DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 9 recite determining an aggregate level of the signal during a period of time and determining a baseline level of the signal during the period of time. The original disclosure fails to provide enabling support for such a feature. It is noted that the only discussion found in the disclosure with respect to the aggregate and baseline levels is that the baseline level is computed from the same window of time using a different filter or computed from a different window of time using a similarly structured filter. Nothing is disclosed with respect to what kind of filter is used for determining either level. This is additionally problematic as elsewhere in the specifications, it is noted that “standard filtering methods are not effective to compensate” for attenuation and that detection of ESA is not trivial. Moreover, there lacks any disclosure on how the use of a baseline level within the same or adjacent time windows would allow for a determination of an attenuation, when the baseline level would also be based on data that would be similarly afflicted with attenuation. To enable the claimed invention, one of ordinary skill in the art would need to know of a detector that is not based on any standard filtering, computed from filters that the specification never identifies, and solve a problem that the specification calls non-trivial, with no equations, no window lengths, no filter types, no working example, and no figures describing how it would be determined. This is undue experimentation, and the claims are not enabled.
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 1-17 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 9 recite determining a “baseline level of a signal during the period of time”. It’s not clear what this means. The only discussion of a baseline disclosed within the original disclosure is found in [0029] of the printed publication, which merely states that a baseline level is “computed from the same window of time using a different filter, or computed from a different window of time using a similarly structured filter”, and is merely defined by reference disjunctively with respect to the aggregate level. Both the baseline level and the aggregate levels are thus filtered levels derived from the same signal over identical or different windows of time, and the specification supplies no criterion by which one of ordinary skill in the art could determine which value is the “aggregate level” and which is the “baseline level”. Moreover, it’s not clear how either levels are calculated, as the disclosure fails to enable their determination, as noted above.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
Claims 4 and 14 recite the determination of a “quadratic absolute ratio”. This is not a term of art, and is not defined in the specifications. The only recitation of the phrase in the specifications, lists it as a “function such as a quadratic absolute ratio between the measured aggregate level and its baseline” without any disclosure on how it is determined.
Claim 9 recites the limitation "the user" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berman (US 2011/0081726) teaches a glucose monitoring system to determine whether a signal was attenuated for a period of time ([0089]). Goode et al. (US 2005/0043598) teaches a glucose sensor in which a first measure of a glucose sensor signal over one time window and a second measure of the same signal over a second time window are compared to identify an artifact ([0365]). Kamath et al. (US 2008/0033254) teaches the determining of a start of a signal artifact event ([0501]).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/25/26
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