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 .
Claims 1-12 are presented for examination.
Claims 15-17, 19, 20 and 22-24 are withdrawn from consideration.
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 02/02/2026 is acknowledged.
Claims 15-17, 19, 20 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/02/2026.
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 8-11 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 8-11 are indefinite as to the phrases “Dn50”, “Dn90” and “Dn10”. Such phrases fail to set forth the intended meaning.
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.
Claim(s)1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (US 20090136650 submitted by the applicant) in view of Marcussen et al. (US 6,455,052).
The claims are drawn to A water-insoluble micro-dispersion comprising
a) dispersed particles of alginic acid in an amount of about 1% to about 10%
by total weight of the micro-dispersion, and
b) a plasticizer in an amount of about 2% to about 6% by total weight of the
micro-dispersion, and
regarding claim 1, Xie teaches a dry suspendible enteric coating composition for suspension in water and then encasing orally ingestible articles. The dry suspendible enteric coating composition comprises a pH-dependent polymer selected from a group consisting of alginates and alginic acids, a pH-independent water insoluble polymer selected from the group comprising ethylcellulose and ethylcellulose-containing compositions, and a plasticizer selected from the group consisting of triethyl citrate, glycerin, propylene glycol, triacetin, acetylated monoglycerides, dibutyl sebacate, polyethylene glycols, sorbitol, middle chain triglycerides and combinations thereof. See the abstract and Paras [0010] and [0012]. Xie teaches the suspendible compositions are easily made into a coating suspension by simply adding a suitable amount of a mixture comprising a suspendible enteric coating composition, to suitable amount of a solvent such as water. See Para [0017]. Xie teaches Suitable pH-dependent polymers are sodium alginate and alginic acid. See Para [0018]. Xie teaches an enteric coating composition according to the present invention, in a dry form, comprises: (a) about 10% to about 70% of a pH-dependent polymer, (b) about 10% to 75% of a pH-independent water insoluble polymer, and (c) about 7% to about 35% of a suitable plasticizer. See Para [0021]. The concentration of water is taught to be 85.8%. See table 3. Xie in table 3, teaches the amount of plasticizer being about 2.18%. Xia does not teach the amount of water being 88% to not more than 96%. Marcussen teaches a coating composition comprises a liquid mixture of a major amount of alginic acid particles dispersed in an aqueous solution of a minor amount of a water soluble binding agent which is approved for use for coating foodstuffs and/or food supplements. See column 2, lines 12-17. Marcussen teaches the liquid mixture of alginic acid particles and binding agent is aqueous, and the water preferably makes up more than 95% of the weight of the mixture. See column 2, lines 42-47.
It would have been obvious to a person skilled in the art to use the water at the claimed concentration motivated by the teachings of Marcussen, which teaches the use of alginic acid dispersed in water in combination with a plasticizer having the water concentration of 95%. The 95% reads on the claimed range of 88% to not more than 96%.
Regarding claim 2, Xie teaches Suitable pH-dependent polymers are sodium alginate, alginic acid. See Para [0018]. Xie teaches an enteric coating composition according to the present invention, in a dry form, comprises: (a) about 10% to about 70% of a pH-dependent polymer. Such concentration reads on the at least 9% as claimed herein.
Regarding claim 3, Xie does not teach the alginic acid being not more than 2%. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 4, Xie teaches the amount of plasticizer being about 7% to about 35%. See Para [0021].
Regarding claim 5, Xia in tables 1-4 teaches the concentration of plasticizer being less than 3.
Regarding claim 6, Xie does not teach the concentrations of water being at least 95%. However, Marcussen teaches a coating composition of the invention is characterized in that it comprises a liquid mixture of a major amount of alginic acid particles dispersed in an aqueous solution of a minor amount of a water soluble binding agent which is approved for use for coating foodstuffs and/or food supplements. See column 2, lines 12-17. Marcussen teaches the liquid mixture of alginic acid particles and binding agent is aqueous, and the water preferably makes up more than 95% of the weight of the mixture. See column 2, lines 42-47.
Regarding claim 7, Xie teaches the concentration of water being maximum 86.57 in table 2. Such concentration is not more than 89% as claimed herein.
Regarding claims 8, Xie does not teach wherein the Dn50 of the dispersed particle size being 4 um and 50% of the dispersed particles have a smaller size. However, Marcussen teaches a particularly good protective effect is obtained by using a mixture of alginic acid particles with varying particles sizes. See column 2, lines 32-33. Further, the determination particle size and distribution is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 9, Xie does not teach wherein the Dn50 of the dispersed particle size being 2 um and 50% of the dispersed particles have a smaller size. However, Marcussen teaches the best protective effect is obtained when the alginic acid particles in the mixture of alginic acid and binding agent have an average particle size of maximally 2 um. See column 2, lines 27-31. Marcussen teaches a particularly good protective effect is obtained by using a mixture of alginic acid particles with varying particles sizes. See column 2, lines 32-33.
Regarding claim 10, Xie does not teach where the Dn90 of the dispersed particles is up to 20 um and 90% of the particles have a smaller size. However, Marcussen teaches a particularly good protective effect is obtained by using a mixture of alginic acid particles with varying particles sizes. See column 2, lines 31-33. Further, the determination particle size and distribution is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 11, Xie does not teach wherein the Dn10 of the dispersed particles is up to 20 um, and 10% of the dispersed particles have a smaller diameter and 90% have a larger diameter. However, Marcussen teaches a particularly good protective effect is obtained by using a mixture of alginic acid particles with varying particles sizes. See column 2, lines 31-33. Further, the determination particle size and distribution is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 12, Xie teaches a plasticizer is selected from the group consisting of triethyl citrate, glycerin, propylene glycol, triacetin, acetylated monoglycerides, dibutyl sebacate, polyethylene glycols, sorbitol, middle chain triglycerides and combinations thereof. See the abstract, Paras [0010] and [0012].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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