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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17, drawn to a nanoemulsion, in the reply filed on March 30 is acknowledged with appreciation.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant additionally elected the species of long chain triglycerides oil (LCT oil) as the vegetable oil; soy lecithin as the emulsifier; orange peel oil as the essential oil; menthol as the bioavailability enhancer; and sucrose stearate as the sugar ester.
Claims 1 and 3-17 read on the elected species. Claim 2 is withdrawn as directed to non-elected subject matter.
Application Status
6. Claims 14-16 are amended.
7. Claims 1 and 3-17 are under examination and are the subject of this office action.
Priority
8. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy was filed November 30, 2023.
It is noted that Applicant has not filed an English language translation of foreign priority Application No. DE10 2021 205 664.4. It is suggested that a certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English be submitted. See 35 U.S.C. 119(b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). A showing of priority that relies on a non-English language application is prima facie insufficient to overcome an intervening reference if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
9. The information disclosure statement (IDS) submitted on January 29, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Specification
10. The abstract of the disclosure is objected to for the following reasons: The abstract recites, “The invention relates to novel oil-in-water nanoemulsion [language omitted]” in line 1. It is suggested that the term novel be deleted from the language of the abstract. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel, since the scope of the invention no longer embraces what is considered “novel.” Thus, the incorporation of “novel” into the language of the abstract is not appropriate.
11. Likewise, the Specification is objected to because it contains multiple instances of the term “novel” (e.g., page 1, first paragraph, first sentence as well as the last sentence). It is suggested that the term novel be deleted from the language of the Specification for the reasons provided above in paragraph “9.”
Appropriate correction is required. See MPEP § 608.01(b).
12. The title of the invention is objected to for the following reasons: The title currently reads “New oil-in-water nanoemulsion”. It is suggested that the term “new” be deleted from the language of the title. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer new, since the scope of the invention no longer embraces what is considered “new.” Thus, the incorporation of “new” into the title is not appropriate.
Claim Objections
13. Claim 1 is objected to for the following informalities:
(a) Claim 1 is missing the article “An” at the beginning of the claim. The claim should recite “An oil-in-water emulsion…”.
(b) Claim 1 is objected to regarding the abbreviated term “LCT” in line 2. The term “LCT” should be spelled out in full (i.e., long-chain triglycerides) with the abbreviated term in parentheticals next to the full name.
Claim Rejections - 35 USC § 112(b)
14. 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.
15. Claims 1 and 3-17 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.
16. Regarding claims 1, 3, 7, and 11, the phrases "preferably" and “more preferably” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
17. Claims 3-17 are rejected as being dependent upon and including all of the limitations of claim 1.
Claim Rejections - 35 USC § 112(a)
18. 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.
19. Claims 1 and 3-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
20. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the entire scope of possible nanoemulsions embraced by the combination(s) of: (a) any oil phase comprising a vegetable oil, (b) a continuous phase comprising water and glycerol, (c) any emulsifier selected from lecithin, mono- and diglycerides of fatty acids, lactic acid and/or citric acid and mixtures thereof, (d) ethanol, and optionally (e) any essential oil, (f) any bioavailability enhancer, and/or (g) any sugar ester, as presently claimed.
21. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163.
22. In the instant case, it is evident that the nanoemulsion embraced by the claims has substantial variance within the near endless combinations of alternative species/ embodiments embraced by each of elements (a), (b), (c), (d), and optionally (e), (f) and/or (g). Indeed, the possible combinations are virtually without limit, embracing hundreds of millions of potential nanoemulsions wherein the possible variations bear no resemblance to one another what-so-ever. Yet, the instant Specification discloses only four oil-in-water nanoemulsions comprising only glycerol, water, lecithin, ethanol, red palm oil, and optionally a sugar ester (Nanoemulsions 1-4 at pages 14-15). None of the nanoemulsions disclosed in the Specification comprise a cannabinoid such as CBD, or a bioavailability enhancer.
23. Thus the instant specification lacks support for the full scope of oil-in-water nanoemulsions comprising the combination of: (a) any oil phase comprising a vegetable oil, (b) a continuous phase comprising water and glycerol, (c) any emulsifier selected from lecithin, mono- and diglycerides of fatty acids, lactic acid and/or citric acid and mixtures thereof, (d) ethanol, and optionally (e) any essential oil, (f) any bioavailability enhancer, and/or (g) any sugar ester, as presently claimed. While Applicant’s specification has provided examples of each of the individual elements (a)-(g); the specification lacks description of the entire scope of various final nanoemulsion formulations prepared from all of the possible combination(s) of each of elements (a)-(d) and optionally (e)-(g).
24. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic claim. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case of a combination of elements (a)-(g), even though Applicant’s specification lists examples of each element in the instantly claimed combination, the specification does not support the full scope of potential combinations of alternative embodiments of (a)-(g). Thus, it is similarly determined that the disclosure of just four exemplary nanoemulsion formulations (pages 14-15) fails to adequately describe the instant claimed nanoemulsions embracing hundreds of millions of possible combinations of alternative elements bearing no relationship with those four disclosed nanoemulsions. That is, the Specification does not disclose sufficient variations of combinations of ingredients to reflect the extreme variance of the recited invention.
25. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the nanoemulsion of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1 and 3-17 are rejected.
Claim Rejections - 35 USC § 103
26. 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.
27. 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.
28. 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.
29. Claims 1 and 3-17 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al., CA 3160271 A1 (published June 17, 2021).
Claim 1 is drawn to an oil-in-water nanoemulsion comprising the components:
(a) an oil phase comprising a vegetable oil, preferably an LCT vegetable oil;
(b) a continuous phase comprising water and glycerol;
(c) an emulsifier selected from the group consisting of lecithin, mono- and diglycerides of fatty acids, lactic acid and/or citric acid and mixtures thereof (more specifically, soy lecithin, present in an amount of 2-10% (w/w) (claim 3));
(d) ethanol;
(e) cannabidiol (CBD) (claim 17); and
(f) an essential oil (claim 5),
wherein the nanoemulsion has an average particle diameter (Dm) of 70 nm or less.
30. Keller et al. teach oil-in-water nanoemulsions, in particular a formulation comprising an oil phase; water; an emulsifying agent; an active ingredient, and a flavorant (Embodiment 1), more specifically the components:
(a) an oil comprising a long chain fatty acid that is olive oil (Embodiment 3);
(b) a continuous phase comprising water and glycerol (Embodiment 2);
(c) an emulsifying agent that is lecithin (Embodiment 12) in an amount up to 15% by weight (Embodiment 13);
(e) an active ingredient that is a cannabinoid (Embodiment 6); and
(f) a flavorant comprising an essential oil that is a citrus oil (Embodiment 9)
(see Embodiments at pages 3-4). In Embodiment 15, Keller et al. teaches that the nanoemulsion comprises nanoparticles having a size of from 20 to about 200 nm, which fully embraces the limitation of “an average particle diameter (Dm) of 70 nm or less,” required by claim 1 (Embodiment 15). And, an amount of lecithin up to 15% (w/w) taught by Keller et al. fully embraces the range of 2-10% required by claim 3.
31. Regarding component (d), ethanol, Keller et al. teach the inclusion of an alcohol, specifically naming ethanol (page 7, third paragraph, lines 11-12).
32. Keller et al. go on to teach preferred cannabinoids, specifically naming CBD (see page 15, third and fifth paragraphs).
33. As such, Keller et al. suggest an oil-in-water nanoemulsion comprising (a) an oil phase comprising olive oil; (b) a continuous phase comprising water and glycerol; (c) an emulsifier comprising lecithin, (d) ethanol; (e) cannabidiol (CBD); and (f) an essential citrus oil, wherein the nanoemulsion has an average particle diameter (Dm) of 70 nm or less, but do not explicitly teach a single formulation comprising Applicant’s (a)-(f).
34. However, it would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to start with the nanoemulsion disclosed in Embodiments 1-3 and 6, and incorporate the additional ingredients/ excipients in Embodiments 6, 9, 12, 13 and 15 as guided by of Keller et al., in order to prepare an improved oil-in-water nanoemulsion comprising CBD, with a reasonable expectation of success.
35. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”; Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
36. As such, claims 1, 3, 5 and 17 are prima facie obvious.
Claim 4 is drawn to claim 1, wherein the oil phase further comprises oleic acid and/or ethyl oleate.
37. Keller et al. additionally teach the inclusion of fatty acids such as oleic acid and linoleic acid (page 8, first full paragraph). As such, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate an oleic acid into the nanoemulsion disclosed by Keller et al., with a reasonable expectation of success.
Thus, claim 4 is prima facie obvious.
Claim 6 is drawn to claim 1, wherein the continuous phase comprises 30-70% (w/w) glycerol.
38. Keller et al. additionally teach that glycerine and/or glycerol esters can be present in a range up to about 10% (w/w) of the nanoemulsion (page 9, third paragraph). And, the optimization of result effect parameters (e.g., percentage of each ingredient by weight) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here 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 with a reasonable expectation of success.
39. Thus, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to start with glycerine/ glycerol at 10% w/w as taught by Keller et al. and optimize said weight percent in the continuous phase of the nanoemulsion disclosed by Keller et al., with a reasonable expectation of success.
As such, claim 6 is prima facie obvious.
Claim 7 is drawn to claim 1, wherein the ethanol is present in the nanoemulsion in an amount of 2-20% (w/w), and preferably 5-10% (w/w).
40. Keller et al. teach that the ethanol is present as a water-soluble component in the emulsion, wherein the water content is about 20% by weight based on the total weight of the nanoemulsion; thus; the ethanol component must be less than 20% by weight of the the total weight of the nanoemulsion, which meets the limitation of 2-20% required by claim 7 (page 7, third paragraph). And, the optimization of result effect parameters (e.g., percentage of each ingredient by weight) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here 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 with a reasonable expectation of success.
41. Thus, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to start with ethanol at 20% w/w as taught by Keller et al. and optimize said weight percent in the continuous phase of the nanoemulsion disclosed by Keller et al., with a reasonable expectation of success
Claim 8 is drawn to the nanoemulsion of claim 1, further comprising a bioavailability enhancer selected from the group consisting of piperine, curcumin, resveratrol, quercetin, menthol, naringin, bergamottin, kaempferol, and rutin.
42. Keller et al. additionally teach the inclusion of one or more antioxidants including bergamot, resveratrol, quercetin, kaempferol, (page 14, third paragraph) and curcumin (page 15, fourth paragraph). Therefore one skilled in the art before the effective filing date of the claimed invention would have been motivated to utilize at least one or more of the antioxidants specifically named by Keller et al. into the nanoemulsion of Embodiments 1-3 and 6, for example, with a reasonable expectation of success.
As such, claim 8 is prima facie obvious.
Claim 9 is drawn to claim 1, wherein the nanoemulsion does not contain ethoxylated compounds.
43. The nanoemulsion of at least Embodiments 1-3 and 6 taught by Keller et al. does not include ethoxylated compounds. Thus, one skilled in the art would reasonably consider preparing the nanoemulsion disclosed by Keller et al. that does not contain an ethoxylated compound, with a reasonable expectation of success.
As such, claim 9 is prima facie obvious.
Claim 10 is drawn to claim 1, wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months.
44. Claim 10 is drafted in terms of the intended outcome following storage of the nanoemulsion of claim 1: “...wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months.” However, a claimed composition maybe obvious because it was suggested by, or structurally similar to, a prior art composition even though a particular benefit of the claimed composition asserted by patentee is not expressly disclosed in the prior art. It is the differences in fact in their respective properties which are determinative of nonobviousness. If the prior art composition does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, Applicant's recognition of the benefit is not in itself sufficient to distinguish the claimed composition from the prior art, In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). In this case, the “average particle size of the nanoemulsion… after storage for 6 months” is considered a latent property of the nanoemulsion disclosed by Keller et al. and the alleged unexpected result does not confer patentability.
45. Therefore one of skill in the art before the effective filing date of the claimed invention would have been motivated to prepare the nanoemulsion of Embodiments 1-3 and 6, wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months, with a reasonable expectation of success.
As such, claim 10 is prima facie obvious.
Claim 11 is drawn to claim 1 and limits wherein the nanoemulsion comprises a sugar ester, preferably a sucrose ester.
46. Keller et al. additionally teach the inclusion of a stabilizer wherein suitable types include a sorbitan ester (i.e., a sugar ester), (page 9, second paragraph). As such, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate a sugar ester into the nanoemulsion disclosed by Keller et al., with a reasonable expectation of success.
As such, claim 11 is prima facie obvious.
Claim 12 is drawn to claim 1 for use in medicine.
Claim 13 is drawn to claim 1 for use in a therapeutic method in which a lipophilic pharmaceutically active agent is administered.
Claim 14 is drawn to claim 1 for use in a method of preparing a pharmaceutical or cosmetic composition.
Claim 15 is drawn to claim 1 for use as an additive in foodstuffs.
Claim 16 is drawn to claim 1 for use as an additive in cosmetics.
47. Regarding claims 12-16, it is noted that the preamble of each claim recites the nanoemulsion of claim 1, and while the use of a descriptive clause, i.e., “for use in medicine…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. That is, a “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969).
And, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Consequently, the preambles of claims 12-16 do not impose any limitation on the product claim.
48. As such, claims 12-16 are prima facie obvious.
49. Claims 1, 3-5, 7, 8, 10 and 11-16 are rejected under 35 U.S.C. 103 as being obvious over Wooster et al., WO 2009067734 A1.
Claim 1 is drawn to an oil-in-water nanoemulsion comprising the components:
(a) an oil phase comprising a vegetable oil, preferably an LCT vegetable oil;
(b) a continuous phase comprising water and glycerol;
(c) an emulsifier selected from the group consisting of lecithin, mono- and diglycerides of fatty acids, lactic acid and/or citric acid and mixtures thereof ((more specifically, lecithin, present in an amount of 2-10% (w/w) (claim 3));
(d) ethanol (wherein the ethanol is present in the nanoemulsion in an amount of 2-20% (w/w) (claim 7); and
(f) an essential oil (claim 5), and
wherein the oil phase further comprises oleic acid and/or ethyl oleate (claim 4),
wherein the nanoemulsion has an average particle diameter (Dm) of 70 nm or less.
50. Wooster et al. specifically disclose the following nanoemulsions:
In Example 1, Wooster et al. disclose a peanut oil nanoemulsion wherein a peanut oil-in-water nanoemulsion was prepared by adding 12 grams of polyoxyethylene sorbitan mono-oleate (Tween 80, which meets the limitation of an ethyl oleate in claim 4, and which meets the limitation of an emulsifier than is a monoglyceride of fatty acids of claim 1) to 23 grams of peanut oil. This oil/surfactant mixture was then intermixed into 120 g of a 3 to 2 water to ethanol solution with a Silverson rotor stator mixer at 12,000 rpm for 2 minutes to form a pre-emulsion. The pre-emulsion was then homogenised with a microfluidizer™ at 1000 bar and 5 passes. The resulting nanoemulsion had a particle size of 45 nm (which meets the limitation of an average particle diameter of 70 nm or less, required by claim 1), and high optical clarity, and when diluted with water (10 to 99% dilution) the nanoemulsion exhibited no change in size over a 100 day storage period. Wooster et al. teach the ethanol content: an aqueous phase ethanol content ranging from 20 to 50%, (which meets the limitation of 2-20% ethanol required by claim 7).
In Example 2: Wooster et al. disclose a flax seed oil nanoemulsion where a flax seed oil nanoemulsion was prepared by adding 8 grams of polyoxyethylene sorbitan mono-oleate (Tween 80, which meets the limitation of an ethyl oleate in claim 4) and 5 grams of Emultop IP (lysolecithin) (which meets the limitation of an emulsifier than is a monoglyceride of fatty acids or lecithin of claim 1) to 22.5 grams of flax seed oil. This oil/surfactant mixture was then intermixed into 120 g of a 3 to 1 water to ethanol solution with a silverson rotor stator mixer at 12,000 rpm for 2 minutes to form a pre-emulsion. The pre-emulsion was then homogenised with a microfluidiser at 1000 bar and 5 passes. The resulting nanoemulsion had a particle size of 45 nm (which meets the limitation of an average particle diameter of 70 nm or less, required by claim 1), had high optical clarity and did not change size or optical clarity over a 100 day storage period. Wooster et al. teach the ethanol content: an aqueous phase ethanol content ranging from 20 to 50% (which meets the limitation of 2-20% ethanol required by claim 7).
In Example 7: Wooster et al. disclose a flavour oil nanoemulsion comprising a clear orange oil flavour concentrate , wherein an orange flavour oil nanoemulsion was prepared by first thoroughly mixing 9 g of orange oil (which meets the limitation of an essential oil required by claim 5) with 11.5 grams of peanut oil. To this mixture of orange oil/peanut oil 8 grams of polyoxyethylene sorbitan mono-oleate (Tween 80, which meets the limitation of an ethyl oleate in claim 4) and 5 grams of Emultop IP (lysolecithin) were added (which meets the limitation of an emulsifier than is a monoglyceride of fatty acids or lecithin of claim 1). This oil/emulsifier mixture was then intermixed into 120 g of a 3 to 1 water to ethanol solution with a Silverson rotor stator mixer at 12,000 rpm for 2 minutes to form a pre-emulsion. The pre-emulsion was then homogenised with a microfluidiser at 1000 bar and 5 passes. The resulting orange flavour nanoemulsion had a particle size of 45 nm (which meets the limitation of an average particle diameter of 70 nm or less, required by claim 1), and had high optical clarity.
51. Wooster et al. teaches that amount of emulsifier (i.e., co-surfactant): “The amount of co- surfactant in the nanoemulsion may be 0.1 to 15 wt%,” which fully embraces the range of 2-10% required by claim 3 (page 12, third paragraph). As such, one of skill in the art would have been motivated to employ the lecithin and/or polyoxyethylene sorbitan mono-oleate emulsifiers in an amount of 2-10%, with a reasonable expectation of success.
52. Wooster et al. does not explicitly teach the component glycerol in the exemplified formulations.
53. Yet, Wooster et al. additionally teach that preferably the nanoemulsion comprises a co-solvent which “lowers the interfacial tension of the aqueous phase which thereby enables the formation of smaller emulsion droplet sizes,” wherein suitable co-solvents include polyols such as glycerol (page 12, under “Co-Solvent,” first and second paragraph).
54. Thus it would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to start with the nanoemulsions disclosed in Embodiments 1, 2 and 6, and incorporate the co-solvent glycerol as guided by Wooster et al., in order to prepare an improved oil-in-water nanoemulsion having smaller droplet sizes, with a reasonable expectation of success.
55. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”; Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
As such, claims 1, 3-5 and 7 are prima facie obvious.
Claim 8 is drawn to the nanoemulsion of claim 1, further comprising a bioavailability enhancer selected from the group consisting of piperine, curcumin, resveratrol, quercetin, menthol, naringin, bergamottin, kaempferol, and rutin.
56. Wooster et al. additionally teach the inclusion of one or more additives including quercetin and resveratrol, (page 14, fourth paragraph). Therefore one skilled in the art before the effective filing date of the claimed invention would have been motivated to utilize at least one or more of the additives specifically named by Wooster et al. into the nanoemulsion Examples 1, 2, and 6, for example, with a reasonable expectation of success.
As such, claim 8 is prima facie obvious.
Claim 10 is drawn to claim 1, wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months.
57. Claim 10 is drafted in terms of the intended outcome following storage of the nanoemulsion of claim 1: “...wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months.” However, a claimed composition maybe obvious because it was suggested by, or structurally similar to, a prior art composition even though a particular benefit of the claimed composition asserted by patentee is not expressly disclosed in the prior art. It is the differences in fact in their respective properties which are determinative of nonobviousness. If the prior art composition does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, Applicant's recognition of the benefit is not in itself sufficient to distinguish the claimed composition from the prior art, In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). In this case, the “average particle size of the nanoemulsion… after storage for 6 months” is considered a latent property of the nanoemulsion disclosed by Keller et al. and the alleged unexpected result does not confer patentability.
58. Therefore one of skill in the art before the effective filing date of the claimed invention would have been motivated to prepare the nanoemulsion of Examples 1, 2 and/or 6 disclosed by Wooster et al., wherein the average particle size of the nanoemulsion does not exceed 100 nm after storage for 6 months, with a reasonable expectation of success.
As such, claim 10 is prima facie obvious.
Claim 11 is drawn to claim 1 and limits wherein the nanoemulsion comprises a sugar ester, preferably a sucrose ester.
59. Wooster et al. additionally teach the inclusion of a hydrophilic non-ionic surfactant and specifically name sugar esters including sucrose monopalmitate, sucrose monolaurate, sucrose distearate, etc (page 10, last paragraph). As such, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate a sucrose sugar ester into the nanoemulsions disclosedin Examples 1, 2 and/or 6, with a reasonable expectation of success.
As such, claim 11 is prima facie obvious.
Claim 12 is drawn to claim 1 for use in medicine.
Claim 13 is drawn to claim 1 for use in a therapeutic method in which a lipophilic pharmaceutically active agent is administered.
Claim 14 is drawn to claim 1 for use in a method of preparing a pharmaceutical or cosmetic composition.
Claim 15 is drawn to claim 1 for use as an additive in foodstuffs.
Claim 16 is drawn to claim 1 for use as an additive in cosmetics.
60. Regarding claims 12-16, it is noted that the preamble of each claim recites the nanoemulsion of claim 1, and while the use of a descriptive clause, i.e., “for use in medicine…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. That is, a “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969).
And, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Consequently, the preambles of claims 12-16 do not impose any limitation on the product claim.
61. As such, claims 12-16 are prima facie obvious over the nanoemulsions disclosed by Wooster et al.
Conclusion
62. Claims 1-18 are present in the application. Claims 2 and 18 are currently withdrawn from consideration. Claims 1 and 3-17 are rejected. No claim is presently allowed.
63. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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