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 .
Status of the Claims
The office action is in response to the claims and remarks filed on September 9, 2026 for the application filed July 14, 2025 which claims priority to a provisional application filed on August 30, 2019. Claims 2-21 are currently pending and have been examined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2, 5-6, 9-12, 15-17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8-9, 11, 15-16 and 18-20 of U.S. Patent No. 12,387,824. Although the claims at issue are not identical, they are not patentably distinct from because they are anticipated by claims 1, 5-6, 8-9, 11, 15-16 and 18-20 of U.S. Patent No. 12,387,824.
Claims 3-4, 7-8, 13-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. Claims 1, 11 and 20 of U.S. Patent No. 12,387,824 in view of Khassanov et al. (U.S. Pub. No. 2019/0327311).
Claims 3-4, 7-8, 13-14 and 18-19 merely define well-understood, routine and conventional steps for preventing unauthorized access to patient data and define known network types and automation which is taught by Khassanov in paragraphs [0075] and [0136] as detailed in the art rejection below, such that these limitations are construed as obvious variations of the claims of U.S. Patent No. 12,387,824.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over Khassanov et al. (U.S. Pub. No. 2019/0327311) in view of Muphy et al. (U.S. Pub. No. 2022/0165413).
Regarding claim 2, Khassanov discloses a system comprising: a wearable device including Paragraph [0136], the patient smartphone 2410 stores the following information 2420: the patient key pair 2421, the provider public key 2422, and patient data encrypted with the patient public key 2423. The patient smartphone is construed as a wearable device.):
output, in response to determining that the wearable device is within a range of a device having access to an electronic health record of the wearer, a medical history Paragraph [0136], On the patient smartphone, in act 1, the facility uses the patient private key stored on the patient smartphone to decrypt encrypted patient data 2423 to share with the provider. In some embodiments, this is the intersection of patient data to which the patient has authorized the provider and patient data requested by the provider.. In act 2, the facility uses the provider public key stored on the patient smartphone to reencrypt the patient data decrypted in act 1. In act 3, the facility sends this reencrypted patient data to the provider computer. In act 4, on the provider computer, the facility receives the reencrypted patient data from the patient smartphone. In act 5, the facility uses the provider private key stored on the provider computer to decrypt the received patient data. In act 6, the facility displays the decrypted patient data to the provider. After act 6, this process ends, or is repeated for additional patient data. Paragraph [0075] discusses that communication with the patient smartphone requires NFC and WIFI connection, construed as requiring a determination that the provider access device computer is within range of the patient smartphone. Also see paragraphs [0106], [0118], [0120] and [0133].).
Khassanov does not appear to explicitly disclose that the patient smartphone wearable device includes one or more sensors configured to gather first data; or that the patient smartphone wearable device is configured to determine, using data from the one or more sensors, a condition associated with the wearer; determine, using the data, first baseline values corresponding to the condition; and determine, based on the data and the first baseline values, second baseline values corresponding to the condition, such that the output medical history comprises the first baseline values and the second baseline values.
Murphy teaches that it was old and well known in the art of wearable devices at the time of the filing to provide a smartphone wearable device including one or more sensors configured to gather first data (Murphy, paragraph [0031], each component device (e.g., each of the body-mountable devices 110 a-d and/or the cell phone 120) of the system could have the same sensor(s) or different sensors. Paragraph [0033], Body-mountable devices 110 a-d, the cell phone 120, or other elements (e.g., a data logger, a controller, a communications bridge) of the system 110 could be in wired or wireless communication or otherwise communicatively coupled. Also see paragraphs [0027] and [0032].), the wearable deice configured to:
determine, using data from the one or more sensors, a condition associated with the wearer (Murphy, paragraph [0115], The method 800 includes detecting, using a first sensor during a first period of time, a first signal relating to motor activity of a person (810). Paragraph [0027], Sensors disposed in one or more body-mounted or otherwise configured devices can generate signals related to the health, disease state, or other properties of a person (e.g., of a wearer of a body-mounted device). By wearing or otherwise interacting with these devices (e.g., by placing a cell phone in a pocket) for a protracted period of time and/or while performing or otherwise engaging in a variety of different activities, the signals generated by such a system (e.g., of multiple body-mountable devices) could be used to determine such properties of the person's body or activities.);
determine, using the data, first baseline values corresponding to the condition (Murphy, paragraph [0085], A baseline activity profile could be determined based on the signal 400 a detected during a first period of time, e.g., during one or more of the illustrated long 410 or short 420 periods of time. For example, a baseline activity profile could be determined based on the signal 400 detected during the indicated 415 long period of time.); and
determine, based on the data and the first baseline values, second baseline values corresponding to the condition (Paragraph [0085], In some examples, the baseline activity profile could be updated when additional portions of the signal 400 are detected. For example, the baseline activity profile could be updated such that the baseline activity profile is determined based on a portion of the signal 400 detected during a specified duration of time prior to a present period of time (e.g., based on portions of the signal 400 detected during previous hour(s), day(s), or week(s). Also see paragraph [0111].) to detect properties of clinical relevance outside of the clinical environment (e.g., in the home, at a person's place of work) in order to reduce the cost of such information, to increase the amount of information generated and/or to increase a temporal resolution of such information (Murphy, paragraph [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art of wearable devices at the time of the filing to modify the patient smartphone wearable device of Khassanov to include one or more sensors configured to gather first data; and such that the patient smartphone wearable device is configured to determine, using data from the one or more sensors, a condition associated with the wearer; determine, using the data, first baseline values corresponding to the condition; and determine, based on the data and the first baseline values, second baseline values corresponding to the condition, as taught by Murphy, such that the output medical history comprises the first baseline values and the second baseline values, in order to detect properties of clinical relevance outside of the clinical environment (e.g., in the home, at a person's place of work) in order to reduce the cost of such information, to increase the amount of information generated and/or to increase a temporal resolution of such information.
Regarding claim 3, Khassanov further discloses wherein the wearable device is configured to prevent output of the medical history until the device is verified as authorized to access electronic health records (Paragraph [0075], Also during this phase, the access device uses the user credentials together with credentials from the service provider 630 and credentials of the access device to decrypt, read, and write the user's encrypted data. Also see paragraphs [0106], [0118] and [0133].).
Regarding claim 4, Khassanov further discloses wherein determining the device is authorized to access electronic health records comprises confirming that the device is operated by a clinician (Paragraph [0075], Also during this phase, the access device uses the user credentials together with credentials from the service provider 630 and credentials of the access device to decrypt, read, and write the user's encrypted data. Also see paragraphs [0106], [0118] and [0133].).
Regarding claim 5, Khassanov does not appear to explicitly disclose, but Murphy teaches that it was old and well known in the art of wearable devices at the time of the filing wherein the condition comprises at least one of heart rate, respiratory rate, blood pressure, blood glucose, sleep patterns, or movement patterns (Paragraph [0032], The sensors of the system (e.g., of the body-mountable devices 110 a-d and/or cell phone 120) could include accelerometers, gyroscopes, pressure sensors, strain sensors, magnetometers, global positioning system (GPS) receivers, photoplethysmographic sensors, laser speckle flowmeters, tonometers, blood pressure cuffs, electrocardiogram (ECG) electrodes, electromyogram (EMG) electrodes, galvanic skin resistance electrodes, thermometers, galvanic skin potential electrodes, ambient light sensors, cameras, touch screens and/or touch sensors of touch screen, user interface elements (e.g., buttons), microphones, or some other sensors or other elements. The sensors of the body-mountable devices 110 a-d could be configured to generate signals related to motion (e.g., acceleration, velocity, rotation) or location (e.g., absolute location, location relative to another body segment, orientation relative to gravity) of a body segment, the temperature of a body segment, hemodynamic properties of blood and/or vasculature of the body segment (e.g., a blood flow rate, a pulse rate, a pulse timing, a pulse transit time, a blood oxygenation percent), an image of the wearer 105 and/or portions of the wearer's 105 body, an angle of a joint, a force exerted on the body segment (e.g., from an object, from the ground), an ambient light or temperature in the environment of the body segment, or some other properties of a body segment and/or its environment. Paragraph [0033], Body-mountable devices 110 a-d, the cell phone 120, or other elements (e.g., a data logger, a controller, a communications bridge) of the system 110 could be in wired or wireless communication or otherwise communicatively coupled. Paragraph [0042], The patch device 110 d could additionally or alternatively include a penetrating sensor configured to detect an amount of glucose or other analytes in the wearer's 105 body (e.g., in the wearer's 105 blood) when the penetrating sensor is inserted into the surface of the wearer's 105 skin. Paragraph [0064], A variety of signals related to motor activity of a person may be detected. Such signals may be related to motion of parts of the person's body (e.g., acceleration, rotation, location of parts of the person's body), physiological properties of the person's body (e.g., heart rate, breathing rate, oxygen saturation), sounds generated by the person (e.g., during speech), forces exerted by the person (e.g., to push an object, to type on a keyboard, to interact with a touch screen), or some other properties related to motor activities of the person. Such signals may also be used to determine a health state, a property of a disease state or process (e.g., of a movement disorder), or to determine some other information about the person. Paragraph [0035], Such a baseline activity profile could describe properties of discrete events (e.g., sensor data or patterns of sensor outputs recorded during such events) or other motor activity of the wearer 105. Paragraph [0116], The controller determining the baseline activity profile could include determining a sleep activity, a rest activity, an exercise activity, a locomotion activity, a specified diagnostic activity, a cooking activity, or some other activity.) to detect properties of clinical relevance outside of the clinical environment (e.g., in the home, at a person's place of work) in order to reduce the cost of such information, to increase the amount of information generated and/or to increase a temporal resolution of such information (Murphy, paragraph [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art of wearable devices at the time of the filing to modify the patient smartphone wearable device of Khassanov such that the condition comprises at least one of heart rate, respiratory rate, blood pressure, blood glucose, sleep patterns, or movement patterns, as taught by Murphy, in order to detect properties of clinical relevance outside of the clinical environment (e.g., in the home, at a person's place of work) in order to reduce the cost of such information, to increase the amount of information generated and/or to increase a temporal resolution of such information.
Regarding claim 6, Khassanov further discloses wherein the wearable device is configured to determine that the wearable device is within the range by detecting a network associated with a healthcare establishment (Paragraph [0075] In a second phase, the data access device turns on WiFi communications, and the smartphone uses the connection properties sent by the access device in the first phase in order to establish a WiFi connection with the access device. In some embodiments, before the smartphone provides the user's public key, or before the smartphone establishes the WiFi link, it explicitly seeks and obtains authorization from the user to connect with the access device. In a third phase, the access device uses the established WiFi connection in order to access the user's credentials and encrypted data on the smartphone.).
Regarding claim 7, Khassanov further discloses wherein the network comprises a local area network of the healthcare establishment (Paragraph [0075], In a second phase, the data access device turns on WiFi communications, and the smartphone uses the connection properties sent by the access device in the first phase in order to establish a WiFi connection with the access device. In some embodiments, before the smartphone provides the user's public key, or before the smartphone establishes the WiFi link, it explicitly seeks and obtains authorization from the user to connect with the access device. In a third phase, the access device uses the established WiFi connection in order to access the user's credentials and encrypted data on the smartphone. Also see paragraph [0044].).
Regarding claim 8, Khassanov further discloses wherein the wearable device is configured to output the medical history automatically in response to determining that the wearable device is within the range (Paragraph [0075], During a first phase, the reader 610 disables WiFi communications and enables NFC communications. In this phase, the data access device 620 sends the cell phone a public key of the reader; the cell phone sends the data access device a public key of the user; and the data access device sends connection properties to the smartphone. In a second phase, the data access device turns on WiFi communications, and the smartphone uses the connection properties sent by the access device in the first phase in order to establish a WiFi connection with the access device. In a third phase, the access device uses the established WiFi connection in order to access the user's credentials and encrypted data on the smartphone. Also see paragraph [0136]. These steps are construed as being performed automatically when the initial NFC connection can be established (i.e. in response to determining the patients smartphone is within range.).)
Regarding claim 9, Khassanov further discloses wherein the device comprises a clinician device located within a healthcare establishment (Paragraph [0044], Typically, each of a number of different service providers—such as physicians, medical testing or imaging centers, etc.—are outfitted with one or more data access devices, or “readers.”).
Regarding claim 10, Khassanov further discloses wherein the wearable device is configured to receive updated electronic health record data from the clinician device (Paragraph [0141], FIG. 28 is a flow diagram showing a process performed by the facility in some embodiments to store new information provided by the provider in the patient health record. In act 3, the facility sends the encrypted patient data created in act 1 and signed in act 2 to the patient smartphone. In act 6, the facility stores the encrypted patient data in the patient medical record, which may be on the patient smartphone.).
Regarding claim 11, Khassanov further discloses wherein the wearable device is configured to store the updated electronic health record data and output the updated electronic health record data to a subsequent device when the wearable device is within range of the subsequent device (Paragraph [0141], FIG. 28 is a flow diagram showing a process performed by the facility in some embodiments to store new information provided by the provider in the patient health record. In act 3, the facility sends the encrypted patient data created in act 1 and signed in act 2 to the patient smartphone. In act 6, the facility stores the encrypted patient data in the patient medical record, which may be on the patient smartphone. Paragraph [0085], The data storage device is connected to the same or a different data access device 810′. At this stage, the data access device detects one or more “Session ID's” each identifying a data record that was not yet complete at the last time the data storage device was communicating with any data access device. Each such data record may now be complete, or may still be incomplete. The data access device then pulls the corresponding “Server IP address” (or other identification) of the server, service, or device the respective record was originally stored on, establishes an appropriate connection, and downloads the previously stored encrypted data record. Paragraph [0087], FIG. 9 is similar to FIG. 8 discussed above, and shows the record completion process where a user's smartphone 920 is used to store the user's credentials and encrypted data. Also see paragraphs [0075] and [0120].).
Regarding claims 12-21: all limitations as recited have been analyzed and rejected with respect to claims 2-11. Claims 12-16 pertain to a method, corresponding to the system of claims 2-11. Claims 17-21 pertain to a wearable device, corresponding to the system of claims 2-11. Claims 12-21 do not teach or define any new limitations beyond claims 2-11 as, Khassanov as modified by Murphy senses conditions using sensors of a wearable device (smartphone of Khassanov having the sensors and determining of Murphy), stores data/values over a period of time (stored Patient data of Khassanov including the baseline data of Murphy) and outputs the stored data based on to proximity of a device when it is determined that the device is within range of the device (patient data sharing protocols of Khassanov); therefore claims 12-21 are rejected under the same rationale.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed September 9, 2026, with respect to claims 3-4, 13-14 and 18-19 being rejected under 35 U.S.C. §112(a) have been fully considered and are persuasive. The rejection of claims 3-4, 13-14 and 18-19 under 35 U.S.C. §112(a) has been withdrawn.
Applicant's arguments filed September 9, 2026 regarding clams 2-21 being rejected under 35 U.S.C. §103 have been fully considered but they are not persuasive.
Applicant argues with respect to claim 2 that Murphy does not disclose to “determine, based on the data and the first baseline values, second baseline values corresponding to the condition”. Specifically, it is argued that Murphy only describes a single baseline activity profile which is updated from a later time window and not from the earlier profile and that this is not the same as using a first baseline activity profile as input to the determination of a later second baseline activity profile. Applicant further argues that because the baseline activity profile is updated, Murphy does not teach the coexistence of the first baseline vales and second baseline values and therefore cannot teach outputting “a medical history comprising the first baseline values and the second baseline values”.
In response, the claims do not recite using a first baseline values as input to the determination of second baseline values. The specification also appears to be silent with regards to the this interpretation of “based on”. Updating a baseline activity profile when additional portions of the signal are detected is construed as determining a second (e.g. updated) baseline activity profile “based on” the original baseline activity profile, as the act of updating is an action performed on the baseline activity profile. Furthermore, While Applicant submits that the updated profile replaces the older profile and thus the old and updated profile cannot be output, the baseline profile and updated profile are construed as separate profiles, as baseline profiles may be determined based on a portion of the signal detected during a specified duration of time prior to a present period of time. This interpretation is supported by paragraph [0111] of Murphy which states “generating individual baselines (e.g., baseline activity profiles) for the person based on data collected over a certain number of measurement periods’.
Applicant argues with respect to claim 2 that Khassanov does not disclose to “output, in response to determining that the wearable device is within a range of a device having access to an electronic health record of the wearer”, the recited medical history. It is argued that the short range communication link of Khassanov is not a determination that the wearable device is within range of a device and the rejection reverses the actors (e.g. the wearable device and the device) in the claim. Specifically, it is argued that paragraph [0075] of Khassanov describes a protocol driven by the reader device and does not describe the smartphone determining it is within range of another device and does not describe any determination that the other device has access to an electronic health record of the wearer.
In response, paragraph [0136] of Khassanov shows the patient smartphone sending encrypted patient data to the provider computer after public keys have been exchanged and a connection has been established . Paragraph [0075] is cited to show that exchanging keys and establishing a connection may be done using NFC and Wifi. Both NFC and Wifi connections are limited to a certain range and that the smartphone outputting the medical history of the wearer in response to the smartphone determining that an NFC and/or Wifi connection has been established is inherently a determination that the smartphone is within a range of a device. This interpretation is consistent with Applicant’s own claim 5. Furthermore, cited paragraph [0120] discussed another method to establish a communication session between the smartphone and a provider computer by the provider scanning a QR displayed on the smartphone or confirming the physical presence of the patient's smartphone which provides access to protected data and the physical proximity of such device to the sharee device (i.e. physician's computer) used for accessing such data. The resulting communication session is an inherent determination that the smartphone is within range of the provider computer. Any connection between the patient’s smartphone and another device necessitates that the other device has access to the electronic medical record of the patient. Also see paragraphs [0106], [0118] and [0133] of Khassanov.
Applicant argues with respect to claim 2 that the Office has not provided proper motivation to combine Khassanov with Murphy as the motivation provided does not provide a rationale to incorporate the two tier baseline of Murphy with the output of Khassanov.
In response, Murphy makes clear that the baseline data are properties of clinical relevance, therefore, the motivation to modify Khassanov with the sensors and baseline determinations of Murphy in order to in detect properties of clinical relevance outside of the clinical environment (e.g., in the home, at a person's place of work) in order to reduce the cost of such information, to increase the amount of information generated and/or to increase a temporal resolution of such information, is determined to be an articulated reasoning with rational underpinning to support the legal conclusion of obviousnes. Also see paragraph [0112] of Murphy
Applicant argues with respect to claims 3 and 4 that paragraph [0075] of Khassanov does not address the claim limitations.
In response, application is directed to cited paragraphs [0118] and [0133]. Also see paragraph [0106].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEVIN C HEIN/Examiner, Art Unit 3686
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