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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Applicant's amendments and remarks, filed 03/31/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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Claims 3, 7, 8, 9, 10, 16, 18, 19 are withdrawn.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).
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” due to the usage of the term “derivative”. For example, the artisan would recognize that a derivative measures the rate of change of a function with respect to its input, representing the slope of the tangent line at any point on the function's graph. However, this is not what is claimed. Applicant is reminded of MPEP 2111.01, section IV: An applicant is entitled to be his or her own lexicographer and may rebut the presumption that claim terms are to be given their ordinary and customary meaning by clearly setting forth a definition of the term that is different from its ordinary and customary meaning(s). See In re Paulsen, 30 F.3d 1475, 1480, 31 USPQ2d 1671, 1674 (Fed. Cir. 1994). Clarification is requested via amendment. In particular, the examiner suggests amending the claim by removing the term “derivative” to avoid any confusion.
Furthermore, the term “based on” suggests steps for determining successive differences between the filtered measurements values (for the first derivative) and determining successive differences of the first derivative (for the second derivative). However, such steps are not positively recited and Applicant is reminded that claim scope is not limited by claim language that “suggests” but does not limit a claim to a particular structure or process. See MPEP 2111.04. As a result, it is unclear in what way the first and second derivative metrics are being calculated “based on successive differences”, i.e. is the first derivative metric just ONE value associated with one difference between two measurement values, MULTIPLE values associated with all measured differences, or otherwise, and with regards to the second derivative, how can there be successive differences between one first derivative value. The specification teaches 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 does not clarify the scope of the computational operations encompassed by the claims. In addition, the specification provides conflicting information with regards to how the derivatives are calculated. For example, the specification also discusses 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 (i.e. averaging is not the same as determining successive differences) and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Therefore, the claims remain indefinite as the boundary of the mathematical operations required to achieve the claimed results cannot be drawn. Clarification is requested via amendment. Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth above and because applicant has not provided any illuminating arguments or clarifying amendments. The examiner suggests amending the claim by adding positive process limitations for calculating successive differences.
Claims 1, 14, 20 recite “determining an adaptive filtering gain value based on the first derivative metric and the second derivative metric”. It is unclear as to the metes and bounds of the term “adaptive filtering gain”. A review of the specification does not provide any limiting definition that would serve to clarify the scope of this term. As a result, for reasons set forth above, it is also unclear in what way the adaptive filtering gain is “based on” the first and second derivative metrics such that the artisan would recognize how to avoid infringement. The specification teaches that the adaptive filtering process “continues by calculating or otherwise determining an intermediate error estimate based on the output error estimate from the preceding iteration of the adaptive filtering process and the process variance metric” [0090]. However, such features are 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.
The following rejection is modified in view of applicant’s amendments.
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) in view of Neumann et al. (The Annals of Mathematical Statistics, Volume 12, Issue 2, pp. 153-162).
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. 12, Col. 29, last two ¶s, Col. 30], which reads on determining filtered measurement values as claimed.
Steil does not specifically teach 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 determining, based on successive differences of the first derivative metric, a second derivative metric for the current filtered measurement, as claimed. However, to the extent that applicant intends for this limitation to require determining first and second derivatives by performing successive difference calculations, the following prior art is applied.
Neumann teaches methods for calculating mean square successive differences for measurement values [Section 1 and 2] and calculating the variance of successive differences [Section 3]. In each case, these calculations are beneficially used to determine if trends exist in the data and/or to minimize the effect of trends [Section 1].
Moreover, Steil teaches calculating differences desired and basal blood glucose levels (i.e. successive differences) and outputting error values (i.e. first and second derivatives) [Col. 12 and Figure 26], which reasonably suggests determining a first derivative and second derivative metrics (i.e. errors) for a plurality of filtered measurements based on successive differences given the breadth of what is being claimed. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Steil by alternatively using successive difference calculations to determine first and second derivative (errors), since Steil already uses methods for calculating differences between filtered measurement values [Col. 12 and Figure 26]. The rationale would have been identify and control any trends or variability in the measurement data.
Steil does not specifically teach determining and applying an adaptive filtering gain value based on first and second derivative metrics, as claimed. However, Steil makes obvious these limitations for the following reasons. Steil additionally teaches correcting the glucose level errors by applying a correction algorithm (i.e. adaptive filtering), determining new glucose level error values, and using the error values as input to a control algorithm which administers, reduces, or stops insulin delivery to a patient based on the measured glucose [Col. 12, Figure 26], which broadly reads on determining and applying adaptive filtering gain values (based on error values) and output a result that causes delivery of insulin to a patient. Alternatively, Steil teaches another correction method that includes determining three different gains (proportional, integral, and derivative gain coefficients) based on SG (filtered sensor glucose) and dGdf (derivative filtered sensor glucose), wherein at least one the gains are based on an integrated error term (i.e. successive differences) [Col. 25]. Steil also teaches a plurality of different filtering methods to minimize the effects of anomalous data points before they are provided as input and that the gains can also be filtered to remove anomalous data points [Col. 27 “Filtering”]. 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 include taking the derivative of sensor values [Col. 32, ¶2, ¶3]. Steil also teaches the input is fed to a controller which is responsible for administering insulin [Col. 37, ¶2, Col. 44, ref. claim 1]. Therefore, Steil at a minimum suggest determining an adaptive filtering gain based on first and second derivatives, determining an output by applying said filtering gain, and outputting a filtered measurement value to an insulin delivery controller to cause delivery of insulin to a patient.
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].
Response to Arguments
Applicant’s arguments have been fully considered but are moot in view of the modified rejection (which is necessitated by applicant’s amendments).
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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