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 .
CLAIMS UNDER EXAMINATION
Claims 1-2, 4-5, 7-8, and 19-32 have been examined on their merits. Claims 10-18 have been withdrawn.
PRIORITY
Foreign priority document GB1904757 filed on 04 April 2019 is acknowledged.
The foreign priority document provides support for 5-70% triglyceride, diglyceride monoglyceride (see pages 8-9 of GB1904757). It does not provide support for the broader range of 1-70% recited in claim 1. PCT/GB2020/050904 filed on 06 April 2020.
provides support for this limitation. The foreign priority document provides support for 1-15% lecithin (see pages 8-9 of GB1904757). It does not provide support for the broader range of 1-45% recited in claim 1. PCT/GB2020/050904 filed on 06 April 2020 provides support for this limitation. The foreign priority document provides support for 3-70% water (see pages 8-9 of GB1904757). It does not provide support for the broader range of 1-70% recited in claim 1. PCT/GB2020/050904 filed on 06 April 2020 provides support for this limitation. The foreign priority document provides support for a ratio of glyceride and lecithin and/or lyso-lecithin is from 30 to 1 to 1 to 1 (see page 9). It does not provide support for the broader range of 45:1 and 1:45 recited in claim 1. PCT/GB2020/050904 filed on 06 April 2020 provides support for this limitation.
Regarding the “additional components” recited in claim 1, the foreign priory document does not provide support for the range of bile acid/salt, cholesterol/sterols, osmotic agents, proteins and preservatives/stabilizer recited in instant claim 1. It does not provide support for antimicrobials. PCT/GB2020/050904 filed on 06 April 2020 provides support for this limitation.
WITHDRAWN REJECTIONS
Claim 1 has been amended to recite a “homogenized fat dispersion”. The rejection of claims 1-2, 4-9, 17 and 19-29 under 35 U.S.C. 101 is withdrawn due to claim amendment.
The rejection of claim 22 under 35 U.S.C. 112(d) has been withdrawn due to claim amendment.
The previous rejections made under 35 U.S.C. 103 have been withdrawn due to claim amendment.
REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-9, 17 and 19-29 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 1 recites “…one or more primary components from group iii)”. The phrase “primary components” lacks antecedent basis. It is unclear what components the claim is referring to. Appropriate correction is required. All dependent claims are included in this rejection. Claim 17 is included in this rejection because it encompasses the composition of claim 1.
Claim 23 recites “…one or more primary components from group iii)”. The phrase “primary components” lacks antecedent basis. It is unclear what components the claim is referring to. Appropriate correction is required.
APPLICANT’S ARGUMENTS
The arguments made on 10 February 2025 are acknowledged. The Applicant argues the claims have been amended to overcome the rejections.
Response to argument: The claims still recite “one or more primary components from group iii)”. Therefore the rejections are maintained.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites the composition is in the form of a “gel concentrate”. Claim 1 has been amended to recite the composition is a homogenized fat dispersion. A gel concentrate does not further limit a homogenized fat dispersion.
Claim 8 recites a “liquid fat dispersion/concentrate”. Claim 1 has been amended to recite a homogenized fat dispersion. A liquid fat dispersion/concentrate does not further limit a homogenized fat dispersion.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-5, 7-8, 19, 21-29 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Eskuchen et al. (Emulsions containing unsaturated fatty acids and esters thereof. US20060057187A1) in view of Virginia Tech (previously cited; Understanding the Water Activity of Your Food. 2012 pages 1-2).
Eskuchen et al. teach an emulsion that shows high stability in storage (Abstract). The art teaches an emulsion comprising the following ingredients [0060]-[0066]:
a) 0.5 to 40% by weight conjugated linoleic acid or derivatives of conjugated linoleic acid,
b) 0.2 to 20% by weight vegetable lecithin mixtures,
c) 0 to 20% by weight co-emulsifiers,
d) 0 to 70% by weight polyols,
e) 10 to 70% by weight carbohydrates,
f) 0 to 1 % by weight antioxidants, and
g) 20 to 89% by weight aqueous phase
Regarding component a) the art teaches the use of triglyceride is preferred ([0030]).
Therefore the art teaches a composition comprising
0.5 to 40% triglyceride;
0.2 to 20% lecithin;
10 to 70% carbohydrate;
20 to 89%aqeous medium; and
0-1% antioxidant.
Claim 1 recites the ratio of a) glycerides+lecithin to b) carbohydrate is in a range of 45:1 to 1:45. Examiner notes this range includes 45 to 0.02 (1 divided by 45). The range taught by the art includes the following ratios:
a = 0.7(0.5 glyceride + 0.2 lecithin)
b= 10
0.07 (0.7 divided by 10)
a=60 (40 glyceride + 20 lecithin)
b=70
0.85 (60 divided by 70).
Therefore the range of ratios taught anticipate the claimed range of ratios.
The art teaches adding antioxidants to stabilize the emulsions against oxidation ([0043]).
The art teaches the emulsion is homogenized ([0019]). Because the emulsion contains fat in water, it is interpreted to be a homogenized fat dispersion.
The art also teaches emulsions are intended to be incorporated in juices, soya milk beverages or protein-rich liquid food substitute beverages and dairy products, such as milk, fermented milk preparations, yogurt, drinking yogurt or cheese preparations ([0016]).
Eskuchen does not teach an antioxidant with sufficient specificity to anticipate the claim.
The art teaches ranges of glyceride, lecithin, carbohydrates and water that overlap with the claimed ranges.
Eskuchen is silent regarding the water activity of the composition.
Virginia Tech teaches foods that depend on water activity as a means of preservation should have a water activity of 0.85 or less (first paragraph under Table 1).
The art also teaches the following:
Water activity refers to the amount of free water that is available in food for microbial growth. Water activity is often used as a way to preserve foods and gain a longer shelf-life (first paragraph of page 1). Water activity is measured in values from 0.0 to 1.0. The lower the water activity value, the more “dry” a food item is considered (second paragraph of page 1). Virginia Tech teaches below 0.60, yeasts, molds, and bacteria will not proliferate (page 2, last sentence of first paragraph). The art teaches water activity can be lowered in a variety of ways, including adding salt and/or sugar, removing water and dehydration (see last three paragraphs of page 2).
It would have been obvious to use an antioxidant in Eskuchen’s emulsion. Eskuchen teaches the emulsion has high stability. One would have been motivated to use an antioxidant to stabilize the composition from oxidation. One would have had a reasonable expectation of success since Eskuchen teaches an antioxidant can added to the disclosed composition. It would have been obvious to optimize the amounts of glyceride, lecithin, carbohdyrates and water. One would do so based on the type of food the emulsion is incorporated in. One would have had a reasonable expectation since the art teaches the amounts that overlaps with the claimed ranges. See MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. It would have been obvious to prepare a composition with a water activity below 0.86. One would have been motivated to do so since Eskuchen is directed to a composition that can be stored long term and used in food and Virginia Tech teaches foods that depend on water activity as a means of preservation should have a water activity of 0.85 or less. One would prepare a composition with a water activity below 0.86 to improve storage stability. One would have had a reasonable expectation of success since Eskuchen teaches the amount of water in the composition can be reduced. One would have expected similar results since both references are directed to compositions that are stored. Therefore claim 1 is rendered obvious.
Eskuchen teaches glucose, fructose and sucrose as cabohydrates ([0041]). Therefore claims 4-5 are included in this rejection.
Eskuchen teaches 20 to 89%aqeous medium can be used (supra). Therefore claims 7-8 are rendered obvious.
Eskuchen teaches the composition has a d90 particle size distribution of 0.117 to 0.281 μm (117 nm to 281nm; see claims 17-20). The claimed range overlaps with the particles recited in the prior art. See MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. Therefore claim 19 is included in this rejection.
The composition recited in claim 1 is rendered obvious. Therefore it would be expected to have the microbiology recited in claim 21.
It would have been obvious to prepare a composition with a water activity below 0.70. One would have been motivated to do so since Eskuchen is directed to a composition that can be stored long term and Virginia Tech teaches reducing water activity to produce compositions with a longer shelf life. One would prepare a composition water a water activity of 0.00-0.60 since Virginia Tech teaches below 0.60, yeasts, molds, and bacteria will not proliferate. One would have had a reasonable expectation of success since Eskuchen teaches the amount of water can be optimized. One would have expected similar results since both references are directed to compositions that are stored. Therefore claim 22 is included in this rejection.
Regarding independent claim 23:
The claim recites the ratio of a) glycerides+lecithin to b) carbohydrate is in a range of 20:1 to 1:20. This includes a range of 20 to 0.05 (1 divided by 20). The range taught by the art includes the following ratios:
a= 0.7(0.5 glyceride + 0.2 lecithin)
b= 10
0.07 (.7 divided by 10)
a=60 (40 glyceride + 20 lecithin)
b=70
0.85 (60 divided by 70).
Therefore the range of ratios taught by Eskuchen anticipate the claimed range of ratios for fats.
Eskuchen teaches a range of glyceride:lecithin that overlaps with the claimed range.
It would have been obvious to optimize the amounts of glyceride and lecithin in Eskuchen’s composition. One would do so based on the type of food the emulsion is incorporated in. One would have had a reasonable expectation since the art teaches the amounts that overlaps with the claimed ranges. MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. Therefore claim 23 is rendered obvious.
Claim 24 encompasses the limitations recited in claim 23. Therefore claim 24 is included in this rejection.
Eskuchen teaches the antioxidant stabilizes the composition (supra). Therefore claim 25 is included in this rejection.
The PG Pub of the instant specification identifies milk as a buffer ([0016]). Eskuchen teaches milk can be used ([0040]). Therefore the art teaches a buffer. Claim 26 is included in this rejection.
Eskuchen teaches the composition can contain salt (hence, an osmotic agent) ([0040]). Therefore claim 27 is included in this rejection.
Eskuchen teaches the composition has a d90 particle size distribution of 0.117 to 0.281 μm (117 nm to 281nm; see claims 17-20). The claimed range overlaps with the particles recited in the prior art. See MPEP 2133.03. Therefore claim 28 is included in this rejection.
Because the claimed product is rendered obvious, it would be expected to be storage stable for the claimed time. Claim 29 is included in this rejection.
Eskuchen teaches a range of water that overlaps with that recited in claim 31.
It would have been obvious to optimize the amounts of water. One would do so based on the type of food the emulsion is incorporated in. One would have had a reasonable expectation since the art teaches the amounts that overlaps with the claimed ranges. MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. Therefore claim 31 is rendered obvious as claimed.
Claim 32 recites an intended use of the simulated biorelevant precursor composition recited in claim 1. Because the product recited in claim 1 is rendered obvious, it is suitable for the intended use. Therefore claim 32 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over the teachings of Eskuchen in view of Virginia Tech as recited in the rejection of claim 1, and further in view of Sadeghpour et al. (Bile Salts Caught in the Act: From Emulsification to Nanostructural Reorganization of Lipid Self-Assemblies. Langmuir et al. 2018, 34 13626-13637).
Claim 1 is rejected on the grounds set forth above. The teachings of the prior art are reiterated. Eskuchen teaches an emulsion (supra). Lecithin is used an emulsifier ([0019]). The lecithin comprises phospholipids (hence, lipids) ([0032]).
Eskuchen teaches use of co-emulsifiers (hence, multiple emulsifiers) ([0037]).
The art does not teach bile salts.
Sadeghpour teaches bile salts are important for the digestion and absorption of fats and fat-soluble vitamins in the small intestine (Abstract). The art teaches bile salts emulsify lipids (Abstract; see Figure 1). The art teaches 0.06-0.20% bile salts (Figure 2e).
It would have been obvious to use 0.06-0.20% bile salt in the composition taught by Eskuchen. One would have been motivated to do so since Eskuchen teaches a lipid emulsion and Sadeghpour teaches bile salts can be used to emulsify lipids. One would have had a reasonable expectation of success since Eskuchen teaches using more than one emuslifer to prepare an emulsion. One would have expected similar results since each reference is directed to a lipid emulsion comprising emulsifiers. Therefore claim 20 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 2 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Eskuchen in view of Virginia Tech as recited in the rejection of claim 1 above, and further in view of Tomsits et al. (Safety and Efficacy of a Lipid Emulsion Containing a Mixture of Soybean Oil, Medium-chain Triglycerides, Olive Oil, and Fish Oil: A Randomised, Double-blind Clinical Trial in Premature Infants Requiring Parenteral Nutrition. 01 October 2010).
Claim 1 is rejected on the grounds stated above. The teachings of the prior art are reiterated. Eskuchen teaches a triglyceride of conjugated linoleic acid (supra). The art does not teach the triglyceride is provided as soybean oil.
Tomsits teaches the most widely used lipid emulsions are still mainly based on soybean oil, rich in n-6 polyunsaturated fatty acids (PUFA), and provide high amounts of linoleic acid (LA, C18:2 n-6) and α-linolenic acid (ALA, C18:3 n-3). See page 514, right column, first paragraph).
It would have been obvious to try providing triglyceride as a soybean boil . One would have been motivated to do so since Tomsits teaches soybean oil contains linoleic acid and is the most widely used to make lipid emulsions. One would have had a reasonable expectation of success since Eskuchen teaches the triglycerides used are a triglyceride of a linoleic acid. One would have expected similar results since both references are directed to methods of making lipid emulsions. Therefore claim 2 is rendered obvious.
Regarding claim 30:
Triglyceride as soybean oil is rendered obvious on the grounds recited in the rejection of claim 2. Eskuchen teaches monoglycerides and diglyceride of conjugated linoleic acid ([0030]). Therefore the art teaches a linoleic monoglyceride and diglyceride. The art teaches glycerides as co-emulsifiers ([0037]).
It would have been obvious to use soybean oil triglyceride, linoleic monoglyceride and linoleic triglyceride in the emulsion taught by Eskuchen. The art teaches the glycerides can be used as emulsifiers. The skilled artisan would have been motivated to use all three to provide an enhanced emulsifying effect. One would have had a reasonable expectation of success since Eskuchen teaches glycerides can be used as co-emulsifiers. Therefore claim 30 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 10 February 2025 are acknowledged. The arguments are based on the amended claims. New grounds of rejection have been set forth above to address the amended claims.
CONCLUSION
No Claims Are Allowed
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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653