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 .
Status of Claims
Claims 1-20 are pending and under examination in this office action.
Claim Rejections - 35 USC § 102/103
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-2, 5, 9 and 17 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Clark (US 2004/0052853)..
Clark with regards to instant claim 1, teach a film forming composition comprising pectin as the film forming polymer (see abstract), wherein the pectin is a high ester pectin (see 0023) comprising water (see 0041) with a degree of esterification higher than 50% (see 0023) comprising a buffering agent a citrate i.e., Na citrate (see0027 and 0051 (see 0027 as required by instant claim 5 and 17) a plasticizer polyethylene glycol (see example 1, see 0047, as required by instant claim 9). However, Clark fail to teach that the degree of esterification is higher than 52%, nonetheless teaches that the degree of esterification is above 50%, therefore would have been obvious to one skilled in the art to have the degree of esterification above 50 and would reasonably have it higher than 52% based on the teaching.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark (US 2004/0052853) in view of Jain et al. (WO 2012/053006) and Chidambaram (US 2007/0148248).
Clark is applied here as above. However, Clark fails to teach that the degree of esterification is higher than 52%, nonetheless teaches that the degree of esterification is above 50%, therefore would have been obvious to one skilled in the art to have the degree of esterification above 50 and would reasonably have it higher than 52% based on the teaching.
Jain et al. teach with regards to instant claim 1, a high ester pectin (see pg 9, lines 20+) wherein the degree of esterification is higher than 50% ( see pg 9 lines 20+, as required by instant claim 2), comprising buffering agents (see pg 5, lines 15+, as required by instant claim 5) and a second film forming agent xanthan gum (as required by instant claim 6, see pg 9, lines 10+), hydroxypropylated starch (as required by instant claims 8) plasticizer glycerol (see pg 10, lines 19 +, as required by instant claim 9, 16), flavoring agent (see pg 5, lines 15+, as required by instant claim 12) in the form of a capsule as an immediate release (see abstract, as required by instant claim 14) and hydroxyethylated cellulose which is a starch (as required by instant claim 19, see pg 7, lines 20+). With regards to instant claim 7, because xanthan gum is listed in claim 6, it will have a starch content less than 100% amylopectin as properties of a compound will not change. With regards to the buffering agents it is within the purview of the skilled artisan to use any buffering agent as recited by instant claim 17, to result in the right pH range because MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore that the skilled artisan would have had reason to try any pH buffering agent with the reasonable expectation that at least one would be successful to result in the right pH of the composition.
Chidambaram teaches a film forming composition comprising capsule encapsulated with a liquid or a semi-solid fill material (see abstract, as required by instant claim13) comprising pectin (see 0006 with a concentration from 10-40%, (see same) wherein the composition comprises a divalent ion calcium (see 0010), buffering agents (see 0030). Chidambaram, also teaches a coating method of the capsule dosage form (see abstract,(as required by instant claim 15). Although Chidambaram did not per-se teach that the divalent ion of calcium is CaCo3, it is within reason that one of ordinary skill in the art would have used a divalent ion that is calcium to be CaCO3 as Chidambaram specifically teach the use of Calcium divalent ion and would have been successful in doing so. CaCO3 is a divalent ion of Calcium absent factual evidence to the contrary.
It would have been obvious to one of ordinary skill in the art to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a). Specifically because Clark teaches a high ester pectin with a degree of esterification higher than 50, it would have been obvious to one of ordinary skill in the art to have modified Clarks teaching to include Jain and Chidambaram and formulate a film-forming composition comprising high ester pectin, with a degree of esterification over 50% at a concentration of 10-50%, with buffering agents, second film forming polymer to result in a capsule-filled with a reasonable expectation of success.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 1/13/26
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