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 .
Applicant’s arguments filed in the reply on August 13, 2026 were received and fully considered. Claim 18 was amended. Claim 27 was cancelled. Claim 30 was added. Withdrawn claims 1 and 29 were amended. Please see below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/13/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 18-22, 24-26, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fougere et al (US 2016/0317088) (“Fougere”) in view of Poeze et al (US 2011/0087083) (“Poeze”) and further in view of Lucisano et al (US 2017/0181674) (“Lucisano”).
Regarding Claim 18, while Fougere teaches a method (Abstract, Figs. 1 and 6, [0043]-[0044], [0086], [0091], [0093]-[0094]) comprising:
Before a user-mountable device that measures glucose is partially inserted into a user’s body ([0093] “The processor 286 is configured to, concurrently with receiving the measurements, present respective sensor-position feedback for each of the plurality of measurements via the user interface device 640. In this way, a user can move the sensor to different locations on the body 100 and receive feedback before adhering the sensor 200 to the body 100. The feedback can be provided via the indicator 240 on the sensor 200 instead of or in addition to being provided via the user interface device 640. Feedback on the sensor 200 permits the sensor 200 to operate in a manner similar (from the user's perspective) to a metal detector or stud finder. The user can sweep the sensor 200 across the body 100 until, e.g., the sensor bars on the segmented display 250, or the green LED 243, or a tone on the speaker 241, all FIG. 2, indicates that the sensor 200 is positioned correctly. The sensor 200 can then be adhered to the body 100 at that position, e.g., by peeling a non-stick backer (not shown) off the adhesive layer 270, FIG. 2B, and pressing the sensor 200 and the exposed adhesive layer 270 against the body 100.”, [0043]-[0044], [0086] where the monitoring system may be applied as part of an invasive sensor and thus is at least partially inserted into a user’s body, the sensor being a user-mountable electronic device [0089], [0091]);
receiving, from at least one sensor of the user-mountable device, sensor output in real-time or substantially real-time that indicates orientation or motion of a user-mountable electronic device (Figs. 4-6, [0091] a processor of the system uses received sensor measurements to identify sensor position over the body and further identifying whether placement acceptance criterion are met for the placement site, using the steps of Figs. 4-5, [0086] where the requirements of an invasive glucose monitor are considered, [0093]-[0094] where the sensor output may be in real-time to facilitate real-time placement feedback to the user, [0049]-[0050], [0058]-[0059], [0098]-[0099] placement feedback for sensor 200 includes motion data from motion sensor 290 to identify whether motion of a user-mountable device aligns with a target location. [0056]-[0072] Fig. 4 teaches sensor placement feedback development for a user, [0073]-[0088] Fig. 5 teaches performing the sensor placement feedback);
identifying, based on the received sensor output, a body part on which a user intends to deploy the user-mountable electronic device ([0049], [0099] accelerometer data used in conjunction with motion models to identify a body part on which a user intends to deploy the user-mountable electronic device, such as identifying that the sensor is placed on a leg of a user); and
comparing the received sensor output to historical sensor output collected from previously deploying the user-mountable electronic device to determine a preferred placement of the user mountable-electronic device relative to the identified body part specific for the user ([0093] comparing the received sensor output to target data to determine whether a preferred position of the user-mountable electronic device on the body is met and further, whether it is the preferred position relative to the identified body part, as highlighted by the comparison of the method to a stud finder or metal detector [0098], [0057]-[0059] where the comparison may be done in view of historical sensor output collected from previously deploying the user-mountable device in the form of generated physiological models and acceptance criterion developed for a particular user);
displaying deployment guidance on an output interface, associated with mounting the user-mountable electronic device on the identified body part ([0093] concurrent sensor-position feedback provided on a user-interface device);
updating the deployment guidance in real-time or substantially real-time in response to the received sensor output during deployment of the user-mountable electronic device ([0093] “The processor 286 is configured to, concurrently with receiving the measurements, present respective sensor-position feedback for each of the plurality of measurements via the user interface device 640. In this way, a user can move the sensor to different locations on the body 100 and receive feedback before adhering the sensor 200 to the body 100.”); and
mounting the user-mountable electronic device on the identified body part of the user in the preferred placement in response to the updated deployment guidance ([0093] “The sensor 200 can then be adhered to the body 100 at that position, e.g., by peeling a non-stick backer (not shown) off the adhesive layer 270, FIG. 2B, and pressing the sensor 200 and the exposed adhesive layer 270 against the body 100. In various examples, the non-stick backer has cutouts, recesses, or other features to permit the sensor contacts 230 to contact the skin on the body 100 even before the non-stick hacker is peeled off.” Where the sensor has previously outlined as potentially an invasive glucose sensor).
Fougere fails to teach
comparing the received sensor output to historical sensor output collected from previously deploying the user-mountable electronic device to determine a preferred orientation of the user mountable-electronic device relative to the identified body part specific for the user;
displaying deployment guidance on an output interface, associated with orienting and mounting the user-mountable electronic device on the identified body part in the preferred orientation.
mounting the user-mountable electronic device on the identified body part of the user in the preferred orientation in response to the updated deployment guidance
However Poeze teaches glucose monitoring system that further includes accelerometers (Fig. 1, Abstract) where proper placement of the glucose monitoring system includes orientation of the system and the tracking of the orientation of the system can be done by accelerometers ([0059], [0068]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further utilize the accelerometers in Fougere to track orientation as taught in Poeze as way to benefit from optimal signal quality for the glucose monitor. And while, Poeze is teaching a non-invasive glucose monitoring, one of ordinary skill in the art would recognize that insertion-based glucose monitors also benefit from optimized orientation (Lucisano: Abstract).
Regarding Claim 19, Fougere, Poeze, and Lucisano teach the method of claim 18, and Fougere teaches wherein:
the output interface comprises a display element of a user device (Fig. 6, [0092] the sensor 200, the processor 286, and the user interface device 640 may all be incorporated together into a user device, with the user interface device 640 being the display element); and
the method causes the display element to display instructions regarding where to position the user-mountable electronic device on the identified body part prior to deployment (Fig. 5, the sensor placement feedback begins at step 505, where a recommended sensor site is displayed), and the orientation feedback of Poeze and Lucisano would motivate the display instructions to also include “how” to position the user-mountable electronic device.
Regarding Claim 20, Fougere, Poeze, and Lucisano teach the method of claim 18, and Fougere teaches wherein:
the output interface comprises a display element of a user device (Fig. 6, [0092] the sensor 200, the processor 286, and the user interface device 640 may all be incorporated together into a user device, with the user interface device 640 being the display element); and
the method causes the display element to display at least one image, at least one video clip, or animated content that shows how to position the user-mountable electronic device on the identified body part prior to deployment (Fig. 5, the sensor placement feedback begins at step 505, where a recommended sensor site is displayed, [0050] displays at least one image that shows to position the user-mountable electronic device), and the orientation feedback of Poeze and Lucisano would motivate the display instructions to also include “how” to position the user-mountable electronic device.
Regarding Claim 21, Fougere, Poeze, and Lucisano teach the method of claim 18, and Fougere further teaches the method further comprising: obtaining an initialization signal, output, or message indicating that the user intends to deploy the user-mountable electronic device ([0072] an interrupt signal is supplied to wake up sensor 200 to begin normal operation), wherein the receiving step, the identifying step, the comparing step, and the causing step are triggered by the obtained initialization signal, the output, or the message ([0073] where the sensor placement feedback may comprise automatic performance of the steps, the automatic performance would logically follow being woken up from the a sleep state noted in [0072]).
Regarding Claim 22, Fougere, Poeze, and Lucisano teach the method of claim 18, and Fougere further teaches the method comprising managing stored data in a database ([0105]), where the data for different body part deployments is stored ([0049], [0059], [0075] different physiological models stored for specific sensor sites), and where preferred orientation will also be included in stored data in view of the combination of references (See Claim 18 Rejection, this renders the inclusion of preferred orientations within the configuration file as obvious).
Regarding Claim 24, Fougere, Poeze, and Lucisano teach the method of claim 18, and Fougere further teaches the method comprising: causing the output interface to identify a recommended body part for deployment of the user-mountable electronic device, based on historical outcomes data ([0079]-[0088] should the first intended site provide data below a certain quality, a second recommended body part utilizing ratings from historical outcomes).
Regarding Claim 25, Fougere, Poeze, and Lucisano teach the method of claim 24, and Fougere further teaches wherein the historical outcomes data includes outcomes data for the user ([0080] reliability on data, [0083] outcomes of comfort, [0086] outcome data of the user can include an acknowledgement of missing limbs or previous sensor sites that necessitate rotation).
Regarding Claim 26, Fougere, Poeze, and Lucisano teach the method of claim 24, and Fougere further teaches wherein the historical outcomes data includes outcomes data for at least one person other than the user ([0047] stored models updates with known changes that occur due to aging, changes recognized from outcomes of people other than the user).
Regarding Claim 28, Fougere, Poeze, and Lucisano teach the method of claim 18,
wherein: the deployment guidance is generated in response to historical sensor output collected from one or more previously deployed user-mountable electronic devices or assemblies; and
the output interface provides the deployment guidance during deployment of the user- mountable electronic device (See Claim 18 Rejection, Fig. 5, models for sensor placement feedback are generated in Fig. 4 and these historical sensor outputs are collected from one or more previous deployments to guide future deployments).
Regarding Claim 30, Fougere, Poeze, and Lucisano teach the method of claim 18, wherein each sensor of the at least one sensor of the user- mountable electronic device comprises at least one of an accelerometer, an inertial measurement unit (IMU), a gyroscope, a magnetometer, a gravimeter, or a global positioning system unit (See Claim 18 Rejection, [0049]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fougere in view of Poeze and further in view of Lucisano and further in view of Patel et al (US 2016/0249174) (“Patel”).
Regarding Claim 23, Fougere, Poeze, and Lucisano teach the method of claim 18, wherein:
the user-mountable electronic device comprises a medical device for the user (See Claim 18 Rejection);
the medical device is operated after deployment on a particular body part and in a specific orientation relative to the particular body part (See Claim 18 Rejection);
their combined efforts fail to teach the method further comprises:
collecting performance or outcome data for the medical device following deployment on the particular body part;
correlating the performance or outcome data with the particular body part and the specific orientation.
However Patel teaches a method (Abstract) comprising:
receiving, from at least one sensor device of a user-mountable electronic device, sensor output that indicates orientation or motion of the user-mountable electronic device (Figs. 4-5, [0080], [0084]-[0085] accelerometer / sensor device of a wearable device / user-mountable electronic device, method of use involves receiving accelerometer data after application of the user-mountable device);
identifying, based on the received sensor output, a body part on which a user intends to deploy the user-mountable electronic device (Figs. 4-5, [0091]-[0092] sensor output of acceleration used to identify location on body at steps 407 and 409, where the analysis is described in Fig. 5, [0093]-[0102] detail the different body parts the system may identify based on the analysis);
determining a preferred orientation of the user-mountable electronic device relative to the identified body part ([0190]-[0196] when measuring for ECG specifically, the system has reference orientations for outputting desired ECG data. The wearable device compares determined orientation with the reference orientations and identifies if there are more preferable orientations that more closely align that of the reference orientation); and
causing an output interface to provide deployment guidance that indicates the preferred orientation of the user-mountable electronic device ([0196] deployment guidance to achieve preferred orientation for ECG monitoring)
where the method further comprises the steps of:
collecting performance or outcome data for the medical device following deployment on the particular body part ([0133]-[0134] body part deployment data is collected, [0146] and may be reviewed by a user query, the user query acts a performance data for the medical device’s location determination function); and
updating the performance or outcome data with the particular body part ([0146] analysis can be updated based on user input), and Patel further teaches that a relationship between datasets can be performed by correlation ([0169]), Patel fails to teach the updating of performance data being a correlation or the correlation of performance or outcome data with specific orientations.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the updating performance monitoring of Patel applied to the glucose monitor positioning of Fougere, Poeze, and Lucisano to ensure suitable health data is being gathered. Further, it would be obvious that the performance data in Patel be updated by correlation as a teaching on how the updating of the decision tree is performed.
Response to Arguments
Applicant’s amendments and arguments filed 8/13/2026 with respect to the 35 USC 101 rejections have been fully considered, and are persuasive. The updated feedback loop guiding deployment of the user-mountable device has been integrated into a practical application by the addition of a mounting step. The mounting step is an example of transforming a particular article to a different state or thing, particularly, transforming the user-mountable device from an unattached state to a mounted state. The rejection is withdrawn.
Applicant’s amendments and arguments filed 8/13/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fougere, Poeze, and Lucisano.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights