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 Objections
Claim 4 is objected to because of the following informalities: the second recitation of the term “comprising” (line 2) should be deleted, as it does not add to claim clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
According to Step 1 of the eligibility analysis, the claim(s) are directed to a “method” which is within a statutory category of invention.
According to Revised Step 2A, Prong One of the eligibility analysis, the claims recite(s) details of mental steps: “calculating a next calibration time based on an input time…” (which refers to performing simple addition, which is within the mental capabilities of a person). According to Revised Step 2A, Prong Two of the eligibility analysis, this judicial exception (abstract ideas: mental process) are not integrated into a practical application because the claims only provide details drawn to generic processing aspects beyond the judicial exception, as the claims merely require the processor to recognize a time when other data was provided via “inputting”. Examiner notes that while information for calibrating is referred to in the “inputting”, the contents of this data does not affect determination of its corresponding time of input, nor do any claimed method steps act upon the input data. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as indicated, additional elements are not recited or required for the processor to be able to have “inputting” of data that is not influencing performance of any steps. Examiner further notes that in the claims an alarm is provided which is merely responsive to the output of the judicial exception but is not indicative of integration of the exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception under the eligibility analysis Step 2B because, as indicated, any additional elements in the claims are merely recited in a generalized/high level manner or do not positively limit the claim scope.
Further, no details in any dependent claim are sufficient to show integration of the judicial exception, nor do any of those claims recite details that are considered to amount to significantly more under the eligibility analysis Step 2B, since they merely recite aspects of the judicial exception and/or mere generalized details.
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.
Claim(s) 1 – 7, 10, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saidara et al. (EP 2256494 – cited by Applicant). Saidara et al. discloses a calibration alarm method (para. [0102]) comprising:
inputting a reference biometric value for calibrating a measurement biometric value measured by a sensor (para. [0102], a reference value is provided);
when the reference biometric value is input, calculating a next calibration time based on input time of the reference biometric value (para. [0102]: " ... the user can be reminded to supply a new reference value after a minimum time period has elapsed' and para. [0099] " ... The reminders can be alarm signals."); and
providing a calibration alarm to a user based on the next calibration time (para. [0089], "prompt the user to perform ... blood glucose test to execute ... calibration routine"), wherein the sensor is configured to be insertable into a body of the user and continuously measure biometric information of the user for a certain period of time (para. [0102] "Thus, the user can be reminded to supply a new reference value after a minimum time period has elapsed.").
Additionally, Saidara et al. disclose details consistent with the scope of claims 2, 10-11, in discussing uses for calibrating and monitoring blood glucose levels (para. [0101]); details regarding claims 3-4 and 7, where Saidara et al. teaches controlling alarm generation to account for events and to avoid creating redundant/nuisance reminders (para. [0104]) and regarding claims 5-6, as Saidara et al. discloses use of techniques to provide a dynamic adjustment to generating the alarm under certain conditions (para. [0098]).
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) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saidara et al. as applied to claim 1 above. Saidara et al. teaches determination of alarm timings relative to calibration data inputs as discussed above, but does not particularly detail calculation and adjustments of the calibration value/factor. However, it is generally recognized that a variety of processing techniques are available for updating calibration factors used in continuous glucose monitoring systems. Without a showing of criticality or unexpected results, it would have been within the skill level of the art before the effective filing date of the claimed invention to rely on previously known calibration factors or modifying them after performing subsequent calibration measurements consistent with known standard calibration techniques to yield predictable results.
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 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/693,126 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the copending application. As such, any invention meeting the limitations of the copending application claims would necessarily meet those of the instant application as well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vaissiere (USPN 10,901,371) teach a method for determining a calibration or maintenance time interval, as generally summarized in column 3, lines 18 - 52.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791