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
Claims 1-4, 6-20, have been reviewed and addressed below. Claim 5 has been cancelled.
Response to Amendment/Arguments
Applicant’s amendments filed on 7-1-26 has been entered and are addressed below.
Applicant argues that the claimed invention provides several practical applications that flow from it’s solution through feedback control loop. Examiner respectfully disagrees. The timing of readings is still gathering of data, it does not improve the medical instrument or the dongle itself. Though the claim mentions that it improves adverse event anticipation, it does not indicate how it improves the adverse event anticipation, just that the dongle prompts a reading at regular time intervals. The instant claims collect data at a certain time frequency, which it then uses to generate risk scores. Providing updated scores/data is not an improvement to the technology, it is just updating the calculated data based on new information received.
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 1-4, 6-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-4, 6-20 are drawn to computer method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1, 8, 18 recite “receive data, the data including one or more metrics being measured”, “send periodic signal of a first frequency”, “wherein when one or more of the one or more metrics exceeds a pre-determined boundary parameter or one or more aggregated metrics generate a high patient risk score, the dongle sends periodic signals of a second frequency”, “wherein the dongle prompts to read at regular intervals to satisfy synchronous and asynchronous readings for multiple metrics, thereby normalizing asynchronous timescales for the one or more metrics to improve adverse event anticipation”.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover mental process since the steps can be performed manually using a pen and paper. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “dongle”, “microcontroller”, “an antenna in communication with the microcontroller”, “one or more medical instruments” which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “processor” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The claims recite the additional element of “one or more metrics being measured by the medical instrument” which is considered limitations directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. See: MPEP 2106.05(g). (g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
paragraph 41 that “a proprietary dongle 10 (shown in two possible sizes, 10a and 10b) is created through a normal small microcontroller 14 (e.g., microchip SAMD21A1 board), antenna 16, and optionally an IUI connector (not shown) when used with an infusion pump”.
The claims recite the additional element of “one or more metrics being measured by the medical instrument” which is considered limitations directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-4, 6-7, 9-17, 19-20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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 REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid R. Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684