DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-20 are pending. Claims 1-20 are rejected.
Priority
This application claims benefit to PRO 63/530,722 filed 08/04/2023.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 01/02/2025 has been considered.
Claim Rejections - 35 USC § 112(a)
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.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a gelled oil-in-water emulsion stabilized by an emulsifier wherein the emulsifier is lecithin, does not reasonably provide enablement for the full scope of lecithin “derivatives”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
The breadth of the claims
The nature of the invention
The state of the prior art
The level of one of ordinary skill
The predictability or lack thereof in the art
The amount of direction or guidance present
The presence or absence of working examples
The quantity of experimentation needed, and
The Breadth of the Claims
The breadth of the claims includes a gelled oil-in-water emulsion in unit dose form that consists at least of low-methoxy amidated pectin and stabilized by a phospholipid emulsifier. The emulsifier is further limited to lecithin or a lecithin derivative. The common meaning of the general term derivative is (Merriam-Webster)1:
a chemical substance related structurally to another substance and theoretically derivable from it;
a substance that can be made from another substance.
Accordingly, the scope of “derivative” as a general term would encompass any compound that can be made from another. This includes compounds that are produced via any chemical reaction (combustion, displacement, addition, etc.) and are not limited to any size, shape, presence of atom types and functional groups, etc. This would include compounds that bear little structural resemblance to a lecithin.
The specification, although discussing examples of lecithins and a hydrolysed lecithin derivative on pages 15 and 16, fails to set forth a clear definition that the term as recited in instant claim 9 should be limited to the examples of the specification.
The Nature of the Invention
The nature of the invention is drawn to a gelled oil-in-water emulsion for use in the oral administration of nutraceuticals and pharmaceuticals.
The State of the Prior Art
It is well known in the art that a derivative is a compound that has been chemically modified in some way to derive a new compound that has at least some structural similarities as the parent compound. The derivatization may occur through a series of synthetic steps and may involve adding, removing, substituting, etc. different functional groups and/or chemical moieties. It is well known that chemical derivatives can have wildly different properties relative to their parent compounds since the structure, types of functional groups, three-dimensional shape, etc. can vary.
The Predictability or Lack Thereof in the Art
Synthetic organic chemistry is quite unpredictable (In re Marzocchi and Horton 169 USPQ at 367 ¶ 3). The following excerpt is taken from Dörwald2:
Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why.
Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task. In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work.
Chemists tend not to publish negative results, because these are, as opposed to positive results, never definite (and far too copious).
The Amount of Direction or Guidance Present and Presence/Absence of Working Examples
The specification discloses hydrolysed lecithin as an example of a lecithin derivative on page 15, line 31. However, the application is silent with respect to any other type of lecithin derivative. The application also includes three examples of lecithin derivatives available from commercial sources in the paragraph bridging pages 15 and 16. The example compositions provided in Table 1 on page 32 utilize GIRALEC HE-60, an enzymatically hydrolysed sunflower lecithin, as the only lecithin derivative. Accordingly, the application has provided sufficient guidance to make and use emulsions incorporating lecithin or hydrolysed lecithin; however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the scope of the numerous lecithin derivatives thereof.
The Quantity of Experimentation Needed and the Level of Skill in the Art
Based on the lack of guidance in the instant specification, a person having ordinary skill in the art would be faced with undue experimentation in making and using the full scope of the instant claims. A person having ordinary skill in the art, in seeking to make lecithin derivatives for use as an emulsifier would be faced with hundreds of possible derivatives. In order to test the properties of these derivatives, the skilled artisan would need to develop synthetic approaches to these compounds, which can be quite unpredictable. Since Applicant only provides a few non-limiting examples of lecithin and/or lecithin derivatives, the skilled artisan would be faced with undue experimentation in attempting to synthesize the numerous structurally dissimilar lecithin derivatives instantly claimed.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather it is a conclusion reached by weighing all the above noted factual considerations. (In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The specification does not teach how to use the full scope of the claimed invention, and, based on the reasons above, it would require undue experimentation for a skilled artisan to embark in a discovery project to test and/or ultimately find which derivatives exhibit the claimed function of stabilizing/emulsifying a gelled oil-in-water emulsion. Based on a preponderance of the evidence presented herein, the conclusion that applicant is insufficiently enabled for making and using all derivatives of lecithin is clearly justified. It is suggested that Applicant amend the instant claim by deleting the phrase “or a lecithin derivative”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baydin et al. in “Physical and functional properties of plant-based pre-emulsified chewable gels for the oral delivery of nutraceuticals” Applied Food Research 2 (2022) 100225, as evidenced by CP Kelco, “GENU pectin type LM-104 AS-FS”.
Baydin et al. teach a pectin emulsion gel comprising the low-methoxy amidated pectin “GENU pectin, LM-104 AS-FS” from CP Kelco, as well as the emulsifier lecithin, which is known to be a mixture of phospholipids. Baydin et al. demonstrate that said emulsion gel, also referred to as PEG, has a water activity of 0.76 (see Table 3 on page 5) and a preferred pH of 4 for faster flavor release (see page 8, left column, first paragraph). The emulsion gel further comprises. Thus instant claim 1 is anticipated.
Regarding the ranges of esterification and amidation recited in instant claims 2-6, “GENU pectin, LM-104 AS-FS” from CP Kelco has a 27% degree of esterification and 20% degree of amidation. See page 2, “Other characteristics” section of the “GENU pectin type LM-104 AS” document. Thus instant claims 2-6 are anticipated.
The PEG also comprises sweeteners xylitol and sorbitol, buffer malic acid (MA), salts trisodium citrate dihydrate (TCD) and ascorbic acid, calcium citrate tetrahydrate salt (CCT), lecithin and corn oil. See page 3, left column, second paragraph as well as Table 1 on page 3, the relevant portion of which is reproduced here:
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465
266
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167
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.
Regarding the calcium ions present per instant claim 7, the prior art reference is silent as to the specific concentration of calcium salt used in the PEG. However, given the composition with relative amounts by weight listed in Table 1 shown above, the molecular mass of CCT being 570.5 g/mol, and approximating the density of the aqueous phase as 1 g/mL, the concentration of CCT in the prior art is approximately 5.6 mM and 16.8 mM of Ca2+ ions. Thus, claim 7 is anticipated.
Regarding the identity and concentration of the emulsifier per instant claims 9 and 10, the prior art discloses 0.45% by weight of lecithin. Thus, claims 9 and 10 are anticipated.
Regarding the narrowed pH range of 3.5 to 5 for the aqueous phase per instant claim 11, the prior art discloses the pH of 4, see page 8, left column, first paragraph. Thus, claim 11 is anticipated.
Regarding the 60 to 99% weight percentage of the aqueous phase per instant claim 12, the prior art discloses 75% by weight of each component less lecithin and corn oil. Thus, claim 12 is anticipated.
Regarding dependent claims 13-14 drawn to the bulking agents used in the aqueous phase, the prior art discloses xylitol and sorbitol, which are sugar alcohols. Thus claim 13 is anticipated. Further, their percentage by weight of the aqueous phase totals 56.5% [(28.4+14)/75)]. Thus, claims 13 and 14 are anticipated.
Regarding dependent claims 15-17 drawn to the identity and percentage of the oil phase, the prior art discloses the use of corn oil at a by weight percentage of 25%. Thus claims 15-17 are anticipated.
Regarding dependent claim 18 drawn to the inclusion of a nutraceutically active agent, the prior art discloses the use of ascorbic acid, also known as vitamin C, in the PEG. The prior art specifies the intended purpose of the PEG is for nutraceutical delivery. See, for instance, the title, abstract, and the last sentence of the Introduction on page 2, right column: “The object of this investigation was to develop plant-based emulsion gels for the oral delivery of nutraceuticals and evaluate their potential as alternatives to gelatin-based emulsion gels”. Thus, claim 18 is anticipated.
Regarding dependent claim 19 drawn to an uncoated form of the emulsion, the prior art discloses the PEG as emulsified droplets. The preparation of the gel on page 3, left column, second paragraph, is silent to any coating or casing. Thus, claim 19 is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(1 of 3) Claims 1-3, 7-8, 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Draget et al. in WO 2011/128631 A2, in view of Thakur et al. “Chemistry and uses of pectin - A review” Critical Reviews in Food Science & Nutrition, (1997) 37:1, 47-73.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Draget discloses an oral pharmaceutical or nutraceutical composition comprising a gelled oil-in-water emulsion with pectin as the gelling agent. See abstract. The main objective in the prior art is to develop gelled oil-in-water emulsions that incorporate gelling agents other than gelatin and in particular pectin. See page 1, paragraphs 3 and 5. Additionally, Draget teaches that such an emulsion might include other nutrients/components such as lipids, especially triglycerides and phospholipids. See page 3, fourth full paragraph.
Draget teaches Examples 1 and 2 on pages 6 and 7. The specific gel Example 1, for instance, is comprised of water with citric acid at a pH of 3.1 (21.3%), pectin (1.8%), sorbitol (17%), xylitol (21.9%), corn oil (36.5%), lemon flavor (1.5%) and color (0.1%). Draget specifies that the emulsion “may be filled into the blisters of a blister pack while still ungelled and then sealed in by fusing a foil lid to the blister tray.” See page 6, paragraph above Example 2.
Thakur et al. teach that pectin is a useful polysaccharide in various industries including pharmaceuticals. See abstract. For the purpose of gelation specifically, they teach that low methoxy pectins have a degree of methoxylation between 25 and 50% are generally more stable to moisture and heat than high methoxy pectins. See page 54, left column, second paragraph. In the same paragraph, they also teach that in LM pectins, gel is formed in the presence of Ca2+.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Draget does not disclose an example wherein a low-methoxy amidated pectin is used, and does not specify the amount of amidation present in the pectin.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
While Draget does not specify that the emulsion possesses a water activity of 0.4 to 0.9 as recited in the instant claims, the prior art contains the same ingredients as applicant’s claimed invention and would therefore perform the same function. Per MPEP 2182, “if the prior art reference teaches the identical structure or acts but is silent about performing the claimed function, a reasonable presumption is that the prior art structure inherently performs the same function. The examiner must provide a "sound basis for believing" that the prior art structure or acts would be capable of performing the claimed function. In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
It would have been obvious to one of ordinary skill in the art to have used Draget’s composition Example 1 and modify it to arrive at the instantly claimed invention. While Draget et al. do not explicitly teach a low-methoxy amidated pectin, they do disclose pectin as a suitable alternative to gelatin as a gelling agent. A person having ordinary skill in the art would have been motivated to optimize the gel emulsion using gelling agents other than gelatin given the drawbacks discussed by Draget. The skilled artisan would have a reasonable expectation of success in substituting low-methoxy amidated pectin for the high-methoxy amidated pectin taught by Draget, in light of the known effect that low-methoxy amidated pectins are more stable to moisture and heat, as taught by Thakur.
As advised by MPEP 2123, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Regarding the ranges in the degree of esterification recited in instant claims 2-3, the Thakur reference discloses that low methoxy pectins are classified as having a degree of methoxylation of of 25 to 50%. See page 54, left column, second paragraph. Thakur also discloses that among low methoxy pectins, those “molecules with an increased number of charged groups and lower degree of methoxylation are straighter than esterified ones, and hence more likely to form a Ca2+ bridge” (see sentence bridging columns on page 55). Therefore a skilled artisan would have been motivated to use a low methoxy pectin at the lower end of the 25-50% range, rendering claims 2 and 3 obvious.
Regarding the calcium ions present per instant claim 7, the Draget reference is silent as to the addition of any calcium salt. Since 0 mM is in the range of “up to 250 mM” disclosed in the instant claim, the claim is obvious. Additionally, given the teaching from Thakur that calcium ions are required to form a gel in LM pectins, it would have been obvious to a skilled artisan to incorporate calcium ions. Moreover, Thakur teaches “under low calcium levels, polygalacturonate forms primary units of two chains in antiparallel configuration” and that “higher Ca2+ concentration at pH 3 to 5 can destroy the gel by increasing the cross-linking to such an extent that pectin is precipitated.” See paragraph bridging pages 55 and 56 as well as second column on page 56. Given this teaching, the skilled artisan would incorporate a low concentration of calcium ions. Thus, claim 7 is obvious.
Regarding dependent claim 8 drawn to the gel being substantially free from calcium ions, the teaching from Draget et al. does not include the addition of any calcium ions. Therefore, claim 8 is obvious.
Regarding the narrowed pH range of 3.5 to 5 for the aqueous phase per instant claim 11, the prior art discloses the pH of “about 3.1” for the water phase. The skilled artisan however, having modified Draget’s teaching to replace a high-methoxy (HM) amidated pectin with a low-methoxy (LM) amidated pectin would expect to adjust the pH at least above 3.6 given Thakur’s teaching that HM pectins only form below pH 3.6 whereas LM pectins require a higher pH since only dissociated carboxylic groups will take part in the salt-like cross-linkages with calcium ions required for gelation. See page 54, both columns, about midway down the page. Thus, claim 11 is obvious.
Regarding the 60 to 99% weight percentage of the aqueous phase per instant claim 12, the prior art Example 1 discloses 61.9% by weight of each component less corn oil, lemon flavor and yellow color. Thus, claim 12 is obvious.
Regarding dependent claims 13-14 drawn to the bulking agents used in the aqueous phase, the prior art Example 1 discloses xylitol and sorbitol, which are sugar alcohols. Thus claim 13 is anticipated. Further, their percentage by weight of the aqueous phase totals 62.8% [(17+21.9)/61.9)]. Thus, claims 13 and 14 are obvious.
Regarding dependent claims 15-17 drawn to the identity and percentage of the oil phase, the prior art discloses the use of corn oil and the oil phase at a by weight percentage of 38.1%. Thus claims 15 and 16 are obvious. Instant claim 17 requires a percentage range of 5 to 30% by weight of the oil phase, and Draget et al. also teach preferred embodiments wherein the weight ratio between the lipid/oil phase and the aqueous phase is 1:19 to 3:1. See page 5, third paragraph. At the ratio of 1:19, the weight percent of the oil phase would be at least 5%. Thus claim 17 is obvious.
Regarding dependent claim 18 drawn to the inclusion of a nutraceutically active agent, Draget et al. specifies the intended purpose of the composition is for pharmaceutical and nutraceutical delivery. See, for instance, the title, abstract, and first paragraph of page 1. Draget also discloses that lipids, vitamins, minerals, and folic acid a preferred components to include in the composition. See page 2, third paragraph. Finally, claim 3 from Draget teaches a composition comprising a drug. Thus, claim 18 is obvious.
Regarding dependent claim 19 drawn to an uncoated form of the emulsion, Draget discloses that the composition of Example 1 “may be filled into the blisters of a blister pack while still ungelled and then sealed in by fusing a foil lid to the blister tray.” See page 6, paragraph above Example 2. This preparation of the gel is silent to any coating or casing. Thus, claim 19 is obvious. Likewise, instant claim 20 drawn to an air-tight and light-tight compartment containing one dose of the gel is also obvious given the prior art teaching of a blister pack with foil packaging. Thus, claim 20 is obvious.
(2 of 3) Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Draget et al. in WO 2011/128631 A2, in view of Thakur et al. “Chemistry and uses of pectin - A review” Critical Reviews in Food Science & Nutrition, (1997) 37:1, 47-73 as applied to claims 1-3, 7-8 and 11-20 above, and further in view of Noor, N. et al. (2021). Pectin. In: Gani, A., Ashwar, B.A. (eds) Food biopolymers: Structural, functional and nutraceutical properties. Springer, Cham. https://doi.org/10.1007/978-3-030-27061-2_6.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
As discussed in the rejection over claims 1-3, 7-8 and 11-20 above, Draget discloses an oral pharmaceutical or nutraceutical composition comprising a gelled oil-in-water emulsion with pectin as the gelling agent. See abstract. Draget teaches Examples 1 and 2 on pages 6 and 7. The specific gel Example 1, for instance, is comprised of water with citric acid at a pH of 3.1 (21.3%), pectin (1.8%), sorbitol (17%), xylitol (21.9%), corn oil (36.5%), lemon flavor (1.5%) and color (0.1%).
Thakur et al. teach that pectin is a useful polysaccharide in various industries including pharmaceuticals. See abstract. For the purpose of gelation specifically, they teach that low methoxy pectins have a degree of methoxylation between 25 and 50% are generally more stable to moisture and heat than high methoxy pectins. See page 54, left column, second paragraph. In the same paragraph, they also teach that in LM pectins, gel is formed in the presence of Ca2+.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Both Draget and Thakur are silent to any specific degree of amidation expected for the pectin taught by Draget.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Thakur discloses that “amidation of LM pectin increases its gel-forming ability” and that “gels made from amidated pectins also showed improved texture and less tendency to synresis, compared with commercially used pectins.” See page 57, left column, second paragraph. Given this suggestion, a skilled artisan would be motivated to identify a reference that disclosed a preferred degree of amidation, such as that of Noor et al. which teaches that “ALMP (amidated low methoxypectin) pectin having a DAm (degree of amidation) value of 15-25 is most commonly used.” See page 130, first full paragraph. The skilled artisan, therefore, would have a reasonable expectation of success in utilizing a low-methoxy amidated pectin with a degree of amidation in the range of 15-25%. Given the prior art range of 15-25% and the instantly claimed ranges of 15-25% of claim 4 and 20-25% of claims 5 and 6, which is fully embraced within the range of the prior art, claims 4-6 are obvious.
(3 of 3) Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Draget et al. in WO 2011/128631 A2, in view of Thakur et al. “Chemistry and uses of pectin - A review” Critical Reviews in Food Science & Nutrition, (1997) 37:1, 47-73 as applied to claims 1-3, 7-8 and 11-20 above, and further in view of Pichot et al. in “Phospholipids at the Interface: Current Trends and Challenges” Int. J. Mol. Sci 2013, 14, 11767-11794.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
As discussed in the preceding rejection over claims 1-3, 7-8 and 11-20 above, Draget discloses an oral pharmaceutical or nutraceutical composition comprising a gelled oil-in-water emulsion with pectin as the gelling agent. See abstract. In addition to the Example 1 gel discussed above, they also disclose Example 2, for instance, is comprised of water (18.66%), agar (0.75%), pectin (0.12%), BLG (0.25%), glycerol (9.95%), sorbitol (17.41%), xylitol (17.41%), citric acid (0.62%), lemon flavor (1.24%), color (0.06%) and corn oil (33.58%). See table bridging pages 6 and 7.
Thakur et al. teach that pectin is a useful polysaccharide in various industries including pharmaceuticals. See abstract. For the purpose of gelation specifically, they teach that low methoxy pectins have a degree of methoxylation between 25 and 50% are generally more stable to moisture and heat than high methoxy pectins. See page 54, left column, second paragraph. In the same paragraph, they also teach that in LM pectins, gel is formed in the presence of Ca2+.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Neither Draget and Thakur disclose lecithin as an emulsifier for the gelled emulsion.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Regarding instant claims 9 and 10, drawn to the gelled oil-in-water emulsion wherein the emulsifier is lecithin and wherein the emulsifier is present at a concentration of from 0.01 to 0.5 wt. %, Draget et al. disclose that “emulsion formation may be effected by conventional techniques” (page 5, fourth paragraph) and in Examples 1 and 2 discloses that the emulsions are made by mixing the solution with a high speed blender or without such agitation, respectively. In Example 2, however, Draget discloses the addition of beta-lactoglobulin (BLG) protein. A skilled artisan would be motivated to identify a reference that discloses BLG in emulsions with a conventional means of emulsifying the protein. Pichot et al., for instance, teach that BLG is a co-emulsifier and when used with lecithin, there is an improvement in stability of an oil-in-water emulsion. See page 11784, second paragraph. Pichot also discusses that lecithin is likely the most common form of phospholipid in the second paragraph of the Introduction on page 11768. A skilled artisan would have a reasonable expectation of success by incorporating lecithin into the gelled suspension taught by Draget and Thakur given that Draget specifies that phospholipids may be added to the gel and Pichot indicates lecithin as the most common type of phospholipid that improves stability when used with BLG. Thus, instant claim 9 is obvious.
Additionally, Pichot indicates that BLG is an emulsifier since it is discussed as a co-emulsifier with lecithin in the second paragraph on page 11784. Since Example 2 from Draget discloses BLG’s weight percentage as 0.25%, instant claim 10 is obvious.
Conclusion
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
1 “Derivative.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/derivative. Accessed 6 Aug. 2026.
2 Dörwald, F. Zaragoza. Side Reactions in Organic Synthesis: A Guide to Successful Synthesis Design, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005, Preface
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