DETAILED ACTION
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 .
Response to Amendment
This office action is responsive to the amendment filed on 1/22/2025. As directed by the amendment: no claims have been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-29 are presently pending in this application.
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.
Claims 1-3, 5-6, 12-13, 15, 21-22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parikh et al. (US 20170049962 A1).
Regarding claim 1, Parikh discloses a computer-implemented method, comprising:
receiving, by an input signal receiver operable on a processor, an input signal from a sensor (104/504/1104) coupled to a user (Figs. 1 and 5, Paragraph [0068]), wherein the input signal represents one or more characteristics (804), detected by the sensor (Paragraph [0068]), of a drug delivery device (102/200/502/1102) coupled to the user (Figs. 1 and 5);
retrieving, from a memory (606), a plurality of baseline characteristics (802);
determining, by a controller operable on the processor, a location of the drug delivery device by comparing the one or more characteristics to the plurality of baseline characteristics (Paragraphs [0068]-[0070]); and
automatically controlling or modifying, by the controller, delivery of a liquid drug from the drug delivery device in response to determining the location of the drug delivery device on the user (Paragraph [0074]).
Regarding claim 2, Parikh discloses the computer-implemented method of claim 1, further comprising integrating the sensor within the drug delivery device (Paragraph [0032]).
Regarding claim 3, Parikh discloses the computer-implemented method of claim 1, further comprising detecting, by the sensor, the one or more characteristics while the user is in a sleep state (Paragraph [0035]).
Regarding claim 5, Parikh discloses the computer-implemented method of claim 1, further comprising:
displaying, on an interface of a local wireless device (1110), an indication of the location of the drug delivery device on the user (Paragraph [0094]);
determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range (Figs. 8-9, Paragraphs [0078]-[0080]); and
generating, by the controller, one or more instructions displayable on the interface, the one or more instructions indicating to the user how to reposition the drug delivery device to bring the deviation between the one or more characteristics and the plurality of baseline characteristics within the acceptable range (Figs. 8-9, Paragraphs [0086] and [0092]).
Regarding claim 6, Parikh discloses the computer-implemented method of claim 5, further comprising receiving a user input via the interface of the local wireless device, the user input providing feedback regarding the location of the drug delivery device on the user (Paragraph [0094]).
Regarding claim 12, Parikh discloses an article (602) comprising a non-transitory computer-readable storage medium (Paragraph [0059]) including instructions that, when executed by a processor, enable a wearable drug delivery system (102/200/502/1102) to:
receive, by an input signal receiver operable on the processor, a plurality of input signals from a sensor (104/504/1104) coupled to a user (Figs. 1 and 5, Paragraph [0068]), wherein the plurality of input signals represents one or more characteristics (804), detected by the sensor (Paragraph [0068]), of a drug delivery device (102/200/502/1102) coupled to the user (Figs. 1 and 5);
retrieve, from a memory (606), a plurality of baseline characteristics (802);
determine, by a controller operable on the processor, a location of the drug delivery device by comparing the one or more characteristics to the plurality of baseline characteristics (Paragraphs [0068]-[0070]); and
automatically control or modify, by the controller, delivery of a liquid drug from the drug delivery device in response to determining the location of the drug delivery device on the user (Paragraph [0074]).
Regarding claim 13, Parikh discloses the article of claim 12, the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to:
determine, by the controller operable on the processor, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range (Figs. 8-9, Paragraphs [0078]-[0080]); and
generate, by the controller operable on the processor, instructions displayable on a display, the instructions indicating to the user how to reposition the drug delivery device so the deviation between the one or more characteristics and the plurality of baseline characteristics is within the acceptable range (Figs. 8-9, Paragraphs [0086] and [0092]).
Regarding claim 15, Parikh discloses the article of claim 13, the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to receive a user input via an interface of a local wireless device (1110), the user input providing feedback regarding the location of the drug delivery device on the user (Paragraph [0094]).
Regarding claim 21, Parikh discloses a wearable drug delivery system (Figs. 1-2, 5-6, 11), comprising:
a processor (Paragraph [0059]) operable with a memory (606);
a drug delivery device (102/200/502/1102) configured to be coupled to a user (Figs. 1 and 5);
a sensor (104/504/1104) configured to be coupled to the user (Figs. And 1 and 5), the sensor operable to detect one or more characteristics (804) of the drug delivery device (Paragraph [0068]);
an input signal receiver operable on the processor to receive an input signal from the sensor, the input signal representing the one or more characteristics (Paragraph [0068]); and
a controller operable on the processor to:
receive the input signal from the input signal receiver (Paragraph [0068]);
retrieve, from the memory, a plurality of baseline characteristics (802);
determine a location of the drug delivery device on the user based on a comparison between the one or more characteristics and the plurality of baseline characteristics (Paragraphs [0068]-[0070]); and
automatically control delivery of a liquid drug from the drug delivery device in response to the location of the drug delivery device on the user (Paragraph [0074]).
Regarding claim 22, Parikh discloses the wearable drug delivery system of claim 21, wherein the sensor is directly coupled to the drug delivery device (Paragraph [0032]), and wherein the sensor is further operable to detect the one or more characteristics while the user is determined to be in a sleep state (Paragraph [0035]).
Regarding claim 24, Parikh discloses the wearable drug delivery system of claim 21, further comprising a local wireless device (1110), wherein the controller is further operable on the processor to display on an interface of the local wireless device an indication of the location of the drug delivery device on the user (Paragraph [0094]), and wherein the controller is further operable on the processor to receive an input from the user, via the interface of the local wireless device, regarding the location of the drug delivery device on the user (Paragraph [0094]).
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.
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.
Claims 4, 14, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of DiMatteo et al. (US 20210401453 A1).
Regarding claim 4, Parikh discloses the computer-implemented method of claim 1 but is silent regarding, further comprising:
detecting, by the sensor, the one or more characteristics during an insertion of a cannula of the drug delivery device; and
determining, by the controller, a tissue profile of the location of the drug delivery device based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device.
In analogous art, DiMatteo teaches
detecting, by a sensor (101/102/103, Fig. 1), one or more characteristics during an insertion of a cannula of a drug delivery device (Paragraph [0146]); and
determining, by a controller (Paragraph [0146]), a tissue profile of a location of the drug delivery device (Paragraphs [0146], [0153], [0227]) based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device (Paragraph [0146]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer-implemented method of Parikh to incorporate the teachings of DiMatteo to incorporate detecting, by the sensor, the one or more characteristics during an insertion of a cannula of the drug delivery device; and determining, by the controller, a tissue profile of the location of the drug delivery device based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device in order to enable a user to detect of location of tissue and stop needle progression by accelerating or decelerating of the actuator (Paragraph [0146], DiMatteo).
Regarding claim 14, Parikh discloses the article of claim 13, but is silent regarding the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to:
detect, by the sensor, the one or more characteristics during an insertion of a cannula of the drug delivery device into the user; and
determine, by the controller, a tissue profile of a tissue at the location of the drug delivery based on an acceleration of the drug delivery device detected by the sensor during the insertion of the cannula of the drug delivery device into the tissue.
In analogous art, DiMatteo teaches
detecting, by a sensor (101/102/103, Fig. 1), one or more characteristics during an insertion of a cannula of a drug delivery device into a user (Paragraph [0146]); and
determining, by a controller (Paragraph [0146]), a tissue profile of a tissue at a location of the drug delivery (Paragraphs [0146], [0153], [0227]) based on an acceleration of the drug delivery device detected by the sensor during the insertion of the cannula of the drug delivery device into the tissue (Paragraph [0146]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-transitory computer-readable storage medium of Parikh to incorporate the teachings of DiMatteo to incorporate including instructions that, when executed by the processor, enable the wearable drug delivery system to detect, by the sensor, the one or more characteristics during an insertion of a cannula of the drug delivery device into the user; and determine, by the controller, a tissue profile of a tissue at the location of the drug delivery based on an acceleration of the drug delivery device detected by the sensor during the insertion of the cannula of the drug delivery device into the tissue in order to enable a user to detect of location of tissue and stop needle progression by accelerating or decelerating of the actuator (Paragraph [0146], DiMatteo).
Regarding claim 23, Parikh discloses the wearable drug delivery system of claim 21, but is silent regarding wherein the sensor is further operable to detect the one or more characteristics during an insertion of a cannula of the drug delivery device, and wherein the controller is further operable on the processor to determine a tissue profile of the location of the drug delivery device based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device.
In analogous art, DiMatteo teaches wherein a sensor (101/102/103, Fig. 1) is further operable to detect one or more characteristics during an insertion of a cannula of a drug delivery device (Paragraph [0146]), and wherein a controller (Paragraph [00146]) is further operable on a processor (Paragraph [0146]) to determine a tissue profile of a location of the drug delivery device (Paragraphs [0146], [0153], [0227]) based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device (Paragraph [0146]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the wearable drug delivery system of Parikh to incorporate the teachings of DiMatteo to incorporate wherein the sensor is further operable to detect the one or more characteristics during an insertion of a cannula of the drug delivery device, and wherein the controller is further operable on the processor to determine a tissue profile of the location of the drug delivery device based on the one or more characteristics detected during the insertion of the cannula of the drug delivery device in order to enable a user to detect of location of tissue and stop needle progression by accelerating or decelerating of the actuator (Paragraph [0146], DiMatteo).
Claims 7, 16-17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of Albertini et al. (US 20220361758 A1).
Regarding claim 7, Parikh discloses the computer-implemented method of claim 1, but is silent regarding wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying delivery timing of a bolus dose.
In analogous art, Albertini teaches wherein controlling delivery of a liquid drug from a drug delivery device comprises modifying delivery timing of a bolus dose (Paragraph [0213]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer-implemented method of Parikh to incorporate the teachings of Albertini to incorporate wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying delivery timing of a bolus dose in order to enable a controller to improve the effectiveness of an infusion device that includes a sensor configured to sense a body parameter (Paragraph [0031], Albertini).
Regarding claim 16, Parikh discloses the article of claim 12, the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to control delivery of the liquid drug from the drug delivery device by modifying delivery timing of a bolus dose.
In analogous art, Albertini teaches enabling a wearable drug delivery system to control delivery of a liquid drug from a drug delivery device by modifying delivery timing of a bolus dose (Paragraph [0213]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-transitory computer-readable storage medium of Parikh to incorporate the teachings of Albertini to incorporate instructions that, when executed by the processor, enable the wearable drug delivery system to control delivery of the liquid drug from the drug delivery device by modifying delivery timing of a bolus dose in order to enable a controller to improve the effectiveness of an infusion device that includes a sensor configured to sense a body parameter (Paragraph [0031], Albertini).
Regarding claim 17, Parikh in view of Albertini disclose the article of claim 16, but Parikh is silent regarding the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to control delivery of the liquid drug from the drug delivery device by delaying delivery of the bolus dose.
Albertini teaches controlling delivery of the liquid drug from the drug delivery device by delaying delivery of the bolus dose (Paragraph [0031]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-transitory computer-readable storage medium of Parikh in view of Albertini to incorporate the teachings of Albertini to incorporate instructions that, when executed by the processor, enable the wearable drug delivery system to control delivery of the liquid drug from the drug delivery device by delaying delivery of the bolus dose in order to enable a controller to improve the effectiveness of an infusion device that include a sensor configured to sense a body parameter (Paragraph [0031], Albertini).
Regarding claim 26, Parikh discloses the wearable drug delivery system of claim 21, wherein the controller is further operable on the processor to control delivery of the liquid drug from the drug delivery device by modifying delivery timing of a bolus dose.
In analogous art, Albertini teaches wherein a controller (296) is further operable on a processor to control delivery of a liquid drug from a drug delivery device by modifying delivery timing of a bolus dose (Paragraph [0213]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the controller of Parikh to incorporate the teachings of Albertini to incorporate being further operable on the processor to control delivery of the liquid drug from the drug delivery device by modifying delivery timing of a bolus dose in order to enable a controller to improve the effectiveness of an infusion device that includes a sensor configured to sense a body parameter (Paragraph [0031], Albertini).
Claims 8, 18, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of Michaud et al. (US 20200261649 A1).
Regarding claim 8, Parikh discloses the computer-implemented method of claim 1, but is silent regarding wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying an infusion rate of the liquid drug based on the location of the drug delivery device.
In analogous art, Michaud teaches wherein controlling delivery of a liquid drug from a drug delivery device (12) comprises modifying an infusion rate of the liquid drug based on a location of the drug delivery device (“Alternatively or additionally, an infusion site test bolus can be delivered periodically for the specific purpose of monitoring the body's response to the bolus to determine the validity of the infusion site.” Paragraph [0036]; interpreted as location of drug delivery device; “For example, the CGM data and medicament delivery data can be used to calculate an effective correction factor for the site.” Paragraph [0042]; interpreted as modifying an infusion rate; “this manner, the systems and methods described herein provide an improvement over previous systems that dictate site rotations based on a predetermined time period.” Paragraph [0039]; “If the effective correction factor is lower than the stored patient correction factor by a predetermined amount such as, for example, 25%, 50%, etc., the infusion site alert can be provided.” Paragraph [000037]; fig 7; one ordinary in the skill may construe controlling or modifying delivery of a liquid drug to be an infusion site alert or stoppage (when the delivery device stops delivering medication) when the correction factor is lower than the stored correction factor; “For example, if a given site shows a decrease in effective correction factor when used again within, e.g., 3 days, but an effective correction factor equivalent with or greater than the stored patient correction factor when used again within, e.g., 4 days, the system cannot recommend and/or prevent a patient from entering that site unless it has been at least 4 days since it has been used” Paragraph [0042]; one of ordinary skill in the art may construe modifying the infusion to be when the delivery device stops medication delivery).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer-implemented method of Parikh to incorporate the teachings of Michaud to incorporate wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying an infusion rate of the liquid drug based on the location of the drug delivery device in order to enable a controller to improve the effectiveness of a given infusion site (Paragraph [0042], Michaud).
Regarding claim 18, Parikh discloses the article of claim 12, but is silent regarding the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to modify an infusion rate of the liquid drug based on the location of the drug delivery device.
In analogous art, Michaud teaches modifying an infusion rate of a liquid drug based on a location of a drug delivery device (12, “Alternatively or additionally, an infusion site test bolus can be delivered periodically for the specific purpose of monitoring the body's response to the bolus to determine the validity of the infusion site.” Paragraph [0036]; interpreted as location of drug delivery device; “For example, the CGM data and medicament delivery data can be used to calculate an effective correction factor for the site.” Paragraph [0042]; interpreted as modifying an infusion rate; “this manner, the systems and methods described herein provide an improvement over previous systems that dictate site rotations based on a predetermined time period.” Paragraph [0039]; “If the effective correction factor is lower than the stored patient correction factor by a predetermined amount such as, for example, 25%, 50%, etc., the infusion site alert can be provided.” Paragraph [000037]; fig 7; one ordinary in the skill may construe controlling or modifying delivery of a liquid drug to be an infusion site alert or stoppage (when the delivery device stops delivering medication) when the correction factor is lower than the stored correction factor; “For example, if a given site shows a decrease in effective correction factor when used again within, e.g., 3 days, but an effective correction factor equivalent with or greater than the stored patient correction factor when used again within, e.g., 4 days, the system cannot recommend and/or prevent a patient from entering that site unless it has been at least 4 days since it has been used” Paragraph [0042]; one of ordinary skill in the art may construe modifying the infusion to be when the delivery device stops medication delivery).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-transitory computer-readable storage medium of Parikh to incorporate the teachings of Michaud to incorporate instructions that, when executed by the processor, enable the wearable drug delivery system to modify an infusion rate of the liquid drug based on the location of the drug delivery device in order to enable a controller to improve the effectiveness of a given infusion site (Paragraph [0042], Michaud).
Regarding claim 27, Parikh discloses the wearable drug delivery system of claim 21, but is silent regarding wherein the controller is further operable on the processor to control delivery of the liquid drug from the drug delivery device by modifying an infusion rate of the liquid drug based on the location of the drug delivery device.
In analogous art, Michaud teaches wherein a controller (42) is further operable on a processor to control delivery of a liquid drug from a drug delivery device (12) by modifying an infusion rate of the liquid drug based on a location of the drug delivery device (“Alternatively or additionally, an infusion site test bolus can be delivered periodically for the specific purpose of monitoring the body's response to the bolus to determine the validity of the infusion site.” Paragraph [0036]; interpreted as location of drug delivery device; “For example, the CGM data and medicament delivery data can be used to calculate an effective correction factor for the site.” Paragraph [0042]; interpreted as modifying an infusion rate; “this manner, the systems and methods described herein provide an improvement over previous systems that dictate site rotations based on a predetermined time period.” Paragraph [0039]; “If the effective correction factor is lower than the stored patient correction factor by a predetermined amount such as, for example, 25%, 50%, etc., the infusion site alert can be provided.” Paragraph [000037]; fig 7; one ordinary in the skill may construe controlling or modifying delivery of a liquid drug to be an infusion site alert or stoppage (when the delivery device stops delivering medication) when the correction factor is lower than the stored correction factor; “For example, if a given site shows a decrease in effective correction factor when used again within, e.g., 3 days, but an effective correction factor equivalent with or greater than the stored patient correction factor when used again within, e.g., 4 days, the system cannot recommend and/or prevent a patient from entering that site unless it has been at least 4 days since it has been used” Paragraph [0042]; one of ordinary skill in the art may construe modifying the infusion to be when the delivery device stops medication delivery).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the controller of Parikh to incorporate the teachings of Michaud to incorporate being operable on the processor to control delivery of the liquid drug from the drug delivery device by modifying an infusion rate of the liquid drug based on the location of the drug delivery device in order to enable a controller to improve the effectiveness of a given infusion site (Paragraph [0042], Michaud).
Claims 9, 19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of Michaud et al. (US 20200261649 A1) further in view of Lee (US 20160128618 A1).
Regarding claim 9, Parikh in view of Michaud disclose the computer-implemented method of claim 8, but are silent regarding wherein determining the location of the drug delivery device comprises classifying acceleration data received by the sensor with machine learning classifiers.
In analogous art, Lee teaches classifying acceleration data received by a sensor with machine learning classifiers (Paragraph [0090]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the determining the location of the drug delivery device of Parikh in view of Michaud to incorporate the teachings of Lee to incorporate classifying acceleration data received by the sensor with machine learning classifiers in order to enable a user to provide information to generate habit data of a user by analyzing data detected from a sensor (Paragraph [0009], Lee).
Regarding claim 19, Parikh in view of Michaud disclose the article of claim 18, but are silent regarding the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to classify acceleration data received by the sensor with machine learning classifiers.
In analogous art, Lee teaches classifying acceleration data received by a sensor with machine learning classifiers (Paragraph [0090]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the determining the location of the drug delivery device of Parikh in view of Michaud to incorporate the teachings of Lee to incorporate classifying acceleration data received by the sensor with machine learning classifiers in order to enable a user to provide information to generate habit data of a user by analyzing data detected from a sensor (Paragraph [0009], Lee).
Regarding claim 28, Parikh in view of Michaud disclose the wearable drug delivery system of claim 27, but are silent regarding wherein the controller is further operable on the processor to determine the location of the drug delivery device by classifying acceleration data received by the sensor with machine learning classifiers.
In analogous art, Lee teaches classifying acceleration data received by a sensor with machine learning classifiers (Paragraph [0090]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the controller being further operable on the processor to determine the location of the drug delivery device of Parikh in view of Michaud to incorporate the teachings of Lee to incorporate classifying acceleration data received by the sensor with machine learning classifiers in order to enable a user to provide information to generate habit data of a user by analyzing data detected from a sensor (Paragraph [0009], Lee).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of Michaud et al. (US 20200261649 A1) further in view of Lee (US 20160128618 A1) further in view of Belliveau et al. (US 20180182491 A1).
Regarding claim 10, Parikh in view of Michaud further in view of Lee disclose the computer-implemented method of claim 9, further comprising causing the sensor to enter a low-power state after determining the location of the drug delivery device.
In analogous art, Belliveau teaches causing a sensor to enter a low-power state (Paragraphs [0379] and [0284]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor after determining the location of the drug delivery device of Parikh in view of Michaud further in view of Lee to incorporate the teachings of Belliveau to incorporate causing the sensor to enter a low-power state in order to save battery power in various steps of a medical device (Paragraph [0378], Belliveau).
Regarding claim 11, Parikh in view of Michaud further in view of Lee further in view of Belliveau disclose the computer-implemented method of claim 10, but Parikh in view of Michaud further in view of Lee are silent regarding further comprising causing the sensor to enter a full-power state from the low-power state after a predetermined period of time.
Belliveau teaches causing the sensor to enter a full-power state from the low-power state after a predetermined period of time (Paragraphs [0379]-[0380]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer-implemented method Parikh in view of Michaud further in view of Lee further in view of Belliveau to incorporate the teachings of Belliveau to incorporate causing the sensor to enter a full-power state from the low-power state after a predetermined period of time in order to save battery power in various steps of a medical device (Paragraph [0378], Belliveau).
Claims 20 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of Belliveau et al. (US 20180182491 A1).
Regarding claim 20, Parikh discloses the article of claim 12, but is silent regarding the non-transitory computer-readable storage medium further including instructions that, when executed by the processor, enable the wearable drug delivery system to:
cause the sensor to enter a low-power state; and
cause the sensor to enter a full-power state from the low-power state after a predetermined period of time.
In analogous art, Belliveau teaches
causing a sensor to enter a low-power state (Paragraphs [0379] and [0284]); and
causing the sensor to enter a full-power state from the low-power state after a predetermined period of time (Paragraphs [0379]-[0380]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor after determining the location of the drug delivery device of Parikh to incorporate the teachings of Belliveau to incorporate instructions that, when executed by the processor, enable the wearable drug delivery system to: cause the sensor to enter a low-power state; and cause the sensor to enter a full-power state from the low-power state after a predetermined period of time in order to save battery power in various steps of a medical device (Paragraph [0378], Belliveau).
Regarding claim 29, Parikh discloses the wearable drug delivery system of claim 21, but is silent regarding further comprising causing the sensor to enter a low-power state after determining the location of the drug delivery device.
In analogous art, Belliveau teaches causing a sensor to enter a low-power state (Paragraphs [0379] and [0284]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor after determining the location of the drug delivery device of Parikh to incorporate the teachings of Belliveau to incorporate causing the sensor to enter a low-power state in order to save battery power in various steps of a medical device (Paragraph [0378], Belliveau).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US 20170049962 A1) in view of O’Connor et al. (US 20170173261 A1).
Regarding claim 25, Parikh discloses the wearable drug delivery system of claim 21, wherein the local wireless device (1110) is a mobile smart device (Paragraph [0094]).
Parikh is silent regarding wherein the sensor is an accelerometer, a gyrometer, a high-resolution altimeter, or an inertial sensor.
In analogous art, O’Connor teaches wherein a sensor is an accelerometer (Paragraph [0045]), a gyrometer, a high-resolution altimeter, or an inertial sensor.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor of Parikh to incorporate the teachings of O’Connor to incorporate being an accelerometer in order to sense motion of the medical device (Paragraph [0045], O’Connor).
Response to Arguments
Applicant's arguments filed 1/22/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments, on pages 10-11, that Parikh does not teach “automatically controlling or modifying, by the controller, delivery of a liquid drug from the drug delivery device in response to determining the location of the drug delivery device on the user”, the Examiner respectfully disagrees. In Paragraph [0074], Parikh discloses the “the site data management process 800 continues by storing or otherwise maintaining delivery data and sensor glucose measurement data in association with the current sensor site location and calculates or otherwise determines one or more performance metrics associated with the current sensor site location (tasks 812, 814). In this regard, the pump control system 520, 600 may store or otherwise maintain information regarding meal boluses and other delivery data (e.g., timing and amounts of insulin delivered) associated with operation of the infusion device 102, 200, 502 using the sensing arrangement 104, 504 at the current site location along with sensor glucose measurements obtained from the sensing arrangement 104, 504. Based on the delivery data and/or the measurement data, the pump control system 520, 600 calculates or otherwise determines one or more metrics indicative of the performance of the infusion device 102, 200, 502 with respect to the glycemic control provided for the user when the infusion device 102, 200, 502 utilizes the sensor glucose measurements for the current sensor site” (see Paragraph [0074]). Therefore, by calculating or otherwise determining one or more performance metrics associated with the current sensor site location in response to storing or otherwise maintaining delivery data and sensor glucose measurement data in association with the current sensor site location, Parikh teaches the limitation of automatically controlling or modifying, by the controller, delivery of a liquid drug from the drug delivery device in response to determining the location of the drug delivery device on the user.
Conclusion
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.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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