DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed 9/4/25. Claims 1-16 are pending.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 has been amended to further Similarly, claim 15 has been amended to cancel its dependence from claim 1, and further to recite: “wherein the consumer electronic device is configured to…”
As drafted, it is unclear whether the recited “consumer electronic device” is an integral component of the recited system, as it is never claimed as a system component. In particular, the antecedent basis for a “consumer electronic device” is an intended use clause describing the communication module a communications module including at least a short range wireless communications capability for communication with a consumer electronic device including any one or more of a smartphone…”
Therefore it is unclear how the additional functionalities recited in wherein clause “wherein the consumer electronic device is configured to” further defines the Applicant’s inventive system. It is not clear whether the recited functions further define the functions of the inventive system because it is not clear whether the “consumer electronic device” is a required, integral component of the inventive system. (i.e. a medical device and secure control system comprising: 1) a wearable medical device; 2) a consumer electronic device including any one or more of a smartphone, a personal computer, a smartwatch and a computer tablet; AND 3) a medical device component comprising i) a communications module…, ii) a memory…and iii) a processor…)
Claim Rejections - 35 USC § 103
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 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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Spencer et al (US 9980140 B1) in view of Dicks et al (US 20150169314 A1), and in further view of Abrahamsson et al (US 20210035670 A1)
Claim 1 Spencer teaches medical device and secure control system comprising:
a wearable medical device comprising a pump configured to inject insulin into a user and (col. 16, lines 19-29: The device can include one or more additional components that implement these features, such as a drug delivery system 226 (e.g., insulin pump); Fig. 9A-C)
a medical device controller, (col. 16, lines 47-60) i) comprising a communications module including at least a short range wireless communications capability for communication with a consumer electronic device (col. 40, lines 1-15) including any one or more of a smartphone, a personal computer, a smartwatch and a computer tablet, ( col. 16, lines 47-60; fig. 1) ii) a memory (col. 16, line 34-col. 17, line 67) configured to store a computer program and encryption keys configured to establish an encrypted communication with the consumer electronics device (col. 14, lines 10-col. 15, lines 47; col. 16, line 34-col. 17, line 67) and
iii) a processor configured to execute the computer program, wherein the medical device controller and the medical device are configured to each store at least one journal for exchange of journal entries between the medical device controller and the consumer electronic device and between the medical device controller and the medical device, the journal entries comprising user identification, user rights, and operations instructed to the medical device, (Fig. 2-instruction sets; col. 14, lines 11-57: the processors 208 and the encryption chipsets 209 can be programmed to encrypt and to store the following as encrypted data 211: patient dosage parameters and models, patient data (e.g., sensor readings, medicine dosing log), keys for authentication and encryption, policies governing commands to which the device 206 responds, firmware and/or instructions that are executed by the device 206 (e.g., the instruction sets 212), and/or other appropriate information; col. 16, line 47-col. 17, line 30: the device controller application 252 can be programmed to use the processors 230 and the encryption chipsets 232 to encrypt all data that is stored locally by the device controller application 252 and to store it as encrypted data 246, and can be programmed to encrypt all packets that are transmitted to the device 206 and/or the computer system 202. Furthermore, the device controller application 252 can be configured to establish a secure network connection, such as a BLE connection using AES in GCM mode) and
wherein the medical device controller is configured to provide encrypted communications to a consumer electronic device and receive information from a consumer electronic device. (col. 9, lines 1-20; col. 17, lines 1-60; Fig. 10; consumer electronic device interpreted as computer system/ mobile computing device- See also col. 17, lines 9-19; col. 28, lines 54-col. 29, line 15;)
Spencer does not disclose, but Dicks teaches:
transmit instructions to the medical device based on the data input comprising instructions for operation of the medical device to cause the medical device to adjust operation of the pump of the medical device. (par. 18; Fig. 10; par. 161-166)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of Spencer with the teaching of Dicks, with the motivation updating software in electronic devices without requiring a wired data interface to affect changes and to track the configuration of electronic devices that are sold to and configured by particular consumers, especially consumers/patients using electronic devices related to health care.
Claim 1 has been amended to further recite that the medical device controller is configured to:
transmit to the consumer electronic device via said encrypted communication: x) a first data entry image comprising at least one first data entry field and instructions to present the first data entry image on a graphical display of the consumer electronic device, or y) instructions to display a second data entry image comprising at least one second data entry field stored in the memory of the consumer electronic device,
receive from the consumer electronic device a captured portion of the first data entry image or the second data entry image including one or more parameters entered into the at least one first data entry field or the at least one second data entry field;…
Spencer does not expressly disclose, but Abrahamsson teaches a system configured to:
transmit to the consumer electronic device via said encrypted communication: x) a first data entry image comprising at least one first data entry field and instructions to present the first data entry image on a graphical display of the consumer electronic device, or y) instructions to display a second data entry image comprising at least one second data entry field stored in the memory of the consumer electronic device, (Encrypted transmission of data: par. 153; par. 161; par. 164; receiving image data: par. 85- The example portable device 104 of FIG. 1 is configured to record images of the medical devices 102a to 102c to obtain medical information. Portable device 104 extracts the medical information from the images and transmits this information to the computer 106. To record images, portable device 104 includes at least one camera 124. The portable device 104 also includes a medical data application 126 programmed or configured to operate with a processor 150 and memory 152 of portable deice 104 to extract text as medical information from the images. The images and/or the extracted medical information are displayed on a screen 128 of portable device 104.)
receive from the consumer electronic device a captured portion of the first data entry image or the second data entry image including one or more parameters entered into the at least one first data entry field or the at least one second data entry field; and (par. 84-85: The example portable device 104 of FIG. 1 is configured to record images of the medical devices 102a to 102c to obtain medical information. Portable device 104 extracts the medical information from the images and transmits this information to the computer 106… The images and/or the extracted medical information are displayed on a screen 128 of portable device 104. Medical data application 126 may also process the extracted data for transmission to populate a file, document, and/or medical device template at computer 106; par. 86-88: CIS computer 106 of FIG. 1 is configured to operate a data entry program, such as a document program, a spreadsheet program, a text entry program, a patient medical template program, or combinations thereof. The programs are configured to display documents, worksheets, templates, or combinations thereof that receive text provided, for example, from a keyboard. )
At the time of the effective filing date it would have been obvious to one of ordinary skill in the art to modify the system and method of Spencer and Dicks in combination with the teaching of Abrahamsson to exchange image information regarding the patient and medical device and to provide the updated operation instructions based on the received parameter data. As suggested by Abrahamsson, one would have been motivated to include this feature to facilitate acquiring medical device data (e.g., medical information) and/or patient physiological data from medical devices, and avoid the need for manual data entry. (par. 4-5).
claim 2. Spencer teaches a medical device and secure control system according to claim 1 wherein the medical device controller (4) is a portable medical device controller formed as a separate component from the wearable medical device (Fig. 1; col. 16, lines 19-45; col. 28, lines 54-67) (2) and intended to be carried separately in short range wireless communication with the wearable medical device, (Fig. 1; col. 16, lines 19-45; col. 28, lines 54-67) the medical device (2) comprising a control system comprising a communications module including at least short range wireless communications capability, the communications module (17) of the medical device controller (4) including at least a short range wireless communications capability for communication with the medical device (2). (col. 39, line 60-col. 40, line 16)
claim 3. Spencer teaches a Medical device and secure control system (1) according to claim 1, wherein the medical device controller (4) is incorporated or physically connected to the medical device (2). (col. 28, lines 54-67: wired connections)
claim 4. Spencer teaches Medical device and secure control system (1) according to claim 1, wherein the at least one journal (16) stored in the medical device controller (4), the consumer electronic device (12) and the medical device (2) comprise each past instructions (hereafter journal entries history) exchanged between the medical device controller (4) and the consumer electronic device (12) and between the medical device controller (4) and the medical device (2), (col. 7, lines 62- col. 8, line 35)
the medical device controller (4) configured to verify the integrity of the consumer electronic device based on the comparison of both journal entries histories stored respectively in the medical device controller (4) and the consumer electronic device (2). (col. 11, lines 65-col. 12, line 50)
claim 5 Spencer teaches the medical device and secure control system (1) according to claim 4, wherein a login session between the consumer electronic device and the medical device controller (4) is allowed only if both journal histories are identical. (col. 11, lines 45-63)
Claim 6. Spencer teaches the medical device and secure control system according to claim 5, wherein the medical device controller (4) is configured to incrementally write an entry in the at least one journal (16) stored in its memory for each login session with the consumer electronic device (12) and with the medical device (2), the medical device controller (4) further configured to copy said entry in the at least one journal stored in the memory of the consumer electronic device and in the memory of the medical device (2). (col. 10, lines 1—55)
Claim 7 Spencer teaches a medical device and secure control system according to claim 1, wherein the consumer electronic device is configured to execute a software application for displaying different user-interface templates or messages according to an output signal of the medical device controller . (col. 28, lines16-23; col. 37, lines 60-65)
Claim 8. Spencer teaches a medical device and secure control system according to any claim 1, further comprising a medical data server storing a copy of the at least one journal stored in the medical device controller (4), and secure communications between the medical data server (6) (col. 2, lines 30-50; col, 9, lines 50-60) and the medical device controller (4), wherein the medical device controller is configured to update said copy through said secure communications. ( col. 25, lines 1-17)
Claim 9. Spencer teaches a Medical device and secure control system (1), according to the claim 8, wherein the medical data server (6) is configured to verify the integrity of the at least one journal stored in the consumer electronic device (12) when the medical device controller is not available. (col. 25, lines 55-col. 26, line 5)
Claim 10 Spencer teaches a medical device and secure control system (1), according to claim 1, wherein the consumer electronic device (12) is connected to the medical device controller (4) through a pairing operation which compares pairing parameters of the consumer electronic device and the medical device controller (4) which have been saved in their respective memory during an initialization step. (col. 8, lines 49-59; col. 12, lines 20-39)
Claim 11. Spencer discloses a medical device and secure control system according to claim 1, wherein the medical device is a drug delivery system, preferably a patch pump. (col. 28, lines 40-50)
Claim 12. Spencer teaches a Medical device and secure control system (1) according to claim 1, wherein the processor (15) of the medical device controller is configured to execute the computer program in order to assign the role of the consumer electronic device to limited functions so as to comply with the software requirements of classes A or B. (col. 9, lines 20-42)
Claim 13. Spencer discloses Medical device and secure control system (1) according to the claim 12, wherein the role of said consumer electronic device (12) is limited to the following functions: display of images containing messages, and data encryption and data transfer for secure communications. (col. 7, lines 17-20; lines 32-35)
Spencer, and Dicks in combination do not disclose, but Abrahamsson teaches a system that uses display of images in the form of user-interface templates with one or more data entry fields for user input; (Fig. 13-15; par. 88-89; par. 130-131.)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of Spencer and Dicks in combination with the teaching of Abrahamsson to incorporate user-interface templates. One would have been motivated to include these features to facilitate acquiring medical device data (e.g., medical information) and/or patient physiological data from medical devices, and avoid the need for manual data entry. (Abrahamsson: par. 4-5).
Claim 14. Spencer teaches a medical device and secure control system (1) according to the claim 13, wherein the instructions for operation of the medical device based on the data input are authorized by the user rights. (col. 13, lines 55-col. 14, lines 10-system includes user restricted access to records, settings and software or firmware)
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spencer et al (US 9980140 B1) in view of Abrahamsson et al (US 20210035670 A1).
Claim 15 Spencer teaches medical device and secure control system comprising:
a wearable medical device comprising a pump configured to inject insulin into a user and (col. 16, lines 19-29: The device can include one or more additional components that implement these features, such as a drug delivery system 226 (e.g., insulin pump); Fig. 9A-C)
a medical device controller, (col. 16, lines 47-60) i) comprising a communications module including at least a short range wireless communications capability for communication with a consumer electronic device (col. 40, lines 1-15) including any one or more of a smartphone, a personal computer, a smartwatch and a computer tablet, ( col. 16, lines 47-60; fig. 1) ii) a memory (col. 16, line 34-col. 17, line 67) configured to store a computer program and encryption keys configured to establish an encrypted communication with the consumer electronics device (col. 14, lines 10-col. 15, lines 47; col. 16, line 34-col. 17, line 67) and
iii) a processor configured to execute the computer program, wherein the medical device controller and the medical device are configured to each store at least one journal for exchange of journal entries between the medical device controller and the consumer electronic device and between the medical device controller and the medical device, the journal entries comprising user identification, user rights, and operations instructed to the medical device, (Fig. 2-instruction sets; col. 14, lines 11-57: the processors 208 and the encryption chipsets 209 can be programmed to encrypt and to store the following as encrypted data 211: patient dosage parameters and models, patient data (e.g., sensor readings, medicine dosing log), keys for authentication and encryption, policies governing commands to which the device 206 responds, firmware and/or instructions that are executed by the device 206 (e.g., the instruction sets 212), and/or other appropriate information; col. 16, line 47-col. 17, line 30: the device controller application 252 can be programmed to use the processors 230 and the encryption chipsets 232 to encrypt all data that is stored locally by the device controller application 252 and to store it as encrypted data 246, and can be programmed to encrypt all packets that are transmitted to the device 206 and/or the computer system 202. Furthermore, the device controller application 252 can be configured to establish a secure network connection, such as a BLE connection using AES in GCM mode) and
wherein the medical device controller is configured to provide encrypted communications to a consumer electronic device and receive information from a consumer electronic device (col. 9, lines 1-20; col. 17, lines 1-60; Fig. 10; consumer electronic device interpreted as computer system/ mobile computing device- See also col. 17, lines 9-19; col. 28, lines 54-col. 29, line 15;)
Spencer teaches a processor of the consumer electronic device (12) of the medical device and secure control system according to claim 1. Spencer discloses providing limited user interfaces (col. 2, lines 5-10):
Spencer does not expressly disclose, but Abrahamsson teaches a system configured to store:
store data of a catalogue of images in the memory of said consumer electronic device, the images representing different user interface templates to be displayed on the consumer electronic device; (Fig. 9; par. 66-portable device; par. 180-181: The example data processor 901 uses, for example, one or more data templates 700 from a data template database 910 to identify relevant medical information from the extracted text. In some examples, data processor 901 receives data templates 700 from computer 106, which may then be stored in database 910. In other examples, data processor 901 maintains database 910 with data templates 700.)
receive according to the instructions received from the medical device controller in order to provide data entry fields allowing parameters to be entered, and wherein the medical device controller is further configured to send second including instructions to the consumer electronic device to cause the consumer electronic device to select a user-interface template including the data entry fields; (par. 85-88; par. 180-181_
display on the consumer electronic device said user-interface template for data entry; (fig. 13; fig. 16; par. 182-186;
capture at least a portion of the displayed image user-interface template on the consumer electronic device with the relevant parameters once entered; and (par. 190-192)
send the captured portion of the displayed image user-interface template to the medical device controller. (par. 191-195; Fig. 13)
At the time of the effective filing date it would have been obvious to one of ordinary skill in the art to modify the system and method of Spencer with the teaching of Abrahamsson to exchange image information regarding the patient and medical device using templates. As suggested by Abrahamsson, one would have been motivated to include this feature to facilitate acquiring medical device data (e.g., medical information) and/or patient physiological data from medical devices, and avoid the need for manual data entry. (par. 4-5).
Claim 16 Spencer discloses the medical device and secure control system, wherein the consumer electronic device is configured to alter the image to be displayed on the consumer electronic device according to instructions received from the medical device controller. (col. 28, lines 15-23)
Response to Arguments
Applicant's arguments filed 9/4/25 have been fully considered.
(A) Applicant argues that the prior art does the claim limitations as amended.
In response, the examiner has provided new grounds of rejection to address the claim limitations of the claims as amended for applicant’s consideration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cole et al (US 20190000360 A1)-discloses a system for synchronous communication between devices in an analyte monitoring system. The devices can be in on body device having an analyte sensor and a reader device. The devices can communicate with each other over one or more wireless links.
Kamen et al (US 20140188516 A1)
Sieh et al (US 20100256047 A1) discloses a system/ method wherein if the daily maximum dosage is exceeded, a signal can be sent from the analyte measurement device to the pump to stop delivering insulin until the next day. In an embodiment of the present invention, the method further comprises sending a signal from the analyte measurement device to multiple dosage devices to stop delivering therapeutic agent if the amount of therapeutic agent delivered exceeds a preset maximum for a preset time window. (par. 39)
THIS ACTION IS MADE FINAL. 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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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, Shahid Merchant can be reached on 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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/Rachel L. Porter/Primary Examiner, Art Unit 3626
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