CTNF 18/838,806 CTNF 95210 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on August 15, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings The drawings filed on August 15, 2024 are accepted. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-20 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 of the subject matter eligibility test (see MPEP 2106.03). Claim 1 is directed to “a method” which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claim 9 is directed to “a method” which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claim 20 is directed to “a system” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture. Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions. Step 2A of the subject matter eligibility test (see MPEP 2106.04). Prong One: Claims 1, 9 and 12 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “determining a rate of change of the plurality of temperature data over the first time period; if the determined rate of change of the plurality of temperature data is above a predetermined threshold, receiving user input to confirm exposure to a radiologic procedure during the first time period; and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to radiologic procedure.” In claims 1, 9 and 12, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the analyte data and temperate data, either in a printout or an electronic format, he/she would be able to perform the calculations to obtain the temperature rate and determine it is above a threshold via pen and paper. There is nothing recited in the claim to suggest an undue level of complexity in how the time period and rate of temperature change is to be identified. Therefore, a person would be able to perform the analysis mentally or with a generic computer. Prong Two: Claims 1, 9 and 12 do not include additional elements that integrate the mental process into a practical application. This judicial exception is not integrated into a practical application. In particular, the claims recites (1) “receiving a plurality of analyte data over a first time period monitored by an analyte sensor in fluid contact with bodily fluid under a skin surface, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data over the first time period from a temperature sensor;” (2) “one or more processors, a memory storing instructions”. The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). The steps in (2) merely recite generic computer components used to implement the abstract idea on, as tools. As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application. Step 2B of the subject matter eligibility test (see MPEP 2106.05). Claims 1, 9 and 12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) “receiving a plurality of analyte data over a first time period monitored by an analyte sensor in fluid contact with bodily fluid under a skin surface, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data over the first time period from a temperature sensor;” (2) “one or more processors, a memory storing instructions”. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. The analyte information is obtained from an analyte sensor and temperature data from a temperature sensor. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of continuous glucose monitoring, as the sensors recited are well understood, routine and conventional, as evidenced by the lack of written descriptions describing the sensors, because they are generic and well-known. See MPEP 2106.05(d)(I). Accordingly, these additional steps and tools for measuring a pulse wave signal, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0061] describing generic computers). Therefore, none of the Claims 1, 9 and 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 9 and 20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG. Dependent Claims The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: Claims 2-3, 5-6, 10-11, 13-14 recitations further limits the abstract idea above, defining the time period or threshold merely further defines the mental process discussed above. The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons: Claims 4, 7, 12, 15, 17 and 19 further define the sensors used for insignificant extra-solution activity (data collection). The sensors recited are well understood, routine and conventional. Claims 8, 16 and 18 recitations merely recite data transmission to the output device discussed above as extra-solution activity (data output). Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 4-9 and 12-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kamen et al. (US 2018/0008788 A1) (“Kamen”) . Regarding claims 1, 9 and 20 , Kamen discloses A method, comprising (Abstract and entire document) : receiving a plurality of analyte data over a first time period monitored by an analyte sensor in fluid contact with bodily fluid under a skin surface, the plurality of analyte data corresponding to an analyte level ([0041], “In other embodiments, the controller additionally includes a glucose monitoring device which receives data from a blood glucose sensor” [0130], “CGM”) ; receiving a plurality of temperature data over the first time period from a temperature sensor ([0039], temperature sensors) ; determining a rate of change of the plurality of temperature data over the first time period ([0059] – [0061] rate of change of temperature) ; if the determined rate of change of the plurality of temperature data is above a predetermined threshold, receiving user input to confirm exposure to a radiologic procedure during the first time period [0093] threshold temp change, and [0057] receiving user input to changes, see also [0058] discussing during an MRI, confirm exposure to treatment by confirming the changes and thus confirming the radiologic procedure, wherein radiologic procedure is interpreted following [0146] of the present application including exposure to MRI as a radiologic procedure) ; and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to radiologic procedure ([0093] and [0057 – 0062] changes in temp confirmed with confirmed exposure to radiation event, i.e. MRI and the insulin delivery is adjusted to compensate, see further [0086]) . Regarding claims 4 and 12 , Kamen discloses The method of claim 1, wherein the user input is received via a reader device ([0057] UI) . Regarding claims 5 and 13 , Kamen discloses The method of claim 1, wherein adjusting the plurality of analyte data includes removing the plurality of analyte data for the first time period ([0058] removing device removes data for the time period) . Regarding claims 6 and 14 , Kamen discloses The method of claim 1, wherein adjusting the plurality of analyte data includes ignoring the plurality of analyte data for the first time period ([0058] removing device ignores data for the time period) . Regarding claims 7 and 15, Kamen discloses The method of claim 1, wherein the temperature data comprises an on-skin temperature data ([0058] attached to skin) . Regarding claims 8 and 16 , Kamen discloses The method of claim 1, wherein confirming exposure to the radiologic procedure comprises generating an alarm ([0057] – 0061] alerted with a user confirmation, see also [0107] alert) . Regarding claims 17 and 19 , Kamen discloses The method of claim 9, wherein the temperature data received from the temperature sensor is at least of on-skin temperature, ambient temperature, subcutaneous temperature, sensor-tip temperature, internal body temperature, of internal temperature of a sensor control device of the analyte sensor ([0058] attached to skin) . Regarding claim 18 , Kamen discloses The method of claim 8, wherein the alarm is at least one of an auditory, visual, or haptic alarm ([0057] – 0061] alerted with a user confirmation, see also [0107] alert) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim s 2-3 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen . Regarding claims 2 and 10 , Kamen discloses The method of claim 1, Kamen fails to explicitly disclose wherein the time period includes one hour ([0092 – 0092] preset time period, 24 hours includes one hour, 20 minutes for example,) . It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal time period, including an hour. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the time period is one hour this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Regarding claims 3 and 11 , Kamen discloses The method of claim 1, Kamen fails to explicitly disclose wherein the predetermined threshold is 4 degrees Celsius over 15 minutes (Kamen discloses monitoring [0092 – 0092] preset time period, for temperature changes) . It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal threshold including 4 degrees Celsius over 15 minutes. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the threshold is 4 degrees Celsius over 15 minutes, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hayter et al. (US 9974472 B2) provide accurate glucose levels by compensating for temperature effects on the sensor. Feldman et al. (US 8185181 B2) teaches concept of using temperature data, including its rate of change and thresholds, in conjunction with analyte data to confirm conditions and manage data integrity, specifically to reduce false alarms related to physiological conditions . Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern). 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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 https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSEPH A TOMBERS/Examiner, Art Unit 3791 Application/Control Number: 18/838,806 Page 2 Art Unit: 3791 Application/Control Number: 18/838,806 Page 3 Art Unit: 3791 Application/Control Number: 18/838,806 Page 4 Art Unit: 3791 Application/Control Number: 18/838,806 Page 5 Art Unit: 3791 Application/Control Number: 18/838,806 Page 6 Art Unit: 3791 Application/Control Number: 18/838,806 Page 7 Art Unit: 3791 Application/Control Number: 18/838,806 Page 8 Art Unit: 3791 Application/Control Number: 18/838,806 Page 9 Art Unit: 3791 Application/Control Number: 18/838,806 Page 10 Art Unit: 3791 Application/Control Number: 18/838,806 Page 11 Art Unit: 3791 Application/Control Number: 18/838,806 Page 12 Art Unit: 3791
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