DETAILED ACTION
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.
Claim(s) 1-10, 12-21, 23-34 is/are rejected under 35 U.S.C. 103 as being obvious over Sobel (US 20170312726 A1) in view of De Kruif (US 10179105 B2).
Regarding claim 1, Sobel discloses a method of providing an active compound powder comprising electrostatic spray drying a formulation comprising at least one active compound (core material) (abstract), an encapsulating agent (carrier or wall material; abstract), and optionally an excipient at an inlet temperature of 150 °C or below and an exhaust temperature of 100 °C or below (abstract), wherein electrical charge is applied externally to droplets of active compound formulation feedstock liquid (para. 25),
EXCEPT: where the charge is applied at a position downstream from a droplet formation site.
However, De Kruif teaches a method of electrostatic spray drying of a pharmaceutical compound (col. 6, lines 62-66), comprising the step of using an electrode ring to apply an electrical charge to droplets at a position downstream from a droplet formation site (col. 8, lines 59-67).
It would have been obvious to a person skilled in the art at the time of effective filing of the application to modify Sobel where the charge is applied, via an electrode ring, at a position downstream from a droplet formation site, since the charge could be applied either before droplet formation or after, and both methods are suitable for 1) driving core material into the center of the atomized droplet and facilitating film formation by the wall material at the droplet surface, as well 2) keeping the sprayed droplets from coalescing in mid air.
Regarding claim 2, modified Sobel discloses the method of claim 1, wherein the atomizing temperature is about 100 C or below (Sobel, para. 26).
Regarding claim 3, modified Sobel discloses the method of claim 1, wherein the applied voltage is about 0.1 kV or more to about 5kV or from about -0.1 kV to about -5 kV (Sobel, para. 23).
Regarding claim 4, modified Sobel discloses the method of claim 1, wherein the applied voltage is continuous (Sobel, para. 55).
Regarding claim 5, modified Sobel discloses the method of claim 1, wherein the applied voltage is modulated between two or more different voltages (Sobel, para. 55).
Regarding claim 6, modified Sobel discloses the method of claim 1, wherein the at least one active compound is an antioxidant, a vitamin, a bacterium, an omega oil, an essential oil, a flavoring agent, a pigment, a dye, or a combination thereof (Sobel, para. 18).
Regarding claim 7, modified Sobel discloses the method of claim 1, wherein when the active compound is an oil the optional excipient is an emulsifier, and when the active compound is other than an oil the optional excipient is an oil (Sobel, para. 19).
Regarding claim 8, modified Sobel discloses the method of claim 7, wherein the oil is plant or animal in origin (Sobel, para. 18).
Regarding claim 9, modified Sobel discloses the method of claim 8, wherein the oil is vegetable oil, vegetable shortening, castor oil, rice brain oil, olive oil, canola oil, corn oil, palm oil, coconut oil, flaxseed oil, hempseed oil, rapeseed oil, linseed oil, grapeseed oil, rosehip seed oil, pomegranate seed oil, watermelon seed oil, seabuckthorn berry oil, camellia seed oil (tea oil), cranberry seed oil, hemp seed oil, borage seed oil, evening primrose oil, argan oil, jojoba oil, marula oil, carrot oil, sesame seed oil, sunflower oil, shea nut oil, soybean oil, peanut oil, walnut oil, almond oil, hazelnut oil, kukui nut oil, pecan oil, macadamia nut oil, meadowfoam oil, avocado oil, apricot kernel oil, an essential oil, silicone oil, fish oil, cocoa butter, shea butter, butter, ghee, medium chain triglycerides (MCT), or any combination thereof (Sobel, para. 18).
Regarding claim 10, modified Sobel discloses the method of any claim 1, wherein the encapsulating agent is a carbohydrate, a lipid, a protein, ascorbic acid, or a combination thereof (Sobel, para. 17).
Regarding claim 12, modified Sobel discloses the method of claim of 10, wherein the lipid is a fatty acid or an ester thereof, a fatty alcohol (e.g., decanol) or an ester thereof, a triglyceride (present in animal and vegetable oils), a phospholipid, a glycolipid, an aminolipid, a lipopeptide, partial acylglycerol, or a combination thereof, and wherein the carbohydrate is maltodextrin, sucrose, dextrose, glucose, lactose, trehalose, amylase, cyclodextrin, dextrin, galactomannan, pectin, starch, modified food starch, inulin, gum Arabic, guar gum, gellan gum, mesquite gum, xanthan gum, alginate, chitosan, shellac, carboxymethylcellulose, or a combination thereof. (Sobel, para. 18).
Regarding claim 13, modified Sobel discloses the method of claim 10, wherein the protein is casein, caseinate, gelatin, casein, soy protein, wheat protein, whey protein, rice protein, pea protein, cocoa shell protein, or a combination thereof (Sobel, para. 17).
Regarding claim 14, modified Sobel discloses (see rejection of claim for citations unless otherwise noted) a method of providing an oil emulsion powder comprising electrostatic spray drying an emulsion comprising at least one oil (para. 18), an encapsulating agent, and optionally an emulsifier at an inlet temperature of 150 °C or below and an exhaust temperature of 100 °C or below, wherein electrical charge is applied externally to droplets of oil emulsion feedstock liquid at a position downstream from a droplet formation site.
Regarding claim 15, modified Sobel discloses the method of claim 14, wherein the atomizing temperature is about 100 C or below (see rejection of claim 2).
Regarding claim 16, modified Sobel discloses the method of claim 14, wherein the applied voltage is about 0.1 kV or more to about 5 kV or from about -0.1 kV to about -5 kV (see rejection of claim 3).
Regarding claim 17, modified Sobel discloses the method of claim 14, wherein the applied voltage is continuous (see rejection of claim 4).
Regarding claim 18, modified Sobel discloses the method of claims 14, wherein the applied voltage is modulated between two or more different voltages (see rejection of claim 5).
Regarding claim 19, modified Sobel discloses the method of claim 14, wherein the oil emulsion powder has lower amount of surface free fat compared to a spray dried powder of the same oil emulsion (Sobel, para. 27).
Regarding claim 20, modified Sobel discloses the method of claim 14, wherein the oil emulsion powder has an encapsulation efficiency of 50% or more (Sobel, para. 42).
Regarding claim 21, modified Sobel discloses the method of claim 20, wherein the oil load (total oil) ranges from 1-60% and the encapsulation efficiency ranges from 90-99% (Sobel, para. 42).
Regarding claim 23, modified Sobel discloses the method of claim 14, wherein the at least one oil is plant or animal in origin (see rejection of claim 8).
Regarding claim 24, modified Sobel discloses the method of claim 23, wherein the at least one oil is vegetable oil, vegetable shortening, castor oil, rice brain oil, olive oil, canola oil, corn oil, palm oil, coconut oil, flaxseed oil, hempseed oil, rapeseed oil, linseed oil, grapeseed oil, rosehip seed oil, pomegranate seed oil, watermelon seed oil, seabuckthorn berry oil, camellia seed oil (tea oil), cranberry seed oil, hemp seed oil, borage seed oil, evening primrose oil, argan oil, jojoba oil, marula oil, carrot oil, sesame seed oil, sunflower oil, shea nut oil, soybean oil, peanut oil, walnut oil, almond oil, hazelnut oil, kukui nut oil, pecan oil, macadamia nut oil, meadowfoam oil, avocado oil, apricot kernel oil, an essential oil, silicone oil, fish oil, cocoa butter, shea butter, butter, ghee, medium chain triglycerides (MCT), or any combination thereof (see rejection of claim 9).
Regarding claim 25, modified Sobel discloses the method of claim 14, wherein the encapsulating agent is a carbohydrate, a lipid, a protein, ascorbic acid, or a combination thereof (see rejection of claim 10).
Regarding claim 26, modified Sobel discloses the method of claim 25, wherein the carbohydrate is maltodextrin, sucrose, dextrose, glucose, lactose, trehalose, amylase, cyclodextrin, dextrin, galactomannan, pectin, starch, modified food starch, inulin, gum Arabic, guar gum, gellan gum, mesquite gum, xanthan gum, alginate, chitosan, shellac, carboxymethylcellulose, or a combination thereof (see rejection of claim 11).
Regarding claim 27, modified Sobel discloses the method of claim of 25, wherein the lipid is a fatty acid or an ester thereof, a fatty alcohol or an ester thereof, a triglyceride, a phospholipid, a glycolipid, an aminolipid, a lipopeptide, partial acylglycerol, or a combination thereof (see rejection of claim 12).
Regarding claim 28, modified Sobel discloses the method of claims 25, wherein the protein is casein, caseinate, gelatin, casein, soy protein, wheat protein, whey protein, rice protein, pea protein, cocoa shell protein, or a combination thereof (see rejection of claim 13).
Regarding claim 29, modified Sobel discloses the method of claim 14, wherein the emulsion comprises an emulsifier (Sobel, para. 19).
Regarding claim 30, modified Sobel discloses the method of claim 29, wherein the emulsifier is at least one selected from casein, caseinate, lecithin, saponin, carrageenan, gum Arabic, xanthan, whey protein isolate, stearate, glyceryl monostearate, sucrose ester, monopropylene glycol, propylene glycol ester of fatty acid, polyglycerol esters of fatty acid, a mono- and diglycerol, mono- and diglycerides of fatty acids, distilled monoglyceride, polyglycerol polyricinoleate, polysorbate 80, a sorbitan ester, a lactylated ester, an ethoxylated ester, a succinated ester, a fruit acid ester, carboxymethyl cellulose, and a combination thereof (Sobel, para. 19).
Regarding claim 31, modified Sobel discloses the method of claim 14, wherein the emulsion further comprises at least one active compound (Sobel, para. 18).
Regarding claim 32, modified Sobel discloses the method of claim 31, wherein the at least one active compound is an antioxidant, a vitamin, a bacterium, an omega oil, an essential oil, a flavoring agent, a pigment, a dye, or a combination thereof (Sobel, para. 18).
Regarding claim 33, modified Sobel discloses the method of claim 1, wherein the electrical charge is applied by an induction ring positioned around a droplet spray path (see De Kruif in the rejection of claim 1; note: an induction ring is the same as an electrode ring).
Regarding claim 34, modified Sobel discloses the method of claim 14, wherein the electrical charge is applied by an induction ring positioned around a droplet spray path (see De Kruif in the rejection of claim 1; note: an induction ring is the same as an electrode ring).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 JASON LAU whose telephone number is (571)270-7644. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/JASON LAU/Primary Examiner, Art Unit 3762
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