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 .
Status of Claims
Applicant’s amendment has been fully acknowledged and considered. Claims 1-4, 6-15 are pending. Claim 5 is canceled. Claim 1 and 7 are amended.
Claim Objections
Claim 8 objected to because of the following informalities: Though claims 8-15 are withdrawn from consideration, Examiner notes that there are two “Claim 8”s. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazlish et al. (US 20190274624 A1 – cited by Applicant), hereinafter Mazlish.
Regarding Claim 1 and 7, Mazlish teaches: A method, performed by an alarm system linked to a drug injector, of differentially generating an alarm (paragraph 0004-0005), as well as a computer-readable recording medium having recorded thereon a program for executing the method on a computer (paragraph 0095; 0105; figure 1A); the method comprising the steps of:
receiving state information from the drug injector (paragraph 0005);
determining priority of an alarm and a type of the alarm based on the received state information of the drug injector and a response scenario corresponding to the state information (paragraph 0005); and
differentially generating an alarm that stimulates at least one of senses of sight, hearing, and touch, based on the type and priority of the alarm, and the response scenario(paragraph 0005 - audible, visual, or haptic alarm);
wherein the step of differentially generating the alarm comprises steps of:
mapping an alarm expression method according to the determined priority and type of the alarm (figure 4);
selectively combining alarm expression methods based on the response scenario (figures 5A-16B; paragraph 0097-0101); and
differentially providing the alarm to a user based on the combined alarm expression methods (figures 5A-16B; paragraph 0097-0101).
Regarding Claim 2, Mazlish teaches: The method of claim 1, wherein the step of receiving the state information comprises: a step of receiving state information regarding an operation or an error of the drug injector, through a communication module of the drug injector, or a communication module of a controller linked to the drug injector (paragraph 0004-0006; 0013).
Regarding Claim 3, Mazlish teaches: The method of claim 1, wherein a type of the response scenario comprises at least one of a response scenario related to a significant risk to a user's safety, a response scenario requiring an urgent process, a response scenario related to a predicted future situation, and a response scenario for managing the drug injector or the controller (paragraph 0007-0008).
Regarding Claim 4, Mazlish teaches: The method of claim 1, wherein the step of differentially generating the alarm comprises a step of:
first providing a visual alarm and a tactile alarm according to the determined priority and type of the alarm and then differentially providing an auditory alarm and a visual alarm, or
providing an auditory alarm along with the visual alarm and the tactile alarm (paragraph 0021-0025).
Regarding Claim 6, Mazlish teaches: The method of claim 1, further comprising a step of recommending an alarm providing method setting suitable for a user based on the user's alarm checking habits (paragraph 0004).
Response to Arguments
Applicant argues that Mazlish does not disclose determining an alarm type, or discloses priority/alarm type based on response scenario. Examiner disagrees. Figure 4 clearly shows different alarm types (alarms/alerts, disruptive and non-disruptive) and also shows different response types (system information, good to know, should know, should act, must act). And further teaches assigning priority to alarms (paragraph 0102). While Applicant argues that figure 4 is merely a concept, and not a “mapping”, Examiner respectfully notes that under the broadest reasonable interpretation, figure 4 can be considered a mapping.
Applicant further argues that Mazlish fails to mention state information. Examiner disagrees. Figure 4 mention system information and paragraph 0106 among others mention alarm priority related to battery conditions.
Applicant argues that paragraph 0005 of Mazlish mentions that alarms may have alternative conditions, and thus cannot anticipate the claimed inventions. Examiner disagrees. The disclosure of alternatives does not mean that the claimed invention cannot be anticipated. Mazlish discloses the claimed limitation, and thus is considered an anticipatory reference.
Regarding Claim 3, Applicant argues that fails to teach “a response scenario related to a significant risk to a user's safety, a response scenario requiring an urgent process, a response scenario related to a predicted future situation, and a response scenario for managing the drug injector or the controller”. Examiner respectfully disagrees. Examiner notes that Claim three also recites “at least one of”. As long as one response scenario is disclosed, the claim is met. Figure 4 Clearly shows many of the recited limitations. Paragraph 0008 also clearly states “a notice regarding a need to administer additional insulin to correct a current or anticipated hyperglycemic condition.” as well as “user is alerted to safety concerns in a timely manner so that the user can take appropriate corrective action. Additional information that may be displayed on the medication delivery device may include an indication that the amount of medication in the medication delivery device is below a threshold or completely depleted, an indication that an amount of power remaining in a battery in the medication delivery device is below a threshold, an indication that the fluid path for the medication is occluded, or an indication that a message is awaiting the user on the remote user-interface device”
Regarding Claim 4, Applicant argues that the limitation “first providing a visual alarm together with a tactile alarm and thereafter differentially providing an auditory alarm together with a visual alarm” is not taught. Examiner respectfully disagrees. This is further explained in paragraphs 0098-0102 and 0111-0116 - that visual audible and haptic alarms can be simultaneously presented, as well as progression of alarms.
Regarding Claim 6, Applicant argues that Mazlish “does not disclose or suggest recommending an alarm providing method setting suitable for a user based on the user's alarm checking habits”. Examiner notes that paragraph 0004 teaches that “a remote user-interface device can be programmed by the user to not provide audible alarms” which, under the broadest reasonable interpretation, can read on the limitation “based on the user's alarm checking habits”. The rejections are maintained.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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