Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 March 2025 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 21 March 2025.
CLAIMS UNDER EXAMINATION
Claims 1-28 and 30-32 are pending and have been examined on their merits.
PRIORITY
Provisional Application 61/852243, filed on 15 March 2013, is acknowledged. Claim 1 has been amended to recite a non-polar compound present in an amount of “between about 0.1% and 99%”. Claim 24 encompasses the composition of claim 1. The Provisional Application provides support for 1-75% non-polar compound (see page 55 line 13 bridging line 11 of page 56; see page 75, lines 24 bridging line 14 of page 76; see claim 21). It does not provide support for “about 0.1 to 99%”.
The specification of the Non-Provisional Application filed on 18 April 2016 provides support for 0.1 to 99% (see page 11, lines 25-29). It does not provide support for “about 0.1 to 99%”. The limitation has support in the claims filed on 21 March 2025.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS:
Independent claim 1 has been amended to recite a range of non-polar compound. New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-27 and 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite a composition comprising a non-polar compound present in an amount of between about 0.1% and 99%. Claim 24 recites a beverage comprising the composition of claim 1. The specification does not define the term “about”. Given its broadest reasonable interpretation, the claim includes amounts outside the claimed range. The specification provides support for 0.1 to 99% of a non-polar compound (see page 11, lines 25-29). Amounts below 0.1% and above 99% are not supported by the original disclosure, and is considered new matter. Claims 2-27 and 30-32 are included in this rejection because they encompass the limitations recited in claim 1.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 21 March 2025 are acknowledged.
The Applicant argues the previous rejection is now moot because claim 1 has been amended to recite an amount between about 0.1% to 99%. The Applicant states the earliest priority date provides support for this limitation.
EXAMINER’S RESPONSE
The arguments are not persuasive. Provisional Application 61/852243 does not provide support for about 0.1% to 99%.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-27 and 30-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bromley et al. (Compositions containing water-soluble derivatives of vitamin E mixtures and modified food starch. US20150110924A1).
Bromley et al. teach a composition comprising modified food starch and a water-soluble derivative of vitamin E mixture containing high concentrations of dimer forms of the PEG-derivative of vitamin E (Abstract). The art teaches the vitamin E mixture is a tocopheryl polyalkylene glycol derivative ([0607]). The composition comprises one or more non-polar compounds and a polar solvent ([0012]). The composition contains one or more non-polar compounds in an amount between 0.1% and 25% ([0013]). The PEG-derivative of vitamin E is a “high dimer composition” that contains monomer and dimer ([0012]). The composition contains a vitamin E mixture that contains between 35% to 65% monomer and 29% to 62% dimer ([0027]).
Bromley teaches high dimer water-soluble derivative of vitamin E mixtures have advantageous properties ([0598]). A mixture containing 40-60% monomer and 35-50% dimer exhibit advantageous properties ([0598]). Example 3 discloses a high dimer TPGS containing 51% dimer and 48% monomer ([0807]). Therefore the art teaches a vitamin E derivative mixture comprising at least 70% of monomer and dimer together.
Bromley also teaches the following at [0306]:
Addition of high dimer water soluble derivative of vitamin E mixture to a composition containing one or more non-polar compounds, including compositions that contain modified food starch, results in advantageous properties, compared to the food starch alone and/or compared to the same composition with a vitamin E derivative that does not contain higher amounts of dimer form, such as a commercially available PEG-derivative of vitamin E, such as a commercially available TPGS. For example, dilution compositions to which concentrates containing the high dimer mixtures, are more clearer than a dilution composition formed from the same composition except containing vitamin E derivative that does not contain the high concentration of dimer
Therefore Bromley teaches addition of high dimer mixture improves the clarity of compositions relative to those that do not contain high dimer mixture.
While Bromley teaches each claim limitation, the art does not do so with sufficient specificity to anticipate the claim.
It would have been obvious to use a high dimer vitamin E mixture with the claimed amounts of monomer and dimer. Bromley teaches using a “high dimer” mixture and teaches the mixture can contain between 35% to 65% monomer and 29% to 62% dimer. Bromley teaches high dimer mixtures have advantageous properties, including increased clarity. Therefore one of ordinary skill in the art would have been motivated to use the high dimer mixture when preparing a composition, such as the beverage taught by Bromley, to provide improved clarity. One would have had a reasonable expectation of success since Bromley teaches high dimer mixtures containing amounts of monomer and dimer that read on the claimed amounts can be used in the disclosed composition. Because Bromley teaches a high dimer mixture, it would be expected to improve solubility of the non-polar compounds used in the composition. Therefore claim 1 is rendered obvious.
Bromley teaches the composition may comprise a polar solvent ([0016]). Therefore claim 2 is included in this rejection.
Bromley teaches a polar protic solvent, including water ([0028]). Therefore claim 3 is included in this rejection.
Water ([0028]) reads on claims 4-5.
The art teaches PEG derivatives of Vitamin E ([0047]). Therefore claim 6 is included in this rejection.
Bromley teaches the water-soluble derivative of vitamin E mixture contains a PEG moiety having a molecular weight between at or about 100 Da and 20,000 Da ([0046]). Therefore claim 7 is included in this rejection.
Bromley teaches tocopheryl polyethylene glycol succinate (TPGS) is an exemplary high dimer water-soluble derivative of a vitamin E mixture used in the provided methods ([0047]). Therefore claims 8-9 are included in this rejection.
The art teaches α-tocopheryl polyethylene glycol succinate 1000 ([0024] [0203]). Therefore claims 10-11 are included in this rejection.
Example 3 discloses a typical high dimer TPGS batch contains 51% dimer and 48% monomer ([0807]). Therefore claims 12-13 are rendered obvious.
Bromley teaches the polar solvent is present in an amount that is between 40% and 85% of the composition ([0028]). This reads on the range recited in claim 14.
Bromley teaches adding high dimer-containing PEG-derivative of vitamin E mixture in an amount between 1% to 98% by weight of the composition (see claim 1 of Bromley). Claim 15 is included in this rejection. The ranges recited in claims 16-17 lie inside the range taught by Bromley. Therefore, the examiner asserts the claimed concentration is prima facie obvious (MPEP 2133.03). Therefore claims 16-17 are included in this rejection.
Bromley teaches the polar solvent can be present in an amount up to between 50% or about 50% and 80% ([0020]). Therefore claim 18 is rendered obvious.
Bromley teaches a composition comprising between 5-15% of one or more non-polar compounds ([0030]). Therefore claims 19-20 are rendered obvious as claimed.
Bromley teaches exemplary non-polar compounds include PUFA containing ingredients, Coenzyme Q Active Ingredients, phytosterols, resveratrol and algae oil ([0112]). Therefore claim 21 is included in this rejection.
Bromley teaches fish oil ([0112]). Therefore claim 22 is included in this rejection.
Bromley teaches Omega-3 fatty acid ([0112]). Therefore claim 23 is included in this rejection.
Regarding independent claim 24:
The teachings of Bromley are reiterated. The composition recited in claim 1 is rendered obvious on the grounds set forth above. Bromley teaches formulation as a beverage comprise a beverage base ([0065]). Therefore a beverage, comprising the composition of claim 1, and a beverage base as recited claim 24 is included in this rejection.
Bromley teaches beverages the contain the composition. Exemplary beverages include water, soda, milk, juice, and sports or nutrition beverages ([0039]). Therefore claim 25 is included in this rejection.
The beverage can contain carbonate ([0065]). This reads on a carbonated beverage as recited in claim 26.
The composition can include stabilizers including bicarbonates, carbonates, acids and antioxidants ([0112]). Therefore claim 27 is included in this rejection.
Example 3 discloses a typical high dimer TPGS batch contains 51% dimer and 48% monomer ([0807]). Therefore claim 30 is rendered obvious.
As manufactured, the high dimer mixture scan include other forms and unreacted components, hence the total amount of dimer and monomer do not necessarily total 100%, by weight, of the composition ([0202]). Therefore the amounts recited in claim 31 are rendered obvious.
Bromley teaches adding high dimer-containing PEG-derivative of vitamin E mixture in an amount between 1% to 98% by weight of the composition (see claim 1 of Bromley). Therefore, the examiner asserts the range recited in claim 32 is prima facie obvious (MPEP 2133.03). Therefore claim 32 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bromley et al. (previously cited; Compositions containing non-polar compounds. US 2009/0297665) in view of Baogen et al. (previously cited; Method for separating vitamin E polyethylene glycol succinate monoester from vitamin E polyethylene glycol succinate diester. CN101721838A 2009).
Bromley teaches compositions for preparing foods and beverages that contain additives (Abstract). Bromley teaches a composition containing non-polar active ingredients, water (a polar solvent), tocopherol polyethylene glycol succinate (TPGS; a surfactant), a preservative and a pH adjuster (see Table 2Ai).
The art identifies TPGS as a polyalkylene glycol derivative of vitamin E [0016]). The amount of surfactant in the composition is between 16% and 30% by weight ([0012]).
Bromley teaches the amount of non-polar compound in the concentrate is between 5% and 10% by weight (w/w) ([0010]).
Bromley teaches the amount of polar solvent in the concentrate is between 60% and 79% or about 79%, by weight (w/w) ([0014]).
Bromley teaches a preservative, in amount sufficient to preserve the concentrate ([0035]).
Bromley teaches exemplary of the TPGS surfactants is TPGS-1000, which has a PEG moiety of 1000 kDa ([0179]). Any known source of TPGS can be used ([0179]).
While Bromley identifies TPGS as a source of vitamin E, the art is silent regarding the presence of monomers and dimers in TPGS. The art does not explicitly teach a monomer and dimer together comprise 5-95% by weight of the water-soluble vitamin E derivative mixture in the composition. The art does not teach 25-69% monomer and 25-75% dimer.
Baogen et al. disclose a Tocopheryl Polyethylene Glycol Succinate (TGPS) ester mixture comprising TPGS monoesters and diesters (See Description, page 1, first paragraph). Baogen discloses the TPGS sold on the market (hence, commercially available) is also a mixture of monoester (hence, a monomer) and diester (hence, dimer) components (page 2, second paragraph). Therefore Baogen teaches a water-soluble vitamin E derivative mixture.
Embodiment 1 of Baogen teaches TPGS-1000 comprising 68.3% monoester (monomer) and 31.4% diester (dimer). These amounts read on the claimed ranges of monomer and dimer. A mixture containing 68.3% monomer and 31.4% dimer amounts to a total of 99.7%. Therefore Baogen teaches the monomer and dimer together comprise at least 70% by weight of the TPGS 1000 mixture.
It would have been obvious to combine the teachings of the prior art by using the Vitamin E derivative high dimer mixture taught by Baogen in the composition disclosed by Bromley. One would have been motivated to do so since Bromley teaches the use of a commercially available TPGS 1000 and Baogen discloses a TPGS 1000 comprising 68.3% monomer and 31.4% dimer. KSR Rationale A indicates that it is scientifically rational to combine prior art elements according to known methods to yield predictable results, when all of the claimed elements were known in the prior art and one skilled in the art could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable. One would have had a reasonable expectation of success since Bromley identifies TPGS 1000 as a TPGS that can be used and Baogen discloses TPGS 1000 comprises between 68.3% monomer and 31.4% dimer. One would use a Vitamin E derivative mixture with at least 70% monomer and dimer since Baogen teaches a Vitamin E derivative mixture comprising at least 70% monomer and dimer. The skilled artisan would use 16-30% of the Vitamin E derivative since Bromley teaches Vitamin E derived surfactants, such as polyethylene glycol (PEG)-derivatives of Vitamin E, are added in an amount between 16-30%. One would have expected similar results since both references are directed to the same vitamin E derivative. Claim 28 recites “whereby the mixture improves the solubility of the non-polar compound in the composition compared to mixtures that have lower amounts of water-soluble vitamin E derivative dimer”. Because Baogen teaches a water-soluble vitamin E derivative mixture comprising the claimed amount of monomer and dimer, it would be expected to improve the solubility of the non-polar compound in the composition compared to mixtures that have lower amounts of dimer as recited in claim 28. Therefore claim 28 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-28 and 30-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 5, 8, 10, 13-5, 17, 21-22 and 25 of US Patent 9861611 (09 January 2018). Although the conflicting claims are not identical, they are not patentably distinct from each other because the claim limitations of the Instant Application encompass claim limitations of the patent.
Regarding instant claim 1: Claim 1 of the ‘611 Patent is directed to a composition comprising a water-soluble Vitamin E derivative mixture. The composition can contain 35-65% monomer and 29-61% dimer (claim 13). The composition comprises 1-75% of a non-polar ingredient (claim 15). The mixture is from 16-30% of the composition (claim 22). Regarding instant claim 2: The ‘611 Patent recites the composition comprises a polar solvent (claim 5). Regarding instant claim 3: The ‘611 Patent recites the composition comprises water (a polar protic solvent) (claim 17). Regarding instant claims 4-5: The ‘611 Patent recites the composition comprises water or an edible alcohol (claim 17). Regarding instant claims 6-9: The ‘611 Patent recites the Vitamin E derivative is a TPGS (claim 8). Regarding instant claim 10: The ‘611 recites the Vitamin E derivative is a D-αTPGS (claim 25). Regarding instant claim 11: claim 10 of the ‘611 Patent discloses TPGS-1000. Regarding instant claims 12-13: The ‘611 Patent recites the composition can contain 35-65% monomer and 29-61% dimer (claim 13).
Regarding instant claim 14: The ‘611 Patent recites the composition comprises 1-75% of a non-polar ingredient (claim 15).Regarding instant claims 15-17: The ‘611 Patent recites the mixture is from 16-30% of the composition (claim 22). Regarding instant claims 18: The ‘611 Patent recites the composition comprises 1-75% of a non-polar ingredient (claim 15). Regarding instant claims 19-20: The ‘611 Patent recites 10-60% non-polar ingredient (claim 2). Regarding instant claim 21: The ‘611 Patent recites the non-polar ingredient is a PUFA (claim 14). Regarding instant claim 22: The ‘611 Patent recites the non-polar ingredient is a PUFA (claim 14). Regarding instant claim 23: The ‘611 Patent recites algal oil (claim 25). Regarding instant claims 24-25: The ‘611 Patent recites the composition comprises water (a beverage base) (claim 17). Regarding claim 26: water is interpreted to be a sports drink. Regarding instant claim 27: The ‘611 Patent recites a stabilizer including vitamin C (claim 25, an antioxidant).
Regarding instant claim 28: Claim 1 of the ‘611 Patent is directed to a composition comprising a water-soluble Vitamin E derivative mixture. The mixture is from 16-30% of the composition (claim 22). The composition can contain 35-65% monomer and 29-61% dimer (claim 13). The composition comprises 1-75% of a non-polar ingredient (claim 15). The ‘611 Patent recites the composition comprises a polar solvent (claim 5). The ‘611 Patent recites a stabilizer including vitamin C (claim 25, a preservative). The ‘611 Patent recites a pH adjuster present in an amount sufficient to adjust the pH of the composition to between 2.0 and 4.0 (claim 21).
Regarding instant claim 30: The ‘611 Patent discloses 29-61% dimer (claim 13).
Regarding instant claim 31: The ‘611 Patent discloses the mixture contains up to 25-60 % monomer and 25-69% dimer. Therefore a mixture that is at least 95% dimer and monomer is obvious. Regarding instant claim 32: The ‘611 Patent discloses the composition comprises 1-75% of a non-polar ingredient (claim 15).
EXAMINER’S RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 21 March 2025 are acknowledged.
As stated in the arguments filed on 20 October 2022, 17 May 2023 and 20 May 2024, the Applicant argues the present claims are within the scope of issued patent 9,351,517.
The Applicant goes on to state the following:
These rejections respectfully are traversed. Attention is directed to the discussion
above, regarding the requirements under 35 U.S.C. §282 and MPEP §1701. As stated by the Examiner, the claim limitations of the instant application encompass claim limitations of the ‘517 patent. Thus, since the claims in the ‘517 patent are presumptively valid, any embodiment within the scope of the presumptively valid claims must be novel and unobvious. Examiners are not permitted to impugn the validity of a fully prosecuted issued patent. Notwithstanding this, the claims of the issued patent are valid; they are novel and unobvious over the references cited in this application for the reasons of record in the parent application, and in this application. None suggest modifying vitamin E derivative compositions by increasing the amount of a component (a dimer) considered to be an impurity, nor the results of such increase, particularly to the levels recited in the instant claims.
The Applicant again requests that the Examiner consult with a Technology Center Director if the claims are rejected.
The arguments directed to Cook et al. are acknowledged.
In response: The arguments are now moot because Cook is not cited as a prior art reference.
The Applicant argues Bromley does not mention a mixture of TPGS monomer and a high amount of dimer compared to the standard surfactant, such as Eastman TPGS used in the example in Bromley. The Applicant argues the TPGS sold by Eastman does not contain the claimed amount of dimer.
In response: The rejection above acknowledges Bromley is silent regarding the presence of monomer and dimer in the disclosed TPGS. Bromley does not require the use of Eastman TPGS. Bromley teaches “any known source of TPGS can be used” ([0179]). Claim 28 encompasses any polyalkylene glycol derivative of Vitamin E. The rejection relies on the TPGS 1000 taught by Baogen, which contains the claimed amounts of monomer and dimer. Therefore the argument is not persuasive.
The Applicant argues Boagen does not teach replacing the vitamin E source of Bromley with a high dimer mixture. The arguments state Baogen discloses two examples the comprise the claimed amounts of monomer and dimer. The Applicant argues Baogen does not teach these TPGS mixtures have improved solubilization properties.
The Applicant argues none of the reference disclose dimer vitamin E derivative mixtures improve the solubility of non-polar compounds compared to compositions comprising TPGS that do not contain a high dimer mixture.
The Applicant states Baogen teaches commercially available TPGS contains diester only as a side product. The Applicant refers to a side product as “an impurity”.
The Applicant alleges Baogen teaches that any dimers present in commercially available TPGS are an undesired byproduct, in relatively low concentrations. The Applicant argues Baogen does not teach using the raw material as a surfactant, but describes that TPGS surfactant is the monoester form.
The Applicant asserts Baogen does not teach compositions containing non-polar compounds and high dimer mixtures of a vitamin E derivative (such as TPGS), nor the use of high dimer mixtures for preparing emulsions or pre-emulsion concentrates.
In response: Contrary to the Applicant’s arguments, Baogen teaches three embodiments comprising TPGS compounds comprising the claimed amounts of monomer and dimer: Example 1 (TPGS 1000), Example 3 (TPGS 400) and Example (TPGS 2000). The rejection relies on the teachings of Bromley in view of Baogen. Bromley teaches the use of TPGS 1000 as an exemplary Vitamin E derivative. Baogen is relied upon because it teaches a TPGS 1000 mixture comprising amounts of monomer and dimer that read on the claimed amounts. Claim 28 recites “whereby the mixture improves the solubility of the non-polar compound in the composition compared to mixtures that have lower amounts of water-soluble vitamin E derivative dimer”. Because Boagen teaches a water-soluble vitamin E derivative mixture comprising the claimed amount of monomer and dimer, it would inherently improve the solubility of the non-polar compound in the composition compared to mixtures that have lower amounts of dimer as recited in claim 28.
The following is noted from the Baogen reference (see page 2, second paragraph):
However, the existing commodity TPGS on the market does not give a detailed description of its ingredients and content, mainly because it has certain difficulties in separation as a polymer. The composition of the product obtained after the reaction of vitamin E succinate with polyethylene glycol is very complex. In addition to the polymer itself having a certain distribution in molecular weight, there is also a side reaction product-vitamin E polyethylene glycol succinic acid Diester. The two differ in structure by only one vitamin E succinate functional group, coupled with a more complex molecular weight distribution, so separation is not easy. The commercial TPGS sold on the market, because of the mixture of diesters, the purity of the monoester is not high, only about 80%. The purity of monoester directly affects the effect of TPGS as a surfactant and another form of vitamin E supplementation. In many literatures, it is not mentioned that TPGS is completely separated before use. In this case, some effects of TPGS obtained are inaccurate. As another product obtained by the reaction, diesters are difficult to completely separate from monoesters. Therefore, the role of diesters and their differences from monoesters have not been well studied. Therefore, it is of great significance to separate and purify the vitamin E succinate and the mixture of polyethylene glycol reaction products.
The art teaches the TPGS on the market does not give a detailed description because the components are difficult to separate. The art teaches diester is difficult to separate from the monoester. Baogen teaches the purity of monoester affects the effect of TPGS when used as a surfactant. Baogen teaches the role of diesters and their differences from monoesters have not been well studied. Therefore, it is of great significance to separate and purify the vitamin E succinate and the mixture of polyethylene glycol reaction products.
The Examples disclosed by Baogen analyze TPGS compounds to determine the amounts of monoester (monomer) and diester (dimer) present. Baogen never refers to the diester as a “contaminant” as alleged by the Applicant. Examiner notes Baogen teaches “the TPGS mixture contains TPGS monoesters, diesters and a small amount of impurities” (see page 5, first sentence of the section titled “Separation Step”). Therefore Baogen never refers to diesters as impurities. Baogen refers to components other than monoesters and diesters as “impurities”. Baogen uses a “sample” of TPGS 1000 as a raw material for chromatographic analysis. Baogen does so because the reference teaches the components TPGS on the market have not been well studied.
The Applicant alleges “Baogen et al. teaches that it is useful to separate and purify the monoester and diester components of the impure TPGS raw material prior to use of the monoester, for example, as a surfactant”. Examiner notes this is not stated in Baogen. Baogen teaches TPGS on the market does not give a detailed description of its ingredients and content. Baogen teaches the purity of monoester directly “affects the effect” of TPGS as a surfactant and another form of Vitamin E supplementation. While Baogen teaches the amount of monoester affects the effect as a surfactant and Vitamin E supplement, Examiner notes the art does not teach it cannot be used for Vitamin E supplementation.
The Applicant asserts Baogen cannot and does not teach compositions containing non-polar compounds and high dimer mixtures of a vitamin E derivative (such as TPGS), nor the use of high dimer mixtures for preparing emulsions or pre-emulsion concentrates. Examiner notes claim 28 does not recite an emulsion or a pre-emulsion concentrate. Therefore the arguments are not persuasive.
The Applicant argues the claimed invention has unexpected properties. The Applicant argues the advantageous properties are pronounced when dimer is present in the mixture at an amount between 29% and 69%. The Applicant states the instant application demonstrates that the solubilization properties of the polyalkylene glycol derivative of vitamin E mixtures increases as the amount of dimer form in the vitamin E derivative mixture increases, and that “this property is most pronounced when there is between about 29% and 69% dimer form in the vitamin E derivative mixture”. The Applicant refers to Example 9 of the instant specification, which uses TPGS from Eastman Chemical Company containing 11% dimer and 86% monomer.
In response: Examiner points out the experiments disclosed in the specification use TPGS from Eastman Chemical Company containing “~11%” dimer and “~86%” monomer. The rejection is not based on the use of Eastman Chemical Company’s TPGS.
The Applicant points to Example 1 of the specification and argues the advantageous properties are pronounced when dimer is present in the mixture at an amount between 29% and 69%. Examiner notes Example 1 discloses monomer between 39.35% and 60% and dimer between 29.27% and 54.90%. It is not commensurate with the scope of claim 28.
The Applicant arguments state the instant application describes that its dimer and monomer mixture of vitamin E derivatives is prepared in such a way that increased dimer formation is favored in the mixture. The intentional mixing of two components is the opposite of the separation of two components. In response, Examiner notes the claims are not directed to a method of making a high dimer mixture. The claims recite a high dimer mixture comprising the claimed ranges of monomer and dimer. The arguments are not persuasive.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653