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 .
Receipt is acknowledged of Amendments and Remarks filed on 01/17/26. Claims 1-6, 8-9, 11, 13, 15-18 have been amended, claim 12 has been canceled and no new claims have been added. Accordingly, claims 1-11 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Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn.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 1, 6-10, 13-16 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. Independent claims 1 and 16 have been amended to include the limitation of “a feed ingredient”. While in two instances, the Specification uses the term “a feed ingredient”, there is no example, description or definition for the term. As such one of ordinary skill in the art would not be readily apprised of what feed ingredients are which feed ingredients would be suitable for the claimed emulsion. This is especially important because the Specification and claims recite the active agent being a feed additive ingredient or a feed ingredient and there is no clear distinction between them.
Specification discloses “Examples of feed additive ingredients include natural oils or nature-identical components including essential oils such as cinnamaldehyde, menthol, thymol, linalool, limonene, capsaicin, eucalyptol, geraniol and eugenol; vegetable oils such as eucalyptus oil, thyme oil, jasmine oil, geranium oil, lemon grass oil, oregano oil and peppermint oil; beneficial bacteria such as Bacillus spp like Bacillus subitilis, Bacillus licheniformis, Bacillus amyloliquefaciens, Bacillus pumilis, Enterococcus spp, Pediococcus spp, Lactobacillus spp, Lactococcus spp and Bifidobacterium spp; and medium and long chain fatty acids such as capric acid, caprylic acid, lauric acid, stearic acid, linoleic acid and oleic acid.” (see [0011] of published Spec).
Thus, the claims are rejected for failing to comply with the written description requirement.
Remaining claims depend on rejected claims 1 and 16 and do not correct the issue.
Claim Interpretation:
Acacia gum is also known as gum Arabic as evidenced by Food hydrocolloids, Martin Glicksman (attached).
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 § 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.
Claims 1-3, 6-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111150706 (Recitations from English translation provided).
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 1-3, 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 an example of such emulsion in Example 1, which 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.
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. 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 2 microns, and 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).
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.
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 1-11 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.
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.
Teachings of CN ‘706 are delineated above and incorporated herein.
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).
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 polysaccharides especially gums including acacia gum and xanthan gum results 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 skill 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.
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.
Applicant’s first argument is that CN ‘706 (Zhou et al) “fails to disclose, teach or suggest a feed ingredient or feed additive ingredient in an oil-in-water emulsion” (See Remarks, page, 4, 1st para).
The argument is not found persuasive. CN ‘706 both discloses and exemplifies an emulsion comprising acer truncatum seed oil, which according to both CN ‘706’s teachings and the Specification is a vegetable oil and a feed additive (See [0011] of published Spec and Page 3 above). Thus CN ‘706 fully anticipates the claimed emulsion.
Regarding the rejection of claims under obviousness over Mellor et al and CN ‘706, Applicant argues that “As the Primary Examiner indicates, Mellor et al. fails to disclose an oil droplet size. Additionally, Mellor et al. does not describe feed additive ingredients or feed ingredients, but instead food ingredients. Those of ordinary skill in the art would not combine Mellor et al. with the at least two patentably distinct teachings from the present invention, and combine it with Zhou et al., if only because Zhou et al. is not concerned with feed additive ingredients or feed ingredients. Moreover, there is no suggestion or motivation found in Mellor et al. to apply the recited oil droplet size, let alone to understand its dilution stability or the necessity thereof” (See Remarks, page 4).
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 is more than motivated to combine the teaching of CN ‘706 into the emulsion of Mellor et al with a reasonable expectation of success. Additionally, both Mellor et al and CN ‘706 teach emulsions comprising an oil as the active agent. Both acer truncatum seed oil and cinnamon oil are known and disclosed as feed additive ingredients. Applicant’s argument regarding the droplet size is similarly unpersuasive because any oil-in-water emulsion as taught by Mellor et al necessarily has droplets. In fact, Mellor et al disclose the droplets (See at least [0040]). However, Mellor et al is silent with regard to the size of such droplets. Thus, one of ordinary skill in the art is more than motivated to look in the art for suggestions.
Applicant makes no particular argument regarding the teachings of JPH ‘882.
Claims 1-11 and 13-18 remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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