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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 07/11/26 has been entered.
Receipt is acknowledged of Amendments and Remarks filed on 07/11/26. Claims 1, 5, 7, 10-11 and 16-17 have been amended, claims 2-3 have been canceled and no new claims have been added. Accordingly, claims 1, 4-11 and 13-18 remain pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 15-16 and 18 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.
Claims 6, 16 and 18 recite ratios of water to the active ingredient, (claims 6 and 16 and acacia gum to polysaccharide (claim 18) which are not disclosed by the Specification. Specification discloses “In one embodiment of the invention, the emulsion comprises the acacia gum and the polysaccharide thickener in a weight ratio of at least 1, preferably at least 2, more preferably at least 3 and most preferably at least 5, and generally at most 100, preferably at most 50, more preferably at most 30 and most preferably at most 20” (See [0031]. There is no recitation of a ratio of 10.
Thus, the Specification fails to comply with written description requirement for the limitation in claims 6, 16 and 18.
Claim 15 is directed to the emulsion of claim 1 further comprising a solvent for dissolving the active ingredient. The active ingredient of claim 1 is an essential oil or a vegetable oil. The Specification does not provide any support for a solvent that dissolves oils. In fact, the Specification discloses that the oil is the solvent for the active ingredient. “The oil suitable in the emulsion of the invention is any oil or hydrophobic liquid known in the art. The oil may be a solvent for the active ingredient, or may predominantly or exclusively comprise the active ingredient per se.” (See [0008] of published Spec).
Thus, the Specification fails to comply with written description requirement for the limitation in claim 15.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-11 and 13-18 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.
Claims 1 and 16 are indefinite for reciting a second emulsifier selected from a group consisting of a food emulsifier, an anionic detergent, a non-ionic detergent, a zwitterionic detergent and an emulsifier used in pharmacy. This is indefinite because it is not clear what the metes and bounds of a food emulsifier and an emulsifier used in pharmacy are.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 16 recite the broad recitation “a food emulsifier and an emulsifier used in pharmacy”, and the claim also recites -an anionic detergent, a non-ionic detergent, a zwitterionic detergent- which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 is indefinite for reciting a ratio of water to the active ingredient that is “at least 1:1”. The term -at least- is a one-sided range with the upper limit being infinity. This is indefinite because it is not clear what ratios meet the claimed range. It is also noted that the Specification does not support a ratio of at least … up to infinity.
Claim 16 is indefinite for reciting a ratio of water to the active ingredient that is “at least 100:1”. The term -at least- is a one-sided range with the upper limit being infinity. This is indefinite because it is not clear what ratios meet the claimed range. It is also noted that the Specification does not support a ratio of at least … up to infinity.
Claim Interpretation:
Acacia gum is also known as gum Arabic as evidenced by Food hydrocolloids, Martin Glicksman (attached).
Acacia gum is a mixture of glycoproteins and polysaccharides and may be obtained from the sap of two species of the acacia tree; Acacia senegal and Acacia seyal, as taught by Mellor et al (See [0049]). Thus, acaci gum is both the emulsifier and the polysaccharide thickener as claimed.
Claim 13 is a product-by-process claim. According to MPEP § 2113 [R-1], product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
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.
Claims 1, 4-11 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mellor et al (US 20150133553) in combination with CN 111150706 as evidenced by Cinnamon & Cinnamon oil profile, and the instant Specification.
Mellor et al teach an emulsion containing 50 to 90% by weight of an aqueous phase and 10 to 50% by weight of an oil phase containing 30 to 90% by weight of a diluent oil, and at least 10% by weight of at least one polyunsaturated fatty acid and/or derivative thereof. The emulsion has improved stability and/or organoleptic properties and can be used as a dietary supplement (See abstract, [0008] and claim 1).
It is disclosed that the said emulsion may be in the form of an oil-in-water or a water-in-oil emulsion (See [0011]). In addition to water, the aqueous phase may also comprise up to 20%, based on the total weight of the aqueous phase, of a co-solvent (See [0038]). The said emulsion may comprise an emulsifier and/or a stabilizer (See [0040]). The emulsifier may be acacia gum. Acacia gum is a mixture of glycoproteins and polysaccharides. Advantageously, the acacia gum may act as both an emulsifier and a stabiliser which may improve the stability of the emulsion or reduce the need for a separate stabiliser component in the emulsion. The emulsion may comprise up to 5wt % of acacia gum, and preferably 1 to 3wt % acacia gum (See [0049]). Suitable stabilizers include gums such as xanthan gum, pectin, guar gum, gum Arabic, etc. Preferred stabilisers are gums, particularly guar gum and/or xanthan gum (See [0051]). The said stabiliser normally forms part of the aqueous phase, and the concentration of stabiliser is present in the aqueous phase in suitably less than 10%, preferably in the range from 0.01 to 5%, and more preferably 0.1 to 3% by weight based upon the total weight of the aqueous phase (See [0053]).
Thus, regarding the ratio of acacia to thickener gum, Mellor et al teach a ratio of 1:1 in claim 6 (e.g. 1% of each) to 50:1 in claims 9 and 16 (5%:0.1%).
Mellor et al also disclose that the said emulsion may also comprise a flavouring agent including cinnamon, lemon, plant extracts including oregano oil, etc, (See [0056]). This meets the claimed agrochemical active of claims 4-5 and 17, as evidenced by Cinnamon and Cinnamon oil profile (See below).
It is disclosed that the said emulsion may also contain additional functionally active ingredients such as colouring agents (e.g. β-carotene, lutein, caramel colouring, lycopene, turmeric, and tartazine), preservatives and pH adjusting agents (e.g. citric acid, lactic acid, malic acid, fumaric acid, tartaric acid, potassium sorbate, sodium propionate, sodium nitrate, sodium nitrite, and disodium EDTA) (See [0062]).
Mellor et al disclose that the said emulsion is suitable for direct consumption as a dietary supplement, providing the individual with their recommended daily dietary intake of omega-3 fatty acids, for incorporation into beverages (e.g. fruit juices), dairy products (e.g. yogurts), baby foods, and a wide range of processed meats, baked goods (e.g. bread), and cereals (See [0066]-[0067]).
Mellor et al exemplify an emulsion comprising acacia gum, and xanthan gum, oil, essential oil (lemon oil) and water. It is also disclosed that commercially available product, ThixogumTM is a mixture of acacia gum and xanthan gum.
PNG
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273
428
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(See Example 2 and [0073]).
Evidence:
Cinnamon & Cinnamon oil profile discloses that cinnamon and cinnamon oil are spices derived from tropical plants with a long and well-established use in food and fragrances. The main biologically active substances in cinnamon are cinnamaldehyde and eugenol, although others also appear to have significant activity. As a pesticide, cinnamon’s main mode of action with insects appears to be as a repellant, although it has biocidal action at higher doses. Phytotoxic effects of cinnamon make it a possible herbicide but also limit its practical foliar application to crops. Cinnamon and its essential oils are antimicrobial in nature and are effective at inhibiting the growth of bacteria and fungi.
Mellor et al differs from the examined claims in that Mellor et al lacks a specific disclosure on the droplet size. This is known in the art as taught by CN ‘706.
CN ‘706 teach a submicron emulsion containing 1-30% of acer truncatum seed oil, and an emulsifier: 0.5-20%, and a flavoring agent: 0% -0.03%, preservative: 0 to 0.03 percent of the total weight of the composition, and the balance of water. Adjuvants can be added into water phase or oil phase. The submicron emulsion containing Acer truncatum seed oil can be used in the fields of medicines, health products and foods (See abstract and claim 1).
Regarding claims 1, 7-8 and 10, CN ‘706 teaches that acer truncatum seed oil is a new resource food and is a vegetable oil processed from seeds of acer truncatum which is a special tree species in China (See page 2, line 5). The particle size of liquid drops in the submicron emulsion is within the range of 100-1000 nm (See page 2, 4th para and claim 2). The said emulsifier is one or more of arabic gum, xanthan gum, tragacanth, etc (See Page 2, 8th para and claim 3). CN ‘706 provides examples of such emulsion, wherein, in Example 1, the emulsion comprises 30 g of acer truncatum seed oil, 6.75 g of arabic gum, 0.75 g of xanthan gum and 100 ml of purified water.
Also, Example 2 comprises 30g of acer truncatum seed oil, 6.75g of arabic gum, 0.75g of tragacanth and 100 ml of purified water. The particle size is 638.3 nm with a PDI of 0.192. Thus, D90 is 760 nm.
Further regarding the droplet particle size, d90 being at most 800 nm, CN ‘706 teaches that the droplet size is from 100 nm to 1000 nm, which meets the claimed range of at most 800 nm.
It is disclosed that “The emulsion containing acer truncatum seed oil has emulsion droplet size within 100-1000 nm and belongs to submicron emulsion in the category of emulsion, and can be used in the fields of medicine, health product, special medical food and food (See 2nd Page).
CN ‘706 anticipates claims by teaching an oil-in-water emulsion comprising an oil phase and an aqueous phase, an active agent (acer truncatum seed oil, which meets the essential oil/vegetable oil and feed active), an emulsifier comprising arabic gum (acacia) and xanthan gum, the ratios of components and droplet size range of less than 1 micron.
Regarding the ratio of acacia to thickener in claims 6 and 9, CN ‘706 teaches emulsions comprising 6.75 g of acacia and 0.75 g of xanthan gum, resulting in a ratio of 9:1 (See Example 1).
Furthermore, regarding the ratio of acacia to thickener in claims 6, 9 and 16
CN ‘706 teaches emulsions comprising 6.75 g of acacia and 0.75 g of xanthan gum, resulting in a ratio of 9:1, which is close to and renders the ratio of 10:1 obvious (See Example 1).
Regarding the amount of active agent based on the weight of the composition in claim 11, CN ‘706 teaches an emulsion composition comprising 1% of active agent (See abstract, claim 1 and page 1).
Cn ‘706 also meets the limitation of claim 15 as water is present and dissolves the active agent.
CN ‘706 further teaches that the emulsion raw materials consist of the following ingredients in weight percentage: acer truncatum seed oil is 1%-30%, emulsifier: 0.5%-20%, flavoring agent: 0%-0.03%, preservative: 0%-0.03%, and the rest is water.
CN ‘706 discloses that the said emulsifier maybe gum arabic, xanthan gum, tragacanth, phospholipid, etc, and other food medically acceptable emulsifiers; co-emulsifiers are propylene glycol, polyglycerides, glycerin and other food and medical fields, one or more of the acceptable co-emulsifiers (See Page 2).
CN ‘706 further discloses a method of making the said emulsion wherein both emulsifier and co-emulsifier are added to the oil and water phase before mixing (See Page 2).
Evidence:
The Specification states that xanthan gum is both an emulsifier and a polysaccharide thickener.
It was further found that the polysaccharide thickener, in particular xanthan gum, serves as an emulsifier in combination with acacia gum (See [0004]).
Preferably, the polysaccharide is selected from xanthan gum and guar gum. Xanthan gum is most preferred (See [0024]).
Thus, the exemplified formulations of CN ‘706 comprising the oil, acacia gum and xanthan gum or tragacanth meet the claimed limitation of the first emulsifier, a polysaccharide thickener and the second emulsifier.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of CN ‘706 with that of Mellor et al to arrive at the instant invention. It would have been obvious to do so because both references teach stable oil-in-water emulsions that can carry an active agent including essential oils, food, herbicides, etc. Both references teach that incorporating two or more emulsifiers and polysaccharides, especially gums including acacia gum and xanthan gum result in stable and effectively thickened emulsions. While Mellor et al teach an oil-in-water emulsion as claimed, it lacks a specific disclosure on the droplet size. However, CN ‘706 which also teaches a similar emulsion, provides guidance on the preferred droplet size. Thus, one of ordinary skills in the art would have been motivated to have taken advice from such guidance and prepared the desired emulsion having the recommended droplet size for optimal effectiveness and delivery.
Mellor et al and CN ‘706 both teach that gums such as acacia gum and xanthan gums comprise polysaccharides and act as both an emulsifier and a thickener. Both references also teach that the said emulsions may comprise more than one emulsifier.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mellor et al (US 20150133553) in combination with CN 111150706 as applied to claim 1 above, and further in view of JPH07101882 (Recitations from attached translation).
Teachings of Mellor et al and CN ‘706 are delineated above and incorporated herein.
The combined references lack a disclosure on the powder of claims 13-14. This is known in the art as taught by JPH ‘882.
JPH ‘882 teach a preparation capable of stably providing desirable flavor, color tone, taste, etc., to foods, pet foods, quasi-drugs, etc., for a long period, which is prepared by using a water-soluble hemicellulose as an emulsifier or a powdered substrate and using ghatti gum (See abstract).
The said emulsions comprise oils including essential oils, vegetable oils including olive oil and DHA oil (See 2nd page, 3rd and 4th paras).
Disclosed is a formulation comprising water-soluble hemicellulose and natural vegetable gum, wherein the water-soluble hemicellulose is a polysaccharide derived from soybean, corn and rice bran and the natural botanical gum substance is gutti gum (See claims 1-3).
The said gums include gatti gum, but in some cases gum arabic, and may be used in combination with tara gum, guar gum, xanthan gum and the like. The gums are contained at a ratio of 01 to 30 parts, preferably 0.05 to 15 parts. The emulsion is made into a powder by a spray drying method. (See translation, page 26th para).
JPH ‘882 exemplifies preparation of an emulsion, spray-dried to a powder composition. In Example 3, 85 g of soybean hemicellulose, 2 g of gutti gum, and 3 g of gum arabic were dissolved in 200 g of ion-exchanged water, and 20 g of grapefruit oil was added and mixed while maintaining at 50 °C. This solution was emulsified with a high-pressure homogenizer, and the emulsion was spray-dried to give 100 g of grapefruit flavor powder (See [0009]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of JPH ‘882 with that of CN ‘706 and Mellor et al to arrive at the instant invention. The reasons for combining Cn ‘706 and Mellor et al’s teachings are delineated above and incorporated herein. The combined references teach preparing an oil-in-water emulsion. It further would have been obvious to incorporate JPH ‘882’s teachings on spray-drying the said emulsion into a powder composition because powder formulations provide other benefits such as ease of transportation and storage.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Response to Arguments
Applicant's arguments filed 01/17/26 have been fully considered but they are not persuasive.
Applicants’ amendments to the claims have necessitated modified grounds of rejections. Applicants’ arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicants’ first argument is that neither CN ‘706 nor Mellor et al teach a second emulsifier (See Remarks, page, 2, 2nd para).
The argument is not found persuasive. As shown above by the rejection and as evidenced by both Mellor et al and the Instant Specification, gums such as acacia gum and xanthan gum act as both an emulsifier and a thickener, Thus, the exemplified formulations do indeed teach an emulsion composition that comprise two emulsifiers. Additionally, it is noted that the rejection is based on obviousness and that the text of both references teach that the emulsion may comprise more than one emulsifier.
Next argument is that CN ‘706 only teaches acer truncatum seed oil which has been excluded from the listed oils in the amended claim 1.
While the statement is correct the argument is not sufficient to place ethe claims in condition for allowance because the modified rejection teaches an emulsion that may comprise other essential oils and vegetable oils such as oregano oil, lemon oil, cinnamon oil and cinnamaldehyde. Thus, it would be obvious to select an oil other than acer truncatum seed oil for the said emulsions with a reasonable expectation of success.
Regarding the particle size, d90, Applicant argues that Neither CN ‘706 nor Mellor et al teach a d90. Applicant points to Example 1 with a particle size, d50, of 781.2 nm and a PDI of 0.565, which would result in a d90 of over 800 nm (See Remarks, page 2).
The above argument is also not found convincing. As the rejection makes clear, Mellor et al do not expressly disclose the droplet size, but CN ‘706 does and one of ordinary skill in the art is more than motivated to combine the teaching of CN ‘706 into the emulsion of Mellor et al with a reasonable expectation of success. Mellor et al teach emulsions and clearly any emulsion would have droplets which are characterized by their size. In fact, Mellor et al disclose the droplets (See at least [0040]). CN ‘706 on the other hand provides adequate teachings to one of ordinary skill in the art to make an emulsion with droplet sizes d90 of less than 800 nm. They disclose that the droplets have a particle size of from 100 to 100 nm. A droplet with a d50 of 100 or 200 or 300 or even 600 nm may have a d90 of less than 800 nm. One embodiment is the emulsion of Example 2, which has a droplet size, d50, of 638.3 nm and a DPI of 0.192, which would result in a d90 of 760 nm, less than the claimed 800 nm.
Applicants make no argument regarding the teachings of JPH ‘882.
Claims 1, 4-11 and 13-18 remain rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights