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 .
Applicant's amendments and remarks, filed 08/25/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1, 2, 4-6, 11-15, 17, 20 are under examination.
Claims 3, 7, 8, 9, 10, 16, 18, 19 are withdrawn.
Priority
This application is a continuation of United States Patent Application Serial No. 15/979,374, filed May 14, 2018, which is a divisional of United States Patent Application Serial No. 14/281,766, filed May 19, 2014 (now US Patent 10,007,765).
Specification
Applicant’s amendments to the specification and title of the invention filed 08/25/2025 are acceptable.
Withdrawn Rejections
The rejection of claims 1, 2, 4-6, 11-15, 17, 20 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) is withdrawn in view of applicant’s amendments to the claims, which not integrate the judicial exception into a practical application.
The rejection of claims 1, 2, 4-6, 11-15, 17, 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicant’s amendments to the claims.
The rejection of claims 1, 2, 4-6, 11-15, 17, 20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 3-15, 21-25 of US application No. 14/281,766, filed May 19, 2014 (now US Patent 10,007,765) is withdrawn in view of the terminal disclaimer filed.
Claim rejections - 35 USC § 112, 2nd Paragraph
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, 2, 4-6, 11-15, 17, 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1, 14 is/are also rejected due to said dependency.
Claims 1, 14, 20 recite “determining, based on successive differences of the plurality of filtered measurements, a first derivative metric for a current filtered measurement of the plurality of filtered measurements and…a second derivative metric for the current filtered measurement”. It remains unclear as to the metes and bounds of the terms “first derivative metric” and “second derivative metric” such that the artisan would recognize what computational operations are intended. The specification teaches, for example, a first derivative metric associated with a respective filtered measurement may be calculated and utilized to determine a frequency metric indicative of an estimated frequency of the filtered measurement signal, while a second derivative metric may be calculated and utilized to determine a noise metric indicative of an estimate of the amount of noise present in the filtered measurement signal” [0027]. However, this merely describes the intended use of these metrics and does not clarify the scope of the computational operations encompassed by the claims. The specification does also discuss calculating a first derivative metric “by averaging the respective first derivative values associated with each of the five-minute filtered measurement values” [0075]. However, this is not commensurate in scope with what is being claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Therefore, the claims are indefinite as the boundary of the mathematical operations required to achieve the claimed results cannot be drawn. Clarification is requested via amendment.
Claims 1, 14, 20 recite “determining an output filtered measurement indicative of a physiological condition of a user based at least in part on the current filtered measurement, the first derivative metric, the second derivative metric, and a previous output measurement”. It is remains unclear in what way the output filtered measurement is “based at least in part” on the current filtered measurement, the first derivative metric, the second derivative metric, and a previous output measurement such that the artisan would recognize what computational operations are actually encompassed by the claims. The specification teaches [0092, FIGS. 5-7] that the output filtered measurement value and the output error estimate determined by the adaptive filtering module are “fed back or otherwise maintained by the adaptive filtering module for use in determining the subsequent output filtered measurement value based on the preceding output filtered measurement value and the preceding output error estimate.” However, this is not commensurate in scope with what is being claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Therefore, the claims are indefinite as the boundary of the mathematical operations required to achieve the claimed results cannot be drawn. Clarification is requested via amendment.
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.
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.
Claims 1, 2, 4, 5, 9, 12, 14, 17, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Steil et al. (US 7,354,420; Issued: 04/08/2008).
Steil teaches a closed loop infusion system controls the rate that fluid is infused into the body of a user. Regarding claim(s) 1, 14, 20, Steil teaches obtaining raw glucose sensor values and then processing the raw glucose sensor values to put them in a form more acceptable for subsequent analysis [See Figure 39b, Figure 19(a), Col. 11, Col. 12, Col. 33, ¶2], which reads on obtaining unfiltered as claimed. Steil teaches additionally methods for processing sensor values including averaging, clipping, scaling, and filtering to minimize the effects of anomalous data points before they are provided as input to the insulin controller [Col. 27, ¶4]. In particular, Steil also teaches filtering sensor signals to reduce noise in particular frequency bands, e.g. using low-pass filtering at specific intervals [Col. 29, last two ¶s, Col. 30], which reads on determining filtered measurement values as claimed.
Steil also teaches calculating the average of a subset of sensor values and values below a threshold are eliminated [Col. 28, ¶2], which broadly reads on determining ‘derivatives’ metrics (wherein the average is broadly interpreted as the derivative absent any limiting definition to the contrary). Alternatively, however, Steil also teaches applying a derivative filter to sensor signals to remove noise from sensor signal before the controller uses it, wherein the processes specifically includes taking the derivative of sensor values [Col. 32, ¶2, ¶3], which explicitly reads on determining first and second derivative metrics since multiple signals are processed.
Steil does not specifically teach determining an output filtered measurement indicative of a physiological condition of a user based at least in part on the current filtered measurement, the first derivative metric, the second derivative metric, and a previous output measurement. However, Steil at a minimum suggests this limitation because the controller which is responsible for administering insulin to a patient only uses the processed glucose sensor data as input (which necessarily includes the various types of processed and filtered sensor data) [Col. 37, ¶2, Col. 44].
Steil additionally teaches that the insulin delivery system receives the processed sensor data as input and generates commands to control the administration of insulin to a subject [ref. claims 1, and Col. 44], which reads on outputting the output filtered measurement to cause delivery of insulin to the user, by an insulin infusion device and based on the output filtered measurement to bring a glucose level of the user to within a target range.
Regarding claim(s) 2, 4, 5, 9, 12, 14, 17, 19, 20, Steil teaches or suggests all aspects of these claims for the following reasons. Regarding claim(s) 2, 15, Steil teaches methods for controlling insulin dosage using their insulin diffusion device [Col. 22], wherein the infusion device includes infusion electrical components to activate an infusion motor according to the commands [Col. 8, Regarding claim(s) 1]. Regarding claim(s) 4, 5, 17, Steil teaches methods for determining frequency, frequency response curves, and determining noise associated with filtered signal data [Col. 29, last two ¶s, Col. 30, and Figure 21]. Steil does not specifically teach scaling first and second derivative metrics by a calibration factor. However, Steil reasonably suggest this feature by teaching methods calibrating and scaling any signals before being sent to the controller in order to minimize effects of anomalous data points [Col. 27, last ¶, Col. 37, ¶1, Col. 32, Fig. 39a]. Regarding claim(s) 6, Steil teaches calculating derivatives, as set forth above, which the artisan would recognize also reads on determining rates of change. Steil does not specifically teach scaling rate of change based on noise estimates. However, Steil reasonably suggest this feature by teaching methods calibrating and scaling any signals before being sent to the controller in order to minimize effects of anomalous data points [Col. 27, last ¶, Col. 37, ¶1, Col. 32, Fig. 39a]. Regarding claim(s) 9, 19, Steil teaches methods for adjusting filtered measurements to compensate for delay (i.e. delay compensation filters) [Col. 30]. Regarding claim(s) 12, Steil teaches implementing a Kalman filter [Col, 19].
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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