DETAILED ACTION
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 2-8, 11, and 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.
As to claim 2, the claim recites the determining based “at least on contextual information indicating that the signal generated by the analyte sensor was stable prior to the drop and criteria including a predetermined signal pattern and/or a rate of change of the signal”. It’s unclear whether the “criteria” is a second, independent basis for the determining step, or a component of the contextual information itself. It is further unclear what the recited criteria are applied to. Clarification is required. For purposes of interpretation, it will be considered to be two separate basis.
Claims 4, 11, and 17 recite the limitation "the determination that the user is compressing the sensor site". There is insufficient antecedent basis for this limitation in the claim. The parent claims only recite the determination that the user “may be compressing at least the sensor site”, and it is unclear whether the dependent claims require a further, affirmative determination of the compression. If not, correction to “the determination that the user may be compressing the sensor site” is suggested.
As to claim 8, the claim recites “the responsive action includes generating an alarm indicating that the user may entering a hypoglycemic state” which is grammatically incomplete and is suggested to amend “may” to “may be”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-6, 8-13, 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,231,659; 10,238,322; 10,238,323; 10,238,324; and 12,048,540. Although the claims at issue are not identical, they are not patentably distinct from each other because the above patents all recite various ways of discriminating a fault type by evaluating clinical context data against clinical context criteria and performing responsive processing based on the discriminated fault type.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9, 11-13 are is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bohm (US 2012/0078071).
As to claim 9, Bohm teaches a method for discriminating a fault type in an analyte sensor inserted at least partially into a user at a sensor site ([0123], [0276] – detecting reduced signal due to compression), the method comprising: receiving sensor data based at least in part on a signal generated by the analyte sensor ([0126]); determining the user may be compressing at least the sensor site based at least on information indicating an activity of the user and a predetermined activity pattern associated with the user ([0104] – the use of known individual physiological patterns. Incorporated reference (US 2007/0208246) teaches in [0519] that information about sleep is something that is obtained. As Bohm teaches that compression can occur while the user is sleeping on the sensor system in [0277], the incorporation of the above reference means it teaches the determination the user may be compressing the sensor site based on activity information or predetermined activity pattern); discriminating the fault type as a compression fault based at least in part on determining the user may be compressing the sensor site ([0281]); and performing a responsive action based at least on discriminating the fault type as a compression fault ([0279]).
As to claim 11, Bohm teaches compensating by at least extending a reliable portion of the sensor signal to replace at least an unreliable portion of the sensor signal ([0088] – extrapolation).
As to claim 12, Bohm teaches the responsive action includes blanking a display configured to display an estimated analyte concentration value ([0279]).
As to claim 13, Bohm teaches the analyte sensor is a glucose sensor (Abstract)
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.
Claim(s) 2-6, 8, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goode (US 2010/0234707) in view of Bohm et al. (US 2012/0078071).
As to claim 2, Goode teaches a method for discriminating a fault type in an analyte sensor ([0007]) inserted at least partially into a user at a sensor site ([0273]), receiving sensor data based at least in part on a signal generated by the analyte sensor, wherein the sensor data indicates a drop in the signal generated by the analyte sensor ([0328] – loss of signal gain in the sensor data); determining the fault based at least on contextual information indicating that the signal generated by the analyte sensor was stable prior to the drop ([0380] – Using the cone of possibility method, data points that are considered to be within said cone would be considered stable) and based on criteria including a predetermined signal pattern and/or a rate of change of the signal ([0136]; [0328] – ischemia); and performing a responsive action based at least on discriminating the fault type ([0334] – replacement initiated in response to detection of signal artifacts).
While Goode does teach that the signal drop can be a result of transient ischemia which is similar to the blanching of skin that can be observed when one puts pressure on it ([0328]), as well as the monitoring of pressure and/or stress of the sensor or any of its components ([0352]), Goode does not expressly teach determining the user may be compressing at least the sensor site and discriminating the fault type as a compression fault based at least in part on determining the user may be compressing the sensor site.
Bohm teaches this limitation. Bohm teaches that sensors can become inaccurate when the tissue in proximity to the sensor is compressed ([0276]) and that one possible cause of said compression is when a user sleeps on the sensor system ([0277]) and to detect the compression ([0281]). As such, Bohm specifically teaches discriminating the fault type as a compression fault. It would have been obvious to modify Goode with Bohm to allow for positive confirmation of a compression fault, so that corrective action can be taken.
As to claim 3, Bohm teaches prompting the user when compression is detected ([0279]) and states that accuracy returns when the patient adjusts position and no longer compresses the sensor ([0278]). Accordingly, it would have been obvious, if not necessarily inherent, that Bohm’s alert would be configured to prompt the user to change positions, as Bohm teaches that accuracy only returns when the patient adjusts position and teaches the output of an alert when compression is detected.
As to claim 4, Goode teaches compensating by at least extending a reliable portion of the sensor signal to replace at least an unreliable portion of the sensor signal ([0335]).
As to claim 5, Goode fails to expressly teach the responsive action includes blanking a display configured to display an estimated analyte concentration value. Bohm teaches that upon detection of compression, the initiated action can include the suspension of display of data on a display device ([0279]). It would have been obvious to further modify the above combination with Bohm to prevent the display of erroneous data to prevent any potential user confusion.
As to claim 6, Goode teaches the analyte sensor is a glucose sensor (Abstract).
As to claim 8, Goode teaches the responsive action includes generating an alarm indicating that the user may entering a hypoglycemic state ([0297] – alerts for present and/or predicted hyper and hypoglycemic conditions), which, in combination with Bohm, would be a result of discriminating the fault type as a compression fault, particularly as Bohm teaches that alerts can be “clinical risk alerts” which combine intelligent and dynamic estimative algorithms that estimate present or predicted danger ([0104]) and that the a proper detection of hypoglycemia can be life-saving ([0275]).
As to claim 15, Goode teaches a method for discriminating a fault type in an analyte sensor ([0007]) inserted at least partially into a user at a sensor site ([0273]), receiving sensor data based at least in part on a signal generated by the analyte sensor, wherein the sensor data indicates a drop in at least a portion of the signal ([0328] – loss of signal gain in the sensor data); receiving oxygen data indicating an oxygen concentration at the sensor site ([0338]); determining based at least on a comparison between the sensor data and the oxygen data, wherein the comparison indicates the drop in at least the portion of the signal generated by the analyte sensor occurred at the same time as a drop in the oxygen concentration ([0341-342] – when insufficient oxygen is available, it affects the counter electrode values, [0335], [0337]), and performing a responsive action based at least on discriminating the fault type as a compression fault ([0334] – replacement initiated in response to detection of signal artifacts).
While Goode does teach that the signal drop can be a result of transient ischemia which is similar to the blanching of skin that can be observed when one puts pressure on it ([0328]), as well as the monitoring of pressure and/or stress of the sensor or any of its components ([0352]), Goode does not expressly teach determining the user may be compressing at least the sensor site and discriminating the fault type as a compression fault based at least in part on determining the user may be compressing the sensor site.
Bohm teaches this limitation. Bohm teaches that sensors can become inaccurate when the tissue in proximity to the sensor is compressed ([0276]) and that one possible cause of said compression is when a user sleeps on the sensor system ([0277]) and to detect the compression ([0281]). As such, Bohm specifically teaches discriminating the fault type as a compression fault. It would have been obvious to modify Goode with Bohm to allow for positive confirmation of a compression fault, so that corrective action can be taken.
As to claim 16, Bohm teaches prompting the user when compression is detected ([0279]) and states that accuracy returns when the patient adjusts position and no longer compresses the sensor ([0278]). Accordingly, it would have been obvious, if not necessarily inherent, that Bohm’s alert would be configured to prompt the user to change positions, as Bohm teaches that accuracy only returns when the patient adjusts position and teaches the output of an alert when compression is detected.
As to claim 17, Goode teaches compensating by at least extending a reliable portion of the sensor signal to replace at least an unreliable portion of the sensor signal ([0335]).
As to claim 18, Goode fails to expressly teach the responsive action includes blanking a display configured to display an estimated analyte concentration value. Bohm teaches that upon detection of compression, the initiated action can include the suspension of display of data on a display device ([0279]). It would have been obvious to further modify the above combination with Bohm to prevent the display of erroneous data to prevent any potential user confusion.
As to claim 19, Goode teaches the analyte sensor is a glucose sensor (Abstract).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm (US 2012/0078071).
As to claim 10, Bohm teaches prompting the user when compression is detected ([0279]) and states that accuracy returns when the patient adjusts position and no longer compresses the sensor ([0278]). Accordingly, it would have been obvious, if not necessarily inherent, that Bohm’s alert would be configured to prompt the user to change positions, as Bohm teaches that accuracy only returns when the patient adjusts position and teaches the output of an alert when compression is detected.
Allowable Subject Matter
Claims 7, 14, 20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as overcoming any applied rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As to claims 7, 14, and 20, the prior art of record fails to teach and/or fairly suggest, in combination with all other recited limitations, determining the user may be compressing at least the sensor site further includes comparing at least a portion of the signal generated by the analyte sensor to a template signal shape indicating a compression artifact.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 9/9/26
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