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.
Claims 1, 5, 7-10, 15-17, and 20 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 1 and 10 both recite “improving stability and universality of catecholamines” without providing context or a definition for the term “universality” within the claim. The specification discusses “universality” in the context of providing a plasma stabilizer formulation with higher universality (pg-pub ¶ 0026). However, it is unclear how a formulation designed to stabilize plasma from a variety of different sources “improves…universality of catecholamines”.
Claim 1 recites a detection kit consisting of a stabilizer and a magnetic medium composite. However, it is unclear how a detection can be made without an assay device, detection means, or some other instrument or test product. It is unclear whether the contents of claim 1 are configured to provide the means for detection, whether the claim omits such means for detection, or some other alternative.
Claims 1 and 10 recite a stabilizer where the concentration of ascorbic acid is 10 mg/mL, the concentration of formic acid is 10%, and the concentration of phosphoric acid is 20%. It is unclear whether applicant intends the concentrations of formic and phosphoric acids to be a %/weight, %/volume, or some other alternative. Since the other components describe concentration as mg/mL, it is unclear whether the % concentration of formic and phosphoric acid should also be described as mg/mL or some other alternative.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gao et al,. US 2004/0048913 discusses ascorbic acid, formic acid, and phosphoric acid as pharmaceutically acceptable salts and/or salts of acids (¶ 0066) in addition to describing EDTA and glutathione as commonly used chelators for formulations (¶ 0232).
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DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779