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 .
DETAILED ACTION
Claims 1-3, 5-9, 11-21, 23-31, 33-49 are pending in the Claim Set 7/09/2025.
Applicants’ election without traverse of Group I: 1-50 in the reply filed on 7/9/2025 is acknowledged.
Further, Applicants election of species shown below is acknowledged. Applicants argue that species election seems to be inconsistent with the claims. To promote compact prosecution election requirement for species in claims 1 and 12-15 are withdrawn.
Applicants elected:
A1: Modified Oil Phase
1. Phospholipid: phosphatidylcholine (present in claims 23, 24, and 25)
2. Polyethylene glycol derivative: polyethylene glycol modified vitamin E
(present in claims 26 and 27)
3. Oil: Medium Chain Triglyceride (present in claims 28, 29, and 30)
4. Alcohol: Ethanol
B. Modified Polar Continuous Phase
1. Sugar or sugar alcohol: glycerol (present in claims 33 and 34)
The requirement is still deemed proper and is therefore made FINAL
Herein, claims 1-3, 5-9, 11-21, 23-31 and 33-39 are for examination.
In response to Applicants’ arguments regarding the species election requirement, the species election requirement in the Restriction Requirement filed 5/19/2025 states that these species are independent or distinct because each species has mutually exclusive characteristics. In addition, it is stated that the species require a different field of search or and/ or the prior art applicable to one species would not likely be applicable to another species. Per MPEP 806.04: Where two or more species are claimed, a requirement to a single species may be proper if the species are mutually exclusive. The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species. Accordingly, there is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The purpose of the Requirement of Restriction is to facilitate examination of the claimed subject matter that encompasses varied species in order to promote compact prosecution and is not intended to hinder the effectiveness of the claimed composition. Once a species election is found allowable the examination will be extended to further include additional non-elected species and/or combinations thereof. Therefore, it is the position of the examiner that a serious search burden does, in fact, exist and the requirement is still deemed proper and is therefore made FINAL.
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 23-25 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 pre-AIA the applicant regards as the invention.
Claim 23-25 are indefinite because they are dependent upon canceled claim 22.
Double Patenting Rejections
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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 1-3, 5-9, 11-21, 23-31 and 33-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 of copending Application No. 17/672, 894 (herein ‘894).
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘894 claims are directed to common subject matter.
Instant claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
Similarly, ‘894 claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
‘894 claims differ from instant claims for at least the reason that the Instant Claims are directed to different alcohol-soluble species such as dienolylmethane, however, both instant claims and the ‘894 claims are both directed to the identical alcohol-soluble species dehydroepiandrosterone, so that share common alcohol-soluble species, and they are both modified oil-in water microemulsion that are visually clear, shelf-stable, ingestible and edible.
Thus, Instant Claims and ‘894 claims are obviously directed to common subject matter. Therefore, the subject matter as instantly claimed is prima facie obvious in view of the ‘894 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-9, 11-21, 23-31 and 33-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of copending Application No. 17972754 (herein ‘754).
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘754 claims are directed to common subject matter.
Instant claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
Similarly, ‘754 claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
‘754 claims differ from instant claims for at least the reason that the ‘754 claims are directed to different alcohol-soluble species such as polyphenol, however, both instant claims and the ‘754 claims are both directed to the identical alcohol-soluble species dehydroepiandrosterone, so that share common alcohol-soluble species, they are both comprise modified oil-in water microemulsion that are visually clear, shelf-stable, ingestible and edible.
Thus, Instant Claims and ‘754 claims are obviously directed to common subject matter. Therefore, the subject matter as instantly claimed is prima facie obvious in view of the ‘754 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5-9, 11-21, 23-31 and 33-39 under 35 U.S.C. 103(a) as being unpatentable over Bromley et al (WO2009/117152, cited in IDS).
Regarding claims 1-3, 5-9, 11-21, 23-31 and 33-39,
Bromley teaches compositions and methods for preparing foods and beverages that contain additives, such as nutraceuticals, pharmaceuticals, and supplements, such as essential fatty acids, including omega-3 fatty acids, omega-6 fatty acids, conjugated fatty acids, and other fatty acids; phytochemicals, including phytosterols; other oils; and coenzymes, including Coenzyme QIO, and other oil- based additives. The composition comprising a PEG-derivative of vitamin E (tocopherol polyethylene glycol derivative) (Abstract; see entire document). For example, the provided compositions include concentrates containing nonpolar active ingredients, surfactants, and polar solvents, at amounts whereby dilution of the concentrate in an aqueous medium, such as a beverage, at a particular amount (e.g., any of the specified amounts, concentrations, and dilutions of the concentrates and any of the amounts of the non-polar active ingredients described herein below), yields a liquid dilution composition containing effective amounts of the non-polar active ingredient and having one or more desired properties. The provided compositions further include liquid dilution compositions, including the liquid dilution compositions made from the concentrates, containing aqueous media, nonpolar active ingredients at effective amounts and polar solvents that have the desired properties. The amount of the concentrate and/or amount of the non-polar active ingredient can be specified. The desired properties include clarity of the liquid dilution compositions, such as compositions that are clear or about as clear as the aqueous medium in the absence of the concentrate and/or in the absence of the nonpolar active ingredient; particle size, such as particle size of less than 200 nm or less than about 200 nm, less than 100 nm or less than about 100 nm, less than 50 nm or 10 less than about 50 nm, or less than 25 nm or less than about 25 nm, at most or on average (reads on claim 11) The provided concentrates typically are liquid nanoemulsion concentrates, which contain surfactants, non-polar compound(s) (which typically is/are a non-polar active ingredient which differs from the surfactant) and a polar solvent (e.g., water or other edible aqueous liquid, such as a polar protic solvent such as a dihydric or trihydric alcohol, e.g., propylene glycol and glycerin (glycerol: elected species)).
Bromley teaches an emulsion, e.g., an oil and water, one of which is part of a continuous phase and the other of which is part of a dispersed phase. The provided compositions include oil-in-water emulsions comprising any oil soluble phase dispersed in any aqueous phase, in which the oil phase is the dispersed phase and the water phase is the continuous phase (Title; Abstract; p.33, lns.13-26; p.26, line 21; p.64, lns.14-17; claim 54; See entire document).
Bromley teaches a composition comprising: an alcohol-soluble species, e.g., testosterone, (p.8, line 11; p.84, line 28) and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species, e.g., testosterone, is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid (e.g., phosphatidylcholine (lecithin) (reads on claim 24; elected species) (p.10, line 18; p.12, line 18; p.13, line 27; p.15, line 3; p.16, line 10; p.17, line 19; p.18, line 18; p.19, line 5; p.24, line 6; p.44, line 21; p.45, lines 1-12: p.107, lns.29-33 to p.108, lns.1-24), a polyethylene glycol derivative (TPGS surfactant, e.g., TPGS-1000, which is d-alpha-tocopheryl acid succinate with polyethylene glycol 1000 (PEG 1000) (p.4, line 28; p.5, line 12; p.35, lns.24-26; p.36, line 14; p.104, lns.9-32: reads on claims 26-27) and an alcohol, e.g., ethanol (elected species) (p.50, line 16-31; p.51, line 4; p.82, line 15; p.109, line27; p.110, line 7; recited in claim 1) and where the modified polar continuous phase comprises a sugar or sugar alcohol, e.g., glycerin (also called glycerol: elected species) (p.3, line 19; p.10, line 8; p.13, line 32; p.15, line 8; p.26, line 9) and water (p.29, line 30; p.33, line 33; See entire document; recited in claims 33-34). Further, Bromley teaches properties of the provided liquid concentrates that are diluted into the aqueous medium contribute to various properties of the provided resulting aqueous liquid dilution compositions, for example, clarity (reads on claim 2); desirability for human consumption, for example, pleasant taste and stability (i.e., shelf stable: reads on claim 3) (p.66, lns.24-29; p.69, line 6 (edible); p.121, lns.15-21; See a. Clarity: start on page 121).
Bromley teaches the desired properties include clarity of the liquid dilution compositions, such as compositions that are clear or about as clear as the aqueous medium in the absence of the concentrate and/or in the absence of the nonpolar active ingredient; particle size, such as particle size (droplets) of less than 200 nm or less than about 200 nm, less than 100 nm or less than about 100 nm, less than 50 nm or 10 less than about 50 nm, or less than 25 nm or less than about 25 nm (p.3, lns.4-14; p.33, lns.7-12; p.46, lns.1-15). Bromley teaches sugar alcohol: glycerol (present in claims 33 and 34)
Bromley teaches combining the oil and water phases. In one example, the oil phase is transferred to the water phase vessel (i.e., continuous phase). Bromley teaches the oil phase comprises MCT oil (p.60, line 31; p.113, line 30). Bromley teaches MCT oil increase the clarity of the composition (concentrate) (p.113, lns.1-32) (Regarding claims 29-31: MCT oil: elected species).
Bromley teaches alcohol-soluble species comprising: dehydroepiandrosterone (DHEA) where pregnenolone and diindolylmethane (DIM) is an obvious variant p.7, lns.10-17; p.8, lns.7-12; p.84, lns,24-29)
In another example, the water phase is transferred to the oil phase vessel. In another example, a plurality of oil phases or water phases are transferred to a water phase or an oil phase vessel. In another example, the water phase(s) and the oil phase(s) are transferred to another vessel, for example, an emulsification vessel (p.140, lns.30-32 to p.141, lns.1-5). Bromley fails to teach specific ratios of the phospholipid to the polyethylene glycol derivative is 1:0.4 to 1:4, however, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration, e.g., ratio of the phospholipid to the polyethylene glycol, is critical. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization. See MPEP 2144.05 recites the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum ratios to best achieve a desired goal.
Regarding claim 5,
Bromley fails to teach that the modified oil-in-water emulsion is configured to provide uptake of the alcohol-soluble species, for example: testosterone, to the bloodstream of a mammal at a therapeutically effective concentration through the oral and gastric mucosa of the mammal. However, the composition comprising the oil-in-water emulsion, as described above, is structurally and chemically indistinguishable from the claimed composition so that it would necessarily follow that the oil-in-water emulsion is configured to provide uptake of the alcohol-soluble species, e.g., testosterone, to the bloodstream of a mammal at a therapeutically effective concentration through the oral and gastric mucosa of the mammal testosterone.
Regarding claims 12-13, Bromley teaches testosterone and progesterone (p.8, lns.7-11).
Regarding claims 15-16. Bromley teaches phystosterols (plant sterol) (p.8).
Regarding claims 24-25, Bromley teaches the phospholipid is phosphatidylcholine (PC), which sometimes is referred to by the general name "lecithin." Exemplary of the phospholipids that can be used as cosurfactants in the provided compositions are the phospholipids sold by Lipoid, LLC, 5 Newark, NJ, for example, Purified Egg Lecithins, Purified Soybean Lecithins, Hydrogenated Egg and Soybean Lecithins, Egg Phospholipids, Soybean Phospholipids, Hydrogenated Egg and Soybean Phospholipids. Synthetic Phospholipids, PEG-ylated Phospholipids and phospholipid blends sold by Lipoid, LLC.
Exemplary of the phosphatidylcholine that can be used as a co-surfactant in the provided compositions is the phosphatidylcholine composition sold by Lipoid, LLC, under the name Lipoid S 100, which is derived from soy extract and contains greater than 95 % or greater than about 95 % phosphatidylcholine.
Regarding claim 41, Bromley teaches d-alpha-tocopheryl acid succinate with polyethylene glycol 1000 (PEG 1000) in about 16% by weight.
Regarding claim 42. The composition of claim 1, where the alcohol is 95% ethanol by weight.
Bromley teaches an alcohol, e.g., ethanol ((p.50, line 16-31; p.51, line 4; p.82, line 15; p.109, line27; p.110, line 7), but fails to mention the purity of the alcohol, e.g., 95% ethanol.
The PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product, e.g., 95% ethanol, when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433-434 (CCPA 1977) as follows: Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, or 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.
Claims 28-30. Bromley teaches MCT oil (i.e., oil) concentration range of between 1 % or about 1 % and 10 % or about 10 %, for example, 1 %, 2 %, 3 %, 3.25 %, 3.5 %, 3.75 %, 4 %, 5 %, 5.25 %, 5.5 % or 5.75 %, w/w, of the concentrate. In another example, the concentration is within the concentration range of between 3 % or about 3 % and 6 % or about 6 %, w/w, of the liquid concentrate. In another example, it is between 3.75 % and 5.25 % w/w, of liquid concentrate (p,113-114). (claims 28-30).,
Regarding claims 46-47. The composition of claim 1, where the alcohol-soluble species comprises from 0.2% to 5% of the composition by weight.
Bromley teaches each of the provided concentrates contains a non-polar compound (e.g., testosterone: p.8, line 11; p.84, line 28), wherein the non-polar compound is a non-polar active ingredient. For formulating the initial concentrate, the starting concentration of the non-polar compound typically is a concentration chosen from within a concentration range of between 5 % or about 5 % and 10 % or about 10 % (w/w) of the concentrate, such as a starting concentration of 5 % or about 5 %, 6 % or about 6 %, 7 % or about 7 %, 8 % or about 8 %, 9 % or about 9 %, or 10 % or about 10 % (w/w) of the concentrate. The non-polar compound typically is added as part of an oil phase, according to the provided methods for making the concentrate (p.73, lns.13-25).
Regarding claim 48, Bromley teaches the concentrate contains polar solvent (e.g., edible polar solvent, e.g., glycerin), typically, the starting concentration of polar solvent is chosen from within a concentration range of between 60 % or about 60 % and 80 % or about 80 % (w/w) of the concentrate, for example, 60 % or about 60 %, 61 % or about 61 %, 62 % or about 62 %, 63 % or about 63 %, 64 % or about 64 %, 65 % or about 65 %, 66 % or about 66 %, 67 % or about 67 %, 68 % or about 68 %, 69 % or about 69 %, 70 % or about 70 %, 71 % or about 71 %, 72 % or about 72 %, 73 % or about 73 %, 74 % or about 74 %, 75 % or about 75 %, 76 % or about 76 %, 77 % or about 77 %, 78 % or about 78 %, 79 % or about 79 %, 80 % or about 80 % (w/w) of the concentrate, such as, for example, 68.29 %, 68.78655 %, 74.25 %, 71.74 %, or 75.8165 % (w/w) of the concentrate. In one example, the concentration range of the polar solvent is between 65 % or about 65 % and 80 % or about 80 % (w/w) of the concentrate. In another example, the concentration range of the polar solvent is between 65 % or about 65 % and 75 % or about 75 % (w/w) of the concentrate or between 65 % or about 65 % and 76 % or about 76 % (w/w) of the concentrate (p.73, lns.26-32 to p.74, lns.1-10) (reads on claim 48).
Regarding claims 36-40, 42-46 and 57.
Claim 36. The composition of claim 1, the modified oil phase further comprising an oil, where a ratio of the phospholipid, to the oil, to the polyethylene glycol derivative, to the alcohol, to the sugar or sugar alcohol, and to the water is 1:2:0.6-3.3:4: 10.5: 1-1.6 ± 10& or 20% by weight.
Claim 37. The composition of claim 1, the modified oil phase further comprising an oil, where a ratio of the phospholipid, to the oil, to the polyethylene glycol derivative, to the alcohol, to the sugar or sugar alcohol, and to the water is 1:2:0.6-3.3:4: 10.5: 1-1.6 ±10% by weight.
Claims 38-39. (The composition of claim 1, the modified oil phase further comprising an oil, where a ratio of the oil to the alcohol-soluble species is 1:0.02 to 0.3 ±10% or 5% by weight.
Claim 40. The composition of claim 1, where the phospholipid comprises from 3 % to 10 % of the composition by weight.
Claims 42-43. The composition of claim 1, where a ratio of the phospholipid to the polyethylene glycol derivative is 1;.04 to 1:4; 1:1.6 to 1 :4 by weight.
Claim 44. The composition of claim 1, the modified oil phase further comprising an oil, where the oil comprises from 5 % to 15 % by weight.
Claim 45. The composition of claim 1, where the alcohol comprises from 5 % to 25 % of the composition by weight.
Claim 46. The composition of claim 1, the modified oil phase further comprising an oil, where a ratio of the oil to the alcohol-soluble species is 1:1.5 to 1:4 by weight.
Claim 57. The composition of claim 1, the modified oil phase further comprising an oil, where a ratio of the oil to the alcohol is 1:1.5 to 1:4 by weight.
Bromley teaches the phospholipid, is between 0.1 % or about 0.1 % and 1 % or about 1 %, by weight (w/w), of the concentrate (p.10, lns.14-20).
Regarding claim 48, Bromley teaches the concentrate contains polar solvent (e.g., edible polar solvent, e.g., glycerin), typically, the starting concentration of polar solvent is chosen from within a concentration range of between 60 % or about 60 % and 80 % or about 80 % (w/w) of the concentrate, for example, 60 % or about 60 %, 61 % or about 61 %, 62 % or about 62 %, 63 % or about 63 %, 64 % or about 64 %, 65 % or about 65 %, 66 % or about 66 %, 67 % or about 67 %, 68 % or about 68 %, 69 % or about 69 %, 70 % or about 70 %, 71 % or about 71 %, 72 % or about 72 %, 73 % or about 73 %, 74 % or about 74 %, 75 % or about 75 %, 76 % or about 76 %, 77 % or about 77 %, 78 % or about 78 %, 79 % or about 79 %, 80 % or about 80 % (w/w) of the concentrate, such as, for example, 68.29 %, 68.78655 %, 74.25 %, 71.74 %, or 75.8165 % (w/w) of the concentrate. In one example, the concentration range of the polar solvent is between 65 % or about 65 % and 80 % or about 80 % (w/w) of the concentrate. In another example, the concentration range of the polar solvent is between 65 % or about 65 % and 75 % or about 75 % (w/w) of the concentrate or between 65 % or about 65 % and 76 % or about 76 % (w/w) of the concentrate (p.73, lns.26-32 to p.74, lns.1-10) (reads on claim 48).
Bromley teaches the starting concentration of the surfactant, e.g., TPGS-1000 (i.e., polyethylene glycol derivative) (p.4, line 28; p.5, line 12; p.35, lns.24-26; p.36, line 14; p.104, lns.9-32) is chosen from within a concentration range of between 16 % or about 16 % and 30 % or about 30 % (w/w), for example, 16 % or about 16 %, 17 % or about 17 %, 18 % or about 18 %, 19 % or about 19 %, 20 % or about 20 %, 21 % or about 21 %, 22 % or about 22 %, 23 % or 5 about 23 %, 24 % or about 24 %, 25 % or about 25 %, 26 % or about 26 %, 27 % or about 27 %, 28 % or about 28 %, 29 % or about 29 %, or 30 % or about 30 %, by weight (w/w), of the concentrate, such as, for example, 17.75 %, 20.25 %, 20.5 %, 22.7 %, or 25.2 % (w/w) of the concentrate (p.73, lns.1-8).
Bromley teaches for evaluation of properties of the aqueous liquid dilution composition, the initial concentrate is diluted into an aqueous medium, typically water or another polar solvent, e.g., ethanol, (i.e., alcohol) for example, at a dilution factor of between 1: 10 or about 1: 10 and 1: 1000 or about 1: 1000, typically between 1: 10 or about 1: 10 and 1 :500 or about 1 :500, for example, diluted not more than 1: 10 or about 1: 10, at least 1 :20 or about 1 :20, at least 15 1 :25 or about 1 :25, at least 1 :50 or about 1 :50, at least 1: 100 or about 1: 100, at least 1 :200 or about 1 :200, at least 1 :250 or about 1 :250, at least 1 :300, at least 1 :400 or at least 1 :500, for example, 1: 10, 1 :20, 1 :25, 1 :30, 1 :35, 1 :40, 1 :50, 1 :5·5, 1 :60, 1 :65, 1:70, 1:75, 1:80, 1:90, 1:100, 1:110, 1:120, 1:130, 1:140, 1:150, 1:160, 1:170, 1:180, 1: 190, 1 :200, 1 :210, 1 :220, 1 :230, 1 :235, 1 :240, 1 :250, 1 :260, 1 :270, 1 :280, 1 :290, 20 1 :300, 1 :350, 1 :400, 1:450, 1 :500, or any other dilution, such as others provided herein (p.75, lns.10-21).
Bromley teaches the concentrate contains polar solvent (e.g., edible polar solvent, e.g., glycerin) (i.e., sugar alcohol) , typically, the starting concentration of polar solvent is chosen from within a concentration range of between 60 % or about 60 % and 80 % or about 80 % (w/w) of the concentrate, for example, 60 % or about 60 %, 61 % or about 61 %, 62 % or about 62 %, 63 % or about 63 %, 64 % or about 64 %, 65 % or about 65 %, 66 % or about 66 %, 67 % or about 67 %, 68 % or about 68 %, 69 % or about 69 %, 70 % or about 70 %, 71 % or about 71 %, 72 % or about 72 %, 73 % or about 73 %, 74 % or about 74 %, 75 % or about 75 %, 76 % or about 76 %, 77 % or about 77 %, 78 % or about 78 %, 79 % or about 79 %, 80 % or about 80 % (w/w) of the concentrate, such as, for example, 68.29 %, 68.78655 %, 74.25 %, 71.74 %, or 75.8165 % (w/w) of the concentrate. In one example, the concentration range of the polar solvent is between 65 % or about 65 % and 80 % or about 80 % (w/w) of the concentrate. In another example, the concentration range of the polar solvent is between 65 % or about 65 % and 75 % or about 75 % (w/w) of the concentrate or between 65 % or about 65 % and 76 % or about 76 % (w/w) of the concentrate (p.73, lns.26-32 to p.74, lns.1-10).
Bromley fails to teach specific ratios of the phospholipid, to the oil, to the polyethylene glycol derivative, to the alcohol, to the sugar or sugar alcohol, and to the water is 1:2:0.6-3.3:4: 10.5: 1-1.6 ± 20% by weight. However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization. See MPEP 2144.05 recites Moreover, the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum ratios to best achieve a desired goal.
Bromley teaches the polyethylene glycol derivative comprises from 5 % to 14 % of the composition by weight.
Bromley teaches the starting concentration of the surfactant, e.g., TPGS-1000 (p.4, line 28; p.5, line 12; p.35, lns.24-26; p.36, line 14; p.104, lns.9-32) is chosen from within a concentration range of between 16 % or about 16 % and 30 % or about 30 % (w/w), for example, 16 % or about 16 %, 17 % or about 17 %, 18 % or about 18 %, 19 % or about 19 %, 20 % or about 20 %, 21 % or about 21 %, 22 % or about 22 %, 23 % or 5 about 23 %, 24 % or about 24 %, 25 % or about 25 %, 26 % or about 26 %, 27 % or about 27 %, 28 % or about 28 %, 29 % or about 29 %, or 30 % or about 30 %, by weight (w/w), of the concentrate, such as, for example, 17.75 %, 20.25 %, 20.5 %, 22.7 %, or 25.2 % (w/w) of the concentrate (p.73, lns.1-8).
Regarding claim 46. The composition of claim 1, the modified oil phase further comprising an oil, where the sugar or sugar alcohol comprises from 43 % to 56 % of the composition by weight.
Regarding claim 47. The composition of claim 1, the modified oil phase further comprising an oil, where the sugar or sugar alcohol comprises from 48 % to 52 % of the composition by weight.
Claim 49. The composition of claim 1, the modified oil phase further comprising 0% by weight of an oil, where the sugar or sugar alcohol comprises from 57 % to 63 % of the composition by weight.
Bromley teaches the concentrate contains polar solvent (e.g., edible polar solvent, e.g., glycerin) (i.e., sugar alcohol) , typically, the starting concentration of polar solvent is chosen from within a concentration range of between 60 % or about 60 % and 80 % or about 80 % (w/w) of the concentrate, for example, 60 % or about 60 %, 61 % or about 61 %, 62 % or about 62 %, 63 % or about 63 %, 64 % or about 64 %, 65 % or about 65 %, 66 % or about 66 %, 67 % or about 67 %, 68 % or about 68 %, 69 % or about 69 %, 70 % or about 70 %, 71 % or about 71 %, 72 % or about 72 %, 73 % or about 73 %, 74 % or about 74 %, 75 % or about 75 %, 76 % or about 76 %, 77 % or about 77 %, 78 % or about 78 %, 79 % or about 79 %, 80 % or about 80 % (w/w) of the concentrate, such as, for example, 68.29 %, 68.78655 %, 74.25 %, 71.74 %, or 75.8165 % (w/w) of the concentrate. In one example, the concentration range of the polar solvent is between 65 % or about 65 % and 80 % or about 80 % (w/w) of the concentrate. In another example, the concentration range of the polar solvent is between 65 % or about 65 % and 75 % or about 75 % (w/w) of the concentrate or between 65 % or about 65 % and 76 % or about 76 % (w/w) of the concentrate (p.73, lns.26-32 to p.74, lns.1-10).
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). MPEP 2144.05.
Regarding claim 49. The composition of claim 1, the modified oil phase further comprising less than 5 % by weight of an oil, where the sugar or sugar alcohol comprises from 53 % to 63 % of the composition by weight.
Bromley teaches MCT oil (i.e., oil) concentration range of between 1 % or about 1 % and 10 % or about 10 %, for example, 1 %, 2 %, 3 %, 3.25 %, 3.5 %, 3.75 %, 4 %, 5 %, 5.25 %, 5.5 % or 5.75 %, w/w, of the concentrate. In another example, the concentration is within the concentration range of between 3 % or about 3 % and 6 % or about 6 %, w/w, of the liquid concentrate. In another example, it is between 3.75 % and 5.25 % w/w, of liquid concentrate (p,113-114). Terpene is an obvious variant.
Bromley teaches the concentrate contains polar solvent (e.g., edible polar solvent, e.g., glycerin) (i.e., sugar alcohol) , typically, the starting concentration of polar solvent is chosen from within a concentration range of between 60 % or about 60 % and 80 % or about 80 % (w/w) of the concentrate, for example, 60 % or about 60 %, 61 % or about 61 %, 62 % or about 62 %, 63 % or about 63 %, 64 % or about 64 %, 65 % or about 65 %, 66 % or about 66 %, 67 % or about 67 %, 68 % or about 68 %, 69 % or about 69 %, 70 % or about 70 %, 71 % or about 71 %, 72 % or about 72 %, 73 % or about 73 %, 74 % or about 74 %, 75 % or about 75 %, 76 % or about 76 %, 77 % or about 77 %, 78 % or about 78 %, 79 % or about 79 %, 80 % or about 80 % (w/w) of the concentrate, such as, for example, 68.29 %, 68.78655 %, 74.25 %, 71.74 %, or 75.8165 % (w/w) of the concentrate. In one example, the concentration range of the polar solvent is between 65 % or about 65 % and 80 % or about 80 % (w/w) of the concentrate. In another example, the concentration range of the polar solvent is between 65 % or about 65 % and 75 % or about 75 % (w/w) of the concentrate or between 65 % or about 65 % and 76 % or about 76 % (w/w) of the concentrate (p.73, lns.26-32 to p.74, lns.1-10). However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization. See MPEP 2144.05 recites Moreover, the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum ratios to best achieve a desired goal.
Regarding claims 62 and 63,
Claim q. The composition of claim 1, where the water comprises from 2 % to 10 % of the composition by weight.
Bromley fails to teach specific amounts of water, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
The prior art discloses the individual elements of applicant's claimed composition, but does not appear to disclose their combination with sufficient specificity.
Nevertheless, it would have been obvious to combine these individually known ingredients as Bromley teaches their inclusion together in a composition. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists. All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
It would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Bromley (WO2009/117152).
Conclusions
No claim is allowed.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619