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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/23/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 10/23/2025. As directed by the amendment: claims 1, 12, and 21 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 § 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 1-2, 7-8, 12, 16-18, 21, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1).
Regarding claims 1, 12, and 21, Pesach discloses a computer-implemented method (Paragraphs [0028]-[0029]), comprising:
receiving, by an input signal receiver operable on a processor, an input signal from a sensor coupled to a user (Paragraphs [0045]-[0046], [0049]-[0050], Figs. 1-2), wherein the input signal represents one or more characteristics, detected by the sensor (Paragraphs [0045]-[0048] and [0050]);
determining, by a controller operable on the processor, a location of the drug delivery device (Paragraph [0059], Fig. 3); and
automatically adjusting a dosage amount or a dosage timing of a next dose of a liquid drug from the drug delivery device (Paragraphs [0049]-[0050] and [00055]-[0061]).
Pesach is silent regarding
wherein the input signal represents one or more characteristics, detected by the sensor, of a drug delivery device coupled to the user;
retrieving, from a memory, a plurality of baseline characteristics;
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; and
automatically adjusting a dosage amount or a dosage timing of a next dose of a liquid drug from the drug delivery device based on whether the determined location of the drug delivery device on the user is associated with a relatively faster or relatively slower absorption of the liquid drug.
In analogous art, Bøggild-Damkvist
wherein input signal represents one or more characteristics, detected by sensor, of a drug delivery device coupled to a user (Paragraphs [0035], [0093]-[0095], and [0107]);
retrieving, from a memory, a plurality of baseline characteristics (Paragraph [0035], [0105], and [0116]);
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 (Claim 1, Paragraph [0101], [0105], [0107]-[0108] and [0116]);
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 drug delivery system of Pesach to incorporate the teachings of Bøggild-Damkvist to incorporate an automatic position-determination system so that Pesach’s controller could obtain reliable information concerning the actual injection location, rather than relying on a manually entered location, which would provide the predictable benefit of automatically associating drug administration information with the actual location at which the drug was administered.
Pesach in view of Bøggild-Damkvist are silent regarding
automatically adjusting a dosage amount or a dosage timing of a next dose of a liquid drug from the drug delivery device based on whether the determined location of the drug delivery device on the user is associated with a relatively faster or relatively slower absorption of the liquid drug.
In analogous art, Regittnig teaches identifying anatomical location as an administration characteristic (Claim 2). Regittnig further teaches that insulin absorption depends on anatomical location, including the example that insulin absorption may be faster from the abdomen than from the thigh (Paragraph [0014]) and adjusting an administration characteristic based on information indicative of tissue resistance to achieve a predetermined/intended absorption rate (Claim 1). Additionally, Regittnig teaches that a previously determined relationship between absorption rate and tissue resistance may depend on covariates including anatomical location of the administration site and that controlling fluid flow may be based on that relationship and a covariate value (Claim 11).
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 Pesarch, after receiving an automatically determined location from the Bøggild-Damkvist position-determination system to incorporate the teachings of Regittnig, to incorporate using that location in determining an appropriate insulin delivery adjustment according to the location/absorption relationship Pesach already recognizes that the injection location affects insulin absorption and adjusts insulin dosage based on absorption-related condition while Bøggild-Damkvist provides automatic determination of the injection location, therefore Regittnig provides a known technique for using characteristics of the administration site to adjust infusion/bolus parameters to obtain a desired absorption rate and applying that technique to the automatically determined location would have predictably allowed the system to tailor subsequent insulin delivery to the absorption characteristic associated with the detected site. The combination of Pesach in view of Bøggild-Damkvist further in view of Regittnig would teach automatically adjusting a dosage amount or a dosage timing of a next dose of a liquid drug from the drug delivery device based on whether the determined location of the drug delivery device on the user is associated with a relatively faster or relatively slower absorption of the liquid drug because Bøggild-Damkvist teaches automatically determining the actual injection device location, Regittnig teaches associating anatomical location with a faster or slower insulin absorption rate, and Pesach teaches adjusting insulin dose amount/timing/delivery profile based on absorption-related information and injection-site information.
Regarding claim 2, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, further comprising integrating the sensor within the drug delivery device (Fig. 1, claim 1, Pesach).
Regarding claim 7, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying delivery timing of a bolus dose (Paragraphs [0049]-[0050], [0061], and [0066], Pesach).
Regarding claim 8, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, wherein controlling delivery of the liquid drug from the drug delivery device comprises modifying an infusion rate of the liquid drug (Paragraphs [0049]-[0051], Pesach) based on the location of the drug delivery device (The combination of Pesach in view of Bøggild-Damkvist would teach this limitation because Pesach teaches location-dependent adjustment of insulin administration rate, see Paragraph [0059], and Bøggild-Damkvist teaches automatic determination of the location of the drug delivery device).
Regarding claim 16, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose 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 (Paragraphs [0049]-[0050], [0061], and [0066], Pesach).
Regarding claim 17, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the article of claim 16, 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 (Paragraphs [0049]-[0050], [0061], and [0066], Pesach).
Regarding claim 18, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose 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 modify an infusion rate of the liquid drug (Paragraphs [0049]-[0051], Pesach) based on the location of the drug delivery device (The combination of Pesach in view of Bøggild-Damkvist would teach this limitation because Pesach teaches location-dependent adjustment of insulin administration rate, see Paragraph [0059], and Bøggild-Damkvist teaches automatic determination of the location of the drug delivery device).
Regarding claim 24, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the wearable drug delivery system of claim 21, but Regittnig is silent regarding further comprising a local wireless device, 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, 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.
Bøggild-Damkvist teaches further comprising a local wireless device (300), 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 (Paragraphs [0101], [0105]-[0106], [0109], [0114]-[0115], and [0131]).
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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Bøggild-Damkvist to incorporate a local wireless device, 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 in order to allow the system to receive automatically determined injection location information and present that information to the user through a portable interface. The combination of Pesach in view of Bøggild-Damkvist further in view of Regittnig would teach 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 because Pesach discloses the user entering the insulin infusion site location through a user interface and Bøggild-Damkvist teaches the local wireless device.
Regarding claim 25, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the wearable drug delivery system of claim 21, wherein the sensor is an accelerometer, a gyrometer (Paragraph [0044], Bøggild-Damkvist), a high-resolution altimeter, or an inertial sensor, but Pesach in view of Regittnig are silent regarding wherein the local wireless device is a mobile smart device.
Bøggild-Damkvist teaches the local wireless device is a mobile smart device (300).
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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Bøggild-Damkvist to incorporate a local wireless device being a mobile smart device in order to provide a readily available portable device for receiving, processing, storing, and communicating the positional information generated by the position-determination device.
Regarding claim 26, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose 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 (Paragraphs [0049]-[0050], [0061], and [0066], Pesach).
Regarding claim 27, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose 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 an infusion rate of the liquid drug (Paragraphs [0049]-[0051], Pesach) based on the location of the drug delivery device (The combination of Pesach in view of Bøggild-Damkvist would teach this limitation because Pesach teaches location-dependent adjustment of insulin administration rate, see Paragraph [0059], and Bøggild-Damkvist teaches automatic determination of the location of the drug delivery device).
Claims 3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Ummat (US 20180279947 A1).
Regarding claim 3, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, but are silent regarding further comprising detecting, by the sensor, the one or more characteristics while the user is in a sleep state.
In analogous art, Ummat teaches detecting, by a sensor, one or more characteristics while the user is in a sleep state (Paragraph [0003]-[0005], [0028]-[0029], [0039], and [0097]).
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 position-determination system of Bøggild-Damkvist to incorporate the teachings of Ummat to incorporate detecting the position and orientation characteristics during periods in which the user is sleeping because it would involve using a known sensor modality (accelerometers/gyroscopes) for a known purpose – obtaining positional and orientation information during sleep – to obtain predictable information concerning the position of the drug delivery device and furthermore because reduced movement during sleep can provide relatively stable positional/orientation measurements. The modification would also provide the benefit of continuing to acquire the location-related characteristics during an overnight period when the system of Pesach is delivering insulin, thereby maintaining the information used for subsequent dose/administration determinations.
Regarding claim 22, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the wearable drug delivery system of claim 21, wherein the sensor is directly coupled to the drug delivery device (Figs. 1-2, Pesach), but are silent regarding wherein the sensor is further operable to detect the one or more characteristics while the user is determined to be in a sleep state.
In analogous art, Ummat teaches a sensor is operable to detect one or more characteristics while the user is determined to be in a sleep state (Paragraph [0003]-[0005], [0028]-[0029], [0039], and [0097]).
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 position-determination system of Bøggild-Damkvist to incorporate the teachings of Ummat to incorporate detecting the position and orientation characteristics during periods in which the user is sleeping because it would involve using a known sensor modality (accelerometers/gyroscopes) for a known purpose – obtaining positional and orientation information during sleep – to obtain predictable information concerning the position of the drug delivery device and furthermore because reduced movement during sleep can provide relatively stable positional/orientation measurements. The modification would also provide the benefit of continuing to acquire the location-related characteristics during an overnight period when the system of Pesach is delivering insulin, thereby maintaining the information used for subsequent dose/administration determinations.
Claims 4 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of DiMatteo et al. (US 20210401453 A1).
Regarding claim 4, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, but are 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig 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]).
Regarding claim 23, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the wearable drug delivery system of claim 21, but are 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
a sensor (101/102/103, Fig. 1) detecting one or more characteristics during an insertion of a cannula of a drug delivery device (Paragraph [0146]); and
a controller (Paragraph [0146]) determining 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig 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]).
Claims 5-6, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Rios et al. (US 20170136185 A1).
Regarding claim 5, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 1, but Pesach in view of Regittnig are silent regarding further comprising:
displaying, on an interface of a local wireless device, an indication of the location of the drug delivery device on the user;
determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range; 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.
Bøggild-Damkvist teaches
displaying, on an interface of a local wireless device, an indication of the location of the drug delivery device on the user (Paragraphs [0021], [0024-[0026], [0031]-[0032], [0097]-[0099], [0109], [0115]);
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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Bøggild-Damkvist to incorporate displaying, on an interface of a local wireless device, an indication of the location of the drug delivery device on the user in order to allow the system to receive automatically determined injection location information and present that information to the user through a portable interface.
Pesach in view of Bøggild-Damkvist further in view of Regittnig are silent regarding
determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range; 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.
In analogous art, Rios teaches
an indication of the location of the drug delivery device on the user (Paragraphs [0060]-[0061]);
determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range (Paragraphs [0060]-[0061]);
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 (Paragraphs [0060]-[0061]);
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-implemented method of Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Rios to incorporate determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range; 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 in order to provide a proper injection location based on landmark information of a user (Paragraph [0059]).
Regarding claim 6, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 5, further comprising receiving a user input via the interface of the local wireless device (The combination of Pesach in view of Bøggild-Damkvist further in view of Regittnig would teach this limitation because Pesach discloses the user entering the insulin infusion site location through a user interface and Bøggild-Damkvist teaches the local wireless device), the user input providing feedback regarding the location of the drug delivery device on the user (The combination of Pesach in view of Bøggild-Damkvist further in view of Regittnig would teach this limitation because Rios teaches processor-generated feedback to the caregiver and Regittnig teaches that insulin absorption strongly depends upon the anatomical location of the administration site, including differences between the abdomen and thigh).
Regarding claim 13, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the article of claim 12, but Pesach in view of Bøggild-Damkvist further in view of Regittnig 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:
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; 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.
In analogous art, Rios teaches
determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range (Paragraphs [0060]-[0061]);
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 (Paragraphs [0060]-[0061]);
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-implemented method of Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Rios to incorporate determining, by the controller, a deviation between the one or more characteristics and the plurality of baseline characteristics is outside an acceptable range; 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 in order to provide a proper injection location based on landmark information of a user (Paragraph [0059]).
Regarding claim 15, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the article of claim 13, 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 receive a user input via an interface of a local wireless device, the user input providing feedback regarding the location of the drug delivery device on the user.
Bøggild-Damkvist teaches a local wireless device (300).
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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Bøggild-Damkvist to incorporate a local wireless device in order to provide a readily available portable device for receiving, processing, storing, and communicating the positional information generated by the position-determination device.
Rio teaches determining the location and position of an injection system relative to the patient’s body and compares the determined location with predefined landmarks and injections zones and provides corresponding indications, warnings, or instructions depending on the detected location (Paragraphs [0060]-[0061]).
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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Rios to incorporate providing location-related feedback in order to permit the system to compare an automatically determined location with a location identified or confirmed by the user. The combination of Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Rios would teach 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 because Pesach discloses the user entering the insulin infusion site location through a user interface and Bøggild-Damkvist teaches the local wireless device and would further teach the user input providing feedback regarding the location of the drug delivery device on the user because Rios teaches processor-generated feedback to the caregiver and Regittnig teaches that insulin absorption strongly depends upon the anatomical location of the administration site, including differences between the abdomen and thigh.
Claims 9, 19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Sarrafzadeh et al. (US 20140032165 A1).
Regarding claim 9, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the computer-implemented method of claim 8, but are silent wherein determining the location of the drug delivery device comprises classifying acceleration data received by the sensor with machine learning classifiers.
In analogous art, Sarrafzadeh teaches determining a location (Paragraphs [0023]-[0024]) comprises classifying acceleration data received by the sensor with machine learning classifiers (Paragraphs [0023]-[0024] and [0027]-[0028]).
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 position-determination system of Bøggild-Damkvist to incorporate the teachings of Sarrafzadeh to incorporate classifying acceleration data using a machine-learning classifier because it would be applying Sarrafzadeh’s known acceleration-data classification technique to acceleration data generated by Bøggild-Damkvist’s position-determination sensor to have a predictable application of a known technique to a known device for the same purpose - determining the location of the sensor/device on a user. The combination Bøggild-Damkvist in view of Sarrafzadeh would teach wherein determining the location of the drug delivery device comprises classifying acceleration data received by the sensor with machine learning classifiers because Bøggild-Damkvist teaches determining the location of a drug delivery device using an accelerometer/gyroscope and Sarrafzadeh teaches using acceleration data and supervised ML/SVM classification to determine device location.
Regarding claim 19, Pesach in view of Bøggild-Damkvist further in view of Regittnig 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, Sarrafzadeh teaches determining a location (Paragraphs [0023]-[0024]) comprises classifying acceleration data received by the sensor with machine learning classifiers (Paragraphs [0023]-[0024] and [0027]-[0028]).
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 position-determination system of Bøggild-Damkvist to incorporate the teachings of Sarrafzadeh to incorporate classifying acceleration data using a machine-learning classifier because it would be applying Sarrafzadeh’s known acceleration-data classification technique to acceleration data generated by Bøggild-Damkvist’s position-determination sensor to have a predictable application of a known technique to a known device for the same purpose - determining the location of the sensor/device on a user. The combination Bøggild-Damkvist in view of Sarrafzadeh would teach wherein determining the location of the drug delivery device comprises classifying acceleration data received by the sensor with machine learning classifiers because Bøggild-Damkvist teaches determining the location of a drug delivery device using an accelerometer/gyroscope and Sarrafzadeh teaches using acceleration data and supervised ML/SVM classification to determine device location.
Regarding claim 28, Pesach in view of Bøggild-Damkvist further in view of Regittnig 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, Sarrafzadeh teaches determining a location (Paragraphs [0023]-[0024]) comprises classifying acceleration data received by the sensor with machine learning classifiers (Paragraphs [0023]-[0024] and [0027]-[0028]).
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 position-determination system of Bøggild-Damkvist to incorporate the teachings of Sarrafzadeh to incorporate classifying acceleration data using a machine-learning classifier because it would be applying Sarrafzadeh’s known acceleration-data classification technique to acceleration data generated by Bøggild-Damkvist’s position-determination sensor to have a predictable application of a known technique to a known device for the same purpose - determining the location of the sensor/device on a user. The combination Bøggild-Damkvist in view of Sarrafzadeh would teach wherein determining the location of the drug delivery device comprises classifying acceleration data received by the sensor with machine learning classifiers because Bøggild-Damkvist teaches determining the location of a drug delivery device using an accelerometer/gyroscope and Sarrafzadeh teaches using acceleration data and supervised ML/SVM classification to determine device location.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Sarrafzadeh et al. (US 20140032165 A1) further in view of Belliveau et al. (US 20180182491 A1).
Regarding claim 10, Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Sarrafzadeh disclose the computer-implemented method of claim 9, but are 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Sarrafzadeh 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]).
Regarding claim 11, Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Sarrafzadeh further in view of Belliveau disclose the computer-implemented method of claim 10, but Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Sarrafzadeh 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Sarrafzadeh 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]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Rios et al. (US 20170136185 A1) further in view of DiMatteo et al. (US 20210401453 A1).
Regarding claim 14, Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Rios disclose the article of claim 13, 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:
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
detect, 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
determine, 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 non-transitory computer-readable storage medium of Pesach in view of Bøggild-Damkvist further in view of Regittnig further in view of Rios 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]).
Claims 20 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 20110184342 A1) in view of Bøggild-Damkvist et al. (US 20180289901 A1) further in view of Regittnig et al. (US 20140221965 A1) further in view of Belliveau et al. (US 20180182491 A1).
Regarding claim 20, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the article of claim 12, 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:
cause the sensor to enter a low-power state after determining the location of the drug delivery device; 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig 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]).
Regarding claim 29, Pesach in view of Bøggild-Damkvist further in view of Regittnig disclose the wearable drug delivery system of claim 21, but are 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 Pesach in view of Bøggild-Damkvist further in view of Regittnig to incorporate the teachings of Belliveau to incorporate entering a low-power state order to save battery power in various steps of a medical device (Paragraph [0378]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
