Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/10/2026 has been entered.
Claim Objections
The previous objections to Claim 1 are withdrawn based on the amendments filed on 4/10/2026.
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.
Claims 1, 3, and 8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation "the memory" in line 7 on page 2. There is insufficient antecedent basis for this limitation in the claim. Claims 3 and 8 are rejected due to their dependence on Claim 1.
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) 1, 3, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al (U.S. Pub. No. 2013/0261927, hereinafter “Erickson”) in view of Halac et al (U.S. Pub. No. 2019/0117133, hereinafter “Halac”), Kuehl (U.S. Pat. No. 4625857), Otero (U.S. Pub. No. 2016/0027084), and Garcia et al (U.S. Pub. No. 2017/0074757, hereinafter “Garcia”).
Regarding independent Claim 1, Erickson teaches a method of manufacturing a sensor assembly (Fig. 3), the method comprising: acquiring product information of a sensor (Fig. 3, step 310/320, paragraph [0024], sensor identification code 22); acquiring product information of a controller (Fig. 3, step 320, controller identification code 32); generating quality management information by mapping the acquired product information of the sensor and the acquired product information of the controller to each other (Fig. 3, step 340, paragraph [0027], authentication code 34b based on combination of sensor identification code 22 and controller identification code 32), and the sensor and the controller are assembled together with each other after generation of the quality management information (paragraph [0027], steps 310, 320, 330, and 340 are part of manufacturing process for forming the device that includes the sensor assembly and the sensor controller); wherein the production information of the transmitter among the quality management information is stored to a first area of the memory, and the production information of the sensor among the quality management information is stored to a second area of the memory (Fig. 3, step 340, paragraph [0027], authentication codes 34a and 34b may both be stored in the sensor controller 26; different bytes in the sensor controller memory are equated to first and second areas of memory; the authentication codes 34a/34b may include the calibration information 24, sensor identification code 22, and controller identification code 32, see paragraph [0026]).
Erickson does not specifically teach that a sensor transmitter is for continuous blood glucose measurement; that the controller is a transmitter; transmitting the quality management information to a management server to store and manage the quality management information in the management server, generating a quality management code used to read the quality management information; and generating a label including the generated quality management code; wherein the label is characterized by being generated so that at least one of the product information of a sensor or the product information of the transmitter can be read. However, Erickson does teach that the sensor controller is used to transform and send raw sensor data to an outside controller (see paragraph [0016]). Further, Halac teaches manufacturing a blood glucose measurement sensor including a sensor and a transmitter (paragraphs [0003]-[0004], glucose, paragraph [0007], paragraph [0187]), transmitting identifier and calibration information (equated to the claimed quality management information) to a remote system (e.g., a server, see paragraph [0201]) in paragraph [0232]; generating a quality management code used to read the quality management information; and generating a label including the generated quality management code; wherein the label is characterized by being generated so that at least one of the product information of a sensor or the product information of the transmitter can be read (identifier 450, which can be a QR code and is equated to the claimed label; see Fig. 4D, and paragraphs [0008] and [0220]). It would have been obvious to one skilled in the art before the effective filing date of the invention assemble the analyte sensor module of Halac according to the sensor assembly method of Erickson, and to associate the identifier of Halac to the mapped product information of Erickson, in order to verify that a sensor assembly is authentic (see Erickson, paragraphs [0001] and [0012]) and in order to ensure accuracy of the sensor via calibration (see Halac, paragraphs [0228]-[0232]).
Erickson and Halac do not specifically teach that the sensor is disposed in a tray; that the transmitter is disposed in the tray; and that the sensor and transmitter are disposed in one same tray. However, Halac does teach moving a sensor assembly between stations (paragraph [0181]). Further, Kuehl teaches in column 1, lines 16-27 that it is typical for factories to include conveyor belts with trays on the surface of the belt to carry articles from one station to another. It would have been obvious to one skilled in the art before the effective filing date of the invention to place the sensor and transmitter of Erickson and Halac together in the trays that are taught in Kuehl, because such trays are typical for moving articles between stations (see Kuehl, column 1, lines 16-27).
Erickson, Halac, and Kuehl do not specifically teach receiving member information for accessing the management server from a first communication terminal; receiving production information from the quality management code of the label from the first communication terminal; receiving a defect message of a defective sensor transmitter from the first communication terminal: and transmitting an alarm information for requesting to stop using a sensor transmitter to second communication terminal, wherein the second communication server is identified by referencing the quality management information stored in the server, and wherein the alarm information is selectively transmitted to a user confirmed, based on the mapping of the acquired product information of the sensor and the acquired product information of the transmitter in the quality management information, to be a user who uses or purchases a sensor transmitter which uses the same sensor as the defective sensor transmitter of which detect message is received or is manufactured with a transmitter using the same component. However, Erickson in view of Halac does teach sensors and associated controllers/transmitters, and also product information of a sensor and product information of a transmitter that are mapped to one another (see above). Further, Otero teaches receiving member information for accessing the management server from a first communication terminal (Fig. 5, paragraph [0049], email address equated to member information); receiving production information from the quality management code of the label from the first communication terminal (paragraph [0049]; product information is stored in user’s inventory; paragraph [0027], product being added to inventory via scanning a code on packaging is known in the art); receiving a defect message of a defective product from the first communication terminal (paragraph [0049], user can report product defects or dangerous events); and transmitting the alarm information for requesting to stop using a product to second communication terminal (paragraph [0044], push recall notification), wherein the second communication server is identified by referencing the quality management information stored in the server (paragraph [0044], the user inventory information that is scanned to identify products affected by the recall is stored in a server, and is equated to quality management information), and wherein the alarm information is selectively transmitted to a user confirmed, based on the mapping of the acquired product information of the sensor and the acquired product information of the transmitter in the quality management information, to be a user who uses or purchases a product that is the same as the defective product of which the defect message is received (paragraph [0044], recall notification is sent selectively only to users that have the affected product) or is manufactured with a transmitter using the same component (optional due to “or”). It would have been obvious to one skilled in the art before the effective filing date of the invention to apply the identifier code, the product defect reporting, and recall notification system of Otero to the quality management code, and the production information of a sensor or production information of a transmitter, that are taught by the system of Erickson in view of Halac, in order to increase the likelihood and frequency of defect reporting, and increase the speed of manufacturers discovering product defects (see Otero, paragraph [0049]), and to provide extra notice of product recalls (see Otero, paragraph [0044]).
Erickson in view of Halac, Kuehl, and Otero does not specifically teach that the label which attached to at least one of an applicator to which the sensor transmitter is mounted, an inner packaging of the applicator, and an outer packaging of the applicator. However, Garcia teaches an RFID device (which is used to identify the sensor) located on an applicator of an analyte sensor in paragraph [0184]. It would have been obvious to one skilled in the art before the effective filing date of the invention to include the identifying information of Halac on the applicator of the sensor, as taught in Garcia, in order to read the identification and calibration information for the sensor when the applicator is used to install the sensor in a patient (see Garcia, paragraph [0184]).
Erickson does not specifically teach wherein the production information of a sensor is acquired by reading a sensor identifier formed on the sensor, and wherein the production information of the transmitter is acquired by reading a transmitter identifier formed on an outer housing of the transmitter. However, Erickson does teach a sensor identification code 22. Further, Halac teaches a visual or optical identifier (such as a QR code) for identifying an analyte sensor that can identify the calibration data for the analyte sensor in paragraph [0008] and [0230]. It would have been obvious to one skilled in the art before the effective filing date of the invention read the visual or optical identifier such as is taught in Halac to determine an identifier of a sensor such as is taught in Erickson, and to determine an identifier of a sensor controller (i.e., a transmitter) such as is taught in Erickson, in order to verify that a sensor assembly is authentic (see Erickson, paragraphs [0001] and [0012]) and in order to ensure accuracy of the sensor via calibration (see Halac, paragraphs [0228]-[0232]).
Regarding Claim 3, Erickson in view of Halac, Kuehl, Otero, and Garcia teach everything that is claimed above with respect to Claim 1. Erickson does not specifically teach wherein the quality management code is used to be capable of reading the production information of the transmitter only among the quality management information (optional due to “or”), or is used to be capable of reading both the production information of the transmitter and the production information of the sensor. However, Halac teaches an identifier (such as a QR code) for identifying an analyte sensor that can identify the calibration data for the analyte sensor in paragraph [0008] and [0230], this calibration data would apply to both the sensor and the transmitter that is paired to the sensor (see paragraph [0004] of Halac). It would have been obvious to one skilled in the art before the effective filing date of the invention to include the identifier of Halac in the system of Erickson, in order to verify that a sensor assembly is authentic (see Erickson, paragraphs [0001] and [0012]) and in order to ensure accuracy of the sensor via calibration (see Halac, paragraphs [0228]-[0232]).
Regarding Claim 8, Erickson in view of Halac, Kuehl, Otero, and Garcia teach everything that is claimed above with respect to Claim 1. Erickson further teaches wherein the production information of the transmitter is stored in the memory of the transmitter (paragraph [0016], controller identification code 32 stored in memory of the sensor controller 26), and the production information of the transmitter is acquired from the memory (controller identification code is acquired from sensor controller 26 for use in method 300).
Response to Arguments
Applicant's arguments filed 4/10/2026 have been fully considered but they are not persuasive.
Regarding Claim 1, Applicant argues on page 6 that the cited references do not teach “wherein the production information of the transmitter among the quality management information is stored to a first area of the memory, and the production information of the sensor among the quality management information is stored to a second area of the memory”. The Examiner disagrees. Erickson teaches storing of multiple authentication codes. These codes would necessarily be stored in different areas of memory, because the same physical byte of memory cannot store two different things at the same time. It is noted that the claim does not define where the memory is, or what would be considered an area of memory (e.g., different bytes, or even bits, of data in storage may be considered to be different areas of memory). Further, it appears that Applicant might intend for this claim feature to refer to “product information”, which is acquired from the sensor and transmitter, rather than production information, which is received from the first communication terminal. It is noted that production information is only required to be received for one of the sensor or the transmitter, due to the recitation of “or” in line 13 on page 1.
Applicant goes on to argues on page 7-9 that the cited references do not teach “wherein the production information of the sensor is acquired by reading a sensor identifier formed on the sensor, wherein the production information of the transmitter is acquired by reading a transmitter identifier formed on an outer housing of the transmitter” The Examiner disagrees. Erikson teaches production information for a sensor and for a transmitter, and Halac teaches a visual or optical identifier (such as a QR code) for identifying an analyte sensor (see the updated rejection of Claim 1 above). Such a visual or optical identifier (e.g., a label) would necessarily be located on an outer surface, or housing, of a device; otherwise, it would not be visible. Such visual or optical identifiers are known in the art (see, for example, paragraphs [0028] and [0029] of Otero, barcode and QR code scanning to identify a product are known in the art). Further, it appears that Applicant might intend for this claim feature to refer to “product information”, which is acquired from the sensor and transmitter, rather than production information, which is received from the first communication terminal. It is noted that production information is only required to be received for one of the sensor or the transmitter, due to the recitation of “or” in line 13 on page 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA L DAVIS whose telephone number is (571)272-1599. The examiner can normally be reached Monday-Friday, 7am to 3pm.
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/CYNTHIA L DAVIS/ Examiner, Art Unit 2857
/SHELBY A TURNER/ Supervisory Patent Examiner, Art Unit 2857
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