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 .
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 19 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.
Claim 19 recites “the method of claim 16.” Claim 16 is a system claim. It is believed that claim 19 should depend upon method claim 17.
Claim 20 depends upon claim 19 and does not cure the deficiencies of claim 19.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 8 and 12 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minor (US PGPUB 2013/0311102 – in IDS).
Regarding claims 1 and 17, Minor discloses a system and method for processing glucose data by efficient glucose database management (e.g. ABSTRACT), comprising: a physical data store containing glucose measurement data and a representation for at least one cluster of the glucose measurement data, wherein the representation approximates a glycemic profile vector array for a cluster of multiple glucose profiles segmented by plural time ranges (e.g. ¶ 68 and Figs. 4-5); and a processor (e.g. 502) and computer memory configured with instructions stored thereon that when executed will cause the processor to: receive glucose measurements (e.g. ¶ 50); convert the glucose measurements into vectorial form (e.g. ¶ 53); search the physical data store by comparing a newly received glucose measurement to a centroid of a cluster using a similarity metric (e.g. ¶ 53); classify the newly received glucose measurement with a cluster having a matched similarity metric based on the comparing (e.g. ¶ 54); and ascribe treatment to the newly received glucose measurement (e.g. ¶ 57).
Regarding claim 2, Minor discloses instructions cause the processor to one or more of: store the classification of the newly received glucose measurement in a data store that is in communication with one or more of a predictive modeling system, a decision support system, an insulin delivery system, an insulin monitoring system, or an automated control system configured to use the classification as input; transmit the classification of the newly received glucose measurement to one or more of a predictive modeling system, a decision support system, an insulin delivery system, an insulin monitoring system, or an automated control system configured to use the classification as input; or monitor, analyze, or influence a concentration of glucose levels in a fluid using the classification of the newly received glucose measurement (e.g. ¶ 64).
Regarding claim 3, Minor discloses instructions cause the processor to receive the glucose measurements from a glucose measurement device (e.g. ¶ 66).
Regarding claim 4, Minor discloses the glucose measurement device (e.g. ¶ 66).
Regarding claim 5, Minor discloses the data store that is in communication with one or more of the predictive modeling system, the decision support system, the insulin delivery system, the insulin monitoring system, or the automated control system; or the one or more of a predictive modeling system, the decision support system, the insulin delivery system, the insulin monitoring system, or the automated control system (e.g. ¶ 57).
Regarding claims 6 and 18, Minor discloses instructions cause the processor to: calculate a Euclidean distance between one or more newly received glucose measurement and one or more centroid as the similarity metric (e.g. ¶ 53).
Regarding claims 7 and 19, Minor discloses plural clusters generated by: generating an array of glucose measurements for each time range, a plurality of arrays forming a glycemic profile vector; assigning a weight to an array; and applying an iterative hierarchical clustering technique that varies a weight until one or more cluster is generated that approximates one or more glycemic profile vector; and defining a cluster of the plural clusters by a cluster's centroid (e.g. ¶ 50 – 54).
Regarding claims 8 and 20, Minor discloses the iterative hierarchical clustering technique computes an R2 value by linear regression for an array and varies a weight to maximize the R2 value (e.g. ¶ 72).
Regarding claim 12, Minor discloses the glucose measurements include plural glucose profiles for an individual, each glucose profile including plural glucose measurements obtained for a predetermined time period, wherein instructions cause the processor to: compile the plural glucose profiles into a single glucose measurement time series for an individual; and classify one or more glucose profile using one or more cluster to generate a sequence of indices representing a classification of one or more glucose profile in the single glucose measurement time series (e.g. ¶ 50 – 54).
Regarding claim 13, Minor discloses instructions cause the processor to: generate, using the sequence of indices, a trace representing glucose variability of he individual (e.g. ¶ 50 – 54).
Regarding claim 14, Minor discloses instructions cause the processor to: generate an approximated Ambulatory Glucose Report (AGP) using the sequence of indices (e.g. ¶ 50 – 54).
Regarding claim 15, Minor discloses one or more glucose profile of the multiple glucose profiles is a continuous monitoring glucose (CGM) profile including glucose measurements obtained over a 24-hour time period (e.g. ¶ 54).
Regarding claim 16, Minor discloses one or more glucose profile of the plural glucose profiles for the individual is a continuous monitoring glucose (CGM) profile including glucose measurements obtained over a 24-hour time period (e.g. ¶ 54).
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.
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.
Claim(s) 9 – 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minor.
Regarding claims 9 – 11¸ Minor discloses the claimed invention as previously described, but fails to explicitly recite that the plural time ranges includes five time ranges and the specific time ranges and glucose measurements. However, Minor does teach in the background of the invention that these are well known standards (e.g. ¶ 6 – 7). It would have been obvious to one having ordinary skill in the art to modify the invention of Minor with well known standards as claimed, since such a modification would provide the predictable results of allowing for simpler classification and presentation of data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796