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 .
Election/Restrictions
Claims 6-8 and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Claim Objections
Claim 1 objected to because of the following informalities: since water and aqueous both contain water there is no need to recite “the wetting agent comprises one or both of water or an aqueous solution of ethanol”. Appropriate correction is required.
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.
Claim(s) 1-5 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 1552309 A, cited by applicants, English translation provided by examiner, in view of Ben-Oren et al. US (2010/0036273).
Ben-Oren teaches use methacetin for evaluation of liver health, methacetin was formulated as granules. See entire disclosure, especially abstract, [0140] and claims.
Ben-Orin while teaches granular form is silent with respect to the excipients claimed including mannitol, cosolvent and wetting agent.
CN is used for its disclosure on granules containing mannitol (preferred hydroaropic agent), solubilizing agents including PEG and wetting agent including preferably water and ethanol. See entire disclosure, especially abstract and claims. The granules were said to have several advantages including easy granulation and good mobility of the particle. See ¶ right before embodiments.
Since Ben-Orin teaches the methacetin could be formulated as a granule one of ordinary skill in the art would have a high expectation of success in formulating methacetin with the excipients taught by CN. Reason to make such a modification would be to provide a granule with easy granulation and good mobility of the particle. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
The references are silent with respect to the MW of PEG and the amounts of excipients used in the ratios recited in claims 2-5 and 13-16. However, the preparation of compositions having variable amount of monomer with varying molecular weight and amount of excipients is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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