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 .
Claim Rejections - 35 USC § 101/112
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claims 17-18 constitute an improper definition of a process insofar as it merely recites a use without any active, positive steps, delimiting how this use is actually practiced.
Claims 17-18 also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
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.
Claims 11, 13, 15 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.
Regarding claim 11, 13, 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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.
1) Claim(s) 1, 3-6, 8-11, 13, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bristow et al., (WO 2014/169778, cited in IDS).
Bristow et al. teaches an agrochemical formulation comprising “microencapsulated clomazone”, wherein “the microcapsules wall is formed from a cellulose derivative, for example carboxymethyl cellulose, a natural gum, for example gum Arabic, and gelatin” (Abstract). “The composition of the present invention comprises microcapsules having a wall formed from a material that is very low in toxicity and is biodegradable” (p. 4, lines 1-3). Below are several embodiments (p. 29):
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Here, the prior art teaches an encapsulating an agrochemical, i.e., clomazone, in a biodegradable capsule, i.e., microcapsule, comprising a complex coacervation of gelatin and a carboxylated polysaccharide (sodium carboxymethyl cellulose; clm. 13), as per claim 16. The amount of gelatin, carboxylated polysaccharide, crosslinker, and agrochemical, shown above, fall within the ranges of claims 8-11.
The instant claim is interpreted to cover other arrangements since there is no evidence in the specification demonstrating the criticality of the arrangement of the method steps. The necessity of the arrangement is further negated by the disclosure of a “second embodiment” that combines steps 1 and 2, creating a two-step process (p. 5, lines 8-13; see also instant claim 6). The specification states, “The second embodiment requires a reduced number of steps relative to the first embodiment and thus has the according time efficiencies” (p. 5, lines 15-16).
In regard to claim 4, the prior art teaches a high-shear homogenization step after the addition of the carboxylated polysaccharide, insofar as it teaches “homogenize the emulsion by agitation using an impellor rotating at as speed of from 3000 to 10000 r/min for 5 to 30min to form a stable oil in water emulsion A”, where the emulsion comprised “carboxymethyl cellulose” (p. 21, lines 14-18).
The prior art method also includes use of “dispersants” (p. 22, line 13), as per claim 5.
In regard to claim 6, the 4:1 to 1:4 weight ratio of gelatin to carboxylated polysaccharide is prima facie obvious insofar as it overlaps with the prior art range, i.e., “The weight ratio of the cellulose derivative to gelatin is preferably from 0.075 to 0.6, still more preferably from 0.08 to 0.5” (p. 10, lines 10-12).
In regard to claim 15, the prior art teaches, “The composition is highly stable and allows the release rate of the clomazone active ingredient to be accurately controlled” (p. 4, lines 3-4).
The prior art method of productions includes: “a) preparing an aqueous solution of a cellulose derivative and a natural gum [clm. 3]: b) adding clomazone and a liquid carrier to the solution prepared in step (a) and agitating to form an emulsion comprising a water-immiscible phase [oil phase] in water; c) preparing an aqueous solution of gelatin; and d) combining the solution prepared in step (c) with the emulsion prepared in step (b)“ (p. 18, line 24 – p.19, line 18). Further, “the method of the present invention comprises as a further step: e) adding to the resulting mixture a cross-linking agent” (p. 20, lines 9-11).
Here, the method does not comprise an addition emulsifier, as claimed. Emulsifiers are an optional ingredient, and, therefore, may be excluded, insofar as the prior art teaches, “One or more emulsifiers and/or stabilizers may be added to the mixture, as required” [emphasis added] (p. 19, lines 15-16).
The prior art is not anticipatory insofar as the sequential arrangement of steps in the prior art method is different from the instant claims. Although arranged differently, the prior art method would have obvious to a person having ordinary skill in the art at the time of applicant’s filing. The artisan would have reasonably been expected to possess the same properties insofar as it teaches complex coacervation of a gelatin and a carboxylated polysaccharide (CMC), forming an emulsion comprising gelatin, an oil phase with the agrochemical (Clomazone), carboxylated polysaccharide, and a crosslinker.
2) Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bristow et al., (WO 2014/169778, cited in IDS) as applied to claim 1 above, and further in view of David et al., (US 5,051,304).
Bristow et al., which is taught above, differs from claim 7 insofar as it does not teach wherein the crosslinker is selected from polyaldehydes, polyacids, polyphenols or aldose sugars.
David et al. teaches microcapsules based on gelatin and polysaccharides, including “carboxymethylcelluloses” (Abstract). The microparticles therein are used to encapsulate “fertilizers, pesticides and insecticides which will be released more slowly in their medium” (col. 5, lines 4-17).
David et al. further teaches, “in order to solidify the walls of the microcapsules” a crosslinking agent is used “such as formaldehyde, glyoxal or glutaraldehyde or a natural tanning agent such as tannic acid is added to the suspension” (col. 4, lines 26-36). Glutaraldehyde suffices as a polyladehyde and tannic acid suffices as a polyacid or polyphenol.
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
Accordingly, it would have been obvious to use a polyaldehyde (glutaraldehyde) or polyacid/polyphenol (tannic acid) as crosslinking agent in the method of Bristow et al., based on their suitability for their intended use in microcapsules comprising gelatin and polysaccharides, as taught by David et al. The artisan would have reasonably expected success with the combination insofar as the microcapsules of Bristow et al. are comprised of gelatin and polysaccharide.
3) Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bristow et al., (WO 2014/169778, cited in IDS) as applied to claim 1 above, and further in view of Meredith et al., (Environmental International, 2016).
Bristow et al., which is taught above, differs from claim 15 insofar as it does not teach a particle size for the microcapsules.
Meredith et al. discusses the influence of size on the toxicity of an encapsulated pesticide. “Size is known to influence biological mobility in terms of adsorption, distribution, metabolism and excretion (ADME) . . . Polymeric microspheres between 2 and 3 µm have been shown to exhibit maximal phagocytosis compared to larger and smaller particles of the same composition” (p. 69, left column, 2nd paragraph).
Meredith et al. teaches, “Here, we have identified a CS [capsule suspension] formulation with an average capsule size of approximately 2 µm with some capsules extending into the nanometer scale” (Abstract).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to modify the diameter of the microparticles of Bristow et al. within the claimed range of less than 15 microns, since microencapsulated pesticides are known to be used having an average capsule size of approximately 2 µm. The artisan would have been motivated to modify the particle diameter for in order to influence biological mobility in terms of adsorption, distribution, metabolism and excretion.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612