instant claim 21 and 22, CN114522142 discloses a composition comprising the above nano-stabilizer and fat-soluble vitamin D (see page 3 of the machine translated document, third paragraph of Example 1 “Take 7 parts of the above nano-stabilizer and add 1 part of vitamin D3, mix well”).
Regarding claims 25 and 27, CN114522142 teaches sunflower oil (see Example 1).
Regarding claim 28, CN114522142 discloses oil carrier 36% which is a point within the range from 5 to 80% recited in the instant claim.
Regarding instant claims 29, it should be noted that sunflower seed natural phospholipid powder (also known as sunflower lecithin) contains phospholipids, including phosphatidylcholine, phosphatidylinositol, and phosphatidylethanolamine (as evidenced by Lončarević: see page 67, right column).
Further, it should be noted that the instant claim 30 recites the phospholipid is present in amount ranging from 1% to 10%. Therefore 8% recited by CN114522142 meets the instant limitation.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-18 and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over CN114522142 (machine translation has been provided) evidenced by Ahsan (Ahsan H, et al., J Chem Biol. 2015 Jan 20; 8(2):45-59) and evidenced by Lončarević (Ivana Lončarević, et al., Journal of Food Engineering, Volume 171, 2016, Pages 67-77) in view of FONG (US 20170326101A1).
This rejection applies to a composition comprising carotenoid wherein the carotenoid is selected from alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, zeaxanthin, lycopene or a combination of two or more thereof.
The teachings of CN114522142 and Ahsan and Lončarević have been discussed above and those teachings are incorporated herein by reference.
CN114522142 teaches a nano stabilizer comprising vitamin E polyethylene glycol succinate, (TPGS), triglyceride or vegetable oil, and a phospholipid (see abstract and Example 1).
Further, CN114522142 discloses a nanometer stabilizer comprising vitamin E polyethylene glycol succinate (TPGS) 50%, natural sunflower oil 36%, sunflower seed natural phospholipid powder 13%, and sorbic acid 1 %. (Example 1, page 3).
Since claim 17 does not require any specific concentration of tocotrienols, therefore the amount of tocotrienol present in sunflower oil meets the instant claim limitations.
Regarding instant claims 21 and 22, CN114522142 discloses a composition comprising the above nano-stabilizer and fat-soluble vitamin D (see page 3 of the machine translated document, third paragraph of Example1 “Take 7 parts of the above nano-stabilizer and add 1 part of vitamin D3, mix well”).
Regarding claims 25 and 27, CN114522142 teaches sunflower oil (see Example 1).
Regarding claim 26, CN114522142 discloses a nanometer stabilizer comprising fatty acid esters of glycerol (medium chain fatty acid triglyceride). See Example 4: “A nano stabilizer, comprising the following raw materials by weight percentage: polyethylene glycol succinate 46.5%, medium chain fatty acid triglyceride 34%, sunflower seed natural phospholipid powder 11 %, sorbic acid 0.5% %, water 7%, sodium benzoate 0.5%, saponin 0.5%” (Example 4, page 4).
Regarding claim 28, CN114522142 discloses oil carrier 36% which is a point within the range from 5 to 80% recited in the instant claim.
Regarding instant claims 29, it should be noted that sunflower seed natural phospholipid powder (also known as sunflower lecithin) contains phospholipids, including phosphatidylcholine, phosphatidylinositol, and phosphatidylethanolamine (as evidenced by Lončarević).
Regarding claim 30, CN114522142 teaches composition comprising 35 to 50 percent of vitamin E polyethylene glycol succinate (TPGS), 25 to 40 percent of triglyceride or vegetable oil, 8 to 15 percent of phospholipid and 0.3 to 0.6 percent of sorbic acid (see claim 1). Since, the instant claim is directed to “the drug delivery formulation according to claim 17 wherein phospholipid is present in an amount ranging from 1% to 10% by weight”, therefore, CN114522142 teaches and claims overlapping ranges.
CN114522142 does not teach a self-emulsifying drug delivery formulation comprising carotenoid wherein the carotenoid is selected from alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, zeaxanthin, lycopene or a combination of two or more thereof.
Regarding instant claim 23, CN114522142 does not teach the lipophilic compound is present in an amount ranging from 5% to 80% by weight.
Regarding instant claim 24, CN114522142 does not teach the Vitamin E TPGS is present in an amount ranging from 0.1% to 30% by weight of the drug delivery formulation.
Regarding claim 26, CN114522142 does not explicitly teach drug a delivery formulation according to claim 25, wherein the fatty acid ester of glycerol is a monoglyceride, diglyceride or triglyceride, in one single embodiment.
Regarding instant claim 31, CN114522142 does not teach that the drug delivery formulation is in a form of a capsule or soft gel.
However, CN114522142 teaches “The nano-stabilizers provided in the examples of the present application can make lipid-soluble active ingredients into translucent nano-emulsions” (see machine translation, page 3, second full paragraph).
Regarding claim 26, CN114522142 discloses a nanometer stabilizer comprising fatty acid esters of glycerol (medium chain fatty acid triglyceride). See Example 4: “A nano stabilizer, comprising the following raw materials by weight percentage: polyethylene glycol succinate 46.5%, medium chain fatty acid triglyceride 34%, sunflower seed natural phospholipid powder 11 %, sorbic acid 0.5%, water 7%, sodium benzoate 0.5%, saponin 0.5%” (Example 4, page 4).
The deficiencies are further cured by FONG (US 2017/0326101 A1).
FONG discloses a formulation in the form of self-emulsifying drug delivery formulation for improved delivery of tocotrienols comprising a fat-soluble compound at least one emulsifier, and an oil carrier (see abstract).
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Regarding claim 20, US 2017/0326101 A1 teaches beta-carotene (see paragraph [0027]:
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Regarding instant claim 31, FONG teaches soft-gelatin capsules (see paragraph [0027]).
Applying KSR prong (A) – Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the nano stabilizer comprising vitamin E polyethylene glycol succinate, (TPGS), triglyceride or vegetable oil, and a phospholipid disclosed by CN114522142 with other lipid-soluble ingredients, for example with beta-carotene, with a reasonable expectation of success. One of ordinary skill would have been motivated by the teaching of CN114522142 that “The nano-stabilizers provided in the examples of the present application can make lipid-soluble active ingredients into translucent nano-emulsions” (see machine translation, page 3, second full paragraph).
Further, it is known in the art to stabilize and formulate the fat-soluble drugs, including beta-carotene, in a self-emulsifying drug delivery system. Accordingly, the said skilled artisan would have readily incorporated beta-carotene into the self-emulsifying drug system of CN114522142, arriving at the presently claimed composition with a reasonable expectation of success.
Furthermore, MPEP 2144.06 states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”.
Since CN114522142 teaches “the nano stabilizer can prepare fat-soluble active ingredients into semitransparent nano emulsion; the optical film can be completely dissolved with water, and simultaneously, the optical transparency and the lasting stability are kept; can improve bioavailability and shorten onset time; can avoid long-time prescription screening and process research and accelerate the speed of product development”(see abstract) and since tocotrienols and beta-carotene are fat soluble, one of ordinary skill in the art would have been motivated to combine tocotrienols and/or beta-carotene and the nano-stabilizers of CN114522142 for the same purpose to achieve improved stability and bioavailability of fat-soluble drugs “including tocopherols, tocotrienols, vitamin A, D and beta-carotene”, as taught by FONG.
In addition, regarding instant claims 23, 24 30, a person of ordinary skill before the effective filing date of the instant application would have been capable to adjust the concentrations of selected components by a routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Claims 17-18 and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over CN114522142 (please note that machine translation has been provided) evidenced by Ahsan (Ahsan H, et al., J Chem Biol. 2015 Jan 20; 8(2):45-59) and evidenced by Lončarević (Ivana Lončarević, et al., Journal of Food Engineering, Volume 171, 2016, Pages 67-77) in view of DENG ( US-20100189596-A1) and in view of BROMLEY (WO2014151109).
This rejection applies to self-emulsifying drug delivery formulation comprising coenzyme Q10 wherein the coenzyme Q10 is selected from ubiquinone, ubiquinol or a combination thereof.
The teachings of CN114522142 and Ahsan and Lončarević have been discussed above and those teachings are incorporated herein by reference.
CN114522142 does not teach a self-emulsifying drug delivery formulation comprising coenzyme Q10 wherein the coenzyme Q10 is selected from ubiquinone, ubiquinol or a combination thereof.
Regarding instant claim 23, CN114522142 does not teach the lipophilic compound is present in an amount ranging from 5% to 80% by weight.
Regarding instant claim 24, CN114522142 does not teach the Vitamin E TPGS is present in an amount ranging from 0.1% to 30% by weight of the drug delivery formulation.
Regarding claim 26, CN114522142 does not explicitly teach drug a delivery formulation according to claim 25, wherein the fatty acid ester of glycerol is a monoglyceride, diglyceride or triglyceride, in one single embodiment.
Regarding instant claim 31, CN114522142 does not teach that the drug delivery formulation is in a form of a capsule or soft gel.
However, CN114522142 teaches “The nano-stabilizers provided in the examples of the present application can make lipid-soluble active ingredients into translucent nano-emulsions” (see machine translation, page 3, second full paragraph).
Regarding claim 26, CN114522142 discloses a nanometer stabilizer comprising fatty acid esters of glycerol (medium chain fatty acid triglyceride). See Example 4: “A nano stabilizer, comprising the following raw materials by weight percentage: polyethylene glycol succinate 46.5%, medium chain fatty acid triglyceride 34%, sunflower seed natural phospholipid powder 11 %, sorbic acid 0.5%, water 7%, sodium benzoate 0.5%, saponin 0.5%” (Example 4, page 4).
DENG teaches that “Coenzyme Q10 is a lipophilic substance with very poor solubility in water (almost insoluble in water). The tablets and capsules for oral administration have the disadvantages of low bioavailability, large individual differences, etc., while the injections exhibit poor physical stability and have tendency to cause precipitation of drug during storage, and thus require heating for re-dissolving.” (see end of paragraph [0006]).
DENG teaches a composition comprising coenzyme Q10 0.25 g, SPC (soybean lecithin), 1.2 g, TPGS 1 g, injectable oils 10 g, glycerol 2.2g, and injectable water as the balance.
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Regarding claim 31, DENG teaches (see paragraph [0007]):
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CN114522142 and DENG does not explicitly teach the coenzyme Q10 is selected from ubiquinone, ubiquinol or a combination thereof.
The deficiency is cured by BROMLEY (WO2014151109).
BROMLEY teaches compositions comprising E derivative mixtures such as tocopheryl polyethylene glycol succinate (TPGS) (see abstract and page 4):
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Further, BROMLEY teaches the compositions comprise a non-polar ingredient (see abstract and summary, page 5):
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BROMLEY teaches compositions comprising coenzyme compounds wherein coenzyme Q10 is selected from ubiquinone or ubiquinol (see page 148):
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See also page 251, lines 4-5:
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Further, BROMLEY discloses liquid nano emulsion comprising CoQ10 (see Table 67):
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Applying KSR prong (A) – Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the nano stabilizer comprising vitamin E polyethylene glycol succinate, (TPGS), triglyceride or vegetable oil, and a phospholipid disclosed by CN114522142 with other lipid-soluble ingredients, including coenzyme Q10 with a reasonable expectation of success. Knowing that Coenzyme Q10 is a lipophilic substance with very poor solubility in water, one of ordinary skill would have been motivated by the teaching of CN114522142 that “The nano-stabilizers provided in the examples of the present application can make lipid-soluble active ingredients into translucent nano-emulsions” (see machine translation, page 3, second full paragraph) to achieve improved bioavailability of the fat-soluble drug. As thought by CN114522142 “the optical film can be completely dissolved with water, and simultaneously, the optical transparency and the lasting stability are kept; can improve bioavailability and shorten onset time; can avoid long-time prescription screening and process research and accelerate the speed of product development” (see abstract).
Further, it is known in the art to stabilize and formulate the fat-soluble drug including coenzyme Q10 in an emulsifying drug delivery system. Accordingly, said skilled artisan would have readily incorporated coenzyme Q10 into the self-emulsifying drug system of CN114522142, arriving at the presently claimed composition with a reasonable expectation of success.
Furthermore, MPEP 2144.06 states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”.
In addition, regarding instant claims 23, 24, 30, a person of ordinary skill before the effective filing date of the instant application would have been capable to adjust the concentrations of selected components by a routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Conclusion
No claims allowed.
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 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 IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
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