DETAILED ACTION
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 of gum acacia as the at least one gum, candelilla wax as the at least one wax, and canola oil as the at least one oil in the reply filed on 21 July 2026 is acknowledged.
Status of the Claims
Claims 1-12 are pending. The amendment to the Claims filed 21 July 2026 has been entered.
Claim Objections
Claims 8-9 are objected to because of the following informalities: the terms candelilla and canola should not be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 12 is 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.
Claim 12 recites the transitional phrase “consisting of” which excludes any element, step, or ingredient not specified in the claim. However, the claim also recites “a particle comprising…” and “a coating layer which comprises…”. The recitation of “comprising” and “comprises” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Therefore, the metes and bounds of the claim are unclear as to whether non-recited components are excluded or whether the claim is inclusive of non-recited elements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Diguet et al. (US 2014/0242179 A1) in view of Achkar et al. (US 2019/0380971 A1).
Diguet et al. teach throughout a novel coating system comprising at least one lipid compound, at least one gum having emulsifying properties, and at least one film forming compound and/or at least one emulsifier ([0001]-[0006]; Claim 1).
Regarding claims 1 and 7-9, Diguet et al. teach a coating system comprising (i) at least one lipid compound chosen from the group consisting of stearic acid or palmitic acid, as well as their salts, (ii) at least one gum chosen from the group consisting of gum acacia, gum ghatti and tic gums, and (iii) at least one film forming compound and/or at least one emulsifier ([0011]-[0014], [0022]-[0025], [0028]-[0031], [0034]-[0038], [0044]-[0053]). Diguet et al. teach that preferred lipid compounds are saturated fatty acids as well as salts thereof ([0018]); and the preferred gum is gum acacia ([0021]). Diguet et al. further teach that the emulsifying properties of the gum are such, which allow to producing oil-in-water emulsions ([0019]). The coating systems according to Diguet et al. also comprise water (Examples 1-4).
Diguet et al. teach saturated fatty acids, such as stearic acid or palmitic acid, but do not explicitly disclose that the lipid compound includes canola oil, as instantly claimed.
Also, Diguet et al. teach a core particle coated with a coating system including HPMC, gum acacia and stearic acid, and further coated with candelilla wax, but do not explicitly disclose coating systems comprising at least one wax, such as candelilla wax, in the emulsion with the water, gum and saturated fatty acid, as instantly claimed.
Achkar et al. teach a process for coating particles, wherein the coating system comprises at least one wax and/or at least one fat ([0006]-[0011]; Claim 1). The at least one wax and/or at least one fat is preferably selected from a group that includes candelilla wax and (fully) hydrogenated rapeseed oil (i.e., canola oil) ([0035], [0037]-[0038]). Achkar et al. teach that the coating system is sprayed onto core particles ([0012]; Claim 1).
Diguet et al. also teach spraying the coating system onto core particles to coat the particles (Examples 1-4).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a coating system according to Diguet et al. wherein the coating system comprises at least one lipid compound, at least one gum, and at least one film forming compound and/or or at least one emulsifier, wherein the saturated fatty acid is substituted with a functionally equivalent saturated fatty acid, such as canola oil, and the coating system further comprises a wax, such as candelilla wax. Such would have been obvious because Diguet et al. and Achkar et al. are both drawn to coating systems for coating a core particle comprising an active ingredient, wherein the coating systems are applied by spraying onto the core particles to improve properties of the resulting coated particles.
The Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. One such rationale includes the simple substitution of one known element for another to obtain predictable results. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. See MPEP 2143.
In the instant case, the substituted components (saturated canola oil in the place of saturated fatty acids such as stearic acid and palmitic acid) and their functions were known in the art at the time of the instant invention. For example, Diguet et al. teach coating systems for core particles, wherein the coating systems comprise at least one saturated fatty acid. Achkar et al. teach a coating system for core particles, wherein the coating system includes fats, such as (fully) hydrogenated rapeseed oil (canola oil). One of ordinary skill in the art could have substituted one known saturated fatty acid for another, and the results of the substitution would have been predictable, that is an effective coating system for core particles to improve the properties of the coated core particles.
Regarding the candelilla wax, Diguet et al. teach a final coating with candelilla wax whereas Achkar et al. teach the coating system comprising at least one wax (e.g., candelilla wax) and/or at least one fat (e.g., hydrogenated rapeseed oil). A person of ordinary skill in the art would have been motivated to combine the candelilla wax with the coating system according to Diguet et al. with the reasonable expectation that the resulting coating system would be effective for coating core particles comprising an active ingredient.
Regarding claims 2-6, Diguet et al. teach that the coating system preferably comprises 10 to 50 wt.% of at least one lipid compound, preferably, 20 to 40 wt.%, based on the total weight of the coating system; and preferably comprises 5 to 30 wt.% of at least one gum having emulsifying properties, preferably 10 to 25 wt.%, based on the total weight of the coating system ([0040]-[0041], [0044]-[0046], [0048]-[0050]). Diguet et al. further teach that the coating system may comprise up to 5 wt.% of further components ([0039], [0052]-[0053]).
Achkar et al. teach that the coated particles comprise 5 to 60 wt.% of a coating system based on the total weight of the coated particle ([0006]-[0011]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the effective concentrations of gum having emulsifying properties, wax, and saturated fatty acid, for use in preparing the coating system according to Diguet et al. and Achkar et al.
Regarding claim 10, Diguet et al. do not explicitly disclose the viscosity of the coating system. However, Diguet et al. teach a coating system comprising water, at least one gum having emulsifying properties, at least one lipid, and further adjuvants. The compositions are sprayed onto the core particles with an inlet temperature of 55-80 °C in order to coat the core particles.
The Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same functional characteristics of the claimed product. The viscosity of the coating system according to Diguet et al. would reasonably be within the scope of the instant claims in order to be sprayed onto the core particles. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Regarding claim 11, Diguet et al. teach preparation of the coating system (i.e. emulsifying the coating system) followed by spraying the core particles with the coating system with an inlet temperature of 55-80 °C (Examples 1-4).
Regarding claim 12, Diguet et al. teach a core comprising an active ingredient, wherein the core is coated with the coating system ([0054]-[0060]; Examples 1-4; Claims 13-15).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the coated particles by emulsifying the coating system and spraying the core particles with the coating system with an inlet temperature of 55-80 °C, as reasonably suggested by Diguet et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/MONICA A SHIN/Primary Examiner, Art Unit 1616
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