DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent
provisions.
Applicant elected Group I, claims 1-11 and 12-17. without traverse.
In in the next communication, the applicant is required to cancel the non-elected
claims.
Information Disclosure Statement
The IDS submitted contain over 160 references. The Examiner has considered
the references to the extent reasonably expected during normal examination time. If Applicant considers there is a particular reference or teaching particularly relevant to the claimed invention it is requested from the Applicant to provide a statement indicating such relevance and a clear identification of such reference.
Under 35 USC § 101
Although claims 1 and 12 include abstract ideas, claims 1 and 12 also recite
additional element such as “disabling the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range”. The inclusion of this additional element integrates the identified judicial exception into a practical application that effects a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Therefore, claims 1-17 are considered to be eligible under 35 USC § 101.
Claim Rejections - 35 USC § 112
6. 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.
Claim 8 is 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 8 recites the limitation “wherein the rate variance comprises 3”. The metes and bounds of this limitation are unclear because it is not reasonably certain what it means for a “rate variance” to “comprise 3”. Specifically, it is unclear whether “3” refers to: (i) a numerical variance value equal to 3; (ii) a threshold greater than or less than 3; (iii) a component or parameter of a variance calculation; (iv) a normalized variance value; or (v) some other statistical relationship. The claim language therefore fails to provide reasonable certainty to one having ordinary skill in the art regarding the scope of the claimed “rate variance”. Accordingly, the scope of claim 8 cannot be determined with reasonable certainty. See MPEP § 2173.02.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject
matter:
Regarding claim 1, the closest prior art of record, including Mault et al. (Pub. No. US 2003/0208113) and Jin et al. (Pub. No. US 2004/0186365), fails to teach or suggest “disabling the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range”, in combination with the rest of the claim limitations as claimed and defined by the applicant. Mault et al. teaches projecting and displaying future blood glucose levels and providing alerts associated with predicted excursions, while Jin et al. teaches continuous glucose monitoring using stored and current glucose measurements. However, neither reference, alone or in combination, teaches or fairly suggests disabling the display trend projection based on a determination that the estimated trend information exceeds a tolerance range or otherwise lacks sufficient reliability. Instead, the references consistently teach continued presentation of projected glucose information and warnings to the user. Accordingly, none of the prior art of record teaches or fairly suggests a method of determining glucose information, comprising: disabling the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range, in combination with the rest of the claim limitations as claimed and defined by the applicant.
Regarding claim 12, the closest prior art of record, including Mault et al. (Pub. No. US 2003/0208113) and Jin et al. (Pub. No. US 2004/0186365), fails to teach or suggest “disabling the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range”, in combination with the rest of the claim limitations as claimed and defined by the applicant. Mault et al. teaches projecting and displaying future blood glucose levels and providing alerts associated with predicted excursions, while Jin et al. teaches continuous glucose monitoring using stored and current glucose measurements. However, neither reference, alone or in combination, teaches or fairly suggests disabling the display trend projection based on a determination that the estimated trend information exceeds a tolerance range or otherwise lacks sufficient reliability. Instead, the references consistently teach continued presentation of projected glucose information and warnings to the user. Accordingly, none of the prior art of record teaches or fairly suggests a glucose monitoring system, comprising: one or more processors; and a memory operatively coupled to the one or more processors for storing instructions which, when executed cause the one or more processors to: disable the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range, in combination with the rest of the claim limitations as claimed and defined by the applicant.
Prior art
The prior art made record and not relied upon is considered pertinent to applicant’s
disclosure:
Brister et al. [‘621] relates to continuous analyte monitoring systems, particularly transcutaneous glucose monitoring systems configured to measure glucose levels in a host using transcutaneous electrochemical sensors. The reference discloses glucose sensor assemblies including working and reference electrodes, analyte controlling membranes, enzyme domains, sensor electronics, wireless communication modules, and remote receivers configured to receive, process, filter, calibrate, store, and display glucose-related information, including numerical values, graphical information, and trend information. The disclosure further describes manufacturing techniques for analyte sensors, user interfaces providing visual, audible, and tactile alerts, and operational control mechanisms such as software keys, license codes, sensor duration controls, and expiration management configured to limit or disable operation of the glucose monitoring system after predetermined usage period.
Kellog et al. [‘621] discloses a system and method for continuous non-invasive glucose monitoring is disclosed. According to one embodiment of the present invention, the method includes the steps of (1) contacting a remote device to an area of biological membrane having a permeability level, the remote device comprising a sensor and a transmitter; (2) extracting the at least one analyte through and out of the area of biological membrane and into the sensor; (3) generating an electrical signal representative of a level of the at least one analyte; (4) transmitting the electrical signal to a base device; (5) processing the electrical signal to determine the level of the at least one analyte; and (6) displaying the level of the at least one analyte in real time. The system includes a remote device that includes a sensor that generates an electrical signal representative of the concentration of the at least one analyte; and a transmitter that transmits the electrical signal. The system further includes a base device that includes a receiver that receives the electrical signal; a processor that processes the electrical signal; and a display that displays the processed signal in real time.
Kamath et al. [‘635] discloses systems and methods for calibrating a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes one or more electrodes to measure an additional analyte. Such measurements may provide a baseline or sensitivity measurement for use in calibrating the sensor. Furthermore, baseline and/or sensitivity measurements may be used to trigger events such as digital filtering of data or suspending display of data.
Contact information
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to MOHAMED CHARIOUI whose telephone number is (571)272-2213. The examiner can normally be reached Monday through Friday, from 9 am to 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached on (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Mohamed Charioui
/MOHAMED CHARIOUI/Primary Examiner, Art Unit 2857
Prosecution Insights