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 § 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 75 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.
The term “in particular” in claim 75 is a relative term which renders the claim indefinite. The term “in particular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The exact parameters of polyelectrolyte B are rendered indefinite.
Claims 76, 80-83, and 86-87 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.
The term “preferably” in claims 76, 80-83, and 86-87 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. With regard to claim 76, the exact nature of the thickener is indefinite. With regard to claims 80-83, the crosslinking agent is indefinite. With regard to claim 86, the time at which the crosslinking agent is added is indefinite. Claim 87 is indefinite as it depends from claim 86.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 73-84 and claims 88-92 are rejected under 35 U.S.C. 103 as being unpatentable over Yulai (WO 2008017962 A2).
With regard to claim 73 and claim 89, Yulai discloses a process for preparing a microcapsule, comprising: a. providing an emulsion comprising a first polymer component, a loading substance, a second polymer component; b. adjusting pH, temperature, concentration, mixing speed, or a combination thereof to form an aqueous mixture comprising a primary shell material, wherein the primary shell material comprises the first and second polymer components and surrounds the loading substance; and c. cooling the aqueous mixture to a temperature above the gel point of the primary shell material until the primary shell material forms agglomerations (see Claim 68). Yulai further discloses the primary shell material and the outer shell comprises a complex coacervate between gelatin and alginate, gelatin and pectin, gelatin and gum arabic, gelatin and xanthan, gelatin and low methoxyl pectin, or gelatin and whey protein (see Claim 132).
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to utilize the method disclosed by Yulai as the method produces microcapsules having improved impermeability and good oxidative barrier to the encapsulated substance, preferably in conjunction with high load volumes, as disclosed by Yulai (see page 1 line 30-page 2 line 3).
With regard to claim 74 and claim 75, Yulai discloses gelatin and xanthan and further discloses gelatin and gum arabic (see Claim 132).
With regard to claim 76, Yulai discloses the microcapsules may comprise thickeners (see page 22 line 25-27).
With regard to claim 77 and claim 83, Yulai discloses the first polymer comprises gum Arabic and carboxymethylcellulose (see Claim 98).
With regard to claim 78, Yulai discloses saccharide chitosan (see Claim 79).
With regard to claim 79, Yulai discloses the first polymer comprises gum Arabic and carboxymethylcellulose (see Claim 98). Yulai further discloses mixtures thereof (see Claim 98). Yulai further teaches saccharide chitosan (see Claim 79).
With regard to claims 80-82, Yulai discloses the shell material can also be cross-linked (see page 29 line 9) and further discloses glutaraldehyde (see page 29 line 17).
With regard to claim 84 and claim 88, Yulai discloses gelatin and fish oil at 35oC and chitosan added later at 25oC (see Example 2.2 and Example 2.2.2).
With regard to claim 90, Yulai discloses the microcapsules as having a diameter of 1-2,000µm (see page 10 line 25-26).
With regard to claim 91, Yulai discloses all of the limitations of claim 89 and claim 73.
While Yulai does not disclose microcapsules characterized in that the shell is composed of biodegradable polyelectrolytes and/or that the microcapsule has a biodegradability after 60 days of at least 40% measured according to OECD 301 B. Yulai discloses all of the limitations of claim 73. It stands to reason that the disclosed composition would meet the requirement of a shell composed of biodegradable polyelectrolytes and/or that the microcapsule has a biodegradability after 60 days of at least 40% measured according to OECD 301 B. Applicant is directed to MPEP 2112.01(I), “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)” and 2112.01(II), "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With regard to claim 92, Yulai discloses the microcapsules may be incorporated into a formulation vehicle (see page 35 line 33-34).
Allowable Subject Matter
Claims 85-87 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY SHARON HARRIS whose telephone number is (571)270-1390. The examiner can normally be reached 7:30-5:00.
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/GREGORY R DELCOTTO/Primary Examiner, Art Unit 1761
/B.S.H./Examiner, Art Unit 1761