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 March 30, 2026 were received and fully considered. Claims 18, 21, 23-24 were amended. Withdrawn claims 1, 4-7, 11, and 29 were amended. Please see below for more detail.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 18, the claim(s) recites “identifying, based on the received sensor output, a body part on which a user intends to deploy the user-mountable electronic device;
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;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“before a user-mountable device is partially inserted into a user’s body:
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;”
“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.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, sensor devices and user-mountable electronic devices are general fields of use and output interfaces are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of receiving orientation data of an user-mountable electronic device, predicting body part location, and providing guidance on preferred orientation for the predicting body part and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 19-28 also do not add significantly more to the exception as they merely provide details to the post-solution activity, add extrasolution data gathering steps, and add details to the extrasolution data gathering steps.
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 and 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard et al (US 2021/0298650) (“Blanchard”) in view of Rebec et al (US 2021/0228114) (“Rebec”) and further in view of Hyde et al (US 2017/0000369) (“Hyde”) and further in view of Rule et al (US 2003/0032872) (“Rule”).
Regarding Claim 18, while Blanchard teaches a method (Abstract, Fig. 14A-14B, [0044], [0110]-[0115])) comprising:
Before a user-mountable device that measures glucose is applied on a user’s body ([0110]-[0115] describes a method applied before an insulin administration device 102 is placed on a patient, [0044] an insulin administration device may alternatively be an insulin management device and specifically a user-mountable glucose monitor, both devices using rotating body site applications, [0053] glucose monitor being a continuous glucose monitor);
receiving, from at least one sensor, sensor output that indicates orientation or motion of a user-mountable electronic device ([0113]-[0115] real-time video and augmented reality are used with a sensor/camera of device 108 to indicate potential site placements and will recognize user-mountable electronic device / insulin management device 102 when placed above a particular site within the video frame);
identifying, based on the received sensor output, a body part on which a user intends to deploy the user-mountable electronic device ([0112]-[0115] a site is preselected and guidance is given on sites to avoid, but the identification described herein will also recognize when the electronic device is applied on a different body part than planned);
comparing the received sensor output to historical sensor output collected from previously deploying the user-mountable electronic device to determine safe application sites ([0043], [0121]);
displaying deployment guidance on an output interface, associated with mounting the user-mountable electronic device on the identified body part ([0110]-[0115] augmented reality feature is deployment guidance on an output interface used to guide mounting of the user-mountable electronic device on the identified body part, [0052] imaging guidance is also applied for insulin management device orientation),
Blanchard fails to teach the glucose sensor being partially inserted into a patient’s body,
receiving, from at least one sensor of the user-mountable device, sensor output that indicates orientation or motion of a user-mountable electronic device;
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.
However Rebec teaches a method (Abstract, [0082]) comprising:
Utilizing a user-mountable device that measures glucose that is partially inserted into a user’s body (Abstract, [0027], [0048] partially implanted glucose sensor, [0033] method of using this glucose sensor, [0143] system is user-mountable on a patient’s torso);
receiving, from at least one sensor of a user-mountable electronic device, sensor output that indicates orientation or motion of the user-mountable electronic device ([0031], [0033], [0082] accelerometer 160 is at least one sensor of a user-mountable electronic device, with accelerometer output indicating orientation or motion of the user-mountable electronic device);
comparing the received sensor output to historical sensor output collected from previously deploying the user-mountable electronic device to determine trends in patient data or trends in system performance ([0112], [0137]) and further determines data related to the accuracy of the user-mountable system that can be user specific ([0070], [0135], [0166]);
displaying deployment guidance on an output interface, associated with mounting the user-mountable electronic device on the identified body part ([0110]-[0115] augmented reality feature is deployment guidance on an output interface used to guide mounting of the user-mountable electronic device on the identified body part, [0052] imaging guidance is also applied for insulin management device orientation),
further comprising determining glucose data integrity issues of the user-mountable electronic device relative to a body part based on sensor output that indicates orientation or motion of the user-mountable electronic device ([0130]-[0133] data integrity may be compromised and context identified by accelerometer, [0172] data integrity issues that are specific to different body parts);
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply teachings of Rebec’s continuous glucose monitor to Blanchard continuous glucose monitor as both are continuous glucose monitoring systems considering a position in space in relation to the efficacy of their glucose monitor (Rebec: considering issues specific to a body part when using the glucose monitor, Blanchard: considering overuse of a body part by a glucose monitor). Correspondingly, it would have been obvious to apply the user-mountable continuous glucose monitor of Blanchard by partial insertion into a user’s body as taught by Rebec as teachings for ensuring consistency on 1measurement conditions across glucose monitoring trials of the invention. Furthermore, it would be obvious that a camera could be directly applied to the user-mountable device Blanchard as confirmed by Rebec. Finally, it would be obvious to consider user-specific context and accuracy when creating the display guidance of Rebec to ensure optimal performance of Blanchard’s glucose monitor.
Yet their combined efforts fail to explicitly teach
receiving, from at least one sensor of the user-mountable device, sensor output that indicates orientation or motion of a user-mountable electronic device; and
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; and
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.
However Hyde teaches a user-mountable physiological monitoring device (Abstract, Fig. 1) comprising receiving, from at least one sensor of the user-mountable device, sensor output that indicates orientation or motion of a user-mountable electronic device in relation to a body part ([0032]-[0034]) and teaches a best fit analysis of the user-mountable device will include orientation ([0076] best fit analysis includes orientation, [0077]-[0078] details of how a preferred position is found) and
Rule teaches a glucose monitoring method (Abstract) comprising
receiving, from at least one sensor of the user-mountable device, sensor output that indicates orientation or motion of a user-mountable electronic device ([0046] optical measurement system 170 for glucose monitoring has an sensor output through visual access of windows 164’, 166’ to indicate orientation of the user-mountable electronic device relative to the user’s skin); and
comparing the received sensor output to alignment markers to determine a preferred orientation of the user-mountable electronic device relative to the identified body part specific for the user ([0018], [0046] an initial identification of tissue area for alignment markers)
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 (Fig. 6, [0046] the visual access of the skin with the alignment markers acts as deployment guidance for orientation), and
where the alignment markers may be placed on multiple locations simultaneously and are based on previously yielded satisfactory results ([0052] the identification of a site for alignment markers based on satisfactory results necessitates that the satisfactory results are from historical data).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the camera within a separate computing device in Blanchard could be included in the user-mountable glucose monitoring device as taught by Rebec for relative positioning purposes in relation to a body part as taught by Hyde ([0033]-[0034]). Blanchard’s video analysis applied to the topography camera data of Hyde enables positioning of the user-mountable device in the same way. Finally, it would have been obvious to determine a preferred orientation for Blanchard, in view of the best fit teachings of Hyde, as this provides a reference with which to guide the orienting step already found in Blanchard. Further, it would be obvious to understand that the visual access provided by Blanchard, Hyde, and Rebec can also be utilized to facilitate the visual access-based alignment taught by Rule. The optimization of selected site in Blanchard synergizes with a teaching of historically-based success of a device orientation taught by Rule. Finally, it would be obvious that the “satisfactory results” of Rule can be based on data specific for the user as this Blanchard specifically notes that accuracy and user-specific data are considered for optimizing system performance ([0070], [0135], [0166]).
Regarding Claim 19, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, and Blanchard teaches wherein:
the output interface comprises a display element of a user device (See Claim 18 Rejection, [0045], [0111] display of device 108 depicted by application 110); and
the method causes the display element to display instructions regarding how to position the user-mountable electronic device on the identified body part prior to deployment ([0114]).
Regarding Claim 20, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, and Blanchard teaches wherein:
the output interface comprises a display element of a user device (See Claim 18 Rejection, [0045], [0111] display of device 108 depicted by application 110); 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 ([0114] augment realities’ video output considered real-time images)
Regarding Claim 21, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, the method further comprising: obtaining an initialization signal, output, or message indicating that the user intends to deploy the user-mountable electronic device (See Claim 18 Rejection, choosing site selection in application 110 is an output), 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 (See Claim 18 Rejection, the initiation of the augmented reality feature based on the site selection output begins the receiving step, the identifying step, the determining step, and the causing step).
Regarding Claim 22, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, and Blanchard further teaches the method comprising managing stored data in a database ([0048]), where the data for different body part deployments is stored ([0097]-[0099] specific configuration file), 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, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, and Blanchard 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 (See Claim 18 Rejection, output interface identifies recommended body part for deployment, the recommendation is based on recency of use of body, this is done based on historical outcomes of overuse).
Regarding Claim 25, Blanchard, Rebec, Hyde, and Rule teach the method of claim 24, and Blanchard further teaches wherein the historical outcomes data includes outcomes data for the user ([0119]-[0121] insulin resistance and efficacy specific to patient tracked and considered in the site rotation).
Regarding Claim 26, Blanchard, Rebec, Hyde, and Rule teach the method of claim 24, wherein the historical outcomes data includes outcomes data for at least one person other than the user ([0099] when initially ran, the application will use population-based premade files to perform the method).
Regarding Claim 27, Blanchard, Rebec, Hyde, and Rule teach the method of claim 18, wherein the output interface provides the deployment guidance in real-time or substantially real-time in response to the sensor output received from the at least one sensor device during deployment of the user-mountable electronic device (See Claim 18 Rejection).
Claim(s) 23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Rebec and further in view of Hyde and further in view of Rule and further in view of Patel et al (US 2016/0249174) (“Patel”).
Regarding Claim 23, while Blanchard, Rebec, Hyde, and Rule 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 Blanchard, Rebec, and Hyde 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.
Regarding Claim 28, while Blanchard, Rebec, Hyde, and Rule teach the method of claim 18,
wherein: the deployment guidance is generated in response to sensor output collected from the deployed user-mountable electronic device;
the output interface provides the deployment guidance during deployment of the user- mountable electronic device (See Claim 18 Rejection), their combined efforts fail to teach the deployment guidance is generated in response to historical sensor output collected from one or more previously deployed user-mountable electronic devices or assemblies.
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 location analysis of the sensor output can be produced in response to historical sensor output collected from one or more previously deployed user-mountable electronic devices or assemblies ([0104] decision tree analysis of acceleration for location can be done from a user or a population based on acceleration information of various locations of the wearable device).
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 deployment guidance of Blanchard, Rebec, and Hyde be based on user expertise and deviation from reference orientations as taught by Patel because historical sensor output collected from one or more previously deployed user-mountable electronic devices is a way to train the system to achieve verifiable results in view of past monitoring success.
Response to Arguments
Applicant’s amendments and arguments filed 3/30/2026 with respect to the 35 USC 101 rejection of Claim 18 with respect to the claiming of a human organism have been fully considered and are persuasive. The rejection is withdrawn.
Applicant’s amendments and arguments filed 3/30/2026 with respect to the 35 USC 101 rejections have been fully considered and are not persuasive.
Applicant argues on page 9-10 of the Remarks that the claimed invention is an improvement in the technical field based on the fact that the displayed deployment guidance is user-specific. Examiner respectfully disagrees. Examiner respectfully disagrees. Devices such as Rebec above, recognize the importance of proper positioning of a glucose monitoring device. Rebec solves their problem by correcting the data after monitoring from the initial position. It is not clear that a calibration step does not provide a comparable improvement in device performance. Further, a user-specific orientation is not singularly tied to sensor accuracy, user comfort, wireless connectivity, aesthetics, etc and cannot be inherently tied to all of these improvements. Further still, the mounting step should be more clearly specified as a positive action in the claim as even if the extrasolution data gathering steps motivate an improvement, a generic postsolution activity of displaying does not guarantee this improvement is materialized in application as a user may still ignore the display or simply misunderstand the communicated deployment guidance. Examiner suggests the addition of a mounting step, if supported by the Specification, to realize the stated improvements and Applicant should consider claim 27 where the deployment guidance updates with sensor output, which would support a final application of the user-mountable electronic device is at the desired position and orientation.
The rejection stands.
Applicant’s amendments and arguments filed 3/30/2026 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 Blanchard, Rebec, Hyde, and Rule.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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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.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights